Evidence Synthesis for Complex Interventions Using Meta-Regression Models.

A goal of evidence synthesis for trials of complex interventions is to inform the design or implementation of novel versions of complex interventions by predicting expected outcomes with each intervention version. Conventional aggregate data meta-analyses of studies comparing complex interventions have limited ability to provide such information. We argue that evidence synthesis for trials of complex interventions should forgo aspirations of estimating causal effects and instead model the response surface of study results to 1) summarize the available evidence and 2) predict the average outcomes of future studies or in new settings. We illustrate this modeling approach using data from a systematic review of diabetes quality improvement (QI) interventions involving at least 1 of 12 QI strategy components. We specify a series of meta-regression models to assess the association of specific components with the posttreatment outcome mean and compare the results to conventional meta-analysis approaches. Compared with conventional approaches, modeling the response surface of study results can better reflect the associations between intervention components and study characteristics with the posttreatment outcome mean. Modeling study results using a response surface approach offers a useful and feasible goal for evidence synthesis of complex interventions that rely on aggregate data.

Equity in prenatal healthcare services globally: an umbrella review.

BACKGROUND: Timely, appropriate, and equitable access to quality healthcare during pregnancy is proven to contribute to better health outcomes of birthing individuals and infants following birth. Equity is conceptualized as the absence of differences in healthcare access and quality among population groups. Healthcare policies are guides for front-line practices, and despite merits of contemporary policies striving to foster equitable healthcare, inequities persist. The purpose of this umbrella review is to identify prenatal healthcare practices, summarize how equities/inequities are reported in relation to patient experiences or health outcomes when accessing or using services, and collate equity reporting characteristics. METHODS: For this umbrella review, six electronic databases were searched (Medline, EMBASE, APA PsychInfo, CINAHL, International Bibliography of the Social Sciences, and Cochrane Library). Included studies were extracted for publication and study characteristics, equity reporting, primary outcomes (prenatal care influenced by equity/inequity) and secondary outcomes (infant health influenced by equity/inequity during pregnancy). Data was analyzed deductively using the PROGRESS-Plus equity framework and by summative content analysis for equity reporting characteristics. The included articles were assessed for quality using the Risk of Bias Assessment Tool for Systematic Reviews. RESULTS: The search identified 8065 articles and 236 underwent full-text screening. Of the 236, 68 systematic reviews were included with first authors representing 20 different countries. The population focus of included studies ranged across prenatal only (n = 14), perinatal (n = 25), maternal (n = 2), maternal and child (n = 19), and a general population (n = 8). Barriers to equity in prenatal care included travel and financial burden, culturally insensitive practices that deterred care engagement and continuity, and discriminatory behaviour that reduced care access and satisfaction. Facilitators to achieve equity included innovations such as community health workers, home visitation programs, conditional cash transfer programs, virtual care, and cross-cultural training, to enhance patient experiences and increase their access to, and use of health services. There was overlap across PROGRESS-Plus factors. CONCLUSIONS: This umbrella review collated inequities present in prenatal healthcare services, globally. Further, this synthesis contributes to future solution and action-oriented research and practice by assembling evidence-informed opportunities, innovations, and approaches that may foster equitable prenatal health services to all members of diverse communities.

Understanding strategies to improve medication adherence among persons with type 2 diabetes: A scoping review.

AIMS: The objectives of this scoping review were to: (1) identify the target audience and contexts in which strategies to improve type 2 diabetes mellitus (T2DM) medication adherence have been used, (2) provide an overview of behaviour change techniques (BCTs) used, (3) describe the determinants of behaviour targeted by strategies and (4) to identify current gaps in strategies. METHODS: A systemic search for articles related to T2DM, medication adherence and strategies was conducted in EMBASE, Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily using the OvidSP platform on 11 March 2021. All publications involving strategies to overcome medication non-adherence among adults with T2DM were included. Strategies were categorized according to the BCT taxonomy and the determinants of behaviour targeted by each strategy were classified by using the Theoretical Domains Framework (TDF). RESULTS: The search identified 58 articles and 61 strategies. The BCT categories Antecedents and Natural consequences and BCTs Feedback on outcome(s) of behaviour, Adding objects to the environment and Information about health consequences were identified most frequently as components of strategies resulting in statistically significant improvement in medication adherence. Strategies targeting the TDF domains Reinforcement and Beliefs about Consequences most often resulted in statistically significant improvements in adherence measures. CONCLUSIONS: The findings from this review identify BCTs and targeted behaviours with demonstrated success. Further exploration of the myriad of BCTs and the corresponding determinants of behaviour which were not accessed may be warranted for the development of future strategies to improve medication adherence in type 2 diabetes.

