Informing the development of the SUCCEED reporting guideline for studies on the scaling of health interventions: A systematic review.

BACKGROUND: Quality reporting contributes to effective translation of health research in practice and policy. As an initial step in the development of a reporting guideline for scaling, the Standards for reporting stUdies of sCaling evidenCEd-informED interventions (SUCCEED), we performed a systematic review to identify relevant guidelines and compile a list of potential items. METHODS: We conducted a systematic review according to Cochrane method guidelines. We searched the following databases: MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, Web of Science, from their respective inceptions. We also searched websites of relevant organizations and Google. We included any document that provided instructions or recommendations, e.g., reporting guideline, checklist, guidance, framework, standard; could inform the design or reporting of scaling interventions; and related to the health sector. We extracted characteristics of the included guidelines and assessed their methodological quality using a 3-item internal validity assessment tool. We extracted all items from the guidelines and classified them according to the main sections of reporting guidelines (title, abstract, introduction, methods, results, discussion and other information). We performed a narrative synthesis based on descriptive statistics. RESULTS: Of 7704 records screened (published between 1999 and 2019), we included 39 guidelines, from which data were extracted from 57 reports. Of the 39 guidelines, 17 were for designing scaling interventions and 22 for reporting implementation interventions. At least one female author was listed in 31 guidelines, and 21 first authors were female. None of the authors belonged to the patient stakeholder group. Only one guideline clearly identified a patient as having participated in the consensus process. More than half the guidelines (56%) had been developed using an evidence-based process. In total, 750 items were extracted from the 39 guidelines and distributed into the 7 main sections. CONCLUSION: Relevant items identified could inform the development of a reporting guideline for scaling studies of evidence-based health interventions. This and our assessment of guidelines could contribute to better reporting in the science and practice of scaling.

Spontaneous Scaling of a Primary Care Innovation in Real-Life Conditions: Protocol for a Case Study.

BACKGROUND: Scaling effective primary care innovations to benefit more people is of interest to decision makers. However, we know little about how promising innovations are being scaled "spontaneously," that is, without deliberate guidance. OBJECTIVE: We aim to observe, document, and analyze how, in real-life conditions, 1 primary care innovation spontaneously scales up across Quebec, Canada. METHODS: We will conduct a participative study using a descriptive single-case study. It will be guided by the McLean and Gargani principles for scaling and reported according to the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. Informed by an integrated knowledge translation approach, our steering committee will include patient users throughout the project. Inspired by the Quebec College of Family Physician's "Dragons' Den" primary care program, we will identify a promising primary care innovation that is being or will be scaled spontaneously. We will interview the innovation team about their scaling experiences every month for 1 year. We will conduct interviews and focus groups with decision makers, health care providers, and end users in the innovation team and the target site about their experience of both scaling and receiving the scaled innovation and document meetings as nonparticipant observers. Interview transcripts and documentary data will be analyzed to (1) compare the spontaneous scaling plan and implementation with the McLean and Gargani principles for scaling and (2) determine how it was consistent with or diverged from the 4 McLean and Gargani guiding principles: justification, optimal scale, coordination, and dynamic evaluation. RESULTS: This study was funded in March 2020 by the Canadian Institutes of Health Research. Recruitment began in November 2023 and data collection began in December 2023. Results are expected to be published in the first quarter of 2024. CONCLUSIONS: Our study will advance the science of scaling by providing practical evidence-based material about scaling health and social care innovations in real-world settings using the 4 guiding principles of McLean and Gargani. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54855.

Engagement of Older Adults Receiving Home Care Services and Their Caregivers in Health Decisions in Partnership With Clinical Teams: Protocol for a Multimethod Study to Prioritize and Culturally Adapt Decision Aids for Home Care.

BACKGROUND: Older adults (people aged 65 years and older) face many difficult decisions. Patient decision aids (PtDAs) can help them and their families make informed value-congruent decisions. Some PtDAs have been developed for the home care context, but little is known about scaling them for use with older adults in a different culture. OBJECTIVE: This study aims to (1) assess the scalability of existing PtDAs for older adults in the home care context; (2) prioritize those that best match the decisional needs of older adults in home care; and (3) culturally adapt the prioritized PtDAs so they can be scaled successfully to the Quebec health care system. METHODS: This multimethod study includes 3 phases. All phases will be overseen by a steering committee of older adults, caregivers, health professionals, decision makers, community organization representatives, and researchers with the needed expertise. In phase 1, we will use the Innovation Scalability Self-administered Questionnaire, a validated scalability self-assessment tool, to assess the scalability of 33 PtDAs previously identified in a systematic review. Based on their scalability, their quality (based on the International Patient Decision Aids Standards), and the importance of the decision point, we will retain approximately a third of these. In phase 2, we will conduct a 2-round web-based Delphi to prioritize the PtDAs selected in phase 1. Using a snowball recruitment strategy, we aim to recruit 60 Delphi participants in the province of Quebec, including older adults, caregivers, health professionals, decision makers involved in home care services, and PtDA experts. In the first round, we will ask participants to rate the importance of several PtDA decision points according to various criteria such as prevalence and difficulty on a 5-point Likert scale (1=not important to 5=very important). Approximately 6 of the highest-rated PtDAs will be retained for presentation in the second round, and we will select up to 3 PtDAs judged as having the highest priority for cultural adaptation. In phase 3, using the Chenel framework and user-centered design methods, we will update and adapt the PtDAs to the Quebec health care system and integrate these PtDAs into an interprofessional shared decision-making training program for home care teams. The adapted PtDAs will respect the International Patient Decision Aids Standards criteria. RESULTS: This study was funded in March 2022 by the Canadian Institutes of Health Research. Data collection for the web-based Delphi began in October 2023. Results are expected to be published in May 2024. CONCLUSIONS: This project will provide relevant and culturally appropriate decision support tools for older adults making difficult decisions and their home care teams that will be ready for scaling across the province of Quebec. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53150.

