METHODS: We reviewed measures of decision quality and decision process in 86 randomized controlled trials (RCTs) from the 2011 Cochrane Collaboration systematic review of PtDAs. Data on development of the measures, reliability, validity, responsiveness, precision, interpretability, feasibility, and acceptability were independently abstracted by 2 reviewers.
RESULTS: Information from 178 instances of use of measures was abstracted. Very few studies reported data on the performance of measures, with reliability (21%) and validity (16%) being the most common. Studies using new measures were less likely to include information about their psychometric performance. The review was limited to reporting of measures in studies included in the Cochrane review and did not consult prior publications.
CONCLUSIONS: Very little is reported about the development or performance of measures used to evaluate the effectiveness of PtDAs in published trials. Minimum reporting standards are proposed to enable authors to prepare study reports, editors and reviewers to evaluate submitted papers, and readers to appraise published studies.
METHODOLOGY: The scoping review will be carried out in six stages: (1) identifying the research question, (2) identifying relevant studies through electronic databases (i.e., PubMed, Scopus, Cochrane Reviews, Google Scholar, EBSCOHOST, Science Direct) and also gray literature, and (3) selection of studies to be included based on inclusion criteria. Search and initial screening of studies to be included will be conducted by two independent reviewers. Discrepancies will then be solved through discussion with other reviewers; (4) charting and categorizing extracted data in a pretested data extraction form; (5) collating, summarizing, and reporting the results; and lastly, (6) conducting consultation with stakeholders and experts in diabetes.
DISCUSSION: This scoping review protocol is aimed to provide a framework enabling us to map and summarize the findings from existing studies involving meal replacement. It will help researchers to identify the research gap and provide recommendations for future meal replacement studies. The results from this scoping review will be useful to various stakeholders in healthcare. It is also part of a research project in which the information obtained will be utilized in a clinical trial of a developed meal replacement plan. Dissemination of knowledge will also be done through presentations at related scientific conferences.
METHODS: Eleven databases were searched without date or language restrictions for systematic reviews of public and patient involvement (PPI) in clinical trials design. This systematic overview of PPI included 27 reviews from which areas of good and bad practice were identified. Strengths, weaknesses, opportunities, and threats of PPI were explored through use of meta-narrative analysis.
RESULTS: Inclusion criteria were met by 27 reviews ranging in quality from high (n = 7), medium (n = 14) to low (n = 6) reviews. Reviews were assessed using CERQUAL NICE, CASP for qualitative research and CASP for systematic reviews. Four reviews report risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow-up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning, and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation, and dissemination. Challenges identified include lack of clarity within common language, roles, and research boundaries, while logistical needs include extra time, training, and funding. Researchers report struggling to report involvement and avoid tokenism.
CONCLUSIONS: Involving patients and the public in clinical trials design can be beneficial but requires resources, preparation, training, flexibility, and time. Issues to address include reporting deficits for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.