The Effect of Financial Conflict of Interest, Disclosure Status, and Relevance on Medical Research from the United States.

BACKGROUND: Financial interactions between industry and healthcare providers are reportable. Substantial discrepancies have been detected between industry and self-report of these conflicts of interest (COIs). OBJECTIVE: Our aim was to determine if authors who fail to disclose reportable COI are more likely to publish findings that are favorable to industry than authors with no COI. DESIGN: In this blinded, observational study of medical and surgical primary research articles in PubMed, 590 articles were reviewed. MAIN MEASURES: Reportable financial relationships between authors and industry were evaluated. COIs were considered to have relevance if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, defined as an impression favorable to the product(s) discussed by an article and determined by 3 independent, blinded clinicians for each article. Primary analysis compared Incomplete Self-Disclosure to No COI. Two-level multivariable mixed-effects ordered logistic regression was used to assess factors associated with favorability. KEY RESULTS: A 69% discordance rate existed between industry and self-report in COI disclosure. When authors failed to disclose COI, their conclusions were more likely to favor industry partners than authors without COI (favorable ratings 73% versus 62%, RR 1.18, p = < 0.001). On univariate (any COI 74% versus no COI 62%, RR 1.11, p = < 0.001) and multivariable analyses, any COI was associated with favorability. CONCLUSIONS: All financial COIs (disclosed or undisclosed, relevant or not relevant, research or non-research) influence whether studies report findings favorable to industry sponsors.

Clinical assessment, radiographic imaging, and patient self-report for abdominal wall hernias.

BACKGROUND: Increasingly, abdominal wall hernias are being diagnosed incidentally through radiographic imaging. Such hernias are referred to as occult. However, the clinical significance of occult hernias is unknown. The objective of this study is to determine the prevalence of occult hernias and to assess the abdominal wall quality of life (AW-QOL) among patients with occult hernias. MATERIALS AND METHODS: A blinded, observational, cross-sectional study, October-December 2016, of patients presenting to single academic institution's general surgery clinics was performed. Inclusion criteria included all patients with a computed tomography scan of the abdomen or pelvis within the last year with no intervening abdominal or pelvic surgery. Patients were administered a validated AW-QOL survey and underwent a standardized clinical examination. Computed tomography scans were reviewed. Primary outcomes were prevalence and AW-QOL measured by the modified Activities Assessment Scale. AW-QOL of patients with no hernias was compared to that of those with occult hernias and clinically apparent hernias using Mann-Whitney U test. RESULTS: A total of 250 patients were enrolled of whom 97 (38.8%) had a hernia noted on clinical examination and 132 (52.8%) had a hernia noted on radiographic imaging. The prevalence of occult hernias was 38 (15.2%). Patients with no hernia had a median (interquartile range) AW-QOL of 82.5 (55.0-95.3), patients with clinically apparent hernias had AW-QOL of 47.7 (31.2-81.6; P < 0.001), and patients with occult hernias had AW-QOL of 72.4 (38.5-97.2; P = 0.36). CONCLUSIONS: Both clinically apparent and occult hernias are prevalent. However, only patients with clinically apparent hernias had differences in AW-QOL when compared to patients with no hernias. Prospective trials are needed to assess the outcomes of patients with occult hernias managed with and without surgical repair.

Epidemiology and Disparities in Care: The Impact of Socioeconomic Status, Gender, and Race on the Presentation, Management, and Outcomes of Patients Undergoing Ventral Hernia Repair.

More research is needed with regards to gender, race, and socioeconomic status on ventral hernia presentation, management, and outcomes. The role of culture and geography in hernia-related health care remains unknown. Currently existing nationwide registries have thus far yielded at best a modest overview of disparities in hernia care. The significant variation in care relative to gender, race, and socioeconomic status suggests that there is room for improvement in providing consistent care for patients with hernias.

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.

Investigation of Financial Conflict of Interest among Published Ventral Hernia Research.

BACKGROUND: Discordance exists between author self-disclosure and the Open Payments Database in various surgical fields, but the effects of this discordance on study design and presentation are unknown. We hypothesized that, among ventral hernia publications, discordance exists between industry and physician self-reported conflicts of interest (COIs); authors disclose relevant COIs; and disclosure and relevant COIs affect study favorability. STUDY DESIGN: We conducted a double-blinded, prospective, observational study of published articles. PubMed was searched in reverse chronological order for clinical articles pertaining to ventral hernias. Authors' self-disclosed conflicts were compared with those on the Open Payments Database. Two reviewers blinded to article disclosure status determined jointly whether the COIs were relevant to the article. Three blinded referees independently voted whether each article was favorable to discussed subject matter. The primary end point was study favorability. Secondary outcomes included disclosure status and relevance. RESULTS: One hundred articles were included. Compared with authors with no COIs, authors with a COI, self-disclosed or not, were twice as likely to write results favorable to industry. Of those with a COI, most of the articles had a relevant COI (37 of 45 [82.2%]), and 25% of relevant COIs were not disclosed by authors. Among authors with a relevant COI, study favorability remained unchanged at 68.5% (control: no COI 33.3%; p < 0.001). CONCLUSIONS: Within the ventral hernia literature, 70% of articles have a COI. Self-reporting of COI is discordant in 63% of articles. Twenty-five percent of relevant COI are not disclosed. Having a COI increases the chances that an article will cast a favorable impression on the company paying the authors by 200%.

