Evidence-based Obstetrics and Gynecology E-Book
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- Herausgeber: John Wiley & Sons
- Kategorie: Fachliteratur
- Serie: Evidence-Based Medicine
- Sprache: Englisch
The most comprehensive evidence-based guide to both obstetrics and gynecology
Aimed at practicing obstetricians, gynecologists, and trainees in the specialty, Evidence-based Obstetrics and Gynecology concentrates on the clinical practice areas of diagnosis, investigation and management. The first section of the book discusses evidence-based medicine methodology in the context of the two specialties. The second and third sections cover all the major conditions in obstetrics and gynecology, with each chapter reviewing the best available evidence for management of the particular condition. The chapters are structured in line with EBM methodology, meaning the cases generate the relevant clinical questions.
Evidence-based Obstetrics and Gynecology provides in-depth chapter coverage of abnormal vaginal bleeding; ectopic pregnancy; pelvic pain; lower genital tract infections; contraception and sterilization; breast diseases; urogynecology; endocrinology and infertility; puberty and precocious puberty; cervical dysplasia and HPV; cervical, vaginal, vulvar, uterine, and ovarian cancer; preconception care; prenatal care and diagnosis; drugs and medications in pregnancy; maternal complications; chronic hypertension; diabetes mellitus; thyroid disease; neurologic disease; psychiatric disease; postterm pregnancy; fetal complications; preeclampsia; and more.
- First book to address evidence-based practice for obstetrics and gynecology combined
- EBM is a highly relevant approach for this high risk specialty
- Edited by leading US specialist involved in the evidence-based medicine movement
Evidence-Based Obstetrics and Gynecology is an important text for obstetricians and gynecologists in practice and in training, as well as for specialist nurses.
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Table of Contents
Cover
List of contributors
CHAPTER 1: Evidence‐based medicine in obstetrics and gynecology
History of obstetrics and evidence‐based medicine
What is evidence‐based medicine?
Systematic review processes
Formulating the question
Searching the literature and identifying relevant studies
Critically appraising studies and assessing the strength of a body of literature
Evidence‐based resources
The Cochrane Collaboration
The US preventive services task force and the US evidence‐based practice centers program
Rationale for this book
References
SECTION 1: Gynecology
General Gynecology
CHAPTER 2: Abnormal menstrual bleeding
Background
Clinical questions
Conclusion
Acknowledgements
References
CHAPTER 3: Termination of pregnancy
Background
Clinical questions
References
CHAPTER 4: Miscarriage and ectopic pregnancy
Background
Ectopic pregnancy
Historical perspective
Clinical questions
Surgical treatment
Medical management
Local therapy
Expectant management
Rh status and antibody screen
References
CHAPTER 5: Pelvic pain
Background
General search strategy
Clinical questions
Summary
Case resolution
Further reading
References
CHAPTER 6: Genital tract infections
Background
Search strategy
Clinical questions
References
CHAPTER 7: Uterine fibroids
Introduction
Epidemiology
Classification
Etiology
Diagnosis
Evidence‐based approach to clinical management
Evidence‐based pregnancy outcomes related to fibroids
Quantitative measures of fibroid disease
Evidence‐based treatment of fibroids
Evidence‐based medical treatment
Additional strategies for management
Evidence‐based non‐surgical treatments
Evidence‐based surgical treatments
Conclusion
Acknowledgments
References
CHAPTER 8: Endometriosis and adenomyosis
Background
Search strategy
Clinical questions
References
CHAPTER 9: Contraception and sterilization
Background
Clinical questions
Conclusions
References
Urogynecology
CHAPTER 10: Pelvic floor prolapse/urinary incontinence
Background
Clinical questions
References
Reproductive endocrinology and infertility
CHAPTER 11: Amenorrhea
Background
Clinical questions
References
CHAPTER 12: Polycystic ovarian syndrome
Clinical questions
Conclusion
References
CHAPTER 13: Recurrent pregnancy loss
Background
Clinical questions
References
CHAPTER 14: Unexplained infertility
Background
Clinical questions
General search strategy
Critical review of the literature
Conclusions
References
CHAPTER 15: Menopause and HRT
Overview
Search strategy
Clinical questions
Discussion of the evidence
References
Gynecologic oncology
CHAPTER 16: Cervical cancer
Background
Clinical questions
Summary
Acknowledgements
References
CHAPTER 17: Vulval/vaginal cancer
Background
General search strategy
Critical appraisal of the literature
Conclusions
References
CHAPTER 18: Endometrial cancer
Clinical questions
References
CHAPTER 19: Cervical dysplasia and HPV
Background
Clinical questions
General search strategy
Searching for evidence synthesis
Critical review of the literature
Conclusions
Conflicts of Interest
References
SECTION 2: Obstetrics
General obstetrics
CHAPTER 20: Preconception care
Introduction
Background and rationale for preconception/interconception care
The evidence for folic acid
The Evidence for chronic diseases
Medications/teratogens
Substance abuse and environmental toxins
Conclusions
References
CHAPTER 21: Prenatal diagnosis
Background
Clinical questions
Conclusion
References
CHAPTER 22: Hyperemesis gravidarum
Incidence
Etiology
Effects of hyperemesis gravidarum
Differential diagnoses
Laboratory Evaluation
Treatment options: outpatient versus inpatient treatment
Key recommendations
References
CHAPTER 23: Drugs and medication in pregnancy
Background
Clinical questions
Critical appraisal of the literature
Conclusion
References
Maternal complications
CHAPTER 24: Asthma
Background
Clinical questions
Conclusion
References
CHAPTER 25: Hypertensive disorders of pregnancy
Background
Clinical questions
References
CHAPTER 26: Cardiovascular disease
Introduction
Acquired cardiac disease
Congenital cardiac disease
Cardiomyopathy
Conclusion
References
CHAPTER 27: Renal disease
Introduction
Renal adaptations during pregnancy
Chronic kidney disease and pregnancy
Management of pregnancy in women with CKD
Specific renal disorders in pregnancy
Dialysis
