scholarly journals Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study)

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Chris Littlewood ◽  
Marcus Bateman ◽  
Kendra Cooke ◽  
Susie Hennnings ◽  
Tina Cookson ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Rotator Cuff ◽  
Qualitative Study ◽  
Rotator Cuff Repair ◽  
Controlled Trial ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled ◽  
Cuff Repair

scholarly journals Rehabilitation following rotator cuff repair: A multi-centre pilot & feasibility randomised controlled trial (RaCeR)

2020 ◽  
pp. 026921552097885
Author(s):  
Chris Littlewood ◽  
Marcus Bateman ◽  
Stephanie Butler-Walley ◽  
Sarah Bathers ◽  
Kieran Bromley ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Rotator Cuff ◽  
Rotator Cuff Repair ◽  
Controlled Trial ◽  
Rotator Cuff Tears ◽  
Serious Adverse Events ◽  
Feasibility Randomised Controlled Trial ◽  
Time Out ◽  
Randomised Controlled ◽  
Cuff Repair

Objective: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. Design: Two-arm, multi-centre pilot and feasibility randomised controlled trial. Setting: Five National Health Service hospitals in England. Participants: Adults ( n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. Interventions: Early patient-directed rehabilitation ( n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation ( n = 36); sling immobilisation for four weeks. Measures: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. Results: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. Conclusion: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery.

scholarly journals Rehabilitation following rotator cuff repair: A survey exploring clinical equipoise among surgical members of the British Elbow and Shoulder Society

2021 ◽  
pp. 175857322110598
Author(s):  
Bruno Mazuquin ◽  
Marcus Bateman ◽  
Alba Realpe ◽  
Steve Drew ◽  
Jonathan Rees ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Rotator Cuff Repair ◽  
Online Survey ◽  
Controlled Trial ◽  
Clinical Equipoise ◽  
Early Mobilisation ◽  
Clinical Scenarios ◽  
Randomised Controlled ◽  
Cuff Repair ◽  
Tear Size

Background We investigated clinical equipoise across surgical members of the British Elbow and Shoulder Society (BESS) in relation to rehabilitation following rotator cuff repair. Method An online survey explored clinical equipoise regarding early patient-directed versus standard rehabilitation after rotator cuff repair to inform the design of a national randomised controlled trial (RCT). It described different clinical scenarios relating to patient age, tear size, location and whether other patient-related and intra-operative factors would influence equipoise. Results 76 surgeons completed the survey. 81% agreed/ strongly agreed that early mobilisation might benefit recovery; 57% were neutral/ disagreed that this approach risks re-tear. 87% agreed/ strongly agreed that there is clinical uncertainty about the effectiveness of different approaches to rehabilitation. As age of the patient and tear size increased, the proportion of respondents who would agree to recruit and accept the outcome of randomisation reduced, and this was compounded if subscapularis was torn. Other factors that influenced equipoise were diabetes and non-secure repair. Conclusion Surgical members of BESS recognise uncertainty about the effectiveness of different approaches to rehabilitation following rotator cuff repair. We identified a range of factors that influence clinical equipoise that will be considered in the design of a new RCT.

scholarly journals Rehabilitation following rotator cuff repair: A nested qualitative study exploring the perceptions and experiences of participants in a randomised controlled trial

2020 ◽  
pp. 026921552098402
Author(s):  
Gareth Stephens ◽  
Chris Littlewood ◽  
Nadine E Foster ◽  
Lisa Dikomitis
Keyword(s):  
Randomised Controlled Trial ◽  
Rotator Cuff ◽  
Qualitative Study ◽  
Perceived Risk ◽  
Surgical Repair ◽  
Controlled Trial ◽  
Ultrasound Scan ◽  
Early Mobilisation ◽  
Structured Interviews ◽  
Randomised Controlled

Objective: To investigate acceptability, barriers to adherence with the interventions, and which outcome measures best reflect the participants’ rehabilitation goals in a pilot and feasibility randomised controlled trial evaluating early patient-directed rehabilitation and standard rehabilitation, including sling immobilisation for four weeks, following surgical repair of the rotator cuff of the shoulder. Design: Nested qualitative study. Setting: Five English National Health Service Hospitals. Subjects: Nineteen patient participants who had undergone surgical repair of the rotator cuff and 10 healthcare practitioners involved in the trial. Method: Individual semi-structured interviews. Data were analysed thematically. Results: Four themes: (1) Preconceptions of early mobilisation; many participants were motivated to enter the trial for the opportunity of removing their sling and getting moving early. (2) Sling use and movement restrictions; for some, sling use for four weeks was unacceptable and contributed to their pain, rather than relieving it. (3) Tensions associated with early mobilisation; clinical tensions regarding early mobilisation and the perceived risk to the surgical repair were apparent. (4) Processes of running the trial; participants found the trial processes to be largely appropriate and acceptable, but withholding the results of the post-operative research ultrasound scan was contentious. Conclusion: Trial processes were largely acceptable, except for withholding results of the ultrasound scan. For some participants, use of the shoulder sling for a prolonged period after surgery was a reported barrier to standard rehabilitation whereas the concept of early mobilisation contributed tension for some healthcare practitioners due to concern about the effect on the surgical repair.

scholarly journals TEST (Trial of Eczema allergy Screening Tests): protocol for feasibility randomised controlled trial of allergy tests in children with eczema, including economic scoping and nested qualitative study

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028428 ◽  
Author(s):  
Matthew J Ridd ◽  
Louisa Edwards ◽  
Miriam Santer ◽  
Joanne R Chalmers ◽  
Lisa Waddell ◽  
...  
Keyword(s):  
Food Allergy ◽  
Randomised Controlled Trial ◽  
Qualitative Study ◽  
Controlled Trial ◽  
Screening Tests ◽  
Dietary Management ◽  
Allergy Testing ◽  
Dietary Restrictions ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

BackgroundEarly onset eczema is associated with food allergy, and allergic reactions to foods can cause acute exacerbations of eczema. Parents often pursue dietary restrictions as a way of managing eczema and seek allergy testing for their children to guide dietary management. However, it is unclear whether test-guided dietary management improves eczema symptoms, and whether the practice causes harm through reduced use of conventional eczema treatment or unnecessary dietary restrictions. The aim of the Trial of Eczema allergy Screening Tests Study is to determine the feasibility of conducting a trial comparing food allergy testing and dietary advice versus usual care, for the management of eczema in children.Methods and analysisDesign: A single centre, two-group, individually randomised, feasibility randomised controlled trial (RCT) with economic scoping and a nested qualitative study. Setting: General Practioner (GP) surgeries in the west of England. Participants: children aged over 3 months and less than 5 years with mild to severe eczema. Interventions: allergy testing (structured allergy history and skin prick tests) or usual care. Sample size and outcome measures: we aim to recruit 80 participants and follow them up using 4-weekly questionnaires for 24 weeks. Nested qualitative study: We will conduct ~20 interviews with parents of participating children, 5–8 interviews with parents who decline or withdraw from the trial and ~10 interviews with participating GPs. Economic scoping: We will gather data on key costs and outcomes to assess the feasibility of carrying out a cost-effectiveness analysis in a future definitive trial.Ethics and disseminationThe study has been reviewed by the Health Research Authority and given a favourable opinion by the NHS REC (West Midlands – South Birmingham Research Ethics Committee, Reference Number 18/WM/0124). Findings will be submitted for presentation at conferences and written up for publication in peer-reviewed journals, which may include mixed-method triangulation and integration of the quantitative and qualitative findings.Trial registrationISRCTN15397185; Pre-results.

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