495 research outputs found

    ORGANIZATIONAL MODEL OF NC MACHINE INSTALLATION

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    The batched stepped wedge design: A design robust to delays in cluster recruitment

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    Stepped wedge designs are an increasingly popular variant of longitudinal cluster randomized trial designs, and roll out interventions across clusters in a randomized, but step‐wise fashion. In the standard stepped wedge design, assumptions regarding the effect of time on outcomes may require that all clusters start and end trial participation at the same time. This would require ethics approvals and data collection procedures to be in place in all clusters before a stepped wedge trial can start in any cluster. Hence, although stepped wedge designs are useful for testing the impacts of many cluster‐based interventions on outcomes, there can be lengthy delays before a trial can commence. In this article, we introduce “batched” stepped wedge designs. Batched stepped wedge designs allow clusters to commence the study in batches, instead of all at once, allowing for staggered cluster recruitment. Like the stepped wedge, the batched stepped wedge rolls out the intervention to all clusters in a randomized and step‐wise fashion: a series of self‐contained stepped wedge designs. Provided that separate period effects are included for each batch, software for standard stepped wedge sample size calculations can be used. With this time parameterization, in many situations including when linear models are assumed, sample size calculations reduce to the setting of a single stepped wedge design with multiple clusters per sequence. In these situations, sample size calculations will not depend on the delays between the commencement of batches. Hence, the power of batched stepped wedge designs is robust to unexpected delays between batches

    Effect of a short message service (SMS) intervention on adherence to a physiotherapist-prescribed home exercise program for people with knee osteoarthritis and obesity: protocol for the ADHERE randomised controlled trial

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    Background Knee osteoarthritis (OA) is a highly prevalent condition. People with knee OA often have other co-morbidities such as obesity. Exercise is advocated in all clinical guidelines for the management of knee OA. It is often undertaken as a home-based program, initially prescribed by a physiotherapist or other qualified health care provider. However, adherence to home-based exercise is often poor, limiting its ability to meaningfully change clinical symptoms of pain and/or physical function. While the efficacy of short message services (SMS) to promote adherence to a range of health behaviours has been demonstrated, its ability to promote home exercise adherence in people with knee OA has not been specifically evaluated. Hence, this trial is investigating whether the addition of an SMS intervention to support adherence to prescribed home-based exercise is more effective than no SMS on self-reported measures of exercise adherence. Methods We are conducting a two-arm parallel-design, assessor-and participant-blinded randomised controlled trial (ADHERE) in people with knee OA and obesity. The trial is enrolling participants exiting from another randomised controlled trial, the TARGET trial, where participants are prescribed a 12-week home-based exercise program (either weight bearing functional exercise or non-weight bearing quadriceps strengthening exercise) for their knee by a physiotherapist and seen five times over the 12 weeks for monitoring and supervision. Following completion of outcome measures for the TARGET trial, participants are immediately enrolled into the ADHERE trial. Participants are asked to continue their prescribed home exercise program unsupervised three times a week for 24-weeks and are randomly allocated to receive a behaviour change theory-informed SMS intervention to support home exercise adherence or to have no SMS intervention. Outcomes are measured at baseline and 24-weeks. Primary outcomes are self-reported adherence measures. Secondary outcomes include self-reported measures of knee pain, physical function, quality-of-life, physical activity, self-efficacy, kinesiophobia, pain catastrophising, participant-perceived global change and an additional adherence measure. Discussion Findings will provide new information into the potential of SMS to improve longer-term exercise adherence and ultimately enhance exercise outcomes in knee OA
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