scholarly journals Comparing an optimised physiotherapy treatment package with usual physiotherapy care for people with Tennis Elbow – protocol for the OPTimisE pilot and feasibility randomised controlled trial.

Author(s):  
Marcus Bateman ◽  
Benjamin Saunders ◽  
Chris Littlewood ◽  
Daniel Davis ◽  
Jacqueline Beckhelling ◽  
...  

Abstract BackgroundPhysiotherapy is recommended for people with Tennis Elbow, but whilst a wide array of treatments is available, the optimal approach remains uncertain. We have therefore recently developed an optimised physiotherapy treatment package for Tennis Elbow based on a synthesis of the evidence, patient input, and clinical consensus. It consists of detailed advice and education, a structured progressive exercise programme and provision of a counter-force elbow brace. Here we report the protocol for our multi-centre pilot and feasibility randomised controlled trial (RCT) designed to a) examine the feasibility of our optimised physiotherapy treatment package, and b) to pilot trial processes for a future fully-powered RCT to test clinical and cost-effectiveness compared with usual physiotherapy treatment.MethodsA multi-centre pilot and feasibility RCT will be conducted across three sites in England, recruiting up to 50 patients (or for a maximum of 12 months). Participants with Tennis Elbow, identified from physiotherapy clinic waiting lists and general practice surgeries, will be randomly allocated to receive the optimised physiotherapy treatment package or usual physiotherapy care. Analysis will focus on feasibility measures including; consent rate, intervention fidelity, follow-up rate, and outcome completion rate. A nested qualitative study will explore the acceptability of the study processes and patient and physiotherapist experiences of the new optimised intervention.DiscussionThis study will determine the feasibility of a new optimised physiotherapy treatment package for people with Tennis Elbow and pilot the processes for a future fully-powered RCT. In the longer term, this treatment package may improve pain and quality of life outcomes for people with Tennis Elbow and help to guide a more clinically and economically efficient treatment pathway design.Trial RegistrationRegistered with the ISRCTN database 19/7/2021. https://www.isrctn.com/ISRCTN64444585

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048178
Author(s):  
Katie Mellor ◽  
Saskia Eddy ◽  
Nicholas Peckham ◽  
Christine M Bond ◽  
Michael J Campbell ◽  
...  

ObjectivesPrespecified progression criteria can inform the decision to progress from an external randomised pilot trial to a definitive randomised controlled trial. We assessed the characteristics of progression criteria reported in external randomised pilot trial protocols and results publications, including whether progression criteria were specified a priori and mentioned in prepublication peer reviewer reports.Study designMethodological review.MethodsWe searched four journals through PubMed: British Medical Journal Open, Pilot and Feasibility Studies, Trials and Public Library of Science One. Eligible publications reported external randomised pilot trial protocols or results, were published between January 2018 and December 2019 and reported progression criteria. We double data extracted 25% of the included publications. Here we report the progression criteria characteristics.ResultsWe included 160 publications (123 protocols and 37 completed trials). Recruitment and retention were the most frequent indicators contributing to progression criteria. Progression criteria were mostly reported as distinct thresholds (eg, achieving a specific target; 133/160, 83%). Less than a third of the planned and completed pilot trials that included qualitative research reported how these findings would contribute towards progression criteria (34/108, 31%). The publications seldom stated who established the progression criteria (12/160, 7.5%) or provided rationale or justification for progression criteria (44/160, 28%). Most completed pilot trials reported the intention to proceed to a definitive trial (30/37, 81%), but less than half strictly met all of their progression criteria (17/37, 46%). Prepublication peer reviewer reports were available for 153/160 publications (96%). Peer reviewer reports for 86/153 (56%) publications mentioned progression criteria, with peer reviewers of 35 publications commenting that progression criteria appeared not to be specified.ConclusionsMany external randomised pilot trial publications did not adequately report or propose prespecified progression criteria to inform whether to proceed to a future definitive randomised controlled trial.


2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Phillip J. Whitehead ◽  
Miriam R. Golding-Day ◽  
Stuart Belshaw ◽  
Tony Dawson ◽  
Marilyn James ◽  
...  

BMJ Open ◽  
2018 ◽  
Vol 8 (12) ◽  
pp. e025630 ◽  
Author(s):  
Catherine M Pound ◽  
Jaime McDonald ◽  
Ken Tang ◽  
Gillian Seidman ◽  
Radha Jetty ◽  
...  

IntroductionAsthma exacerbations are a leading cause of paediatric hospitalisations. Corticosteroids are key in the treatment of asthma exacerbations. Most current corticosteroids treatment regimens for children admitted with asthma exacerbation consist of a 5-day course of prednisone or prednisolone. However, these medications are associated with poor taste and significant vomiting, resulting in poor compliance with the treatment course. While some centres already use a short course of dexamethasone for treating children hospitalised with asthma, there is no evidence to support this practice in the inpatient population.Methods and analysisThis single-site, pragmatic, feasibility randomised controlled trial will determine the feasibility of a non-inferiority trial, comparing two treatment regimens for children admitted to the hospital and receiving asthma treatment. Children 18 months to 17 years presenting to a Canadian tertiary care centre will be randomised to receive either a short course of dexamethasone or a longer course of prednisone/prednisolone once admitted to the inpatient units. The primary clinical outcome for this feasibility study will be readmission to hospital or repeat emergency department visits, or unplanned visits to primary healthcare providers for asthma symptoms within 4 weeks of hospital discharge. Feasibility outcomes will include recruitment and allocation success, compliance with study procedures, retention rate, and safety and tolerability of study medications. We plan on recruiting 51 children, and between-group comparisons of the clinical outcome will be conducted to gain insights on probable effect sizes.Ethics and disseminationResearch Ethics Board approval has been obtained for this study. The results of this study will inform a multisite trial comparing prednisone/prednisolone to dexamethasone in inpatient asthma treatment, which will have the potential to improve the delivery of asthma care, by improving compliance with a mainstay of treatment. Results will be disseminated through peer-reviewed publications, organisations and meetings.Trial registration numberNCT03133897; Pre-results.


