Conflict Of Interest Statement Research Articles

Conflict of Interest Statement

Conflict of Interest Statement

Adoption of the voluntary conflict of interest statement on PubMed.

In 2017, the National Library of Medicine (NLM) added a voluntary field for conflict of interest (COI) statements ("posted COI") on the abstract page of PubMed, but the extent to which it is used is unknown. This repeated cross-sectional study examined journals and articles indexed on PubMed from 2016 through 2021. We described the proportion of all journals with at least one article that included a posted COI and the percentage of all articles that included a posted COI over time. We also examined 100 randomly selected articles published between June 2021 and May 2022 from each of the 40 highest impact journals. For these, we established whether the articles had published COIs, and, of these, the proportion that included a posted COI. Among approximately 7,000 journals publishing articles each year, the proportion of journals with at least one article with a posted COI statement increased from 25.9% in 2016 to 33.2% in 2021. Among nearly 400,000 articles published each year, the proportion of articles that included a posted COI also increased from 9.0% in 2016 to 43.0% in 2021. Among 3,888 articles published in the 40 highest impact journals in 2021-2022, 30.2% (95% CI: 28.7%-31.6%) had published COIs; of these, 63.3% (95% CI: 60.4%-66.0%) included a posted COI. Use of the PubMed COI statement has increased since it became available in 2017, but adoption is still limited, even among high impact journals. NLM should carry out additional outreach to journals that are not using the statement to promote greater transparency of COIs.

Differences in the reporting of conflicts of interest and sponsorships in systematic reviews with meta-analyses in dentistry: an examination of factors associated with their reporting

BackgroundReporting conflicts of interest (COI) and sources of sponsorship are of paramount importance in adequately interpreting the results of systematic reviews. Some evidence suggests that there is an influence of COI and sponsorship on the study results.The objectives of this meta-research study were twofold: (a) to assess the reporting of COI and sponsorship statements in systematic reviews published in dentistry in three sources (abstract, journal’s website and article’s full text) and (b) to assess the associations between the characteristics of the systematic reviews and reporting of COI.MethodsWe searched the PubMed database for dental systematic reviews published from database inception to June 2023. We assessed how COI and sponsorship statements were reported in the three sources. We performed a logistic regression analysis to assess the associations between the characteristics of the systematic reviews and the reporting of COI.ResultsWe assessed 924 abstracts published in PubMed and on the corresponding journals´ websites. Similarly, full texts associated with the 924 abstracts were also assessed. A total of 639 (69%) and 795 (88%) studies had no statement of COI in the abstracts on PubMed and the journal’s website, respectively. In contrast, a COI statement was reported in 801 (87%) full texts. Sponsorship statements were not reported in 911 (99%) and 847 (93%) abstracts published in PubMed and a journal´s website, respectively. Nearly two-thirds of the full-text articles (N = 607) included sponsorship statements. Journal access was significantly associated with COI statement reporting in all three sources. Open-access journals have significantly higher odds to report COI in PubMed and full-texts, while have significantly lower odds to report COI in the websites, compared with subscription or hybrid journals. type was significantly associated with COI statement reporting on the journal’s website and in the full text. Review registration based on the full text and the number of authors were significantly associated with COI statement reporting in PubMed and in the full texts. Several other variables were found to be significantly associated with COI statement reporting in one of the three sources.ConclusionsCOI and sponsorship statements seem to be underreported in the abstracts and homepage of the journals, compared to the full-texts. These results were particularly more pronounced in abstracts published in both the PubMed database and the journals’ websites. Several characteristics of systematic reviews were associated with COI statement reporting.

Assessment of conflicts of interest in literature on monoclonal antibodies for chronic rhinosinusitis with nasal polyposis using the Open Payments Database.