Mapping health service coverage inequalities in Africa: a scoping review protocol.

INTRODUCTION: Addressing inequities in health service coverage is a global priority, especially with the resurgence of interest in universal health coverage. However, in Africa, which has the lowest health service coverage index, there is limited information on the progress of countries in addressing inequalities related to health services. Thus, we seek to map the evidence on inequalities in health service coverage in Africa. METHODS AND ANALYSIS: We will conduct a scoping review following the Joanna Briggs Institute Manual for Evidence Synthesis. We preregistered this protocol with the Open Science Framework on 26 July 2022 (https://osf.io/zd5bt). We will consider any empirical research that assesses inequalities in relation to services for reproductive, maternal, newborn and child health (eg, family planning), infectious diseases (eg, tuberculosis treatment) and non-communicable diseases (eg, cervical cancer screening) in Africa. We will search MEDLINE, Embase, Web of Science, CINAHL, PsycINFO and Cochrane Library from their inception onwards. We will also hand-search Google and Global Index Medicus, and screen reference lists of relevant studies. We will evaluate studies for eligibility and extract data from included studies using pre-piloted and standardised forms. We will further extract a core set of health service coverage indicators, which are disaggregated by place of residence, race/ethnicity/culture, occupation, gender, religion, education, socioeconomic status and social capital plus equity stratifiers. We will summarise data using a narrative approach involving thematic syntheses and descriptive statistics. We will report our findings according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. ETHICS AND DISSEMINATION: Ethical approval is not required as primary data will not be collected. This work will contribute to identifying knowledge gaps in the evidence of inequalities in health service coverage in Africa, and propose strategies that could help overcome current challenges. We will disseminate our findings to knowledge users through a publication in a peer-reviewed journal and organisation of workshops.

Evidence on Scaling in Health and Social Care: An Umbrella Review.

Policy Points More rigorous methodologies and systematic approaches should be encouraged in the science of scaling. This will help researchers better determine the effectiveness of scaling, guide stakeholders in the scaling process, and ultimately increase the impacts of health innovations. The practice and the science of scaling need to expand worldwide to address complex health conditions such as noncommunicable and chronic diseases. Although most of the scaling experiences described in the literature are occurring in the Global South, most of the authors publishing on it are based in the Global North. As the science of scaling spreads across the world with the aim of reducing health inequities, it is also essential to address the power imbalance in how we do scaling research globally. CONTEXT: Scaling of effective innovations in health and social care is essential to increase their impact. We aimed to synthesize the evidence base on scaling and identify current knowledge gaps. METHODS: We conducted an umbrella review according to the Joanna Briggs Institute Reviewers' Manual. We included any type of review that 1) focused on scaling, 2) covered health or social care, and 3) presented a methods section. We searched MEDLINE (Ovid), Embase, PsycINFO (Ovid), CINAHL (EBSCO), Web of Science, The Cochrane Library, Sociological Abstracts (ProQuest), Academic Search Premier (EBSCO), and ProQuest Dissertations & Theses Global from their inception to August 6, 2020. We searched the gray literature using, e.g., Google and WHO-ExpandNet. We assessed methodological quality with AMSTAR2. Paired reviewers independently selected and extracted eligible reviews and assessed study quality. A narrative synthesis was performed. FINDINGS: Of 24,269 records, 137 unique reviews were included. The quality of the 58 systematic reviews was critically low (n = 42). The most frequent review type was systematic review (n = 58). Most reported on scaling in low- and middle-income countries (n = 59), whereas most first authors were from high-income countries (n = 114). Most reviews concerned infectious diseases (n = 36) or maternal-child health (n = 28). They mainly focused on interventions (n = 37), barriers and facilitators (n = 29), frameworks (n = 24), scalability (n = 24), and costs (n = 14). The WHO/ExpandNet scaling definition was the definition most frequently used (n = 26). Domains most reported as influencing scaling success were building scaling infrastructure (e.g., creating new service sites) and human resources (e.g., training community health care providers). CONCLUSIONS: The evidence base on scaling is evolving rapidly as reflected by publication trends, the range of focus areas, and diversity of scaling definitions. Our study highlights knowledge gaps around methodology and research infrastructures to facilitate equitable North-South research relationships. Common efforts are needed to ensure scaling expands the impacts of health and social innovations to broader populations.

Difficult Decisions for Older Canadians Receiving Home Care, and Why They Are So Difficult: A Web-Based Decisional Needs Assessment.