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

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.

Readability Assessment of Internet-Based Patient Education Materials Related to Parathyroid Surgery.

OBJECTIVES: Patient education is critical in obtaining informed consent and reducing preoperative anxiety. Written patient education material (PEM) can supplement verbal communication to improve understanding and satisfaction. Published guidelines recommend that health information be presented at or below a sixth-grade reading level to facilitate comprehension. We investigate the grade level of online PEMs regarding parathyroid surgery. METHODS: A popular internet search engine was used to identify PEM discussing parathyroid surgery. Four formulas were used to calculate readability scores: Flesch Reading Ease (FRE), Flesch-Kincaid Grade Level (FKGL), Gunning Frequency of Gobbledygook (GFOG), and Simple Measure of Gobbledygook (SMOG). RESULTS: Thirty web-based articles discussing parathyroid surgery were identified. The average FRE score was 42.8 (±1 standard deviation [SD] 16.3; 95% confidence interval [CI], 36.6-48.8; range, 6.1-71.3). The average FKGL score was 11.7 (±1 SD 3.3; 95% CI, 10.5-12.9; range, 6.1-19.0). The SMOG scores averaged 14.2 (±1 SD 2.6; 95% CI, 13.2-15.2; range, 10.7-21.9), and the GFOG scores averaged 15.0 (±1 SD 3.5; 95% CI, 13.7-16.3; range, 10.6-24.8). CONCLUSION: Online PEM on parathyroid surgery is written above the recommended sixth-grade reading level. Improving readability of PEM may promote better health education and compliance.

Readability assessment of Internet-based patient education materials related to acoustic neuromas.

OBJECTIVE: The objectives of this study were to assess the readability of Internet-based patient education materials related to acoustic neuromas (AN-IPEMs) by 4 widely validated readability indices, to evaluate scores against the existing sixth grade recommended reading level, and to compare the readability scores of patient education materials (PEMs) produced by professional organizations, clinical practices, hospitals, and miscellaneous sources. MATERIALS AND METHODS: AN-IPEMs from 67 web sites (6 professional societies, 33 clinical practices, 19 hospitals, and 9 miscellaneous) were assessed using Flesch Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Simple Measure of Gobbledygook (SMOG), and Gunning Frequency of Gobbledygook (Gunning FOG). Scores were then evaluated against national recommendations by 1-tailed t tests and against each other using 1-way ANOVAs. RESULTS: The average FKGL, SMOG, and Gunning FOG scores were all significantly higher than the recommended sixth grade reading level suggested by the USDHHS (p < 0.0001, single sample 1-tailed t test). Zero articles, by all indices, had a reading level equal to or below the sixth grade reading level. The FKGLs also varied between the various sources at a significant level (p = 0.01 one-way ANOVA independent samples). The average FKGLs of clinical practice and professional society AN-IPEMs were significantly higher than the average FKGLs of hospital AN-IPEMs (both p ≤ 0.05 one-tailed t-tests assuming unequal variances). CONCLUSION: AN-IPEMs are written at a level significantly higher than that suggested by national recommendations. Current AN-IPEMs may need to be revised in order to enhance patient comprehension.

Gender disparities in research productivity among 9952 academic physicians.

OBJECTIVES/HYPOTHESIS: The number of women in medicine has increased considerably over the past 3 decades, and they now comprise approximately half of medical school matriculants. We examine whether gender disparities in research productivity are present throughout various specialties and compare these findings to those previously described among otolaryngologists. STUDY DESIGN: Bibliometric analysis. METHODS: Research productivity, measured by the h-index, was calculated for 9,952 academic physicians representing 34 medical specialties. Additionally, trends in how rate of research productivity changed throughout different career stages were compared. RESULTS: Women were underrepresented at the level of professor and in positions of departmental leadership relative to their representation among assistant and associate professors. Male faculty had statistically higher research productivity both overall (H = 10.3 ± 0.14 vs. 5.6 ± 0.14) and at all academic ranks. For the overall sample, men and women appeared to have equivalent rates of research productivity. In internal medicine, men had higher early-career productivity, while female faculty had productivity equaling and even surpassing that of their male colleagues beyond 20 to 25 years. Men and women had equivalent productivity in surgical specialties throughout their careers, and similar rates in pediatrics until 25 to 30 years. CONCLUSIONS: Female academic physicians have decreased research productivity relative to men, which may be one factor contributing to their underrepresentation at the level of professor and departmental leader relative to their proportions in junior academic ranks. Potential explanations may include fewer woman physicians in the age groups during which higher academic ranks are attained, greater family responsibilities, and greater involvement in clinical service and educational contributions.

