- Introduction to Obstetrics
- Normal Pregnancy
- Fetal Evaluation
- Early Pregnancy Complications
- Pregnancy with Pre-existing Morbidities
- Maternal Complications Arising in Pregnancy
- Fetal Complications
- Late Pregnancy Complications
- Labor
- Postpartum Issues: Maternal and Neonatal
- Social Obstetrics
1.1 A BRIEF HISTORY OF WOMEN'S HEALTH
Parikshit Tank
HISTORY IS HERSTORY TOO
The study of history is a window into the minds of the thinkers and influences that have brought science to the current state. It is not merely a collection of facts or a source of trivia, but an evolution of thought and attitude that determines history in any field. History is the witness that testifies to the passing of time; it illuminates reality, vitalizes memory, provides guidance in daily life and brings us tidings of antiquity.1 The history of women's health is very broad. There are fragments of the history of evolution, humanity, medicine, and specific techniques. But it is also a history of the place of women, their achievements and the attitudes toward them with the passage of time.
TIMELINES
To set the context in terms of evolutionary history, Figure 1 is a broad timeline of the universe, which is believed to be 14 billion years old. Homo sapiens or modern man has existed for about 200,000 years which is a tiny fraction of the age of the universe. Modern history is then, just a blink of an eye in such a large timeframe. Table 1 indicates the division of the more recent timeline into historical ages. Though this construct is simplistic, it helps to describe and structure the discussion on historical evolution.
PREHISTORY (FIRST HUMANS: 200,000 YEARS AGO TILL BEFORE CHRIST ERA)
The earliest representations of the female form date back to about 20,000 years bce. This was in the form of cave drawings and stone figures. One of the oldest preserved statuettes is the Venus of Willendorf from the Middle Aurignacian period somewhere in Western Europe. The statuette probably represents a fertility goddess.2
There are scattered instances of cave drawings, figurines, statuettes and representations of the female form till about 2,000 bce when the Indus valley came into existence. As we explore the origins of recorded and credible medical history and science, a central theme which emerges is that much of medicine seems to have evolved in the Indus valley. There are some records that the uterus was identified as a separate 4organ with a study of its function as early as 900 years bce.
The Hindus (in this context, it means people of the Indus valley) recorded this in the Rigveda. The Garbha Upanishad describes the formation of the embryo, its growth in the uterus, the time of pregnancy at which it can be deemed viable and the process of labor. These observations are in line with the knowledge we have today. It also contains spiritual and philosophical discussions which are not possible to substantiate even with the current state of knowledge as these deal with fundamental questions such as the origins of life and the place of self in the cosmos.3 Much of this knowledge remained mysterious and inaccessible to the rest of the world for centuries to follow.
ANCIENT HISTORY (AFTER CHRIST ERA TILL 5TH CENTURY AD)
In this period, the study of human beings, medicine, and philosophy was largely in the Greek, Roman, and Middle Eastern empires. Hippocrates, Heraclides and a number of Greek and Roman physicians wrote about birth and diseases of women in general. However, the authoritative treatise on the subject of women's disease in those times came from Soranus. He was a Greek scholar born in the city of Ephesus. The city was a seat of learning and housed the great library of Celsus. In the first century ad, Soranus published on the diseases in women: De Morbis Mulierum. He gave an accurate description of the human uterus, correctly describing the size, position, layers, and internal structure. It was clear from his descriptions that he had access to studying human cadavers. Soranus is also credited with performing the first recorded hysterectomy for prolapse, which was more of an amputation than a surgery.4 Another figure of note is Agnocide. There is debate about the veracity of her story and her origins. She was an exception to the gender rule and is perhaps the first woman midwife of record. She had to dress herself up as a man to render her services and was so popular among women that she was accused of seducing them. In court, she was exonerated when she revealed her gender.5 A better documented history belongs to the Roman midwife Scribonia Attica whose tomb in Ostia, near Rome is maintained even today. It has bas-relief of her at work in a special birthing chair. Incidentally, she married an equally illustrious surgeon of the times, Marcus Ulpius.6
DARK AGES (5TH–15TH CENTURY AD)
For religious and political reasons, cadaver study was banned in much of the Western world after the second century. Cadavers were difficult to obtain, their study was strictly regulated and performing dissection was punishable by law. Autopsies were meant only for the clergy and royalty. This inhibition of exploration and knowledge led to the Dark Ages. Myths abounded. One of the enduring myths which originated at this time was that the uterus was responsible for hysteria. The uterus was depicted as a separate animal, a parasite in the woman's body. The anatomy of the female body was represented wrongly with many descriptions being far removed from reality in Arabic, European, and Persian texts. Anatomical descriptions ranged from the simplistic to the ridiculous. One of the most popular ones was that the uterus was made up of two compartments, separate for male and female fetuses. A seven compartment model was also proposed. The fetus would occupy a different compartment based on the day of the week it was conceived. Science stagnated and knowledge from the ages before was drowned in a pool of ignorance and myth.7
RENAISSANCE AND WOMEN'S HEALTH (1500–1700s)
In the West, in the 1600s, the change in the political climate saw a change in the mindset of the leading thinkers—scientists, artists, and scholars. Anatomical dissection and study of the 5human body resumed in the 16th century. A notable figure in this context is Andreas Vesalius from Belgium. Much of the knowledge and detailed description from this time comes from his treatise, De Humani Corporis Fabrica. It had the first good illustrations and descriptions of the uterus in modern times.8
In women's health, perhaps the most significant change was the scientific understanding of the process of vaginal delivery. The accurate description of the cardinal movements of the fetal head through the maternal pelvis was given by a Scottish obstetrician, William Smellie. But even more significant was the discovery of the obstetric forceps. Before the obstetric forceps came into being, obstructed labor was dealt with by destructive operations. The history of this instrument is one filled with myth and wonder. The Chamberlen family of French Huguenots from Normandy is credited with this invention in the 1570s, more specifically, Peter (the Elder) Chamberlen. He was appointed as the royal obstetrician to the English and French courts. The forceps was a secret instrument which only the members of the Chamberlen family used. It remained hidden for about 150 years after its invention. Much later, in 1813, Peter Chamberlen's tools were discovered in an attic of a house in Mortimer Hall in Oxford, United Kingdom. The forceps is an instrument that has undergone innumerable iterations and will forever be in a state of evolution. Notable Indian contributions to the field were from Sir Kedarnath Das (modification of the Simpson's forceps making it lighter and more friendly to the maternal pelvis) and Dr Aroo Mulgaonkar (modification of the Kielland's forceps). James Young Simpson made a significant contribution to the advancement of the forceps and also described the use of the first vacuum device—the suction tractor—to facilitate delivery.9
An important event in women's health in this period was the first recorded intentional cesarean birth where the mother and the child survived. There are anecdotal reports dated before this where babies have been delivered by cesarean performed by mothers themselves or accidentally by injuries from horns of livestock. But these are to be considered with due skepticism. In 1500, Jacob Nufer, a gelder in Switzerland recorded this event. His wife was in labor for days and despite help from a number of midwives, could not be delivered. He sought permission from the authorities and with his rudimentary knowledge of animal husbandry, performed a cesarean birth for his wife. The mother and child survived. The couple had five more children.10
EARLY MODERN HISTORY (1700–1850s)
The early modern history of women's health is marked by a number of innovations from “medicine men”. These were times of great advancements in chemistry and experimentations with newly discovered elements and compounds on the human body. There were also some attempts at characterization of herbal and vegetable products by their chemical composition.
In women's health, surgery made some progress. Before the 19th century, vaginal hysterectomies were largely palliative procedures for cervical cancer. The first planned, successful vaginal hysterectomy is credited to JCM (Conrad) Langenbeck in 1813. Around the same time, other surgeons such as Osiander, Dupuytren and Hatin had also performed vaginal hysterectomies but these were either accidental or emergencies (for severe hemorrhage in cervical cancer or uterine inversion) or resulted in the woman's death. Langenbeck operated on a 50-year-old woman with cervical cancer. There was alarming hemorrhage toward the end of the surgery. Working without an assistant, anesthesia, or a hemostatic forceps, Langenbeck heroically compressed the bleeding part with his left hand and managed to throw the last hemostatic suture with his right hand, holding the other end between his teeth. The woman survived—almost miraculously.11
Another advance in surgery on women was made in deliberately opening the abdomen to remove an ovarian cyst by Ephraim McDowell in Kentucky in 1809. The first abdominal hysterectomy was performed by Charles Clay in Manchester, England in 1843; unfortunately the diagnosis was wrong and the patient died in the immediate postoperative period. The following year, Charles Clay was almost the first to claim a surviving patient; however, she died postoperatively and it was not until 1853 that Ellis Burnham from Lowell, Massachusetts achieved the first successful abdominal hysterectomy although again the diagnosis was wrong. He was performing exploratory surgery for what he believed to be an enlarged ovarian tumor. During the procedure, the patient vomited, pushing an enlarged uterus through the abdominal incision. Burnham was unable to reduce it into the abdominal cavity, and had no alternative but to remove it. The woman survived the procedure.12
LATER MODERN HISTORY (1850s ONWARD)
Medical science as we know it today had its Big Bang moment in the early 1900s. There were rapid strides in every field of science. The cross applications into medicine significantly improved safety and technique in medical practice and surgery. The most significant strides are outlined in Table 2. These are general advances but had an important role to play in women's health, just as for everyone else.6
This period of history saw some events in medical history specific to women which form the basis of care even in modern times. These advances and discoveries have shaped women's health in the most significant of ways. Some of these are highlighted here.
Childbirth fever was recognized as a ruthless killer since 3,000 years. Various myths surrounded its causation including remorse, possession by spirits, seduction, and fretting. The institutionalization of obstetrics in the 18th century brought a keen focus on the problem.6
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Oliver Wendell Holmes, though not an obstetrician, was an astute clinician and hypothesized that childbirth fever was contagious and could possibly be prevented. It was Ignaz Philipp Semmelweis, a Hungarian physician working at the University of Pest who took a keen interest and studied this subject. He observed that units where care was provided by midwives had a tenfold lower rate of puerperal fever than where care was provided by medical students and doctors. This difference was that midwives did not conduct autopsies. He further studied the autopsy findings of women who died of puerperal fever and concluded that they arose due to “toxins”. To perform detoxification, he advocated washing hands, and later instruments and the entire ward with a chlorinated solution of lime. This nearly eliminated mortality from puerperal fever. However, his findings were treated with scorn and he was dismissed from his professional position. Ironically, he died of sepsis himself, in a mental asylum. It was only later that the value of his observations was realized and he was feted.13
Surgery became safer with the practice of anesthesia, antisepsis, blood transfusions, and antibiotics. Performing an operation was not looked upon as a death sentence anymore and it became a reasonable option for treating certain conditions. The rapid evolution of safe surgery had a major impact on the practice of cesarean birth. From the practice of leaving the uterine wound open, to exteriorizing or cauterizing it to finally, suturing it the cesarean operation was largely an upper segment procedure. It was the untiring advocacy and practice in the 1920s of John Munro Kerr in Britain and Joseph B DeLee in the United States that the operation became a lower segment procedure. Munro Kerr is said to have exclaimed “Hallelujah! The battle's o'er; the victory's won” when the Royal College accepted that the lower segment procedure was the superior one.14
Around the same time, Professor Henry Dale, a British pharmacologist described the uterotonic actions of oxytocin in 1906. Oxytocin was also the first ever polypeptide hormone to be sequenced and synthesized. This of course was much later in 1953 by the French chemist, Vincent du Vigneaud.15
A pioneer who was inspired by personal tragedy was Victor Bonney. His wife had large fibroids causing intractable symptoms which resulted in a hysterectomy. The couple was left childless. Working at the Chelsea Hospital for Women in London, Bonney refined the myomectomy and ovarian cystectomy in the 1920s. He is looked upon as a major influence in propagating the concept of organ preservation in gynecological surgery.16
As with conservative gynecological surgery, the hysterectomy operation was also progressing in technique. 7The mortality rates of the 1880s in the range of 75% were down to 2–3% by the 1920s. This was keeping in line with the general improvements in surgical outcomes. In the 1920s, two important advancements were the development of the total hysterectomy with the removal of the cervix by Richardson in United States of America and the use of the lower transverse abdominal incision by Johannes Pfannenstiel in Austria.17
The field of contraception saw some great improvements moving away from the myth-bound traditional techniques which were marred by risk and dubious efficacy. The intrauterine device is a classic example of a technique that has had a long evolution. From the legends of pebbles being inserted into the wombs of camels in the Middle East centuries ago, we know that the concept of a foreign body in the uterus providing contraception is not a new one. In modern history, the first intrauterine device that was published and invented in 1909 by Richard Richter in Germany. It was made of two strands of silkworm gut with a bronze filament thread to diagnose expulsion and retrieve it. Some early devices were the Grafenberg ring (Germany) and the Ota device (Japan). The devices evolved in term of design (rings, coils, loops, T-shaped frames) and content (nonmedicated, silver, copper and hormones) and have reached a point where low-dose hormones can be delivered directly into the uterine cavity.18
Perhaps the single most important change in women's health which empowered women to a greater extent than any other came with the evolution of hormones and the oral contraceptive pill. Oral contraception was practiced with herbs, roots, minerals, and oils. However, a reliable method did not exist. Edgar Allen and Edward Doisy published about the hormonal activity of the “ovarian hormone”; this was estrogen. Early work on the extraction of progesterone was being done in the 1930s by Russell Marker and Carl Djerassi which was important for the mass production of the hormone. It was the passion of Margaret Sanger, the capital of Katherine McCormick, the pharmacological genius of Gregory Pincus and the clinical responsibility of John Rock that saw the birth of the pill.19 It was introduced in the United States of America in 1955 under the guise of regularizing the menstrual period and ironically, to promote fertility. However, further trials in Latin America proved its efficacy as a contraceptive. The pill has undergone generations of changes and today, more than a 100 million women use it.
CONTEMPORARY HISTORY AND EMERGENCE OF SUBSPECIALTIES
Women's health, just like all other medical fields, has diversified vastly in contemporary history. This has come about through an amalgamation of various medical and nonmedical specialties especially genetics, molecular biology, radiology, and engineering in various contexts (mechanical, electrical, and lenses). Over and above all these are the overarching influence of an exponential rise in the computing power that is available for research and day-to-day clinical practice. These have changed the way medicine in general and women's health in particular is practiced.
The treatment of cervical cancer had been proposed, studied, and practiced with varying degrees of success and safety. The early 1900s saw the emergence of the “radical hysterectomy” under the surgical expertise of surgeons such as John Clark in the United States of America and the Austrian teacher-pupil team of Friedrich Schauta and Ernst Wertheim. The technique was refined to a great degree in the 1940s by Joe Vincent Meigs in the United States of America.17 These techniques along with radiotherapy had reduced mortality from cervical cancer to some extent. However, in terms of public health, the big breakthrough in women's cancer care came from early detection by a cervicovaginal smear. Since the 1960s, this is arguably the most successful preventive health program in any form of medicine. The success stories have been resounding and repeated across geographies. The credit goes to a Greek military doctor, George Papanicolaou, who migrated to the United States of America. His wife, Andromache (Mary) Mavroyeni, whom he met on the ferry crossing, was an equal contributor to the research.20 In the 1940s, they teamed up with Herbert Taut, a gynecological pathologist at the Cornell University and published on the early detection of uterine cancer by vaginal smear.21 The practice was adopted gradually and is a routine test in modern times.
The Second World War brought great tragedy but also saw advancement in technology. One such instance was the use of SONAR (sound navigation and ranging) for submarines. Later, the same technology was extrapolated to medical imaging. Ian Donald was the epitome of a modern day renaissance man for obstetrics. He was born in Cornwall, United Kingdom and after spending his childhood in South Africa, returned to practice in the United Kingdom in the 1930s. After his wartime assignment as a Royal Air Force pilot, he specialized in obstetrics and published the treatise on Practical Obstetric Problems, which has undergone a number of editions and is still in circulation. But his most significant work came through his curiosity about imaging. He worked with Tom Brown, an engineer at the Babcock and Wilcox factory at Renfrew and devised the first contact scanner. They published their work and laid emphasis on the instant feedback that the technique provided.22 Ultrasound has become a specialty in its own right and has made it possible to treat the fetus as a patient in today's world.
Just as the imaging, the field of endoscopy has evolved from a similar curiosity to understand the internal structure and function of human beings. The revolution of endoscopy had begun in the early 1800s, with the work of Philipp Bozzini. In 1869, Pantaleoni from Ireland looking into the uterine cavity of a postmenopausal woman with a modified cystoscope and candlelight. This was the first hysteroscopy and he even went on to operate on the uterine polyps by cauterizing them with silver nitrate. It was only in the 1970s that hysteroscopy 8progressed from being a novelty to a reasonable treatment option. Neuwirth and Amin reported the first series of hysteroscopic submucous fibroids excision in 1976. In 1987, Alan DeCherney at the University of California, Los Angeles (UCLA) described the use of a urological resectoscope to treat intractable uterine bleeding.23 Similarly, by the 1900s, various surgeons had described laparoscopy but it was Harry Reich, who first published about laparoscopically assisted vaginal hysterectomy in 1989 and Kurt Semm described the classic intrafascial serrated edged macro-morcellator (SEMM) hysterectomy in the early 1990s. This has paved the way for innumerable innovations and changed the approach to surgery in the pelvis. Today, we are looking at the frontiers in the form of robotic surgery.17
In 1978, one of the most revolutionary events occurred with the birth of Louise Brown. Ordinarily, the birth of a girl in a remote English town would not have been newsworthy, but she was on the front page of every newspaper in the world, for she was conceived outside a human body. Apart from her parents and nature, she was as much a creation of Patrick Steptoe and Robert Edwards. Patrick Steptoe was a naval surgeon and after the war, his career interest was in laparoscopic surgery. He published on the detection of ovulation in women by laparoscopy. This caught the attention of Robert Edwards, who was studying oocytes maturation in mammals. His work was facilitated by Molly Rose, who provided him with ovarian tissue resected from women with Stein–Leventhal syndrome (modern day polycystic ovarian syndrome). The partnership between Edwards and Steptoe began with a phone call and flourished at the Oldham and District General Hospital. The first attempts were futile and in fact, the first in vitro fertilization pregnancy was an ectopic. Working against the odds and with courageous and persistent patients, the field of assisted reproduction was born with success in the form of Louise Brown's birth. Since then, various technological advances such as intracytoplasmic sperm injection, culture systems and robust equipment, and drug protocols have changed the face of human reproduction forever.
A DISREPUTABLE HISTORY
Human attitude and behavior is a product of the times and what is deemed to be acceptable in those times and circumstances. There could be a lot said and criticisms leveled about each and every advance of science in terms of the documentation, consent, and safety standards when compared to current ones. However, these criticisms could be dismissed as hindsight. But there are certain events in medical history which are unacceptable by any set of standard scientific or human behavior.