Up-to-date on cancer screening among Ontario patients seen by walk-in clinic physicians: A retrospective cohort study.

Walk-in clinics are typically viewed as high-volume locations for managing acute issues but also may serve as a location for primary care, including cancer screening, for patients without a family physician. In this population-based cohort study, we compared breast, cervical and colorectal cancer screening up-to-date status for people living in the Canadian province of Ontario who were formally enrolled to a family physician versus those not enrolled but who had at least one encounter with a walk-in clinic physician in the previous year. Using provincial administrative databases, we created two mutually exclusive groups: i) those who were formally enrolled to a family physician, ii) those who were not enrolled but had at least one visit with a walk-in clinic physician from April 1, 2019 to March 31, 2020. We compared up to date status for three cancer screenings as of April 1, 2020 among screen-eligible people. We found that people who were not enrolled and had seen a walk-in clinic physician in the previous year consistently were less likely to be up to date on cancer screening than Ontarians who were formally enrolled with a family physician (46.1% vs. 67.4% for breast, 45.8% vs. 67.4% for cervical, 49.5% vs. 73.1% for colorectal). They were also more likely to be foreign-born and to live in structurally marginalized neighbourhoods. New methods are needed to enable screening for people who are reliant on walk-in clinics and to address the urgent need in Ontario for more primary care providers who deliver comprehensive, longitudinal care.

A comparison of family physician and dermatologist topical corticosteroid prescriptions: A population-based cross-sectional study.

BACKGROUND: Topical corticosteroids (TCS) are commonly prescribed to treat inflammatory skin diseases, and appropriate prescription is necessary for treatment success. OBJECTIVE: To quantify differences between TCS prescribed by dermatologists at consultation and family physicians for patients treated for any skin condition. METHODS: Using administrative health data in Ontario, we included all Ontario Drug Benefit recipients who filled at least one TCS prescription from a dermatologist at consultation and a family physician in the year prior between January 2014 and December 2019. We estimated mean differences and 95% confidence intervals in amount (in grams) and potency between the index dermatologist prescription and the highest and most recent family physician prescription amounts and potencies in the preceding year using linear mixed-effect models. RESULTS: A total of 69,335 persons were included. The mean dermatologist amount was 34% larger than the highest amount and 54% larger than the most recent amount prescribed by family physicians. There were small but statistically significant differences in potency using established 7-category and 4-category potency classification systems. CONCLUSIONS: Compared to family physicians, dermatologists prescribed substantially larger amounts and similarly potent TCS at consultation. Further research is needed to determine the effect of these differences on clinical outcomes.

The co-development of a linguistic and culturally tailored tele-retinopathy screening intervention for immigrants living with diabetes from China and African-Caribbean countries in Ottawa, Canada.

BACKGROUND: Diabetic retinopathy is a sight-threatening ocular complication of diabetes. Screening is an effective way to reduce severe complications, but screening attendance rates are often low, particularly for newcomers and immigrants to Canada and people from cultural and linguistic minority groups. Building on previous work, in partnership with patient and health system stakeholders, we co-developed a linguistically and culturally tailored tele-retinopathy screening intervention for people living with diabetes who recently immigrated to Canada from either China or African-Caribbean countries. METHODS: Following an environmental scan of diabetes eye care pathways in Ottawa, we conducted co-development workshops using a nominal group technique to create and prioritize personas of individuals requiring screening and identify barriers to screening that each persona may face. Next, we used the Theoretical Domains Framework to categorize the barriers/enablers and then mapped these categories to potential evidence-informed behaviour change techniques. Finally with these techniques in mind, participants prioritized strategies and channels of delivery, developed intervention content, and clarified actions required by different actors to overcome anticipated intervention delivery barriers. RESULTS: We carried out iterative co-development workshops with Mandarin and French-speaking individuals living with diabetes (i.e., patients in the community) who immigrated to Canada from China and African-Caribbean countries (n = 13), patient partners (n = 7), and health system partners (n = 6) recruited from community health centres in Ottawa. Patients in the community co-development workshops were conducted in Mandarin or French. Together, we prioritized five barriers to attending diabetic retinopathy screening: language (TDF Domains: skills, social influences), retinopathy familiarity (knowledge, beliefs about consequences), physician barriers regarding communication for screening (social influences), lack of publicity about screening (knowledge, environmental context and resources), and fitting screening around other activities (environmental context and resources). The resulting intervention included the following behaviour change techniques to address prioritized local barriers: information about health consequence, providing instructions on how to attend screening, prompts/cues, adding objects to the environment, social support, and restructuring the social environment. Operationalized delivery channels incorporated language support, pre-booking screening and sending reminders, social support via social media and community champions, and providing using flyers and videos as delivery channels. CONCLUSION: Working with intervention users and stakeholders, we co-developed a culturally and linguistically relevant tele-retinopathy intervention to address barriers to attending diabetic retinopathy screening and increase uptake among two under-served groups.