Background. Older adults receiving home care services often face decisions related to aging, illness, and loss of autonomy. To inform tailored shared decision making interventions, we assessed their decisional needs by asking about the most common difficult decisions, measured associated decisional conflict, and identified factors associated with it. Methods. In March 2020, we conducted a cross-sectional survey with a pan-Canadian Web-based panel of older adults (≥65 y) receiving home care services. For a difficult decision they had faced in the past year, we evaluated clinically significant decisional conflict (CSDC) using the 16-item Decisional Conflict Scale (score 0-100) with a >37.5 cutoff. To identify factors associated with CSDC, we performed descriptive, bivariable, and multivariable analyses using the stepwise selection method with an assumed entry and exit significance level of 0.15 and 0.20, respectively. Final model selection was based on the Bayesian information criterion. Results. Among 460 participants with an average age of 72.5 y, difficult decisions were, in order of frequency, about housing and safety (57.2%), managing health conditions (21.8%), and end-of-life care (8.3%). CSDC was experienced by 14.6% (95% confidence interval [CI]: 11.5%, 18.1%) of respondents on all decision points. Factors associated with CSDC included household size = 1 (OR [95% CI]: 1.81 [0.99, 3.33]; P = 0.27), household size = 3 (2.66 [0.78, 8.98]; P = 0.83), and household size = 4 (6.91 [2.23, 21.39]; P = 0.014); preferred option not matching the decision made (4.05 [2.05, 7.97]; P < 0.001); passive role in decision making (5.13 [1.78, 14.77]; P = 0.002); and lower quality of life (0.70 [0.57, 0.87]; P<0.001). Discussion. Some older adults receiving home care services in Canada experience CSDC when facing difficult decisions. Shared decision-making interventions could mitigate associated factors. Highlights: This is the first study in Canada to assess the decisional needs of older adults receiving care at home and to identify their most common difficult decisions.Difficult decisions most frequently made were about housing and safety. The most significant decisional conflict was experienced by people making decisions about palliative care.When their quality-of-life score was low, older adults experienced clinically significant decision conflict.

Implementation Strategies for Knowledge Products in Primary Health Care: Systematic Review of Systematic Reviews.

BACKGROUND: The underuse or overuse of knowledge products leads to waste in health care, and primary care is no exception. OBJECTIVE: This study aimed to characterize which knowledge products are frequently implemented, the implementation strategies used in primary care, and the implementation outcomes that are measured. METHODS: We performed a systematic review (SR) of SRs using the Cochrane systematic approach to include eligible SRs. The inclusion criteria were any primary care contexts, health care professionals and patients, any Effective Practice and Organization of Care implementation strategies of specified knowledge products, any comparators, and any implementation outcomes based on the Proctor framework. We searched the MEDLINE, EMBASE, CINAHL, Ovid PsycINFO, Web of Science, and Cochrane Library databases from their inception to October 2019 without any restrictions. We searched the references of the included SRs. Pairs of reviewers independently performed selection, data extraction, and methodological quality assessment by using A Measurement Tool to Assess Systematic Reviews 2. Data extraction was informed by the Effective Practice and Organization of Care taxonomy for implementation strategies and the Proctor framework for implementation outcomes. We performed a descriptive analysis and summarized the results by using a narrative synthesis. RESULTS: Of the 11,101 records identified, 81 (0.73%) SRs were included. Of these 81, a total of 47 (58%) SRs involved health care professionals alone. Moreover, 15 SRs had a high or moderate methodological quality. Most of them addressed 1 type of knowledge product (56/81, 69%), common clinical practice guidelines (26/56, 46%) or management, and behavioral or pharmacological health interventions (24/56, 43%). Mixed strategies were used for implementation (67/81, 83%), predominantly education-based (meetings in 60/81, 74%; materials distribution in 59/81, 73%; and academic detailing in 45/81, 56%), reminder (53/81, 36%), and audit and feedback (40/81, 49%) strategies. Education meetings (P=.13) and academic detailing (P=.11) seemed to be used more when the population was composed of health care professionals alone. Improvements in the adoption of knowledge products were the most commonly measured outcome (72/81, 89%). The evidence level was reported in 12% (10/81) of SRs on 62 outcomes (including 48 improvements in adoption), of which 16 (26%) outcomes were of moderate or high level. CONCLUSIONS: Clinical practice guidelines and management and behavioral or pharmacological health interventions are the most commonly implemented knowledge products and are implemented through the mixed use of educational, reminder, and audit and feedback strategies. There is a need for a strong methodology for the SR of randomized controlled trials to explore their effectiveness and the entire cascade of implementation outcomes.

Tools for assessing the scalability of innovations in health: a systematic review.

BACKGROUND: The last decade has seen growing interest in scaling up of innovations to strengthen healthcare systems. However, the lack of appropriate methods for determining their potential for scale-up is an unfortunate global handicap. Thus, we aimed to review tools proposed for assessing the scalability of innovations in health. METHODS: We conducted a systematic review following the COSMIN methodology. We included any empirical research which aimed to investigate the creation, validation or interpretability of a scalability assessment tool in health. We searched Embase, MEDLINE, CINAHL, Web of Science, PsycINFO, Cochrane Library and ERIC from their inception to 20 March 2019. We also searched relevant websites, screened the reference lists of relevant reports and consulted experts in the field. Two reviewers independently selected and extracted eligible reports and assessed the methodological quality of tools. We summarized data using a narrative approach involving thematic syntheses and descriptive statistics. RESULTS: We identified 31 reports describing 21 tools. Types of tools included criteria (47.6%), scales (33.3%) and checklists (19.0%). Most tools were published from 2010 onwards (90.5%), in open-access sources (85.7%) and funded by governmental or nongovernmental organizations (76.2%). All tools were in English; four were translated into French or Spanish (19.0%). Tool creation involved single (23.8%) or multiple (19.0%) types of stakeholders, or stakeholder involvement was not reported (57.1%). No studies reported involving patients or the public, or reported the sex of tool creators. Tools were created for use in high-income countries (28.6%), low- or middle-income countries (19.0%), or both (9.5%), or for transferring innovations from low- or middle-income countries to high-income countries (4.8%). Healthcare levels included public or population health (47.6%), primary healthcare (33.3%) and home care (4.8%). Most tools provided limited information on content validity (85.7%), and none reported on other measurement properties. The methodological quality of tools was deemed inadequate (61.9%) or doubtful (38.1%). CONCLUSIONS: We inventoried tools for assessing the scalability of innovations in health. Existing tools are as yet of limited utility for assessing scalability in health. More work needs to be done to establish key psychometric properties of these tools. Trial registration We registered this review with PROSPERO (identifier: CRD42019107095).

