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Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services.

ABSTRACT: BACKGROUND:The Open Payments Database (OPD) discloses financial transactions between manufacturers and physicians. The concordance of OPD versus self-reported conflicts of interest (COI) is unknown. MATERIALS AND METHODS:Our objectives were to compare (1) industry and self-disclosed COI in clinical literature, (2) payments within each disclosure level, and (3) industry- and self-disclosed COI and payments by specialty. This was an observational study. PubMed was searched for clinical studies accepted for publication from January 2014 to June 2016. Author and OPD-disclosed COIs were compared. Articles and authors were divided into full disclosure, incomplete industry disclosure, incomplete self-disclosure, and no COI. Primary outcome (differences in reported COI per article) was assessed using McNemar's test. Payment differences were compared using Kruskal-Wallis test. RESULTS:OPD- and self-disclosed COI differed (65.0% discordance rate by article, P < 0.001). Percentages of authors within each disclosure category differed between specialties (P < 0.001). Hematology articles exhibited the highest discordance rate (79.0%) and received the highest median payment for incomplete self-disclosure ($30,812). CONCLUSIONS:Significant discordance exists between self- and OPD-reported COI. Additional research is needed to determine reasons for these differences.

SUBMITTER: Cherla DV

PROVIDER: S-EPMC5643021 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services.

Cherla Deepa V DV Olavarria Oscar A OA Holihan Julie L JL Viso Cristina Perez CP Hannon Craig C Kao Lillian S LS Ko Tien C TC Liang Mike K MK

The Journal of surgical research 20170515

<h4>Background</h4>The Open Payments Database (OPD) discloses financial transactions between manufacturers and physicians. The concordance of OPD versus self-reported conflicts of interest (COI) is unknown.<h4>Materials and methods</h4>Our objectives were to compare (1) industry and self-disclosed COI in clinical literature, (2) payments within each disclosure level, and (3) industry- and self-disclosed COI and payments by specialty. This was an observational study. PubMed was searched for clini ...[more]

PMID: 28985847

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Project description:STUDY OBJECTIVES:Centers for Medicare and Medicaid Services (CMS) reimbursement for positive airway pressure (PAP) devices for obstructive sleep apnea treatment is dependent on patients meeting adherence expectations within the first 3 months on therapy. Adherence is defined as usage of the device for at least 4 hours per night on 70% of nights during a consecutive 30-day period. We hypothesize that the adherence pattern may be established beyond this initial period, which may limit the opportunity to treat many patients. METHODS:Treatment and adherence data from PAP devices were monitored via wireless modems for 42 consecutive PAP-naïve military veterans who completed 1 year of nightly monitoring. Their baseline characteristics were as follows: age (mean ± standard deviation) 58.5 ± 12.5 years; body mass index 33.7 ± 5.7 kg/m2; diagnostic apnea-hypopnea index (pretreatment) 28.1 ± 18.5 events/h; apnea-hypopnea index on PAP: 4.3 ± 3.3 events/h. We examined daily, monthly, quarterly, semiannual, and annual reports, and the best 30-day adherence report for each quarter. RESULTS:In the first 3 months, 19 of 42 participants were adherent by CMS criteria, and 23 of 42 participants were not. Of the 19 adherent participants, 13 remained adherent and 6 became nonadherent or stopped PAP treatment for the remainder of the year. In the 23 initially nonadherent participants, 16 stopped PAP treatment, and 7 participants (30.4%) became adherent (using CMS criteria) during the rest of the year. Thus, PAP adherence during the first 3 months was predictive for the rest of the year in only 68.4%. PAP nonadherence during the first 3 months was predictive for further nonadherence in only 69.6% of the cases. Overall, this led to a 65% sensitivity and 72% specificity of using adherence at 3 months in predicting adherence at 1 year. CONCLUSIONS:CMS adherence criteria affecting PAP coverage are restrictive and can result in the withholding of therapy in many patients who otherwise might become adherent. CLINICAL TRIAL REGISTRATION:Registry: ClinicalTrials.gov, Title: Remote Monitoring in Obstructive Sleep Apnea, Identifier: NCT01678560, URL: https:// clinicaltrials.gov/ct2/show/NCT01678560.

Project description:Importance:The Centers for Medicare & Medicaid Services (CMS) Five-Star measure for nursing homes is designed with input from expert panels about the importance of multiple quality indicators. Consumers may assign different values to these indicators, creating different 5-star ratings. Objective:To compare nursing homes' rankings based on the CMS Five-Star measure with rankings based on consumers' judgment about the importance of the same quality indicators. Design, Setting, and Participants:In this quality improvement study, CMS Five-Star data were linked with a measure calculated from CMS quality indicators and consumer values obtained from a national survey. Data covered the last quarter of 2016 and the first three quarters of 2017. The study included 10?676 nursing homes, comprising 69.8% of those with reported Five-Star measures. The national survey included adults, either nursing home residents or their family members who reported being familiar with the quality of care their relative received. Data analysis was performed from January 2019 to February 2020. Main Outcomes and Measures:The contingent valuation method was administered via the survey to obtain consumers' relative values of the quality indicators, and statistical analyses were used to create the contingent valuation measure. Agreement in nursing home rankings was assessed using the Five-Star measure, which is based on weights developed by expert panels, compared with rankings based on the contingent valuation measure. Results:Among 10?676 study nursing homes with a mean (SD) of 119.4 (59.4) beds, 7845 (73.5%) were for profit, 6424 (61.8%) were part of a chain, and 8009 (75.0%) were urban. The 4310 survey respondents (mean [SD] age, 39.9 [15.6] years; 1143 [26.5%] men; 3448 [80%] white) included mostly family members (3879 participants [90.0%]). The Pearson correlation coefficient (0.65) and weighted ? statistics (0.48) indicated only moderate agreement between ranking of nursing homes' performance by the 2 measures and disagreement on ranking for approximately one-half of the nursing homes. Conclusions and Relevance:Current nursing home report cards might not reflect consumers' values and the relative importance consumers place on each of the quality indicators that compose the overall Five-Star measure. Quality report cards might be more relevant to consumers by augmenting the Five-Star measure with a measure reflecting consumers' preferences. It is unknown whether these conclusions are generalizable to other report cards, such as Hospital and Home Health Compare, without conducting similar studies for these report cards.