Renal transplant
References
CHAPTER 28: Diabetes mellitus
Clinical questions
References
CHAPTER 29: Thyroid disease
Background
Hypothyroid disease
Background
References
CHAPTER 30: Neurologic disease
Introduction
Background
Background
Background
Background
References
CHAPTER 31: Diagnosis and management of antiphospholipid syndrome
Introduction
Clinical vignettes
Clinical questions
Pregnancy considerations
References
CHAPTER 32: Hematologic disease
Background
Clinical questions
Acknowledgment
References
CHAPTER 33: Infections in pregnancy
Cytomegalovirus
Parvovirus
Varicella zoster
Listeria
References
CHAPTER 34: Venous thromboembolic disease
Introduction
Clinical questions
References
CHAPTER 35: Gastrointestinal disorders
Cholelithiasis
Pancreatitis
Intrahepatic cholestasis of pregnancy
Inflammatory bowel disease
Appendicitis
Recommendations
References
CHAPTER 36: Psychiatric disease
Introduction
Clinical questions
References
CHAPTER 37: Preterm labor
Background
Clinical questions
Conclusions and recommendations
References
CHAPTER 38: Preterm premature rupture of membranes (PPROM)
Background
Etiology of preterm premature rupture of membranes
Complications of preterm premature rupture of membranes
Diagnosis
Management of PPROM
The latency period
Corticosteroids for prematurity
Magnesium sulfate for fetal neuroprotection
Prophylactic antibiotics in PPROM
Tocolysis
Timing of delivery in PPROM
Preterm premature rupture of membranes before fetal viability
Special circumstances
Conclusions
References
CHAPTER 39: Antepartum hemorrhage
Background
Management
Clinical questions
Clinical questions
Clinical questions
References
CHAPTER 40: Vaginal birth after cesarean delivery
Background
Critical review of the literature and clinical questions
Conclusions and recommendations
References
CHAPTER 41: Post‐term pregnancy
Introduction
Clinical questions
References
Fetal complications
CHAPTER 42: Disorders of amniotic fluid volume
Background
Clinical questions
Case conclusion
References
CHAPTER 43: Disorders of fetal growth
Background
Clinical questions
Conclusions
References
CHAPTER 44: Multiple pregnancies and births
Biology
Maternal consequences
Fetal–neonatal consequences
Delivery considerations
Outcome
Summary: Prevention vs. cure
References
CHAPTER 45: Intrauterine fetal demise
Introduction
Compassionate care
Choices for care and delivery
Assessment
The autopsy
Communication around autopsy
The umbilical cord
Summary
References
CHAPTER 46: Fetal anomalies
Introduction and background
Genetics
Associated findings
Imaging
Fetal surgery
Delivery mode and timing
Fetal risks
Termination
Maternal risks
Conclusions
References
CHAPTER 47: Antepartum/intrapartum fetal surveillance
Introduction
Randomized trials of EFM versus intermittent auscultation
The evolution of standardized FHR definitions
The 2008 NICHD consensus report
NICHD definitions – general considerations
Physiology of fetal heart rate patterns
Interpretation
A simplified, standardized approach to management
Adjunct methods of intrapartum fetal monitoring
Summary
References
CHAPTER 48: Hydrops fetalis
Background
Clinical questions
References
CHAPTER 49: Malpresentation
Background
Clinical questions
References
Peripartum complications
CHAPTER 50: Induction/augmentation of labor
Background
Clinical questions: induction of labor
Background
Clinical questions: augmentation of labor
Background
Clinical question: mid‐trimester induction of labor
References
CHAPTER 51: Postpartum hemorrhage
Introduction
Background
Clinical questions
Bimanual uterine compression and uterine tamponade
Systemic devascularization (arterial ligation)
Compression sutures
Uterine artery embolization (UAE)
Conclusions
Background
Clinical questions
References
CHAPTER 52: Obstetric emergencies
Introduction
Background
Background
Clinical questions
Conclusions
References
CHAPTER 53: Methods for spontaneous delivery
Background
Clinical questions
Summary recommendations/considerations
References
CHAPTER 54: Operative vaginal delivery
Informed consent
Pre‐procedure checklist and clinical documentation
Guideline considerations
Evidence‐based procedural aspects to performing OVD
Other safety considerations
Training, competency, and simulation
On the horizon
Conclusions
References
CHAPTER 55: Cesarean delivery in the obese parturient
Introduction
Clinical questions
Thromboprophylaxis
Conclusions
References
Index
End User License Agreement
List of Tables
Chapter 1
Table 1.1 Steps for evidence‐based obstetrics
Table 1.2 PICOTS
Table 1.3 Studies applicable to particular review questions
Table 1.4 GRADING the quality of a body of literature [22]
Table 1.5 List of evidence‐based organizations and resources
Chapter 2
Table 2.1 Suggested “normal” limits for menstrual parameters in the mid‐reproduc...
Table 2.2 Pharmacological treatment options for heavy menstrual bleeding
Table 2.3 Benefits and harms of the two surgical approaches
Chapter 6
Table 6.1 Dosing and frequency options for medications to treat recurrent HSV in...
Chapter 7
Table 7.1 Fibroid effect on fertility compared to age matched control
Table 7.2 Fibroid effect on pregnancy compared to age matched control
Table 7.3 Effects of treatment by modality
Chapter 9
Table 9.1 Percentage of women experiencing an unintended pregnancy during the fi...
Chapter 12
Table 12.1 Defining PCOS.
Table 12.2 Objective Assessment of Hirsutism
:
modified Ferriman‐Gallwey (9 site) ...
Table 12.3 Differential diagnoses for PCOS.
Table 12.4 Laboratory evaluation in PCOS.
Table 12.5 Stepwise approach to management of PCOS related ovulatory infertility...
Table 12.6 Evaluation of co‐existing and long term health risks in PCOS.
Chapter 13
Table 13.1 Aspirin in unexplained RPL
Table 13.2 Aspirin in hereditary thrombophilias
Table 13.3 Heparins in unexplained RPL
Table 13.4 Heparins in hereditary thrombophilias.
Chapter 16
Table 16.1 Cervical cancer risk factors
Table 16.2 2008 International Federation of Gynecology and Obstetrics (FIGO) sta...
Chapter 17
Table 17.1 Results of multicenter cohort studies and
standardized incidence ratio
Table 17.2 Summary of studies performed to evaluate the detection rates and fals...
Chapter 20
Table 20.1 Drugs and medications with known teratogenic potential
Table 20.2 Major components of a routine preconception visit for reproductive wo...
