Reporting of Factorial Randomized Trials: Extension of the CONSORT 2010 Statement.

Importance: Transparent reporting of randomized trials is essential to facilitate critical appraisal and interpretation of results. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, reporting of factorial trials is suboptimal. Objective: To develop a consensus-based extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for factorial trials. Design: Using the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT extension for factorial trials was developed by (1) generating a list of reporting recommendations for factorial trials using a scoping review of methodological articles identified using a MEDLINE search (from inception to May 2019) and supplemented with relevant articles from the personal collections of the authors; (2) a 3-round Delphi survey between January and June 2022 to identify additional items and assess the importance of each item, completed by 104 panelists from 14 countries; and (3) a hybrid consensus meeting attended by 15 panelists to finalize the selection and wording of items for the checklist. Findings: This CONSORT extension for factorial trials modifies 16 of the 37 items in the CONSORT 2010 checklist and adds 1 new item. The rationale for the importance of each item is provided. Key recommendations are (1) the reason for using a factorial design should be reported, including whether an interaction is hypothesized, (2) the treatment groups that form the main comparisons should be clearly identified, and (3) for each main comparison, the estimated interaction effect and its precision should be reported. Conclusions and Relevance: This extension of the CONSORT 2010 Statement provides guidance on the reporting of factorial randomized trials and should facilitate greater understanding of and transparency in their reporting.

Heterogeneity in pragmatic randomised trials: sources and management.

BACKGROUND: Pragmatic trials aim to generate evidence to directly inform patient, caregiver and health-system manager policies and decisions. Heterogeneity in patient characteristics contributes to heterogeneity in their response to the intervention. However, there are many other sources of heterogeneity in outcomes. Based on the expertise and judgements of the authors, we identify different sources of clinical and methodological heterogeneity, which translate into heterogeneity in patient responses-some we consider as desirable and some as undesirable. For each of them, we discuss and, using real-world trial examples, illustrate how heterogeneity should be managed over the whole course of the trial. MAIN TEXT: Heterogeneity in centres and patients should be welcomed rather than limited. Interventions can be flexible or tailored and control interventions are expected to reflect usual care, avoiding use of a placebo. Co-interventions should be allowed; adherence should not be enforced. All these elements introduce heterogeneity in interventions (experimental or control), which has to be welcomed because it mimics reality. Outcomes should be objective and possibly routinely collected; standardised assessment, blinding and adjudication should be avoided as much as possible because this is not how assessment would be done outside a trial setting. The statistical analysis strategy must be guided by the objective to inform decision-making, thus favouring the intention-to-treat principle. Pragmatic trials should consider including process analyses to inform an understanding of the trial results. Needed data to conduct these analyses should be collected unobtrusively. Finally, ethical principles must be respected, even though this may seem to conflict with goals of pragmatism; consent procedures could be incorporated in the flow of care.

Is primary health care ready for artificial intelligence? Stakeholder perspectives: Worth the risk as long as you do it well.

Context: The effective deployment of artificial intelligence (AI) in primary health care requires a match between the AI tools that are being developed and the needs of primary health care practitioners and patients. Currently, the majority of AI development targeted toward potential application in primary care is being conducted without the involvement of these stakeholders. Objective: To identify key issues regarding the use of AI tools in primary health care by exploring the views of primary health care and digital health stakeholders. Study Design: A descriptive qualitative approach was taken in this study. Fourteen in-depth interviews were conducted with primary care and digital health stakeholders. Setting: Province of Ontario, Canada Population studied: Primary health care and digital health stakeholders Outcome Measures: N/A Results: Two main themes emerged from the data analysis: Worth the Risk as Long as You Do It Well; and, Mismatch Between Envisioned Uses and Current Reality. Participants noted that AI could have value if used for specific purposes, for example: supporting care for patients; reducing practitioner burden; analyzing existing evidence; managing patient populations; and, supporting operational efficiencies. Participants identified facilitators of AI being used for these purposes including: use of relevant case studies/success stories with realistic uses of AI highlighted; easy or low risk applications; and, end user involvement. However, barriers to the use of AI included: data quality; digital divide/equity; distrust of AI including security/privacy issues; for-profit motives; need for transparency about how AI works; and, fear about impact on practitioners regarding clinical judgement. Conclusion: AI will continue to become more prominent in primary health care. There is potential for positive impact, however there are many factors that need to be considered regarding the implementation of AI. The findings of this study can help to inform the development and deployment of AI tools in primary health care.