Accurate conflict of interest (COI) information is essential for promoting transparency and trust in research. We aim to assess COI disclosure patterns in monoclonal antibodies (MABs) research for chronic rhinosinusitis with nasal polyposis (CRSwNP) using the Open Payments Database (OPD). Studies on FDA-approved MABs for CRSwNP (dupilumab, omalizumab, mepolizumab) published between 2019 and 2021 with at least one US author were identified through PubMed. Industry-reported payments from the manufacturers (Sanofi, Regeneron, Genentech, Novartis, and GlaxoSmithKline) between 2018 and 2021 in OPD's General Payments category were collected. Authors were cross-checked against OPD metadata using a previously published ChatGPT-based algorithm. Additionally, this novel algorithm analyzed COI statements for relevant author‒company specific disclosures, identifying disclosed and undisclosed payments made 3‒15 months prior to publication. A total of 214 unique authors from 76 studies were included. Of 30 articles that received at least one relevant payment, 21 (70%) were found to have an undisclosed COI, with a mean total undisclosed payment of $4890 and a median of $10,331. Fifty-six authors had relevant OPD payments and 40 (71.4%) authors did not declare a potential COI. Interestingly, 158 authors had no relevant payments and 62 (39.2%) declared a potential COI. Author order was not significantly associated with potential under- or over-disclosure. This study characterizes COI disclosure patterns in rhinosinusitis-relevant MABs research using a novel automated approach. Given the discrepancy between disclosures and industry-reported payments, our findings suggest a need for improved disclosure education and practices.

RETRACTION: Reduced self-harm on acute mental health wards following the implementation of a vision-based patient monitoring system: Evidence from five NHS trusts.

M. Kekic, A. Rose, C. Baker, and D. Bayley, 'Reduced self-harm on acute mental health wards following the implementation of a vision-based patient monitoring system: Evidence from five NHS trusts,' Journal of Psychiatric and Mental Health Nursing (Early View), https://doi.org/10.1111/jpm.13036. The above article, published online on 05 March 2024 in Wiley Online Library (wileyonlinelibrary.com), has been retracted by agreement between the journal Editor-in-Chief, Hugh McKenna, and John Wiley & Sons Ltd. The retraction has been agreed due to an undisclosed conflict of interest by the authors, which was reported in a complaint by a third party. Following an investigation, it was confirmed that, while the authors reported their employment status with Oxehealth Ltd. in their personal affiliations section, they failed to do so in a conflict of interest statement as required by the journal. Because the journal uses a double-blind peer review process, neither the names of the authors nor their affiliations were visible to the reviewers and editors during evaluation of the manuscript. Had an employment status disclosure been made clear in a conflict-of-interest statement in accordance with the journal's submission guidelines, the Editor-in-Chief and all associate editors would have considered author employment by Oxehealth Ltd., the developer of the technology evaluated by the authors, as a major competing interest and would have rejected the manuscript without peer review. Therefore, the article must be retracted. Dr. Kekic disagrees with the retraction, on behalf of all the authors.

Analyzing the impact of different implant placement protocols on the esthetic stability of single implants: A comprehensive systematic review and meta-analysis.

Aims: To analyse impact of different implant placement timings on the esthetic stability of a single implant restoration in maxillary anterior region. Materials and methods: The systematic review and meta-analysis adhered to the PRISMA guidelines and were registered in the PROSPERO database. In addition to systematic searches on the national library of medicine (MEDLINE PubMed), Cochrane library, Google Scholar, and EbscoHost, manual searches were also conducted to identify articles published from January 1, 2000, to December 1, 2020. The included studies comprised randomized controlled trials, as well as prospective and retrospective cohort clinical studies. The assessment of risk of bias employed the Cochrane Collaboration's tool, MINORS tool, and a quality appraisal checklist. Utilizing the Review Manager software tool, a meta-analysis was conducted, and the robustness of the meta-analytic findings was duly evaluated. Results: Out of 313 studies screened, seven met the predetermined inclusion and exclusion criteria for incorporation into the systematic review. The meta-analysis disclosed an effect on marginal bone loss associated with different implant placement timings. However, the overall impact on esthetic stability was not statistically significant. Furthermore, there is moderate evidence suggesting a decrease in marginal bone loss following immediate implant placement, with a mean difference of -0.33mm. Conclusions: The timing of implant placement appears to have some impact on both marginal bone loss and pink esthetic score. However, no statistically significant difference was observed when comparing various implant placement timings in terms of pink esthetic score and marginal bone loss. The evidence lacked sufficient strength to firmly support the aforementioned observations, emphasizing the need for additional well-designed randomized clinical trials to draw definitive conclusions. Conflict of interest statement: The author reports no conflicts of interest related to this study.This study received no external funding.

