A proposed methodology for uncertainty extraction and verification in priority setting partnerships with the James Lind Alliance: an example from the Common Conditions Affecting the Hand and Wrist Priority Setting Partnership.

BACKGROUND: To report our recommended methodology for extracting and then confirming research uncertainties - areas where research has failed to answer a research question - derived from previously published literature during a broad scope Priority Setting Partnership (PSP) with the James Lind Alliance (JLA). METHODS: This process was completed in the UK as part of the PSP for "Common Conditions Affecting the Hand and Wrist", comprising of health professionals, patients and carers and reports the data (uncertainty) extraction phase of this. The PSP followed the robust methodology dictated by the JLA and sought to identify knowledge gaps, termed "uncertainties" by the JLA. Published Cochrane Systematic Reviews, Guidelines and Protocols, NICE (National Institute for Health and Care Excellence) Guidelines, and SIGN (Scottish Intercollegiate Guidelines Network) Guidelines were screened for documented "uncertainties". A robust method of screening, internally verifying and then checking uncertainties was adopted. This included independent screening and data extraction by multiple researchers and use of a PRISMA flowchart, alongside steering group consensus processes. Selection of research uncertainties was guided by the scope of the Common Conditions Affecting the Hand and Wrist PSP which focused on "common" hand conditions routinely treated by hand specialists, including hand surgeons and hand therapists limited to identifying questions concerning the results of intervention, and not the basic science or epidemiology behind disease. RESULTS: Of the 2358 records identified (after removal of duplicates) which entered the screening process, 186 records were presented to the PSP steering group for eligibility assessment; 79 were deemed within scope and included for the purpose of research uncertainty extraction (45 full Cochrane Reviews, 18 Cochrane Review protocols, 16 Guidelines). These yielded 89 research uncertainties, which were compared to the stakeholder survey, and added to the longlist where necessary; before derived uncertainties were checked against non-Cochrane published systematic reviews. CONCLUSIONS: In carrying out this work, beyond reporting on output of the Common Conditions Affecting the Hand and Wrist PSP, we detail the methodology and processes we hope can inform and facilitate the work of future PSPs and other evidence reviews, especially those with a broader scope beyond a single disease or condition.

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

PURPOSE: The purpose of this study is to assess the feasibility of conducting a large, multicentre randomised controlled trial (RCT) comparing needle fasciotomy with limited fasciectomy for treatment of Dupuytren's contractures. DESIGN: The design of this study is a parallel, two-arm, multicentre, randomised feasibility trial with embedded QuinteT Recruitment Intervention. PARTICIPANTS: Patients aged 18 years or over who were referred from primary to secondary care for treatment of a hand with Dupuytren's contractures of one or more fingers of more than 30° at the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints and well-defined cord(s). Patients were excluded if they had undergone previous Dupuytren's contracture surgery on the same hand. METHODS: Potential participants were screened for eligibility. Recruited participants randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy and followed-up for up to 6 months after treatment. Data on recruitment rates, completion of follow-up, and procedure costs were collected. Four patient reported outcome measures (PROMs) and objective outcome measures were collected before intervention and 6 weeks and 6 months afterwards. RESULTS: One hundred and fifty-three of 267 (57%) primary-care referrals for Dupuytren's contractures met the eligibility criteria for the study. Seventy-one of the 153 (46%) agreed to participate and were randomly allocated to treatment with needle fasciotomy or limited fasciectomy. Sixty-seven of these underwent their allocated treatment, two were crossovers from limited fasciectomy to needle fasciotomy, and two (both allocated limited fasciectomy) received no treatment. Fifty-nine participants (85%) completed 6-month follow-up PROMs. Participants felt the MYMOP, PEM and URAM PROMs allowed them to better describe how their treatment affected their hand function than the DASH PROM. The estimated costs of limited fasciectomy (in an operating theatre) and needle fasciotomy (in a clinic room) were £777 and £111 respectively. CONCLUSION: A large RCT comparing treatment of Dupuytren's contractures by needle fasciotomy and limited fasciectomy is feasible. Data from this study will help determine the number of sites and duration of recruitment required to complete an adequately powered RCT and will assist the selection of PROMs in future studies on the treatment of Dupuytren's contractures. (Level 1 feasibility study). TRIAL REGISTRATION: Trial registered with ISRCTN (registration number: ISRCTN11164292), date assigned - 28/08/2015.

Evidence-based management of adult trigger digits.