Chapter 21
Table 21.1 Detection rate of Trisomy 21 with first trimester screening given 5% ...
Table 21.2 Detection rate of trisomy 21 with combined first and second trimester...
Table 21.3 Likelihood ratios (LR) of trisomy 21 with detection of isolated sonog...
Chapter 22
Table 22.1 Differential diagnosis of persistent vomiting in pregnancy
Table 22.3 Randomized trials of antiemetics in pregnancy
Table 22.4 Medrol dosing schedule
Chapter 23
Table 23.1 Pregnancy induced pharmacokinetic changes for selected drugs
Table 23.2 Most common teratogens
Table 23.3 Common fetal drug toxicities
Chapter 24
Table 24.1 Adverse fetal outcomes reported to be increased in infants of asthmat...
Table 24.2 Steps of asthma therapy during pregnancy
Table 24.3 Safety of commonly used medications for the treatment of asthma durin...
Chapter 25
Table 25.1 Criteria for the diagnosis of pre‐eclampsia
Table 25.2 Factors associated with an increased risk of developing pre‐eclampsia
Chapter 26
Table 26.1 CARPREG risk prediction score for a cardiac event during pregnancy
Table 26.2 ZAHARA risk prediction score for a cardiac event during pregnancy
Chapter 27
Table 27.1 Normal laboratory parameters in pregnancy
Table 27.2 Stages of chronic kidney disease and
approximate correlation
with earl...
Table 27.3a Pregnancy outcome based on pre‐pregnancy renal function in women wit...
Table 27.3b Estimated impact of pregnancy on maternal renal function in women wi...
Table 27.4 Clinical features that may help differentiate pre‐eclampsia and acute...
Chapter 28
Table 28.1 American Diabetes Association three types of glucose intolerance
Table 28.2 White classification for diabetes in pregnancy
Table 28.3 Diagnostic criteria for three‐hour 100 g oral GTT
Table 28.4 Target capillary glucose levels in pregnancy
Table 28.5 Regular insulin intrapartum infusion
Chapter 29
Table 29.1 Thyroid dysfunction and TSH and FT4 Levels
Table 29.2 TSH trimester specific norms
a
Table 29.3 Thioamides
Chapter 31
Table 31.1 Revised classification criteria for the antiphospholipid syndrome (AP...
Table 31.2 Preliminary classification criteria for catastrophic antiphospholipid...
Chapter 32
Table 32.1 Some available iron preparations
Table 32.2 Pregnancy outcomes in some of the more common hemoglobin disorders
Table 32.3 Disorders associated with excessive mucosal bleeding in apparently he...
Table 32.4 Major types of von Willebrand disease and suggested management option...
Table 32.5 Common causes of thrombocytopenia during pregnancy
Table 32.6 Incidence of microangiopathic disorders during pregnancy
Chapter 33
Table 33.1 Risk of fetal transmission based on timing of maternal CMV infection
Table 33.2 Possible ultrasound findings in fetuses affected with CMV
Table 33.3 Potential results of serum testing after expose and management guidel...
Table 33.4 Characteristic findings of congenital varicella syndrome
Table 33.5 Ultrasound findings suggestive of congenital varicella syndrome
Table 33.6 Symptoms that can be associated with maternal listeria infection
Chapter 34
Table 34.1 American College of Chest Physicians risk factors for venous thromboe...
Table 34.2 The risk of venous thromboembolism in pregnant patient with selected ...
Table 34.3 National Partnership for Maternal Safety recommendations for antepart...
Table 34.4 National Partnership for Maternal Safety recommendations for postpart...
Chapter 35
Table 35.1 Summary of studies examining symptoms and physical exam findings in a...
Table 35.2 Summary of studies examining the ability of ultrasound, CT, and MRI t...
Chapter 37
Table 37.1 Risk factors for spontaneous preterm birth with corresponding referen...
Table 37.2 Evidence‐based management recommendations listed according to patient...
Chapter 40
Table 40.1 Augmentation and induction.
Chapter 41
Table 41.1 Perinatal risks of post‐term pregnancy
Chapter 42
Table 42.1 Performance of various clinical measures of AF volume in the diagnosi...
Table 42.2 Detection rate for total fetal anomalies by prenatal ultrasound. The ...
Table 42.3
False positive rate
(
FPR
) for detection of fetal anomalies by prenatal...
Table 42.4 Effect of indomethacin on maternal symptoms, fluid volume, and delive...
Chapter 43
Table 43.1 Summary results of currently published meta‐analyses comparing routin...
Table 43.2 Summary of results from recently‐published studies evaluating neurode...
Table 43.3 Number of cesarean deliveries necessary to prevent shoulder dystocia ...
Chapter 44
Table 44.1 Maternal complications more frequently seen in multiple pregnancies
Table 44.2 Categories of structural defects in twins
Chapter 47
Table 47.1 Randomized trials of EFM versus Intermittent auscultation
Table 47.2 Standard fetal heart rate definitions
Table 47.3 Fetal heart rate categories
Table 47.4 Potential causes of prolonged deceleration
Table 47.5 Essential criteria that define an acute intrapartum event sufficient ...
Table 47.6 Criteria that collectively suggest the event occurred within 48 hours...
Table 47.7 A standardized “ABCD” approach to intrapartum EFM management
Table 47.8 Several maternal and fetal factors can influence tie appearance of th...
Chapter 48
Table 48.1 Distribution of cases with nonimmune hydrops fetalis in relation to e...
Table 48.2 Pregnancy outcome in prenatal studies of nonimmune hydrops fetalis
Table 48.3 Survival rate among live births with nonimmune hydrops fetalis
Chapter 50
Table 50.1 Indications for labor induction
Table 50.2 Modified Bishop score
Table 50.3 Methods of cervical ripening
Table 50.4 Second trimester termination methods
Chapter 51
Table 51.1 Acute causes of postpartum hemorrhage
Table 51.2 Uterotonic medications
Chapter 52
Table 52.1 Brief list of differential diagnoses based on symptoms of pulmonary e...
Table 52.2 Comparison of symptom overlap between physiologic changes in pregnanc...
