Financial Conflicts of Interest Among Systematic Review Authors Investigating Interventions for Achilles Tendon Ruptures.
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ABSTRACT: Background
The primary aim of our study was to evaluate the effects of undisclosed financial conflicts of interest in Achilles tendon rupture repair-focused systematic reviews.Methods
Following a cross-sectional study design, we searched MEDLINE and Embase for Achilles tendon rupture repair systematic reviews. We performed screening and data extraction in a blind, triplicate fashion. Each systematic review was evaluated on the individual characteristics of the study, presence of undisclosed and disclosed conflicts of interest, favorability of results and conclusions, and the relationship between conflicts of interest and the favorability of results and conclusions.Results
Our search produced 172 total systematic reviews pertaining to Achilles tendon rupture repair; of those, only 12 were included in our study. Undisclosed conflicts of interest were found in half (6/12) of the included reviews. However, no significant association was found between conflict of interest and the favorability of results and conclusions.Conclusion
Undisclosed conflicts of interests were discovered in a large percentage of our sample. This lack of disclosure did not appear to increase the likelihood of the systematic review results or conclusions reporting favorability of the intervention being investigated.Level of evidence
Level II.
SUBMITTER: Cole WT
PROVIDER: S-EPMC8702762 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPrevious studies have highlighted the potential influence that industry relationships may have on the outcomes of medical research.ObjectiveWe aimed to determine the prevalence of author conflicts of interest (COIs) in systematic reviews focusing on melanoma interventions, as well as to determine whether the presence of these COIs were associated with an increased likelihood of reporting favorable results and conclusions.MethodsThis cross-sectional study included systematic reviews with or without meta-analyses focusing on interventions for melanoma. We searched MEDLINE and Embase for eligible systematic reviews published between September 1, 2016, and June 2, 2020. COI disclosures were cross-referenced with information from the CMS (Centers for Medicare & Medicaid Services) Open Payments database, Dollars for Profs, Google Patents, the United States Patent and Trademark Office, and previously published COI disclosure statements. Results were quantified using descriptive statistics, and relationships were evaluated by Fisher exact tests.ResultsOf the 23 systematic reviews included in our sample, 12 (52%) had at least one author with a COI. Of these 12 reviews, 7 (58%) reported narrative results favoring the treatment group and 9 (75%) reported conclusions favoring the treatment group. Of the 11 systematic reviews without a conflicted author, 4 (36%) reported results favoring the treatment group and 5 (45%) reported conclusions favoring the treatment group. We found no significant association between the presence of author COIs and the favorability of results (P=.53) or conclusions (P=.15).ConclusionsAuthor COIs did not appear to influence the outcomes of systematic reviews regarding melanoma interventions. Clinicians and other readers of dermatology literature should be cognizant of the influence that industry may have on the nature of reported outcomes, including those from systematic reviews and meta-analyses.
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Project description:ImportanceIt is unclear how medical journals address authors' financial and non-financial conflict of interest (COI).ObjectiveTo assess the policies of clinical journals for disclosure of financial and non-financial COI.MethodsCross sectional study that included both review of public documents as well as a simulation of a manuscript submission for the National Library of Medicine's "core clinical journals". The study did not involve human subjects. Investigators who abstracted the data, reviewed "instructions for authors" on the journal website and, in order to reflect the actual implementation of the COI disclosure policy, simulated the submission of a manuscript. Two individuals working in duplicate and independently to abstract information using a standardized data abstraction form, resolved disagreements by discussion or with the help of a third person.ResultsAll but one of 117 core clinical journals had a COI policy. All journals required disclosure of financial COI pertaining to the authors and a minority (35%) asked for financial COI disclosure pertaining to the family members or authors' institution (29%). Over half required the disclosure of at least one form of non-financial COI (57%), out of which only two (3%) specifically referred to intellectual COI. Small minorities of journals (17% and 24% respectively) described a potential impact of disclosed COI and of non-disclosure of COI on the editorial process.ConclusionWhile financial COI disclosure was well defined by the majority of the journals, many did not have clear policies on disclosure of non-financial COI, disclosure of financial COI of family members and institutions of the authors, and effect of disclosed COI or non-disclosure of COI on editorial policies.
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Project description:ObjectiveTo systematically evaluate the prevalence of disclosed and undisclosed financial conflicts of interest (FCOI) among clinical practice guidelines (CPGs).MethodsIn this systematic review, we ascertained the prevalence and types of FCOI for CPGs from January 1, 1980, to March 3, 2019. The primary outcome was the prevalence of FCOI among authors of CPGs. FCOI disclosures were compared between medical subspecialties and societies producing CPGs.ResultsAmong the 37 studies including 14,764 total guideline authors, 45% had at least one FCOI. The prevalence of FCOI per study ranged from 6% to 100%. More authors had FCOI involving general payments (39%) compared with research payments (29%). Oncology, neurology, and gastroenterology had the highest prevalence of FCOI compared with other medical specialties. Among the 8 studies that included the monetary values in US dollars of FCOI, average payments per author ranged from $578 to $242,300. Among the 10 studies that included data on undisclosed FCOI, 32% of authors had undisclosed industry payments.ConclusionThere are numerous FCOI among authors of CPGs, many of which are undisclosed. Our study found a significant difference in FCOI prevalence based on types of FCOI and CPG sponsor society. Additional research is required to quantify the implications of FCOI on clinical judgment and patient care.
