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AnteayerInterdisciplinares

Mixed-methods study protocol to develop and pilot a Competency Assessment Tool to support therapists in the care of patients with blunt CHest trauma (CATCh study)

Por: Battle · C. · Barnett · J. · Driscoll · T. · Hutchings · H. A. · ONeill · C. · Toghill · H. · Whelan · R. · Baker · E.
Introduction

Competency assessment tools are well-recognised as a method to achieve a standardised level of practice for a group of healthcare professionals with similar characteristics. The aim of this study is to develop and pilot a new competency assessment tool to support therapists caring for patients with blunt chest trauma from prehospital care through to long-term follow-up following hospital discharge.

Methods and analysis

A mixed-methods study will be undertaken, with three distinct phases: (1) an integrative narrative review to examine the literature regarding therapist competencies; (2) focus groups with patients, therapists and key stakeholders to explore opinions regarding important aspects of care (phases I and II will inform the content of the tool), followed by final tool development by an international expert panel; and (3) a multicentre pilot study using questionnaires and elicitation interviews, in which final tool acceptability to therapists will be tested. The total sample size will be between 40 and 50 participants for the focus groups. For the final tool development work, a panel of 10 international experts will be identified, with a subgroup of 3–5 experts who will be recruited to confirm content validity. We will pilot the tool at five health boards in Wales, aiming for 10 therapists from each. Elicitation interviews will be undertaken with a smaller sample size of between 15 and 20 therapists. A mixed qualitative and quantitative data analysis approach will be used.

Ethics and dissemination

Proportionate ethics approval has been granted (South Yorkshire Research Ethics Committee, reference number: 24/YH/0231). We will publish the work in an open-access peer-reviewed journal to ensure equitable access and present at relevant conferences. Webinars will be used to achieve a wide audience. The results will be shared with the research participants via an infographic which will be designed and developed with the public research partners.

Trial registration number

Integrative review is registered at the Open Science Framework: https://doi.org/10.17605/OSF.IO/CEXNR

Feasibility randomised controlled trial to assess the delivery of a novel isometric exercise intervention for people diagnosed with uncomplicated stage 1 hypertension in the National Health Service: key quantitative findings

Por: Wiles · J. D. · Santer · E. · Rees-Roberts · M. · Borthwick · R. · Doulton · T. · Swift · P. A. · Pellatt-Higgins · T. · Saxby · K. · Mills · A. · Gousia · K. · MacInnes · D. · ODriscoll · J. · West · A. · Darby · J. · Short · V. · Farmer · C. K.
Objectives

The aim of this study was to determine the feasibility of delivering personalised isometric exercise (IE) for people with stage 1 hypertension. Is it feasible to deliver an isometric wall squat intervention in the National Health Service and what sample size is required to conduct an appropriately powered effectiveness randomised controlled trial (RCT)?

Design

Randomised controlled open-label multicentre feasibility study of IE compared with standard care in unmedicated people with stage 1 hypertension.

Setting

Initially, the study aimed to recruit through primary care, but this process coincided with the advent of the COVID-19 pandemic. Therefore, we shifted focus to direct-to-public advertising and delivery in secondary care.

Participants

People with unmedicated stage 1 hypertension aged over 18 able to perform IE were included. Patients were excluded if average home systolic blood pressure (sBP)

Intervention participants were randomised (1:1) to either standard lifestyle advice or an individualised isometric wall squat prescription, performed 4x2-min bouts three times a week for 6 months.

Primary and secondary outcome measures

We assessed deliverability, attrition, adherence and variance in blood pressure (BP) change.

Results

IE was found to be easily deliverable to all participants. At 6 months, 34% had withdrawn. Of those who completed IE, 85% of their sessions were at the correct intensity, meeting our retention criterion for success. Variance in BP change was 14.4 mm Hg. The study was not powered to show a difference in BP between groups; however, BP reductions were seen in the intervention group at all study time points compared with baseline. There were no adverse events related to study participation.

Conclusions

We met our a priori recruitment criteria which allowed us to calculate a sample size (n=542) for a full RCT. The results demonstrate good acceptability and adherence rates to the treatment protocol. Our results show a signal towards a consistent sBP reduction in the IE group compared with baseline.

Trial registration number

NCT04936022 (https://classic.clinicaltrials.gov/ct2/show/NCT04936022?cond=isometric+exercise&draw=2&rank=7); registry identifier: ISRCTN 13472393.

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