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.
RECENT FINDINGS: The systematic review of the literature on decriminalization resulted in seven articles that discuss decriminalization as compared with 57 published articles on legalization. Decriminalization of drug use did not have an effect on the age of onset of drug use and the prices of drugs did not decrease after the implementation of drug decriminalization. Policy-based studies on decriminalization suggest shifting from criminal sanctions to a public health approach, which was endorsed by the United Nations (UN) that viewed drug addiction as a preventable and treatable health disorder. One study preferred decriminalization only for cannabis and cautioned against regulating cannabis like alcohol. Another study indicated that general medical practitioners in Ireland did not favour the decriminalization of cannabis.
SUMMARY: Scientific evidence supporting drug addiction as a health disorder and the endorsement by the UN strengthen the case for decriminalization. However, studies reporting on the positive outcomes of decriminalization remain scarce. The evidence needs to be more widespread in order to support the case for decriminalization. Furthermore, the endorsement by the UN needs to be acted upon by individual member states.