Characteristics and Health Care Use of Patients Attending Virtual Walk-in Clinics in Ontario, Canada: Cross-sectional Analysis.

BACKGROUND: Funding changes in response to the COVID-19 pandemic supported the growth of direct-to-consumer virtual walk-in clinics in several countries. Little is known about patients who attend virtual walk-in clinics or how these clinics contribute to care continuity and subsequent health care use. OBJECTIVE: The objective of the present study was to describe the characteristics and measure the health care use of patients who attended virtual walk-in clinics compared to the general population and a subset that received any virtual family physician visit. METHODS: This was a retrospective, cross-sectional study in Ontario, Canada. Patients who had received a family physician visit at 1 of 13 selected virtual walk-in clinics from April 1 to December 31, 2020, were compared to Ontario residents who had any virtual family physician visit. The main outcome was postvisit health care use. RESULTS: Virtual walk-in patients (n=132,168) had fewer comorbidities and lower previous health care use than Ontarians with any virtual family physician visit. Virtual walk-in patients were also less likely to have a subsequent in-person visit with the same physician (309/132,168, 0.2% vs 704,759/6,412,304, 11%; standardized mean difference [SMD] 0.48), more likely to have a subsequent virtual visit (40,030/132,168, 30.3% vs 1,403,778/6,412,304, 21.9%; SMD 0.19), and twice as likely to have an emergency department visit within 30 days (11,003/132,168, 8.3% vs 262,509/6,412,304, 4.1%; SMD 0.18), an effect that persisted after adjustment and across urban/rural resident groups. CONCLUSIONS: Compared to Ontarians attending any family physician virtual visit, virtual walk-in patients were less likely to have a subsequent in-person physician visit and were more likely to visit the emergency department. These findings will inform policy makers aiming to ensure the integration of virtual visits with longitudinal primary care.

Length of initial prescription at hospital discharge and long-term medication adherence for elderly, post-myocardial infarction patients: a population-based interrupted time series study.

BACKGROUND: Preliminary evidence suggests that providing longer duration prescriptions at discharge may improve long-term adherence to secondary preventative cardiac medications among post-myocardial infarction (MI) patients. We implemented and assessed the effects of two hospital-based interventions-(1) standardized prolonged discharge prescription forms (90-day supply with 3 repeats for recommended cardiac medications) plus education and (2) education only-on long-term cardiac medication adherence among elderly patients post-MI. METHODS: We conducted an interrupted time series study of all post-MI patients aged 65-104 years in Ontario, Canada, discharged from hospital between September 2015 and August 2018 with ≥ 1 dispensation(s) for a statin, beta blocker, angiotensin system inhibitor, and/or secondary antiplatelet within 7 days post-discharge. The standardized prolonged discharge prescription forms plus education and education-only interventions were implemented at 2 (1,414 patients) and 4 (926 patients) non-randomly selected hospitals in September 2017 for 12 months, with all other Ontario hospitals (n = 143; 18,556 patients) comprising an external control group. The primary outcome, long-term cardiac medication adherence, was defined at the patient-level as an average proportion of days covered (over 1-year post-discharge) ≥ 80% across cardiac medication classes dispensed at their index fill. Primary outcome data were aggregated within hospital groups (intervention 1, 2, or control) to monthly proportions and independently analyzed using segmented regression to evaluate intervention effects. A process evaluation was conducted to assess intervention fidelity. RESULTS: At 12 months post-implementation, there was no statistically significant effect on long-term cardiac medication adherence for either intervention-standardized prolonged discharge prescription forms plus education (5.4%; 95% CI - 6.4%, 17.2%) or education only (1.0%; 95% CI - 28.6%, 30.6%)-over and above the counterfactual trend; similarly, no change was observed in the control group (- 0.3%; 95% CI - 3.6%, 3.1%). During the intervention period, only 10.8% of patients in the intervention groups received ≥ 90 days, on average, for cardiac medications at their index fill. CONCLUSIONS: Recognizing intervention fidelity was low at the pharmacy level, and no statistically significant post-implementation differences in adherence were found, the trends in this study-coupled with other published retrospective analyses of administrative data-support further evaluation of this simple intervention to improve long-term adherence to cardiac medications. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03257579 , registered June 16, 2017 Protocol available at: https://pubmed.ncbi.nlm.nih.gov/33146624/ .