The aim of this systematic review was to develop an evidence-based guideline to assist clinicians in the treatment of adult trigger digits. There is moderate evidence to suggest that local corticosteroid injection is a safe and effective short-term treatment and it may, therefore, be recommended as an initial treatment for this condition. However, when compared with surgery, there is strong evidence that corticosteroid injection is associated with increased rates of ongoing or recurrent symptoms at 6 months after intervention. There is strong evidence suggesting that trigger digit can be managed safely by surgical release. There is weak evidence to support the use of splinting or other non-operative modalities. Hence a single corticosteroid injection may be offered as the first line in treatment of adult trigger digits, but percutaneous release is a safe alternative. Surgery should be the next line if the injection fails, symptoms recur or the patient chooses. LEVEL OF EVIDENCE: I.

Functional outcome and complications following surgery for Dupuytren's disease: a multi-centre cross-sectional study.

Variables associated with recurrent Dupuytren's disease, or a 'diathesis', have been investigated, but those associated with functional outcome and complications are less well studied. Outcomes 1 or 5 years after an aponeurotomy, fasciectomy or dermofasciectomy were assessed by patient interview and examination at five UK centres. A total of 432 procedures were studied. The reoperation rate did not differ at 1 year ( p = 0.396, Chi-square test with Monte Carlo simulation), but was higher after aponeurotomy in the 5-year group (30%, versus 6% after fasciectomy and 0% after dermofasciectomy, p = 0.003, Chi square test with Monte Carlo simulation). Loss of function (DASH>15) did not differ between procedures at 5 years, even when reoperation and other variables were controlled. Diabetes, female gender and previous ipsilateral surgery were associated with poorer function in logistic regression analysis. The variables associated with poor function after treatments differ from diathesis variables. Aponeurotomy had lower complication rates than fasciectomy and dermofasciectomy. This may counterbalance the former's higher recurrence rate and explain why aponeurotomy demonstrated similar long-term functional outcome compared with excisional surgery in this study. LEVEL OF EVIDENCE: III.

Recovery, responsiveness and interpretability of patient-reported outcome measures after surgery for Dupuytren's disease.

This prospective cohort study investigated the responsiveness and interpretability of the Disabilities of the Arm, Shoulder and Hand (DASH) and Unité Rhumatologique des Affections de la Main (URAM) outcome measures for assessing recovery after fasciectomy and dermofasciectomy for Dupuytren's disease. DASH outcome scores at 1 year were significantly better than at 6 weeks, suggesting that recovery is not complete by 6 weeks. Of the 101 patients recruited to the DASH cohort, 71 completed preoperative, 6 week and 1 year postoperative DASH scores; 68 of them completed preoperative and 1 year postoperative DASH scores and an external anchor question. In the URAM cohort, 30/44 completed the preoperative and the 1 year postoperative URAM scores and the anchor question. The DASH score exhibited moderate responsiveness but poor interpretability on receiver operating characteristic curve analysis, such that a minimal important change could not be estimated. The URAM score showed acceptable responsiveness, and an MIC of 10.5 on receiver operating characteristic analysis. LEVEL OF EVIDENCE: II.

Scaphoid fracture non-union: a systematic review of surgical treatment using bone graft.

UNLABELLED: This systematic review assesses the quality and outcomes of published articles concerning bone graft surgery for scaphoid fracture non-union. Searches of the CENTRAL, MEDLINE, EMBASE, CINAHL and AMED databases captured 2710 articles. Each article was screened and 144 met our inclusion criteria. Data regarding source, study design, population, intervention, comparator and outcomes were extracted. There were 5464 scaphoid non-union outcomes within the 144 studies. Mean reported union rates for vascularized and non-vascularized bone graft were 84% and 80%, respectively. Avascular necrosis was diagnosed in several ways and, when present, the vascularized bone graft union rate was 74% compared with 62% with non-vascularized bone graft. Reported union rates vary considerably. These differences may be due to patient factors, fracture factors, treatment factors or study design failures or bias. We recommend that future researchers take into account the deficiencies of previous studies and use the suggested minimum data set in future studies. LEVEL OF EVIDENCE: II.

Cost-effectiveness of volar locking plate versus percutaneous fixation for distal radial fractures: Economic evaluation alongside a randomised clinical trial.