Identifying priorities for artificial intelligence and primary care in ontario: A multi-stakeholder engagement event.

CONTEXT: Artificial intelligence (AI) is increasingly being recognized as having potential importance to primary care (PC). However, there is a gap in our understanding about where to focus efforts related to AI for PC settings, especially given the current COVID-19 pandemic. OBJECTIVE: To identify current priority areas for AI and PC in Ontario, Canada. STUDY DESIGN: Multi-stakeholder engagement event with facilitated small and large group discussions. A nominal group technique process was used to identify and rank challenges in PC that AI may be able to support. Mentimeter software was used to allow real-time, anonymous and independent ranking from all participants. A final list of priority areas for AI and PC, with key considerations, was derived based on ranked items and small group discussion notes. SETTING: Ontario, Canada. POPULATION STUDIED: Digital health and PC stakeholders. OUTCOME MEASURES: N/A. RESULTS: The event included 8 providers, 8 patient advisors, 4 decision makers, 3 digital health stakeholders, and 12 researchers. Nine priority areas for AI and PC were identified and ranked, which can be grouped into those intended to support physician (preventative care and risk profiling, clinical decision support, routine task support), patient (self-management of conditions, increased mental health care capacity and support), or system-level initiatives (administrative staff support, management and synthesis of information sources); and foundational areas that would support work on other priorities (improved communication between PC and AI stakeholders, data sharing and interoperability between providers). Small group discussions identified barriers and facilitators related to the priorities, including data availability, quality, and consent; legal and device certification issues; trust between people and technology; equity and the digital divide; patient centredness and user-centred design; and the need for funding to support collaborative research and pilot testing. Although identified areas do not explicitly mention COVID-19, participants were encouraged to think about what would be feasible and meaningful to accomplish within a few years, including considerations of the COVID-19 pandemic and recovery phases. CONCLUSIONS: A one-day multi-stakeholder event identified priority areas for AI and PC in Ontario. These priorities can serve as guideposts to focus near-term efforts on the planning, development, and evaluation of AI for PC.

Is primary health care ready for artificial intelligence? What do primary health care stakeholders say?

BACKGROUND: Effective deployment of AI tools in primary health care requires the engagement of practitioners in the development and testing of these tools, and a match between the resulting AI tools and clinical/system needs in primary health care. To set the stage for these developments, we must gain a more in-depth understanding of the views of practitioners and decision-makers about the use of AI in primary health care. The objective of this study was to identify key issues regarding the use of AI tools in primary health care by exploring the views of primary health care and digital health stakeholders. METHODS: This study utilized a descriptive qualitative approach, including thematic data analysis. Fourteen in-depth interviews were conducted with primary health care and digital health stakeholders in Ontario. NVivo software was utilized in the coding of the interviews. RESULTS: Five main interconnected themes emerged: (1) Mismatch Between Envisioned Uses and Current Reality-denoting the importance of potential applications of AI in primary health care practice, with a recognition of the current reality characterized by a lack of available tools; (2) Mechanics of AI Don't Matter: Just Another Tool in the Toolbox- reflecting an interest in what value AI tools could bring to practice, rather than concern with the mechanics of the AI tools themselves; (3) AI in Practice: A Double-Edged Sword-the possible benefits of AI use in primary health care contrasted with fundamental concern about the possible threats posed by AI in terms of clinical skills and capacity, mistakes, and loss of control; (4) The Non-Starters: A Guarded Stance Regarding AI Adoption in Primary Health Care-broader concerns centred on the ethical, legal, and social implications of AI use in primary health care; and (5) Necessary Elements: Facilitators of AI in Primary Health Care-elements required to support the uptake of AI tools, including co-creation, availability and use of high quality data, and the need for evaluation. CONCLUSION: The use of AI in primary health care may have a positive impact, but many factors need to be considered regarding its implementation. This study may help to inform the development and deployment of AI tools in primary health care.

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).

Achieving holistic, quality-of-life focused care: description of a Compassion Care Community initiative in Canada.

