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The Cochrane Database of Systematic... Dec 2015Dupuytren's disease is a benign fibroproliferative disorder that causes the fingers to be drawn into the palm via formation of new tissue under the glabrous skin of the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Dupuytren's disease is a benign fibroproliferative disorder that causes the fingers to be drawn into the palm via formation of new tissue under the glabrous skin of the hand. This disorder causes functional limitations, but it can be treated through a variety of surgical techniques. As a chronic condition, it tends to recur.
OBJECTIVES
To assess the benefits and harms of different surgical procedures for treatment of Dupuytren's contracture of the index, middle, ring and little fingers.
SEARCH METHODS
We initially searched the following databases on 17 September 2012, then re-searched them on 10 March 2014 and on 20 May 2015: the Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library, the British Nursing Index and Archive (BNI), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMBASE, the Latin American Caribbean Health Sciences Literature (LILACS), Ovid MEDLINE, Ovid MEDLINE-In-Process and Other Non-Indexed Citations, ProQuest (ABI/INFORM Global and Dissertations & Theses), the Institute for Scientific Information (ISI) Web of Science and clinicaltrials.gov. We reviewed the reference lists of short-listed articles to identify additional suitable studies.
SELECTION CRITERIA
We included randomised clinical trials and controlled clinical trials in which groups received surgical intervention for Dupuytren's disease of the index, middle, ring or little finger versus control, or versus another intervention (surgical or otherwise). We excluded the thumb, as cords form on the radial aspect of the thumb and thus are not readily accessible in terms of angular deformity. Furthermore, thumb disease is rare.
DATA COLLECTION AND ANALYSIS
A minimum of two review authors independently reviewed search results to select studies for inclusion by using pre-specified criteria, assessed risk of bias of included studies and extracted data from included studies.We grouped outcomes into the following categories: (1) hand function, (2) other patient-reported outcomes (e.g. satisfaction, pain), (3) early objective outcomes (e.g. correction of angular deformity), (4) late objective outcomes (e.g. recurrence) and (5) adverse effects.
MAIN RESULTS
We included 14 articles describing 13 studies, comprising 11 single-centre studies and two multi-centre studies. These studies involved 944 hands of 940 participants; of these, 93 participants were reported twice in separate articles describing early and late outcomes of one trial. Three papers reported the outcomes of two trials comparing different procedures. One trial compared needle fasciotomy versus fasciectomy (125 hands, 121 participants), and the other compared interposition firebreak skin grafting versus z-plasty closure of fasciectomy (79 participants). The other 11 studies reported trials of technical refinements of procedures or rehabilitation adjuncts. Of these, three investigated effects of postoperative splinting on surgical outcomes.Ten studies (11 articles) were randomised controlled trials (RCTs) of varying methodological quality; one was a controlled clinical trial. Trial design was unclear in two studies awaiting classification. All trials had high or unclear risk of at least one type of bias. High risks of performance and detection bias were particularly common. We downgraded the quality of evidence (Grades of Recommendation, Assessment, Development and Evaluation - GRADE) of outcomes to low because of concerns about risk of bias and imprecision.Outcomes measured varied between studies. Five articles assessed recurrence; two defined this as reappearance of palpable disease and two as deterioration in angular deformity; one did not explicitly define recurrence.Hand function on the Disabilities of the Arm, Shoulder and Hand (DASH) Scale (scores between 0 and 100, with higher scores indicating greater impairment) was 5 points lower after needle fasciotomy than after fasciectomy at five weeks. Patient satisfaction was better after fasciotomy at six weeks, but the magnitude of effect was not specified. Fasciectomy improved contractures more effectively in severe disease: Mean percentage reduction in total passive extension deficit at six weeks for Tubiana grades I and II was 11% lower after needle fasciotomy than after fasciectomy, whereas for grades III and IV disease, it was 29% and 32% lower.Paraesthesia (defined as subjective tingling sensation without objective evidence of altered sensation) was more common than needle fasciotomy at one week after fasciectomy (228/1000 vs 67/1000), but reporting of complications was variable.By five years, satisfaction (on a scale from 0 to 10, with higher scores showing greater satisfaction) was 2.1/10 points higher in the fasciectomy group than in the fasciotomy group, and recurrence was greater after fasciotomy (849/1000 vs 209/1000). Firebreak skin grafting did not improve outcomes more than fasciectomy alone, although this procedure took longer to perform.One trial investigated four weeks of day and night splinting followed by two months of night splinting after surgery. The other two trials investigated three months of night splinting after surgery, but participants in 'no splint' groups with early deterioration at one week were issued a splint for use. All three studies demonstrated no benefit from splinting. The two trials investigating postoperative night splinting were suitable for meta-analysis, which demonstrated no benefit from splinting: Mean DASH score in the splint groups was 1.15 points lower (95% confidence interval (CI) -2.32 to 4.62) than in the no splint groups. Mean total active extension in the splint groups was 2.21 degrees greater (95% CI -3.59 to 8.01 degrees) than in the no splint groups. Mean total active flexion in the splint groups was 8.42 degrees less (95% CI 1.78 to 15.07 degrees) than in the no splint groups.
