Paper 37: Industry funding in rotator cuff repair with patch augmentation does not influence reported outcomes

Objectives: Industry funding has been shown to affect study outcomes in orthopaedic literature. This systematic review aimed to evaluate the influence of industry funding on outcomes of studies investigating rotator cuff repair with patch augmentation.
Methods: Article Selection This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Pubmed, Scopus, and Web of Science were queried from January 1, 2000 to July, 2024 for studies investigating efficacy of patch augmentation in rotator cuff repair. Studies were screened by title and abstract by two independent reviewers (E.H.L and C.L.F) using Covidence (Veritas Health Innovation, Melbourne, Australia). A third author (J.N.L.) resolved any conflicts that arose from any scoring from the prior two reviewers. Inclusion criteria were studies that reported funding sources and conflict of interests in the manuscript, were written in English, and were published in a peer-reviewed journal. Studies were included if funding sources or conflict of interests were 'none.' Exclusion criteria were systematic reviews, meta-analyses, or case reports. After title and abstract screening were completed, full-text manuscripts were screened for inclusion.Data Collection General study characteristics were collected, including publication year, journal, and level of evidence. Study funding was categorized into one of five categories: 'Industry', 'special society', 'National Institute of Health' (NIH), 'grant', or 'none'. A study was considered funded if they received any monetary support or gifts (including the patch itself) from the funder. A study was considered to have a conflict of interest if any of the authors had any affiliation with the manufacturers of the patch or the funding institution. Study outcome was categorized into one of three categories: 'positive', 'neutral', or 'negative'. Studies were deemed 'positive' if the primary outcome measure findings favored the implant, if the implant was claimed to be cost-effective, or if there was a recommendation for its implementation. Studies were deemed 'negative' if the primary outcome measure findings did not favor the implant, if the study recommended against its implementation, or if the implant was claimed to be cost-ineffective. Studies were deemed 'neutral' if the null hypothesis failed to be rejected, or if the primary outcome measure findings did not favor or discourage use of the implant. Studies were also categorized into one of two categories for patch type: 'structural' or 'biological'. 'Structural' patches were those composed of acellular dermal or synthetic patches. 'Biological' patches were those composed of collagen, fascia lata, tendon allografts, small intestine, or pericardial patches. Cohen's kappa was used to analyze level of agreement between the two authors. A Cohen's kappa of more than 0.8 indicated almost perfect agreement, 0.61-0.8 indicated substantial agreement, 0.41-0.6 indicated moderate agreement, 0.21-0.4 indicated fair agreement, and 0-0.2 indicated slight agreement. Quality/Bias AssessmentAssessment of study quality was done based on study type. For randomized clinical studies, the Jadad score was used.18 For non-randomized clinical studies, the Methodological Index for Non-Randomized Studies (MINORS) was utilized to grade quality. For cadaver studies, the QUality Appraisal for Cadaveric Studies (QUACS) scale was used. For animal studies, the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool was used.
Results: Quality Assessment The average Jadad score for the 9 randomized studies was 2.8 out of 5. The average QUACS score for cadaver studies was 10.6 out of 13. The average MINORS score for the non-randomized clinical studies was 10.3 out of 16 in the 46 non-comparative studies and 17.8 out of 24 in the 21 comparative studies. The average SYRCLE score for animal studies was 5.0 out of 10. There were 29 studies that did not meet criteria for any of the methodological bias tools.Study Funding and OutcomesOf the 147 included studies, 17 (11.6%) were industry-funded, 98 (66.7%) were not funded, and 32 (21.8%) were classified as 'other.' In terms of outcome, 126 (85.7%) of studies were positive, 15 (10.2%) were neutral, and 6 (4.08%) were negative (Table 1)Of the industry-funded studies, 13 were positive, 3 were neutral, and 1 was negative. Of the non-funded studies, 84 were positive, 10 were neutral, and 4 were negative. Of other studies, 29 were positive, 2 were neutral, and 1 was negative. There was no association between funding type and study outcome (p=0.758). There were 36 studies that had a conflict of interest compared to 111 that did not. There was no association between reported conflict of interests and study outcome (p=0.851).Patch Type and OutcomesIn the patch type groups, there were 47 biological, 80 structural, and 20 other patches. There was no association between patch type and study outcome (p=0.818) (Table 2). There was also no association between patch type and funding source (p=0.242) or presence of conflict of interest (0.879).
Conclusions: Industry funding does not result in significantly more positive results in studies investigating patch augmentation in rotator cuff repair. The majority of available research of patch augmentation demonstrates favorable outcomes. Clinicians using research to help inform their practice should always be wary for the presence of biases within research, however, industry bias does not appear to impact this group of studies.