Assessing outcome measures used after rib fracture: A COSMIN systematic review

PurposeThe incidence of invasive treatment of rib fracture has increased significantly over the last decade however the evidence of improved patient outcomes to support this is lacking. A systematic review was performed to identify patient reported outcome measures (PROMs) used in the assessment of outcomes following chest wall injury. The quality of evidence for the psychometric properties of the identified PROMs was graded using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology.MethodsRib fracture studies measuring patient reported outcomes were identified using PubMed/Medline, EMBASE, AMED and PsycINFO. Methodological quality of measurement properties was evaluated with the COnsensus-based Standards for selection of health status Measurement INstruments (COSMIN) checklist.ResultsA total of 64 studies were identified including 19 different PROM instruments. Domains included in the reported PROMs included pain, breathlessness, general health quality of life, physical function and physiological health. No rib fracture specific PROM was identified. The most frequently reported instrument was the SF-36 reporting overall quality of life (HRQoL) although there was very low quality evidence for its content validity. There was low quality evidence to support good content validity for the Medical Research Council (MRC) dyspnoea scale, Brief Pain Index (BPI) and McGill Pain Questionnaire (MPQ). No PROM had undergone validation in a rib fracture population. The overall quality of the PROM development studies was poor. While we were unable to identify a clear “gold standard”, based on the limited current evidence, we recommend that the EQ-5D-5L is used in combination with the MRC and BPI or MPQ for future rib fracture studies.ConclusionThe lack of validated outcome measures for rib fracture patients is a significant limitation of the current literature. Further studies are needed to provide validated outcome measures to ensure accuracy of the reported results and conclusions. As interventions for rib fractures have become more common in both research and clinical practice this has become an urgent priority.     

Management of achilles tendon injury: A current concepts systematic review

Achilles tendon rupture has been on the rise over recent years due to a variety of reasons. It is a debilitating injury with a protracted and sometimes incomplete recovery. Management strategy is a controversial topic and evidence supporting a definite approach is limited. Opinion is divided between surgical repair and conservative immobilisation in conjunction with functional orthoses. A systematic search of the literature was performed. Pubmed, Medline and EmBase databases were searched for Achilles tendon and a variety of synonymous terms. A recent wealth of reporting suggests that conservative regimens with early weight bearing or mobilisation have equivalent or improved rates of re-rupture to operative regimes. The application of dynamic ultrasound assessment of tendon gap may prove crucial in minimising re-rupture and improving outcomes. Studies employing functional assessments have found equivalent function between operative and conservative treatments. However, no specific tests in peak power, push off strength or athletic performance have been reported and whether an advantage in operative treatment exists remains undetermined.     

Treatment outcome at 1 year did not differ between use of cast or walker in the first 3 weeks after an acute Achilles tendon rupture. A registry study of 1304 patients from the Danish Achilles tendon database

BackgroundThe best choice of orthosis in the treatment of acute Achilles tendon rupture is still under debate.ObjectiveTo investigate if choice of orthosis in the first 3 weeks of treatment affected patient reported outcome (Achilles tendon Total Rupture Score (ATRS)), tendon elongation (Achilles Tendon Resting Angle (ATRA) and Heel Rise Height (HRH)) and re-rupture.MethodsRegistry study in the Danish Achilles tendon Database. Patients treated with cast and patients treated with walker in the first 3 weeks of treatment were compared using a linear mixed-effects model adjusted for potential confounders.Results1304 patients were included in the study. No clinically relevant difference was found: Adjusted mean difference (using walker the whole period as reference)(95% CI) ATRS after 1 year = 0.1(?3.0; 4.1), ATRS after 6 months = 2.0(?4.5; 5.8), ATRS after 2 years = 3.0(?0.7; 7.0), HRH difference = 0.6(?6.6; 8.2), ATRA difference = 0.03°(?1.5; 1.6), re-rupture(odds ratio) = 0.812(0.4; 1.61).ConclusionPatients treated with cast the first 3 weeks after acute Achilles tendon rupture did not have better treatment outcome than patients treated with walker.     

