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The complexity associated with how interventions result--or fail to result--in outcomes and how context matters is increasingly recognised. Logic models provide an important tool for handling complexity, with contrasting uses in programme evaluation and evidence synthesis. To reconcile these, we developed an approach that combines the strengths of both traditions, propose a taxonomy of logic models, and provide guidance on how to choose between approaches and types of logic models in systematic reviews and health technology assessments (HTA). The taxonomy distinguishes 3 approaches (a priori, staged, and iterative) and 2 types (systems-based and process-orientated) of logic models. An a priori logic model is specified at the start of the systematic review/HTA and remains unchanged. With a staged logic model, the reviewer prespecifies several points, at which major data inputs require a subsequent version. An iterative logic model is continuously modified throughout the systematic review/HTA process. System-based logic models describe the system, in which the interaction between participants, intervention, and context takes place; process-orientated models display the causal pathways leading from the intervention to multiple outcomes. The proposed taxonomy of logic models offers an improved understanding of the advantages and limitations of logic models across the spectrum from a priori to fully iterative approaches. Choice of logic model should be informed by scope of evidence synthesis, presence/absence of clearly defined population, intervention, comparison, outcome (PICO) elements, and feasibility considerations. Applications across distinct interventions and methodological approaches will deliver good practice case studies and offer further insights on the choice and implementation of logic modelling approaches.

Objective: In this randomized noninferiority study, the effectiveness and efficiency of stepped care for chronic fatigue syndrome (CFS) was compared to care as usual. Stepped care was formed by guided self-instruction, followed by cognitive behavior therapy (CBT) if the patient desired it. Care as usual encompassed CBT after a waiting period. Method: A total of 171 CFS patients were randomly allocated to stepped care or care as usual. Patients in both conditions were assessed 3 times: at baseline, after guided self-instruction or the waiting period, and after CBT. The primary outcome variables were fatigue severity (Checklist Individual Strength) and disabilities (Sickness Impact Profile and Medical Outcomes Survey Short Form-36). Results: An intention to treat analysis showed that stepped care (N = 84) for CFS is noninferior to care as usual (N = 85). Both conditions were equivalent in reducing fatigue severity, reducing disabilities, and increasing physical functioning. The treatment results of both conditions were in accordance with those of previous randomized controlled trials testing the effectiveness of CBT for CFS. The total therapist time needed to treat a patient was significantly less in the stepped care condition. Conclusions: Stepped care is as effective as CBT and is more time efficient for the therapist. (Contains 6 tables and 1 figure.)

Background: There is a wide variety of participatory approaches to involve stakeholders in the development of medical devices, but there is no comprehensive overview of these approaches. We therefore studied what participatory approaches are used in the development of medical devices as well as the most important characteristics and challenges of these approaches. Methods: We conducted a scoping review and searched PubMed, Embase and Web of Science for articles published between July 2014 and July 2019. Papers were included if they presented original research featuring any form of stakeholder participation in the development of medical devices. We used The Spectrum of Public Participation to categorise the approach of each paper. Subsequently, we described the characteristics of each approach: the stakeholders involved, data collection methods, and topics addressed. We also identified challenges of the approaches as reported by researchers. Results: 277 papers were included, which could be categorised into three levels of participation: collaboration, involvement, and consultation. Patients and healthcare professionals are frequently engaged in all approaches. The most often used methods are workshops in the collaboration approach papers, and interviews in the involvement and consultation approach papers. Topics addressed in all approaches are: the problem, device requirements, design choices, testing, and procedural aspects of involvement. Reported challenges entail issues related to sampling, analysis, social dynamics, feasibility, and the limited number of topics that can be addressed. Conclusion: Participatory approaches reported in literature can be categorised in three overarching approaches that have comparable methodological characteristics. This suggests that if researchers want to apply a participatory approach it is not necessary to adopt a pre-determined approach, such as 'participatory action research' (PAR). Instead, they can independently determine the degree of participation, stakeholders, methods, topics, and strategies to account for challenges, making sure the participatory approach fits their research question and context. [ABSTRACT FROM AUTHOR]

Background: A deliberative Citizen Forum 'Choices in healthcare' was held in the Netherlands to obtain insight into the criteria informed citizens would propose for the public reimbursement of healthcare. During 3 weekends, 24 citizens participated in evidence-informed deliberation on the basis of 8 case studies. The aim of this study was to assess how the opinions of 8 participants in the deliberative Citizens Forum changed and if so, why participants themselves believe their opinions have changed, whether participation influenced their perceived reasonableness of other participants in the forum and whether it influenced their opinions about involvement of citizens in decision-making. Methods: Semi-structured interviews were held with 8 participants before and after their participation in the Citizen Forum. Using the method of reconstructing interpretive frames opinions about the public reimbursement of healthcare were reconstructed. Results: Participants' opinions changed over time; they became more aware of the complexity of decision-making and came to accept that there are limits to the available resources and accept cost as a criterion for reimbursement decisionmaking. Participants report that exchanging arguments and personal experiences with other participants made them change their initial opinions. Participants ascribed increases in the perceived reasonableness of other participants' opinions to feelings of group-bonding and becoming more familiar with each other's personal circumstances. Participants further believe that citizens represent an additional opinion to that of other stakeholders and believe their opinions should be considered in relation to those of other stakeholders, given they are provided with opportunities for critical discussion. Conclusion: Organized deliberation should allow for the exchange of arguments and the sharing of personal experiences which is linked to learning. On the one hand this is reflected in the uptake of new arguments and on the other hand in the revision, specification or expansion of personal argumentation. Providing opportunities for critical deliberation is key to prevent citizens from adhering to initial emotional reactions that remain unchallenged and which may no longer be supported after deliberation. [ABSTRACT FROM AUTHOR]

Background: Treatment effects differ across patients. To guide selection of treatments for patients, it is essential to acknowledge these differences and identify moderators or predictors. Our aim was to generate optimal search strategies (commonly known as filters) for PubMed to retrieve papers identifying moderators and predictors of treatment effects. Methods: Six journals were hand‐searched for articles on moderators or predictors. Selected articles were randomly allocated to a development and validation set. Search terms were extracted from the development set and tested for their performance. Search filters were created from combinations of these terms and tested in the validation set. Results: Of 4407 articles, 198 were considered to be relevant. The most sensitive filter in the development set '("Epidemiologic Methods" [MeSH] OR assign* OR control*[tiab] OR trial*[tiab]) AND therapy*[sh]' yielded in the validation set a sensitivity of 89% [88%–90%] and a specificity of 80% [79%–82%]. Conclusions: The search filters created in this study can help to efficiently retrieve evidence on moderators and predictors of treatment effect. Testing of the filters in multiple domains should reveal robustness across disciplines. These filters can facilitate the retrieval of evidence on moderators and predictors of treatment effects, helping the implementation of stratified or personalised health care. [ABSTRACT FROM AUTHOR]