This study compares the cost-effectiveness of treating dorsally displaced distal radial fractures with a volar locking plate and percutaneous fixation. It was performed from the perspective of the National Health Service (NHS) using data from a single-centre randomised controlled trial. In total 130 patients (18 to 73 years of age) with a dorsally displaced distal radial fracture were randomised to treatment with either a volar locking plate (n = 66) or percutaneous fixation (n = 64). The methodology was according to National Institute for Health and Care Excellence guidance for technology appraisals. . There were no significant differences in quality of life scores between groups at any time point in the study. Both groups returned to baseline one year post-operatively. NHS costs for the plate group were significantly higher (p < 0.001, 95% confidence interval 497 to 930). For an additional £713, fixation with a volar locking plate offered 0.0178 additional quality-adjusted life years in the year after surgery. The incremental cost-effectiveness ratio (ICER) for plate fixation relative to percutaneous fixation at list price was £40 068. When adjusting the prices of the implants for a 20% hospital discount, the ICER was £31 898. Patients who underwent plate fixation did not return to work earlier. We found no evidence to support the cost-effectiveness, from the perspective of the NHS, of fixation using a volar locking plate over percutaneous fixation for the operative treatment of a dorsally displaced radial fracture.

Minimal important changes and differences in elective hand surgery.

UNLABELLED: Minimal important changes and differences describe the smallest changes and differences between individuals that are relevant to patients following treatment. Minimal important differences may vary between conditions, treatments and lengths of follow-up, and can be calculated in different ways. Minimal important differences for elective hand surgery were reviewed. A total of 99 minimal important differences were identified in 29 articles. The conditions, treatments, outcome measures used and follow-up periods are discussed. The Disabilities of the Arm, Shoulder and Hand had the most estimates of minimal important differences, but these varied. The methods used in the included studies were reviewed and appraised. Most minimal important differences were calculated using retrospective anchors. Future research directions in this area are suggested. LEVEL OF EVIDENCE: II.

Dynamism in Dupuytren's contractures.

Dynamism of Dupuytren's contractures may occur if a contracture crosses over both the metacarpophalangeal (MCPJ) and proximal interphalangeal (PIPJ) joints of one finger. In this situation the extension deficit at one joint can be influenced by the position of the other. This may affect clinical measurements and introduce errors and bias into research using angular deformity as an endpoint. This study reports the dynamism encountered when measuring passive joint extension deficits in pre-operative contractures. Eighty-five digits with a contracture affecting the PIPJ or MCPJ and PIPJ on 72 hands from 70 patients were studied. Seventy-six digits showed dynamism at either the MCPJ or PIPJ (89%). Seventy-four showed dynamism at the PIPJ (87%). The mean dynamism observed was 6° at the MCPJ and 14° at the PIPJ. Previous Dupuytren's surgery to the finger did not influence the amount of dynamism seen. Dynamism is common and may be a source of error or bias in trials of Dupuytren's disease treatment.

What patients want from the treatment of Dupuytren's disease--is the Unité Rhumatologique des Affections de la Main (URAM) scale relevant?

Patients awaiting surgery for Dupuytren's contractures listed the problems from their Dupuytren's disease that had led them to request surgery and their relative priorities of the results of surgery. The listed problems were compared with the nine items comprising the Unité Rhumatologique des Affections de la Main (URAM) Dupuytren's disease-specific outcome measure. One hundred and ten patients reported 278 problems. Ninety-four different combinations of problems were provided by patients, and over half (55%) of the problems were not captured by items in the URAM scale. The long-term outcome from surgery was relatively more important to patients than speed of recovery. The URAM tool may not be relevant to patients in the UK, and further assessment of its face validity is required before it is used.

Palmar plate capsulodesis for thumb metacarpophalangeal joint hyperextension in association with trapeziometacarpal osteoarthritis.

Hyperextension of the thumb metacarpophalangeal (MCP) joint is frequently seen with trapeziometacarpal osteoarthritis, but there is no consensus on the indication for, or type of, treatment. We re-examined 12 thumbs at a mean of 9 (range 6-13) years following MCP capsulodesis using a suture anchor performed with trapeziectomy. Mean MCP hyperextension improved from 45° pre-operatively to 19° at 1 year post-operatively. At 9 years follow-up, it had increased to 30° but was still significantly better than pre-operatively (p = 0.007). Mean MCP flexion was 37° and near normal opposition was retained. The median pain score had improved from 5.5 to 1 (p = 0.002). Thumb key and tip pinch and hand grip strength showed no significant change from pre-operative values. No thumb MCP had symptomatic radiological degeneration. Our results suggest that MCP capsulodesis preserves a useful range of MCP flexion but stretches out over time. However, this did not result in increased pain or thumb weakness.

Prediction of outcome of non-operative treatment of acute scaphoid waist fracture.