腰腿痛患者报告结局量表的应用分析

目的:检验腰腿痛患者报告结局量表的信度、效度及反应度.方法:2010年8月至2012年1月,纳入住院腰椎间盘突出症及腰椎管狭窄症患者患者200例,男93例,女107例;年龄22～65岁,平均50.3岁;腰椎间盘突出症144例,腰椎管狭窄症56例 应用腰腿痛患者报告结局量表对患者进行测评,并对量表进行信度、效度、反应度分析.结果:39例病情无变化患者两次评分无显著性差异(P＞0.05),且有显著相关性(r＞0.9);该量表同Oswestry功能障碍指数问卷(ODI)对患者评分结果具有显著相关性(r＞0.8);该量表总体克朗巴赫α系数为0.931,总体Guttman折半系数为0.912;该量表KMO统计量为0.919,Bartlett球形检验卡方值l 882.975(P＜0.01),因子分析方法提取特征根值＞1的3个公因子,累计贡献率为64.364％;43例病情有好转患者两次评分结果分别为34.80±9.00和28.77±8.73,两者差异有统计学意义(P＜0.01).结论:腰腿痛患者报告结局量表有较好的信度、效度及反应度,可作为腰腿痛患者临床疗效的评价工具.     

A meta-analysis of randomised controlled trials comparing conventional to minimally invasive approaches for repair of an Achilles tendon rupture

Achilles tendon ruptures are a common injury afflicting predominantly the young male occasional sportsman. Previous studies have shown that outcome is better with surgical repair for the young active patient. There is no consensus as to whether there is a difference in outcome between open and percutaneous minimally invasive surgery (MIS). A meta-analysis was undertaken to compare the clinical outcomes of MIS with conventional open surgical repair. Six randomised controlled trials of 277 Achilles tendon repairs were eligible for review. This included 136 minimally invasive repairs and 141 conventional open repairs. On analysis, there was no significant difference between the two surgical approaches in respect to the incidence of re-rupture, tissue adhesion, sural nerve injury, deep infection and deep vein thrombosis (p > 0.05). However, MIS had a significantly reduced risk of superficial wound infection, with three times greater patient satisfaction for good to excellent results compared with conventional open surgical approaches.     

Calcaneal positioning in equinus immobilization of the ankle joint: A comparison of common orthoses used in the treatment of acute Achilles tendon ruptures

Orthoses are an important part of both conservative and operative treatment of acute Achilles tendon rupture as they can be used to position the foot in equinus and protect the torn tendon from strain in the healing phase. The aim of the study was to test four different orthoses ability to position the foot in equinus. The study was performed as a cross-sectional study. 15 healthy study participants underwent radiographic examination with 11 true lateral radiographs of the right ankle and foot, one with the ankle joint in neutral position; one of a circular equinus cast (CEC); three of an adjustable equinus boot (AEB) with the foot in 30°, 15°, and 0° of plantar flexion, respectively; three of a fixed angle orthosis with 1, 2, and 3 wedges with a plateau (WWP); and three of a fixed angle orthosis with 1, 2, and 3 wedges without plateau (WWOP). The primary outcome was the Achilles Relief Distance (ARD). Secondary outcomes were the tibiocalcaneal angle (TCA), the tibiotalar angle (TTA), and the tibio- 1st metatarsal angle (1MTP). All measurements were performed by a radiologist. The mean (SD) ARD was 11 mm (7) in CEC, 23 mm (6) with 3 WWP, 11 mm (5) with 3 WWOP, and 15 mm (5) using AEB in 30° of plantarflexion. The mean (SD) TCA was 86° (7,8) in CEC, 76° (7,3) with 3 WWP, 90° (6,9) with 3 WWOP, and 84° (6,6) using the AEB in 30° of plantarflexion. CEC, AEB, and WWOP showed statistically significantly larger plantarflexion than WWP. CEC, AEB and WWOP produced significantly greater plantarflexion compared to WWP.     

Negative-pressure wound therapy in skin grafts: A systematic review and meta-analysis of randomized controlled trials

