Article type
Year
Abstract
Background: When randomised controlled trial (RCT) evidence is unavailable, systematic reviews cannot normally draw firm conclusions regarding practice. A key output from such reviews should therefore be clear recommendations for future research. Unfortunately, these are often brief, lacking the detail needed by research commissioners. We contend that in areas where very limited evidence is anticipated, reviews of effectiveness studies alone may not be sufficient to enable reviewers to make optimal research recommendations.
Methods: Across two reviews where limited evidence was expected - one of extravasation injury treatments, and one of neuromodulation for phantom limb pain (PLP) - we prospectively undertook additional research to inform and optimise review research recommendations. This included: extracting data on research ideas; surveying NHS clinicians about current practice and future research; reviewing epidemiological evidence; reviewing studies in related areas; and allocating sufficient review time to explore study designs deemed to be useful when recruitment is challenging.
Results: Both clinician surveys provided clear indications about the specific treatments where further research was thought most worthwhile. Most clinicians thought RCTs could be successfully undertaken, those who did not provided reasons that were informative when researching alternative study designs. A review of chronic PLP epidemiology identified evidence on important prognostic factors, and prevalence data, useful for informing eligibility criteria, and sample size feasibility, respectively. Consideration of studies in related clinical areas identified two examples of RCTs - one in each review - where recruitment was problematic (e.g. 37 patients recruited in 7 years). Additional studies also revealed potentially useful outcome measures, lacking in the included effectiveness studies. The alternative, less well-known study designs we identified and then used in our specific research recommendations included randomised registry trials, sequential trials and N-of-1 trials.
Conclusions: Use of complementary research such as surveys and reviews of evidence other than effectiveness can enhance review research recommendations. Better recommendations should maximise the probability of future studies reaching completion.
Patient involvement: PPI used for questionnaire content.
Methods: Across two reviews where limited evidence was expected - one of extravasation injury treatments, and one of neuromodulation for phantom limb pain (PLP) - we prospectively undertook additional research to inform and optimise review research recommendations. This included: extracting data on research ideas; surveying NHS clinicians about current practice and future research; reviewing epidemiological evidence; reviewing studies in related areas; and allocating sufficient review time to explore study designs deemed to be useful when recruitment is challenging.
Results: Both clinician surveys provided clear indications about the specific treatments where further research was thought most worthwhile. Most clinicians thought RCTs could be successfully undertaken, those who did not provided reasons that were informative when researching alternative study designs. A review of chronic PLP epidemiology identified evidence on important prognostic factors, and prevalence data, useful for informing eligibility criteria, and sample size feasibility, respectively. Consideration of studies in related clinical areas identified two examples of RCTs - one in each review - where recruitment was problematic (e.g. 37 patients recruited in 7 years). Additional studies also revealed potentially useful outcome measures, lacking in the included effectiveness studies. The alternative, less well-known study designs we identified and then used in our specific research recommendations included randomised registry trials, sequential trials and N-of-1 trials.
Conclusions: Use of complementary research such as surveys and reviews of evidence other than effectiveness can enhance review research recommendations. Better recommendations should maximise the probability of future studies reaching completion.
Patient involvement: PPI used for questionnaire content.