A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures

Davis, T. R. C.; Tan, Wei; Hollingworth, William; Karantana, Alexia; Mills, Nicola; Hepburn, Trish; Sprange, Kirsty; Duley, Lelia; Blazeby, Jane M; Bainbridge, L. C.; Murali, S. R.; Montgomery, Alan

doi:10.1186/s40814-019-0546-y

Cited by 5 publications

(6 citation statements)

References 23 publications

(21 reference statements)

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“…Two previous cost-based analyses have found that open fasciectomy may not be as cost effective in comparison to minimally invasive approaches, 27 , 28 while Davis et al. (2020) 26 find that there is on average a seven-fold increase in cost from £111 in PNF to £777 in open fasciectomy.…”

Section: Discussionmentioning

confidence: 96%

“…In our series, release of each ray was expected to take no longer than 20 min by a single performing surgeon and a surgical assistant. This is in contrast to an open approach, which takes significantly longer, 26 requires an anaesthetist to perform either a general anaesthetic or a regional block as well as substantially greater resources and arguably more intensive post-operative wound care. Two previous cost-based analyses have found that open fasciectomy may not be as cost effective in comparison to minimally invasive approaches, 27 , 28 while Davis et al.…”

Section: Discussionmentioning

confidence: 99%

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Versatility of percutaneous needle fasciotomy for Dupuytren's disease across a spectrum of disease severity: A single-surgeon experience of 118 rays

Patel

2021

JPRAS Open

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Background Percutaneous needle fasciotomy (PNF) represents the only minimally invasive approach for treatment of Dupuytren's disease in Europe since withdrawal of collagenase from European markets. Though well-established, surgeon preference and uncertainty regarding safety and efficacy, results in limited provision in favour of open fasciectomy. Methods A retrospective review of 74 patients who self-opted to receive PNF between 2017 and 2020 was conducted. Demographic data, complications and degree of release achieved were compared across three cohorts based on contracture severity as per Tubiana staging (TS): Stage 1, 0–45°; Stage 2, 46–90°; Stage 3, 91–130° with χ 2 analysis. Results One hundred and eighteen rays were treated amongst 74 patients (mean age, 68 years (R, 32–86), males: 74%) with mean follow-up 51 weeks (IQR 28–76 weeks) with no significant difference in baseline characteristics across cohorts. No cases of permanent sensory disturbance, flexor tendon rupture, arterial transection nor infection were observed. Neuropraxia was seen in six patients, resolving with mean recovery of 6 weeks. 86% ( n = 166) of joints had satisfactory release (residual passive extension deficit (PED) ≤10°) with full release in 67%. Full release was most likely in metacarpophalangeal joint (MCPJ; 93%) than distal interphalangeal joint (DIPJ; 67%) or proximal interphalangeal joint (PIPJ; 45%; p <0.0001). Mean release was 54° in MCPJ and 56° in PIPJ. All TS1 patients achieved release with ≤10° residual PED versus 75% of TS2 patients and 22% of TS3 patients ( p <0.05), the latter of whom had a mean residual PED of 12° Ninety-two percent of patients stated they would undergo PNF again if necessary, in preference to open fasciectomy. Conclusion We find PNF to facilitate a safe, effective yet minimally invasive approach amongst patients of varying disease severity, across different age groups, with recurrent disease, associated comorbidities or concurrent anticoagulation therapy. Patients reported high satisfaction in preference to open procedures. We, therefore, intend to recommend PNF first-line to all patients regardless of disease severity.

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Versatility of percutaneous needle fasciotomy for Dupuytren's disease across a spectrum of disease severity: A single-surgeon experience of 118 rays

Patel

2021

JPRAS Open

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“…There was a steady improvement in recruitment, with some of the more pronounced increases occurring soon after delivery of QRI data feedback and recruiter training. The feasibility study achieved its recruitment target within the required timeframe [ 17 ], demonstrating that recruitment to a main trial of NF and LF with integrated QRI is feasible. The QRI study also demonstrated that it is possible for surgeons to be trained to recruit into an RCT of two surgical procedures with very different patient experiences, despite some initial reservations that patient and recruiter equipoise would hinder participation.…”