IntroductionAlthough skin grafts are widely used in reconstruction of large skin defect and complex wounds, many factors lead to suboptimal graft take. Negative-pressure wound therapy (NPWT) reportedly increases the graft take rates when added to skin grafting, but a summary analysis of the data of randomized controlled trials has yet to be performed. We conducted this systematic review and meta-analysis of randomized controlled trials to compare the effectiveness and safety of NPWT and non-NPWT for patients with skin grafts.MethodsWe searched PubMed, Embase, Cochrane Library, and CNKI for relevant trials based on predetermined eligibility criteria from database establishment to February 2020. Two reviewers screened citations and extracted data independently. The quality of the included studies was evaluated according to the Cochrane Handbook, whereas statistical heterogeneity was assessed using chi-square tests and I2 statistics. Review Manager 5.3 was used for statistical analysis.ResultsTen randomized controlled trials with 488 patients who underwent NPWT or non-NPWT were included. Compared with non-NPWT, NPWT yielded an improved the percentage of graft take, a reduction in days from grafting to discharge, with lower relative risk of re-operation, and no increased relative risk of adverse event. Further, the subgroup analysis showed an improved the percentage of graft take in negative pressure of 80 mmHg, and no improved the percentage of graft take in negative pressure of 125 mmHg.ConclusionNPWT is more effective than non-NPWT for the integration of skin grafts, and the negative pressure of 80 mmHg can be recommended. Data on adverse events and negative pressure are, however, limited. A better understanding of complications after NPWT and the ideal negative pressure for the integration of skin grafts is imperative.     

Contralateral prophylactic mastectomy (CPM): A systematic review of patient reported factors and psychological predictors influencing choice and satisfaction

ObjectiveConduct a systematic review of quantitative and qualitative studies exploring patient reported factors and psychological variables influencing the decision to have contralateral prophylactic mastectomy (CPM), and satisfaction with CPM, in women with early stage breast cancer.MethodsStudies were identified via databases: Medline, CINAHL, Embase and PsycINFO. Data were extracted by one author and crosschecked by two additional authors for accuracy. The quality of included articles was assessed using standardised criteria by three authors.ResultsOf the 1346 unique citations identified, 17 were studies that met the inclusion criteria. Studies included were primarily cross-sectional and retrospective. No study utilised a theoretical framework to guide research and few studies considered psychological predictors of CPM. Fear of breast cancer was the most commonly cited reason for CPM, followed by cosmetic reasons such as desire for symmetry. Overall, women appeared satisfied with CPM, however, adverse/diminished body image, poor cosmetic result, complications, diminished sense of sexuality, emotional issues and perceived lack of education regarding alternative surveillance/CPM efficacy were cited as reasons for dissatisfaction.ConclusionCurrent literature has begun to identify patient-reported reasons for CPM; however, the relative importance of different factors and how these factors relate to the process underlying the decision to have CPM are unknown. Of women who considered CPM, limited information is available regarding differences between those who proceed with or ultimately decline CPM.     

Porous-coated femoral components with or without hydroxyapatite in primary uncemented total hip arthroplasty: a systematic review of randomized controlled trials

The purpose of this systematic review was to determine the clinical and radiologic benefit of hydroxyapatite coating in uncemented primary total hip arthroplasty. A database of Medline articles published up to September 2007 was compiled and screened. Eight studies involving 857 patients were included in the review. Pooled analysis for Harris hip score as a clinical outcome measure demonstrated no advantage of the hydroxyapatite coating (WMD: 1.49, P = 0.44). Radiologically, both groups showed equal presence of endosteal bone ingrowth (RR: 1.04, P = 0.66) and radioactive lines (RR: 1.02, P = 0.74) in the surface area of the prosthesis. This meta-analysis demonstrates neither clinical nor radiologic benefits on the application of a hydroxyapatite coating on a femoral component in uncemented primary total hip arthroplasty.     

Rates of complications in Achilles tendon rupture repair using absorbable and nonabsorbable suture material; A systematic review

BackgroundThe impact of suture type on tensile strength, re-rupture rates and infection risk in Achilles tendon rupture repair is not been well established. The aim of this review is to evaluate existing literature on the associated risk of postoperative infection with absorbable and non-absorbable suture materials in Achilles tendon rupture repair.MethodsA systematic review of search databases PubMed; Google Scholar; and OVID Medline was made to identify studies related to complications associated with Achilles tendon rupture repair. PRISMA guidelines were utilised for this review. Meta-analysis was used to compare rupture rates and infections following rupture repair.Results12 studies with a total of 460 patients, 230 in both nonabsorbable and absorbable suture groups were included for analysis. Risk of wound complications was significantly higher in patients with non-absorbable sutures (p < 0.001).ConclusionNonabsorbable braided sutures is associated with the highest risk of postoperative wound complications following Achilles tendon rupture repair.     

