Retrospective use of the PRECIS-2 trial design tool to assess design choices in randomised controlled trials; An empirical review.

Introduction: The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tool has been widely used to help investigators design randomised trials, facilitating the task of aligning design choices with an explanatory or pragmatic primary trial intention. PRECIS-2 is increasingly being used to retrospectively assess the degree of pragmatism or explanatoriness among published trials within reviews. There is little information on the interrater reliability of the tool and no consensus on the preferred method of achieving an accurate and reliable judgement of trial 'pragmatism' when using PRECIS-2 retrospectively.

Spillover From an Intervention on Antibiotic Prescribing for Family Physicians: A Post Hoc Secondary Analysis of a Randomized Clinical Trial.

Importance: Antibiotic audit and feedback is effective at reducing antibiotic prescribing in primary care.

Objective: To evaluate the spillover of an audit-and-feedback intervention originally targeted at patients aged 65 years or older on a broader population of all age groups.

Design, Setting, And Participants: This is a post hoc secondary analysis of a randomized clinical trial that was conducted among primary care physicians in Ontario, Canada.

Bayesian Analysis of Time-To-Event Data in a Cluster-Randomized Trial: Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP) Trial.

Background: MyTEMP was a cluster-randomized trial to assess the effect of using a personalized cooler dialysate compared to standard temperature dialysate for potential cardiovascular benefits in patients receiving maintenance hemodialysis in Ontario, Canada.

Objective: To conduct Bayesian analyses of the MyTEMP trial, which sought to determine whether adopting a center-wide policy of personalized cooler dialysate is superior to a standard dialysate temperature of 36.5°C in reducing the risk of a composite outcome of cardiovascular-related deaths or hospitalizations.

Master protocol for a series of cohort-based randomized controlled trials to test tools to communicate research results to study participants and others with relevant lived experience: the SPIN-CLEAR Trials.

Background: Research results are often not communicated to study participants or others with relevant lived experience. Effective communication of research results would help study participants understand their contribution to research and could improve trust in research and likelihood of research participation. Few randomized controlled trials (RCTs), however, have compared the effectiveness of research communication tools, and it is not known which tools work best for different people.

Novel uses of healthcare technology for individuals with mild to moderate hip or knee osteoarthritis: The technology, exercise and activity prescription for enhanced mobility (TEAM) study randomized controlled trial protocol.

Objectives: Patient education, physical activity, and exercise are recommended as first-line treatments for mild to moderate hip and knee osteoarthritis (OA). We developed two novel healthcare interventions: an electronic medical record-embedded physical activity prescription tool (PARx) for physicians, and a free, online educational platform (Joint Management (JM)) with exercise programming and optional telerehabilitation with a physiotherapist for patients. Objectives: 1) Determine the effectiveness of PARx ​± ​JM on patient-reported outcomes, physical activity levels, and performance-based functional outcomes in individuals with mild to moderate hip or knee OA, versus usual care; 2) evaluate engagement and adherence to PARx ​+ ​JM; and 3) explore the feasibility of PARx and PARx ​+ ​JM.

Definitions of validity terms for use in discussions of randomized controlled trials.

Objectives: We review existing definitions and usages of validity terms and propose a single definition for each term for use in communicating inferences from randomized controlled trials (RCTs).

Methods: Two trialists and a statistician reviewed definitions in various dictionaries and literature to identify confusions and propose a unified definition for each term.

Results: We propose the following disambiguated and mutually coherent set of definitions for validity terms: Target population: A well-defined population for whom inferences from an RCT are asserted as valid by the investigators or by other users.

Cultivating Innovative, Pragmatic, Randomized Controlled Registry Trials Embedded in Hemodialysis Care: Conference Proceeding From Gardener's Grove 2023.

Purpose Of The Conference: Hemodialysis is a life-sustaining treatment for patients with end-stage kidney disease. However, patients on dialysis continue to face poor quality of life and short life expectancies. Despite this, the nephrology community conducts the fewest randomized controlled trials of any medical discipline, relying instead on expert opinion to guide many aspects of hemodialysis care.

Guidance for protocol content and reporting of factorial randomised trials: explanation and elaboration of the CONSORT 2010 and SPIRIT 2013 extensions.

This report presents the explanation and elaboration paper for the CONSORT (Consolidated Standards of Reporting Trials) 2010 and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 extensions for factorial trials. Factorial trials involve randomising participants to more than one intervention, often with the aim of evaluating multiple interventions in one study or assessing whether treatments interact. The CONSORT and SPIRIT statements have been extended to allow for the unique features of the factorial design.

Cross-cultural adaptation and evidence of validity of the interprofessional collaboration scale (IPC-BR) for Brazil.

We aimed to perform cross-cultural adaptation of the Interprofessional Collaboration Scale (IPC-BR) and to evaluate evidence of its validity for the Brazilian hospital context. The research consisted of six steps: translation of the instrument into the new language, synthesis of the translated versions, back-translation, synthesis of the versions in the original language, evaluation of the syntheses by an expert committee, and pilot testing or pretesting and validation of the internal structure of the items of the instrument. The pilot testing involved 4 translators, 14 judges, and 30 healthcare professionals; the validation of the internal structure involved 686 professionals including nurses, physicians and physiotherapists.

