Undisclosed Conflict of Interest Is Prevalent in Spine Literature.

STUDY DESIGN: Cohort study. OBJECTIVE: The aim of this study was to determine the rate of accurate conflict of interest (COI) disclosure within three prominent subspecialty Spine journals during a 4-year period. SUMMARY OF BACKGROUND DATA: Industry-physician relationships are crucial for technological advancement in spine surgery but serve as a source of bias in biomedical research. The Open Payments Database (OPD) was established after 2010 to increase financial transparency. METHODS: All research articles published from 2014 to 2017 in Spine, The Spine Journal (TSJ), and the Journal of Neurosurgery: Spine (JNS) were reviewed in this study. In these articles, all author's COI statements were recorded. The OPD was queried for all author entries within the disclose period of the journal. Discrepancies between the author's self-reported COIs and the documented COIs from OPD were recorded. RESULTS: A total of 6816 articles meeting inclusion criteria between 2014 and 2017 in Spine, TSJ, and JNS with 39,869 contributing authors. Overall, 15.8% of all authors were found to have an OPD financial relationship. Of 2633 authors in Spine with financial disclosures, 77.1% had accurate financial disclosures; 42.5% and 41.0% of authors with financial relationships in the OPD had accurate financial disclosures in TSJ and JNS, respectively. The total value of undisclosed conflicts of interest between 2014 and 2017 was $421 million with $1.48 billion in accurate disclosures. Of undisclosed payments, 68.7% were <$1000 and only 7.2% were >$10,000. Undisclosed payments included $180 million in research funding and $188 million in royalties. CONCLUSION: This study demonstrates that undisclosed COI is highly prevalent for authors in major Spine journals. This study indicates that there remains a need to standardize definitions and financial thresholds for significant COI as well as to shift the reporting burden for COI to journals who actively review potential COIs instead of relying on self-reporting. LEVEL OF EVIDENCE: 3.

Industry compensation and self-reported financial conflicts of interest among authors of highly cited peripheral artery disease studies.

OBJECTIVE: Industry compensation to authors may influence the interpretation of study results. Scientific journals often require author disclosure of a relevant financial conflict of interest (FCOI) but seldom quantify compensation and leave reporting up to the author's discretion. Professional and public concerns related to potential bias introduced into medical research by FCOI have arisen, especially when physician compensation from manufacturers is not disclosed. Little is known, however, about the prevalence of industry compensation to authors of related publications, payment amounts, or how this information compares with self-reported FCOI. The objective of this study was to compare industry compensation and disclosed FCOI among highly referenced publications related to treatment of peripheral artery disease, a disease that affects approximately 8.5 million Americans and is often treated with medications and devices. METHODS: "Peripheral artery disease" was used as a Web of Science search term to identify publications from 2013 to 2016, excluding review articles, conference proceedings, book chapters, abstract publications, and non-English language publications. The top 99 most cited publications were abstracted for self-reported FCOI by author. Industry compensation to authors was queried using a ProPublica Dollars for Docs custom data set based on Centers for Medicare and Medicaid Services Open Payments data. Providers practicing in the United States in any of the following specialties were included: cardiology, cardiothoracic surgery, vascular and interventional radiology, or vascular surgery. Payment transactions were matched to physician authors on the basis of provider name, specialty, and geographic location. Statistical analysis included descriptive statistics and categorical tests. Descriptive statistics are reported as frequency (percentage) or median (interquartile range). RESULTS: Among 1008 vascular specialist authors identified, 218 (22%) self-reported FCOI. Fifty-six physician authors had compensation reported to the Centers for Medicare and Medicaid Services by industry during the study period. Among those identified as recipients of industry compensation, 28 (50%) self-reported FCOI. Industry payments to the 56 authors totaled $11,139,987, with a median total payment of $18,827 (interquartile range, $152,084) per author. Food and beverage was the most frequently identified nature of payment (n = 8981 [74%]), promotional speaking involved the largest total amount of payments ($3,256,431), and royalty or license was the highest median payment ($51,431 [$72,215]). Physicians reporting FCOI received a total of $9,435,340 during the study period vs $1,706,647 for those who did not report any FCOI. Median total payments were higher among authors reporting FCOI vs not ($81,224 [$324,171] vs $9494 [$43,448]; P < .001). CONCLUSIONS: Nondisclosed author compensation from industry is relatively uncommon among highly cited peripheral artery disease research studies but may be associated with substantial payments. These results suggest that self-reported FCOI does not provide a comprehensive overview of industry compensation. Reporting all payments rather than only those deemed relevant by the author might provide a more complete and transparent report of potential FCOI, allowing independent assessment of relevance in interpreting study findings.