James Marion Sims is a classic example of such a revised view of historical events.24 He was arguably the greatest American gynecological surgeon and was regarded as the “Father of Gynaecology” in the United States of America. His fame grew from the surgical technique for the repair of vesicovaginal fistulae. Even though he eventually perfected the technique and the principles are in use even today, it is the way in which he conducted the surgical experiments that has changed modern views about him. The criticisms that have been leveled against him are that he experimented on African slaves without their consent. The surgeries were repeated over and over again on the same individual. Among the first women who had the surgeries were Anarcha, Betsy, and Lucy. It is estimated that there were forty surgeries conducted on them before a successful result was achieved. More disturbingly, Sims would not use anesthesia for these women, even though ether anesthesia was established practice. This was a racist attitude as he would perform the same procedures under anesthesia for white women. The changed views on Sims have led to a fall from grace as was witnessed by the removal of several of his statues in American cities.25
Scientific knowledge has advanced in subhuman conditions at times. War, genocide and unethical acts have been involved in the advancement of scientific knowledge and knowledge about women's health care. Some examples are the knowledge about the timing of Anti-D administration from the work of Nazi physicians in the Second World War, the use of cervical cancer cells from Henrietta Lacks without her consent or even acknowledgment and so many others. As history evolves, there is bound to be revisionism and changes in our view of events of the past.
INDIAN CONTRIBUTION IN MODERN TIMES
Indian gynecologists have in the large part embraced modern practice and have contributed to scientific advances with some important works. One name that stands out is that of Professor VN Shirodkar. In the 1950s, second trimester abortions were a mysterious entity. He studied the cervix in the nonpregnant and pregnant states, understanding the changes in anatomy and physiology. He was particularly interested in the changing nature of the cervix in normal pregnancy from a fibrous one to a dynamic muscular organ. His answer to the problem of habitual second trimester abortion was a surgery which put India firmly on the map of operative obstetrics and gynaecology. In 1955, Shirodkar described the cervical cerclage operation. Over time, it has been modified by many surgeons, most notably by McDonald, but the original surgery is a masterpiece. Through his illustrious career, he developed various gynecological surgical techniques for tuboplasty, vaginoplasty, and sling surgery for conservative repair of prolapse.26
The problem—genital prolapse and its conservative repair—has been addressed by doyens of Indian gynaecology including VN Purandare, RP Soonawala, Brigadier SD Khanna, and Ajit Virkud. These surgeries have been innovative and scientific. They are being modified to suit the laparoscopic route.27
Professor VB Patwardhan is credited with describing formally, the technique of delivering the fetal head that is 9impacted into the pelvis in the second stage of labor.28 This technique is now accepted to be a better alternative to pushing the head up in terms of reducing maternal and fetal injury and morbidity.
One of the tragic events in Indian gynecological history is the life and death of Professor Subhas Mukhopadhyay. He created history in India working with Sunit Mukherji, a cryobiologist and gynecologist Dr Saroj Kanti Bhattacharya. This team was responsible for the birth of Durga (Kanupriya Agarwal) in October 1978, just a few months after Louise Brown. However, Mukhopadhyay faced criticism, ostracism and was driven to suicide by the hostility of the bureaucracy and the state government of the day. It was only later that his contributions were acknowledged and accepted.29
CONCLUSION
The history of medicine is impossible to encapsulate completely in a text of any length. This chapter is a bird's eye view of the important events and milestones that have shaped how we care for women in today's time. It is hoped that it serves as a stimulus for the interested reader to delve deeper into history and to reflect on the road ahead.
REFERENCES
- Cicero MT, Grant M. Selected Works. New York: Penguin Classics; 1962.
- Witcombe CL. Venus of Willendorf. Art History and Image Studies—Essay 1. Cambridge: Cambridge University Press; 1995. [online] Available from: http://arthistoryresources.net/willendorf/ [Last accessed September, 2021].
- Kak S. (2019). The Garbha Upanishad: How Life Begins. [online] Available from: https://subhashkak.medium.com/the-garbha-upanishad-how-life-begins-76e25d68da45. [Last accessed September, 2021].
- Drabkin IE. Soranus and his system of medicine. Bull Hist Med. 1951;25:503–18.
- Fluff35. (2017). Agnodice: reading the story. Mistaking histories. [online] Available from: https://mistakinghistories.wordpress.com/2017/10/18/agnodice-reading-the-story/ [Last accessed September, 2021]
- British Broadcasting Corporation (BBC). The Story of Medicine. London: Immediate Media Company; 2017.
- Green MH. The Trotula: An English Translation of the Medieval Compendium of Women's Medicine. Pennsylvania: University of Pennsylvania Press; 2010.
- Fulton JF. Logan Clendening Lectures on the History and Philosophy of Medicine. Vesalius Four Centuries Later. Lawrence, Kansas: University of Kansas Press; 1950. [online] Available from: https://kuscholarworks.ku.edu/bitstream/handle/1808/6347/upk.vesalius_four_centuries_later.pdf?sequence=1&isAllowed=y [Last accessed September, 2021].
- Drife J. The start of life: a history of obstetrics. Postgrad Med J. 2002;78:311–5.
- US National Library of Medicine. (1993). Cesarean section - a brief history. [online] Available from: https://www.nlm.nih.gov/exhibition/cesarean/part1.html [Last accessed September, 2021].
- Senn N. The Early History of Vaginal Hysterectomy. Chicago: American Medical Association Press; 1895.
- Sutton C. Hysterectomy: a historical perspective. Baillieres Clin Obstet Gynaecol. 1997;1:1–22.
- Dastur AE, Tank PD. Milestones: Ignaz Philipp Semmelweis and puerperal fever. J Obstet Gynecol India. 2008;58:206–7.
- Baskett, T. On the Shoulders of Giants: Eponyms and Names in Obstetrics and Gynaecology, 2nd edition. London: Royal College of Obstetricians and Gynaecologists; 2010. p. 214.
- Magon N, Kalra S. The orgasmic history of oxytocin: love, lust, and labor. Indian J Endocrinol Metab. 2011;15:S156–61.
- Chamberlain G. Victor Bonney: The Gynaecological Surgeon of the Twentieth Century, 1st edition. London: CRC Press; 2000.
- Sparic R, Hudelist G, Berisava M, Gudović A, Buzadzić S. Hysterectomy throughout history. Acta Chir Iugosl. 2011;54:9–14.
- Thiery M. Pioneers of the intrauterine device. Eur J Contracept Reprod Health Care. 1997;2:15–23.
- Dastur AE, Tank PD. The oral contraceptive pill: the early days of a 50-year old legend. J Obstet Gynecol India. 2010;60:207–9.
- Dastur AE, Tank PD. George Papanicolaou and the cervicovaginal smear. J Obstet Gynecol India. 2009;59:299–300.
- Papanicolaou GN, Traut HF. The diagnostic value of vaginal smears in carcinoma of the uterus. Am J Obstet Gynecol. 1941;42:193–206.
- Donald I, MacVicar J, Brown TG. Investigation of abdominal masses by pulsed ultrasound. Lancet. 1958;1:1188–95.
- Tarneja P, Duggal BS. Hysteroscopy: past, present and future. Med J Armed Forces India. 2002;58:293–4.
- Wall LL. The medical ethics of Dr J Marion Sims: a fresh look at the historical record. J Med Ethics. 2006;32:346–50.
- BBC News. New York: James Marion Sims statue removed from Central Park. BBC Online. April 17, 2018.
- Shirodkar VN. Contributions to Obstetrics and Gynaecology. London: E and S Livingstone Ltd.; 1960.
- Virkud A. Conservative operations in genital prolapse. J Obstet Gynecol India. 2016;66:144–8.
- Patwardhan BD, Motashaw ND. Caesarean section. J Obstet Gynecol India. 1957;8:1–15.
- Mukherjee S, Mehta RH. Dr. Subhas Mukherjee: A Visionary and Pioneer of IVF. Mumbai: ICMR-National Institute for Research in Reproductive Health; 2020.
LONG QUESTIONS
1. What are the important events in the 1800s that contributed to safety of surgery on women and in general?
2. Write an overview of the important contributions of Indian obstetrician and gynecologists in modern practice.
3. Write a critique the statement “James Marion Sims as the father of modern gynaecology”.
SHORT QUESTIONS
1. Write a short note on the history of the obstetric forceps.
2. Why was puerperal sepsis a deadly disease and how did Semmelweis deal with it?
3. Ian Donald is looked upon as the modern day legend in obstetrics. Mention his stellar contributions.
MULTIPLE CHOICE QUESTIONS
1. What is the estimated age of the universe?
- 34 billion years
- 14 billion years
- 4 billion years
- 1 billion years
2. From how long ago are the oldest representations of the female form and anatomy?
- 50,000 years bce
- 40,000 years bce
- 20,000 years bce
- 2,000 years bce
3. The following Indian text has the earliest scientific description about embryology:
- Govind Upanishad
- Yuga Upanishad
- Rig Upanishad
- Garbha Upanishad
4. The landmark textbook of women's health and disease published by Soranus of Ephesus was:
- De Morbis Mulierum
- De Humani Corporis Fabrica
- Historia Plantarum
- Hippocratic Corpus
5. The accurate description of human anatomy from dissection of cadavers was published by:
- Andreas Vesalius
- William Smellie
- Marcus Ulpius
- Agnocide
6. The first vaginal hysterectomy that was conducted successfully in modern times is credited to:
- Ephraim McDowell
- JCM (Conrad) Langenbeck
- Charles Clay
- James Marion Sims
7. Professor Henry Dale described the action of which commonly used drug?
- Methergin
- Prostaglandin F2 alpha
- Oxytocin
- Misoprostol
8. The following are considered as the pioneers of radical hysterectomy, except:
- Joe Vincent Meigs
- James Young Simpson
- Friedrich Schauta
- John Clark
9. All the following played a vital role in the development of the cervicovaginal smear technique for early detection of cervical cancer, except:
- Ernst Wertheim
- Herbert Taut
- Andromache (Mary) Mavroyeni
- George Papanicolaou
10. The first baby by the in vitro fertilization technique was born in:
- 1968
- 1975
- 1978
- 1982
1. b | 2. c | 3. d | 4. a | 5. a | 6. b |
7. c | 8. b | 9. a | 10. c |
1.2 COMMUNICATION AND COUNSELING
Tripti Nagaria
“Extensive research has shown that no matter how knowledgeable a clinician might be, if he or she is not able to open good communication with the patient, he or she may be of no help”.
Healthcare system is dependent upon the effective communication between the healthcare provider and the receiver, i.e., the patient and the community. Communication should not be considered as simple interaction or process of exchange of information, it is an important and powerful tool in bringing about change in existing human behavior and attitude increasing the knowledge and acquiring skill.
WHAT IS COMMUNICATION?
“Communicate”, a Latin word from which the word communication is derived, means to share. Communication is defined as the process of transmission of information from one individual to another individual or group of people or from one organization to another by using any suitable medium like speaking, writing, or any other.
COMMUNICATION PROCESS
- Sender (source of generation of information)
- Receiver (recipient of information)
- Message (content of information)
- Channel (medium of communication)
- Feedback (effect of communication)
Sender
The sender or the communicator is the one who originates the message or information and sends it to other individual/individuals or organization/organizations.
- Objective of communication—clearly defined
- Receiver—about their type, interest and abilities
- Message—must have accurate, useful contents
- Channel(s) of communication—medium of transmitting information written, spoken or otherwise
- Professional limitations and abilities as sender.
Status and the knowledge of the communicator also influence the impact of the communication.
Receiver
The receiver is the individual/organization or a group of the individuals/organizations whom the message is directed. The group can be homogeneous means a group having common interest or heterogeneous having varying interests. Communication of message in a homogeneous group is more effective as compared to heterogeneous one. The extent of comprehension of the message by the receiver depends on their receptivity or readiness to accept the message, prior knowledge about the topic and the relationship and trust that exists between sender and receiver.
Message
It is the information the sender wishes to deliver to the receiver to understand, accept or act upon. It may be in form of words, spoken or written, in form of signs, symbols, audio or video, drawing, pictures, placards.
- The key to success of communication is transmission of right message at right time to right audience in right way.
Channels of Communication
Channel is the media of communication between the sender and the receiver(s).
Media systems which can be used:
- For interpersonal communication:
- Verbal both oral and written, or sign language
- For mass communication:
- Television (TV), radio, printed media, etc.
- Traditional folk media—folk dances, drama, singing, Nautanki, etc.
Considering the advantages and limitations of every channel, many a time one may use more than one medium for effective communication. Selection of the right media whether oral or written is very important for effective delivery of message. It depends upon several factors like:
- Urgency
- Need of feedback
- Need of documentation or a permanent record
- Complexity of message
- In case of organization—whether the message will be delivered to individual/s or department/s of the organization or outside the organization
- The skill of the receiver to understand the verbal or written communication
- The audience whether a person, a small group or large group or population.
Feedback
Feedback is the response of the receiver to the message transmitted. It may be again verbal or nonverbal like a spoken or written comment, a gesture, facial expression, nonverbal behavior, a smile, or some other action. “No response is also a form of response”.
Feedback is of paramount importance in communication as it allows evaluation of the effectiveness of the message and provides an opportunity to modify or clarify a misunderstood message, rectify the transmission errors, and make it acceptable. Feedback can be immediate as in interpersonal communication or can take some time as in mass media communication. Feedback is the key component of the communication to confirm that the receiver has interpreted the message correctly.
In healthcare settings, all these elements of the communication are affected by various factors particularly in an understaffed setting.
In such setup, the healthcare personnel have to do many works or perform duties at multiple sites. The pressure of working result in fatigue, less concentration, distractions, lapses in memory, stress, frustrations, etc., these can lead to errors, misunderstanding of messages, miscommunication, poorer responses and can affect the patient care.
COMMUNICATION SKILLS
In a healthcare system, knowledge of the processes of communication and communication skill play a very vital role. From the very first contact with, till discharge from the health- care system the patient and their relative/caretakers need to know various information essential for the management of the case, may it be information about disease, diagnosis, how to and where to get admitted, for making decision for various intervention, medicines, follow-up, etc. Thus, interaction with various persons of different cadres in the system is a routine in hospital setting. Different patients and relatives have different ability to transmit, receive and understand the message, as well as to react based upon their age, literacy skills, language, social and cultural background, disabilities, etc.
Similarly in the system not all the personnel have similar efficiencies in communication and various factors apart from above mentioned other factors like pressure of the work, multitasking, background noises, interruptions, fatigue, lack of sleep, etc., may affect their ability.
Discharge summary or transfer tickets at the time of shifting to another care system is another very essential and important written document which conveys the essential features of condition of intervention done and the treatment and 12follow-up instructions. Improperly made or communicated notes can lead to errors in the further understanding and management of the patient.
At various points of contact and stages of care, the communication method may change in terms of senders, messages need to be given, means or channels used, receivers may be patient himself or family members and expected feedback. Therefore, ultimate outcome depends upon both how efficiently message is conveyed as well how efficiently the receiver has perceived and understood it. Thus, a deep understanding and knowledge of communication skill is essential for success and failure of the system.
METHODS OF COMMUNICATION
Broad categories of communication are:
- One-way communication (Didactic method)
- Two-way communication (Socratic method)
The characteristics of two methods are as shown in Table 1.
Communication can also be categorized as follows (Table 2):
- Based on communication channels
- Based on style and purpose
Verbal Communication
Verbal literally means spoken, oral, vocal or unwritten; therefore, verbal communication in general gives an impression of spoken communication. However, in communication, verbal includes use of language and words in both spoken and written forms and for those who are with hearing impairment sign language as well.
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Examples of two methods are as shown in Table 3.
Nonverbal Communication
Nonverbal communication is “Wordless communication”, where no words whether spoken or written are used still it is a powerful tool of conveying message and feedback. It is often complementary to verbal communication and if used properly aids to its effectiveness. It usually expresses the mood, opinion, reluctance, and reaction to the message received.
Some of the modes of nonverbal communication are:
- Physical nonverbal communication: Bodily physical movements can be most expressive observable way of nonverbal communication. In day-to-day practices and routine life, it comprises more than half of the communication. Some of the common examples are facial expressions, body language, hand movements, gestures, posture, walk, touch, gaze, etc. these are the common way of expressing reactions to the messages received.
- Paralanguage: Nonverbal aids to spoken communication are by changes in the tone, pitch and quality of voice, and style of speaking. It conveys the mood of the sender as well as the receiver, reaction of the receiver, expresses the emotions in more or less 36% of communications are supported or aided with these paralanguages to convey the feelings.Major differences between verbal and nonverbal communication are as shown in Table 4.Nonverbal communication by patient: Nonverbal communication plays a vital role in the healthcare delivery system as it may be more important feedback from the patient than any verbal one. It provides a reliable indicator about the condition of the patient.
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- While examining, interacting with the patient, observation of the nonverbal communication of like facial expression is informative. However, while examining a patient, one should watch for the comfort zone of the patient, sometimes closeness may disturb and make the patient uncomfortable.
- Body language: Various body languages of the patient can express the emotional response like anger, depression, frustration, feeling good, greeting, etc., For example, avoiding of eye contact, silence, various gestures, hand movements, eye movements, clinching of jaw, fist, etc.
- Paralanguage: Pauses, changes or variations in voices during communication again give important clue of the emotional status of the patient.
Some of the nonverbal behaviors are as shown in Table 5.
Both verbal and nonverbal forms of communication are complementary to each other. Whereas the verbal form is the face-to-face communication and better way of understanding the message, the nonverbal form satisfies the emotional understanding.
Other ways of nonverbal communication: Following are some of other ways particularly in group or mass communication.
- Visual communication: Communication through visual aids like drawings, placards, tables, maps, charts, graphs, pictogram, poster presentations, illustrations, etc.
- Esthetic communication: Various types of art forms like drawing, sketches, and paintings are also powerful means of transmitting the message.
- Appearance: The appearance, clothes, and the color of the fabrics, etc., also have important impact on the reaction of audience.
Formal and Informal Communication
Written verbal communication using scientific and official language, observing systematic policies, and procedures is formal communication. In healthcare system, this form of communication is done with following objectives:
- Patients’ education and counseling to ensure their safety
- Information or documents on medical policies, rules and regulations, guidelines, notifications, publications, instructions, etc.
- Formal records system and prescription, etc.
Informal communication is casual nonspecific or common communication between members of the organizations (gossips). However, health information internet has expanded this form of communication. Various healthcare-related advertisements and information are now available on health- care media. Exchange of information between patients and their healthcare providers related to patients’ illness is another example of it.
Both formal and informal communication play vital role in improving the quality of healthcare, patient safety, and behavior of patients.
CHARACTERISTICS OF EFFECTIVE COMMUNICATION
Effective communication is one which end with transmission of message or feeling from the sender and perceived by the receiver.
There is a concept of “7Cs” or characteristics that must qualify the communicating activities and processes to make it effective (Box 1).
- Clear: The message being transmitted must be very clear and easily understandable with simple and short sentences. In written documentation, one should use active voice over the passive voice and if multiple messages are to be conveyed separate bulleted points must be used.
- Concise: Any attention span is just a few minutes long; therefore, to be effective the message should be short and concise.
- Concrete: Whatever message or information or data is present in the communication, it should be suitably backed up. A tangible argument is always easy to understand.
- Coherent: For written documentation, coherence is very essential. It should be well planned, the information should be in sequential manner, follow each other. The main ideas should be well-differentiated.
- Consideration: For effective communication, one must get connected to and involved with the target audience. Hence, the presenter must know/assess the background knowledge on the topic, level of literacy, age, and interests of the receiver/s before start of communication.
- Consistent: Consistency in the information given adds to clarity of communication. Various statements or facts must be systematically presented to avoid any confusion.
WHAT ARE THE BARRIERS OF COMMUNICATION? (BOX 2)
Any parameter that limits the purpose or channel of communication between the transmitter and the receiver is a barrier to communication. It may limit or reduce the ease at which one communicates and the intended message will often be disturbed and distorted leading to a condition of misunderstanding and failure of communication.