Hepatic Ablation Technology: Assessment of Conflicts of Interest in Recent Literature.

Collaboration between the health care industry and surgeons is critical in modern medicine. Conflict of interest (COI) has the risk of introducing bias into research studies. We investigated the accuracy of self-disclosed COI for studies that researched the use of microwave ablation for liver metastasis. A literature search identified studies that investigated the use of microwave ablation for liver cancer between 2016 and 2022. We utilized the Open Payments Database to query individual authors' financial contributions from the industry. The accuracy of the disclosure statement and financial contribution for each study and author was calculated. We compared the amount of financial contribution authors received based on the accuracy of their COI statement. Twenty-five studies of interest were identified. The mean number of authors was 8.24. A disclosure statement was present in 52% of studies. Of those, 28% had an incongruent disclosure statement. 9/25 (36%) of studies had a conflict of interest based on financial payments provided by industry. Overall, authors received an average of $440,483.41 (SD $1,889,375.34). We did not find a difference in the financial contribution's value based on the disclosure statement's accuracy (P = .55). Over a quarter of studies in our review of microwave ablation literature had discrepancies in the reporting of conflicts of interest, highlighting the need for improved reporting of potential conflicts of interest to protect the integrity of clinical research. Compared to other fields of surgery, we found a lower rate of undisclosed COI, suggesting that the scope of cancer-directed surgery may be more resistant to industry influence.

Co-design workshops to develop evidence synthesis summary formats for use by clinical guideline development groups

BackgroundEvidence synthesis is used by decision-makers in various ways, such as developing evidence-based recommendations for clinical guidelines. Clinical guideline development groups (GDGs) typically discuss evidence synthesis findings in a multidisciplinary group, including patients, healthcare providers, policymakers, etc. A recent mixed methods systematic review (MMSR) identified no gold standard format for optimally presenting evidence synthesis findings to these groups. However, it provided 94 recommendations to help produce more effective summary formats for general evidence syntheses (e.g., systematic reviews). To refine the MMSR recommendations to create more actionable guidance for summary producers, we aimed to explore these 94 recommendations with participants involved in evidence synthesis and guideline development.MethodsWe conducted a descriptive qualitative study using online focus group workshops in February and March 2023. These groups used a participatory co-design approach with interactive voting activities to identify preferences for a summary format's essential content and style. We created a topic guide focused on recommendations from the MMSR with mixed methods support, ≥ 3 supporting studies, and those prioritized by an expert advisory group via a pragmatic prioritization exercise using the MoSCoW method (Must, Should, Could, and Will not haves). Eligible participants must be/have been involved in GDGs and/or evidence synthesis. Groups were recorded and transcribed. Two independent researchers analyzed transcripts using directed content analysis with 94 pre-defined codes from the MMSR.ResultsThirty individuals participated in six focus groups. We coded 79 of the 94 pre-defined codes. Participants suggested a “less is more” structured approach that minimizes methodological steps and statistical data, promoting accessibility to all audiences by judicious use of links to further information in the full report. They emphasized concise, consistently presented formats that highlight key messages, flag readers to indicators of trust in the producers (i.e., logos, websites, and conflict of interest statements), and highlight the certainty of evidence (without extenuating details).ConclusionsThis study identified guidance based on the preferences of guideline developers and evidence synthesis producers about the format of evidence synthesis summaries to support decision-making. The next steps involve developing and user-testing prototype formats through one-on-one semi-structured interviews to optimize evidence synthesis summaries and support decision-making.

ChatGPT for Automated Cross-Checking of Authors' Conflicts of Interest Against Industry Payments.

