Discrepancies in spine surgeon conflict of interest disclosures between a national meeting and physician payment listings on device manufacturer web sites

Background contextPrevious studies have identified inconsistencies in physician conflict-of-interest disclosures at academic meetings. The Physician Payment Sunshine Act (PPSA) will require industry to disclose anything of value given to physicians by 2014. In preparation, some spine device companies have begun reporting payments online.PurposeTo evaluate potential inconsistencies between physician disclosures and payments reported by industry before the PPSA implementation.Study designComparison of publically available disclosure/payment data.Patient samplePhysicians participating in the 2011 North American Spine Society (NASS) annual meeting and physicians listed on the 2010 physician payment web sites of Medtronic and Depuy Spine.MethodsDisclosures of participants at NASS were compared with the published Medtronic and Depuy Spine physician payments. The periods reflected by the disclosures compared should have coincided (except the Depuy site, which was only listed for one quarter of the NASS disclosure period). Discrepancies were noted whenever participant disclosures and company listings did not match as well as whenever payment ranges did not overlap. Fisher's exact test was used to compare disclosure discrepancy rates based on Medtronic payment size. No funding was received for this work. The authors report no conflicts of interest directly related to this study; however, one of the authors does do consulting unrelated to this study.ResultsMedtronic and Depuy Spine were disclosed by 12.1% and 8.75% of NASS participants, respectively. Based on NASS disclosures, 52.4% of NASS participants affiliated with Medtronic had their disclosures inaccurately reflected on the Medtronic web site. Based on Medtronic payment postings, 45.7% of NASS participants listed on Medtronic's webpage had discrepancies in their NASS disclosures. Those who received payments <$100,000 from Medtronic were more likely to have discrepancies in their disclosures than those who received payments >$100,000 (p=.009). Based on Depuy Spine payment postings, 30% of NASS participants listed on Depuy Spine's site had discrepancies in their NASS disclosures.ConclusionsDiscrepancy rates between what spine surgeons disclosed at NASS 2011 and what companies reported for their consultants were high. This is concerning given the passage of the PPSA as well as the increased public visibility of potential discrepancies. More uniform practices will certainly be necessary.     

Industry-sponsored research

Financial conflicts of interest are exceedingly common in biomedical research. Investigators with conflicts of interest are more likely to arrive at positive conclusions, perhaps as a result of biased study design, industry suppression of negative results, preferential funding by industry of projects that are likely to succeed, or biased interpretation of results on the part of investigators. Government and professional organisations have proposed guidelines for managing conflicts of interest, but in practice it is the policies of universities and medical journals that direct the actions of investigators. Academic researchers and the media have expressed concern about the influence of industry sponsorship on biomedical research, while industry is increasingly turning to private entities (such as contract research organisations) to conduct clinical trials. Research participants appear less concerned with conflicts of interest in biomedical research, perhaps due to a faith that such conflicts are being appropriately managed by institutions. After reviewing the literature, we provide recommendations for the ethical conduct of biomedical research in the presence of financial conflicts of interest.     

Surgeon-industry conflict of interest: survey of North Americans' opinions regarding surgeons consulting with industry

Background contextSurgeon-industry conflict of interest (COI) has become a source of considerable interest. Professional medical societies, industry, and policy makers have attempted to regulate potential COI without consideration for public opinion.PurposeThe objective of this study was to report on the opinions of individuals representing the general public regarding surgeon-industry consulting relationships.Study design/settingWeb-based survey.MethodsSurvey was administered using a “spine Web site,” and opinions are collected on surgeon-industry consulting and regulation. Associations among responses to similar questions were assessed to ensure validity and subgroup analysis performed for respondent age, sex, education, insurance, employment, and patient status.ResultsSix hundred ten of 642 surveys had complete data. The sample population comprised more females and was older and more educated than the American population. About 80% of respondents felt it was ethical and either beneficial or of no influence to the quality of health care if surgeons were consultants for surgical device companies. Most felt disclosure of an industry relationship was important and paying surgeons royalties for devices, other than those they directly implant, would not affect quality of care. Respondents support multidisciplinary surgeon-industry COI regulation and trust doctors and their professional societies to head this effort.ConclusionsDespite the known potential negative impact of surgeon-industry COI on patient care, this study revealed that this does not seem to be reflected in the opinion of the general public. The respondents felt that disclosure is deemed one of the most important means of self-regulation and COI management, which is in agreement with current trends of most spine societies and journals that are increasing the stringency of disclosure policies.     

