Introduction to Obstetrics

Anahita  Chauhan; Dilip  Walke; MC  Patel; Tripti  Nagaria; Madhva Prasad S; Parikshit  Tank; Ramalingappa C Antaratani; Sanjana  K; Bhavik  Doshi; Ashvin  Vachhani

PART 1

1Obstetrics and Perinatology

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
Critical Care in Obstetrics2

Introduction to ObstetricsSECTION 1

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.

Fig. 1: Broad timelines of the universe.

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.

TABLE 1 Historical ages and women's health.

Time	Nomenclature	Important events related to women's health
200,000 years ago till Before Christ Era (bce)	Prehistory	Earliest references to women's bodies, their anatomy in recorded history Indus valley civilization, Upanishads (Garbha Upanishad) and Ayurveda addresses women's health and science
After Christ Era to 5th century Anno Domini (ad)	Ancient history	Greek, Egyptian and Middle Eastern science predominate the world
5th–15th century ad	Dark ages	Older Roman and European literature on women's health and the misconceptions
1500–1700s	Renaissance	Initiation of scientific study of human anatomy and health in Europe
1700–1850s	Early modern history	Rudimentary surgery and medicinal cures
1850s onward	Late modern history	Rapid revolutionary strides in all aspects of health and those pertaining to women's health
Current times	Contemporary history	Subspecialization and evolution of molecular technology

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

TABLE 2 Significant strides in general medical practice in the 1800s onward.

Field	Year	Scientist	Background and comments
Anesthesia	1846	Francis Bott (USA), Robert Liston (UK)	Started consistently using ether for anesthesia in surgery
	1850s	James Young Simpson (UK)	Advocated the use of ether inhalation as an analgesic in labor
	1850s	John Snow (UK)	Replaced ether with chloroform, which was safer. Administered analgesia to Queen Victoria during childbirth and gained royal backing and widespread approval for anesthesia by chloroform
Antisepsis	1890s	Louis Pasteur (France)	Proposed the germ theory, mechanisms of infection and decay and possible methods to avoid the effects of microbes
	Early 1900s	Joseph Lister (UK)	Applied the principles of germ theory to surgical practice and devised the antisepsis system which forms the basis of infection control till date
Blood transfusion	1900	Karl Landsteiner (Austria)	Described the ABO system of blood groups and the technique of crossmatching, making transfusions compatible
Radiology	1895	Wilhelm Röntgen (The Netherlands)	Röntgen was studying the effect of passing electricity through a gas at very low pressures and noticed the effect on a plate. He took an impression of his wife's hand and this was the first Roentgenogram (X-ray)
Radiation	1903	Marie Curie, Pierre Curie, Henri Becquerel (France)	Jointly, these three scientists described the theory of radioactivity. Marie Curie further went on to discover two elements—radium and polonium. She also described isotopes which are important tools in the treatment of cancers
Insulin	1922	Frederick Banting and Charles Best (Canada)	Banting, an orthopedic surgeon and Best, a research assistant studied glucose metabolism in dogs who had been subjected to removal of the pancreas and developed diabetes. John Macleod was instrumental in purifying the extract called “isletin” for human use
Antibiotics	1928	Alexander Fleming (UK)	Serendipitous observation of elimination of bacterial growth due to the growth of a mold (fungus) identified as Penicillium
	1938	Various scientists working in the United Kingdom	Various scientists working in Oxford—Howard Florey (Australia), Ernst Chain (German), and Dorothy Hodgkin (UK)—worked out the chemical structure of penicillin and mass produced it for clinical use

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.

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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.

4. How has the history of assisted reproduction been rewritten in India in recent times?10

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

Answers

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

The key elements in the communication process (Fig. 1) are:^1,2

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.

Fig. 1: Key elements in the communication process.

11For effective communication sender must have the knowledge of:

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.

TABLE 1 Characteristics of one-way and two-way communication.

	One-way communication	Two-way communication
Flow of transmission of information	One-way from sender to receiver	Two-way both take part
Active participation of receiver	No	Yes
Feedback generation	No	Yes
Place for clarification	No	Yes
Learning	Passive, authoritative	Active, democrative
Influence on human behavior	No	Yes
Complex message	Difficult to transmit	Easier, more effective
Examples	Classroom lecture, notice, advertisement	Discussion, interpersonal communication

TABLE 2 Categories of communication.

Communication
Based on communication channel		Based on style and purpose
Nonverbal	Verbal	Formal	Nonformal
	Oral Face-to-face Distance
	Written
	Visual

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.

TABLE 3 Examples of verbal communication.