AUTHORS' CONCLUSIONS
Currently, insufficient evidence is available to show the relative superiority of different surgical procedures (needle fasciotomy vs fasciectomy, or interposition firebreak skin grafting vs z-plasty closure of fasciectomy). Low-quality evidence suggests that postoperative splinting may not improve outcomes and may impair outcomes by reducing active flexion. Further trials on this topic are urgently required.
Topics: Controlled Clinical Trials as Topic; Dupuytren Contracture; Fasciotomy; Fingers; Humans; Randomized Controlled Trials as Topic
PubMed: 26648251
DOI: 10.1002/14651858.CD010143.pub2 -
Health Technology Assessment... Oct 2015Dupuytren's disease is a slowly progressive condition of the hand, characterised by the formation of nodules in the palm that gradually develop into fibrotic cords.... (Review)
Review
BACKGROUND
Dupuytren's disease is a slowly progressive condition of the hand, characterised by the formation of nodules in the palm that gradually develop into fibrotic cords. Contracture of the cords produces deformities of the fingers. Surgery is recommended for moderate and severe contractures, but complications and/or recurrences are frequent. Collagenase clostridium histolyticum (CCH) has been developed as a minimally invasive alternative to surgery for some patients.
OBJECTIVES
To assess the clinical effectiveness and cost-effectiveness of collagenase as an alternative to surgery for adults with Dupuytren's contracture with a palpable cord.
DATA SOURCES
We searched all major electronic databases from 1990 to February 2014.
REVIEW METHODS
Randomised controlled trials (RCTs), non-randomised comparative studies and observational studies involving collagenase and/or surgical interventions were considered. Two reviewers independently extracted data and assessed risk of bias of included studies. A de novo Markov model was developed to assess cost-effectiveness of collagenase, percutaneous needle fasciotomy (PNF) and limited fasciectomy (LF). Results were reported as incremental cost per quality-adjusted life-year (QALY) gained. Deterministic and probabilistic sensitivity analyses were undertaken to investigate model and parameter uncertainty.
RESULTS
Five RCTs comparing collagenase with placebo (493 participants), three RCTs comparing surgical techniques (334 participants), two non-randomised studies comparing collagenase and surgery (105 participants), five non-randomised comparative studies assessing various surgical procedures (3571 participants) and 15 collagenase case series (3154 participants) were included. Meta-analyses of RCTs assessing CCH versus placebo were performed. Joints randomised to collagenase were more likely to achieve clinical success. Collagenase-treated participants experienced significant reduction in contracture and an increased range of motion compared with placebo-treated participants. Participants treated with collagenase also experienced significantly more adverse events, most of which were mild or moderate. Four serious adverse events were observed in the collagenase group: two tendon ruptures, one pulley rupture and one complex regional pain syndrome. Two tendon ruptures were also reported in two collagenase case series. Non-randomised studies comparing collagenase with surgery produced variable results and were at high risk of bias. Serious adverse events across surgery studies were low. Recurrence rates ranged from 0% (at 90 days) to 100% (at 8 years) for collagenase and from 0% (at 2.7 years for fasciectomy) to 85% (at 5 years for PNF) for surgery. The results of the de novo economic analysis show that PNF was the cheapest treatment option, whereas LF generated the greatest QALY gains. Collagenase was more costly and generated fewer QALYs compared with LF. LF was £1199 more costly and generated an additional 0.11 QALYs in comparison with PNF. The incremental cost-effectiveness ratio was £10,871 per QALY gained. Two subgroup analyses were conducted for a population of patients with moderate and severe disease and up to two joints affected. In both subgroup analyses, collagenase remained dominated.
LIMITATIONS
The main limitation of the review was the lack of head-to-head RCTs comparing collagenase with surgery and the limited evidence base for estimating the effects of specific surgical procedures (fasciectomy and PNF). Substantial differences across studies further limited the comparability of available evidence. The economic model was derived from a naive indirect comparison and was hindered by a lack of suitable data. In addition, there was considerable uncertainty about the appropriateness of many assumptions and parameters used in the model.