The compassionate community movement as both a public health approach and a social model of care for various life stages is gaining traction in Canada and elsewhere. One example is the Windsor-Essex Compassion Care Community (WECCC), an evidence-based model and set of tools to improve the quality of life, health and wellness of vulnerable and aging populations by identifying and addressing upstream and downstream social and other risks to physical and mental health. This paper presents findings from the WECCC pilot evaluation. The WECCC initiative provided one-on-one volunteer-supported quality of life assessment, resource navigation and goals support program (Catalyzing Community Connections). This was augmented with public education sessions on social connection and loneliness (Importance of Being Connected) for the broader population. The RE-AIM framework was used to frame evaluation of WECCC through the first 4 years. Questionnaires were used to evaluate participant outcomes related to implementation and effectiveness. Interviews and focus groups were completed to understand impacts. From 2017 to 2020, WECCC has engaged over 2,500 individuals, 65 organizations and 400 volunteers combined in both programs. Nearly all (82% to 95%) participants reported positive changes to health, quality of life and/or social connections. This developmental phase of a compassionate community initiative has allowed piloting of an evaluation framework focusing on reach, adoption, implementation and early signals of effectiveness and maintenance. This demonstration provides information on feasibility, acceptability and potential impacts of this type of over-arching community initiative.

The compassionate communities movement is a social and holistic approach to care that engages community members in caring for others. The movement is growing around the world. The philosophy is that all citizens benefit from participating in care for others who are aging, disabled, nearing end-of-life or struggling with determinants of health. The Windsor-Essex Compassion Care Community (WECCC) is a Canadian example of this model. WECCC seeks to improve the health of people at any stage of life by helping them to identify their life needs and goals and providing them support to meet them. The program has two core components: one-on-one volunteer-support for person-directed goals and navigation (Catalyzing Community Connections) and public education sessions about loneliness and social connection (Importance of Being Connected). Evaluation is a routine part of program delivery with questionnaires, interviews and focus groups used to understand the program's outcomes. From 2017 to 2020, WECCC has worked with over 2,500 individuals, 65 organizations and 400 volunteers. Satisfaction with the program is very high (95%). Nearly all participants reported positive changes to their quality of life (82%) and social connections (95%). Although pilot results are favorable, continued evaluation and stronger research designs are needed to comprehensively evaluate the WECCC program over time and to support growth and spread of the model.

Scaling Up Patient-Centered Interdisciplinary Care for Multimorbidity: A Pragmatic Mixed-Methods Randomized Controlled Trial.

PURPOSE: To measure the effectiveness of a 4-month interdisciplinary multifaceted intervention based on a change in care delivery for patients with multimorbidity in primary care practices. METHODS: A pragmatic randomized controlled trial with a mixed-methods design in patients aged 18 to 80 years with 3 or more chronic conditions from 7 family medicine groups (FMGs) in Quebec, Canada. Health care professionals (nurses, nutritionists, kinesiologists) from the FMGs were trained to deliver the patient-centered intervention based on a motivational approach and self-management support. Primary outcomes: self-management (Health Education Impact Questionnaire); and self-efficacy. SECONDARY OUTCOMES: health status, quality of life, and health behaviors. Quantitative analyses used multi-level mixed effects and generalized linear mixed models controlling for clustering within FMGs. We also conducted in-depth interviews with patients, family members, and health care professionals. RESULTS: The trial randomized 284 patients (144 in intervention group, 140 in control group). The groups were comparable. After 4 months, the intervention showed a neutral effect for the primary outcomes. There was significant improvement in 2 health behaviors (healthy eating with odds ratios [OR] 4.36; P = .006, and physical activity with OR 3.43; P = .023). The descriptive qualitative evaluation revealed that the patients reinforced their self-efficacy and improved their self-management which was divergent from the quantitative results. CONCLUSIONS: Quantitatively, this intervention showed a neutral effect on the primary outcomes and substantial improvement in 2 health behaviors as secondary outcomes. Qualitatively, the intervention was evaluated as positive. The combination of qualitative and quantitative designs proved to be a good design for evaluating this complex intervention.

Learning health systems in primary care: a systematic scoping review.