Investments for effective functionality of health systems towards Universal Health Coverage in Africa: A scoping review.

The health challenges in Africa underscore the importance of effectively investing in health systems. Unfortunately, there is no information on systems investments adequate for an effective functional health system. We aimed to address this by conducting a scoping review of existing evidence following the Joanna Briggs Institute Manual for Evidence Synthesis and preregistered with the Open Science Framework (https://osf.io/bvg4z). We included any empirical research describing interventions that contributed to the functionality of health systems in Africa or any low-income or lower-middle-income regions. We searched Web of Science, MEDLINE, Embase, PsycINFO, Cochrane Library, CINAHL, and ERIC from their inception, and hand-searched other relevant sources. We summarized data using a narrative approach involving thematic syntheses and descriptive statistics. We identified 554 unique reports describing 575 interventions, of which 495 reported evidence of effectiveness. Most interventions were undertaken in Africa (80.9%), covered multiple elements of health systems (median: 3), and focused on service delivery (77.4%) and health workforce (65.6%). Effective interventions contributed to improving single (35.6%) or multiple (64.4%) capacities of health systems: access to essential services (75.6%), quality of care (70.5%), demand for essential services (38.6%), or health systems resilience (13.5%). For example, telemedicine models which covered software (technologies) and hardware (health workers) elements were used as a strategy to address issues of access to essential services. We inventoried these effective interventions for improving health systems functionality in Africa. Further analyses could deepen understanding of how such interventions differ in their incorporation of evidence for potential scale across African countries.

Strategies for involving patients and the public in scaling-up initiatives in health and social services: protocol for a scoping review and Delphi survey.

BACKGROUND: The scale-up of evidence-based innovations is required to reduce waste and inequities in health and social services (HSS). However, it often tends to be a top-down process initiated by policy makers, and the values of the intended beneficiaries are forgotten. Involving multiple stakeholders including patients and the public in the scaling-up process is thus essential but highly complex. We propose to identify relevant strategies for meaningfully and equitably involving patients and the public in the science and practice of scaling up in HSS. METHODS: We will adapt our overall method from the RAND/UCLA Appropriateness Method. Following this, we will perform a two-prong study design (knowledge synthesis and Delphi study) grounded in an integrated knowledge translation approach. This approach involves extensive participation of a network of stakeholders interested in patient and public involvement (PPI) in scaling up and a multidisciplinary steering committee. We will conduct a systematic scoping review following the methodology recommended in the Joanna Briggs Institute Reviewers Manual. We will use the following eligibility criteria: (1) participants-any stakeholder involved in creating or testing a strategy for PPI; (2) intervention-any PPI strategy proposed for scaling-up initiatives; (3) comparator-no restriction; (4) outcomes: any process or outcome metrics related to PPI; and (5) setting-HSS. We will search electronic databases (e.g., Medline, Web of Science, Sociological Abstract) from inception onwards, hand search relevant websites, screen the reference lists of included records, and consult experts in the field. Two reviewers will independently select and extract eligible studies. We will summarize data quantitatively and qualitatively and report results using the PRISMA extension for Scoping Reviews (PRISMA-ScR) checklist. We will conduct an online Delphi survey to achieve consensus on the relevant strategies for PPI in scaling-up initiatives in HSS. Participants will include stakeholders from low-, middle-, and high-income countries. We anticipate that three rounds will allow an acceptable degree of agreement on research priorities. DISCUSSION: Our findings will advance understanding of how to meaningfully and equitably involve patients and the public in scaling-up initiatives for sustainable HSS. SYSTEMATIC REVIEW REGISTRATION: We registered this protocol with the Open Science Framework on August 19, 2020 ( https://osf.io/zqpx7/ ).

Extent and Predictors of Decision Regret among Informal Caregivers Making Decisions for a Loved One: A Systematic Review.