The Centers for Medicare & Medicaid Services "OpenPayments" database tracks industry payments to US physicians to improve research conflicts of interest (COIs) transparency, but manual cross-checking of articles' authors against this database is labor-intensive. This study aims to assess the potential of large language models (LLMs) like ChatGPT to automate COI data analysis in medical publications. An observational study analyzing the accuracy of ChatGPT in automating the cross-checking of COI disclosures in medical research articles against the OpenPayments database. Publications regarding Food and Drug Administration-approved biologics for chronic rhinosinusitis with nasal polyposis: omalizumab, mepolizumab, and dupilumab. First, ChatGPT evaluated author affiliations from PubMed to identify those based in the United States. Second, for author names matching 1 or multiple payment recipients in OpenPayments, ChatGPT undertook a comparative analysis between author affiliation and OpenPayments recipient metadata. Third, ChatGPT scrutinized full article COI statements, producing an intricate matrix of disclosures for each author against each relevant company (Sanofi, Regeneron, Genentech, Novartis, and GlaxoSmithKline). A random subset of responses was manually checked for accuracy. In total, 78 relevant articles and 294 unique US authors were included, leading to 980 LLM queries. Manual verification showed accuracies of 100% (200/200; 95% confidence interval [CI]: 98.1%-100%) for country analysis, 97.4% (113/116; 95% CI: 92.7%-99.1%) for matching author affiliations with OpenPayments metadata, and 99.2% (1091/1100; 95% CI: 98.5%-99.6%) for COI statement data extraction. LLMs have robust potential to automate author-company-specific COI cross-checking against the OpenPayments database. Our findings pave the way for streamlined, efficient, and accurate COI assessment that could be widely employed across medical research.

Disclosure of patenting activities within scientific publications as potential conflicts-of-interest: Evidences from biomedical literature

Most scientific publishers require authors to submit their manuscripts with a text reporting their parallel activities which might be considered as Conflicts-of-Interest (COI), including patent-related ones. The patenting activities that are disclosed by authors or institutions as COI in articles within Conflicts-of-Interest Statements (COIS) are generally analyzed in the literature either within small datasets or using non-systematic methodologies. This study proposes methods for assessing COIS presence and their main features across biomedical topics and journals, particularly with respect to the patent filing details that may be disclosed herein. These methods have been established and tested in the freely available PubMed database by searching the literature indexed herein during the period 2011–2022. However, when comparing the results of such searches within PubMed and a selection of journals’ websites for a specific topic (such as COVID-19), COIS appear unevenly available and searchable in PubMed owing to the varying practices that each journal implements. Thus, COIS appear a possibly underestimated source of patent information but the search and analysis of COI disclosures in biomedical literature requires well-designed and controlled strategies for identifying the relevant evidences for a given scope, such as prior art analysis and legal or strategic evaluation of patenting activities.

Assessment of Usefulness of Randomized Control Trials in Child Health Research Published in 2007 and 2017

ObjectiveTo examine how clinical usefulness in pediatric research with randomized controlled trials (RCTs) has changed over a 10-year period via a research usefulness tool composed of unique clinical usefulness criteria. Study designWe leveraged a pre-existing sample of child health RCTs published in 2007, used by our team in a previous study. Using the same methods, a research librarian executed a literature search in the Cochrane Central Register of Controlled Trials for the 2017 cohort. We included the first 300 eligible citations from the randomly ordered list for each year, creating two cohorts of 300 publications each, one in 2007 and one in 2017. Each publication was analyzed and data regarding primary and secondary outcomes, as well as 11 unique criteria of clinical usefulness, were extracted. Each publication was then graded using a tool created by our research team. After quality review, statistical analysis was then performed. Results600 pediatric RCT publications were included in this review. The mean score increased from 6.07 in 2007 to 9.20 in 2017 (P<0.001). Usefulness factors that saw the largest increase in reporting were context placement, funding statements, and conflict of interest statements, while patient centeredness, value for money, and raw data availability remained infrequently reported. ConclusionOur results demonstrate that clinical usefulness of pediatric research improved over this 10-year period, but there are still areas that need a great deal of improvement in order to maximize clinical usefulness and reduce research waste.