BACKGROUND: Learning health systems have been gaining traction over the past decade. The purpose of this study was to understand the spread of learning health systems in primary care, including where they have been implemented, how they are operating, and potential challenges and solutions. METHODS: We completed a scoping review by systematically searching OVID Medline®, Embase®, IEEE Xplore®, and reviewing specific journals from 2007 to 2020. We also completed a Google search to identify gray literature. RESULTS: We reviewed 1924 articles through our database search and 51 articles from other sources, from which we identified 21 unique learning health systems based on 62 data sources. Only one of these learning health systems was implemented exclusively in a primary care setting, where all others were integrated health systems or networks that also included other care settings. Eighteen of the 21 were in the United States. Examples of how these learning health systems were being used included real-time clinical surveillance, quality improvement initiatives, pragmatic trials at the point of care, and decision support. Many challenges and potential solutions were identified regarding data, sustainability, promoting a learning culture, prioritization processes, involvement of community, and balancing quality improvement versus research. CONCLUSIONS: We identified 21 learning health systems, which all appear at an early stage of development, and only one was primary care only. We summarized and provided examples of integrated health systems and data networks that can be considered early models in the growing global movement to advance learning health systems in primary care.

Printed educational materials directed at Ontario family physicians do not improve adherence to guideline recommendations for diabetes management: a pragmatic, factorial, cluster randomized controlled trial [ISRCTN72772651].

BACKGROUND: Printed educational materials (PEMs) have long been used to inform clinicians on evidence-based practices. However, the evidence for their effects on patient care and outcomes is unclear. In Ontario, despite widely available clinical practice guidelines recommending antihypertensives and cholesterol-lowering agents for patients with diabetes, prescriptions remain low. We aimed to determine whether PEMs can influence physicians to intensify prescribing of these medications. METHODS: A pragmatic, 2 × 2 factorial, cluster randomized controlled trial was designed to ascertain the effect of two PEM formats on physician prescribing: a postcard-sized message ("outsert") or a longer narrative article ("insert"). Ontario family physician practices (clusters) were randomly allocated to receive the insert, outsert, both or neither. Physicians were eligible if they were in active practice and their patients were included if they were over 65 years with a diabetes diagnosis; both were unaware of the trial. Administrative databases at ICES (formerly the Institute for Clinical Evaluative Sciences) were used to link patients to their physician and to analyse prescribing patterns at baseline and 1 year following PEM mailout. The primary outcome was intensification defined as the addition of a new antihypertensive or cholesterol-lowering agent, or dose increase of a current drug, measured at the patient level. Analyses were by intention-to-treat and accounted for the clustering of patients to physicians. RESULTS: We randomly assigned 4231 practices (39% of Ontario family physicians) with a total population of 185,526 patients (20% of patients with diabetes in Ontario primary care) to receive the insert, outsert, both, and neither; among these, 4118 practices were analysed (n = 1025, n = 1037, n = 1031, n = 1025, respectively). No significant treatment effect was found for the outsert (odds ratio (OR) 1.01, 95% confidence interval (CI) 0.98 to 1.04) or the insert (OR 0.99, 95% CI 0.96 to 1.02). Percent of intensification in the four arms was similar (approximately 46%). Adjustment for physician characteristics (e.g., age, sex, practice location) had no impact on these findings. CONCLUSIONS: PEMs have no effect on physician's adherence to recommendations for the management of diabetes-related complications in Ontario. Further research should investigate the effect of other strategies to narrow this evidence-to-practice gap. TRIAL REGISTRATION: ISRCTN72772651 . Retrospectively registered 21 July 2005.

Artificial Intelligence and Primary Care Research: A Scoping Review.

PURPOSE: Rapid increases in technology and data motivate the application of artificial intelligence (AI) to primary care, but no comprehensive review exists to guide these efforts. Our objective was to assess the nature and extent of the body of research on AI for primary care. METHODS: We performed a scoping review, searching 11 published or gray literature databases with terms pertaining to AI (eg, machine learning, bayes* network) and primary care (eg, general pract*, nurse). We performed title and abstract and then full-text screening using Covidence. Studies had to involve research, include both AI and primary care, and be published in Eng-lish. We extracted data and summarized studies by 7 attributes: purpose(s); author appointment(s); primary care function(s); intended end user(s); health condition(s); geographic location of data source; and AI subfield(s). RESULTS: Of 5,515 unique documents, 405 met eligibility criteria. The body of research focused on developing or modifying AI methods (66.7%) to support physician diagnostic or treatment recommendations (36.5% and 13.8%), for chronic conditions, using data from higher-income countries. Few studies (14.1%) had even a single author with a primary care appointment. The predominant AI subfields were supervised machine learning (40.0%) and expert systems (22.2%). CONCLUSIONS: Research on AI for primary care is at an early stage of maturity. For the field to progress, more interdisciplinary research teams with end-user engagement and evaluation studies are needed.