Table 52.3 Proposed algorithms for evaluation and diagnosis of VTE in pregnancy
Table 52.4 Comparison of imaging modalities used to diagnose VTE in pregnancy
Table 52.5 Comparison of clinical scoring systems
Chapter 53
Table 53.1 Diagnosis of active‐phase arrest
Table 53.2 Greenberg‐maternal age‐median length first stage labor
Table 53.4 Zaki‐labor duration from 4–10 cm by maternal age group
Table 53.3 Impact of body mass index on duration of first stage of labor
Table 53.5 Yee maternal and neonatal outcomes with early compared with delayed p...
Table 53.6 Gizzo (2014) [19], comparison of maternal position choice and labor c...
Table 53.7 Bleich (2012) [24], nulliparous women and route of delivery in relati...
Table 53.8 Rouse et al. (2009) [20] delivery mode by duration of second stage of...
Table 53.9 Grobman (2016) [21], duration of active pushing with maternal outcome...
Table 53.10 Grobman (2016) [21], duration of active pushing with route of delive...
Table 53.11 Comparison of active management versus physiological management of t...
Table 53.12 Misoprostol comparison of route‐onset of action and duration of acti...
Chapter 54
Table 54.1 Reported potential maternal‐fetal complications of operative vaginal ...
List of Illustrations
Chapter 1
Figure 1.1 Systematic review processes.
Chapter 7
Figure 7.1 Sonographic image showing a single 4.8 × 4.1 cm posterior submucosa...
Chapter 12
Figure 12.1 Photographs depicting facial and body terminal hair growth scored a...
Figure 12.2 Acne – a commonly encountered symptom of hyperandrogenism.
Figure 12.3 Female pattern hair loss or androgenic alopecia.
Figure 12.4 Acanthosis nigrans.
Figure 12.5 Clitoromegaly, a sign of virilization, is
not
a feature of PCOS.
Chapter 13
Figure 13.1 Updated meta‐analysis on hCG supplementation. (a) Updated Meta‐ana...
Chapter 23
Figure 23.1 Mechanism of placental drug transport. Pgp, phosphoglycoprotein; MR...
Chapter 33
Figure 33.1 Intracerebral calcification.
Figure 33.2 Echogenic bowel.
Figure 33.3 Abdominal calcification.
Figure 33.4 Ventriculomegaly.
Chapter 34
Figure 34.1 Diagnostic algorithm for suspected PE in pregnancy. Source: Reprint...
Chapter 41
Figure 41.1 A suggested management algorithm for prolonged pregnancies.
Chapter 43
Figure 43.1 Normal Doppler Waveforms in (a) the umbilical artery, (b) the midd...
Chapter 44
Figure 44.1 Twin oligopolyhydramnios sequence in a monochorionic pair. This is ...
Figure 44.2 The so‐called lambda (“twin pick”) sign seen by transabdominal ultr...
Figure 44.3 The absence of the lambda sign is suggestive of monochorionicity. T...
Chapter 47
Figure 47.1 Fetal heart rate.
Figure 47.2 Early decelerations.
Figure 47.3 Late decelerations.
Figure 47.4 Variable decelerations.
Figure 47.5 Sinusoidal pattern.
Figure 47.6 Mechanisms of late deceleration.
Figure 47.7 Components of fetal oxygenation.
Figure 47.8 Two central principles of electronic intrapartum fetal heart rate m...
Figure 47.9 Intrapartum FHR monitoring management decision algorithm.
Chapter 48
Figure 48.1 Congenital pulmonary airway malformation at presentation.
Figure 48.2 Associated findings of fetal hydrops (left: ascites, right: anasarc...
Figure 48.3 Aggravation of fetal hydrops at 24
+5
weeks of gestation.
Figure 48.4 In utero treatments of thoracoamniotic shunting.
Figure 48.5 Flowchart for diagnostic approach of non‐immune hydrops fetalis.
Chapter 51
Figure 51.1 B‐Lynch uterine compression suture.
Figure 51.2 Hayman suture – Modified B‐Lynch suture.
Chapter 53
Figure 53.1Figure 53.1 (a) Graph. Friedman Labor Curve. (b) Average Labor Curve...
Figure 53.3 Graphic 3. Nulliparous women and route of delivery in relation to l...
Figure 53.2Figure 53.2 (Graph 2a). Duration of active pushing and obstetrical ou...
Figure 53.4 Graph 4. Delivery mode in nulliparous women by second stage of labo...
Figure 53.5Figure 53.5 (Graph 5a) Effects of higher dose oxytocin on hematocrit....
Chapter 54
Figure 54.1 Cesarean, forceps, and vacuum delivery rates in the United States ...
Figure 54.2 Median forceps and vacuum procedures for US Residents completing re...
Figure 54.3 Pre‐procedure and Post‐procedure delivery notes.
Pre‐operative vaginal delivery checklist.
Potential audible standards for operative vaginal delivery (OVD), Modified fro...
Guide
Cover
Table of Contents
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E1
Evidence‐Based Obstetrics and Gynecology
Edited by
Errol R. Norwitz, MD, PhD, MBA
Louis E. Phaneuf Professor of Obstetrics & GynecologyTufts University School of Medicine Chief Scientific OfficerChair, Department of Obstetrics & GynecologyTufts Medical Center800 Washington Street Boston, MA USA
Carolyn M. Zelop, MD
Director of Ultrasound and Perinatal ResearchDivision of MFM and Department of Obstetrics and GynecologyThe Valley Hospital, Ridgewood, NJ, USAClinical Professor of Obstetrics and GynecologyNYU School of Medicine, New York, NY USA
David A. Miller, MD
Division of Maternal‐Fetal MedicineDepartment of Obstetrics and GynecologyKeck School of MedicineUniversity of Southern CaliforniaLos Angeles, CA, USA
David L. Keefe, MD
Stanley H. Kaplan ProfessorDepartment of Obstetrics and GynecologyNYU Langone Medical CenterNew York, NY, USA
Copyright
This edition first published 2019
© 2019 John Wiley & Sons Ltd
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Library of Congress Cataloging‐in‐Publication Data
Names: Norwitz, Errol R., editor. | Zelop, Carolyn M., editor. | Miller,
David A. (David Arthur), 1961‐ editor. | Keefe, David (David L.), editor.
Title: Evidence‐based obstetrics and gynecology / edited by Errol R. Norwitz,
Carolyn M. Zelop, David A. Miller, David L. Keefe.