CONCLUSIONS
Collagenase was significantly better than placebo. There was no evidence that collagenase was clinically better or worse than surgical treatments. LF was the most cost-effective choice to treat moderate to severe contractures, whereas collagenase was not. However, the results of the cost-utility analysis are based on a naive indirect comparison of clinical effectiveness, and a RCT is required to confirm or refute these findings.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42013006248.
FUNDING
The National Institute for Health Research Health Technology Assessment programme.
Topics: Adult; Cost-Benefit Analysis; Dupuytren Contracture; Humans; Microbial Collagenase; Postoperative Complications; Quality-Adjusted Life Years
PubMed: 26524616
DOI: 10.3310/hta19900 -
The Cochrane Database of Systematic... Aug 2015Henoch-Schönlein purpura (HSP) is the most common vasculitis of childhood but may occur in adults. This small vessel vasculitis is characterised by palpable purpura,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Henoch-Schönlein purpura (HSP) is the most common vasculitis of childhood but may occur in adults. This small vessel vasculitis is characterised by palpable purpura, abdominal pain, arthritis or arthralgia and kidney involvement. This is an update of a review first published in 2009.
OBJECTIVES
To evaluate the benefits and harms of different agents (used singularly or in combination) compared with placebo, no treatment or any other agent for: (1) the prevention of severe kidney disease in patients with HSP without kidney disease at presentation; (2) the prevention of severe kidney disease in patients with HSP and minor kidney disease (microscopic haematuria, mild proteinuria) at presentation; (3) the treatment of established severe kidney disease (macroscopic haematuria, proteinuria, nephritic syndrome, nephrotic syndrome with or without acute kidney failure) in HSP; and (4) the prevention of recurrent episodes of HSP-associated kidney disease.
SEARCH METHODS
We searched the Cochrane Kidney and Transplant's Specialised Register to 13 July 2015 through contact with the Trials Search Co-ordinator using search terms relevant to this review.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing interventions used to prevent or treat kidney disease in HSP compared with placebo, no treatment or other agents were included.
DATA COLLECTION AND ANALYSIS
Two authors independently determined study eligibility, assessed risk of bias and extracted data from each study. Statistical analyses were performed using the random effects model and the results were expressed as risk ratio (RR) or risk difference (RD) for dichotomous outcomes and mean difference (MD) for continuous outcomes with 95% confidence intervals (CI).
MAIN RESULTS
Thirteen studies (1403 enrolled patients) were identified. Risks of bias attributes were frequently poorly performed. Low risk of bias was reported in six studies (50%) for sequence generation (selection bias) and in seven (58%) for allocation concealment (selection bias). Blinding of participants and personnel (performance bias) and of outcome assessment (detection bias) was at low risk of bias in three studies. Five studies reported complete outcome data (attrition bias) while eight studies reported expected outcomes so were at low risk of reporting bias.Eight studies evaluated therapy to prevent persistent kidney disease in HSP. There was no significant difference in the risk of persistent kidney disease any time after treatment (5 studies, 746 children: RR 0.74, 95% CI 0.42 to 1.32), or at one, three, six and 12 months in children given prednisone for 14 to 28 days at presentation of HSP compared with placebo or supportive treatment. There were no significant differences in the risk of persistent kidney disease with antiplatelet therapy in children with or without kidney disease at entry. Heparin significantly reduced the risk of persistent kidney disease by three months compared with placebo (1 study, 228 children: RR 0.27, 95% CI 0.14 to 0.55); no significant bleeding occurred. Four studies examined the treatment of severe HSP-associated kidney disease. Two studies (one involving 56 children and the other involving 54 adults) compared cyclophosphamide with placebo or supportive treatment and found no significant benefit of cyclophosphamide. There were no significant differences in adverse effects. In one study comparing cyclosporin with methylprednisolone (15 children) there was no significant difference in remission at final follow-up at a mean of 6.3 years (RR 1.37, 95% CI 0.74 to 2.54). In one study (17 children) comparing mycophenolate mofetil with azathioprine, there was no significant difference in the remission of proteinuria at one year (RR 1.32, 95% CI 0.86 to 2.03). No studies were identified which evaluated the efficacy of therapy on kidney disease in participants with recurrent episodes of HSP.
