Background Numerous frameworks for supporting, evaluating and reporting patient and public involvement in research exist. The literature is diverse and theoretically heterogeneous. Objectives To identify and synthesize published frameworks, consider whether and how these have been used, and apply design principles to improve usability. Search strategy Keyword search of six databases; hand search of eight journals; ancestry and snowball search; requests to experts. Inclusion criteria Published, systematic approaches (frameworks) designed to support, evaluate or report on patient or public involvement in health‐related research. Data extraction and synthesis Data were extracted on provenance; collaborators and sponsors; theoretical basis; lay input; intended user(s) and use(s); topics covered; examples of use; critiques; and updates. We used the Canadian Centre for Excellence on Partnerships with Patients and Public (CEPPP) evaluation tool and hermeneutic methodology to grade and synthesize the frameworks. In five co‐design workshops, we tested evidence‐based resources based on the review findings. Results Our final data set consisted of 65 frameworks, most of which scored highly on the CEPPP tool. They had different provenances, intended purposes, strengths and limitations. We grouped them into five categories: power‐focused; priority‐setting; study‐focused; report‐focused; and partnership‐focused. Frameworks were used mainly by the groups who developed them. The empirical component of our study generated a structured format and evidence‐based facilitator notes for a “build your own framework” co‐design workshop. Conclusion The plethora of frameworks combined with evidence of limited transferability suggests that a single, off‐the‐shelf framework may be less useful than a menu of evidence‐based resources which stakeholders can use to co‐design their own frameworks.
BackgroundDespite significant teratogenic risks, sodium valproate is still widely prescribed in many countries to women of childbearing age, as a mood stabiliser in bipolar disorder and also in epilepsy. The UK has recently banned valproate use in women who are not in a pregnancy prevention programme. Whilst this ruling reflects prevailing clinical practice, it also highlights an ongoing debate about when (if ever) a woman who is or could become pregnant should be allowed to choose to take valproate.Main bodyWe review the benefits and harms of drugs available for bipolar disorder and epilepsy in women of childbearing age, with a particular focus on teratogenic risk. We speculate on hypothetical rare situations in which potential benefits of valproate may outweigh potential harms in such women. We also review the literature on shared decision-making – on which there is now a NICE guideline and numerous evidence-based decision tools. Drawing on previous work by experts in shared decision-making, we offer a list of ‘frequently asked questions’ and a matrix of options to support conversations with women about continuing or discontinuing the drug in (or in anticipation of) pregnancy. We also consider whether shared decision-making is an appropriate paradigm when considering whether to continue a teratogenic drug.ConclusionWe conclude that because valproate in pregnancy remains the subject of such debate, there is scope for further research – not only into the relative efficacy and safety of alternatives to it – but also into the dynamics of communication and shared decision-making in this situation.
Background Cytomegalovirus (CMV) is an important opportunistic pathogen following transplantation. Some virological variation in post-transplant patients is explained by donor and recipient CMV serostatus, but not all. Circadian variability of herpesviruses has been described, so we investigated the effect of time of day of transplant on CMV viremia post-transplant. Methods We performed a retrospective analysis of 1517 patients receiving liver or kidney allografts at a single center from 2002-2018. All patients were managed by pre-emptive therapy with CMV viremia monitoring post-transplant. Circulatory arrest and reperfusion time of donor organ were categorized into four periods. Patients were divided into serostatus groups based on previous CMV infection in donor and recipient. CMV viremia parameters were compared between time categories for each group. Factor analysis of mixed data (FAMD) was used to interrogate this complex dataset. Results Live transplant recipients were less likely to develop viremia than recipients of deceased-donor organs (48% vs. 61%, p<0.001). After controlling for this, there was no evidence of time-of-day of transplant affecting CMV parameters in any serostatus group by logistic regression or FAMD. Discussion We found no evidence for a circadian effect of transplant on CMV viremia, but these novel results warrant confirmation by other centers.
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