Other titles: Evidence‐based obstetrics and gynecology (Norwitz)
Description: Hoboken, NJ : Wiley, 2019. | Includes bibliographical references
and index. |
Identifiers: LCCN 2018041057 (print) | LCCN 2018041689 (ebook) | ISBN
9781119072928 (Adobe PDF) | ISBN 9781119072959 (ePub) | ISBN 9781444334333
(hardback)
Subjects: | MESH: Genital Diseases, Female | Pregnancy Complications |
Evidence‐Based Medicine
Classification: LCC RG101 (ebook) | LCC RG101 (print) | NLM WP 140 | DDC
618.1–dc23
LC record available at https://lccn.loc.gov/2018041057
Cover Design: Wiley
Cover Images: © monkeybusinessimages/Getty Images
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List of contributors
Veronica Ades
Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Jennifer Amorosa
Department of Obstetrics, Gynecology and Reproductive Sciences
Icahn School of Medicine, Mt Sinai Hospital
New York, NY, USA
Karen Archabald
Legacy Health
Portland, OR, USA
Stephanie Bakaysa
Department of Maternal‐Fetal Medicine
Tufts Medical Center
Boston, MA, USA
Oren Barak
Rehovot, affiliated with the Hadassah‐Hebrew University School of Medicine, Department of Obstetrics and Gynecology
Kaplan Medical Center
Jerusalem, Israel
Marie Beall
Obstetrics and Gynecology
Harbor UCLA Medical Center
Torrance, CA, USA
Mila de Moura Behar Pontremoli Salcedo
Department of Gynecology and Obstetrics
Federal University of Health Sciences (UFCSPA)/Santa Casa de Porto Alegre
Porto Alegre, RS, Brazil
Rana Snipe Berry
Department of Obstetrics and Gynecology
Indiana University School of Medicine
Indianapolis, IN, USA
Stephanie V. Blank
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Isaac Blickstein
Obstetrics and Gynecology, Kaplan Medical Center, Rehovot, The Hadassah‐Hebrew University School of Medicine, Jerusalem, Israel
Anne‐Sophie Boes
Leuven University Fertility Centre (LUFC)
UZ Leuven, Leuven, Belgium
Ware Branch
Division of Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology, Medical Director of Women and Newborns Clinical Program for Intermountain Healthcare, Intermountain Medical Center
University of Utah
Murray, UT, USA
Haywood Brown
Morsani College of Medicine
University of South Florida Health Center
Tampa, FL, USA
Julie Brown
Department of Obstetrics and Gynecology
University of Auckland
New Zealand
Steve N. Caritis
Division of Maternal‐Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences
Magee Women's Hospital of UPMC
Pittsburgh, PA, USA
H. J. A. Carp
Department Obstetrics and Gynecology
Sheba Medical Center
Tel HaShomer, Israel
Steven L. Clark
Department of Obstetrics and Gynecology
Baylor College of Medicine Obstetrics and Gynecology, Service Chief MFM, Texas Children's Hospital, TCH Pavilion for Women
Houston, TX, USA
Joshua Copel
Department Obstetrics, Gynecology & Reproductive Sciences, Division of Maternal‐Fetal Medicine
Yale School of Medicine
New Haven, CT, USA
Sabrina D. Craigo
Division of Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology
Tufts Medical Center
Boston, MA, USA
John P. Curtin
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Thomas D'Hooghe
Division of Reproductive Medicine and Biology, Department of Obstetrics and Gynecology
University of Leuven
Leuven, Belgium
Gary A. Dildy
Department of Obstetrics and Gynecology
Baylor College of Medicine Obstetrics and Gynecology, Service Chief MFM, Texas Children's Hospital, TCH Pavilion for Women
Houston, TX , USA
Margaret Dziadosz
Department of Obstetrics and Gynecology, NYU School of Medicine
New York University
New York, NY, USA
Britt K. Erickson
Division of Gynecologic Oncology
University of Alabama at Birmingham
Birmingham, AL, USA
Christine Farinelli
Obstetrix Medical Group
Tucson Medical Center
Tucson, AZ, USA
Cynthia Farquhar
Department of Obstetrics and Gynecology
University of Auckland
New Zealand
Maisa N. Feghali
Division of Maternal‐Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences
Magee Women's Hospital of UPMC
Pittsburgh, PA, USA
Kimberley Ferrante
Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Michael R. Foley
Banner University Medical Center Phoenix, Obstetrics and Gynecology
University of Arizona College of Medicine Phoenix
Phoenix, AZ, USA
Karin Fox
Maternal‐Fetal Medicine, Baylor College of Medicine
Texas Children's Hospital, Pavilion for Women
Houston, TX, USA
Jenna Friedenthal
Department of Obstetrics and Gynecology
New York University
New York, NY, USA
Joanna Gibson
Obstetrics and Gynecology
Yorkshire and Humber, UK
Veronica Gillispie
Ochsner Health System
New Orleans, LA, USA
Dianne Glass
Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Urology
NYU Langone Medical Center
New York, NY, USA
Katherine R. Goetzinger
Department of Obstetrics, Gynecology and Reproductive Sciences
University of Maryland School of Medicine
Baltimore, MD, USA
Jane Goldman
Division of Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology
The Valley Hospital
Ridgewood, NJ, USA
Steven Goldstein
Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
George Graham
Department of Maternal‐Fetal Medicine
Tufts Medical Center
Boston, MA, USA
Jeanne‐Marie Guise
Division of Maternal‐Fetal Medicine, Departments of Obstetrics and Gynecology, Medical Informatics and Clinical Epidemiology, Public Health and Preventive Medicine, and Emergency Medicine
Oregon Health and Science University
Portland, OR, USA
Cynthia Gyamfi‐Bannerman
Columbia University Medical Center
New York, NY, USA
Cara Heuser
Division of Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology
University of Utah and Intermountain Medical Center
Murray, UT, USA
Alexandria J. Hill
High Risk Pregnancy Center
Las Vegas, NV, USA
Texas A&M College of Medicine
College Station, TX, USA
University of Arizona
Phoenix, AZ, USA
Kathy Huang
Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Warner K. Huh
Division of Gynecologic Oncology
University of Alabama at Birmingham
Birmingham, AL, USA
Joses A. Jain
Columbia University Medical Center
New York, NY, USA
Arun Jeyabalan
Division of Maternal‐Fetal Medicine, Department of Obstetrics, Gynecology and Reproductive Sciences
University of Pittsburgh School of Medicine, Magee‐Women's Hospital
Pittsburgh, PA, USA
Carrie Lynn Johnson
Department of Obstetrics and Gynecology
University of Miami, Miller School of Medicine
Miami, FL, USA
Emily L. Johnson
Johns Hopkins Bayview Medical Center, Department of Neurology