Conflict of Interest Statement

Conflict of Interest Statement

Reproducible research practices and transparency across linguistics

Scientific studies of language span across many disciplines and provide evidence for social,&amp;nbsp; cultural, cognitive, technological, and biomedical studies of human nature and behavior. As it becomes increasingly empirical and quantitative, linguistics has been facing challenges and limitations of the scientific practices that pose barriers to reproducibility and replicability. One of the&amp;nbsp; proposed solutions to the widely acknowledged reproducibility and replicability crisis has been the implementation of transparency practices,&amp;nbsp; e.g., open access publishing, preregistrations, sharing study materials, data, and analyses, performing study replications, and declaring conflicts of interest. Here, we have assessed the prevalence of these practices in 600 randomly sampled journal articles from linguistics across two time points. In line with similar studies in other disciplines, we found that 35% of the articles were published open access and the rates of sharing materials, data, and protocols were below 10%. None of the articles reported preregistrations, 1% reported replications, and 10% had conflict of interest statements. These rates have not increased noticeably between 2008/2009 and 2018/2019, pointing to remaining barriers and the slow adoption of open and reproducible research practices in linguistics. To facilitate adoption of these practices, we provide a range of recommendations and solutions for implementing transparency and improving reproducibility of research in linguistics.

Impact of Reporting Bias, Conflict of Interest, and Funding Sources on Quality of Orthopaedic Research

BackgroundInfluence of factors like reporting outcomes, conflicts of interest, and funding sources on study outcomes, particularly positive outcomes in orthopedics, remains underexplored. As transparency of partnerships in orthopaedic surgery through conflicts of interest statements has increased over the years, there has been a lack of focus on the value of these partnerships in influencing study outcomes. We aimed to investigate the associations between reporting outcomes, conflicts of interest, and sources of funding on study outcomes. MethodsWe reviewed articles published in 1 year in The Journal of Bone and Joint Surgery, The American Journal of Sports Medicine, and The Journal of Arthroplasty. The abstracts were examined for appropriate inclusion, while the authors’ names, academic degrees, funding disclosures, and departmental and institutional affiliations were redacted. There were a total of 1,351 publications reviewed from January 1, 2021 to December 31, 2021. ResultsA significant association was found between positive outcomes and reported conflicts of interest (75% versus 25%, P < .001). Likewise, conflicts of interest showed significant association with industry-sponsored studies (88% versus 12%, P < .001) and evidence level > II (72% versus 28%, P < .001). Industry-sponsored research accounted for the highest percentage of studies involving a conflict of interest (88%) and level I studies (12%). ConclusionsConflicts of interest are significantly associated with positive outcomes in orthopaedics. Sponsored studies were more inclined to have conflicts of interest and accounted for the majority of level I studies.

Home sleep apnea tests: Conflicts of interest and funding

ObjectivePediatric otolaryngologists rely on HSAT literature to guide their diagnostic methods related to obstructive sleep apnea (OSA). Our objectives were to review the rates of presence of funding and/or potential conflict of interest (COI), as well as its relationship to the overall quality of HSAT publications in the literature over the last two decades. Data sourcesMedline, Web of Science and Embase databases. Review methodsA review was performed reviewing publications from January 2000 to December 2021. Oxford Level of Evidence (OLE) was used as a quality metric. COI and funding were recorded verbatim as self-declared in the text of the manuscript. ResultsLiterature search yielded 4257 articles with 400 articles included in final analysis. The odds of higher quality studies (LOE 1 or 2) were higher in the last five years from 2016 to 2021 (OR, 3.6; 95% CI 1.4 to 6.9). Nearly half of all articles (43.0%) lacked a statement regarding funding or COI. There was a positive correlation between level of evidence and industry funding. The largest source of funding was from industry, comprising 39.6% of all studies that had a funding statement. Of these industry-funded studies, 37.5% reported no COI or lacked a COI statement. ConclusionDespite a growing interest in HSATs for OSA evaluation, there is heterogeneity in reporting of COI and high prevalence of industry funding and COI. Re-evaluation and consensus amongst journals on guidelines for reporting disclosures are needed. Level of evidence4

Open science practices need substantial improvement in prognostic model studies in oncology using machine learning

