Implement Sci
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The need for high-quality evidence that is applicable in real-world, routine settings continues to increase. Pragmatic trials are designed to evaluate the effectiveness of interventions in real-world settings, whereas explanatory trials aim to test whether an intervention works under optimal situations. There is a continuum between explanatory and pragmatic trials. Most trials have aspects of both, making it challenging to label and categorize a trial and to evaluate its potential for translation into practice. ⋯ Combining both frameworks can specifically help identify where and how a study is and is not pragmatic. Using both PRECIS and RE-AIM allows for standard reporting of key study characteristics related to pragmatism and translation. Such measures should be used more consistently to help plan more pragmatic studies, evaluate progress, increase transparency of reporting, and integrate literature to facilitate translation of research into practice and policy.
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Randomized Controlled Trial
Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care--the Management of OsteoArthritis In Consultations (MOSAICS) study protocol.
There is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving 'quality markers' of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain. ⋯ The main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance.
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Randomized Controlled Trial
Theory of planned behaviour can help understand processes underlying the use of two emergency medicine diagnostic imaging rules.
Clinical decision rules (CDRs) can be an effective tool for knowledge translation in emergency medicine, but their implementation is often a challenge. This study examined whether the Theory of Planned Behaviour (TPB) could help explain the inconsistent results between the successful Canadian C-Spine Rule (CCR) implementation study and unsuccessful Canadian CT Head Rule (CCHR) implementation study. Both rules are aimed at improving the accuracy and efficiency of emergency department radiography use in clinical contexts that exhibit enormous inefficiency at the present time. The rules were prospectively derived and validated using the same methodology demonstrating high sensitivity and reliability. The rules subsequently underwent parallel implementations at 12 Canadian hospitals, yet only the CCR was observed to significantly reduce radiography ordering rates, while the CCHR failed to have any significant impact at all. The drastically different results are unlikely to be the result of differences in implementation strategies or the decision rules. ⋯ The TPB can be used to better understand processes underlying use of CDRs. TPB constructs were significantly associated with intention to perform both imaging behaviours, but intention was only associated with actual behaviour for CCR, suggesting that constructs outside of the TPB framework may need to be considered when seeking to understand use of CDRs.
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Randomized Controlled Trial
Improving community case management of diarrhoea and pneumonia in district Badin, Pakistan through a cluster randomised study--the NIGRAAN trial protocol.
Diarrhoea and pneumonia contribute 30% of deaths in children under 5 in Pakistan. Pakistan's Lady Health Workers Programme (LHW-P) covers about 60% of the population but has had little impact in reducing morbidity and mortality related to these major childhood killers. An external evaluation of the LHW-P suggests that lack of supportive supervision of LHWs by lady health supervisors (LHSs) is a key determinant of this problem. Project NIGRAAN aims to improve knowledge and skills of LHWs and community caregivers through supervisory strategies employed by LHSs. Ultimately, community case management (CCM) of childhood pneumonia and diarrhoea will improve. ⋯ NIGRAAN takes a novel approach to implementation research and explores whether training of LHSs in supervisory skills results in improving the CCM practices of childhood diarrhoea and pneumonia. No significant harm to participants is anticipated. The enablers and barriers towards improved CCM would provide recommendations to policymakers for scale up of this intervention nationally and regionally.
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Randomized Controlled Trial
Can primary care team-based transition to insulin improve outcomes in adults with type 2 diabetes: the stepping up to insulin cluster randomized controlled trial protocol.
Type 2 diabetes (T2D) brings significant human and healthcare costs. Its progressive nature means achieving normoglycaemia is increasingly difficult, yet critical to avoiding long term vascular complications. Nearly one-half of people with T2D have glycaemic levels out of target. Insulin is effective in achieving glycaemic targets, yet initiation of insulin is often delayed, particularly in primary care. Given limited access to specialist resources and the size of the diabetes epidemic, primary care is where insulin initiation must become part of routine practice. This would also support integrated holistic care for people with diabetes. Our Stepping Up Program is based on a general practitioner (GP) and practice nurse (PN) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses. Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care. ⋯ The study is a pragmatic translational study with important potential implications for people with T2D, healthcare professionals and funders of healthcare though making better use of scarce healthcare resources, improving timely access to therapy that can improve disease outcomes.