Fifteen per cent of acute fractures of the scaphoid waist fail to unite if treated non-operatively in plaster, resulting in persistent loss of function. Suspected risk factors for non-union include proximal fracture fragment avascularity and assessments of fracture displacement and comminution. This series of studies investigated whether one can accurately identify which scaphoid waist fractures will unite with plaster treatment. They suggest that proximal fracture fragment vascularity is not a predictor of outcome. In contrast, assessments of fracture displacement on magnetic resonance imaging (MRI) and computed tomography (CT) but not scaphoid series radiographs can be used to predict outcome. Undisplaced fractures are benign and unite reliably with 4-8 weeks' treatment in plaster. Displaced fractures with 3mm or more gapping have a significant non-union rate if treated in plaster and might be better treated operatively. Use of MRI/CT may allow reliable, cost effective treatment of acute fractures through the scaphoid waist.

Extra-articular fractures of the distal radius--a European view point.

There is no unified consensus view on the management of distal radius fractures within Europe. This is partially because of the failure of clinical studies to demonstrate superiority of one treatment technique over the others. Nonclinical factors, such as cost and operating room availability, also contribute to the decision making regarding treatment, and there remains uncertainty as to the criteria that need to be fulfilled to achieve a good functional result. This article therefore does not describe a unified European viewpoint, but the viewpoint of two Europeans working within the health care system of one European country.

Six year outcome excision of the trapezium for trapeziometacarpal joint osteoarthritis: is it improved by ligament reconstruction and temporary Kirschner wire insertion?

This randomized prospective study compared the treatment of trapeziometacarpal joint osteoarthritis with a) trapeziectomy with no ligament reconstruction, no soft tissue interposition and no temporary Kirschner wire stabilization (Group T); b) trapeziectomy with flexor carpi radialis ligament reconstruction and interposition and temporary K-wire stabilization (Group T+LRTI). We followed 99 patients with 114 thumbs (59 T and 55 T+LRTI) for a mean of 6.2 (range, 4.2-8.1) years. There were no significant differences between the two treatments in any subjective or objective outcome measure at 6 year follow-up. Eighty-two percent of the thumbs were painless or only ached after use. The DASH (Group T mean, 31; 95% CI, 26-42: Group T+LRTI mean 30; 95% CI, 22-35) and Patient Evaluation Measure (Group T mean, 35; 95% CI, 29-41: Group T+LRTI mean 34; 95% CI, 27-39) scores were significantly better than preoperatively. Thumb key pinch strength did not differ significantly between the two treatment groups (Group T mean 3.7 kg: 95% CI, 3.3-4.2: Group T+LRTI mean 4.1 kg, 95% CI, 3.7-4.7) and was not significantly different from the preoperative key pinch strength. This study does not provide evidence to support the use of LRTI and temporary K-wire stabilization after trapeziectomy.

Displaced scaphoid waist fractures: the use of a week 4 CT scan to predict the likelihood of union with nonoperative treatment.

This study assessed whether nonunion of displaced scaphoid waist fractures with nonoperative treatment could be predicted from 4 week CT scans. Thirty-one patients with unilateral displaced scaphoid waist fractures and adequate follow-up were included. CT scans in the longitudinal axis of the scaphoid with sagittal and coronal slices were done 4 weeks after the index injury. The effects of fracture gap, sclerosis and bone resorption on union were assessed. Fracture union was observed in all 13 displaced fractures with a < 2 mm gap, four of the seven with a gap of 2-3 mm and only four of the 11 with a gap > 3 mm (p = 0.01). Bone resorption involving more than 50% of the fracture cross-section was also associated with nonunion, but sclerosis was not.

Management of hyperextension of the metacarpophalangeal joint in association with trapeziometacarpal joint osteoarthritis.

This study investigates the management of metacarpophalangeal joint (MCP) hyperextension in patients undergoing trapeziectomy for thumb base osteoarthritis. A total of 297 thumbs with painful trapeziometacarpal osteoarthritis were assessed on pain and thumb key and tip pinch preoperatively and at 1 year. Before surgery 101 had no MCP hyperextension, 168 had hyperextension ≤ 30° and 28 had hyperextension ≥ 35°. Of these 157 hyperextension deformities ≤ 30° and eight ≥ 35° were not treated. The others were treated by temporary insertion of a Kirschner wire (n = 9), MCP fusion (n = 6), sesamoid bone tethering to the MC head (n = 5) and palmar capsulodesis using a bone anchor (n = 11). Untreated MCP hyperextension deformities < 30° did not influence the outcome of trapeziectomy. MCP hyperextension deformities ≥ 35° can be improved by capsulodesis or MCP fusion but this may not improve the clinical outcome.