Johns Hopkins University School of Medicine
Baltimore, MD, USA
Megan L. Jones
The University of Ohio Wexner Medical Center
Columbus, OH, USA
Peter W. Kaplan
Johns Hopkins Bayview Medical Center, Department of Neurology
Johns Hopkins University School of Medicine
Baltimore, MD, USA
David L. Keefe
Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Rasha S. Khoury
Division of Family Planning and Global Women's Health
Department of Obstetrics, Gynecology & Reproductive Biology
Brigham and Women's Hospital, Harvard Medical School
Boston, MA, USA
Sarah J. Kilpatrick
Department of Obstetrics and Gynecology
Cedars‐Sinai Medical Center
Los Angeles, CA, USA
David L. Kulak
Department of Obstetrics and Gynecology
Johns Hopkins Medical Center
Baltimore, MD, USA
Jessica Lee
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Richard H. Lee
Division of Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology, University of Southern California, Keck School of Medicine
Los Angeles, CA, USA
Patricia A. Lohr
bpas (British Pregnancy Advisory Service)
Stratford Upon Avon, UK
Sherri Longo
Ochsner Health System
New Orleans, LA, USA
Richard Lyus
bpas (British Pregnancy Advisory Service) Richmond
East Twickenham, UK
Dominique Malacarne
Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Urology
NYU Langone Medical Center
New York, NY, USA
Peter W. Marks
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
Silver Spring, MD, USA
Jovana Y. Martin
Department of Obstetrics and Gynecology
University of Alabama at Birmingham
Birmingham, AL, USA
Stephanie R. Martin
Clinical Concepts in Obstetrics
Scottsdale, AZ, USA
Christel Meuleman
Leuven University Fertility Centre (LUFC)
UZ Leuven, Leuven, Belgium
David A. Miller
Division of Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology, Keck School of Medicine
University of Southern California
Los Angeles, CA, USA
Payam Mohassel
Johns Hopkins Bayview Medical Center, Department of Neurology
Johns Hopkins University School of Medicine
Baltimore, MD, USA
Jane Moore
Nuffield Department of Obstetrics and Gynecology
University of Oxford
Oxford, UK
Lila Nachtigall
Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Frederick Naftolin
Department of Obstetrics and Gynecology
New York University
New York, NY, USA
Jennifer A. Namazy
Scripps Clinic
San Diego, CA, USA
James Neilson
Obstetrics and Gynecology
University of Liverpool
Liverpool, UK
Diane De Neubourg
Leuven University Fertility Centre (LUFC)
UZ Leuven, Leuven, Belgium
Errol R. Norwitz
Louis E. Phaneuf Professor of Obstetrics & Gynecology
Tufts University School of Medicine
Chief Scientific Officer Chair, Department of Obstetrics & Gynecology Tufts Medical Center
Boston, USA
Anthony O. Odibo
Department of Obstetrics and Gynecology
University of South Florida
Tampa, FL, USA
Joseph G. Ouzounian
Division of Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology
University of Southern California, Keck School of Medicine
Los Angeles, CA, USA
Michael J. Paidas
Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine
Section of Maternal‐Fetal Medicine
New Haven, CN, USA
Lubna Pal
Department of Obstetrics, Gynecology and Reproductive Sciences
Yale University School of Medicine
New Haven, CT, USA
Joong Shin Park
Department of Obstetrics and Gynecology
Seoul National University College of Medicine
Seoul National University Hospital
Seoul, Korea
Anita Patel
University of Central Florida
Center for Reproductive Medicine
Orlando, FL, USA
Shivani R. Patel
Division of Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology
University of Southern California, Keck School of Medicine
Los Angeles, CA, USA
Shefali Pathy
Department of Obstetrics, Gynecology and Reproductive Sciences
Yale University School of Medicine
New Haven, CT, USA
Karen Peeraer
Leuven University Fertility Centre (LUFC)
UZ Leuven, Leuven, Belgium
Ashley T. Peterson
Division of Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology
Tufts Medical Center
Boston, MA, USA
Joanne Quinones
Department of Obstetrics and Gynecology, Maternal Fetal Medicine, Lehigh Valley Health Network
The Center for Advanced Perinatal Care, Allentown, PA, USA
University of South Florida‐Morsani College of Medicine
Tampa, FL, USA
Diana A. Racusin
Department of Obstetrics and Gynecology, Division of Maternal‐Fetal Medicine
Baylor College of Medicine, Texas Children's Hospital Pavilion for Women
Houston, TX, USA
A. Reza Radjabi
Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Andrei Rebarber
Mount Sinai St. Luke's and Mount Sinai West, Mount Sinai Beth Israel, The Mount Sinai Hospital
Obstetrics, Gynecology and Reproductive Sciences
New York, NY, USA
Danielle M. Roncari
Division of Family Planning, Department of Obstetrics and Gynecology
Tufts University School of Medicine
Boston, MA, USA
Ashley S. Roman
Department of Obstetrics and Gynecology, NYU School of Medicine
New York University
New York, NY, USA
Michael Ross
Obstetrics and Gynecology
Harbor UCLA Medical Center
Torrance, CA, USA
B. Ryan Ball
Department of Obstetrics, Gynecology and Reproductive Sciences, Yale School of Medicine
Section of Maternal‐Fetal Medicine
New Haven, CN, USA
Nada Sabir
Obstetrics and Gynecology/Maternal Medicine, Bradford Teaching Hospitals NHS Foundation Trust
Bradford, UK
Michael Schatz
Kaiser Permanente
San Diego, CA, USA
Kathleen M. Schmeler
Department of Gynecologic Oncology and Reproductive Medicine
The University of Texas, MD Anderson Cancer Center
Houston, TX, USA
Zachary P. Schwartz
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
James H. Segars
National Institute of Child Health and Human Development
National Institutes of Health
Bethesda, MD, USA
Lili Sheibani
Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology
University of California
Irvine, Orange, CA, USA
Celso Silva
University of Central Florida, Center for Reproductive Medicine
Orlando, FL, USA
Michael K. Simoni
Department of Psychiatry
Yale School of Medicine
Yale, New Haven, CN, USA
Scott W. Smilen
Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology
NYU Langone Medical Center
New York, NY, USA
Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery, Department of Urology
NYU Langone Medical Center
New York, NY, USA
John Smulian
Department of Obstetrics and Gynecology, Maternal Fetal Medicine, Lehigh Valley Health Network
The Center for Advanced Perinatal Care, Allentown, PA, USA
