Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial

Brown, Sarah; Nixon, Jane; Ransom, Myka; Gilberts, Rachael; Dewhirst, Nikki; McGinnis, Elizabeth; Longo, Roberta; Game, Frances; Bojke, Chris; Chadwick, Paul; Chandrasekar, Akila; Chetter, Ian; Collier, Howard E.; Fernandez, Catherine; Homer‐Vanniasinkam, Shervanthi; Jude, Edward B.; Leigh, Richard; Lomas, Richard; Vowden, Peter; Wason, James; Sharples, Linda D.; Russell, David

doi:10.1136/bmjopen-2019-035947

Cited by 10 publications

(10 citation statements)

References 37 publications

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“…Participants indicated that funders often ask for blinded trials but not blinded statisticians. Although there are examples for trials where funders paid for multiple statisticians [ 16 , 17 ], the perception and indeed experience of some participants was that funders pushed back on applications including funding for multiple statisticians. “…funders don’t want to pay for multiple statisticians, as we know.…”

Section: Resultsmentioning

confidence: 99%

Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units

Iflaifel

Partlett

Bell

et al. 2022

Trials

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Background Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the practice of blinding statisticians. Guidelines recommend that statisticians remain blinded to allocation prior to the final analysis. As these guidelines are not based on empirical evidence, this study undertook a qualitative investigation relating to when and how statisticians should be blinded in clinical trials. Methods Data were collected through online focus groups with various stakeholders who work in the delivery and oversight of clinical trials. Recordings of the focus groups were transcribed verbatim and thematic analysis was used to analyse the transcripts. Results Thirty-seven participants from 19 CTUs participated in one of six focus groups. Four main themes were identified, namely statistical models of work, factors affecting the decision to blind statisticians, benefits of blinding/not blinding statisticians and practicalities. Factors influencing the decision to blind the statistician included available resources, study design and types of intervention and outcomes and analysis. Although blinding of the statistician is perceived as a desirable mitigation against bias, there was uncertainty about the extent to which an unblinded statistician might impart bias. Instead, in most cases, the insight that the statistician offers was deemed more important to delivery of a trial than the risk of bias they may introduce if unblinded. Blinding of statisticians was only considered achievable with the appropriate resource and staffing, which were not always available. In many cases, a standard approach to blinding was therefore considered unrealistic and impractical; hence the need for a proportionate risk assessment approach identifying possible mitigations. Conclusions There was wide variation in practice between UK CTUs regarding the blinding of trial statisticians. A risk assessment approach would enable CTUs to identify risks associated with unblinded statisticians conducting the final analysis and alternative mitigation strategies. The findings of this study will be used to design guidance and a tool to support this risk assessment process.

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Section: Resultsmentioning

confidence: 99%

Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units

Iflaifel

Partlett

Bell

et al. 2022

Trials

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“…This may be because diabetic foot complications are different from most diseases, and the treatment requires the involvement of multiple specialties. Diseases treated by multidisciplinary collaboration are likely to become more common in the future (37). Therefore, further research on the needs of patients with this disease can provide helpful insight regarding modern medical treatment-oriented by patient needs and interdisciplinary collaborative treatment models.…”

Section: Discussionmentioning

confidence: 99%

Exploring the barriers of patients with diabetic foot complications in China: a qualitative interview study

Liu¹,

Chu²,

Zhao³

et al. 2021

Ann Transl Med

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Background: Patients with diabetic foot complications are associated with high rates of morbidity, disability, and mortality. Through findings of qualitative interviews with patients with this disease, we aimed to explore the barriers they encountered, provide evidence to improve the efficacy of medical services, discuss prevention and treatment strategies for future policymakers, and attract widespread attention from the Chinese society.Methods: Patients with diabetic foot complications were recruited from three tertiary hospitals in China between July to September 2020. Patients were included who had a clinical diagnosis of diabetic foot complications, were 18 years or older, spoke Chinese as their first language, and were willing to share treatment experiences. An interview guide was used during the in-person semi-structured interviews that lasted 20 to 50 minutes and were audio-recorded. Transcripts were analyzed for qualitative themes.Results: Forty-one patients (range, 38-79 years; 12 men, 29 women) were recruited. Data analysis indicated five thematic dimensions on barriers encountered by patients with diabetic foot complications: hospital visits, doctor-patient communication, mental burden, economic burden, and social support.Conclusions: Patients with diabetic foot complications face serious financial, mental, and social burdens in China. Future studies can use the five dimensions to help solve the existing problems and improve treatment outcomes of this patient population.

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“…The full texts of the remaining 128 articles were assessed. The following articles were excluded due to: reviews (55); study about nonadjuvant therapy (18); study on fresh fracture (10); conference abstract (6); duplicate publication (2); study about same therapeutic strategies (2); no predetermined outcomes reported (2); comments (2); study on children congenital anomaly (1). Finally, thirty studies were included in the analysis (Figure 1).…”

Section: Literature Searchmentioning

confidence: 99%

Efficacy of Adjuvant Treatment for Fracture Nonunion/Delayed Union: A Network Meta-Analysis of Randomized Controlled Trials

Yang¹,

Zhang²,

Liang³

et al. 2022

Preprint

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BackgroundFracture nonunion/delayed union seriously affects physical and mental health and quality of life. The aim of this study was to evaluate the relative efficacy of different adjuvant treatments for nonunion/delayed union by network meta-analysis.MethodsA comprehensive search was performed to identify randomized controlled trials (RCTs) evaluating adjuvant treatment in the management of nonunion/delayed union. A network meta-analysis reporting on healing rate, healing time, and adverse effect (AE) outcomes was conducted to assess and compare different interventions.ResultsThirty studies were included in analysis. For healing rate outcome, bone marrow aspirate (BMA) + autologous cancellous bone (ACB) was found to be significantly better than ACB alone (Odds ratio: 0.12; 95% confidence interval: 0.03, 0.59). In the ranking results, BMA+ platelet-rich plasma (PRP) (96%), BMA+ACB (90%), and BMA alone (82%) showed relative advantages in healing rate. Low-intensity pulsed ultrasonography (LIUS) intervention significantly shortened the healing time compared with ACB (Standardized mean difference: -8.93; 95% confidence interval: -14.37, -3.48). LIUS (99%), BMA+PRP (74%), and bone morphogenetic proteins (BMPs) (69%) have relative advantages.ConclusionsAmong the current intervention strategies, BMA and combination with PRP and ACB can improve the healing rate of nonunion/delayed union. LIUS can significantly shorten the healing time. However, large-scale, well-designed studies are still needed to confirm the results.Trial registration: retrospectively registered

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Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial

Cited by 10 publications

References 37 publications

Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units

Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units

Exploring the barriers of patients with diabetic foot complications in China: a qualitative interview study

Efficacy of Adjuvant Treatment for Fracture Nonunion/Delayed Union: A Network Meta-Analysis of Randomized Controlled Trials

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