Impacts of two behavior change interventions on determinants of medication adherence: process evaluation applying the health action process approach and habit theory alongside a randomized controlled trial.

Investigating the mechanisms of behavior change interventions provides a more fulsome understanding of how and why interventions work (or don't work). We assessed mechanisms of two interventions (mailouts alone, and mailouts plus telephone support, informed by the Health Action Process Approach (HAPA) and Habit Theory), designed to increase medication adherence after myocardial infarction. We conducted a process evaluation alongside a pragmatic trial. Medication adherence was assessed via self-report at 12-months in the trial, and participants in all trial groups were invited to contemporaneously complete an additional questionnaire assessing targeted mechanisms (HAPA constructs and automaticity). We used multiple regression-based mediation models to investigate indirect effects. Of 589 respondents, 497 were analyzed (92 excluded due to missing data). Mailouts plus telephone support had statistically significant but small effects on intention, social support, action planning, coping planning, and automaticity. There were no indirect effects of interventions on medication adherence via these constructs. Therefore, while this intervention led to changes in proposed mechanisms, these changes were not great enough to lead to behavior change. Refinements (and subsequent evaluation) of the interventions are warranted, and our findings indicate that this could involve offering more intensive support to form plans and identify cues for taking medications, in addition to providing physical supports to encourage self-monitoring, feedback, and habit formation. Trial registration: ClinicalTrials.gov: NCT02382731.

Barriers to and enablers of attendance at diabetic retinopathy screening experienced by immigrants to Canada from multiple cultural and linguistic minority groups.

AIM: To identify barriers to/enablers of attendance at eye screening among three groups of immigrantsto Canada from cultural/linguistic minority groups living with diabetes. METHODS: Using a patient-oriented research approach leveraging Diabetes Action Canada's patient engagement platform, we interviewed a purposeful sample of people with type 2 diabetes who had immigrated to Canada from: Pakistan (interviews in Urdu), China (interviews in Mandarin) and French-speaking African and Caribbean nations (interviews in French). We collected and analysed data based on the Theoretical Domains Framework covering key modifiable factors that may operate as barriers to or enablers of attending eye screening. We used directed content analysis to code barrier/enabler domains. Barriers/enablers were mapped to behaviour change techniques to inform future intervention development. RESULTS: We interviewed 39 people (13 per group). Many barriers/enablers were consistent across groups, including views about harms caused by screening itself, practical appointment issues including forgetting, screening costs, wait times and making/getting to an appointment, lack of awareness about retinopathy screening, language barriers, and family and clinical support. Group-specific barriers/enablers included a preference to return to one's country of birth for screening, the impact of winter, and preferences for alternative medicine. CONCLUSION: Our results can inform linguistic and culturally competent interventions to support immigrants living with diabetes in attending eye screening to prevent avoidable blindness.

Effects of hospital funding reform on wait times for hip fracture surgery: a population-based interrupted time-series analysis.