The Impact of Author Financial Conflicts on Robotic-Assisted Joint Arthroplasty Research

BackgroundRecent studies have suggested clinical superiority with robotic-assisted arthroplasty compared to traditional techniques. However, concerns exist regarding the author’s financial conflicts of interest (COI), which may influence research outcomes. This study aimed to determine whether COI relating to robotic-assisted arthroplasty influences the results of published outcomes following total hip (THA), total knee (TKA), and unicompartmental knee arthroplasty (UKA).MethodsWe performed a systematic review to identify all studies evaluating the use of robotics in THA, TKA, and UKA. An author’s financial COI was identified if they reported a relevant disclosure through the American Academy of Orthopedic Surgeons or within the study article. We then queried the Open Payments website to record all payments made from a robotic company in the year prior to publication. Each study was categorized as either favoring robotics (n = 42), neutral (n = 10), or favoring traditional techniques (n = 2). We then compared the number of conflicted authors, journal impact factor, level of evidence, and mean annual industry payment to each author.ResultsOf the 54 studies meeting inclusion criteria, 49 (91%) had an author financial COI. Conflicted studies were more likely to report favorable results of robotics than nonconflicted studies. When compared to studies favoring conventional techniques, those demonstrating favorable robotics outcomes had a higher number of conflicted authors and a higher mean industry payment per author. There was no difference in the level of evidence or journal impact factor.DiscussionNearly all studies comparing robotic THA, TKA, and UKA to conventional techniques involve financially conflicted authors. Further studies without COI may provide unbiased results.     

Conflict of interest disclosure in orthopaedic and general surgical trauma literature

SignificanceFinancial relationships between industry and physicians are a key aspect for the advancement of surgical practice and training, but these relationships also result in a conflict of interest with respect to research. Financial payments to physicians are public within the United States in the Open Payments Database, but the rate of accurate financial disclosure of payments has not previously been studied in trauma surgery publications.ObjectiveTo determine the rate of accurate financial disclosure in major surgical trauma journals compared with the Open Payments Database.Materials and MethodsThe names of all authors publishing in The Journal of Orthopaedic Trauma, Injury, and The Journal of Trauma and Acute Care Surgery between 2015 and 2018 were obtained from MEDLINE. Non-physicians, physicians outside of the United States, physicians without payments in the Open Payments Database, and physicians with payments types of only “Food and Drink” were excluded. Financial disclosure statements were obtained from the journal websites and manually compared against Open Payments Database entries the year prior to submission and during the year of submission up until 3 months prior to publication for each individual physician. Main outcomes were accuracy of disclosure published with each article, total amount of payments received (disclosure or undisclosed), surgical subspecialty of the reporting physician. Statistical comparisons were made using Chi-square testing with significance defined as p<0.05.ResultsBetween 2015 and 2018, 5070 articles were published involving 28,948 authors. 2945 authors met inclusion criteria. 490 authors accurately disclosed their financial relationships with industry (16.6%). The median value of undisclosed payments was $22,140 [IQR $6465, $77,221] which was significantly less than the medial value of disclosed payment of $66,433 [IQR $24,624, $161,886], p<0.001 Orthopaedic surgeons disclosed at a higher rate (26.3%, 479/1818) than general surgeons (4.8%, 47/971), p<0.001.ConclusionsPhysician-industry relationships are key for advancing surgical practice and providing training to physicians. These relationships are not inherently unethical, but there is consistently high inaccuracy of financial disclosure across multiple trauma surgery journals which may indicate the need for further education on financial disclosures during surgical training or active obtainment of publicly available financial disclosures by journals.     

Professionalism and the role of medical colleges

BackgroundThere has been substantial interest and emphasis on medical professionalism over the past twenty years. This speaks to the history of the medical profession, but increasingly to a broader understanding of the importance of socialisation and professional identity formation.MethodA literature review was undertaken of professionalism and the role of professions and medical professional organisations.ResultsA key outcome has been the recognition that medical professionalism must be actively taught and assessed. Substantial effort is required to improve the educational environment, so that it nurtures the development of professionalism within the work-place.Although medical colleges have been prominent in identifying and progressing the recent developments within professionalism there is still much to be done to deliver fully on the societal contract between the public and the profession.There are key gaps to address, particularly with regards to self-regulation, civil behaviour and effective leadership and advocacy.ConclusionMedical colleges need to take direct responsibility for the professionalism of their members. The expectations of the community are increasingly clear in this regard.     

Industry and evidence-based medicine: Believable or conflicted? A systematic review of the surgical literature

Background

Over the last few decades medical research and development has come to depend more heavily on the financial support of industry. However, there is concern that financial relations between the medical community and medical industry could unduly influence medical research and therefore patient care. Our objective was to determine whether conflict of interest owing to authors’/investigators’ financial affiliation with industry associated with their academic research has been identified in the surgical literature. In particular, we sought to answer the following questions: What is the extent of such conflict of interest? Does conflict of interest bias the results of academic surgical research in favour of industry? What are the potential causes of this proindustry bias?