BACKGROUND: Informal caregivers often serve as decision makers for dependent or vulnerable individuals facing health care decisions. Decision regret is one of the most prevalent outcomes reported by informal caregivers who have made such decisions. OBJECTIVE: To examine levels of decision regret and its predictors among informal caregivers who have made health-related decisions for a loved one. DATA SOURCES: We performed a systematic search of Embase, MEDLINE, Web of Science, and Google Scholar up to November 2018. Participants were informal caregivers, and the outcome was decision regret as measured using the Decision Regret Scale (DRS). REVIEW METHODS: Two reviewers independently selected eligible studies, extracted data, and assessed the methodological quality of studies using the Mixed Methods Appraisal Tool. We performed a narrative synthesis and presented predictors of decision regret using a conceptual framework, dividing the predictors into decision antecedents, decision-making process, and decision outcomes. RESULTS: We included 16 of 3003 studies identified. Most studies (n = 13) reported a mean DRS score ranging from 7.0 to 32.3 out of 100 (median = 14.3). The methodological quality of studies was acceptable. We organized predictors and their estimated effects (ß) or odds ratio (OR) with 95% confidence interval (CI) as follows: decision antecedents (e.g., caregivers' desire to avoid the decision, OR 2.07, 95% CI [1.04-4.12], P = 0.04), decision-making process (e.g., caregivers' perception of effective decision making, ß = 0.49 [0.05, 0.93], P < 0.01), and decision outcomes (e.g., incontinence, OR = 4.4 [1.1, 18.1], P < 0.001). CONCLUSIONS: This review shows that informal caregivers' level of decision regret is generally low but is high for some decisions. We also identified predictors of regret during different stages of the decision-making process. These findings may guide future research on improving caregivers' experiences.

Assessing the scalability of innovations in primary care: a cross-sectional study.

BACKGROUND: Canadian health funding currently prioritizes scaling up for evidence-based primary care innovations, but not all teams prepare for scaling up. We explored scalability assessment among primary care innovators in the province of Quebec to evaluate their preparedness for scaling up. METHODS: We performed a cross-sectional survey from Feb. 18 to Mar. 18, 2019. Eligible participants were 33 innovation teams selected for the 2019 Quebec College of Family Physicians' Symposium on Innovations. We conducted a Web-based survey in 2 sections: innovation characteristics and the Innovation Scalability Self-administered Questionnaire. The latter includes 16 criteria (scalability components) grouped into 5 dimensions: theory (1 criterion), impact (6 criteria), coverage (4 criteria), setting (3 criteria) and cost (2 criteria). We classified innovation types using the International Classification of Health Interventions. We performed a descriptive analysis using frequency counts and percentages. RESULTS: Out of 33 teams, 24 participated (72.7%), with 1 innovation each. The types of innovation were management (15/24), prevention (8/24) and therapeutic (1/24). Most management innovations focused on patient navigation (9/15). In order of frequency, teams had assessed theory (79.2%) and impact (79.2%) criteria, followed by cost (77.1%), setting (59.7%) and coverage (54.2%). Most innovations (16/24) had assessed 10 criteria or more, including 10 management innovations, 5 prevention innovations and 1 therapeutic innovation. Implementation fidelity was the least assessed criterion (6/24). INTERPRETATION: The scalability assessments of a primary care innovation varied according to its type. Management innovations, which were the most prevalent and assessed the most scalability components, appear to be most prepared for primary care scale-up in Canada.

Decision Regret among Informal Caregivers Making Housing Decisions for Older Adults with Cognitive Impairment: A Cross-sectional Analysis.

Background. Informal caregivers are regularly faced with difficult housing decisions for older adults with cognitive impairment. They often regret the decision they made. We aimed to identify factors associated with decision regret among informal caregivers engaging in housing decisions for cognitively impaired older adults. Methods. We performed a secondary analysis of cross-sectional data collected from a cluster-randomized trial. Eligible participants were informal caregivers involved in making housing decisions for cognitively impaired older adults. Decision regret was assessed after caregivers' enrollment in the study using the Decision Regret Scale (DRS), scored from 0 to 100. We used a conceptual framework of potential predictors of regret to identify independent variables. We performed multilevel analyses using a mixed linear model by estimating fixed effects (ß) and 95% confidence intervals (CIs). Results. The mean (SD) DRS score of 296 informal caregivers (mean [SD] age, 62 [12] years) was 12.4 (18.4). Factors associated with less decision regret were having a college degree compared to primary education (ß [95% CI]: -11.14 [-18.36, -3.92]), being married compared to being single (-5.60 [-10.05, -1.15]), informal caregivers' perception that a joint process occurred (-0.14 [-0.25, -0.02]), and older adults' not having a specific housing preference compared to preferring to stay at home (-4.13 [-7.40, -0.86]). Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). Limitations. Our analysis may not illustrate all predictors of decision regret among informal caregivers. Conclusions. Our findings will allow risk-mitigation strategies for informal caregivers at risk of experiencing regret.

Capacity building and mentorship among pan-Canadian early career researchers in community-based primary health care.

AIM: To describe activities and outcomes of a cross-team capacity building strategy that took place over a five-year funding period within the broader context of 12 community-based primary health care (CBPHC) teams. BACKGROUND: In 2013, the Canadian Institutes of Health Research funded 12 CBPHC Teams (12-Teams) to conduct innovative cross-jurisdictional research to improve the delivery of high-quality CBPHC to Canadians. This signature initiative also aimed to enhance CBPHC research capacity among an interdisciplinary group of trainees, facilitated by a collaboration between a capacity building committee led by senior researchers and a trainee-led working group. METHODS: After the committee and working group were established, capacity building activities were organized based on needs and interests identified by trainees of the CBPHC Teams. This paper presents a summary of the activities accomplished, as well as the outcomes reported through an online semistructured survey completed by the trainees toward the end of the five-year funding period. This survey was designed to capture the capacity building and mentorship activities that trainees either had experienced or would like to experience in the future. Descriptive and thematic analyses were conducted based on survey responses, and these findings were compared with the existing core competencies in the literature. FINDINGS: Since 2013, nine webinars and three online workshops were hosted by trainees and senior researchers, respectively. Many of the CBPHC Teams provided exposure for trainees to innovative methods, CBPHC content, and showcased trainee research. A total of 27 trainees from 10 of the 12-Teams responded to the survey (41.5%). Trainees identified key areas of benefit from their involvement in this initiative: skills training, networking opportunities, and academic productivity. Trainees identified gaps in research and professional skill development, indicating areas for further improvement in capacity building programs, particularly for trainees to play a more active role in their education and preparation.