BACKGROUND: Health care funding reforms are being used worldwide to improve system performance but may invoke unintended consequences. We assessed the effects of introducing a targeted hospital funding model, based on fixed price and volume, for hip fractures. We hypothesized the policy change was associated with reduction in wait times for hip fracture surgery, increase in wait times for non-hip fracture surgery, and increase in the incidence of after-hours hip fracture surgery. METHODS: This was a population-based, interrupted time series analysis of 49,097 surgeries for hip fractures, 10,474 for ankle fractures, 1,594 for tibial plateau fractures, and 40,898 for appendectomy at all hospitals in Ontario, Canada between April 2012 and March 2017. We used segmented regression analysis of interrupted monthly time series data to evaluate the impact of funding reform enacted April 1, 2014 on wait time for hip fracture repair (from hospital presentation to surgery) and after-hours provision of surgery (occurring between 1700 and 0700 h). To assess potential adverse consequences of the reform, we also evaluated two control procedures, ankle and tibial plateau fracture surgery. Appendectomy served as a non-orthopedic tracer for assessment of secular trends. RESULTS: The difference (95 % confidence interval) between the actual mean wait time and the predicted rate had the policy change not occurred was - 0.46 h (-3.94 h, 3.03 h) for hip fractures, 1.46 h (-3.58 h, 6.50 h) for ankle fractures, -3.22 h (-39.39 h, 32.95 h) for tibial plateau fractures, and 0.33 h (-0.57 h, 1.24 h) for appendectomy (Figure 1; Table 3). The difference (95 % confidence interval) between the actual and predicted percentage of surgeries performed after-hours - 0.90 % (-3.91 %, 2.11 %) for hip fractures, -3.54 % (-11.25 %, 4.16 %) for ankle fractures, 7.09 % (-7.97 %, 22.14 %) for tibial plateau fractures, and 1.07 % (-2.45 %, 4.59 %) for appendectomy. CONCLUSIONS: We found no significant effects of a targeted hospital funding model based on fixed price and volume on wait times or the provision of after-hours surgery. Other approaches for improving hip fracture wait times may be worth pursuing instead of funding reform.

An 11-Item Measure of User- and Human-Centered Design for Personal Health Tools (UCD-11): Development and Validation.

BACKGROUND: Researchers developing personal health tools employ a range of approaches to involve prospective users in design and development. OBJECTIVE: The aim of this paper was to develop a validated measure of the human- or user-centeredness of design and development processes for personal health tools. METHODS: We conducted a psychometric analysis of data from a previous systematic review of the design and development processes of 348 personal health tools. Using a conceptual framework of user-centered design, our team of patients, caregivers, health professionals, tool developers, and researchers analyzed how specific practices in tool design and development might be combined and used as a measure. We prioritized variables according to their importance within the conceptual framework and validated the resultant measure using principal component analysis with Varimax rotation, classical item analysis, and confirmatory factor analysis. RESULTS: We retained 11 items in a 3-factor structure explaining 68% of the variance in the data. The Cronbach alpha was .72. Confirmatory factor analysis supported our hypothesis of a latent construct of user-centeredness. Items were whether or not: (1) patient, family, caregiver, or surrogate users were involved in the steps that help tool developers understand users or (2) develop a prototype, (3) asked their opinions, (4) observed using the tool or (5) involved in steps intended to evaluate the tool, (6) the process had 3 or more iterative cycles, (7) changes between cycles were explicitly reported, (8) health professionals were asked their opinion and (9) consulted before the first prototype was developed or (10) between initial and final prototypes, and (11) a panel of other experts was involved. CONCLUSIONS: The User-Centered Design 11-item measure (UCD-11) may be used to quantitatively document the user/human-centeredness of design and development processes of patient-centered tools. By building an evidence base about such processes, we can help ensure that tools are adapted to people who will use them, rather than requiring people to adapt to tools.

Are quality improvement plans perceived to improve the quality of primary care in Ontario? Qualitative study.

OBJECTIVE: To explore primary care administrators' perceptions of provincially mandated quality improvement plans, and barriers to and facilitators of using quality improvement plans as tools for improving the quality of primary care. DESIGN: Qualitative descriptive study using semistructured interviews. SETTING: Ontario. PARTICIPANTS: Eleven primary care administrators (ie, executive directors, director of clinical services, office administrators) at 7 family health teams and 4 community health centres. METHODS: All interviews were audiotaped and transcribed verbatim. Data were analyzed deductively to generate a framework based on a conceptual model of structural, organizational, individual, and innovation-related factors that influence the success of improvement initiatives and, inductively, to generate additional themes. MAIN FINDINGS: Provincially mandated quality improvement plans seem to have raised awareness of and provided an overall focus on quality improvement, and have contributed to primary care organizations implementing initiatives to address quality gaps. Four factors that have contributed to the success of quality improvement plans relate to attributes of the quality improvement plans (adaptability and compatibility) and contextual factors (leadership and organizational culture). However, participants expressed that the use of quality improvement plans have not yet led to substantial improvements in the quality of primary care in Ontario, which may be owing to several challenges: poor data quality, lack of staff and physician engagement and buy-in, and lack of resources to support measurement and quality improvement. CONCLUSION: Awareness of and focused attention on the need for high-quality patient care may have increased, but participants expressed that substantial improvements in quality care have yet to be achieved in Ontario. The lack of perceived improvements is likely the result of multifaceted and complex challenges primary care organizations face when trying to improve patient care. To effect positive change, organization- and health system-level efforts are needed to improve measurement capabilities, improve staff and physician engagement, and increase capacity for quality improvement among organizations.