Primary Care Practitioner Training in Child and Adolescent Psychiatry (PTCAP): A Cluster-Randomized Trial.

OBJECTIVES: Rural primary care practitioners (PCPs) have a pivotal role to play in frontline pediatric mental health care, given limited options for referral and consultation. Yet they report a lack of adequate training and confidence to provide this care. The aim of this study was to test the effectiveness of the Practitioner Training in Child and Adolescent Psychiatry (PTCAP) program, which was designed to enhance PCPs' pediatric mental health care confidence. The program includes brief therapeutic skills and practice guidelines PCPs can use to address both subthreshold concerns and diagnosable conditions, themselves. METHODS: The study design was a pilot, cluster-randomized, multicenter trial. Practices were randomly assigned to intervention (n practices = 7; n PCPs = 42) or to wait-list control (n practices = 6; n PCPs = 34). The intervention involved 8 hr of training in practice guidelines and brief therapeutic skills for depression, anxiety, attention deficit hyperactivity disorder, and behavioral disorders with case discussion and video examples, while the control practiced as usual. A linear random-effects model controlling for clustering and baseline was carried out on the individual-level data to examine between-group differences in the primary (i.e., confidence) and secondary (i.e., attitude and knowledge) outcomes at 1-week follow-up. RESULTS: Findings were a statistically significant difference in the primary outcomes. Compared to the control group, the intervention group indicated significantly greater confidence in managing diagnosable conditions (d = 1.81) and general concerns (d = 1.73), as well as in making necessary referrals (d = 1.27) and obtaining consults (d = 0.74). While the intervention did not significantly impact secondary outcomes (attitudes and knowledge), regression analysis indicated that the intervention may have increased confidence, in part, by ameliorating the adverse impact of negative mental health care attitudes. CONCLUSION: PTCAP enhances PCPs' child/youth mental health care confidence in managing both general and diagnosable concerns. However, an 8-hr session focused on applying brief therapeutic skills was insufficient to significantly change attitudes and knowledge. Formal testing of PTCAP may be warranted, perhaps using more intensive training and including outcome assessments capable of determining whether increased PCP confidence translates to more effective management and better patient outcomes.

Unpacking 'the cloud': a framework for implementing public health approaches to palliative care.

Designing and implementing population-based systems of care that address the social determinants of health, take action on multiple levels, and are guided by evidence-based principles is a pressing priority, and an international challenge. Aging persons are a priority demographic whose health needs span physical, psychosocial and existential care domains, increase in the last year of life, are often poorly coordinated and therefore remain unmet. Compassionate communities (CCs) are an example of a public health approach that fully addresses the holistic healthcare needs of those who are aging and nearing end of life. The sharing of resources, tools, and innovations among implementers of CCs is occurring globally. Although this can increase impact, it also generates complexity that can complicate robust evaluation. When initiating population health level projects, it is important to clearly define and organize concepts and processes that are proposed to influence the health outcomes. The Health Impact Change Model (HICM) was developed to unpack the complexities associated with the implementation and evaluation of a Canadian CC intervention. The HICM offers utility for citizens, leaders and decision-makers who are engaged in the implementation of population health level strategies or other social approaches to care, such as compassionate cities and age or dementia-friendly communities. The HICM's concepts can be adapted to address a community's healthcare context, needs, and goals for change. We share examples of how the model's major concepts have been applied in the development, evaluation and spread of a complex CC approach.

Building research culture and capacity in academic family medicine departments: Insights from a simulation workshop.

OBJECTIVE: To use data from a workshop in which various representatives from departments of family medicine (DFMs) aimed to identify strategies to increase research activity, particularly among clinical faculty members. DESIGN: Descriptive qualitative study using data from a workshop in which participants role-played (ie, as clinician-teachers, department chairs, and mentors) and, while in the role-playing scenario, were asked to imagine strategies that would encourage the clinical faculty members to engage in research. SETTING: The 2014 North American Primary Care Research Group Annual Meeting in New York City, NY. PARTICIPANTS: Thirty-two workshop participants who belonged to DFMs and other academic primary care organizations: 18 from Canada, 11 from the United States, 2 from Australia, and 1 from the Netherlands. METHODS: Facilitators recorded the strategies at the workshop. Strategies were organized into themes and vetted by facilitators to ensure that they adequately represented the data. Finalized themes were compared and integrated across scenarios. MAIN FINDINGS: Participants enthusiastically and productively engaged in the role-playing scenarios. The themes that emerged from the workshop discussions indicated that in order to increase clinician-teacher engagement in research, the following factors needed to be attended to: gaining confidence in conducting research; finding research topics that have personal relevance; presenting clarity of expectations; fostering collaborative relationships; using a tailored approach; providing resources, structures, and processes; and having leadership and vision. Finally, it was important to recognize these efforts in the context of the existing research environment of the DFM and the various responsibilities of clinician-teachers. CONCLUSION: The analysis of data arising from this simulation workshop elucidated practical strategies for building and sustaining research in DFMs. There is a clear indication that one size does not fit all with respect to strategies for building a research culture in a DFM; the authors' recommendations guide departments to tailor strategies to their unique context.

