Assessing the usefulness of randomized trials in obstetrics and gynaecology
Janneke van ‘t Hooft et al.
Health care professionals will be familiar with how little of what they read in medical journals is of direct value (useful) to their practice.(1) Randomized controlled trials (RCTs) are traditionally at the top of the evidence validity hierarchy for health care interventions. However, even the majority of RCTs do not seem useful in that they may not lead to any tangible improvements in clinical decision making. Increasing usefulness of RCTs can benefit society, providing better solutions for patient problems and reducing waste of medical research budgets.(2,3) In this commentary we discuss usefulness of RCTs evaluating health care interventions, proposing a tool for its structured assessment. We describe some examples of where RCTs have demonstrated usefulness in women’s health and some where they might have been less useful. Why another tool? Many collaborative initiatives have developed checklists to address issues like bias and transparency in RCTs.(4,5) These tools and their various versions can help judgments about the validity and reporting quality of effectiveness research, but they fail to capture whether the trial itself is useful or wasteful. A 2016 paper (6) highlighted the need to consider usefulness at the conception, design and planning phase of a study. Will a particular study, upon completion, have the potential to improve outcomes? This question matters for clinical researchers, their employers, funding bodies, ethics committees, patient organizations and prospective participants. For completed studies, an assessment of usefulness before publication is of interest for journal editors and peer reviewers, even if improvement of fundamental flaws in the design will be difficult, if not impossible at this stage. For already published studies, assessments of usefulness matter for clinicians, patients, and other stakeholders involved in healthcare provision and research, e.g. an assessment of usefulness of RCTs in a specific domain in medicine may offer feedback on where to improve future study design. The assessment of usefulness should be comprehensive (covering multiple aspects of usefulness), simple enough so that it can be routinely applied, and unambiguous to avoid too subjective interpretations.(6)