Endorsement of clinical practice guidelines: Criteria from the College of Family Physicians of Canada.

OBJECTIVE: To refine the process for endorsement of guidelines and establish the expectations of the College of Family Physicians of Canada (CFPC) regarding the quality and relevance of clinical practice guidelines targeting family physicians and their patients. COMPOSITION OF THE COMMITTEE: Initially, a group of 6 CFPC staff and selected College members reviewed the previous process for endorsement with the aim of providing a new direction, if needed. The work was then assumed by the Guideline and Knowledge Translation Expert Working Group, a purposefully selected group of 9 family physicians from across Canada with expertise in research, evidence, guidelines, knowledge translation, and continuing professional development and education. METHODS: The initial task force reviewed the endorsement process and identified areas for improvement. A draft new process and core criteria for high-quality guidelines were developed. This was approved by the CFPC board. A Guideline and Knowledge Translation Expert Working Group was then formed to further refine the process and the criteria. Multiple resources were used to inform the criteria. The Guideline and Knowledge Translation Expert Working Group will manage the endorsement process of external submitted guidelines, as well as provide high-level guidance to the CFPC regarding in-house guidelines and continuing professional development content. REPORT: This article provides the expectations of the CFPC regarding clinical practice guidelines and describes in detail the process and criteria for endorsement. Key principles include family physician involvement and guideline funding unlikely to introduce bias, with most criteria falling under 4 themed areas: relation to family medicine, CFPC values, patient engagement and decision making, and scientific rigour. The Guideline and Knowledge Translation Expert Working Group will report to the CFPC board at least once a year. It is hoped that this fully transparent process and these criteria will help advance the quality and standards of clinical practice guideline production in Canada. CONCLUSION: A comprehensive but reasonable list has been provided that reflects the best standards and recommendations and is consistent with the CFPC's values while recognizing the landscape of guideline development for its national partners and colleagues. As with all processes, careful consideration and evaluation will be essential.

Prescribing of oral anticoagulants in the emergency department and subsequent long-term use by older adults with atrial fibrillation.

BACKGROUND: Patients with atrial fibrillation frequently seek emergency care. Rates of guideline-concordant oral anticoagulant therapy for stroke prevention are suboptimal in the community. We assessed the association between prescribing of oral anticoagulants in the emergency department (relative to referral to a longitudinal care provider for treatment initiation) and long-term use of oral anticoagulants. METHODS: This retrospective cohort study performed at 15 hospitals in Ontario, Canada, involved patients aged 65 years or older who visited the emergency department between 2009 and 2014, who had a primary diagnosis of atrial fibrillation, were discharged home, and were eligible for and willing to take stroke-prevention therapy. We used inverse probability-of-treatment weighting based on the propensity score to compare patients who were and were not given a prescription for an oral anticoagulant. The primary outcome was a prescription fill for an oral anticoagulant 6 months later. Secondary outcomes included a prescription fill at 1 year, all-cause mortality, and strokes or bleeding events leading to hospital admission. RESULTS: Of 2132 eligible patients, 402 (18.9%) were given a prescription for an oral anticoagulant in the emergency department. After weighting, 67.8% of these patients had filled a prescription for an oral anticoagulant at 6 months versus 37.2% of those who did not receive a prescription in the emergency department (absolute risk increase [ARI] 30.6%, number needed to treat [NNT] 3). At 1 year, the ARI was 23.2% and the NNT was 4. Rates of death, stroke and bleeding events did not differ significantly. INTERPRETATION: In patients with atrial fibrillation who were eligible for stroke prevention, prescribing an oral anticoagulant in the emergency department was associated with substantially higher long-term use of oral anticoagulants compared with deferring to the longitudinal care provider to initiate this therapy. Physicians working in the emergency department should consider initiating oral anticoagulation in eligible patients who are being discharged to home.

Extending access to a web-based mental health intervention: who wants more, what happens to use over time, and is it helpful? Results of a concealed, randomized controlled extension study.