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Project description:Achilles tendon ruptures are a common tendon injury, usually occurring in middle-aged men during recreational sporting activities. Both nonoperative and operative management are employed to treat these injuries. Several operative treatments are described in the literature, including percutaneous Achilles repair, mini-open repair, and open repair. Open Achilles repair is associated with higher rates of impaired wound healing and infection, whereas minimally invasive techniques have been reported to have an increased risk of iatrogenic sural nerve injury. More recently, low complication rates, improved cosmetic appearance, reduced operating times, and improved clinical outcomes have been reported for the percutaneous Achilles repair technique. In this Technical Note, we present our preferred technique using the Percutaneous Achilles Repair System (Arthrex, Naples, FL), which has been reported to have minimal wound and nerve complications, and early return to activity.
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Project description: Not available
| S-EPMC1336787 | biostudies-literature
Project description:BackgroundThe requirements of the health policy and services journals for authors to report their financial and non-financial conflicts of interest (COI) are unclear. The present article aims to assess the requirements of health policy and services journals for authors to disclose their financial and non-financial COIs.MethodsThis is a cross-sectional study of journals listed by the Web of Science under the category of 'Health Policy and Services'. We reviewed the 'Instructions for Authors' on the journals' websites and then simulated the submission of a manuscript to obtain any additional relevant information made available during that step. We abstracted data in duplicate and independently using a standardised form.ResultsOut of 72 eligible journals, 67 (93%) had a COI policy. A minority of policies described how the disclosed COIs of authors would impact the editorial process (34%). None of the policies had clear-cut criteria for rejection based on the content of the disclosure. Approximately a fifth of policies (21%) explicitly stated that inaccurate or incomplete disclosures might lead to manuscript rejection or retraction. No policy described whether the journal would verify the accuracy or completeness of authors' disclosed COIs. Most journals' policies (93%) required the disclosure of at least one form of financial COI. While the majority asked for specification of source of payment (71%), a minority asked for the amount (18%). Overall, 81% of policies explicitly required disclosure of non-financial COIs.ConclusionA majority of health policy and services journal policies required the disclosure of authors' financial and non-financial COIs, but few required details on disclosed COIs. Health policy journals should provide specific definitions and instructions for disclosing non-financial COIs. A framework providing clear typology and operational definitions of the different types of COIs will facilitate both their disclosure by authors and reviewers and their assessment and management by the editorial team and the readers.
| S-EPMC5606121 | biostudies-literature
Project description:BackgroundAchilles tendon ruptures are a common injury and are increasing in incidence. Several management strategies exist for both non-operative and operative care, with each strategy offering unique risks and benefits. Traditional pairwise meta-analyses have been performed to compare management strategies; however, all treatment options have never been integrated in a single analysis. Network meta-analysis (NMA) is a generalization of pairwise meta-analysis, which allows for the comparison of multiple interventions based on all available direct and indirect evidence. The objectives of this review are to synthesize the evidence on the management options for acute Achilles tendon rupture and identify which treatment gives the best functional outcomes.MethodsA systematic review with NMA is planned. An electronic literature search will be performed in conjunction with an experienced information specialist in MEDLINE, EMBASE, CINAHL, PEDro, and the Cochrane Central Register of Controlled Trials. We will include randomized controlled trials with a minimum 6-month follow-up. Two independent reviewers will screen citations for eligibility, extract study data, and perform risk of bias assessments. The primary outcome will be disease-specific functional outcome scores (AOFAS, Leppilahti, modified Leppilahti) at 1 year. Secondary outcomes will include complications (re-rupture, sural nerve injury, wound complications, deep infection, secondary surgeries), strength, range of motion, return to work, return to sport, and quality-of-life measures (including the SF-36 questionnaire). Traditional pairwise meta-analyses will be performed for all direct comparisons where evidence is available, and NMAs will subsequently be performed where possible to compare all management strategies.DiscussionThe data generated from this review will provide health-care providers with a clear evidence synthesis of all Achilles tendon rupture management strategies. Additionally, these data will be incorporated into the development of a patient decision aid to assist patients and clinicians in making a preference-based decision when faced with an Achilles tendon rupture.Systematic review registrationPROSPERO CRD42018093033 .