University of South Florida‐Morsani College of Medicine
Tampa, FL, USA
Rhoda Sperling
Department of Obstetrics, Gynecology and Reproductive Sciences
Icahn School of Medicine, Mt Sinai Hospital
New York, NY, USA
Medicine, Infectious Diseases
Icahn School of Medicine, Mt Sinai Hospital
New York, NY, USA
Carla Tomassetti
Leuven University Fertility Centre (LUFC)
UZ Leuven, Leuven, Belgium
Maria Victoria Vargas
Department of Obstetrics and Gynecology
George Washington University Medical Center
USA
Alex C. Vidaeff
Department of Obstetrics and Gynecology, Division of Maternal‐Fetal Medicine
Baylor College of Medicine, Texas Children's Hospital Pavilion for Women
Houston, TX, USA
Deborah Wing
Maternal‐Fetal Medicine, Department of Obstetrics and Gynecology
University of California
Irvine, Orange, CA, USA
Kimberly Yonkers
Department of Psychiatry
Yale School of Medicine
Yale, New Haven, CN, USA
Carolyn M. Zelop
Ultrasound and Perinatal Research, Division of MFM and Department of Obstetrics and Gynecology, The Valley Hospital, Ridgewood, NJ, USA
Department of Obstetrics and Gynecology NYU School of Medicine, New York, NY, USA
Lisa C. Zuckerwise
Department of Obstetrics, Gynecology & Reproductive Sciences, Division of Maternal‐Fetal Medicine
Yale School of Medicine
New Haven, CT, USA
CHAPTER 1Evidence‐based medicine in obstetrics and gynecology
Jeanne‐Marie Guise
Division of Maternal‐Fetal Medicine, Departments of Obstetrics and Gynecology, Medical Informatics and Clinical Epidemiology, Public Health and Preventive Medicine, and Emergency Medicine, Oregon Health and Science University, Portland, OR, USA
…decisions about the care of individual patients should be based on the conscientious, explicit, and judicious use of the current best evidence on the effectiveness of clinical services.
IOM Knowing What Works in Health Care 2008 [1]
While all clinicians want to use the best evidence to make health care decisions, with 37 reviews, 47 randomized control trials (RCTs), and two guidelines published every day, it is impossible for practicing clinicians to keep up with all the new evidence and decide whether it is sufficient to suggest that they should change their practice. This book provides a summary of evidence for the major clinical areas of practice within the specialty of Obstetrics and Gynecology (OB/GYN), and this chapter (i) provides an overview and context, discussing the history of evidence based medicine (EBM) in OB/GYN; (ii) describes the importance and conduct of a systematic evidence review, a hallmark of EBM and contemporary evidence‐based decision‐making; and (iii) provides additional EBM resources and references for interested readers.
History of obstetrics and evidence‐based medicine
OB/GYN has played a long and important role in shaping what is known today as EBM, although it did not always embrace evidence. The beginnings of OB/GYNs relationship with EBM may have started in the 1800s when women went to Lying‐in Hospitals to stay for days or months in preparation for and recovery from childbirth. Lying‐in hospitals were often crowded, and rates of maternal and child death from childbed fever (puerperal sepsis) were high. Some women were said to prefer giving birth in the streets, pretending to have given birth en route to the hospital. Ignac Semmelweiss, perplexed by the lower rates of maternal mortality for women delivering outside the hospital said: “To me, it appeared logical that patients who experienced street births would become ill at least as frequently as those who delivered in the clinic…What protected those who delivered outside the clinic from these destructive unknown endemic influences?” [2]. He also observed that there were higher rates of maternal mortality from childbed fever in the First Division Hospital, which was staffed by physicians, compared with the Second which was staffed by midwives. Both units had trainees, performed examinations, and saw roughly similar populations. He realized that unlike the midwives, physicians all performed autopsies on women who died the night before prior to beginning their clinical duties on the maternity ward. In 1847, Semmelweiss figured out what might be occurring when a forensic medical professor, Jakob Kolletschka, died of sepsis after sustaining an accidental finger stick during an autopsy. He concluded that, “In Kolletschka, the specific causal factor was the cadaverous particles that were introduced into his vascular system. I was compelled to ask whether cadaverous particles had been introduced into the vascular systems of those patients whom I had seen die of this identical disease. I was forced to answer affirmatively” [2]. He required physicians wash their hands with chlorinated lime before examining patients. The mortality rate in District 1 fell from 11.4% prior to handwashing to 1.27% (rates were 2.7% and 1.33% in District 2). The medical community did not embrace this new evidence. Semmelweiss was ridiculed by physicians who were offended by the suggestion they were unclean, and his theory was rejected because it was contrary to the accepted belief that childbed fever was caused by miasmas or “bad air.” In response, Semmelweiss could only figuratively shake his head: “One would believe that the clarity of things would have made the truth apparent to everyone and that they would have behaved accordingly. Experience teaches otherwise. Most medical lecture halls continue to resound with lectures on epidemic childbed fever and with discourses against my theories” [2].
Fast forward to the 1950s and 1960s and two stories demonstrate how difficult it is for new evidence to change clinical practice even when that evidence is strong – and how profound the consequences for this failure.
In the 1950s, diethylstilboestrol (DES) therapy was used to prevent miscarriage. Its use was established through uncontrolled studies. Even though randomized controlled trials were published in the mid‐1950s that found no significant prevention offered by DES, its use had become so commonplace that it continued despite the evidence. It was not until 1971 that the food and drug administration (FDA) brought national attention to the harms of DES exposure (associated with vaginal clear cell carcinoma) and banned its use in pregnancy. Total exposure to DES for mothers and daughters has been estimated to exceed 10 million worldwide.