Estimating the costs and cost-effectiveness of HIV self-testing among men who have sex with men, United States.

INTRODUCTION: HIV testing is an essential prerequisite for accessing treatment with antiretroviral therapy or prevention using pre-exposure prophylaxis. Internet distribution of HIV self-tests is a novel approach, and data on the programmatic cost of this approach are limited. We analyse the costs and cost-effectiveness of a self-testing programme. METHODS: Men who have sex with men (MSM) reporting unknown or negative HIV status were enrolled from March to August 2015 into a 12-month trial of HIV self-testing in the United States. Participants were randomly assigned either to the self-testing arm or the control arm. All participants received information on HIV testing services and locations in their community. Self-testing participants received up to four self-tests each quarter, which they could use themselves or distribute to their social network associates. Quarterly follow-up surveys collected testing outcomes, including number of tests used and new HIV diagnoses. Using trial expenditure data, we estimated the cost of implementing a self-testing programme. Primary outcomes of this analysis included total programme implementation costs, cost per self-test completed, cost per person tested, cost per new HIV diagnosis among those self-tested and cost per quality adjusted life year (QALY) saved. RESULTS: A total of 2665 men were assigned either to the self-testing arm (n = 1325) or the control arm (n = 1340). HIV testing was reported by 971 self-testing participants who completed a total of 5368 tests. In the control arm, 619 participants completed 1463 HIV tests. The self-testing participants additionally distributed 2864 self-tests to 2152 social network associates. Testing during the trial identified 59 participants and social network associates with newly diagnosed HIV infection in the self-testing arm; 11 control participants were newly diagnosed with HIV. The implementation cost of the HIV self-testing programme was $449,510. The cost per self-test completed, cost per person tested at least once, and incremental cost per new HIV diagnosis was $61, $145 and $9365 respectively. We estimated that self-testing programme potentially averted 3.34 transmissions, saved 14.86 QALYs and nearly $1.6 million lifetime HIV treatment costs. CONCLUSIONS: The HIV self-testing programme identified persons with newly diagnosed HIV infection at low cost, and the programme is cost saving.

Quality of Life Is Influenced by Body Weight, Education, and Family Income in Adolescents with Chronic Diseases.

OBJECTIVE: To evaluate the health-related quality of life (HRQoL) of adolescents diagnosed with different chronic conditions and to identify demographic, socioeconomic, and health-status outcomes associated with the impairment in HRQoL. STUDY DESIGN: Cross-sectional study. METHODS: We evaluated 276 adolescents (50.7% male) aged 14 ± 2 years that were assisted by healthcare public service and diagnosed with cancer (CA), type 1 diabetes mellitus (DM1), overweight (OW), asthma (AS), and no chronic health condition-control group (CG). Adolescents and parent-proxy completed age-appropriate self-report and/or parent-proxy report on generic HRQoL measures using PedsQL™. RESULTS: Adolescents with CA had lower overall HRQoL as well as poorer scores in all dimensions than either healthy participants or other chronic disease sufferers. HRQoL scores reported by parent-proxy were similar to those reported by adolescents across all chronic diseases. CG members reported better scores in all dimensions. Maternal education, family income, and marital status of parents were correlated with HRQoL scores in all dimensions. The risk of having an affected HRQoL score was higher in adolescents with CA than in adolescents with other chronic diseases. CONCLUSIONS: The likelihood of cancer affecting HRQoL was higher when compared to other chronic diseases, and the OW group had a worse overall score compared to CG. Adolescents with CA, AS, and OW reported worse school dimensions when compared to healthy adolescents. The education of adolescents and their parent-proxy, body weight, and family income influence the dimensions of HRQoL in adolescents with chronic diseases.

Financial Hardship after Hematopoietic Cell Transplantation: Lack of Impact on Survival.

Background: Financial hardship is a growing challenge for patients with blood cancer who undergo hematopoietic cell transplantation (HCT), and it is associated with poor patient-reported outcomes. In contrast, little is known about the potential impact of patient-reported financial hardship on post-HCT survival.Methods: We sought to describe the association of financial hardship with survival after HCT in a prospectively assembled cohort of patients from three large transplant centers (n = 325).Results: There was no association between financial hardship measures assessed at 6 months post-HCT and 1- or 2-year survival after HCT.Conclusions: Patient-reported financial distress after HCT does not seem to adversely affect post-HCT survival.Impact: When assessing the effectiveness of interventions to ameliorate familial financial burden among HCT, the focus should be on patient-reported outcomes rather than survival. Cancer Epidemiol Biomarkers Prev; 27(3); 345-7. ©2018 AACR.