National Survey of Indigenous primary healthcare capacity and delivery models in Canada: the TransFORmation of IndiGEnous PrimAry HEAlthcare delivery (FORGE AHEAD) community profile survey.

BACKGROUND: There is a significant deficiency of national health information for Indigenous peoples in Canada. This manuscript describes the Community Profile Survey (CPS), a community-based, national-level survey designed to identify and describe existing healthcare delivery, funding models, and diabetes specific infrastructure and programs in Indigenous communities. METHODS: The CPS was developed collaboratively through FORGE AHEAD and the First Nations and Inuit Health Branch of Health Canada. Regional and federal engagement and partnerships were built with Indigenous organizations to establish regionally-tailored distribution of the 8-page CPS to 440 First Nations communities. Results were collected (one survey per community) and reported in strata by region, with descriptive analyses performed on all variables. Results were shared with participating communities and regional/federal partners through tailored reports. RESULTS: A total of 84 communities completed the survey (19% response rate). The majority of communities had a health centre/office to provide service to their patients with diabetes, with limited on-reserve hospitals for ambulatory or case-sensitive conditions. Few healthcare specialists were located on-site, with patients frequently travelling off-site (> 40 km) for diabetes-related complications. The majority of healthcare professionals on-site were Health Directors, Community Health Nurses, and Home Care Nurses. Many communities had a diabetes registry but few reported a diabetes surveillance system. Regional variation in healthcare services, diabetes programs, and funding models were noted, with most communities engaging in some type of innovative strategy to improve care for patients with diabetes. CONCLUSIONS: The CPS is the first community-based, national-level survey of its kind in Canada. Although the response rate was low, the CPS was distributed and successfully administered across a broad range of First Nations communities, and future considerations would benefit from a governance structure and leadership that strengthens community engagement, and a longitudinal research approach to increase the representativeness of the data. This type of information is important for communities and regions to inform decision making (maintain successes, and identify areas for improvement), strengthen health service delivery and infrastructure, increase accessibility to healthcare personnel, and allocate funding and/or resources to build capacity and foster a proactive chronic disease prevention and management approach for Indigenous communities across Canada. TRIAL REGISTRATION: Current ClinicalTrial.gov protocol ID NCT02234973 . Registered: September 9, 2014.

Stakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol.

BACKGROUND: Randomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions (efficacy), whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. METHODS: Semi-structured interviews with key stakeholders (e.g. trialists, methodologists, lay members of study teams, bioethicists, and research ethics committee members), across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. DISCUSSION: We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications.

Examining the nature of interprofessional practice: An initial framework validation and creation of the InterProfessional Activity Classification Tool (InterPACT).

The practice of, and research on interprofessional working in healthcare, commonly referred to as teamwork, has been growing rapidly. This has attracted international policy support flowing from the growing belief that patient safety and quality of care can only be achieved through the collective effort of the multiple professionals caring for a given patient. Despite the increasing policy support, the evidence for effectiveness lags behind: while there are supporting analytic epidemiological studies, few reliable intervention studies have been published and so we have yet to confirm a causal link. We argue that this lag in evidence development may be because interprofessional terms (e.g. teamwork, collaboration) remain conceptually unclear, with no common terminology or definitions, making it difficult to distinguish interventions from each other. In this paper, we examine published studies from the last decade in order to elicit current usage of terms related to interprofessional working; and, in so doing, undertake an initial empirical validation of an existing conceptual framework by mapping its four categories (teamwork, collaboration, coordination and networking) against the descriptions of interprofessional interventions in the included studies. We searched Medline and Embase for papers describing interprofessional interventions using a standard approach. We independently screened papers and classified these under set categories following a thematic approach. Disagreements were resolved through consensus. Twenty papers met our inclusion criteria. Identified interprofessional work interventions fall into a range, from looser to tighter links between members. Definitions are inconsistently and inadequately applied. We found the framework to be a helpful and practical tool for classifying such interventions more consistently. Our analysis enabled us to scrutinise the original dimensions of the framework, confirm their usefulness and consistency, and reveal new sub-categories. We propose a slightly revised typology and a classification tool (InterPACT) for future validation, with four mutually exclusive categories: teamwork, collaboration, coordination and networking. Consistent use, further examination and refinement of the new typology and tool may lead to greater clarity in definition and design of interventions. This should support the development of a reliable and coherent evidence base on interventions to promote interprofessional working in health and social care.