The story of antenatal corticosteroids is not only a major discovery in obstetrics but is also emblematic of the importance of EBM. In the 1960s, Graham “Mont” Liggins, an Australian obstetrician, had a sheep farmer neighbor and wondered why ewes delivered prematurely when worried by dogs [3]. Liggins suspected it may have something to do with the stress‐response in the mother and the release of cortisol. He conducted an experiment where he administered corticosteroids to pregnant ewes and found they delivered prematurely. Unexpectedly, he also found that the lambs delivered by ewes that received corticosteroids survived in far greater numbers than he would have expected given the severe degree of their prematurity [4]. In the 1970s, Liggins and a pediatrician colleague, Ross Howie, conducted the first randomized trial in humans to test their theory that corticosteroids reduced the occurrence of respiratory distress syndrome (RDS). RDS and mortality rates were significantly reduced in the treated group (6.4%) as opposed to 18% in placebo treated mothers. Within a decade of this first RCT additional studies supported the conclusion that corticosteroids significantly reduced infant mortality for prematurely born children. However it was not until the mid‐1990s that antenatal steroids became part of routine practice for women at risk of premature delivery (after a meta‐analysis was published in 1989). The forest plot from a meta‐analysis of antenatal corticosteroids represents this delay, demonstrates the potential power of systematic reviews and meta‐analyses of a body of evidence, and has become the symbol for the Cochrane Collaboration, the most recognized source for evidence‐based systematic reviews in medicine. It has been estimated that tens of thousands of babies would have been saved by earlier implementation of steroids.
It is perhaps not a surprise that Archie Cochrane, for whom the Cochrane Collaboration is named awarded the field of OB/GYN the first wooden spoon award for failing to evaluate the care they provide with RCTs and failing to apply results of RCTs in practice [5]. He went further stating that GO in Gynecology and Obstetrics should stand for “go ahead without evidence” [6].
What is evidence‐based medicine?
EBM, refers to a process of turning clinical problems into questions and systematically locating, appraising, and synthesizing research findings as a basis for clinical decision‐making. Gordon Guyatt [7] first used the term “EBM” in the 1980s to describe an approach to residency training at McMaster University School of Medicine where residents were taught how to identify, interpret, and use the literature in their clinical decision‐making. At first he wanted to call it “Scientific Medicine” but reconsidered when others argued that the title would imply all other medicine was non‐scientific [8]. Further refined by David Sackett, “EBM requires a bottom‐up approach that integrates the best external evidence with individual clinical expertise and patient choice” [9].
The systematic review is a hallmark of EBM. Systematic reviews apply a scientific review strategy that limits bias by the systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic. As shown in Figure 1.1, systematic reviews are at the top of the evidence hierarchy pyramid. Clinicians in pursuit of the best evidence, should first search for high‐quality systematic reviews. Since systematic reviews are such an important part of EBM and are instrumental to clinical decision‐making, this chapter provides a brief description of the systematic review process.
Figure 1.1 Systematic review processes.
Systematic review processes
If, as is sometimes supposed, science consisted in nothing but the laborious accumulation of facts, it would soon come to a standstill, crushed, as it were, under its own weight... Two processes are thus at work side by side, the reception of new material and the digestion and assimilation of the old [10]
A systematic review is a scientific review strategy that limits bias by the systematic assembly, critical appraisal, and synthesis of all relevant studies on a specific topic. Table 1.1 presents the six steps for Evidence‐based Obstetrics. The first four of these are covered by, and critical to, systematic review. Therefore, busy clinicians can shortcut these steps if they are able to find a high‐quality systematic review that answers their clinical question.
Table 1.1 Steps for evidence‐based obstetrics
1. Formulate a clear clinical question
2. Search the literature and identify relevant reviews and studies
3. Critically appraise individual studies and the overall body of evidence
4. Synthesize results given context and patient factors
5. Implement
6. Evaluate the application into clinical practice
Each of these steps is covered briefly below.
Formulating the question
A prudent question is one‐half of wisdom [11]
Sir Francis Bacon
Questions arise every day a clinician cares for patients: some they can answer easily, others they know where to find the answers quickly, and many require investigation. The ability to take an everyday dilemma and turn it into an answerable and searchable question is important not only for systematic reviews, but also for good clinical care. Questions often fall into specific categories: incidence/prevalence, causation/etiology, screening, diagnostic, therapeutic/treatment, prevention, outcomes (benefits and/or harms), prognostic, and they can be expressed as, “In patients with…how effective is…compared with…for the outcome[s] of…”. Formulating an answerable and relevant question is a critical foundational step to determining the relevant scope of a review; too big and the review may not be feasible, too narrow and the results may not be relevant. Systematic review questions are often formulated according to a PICOTS format, that is, Population, Intervention, Comparator, Outcome, Timing, and Setting (Table 1.2).
Population
– Understanding the population of reviews and research studies is often one of the clearest ways clinicians can determine whether the scope of a review or study is pertinent to their clinical population. Factors often considered include age (e.g. child, teen, young adult, elderly), sex, medical conditions, pregnancy status, and social factors (education required, skill‐level, access to care). A description of such factors helps clinicians understand whether the review will be applicable to their patient population.
Intervention
– The intervention is often the main subject of reviews. Interventions can involve medical, surgical, health systems, social, or behavioral interventions and can have one or many components.
Comparator
– The comparator group is often overlooked, yet is critical to understanding the relative effectiveness of an intervention. Comparators include no treatment, placebo, “standard of care,” active alternative treatment. It is important to describe the underlying condition considered “standard of care” as what is considered standard might be an intervention in other settings.
Outcomes
– Outcomes include health outcomes, intermediate outcomes, and harms.
Timing
– Timing is increasingly recognized as an important consideration. Timing refers to the timing of the intervention or parts of the intervention and also may describe the time of patient eligibility, intervention, and follow‐up for a target trial.
Setting
– Setting or context factors such as organizational characteristics, financial setting (fee‐for‐ service, capitated, uninsured; geographic and clinical settings (solo or group practice, public or private, for profit or non‐profit, etc.) are often critical to interventional effectiveness and should be described in systematic reviews.
Table 1.2 PICOTS
P
opulation – Who does the review topic pertain to
I
ntervention – What is the intervention or treatment that is being evaluated?
C
