Evidence-based Medicine, Obstetrics and Gynaecology (C-Gen 15)

Best practice statement

RANZCOG recognises the NHMRC levels of evidence and associated grading of recommendations.[1]NHMRC. How to use the evidence: assessment and application of scientific evidence.[2]NHMRC. Additional levels of evidence and grades for recommendations.[3]Craig JC, Irwig LM, Stockler MR. Evidence-based medicine: useful tools for decision making. The Medical journal of Australia. 2001;174(5):248-53. These classify systematic reviews of randomised controlled trials (RCTs) and RCTs themselves as the strongest evidence types to estimate the effect of clinical interventions. RANZCOG upholds the principle that clinical decision-making should be based on the strongest and most relevant evidence available, as applied to the patient’s particular situation. In an era of exponentially increasing complexity of disease and medicine, this calls on clinicians to integrate available evidence, representing summarised experiences of a population, with clinical experience and patient preferences to best individualise management.[4]Sturmberg JP. Evidence-based medicine-Not a panacea for the problems of a complex adaptive world. J Eval Clin Pract. 2019;25(5):706-16.

Systematic reviews and RCTs constitute the highest level of evidence, because their findings represent the systematic and unbiased findings of many individual doctors on the scientifically proven benefits and harms of a given intervention. Accordingly, RANZCOG strongly supports clinicians recruiting to randomised controlled trials to scientifically test interventions for which there is clinical uncertainty, and applying their findings.

Nevertheless, it is important to also acknowledge that the best available evidence may not come from randomised trials, and other sources of evidence may need to be considered. Firstly, it is unfortunately often the case that pregnant and breastfeeding women are systematically excluded from clinical trials of therapeutics.[5]Whitehead CL, Walker SP. Consider pregnancy in COVID-19 therapeutic drug and vaccine trials. Lancet. 2020;395(10237):e92.[6]LaCourse SM, John-Stewart G, Adams Waldorf KM. Importance of inclusion of pregnant and breastfeeding women in COVID-19 therapeutic trials. Clin Infect Dis. 2020. Because of their frequent exclusion from trials, RCT evidence is not always available for these unique, but not uncommon, populations. RANZCOG strongly advocates for the inclusion of pregnant and breastfeeding women in clinical trials. Secondly, a number of important adverse outcomes in obstetrics, are rare but due to the severity of the outcome, still occur at frequencies of clinical importance to some or most women.[7]Walker SP, McCarthy EA, Ugoni A, Lee A, Lim S, Permezel M. Cesarean delivery or vaginal birth: a survey of patient and clinician thresholds. Obstetrics and gynecology. 2007;109(1):67-72. Where infrequent outcomes are endpoints, the number of subjects required for a meaningful RCT are necessarily massive and may be unattainable. In such situations, observational studies may provide additional meaningful evidence.[8]Glezerman M. Five years to the term breech trial: the rise and fall of a randomized controlled trial. American journal of obstetrics and gynecology. 2006;194(1):20-5. Finally, not all clinical recommendations lend themselves to assessment by RCTs or even case-­control, cohort or population studies. Sometimes the evidence is such that subjecting the matter to direct investigation is inappropriate or unnecessary. Gordon Smith’s analogy with “use or non-use of the parachute” has been widely quoted as an example.[9]Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. Bmj. 2003;327(7429):1459-61. Likewise in medicine, the evidence that guides some recommendations may be derived from a compelling rationale[10]Diaz M ND. Heroes and martyrs of quality and safety. Pasteur and parachutes: when statistical process control is better than a randomized controlled trial. Quality and Safety in Health Care 2005. … Continue reading For example, no one would suggest a trial of caesarean versus vaginal birth for a grade IV placenta praevia or enter their patients into a trial of placebo versus medication for a blood pressure of 200/150. These situations are however rare in medicine, and in the majority of situations such a compelling rationale cannot be derived from case-reports alone. Summarizing however, evidence-based medicine aims to help in getting the best estimate of the truth underlying medical interventions, be it from randomised clinical trials and meta-analysis or from studies more prone to bias, together with pathophysiological rationale and clinical expertise.

Recommendations for clinical practice in the form of Guidelines or College Statements are ultimately made by panels using their clinical expertise, and/or their expertise in the interpretation of all the available evidence. They aim to guide clinicians who simply lack the time and/or expertise to adequately find and assess the individual pieces of relevant evidence to support clinical decisions.[11]Mercuri M. The ever-shifting source of authority on what works in clinical medicine. J Eval Clin Pract. 2019;25(5):703-5. It is essential that experienced clinicians are adequately represented on these panels to ensure appropriate interpretation and applicability to specified clinical situations. Maybe the most important success factor for evidence-based medicine is the continuous awareness that our own perception of the world around us is biased.

Although guidelines are semantically a “guide” to clinical practice, they should be followed where they are relevant to a clinical decision, informed by the best scientific evidence that is available. If the circumstances of an individual patient result in a care recommendation contrary to the guideline, the rationale for deviation from accepted clinical practice should be clearly documented. 


Version history

First endorsed by RANZCOG:November 2009
Current: March 2021
Review due: March 2024

Background: This statement was first developed by Women’s Health Committee in November 2009 and most recently reviewed in March 2021.

Funding: This statement was developed by RANZCOG and there are no relevant financial disclosures.