BJPsych Open ◽  
2017 ◽  
Vol 3 (1) ◽  
pp. 12-14 ◽  
Author(s):  
Kathryn Lord ◽  
Gill Livingston ◽  
Claudia Cooper

SummaryFamily carers report high levels of decisional conflict when deciding whether their relative with dementia can continue to be cared for in their own home. We tested, in a feasibility randomised controlled trial, the first decision aid (the DECIDE manual) aiming to reduce such conflict. Twenty family carers received the DECIDE intervention, and 21 received usual treatment. The intervention group had reduced decisional conflict compared with controls (mean difference −11.96, 95% confidence interval −20.10 to −3.83, P=0.005). All carers receiving the intervention completed and valued it, despite some still reporting difficulties with family conflict and problems negotiating services.


BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e025141
Author(s):  
Tina Sara Verghese ◽  
Lee Middleton ◽  
Versha Cheed ◽  
Lisa Leighton ◽  
Jane Daniels ◽  
...  

ObjectiveTo evaluate the feasibility of a multicentre randomised controlled trial (RCT) comparing oestrogen treatment with no oestrogen supplementation in women undergoing pelvic organ prolapse (POP) surgery.Design and settingA randomised, parallel, open, external pilot trial involving six UK urogynaecology centres (July 2015–August 2016).ParticipantsPostmenopausal women with POP opting for surgery, unless involving mesh or for recurrent POP in same compartment.InterventionWomen were randomised (1:1) to preoperative and postoperative oestrogen or no treatment. Oestrogen treatment (oestradiol hemihydrate 10 μg vaginal pessaries) commenced 6 weeks prior to surgery (once daily for 2 weeks, twice weekly for 4 weeks) and twice weekly for 26 weeks from 6 weeks postsurgery.Outcome measuresThe main outcomes were assessment of eligibility and recruitment rates along with compliance and data completion. To obtain estimates for important aspects of the protocol to allow development of a definitive trial.Results325 women seeking POP surgery were screened over 13 months and 157 (48%) were eligible. Of these, 100 (64%) were randomised, 50 to oestrogen and 50 to no oestrogen treatment, with 89 (44/45 respectively) ultimately having surgery. Of these, 89% (79/89) returned complete questionnaires at 6 months and 78% (32/41) reported good compliance with oestrogen. No serious adverse events were attributable to oestrogen use.ConclusionsA large multicentre RCT of oestrogen versus no treatment is feasible, as it is possible to randomise and follow up participants with high fidelity. Four predefined feasibility criteria were met. Compliance with treatment regimens is not a barrier. A larger trial is required to definitively address the role of perioperative oestrogen supplementation.Trial registration numberISRCTN46661996.


2021 ◽  
Author(s):  
Parvati Rose Perman-Howe ◽  
Emma L Davies ◽  
David R Foxcroft

Abstract Background Reducing the alcohol content of drinks has the potential to reduce alcohol consumption. Aims: (1) test the feasibility of a randomised controlled trial (RCT) to assess the effect of alcohol strength on alcohol consumption within licensed premises in the United Kingdom (UK), (2) provide data to estimate key parameters for a RCT. Methods Double-blind randomised controlled cross-over pilot trial based within four licensed premises in the UK. Participants (n=36) purchased and consumed ad libitum a 3.5% lager and a 4.8% lager during two separate study sessions. Descriptive statistics reported the efficacy and efficiency of the study processes, and the rates of licensed premises recruitment, and participant recruitment and attrition. Mean and the 95% confidence interval (CI) compared alcohol consumption between conditions. The mean, standard deviation (SD) and CI of UK units of alcohol consumed were used to calculate a sample size for a RCT. Responses to participant questionnaires and duration of participation in study sessions between conditions were analysed.Results Components of the study protocol were effective and efficient. The venue recruitment rate was less than anticipated. The participant recruitment rate was greater than anticipated. The rate of attrition was 23% and varied by less than 1% according to the arm of the trial. There was a reduction of alcohol consumed under the intervention conditions. Estimated mean difference, and 95% CI (UK units): -3.76 (-5.01 to -2.52).The sample size required for a RCT is 53. Participants did not find one lager more pleasant in taste: (on a scale of one to 10) -0.95 (-2.11 to 0.21). Participants found the reduced-strength lager less enjoyable: (on a scale of one to 10) -1.44 (-2.64 to -0.24) and they perceived themselves to be less intoxicated after consuming it: (on a scale of one to 10) -1.00 (-1.61 to -0.40).Conclusion A RCT is feasible with minor alterations to the study protocol and scoping work to establish different brands of alcohol that are more alike and more enjoyable than the products used in the pilot trial. Trial registration Registered in the American Economic Association (AEA) Randomised Controlled Trial (RCT) Registry as of 16 June 2017: https://www.socialscienceregistry.org/trials/2266. Unique identifying number: AEARCTR-0002266.


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