Written	Oral
Exchange of information in written form	Exchange in spoken words
Exchange of information in written form	Direct, face-to-face	Indirect, distance
Examples: Emails Letters Reports Consent Discharge papers Posters, flyers Documents Handbooks Posts on social media, etc.	Examples: Face-to-face communication, Counseling Personal communication Presentation Meetings Lectures Discussions Conferences Interviews	Examples: Telephonic conversation Chat talk Voice message

TABLE 4 Differences between verbal and nonverbal communication.

	Verbal communication	Nonverbal communication
Based upon	Use of language, words	Use of signs, body language, and others
Chances of confusion in understanding the message	Very few as language is used	High as no language is used
Time taken in interchanging the message between the receiver and sender	Fast hence feedback is also rapid	Takes time to understand hence slow
Location of both the parties	May or may not be at same location	Needed for effective communication

TABLE 5 Examples of nonverbal behavior.

Nonverbal behavior
Body language Gestures Facial expressions Postures Body orientations Body proximity/distance Eye contact Mirroring Remove the barriers (e.g., desks, keeping the mobiles off/silent	Paralanguage Sighs Grunts Groans Voice volume Voice pitch alteration Voice fluency Nervous giggles

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.
Courteous: The information or the communication whether written or verbal must not hurt the feelings of 14the receiver, it should be respectful, polite, thoughtful, with proper care and kindness. Language used must not be offensive, insensitive or awful to the receiver.
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.

TABLE 6 Barriers of communication.

S. No.	Barriers	Factors causing difficulties in communication
1.	Linguistic barriers	Difference in language or dialects between the providers and receiver
2.	Psychological barriers	Mental issues like fear, speech disorder, depression, etc.
3.	Emotional barrier	Emotional IQ of persons, anger, frustration, humor, etc.
4.	Physical barrier	Noise, closed doors, faulty equipment used for communication, etc.
5.	Cultural barriers	Differences in cultural values of the society
6.	Attitude barriers	Ego, inconsiderate behavior, etc.
7.	Perception barrier	Differences in ability to perceive, understand the messages, literacy, previous knowledge, age, prolong ill health, etc.
8.	Physiological barrier	Disorder like shrillness of voice, dyslexia, etc.
9.	Socioreligious barrier	Woman, transgender may face difficulty in certain community

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:
1. Listening to understand the verbal message of the client
2. 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.
3. Listening to and considering the client in perspective of her social background
4. 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
- Be empathetic16
- 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.
Computer-generated discharge summaries or standardized format must be used to emphasize the most important information to improve the quality of documents.17

TABLE 7 I-PASS tool for handover.

I	Illness severity	Current status of the patient: OK/under observation/stable/unstable/to be discharged
P	Patient summary	At admission: History, physical finding, test results During the course of stay in the hospital Ongoing assessment Plan for further management
A	Action list	To do list—includes: Actions to complete, e.g., diagnostic tests, consultations, procedures Timeline and ownership
S	Situational awareness and contingency planning	Know what is going on and Plan for what might happen, e.g., if the condition deteriorates, what is to be done immediately to address the change
S	Synthesis (by the receiver)	The receiver summarizes what was heard Clarifies any doubt, asks questions Repeats the key actions/to do list

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

TABLE 8 5Ds of discharge.

Element	Points to be discussed and ensured
Diagnosis	Why was he admitted and given care?
Drugs	Medicines—need for taking them How to take—dose, route, time, in relation to meals. etc.
Diet	Any dietary restriction, consultation with nutrition specialist if suggested
Doctor follow-up	Plan for next visit/s, name of doctor and place where to visit for further continuum of care
Directions	Any other direction for achieving optimal health, e.g., exercise Warning signs of urgency/emergency If emergency arise whom to contact and/where to report for care

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
Give information in simple language, allow questioning.18

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
Avoid or reduce visual and auditory distractions^37,38
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].

REFERENCES

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.

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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Senot C, Chandrasekaran A, Ward PT, Tucker AL, Moffatt-Bruce S. The impact of combining conformance and experiential quality on hospitals' readmissions and cost performance. Manage Sci. 2015;62(3):829–48.

20 Baggs JG, Schmitt MH, Mushlin AI, Mitchell PH, Eldredge DH, Oakes D, et al. Association between nurse-physician collaboration and patient outcomes in three intensive care units. Crit Care Med. 1999;27:1991–8.

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.

Mitchell PH, Armstrong S, Simpson TF, Lentz M. American Association of Critical-Care Nurses demonstration project: profile of excellence in critical care nursing. Heart Lung. 1989;18:219–37.

Zwarenstein M, Reeves S. Working together but apart: barriers and routes to nurse—physician collaboration. Jt Comm J Qual Improv. 2002;28:242–7.

Fagin C. Collaboration between nurses and physician: no longer a choice. Acad Med. 1992;67:295–303.

Woolf SH, Kuzel AJ, Dovey SM, Phillips RL Jr. A string of mistakes: the important of cascade analysis in describing, counting, and preventing medical errors. Ann Fam Med. 2004; 2(4):317–26.