Appendix A: Women’s Health Committee authors

NamePosition on Committee at time of publication
Professor Yee LeungChair and Board Member
Dr Gillian GibsonDeputy Chair, Gynaecology
Dr Scott WhiteDeputy Chair, Obstetrics and Subspecialties Representative
Associate Professor Ian PettigrewMember and EAC Representative
Dr Kristy MilwardMember and Councillor
Dr Will MilfordMember and Councillor
Dr Frank O’KeeffeMember and Councillor
Professor Sue WalkerMember
Professor Steve RobsonMember
Dr Roy WatsonMember and Councillor
Dr Susan FlemingMember and Councillor
Dr Sue BelgraveMember and Councillor
Dr Marilyn ClarkeATSI Representative
Associate Professor Kirsten BlackMember
Dr Thangeswaran RudraMember
Dr Nisha KhotMember and SIMG Representative
Dr Judith GardinerDiplomate Representative
Dr Angela BrownMidwifery Representative 
Ms Ann JorgensenCommunity Representative
Dr Ashleigh SeilerTrainee Representative
Prof Caroline De CostaCo-opted member (ANZJOG member)
Dr Christine SammartinoObserver

Appendix B: Contributing authors

The Women’s Health Committee acknowledges the contribution of Prof Ben W. Mol to this statement.

Appendix C: Full disclaimer

Purpose

This Guideline has been developed to provide general advice to practitioners about women’s health issues concerning evidence based medicines, obstetrics and gynaecology and should not be relied on as a substitute for proper assessment with respect to the particular circumstances of each case. It is the responsibility of each practitioner to have regard to the particular circumstances of each case. Clinical management should be responsive to the needs of the individual person with an intent to use water immersion during labour and birth and the particular circumstances of each case.

Quality of information

The information available in the evidence based medicines, obstetrics and gynaecology is intended as a guide and provided for information purposes only. The information is based on the Australian context using the best available evidence and information at the time of preparation. While the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) had endeavoured to ensure that information is accurate and current at the time of preparation, it takes no responsibility for matters arising from changed circumstances or information or material that may have become subsequently available. The use of this information is entirely at your own risk and responsibility.

For the avoidance of doubt, the materials were not developed for use by patients, and patients must seek medical advice in relation to any treatment. The material includes the views or recommendations of third parties and does not necessarily reflect the views of RANZCOG or indicate a commitment to a particular course of action.

Third-party sites

Any information linked in this guideline is provided for the user’s convenience and does not constitute an endorsement or a recommendation or indicate a commitment to a particular course of action of this information, material, or content unless specifically stated otherwise.

RANZCOG disclaims, to the maximum extent permitted by law any responsibility and all liability (including without limitation, liability in negligence) to you or any third party for inaccurate, out of context, incomplete or unavailable information contained on the third-party website, or for whether the information contained on those websites is suitable for your needs or the needs of any third party for all expenses, losses, damages and costs incurred.

Exclusion of liability

The College disclaims, to the maximum extent permitted by law, all responsibility and all liability (including without limitation, liability in negligence) to you or any third party for any loss or damage which may result from your or any third party’s use of or reliance of this guideline, including the materials within or referred to throughout this document being in any way inaccurate, out of context, incomplete or unavailable for all expenses, losses, damages, and costs incurred.

DISCLAIMER

This information is intended to provide general advice to practitioners. This information should not be relied on as a substitute for proper assessment with respect to the particular circumstances of each case and the needs of any patient. This document reflects emerging clinical and scientific advances as of the date issued and is subject to change. The document has been prepared having regard to general circumstances.


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References

References
1 NHMRC. How to use the evidence: assessment and application of scientific evidence.
2 NHMRC. Additional levels of evidence and grades for recommendations.
3 Craig JC, Irwig LM, Stockler MR. Evidence-based medicine: useful tools for decision making. The Medical journal of Australia. 2001;174(5):248-53.
4 Sturmberg JP. Evidence-based medicine-Not a panacea for the problems of a complex adaptive world. J Eval Clin Pract. 2019;25(5):706-16.
5 Whitehead CL, Walker SP. Consider pregnancy in COVID-19 therapeutic drug and vaccine trials. Lancet. 2020;395(10237):e92.
6 LaCourse SM, John-Stewart G, Adams Waldorf KM. Importance of inclusion of pregnant and breastfeeding women in COVID-19 therapeutic trials. Clin Infect Dis. 2020.
7 Walker SP, McCarthy EA, Ugoni A, Lee A, Lim S, Permezel M. Cesarean delivery or vaginal birth: a survey of patient and clinician thresholds. Obstetrics and gynecology. 2007;109(1):67-72.
8 Glezerman M. Five years to the term breech trial: the rise and fall of a randomized controlled trial. American journal of obstetrics and gynecology. 2006;194(1):20-5.
9 Smith GC, Pell JP. Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. Bmj. 2003;327(7429):1459-61.
10 Diaz M ND. Heroes and martyrs of quality and safety. Pasteur and parachutes: when statistical process control is better than a randomized controlled trial. Quality and Safety in Health Care 2005. 2005;14:140-3.
11 Mercuri M. The ever-shifting source of authority on what works in clinical medicine. J Eval Clin Pract. 2019;25(5):703-5.