BACKGROUND: Web-based mental health applications may be beneficial, but adoption is often low leaving optimal implementation and payment models unclear. This study examined which users were interested in extended access to a web-based application beyond an initial 3-month trial period and evaluated if an additional 3 months of access was beneficial. METHODS: This study was a concealed extension of a multi-center, pragmatic randomized controlled trial that assessed the benefit of 3 months of access to the Big White Wall (BWW), an anonymous web-based moderated, multi-component mental health application offering self-directed activities and peer support. Trial participants were 16 years of age or older, recruited from hospital-affiliated mental health programs. Participants who received access to the intervention in the main trial and completed 3-month outcome assessments were offered participation. We compared those who were and were not interested in an extension of the intervention, and re-randomized consenting participants 1:1 to receive extended access or not over the subsequent 3 months. Use of the intervention was monitored in the extension group and outcomes were measured at 3 months after re-randomization in both groups. The primary outcome was mental health recovery as assessed by total score on the Recovery Assessment Scale (RAS-r), as in the main trial. Linear mixed models were used to examine the time by group interaction to assess for differences in responses over the 3-month extension study. RESULTS: Of 233 main trial participants who responded, 119 (51.1%) indicated an interest in receiving extended BWW access. Those who were interested had significantly higher baseline anxiety symptoms compared to those who were not interested. Of the 119, 112 were re-randomized (55 to extended access, 57 to discontinuation). Only 21 of the 55 extended access participants (38.2%) used the intervention during the extension period. Change in RAS-r scores over time was not significantly different between groups (time by group, F(1,77) = 1.02; P = .31). CONCLUSIONS: Only half of eligible participants were interested in extended access to the intervention with decreasing use over time, and no evidence of added benefit. These findings have implications for implementation and payment models for this type of web-based mental health intervention. TRIAL REGISTRATION: Clinicaltrials.gov NCT02896894 . Registered retrospectively on September 12, 2016.

Measurement without management: qualitative evaluation of a voluntary audit & feedback intervention for primary care teams.

BACKGROUND: The use of clinical performance feedback to support quality improvement (QI) activities is based on the sound rationale that measurement is necessary to improve quality of care. However, concerns persist about the reliability of this strategy, known as Audit and Feedback (A&F) to support QI. If successfully implemented, A&F should reflect an iterative, self-regulating QI process. Whether and how real-world A&F initiatives result in this type of feedback loop are scarcely reported. This study aimed to identify barriers or facilitators to implementation in a team-based primary care context. METHODS: Semi-structured interviews were conducted with key informants from team-based primary care practices in Ontario, Canada. At the time of data collection, practices could have received up to three iterations of the voluntary A&F initiative. Interviews explored whether, how, and why practices used the feedback to guide their QI activities. The Consolidated Framework for Implementation Research was used to code transcripts and the resulting frameworks were analyzed inductively to generate key themes. RESULTS: Twenty-five individuals representing 18 primary care teams participated in the study. Analysis of how the A&F intervention was used revealed that implementation reflected an incomplete feedback loop. Participation was facilitated by the reliance on an external resource to facilitate the practice audit. The frequency of feedback, concerns with data validity, the design of the feedback report, the resource requirements to participate, and the team relationship were all identified as barriers to implementation of A&F. CONCLUSIONS: The implementation of a real-world, voluntary A&F initiative did not lead to desired QI activities despite substantial investments in performance measurement. In small primary care teams, it may take long periods of time to develop capacity for QI and future evaluations may reveal shifts in the implementation state of the initiative. Findings from the present study demonstrate that the potential mechanism of action of A&F may be deceptively clear; in practice, moving from measurement to action can be complex.

Imaging use for low back pain by Ontario primary care clinicians: protocol for a mixed methods study - the Back ON study.