Although the barriers to effective communication may be different for different situations, the following are some of the main barriers as shown in Table 6.
APPLICATIONS OF HEALTH COMMUNICATION
- IEC—information, education, and communication—aims to generate specific awareness in targeted population.
- BCC—behavior change communication—aims to generate awareness in the targeted population with an aim to change the behavior.
- SBCC—social behavior change communication—aims to change the social condition and individual behavior.
Health education can be defined as the principle by which individuals and groups of people learn to behave in a manner conducive to the promotion, maintenance, or restoration of health, e.g., information and awareness about various national programs, immunization program, antenatal intranatal and postnatal care services, family planning services, safe abortion services, breastfeeding awareness, cancer awareness, etc.
This can be done using all the methods of communication:
- Individual method: Counseling and interview
- Group method: Group discussion, role play, brainstorming, workshop/seminar, demonstration, mini-lecture, symposium. problem solving, panel discussion, field trip/educational tour, etc.
- Mass media method: Using visual aids—posters, video, paintings, etc.
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COUNSELING
Counseling is a bidirectional interpersonal communication to analyze the feelings, opinion, believes, thoughts, and problems of a person and helps him to take sensible decision. Herein two unrelated persons meet to discuss and find out the ways to conquer the crisis or problem in an atmosphere which is supportive to let the person define the situation, build up self-confidence and respect and readiness to bring about lifestyle modifications to reduce the brunt of the problem on himself and on their close ones.
Counseling is not about taking the decision for the person/client and also not about judging, cross-examining, disagreeing with what the client is speaking or instructing the client but it is a process by which the client is conversed in such a way that he himself becomes confident enough to take suitable decision, it can only be done when the counselor though working very closely is not emotionally attached to the client. This approach aims to help the clients in developing 15the skills to solve the problems and to cope up better with the situations they are facing. This engrosses the individual to handle with their emotions and feelings and to help them make positive choices and decisions.
BASIC COMMUNICATION QUALITIES OF A COUNSELOR
- Focus and attention: While receiving or transmitting information, focus and attention are very important. Any mislaid communication could be unsuccessful as if one loses attention, important part of the information may be overlooked or failed to notice altogether.Attending: It refers to the way the counselor is connected to the patient both physically and psychologically, i.e., how does he position himself to listen to the client carefully. Gerard Egan defined SOLER as a part of his “Skilled Helper” staged approach to counseling. It is a nonverbal listening process used in communication and is stand for:
- S: Squarely face your patient
- O: Open posture
- L: Lean toward the patient
- E: Eye contact with the patient
- R: Try to be Relaxed or natural with the patient
- Listening for understanding: It refers to capturing and understanding the message, the patient wants to give irrespective of the way verbal or nonverbal.Four skills are involved in active listening:
- Listening to understand the verbal message of the client
- Listening to and interpreting the nonverbal message of the client such as bodily posture, gestures, groaning, facial expression, voice-related behavior, psychological reactions, general appearance, etc.
- Listening to and considering the client in perspective of her social background
- Listening with empathy.
- Basic empathy: Basic empathy involves active listening skill of the counselor to appreciate and consider the concerns of clients as best as he can. The understanding should then be communicated back to the clients in such a manner that help them to comprehend themselves more fully and act thoughtful. In other words, it is the skill to be acquainted with and acknowledge the reaction or emotions of another person with experiencing those same emotions. These feelings then must be communicated to the client in either verbal or nonverbal way.
- Questioning: It makes the counselor to get more issues from the clients. It also helps keeping the client more focused on main issues describing at large. Care must be taken to ask open-ended questions to let client describe the problem.
- Use silence effectively; do not interrupt unless necessary.
- Reflection and echoing: The provider observes the clients emotions and reflects them back. This helps provider to check whether his/her observations are correct. It also reflects the empathy and respect toward clients feeling.
- Praise and encouragement: The provider uses gestures and words to encourage and motivate the client and ensure his/her approval.
- Give information to the client clearly.
- Being nonjudgmental
- Emotional awareness and control: Remain emotionally stable to accept or reject any message with the intention, it is being relayed.
- Summarizing and paraphrasing: At the end, the counselor must summarize what the client had described; it provides an opportunity to the client to clarify.
The counseling is intended to help the patient to understand and develop the capability to cope up with his or her condition/disease, so as to promote a better quality of life.
IMPACT OF COMMUNICATION IN HEALTH CARE
Success of integrated healthcare delivery system to provide quality care to the patients and good outcome is founded in effective communication. Apart from providing better working environment with increased job satisfaction, it is the key to better patient outcomes with higher rates of patient satisfaction and continuation of treatment and reduced adverse events, hospital stay, and readmission rates.3–8 Several researchers have observed communication failure as the main factor contributing to the just the contrary outcomes.9–15
CHALLENGES IN COMMUNICATION IN DIFFERENT SITUATIONS
There are many models of communication and every health- care provider has his or her own style. Certain principles from different sources may be followed for effective communication as discussed here.
In Outpatient Department
From the very first contact to start of the treatment by the patient communication is the constant and most essential aspect of the medical practice involved right from getting the history of illness to explaining the treatment plan. Effective communication not only builds up good physician patient relationship but also leaves therapeutic effect on the patient.3
Steps to be followed:
- Greet the patient and know the problem he/she had
- Interview the patient:16
- Focus and attention
- Discover the understanding and knowledge the patient is already having about her illness
- Evaluate or assess what does she want to know, before starting to inform
- Give information slowly
- Keep it simple
- Tell the truth
- Observe nonverbal behavior of patient
- Be prepared for reaction
- Closing:
- Use name of patient
- Make positive statement.
A number of factors may affect the outcome like a busy outpatient department (OPD), short of time, noises, multitasking situation, mobile phone, etc. only by careful and effective handling of barriers and following principles of effective communication a trust and rapport can be build up.
During Transition of Care
Throughout the continuum of care, patients need to be transferred to different locations of varying levels, and to various healthcare providers for management as their condition demands, this needs movements of patients and their family members and/caretakers to different places within and sometimes to different hospitals. It involves multiple other persons too like medical, paramedical, and ancillary staff of healthcare delivery system.17 As with this transfer or relocation of the patient, the healthcare providers, decision taker, and the setup changes, a clear communication of the patient status regarding disease is necessary to make sure the quality of care.18 For effective transition, care apt and precise communication of information between providers, patients, and family caregivers are decisive. Any failure in execution of this safety measure leads to uncertainty about the care the patient is receiving, therefore, delay in care, improper monitoring, roughly one-half of all hospital-related medication errors and one-fifth of all adverse drug events, adverse outcomes, rehospitalization, and increased health- care expenditures.3,19–21
Inadequate Handovers
During hospital stay, the patient has to come across many medical and paramedical staff in each shift of duty, intradepartmental or interdepartmental shifting to different location, for consultations, checkups, investigations and interventions, discharge, etc. For continuity of care and safety of patient during these shifting and change of heathcare providers, proper handovers are of paramount importance.22 Effective communication is therefore fundamental to safe and effective patient care.23 Failure of proper communication is identified as the one of the main root causes of serious medical errors.24 Penalty of such failure during handovers is in the form of medication errors, erroneous patient plans, delay in discharge or transfer to critical care, or/and repetitive tests among others.25
Lack of proper communication can occur at multiple levels; between physicians, physician and nurses, between nurses, between medical and paramedical staff, and between members of team involved in providing health care and the patients and the caretakers, relatives, etc. These can result in delay in start of treatment, wrong treatment, medication error and sometime wrong surgical invention and even fatalities.
This can be avoided by following measures during handing over:
- Bedside handovers at all the levels should be done.
- Properly written records should be provided.
- Instructions must be clear.
- Recent updates of the condition and treatment must be provided.
- Using SBAR structured format26 to transfer the information.S—Situation: Why the information is being communicated? What updating the patient's condition, clarifying orders, alerting regarding emergency developed, etc.B—Background: What is the background information? (History or complaints or diagnosis with which patient was admitted/referred, treatment being given, change in condition of case, any new development of sign or symptom or emergency).A—Assessment: What is the assessment of problem at that moment of time? (Clinical examination finding) what appears to be the problem based upon clinical examination finding?R—Recommendation: What is needed to be done for solving the problem at that moment of time? How should the problem be corrected?
The use of SBAR tool in clinical setting has been endorsed by many healthcare organizations including WHO for improving the verbal communication among healthcare providers for handover.27–31
I-PASS is another strong tool for communication for handovers during shift change and other transition care by healthcare providers, physician and nursing staff, to cut down the miscommunication and adverse outcomes. I-PASS is a mnemonic for: Illness severity (I), Patient summary (P), Action list (A), Situation awareness and contingency planning (S), and Synthesis by receiver (S).32 Facilities can adapt to ensure all the following information is communicated when providers perform handoffs (Table 7).
Inadequate Discharge
In a meta-analysis, Kripalani et al. observed discharge summaries often lacked important information such as main diagnosis (13–17.5%), diagnostic test results (missing from 33 to 63%), treatment or hospital course (7–22%), discharge medications (2–40%), test results pending at discharge (65%), patient or family counseling (90–92%), and follow-up plans (2–43%).33
To avoid this, few points should be kept in mind:
- Discharge must be well-planned.
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- Sufficient time must be given to explain the contents of discharge summary, i.e., about the condition of the patient at the time of discharge, plan for follow-up and treatment in simple language in a way which is easily understandable and to make sure that the patient and their relatives have understood.
- “5Ds of discharge” is one important tool which can be stressed in communication at the time of discharge to make sure the patient understands the information given and to do list.34 Following are the elements of 5Ds—Diagnosis, Drugs, Diet, Doctor follow-up plan, and Directions for any emergent situation (Table 8).
Handling Difficult Patient
Many a times certain difficulties to handle patients are encountered by healthcare providers, if not properly handled frustrations are likely to develop in both the parties.
Prevention of difficult interaction is best approach.
- Recognize and concentrate on the psychological issues of the patient.
- Listen to them with great attention and empathy as the feeling that “they are not heard” or “they are not worth” is the greatest cause of dissatisfaction of most of the patients.
- Body language should be appropriate, should not be a cause of displeasure to patient.
- Be careful of your own emotional state.
If encounter becomes tense, follow the following points:
- Remain professional
- Do not let your emotion overcome you
- Active listening with summarizing
- Acknowledging the emotions they are expressing.16
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COMMUNICATING WITH SERIOUSLY ILL PATIENTS
Special care and attention is required while communicating with seriously ill patients and to improve it various principles have been recommended, as follows:35
- Before starting the interaction specific to her illness, spend a few moments giving the patient completely focused attention.
- Start with what the patient wants to discuss or know.
- Observe and follow the emotional feedback from the patient.
- Move the conversation forward slowly, one step at a time.
- Express empathy overtly.
- Start with positive information like what can be done before informing what cannot be.
- Start with ultimate big goals before talking about specific medical interventions.
Age-related Challenges
There are particularly unique challenges associated with communicating with extremes of age, adolescents as well as elderly people.
Communication with Adolescent
Adolescents may get engage in high-risk behavior and require medical advices or care. However, to get the information from them is not always easy as they are afraid of being assessed.
- Greet them
- Break the ice by asking few general questions not related to health
- Give privacy
- Avoid distractions while interactions
- Listen with concentration, observe, and understand the nonverbal communications of the patient
- Allow her to speak, too many interruptions may let them feel being judged
- Mind your body language while interacting
- Show concern
If given appropriate friendly atmosphere, appreciated as adult and opportunity to discuss, they may disclose their information. Confidentiality is the foundation of building up of healthy relationship with youth. With proper communication/counseling, adolescents can be helped to take sensible decision to overcome the situations or the problems they are facing.
At the other extreme end of the age range, the elderly patients also present challenges in different ways. Multiple age-related and psychological issues make the communications challenging for the healthcare workers. Physical disabilities like visual and hearing impairment, medical disorder or comorbidities and medications for chronic disease, along with memory lapses and lack of psychological, social support put them at higher risk for adverse outcome, suboptimal care and medications particularly at the transition of care.
- Spare more time for older patients; do not appear hurried or uninterested36
- Assess and compensate for any visual or auditory impairment
- Ascertain respect from the beginning
- Maintain eye contact4
- Begin conversation with questions about family members or other interests rather than illness to decrease the anxiety
- Go slow—speak slowly, in a clear and loud voice and give patient sufficient time to understand the information
- Do not interrupt—listen till she completes
- Use simple, common words.
- Summarize repeatedly the most salient points
- Discuss only one topic at a time, inform the patients at the time of changing the subject
- Give clue to help her understand what is being said—such as brief pause, speaking a little louder, indicating or making gestures to make her understand topic to be discussed, asking questions to lead to the topic, etc.
- Think about use of alternatives to printed materials for visually impaired patients or patients with low literacy skill—such as vocal instructions, e.g., recorded instructions, visual large pictures or diagrams, or other aids.
Cultural Difference
It must be addressed while providing health care. Providing efficient and effective care requires having conversations in which the provider and patient both understand the meaning of words, concepts, and metaphors. Cultural differences also affect the working relationships between providers, as physicians and nurses, for example, sometimes have different value systems relating to how patients are cared for and treated.
Errors in Medical Orders and Test Results
Errors in medication in healthcare system can also be due to the verbal communication of the orders and test reports to the comembers of the team, patient or their caretakers, especially over phone.
- Difficulty can arise in understanding the message or the order due to difference in language, tone of voice and pronunciation or articulations.
- Another error prone verbal communication is giving instruction about sound alike drug name, number as this may affect the accuracy of the order and thereby the end result.
- Distracters like background noise, any break in continuity of speech due to other involvement, and use of unusual or new drug names and terminology often accentuate the magnitude the problem.
- Verbal and vague orders often end up with mismanagement, delay in treatment, over treatment or even omissions of medication treatment jeopardizing the patient safety.
To avoid this type of error, the healthcare system should develop a standardized protocol of communicating the order and test reports. Orders, prescription, reports should be properly written rather than verbally communicated. Health- care providers must use of specific rather than uncommon terms for the intervention.39
During Treatment/Intervention
Communication failures during health care can be of multiple types viz. too late to be effective, not communicated to all the members of the team involved in the particular health care, incomplete and inaccurate transmission of information and not ending with fulfillment of the purpose until emergent situation arises.38 Such failures are responsible for poor outcome and need to be addressed.
Also, throughout the continuum of care of a patient a number of procedures are needed and carried out which require adequate and effective communication to explain the procedure, need and related risk and benefits. Any deficient communication or no communication can end up in patients or relative's dissatisfaction and professional liability. Therefore, a defined procedure must be developed by every hospital to obtain an informed patient consent for various procedures being carried out during the inpatient care like any high-risk treatment, blood or blood product transfusion, surgical intervention, anesthesia, investigative procedures requiring anesthesia or sedation or carrying inherent risk, etc., in a manner and language the patient can understand.
Errors likely to Occur during Surgical Procedure in Operation Theater
Analysis of 421 communication events in the operating room (OR) found communication failures in approximately 30% of team exchanges; one-third of these jeopardized patient safety by increasing cognitive load, interrupting routine, and increasing tension in the OR setting.40
The most dreaded adverse event that can occur is a wrong operation carried out on a wrong person or wrong site. To prevent errors during surgery (wrong site, procedure, and 19person), a universal protocol is designed.41 One must check for the following before start of the surgery.
- Preprocedure verification process of the correct patient, procedure, and site
- Surgical site marking
- Ensuring the availability of all relevant documents and studies of the patients
- Images are properly labeled and displayed
- Verifying the availability of any required blood products grouped and crossed matched
- Special medical equipment if needed are present42
- To ascertain the site, patient must be actively involved in marking whenever possible and having the mark be visible after the patient is prepared and draped.
Obtaining a Consent for Surgical Treatment
- Obtaining an informed consent for surgical treatment is the need and also a challenge for the treating doctor/surgeon. It is not merely asking the patient and/their relatives sign the form. It requires surgeon to have good rapport with the patient and their relative or their caretakers so that necessary information can be transmitted to help them to decide to undergo surgical treatment. There should be clarity of explanation that leads to informed and deliberate consent.
- There must be a discussion on the various options of the management.
- Outcomes if the patient does not opt for surgery.
- Discussion on the need of procedure, the expected benefits, chances of success or failure, risks involved and complications that may develop.
- Need of additional management should the need arise.
- Type of anesthesia and related information.
- Follow-up plans and further additional management if needed.
- Surgeons involved in the intervention.
- The patient and relative/caretaker should be given time to think over, discuss and to ask any question or more information if they want.
- Consequences of nonoperative alternatives should also be explained.
- Consent should be in the language they understand.
- It must be read, understood and signed by the patient, relative or guardian and witnessed with a mention of time.
Consent should be looked as a procedure of shared decision making with patient and their relative/guardian. Informed consent as the one where the treating physician has explained the patient and their relative and they understood diagnosis, treatment options, the risk and benefits involved therein, chances of success and failure of the procedure, immediate and delayed complication if any and also of no treatment if they opt for and finally came to the decision.43
Thus, obtaining informed consent challenges professional competence. It is a time taking process of communication involving education, patient sympathetic listening and satisfying the queries of the patient, relatives/caregivers that continues through the continuum of care. It requires good patient-surgeon communication and lack of which may lead to professional liability.44
CONCLUSION
Effective communication and counseling play a very vital role in improving the health outcomes in healthcare system resulting in better management, patients’ satisfaction, and higher chances of continuation of treatment and follow up and building up of trust in the system. It is the responsibility of not only the doctors and nursing staff but of every member of the team involved in the management of patient including the paramedical and the ancillary staff to develop the skill of effective communication and counseling for achieving the ultimate goal of health care.
FURTHER READING
- AIPC's Counsellor Skills Series. [online] Available from: https://www.aipc.net.au/articles/; https//www.counsellingconnection.com/ [Last accessed September, 2021].
- Joint Commission International. Communicating Clearly and Effectively to Patients: How to Overcome Common Communication Challenges in Health Care. A white paper by Joint Commission International. 2018.
- Kabir SM. Essentials of Counseling. Banglabazar, Dhaka: Abosar Prokashana Sangstha; 2017.
- Kadri AM, Kundapur R, Khan AM, Kakkar R. IAPSM'S Textbook of Community Medicine, 1st edition. New Delhi: Jaypee Brothers Medical Publishers Pvt. Ltd.; 2019.
- Park K. Park's Textbook of Preventive and Social Medicine, 25th edition. Jabalpur, Madhya Pradesh: Banarasidas Bhanot Publishers; 2019.
- The Naz Foundation (India) Trust. Guide to Communication and Counseling: A Training Manual for Trainers. [online] Available from: https://www.who.int/hiv/topics/vct/sw_toolkit/guide_communication_counseling_naz.pdf [Last accessed September, 2021].
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- Travaline JM, Ruchinskas R, D'Alonzo GE. Patient-physician communication: why and how. J Am Osteopath Assoc. 2005;105(1):13–8.
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- Baggs JG, Ryan SA, Phelps CE, Richeson JF, Johnson JE. The association between interdisciplinary collaboration and patient outcomes in a medical intensive care unit. Heart Lung. 1992;21:18–24.
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- Balogh EP, Miller BT, Ball JR. Improving Diagnosis in Health Care. Washington (DC): National Academies Press (US); 2015.
- Larson E. The impact of physician-nurse interaction on patient care. Holist Nurs Prac. 1999;13:38–47.