Essential items for reporting of scaling studies of health interventions (SUCCEED): protocol for a systematic review and Delphi process.

BACKGROUND: The lack of a reporting guideline for scaling of evidence-based practices (EBPs) studies has prompted the registration of the Standards for reporting studies assessing the impact of scaling strategies of EBPs (SUCCEED) with EQUATOR Network. The development of SUCCEED will be guided by the following main steps recommended for developing health research reporting guidelines. METHODS: Executive Committee. We established a committee composed of members of the core research team and of an advisory group. Systematic review. The protocol was registered with the Open Science Framework on 29 November 2019 (https://osf.io/vcwfx/). We will include reporting guidelines or other reports that may include items relevant to studies assessing the impact of scaling strategies. We will search the following electronic databases: EMBASE, PsycINFO, Cochrane Library, CINAHL, Web of Science, from inception. In addition, we will systematically search websites of EQUATOR and other relevant organizations. Experts in the field of reporting guidelines will also be contacted. Study selection and data extraction will be conducted independently by two reviewers. A narrative analysis will be conducted to compile a list of items for the Delphi exercise. CONSENSUS PROCESS: We will invite panelists with expertise in: development of relevant reporting guidelines, methodologists, content experts, patient/member of the public, implementers, journal editors, and funders. We anticipated that three rounds of web-based Delphi consensus will be needed for an acceptable degree of agreement. We will use a 9-point scale (1 = extremely irrelevant to 9 = extremely relevant). Participants' response will be categorized as irrelevant (1-3), equivocal (4-6) and relevant (7-9). For each item, the consensus is reached if at least 80% of the participants' votes fall within the same category. The list of items from the final round will be discussed at face-to-face consensus meeting. Guideline validation. Participants will be authors of scaling studies. We will collect quantitative (questionnaire) and qualitative (semi-structured interview) data. Descriptive analyses will be conducted on quantitative data and constant comparative techniques on qualitative data. DISCUSSION: Essential items for reporting scaling studies will contribute to better reporting of scaling studies and facilitate the transparency and scaling of evidence-based health interventions.

The pitfalls of scaling up evidence-based interventions in health.

Policy-makers worldwide are increasingly interested in scaling up evidence-based interventions (EBIs) to larger populations, and implementation scientists are developing frameworks and methodologies for achieving this. But scaling-up does not always produce the desired results. Why not? We aimed to enhance awareness of the various pitfalls to be anticipated when planning scale-up. In lower- and middle-income countries (LMICs), the scale-up of health programs to prevent or respond to outbreaks of communicable diseases has been occurring for many decades. In high-income countries, there is new interest in the scaling up of interventions that address communicable and non-communicable diseases alike. We scanned the literature worldwide on problems encountered when implementing scale-up plans revealed a number of potential pitfalls that we discuss in this paper. We identified and discussed the following six major pitfalls of scaling-up EBIs: 1) the cost-effectiveness estimation pitfall, i.e. accurate cost-effectiveness estimates about real-world implementation are almost impossible, making predictions of economies of scale unreliable; 2) the health inequities pitfall, i.e. some people will necessarily be left out and therefore not benefit from the scaled-up EBIs; 3) the scaled-up harm pitfall, i.e. the harms as well as the benefits may be amplified by the scaling-up; 4) the ethical pitfall, i.e. informed consent may be a challenge on a grander scale; 5) the top-down pitfall, i.e. the needs, preferences and culture of end-users may be forgotten when scale-up is directed from above; and 6) the contextual pitfall, i.e. it may not be possible to adapt the EBIs to every context. If its pitfalls are addressed head on, scaling-up may be a powerful process for translating research data into practical improvements in healthcare in both LMICs and high-income countries, ensuring that more people benefit from EBIs.

Implementation Research on Shared Decision Making in Primary Care: Inventory of Intracluster Correlation Coefficients.

Background. Cluster randomized trials are important sources of information on evidence-based practices in primary care. However, there are few sources of intracluster correlation coefficients (ICCs) for designing such trials. We inventoried ICC estimates for shared decision-making (SDM) measures in primary care. Methods. Data sources were studies led by the Canada Research Chair in Shared Decision Making and Knowledge Transition. Eligible studies were conducted in primary care, included at least 2 hierarchical levels, included SDM measures for individual units nested under any type of cluster (area, clinic, or provider), and were approved by an ethics committee. We classified measures into decision antecedents, decision processes, and decision outcomes. We used Bayesian random-effect models to estimate mode ICCs and the 95% highest probability density interval (HPDI). We summarized estimates by calculating median and interquartile range (IQR). Results. Six of 14 studies were included. There were 97 ICC estimates for 17 measures. ICC estimates ranged from 0 to 0.5 (median, 0.03; IRQ, 0-0.07). They were higher for process measures (median, 0.03; IQR, 0-0.07) than for antecedent measures (0.02; 0-0.07) or outcome measures (0.02; 0-0.06), for which, respectively, "decisional conflict" (mode, 0.48; 95% HPDI, 0.39-0.57), "reluctance to disclose uncertainty to patients" (0.5; 0.11-0.89), and "quality of the decision" (0.45; 0.14-0.84) had the highest ICCs. ICCs for provider-level clustering (median, 0.06; IQR, 0-0.13) were higher than for other levels. Limitations. This convenience sample of studies may not reflect all potential ICC ranges for primary care SDM measures. Conclusions. Our inventory of ICC estimates for SDM measures in primary care will improve the ease and accuracy of power calculations in cluster randomized trials and inspire its further expansion in SDM contexts.