Interprofessional collaboration to improve professional practice and healthcare outcomes.

BACKGROUND: Poor interprofessional collaboration (IPC) can adversely affect the delivery of health services and patient care. Interventions that address IPC problems have the potential to improve professional practice and healthcare outcomes. OBJECTIVES: To assess the impact of practice-based interventions designed to improve interprofessional collaboration (IPC) amongst health and social care professionals, compared to usual care or to an alternative intervention, on at least one of the following primary outcomes: patient health outcomes, clinical process or efficiency outcomes or secondary outcomes (collaborative behaviour). SEARCH METHODS: We searched CENTRAL (2015, issue 11), MEDLINE, CINAHL, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform to November 2015. We handsearched relevant interprofessional journals to November 2015, and reviewed the reference lists of the included studies. SELECTION CRITERIA: We included randomised trials of practice-based IPC interventions involving health and social care professionals compared to usual care or to an alternative intervention. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility of each potentially relevant study. We extracted data from the included studies and assessed the risk of bias of each study. We were unable to perform a meta-analysis of study outcomes, given the small number of included studies and their heterogeneity in clinical settings, interventions and outcomes. Consequently, we summarised the study data and presented the results in a narrative format to report study methods, outcomes, impact and certainty of the evidence. MAIN RESULTS: We included nine studies in total (6540 participants); six cluster-randomised trials and three individual randomised trials (1 study randomised clinicians, 1 randomised patients, and 1 randomised clinicians and patients). All studies were conducted in high-income countries (Australia, Belgium, Sweden, UK and USA) across primary, secondary, tertiary and community care settings and had a follow-up of up to 12 months. Eight studies compared an IPC intervention with usual care and evaluated the effects of different practice-based IPC interventions: externally facilitated interprofessional activities (e.g. team action planning; 4 studies), interprofessional rounds (2 studies), interprofessional meetings (1 study), and interprofessional checklists (1 study). One study compared one type of interprofessional meeting with another type of interprofessional meeting. We assessed four studies to be at high risk of attrition bias and an equal number of studies to be at high risk of detection bias.For studies comparing an IPC intervention with usual care, functional status in stroke patients may be slightly improved by externally facilitated interprofessional activities (1 study, 464 participants, low-certainty evidence). We are uncertain whether patient-assessed quality of care (1 study, 1185 participants), continuity of care (1 study, 464 participants) or collaborative working (4 studies, 1936 participants) are improved by externally facilitated interprofessional activities, as we graded the evidence as very low-certainty for these outcomes. Healthcare professionals' adherence to recommended practices may be slightly improved with externally facilitated interprofessional activities or interprofessional meetings (3 studies, 2576 participants, low certainty evidence). The use of healthcare resources may be slightly improved by externally facilitated interprofessional activities, interprofessional checklists and rounds (4 studies, 1679 participants, low-certainty evidence). None of the included studies reported on patient mortality, morbidity or complication rates.Compared to multidisciplinary audio conferencing, multidisciplinary video conferencing may reduce the average length of treatment and may reduce the number of multidisciplinary conferences needed per patient and the patient length of stay. There was little or no difference between these interventions in the number of communications between health professionals (1 study, 100 participants; low-certainty evidence). AUTHORS' CONCLUSIONS: Given that the certainty of evidence from the included studies was judged to be low to very low, there is not sufficient evidence to draw clear conclusions on the effects of IPC interventions. Neverthess, due to the difficulties health professionals encounter when collaborating in clinical practice, it is encouraging that research on the number of interventions to improve IPC has increased since this review was last updated. While this field is developing, further rigorous, mixed-method studies are required. Future studies should focus on longer acclimatisation periods before evaluating newly implemented IPC interventions, and use longer follow-up to generate a more informed understanding of the effects of IPC on clinical practice.

