How we make clinical recommendations
Ipas strives to integrate the best scientific evidence into our clinical programs. This section documents the methodology Ipas uses to make its clinical recommendations.
Using evidence to support recommendations
Clinical recommendations are based on relevant published, peer-reviewed evidence. For each clinical topic contained in the Clinical Updates in Reproductive Health, we conduct systematic reviews of the literature using a methodology drawn from the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines (Moher, Liberati, Tetzlaff, Altman, & the PRISMA Group, 2009; Stroup, Berlin, & Morton, 2000).
Process for making recommendations
Ipas applies the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to its recommendation formation (Guyatt et al., 2008b). The GRADE system provides a framework to evaluate the quality of the available evidence, and to translate that evidence into a context-appropriate recommendation. For every recommendation in the Clinical Updates, both the quality of evidence and the strength of the recommendation based on that evidence are reported.
Quality of evidence
Sources of clinical evidence range from well-designed large clinical studies that have minimized bias to uncontrolled clinical observations, case series or reports. When there is no available evidence, expert opinion may be used. In the GRADE system, the quality of evidence related to a specific clinical topic is defined as both the extent to which one can be confident that an estimate of effect is correct, and the extent to which the evidence relates to the specific context in which it is being applied (Guyatt et al., 2008a). When assessing the quality of evidence, the following criteria are considered (Guyatt et al., 2008a):
1. study design
2. study limitations and the risk of bias
3. consistency of the results across available studies
4. precision of the results (wide or narrow confidence intervals)
5. applicability with respect to populations, interventions and settings where the proposed intervention may be used
6. likelihood of publication bias
Quality of evidence determinations are reported as follows (Balshem et al., 2011):
- A high grade: we are very confident that the true effect lies close to the estimate of the effect.
- A moderate grade: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
- A low grade: confidence in the effect estimate is limited. The true effect may be substantially different from the estimate.
- A very low grade: we have very little confidence in the estimate of the effect. The true effect is likely to be substantially different from the estimate.
For example, randomized trials are initially given a high grade, while observational studies are initially labeled as low quality.
Strength of recommendation
Strength of recommendation is defined as the extent to which one can be confident that the desireable consequences of a recommendation outweigh its undesireable consequences (Andrews et al., 2013). Desirable effects include improved health outcomes, less burden for providers and health systems, and cost savings. Undesirable effects include harm to patients, inconvenience or hassle, and increased resource use.
· Strong recommendations are made when the desirable effects of a recommended intervention clearly outweigh the undesirable effects (Guyatt et al., 2008b). Most informed people would make the recommended choice for an intervention (Andrews et al., 2013).
· Weak recommendations are made when evidence suggests that desirable effects of a recommended intervention probably outweigh the undesirable effects, but there are small benefits or benefits that may not be worth the costs (Guyatt et al., 2008b). While most informed people would choose the recommended course of action, a substantial number would not (Andrews et al., 2013).
Can you have a strong recommendation based on low-quality evidence?
Answer: Yes. There are many factors that influence the strength of a recommendation.
For example, although there is limited evidence about bimanual examination prior to uterine aspiration, several factors increase the strength of the recommendation that bimanual examination should be performed by the clinician who will perform the procedure: 1) the potential benefit to patients, 2) the low risk of harm associated with bimanual examination, and 3) its low cost as well as potential savings when complications are avoided. All or almost all providers and women, when informed of the balance between desireable and undesireable effects, would choose to include a bimanual examination before uterine procedures.
Maintaining the Clinical Updates
The Clinical Updates are revised annually. The “last reviewed” date for each topic indicates all relevant published literature up to that date has been considered and included where appropriate. New topics and proposed revisions to the document come from end-users, a regionally representative Clinical Updates Advisory Group, and observations made during routine quality monitoring of clinical services in Ipas-supported programs. The Lead Writer, Medical Editors and Medical Director review all proposed updates. New recommendations or substantially revised recommendations may undergo an internal peer review process. The revision process–including systematic review of literature, documentation of the body of evidence, generation and revision of recommendations, and resultant changes to the Clinical Updates in Reproductive Health–is documented and archived.
Andrews, J., Guyatt, G., Oxman, A., Alderson, P., Dahm, P., Falck-Ytter, Y., … Schunemann, H. J. (2013). GRADE Guidelines: 14. Going from evidence to recommendations: The significance and presentation of recommendations. Journal of Clinical Epidemiology, 66, 719-725.
Balshem, H., Helfand, M., Schunemann, H. J., Oxman, A. D., Kunz, R., Brozek, J., … Guyatt, G. H. (2011). GRADE Guidelines: 3. Rating the quality of the evidence. Journal of Clinical Epidemiology, 64, 401-406.
Guyatt, G. H., Oxman, A. D., Kunz, R., Vist, G. E., Falck-Ytter, Y., & Schünemann, H. J. (2008a). What is “quality of evidence” and why is it important to clinicians? BMJ: British Medical Journal, 336(7651), 995-998.
Guyatt, G. H., Oxman, A. D., Vist, G. E., Kunz, R., Falck-Ytter, Y., Alonso-Coello, P., & Schünemann, H. J. (2008b).
GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ: British Medical Journal, 336(7650), 924-926.
Moher, D., Liberati, A., Tetzlaff, J., Altman, D. G., & the PRISMA Group. (2009). Preferred Reporting Items for Systematic Reviews and Meta-analyses: The PRISMA statement. BMJ, 339, b2535.
Stroup, D. F., Berlin, J. A., Morton, S. C., Olkin, I., Williamson, G. D., Rennie, D. … for the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) Group. (2000). Meta-analysis of Observational Studies in Epidemiology: A proposal for reporting. JAMA, 283(15), DOI:10.1001/jama.283.15.2008.