- Sexton J, Thomas EJ, Helmreich RL. Error, stress, and teamwork in medicine and aviation: cross sectional surveys. Br Med J. 2000;320:745–9.
- Vermeir P, Vandijck D, Degroote S, Peleman R, Verhaeghe R, Mortier E, et al. Communication in healthcare: a narrative review of the literature and practical recommendations. Int J Clin Pract. 2015;69:1257–67.
- State of Washington Medical Quality Assurance Commission Guideline. Communication with patients, family, and health care team. MD2016-04.
- National Transitions of Care Coalition. (2016). Improving transitions of care: findings and considerations of the ‘Vision of the National Transitions of Care Coalition. [online] Available from: http://www.ntocc.org/portals/0/pdf/resources/ntoccissuebriefs.pdf [Last accessed September, 2021].
- Wittkowsky AK. Impact of target-specific oral anticoagulants on transitions of care and outpatient care models. J Thromb Thrombolysis. 2013;35(3):304–11.
- The Joint Commission. Hot topics in health care: transitions of care: the need for a more effective approach to continuing patient care. [online] Available from: http://www.jointcommission.org/assets/1/18/hot_topics_transitions_of_care.pdf [Last accessed September, 2021].
- American Pharmacists Association, American Society of Health-System Pharmacists, Steeb D, Webster L. Improving care transitions: optimizing medication reconciliation. J Am Pharm Assoc. 2012;52(4):e43–52.
- American College of Clinical Pharmacy, Kirwin J, Canales AE, Bentley ML, Bungay K, Chan T, et al. Process indicators of quality clinical pharmacy services during transitions of care. Pharmacotherapy. 2012;32(11):e338–47.
- Edwards C, Woodard EK. SBAR for maternal transports: going the extra mile. Nurs Womens Health. 2008;12(6):515–20.
- Riesenberg LA, Leitzsch J, Little BW. Systematic review of handoff mnemonics literature. Am J Med Qual. 2009;24(3): 196–204.
- The Joint Commission. Sentinel event statistics released for 2014. [online] Available from: http://www.jointcommission.org/sentinel_event.aspx.last [Last accessed September, 2021].
- Flemming D, Hübner U. How to improve change of shift handovers and collaborative grounding and what role does the electronic patient record system play? Results of a systematic literature review. Int J Med Inform. 2013;82(7):580–92.
- Shahid S, Thomas S. Situation, background, assessment, recommendation (SBAR) communication tool for handoff in health care—a narrative review. Saf Health. 2018;4:7.
- Von Dossow V, Zwissler B. Recommendations of the German Association of Anesthesiology and Intensive Care Medicine (DGAI) on structured patient handover in the perioperative setting: The SBAR concept. Anaesthesist. 2016;65(1):1–4.
- Agency for Health care Research and Quality. [online] Available from: https://psnet.ahrq.gov/search?topic=SBAR&f_topicIDs=680,711 [Last accessed September, 2021].
- Australian Commission for Safety and Quality in Health Care. ISBAR revisited: identifying and solving barriers to effective handover in inter-hospital transfer. [online] https://www.safetyandquality.gov.au/sites/default/files/migrated/ISBAR-toolkit.pdf
- Institute of Health Care improvement, Tools. [online] Available from: http://www.ihi.org/resources/Pages/Tools/SBARToolkit.aspx [Last accessed September, 2021].
- WHO Collaborating Centre for Patient Safety Solutions. (2007). Patient safety solutions. [online] Available from: www.who.int/patientsafety/solutions/patientsafety/PS-Solution3.pdf [Last accessed September, 2021].
- Starmer AJ, Spector ND, Srivastava R, Allen AD, Landrigan CP, Sectish TC, et al. I-PASS, a mnemonic to standardize verbal handoffs. Pediatrics. 2012;129:201–4.
- Kripalani S, LeFevre F, Phillips CO, Williams MV, Basaviah P, Baker DW. Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity of care. JAMA. 2007;297:831–41.
- Joint Commission International. Communicating Clearly and Effectively to Patients: How to Overcome Common Communication Challenges in Health Care. A white paper by Joint Commission international. 2018.
- Back A, Arnold R, Tulsky J. Mastering Communication with Seriously Ill Patients: Balancing Honesty with Empathy and Hope. New York, NY: Cambridge Univ Press; 2009.
- Robinson TE 2nd, White GL Jr, Houchins JC. Improving communication with older patients: tips from the literature. Fam Pract Manag. 2006;13(8):73–8.
- Dreher BB. Communication Skills for Working with Elders. New York: Springer; 1987.
- Osborne H. Communicating with clients in person and over the phone. Issue Brief Cent Medicare Educ. 2003;4(8):1–8.
- Kaufmann J, Laschat M, Wappler F. Medication errors in pediatric emergencies: a systematic analysis. Dtsch Arztebl Int. 2012;109:609–16.
- Lingard L, Espin S, Whyte S, Regehr G, Baker GR, Reznick R, et al. Communication failures in the operating room: an observational classification of recurrent types and effects. Qual Saf Health Care. 2004;13:330–4.
- The Joint Commission. Universal protocol. [online] Available from: https://www.jointcommission.org/standard/universal-protocol/ [Last accessed September, 2021].
- Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ. 2012;184(5):533–40.
- Bernat JL, Peterson LM. Patient-centered informed consent in surgical practice. Arch Surg. 2006;141(1):86–92.
LONG QUESTIONS
1. What are the characteristics of effective communications?
2. Discuss the barriers to good communication and modalities to overcome them.
SHORT QUESTIONS
1. What are the key elements of the communication process.
2. What are the broad methods of communication?
3. What are the characteristics of one-way and two-way communications?
4. What are the differences between verbal and nonverbal communication?
MULTIPLE CHOICE QUESTIONS
1. Sign language is an example of:
- Nonverbal communication
- Verbal communication
- Formal communication
- Paralanguage
- None of the above
2. Feedback allows the sender:
- To evaluate the effectiveness of message
- To clarify the message
- To confirm whether it is interpreted correctly by the receiver
- To rectify transmission error
- All of the above
3. SOLER is a:
- Method of questioning
- Method of listening and attending the patient
- Method of giving information
- Method of judging the patient
- Method of taking informed consent
4. In counseling, all are true, except:
- Listening
- Summarizing
- Being judgmental
- Questioning
- Giving information
5. Effective communication is helpful in all, except:
- Reducing readmission rate
- Reducing hospital stay
- Reducing patient satisfaction
- Reducing unnecessary investigation
- Reducing adverse events
6. Transition of care is movement of patient between:
- One location to another in same hospital
- One hospital to another
- Health care providers
- Hospital and home setting at the time of discharge
- All of the above
7. SBAR structured format comprises of:
- Safety, background, assessment, recommendation
- Situation, background, assessment, rationale
- Safety, background, awareness, recommendation
- Situation, background, assessment, recommendation
- Situation, barriers, awareness, review
8. 5Ds are used for:
- Disabilities
- Diseases
- Difficulties
- Discharge
- Dilemmas
9. While communicating with adolescents which one is most important:
- Confidentiality
- Concise
- Consistency
- Clarity
- None of the above
10. Current evidences suggest for better management of patient with effective communication skill, the approach should be:
- Disease-centered approach
- Treatment-centered approach
- Outcome-centered approach
- Patient-centered approach
- None of the above
11. Informed consent for surgery should include:
- Purpose of intervention
- Expected benefit
- Follow-up plans
- Complications
- All of the above
12. Communication is a responsibility of:
- Doctors and nurses only
- Doctors only
- Nurses only
- Paramedical staff and doctors only
- Whole health care team
13. All except one are not an example of verbal communication:
- Informed consent
- Discharge ticket
- Hospital policy document
- Groan
- History taking
14. Medication error can occur:
- Sound alike drug
- Sound like number
- Inadequate handovers
- Illegible handwriting
- All of the above
15. IEC means:
- Information, education, and communication
- Information, education, and compliance
- In house, education center
- Individual education chart
- None of the above
1. a | 2. e | 3. b | 4. c | 5. c | 6. e |
7. d | 8. d | 9. a | 10. d | 11. e | 12. e |
13. d | 14. e | 15. a |
Anahita Chauhan, Madhva Prasad S
INTRODUCTION
Medical textbooks usually begin with the disclaimer “Medicine is an ever-changing science, with new information being added on a regular basis. The reader is advised to verify the validity of the information provided in light of constant changes.” This oft-neglected guidance is extremely important as there is now a steady and sure movement away from traditional repositories of knowledge (such as physical/paper books and journals), toward an increasingly electronic interface. Textbooks undergo revisions and updating once in a few years, and serve only as a starting point for information; hence online resources are relied upon and encouraged by many institutions. In-person seminars are also being replaced by internet-based webinars, as are in-patient consultations. These changes in our understanding of the subject and our practice can be overwhelming for the student and the reader.
This chapter aims to decode EBM and stimulate the student to pose the inquisitive question “Is this evidence-based?” while reading any medical text. Exciting changes occurring at the intersection between information technology and medicine are also addressed in Medical Informatics. We hope this chapter provides the student “a lens” through which the rest of this textbook can be viewed.
EVIDENCE-BASED MEDICINE
Definitions
Evidence-based medicine has been defined as “the use of scientific methods to organize and apply current data to improve health care decisions. Thus, the best available science is combined with the healthcare professional's clinical experience and the patient's values to arrive at the best medical decision for the patient”.1
Evidence-based medicine can also be defined as “the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients”.2
The three key elements of an EBM approach are shown in Figure 1.
- Good clinical expertise: This refers to “what the clinician knows”. This mainly relates to the competency of each individual clinician, which is irreplaceable and is learnt over years of practice.
- Patient preferences and values: This refers to “what the patient is desirous of”. Consenting to the type of the treatment forms the crux of the matter.While these two concepts are being learned constantly, the third concept is a relatively new one.
- Best available evidence from research: This is the major addition to the field and refers to how the healthcare provider can utilize constantly evolving data and information to best serve the patient.
The term “evidence-based medicine” was first introduced by the pioneering clinician epidemiologist David Sackett, at the McMaster Medical School, Canada.3 It was a gradual movement which attempted to increase the quality of clinical research and help in better decision making. For most of the 20th century, medicine “trusted in the experts”. The EBM movement helped in changing the mindset toward “trust in the numbers”. The biggest change is the introduction of systematic reviews, with the ability to identify individual studies which are similar and of good quality, and interpret them after combining them. Thus, the conclusions are drawn from a larger number.
Levels of Evidence
The level of evidence, which is now a standard nomenclature, is available as an essential information in most guideline documents/textbooks and is summarized in Table 1.4
There is a clear hierarchy among the different types of studies (Fig. 2) and their corresponding levels of EBM. Individual case reports and case series of a few patients do not help in drawing any particular conclusions. These form the bottom of the pyramid. Next are case-control studies and cohort studies. While they answer questions pertaining to the epidemiology, risk factors and associations of a condition, they cannot provide specific clinical guidance, and may in fact, be biased in study design and methodology. A correctly conducted randomized controlled trial (RCT) is the gold standard of EBM. A group of patients having a particular clinical condition are subjected to two different management modalities, in a systematic manner. The data of the clinical outcomes are analyzed by an impartial observer, 23and the results of such a study are considered to be “Level 1 evidence” (Table 1).
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A nonstatistical collation of the results of various RCTs presented as evidence summaries and clinical guidelines are inferior to systematic reviews. Meta-analysis and systematic reviews, which bring all available information on the subject together, form the apex of the pyramid or the highest level of evidence.
Grading of Recommendations
In any particular subject, each recommendation is assigned a particular grade based on the level of evidence available. The higher the grade of recommendation, the stronger is the support given by the body of evidence available. Grading of evidence is shown in Table 2. Various international bodies and institutions develop guidelines systematically using standardized methodology after reviewing all the available literature. For example, the Royal College of Obstetricians and Gynaecologists (RCOG) defines “clinical guidelines” as “systematically developed statements which assist clinicians and patients in making decisions about appropriate treatment for specific conditions”. Details about how these guidelines are developed and kept transparent are also published.24
Effective Utilization of Evidence-based Medicine
Incorporating EBM is a lifelong process, which is self-directed, and is a problem-based approach while caring for one's patients. An effective method of utilizing EBM in practice is summarized in Figure 3. Apart from the clinical skills that are acquired to manage patients, the EBM movement requires the clinician to be able to:
- Use summary of evidence in clinical practice
- Help in development and updating of systematic reviews or guidelines in their specific areas
- Enrol patients in studies to eventually help in generation of better evidence.
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Types of Questions Answered by Evidence-based Medicine
- Therapy question: In pregnant women with hypertension of 160/110 mm Hg, is labetalol a better choice than nifedipine?
- Prognosis question: Does the use of alpha methyldopa among preeclamptic women have any implication on postpartum psychosis?
- Diagnosis question: Is 24-hour urine albumin mandatory to achieve a diagnosis of preeclampsia?
- Harm question: Does preconceptional smoking increase the risk of development of preeclampsia?
It is advisable to fit any clinical question into a PICO (patient/population, intervention, comparison/control, and outcome) format, which is illustrated with examples in Table 3.5
Acquisition of Best Evidence
While textbooks form the best source of consolidated evidence, by the time they are published, medical science may already be outdated. Hence, an electronic search of available literature is the preferred method for the latest updated evidence. Cochrane review, disseminated by Cochrane Database, is a charitable independent group which focuses on systematically reviewing the available health care information and facilitating evidence-based health interventions. Scores of health care scientists and volunteers contribute to the evidence generation in an impartial manner. The motto of Cochrane, “Trusted Evidence, Informed Decisions, Better Health” is the embodiment of EBM. For any particular subject or intervention, a Cochrane review is considered equivalent to the highest possible level of evidence. Efficient and correct use of search engines to perform a literature search using resources such as PubMed, UpToDate, and ClinicalKey are essential skills which the clinician should learn early in his career.
Critical Appraisal of the Evidence
The ideal information should be valid, relevant, comprehensive, and user-friendly. Blindly trusting all published information is near-sighted; not all published material is of equal importance or value.
Ensuring the Correct Perspective of Evidence-based Medicine
The intention of clinical recommendations is not to “dictate” a singular course of treatment or management. However, these recommendations should be utilized after a critical evaluation with special reference to each individual patient's needs and resources. The clinician should exercise judgment and understanding of the limitations which prevail in their respective institution(s) and local population variations. It is important to explain to the patient the evidence-based rationale behind a particular treatment modality.625
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Challenges in the Everyday Application of Evidence-based Medicine7
Inability to Subject Every Aspect of Medicine to an RCT
“If truth speaks for itself, why do you have to test it with the nontruth?”
Though RCT is the gold standard, no formal RCT has been conducted to prove the efficacy of Pap smear in preventing cancer cervix. Subjecting patients who have an open wound to an RCT comparing suturing and nonsuturing is never possible. Clinical medicine offers many such scenarios. It is absurd to say that the level of evidence and grade of recommendation regarding such “obvious” clinical practice are “poor”.
Statistical Jingo, Mathematical Absurdity, and Extrapolative Fallacies
“I chose to study biology and medicine, because I knew I was weak in Math.”
“If there is indeed a difference between the two groups, no statistical test should be required to prove the difference.”
In most higher levels of evidence, there is a definite reliance on statistical formula and tests of significance, proving either difference or similarity. However, one should refrain from blindly trusting any result as “the absolute proof” if the statistical cutoff p value < 0.05 is reached.
There are a few infamous and controversial examples of how even a statistically significant yet realistically small difference has been blown out of proportion and brought in rather major changes in clinical practice. For example, use of tamoxifen and aromatase inhibitors in breast cancer was found to have similar survival rates. However, the disease-free survival period was slightly better with aromatase inhibitors. Though this is an unmissable statistical derivation, it means little to the patient. Notwithstanding this, multiple publications favored the replacement of tamoxifen by aromatase inhibitor, which is considered unjustified, in retrospect.
Publication Bias
“We do not know what we do not see.”
The process involved from the generation of data up to appearance in scientific literature leads to a host of possibilities of bias. Once analysis is done, if the result is “positive”, there is a tendency to hasten its submission. Upon submission, “positive” results have higher chance of acceptance by journals. On the contrary, “negative” results tend to be abandoned, and not worked upon further for publication. Even if it is eventually submitted to journals, a lot of time has elapsed. Even after submission, the chance of acceptance is diminished. All these constitute “publication bias”.
“In Situ” Publication Bias
“If I choose not to show, you do not get to see.”
Researchers are free to analyze the specific parameters that they wish to analyze, and hence this leads to writing up of only that data which the researcher feels relevant and important. The overall picture tends to be narrow-visioned, because a lot of what has to be presented lies shelved in the researcher's drawers.
Many initiatives have been taken to reduce such publication bias. This includes mandatory registration of clinical trial protocols with trial registries. This ensures that every protocol which is registered is analyzed and the details published within a given time frame.
MEDICAL INFORMATICS
The standard dictionary definition of “informatics” is “the sciences concerned with gathering and manipulating and storing and retrieving and classifying recorded information”. Hence, medical informatics can be regarded as “an interdisciplinary field combining systematic processing of data, information and knowledge in medicine and health care”.26
The definitions can vary and depend on the specific subfield they relate to. For example, clinical informatics will refer to the activities pertaining to clinical information; “pathology informatics” referring to pathological laboratory data, etc.8
Types of Data
Before we can make sense of what informatics systems can do with data, it is important to identify what types of data can be collected. Table 4 lists the various types of data, which we clinicians are otherwise familiar with.9 Figure 4 shows the differences between the traditional model and the “informatics” model of medical data handing.
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Advantages of Electronic Health Informatics
The health informatics evolution promises changes such as efficiency, EBM, enhancement of quality of care, etc. which are summarized in Figure 5.10
ARTIFICIAL INTELLIGENCE
Artificial intelligence is simply defined as “the ability of machines to learn and display intelligence”. Such intelligence may be in stark contrast to the “natural” intelligence which is demonstrated by humans and animals.
The rise of artificial intelligence is supported by the rise of computer power, vast amounts of memory, ability to store data securely; this has led to the successful handling of increasingly complex learning tasks. Speech recognition, face recognition, advanced gaming, voice assistants, and self-driving vehicles are some examples.
The exponential rise in the volume of biomedical data generated has led to clinicians grappling with how to make sense of this vast data; the best way to deal with this is to automatism it using artificial intelligence systems.11
Computer Calculations versus Artificial Intelligence
The difference between simple use of mathematical calculators and artificial intelligence is vast.27
Mathematical models enable computerized programs to identify patterns which are present in voluminous and complex data entities automatically. These are then used to make predictions and prognostications, important for clinicians. In traditional computer-based statistics, the main objective is to merely estimate the disease condition and score the severity or classify the disease conditions. However, machine learning has the ability to build on automated clinical decisions for the optimal management of conditions. This assists doctors to solve clinical problems. The accuracy of the model improves when more data is inputted. Supervised learning, unsupervised learning, self-learning, artificial neural networks, decision trees, and support vector machines are some examples of machine learning modes.
MEDICAL SIMULATION TECHNOLOGY
Simulation technology development is an important offshoot of medical informatics. The Medical Council of India (MCI) is also promoting and emphasizing the use of simulation technology for teaching undergraduates and postgraduates. The steady advances in patient activism and unfavorable teacher:patient:student ratios make simulation-based teaching imperative. Readers are encouraged to get accustomed to this exciting field of medical education. The flipside of utilization of applications such as YouTube, where vast amount of material may be available, is that there may be loss of authenticity and accuracy.