Impact on Smoking Behavior of the New Zealand Annual Increase in Tobacco Tax: Data for the Fifth and Sixth Year of Increases.

INTRODUCTION: New Zealand has implemented a series of seven annual increases in tobacco tax since 2010. All tax increases, except for the first in the series, were preannounced. It is unusual for governments to introduce small, persistent, and predictable increases in tobacco tax, and little is known about the impact of such a strategy. This paper evaluates the impact of the fifth and sixth annual increases. METHODS: Smokers' behaviors were self-reported during the 3-month period before, and the 3-month period after, the two annual increases. Responses to the two increases were analyzed separately, and generalized estimating equations models were used to control for sociodemographic variables, recent quit attempts, and the research design. RESULTS: Findings were consistent across years. The proportion of participants who made a smoking-related (54%-56% before and after each tax increase) or product-related change (fifth tax increase: 17%-19%; sixth tax increase: 21%-22%) did not significantly alter from before to after each tax increase. However, it should be noted that the proportion of participants making smoking-related changes was generally high, even prior to each increase. For example, before the 2015 tax increase, 1% reported quitting completely, 21% trying to quit, and 53% cutting down. CONCLUSIONS: In New Zealand, with its series of annual tobacco tax increases since 2010, there were no significant changes in smoking- or product-related behavior associated with the fifth and sixth increases. Nevertheless, overall cessation-related activity was high, with a majority of participants reporting either quitting and/or cutting down recently. IMPLICATIONS: Little is known about the impact of small, persistent, predictable tobacco tax increases on smoking behavior. This study evaluated the impact of the fifth (in 2014) and sixth (2015) tax increases in an annual series implemented in New Zealand. Although there were no detectable changes in smoking behaviors from before to after each tax increase, self-reported cessation-related activity was high overall (i.e., even prior to each increase). Given that there are multiple possible interpretations for these findings, more in-depth time-series analyses are needed to understand how such a tax strategy influences smoking behavior.

Validation of a substance and alcohol use assessment instrument among orphans and vulnerable children in Zambia using Audio Computer Assisted Self-Interviewing (ACASI).

BACKGROUND: Substance and alcohol misuse is a global problem that increases the risk of HIV infection. This is a concern among orphans and vulnerable children (OVC) in sub-Saharan Africa who may have elevated substance use rates. The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) is a reliable and valid instrument of substance use among adults in primary care high-income settings. This study examined psychometric properties of the ASSIST among OVC in Zambia using Audio Computer Assisted Self-Interviewing (ACASI). METHODS: Baseline data from an ongoing randomized trial of interventions to reduce HIV risk behaviors were analyzed. The analysis included 502 OVC ages 13-17 living in low-income, high-density neighborhoods in Lusaka, Zambia. Internal consistency of the ASSIST was assessed and discriminant validity was measured using items from the Youth Self Report as criterion variables. RESULTS: Internal reliability was strong with a Cronbach's alpha of ≥0.80 for each of the specific substance scales and total substance involvement. For all substances except tobacco and sedatives, discriminant validity was demonstrated in distinguishing between low risk use and moderate use. Sensitivity and specificity analysis indicated adequate area under the curve across substance types (AUC range: 0.68-0.80). Discrimination between moderate and high risk was demonstrated for alcohol and total substance involvement. CONCLUSIONS: ASSIST administered via ACASI is a reliable instrument and an appropriate tool for distinguishing between low and hazardous substance use among adolescent OVC populations in sub-Saharan Africa. Additional examination is warranted to determine its ability to measure gradations of severity within hazardous use.

How the economic recession has changed the likelihood of reporting poor self-rated health in Spain.