Methods

We conducted a systematic review of the literature in May 2008 using the OVID SP search engine of MEDLINE, EMBASE, CINAHL, the Cochrane Database of Systematic Reviews, DARE and Health Technology Assessment. Quantitative studies that included a methods section and reported on conflict of interest as a result of industry funding in surgery-related research specifically were included in our analysis.

Results

The search identified 190 studies that met our criteria. Author/investigator conflict of interest owing to financial affiliation with industry associated with their academic research is well documented in the surgical literature. Six studies demonstrated that authors with such conflicts of interest were significantly more likely to report a positive outcome than authors without industry funding, which demonstrates a proindustry bias. Two studies found that the proindustry bias could not be explained by variations in study quality or sample size.

Conclusion

The conflict of interest that exists when surgical research is sponsored by industry is a genuine concern.     

Periarterial divestment in pancreatic cancer surgery

BackgroundModern pancreatic cancer surgery changed with the introduction of effective neoadjuvant therapies. Complete tumor resection is the mainstay for long-term, disease-free, and overall survival and has been a prerequisite for decreasing local recurrence. The medial resection margin in the area of the superior mesenteric vessels limits the radicalness of the resection, especially in borderline and locally advanced cases. Therefore, the periarterial soft tissue around the peripancreatic visceral arteries must be completely cleared. This procedure, namely periarterial divestment, is technically demanding but often represents an alternative to arterial resection.ObjectiveHere we describe the technique and our initial experience with periarterial divestment along the peripancreatic visceral arteries during pancreatic surgery. This technique, in combination with previously published resection strategies, such as artery first maneuver and mesenterico-portal venous bypass first, enables tumor resection in locally advanced pancreatic cancer.ConclusionPeriarterial divestment can prevent the need for arterial resection in borderline and locally advanced pancreatic cancer, especially after neoadjuvant therapy. The feasibility, improved safety, and oncologic equivalence of arterial divestment versus arterial resection for pancreatic cancer surgery must be evaluated by clinical trials.     

Gender diversity in chiropractic leadership: a cross-sectional study

BackgroundThe purpose of this cross-sectional study was to compare the number of males and females in leadership positions, and whether there is a relationship between gender and degrees held in those positions, within chiropractic academic institutions, national regulatory bodies and the most widely representative national professional associations in the United States and Canada.MethodsPublicly accessible websites from chiropractic institutions and organizations were used to collect data. Pearson χ² tests of independence were conducted to determine the relationship between gender (male vs. female) and other variables, including position (principal vs secondary), and chiropractic and other advanced professional degrees.ResultsA total of 107 leaders were identified across institutions and organizations. Under one-third of leaders (30.8%) were identified as female. Males were more likely to be in principal leadership roles (86.2%) and more likely to be in a secondary leadership position (62.8%).ConclusionMale leaders significantly outnumber female leaders in both principal and secondary leadership positions within American and Canadian chiropractic institutions. Strategies should be developed to include gender diversity within all chiropractic organizations.     

The orthopaedic surgeon and industry. Ethics and industry incentives

Physicians may receive various gifts and incentives from companies that make pharmaceuticals and medical devices. Although such incentives may benefit patients and physicians, they often pose serious conflicts of interest that violate a physician's professional responsibility. The physician-patient relationship is predicated on the physician acting in the best interest of the patient. The application of medical knowledge to complex clinical circumstances is difficult, even without biased sources of information and internal conflicts attributable to financial incentives. Yet, industry resources often are dedicated to the dissemination of information and incentives aimed to influence decisions not necessarily aimed at the goals of the patient. Physicians often are unaware of the nature of the incentives and commonly deny their demonstrated impact. Any incentive that is designed to impede, rather than enhance, the clinician's ability to make optimal patient care decisions is unethical for a physician to accept. These incentives should play no role in the practice of orthopaedic surgery.     

Orthopedic specialty hospitals: centers of excellence or greed machines?