ELECTRONIC HEALTH RECORD
Though not exhaustive, a list of the components of an electronic health record (EHR) is mentioned in Figure 6. The ideal EHR allows for flexibility and inclusion of information pertaining to specific problems such as maternal conditions, neonatal outcomes, etc. Since pregnancy has both a discrete starting and ending point, obstetrics is one field where accuracy of EHR can be easily achieved.12
Ensuring Uniformity and Interuser Portability of Health Information and the Indian Perspective
One of the major disadvantages of the traditional method of health information process is the arbitrary manner in which data is collected. However, the informatics approach can also be plagued by arbitrariness if uniformity is not maintained.
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Successfully classifying “cause of death” was one of the initial successes of medical informatics. The use of the International Classification of Diseases (ICD), with its regular modifications, greatly helped in ensuring uniformity.
Now, each and every data set of health care informatics should undergo standardization (Table 5), as promulgated by the Ministry of Health and Family Welfare's (MoHFW) National Digital Health Blueprint 2017. This blueprint envisages “creation of a national digital health ecosystem that supports universal health coverage in an efficient, accessible, inclusive, affordable, timely, and safe manner, through provision of a wide-range of data, information and infrastructure services, duly leveraging open, interoperable, standards-based digital systems, and ensuring the security, confidentiality and privacy of health-related personal information”.13
POSITIVE IMPACT BY INFORMATICS ON OBSTETRIC AND GYNaECOLOGICAL PRACTICE
Cardiotocography/Electronic Fetal Monitoring
Can the dependence on paper be reduced? Can this be done on a handheld mobile device? Yes. Das et al.14 have proved in a Indian setting that there is good clinical accuracy and inter-rater agreement between interpretation of antepartum/intrapartum traces visualized conventionally and those on a mobile cardiotocography (CTG) device. The interobserver variability has been overcome by Sbrollini et al.,15 who have developed and validated automatic identification, interpretation, and classification of fetal heart rate (FHR) abnormalities using computerized algorithms. This is a rapidly evolving field.
Estimation of Fetal Aneuploidy Risk
A few decades ago, the only risk estimation of fetal aneuploidy was based on age. One of the major areas of success of health informatics is in the prediction of fetal aneuploidy risk. Using demographic, physical (examination), ultrasonographic, and biochemical parameters, multiple statistical analytics are done to determine risk ratios. However, it should be noted that machine learning approaches are likely to be even better than the conventional informatics approach.16
Cervical Cancer Screening
Cervical cancer screening has moved on from conventional smears to liquid-based cytology (LBC). Lack of skilled manpower has been cited as a major reason for inadequate coverage of screening. Feasibility of screening of patients at remote locations using smartphones by nurses has been demonstrated by Sharma et al.17 One skilled cytologist using a centralized computer can analyze thousands of images generated at different locations, enabling better coverage. Machine learning approaches are being studied and have been proven to be more accurate in Indian settings.18
Male Infertility
For over half a century, diagnosis has relied upon manual visual counting of spermatozoa of semen smeared over a slide. Computer-assisted analysis has helped recreate the volumetric three-dimensional spaces similar to the intrauterine milieu. This method has much higher accuracy than conventional analysis.19 Here again, machine learning models are in the nascent stage and further expansion is expected in the subject.20
Carcinoma Ovary
The development of a vast database of the molecular and genomic variations in serous ovarian cancer is a major contribution of medical informatics to our field. “Individuals with similarities in genetic makeup tend to respond better with some specific chemotherapeutic agents than the others”—is the simple principle applied. This is an example for “personalized medicine” or “precision medicine”.21 This individualization of treatment based on patient characteristics not only helps in improving accuracy, prevention of side effects but also in reduction of economic burden.
The application of “big data” in this context is exemplified by the establishment of data portals such as the “Clinical Proteomic Tumor Analysis Consortium (CPTAC)” portal. This is an online repository of all available clinical data including proteomic characterization, as a part of the Cancer Genome Atlas. Such open-source models give rise to hitherto unavailable opportunities for improvement of patient care.22 A completely online Indian National Cancer Registry Programme is also functional.23
National Registries
A contemporary example of the use of informatics in developing good data is the barrage of minute-by-minute facts and figures available online about the coronavirus disease 2019 (COVID-19) pandemic. To this end, FOGSI's National Registry on COVID-19 Infection in Pregnancy is an excellent tool which could be developed rapidly only due to informatics.24
TELEMEDICINE
Telemedicine can be defined as the “healthcare service delivery, distance being a critical factor, provided by healthcare professionals by utilizing information and communication technologies for the exchange of reliable information for diagnosis, management, and prevention of disease”. Telemedicine is the result of enhanced penetration of informatics into both the medical field and ease of availability by the population. The obvious advantages are quicker access to services, better healthcare delivery in remote areas, and feasible option during accidents, epidemics, and disasters. While in some situations like chronic diseases, long-term dependence on telemedicine is possible by interlinking patients, physicians, laboratories, and pharmacies; in some situations, like hypoglycemic episodes, short-term usage is appropriate. Telemedicine can be administered using short messaging services (SMS), voice messages over the phone, livestreaming over internet or suitable application platforms, or via email.
The National Medical Commission (erstwhile MCI) have published the “Telemedicine Practice Guidelines: Enabling Registered Medical Practitioners to Provide Healthcare Using Telemedicine” in March 2020.25
In this elaborate document, detailed definitions of the terms “telemedicine” and “telehealth” are provided. It is summarized that most consultations are in the form of:
- Providing health education as appropriate in the case; and/or
- Providing counseling related to specific clinical condition; and/or
- Prescription of medicines
The various tools for telemedicine are enumerated and a classification is provided:
- Timing of transmission of information [real-time (immediate)/asynchronous (late)]
- The purpose of the consultation (emergency/nonemergency)
- Interaction between the individuals [patient to Registered Medical Practitioner (RMP)/RMP to RMP/caregiver to RMP, etc.)].
Some salient principles that are to be kept in mind when using telemedicine are listed:
- Accurate identification of the patient using digital information like phone number/email ID is needed.
- Accurate verification of the doctors’ details such as qualifications and registration number is needed.
- Ascertaining that the patient is willing to abide for advice suggesting an in-person referral if the doctor deems fit, and in situations such as life-threatening emergencies, in-person consultation is needed.
- An appropriate form of consent (implied if patient initiates the consultation) has to be ensured.
- Adherence to the explicit details regarding medicine prescription should be ensured.
- Adherence to the tenets regarding medical ethics, data privacy (with respect to images and videos) and confidentiality should hold importance.
The strengths and limitations based on technical, financial, and feasibility issues are explained in the guideline. The commission has also proposed a compulsory training in telemedicine for all RMPs. Immaterial of which technological platform is used for communicating with the patient, the basic tenets of medical ethics which govern in-patient consultations, should be adhered to at all times. All RMPs are encouraged to familiarize themselves with this important document.25
CONCLUSION
Understanding the levels of EBM and learning how to utilize the available information is an essential skill set which should be learned by every practicing clinician. As the world uses digital platforms for more and more aspects of daily life, advances in information technology should also be assimilated and incorporated by every practitioner.
KEY MESSAGEs
The singular aim of clinicians is to offer the best care to their patients. Evidence-based medicine (EBM) is a systematic collation and rational presentation of clinical information gathered in settings all over the world. Simply put, it aims at answering questions like “In this patient, what works; what does not work?” EBM is “a lens” through which all medical information should be viewed. The use of modern advances in information technology in the improvement of patient care is “medical informatics”. The modern doctor should acquaint himself and embrace the exciting changes in this field.
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- Wang R, Pan W, Jin L, Li Y, Geng Y, Gao C, et al. Artificial intelligence in reproductive medicine. Reproduction. 2019;158:R139–54.
- Ministry of Electronics and Information Technology, Government of India. National digital health blueprint. [online] Available from: https://www.meity.gov.in/DeitY_e-book/e-gov_policy/download/Policy%20Document.pdf [Last accessed September, 2021].
- Ministry of Health and Family Welfare, Government of India. Electronic health record standards - 2016 for India. [online] Available from: https://www.nhp.gov.in/NHPfiles/EHR-Standards-2016-MoHFW.pdf [Last accessed September, 2021].
- Das MK, Tripathi R, Kashyap NK, Fotedar S, Bisht SS, Rathore AM, et al. Clinical validation of mobile cardiotocograph device for intrapartum and antepartum monitoring compared to standard cardiotocograph: an Inter-Rater Agreement Study. J Family Reprod Health. 2019;13(2):109–15.
- Sbrollini A, Carnicelli A, Massacci A, Tomaiuolo L, Zara T, Marcantoni I, et al. Automatic identification and classification of fetal heart rate decelerations from cardiotocographic recordings. Annu Int Conf IEEE Eng Med Biol Soc. 2018;2018:474–7.
- Yang J, Ding X, Zhu W. Improving the calling of non-invasive prenatal testing on 13-/18-/21-trisomy by support vector machine discrimination. PLoS One. 2018;13(12):e0207840.
- Sharma D, Rohilla L, Bagga R, Srinivasan R, Jindal HA, Sharma N, et al. Feasibility of implementing cervical cancer screening program using smartphone imaging as a training aid for nurses in rural India. Public Health Nurs. 2018;35(6):526–33.
- Talarczyk-Desole J, Berger A, Taszarek-Hauke G, Hauke J, Pawelczyk L, Jedrzejczak P. Manual vs. computer-assisted sperm analysis: can CASA replace manual assessment of human semen in clinical practice? Ginekol Pol. 2017;88(2):56–60.
- Goodson SG, White S, Stevans AM, Bhat S, Kao CY, Jaworski S, et al. CASAnova: a multiclass support vector machine model for the classification of human sperm motility patterns. Biol Reprod. 2017;97(5):698–708.
- Cojocaru E, Parkinson CA, Brenton JD. Personalising treatment for high-grade serous ovarian carcinoma. Clin Oncol (R Coll Radiol). 2018;30(8):515–24.
- Edwards NJ, Oberti M, Thangudu RR, Cai S, McGarvey PB, Jacob S, et al. The CPTAC data portal: a resource for cancer proteomics research. J Proteome Res. 2015;14(6):2707–13.
- National Cancer Registry Programme (Indian Council of Medical Research). Development of an Atlas of Cancer in India. [online] Available from: http://www.ncdirindia.org/ncrp/ca/about.aspx. [Last accessed September, 2021].
- FOGSI's National Registry on COVID-19 Infection in Pregnancy. [online] Available from: https://www.fogsi.org/fogsi-national-registry-on-covid-19-infection-in-pregnancy/ [Last accessed September, 2021].
- Ministry of Health and Family Welfare, Government of India. Telemedicine Practice Guidelines: Enabling Registered Medical Practitioners to Provide Healthcare Using Telemedicine. [online] Available from: https://www.mohfw.gov.in/pdf/Telemedicine.pdf [Last accessed September, 2021].
LONG QUESTIONS
1. What is evidence based medicine? What is meant by Levels of Evidence? Discuss the advantages, disadvantages and problems in applications of evidence based medicine in daily clinical practice.
2. What is a Randomized Controlled Trial? What are the features of a well-conducted Randomized Controlled Trial? Explain using practical clinical examples.
SHORT QUESTIONS
1. Discuss the role of information technology in medicine, with specific reference to obstetrics and gynaecology.
2. Evidence pyramid.
3. Publication bias.
MULTIPLE CHOICE QUESTIONS
1. The following are components of the Evidence Based Medicine Triad, except:
- Good Clinical Expertise
- Patient preferences and values
- Availability of medico-legal consultant
- Best available evidence from research
2. All statements about EBM are true, except:
- Introduced by Prof David Sackett in Canada
- Focusses on “trusting the experts”
- Focusses on “trusting the numbers”
- Is a gradual movement rather than a revolutionary change
3. Which of the following is true?
- Case series provide a good guide to clinical management of common conditions
- Case control studies are appropriate for rare diseases
- Retrospective study designs are equivalent to prospective study designs
- Expert opinions are usually consistent and homogenous
4. Which of the following is false?
- Randomized controlled trials form the “gold standard” in Evidence Based Medicine
- All topics in medicine can be resolved by Randomized Controlled Trials
- Systematic review of RCTs form the highest level of evidence available
- It is possible to classify different RCTs as having high probability of bias or lesser probability of bias
5. While obtaining the best evidence all these steps should be followed, except:
- Narrow down the clinical dilemmas into precise questions
- Fit the question into a PICOT format
- Search for evidence from the single best source
- Check for applicability of evidence obtained in the local setting
6. A clinician wants to check the usefulness of a new antihypertensive drug for management of preeclampsia. Regarding generation of good quality evidence, which one of the following statements is appropriate?
- Interviewing of many experts and noting their views and opinions about how the drug has performed in their patients is likely to yield good quality evidence
- Analysis of the clinical records of patients who have used the drug in the past one year is likely to yield the best evidence
- It would be acceptable to start the new antihypertensive drug for all forthcoming patients to generate good quality evidence
- Allocating few patients to the new drug and other patients to the existing gold standard drug is likely to generate good quality evidence
7. Artificial Intelligence/Machine Learning. Find the false statement:
- They can analyze patterns, predict and prognosticate clinical conditions
- There is standardization in data entry and data output.
- Data access is possible at locations by multiple individuals
- Providing more data reduces the accuracy of the machine learning process
8. All are true about Telemedicine, except:
- It ensures accessibility to remote areas also
- The usual tenets of ethical practice in medicine are applicable
- It should not be used for chronic diseases.
9. While reading and evaluating a published scientific medical article, which is appropriate:
- All published material should be given equal merit and accepted unconditionally
- It is acceptable to skip reading the analysis and look into only the conclusions
- Evidence generated on patients of different population groups should be extrapolated to local population with utmost caution
- A statistical significance of p<0.05 is considered absolute mathematical proof
10. With respect to the PICO methodology of forming a research question, choose the correct combination:
- P-Population, I-Information, C-Comparison, O-Outcome
- P-Population, I-Intervention, C-Comparison, O-Outcome
- P-Population, I-Information, C-Complication, O-Outcome
- P-Population, I-Intervention, C-Complication, O-Outcome
1. c | 2. b | 3. b | 4. b | 5. c | 6. d |
7. d | 8. d | 9. c | 10. b |
1.4 GOOD CLINICAL PRACTICE AND RESEARCH METHODOLOGY FOR OBSTETRICIANS
Ramalingappa C Antaratani, Sanjana K
INTRODUCTION
Today, clinical research is a necessity to establish the safety and efficacy of medical products and practices. All that we have known about the medical products or treatments have come from randomized control clinical trials. A general definition of human research is—“Any proposal related to human subjects including healthy volunteers that cannot be considered as a part of accepted clinical management or public health practice and the one that involves either physical or psychological intervention or observation; or collection, storage or dissemination of information related to individuals”.1 Before medical products are introduced to the market or to public health programs, they must undergo a series of investigations designed to evaluate the safety and efficacy and detailed information on the method of administration, dosage, contraindications, warnings, precautions, interactions, and safely information has to be documented.
The research work can be relied upon only if they have been conducted as per the principles and standards collectively known as “Good clinical research practice” (GCP). The responsibility of GCP is to be shared by the sponsors, investigators, site staff, contract research organizations (CROs), ethical committees, regulatory authorities, and the research subjects.
DEFINITION OF GOOD CLINICAL PRACTICE
Good clinical practice is an international ethical and scientific quality standard for designing, conduct, performance, monitoring, recording, auditing, analysis, and reporting of clinical trials. GCP assures that data and reported results are credible, accurate and that the rights, integrity, and confidentiality of trial subjects are respected and protected.2
HISTORY
It is interesting to know why and how the GCP were put forward. Like it is said “curiosity is the mother of discoveries”, many curious and enthusiastic researchers since a very long time carried out experiments on humans and animals. On a negative note, this led to disastrous effects on mankind including death due to unregulated and unlawful research activities. This made laws for carrying out research very much necessary. The events that led to the acts and the acts perse have been chronologically tabulated in Table 1.
INTERNATIONAL COUNCIL FOR HARMONISATION-GOOD CLINICAL PRACTICE
The International Council for Harmonisation-Good Clinical Practice (ICH-GCP) is defined as a harmonized standard that protects the rights, safety, and welfare of human subjects, minimizes the exposure of human beings to investigational products, improves the quality of data, speeds up marketing of new drugs and decreases the cost to sponsors as well as to the public.
REASONS FOR GOOD CLINICAL PRACTICE
- Increase in ethical awareness among the people
- Improved methods of clinical trials
- Better understanding of concept of clinical trial
- Public or political concern over the aspects of safety
- Frauds and accidents during the clinical trials
- Increasing research and development costs
- Increasing competition
- Mutual recognition of data
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PRINCIPLES OF ICH-GCP6
- Clinical trials should be conducted in accordance with ethical principles that have their origin from the declaration of Helsinki, and are consistent with GCP.
- Before a trial is initiated, probable risks and inconveniences should be weighed against anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits outweigh the risks.
- The rights, safety, and well-being of the trial subjects are the most important considerations and should be considered over the interest of science and society.
- The available nonclinical as well as clinical information on a particular investigational product should be adequate to support the proposed clinical trial.
- Clinical trials must be scientifically sound, and need to be described in a clear and detailed protocol.
- A trial should be conducted according to the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
- The medical care that is given the subjects and medical decisions made on behalf of subjects should always be the responsibility of a qualified physician.
- Each individual involved in conducting a particular trial should be qualified by education, training, and experience to perform his or her respective tasks.
- Freely given informed consent from every subject is a must prior to participation in clinical trials.
- The clinical trial information should be recorded, handled, and stored in a way that helps its accurate reporting, interpretation, and verification.
- The confidentiality of records which identify the subjects should be protected hence respecting the privacy and confidentiality of the subjects.
- Investigational products must be manufactured, handled, and stored in accordance with good manufacturing practice (GMP). They must be used in accordance with the approved protocol.
- Systems with procedures that can assure the quality of the trial should be implemented.
Ethical Principles of GCP
The ICH-GCP guidelines are considered the “Bible” of clinical trials and have become a global law which safeguards humanity, it has three basic ethical principles being:
- Respect for persons
- Beneficence
OVERVIEW OF THE CLINICAL RESEARCH PROCESS
The process of clinical research is guided by a sequence of activities for which the sponsors, investigators, ethics committees, and regulatory authorities are collectively responsible. Table 2 briefly describes the key activities involved in the conduct of a clinical trial and the individuals responsible for each of them.
TRIALS IN OBSTETRICS
Research in pregnant women is associated with scientific, legal, and ethical problems. The physiology of pregnancy changes drastically over weeks, months, and trimesters within and between the maternal body, placenta, and fetus. Attitudes of researchers toward inclusion of women in trials have changed grossly over the past few decades although a gap still exists in the available data on health and disease in pregnant women.