Section: Discussionmentioning

confidence: 99%

“…This paper reports on the identification of barriers to recruitment and informed consent through the QRI, and the strategies designed and delivered to overcome them, enabling the study to recruit to target. The main results of HAND-1 feasibility study are reported separately [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI)

Husbands

Elliott

Davis

et al. 2020

Pilot Feasibility Stud

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Background Recruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome recruitment obstacles. This paper reports on an intervention—the QuinteT Recruitment Intervention (QRI)—to optimise recruitment within a randomised feasibility study of surgical treatments for patients with Dupuytren’s contracture (the HAND-1 study). Methods The QRI was introduced in 2-phases: phase 1 sought to understand the recruitment challenges by interviewing trial staff, scrutinising screening logs and analysing audio-recorded patient consultations; in phase 2 a tailored plan of action consisting of recruiter feedback and training was delivered to address the identified challenges. Results Two key recruitment obstacles emerged: (1) issues with the recruitment pathway, in particular methods to identify potentially eligible patients and (2) equipoise of recruiters and patients. These were addressed by liaising with centres to share good practice and refine their pathway and by providing bespoke feedback and training on consent discussions to individual recruiters and centres whilst recruitment was ongoing. The HAND-1 study subsequently achieved its recruitment target. Conclusions Transferable lessons learnt from the QRI in the feasibility study will be implemented in the definitive RCT, enabling a “head start” in the tackling of wider issues around screening methods and consent discussions in the set up/early recruitment study phases, with ongoing QRI addressing specific issues with new centres and recruiters. Findings from this study are likely to be relevant to other surgical and similar trials that are anticipated to encounter issues around patient and recruiter equipoise of treatments and variation in recruitment pathways across centres. The study also highlights the value of feasibility studies in fine-tuning design and conduct issues for definitive RCTs. Embedding a QRI in an RCT, at feasibility or main stage, offers an opportunity for a detailed and nuanced understanding of key recruitment challenges and the chance to address them in “real-time” as recruitment proceeds.

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“…Of the studies included, two pilots described a more comprehensive or ''optimized'' recruitment strategy. The first was an orthopedic trial conducted in the UK comparing needle fasciotomy with limited fasciectomy for treatment of Dupuytren contractures [14]. To initiate contact with the patient, researchers sent a letter of invitation prior to their clinic appointment.…”

Section: Strategies To Optimize Recruitmentmentioning

confidence: 99%

Methods of Recruitment for Surgical and Perioperative Randomized Controlled Trials: A Rapid Review

Ninomiya,

Hiemstra,

Nicholson

et al. 2023

World j. surg.

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Due to the complex nature of surgical randomized controlled trials (RCTs), reaching target recruitment can be challenging. The primary objective was to report on characteristics of successful pilot surgical and perioperative RCTs and the methodological strategies implemented to optimize recruitment. The secondary objective was to provide recommendations for successful recruitment strategies for future surgical RCTs. Ovid MEDLINE, Ovid EMBASE, and Web of Science (via Ovid) databases were searched from 2012 to 2022. This review included surgical and perioperative pilot studies that met their recruitment targets. Study and recruitment characteristics were summarized, and potential relationships between study design and recruitment rate were assessed. Optimized recruitment strategies were extracted when reported. Of 4156 total articles identified, 255 underwent full-text screening, and 52 articles were included. Of the included pilot studies, 21% (n = 11) did not indicate a target sample size or recruitment rate. Recruitment methods were minimally reported in pilot studies for perioperative or surgical RCTs. Strategies to optimize recruitment included internal iterative evaluations of the recorded recruitment appointments and staged introduction of the study. Recruitment rate was not associated with invasiveness of intervention or burden of participation. Patient involvement is absent from current reports on methodological design and offers valuable opportunity to optimize recruitment. Recruitment strategies in perioperative and surgical RCTs can be optimized with iterative qualitative evaluation of the recruitment methods with input from the interdisciplinary research team.

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A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures

Cited by 5 publications

References 23 publications

Versatility of percutaneous needle fasciotomy for Dupuytren's disease across a spectrum of disease severity: A single-surgeon experience of 118 rays

Versatility of percutaneous needle fasciotomy for Dupuytren's disease across a spectrum of disease severity: A single-surgeon experience of 118 rays

Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI)

Methods of Recruitment for Surgical and Perioperative Randomized Controlled Trials: A Rapid Review

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