Sexual Health Problems and Discussion in Colorectal Cancer Patients Two Years After Diagnosis: A National Cross-Sectional Study.

BACKGROUND: Colorectal cancer (CRC) is accompanied by specific treatment-related physical (ostomy, incontinence) and psychosexual (body image, depression) consequences on sexual health. AIM: To assess sexual health of patients with CRC 2 years after diagnosis. METHODS: We selected all patients with CRC from a French nationwide longitudinal study. Data sources included patient questionnaires, medical questionnaires, and medico-administrative databases. MAIN OUTCOME MEASURE: We evaluated sexual health using the Relationship and Sexuality Scale and assessed self-reported rates of discussion about sexuality with health care providers. RESULTS: Across the 487 patients, 258 were men and 229 were women; 77% were diagnosed with colon cancer and 23% with rectal cancer. Overall, 54% of patients reported a decrease in sexual desire, 61% a decrease in frequency of intercourse, and 48% a decrease in the possibility to reach an orgasm. Patients still experiencing fecal incontinence 2 years after diagnosis had decreases in all sexual desire, intercourse, orgasm, and satisfaction Relationship and Sexuality Scale items. Patients with rectal cancer had significantly more frequent troubles with desire and orgasm than did patients with colon cancer (P = .003 and P = .014, respectively). Regarding the discussion about sexuality, only 20% of men, 11% of women, 11% of patients with colon cancer, and 33% of patients with rectal cancer recalled having discussed sexuality with the medical team. Factors independently increasing the chance to have discussed sexuality with the medical team were younger age (odds ratio [OR] = 2.77 [1.31; 5.84]; P = .007), having an ostomy (OR = 2.93 [1.27; 6.73]; P = .011), and radiotherapy (OR = 2.78 [1.23; 6.27]; P = .014). CLINICAL IMPLICATIONS: These results highlight the need for developing interventions to improve information delivery at cancer announcement and for managing sexual troubles during survivorship in patients with CRC, particularly those experiencing fecal incontinence. STRENGTH & LIMITATIONS: Strengths are the sample size and the national representation using the data of a large-scale nation-wide survey, with the possibility of comparing colon and rectal cancers. Limitations are the assessment of sexuality 2 years after diagnosis and using only self-reported measures. CONCLUSION: This study highlights the lack of discussion about sexuality with the oncology team and the need for specific sexual rehabilitation interventions, especially for patients with rectal cancer and fecal incontinence. Developing these aspects may help patients with CRC improve their sexual prognosis. Almont T, Bouhnik A-D, Charif AB, et al. Sexual Health Problems and Discussion in Colorectal Cancer Patients Two Years After Diagnosis: A National Cross-Sectional Study. J Sex Med 2019;16:96-110.

Strategies to improve the implementation of workplace-based policies or practices targeting tobacco, alcohol, diet, physical activity and obesity.

