Feasibility of an Updated Randomised Controlled Trial on Surgical Urolithiasis Treatments: The Pilot Trial for the German Endoscopic versus Shock Wave Therapy Study (GESS)

2021 ◽  
Author(s):  
Martin Schoenthaler ◽  
Simon Hein ◽  
Konrad Wilhelm ◽  
Philippe-Fabian Pohlmann ◽  
Friederike Praus ◽  
...  
Keyword(s):  
Shock Wave ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Shock Wave Therapy ◽  
Randomised Controlled

scholarly journals Progression from external pilot to definitive randomised controlled trial: a methodological review of progression criteria reporting

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048178
Author(s):  
Katie Mellor ◽  
Saskia Eddy ◽  
Nicholas Peckham ◽  
Christine M Bond ◽  
Michael J Campbell ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
A Priori ◽  
Pilot Trial ◽  
Public Library ◽  
Feasibility Studies ◽  
Methodological Review ◽  
Pilot Trials ◽  
Trial Protocols ◽  
Randomised Controlled

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.

scholarly journals Randomised controlled trial to investigate the effectiveness of local oestrogen treatment in postmenopausal women undergoing pelvic organ prolapse surgery (LOTUS): a pilot study to assess feasibility of a large multicentre trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e025141
Author(s):  
Tina Sara Verghese ◽  
Lee Middleton ◽  
Versha Cheed ◽  
Lisa Leighton ◽  
Jane Daniels ◽  
...  
Keyword(s):  
Pelvic Organ Prolapse ◽  
Randomised Controlled Trial ◽  
Postmenopausal Women ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Pelvic Organ ◽  
Oestrogen Treatment ◽  
Pop Surgery ◽  
Randomised Controlled ◽  
Oestrogen Supplementation

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.

scholarly journals The effect of alcohol strength on alcohol consumption: findings from a randomised controlled cross-over pilot trial.

2021 ◽  
Author(s):  
Parvati Rose Perman-Howe ◽  
Emma L Davies ◽  
David R Foxcroft
Keyword(s):  
Randomised Controlled Trial ◽  
Alcohol Consumption ◽  
Sample Size ◽  
Study Protocol ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Recruitment Rate ◽  
Participant Recruitment ◽  
Licensed Premises ◽  
Randomised Controlled

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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