The relationship between patient volume and mortality in American trauma centres: A systematic review of the evidence

ObjectiveTo synthesise published and unpublished findings examining the relationship between institutional trauma centre volume or trauma patient volume per surgeon and mortality.BackgroundEvidence on the relationship between patient volume and survival in trauma patients is inconclusive in the literature and remains controversial.MethodsA literature search was performed to identify studies published between 1976 and 2013 via MEDLINE (Pubmed) and the Cumulative Index to Nursing and Allied Health Literature (EbscoHost) as well as footnote chasing. Abstracts from appropriate conferences and ProQuest Dissertations and Theses were also searched. Inclusion criteria required studies to be original research published in English that examined the relationship between mortality and either institutional or per surgeon volume in American trauma centres. We employed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement checklist and flowchart. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was employed to rate the quality of the evidence.ResultsOf 1392 studies reviewed, 19 studies met defined inclusion criteria; all studies were retrospective. The definition of volume was heterogeneous across the studies. Patient population and analysis methods also varied across the studies. Sixteen studies (84%) examined the relationship between institutional trauma centre volume and mortality. Of the 16 studies, 12 examined the volume of severely injured patients and eight examined overall trauma patient volume. High institutional volume was associated with at least somewhat improved mortality in ten of 16 studies (63%); however, nearly half of these studies found only some subpopulations experienced benefits. In the remaining six studies, volume was not associated with any benefits. Four studies (25%) analysed the impact of surgeon volume on mortality. High volume per surgeon was associated with improved mortality in only one of four studies (25%).ConclusionsThe studies were extremely heterogeneous, thus definitive conclusions cannot be drawn regarding optimal volume before a clear advantage in survival is observed. A prospective study defining volume as a continuous variable is warranted to support current admission criteria for American trauma patients.     

Analysis of reporting return to work in studies comparing open with endoscopic carpal tunnel release: A review of randomized controlled trials

BACKGROUND:

In studies comparing open with endoscopic carpal tunnel release, return to work (RTW) is often cited as a primary outcome.

OBJECTIVE:

The present study assessed the reporting of RTW and evaluated its usefulness in studies comparing these two methods of carpal tunnel release.

METHODS:

A computerized search was conducted to find randomized controlled trials that compared open with endoscopic carpal tunnel release, with RTW as an outcome measure. The factors that were compared across the studies included definition of RTW, units quantifying RTW, measures of hand function, patients’ type of employment, worker’s compensation or insurance status, patients’ handedness, unilateral or bilateral carpal tunnel release, and use of rehabilitation.

RESULTS:

Fifteen studies met the inclusion criteria for the present systematic review. Of the 15 studies reviewed, there were seven definitions of RTW. All studies defined whether the patients underwent unilateral or bilateral carpal tunnel release but there was variability in the calculation of RTW when bilateral releases were performed. The impact of worker’s compensation or insurance, type of work, handedness and rehabilitation were inconsistently addressed as factors affecting RTW.

CONCLUSIONS:

Although RTW ideally reflects function and recovery, it is inadequately measured and reported. The present review revealed that, in studies comparing open carpal tunnel release with endoscopic carpal tunnel release, there is lack of uniformity in reporting RTW, which may contribute to the inconclusive results for RTW. Future research needs to ensure that RTW is used in a consistent manner.     

Evidence for the use of PRP in chronic midsubstance Achilles tendinopathy: A systematic review with meta-analysis

