Cailan L Feingold, Eric H Lin, Ajith K Subhash, Joshua M Yazditabar, Avinesh Agarwalla, Joseph N Liu
{"title":"Investigating the Relationship Between Subacromial Balloon Spacer Study Outcomes and Study Funding.","authors":"Cailan L Feingold, Eric H Lin, Ajith K Subhash, Joshua M Yazditabar, Avinesh Agarwalla, Joseph N Liu","doi":"10.1016/j.jse.2024.12.052","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Subacromial balloon spacers are implants used for the treatment of irreparable rotator cuff tears. Many studies on subacromial balloon spacers use industry funding and existing literature has shown that industry funding can impact reported outcomes in research. This study aims to evaluate the outcomes of industry-funded balloon spacer studies. We hypothesized that industry-funded studies are more likely to report positive results than studies without funding.</p><p><strong>Methods: </strong>PubMed, Scopus, and Embase were searched using the term \"balloon spacer\" from January 1, 2000, to the present. Inclusion criteria were (1) a study on subacromial balloon spacers with (2) funding or conflict of interest (COI) explicitly documented. Outcomes of studies were categorized into \"positive\" if the null hypothesis was rejected or the outcomes favored the implant, \"neutral\" if the null hypothesis was confirmed, or \"negative\" if the result did not favor the implant. Funding type was grouped by \"no funding\" or \"industry funding\", studies with other funding types such as specialty society or National Institute of Health. Agreement between two reviewers in categorization of study outcome was analyzed using Cohen's kappa. Statistical analyses were conducted using Fisher exact tests. The level of significance was set at α = 0.05 with a Bonferroni correction of p < 0.0125.</p><p><strong>Results: </strong>Twenty studies were included for analysis; 9 (45 %) were industry-funded, 8 (40%) received no funding, and 3 (15%) received other funding. Of the 9 industry-funded studies, 8 (88.9%) reported \"positive\" outcomes and 1 (11.1%) reported a \"neutral\" outcome. Of the 8 non-funded studies, 4 (50%) reported \"positive\" outcomes, 2 (25%) reported \"negative\" outcomes, and 2 (25%) reported \"neutral\" outcomes. For studies with other funding, 1 (33.3%) was \"positive\", 1 (33.3%) was \"negative\", and 1 (33.3%) was \"neutral.\" Cohen's kappa of 0.806 indicated substantial agreement. By Fisher exact test, industry-funded studies were significantly more likely to report \"positive\" outcomes than non-funded studies (p=0.0105) but not more than studies with other funding (p=0.6000).</p><p><strong>Conclusion: </strong>Industry funding in studies on subacromial balloon spacers significantly increases the chance of the study reporting a \"positive\" outcome compared with non-funded studies. Clinicians using published literature to direct the use of subacromial balloon spacers in their practice should be wary of how study funding might impact their reported outcomes.</p>","PeriodicalId":50051,"journal":{"name":"Journal of Shoulder and Elbow Surgery","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Shoulder and Elbow Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jse.2024.12.052","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ORTHOPEDICS","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Subacromial balloon spacers are implants used for the treatment of irreparable rotator cuff tears. Many studies on subacromial balloon spacers use industry funding and existing literature has shown that industry funding can impact reported outcomes in research. This study aims to evaluate the outcomes of industry-funded balloon spacer studies. We hypothesized that industry-funded studies are more likely to report positive results than studies without funding.
Methods: PubMed, Scopus, and Embase were searched using the term "balloon spacer" from January 1, 2000, to the present. Inclusion criteria were (1) a study on subacromial balloon spacers with (2) funding or conflict of interest (COI) explicitly documented. Outcomes of studies were categorized into "positive" if the null hypothesis was rejected or the outcomes favored the implant, "neutral" if the null hypothesis was confirmed, or "negative" if the result did not favor the implant. Funding type was grouped by "no funding" or "industry funding", studies with other funding types such as specialty society or National Institute of Health. Agreement between two reviewers in categorization of study outcome was analyzed using Cohen's kappa. Statistical analyses were conducted using Fisher exact tests. The level of significance was set at α = 0.05 with a Bonferroni correction of p < 0.0125.
Results: Twenty studies were included for analysis; 9 (45 %) were industry-funded, 8 (40%) received no funding, and 3 (15%) received other funding. Of the 9 industry-funded studies, 8 (88.9%) reported "positive" outcomes and 1 (11.1%) reported a "neutral" outcome. Of the 8 non-funded studies, 4 (50%) reported "positive" outcomes, 2 (25%) reported "negative" outcomes, and 2 (25%) reported "neutral" outcomes. For studies with other funding, 1 (33.3%) was "positive", 1 (33.3%) was "negative", and 1 (33.3%) was "neutral." Cohen's kappa of 0.806 indicated substantial agreement. By Fisher exact test, industry-funded studies were significantly more likely to report "positive" outcomes than non-funded studies (p=0.0105) but not more than studies with other funding (p=0.6000).
Conclusion: Industry funding in studies on subacromial balloon spacers significantly increases the chance of the study reporting a "positive" outcome compared with non-funded studies. Clinicians using published literature to direct the use of subacromial balloon spacers in their practice should be wary of how study funding might impact their reported outcomes.
期刊介绍:
The official publication for eight leading specialty organizations, this authoritative journal is the only publication to focus exclusively on medical, surgical, and physical techniques for treating injury/disease of the upper extremity, including the shoulder girdle, arm, and elbow. Clinically oriented and peer-reviewed, the Journal provides an international forum for the exchange of information on new techniques, instruments, and materials. Journal of Shoulder and Elbow Surgery features vivid photos, professional illustrations, and explicit diagrams that demonstrate surgical approaches and depict implant devices. Topics covered include fractures, dislocations, diseases and injuries of the rotator cuff, imaging techniques, arthritis, arthroscopy, arthroplasty, and rehabilitation.