ObjectiveTo describe the frequency of open science practices in a contemporary sample of studies developing prognostic models using machine learning methods in the field of oncology. Study design and settingWe conducted a systematic review, searching the MEDLINE database between December 1, 2022, and December 31, 2022, for studies developing a multivariable prognostic model using machine learning methods (as defined by the authors) in oncology. Two authors independently screened records and extracted open science practices. ResultsWe identified 46 publications describing the development of a multivariable prognostic model. The adoption of open science principles was poor. Only one study reported availability of a study protocol, and only one study was registered. Funding statements and conflicts of interest statements were common. Thirty-five studies (76%) provided data sharing statements, with 21 (46%) indicating data were available on request to the authors and seven declaring data sharing was not applicable. Two studies (4%) shared data. Only 12 studies (26%) provided code sharing statements, including 2 (4%) that indicated the code was available on request to the authors. Only 11 studies (24%) provided sufficient information to allow their model to be used in practice. The use of reporting guidelines was rare: eight studies (18%) mentioning using a reporting guideline, with 4 (10%) using the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis Or Diagnosis statement, 1 (2%) using Minimum Information About Clinical Artificial Intelligence Modeling and Consolidated Standards Of Reporting Trials-Artificial Intelligence, 1 (2%) using Strengthening The Reporting Of Observational Studies In Epidemiology, 1 (2%) using Standards for Reporting Diagnostic Accuracy Studies, and 1 (2%) using Transparent Reporting of Evaluations with Nonrandomized Designs. ConclusionThe adoption of open science principles in oncology studies developing prognostic models using machine learning methods is poor. Guidance and an increased awareness of benefits and best practices of open science are needed for prediction research in oncology.

Communicating evidence synthesis: co-designing summary formats with end users

Abstract Background Evidence syntheses are essential to the creation of evidence-based guidelines that guide health care. Findings from our recent mixed methods systematic review (MMSR) identified no gold standard format for communicating summaries of evidence syntheses to guideline development groups. This is important as these groups are comprised of patients, healthcare providers, policymakers, etc., who all have different expertise, perspectives and priorities. Our overall aim is to develop evidence-informed prototype summary formats for use in guideline development. To inform this process, we held online co-design focus group workshops shaped by findings from our MMSR. Methods We held six focus groups with 30 participants involved in developing guidelines and/or evidence synthesis (February - March 2023). The topic guide was informed by the MMSR -- focusing on recommendations with mixed methods support, ≥3 supporting studies, and those prioritised by an expert advisory group through a pragmatic prioritisation exercise using the MoSCoW method (Must, Should, Could, and Will not haves). Focus groups were recorded and transcripts were analysed using a directed content analysis. Results Participants suggested a “less-is-more” structured approach that minimises methodological steps and statistical data, promoting accessibility to all audiences by judicious use of links to the full technical report. They emphasized the importance of concise consistently-presented formats which emphasize key messages, flag readers to indicators of trust in the producers (i.e., logos, websites, and conflict of interest statements), and highlight the quality of evidence. Conclusions Project findings are informing the creation of accessible and actionable guidance on best-practices for creating summary formats. Next steps involve user-testing prototype formats through semi-structured interviews which will then be integrated into the National Clinical Guideline development process in Ireland. Key messages • Co-design workshops delineated key aspects of effective and acceptable evidence synthesis summary formats to help create reproducible format templates for use in clinical guideline development. • Creating summary formats accessible to all guideline development group members will promote better communication and translation of research evidence into recommendations and practice.

Tight Cutting Seton for Anal Fistulae Revisited

Abstract Background: Anal fistulas are a common medical problem affecting thousands of patients annually well over 2000 years. There are many new novel approaches to this old condition but none with overwhelming success and low complication rates. The aim of this retrospective review was to revisit our experience in the treatment of anal fistulas with a tight cutting seton. Objectives: Observational study of retrospective collected data. Design: Retrospective study. Patients and Methods: Between 2008 - 2018 a retrospective study included all patients with primary or recurrent fistulas who were treated using tight seton were analyzed. Main Outcome Measures: The primary outcomes measured were healing rate, procedure-related complications, and incontinence. Sample Size: The study included 41 cases of anal fistula treated with a tight cutting and complete records of follow-up. Results: Firty-one patients with a median age of 37.9 years with a median follow up of 14.37 months were identified and included in the study. Among these, 66% of the fistulas were primary and 34% persisting or recurrent fistulas. Fistulas were classified as trans-sphincteric in 71% of patients, inter-sphincteric in 20%, horseshoe in 7%, and extra-sphincteric in 2% of the patients. All patients were treated with a cutting seton. The total healing rate was 95%. Two patients developed a persistent fistula. Four patients (9.8%) complained of different degrees of incontinence. There were no incidents of solid stool incontinence. In one case, the cause of fecal incontinence was keyhole deformity which was resolved after a buried island transposition flap. Conclusion: Our study evaluates a series of patients who were treated by a single surgeon in nonrandomized studies, emphasizing that tight cutting seton technique first described by Hippocrates in 430 BCE is a simple, highly effective, and safe procedure that should not be abandoned. Limitations: This study has limitations, including its retrospective nature. We collected data for this study from electronic records and databases of patients after completion of followup. Conflict of Interest Statement: The authors declare that there is no conflict of interests in this study.