BACKGROUND: Between 2006 and 2011 self-rated health (SRH) (the subjective report of an individual's health status) actually improved in Spain despite its being in the grips of a serious economic recession. This study examines whether the likelihood of reporting poor health has changed because of the global financial crisis. It also attempts to estimate the differences between SRH and other self-perceived measures of health among groups before and during the current economic crisis in Spain. METHODS: Cross-sectional population-based surveys were conducted in Spain (ENSE 2006 and ENSE 2011) and in Catalonia (ESCA 2006 and ESCA 2011) in 2006 and again in 2011. In this research work we have used random effects logistic models (dependent variable SRH 1 Poor, 0 Good) and exact matching and propensity score-matching. RESULTS: The results of the ENSE explanatory variables are the same in both 2006 and 2011. In other words, all diseases negatively affect SRH, whereas alcohol habits positively affect SRH and obesity is the only disease unrelated to SRH. ESCA explanatory variables' results show that in 2006 all diseases are significant and have large odds ratio (OR) and consequently those individuals suffering from any of these diseases are more likely to report poor health. In 2011 the same pattern follows with the exception of allergies, obesity, high cholesterol and hypertension, albeit they are not statistically significant. Drinking habits had a positive effect on SRH in 2006 and 2011, whereas smoking is considered as unrelated to SRH. The likelihood of reporting poor health in 2006 is added as a variable in with the logistic regression of 2011 and is not, in either the ENSE data or the ESCA data, significant. Furthermore, neither is it significant when controlling by age, gender, employment status or education. CONCLUSIONS: The results of our analysis show that the financial crisis did not alter the likelihood of reporting poor health in 2011. Therefore, there are no differences between our perceived health in either 2006 or in 2011.

Young adult cannabis users report greater propensity for risk-taking only in non-monetary domains.

BACKGROUND: Though substance use is often associated with elevated risk-taking in real-world scenarios, many risk-taking tasks in experimental psychology using financial gambles fail to find significant differences between individuals with substance use disorders and healthy controls. We assessed whether participants using marijuana would show a greater propensity for risk-taking in distinct domains including, but not limited to, financial risk-taking. METHODS: In the current study, we assessed risk-taking in young adult (age 18-25) regular marijuana users and in non-using control participants using a domain-specific risk-taking self-report scale (DOSPERT) encompassing five domains of risk-taking (social, financial, recreational, health/safety, and ethical). We also measured behavioral risk-taking using a laboratory monetary risk-taking task. RESULTS: Marijuana users and controls reported significant differences on the social, health/safety, and ethical risk-taking scales, but no differences in the propensity to take recreational or financial risks. Complementing the self-report finding, there were no differences between marijuana users and controls in their performance on the laboratory risk-taking task. CONCLUSIONS: These findings suggest that financial risk-taking may be less sensitive than other domains of risk-taking in assessing differences in risky behavior between those who use marijuana and those who do not. In order to more consistently determine whether increased risk-taking is a factor in substance use, it may be necessary to use both monetary risk-taking tasks and complementary assessments of non-monetary-based risk-taking measures.

The impact of retirement on health in Canada.

This study estimates the impact of retirement on subsequent health outcomes as measured by self-reported health status. The empirical study is based on seven longitudinal waves of the Canadian National Population Health Survey, spanning 1994 through 2006. To account for biases due to unobserved individual-specific heterogeneity, this study uses a fixed-effects method. The results indicate that retirement has a positive but insignificant impact on self-reported health status. The study further examined this issue using different subgroups based on gender and income and again found that retirement has no significant impact on health status.

Economic and patient-reported outcomes of outpatient home-based versus inpatient hospital-based chemotherapy for patients with colorectal cancer.

PURPOSE: This study aims to compare the economic- and patient-reported outcomes between outpatient home-based and inpatient hospital-based chemotherapy in advanced colorectal cancer patients. METHODS: A total of 80 patients from Severance Hospital in Seoul, Korea, who had stage III colorectal cancer and underwent home-based (n = 40) or hospital-based chemotherapy (n = 40) with a FOLFOX regimen between January 2007 and April 2008 were enrolled. Patient satisfaction data were collected by a self-administered questionnaire survey. Based on hospital charge records, average cost (in 2008 Korean won (KW)) per chemotherapy session was estimated and compared between home- and hospital-based chemotherapy from a societal perspective. RESULTS: Patients receiving chemotherapy at home showed higher satisfaction with their treatment (mean satisfaction score 3.58 ± 0.15, 5-point Likert-type scale, with a higher score indicating higher satisfaction) than did those treated at the hospital (3.23 ± 0.21; p < 0.01). After adjusting for differences in baseline characteristics between the two groups using multivariate analysis, those receiving home-based chemotherapy still showed significantly higher satisfaction than those undergoing hospital-based therapy (ß = 0.271, p < 0.001). Additionally, home-based therapy reduced the cost per chemotherapy session by 16.6%, compared with hospital-based treatment (1,694,216 versus 2,030,383 KW, 1,200 KW ≈ 1 US dollar). The largest cost reduction was attributable to medical costs (-201,122 KW), followed by caregiver's opportunity costs (-135,000 KW). CONCLUSIONS: Higher satisfaction and lower economic cost for home-based chemotherapy suggests that home-based chemotherapy could be a popular and cost-effective treatment option for colorectal cancer patients who are eligible for home-based chemotherapy.