Readability assessment of online thyroid surgery patient education materials.

BACKGROUND: Published guidelines recommend written health information be written at or below the sixth-grade level. We evaluate the readability of online materials related to thyroid surgery. METHODS: Thyroid surgery materials were evaluated using Flesch Reading Ease Score (FRES), Flesch Kincaid Grade Level (FKGL), Gunning Frequency of Gobbledygook (GFOG), and Simple Measure of Gobbledygook (SMOG). RESULTS: Thirty-one documents were evaluated. FRES scores ranged from 29.3 to 67.8 (possible range = 0 to 100), and averaged 50.5. FKGL ranged from 6.9 to 14.9 (possible range = 3 to 12), and averaged 10.4. SMOG scores ranged from 11.8 to 14.5 (possible range = 3 to 19), and averaged 13.0. GFOG scores ranged from 10.6 to 18.0 (possible range = 3 to 19), and averaged 13.5. CONCLUSIONS: Readability scores for online thyroid surgery materials are higher (i.e., more difficult) than the recommended levels. However, readability is only one aspect of comprehension. Written information should be designed with that fact in mind.

Readability assessment of internet-based patient education materials related to facial fractures.

OBJECTIVE/HYPOTHESIS: Various professional societies, clinical practices, hospitals, and health care-related Web sites provide Internet-based patient education material (IPEMs) to the general public. However, this information may be written above the 6th-grade reading level recommended by the US Department of Health and Human Services. The purpose of this study is to assess the readability of facial fracture (FF)-related IPEMs and compare readability levels of IPEMs provided by four sources: professional societies, clinical practices, hospitals, and miscellaneous sources. STUDY DESIGN: Analysis of IPEMs on FFs available on Google.com. METHODS: The readability of 41 FF-related IPEMs was assessed with four readability indices: Flesch-Kincaid Grade Level (FKGL), Flesch Reading Ease Score (FRES), Simple Measure of Gobbledygook (SMOG), and Gunning Frequency of Gobbledygook (Gunning FOG). Averages were evaluated against national recommendations and between each source using analysis of variance and t tests. RESULTS: Only 4.9% of IPEMs were written at or below the 6th-grade reading level, based on FKGL. The mean readability scores were: FRES 54.10, FKGL 9.89, SMOG 12.73, and Gunning FOG 12.98, translating into FF-related IPEMs being written at a "difficult" writing level, which is above the level of reading understanding of the average American adult. CONCLUSIONS: IPEMs related to FFs are written above the recommended 6th-grade reading level. Consequently, this information would be difficult to understand by the average US patient.

Readability assessment of Internet-based patient education materials related to endoscopic sinus surgery.

OBJECTIVES/HYPOTHESIS: Numerous professional societies, clinical practices, and hospitals provide Internet-based patient education materials (PEMs) to the general public, but not all of this information is written at a reading level appropriate for the average patient. The National Institutes of Health and the US Department of Health and Human Services recommend that PEMs be written at or below the sixth-grade level. Our purpose was to assess the readability of endoscopic sinus surgery (ESS)-related PEMs available on the Internet and compare readability levels of PEMs provided by three sources: professional societies, clinical practices, and hospitals. STUDY DESIGN: A descriptive and correlational design was used for this study. METHODS: The readability of 31 ESS-related PEMs was assessed with four different readability indices: Flesch-Kincaid Grade Level (FKGL), Flesch Reading Ease Score (FRES), Simple Measure of Gobbledygook (SMOG), and Gunning Frequency of Gobbledygook (Gunning FOG). Averages were evaluated against national recommendations and between each source using analysis of variance and t tests. RESULTS: The majority of PEMs (96.8%) were written above the recommended sixth-grade reading level, based on FKGL (P < .001). Only one article (3.2%) had an FKGL at or below the sixth-grade level. The mean readability values were: FRES 47.1 ± 13.4, FKGL 10.7 ± 2.4, SMOG 13.7 ± 1.6, and Gunning FOG 12.4 ± 2.7. CONCLUSIONS: Current Internet-based PEMs related to ESS, regardless of source type, were written well above the recommended sixth-grade level. Materials from the hospitals/university-affiliated websites had lower readability scores, but were still above recommended levels. Web-based PEMs pertaining to ESS should be written with the average patient in mind.