Orthopedic specialty hospitals have recently been the subject of debate. They are patient-centered, physician-friendly health care alternatives that take advantage of the economic efficiencies of specialization. Medically, they provide a higher quality of care and increase patient and physician satisfaction. Economically, they are more efficient and profitable than general hospitals. They also positively affect society through the taxes they pay and the beneficial aspects of the competition they provide to general hospitals. Their ability to provide a disruptive innovation to the existing hospital industry will lead to lower costs and greater access to health care. However, critics say that physician ownership presents potential conflicts of interest and leads to overuse of medical care. Some general hospitals are suffering as a result of unfair specialty hospital practices, and a few drastic medical complications have occurred at specialty hospitals. Specialty hospitals have been scrutinized for increasing the inequality of health care and continue to be a target of government regulations. In this article, the pros and cons are examined, and the Emory Orthopaedics and Spine Hospital is analyzed as an example. Orthopedic specialty hospitals provide excellent care and are great assets to society. Competition between specialty and general hospitals has provided added value to patients and taxpayers. However, physicians must take more responsibility in their appropriate and ethical leadership. It is critical to recognize financial conflicts of interest, disclose ownership, and act ethically. Patient care cannot be compromised. With thoughtful and efficient leadership, specialty hospitals can be an integral part of improving health care in the long term.     

Career barriers for women in surgery

BackgroundDespite the increasing numbers of female medical students, surgery remains male-dominated.PurposeTo highlight the principal career obstacles experienced by aspiring female surgeons.MethodsA narrative review of literature on the position and career barriers of female surgeons has been conducted, using the MEDLINE and EMBASE databases.Main findingsImplicit and even explicit biases against female surgeons remain prevalent, negatively impacting their training performance and overall professional trajectory. Female surgeons are globally underrepresented in leadership positions and senior academic rankings, especially that of a full professor. They feel hampered by lack of effective mentorship, whose value for a successful career has been acknowledged by all medical students, surgeons and surgical leaders. Their work-life imbalance is sometimes expressed as lower likelihood than their male contemporaries of getting married or having children and may be attributed to their conventional association with the role of caretaker, their personal desire to accommodate occupational and family duties and the inadequate implementation of parental leave and childcare policies. Female surgeons’ “infertility” may be further explained by direct and indirect pregnancy-related difficulties. Female surgeons are also financially undercompensated compared to their male contemporaries. Finally, specialty-specific challenges should not be overlooked.ConclusionsWhile encouraging steps have been made, women in surgery feel still hindered by various obstacles. The qualitative, interview-based nature of current literature requires more meticulous studies on these barriers with a more quantitative and objective approach. Attenuation of gender imbalance in surgical specialties requires further changes in mentality and more targeted modifications in relevant policies.     

Herausforderungen in der Organisation ?investigator initiated trials��

Introduction

Transplantation medicine offers multiple translational questions which should preferably be transfered to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific aproach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product.

Methods

We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach.

Results

Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry.

Conclusions

Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.     

Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain

Background contextThe North American Spine Society's (NASS) Evidence Based Clinical Guideline for the Diagnosis and Treatment of Low Back Pain features evidence-based recommendations for diagnosing and treating adult patients with nonspecific low back pain. The guideline is intended to reflect contemporary treatment concepts for nonspecific low back pain as reflected in the highest quality clinical literature available on this subject as of February 2016.PURPOSEThe purpose of the guideline is to provide an evidence-based educational tool to assist spine specialists when making clinical decisions for adult patients with nonspecific low back pain. This article provides a brief summary of the evidence-based guideline recommendations for diagnosing and treating patients with this condition.Study designThis is a guideline summary review.MethodsThis guideline is the product of the Low Back Pain Work Group of NASS’ Evidence-Based Clinical Guideline Development Committee. The methods used to develop this guideline are detailed in the complete guideline and technical report available on the NASS website. In brief, a multidisciplinary work group of spine care specialists convened to identify clinical questions to address in the guideline. The literature search strategy was developed in consultation with medical librarians. Upon completion of the systematic literature search, evidence relevant to the clinical questions posed in the guideline was reviewed. Work group members utilized NASS evidentiary table templates to summarize study conclusions, identify study strengths and weaknesses, and assign levels of evidence. Work group members participated in webcasts and in-person recommendation meetings to update and formulate evidence-based recommendations and incorporate expert opinion when necessary. The draft guideline was submitted to an internal and external peer review process and ultimately approved by the NASS Board of Directors.ResultsEighty-two clinical questions were addressed, and the answers are summarized in this article. The respective recommendations were graded according to the levels of evidence of the supporting literature.ConclusionsThe evidence-based clinical guideline has been created using techniques of evidence-based medicine and best available evidence to aid practitioners in the diagnosis and treatment of adult patients with nonspecific low back pain. The entire guideline document, including the evidentiary tables, literature search parameters, literature attrition flowchart, suggestions for future research, and all of the references, is available electronically on the NASS website at https://www.spine.org/ResearchClinicalCare/QualityImprovement/ClinicalGuidelines.aspx     

Breast cancer in Latin America: Experts perceptions compared with medical care standards