BACKGROUND: Given the substantial period of time adults spend in their workplaces each day, these provide an opportune setting for interventions addressing modifiable behavioural risk factors for chronic disease. Previous reviews of trials of workplace-based interventions suggest they can be effective in modifying a range of risk factors including diet, physical activity, obesity, risky alcohol use and tobacco use. However, such interventions are often poorly implemented in workplaces, limiting their impact on employee health. Identifying strategies that are effective in improving the implementation of workplace-based interventions has the potential to improve their effects on health outcomes. OBJECTIVES: To assess the effects of strategies for improving the implementation of workplace-based policies or practices targeting diet, physical activity, obesity, tobacco use and alcohol use.Secondary objectives were to assess the impact of such strategies on employee health behaviours, including dietary intake, physical activity, weight status, and alcohol and tobacco use; evaluate their cost-effectiveness; and identify any unintended adverse effects of implementation strategies on workplaces or workplace staff. SEARCH METHODS: We searched the following electronic databases on 31 August 2017: CENTRAL; MEDLINE; MEDLINE In Process; the Campbell Library; PsycINFO; Education Resource Information Center (ERIC); Cumulative Index to Nursing and Allied Health Literature (CINAHL); and Scopus. We also handsearched all publications between August 2012 and September 2017 in two speciality journals: Implementation Science and Journal of Translational Behavioral Medicine. We conducted searches up to September 2017 in Dissertations and Theses, the WHO International Clinical Trials Registry Platform, and the US National Institutes of Health Registry. We screened the reference lists of included trials and contacted authors to identify other potentially relevant trials. We also consulted experts in the field to identify other relevant research. SELECTION CRITERIA: Implementation strategies were defined as strategies specifically employed to improve the implementation of health interventions into routine practice within specific settings. We included any trial with a parallel control group (randomised or non-randomised) and conducted at any scale that compared strategies to support implementation of workplace policies or practices targeting diet, physical activity, obesity, risky alcohol use or tobacco use versus no intervention (i.e. wait-list, usual practice or minimal support control) or another implementation strategy. Implementation strategies could include those identified by the Effective Practice and Organisation of Care (EPOC) taxonomy such as quality improvement initiatives and education and training, as well as other strategies. Implementation interventions could target policies or practices directly instituted in the workplace environment, as well as workplace-instituted efforts encouraging the use of external health promotion services (e.g. gym membership subsidies). DATA COLLECTION AND ANALYSIS: Review authors working in pairs independently performed citation screening, data extraction and 'Risk of bias' assessment, resolving disagreements via consensus or a third reviewer. We narratively synthesised findings for all included trials by first describing trial characteristics, participants, interventions and outcomes. We then described the effect size of the outcome measure for policy or practice implementation. We performed meta-analysis of implementation outcomes for trials of comparable design and outcome. MAIN RESULTS: We included six trials, four of which took place in the USA. Four trials employed randomised controlled trial (RCT) designs. Trials were conducted in workplaces from the manufacturing, industrial and services-based sectors. The sample sizes of workplaces ranged from 12 to 114. Workplace policies and practices targeted included: healthy catering policies; point-of-purchase nutrition labelling; environmental supports for healthy eating and physical activity; tobacco control policies; weight management programmes; and adherence to guidelines for staff health promotion. All implementation interventions utilised multiple implementation strategies, the most common of which were educational meetings, tailored interventions and local consensus processes. Four trials compared an implementation strategy intervention with a no intervention control, one trial compared different implementation interventions, and one three-arm trial compared two implementation strategies with each other and a control. Four trials reported a single implementation outcome, whilst the other two reported multiple outcomes. Investigators assessed outcomes using surveys, audits and environmental observations. We judged most trials to be at high risk of performance and detection bias and at unclear risk of reporting and attrition bias.Of the five trials comparing implementation strategies with a no intervention control, pooled analysis was possible for three RCTs reporting continuous score-based measures of implementation outcomes. The meta-analysis found no difference in standardised effects (standardised mean difference (SMD) -0.01, 95% CI -0.32 to 0.30; 164 participants; 3 studies; low certainty evidence), suggesting no benefit of implementation support in improving policy or practice implementation, relative to control. Findings for other continuous or dichotomous implementation outcomes reported across these five trials were mixed. For the two non-randomised trials examining comparative effectiveness, both reported improvements in implementation, favouring the more intensive implementation group (very low certainty evidence). Three trials examined the impact of implementation strategies on employee health behaviours, reporting mixed effects for diet and weight status (very low certainty evidence) and no effect for physical activity (very low certainty evidence) or tobacco use (low certainty evidence). One trial reported an increase in absolute workplace costs for health promotion in the implementation group (low certainty evidence). None of the included trials assessed adverse consequences. Limitations of the review included the small number of trials identified and the lack of consistent terminology applied in the implementation science field, which may have resulted in us overlooking potentially relevant trials in the search. AUTHORS' CONCLUSIONS: Available evidence regarding the effectiveness of implementation strategies for improving implementation of health-promoting policies and practices in the workplace setting is sparse and inconsistent. Low certainty evidence suggests that such strategies may make little or no difference on measures of implementation fidelity or different employee health behaviour outcomes. It is also unclear if such strategies are cost-effective or have potential unintended adverse consequences. The limited number of trials identified suggests implementation research in the workplace setting is in its infancy, warranting further research to guide evidence translation in this setting.

Assessment of scalability of evidence-based innovations in community-based primary health care: a cross-sectional study.

BACKGROUND: In 2013, the Canadian Institutes of Health Research funded 12 community-based primary health care research teams to develop evidence-based innovations. We aimed to explore the scalability of these innovations. METHODS: In this cross-sectional study, we invited the 12 teams to rate their evidence-based innovations for scalability. Based on a systematic review, we developed a self-administered questionnaire with 16 scalability assessment criteria grouped into 5 dimensions (theory, impact, coverage, setting and cost). Teams completed a questionnaire for each of their innovations. We analyzed the data using simple frequency counts and hierarchical cluster analysis. We calculated the mean number and standard deviation (SD) of innovations that met criteria within each dimension that included more than 1 criterion. The analysis unit was the innovation. RESULTS: The 11 responding teams evaluated 33 evidence-based innovations (median 3, range 1-8 per team). The innovations focused on access to care and chronic disease prevention and management, and varied from health interventions to methodological innovations. Most of the innovations were health interventions (n = 21), followed by analytical methods (n = 4), conceptual frameworks (n = 4), measures (n = 3) and strategies to build research capacity (n = 1). Most (29) met criteria in the theory dimension, followed by impact (mean 22.3 [SD 5.6] innovations per dimension), setting (mean 21.7 [SD 8.5]), cost (mean 17.5 [SD 2.1]) and coverage (mean 14.0 [SD 4.1]). On average, the innovations met 10 of the 16 criteria. Adoption was the least assessed criterion (n = 9). Most (20) of the innovations were highly ranked for scalability. INTERPRETATION: Scalability varied among innovations, which suggests that readiness for scale up was suboptimal for some innovations. Coverage remained largely unaddressed; further investigation of this critical dimension is necessary.