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Pregnancy Research: Historical Background of Exclusion
Pregnant women have often been kept away from trials, possible reasons include:
- Fear of harm to the fetus
- Concern about the complicated physiology of pregnant women
- Uncertainty whether pregnant women will consent to participate
- Labeling pregnant women as the “vulnerable” population7
Pregnant Women in Clinical Trials
- Problems with excluding women from research trials: Though there is concern that including pregnant women in the study of new drugs could harm the fetus, it is also true that excluding pregnant women from research also can lead to considerable harm. The best example that can be quoted in this context is teratogenicity due to thalidomide leading to >10,000 adverse pregnancy outcomes; had it been studied in pregnant women before it was released in the market, the disaster would not have occurred.8Another apt example that can be quoted in the current scenario is the “the exclusion of pregnant and lactating women from coronavirus disease 2019 (COVID-19) vaccine”. This represents a missed opportunity for the protection of a huge group at risk for COVID-19 that is—pregnant and puerperal women. This exclusion cannot be justified as Pfizer and Moderna excluded pregnant and lactating women from their mRNA COVID-19 vaccine trial with no evidence to suggest that the vaccine could be teratogenic or could be secreted in breast milk.9
- Nonpregnancy-related interventions that benefit a woman during pregnancy: With increasing number of pregnancies in old age, there has been a proportionate increase in the incidence of medical disorders in pregnancy. A significant proportion of the pregnant women undergo therapies aimed at managing nonobstetrics medical conditions most of which have not be studied specifically in pregnancy.10 Had these drugs been adequately studied in pregnant women, we would have an opportunity to balance the risks and benefits of their use.
- Interventions directly related to pregnancy: Pregnancy is the only opportunity to conduct studies related to interventions in pregnancy like tocolysis, prevention on preterm birth, and so on. Research during pregnancy and labor is the only way to improve care for women and their newborns.
- Paternal consent issues: Consent of the pregnant woman alone is sufficient in most cases whereas, consent of the father is also required in cases where there is a chance of significant benefit or harm to the fetus. However, the regulations regarding this are controversial.11
- Trials on lactating women: When we consider exposure of a breastfed infant to a risk, the research must not involve “greater than minimal risk” unless the research would provide generalizable knowledge about the child's disorder or condition. All clinical lactational studies should define the risks to the breastfed infant that occur only as a result of the research and obtain informed consent from the lactating woman.
During the Office of Research on Women's Health (ORWH) workshop in 2010, the present status of research involving pregnant women and its future needs were discussed and a few recommendations were put forward:12
Recommendation 1: Define Pregnant Women as a Scientifically Complex and Change the Presumption of Exclusion
- Pregnant women should be reclassified from their present status as “vulnerable group” to that as a medically complex population necessitating special scientific and ethical considerations.
- Pregnant women are a dynamic subset of women in whom as physiological changes of pregnancy can alter a drug's pharmacokinetics and efficacy. Treatment of conditions in pregnant women has to optimize results for the maternal-fetal pair.
Recommendation 2: Clarify Existing Regulations and Focus on IRB as it Facilitates or Impedes Pregnancy Research
There is a need for clarifying the regulations governing the inclusion of pregnant women and fetuses in clinical research and for increasing the consistency among IRBs in decision-making procedures.
Recommendation 3: Develop a Pregnancy Research Agenda
- A pregnancy research agenda should include the following: research to promote evidence-based clinical practice, identification of questions that can be addressed with existing data and through ongoing studies, identification of new studies in high scientific impact areas
- Promotion of evidence-based clinical practice
- Capitalizing on existing studies and resources.
LANDMARK TRIALS IN OBSTETRICS
What is a Landmark Trial?
- A trial which has made an impact on our understanding of a disease.
- A trial which has caused a dramatic change in our approach to a clinical condition.
- A trial which has changed our management of a disease.
- A trial which has changed our clinical practice.
The following is a list of some of the landmark trials in obstetrics:
- Antenatal steroid trial: A controlled trial of antepartum glucocorticoid treatment for prevention of the respiratory distress syndrome in premature infants (Liggins GC, Howie RN. Pediatrics. 1972;50(4):515-25.) → Early neonatal mortality was found to be 3.2% in the steroid-treated group compared to 15% in the control group.
- The eclampsia trial: Study on the choice of anticonvulsant for women with eclampsia: evidence from the Collaborative Eclampsia Trial. The Eclampsia Trial Collaborative Group (Lancet. 1995:345(8963);1455-63.) → There is compelling evidence for the use of magnesium sulfate over phenytoin or diazepam for eclampsia.
- MAGPIE trial: Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie trial: a randomized placebo-controlled trial (Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, et al. Lancet. 2002;359(9321):1877-90.) → Concluded that magnesium sulfate halves the risk of eclampsia and probably reduces the risk of maternal death.
- Term breech trial: Planned cesarean section compared to planned vaginal birth for breech presentation at term: a randomised multicentre trial (Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Lancet. 2000;356(9239):1375-83.) → Concluded that planned C-section is better than planned vaginal delivery for a term fetus in breech presentation.
- ASPRE trial: Combined multimarker screening and randomized patient treatment with low-dose aspirin: evidence-based preeclampsia prevention trial (Rolnik DL, Wright D, Poon LC, Syngelaki A, O'Gorman N, de Paco Matallana C, et al. Ultrasound Obstet Gynecol. 2017;50(4):492-5.) → Estimated detection rate of screening using the stated factors was 77% for preterm preeclampsia and administration of aspirin 150 mg to high-risk group resulted in 62% decrease in the incidence of preterm preeclampsia.
KEY MESSAGES
- Clinical research is a necessity to establish the safety and efficacy of medical products and practices.
- Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.
- GCP assures that the data and reported results are credible, accurate and that the rights, integrity, and confidentiality of trial subjects are respected and protected.
- The ICH-GCP guidelines have become a global law which safeguards humanity, it has three basic ethical principles being: (1) respect for persons, (2) beneficence, and (3) justice.
- Pregnant women should be reclassified from their present status as “vulnerable group” to that as a medically complex population necessitating special scientific and ethical considerations—research in pregnancy to be encouraged.
REFERENCES
- World Health Organization. Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation. Geneva: World Health Organization; 2005.
- Malaysian Guidelines for Good Clinical Practice, 2nd edition. Ministry of Health Malaysia: National Committee for Clinical Research (NCCR); 2004.
- Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181–2. Washington DC: U.S. Government Printing Office; 1949. [online] Available from: https://www.loc.gov/rr/frd/Military_Law/pdf/NT_war-criminals_Vol-II.pdf [Last accessed September, 2021].
- World Medical Association. (2004). Declaration of Helsinki 2004; [online] Available from: https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/doh-oct2004/ [Last accessed September, 2021].
- The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. 1979.
- European Medicines Agency. ICH Harmonised Tripartite Guideline E6: Note for Guidance on Good Clinical Practice (PMP/ICH/135/95). London: European Medicines Agency; 2002.
- Blehar MC, Spong C, Grady C, Goldkind SF, Sahin L, Clayton JA. Enrolling pregnant women: issues in clinical research. Womens Health Issues. 2013;23(1):e39–45.
- Kim JH, Scialli AR. Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicol Sci. 2011;122:1–6.
- Van Spall HG. Exclusion of pregnant and lactating women from COVID-19 vaccine trials: a missed opportunity. Eur Heart J. 2021;42(28):2724–6.
- Daw JR, Mintzes B, Law MR, Hanley GE, Morgan SG. Prescription drug use in pregnancy: a retrospective, population-based study in British Columbia, Canada (2001–2006). Clin Ther. 2012;34:239-49.e2.
- US Department of Health and Human Services. Protection of human subjects. 45 CFR part 46. 2014.
- US Department of Health and Human Services, Public Health Service, National Institutes of Health, Office of Research on Women's Health. Enrolling Pregnant Women: Issues in Clinical Research. Bethesda, MD: National Institutes of Health; 2011.
LONG QUESTIONS
1. Describe in detail the history, reasons for recommendation, and the basic ethical principles of ICH-GCP.
2. Explain the key activities in the conduct of a clinical trial.
3. Define ICH-GCP. Add a note on the recommendations for research in obstetrics and the challenges faced in obstetric trials.
SHORT QUESTIONS
1. Define GCP recommendations. Why are they required?
2. What are the three basic ethical principles of ICH-GCP?
4. State three reasons why pregnant and lactating women have been excluded from most trials.
5. What are the challenges faced by the researcher in obstetric trials?
6. What are landmark trials? Name a few landmark trials in obstetrics.
7. Why are GCP recommendations necessary?
8. Write a brief note on the history and evolution of the GCP recommendations.
9. Write a note on recommendations for research in obstetrics.
MULTIPLE CHOICE QUESTIONS
1. A clinical trial refers to experiments on:
- Animals
- Healthy human volunteers
- Humans with disease
- Both healthy and diseased human beings
2. The current GCP guidelines have been derived from:
- The Hippocratic oath
- Kefauver–Harris amendment
- Declaration of Helsinki
- The Belmont report
3. Which of the following is false regarding the reasons for GCP?
- Increased ethical awareness
- Improved clinical trial methods
- Better understanding of clinical trial concept
- Decreasing competition
4. Which of the following is false regarding the Kefauver–Harris amendment?
- It was passed in 1962
- It was done in response to severe fetal limb deformities linked to the use of maternal thalidomide
- It forms the basis of the current GCP recommendations
- It requires the FDA to evaluate all new drugs for safety and efficacy
5. Development of standard operating procedures (SOPs) for a clinical trial is done by:
- Sponsors
- Clinical investigators
- Ethics committees
- All of the above
6. In a clinical trial, which of the following is not a responsibility of the sponsors?
- Ethics committee review and approval of the protocol
- Development of support systems and tools
- Generation and approval of trial-related documents
- Selection of properly qualified, trained, and experienced investigators and study personnel
7. The term breech trial compared:
- Planned vaginal delivery and planned cesarean section (C-section) in term pregnant women with fetus in breech presentation
- Planned vaginal delivery versus emergency C-section in term pregnant women with fetus in breech presentation
- Spontaneous unplanned vaginal delivery versus emergency C-section in term pregnant women with fetus in breech presentation
- Spontaneous unplanned vaginal delivery versus planned C-section in term pregnant women with fetus in breech presentation
8. Which of these is the right description of a landmark trial?
- A trial which has made an impact on our understanding of a disease
- A trial which has caused a dramatic change in our approach to a clinical condition
- A trial which has changed our management of a disease
- All of the above
9. Which of these is not a basic ethical principle of ICH-GCP?
- Respect for persons
- Confidentiality
- Beneficence
- Justice
10. Which of the following is not a recommendation for clinical trials in pregnant women?
- Define pregnant women as a scientifically complex and change the presumption of exclusion
- Clarify existing regulations and focus on IRB as it facilitates or impedes pregnancy research
- Consider the pregnant as “vulnerable” group and avoid clinical trials on them
- Develop a pregnancy research agenda
11. What are the challenges in obstetric trials?
- Dynamic physiology of pregnancy
- Possibility of teratogenicity to the fetus
- Less cooperation and consent by the women
- All of the above
12. Which of the following is false as per the ICH-GCP?
- The medical care given to the subjects and medical decisions made on behalf of subjects should always be the responsibility of a qualified physician.
- Each individual involved in conducting a particular trial should be qualified by education, training, and experience.
- Informed consent from subjects is not necessary prior to participation in clinical trials.
- All clinical trial information should be recorded, handled, and stored in a way that helps its accurate reporting, interpretation, and verification.
1. d | 2. c | 3. d | 4. c | 5. d | 6. a |
7. a | 8. d | 9. b | 10. c | 11. d | 12. c |
Bhavik Doshi, Ashvin Vachhani
INTRODUCTION
Female reproductive tract can be divided into external genitalia and internal genitalia. The external genitalia (Fig. 1) include labia minora, labia majora, clitoris, vestibule, greater vestibular glands, and bulbs of vestibule. Internal organs include uterus, cervix, fallopian tubes, and ovary.
Vulva includes mons pubis, labia majora and minora, clitoris, hymen, and vestibule. Blood is supplied from branches of internal pudendal artery and superficial external pudendal artery. Venous return is internal pudendal vein and long saphenous vein. Lymphatic is drained from vulva into superficial inguinal nodes, deeper tissues to internal iliac nodes. Nerve supply to vulva is anteriorly ilioinguinal and genital branch of genitofemoral nerve (L1–L2), posteriorly pudendal branches of posterior cutaneous nerve of thigh (S1–S3), and pudendal nerve (S2–S4).
Mons pubis: It is fibrofatty tissue that produces the rounded elevation just in front of pubic symphysis. The pubic hair grows over the mons pubis at the onset of puberty.
Labia majora: It is homologous with scrotum in male. It is rounded fold of skin, narrow behind where it reaches to anus, but as it passes forward, becomes increasing in size. Anteriorly it meets in midline at anterior commissure and ends in median elevation as mons pubis. Laterally it contains numerous sebaceous glands and medially it is smooth and covered by delicate cutaneous covering. It does not contain any muscle fiber as we found in scrotum. Posteriorly it is connected across the midline in front of anus, by the posterior commissure.
Labia majora hide the pudendal cleft and opening of urethra and vagina are in cleft. The round ligament of uterus is attached to skin and fibrofatty tissue of labium majus.
It develops from genital swellings. The ilioinguinal nerve supplies anterior part of majora and pudendal nerve supplies posteriorly.
Labia minora: They are a pair of fat-free narrower longitudinal folds of skin usually completely hidden in between the cleft of labia majora. When traced it forward, it splits into two parts upper and lower in relation to clitoris. The upper layer of both sides covers the upper surface of glans clitoris is known as prepuce of clitoris. The lower layer of both sides covers the lower surface of glans is known as frenulum of clitoris. Frenulum of vestibule is a fold which lies posteriorly where two sides of labia minora meet.
Developmentally, it resembles fused ventral surface of the penis and the floor of the spongy urethra.
Vestibule: It is a space between two labia minora where opening of urethra and vagina lies. The urethral opening has a vertical slit or inverted V-shaped appearance situated 2.5 cm behind the glans. The vaginal opening is H-shaped and covered by hymen. Hymen is a muscular fold projecting into vaginal opening and its margin is smooth in outline. But when margin is fissured during sexual act, it is known as caruncula hymenalis. The greater vestibular gland opens on either side of opening of vagina in vestibule.
Clitoris: It resembles the penis of male only difference is that it is not traversed by urethra. The body of clitoris is made up of erectile tissue and tapering anteriorly. It is made up 38of pair of corpora cavernosa which form crura near the root of clitoris. A glans is mass of erectile tissue present over the pointed end of the body and covered by sensitive epithelium. The crus is attached to pubic arch. Each crus is continuous with firm fibrous fascia which is covered by corresponding ischiocavernosus muscle.
The crus is supplied by deep artery of the clitoris, a branch of internal pudendal artery. The dorsal arteries of clitoris supply the glans. The nerve supply is from inferior hypogastric plexuses and partly from dorsal nerves of clitoris which are branches from pudendal nerves.
Bulbs of vestibule:They are a pair of erectile tissue which lies in the lateral wall of the vagina and lower surface of perineum. They are elongated masses which are pointed anteriorly and separated by vaginal and urethral opening anteriorly. They are covered by bulbospongiosus superficially.
Greater vestibular glands (Bartholin's glands) (Fig. 2): They are a pair of mucus-secreting tubule—alveolar glands similar to bulbourethral gland situated in superficial perineal pouch and its ducts open into each side of vaginal orifice below the hymen. Each is about size of small bean and having long slender ducts which pierce the perineal membrane. It is involved in acute gonorrhea. Blockage of its duct due to recurrent infection can lead to Bartholin's cyst/abscess.
Hymen: It is a delicate incomplete membrane at the entrance of vagina. It has one or more apertures for blood flow. It is generally avascular. Imperforate hymen can lead to cryptomenorrhea and requires surgical incision.
Vagina: It is a highly distensible muscular passage of about 9 cm size. It is directed upward and backward having slight convex curve forward. It makes 90° angle with uterus. The cervix enters vagina through its upper part in anterior wall. The more posterior portion of cervix is inserted in vagina then its anterior portion, so recess (fornix) between vaginal wall and cervix is deep in posterior part. This is anterior recess, posterior recess, and lateral recess in relation to cervix and vagina. The anterior wall of vagina is about 7.5 cm, whereas the posterior wall is about 9 cm.
Anteriorly vagina is related from above downward to cervix, base of urinary bladder, and terminal parts of ureters separated by loose areolar tissue. It is also related anteriorly to urethra.
Posteriorly vagina is related from above downward to rectouterine peritoneal pouch for upper one-third part then to ampulla of rectum which is separated from vagina by rectovaginal fascia. In lower one-third part, it is related posteriorly to perineal body.
Laterally, it is related to root of broad ligament, and crossing of ureter by uterine vessels. Levator ani muscle forms slings surrounding vagina and forms the sphincter vaginae. Still lower it is related to greater vestibular gland, bulb of vestibule, and bulbospongiosus muscle (Fig. 3).
It is made up of serous coat derived from peritoneum on its outward aspect, then fascial coat derived from endopelvic fascia and inner muscular coat. There are two muscle layers—outer longitudinal and inner circular layer of smooth muscle. Still internally it is lined by nonkeratinized stratified squamous epithelium and is devoid of mucus glands.
The Doderlein's bacilli are normal inherent of vagina and produce lactic acid so vaginal fluid is acidic in reaction having pH 4–5.
The arterial supply is from vaginal artery, vaginal branches from uterine artery, the vaginal branches of the middle rectal artery, and the branch of internal pudendal artery.
The lymphatic from upper two-thirds drains into internal iliac nodes and lower one-third drains into upper superficial inguinal nodes in the groin.
Defects in the supports of vagina can lead to anterior and posterior vaginal wall prolapsed, stress incontinence, and vault prolapsed after hysterectomy.
Pelvic hematoma: Collection of blood anywhere between pelvic peritoneum and perineal skin is known as pelvic hematoma. It may be infralevator or supralevator hematomas. Infralevator is common.
Vulval hematoma is the common infralevator hematoma which may be due to vaginal tears, episiotomy (apex not sutured), and rupture of paravaginal venous plexus during instrumental delivery. It can cause pain, swelling, and rectal tenesmus. Exploration in operation theater under anesthesia is done, bleeders are secured, dead space is obliterated by deep mattress sutures.
Supralevator hematoma can occur due to extension of cervical tears, colporrhexis, and rupture of lower segment of uterus. It can cause pain late, bladder tenesmus, unexplained shock, uterus pushed to contralateral side, boggy swelling in Figures 4 and 5. Laparotomy is performed to treat it, anterior leaf of broad ligament is opened and then bleeders are sutured. If needed, anterior division of internal iliac artery is ligated.39
UTERUS
It is a pyriform-shaped hollow muscular organ situated in lesser pelvis and projects upward and forward above the bladder. In nulliparous uterus, the length of the uterus is about 7.5 cm. It divided into fundus, body, and cervix. The ratio of body, fundus with cervix is 2:1 in adults and 1:2 in children. The uterine cavity is about 6 cm long and weight of the uterus is 30–40 g.
The axis between the cervix and that of vagina measuring about 90° is called anteversion. The normal uterus lies in pelvic cavity and slightly inclines laterally frequently on left side. The uterus corresponds with the axis of pelvic inlet and vagina corresponds with the axis of the pelvic outlet. This position (anteversion) is maintained by forward pull of round ligament and backward pull of the cervix by uterosacral ligament.
The cervix is continuous with the wall of vagina and makes 125° angle with that of body of uterus is called anteflexion. The transverse axis passes through internal os.
Lower segment of the uterus: Anatomically, it is a part which lies below the uterovesical fold of the peritoneum. Physiologically, it is a part which passively stretches in labor and takes hardly any active contractile part in expulsion of fetus. Taking up of lower segment of uterus is a very important event during progress of labor. It facilitates labor process.
Parts of the Uterus
Fundus: The expanded upper part of uterus lying above the opening of uterine tube is called fundus.