BackgroundPlatelet-rich plasma (PRP) injections have been proposed as an additional therapy in the treatment of chronic midsubstance Achilles tendinopathy (AT). The use of PRP injections as pharmacological treatment added to a conservative approach has gained growing interest, but the efficacy remains highly debated. The varying methodological quality of the available studies may contribute to these contradictory results. The aim of this systematic review with meta-analysis was to establish the existing evidence of PRP injections for chronic midsubstance AT on the functional outcome, with a risk of bias assessment of each included study.MethodsAccording to the PRISMA guidelines systematic searches were performed in Embase, the Cochrane library and Pubmed on June 12, 2020 for relevant literature. Only clinical trials comparing PRP injections with placebo, additional to an eccentric training program, in midsubstance AT were included. The primary outcome was Victorian Institute of Sport Assessment - Achilles (VISA-A) score at 3, 6 and 12 months post-injection. Risk of bias was assessed using the Cochrane risk-of-bias tool for randomized trials (Rob 2). As secondary outcome we assessed reported changes in tendon structure after PRP injections.ResultsA total of 367 studies were identified with the initial database search. Finally, four randomized controlled trials (RCTs) met inclusion criteria for systematic review and meta-analysis with data of 170 patients available for pooling. Results showed no difference in clinical outcome between the PRP and placebo group at different points in time using the VISA-A score as outcome parameter (3 months 0.23 (CI -0.45, 0.91); 6 months 0.83 (CI -0.26, 1.92); 12 months 0.83 (CI -0.77, 2.44)). The bias analysis showed a low or intermediate risk of bias profile for all studies which supports the good methodological quality of each included article. Finally, it is unclear whether PRP injections cause an improvement in tendon structure. However, no direct relationship between tendon structure and clinical presentation of AT could be found.ConclusionPRP has no clear additional value in management of chronic midsubstance Achilles tendinopathy and therefore should not be used as a first-line treatment option.     

Methodological quality of randomised controlled trials in burns care. A systematic review

Objective

To evaluate the methodological quality of published randomised controlled trials (RCTs) in burn care treatment and management.

Methods

Using a predetermined search strategy we searched Ovid MEDLINE (1950 to January 2008) database to identify all English RCTs related to burn care. Full text studies identified were reviewed for key demographic and methodological characteristics. Methodological trial quality was assessed using the Jadad scale.

Results

A total of 257 studies involving 14,535 patients met the inclusion criteria. The median Jadad score was 2 (out of a best possible score of 5). Information was given in the introduction and discussion sections of most RCTs, although insufficient detail was provided on randomisation, allocation concealment, and blinding. The number of RCTs increased between 1950 and 2008 (Spearman's rho = 0.6129, P < 0.001), although the reporting quality did not improve over the same time period (P = 0.1896) and was better in RCTs with larger sample sizes (median Jadad score, 4 vs. 2 points, P < 0.0001). Methodological quality did not correlate with journal impact factor (P = 0.2371).

Conclusions

The reporting standards of RCTs are highly variable and less than optimal in most cases. The advent of evidence-based medicine heralds a new approach to burns care and systematic steps are needed to improve the quality of RCTs in this field. Identifying and reviewing the existing number of RCTs not only highlights the need for burn clinicians to conduct more trials, but may also encourage burn health clinicians to consider the importance of conducting trials that follow appropriate, evidence-based standards.     

Aromatherapy for the relief of symptoms in burn patients: A systematic review of randomized controlled trials

Background

Aromatherapy is often used to manage several conditions, including pain, psychological distress, and burn-related symptoms. The objective of this review was to assess the current evidence regarding the efficacy of aromatherapy as a treatment for burn wounds.

Long-term follow-up of functional outcome in patients with a cloacal malformation: A systematic review

Background

Reconstructive surgery is performed in patients with cloacal malformations to achieve anorectal, urological, and gynecological function. The aim of this study was to evaluate the functional outcome of cloacal malformation repair as reported in literature.

Methods

A systematic literature search was conducted according to PRISMA guidelines using PubMed, EMbase, and Web-of-Science. Records were assessed for the reporting of functional outcomes, which was divided into anorectal, urological, or gynecological function. Studies were used in qualitative (Rangel score) and quantitative syntheses.

Results

Twelve publications were eligible for inclusion. Voluntary bowel movements were reported in 108 of 188 (57%), soiling in 146 of 205 (71%), and constipation in 31 of 61 patients (51%). Spontaneous voiding was reported for 138 of 299 patients (46%). 141 of 332 patients (42%) used intermittent catheterization, and 53 of 237 patients (22%) had a urinary diversion. Normal menstruations were reported for 25 of 71 patients (35%). Centers with limited experience reported similar outcome compared to centers with more experience (≥ 1 patients/year).

Conclusion

In this review we present functional outcome of the largest pooled cohort of patients with cloacal malformations as reported from 1993 to 2012. Functional disturbances are frequently encountered in anorectal, urological, as well as gynecological systems. Reporting of functional outcome in these patients should improve to increase knowledge about long-term results in patients with this rare malformation and to reach higher study quality. Especially, sacral and spinal anomalies should always be reported given their impact on functional outcome. Specialized care centers may be of great importance for patients with rare and complex conditions.