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.

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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.

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21 Stahel PF, Mehler PS, Clarke TJ, Varnell J. The 5th anniversary of the ‘Universal Protocol’: pitfalls and pearls revisited. Patient Saf Surg. 2009;3:14.

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

Answers

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

1.3 EVIDENCE-BASED MEDICINE AND MEDICAL INFORMATICS22

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.

Fig. 1: Evidence-based medicine (EBM) triad.

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).

TABLE 1 Levels of evidence.

Level	Components	Comments
1++	Meta-analysis of high quality, systematic reviews of RCTs or RCTs with a very low risk of bias	Properly-conducted RCTs when repeated and combined in meta-analysis yield the strongest results The properly-conducted RCT is considered the gold standard in medicine
1+	Meta-analysis, systematic reviews of RCTs or RCTs with a low risk of bias
1−	Meta-analysis, systematic reviews of RCTs or RCTs with a high risk of bias
Level 2++	High-quality systematic reviews of case-control or cohort studies or high-quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal	Introduction of bias is possible when there is no randomization Some topics in medicine cannot be addressed ethically or effectively by randomization (inability to take a control group)
Level 2+	Well-conducted case-control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal
Level 2−	Case-control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal
Level 3	Nonanalytical; nonexperimental study such as case-series. A poorly-designed case-control or cohort study also features here	Control groups or cohorts are not possible in some rare diseases or occasional occurrences
Level 4	Expert opinion from respected authorities on the subject	Extreme level of inter-expert heterogeneity is possible

Fig. 2: Evidence pyramid (types of research).

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.

TABLE 2 Grades of recommendation.

Grade of recommendation	Interpretation
A	At least one meta-analysis, systematic review or randomized controlled trial rated as 1++. A systematic review of RCTs or a group of evidence composed of studies rated as 1+. These should be applicable to the population concerned. There should be overall consistency of results
B	Evidence from studies which are 2++ with overall consistency of results. This should be applicable to the population concerned Evidence extrapolated from studies ranked as 1++ or 1+
C	Evidence from studies which are 2+ with overall consistency of results. This should be applicable to the target population Extrapolated evidence from studies rated as 2++
D	Evidence level 3 or 4; or extrapolated evidence from studies rated as 2+
Good practice point (GPP)	Recommended best practice based on the clinical experience of the guideline development group

Fig. 3: Steps in utilizing evidence-based medicine.

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

TABLE 3 Constructing a question using the PICO format.

P—Patient/Population	I—Intervention	C—Comparison	O—Outcome
Who?	What?	Alternative intervention?	Outcomes
To which group would this patient be described as belonging to?	Which treatment, test or other intervention is being considered for this patient/group	Is there an existing gold standard? What other treatment or test exists or perhaps to doing nothing	What are the patient-oriented outcomes? Better survival? Better prognosis? Higher rate of cure? etc.
Examples
Patients with preeclampsia beyond 37 weeks of gestation	Induction of labor	Watchful expectancy	Occurrence of eclampsia/maternal morbidity/maternal mortality
Patients with polycystic ovary syndrome (PCOS) with infertility	Ovulation induction with letrozole	Ovulation induction with clomiphene	Documentation of ovulation, chemical pregnancy rate, clinical pregnancy rate, live birth
Patients with stage III epithelial ovarian cancer	Neoadjuvant chemotherapy followed by operative procedure	Operative procedure	Success at debulking, residual disease, 1-year survival, 5-year survival

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.

TABLE 4 Types of clinical data.

Type of data	Brief description
Survey	Includes questionnaires or survey tools It may be target-specific or population-specific
Admission data/Discharge data	Includes the demographic and treatment details of patients admitted in a healthcare facility
Administrative data/Claims data	Includes the details of patients who have submitted their records for the purpose of reimbursement or otherwise
Registries	Includes details of patients suffering from a particular condition, e.g., cancer registry
Population data	Includes (basic) information about the entire population Birth and Death registration is one example
Electronic medical record	Includes the details of all complaints, evaluation, consultations, advice, interventions and improvement of individuals involved in one particular institution

Fig. 4: Traditional and informatics model of healthcare information processing.

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

Fig. 5: Possible improvements with health informatics.

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.

Fig. 6: Components of an electronic health record.

TABLE 5 Data sets and suggested standards.

Data gathered	Suggested standard
Structured clinical information exchange	Fast Healthcare Interoperability Resources® (FHIR 4)
Clinical terminology	SNOMED CT
Coding system for diseases	ICD-10
Laboratory measurements, test-panels, etc.	LOINC
Still images	JPEG
Documents	PDF
Audio/Video	MP3 (OGG)/MP4 (MOV)
Radiological investigations	DICOM

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

Conventional electronic fetal monitoring uses paper tracings and human visual interpretation.28

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:

Based on the mode of communication (video/audio/text based)29
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.