Body or corpus: It is a triangular part which lies between fundus above and isthmus below. Body has anteroinferior or vesical surface and posterosuperior or intestinal surface and these two surfaces are separated by right and left borders. 40The length, breadth, and thickness of body are 5 cm, 5 cm, and 2.5 cm, respectively. The uterine cavity is a vertical slit on sagittal section. The cavity of body is triangular on cross section, the base is formed by line joining opening of uterine tube and apex is by internal os.
The peritoneum from the superior surface of bladder is reflected posteriorly on vesical surface of uterus (up to isthmus) and then covers the intestinal surface of uterus (up to posterior fornix of vagina) and projects to anterior wall of rectum. The vesicouterine pouch and the rectouterine pouch are formed by above reflections, respectively. The deepness of rectouterine pouch is 7.5 cm or just above the anus. The peritoneum reflections on uterus are extended laterally on the lateral pelvic wall from its lateral borders as an extensive peritoneal fold which is known as the broad ligament of uterus. The round ligament of uterus and ligament of ovary are attached to uterus just below the opening of uterine tube anteroinferiorly and posterosuperiorly, respectively. These three structures are all enclosed in broad ligament near its upper free end.
The anterior part of broad ligament is drawn forward by the round ligament of uterus, which is a narrow flat band of fibrous tissue, extending from lateral border of uterus, crossing the obliterated umbilical artery and external iliac vessels, and reaches to deep inguinal ring. Here, it hooks around the lateral side of inferior epigastric artery and traversing the inguinal canal and ends in subcutaneous tissue of the labium majus. The ligament of ovary is a round fibrous band extending from uterus to ovary.
The part of broad ligament between the ligament of ovary, the ovary and uterine tube is known as mesosalpinx. The lateral part of mesosalpinx is freer and permits posterior curve of lateral end of uterine tube around the ovary. The mesosalpinx contains epoophoron and paroophoron and the anastomosis between the uterine and ovarian arteries. The ovary is attached to posterior layer of broad ligament by mesovarium.
Layers of the uterus: Uterus has mainly three layers: (1) serous, (2) muscular, and (3) endometrium. Serous is formed by the peritoneum which covers the anterior two-thirds and whole of posterior surface.
Muscular is middle layer which consists of smooth muscle cells, arranged in three layers—outer in longitudinal, inner in circular, and middle interlacing muscles.
Endometrium is a mucosal layer lining uterus cavity. Endometrium is directly apposed to the muscle coat. It is the inner most layer with thickness of 1–10 mm based on different days of menstrual cycle. Thickness varies due to repetitive cyclic changes (Fig. 6). It has two layers: (1) functional and (2) basal. It consists of surface epithelium glands and interglandular tissue, columnar epithelium dips to form tubular or spiral glands. Basal one-third of it is supplied by small straight and short artery and superficial two-thirds by coiled artery. Excessive thin endometrium compare to the day of menstrual cycle can cause problem with implantation of fertilized ovum and can cause infertility.
Cervix: It is a part below the internal os and separated from body of uterus by constriction, isthmus. It contains the cervical canal which communicates the uterine cavity with the vagina. It is divided into supravaginal and vaginal parts as it opens into vagina. The external os through which it opens into vagina has anterior and posterior lips. The cervicovaginal junction is strengthened by condensed bands of parametric tissue which extends to lateral pelvic walls. A pair of Mackenrodt's ligaments laterally, a pair of uterosacral ligaments posteriorly, and a pair of bulbocervical ligaments anteriorly help in positioning of cervix and prevent downward displacement of the uterus through the vagina.
Relations of uterus: Anteriorly above the internal os, the body forms the posterior wall of vesicouterine pouch and below the internal os, it separates from the base of the bladder by the loose areolar tissue. Posteriorly, it forms anterior wall of pouch of Douglas containing coils of intestine. Laterally, it is related to broad ligament of uterus with its contents. Laterally, cervix is also related to ureter where it is crossed superiorly by uterine arteries.
Ligaments of Uterus
They are true and false ligaments which support the uterus and prevent its prolapsed. There are eight fibromuscular bands which are true ligaments and six peritoneal folds which are false ligaments.
Round ligaments of uterus, Mackenrodt's ligaments, uterosacral ligaments, and pubocervical ligaments are true ligaments in which round ligaments discussed earlier.
The Mackenrodt's or transverse cervical ligaments form a fan-shaped fibromuscular band extending from cervicovaginal junction to the fascia covering the levator ani muscle. It is related above with the broad ligament and crossing of uterine artery over ureter.41
The uterosacral ligaments extend from the cervix to the 3rd sacral vertebra and help in anteversion and anteflexion position of uterus.
The pubocervical ligaments extend from the cervix to pubic bone and pull the uterus forward.
The levator ani muscle, urogenital diaphragm, perineal body, and superior surface of urinary bladder give support to uterus from below.
FALLOPIAN TUBE
It is a hollow tube, two in number transporting ova from ovary and sperm from uterus for fertilization. It is about 10 cm in length, extending from lateral angle of uterus to ovary in upper part of broad ligament of uterus. It is more or less transversely placed in upper free margin of broad ligament having curve in lateral part.
It has four parts from lateral to medial: (1) infundibulum, (2) ampulla, (3) isthmus, and (4) intramural part.
The infundibulum is lateral end of fallopian tube around 1 cm in length and 3 mm in diameter. It is in contact with ovary through its fimbriae. One of the fimbriae is long enough to reach the surface of ovary which is known as ovarian fimbriae.
The ampulla is thin-walled, dilated, and tortuous 5 cm long part of fallopian tube having 4 mm diameter. Fertilization takes place in ampulla. The isthmus is about 3 cm in length and 2 mm in diameter. It is succeeded by intramural part which is 1 cm in length, 1 mm in diameter and passes through the muscle layer of uterus.
Microscopically, from outside to inside, it is made up of parietal layer, muscle layer, and inner mucous membrane. The muscle layer consists of outer longitudinal and inner circular smooth muscle. Mucous layer is made up of ciliated columnar cell showing primary, secondary and tertiary longitudinal folding.
It is supplied by uterine and ovarian artery which forms anastomoses below the fallopian tube in broad ligament of uterus.
Lymphatics drain into preaortic and lateral aortic group of lymph node except that of intramural part which drains into superficial inguinal group of lymph node.
Developmentally, it is derived from upper vertical part of paramesonephric or Müllerian duct.
Clinical importance: Acute infection of fallopian tube is known as salpingitis and it is responsible for most common cause for tubal block and subsequent infertility. Fallopian tube is the most common site for ectopic pregnancy. Tubectomy/tubal ligation is the permanent method of female contraception.
OVARY
It is a pair of female reproductive glands situated in lesser pelvis in ovarian fossa. Ovarian fossa is bounded anteriorly by obliterated umbilical artery, behind by ureter and internal iliac artery.
Dimensions: 3 cm vertical, 2 cm transverse, and 1.5 cm anteroposterior diameter.
External features: It is almond-shaped. In nulliparous women, it is vertically situated. Each ovary has two ends (tubal and uterine), two borders (mesovarium or anterior and free or posterior), two surfaces (medial and lateral). The upper end is in relation with fallopian tube which arches over the ovary. The upper end of ovary and infundibulum is attached to lateral pelvic wall by double fold of peritoneum known as infundibulopelvic ligament or suspensory ligament of ovary. The lower end of ovary is attached to uterus by ligament of ovary. The anterior border is attached to posterior layer of broad ligament through peritoneal fold which acts as a hilum through which ovarian vessels and nerves pass. Free posterior border is in relation with fallopian tube in its upper part. Medial surface is convex and related in its upper part with ovarian fimbriae. The lateral surface lies in ovarian fossa.
The blood supply of ovary is by ovarian artery which is a branch of abdominal aorta. It runs into suspensory ligament of ovary then into mesovarium and then it reaches to ovary.
Lymphatics drain into lateral and preaortic group of lymph node.
Structure of Ovary (Fig. 7)
Its surface is covered by a single layer of cubical cells that constitute the germinal epithelium. But it does not produce germ cells. The substance is divided into cortex and medulla. In cortex, it contains various stages of development of ovarian follicles. Each follicle contains developing ovum. The medulla consists of connective tissue in which numerous blood vessels, elastic fibers, and smooth muscles are seen. It contains the Graafian follicle, which undergoes ovulation.
Developmentally, the ovary is developed from the middle part of the genital ridge. It is bulging of coelomic mesothelium covering the medial surface of the mesonephric ridge. The primitive sex cells derived from the dorsal wall of hindgut by the proliferation of the endodermal cells.
Clinical importance: Ovulation study is important clinical aspect in infertile women and usually done by transvaginal ultrasonography (USG). Various drugs are used for ovulation induction. Abnormal ovarian function can lead to various types of functional ovarian cysts like follicular cyst, corpus luteal cyst, theca-lutein cysts, etc. Many types of benign and malignant tumors may arise from ovary.
Muscles of pelvic region: The piriformis and obturator internus form part of lateral wall of pelvis and they are considered as muscles of lower limb. The levator ani and coccygeus muscles form pelvic diaphragm which in turn forms the floor of true pelvis. It forms partition between the pelvic cavity and perineum.
Two muscles are levator ani and coccygeus. Morphologically, they are considered as single muscular unit and divided into three parts: (1) pubococcygeus, (2) iliococcygeus, and (3) ischiococcygeus from before backward.
Pubococcygeus arises from posterior surface of body of pubis and anterior part of white line. It passes backward, downward and medially, and anterior most fibers form sling around the posterior wall of vagina and inserted on perineal body. Some fibers are inserted in wall of anal canal and called puboanalis. Puborectalis fibers wind the posterior part of anorectal junction and form puborectal sling and continue with deep part of external anal sphincter.
The iliococcygeus arises from the posterior part of the white line on the obturator fascia and from ischial spine and inserts into anorectal raphe and side of lower two pieces of coccyx.
The ischiococcygeus arises from ischial spine and sacrospinous ligament and inserts into side of upper two pieces of coccyx and last piece of sacrum.
Pubococcygeus and iliococcygeus are supplied by 4th sacral nerve and perineal branch of pudendal nerve and ischiococcygeus is supplied by 4th and 5th sacral nerves.
Pelvic fascia: There are two types of pelvic fascia: (1) parietal fascia and (2) visceral fascia.
The parietal fascia covers the lateral pelvic wall to form strong membrane. Here, it forms obturator fascia over obturator internus muscle. Obturator fascia shows linear thickening for the origin of levator ani muscle. The fascia covering piriformis is thin and beyond the muscle it attaches to periosteum.
The parietal fascia covers the both superior and inferior layer of pelvic diaphragm.
The visceral layer surrounds the pelvic viscera loosely and allows the distention of bladder, rectum, and vagina.
Perineal body: It is a fibromuscular node situated about 1.25 cm in front of the anal margin. Most of muscles of perineum converge to insert on it.
Clinical importance: Injury to perineal body, pelvic fascia and/or pelvic diaphragm may occur during difficult childbirth, which may lead to uterine prolapsed, vaginal prolapsed, rectal prolapsed, stress urinary incontinence or fecal incontinence.
INTERNAL ILIAC ARTERY (FIG. 8)
The internal iliac artery is the smaller terminal branch of the common iliac artery which supplies all pelvic organs except those supplied by superior rectal, ovarian and median sacral arteries.
Course: It begins in front of the sacroiliac joint where it lies medial to the psoas muscle. The artery runs downward and backward, and ends near the upper margin of the greater sciatic notch, by dividing into anterior and posterior divisions.43
Branches of anterior division: (1) superior vesical, (2) obturator, (3) middle rectal, (4) vaginal artery, (5) inferior gluteal, (6) internal pudendal, and (7) uterine artery.
Branches of posterior division: (1) iliolumbar, (2) two lateral sacral, and (3) superior gluteal.
Clinical importance: Bilateral or unilateral ligation of the IIA is a lifesaving surgical procedure to stop pelvic hemorrhage (Fig. 9). Bilateral ligation of IIA reduces the pelvic arterial blood flow by 49% and pulse pressure by 85% which allows clot formation at bleeding site. After bilateral IIA ligation in a long-term period, the collateral circulation will maintain the refunctioning of the IIA. This procedure is commonly used for stoppage of bleeding in case of uncontrolled atonic postpartum hemorrhage (PPH), broad ligament hematoma, advance cervical cancer with intractable bleeding, and uncontrolled intraoperative or postoperative bleeding.
PELVIC URETERS
Anatomy: The ureter is a tubular viscus about 25 cm long, divided into abdominal and pelvic portion of equal length, made up of inner longitudinal and outer circular muscle layers. It enters in pelvis by passing over the bifurcation of the internal and external iliac arteries (Fig. 10), just medial to the ovarian vessels. During in its course through the cardinal ligaments, ureter crosses under the uterine artery (“water under bridge”). At this point, it lies along the anterolateral surface of the cervix, about 1 cm from it. Then it passes to lie on the anterior vaginal wall and enters into the bladder.
During its pelvic course, the ureter receives blood from the common iliac, internal iliac, uterine, and vesical arteries.
Fig. 9: Ureter (lifted with artery forceps, black arrow) crossing the internal iliac artery (green arrow).
44Clinical importance: Ureteric injuries have been recognized as potential complications of gynecologic surgery in nearly 1–2% of cases. It can occur during many gynecological surgeries like total laparoscopic hysterectomy (TLH), total abdominal hysterectomy (TAH), adnexal surgery, retropubic surgery, radical pelvic surgery. Sound knowledge of ureteral anatomy is crucial to the avoidance of injury.
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Bony pelvis: It is formed by two hip bones: (1) sacrum and (2) coccyx. The pelvis can be described to have the following three major planes:
- Pelvic inlet: The line between the narrowest bony points formed by the sacral promontory and the inner pubic arch is termed obstetrical conjugate. It should be 11.5 cm or more. This anteroposterior line at the inlet is 2 cm less than the diagonal conjugate (distance from undersurface of pubic arch to sacral promontory). The transverse diameter of the pelvic inlet measures 13.5 cm. The pelvic inlet divides the pelvic cavity into upper part—greater or false pelvis and lower part—lesser or true pelvis. The pelvic inlet is obliquely placed and makes 50–60° angle with horizontal plane.
- Midpelvis: The line between the narrowest bone points connects the ischial spines; it typically exceeds 12 cm. The importance of the ischial spine known as obstetric plane is manifold. Plane at this level is of the least pelvic dimensions. The levator ani muscles are situated at this level. The obstetric axis of the pelvis changes its direction. The head is considered engaged when it is felt at or below 45this level. Internal rotation of the head occurs when the occiput is at this level. Forceps is applied only when the head is below it. Pudendal nerve block is carried out at this level.
- Pelvic outlet: The distance between the ischial tuberosities (normally > 10 cm), and the angulation of the pubic arch.The conjugate diameter is distance from midpoint of sacral promontory to upper margin of pubic symphysis. It is about 11 cm in female. The transverse diameter is widest measurement of inlet.So, according to pelvic brim index that is conjugate diameter of brim × 100/widest transverse diameter, we divide the pelvis into four types.Dolichopellic or anthropoid, when the conjugate diameter is greater than the transverse diameter. Platypellic, when the transverse diameter is much greater than the conjugate diameter. Mesatipellic or gynecoid, when the transverse diameter is slightly greater than the conjugate diameter as in normal female. Brachypellic or android type which resembles to male pelvis. In all above types, only mesatipellic permits normal delivery and others are considered as contracted pelvis.
CLINICAL PELVIMETRY
- It is also known as internal pelvimetry and it is done by digital examination per vaginum.
- The diagonal conjugate is the distance between midpoint of promontory and lower border of anterior surface of pubic symphysis. By deducting 1.5–2 cm from diagonal conjugate, we can know true conjugate.
- Try to touch both ischial spines during digital examination to measure interischial spinous diameter which is difficult to touch normally.
- Also assess the curvature of the sacrum, the mobility of the coccyx, length of the sacrospinous ligament, and pelvic sidewalls for any conversion inside.
- Disproportion in the size of fetal head and maternal pelvis leads to cephalopelvic disproportion or contracted pelvis, which requires delivery of fetus by cesarean section.
CONCLUSION
Understanding of basic anatomy and physiological functions are very much important in management of obstetrics and gynecological conditions. Surgical procedure can be learned easily if knowledge of reproductive anatomy is clear. Prevention of surgical complication and their management require sound knowledge of pelvic anatomy.
FURTHER READING
- Garg K. BD Chaurasia's Human Anatomy, 8th edition, Vol. 2. India: CBS Publishers and Distributors Pvt Ltd; 2021.
- Jones HW, Rock JA. Te Linde's Operative Gynecology, 11th edition. Philadelphia: Wolters Kluwer Health; 2015.
- Singh V. Textbook of Anatomy: Abdomen and Lower Limb, 3rd edition, Vol. 2. India: Elsevier Health Science; 2020.
LONG QUESTIONS
1. Discuss the muscular and ligamentous supports of the uterus.
2. What are the branches of the internal iliac artery and discuss the applied surgical anatomy of internal iliac artery ligation.
SHORT QUESTIONS
1. What are the important characteristics of the vaginal epithelium?
2. Name the parts of the fallopian tube and their importance in pelvic pathology.
3. What are the types of pelvis based on bony characteristics?
MULTIPLE CHOICE QUESTIONS
1. Nerve supply to the vulva anteriorly is by:
- Pudendal branches of cutaneous nerves
- Pudendal nerves
- Ilioinguinal and genitofemoral nerves
- Sciatic nerve
2. Regarding the Bartholin's glands the following is false:
- They are tubuloalveolar glands
- They are located in the deep perineal pouch
- It is involved in acute gonorrhea
- Blockage of the duct leads to a cyst or abscess
3. The arterial supply of the vagina include all the following, except:
- Vaginal artery
- Branches of the inferior rectal artery
- Branches of the uterine artery
- Branches of the internal pudendal artery
4. The following statement of the bony pelvis is true:
- AP diameter of inlet is usually 11 cm
- AP diameter of the outlet is the widest diameter of the pelvis
- Gynecoid pelvis is flat and narrow
- Subpubic angle is narrow in platypeloid pelvis
5. The following is NOT a branch of the anterior division of the internal iliac artery:
- Middle rectal
- Uterine
- Internal pudendal
- Inferior rectal
1. c | 2. b | 3. b | 4. a | 5. d |
MC Patel, Dilip Walke
INTRODUCTION
The medical profession is considered the noblest profession but dealing with the most complicated science of human life which is very precious. It is an unpredictable science. Even in common clinical situations, there are plenty of variables such as a person's individual biology, disease stage and process, drugs, doses, and surgical techniques. To say the least, medicine is not exact science.
One would expect that violence would become uncommon as the population becomes literate. However, this has not been the case in the real world. One may also believe that violence against doctors would be restricted to a particular type of patient population based on socioeconomic status, religion, or occupation. However, global and local experience tells us that these notions do not always hold true.
HISTORY
Violence against physicians and healthcare professionals is not a new phenomenon. The oldest of ethical and moral codes, the one established by Hammurabi is based on the principle of “an eye for an eye” and it was particularly severe on physicians. If a patient lost his life the physician may be sentenced to have his hand cutoff, if the patient was a nobleman. If the patient happened to be a slave, the physician was expected to pay the price of the slave to his master.1
Even in more recent history, a paper from 1892 can be quoted below:
“No physician, however conscientious or careful, can tell what day or hour he may not be the object of some undeserved attack, malicious accusation, black mail or suit for damages….”2
In recent times, one could argue, that the frequency of such incidents is increasing. However, this could simply be from more visibility due to media and social media.