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Project description:ObjectivesTo compare re-rupture rate, complication rate, and functional outcome after operative versus nonoperative treatment of Achilles tendon ruptures; to compare re-rupture rate after early and late full weight bearing; to evaluate re-rupture rate after functional rehabilitation with early range of motion; and to compare effect estimates from randomised controlled trials and observational studies.DesignSystematic review and meta-analysis.Data sourcesPubMed/Medline, Embase, CENTRAL, and CINAHL databases were last searched on 25 April 2018 for studies comparing operative versus nonoperative treatment of Achilles tendon ruptures.Study selection criteriaRandomised controlled trials and observational studies reporting on comparison of operative versus nonoperative treatment of acute Achilles tendon ruptures.Data extractionData extraction was performed independently in pairs, by four reviewers, with the use of a predefined data extraction file. Outcomes were pooled using random effects models and presented as risk difference, risk ratio, or mean difference, with 95% confidence interval.Results29 studies were included-10 randomised controlled trials and 19 observational studies. The 10 trials included 944 (6%) patients, and the 19 observational studies included 14?918 (94%) patients. A significant reduction in re-ruptures was seen after operative treatment (2.3%) compared with nonoperative treatment (3.9%) (risk difference 1.6%; risk ratio 0.43, 95% confidence interval 0.31 to 0.60; P<0.001; I2=22%). Operative treatment resulted in a significantly higher complication rate than nonoperative treatment (4.9% v 1.6%; risk difference 3.3%; risk ratio 2.76, 1.84 to 4.13; P<0.001; I2=45%). The main difference in complication rate was attributable to the incidence of infection (2.8%) in the operative group. A similar reduction in re-rupture rate in favour of operative treatment was seen after both early and late full weight bearing. No significant difference in re-rupture rate was seen between operative and nonoperative treatment in studies that used accelerated functional rehabilitation with early range of motion (risk ratio 0.60, 0.26 to 1.37; P=0.23; I2=0%). No difference in effect estimates was seen between randomised controlled trials and observational studies.ConclusionsThis meta-analysis shows that operative treatment of Achilles tendon ruptures reduces the risk of re-rupture compared with nonoperative treatment. However, re-rupture rates are low and differences between treatment groups are small (risk difference 1.6%). Operative treatment results in a higher risk of other complications (risk difference 3.3%). The final decision on the management of acute Achilles tendon ruptures should be based on patient specific factors and shared decision making. This review emphasises the potential benefits of adding high quality observational studies in meta-analyses for the evaluation of objective outcome measures after surgical treatment.
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Project description:BackgroundAs no evidence-based treatment guidelines exist for chronic Achilles tendon rupture (CATR), a systematic review of the literature was performed to compare the different treatment options and recommend a literature-based algorithm.MethodsIn June 2022, MEDLINE, Embase, and Cochrane Library databases were systematically reviewed based on the PRISMA guidelines. The level of evidence (LOE) and quality of evidence were evaluated, and statistics on clinical outcomes and complications were calculated.ResultsTwenty-seven studies with 614 patients were included. Three studies were LOE III and 25 studies were LOE IV. The mean Achilles tendon rupture score improved from a preoperative weighted mean of 38.8 ± 12.4 to a postoperative score 90.6 ± 4.7. The overall complication rate was 11.4%. Single techniques were used in 23 studies and dual techniques were used in 5 studies. The FHL tendon transfer was the most frequently used technique. We devised an algorithmic approach based on time from injury to surgical intervention and the length of the gap between the tendon stumps: >3 months: FHL transfer; <3 months (a) gap <2 cm, end-to-end repair; (b) gap 2 to 5 cm, gastrocnemius transfer, (c) gap >5 cm, semitendinosus autograft.ConclusionSurgical management of CATR produced improvements in patient-reported outcome scores at midterm follow up, but a high complication rate (11.4%) was noted. Our proposed treatment algorithm may assist in shared decision making for this complex problem.
| S-EPMC10557420 | biostudies-literature
Project description:PurposeThe aim of this systematic review and meta-analysis was to compare re-rupture rates, complication rates, functional outcomes, as well as return to work (RTW)/sport (RTS) among different rehabilitation protocols following operative treatment of acute Achilles tendon ruptures.MethodsSystematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Five databases were searched for randomized controlled trials (RCTs) comparing at least two rehabilitation protocols following surgical repair of acute Achilles tendon ruptures. Rehabilitation protocols were classified as a variation of either non-weightbearing (NWB) or weightbearing (WB) and immobilization (IM) or mobilization (M). The data collection consisted of re-ruptures, complications, and RTW/RTS.ResultsOut of 2760 studies screened, 20 RCTs with 1007 patients were eligible. Fourteen studies included a group consisting of WB + M (Group 1), 11 of WB + IM (Group 2), 3 of NWB + M (Group 3), and 13 of NWB + IM (Group 4). Outcome parameters available for a meta-analysis were re-ruptures, complications, RTW, and RTS. Re-ruptures overall occurred in 2.7%, with prevalences ranging between 0.04 and 0.08. Major complications occurred in 2.6%, with prevalences ranging between 0.02 and 0.03. Minor complications occurred in 11.8% with prevalances ranging between 0.04 to 0.17. Comparing the odds-ratios between the four different groups revealed no significant differences with overall favourable results for group 1 (WB+M).ConclusionEarly functional rehabilitation protocols with early ankle M and WB following surgical repair of acute Achilles tendon ruptures are safe and they apparently allow for a quicker RTW and RTS and seem to lead to favourable results.
| S-EPMC9619394 | biostudies-literature