Lay health workers perceptions of an anemia control intervention in Karnataka, India: a qualitative study.

BACKGROUND: Lay health workers (LHWs) are increasingly used to complement health services internationally. Their perceptions of the interventions they implement and their experiences in delivering community based interventions in India have been infrequently studied. We developed a novel LHW led intervention to improve anemia cure rates in rural community dwelling children attending village day care centers in South India. Since the intervention is delivered by the village day care center LHW, we sought to understand participating LHWs' acceptance of and perspectives regarding the intervention, particularly in relation to factors affecting daily implementation. METHODS: We conducted a qualitative study alongside a cluster randomized controlled trial evaluating a complex community intervention for childhood anemia control in Karnataka, South India. Focus group discussions (FGDs) were conducted with trained LHWs assigned to deliver the educational intervention. These were complemented by non-participant observations of LHWs delivering the intervention. Transcripts of the FGDs were translated and analyzed using the framework analysis method. RESULTS: Several factors made the intervention acceptable to the LHWs and facilitated its implementation including pre-implementation training modules, intervention simplicity, and ability to incorporate the intervention into the routine work schedule. LHWs felt that the intervention impacted negatively on their preexisting workload. Fluctuating relationships with mothers weakened the LHWs position as providers of the intervention and hampered efficient implementation, despite the LHWs' highly valued position in the community. Modifiable barriers to the successful implementation of this intervention were seen at two levels. At a broader contextual level, hindering factors included the LHW being overburdened, inadequately reimbursed, and receiving insufficient employer support. At the health system level, lack of streamlining of LHW duties, inability of LHWs to diagnose anemia and temporary shortfalls in the availability of iron supplements constituted potentially modifiable barriers. CONCLUSION: This qualitative study identified some of the practical challenges as experienced by LHWs while delivering a community health intervention in India. Methodologically, it highlights the value of qualitative research in understanding implementation of complex community interventions. On the contextual level, the results indicate that efficient delivery of community interventions will require streamlining of LHW workloads and improved health system infrastructure support. TRIAL REGISTRATION: This trial was registered with ISRCTN.com (identifier: ISRCTN68413407 ) on 23 September 2013.

Perspectives of health care professionals on the facilitators and barriers to the implementation of a stroke rehabilitation guidelines cluster randomized controlled trial.

BACKGROUND: The Stroke Canada Optimization of Rehabilitation by Evidence Implementation Trial (SCORE-IT) was a cluster randomized controlled trial that evaluated two knowledge translation (KT) interventions for the promotion of the uptake of best practice recommendations for interventions targeting upper and lower extremity function, postural control, and mobility. Twenty rehabilitation centers across Canada were randomly assigned to either the facilitated or passive KT intervention. The objective of the current study was to understand the factors influencing the implementation of the recommended treatments and KT interventions from the perspective of nurses, occupational therapists and physical therapists, and clinical managers following completion of the trial. METHODS: A qualitative descriptive approach involving focus groups was used. Thematic analysis was used to understand the factors influencing the implementation of the recommended treatments and KT interventions. The Clinical Practice Guidelines Framework for Improvement guided the analysis. RESULTS: Thirty-three participants were interviewed from 11 of the 20 study sites (6 sites from the facilitated KT arm and 5 sites from the passive KT arm). The following factors influencing the implementation of the recommended treatments and KT interventions emerged: facilitation, agreement with the intervention - practical, familiarity with the recommended treatments, and environmental factors, including time and resources. Each of these themes includes the sub-themes of facilitator and/or barrier. Improved team communication and interdisciplinary collaboration emerged as an unintended outcome of the trial across both arms in addition to a facilitator to the implementation of the treatment recommendations. Facilitation was identified as a facilitator to implementation of the KT interventions in the passive KT intervention arm despite the lack of formally instituted facilitators in this arm of the trial. CONCLUSIONS: This is one of the first studies to examine the factors influencing the implementation of stroke recommendations and associated KT interventions within the context of a trial. Findings highlight the important role of self-selected facilitators to implementation efforts. Future research should seek to better understand the specific characteristics of facilitators that are associated with successful implementation and clinical outcomes, especially within the context of stroke rehabilitation.