BACKGROUND: At any one time, one in every five Canadians has low back pain (LBP), and LBP is one of the most common health problems in primary care. Guidelines recommend that imaging not be routinely performed in patients presenting with LBP without signs or symptoms indicating a potential pathological cause. Yet imaging rates remain high for many patients who present without such indications. Inappropriate imaging can lead to inappropriate treatments, results in worse health outcomes and causes harm from unnecessary radiation. There is a need to understand the extent of, and factors contributing to, inappropriate imaging for LBP, and to develop effective strategies that target modifiable barriers and facilitators. The primary study objectives are to determine: 1) The rate of, and factors associated with, inappropriate lumbar spine imaging (x-ray, CT scan and MRI) for people with non-specific LBP presenting to primary care clinicians in Ontario; 2) The barriers and facilitators to reduce inappropriate imaging for LBP in primary care settings. METHODS: The project will comprise an inception cohort study and a concurrent qualitative study. For the cohort study, we will recruit 175 primary care clinicians (50 each from physiotherapy and chiropractic; 75 from family medicine), and 3750 patients with a new episode of LBP who present to these clinicians. Clinicians will collect data in the clinic, and each participant will be tracked for 12 months using Ontario health administrative and self-reported data to measure diagnostic imaging use and other health outcomes. We will assess characteristics of the clinicians, patients and encounters to identify variables associated with inappropriate imaging. In the qualitative study we will conduct in-depth interviews with primary care clinicians and patients. DISCUSSION: This will be the first Canadian study to accurately document the extent of the overuse of imaging for LBP, and the first worldwide to include data from the main healthcare professions offering primary care for people with LBP. This study will provide robust information about rates of inappropriate imaging for LBP, along with factors associated with, and an understanding of, potential reasons for inappropriate imaging.

A Web-Based Mental Health Platform for Individuals Seeking Specialized Mental Health Care Services: Multicenter Pragmatic Randomized Controlled Trial.

BACKGROUND: Web-based self-directed mental health applications are rapidly emerging to address health service gaps and unmet needs for information and support. OBJECTIVE: The aim of this study was to determine if a multicomponent, moderated Web-based mental health application could benefit individuals with mental health symptoms severe enough to warrant specialized mental health care. METHODS: A multicenter, pragmatic randomized controlled trial was conducted across several outpatient mental health programs affiliated with 3 hospital programs in Ontario, Canada. Individuals referred to or receiving treatment, aged 16 years or older, with access to the internet and an email address, and having the ability to navigate a Web-based mental health application were eligible. A total of 812 participants were randomized 2:1 to receive immediate (immediate treatment group, ITG) or delayed (delayed treatment group, DTG) access for 3 months to the Big White Wall (BWW), a multicomponent Web-based mental health intervention based in the United Kingdom and New Zealand. The primary outcome was the total score on the Recovery Assessment Scale, revised (RAS-r) which measures mental health recovery. Secondary outcomes were total scores on the Patient Health Questionnaire-9 item (PHQ-9), the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7), the EuroQOL 5-dimension quality of life questionnaire (EQ-5D-5L), and the Community Integration Questionnaire. An exploratory analysis examined the association between actual BWW use (categorized into quartiles) and outcomes among study completers. RESULTS: Intervention participants achieved small, statistically significant increases in adjusted RAS-r score (4.97 points, 95% CI 2.90 to 7.05), and decreases in PHQ-9 score (-1.83 points, 95% CI -2.85 to -0.82) and GAD-7 score (-1.55 points, 95% CI -2.42 to -0.70). Follow-up was achieved for 55% (446/812) at 3 months, 48% (260/542) of ITG participants and 69% (186/270) of DTG participants. Only 58% (312/542) of ITG participants logged on more than once. Some higher BWW user groups had significantly greater improvements in PHQ-9 and GAD-7 relative to the lowest use group. CONCLUSIONS: The Web-based application may be beneficial; however, many participants did not engage in an ongoing way. This has implications for patient selection and engagement as well as delivery and funding structures for similar Web-based interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02896894; https://clinicaltrials.gov/ct2/show/NCT02896894 (Archived by WebCite at http://www.webcitation.org/78LIpnuRO).

Out of sync: a Shared Mental Models perspective on policy implementation in healthcare.

The impact of policy ambiguity on implementation is a perennial concern in policy circles. The degree of ambiguity of policy goals and the means to achieve them influences the likelihood that a policy will be uniformly understood and implemented across implementation sites. We argue that the application of institutional and organisational theories to policy implementation must be supplemented by a socio-cognitive lens in which stakeholders' interpretations of policy are investigated and compared. We borrow the concept of 'Shared Mental Models' from the literature on industrial psychology to examine the microprocesses of policy implementation. Drawing from interviews with 45 key informants involved in the implementation of a hospital funding reform, known as Quality-Based Procedures in Ontario, Canada, we identify divergent mental models and explain how these divergences may have affected implementation and change management. We close with considerations for future research and practice.