Project description:ImportancePredicting payments for particular conditions or populations is essential for research, benchmarking, public reporting, and calculations for population-based programs. Centers for Medicare & Medicaid Services (CMS) models often group codes into disease categories, but using single, rather than grouped, diagnostic codes and leveraging present on admission (POA) codes may enhance these models.ObjectiveTo determine whether changes to the candidate variables in CMS models would improve risk models predicting patient total payment within 30 days of hospitalization for acute myocardial infarction (AMI), heart failure (HF), and pneumonia.Design, setting, and participantsThis comparative effectiveness research study used data from Medicare fee-for-service hospitalizations for AMI, HF, and pneumonia at acute care hospitals from July 1, 2013, through September 30, 2015. Payments across multiple care settings, services, and supplies were included and adjusted for geographic and policy variations, corrected for inflation, and winsorized. The same data source was used but varied for the candidate variables and their selection, and the method used by CMS for public reporting that used grouped codes was compared with variations that used POA codes and single diagnostic codes. Combinations of use of POA codes, separation of index admission diagnoses from those in the previous 12 months, and use of individual International Classification of Diseases, Ninth Revision, Clinical Modification codes instead of grouped diagnostic categories were tested. Data analysis was performed from December 4, 2017, to June 10, 2019.Main outcomes and measuresThe models' goodness of fit was compared using root mean square error (RMSE) and the McFadden pseudo R2.ResultsAmong the 1 943 049 total hospitalizations of the study participants, 343 116 admissions were for AMI (52.5% male; 37.4% aged ≤74 years), 677 044 for HF (45.5% male; 25.9% aged ≤74 years), and 922 889 for pneumonia (46.4% male; 28.2% aged ≤74 years). The mean (SD) 30-day payment was $23 103 ($18 221) for AMI, $16 365 ($12 527) for HF, and $17 097 ($12 087) for pneumonia. Each incremental model change improved the pseudo R2 and RMSE. Incorporating all 3 changes improved the pseudo R2 of the patient-level models from 0.077 to 0.129 for AMI, from 0.042 to 0.129 for HF, and from 0.114 to 0.237 for pneumonia. Parallel improvements in RMSE were found for all 3 conditions.Conclusions and relevanceLeveraging POA codes, separating index from previous diagnoses, and using single diagnostic codes improved payment models. Better models can potentially improve research, benchmarking, public reporting, and calculations for population-based programs.

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Project description:ObjectiveWe undertook this investigation to characterize conflict of interest (COI) policies of biomedical journals with respect to authors, peer-reviewers, and editors, and to ascertain what information about COI disclosures is publicly available.MethodsWe performed a cross-sectional survey of a convenience sample of 135 editors of peer-reviewed biomedical journals that publish original research. We chose an international selection of general and specialty medical journals that publish in English. Selection was based on journal impact factor, and the recommendations of experts in the field. We developed and pilot tested a 3-part web-based survey. The survey included questions about the presence of specific policies for authors, peer-reviewers, and editors, specific restrictions on authors, peer-reviewers, and editors based on COI, and the public availability of these disclosures. Editors were contacted a minimum of 3 times.ResultsThe response rate for the survey was 91 (67%) of 135, and 85 (93%) of 91 journals reported having an author COI policy. Ten (11%) journals reported that they restrict author submissions based on COI (e.g., drug company authors' papers on their products are not accepted). While 77% report collecting COI information on all author submissions, only 57% publish all author disclosures. A minority of journals report having a specific policy on peer-reviewer 46% (42/91) or editor COI 40% (36/91); among these, 25% and 31% of journals state that they require recusal of peer-reviewers and editors if they report a COI. Only 3% of respondents publish COI disclosures of peer-reviewers, and 12% publish editor COI disclosures, while 11% and 24%, respectively, reported that this information is available upon request.ConclusionMany more journals have a policy regarding COI for authors than they do for peer-reviewers or editors. Even author COI policies are variable, depending on the type of manuscript submitted. The COI information that is collected by journals is often not published; the extent to which such "secret disclosure" may impact the integrity of the journal or the published work is not known.

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Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services.

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Discordance of conflict of interest self-disclosure and the Centers of Medicare and Medicaid Services.

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