When empirically supported interventions are implemented in real-world practice settings, the process of how these interventions are implemented is highly relevant for their potential success. Implementation Mapping is a method that provides step-by-step guidance for systematically designing implementation processes that fit the respective intervention and context. It includes needs assessments among relevant stakeholders, the identification of implementation outcomes and determinants, the selection and design of appropriate implementation strategies, the production of implementation protocols and an implementation outcome evaluation. Implementation Mapping is generally conceptualized as a tool to prospectively guide implementation. However, many implementation efforts build on previous or ongoing implementation efforts, i.e., “existing implementation.” Learnings from existing implementation may offer insights critical to the success of further implementation activities. In this article, we present a modified Implementation Mapping methodology to be applied when evaluating existing implementation. We illustrate the methodology using the example of evaluating ongoing organized colorectal cancer screening programs in Switzerland. Through this example, we describe how we identify relevant stakeholders, implementation determinants and outcomes as well as currently employed implementation strategies. Moreover, we describe how we compare the types of strategies that are part of existing implementation efforts with those that implementation science would suggest as being suited to address identified implementation determinants. The results can be used for assessing the current state of implementation outcomes, refining ongoing implementation strategies, and informing future implementation efforts.
Study design Single center, two-parallel group, blinding feasibility randomized controlled trial. Background Clinical trials of manual therapy interventions for back pain face methodological challenges regarding blinding of assigned interventions. We assessed blinding of participants and outcome assessors in a methodological randomized trial of two manual therapy interventions of the back and explored factors influencing perceptions about intervention assignment. Methods In a doctoral-level Introduction to Epidemiology course on 7–8 November 2022, 24 healthy students were randomly allocated (1:1) to active or control manual therapy interventions. The active manual therapy group (n = 11) received soft tissue mobilization of the lumbar musculature. The control group (n = 13) performed deep breathing exercises while receiving light touch over the thoracic region. The primary outcome was blinding feasibility of study participants immediately after intervention, derived from a 5-point scale and measured by the Bang blinding index (Bang BI), with values ranging from − 1 (opposite guessing) to 1 (complete unblinding), with 0 indicating random guessing (50% correct). Secondary outcomes included blinding feasibility of outcome assessors and factors influencing perceptions about intervention assignment in participants and outcome assessors, explored via thematic analysis. Results 24 participants were analyzed following an intention-to-treat approach. 55% of participants in the active manual therapy group correctly identified their group allocation beyond chance immediately after intervention (Bang BI: 0.55 [95% confidence interval (CI), 0.25 to 0.84]), and 8% did so in the control manual therapy group (0.08 [95% CI, -0.37 to 0.53]). Bang BIs in outcome assessors suggested adequate blinding, with indices of 0.09 (-0.12 to 0.30) and − 0.10 (-0.29 to 0.08) for perceived allocation of active and control manual therapy participants, respectively. Blinding estimates were limited due to imprecision and suboptimal generalizability to real-world clinical settings. Participants and outcome assessors reported varying factors related to perceived intervention arm allocation. Conclusions Our findings suggest that blinding of participants and outcome assessors immediately after a one-time manual therapy intervention is feasible in randomized controlled trial settings. Careful thinking and consideration of blinding in manual therapy intervention trials is warranted and needed. Trial registration: Retrospectively registered at ClinicalTrials.gov ― currently under Protocol Registration and Results System (PRS) review.
Background With a high mortality of 12.6% of all cancer cases, colorectal cancer (CRC) accounts for substantial burden of disease in Europe. In the past decade, more and more countries have introduced organized colorectal cancer screening programs, making systematic screening available to entire segments of a population, typically based on routine stool tests and/or colonoscopy. While the effectiveness of organized screening in reducing CRC incidence and mortality has been confirmed, studies continuously report persistent program implementation challenges. This systematic review will synthesize the literature on organized CRC screening programs. Its aim is to understand what is currently known about the barriers and facilitators that influence the implementation of these programs and about the implementation strategies used to navigate these determinants. Methods A systematic review of primary studies of any research design will be conducted. CENTRAL, CINAHL, EMBASE, International Clinical Trials Registry Platform, MEDLINE, PsycINFO, and Scopus will be searched. Websites of (non-)government health care organizations and websites of organizations affiliated with authors of included studies will be screened for unpublished evaluation reports. Existing organized CRC screening programs will be contacted with a request to share program-specific grey literature. Two researchers will independently screen each publication in two rounds for eligibility. Included studies will focus on adult populations involved in the implementation of organized CRC screening programs and contain information about implementation determinants/ strategies. Publications will be assessed for their risk of bias. Data extraction will include study aim, design, location, setting, sample, methods, and measures; program characteristics; implementation stage, framework, determinants, strategies, and outcomes; and service and other outcome information. Findings will be synthesized narratively using the three stages of thematic synthesis. Discussion With its sole focus on the implementation of organized CRC screening programs, this review will help to fill a central knowledge gap in the literature on colorectal cancer screening. Its findings can inform the decision-making in policy and practice needed to prioritize resources for establishing new and maintaining existing programs in the future. Systematic review registration PROSPERO (CRD42022306580).
Background: With a high mortality of 12.6% of all cancer cases, colorectal cancer (CRC) is a substantial burden of disease in Europe. In the past decade, more and more countries have introduced organized colorectal cancer screening programs, making systematic screening available to entire segments of a population, typically based on routine stool tests and/or colonoscopy. While the effectiveness of organized screening in reducing CRC incidence and mortality has been confirmed, studies continuously report persistent program implementation challenges. This systematic review will synthesize the literature on organized colorectal cancer screening programs. Its aim is to understand what is currently known about the barriers and facilitators, that influence the implementation of these programs, and about the implementation strategies used to navigate these determinants. Methods: A systematic review of primary studies of any research design will be conducted. CINAHL, Cochrane, EMBASE, International Clinical Trials Registry Platform, MEDLINE, PsycINFO and Scopus will be searched. Websites of (non-)government health care organizations and websites of organizations affiliated with authors of included studies will be screened for unpublished evaluation reports. Existing organized CRC screening programs will be contacted with a request to share program-specific grey literature. Two researchers will independently screen each publication in two rounds for eligibility. Included studies will focus on adult populations involved in the implementation of organized CRC screening programs and contain information about implementation determinants/ strategies. Publications will be assessed for their risk of bias. Data extraction will include study aim, design, location, setting, sample, methods, and measures; program characteristics; implementation stage, framework, determinant, strategies, and outcomes; and service and other outcome information. Findings will be synthesized narratively using the three stages of thematic synthesis. Discussion: With its sole focus on the implementation of organizedCRC screening programs, this review will help to fill a central knowledge gap in the literature on colorectal cancer screening. Its findings can inform the decision making in policy and practice needed to prioritize resources for establishing new and maintaining existing programs in the future. Systematic review registration PROSPERO (CRD42022306580)
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