Randomized Trials Using Provincial Health Numbers for Group Assignment.

Purpose: Using data from Ontario, Canada, this report shows how provincial government-assigned health card numbers can be used for individual-level randomization in large pragmatic trials. We describe how health card numbers are assigned and analyze the distribution of health card digits in a trial setting. We then provide an example of how they can be used for randomization and discuss the methodological and practical considerations of the approach.

The hockey fans in training intervention for men with overweight or obesity: a pragmatic cluster randomised trial.

Background: Obesity disproportionately impacts men's health yet fewer men engage in preventive healthcare. We examined the effectiveness of Hockey Fans in Training (Hockey FIT), a gender-sensitised lifestyle intervention that engages men with overweight/obesity through their passion as fans of a local sports team, on weight change and other health indicators.

Methods: Pragmatic, cluster randomised trial (aged 35-65 years, body mass index ≥ 27 kg/m) within 42 community-based sites in Canada and the United States, randomly assigned (1:1) to intervention (Hockey FIT) or control (wait-list) and stratified by region.

Comments, suggestions, and criticisms of the Pragmatic Explanatory Continuum Indicator Summary-2 design tool: a citation analysis.

Introduction: The pragmatic explanatory continuum indicator summary (PRECIS) tool, initially published in 2009 and revised in 2015, was created to assist trialists to align their design choices with the intended purpose of their randomised controlled trial (RCT): either to guide real-world decisions between alternative interventions (pragmatic) or to test hypotheses about intervention mechanisms by minimising sources of variation (explanatory). There have been many comments, suggestions, and criticisms of PRECIS-2. This summary will be used to facilitate the development of to the next revision, which is PRECIS-3.

Randomised pilot study comparing a coach to SMARTPhone reminders to aid the management of heart failure (HF) patients: humans or machines.

Ambulatory management of congestive heart failure (HF) continues to be a challenging clinical problem. Recent studies have focused on the role of HF clinics, nurse practitioners and disease management programmes to reduce HF readmissions. This pilot study is a pragmatic factorial study comparing a coach intervention, a SMARTPHONE REMINDER system intervention and BOTH interventions combined to Treatment as USUAL (TAU).

Randomised trials conducted using cohorts: a scoping review.

Introduction: Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.

Objective: To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.

Consensus Statement for Protocols of Factorial Randomized Trials: Extension of the SPIRIT 2013 Statement.

Importance: Trial protocols outline a trial's objectives as well as the methods (design, conduct, and analysis) that will be used to meet those objectives, and transparent reporting of trial protocols ensures objectives are clear and facilitates appraisal regarding the suitability of study methods. Factorial trials, in which 2 or more interventions are assessed in the same set of participants, have unique methodological considerations. However, no extension of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement, which provides guidance on reporting of trial protocols, for factorial trials is available.

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.

Describing a complex primary health care population to support future decision support initiatives.

Introduction: Developing decision support tools using data from a health care organization, to support care within that organization, is a promising paradigm to improve care delivery and population health. Descriptive epidemiology may be a valuable supplement to stakeholder input towards selection of potential initiatives and to inform methodological decisions throughout tool development. We additionally propose that to properly characterize complex populations in large-scale descriptive studies, both simple statistical and machine learning techniques can be useful.

Perceptions of Artificial Intelligence Use in Primary Care: A Qualitative Study with Providers and Staff of Ontario Community Health Centres.

Purpose: To understand staff and health care providers' views on potential use of artificial intelligence (AI)-driven tools to help care for patients within a primary care setting.

Methods: We conducted a qualitative descriptive study using individual semistructured interviews. As part of province-wide Learning Health Organization, Community Health Centres (CHCs) are a community-governed, team-based delivery model providing primary care for people who experience marginalization in Ontario, Canada.

The Alliance for Healthier Communities' journey to a learning health system in primary care.

Introduction: The Alliance for Healthier Communities represents community-governed healthcare organizations in Ontario, Canada including Community Health Centres, which provide primary care to more disadvantaged populations.

Methods: In this experience report, we describe the Alliance's journey towards becoming a learning health system using examples for organizational culture, data and analytics, people and partnerships, client engagement, ethics and oversight, evaluation and dissemination, resources, identification and prioritization, and deliverables and impact.

Results: Many of the foundational elements for a learning health system were already in place at the Alliance including an integrated and accessible data platform.

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.

How pragmatic are randomized trials of remdesivir and favipiravir for in-hospital treatment of COVID-19: a descriptive methodological review of trial design using the PRECIS-2 framework.

Objectives: To review the pragmatism of published randomized trials of remdesivir and favipiravir based on the Pragmatic-Explanatory Continuum Indicator Summary (PRECIS-2) framework.

Study Design And Setting: Ten eligible trials were identified from an existing comprehensive living review and were evaluated across the nine PRECIS-2 domains by two independent reviewers.

Results: All 10 trials had mostly pragmatic design characteristics.