All that Glitters is Not Gold: Examining Cost Effectiveness Analyses in Radiation Oncology

Cost effectiveness analyses (CEA) provide data for health policy decisions in resource constrained environments. These are important in Radiation Oncology as infrastructure and delivery costs increase and indications expand. The purpose of this study was to systematically review methodologic quality and trends in CEAs involving radiotherapy (RT). A systematic review was performed on cost effectiveness/utility studies involving RT, querying PubMed and Embase from inception to September 2020. Non-English, reviews, abstracts and cost-only studies were excluded. Independent reviewers screened and abstracted study demographics, economic parameters and methodological details. After screening 1652 abstracts, 214 met criteria. The first publication was in 1995, and more than half (n = 113, 53%) were published after 2014. Author institutions were from North America (n = 128, 60%), Europe (n = 49, 23%) and Asia (n = 30, 14%) with most reporting in US$ (n = 143, 67%). A majority utilized a decision model (n = 164, 77%), healthcare payer perspective (n = 171, 80%) and a finite time horizon (n = 108, 50%). Publications spanned 96 unique journals, most commonly International Journal of Radiation and Oncological Biology and Physics (n = 35, 16%). Treatment intent was curative in 171 studies. Disease sites included breast (n = 34, 16%), genitourinary (n = 31, 14%), and gastrointestinal (n = 31, 14%). RT was mostly used as primary treatment (n = 144, 67%), followed by adjuvant (n = 70, 33%) and neoadjuvant (n = 10, 5%). Emerging topics included stereotactic RT (n = 45, 21%), immunotherapy (n = 6, 3%), oligometastasis (n = 4, 2%), and heavy particles (n = 23, 11%). RT was compared to other RT (n = 136, 64%), surgery (n = 43, 20%), drugs (n = 14, 7%) and observation (n = 31, 17%). Incomplete reporting was common. Missing elements included analysis perspective (n = 13, 6%), time horizon (n = 38, 18%), discounting of utilities (n = 71, 33%) or costs (n = 54, 25%), and willingness-to-pay threshold (n = 59, 28%). Furthermore, 27 studies did not perform sensitivity analyses, 36 did not evaluate incremental cost-effectiveness ratio and only 60 explicitly utilized recognized reporting guidelines. Conflict of interest statements were found in 63%, with sponsor statements in 59%; 25% were industry sponsors. Outcome parameters were obtained from primary (author institution/trial data) sources in 33%, including randomized trials (RCTs) (n = 20, 9%), retrospective data (n = 20, 9%) and population data (n = 9, 4%). The remainder utilized secondary sources including RCTs (n = 71, 33%), retrospective data (n = 35, 16%) or meta-analyses (n = 11, 5%). Outcomes included quality adjusted life years (n = 158, 74%), life-years (n = 30, 14%) or toxicity (n = 26,12%). 31% utilized author generated utilities; of literature derived only 49% were matched to disease and clinical context. While CEAs are increasingly common in RT, reporting and methodologic rigor must improve. Greater use of published guidelines will improve data quality for decision makers.

Commentary on "The Impact of Vertical Integration on Physician Behavior and Healthcare Delivery: Evidence from Gastroenterology Practices".

This paper was accepted by Stefan Scholtes, healthcare management. Conflict of Interest Statement: E. D. Shah has consulted or served on advisory boards for Ardelyx, GI Supply, Mahana, Mylan, Neuraxis, Salix, Sanofi, and Takeda. Funding: E. D. Shah is funded by the National Institute of Diabetes and Digestive and Kidney Diseases [Grant NIH 1K23DK134752].