BackgroundThe BCRF II study presents a systematic review of the norms, recommendations and guidelines that are considered medical care standards (MCS) for breast cancer in 12 Latin American and Caribbean countries. Three key questions from the BCRF I survey data on early detection and diagnosis are presented to identify implementation practice patterns related to MCS.MethodsInformation related to MCS was requested from governmental health authorities, cancer institutes, and national scientific and professional societies in 12 Latin American and Caribbean countries. Documents received were reviewed by breast cancer experts from each respective country. Three key survey questions from the BCRF I survey on early detection and diagnosis were reprocessed to provide information related to implementation practice of existing MCS. Results: All countries included in the BCRF II study had medical care standards (MCS) whether published by governmental authorities, national professional or scientific associations, cancer institutes, or adoption of international MCS. Experts reported different practice patterns at a Country level versus a Center level. Overall, 85% of the experts reported that less than 50% of the women with no symptoms undergo a mammography at the Country level compared to 43% at the Center level. For diagnostic suspicion of breast cancer, 80% of experts considered the diagnostic suspicion at a Country level to come from the patient compared to 50% at a Center level. About 30% of patients waited for more than 3 months for a diagnosis at the Country level compared to 7% at the Center level.ConclusionAll the Latin America and Caribbean countries in the study reported the use of similar MCS for breast cancer care. The reported difference between care practiced at a Country level versus a Center level suggests the challenge is not in generating new MCS, but in implementing policies and control mechanisms for compliance with existing MCS, guaranteeing their applicability to all populations.     

The Impact of Financial Conflict of Interest on Surgical Research: An Observational Study of Published Manuscripts

Background

Substantial discrepancies exist between industry-reported and self-reported conflicts of interest (COI). Although authors with relevant, self-reported financial COI are more likely to write studies favorable to industry sponsors, it is unknown whether undisclosed COI have the same effect. We hypothesized that surgeons who fail to disclose COI are more likely to publish findings that are favorable to industry than surgeons with no COI.

Methods

PubMed was searched for articles in multiple surgical specialties. Financial COI reported by surgeons and industry were compared. COI were considered to be relevant if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, which was defined as an impression favorable to the product(s) discussed by an article and was determined by 3 independent, blinded clinicians for each article. Primary analysis compared incomplete self-disclosure to no COI. Ordered logistic multivariable regression modeling was used to assess factors associated with favorability.

Results

Overall, 337 articles were reviewed. There was a high rate of discordance in the reporting of COI (70.3%). When surgeons failed to disclose COI, their conclusions were significantly more likely to favor industry than surgeons without COI (RR 1.2, 95% CI 1.1–1.4, p < 0.001). On multivariable analysis, any COI (regardless of relevance, disclosure, or monetary amount) were significantly associated with favorability.

Conclusions

Any financial COI (disclosed or undisclosed, relevant or not relevant) significantly influence whether studies report findings favorable to industry. More attention must be paid to improving research design, maximizing transparency in medical research, and insisting that surgeons disclose all COI, regardless of perceived relevance.

     

Quantifying the variability of financial disclosure information reported by authors presenting research at multiple sports medicine conferences

In the study reported here, we compared self-reported industry relationships of authors who attended 3 major orthopedic sports medicine conferences during a single calendar year. Our goal was to calculate the variability between disclosure information over time. A significant percentage of authors who attended these meetings were inconsistent in submitting their disclosure information. In addition, most authors with irregularities had more than 1 discrepancy. We believe that the vast majority of the observed discrepancies did not result from intentional deception on the part of the authors but instead from ongoing confusion regarding which industry relationships should be acknowledged for particular meetings (some specialty societies require that all relationships be divulged, whereas others require only those affiliations directly applicable to research being presented). In the absence of a uniform disclosure policy that is widely adopted by many specialty societies, these findings suggest that the disclosure process will continue to be plagued by inconsistent reporting of financial conflicts of interest.     

Conflicts of interest in dialysis: A barrier to policy reforms

Conflicts of interest involving physicians are commonplace in the US, occurring across many different specialties and subspecialties in a variety of clinical settings. In nephrology, two important scenarios in which conflicts of interest arise are dialysis facility joint venture (JV) arrangements and financial participation in End-stage Kidney Disease Seamless Care Organizations (ESCOs). Whether conflicts of interest occurring in either of these settings influence decision-making or patient care outcomes is not known due to a lack of transparent, publicly available information, and opportunities to conduct independent study. We discuss possible benefits and risks of nephrologist's financial participation in JVs and ESCOs and possible mechanisms for disclosure and reporting of such arrangements as well as risk mitigation.