REFERENCES

Tenny S, Varacallo M. Evidence Based Medicine. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021.

Masic I, Miokovic M, Muhamedagic B. Evidence-based medicine—new approaches and challenges. Acta Inform Med. 2008;16(4):219–25.

Thoma A, Eaves FF 3rd. A brief history of evidence-based medicine (EBM) and the contributions of Dr David Sackett. Aesthet Surg J. 2015;35(8):NP261–3.

Royal College of Obstetricians and Gynaecologists. Green-top guideline development. [online] Available from: http://www.rcog.org.uk/green-top-development [Last accessed September, 2021].

Ford LG. Melnyk BM. The underappreciated and misunderstood PICOT question: a critical step in the EBP process. Worldviews Evid Based Nurs. 2019;16(6):422–3.

Jassem J. Bright and dark sides of evidence-based Medicine. Pol Arch Med Wewn. 2016;126(5):347–52.

Braithwaite RS. Evidence-based medicine: clinicians are taught to say it but not taught to think it. BMJ Evid Based Med. 2019;24(5):165–7.

Medical informatics. [online] Available from: https://www.wikilectures.eu/w/Medical_Informatics [Last accessed September, 2021].

Goodin A, Delcher C, Valenzuela C, Wang X, Zhu Y, Roussos-Ross D, et al. The power and pitfalls of big data research in obstetrics and gynecology: a consumer's guide. Obstet Gynecol Surv. 2017;72(11):669–82.

Emerging into E-health information management. [online] Available from: https://www.slideshare.net/katnick56/emerging-into-ehealth-information-management [Last accessed September, 2021].

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.

30 Kudva V, Prasad K, Guruvare S. Automation of detection of cervical cancer using convolutional neural networks. Crit Rev Biomed Eng. 2018;46(2):135–45.

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
It should be preferred during epidemic31
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

Answers

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
New market structure.32

TABLE 1 History of good clinical practice (GCP) recommendations.

S. No	Year	Landmark act/declaration	Events that forced the act	Laws laid down by the act
1.	460 bc	The Hippocratic oath		Brought out the concept of “Good physician”
2.	1906	Food and drugs act	Over the counter sale of harmful and lethal drugs in the United States
3.	1930	US Food, Drugs, And Cosmetic Act		Compulsory testing of drugs for safety before marketing
4.	1947	Nuremberg code³	Unethical and horrific experiments conducted during World War II at Nazi war camps	Need for scientific basis in research on human subjects and voluntary consent
5.	1948	Declaration of Human Rights	Atrocities of World War II	Further reiterated the human factor involved in medical experiments
6.	1962	Kefauver–Harris amendment	Severe fetal limb deformities linked to the use of maternal thalidomide	Required the Food and Drug Administration (FDA) to evaluate all new drugs for safety and efficacy
7.	1964	Declaration of Helsinki by the World Medical Association⁴		Statement of ethical principles to provide guidance to physicians and participants in Human Research Forms
8.	1979	The Belmont report⁵	For the protection of human subjects of biomedical research	Laid down principles of respect for people, beneficence, and justice
9.	1982	International guidelines for biomedical research involving human subjects by the World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS)		Issued a document entitled “International guidelines for biomedical research involving human subjects”
10.	1996	ICH-GCP guidelines⁶	International GCP inconsistencies	Standards to protect the rights, safety, and welfare of human subjects

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
Justice.33

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.

TABLE 2 Key activities in conducting a clinical trial.

S. No.	Key trial activity	Responsibility	Details of the activity
1.	Development of trial protocol	Sponsor in consultation with clinical investigators	Risk identification, study design, statistical methodology
2.	Development of standard operating procedures (SOPs)	Sponsors, clinical investigators, ethics committees, institutional review boards, contract research organizations (CROs)	Develop SOPs that define responsibilities, records, and methods to be used for study-related activities
3.	Development of support systems and tools	Sponsor	Tools to facilitate the conduct of the study and collection of data required by the protocol
4.	Generation and approval of trial-related documents	Sponsor	Provision of standardized forms and checklists to assist the clinical investigator to capture and report data
5.	Selection properly qualified, trained, and experienced investigators and study personnel	Sponsor	Sponsors should review the requirements of the study protocol and recruit appropriate staff who are qualified
6.	Ethics committees review and approval of the protocol	Investigator	Study to be reviewed by ethics committee or institutional review board
7.	Review by regulatory authorities	Sponsor	To ensure that the study is appropriately designed to meet its stated objectives
8.	Enrollme

Chapter Notes

Introduction to ObstetricsSECTION 1

BOX 1 : Characteristics (“7Cs”) of effective communication.

BOX 2 : Barriers of communication.