AUTHORS' CONCLUSIONS
There are no substantial changes in conclusions from this update compared with the initial review. From generally low quality evidence, we found no evidence of benefit from RCTs for the use of prednisone or antiplatelet agents to prevent persistent kidney disease in children with HSP. Though heparin appeared effective, this potentially dangerous therapy is not justified to prevent serious kidney disease when fewer than 2% of children with HSP develop severe kidney disease. No evidence of benefit has been found for cyclophosphamide treatment in children or adults with HSP and severe kidney disease. Because of small patient numbers and events leading to imprecision in results, it remains unclear whether cyclosporin and mycophenolate mofetil have any roles in the treatment of children with HSP and severe kidney disease.
Topics: Adrenal Cortex Hormones; Child; Child, Preschool; Cyclophosphamide; Humans; IgA Vasculitis; Immunosuppressive Agents; Kidney Diseases; Platelet Aggregation Inhibitors; Randomized Controlled Trials as Topic
PubMed: 26258874
DOI: 10.1002/14651858.CD005128.pub3 -
Danish Medical Journal May 2015The objective of this study was to investigate the evidence for positive predictive value (PPV) of alarm symptoms and combinations of symptoms for colorectal cancer,... (Review)
Review
INTRODUCTION
The objective of this study was to investigate the evidence for positive predictive value (PPV) of alarm symptoms and combinations of symptoms for colorectal cancer, breast cancer, prostate cancer and lung cancer in general practice.
METHODS
This study is based on a literature search performed in PubMed, Embase, the Cochrane database and at ClinicalTrials.gov in accordance with the PRISMA guidelines. The main outcome measure used was PPV.
RESULTS
A total of 16 eligible studies were identified. The intervals in the brackets refer to the variation of the results in the studies. Colorectal cancer: The PPV of "rectal bleeding" was high for patients > 60 years (6.6-21.2%), but much lower in younger age groups. For "change in bowel habits" and "significant general symptoms", the PPV was 3.5-8.5%. Breast cancer: "Palpable suspected tumour" was well supported (8.1-24%). No studies on the predictive value of "pitting of the skin", "papil-areola eczema/ulceration" and "suspect axillary lymph nodes" were found. Prostate cancer: One study showed a high PPV for positive rectal examination (12%). The value for "lower urinary tract symptoms" was low (1.0-3.0%). PPV for "perianal pain" and "haemospermia" were not found. Lung cancer: For "haemoptysis" the PPV increased from 8.4 in patients aged 55 years to 20.4 at the age of > 85 years. PPV for "cough", "pain in the thorax", "dyspnoea" and "general symptoms" were low (0.4-1.1%). Using a new algorithm that estimates the PPV of combinations of symptoms and risk factors, a higher PPV may be achieved.
CONCLUSION
A few of the alarm symptoms show a high PPV, whereas the PPV for some symptoms currently remains unknown. To improve the GPs' diagnostic judgment, a new algorithm for calculating the PPV for combinations of symptoms and risk factors seems promising.
Topics: Breast Neoplasms; Colorectal Neoplasms; Early Detection of Cancer; Female; General Practice; Humans; Lung Neoplasms; Male; Predictive Value of Tests; Prostatic Neoplasms; Symptom Assessment
PubMed: 26050833
DOI: No ID Found -
Canadian Family Physician Medecin de... Aug 2014To systematically review the diagnostic accuracy of clinical features associated with colorectal cancer (CRC) presenting in primary care. (Review)
Review
OBJECTIVE
To systematically review the diagnostic accuracy of clinical features associated with colorectal cancer (CRC) presenting in primary care.
DATA SOURCES
MEDLINE and EMBASE were searched for studies in primary care that provided information on clinical features predictive of CRC. Positive predictive values were used to guide the determination of clinical features associated with increased risk of CRC.
STUDY SELECTION
Systematic reviews or primary studies that provided possible clinical features predictive of CRC were included.
SYNTHESIS
Clinical features of patients presenting in primary care that are associated with increased risk of CRC, listed in descending order of association, included palpable rectal or abdominal mass; rectal bleeding combined with weight loss; iron deficiency anemia; rectal bleeding mixed with stool; rectal bleeding in the absence of perianal symptoms; rectal bleeding combined with change in bowel habits; dark rectal bleeding; rectal bleeding and diarrhea; and change in bowel habits. Being male and increasing age were also, in general, associated with increased risk of CRC.
CONCLUSION
Recognition of clinical features associated with increased risk of CRC by FPs might help with earlier identification and referral among patients presenting in primary care. This review might help inform providers and CRC diagnostic assessment programs about indications for assessment and further investigation.
Topics: Colorectal Neoplasms; Humans; Practice Guidelines as Topic; Primary Health Care
PubMed: 25122831
DOI: No ID Found