INCIDENCE
Violence against doctors is a common problem in India. It is only recently being highlighted in media and coming into public attention. It is estimated that nearly three-fourths of all doctors face some form of violence during their careers.3 The survey was carried out by the Indian Medical Association and further stated that a majority of incidents of violence are related to emergency care, intensive care, and postsurgical situations. This is a startlingly high number. There are numerous news articles and publications which bear witness to the incidents in recent times.4 Such incidents are often followed by doctors’ strikes in the public and private sector. Even in the times of the coronavirus disease (COVID) pandemic, when there has been a new awareness and positive media portrayal of healthcare workers (HCWs), attacks on doctors have not stopped.
Violence against doctors is not unique to India. It is seen with a similar frequency in the South East Asian Region. Israel, Pakistan, and Bangladesh have all reported similar incidents of violence.4 Even in the Western countries, violence against doctors is a well-documented phenomenon.
A global review of 253 eligible studies (with a total of 331,544 participants) showed that 61.9% of the participants reported exposure to any form of workplace violence, 42.5% reported exposure to nonphysical violence, and 24.4% experienced physical violence. The form of violence was most commonly verbal, but also included threats, physical violence, and sexual harassment. The prevalence of violence against HCWs was particularly high in Asian and North American countries, in Psychiatric and Emergency departments, and among nurses and physicians.5
In the United States of America, the rates are similar to those in India. Chinese doctors also face violence at the workplace just as commonly. It appears that the frequency of serious attacks on doctors may be higher in these two countries resulting in more severe physical damage, deaths, loss of professional ability, and forced retirement.6
WHO IS AT RISK?
Every doctor and HCW can be at risk of violence. This includes doctors of all cadres (from duty doctors to consultants), paramedical workers (nurses, physiotherapists, ward boys, ayahs, and cleaners), and personnel who do not have any medical context (receptionists, security staff, etc.).
The risk level could be graded according to the likelihood of violent incidents. The highest risk is faced by doctors on duty in the casualty or emergency departments. Physical violence is usually first directed towards the on-duty doctor in these departments. In these settings, the male doctor is more likely to face violence than females.4 Other studies have shown a substantial risk for younger doctors as compared to more senior ones. Nonphysical violence is more likely to be directed towards female doctors and nurses in the obstetrics and gynaecology department.7
HIGH-RISK SITUATIONS
Work place violence often takes place during times of high activity, at the time of hurried and emergent interaction with patients, such as admission in emergency ward, at the time of patient transportation, or when patient is involuntarily 47admitted. The risk in these situations gets magnified at times of negative outcomes. Other situations where violence may occur is when hospital rules are enforced such as on number of visitors, use of certain facilities, and at the time of billing and clearing financial dues.
TYPES OF VIOLENCE
Violence does not only mean a physical attack. It encompasses a range of negative behaviors exhibited by the patient and/or attendants against HCWs. By legal definition, “violence” means an act, which causes or may cause any harm, injury or endangering the life of, or intimidation, obstruction or hindrance to, any Medicare Service Person in discharging his duty in a Medicare Service Institution or causing damage or loss to the property in a Medicare Service Institution.8
The gamut of violence against doctors and HCWs is depicted in Figure 1. A grading system of violence against HCWs has been proposed. This is useful for a quick assessment of a situation and statistical comparisons.9 Such systems are useful but may not encompass all the permutations in a given situation. Nonpersonal violence could be a damage or loss of property in terms of breaking furniture, furnishings, nonmedical machinery, and medical equipment. Nonphysical violence includes a large range including remotely directed or in-person violence. Remotely directed violence could be threatening or intimidating electronic messages or pictures and telephonic conversations which are abusive or repeated phone calls. In-person nonphysical violence includes the above behaviours and also staring, abusive gestures, and threats. Physical violence could result in minor injuries such as cuts and bruises, grievous injuries such as loss of an eye, hearing or limb, and even murder. Sexual violence is almost entirely directed towards female HCWs and could range from insulting the modesty of a woman to assault and rape.
A particular situation that occurs in some settings is the violent mob. This is considered more in detail as it represents a high-risk situation for the physical health of the doctor, other HCWs, and the facility. The genesis and inciting factors leading to mob violence are illustrated in Figure 2. It is observed that in a mob, there are only a handful of people who actually take part in the violence, while a majority may encourage the violent ones or will only stand by silently, take pictures or videos. The typical distribution of a mob is illustrated in Figure 3.10
WHAT CONTRIBUTES TO VIOLENCE AGAINST DOCTORS AND HEALTHCARE PERSONNEL?
Various other factors also play a role in the general situation of causing dissatisfaction and possible violence against HCWs.
With advancements in science in general and medicine in particular, there is a dramatic shift in the expectation with which patients and their attendants view doctors, HCWs, and the therapeutic process. The expectation of a “guaranteed result” is altogether misplaced, yet these expectations are commonplace.
The world in general has become a faster and more impulsive place to be in over the last few decades marked by “on touch technology” and this has fuelled expectations further with a very small tolerance for unfavorable outcomes.
When there is an unexpected or unfavorable outcome in a given clinical situation, it becomes a trigger for the patient and/or attendants to be dissatisfied or aggrieved at best and violent at worst.
Some contributory factors are highlighted in Table 1.
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EFFECTS OF VIOLENCE AGAINST DOCTORS
Violence against HCWs can have a negative multiplier effect as illustrated in Figure 4. There could be a combination and compounding of these effects from a single incident.
Doctors who face physical violence suffer from the physical impact of the injuries which could be minor or serious ones. They could result in temporary or long-term physical disability leading to a loss of ability to work at all or to one's full capacity. In turn, this impacts the professional, emotional, and financial wellbeing of a doctor.9
Violence can also result in a range of mental health problems including anxiety, agoraphobia, panic attacks, posttraumatic stress disorder, and depression. It could lead to absenteeism as a mechanism to avoid the workplace and the loss of profession and livelihood.11
The effect of violence is not restricted only to doctors, but also translates to other patients and the society at large. When a doctor faces violence, it immediately hampers her ability to provide good quality care or any care to the patients who are in her charge. Incidents of physical violence are often followed by strikes or periods of limited medical service provision, which further affect medical care delivery. In the long term, violence or even the threat of violence leads to more defensive medical practice and therefore, more medical tests, investigations, interventions, and costs.9,11
Incidents of violence and their reporting results in young people and doctors from getting disheartened and disillusioned with regards to the profession. Fewer young people may opt for medicine as a profession. Fewer doctors would accept challenging assignments such as emergency care or the high-risk settings mentioned above or would agree to work in remote rural areas where this is isolation. Ultimately, this could result in fewer available doctors where they are needed the most and could have a long-term negative impact to society.11
MEASURES TO MITIGATE VIOLENCE IN HEALTH CARE
All HCWs, doctors, and facilities should do their utmost to prevent violence towards themselves. Some measures can be taken to reduce the risk as discussed in Table 2. Ultimately, the situation has to be addressed at the level of the establishment and the society. All incidents of violence may not be preventable. However, the goal is to reduce their frequency and intensity and the risk of physical injury.
One of the common spark points in violence is a death. Every hospital or facility should have a protocol or drill to handle these situation. Death should not be announced casually or abruptly. It should be done in a gradual manner 49with information being conveyed about the deteriorating condition of the patient. Death should be announced in the presence of a rush team or other doctors and if thought necessary, in the presence of security personnel.
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When a death occurs, there are plenty of questions surrounding issuing the death certificate and the cause of death. In case of a postoperative or maternity death, this has important legal ramifications. No law in our country prevents doctors from giving a death certificate, if the cause of death is known. However, in case of intraoperative or maternal death which is generally not expected to occur, it is better to get the postmortem examination done. Hence even if the relatives (or even at time the police) are forcing the doctors to give a death certificate, it is prudent to convince the police to take away the body for a medicolegal postmortem examination.
THE RUSH TEAM
This is a measure that should be in place in every hospital, locality, and geographical setting. It is a group of geographically accessible and closeby doctors.
- The team should comprise of senior, well-known and familiar, respectable practitioners such as general practitioners, anesthetists, surgeons, gynecologists, and physicians.
- A group such as this should be only a phone call away to other doctors working in the geographical location. It is useful to have a social media group which is used only as an SOS call in distress situations.
- The team should be called in situations of distress when there is impending violence or when violence has occurred.
- The team's responsibility is to ease the situation that a doctor may be faced with by opening rational channels of communication with the attendants. If there has been a death, it should preferably be declared only when the team has arrived on site.
- The team should assess the situation and mobilize other resources in the background.
- The treating doctor is stabilized and encouraged to communicate with a small group of three to four attendants. The team members should support this process and not have an interfering attitude. They should contribute by their presence and occasional inputs to cool down flared tempers and if the communication is being derailed.
ACTION IN SITUATIONS WHERE VIOLENCE IS OCCURrING OR LIKELY
The doctor and other HCWs when faced with a situation where violence is likely or is occurring should do their best to protect their own physical condition. The most important and protective measure in these situation is to leave the site as soon as possible. Even though, this may appear like cowardice, it drastically reduces the chance of physical harm and may actually diffuse the situation.
In the meantime, other team members can take over the medical duties of the doctor. The hospital establishment and/or the rush team should be activated and they should swing into action. Locally stationed security personnel should be summoned, but it may be possible that they may flee looking at a mob.
The police should be immediately informed in situations where there is violence likely occur or is occurring. This in fact is the first step that has to be taken, when mob violence is even suspected. Presence of police usually averts any law and order problem.50
The role of politicians during the incident and in the wake of violence is debatable. It could be a double-edged sword. In case of physical risk which the doctor may think could be averted by a politician's intervention, the help should be sought without hesitation. However, the downside to their routine involvement could be that:
- They may side with the mob who could be their “vote bank”
- Erasing of evidence or influencing police work negatively
- Pressurizing the doctor to withdraw the complaint.
There is a raging debate about whether doctors and other HCWs should bear arms legally to protect themselves. This gains ground when one hears about violent attacks resulting in loss of life and limb. However, violence may beget more violence and accidental events from arms are a huge risk to be considered.
ACTIONS AFTER THE INCIDENT OF VIOLENCE IN HEALTH CARE
The following are the important aspects to bear in mind when violent incidents have occurred in a healthcare setting.
- Physical condition of doctors and healthcare personnel should be assessed and appropriate care should be administered.
- Injury certificate should be obtained from the closest government hospital to document the injuries to any doctor or HCW. This is important for the further legal process.
- The doctor and other team members may be in a state of mental shock. Early intervention with mental health professionals at an appropriate time can reduce the long-term impact.
- Documentation and recording of the events is a vital step. The doctor and healthcare team should collectively list out the events in a chronological manner at the earliest opportunity. The paperwork related to patient care should be completed. The conversations, events, and incidents leading to the violence should be documented separately.
- Photographs, video footage from mobile phones of bystanders, and other hospital personnel should be collated. The closed-circuit television (CCTV) footage should be downloaded. All these should be secured in an electronic format. These are important for the police enquiry and insurance claim.
- The police should be informed in case they have not been informed earlier. They will then conduct a “panchanama” or enquiry. It is imperative that the doctor and healthcare team should cooperate with the police. The evidence in the form of papers, notes, documents, and the electronic evidence as outlined above should be made available to them. They may take the originals with them, so a copy should be made without fail before handing over.
- The police are obliged to register an first information report (FIR) in these circumstances. They may avoid or delay in doing this to prevent a backlash from a violent crowd or in fact take the doctor into protective custody. However, the doctor should insist on an FIR. If there is a delay or denial, the doctor should bring this to the notice of the supervising officer at the local police station. Further actions include filing an right to information (RTI) or a writ petition in case of inaction. Occasionally, the police personnel who are attending the situation may not be aware of the available laws on violence against HCWs. They may be gently reminded of the same.
- The further legal process usually takes its own time. The doctor and other HCWs may not wish to pursue the same under pressure or of their own will. However, they should be encouraged strongly to do so. They should be supported by the hospital that they are working in and local professional bodies. This is important to ensure the full carriage of justice.
THE LAW AND HEALThCARE-RELATED VIOLENCE
The Protection of Medicare Service Persons and Medicare Service Institutions (Prevention of Violence and Damage to Property) Act, also known as the Medical Protection Act (MPA), has currently been implemented in about 23 states in India.8,12
Some of the key points of MPA are as follows:
- Any act of violence against a “Medicare Service Person” or damage or loss to the property of a “Medicare Service Institution” is prohibited.
- Any offender who commits or attempts to commit or abets or incites the commission of any act of violence shall be punished with imprisonment, which may extend to 3 years and with a fine, which may extend to Rs 50,000 and compensation double the amount of loss or as judged by the court.
- Any offense committed under this act shall be cognizable and nonbailable and triable by the Court of Judicial Magistrate of the First Class.The Epidemic Diseases (Amendment) Ordinance, 2020 was promulgated on April 22, 2020. The Ordinance amends the earlier Epidemic Diseases Act of 1897. The Ordinance provides for the prevention of the spread of dangerous epidemic diseases. The key point is that this Ordinance amends the Act to include protections for the healthcare personnel combatting epidemic diseases such as COVID-19 and expands the powers of the central government to prevent the spread of such diseases.13 The text of key provisions of the Ordinance is set out below:
- “Healthcare service personnel” as a person who is at risk of contracting the epidemic disease while carrying out 51duties related to the epidemic. They include: (1) public and clinical healthcare providers such as doctors and nurses, (2) any person empowered under the Act to take measures to prevent the outbreak of the disease, and (3) other persons designated as such by the state government.
- An “act of violence” includes any of the following acts committed against a healthcare service personnel: (1) harassment impacting living or working conditions, (2) harm, injury, hurt, or danger to life, (3) obstruction in the discharge of his duties, and (4) loss or damage to the property or documents of the healthcare service personnel. Property is defined to include a: (1) clinical establishment, (2) quarantine facility, (3) mobile medical unit, and (4) other property in which a healthcare service personnel has a direct interest, in relation to the epidemic.
- The Ordinance specifies that no person can: (1) commit or abet the commission of an act of violence against a healthcare service personnel, or (2) abet or cause damage or loss to any property during an epidemic. Contravention of this provision is punishable with imprisonment between 3 months and 5 years, and a fine between ₹ 50,000 and 2 lakh. This offense may be compounded by the victim with the permission of the Court. If an act of violence against a healthcare service personnel causes grievous harm, the person committing offense will be punishable with imprisonment between 6 months and 7 years, and a fine between ₹ 1 lakh and 5 lakh. These offenses are cognizable and nonbailable.
CONCLUSION
Violence against doctors is not always avoidable. Until there is a sociological gap, economic rift and frustration, this phenomenon will be there. It is imperative that every effort should be made to curb violence. These measures should be institutionalized. Violence against HCWs should be curbed with a firm hand. The doctor who is assaulted is not in the same position as a lay person. He is discharging his duty while being assaulted. The full force of justice should be faced by the perpetrators of such incidents.
REFERENCES
- Halwani T, Takrouri M. Medical laws and ethics of Babylon as read in Hammurabi's code (History). Internet J Law Healthc Ethics. 2006;4:1–8.
- Assaults on Medical Men. JAMA. 1892;18:399–400.
- S Dey. Over 75% of doctors have faced violence at work, study finds. Mumbai: Times of India; 2015.
- Dora SK, Batool H, Nishu RI, Hamid P. Workplace Violence Against Doctors in India: A Traditional Review. 2020;12: e8706.
- Liu J, Gan Y, Jiang H, Li L, Dwyer R, Lu K, et al. Prevalence of workplace violence against healthcare workers: a systematic review and meta-analysis. Occup Environ Med. 2019;76:927–37.
- Yang SZ, Wu D, Wang N, Hesketh T, Sun KS, Li L, et al. Workplace violence and its aftermath in China's health sector: implications from a cross-sectional survey across three tiers of the health system. BMJ Open. 2019;9: e031513.
- Kumar M, Verma M, Das T, Pardeshi G, Kishore J, Padmanandan A. A study of workplace violence experienced by doctors and associated risk factors in a Tertiary care hospital of South Delhi, India. J Clin Diagn Res, 2016;10:LC06–10.
- Government of Maharashtra. (2010). The Maharasthra Medicare Service Persons and Medicare Service Institutions (Prevention of Violence and Damage or Loss of Property) Act 2010. [Online] Available from https://lj.maharashtra.gov.in/Site/Upload/Acts/H-75%20Act%20PDF.pdf. [Last accessed October, 2021].
- Kumari A, Kaur T, Ranjan P, Chopra S, Sarkar S, Baitha U. Workplace violence against doctors: Characteristics, risk factors, and mitigation strategies. J Postgrad Med. 2020;66:149–54.
- Russel GW. Aggression in the Sports World: A Social Psychological Perspective. Oxford: Oxford University Press; 2008.
- Sun T, Gao L, Li F, Shi Y, Xie J, Wang S, et al Workplace violence, psychological stress, sleep quality and subjective health in Chinese doctors: a large cross-sectional study. BMJ Open. 2017;7:e017182.
- Indian Medical Association (IMA). (2018). States Acts and Ordinance on Violence Against Doctors and Medical Insitutions. [Online] Available from: https://ima-india.org/windata/ccima/Legal/17.pdf. [Last accessed October, 2021].
- Ministry of Health and Family Welfare, Government of India. (2020). The Epidemic Diseases (Amendment) Ordinance, 2020. [Online] Available from: https://prsindia.org/billtrack/the-epidemic-diseases-amendment-ordinance-2020. [Last accessed October, 2021].
LONG QUESTIONS
1. What is the broad meaning of the term violence against doctors? What are the types of violence that healthcare workers face?
2. Discuss the short- and long-term impact of violence against doctors.
3. Discuss the short- and long-term strategies to mitigate violence against healthcare workers.
4. How should the aftermath of a violent incident against healthcare workers and facilities be managed?
SHORT QUESTIONS
1. What is Hammurabi's code? What does it say about punishment of doctors?
2. Which medical personnel are considered as high risk for violence in healthcare?
3. What are high-risk situations for violence in healthcare?
4. What are the usual inciting factors for mob violence?
6. What are the vital steps that a doctor should take when faced with a situation that has potential for violence or when violence is occurring?
MULTIPLE CHOICE QUESTIONS
1. Which of the following about violence against doctors is true?
- It occurs only in illiterate sections of society
- Violence is a problem seen in public hospitals only
- It is an ancient phenomenon
- Violence is only communal in origin
What proportion of doctors have faced violence in some form in India?
- 10%
- 50%
- 75%
- 95%
Of the following who are considered not to be at a high risk of violence in healthcare?
- Gynecologists
- Casualty doctors
- Women doctors
- Pathologists
The majority of people who gather in a mob violence situation will be:
- Physically assaulting doctors
- Will be shouting slogans
- Bystanders
- Trying to prevent violence
Which of the following is true about impact of violence against doctors?
- Most doctors stop working after one episode of violence
- Doctors are financially compensated by the state when faced with violence
- Doctors who face violence encourage young people to take up medicine as a profession
- Absenteeism is common in doctors who face violence
Under the Medical Protection Act a violent incident against healthcare is:
- Bailable
- To be tried in the High Court
- Punishable by imprisonment up to 3 years
- A fine of ₹ 5,000,000 can be levied
1. c | 2. c | 3. d | 4. c | 5. d | 6. c |