When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

BACKGROUND: Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. METHODS: An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. RESULTS: A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. CONCLUSION: The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity.

Deprescribing proton pump inhibitors: evidence-based clinical practice guideline

OBJECTIVE: To develop an evidence-based guideline to help clinicians make decisions about when and how to safely taper or stop proton pump inhibitors (PPIs); to focus on the highest level of evidence available and seek input from primary care professionals in the guideline development, review, and endorsement processes. METHODS: Five health professionals (1 family physician, 3 pharmacists, and 1 gastroenterologist) and 5 nonvoting members comprised the overall team; members disclosed conflicts of interest. The guideline process included the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach, with a detailed evidence review in in-person, telephone, and online meetings. Uniquely, the guideline development process included a systematic review of PPI deprescribing trials and examination of reviews of the harm of continued PPI use. Narrative syntheses of patient preferences and resource-implication literature informed recommendations. The team refined guideline content and recommendation wording through consensus and synthesized clinical considerations to address common front-line clinician questions. The draft guideline was distributed to clinicians and then to health care professional associations for review and revisions made at each stage. A decision-support algorithm was developed in conjunction with the guideline. RECOMMENDATIONS: This guideline recommends deprescribing PPIs (reducing dose, stopping, or using "on-demand" dosing) in adults who have completed a minimum of 4 weeks of PPI treatment for heartburn or mild to moderate gastroesophageal reflux disease or esophagitis, and whose symptoms are resolved. The recommendations do not apply to those who have or have had Barrett esophagus, severe esophagitis grade C or D, or documented history of bleeding gastrointestinal ulcers. CONCLUSION: This guideline provides practical recommendations for making decisions about when and how to reduce the dose of or stop PPIs. Recommendations are meant to assist with, not dictate, decision making in conjunction with patients.

Protocol for the development of a CONSORT-equity guideline to improve reporting of health equity in randomized trials.

BACKGROUND: Health equity concerns the absence of avoidable and unfair differences in health. Randomized controlled trials (RCTs) can provide evidence about the impact of an intervention on health equity for specific disadvantaged populations or in general populations; this is important for equity-focused decision-making. Previous work has identified a lack of adequate reporting guidelines for assessing health equity in RCTs. The objective of this study is to develop guidelines to improve the reporting of health equity considerations in RCTs, as an extension of the Consolidated Standards of Reporting Trials (CONSORT). METHODS/DESIGN: A six-phase study using integrated knowledge translation governed by a study executive and advisory board will assemble empirical evidence to inform the CONSORT-equity extension. To create the guideline, the following steps are proposed: (1) develop a conceptual framework for identifying "equity-relevant trials," (2) assess empirical evidence regarding reporting of equity-relevant trials, (3) consult with global methods and content experts on how to improve reporting of health equity in RCTs, (4) collect broad feedback and prioritize items needed to improve reporting of health equity in RCTs, (5) establish consensus on the CONSORT-equity extension: the guideline for equity-relevant trials, and (6) broadly disseminate and implement the CONSORT-equity extension. DISCUSSION: This work will be relevant to a broad range of RCTs addressing questions of effectiveness for strategies to improve practice and policy in the areas of social determinants of health, clinical care, health systems, public health, and international development, where health and/or access to health care is a primary outcome. The outcomes include a reporting guideline (CONSORT-equity extension) for equity-relevant RCTs and a knowledge translation strategy to broadly encourage its uptake and use by journal editors, authors, and funding agencies.

Realist review to understand the efficacy of culturally appropriate diabetes education programmes.

AIMS: Minority populations often face linguistic, cultural and financial barriers to diabetes education and care. The aim was to understand why culturally appropriate diabetes education interventions work, when they work best and for whom they are most effective. METHODS: This review used a critical realist approach to examine culturally appropriate diabetes interventions. Beginning with the behavioural model and access to medical care, it reanalysed 11 randomized controlled trials from a Cochrane systematic review and related programme and training documents on culturally appropriate diabetes interventions. The analysis examined context and mechanism to understand their relationship to participant retention and statistically improved outcomes. RESULTS: Minority patients with language barriers and limited access to diabetes programmes responded to interventions using health workers from the same ethnic group and interventions promoting culturally acceptable and financially affordable food choices using local ingredients. Programme incentives improved retention in the programmes and this was associated with improved HbA(1c) levels at least in the short term. Adopting a positive learning environment, a flexible and less intensive approach, one-to-one teaching in informal settings compared with a group approach in clinics led to improved retention rates. CONCLUSIONS: Minority and uninsured migrants with unmet health needs showed the highest participation and HbA(1c) responses from culturally appropriate programmes.

Shifts in expectations: evaluating physicians' perceptions as pharmacists become integrated into family practice.

The objective of this study was to measure how primary care family physicians perceived their own and pharmacists' contributions to medication processes as pharmacists become integrated into primary care group family practices. The 22- item Family Medicine Medication Use Processes Matrix was mailed to physicians in seven sites at the 3rd, 12th and 19th month of pharmacist integration. Paired sample t-tests for the third month results were conducted to compare perceptions between pharmacist and physician contributions. One way repeated measure ANOVA test was conducted to determine significant changes over time. Physicians initially perceived their own contributions to be significantly higher than pharmacists in three subscales: Diagnosis & Prescribing, Monitoring and Administration/Documentation and their own contributions to be significantly lower than the pharmacists in the Education subscale. Over time, physicians perceived increases in the pharmacists' contribution to the Diagnosis & Prescribing, Monitoring and Medication Review subscales and decreases in their own contribution to the Diagnosis & Prescribing and Education subscales. Changes in family physicians' perceptions of pharmacists' contribution demonstrate an initial underestimate of pharmacists' role in primary care family practice and a gradual recognition of expertise and competence. This may have led to increased comfort in sharing aspects of contribution to medication use processes.

Integrating family medicine and pharmacy to advance primary care therapeutics.

The prevalence of suboptimal prescribing of medications is well documented. Patients are often undertreated or not offered therapeutic treatments that are likely to confer benefit. As a result, drug-related hospital admissions are common and often preventable. Improvements to the health-care system are clearly needed in order to maximize the benefits that can be derived from medications. Many countries are changing their primary health-care systems to improve the quality of health-care delivery. One main transformation is the use of multidisciplinary care teams to provide care in a coordinated manner often from the same location or by using the common medical record of the patients. It has been demonstrated that pharmacists can improve prescribing, reduce health-care utilization and medication costs, and contribute to clinical improvements in many chronic medical conditions, such as cardiovascular disease, diabetes, and psychiatric illness. However, the effect of integrating a pharmacist providing general services into a primary care group has not been extensively studied. The Integrating Family Medicine and Pharmacy to Advance Primary Care Therapeutics (IMPACT) project was designed to provide a real-world demonstration of the feasibility of integrating the pharmacist into primary care office practice. This article provides a description of the IMPACT project participants; the IMPACT practice model and the concepts incorporated in its development; some initial results from the program evaluation; sustainability of the model; and some reflections on the implementation of the practice model.