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Factors influencing the participation of gastroenterologists and hepatologists in clinical research.

ABSTRACT: BACKGROUND: Although clinical research is integral to the advancement of medical knowledge, physicians face a variety of obstacles to their participation as investigators in clinical trials. We examined factors that influence the participation of gastroenterologists and hepatologists in clinical research. METHODS: We surveyed 1050 members of the American Association for the Study of Liver Diseases regarding their participation in clinical research. We compared the survey responses by specialty and level of clinical trial experience. RESULTS: A majority of the respondents (71.6%) reported involvement in research activities. Factors most influential in clinical trial participation included funding and compensation (88.3%) and intellectual pursuit (87.8%). Barriers to participation were similar between gastroenterologists (n = 160) and hepatologists (n = 189) and between highly experienced (n = 62) and less experienced (n = 159) clinical researchers. These barriers included uncompensated research costs and lack of specialized support. Industry marketing was a greater influence among respondents with less trial experience, compared to those with extensive experience (15.7% vs 1.6%; P < .01). Hepatologists and respondents with extensive clinical trial experience tended to be more interested in phase 1 and 2 studies, whereas gastroenterologists and less experienced investigators were more interested in phase 4 studies. CONCLUSION: This study suggests that the greatest barrier to participation in clinical research is lack of adequate resources. Respondents also favored industry-sponsored research with less complex trial protocols and studies of relatively short duration.

SUBMITTER: Dev AT

PROVIDER: S-EPMC2572062 | biostudies-literature | 2008

REPOSITORIES: biostudies-literature

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Factors influencing the participation of gastroenterologists and hepatologists in clinical research.

Dev Anouk T AT Kauf Teresa L TL Zekry Amany A Patel Keyur K Heller Karen K Schulman Kevin A KA McHutchison John G JG

BMC health services research 20081008

<h4>Background</h4>Although clinical research is integral to the advancement of medical knowledge, physicians face a variety of obstacles to their participation as investigators in clinical trials. We examined factors that influence the participation of gastroenterologists and hepatologists in clinical research.<h4>Methods</h4>We surveyed 1050 members of the American Association for the Study of Liver Diseases regarding their participation in clinical research. We compared the survey responses b ...[more]

PMID: 18842135

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Project description:BackgroundNonalcoholic steatohepatitis (NASH), the inflammatory subtype of nonalcoholic fatty liver disease, is underdiagnosed and expected to become the leading indication for liver transplant in the United States. We aimed to understand the medical journey of patients with NASH and role of hepatologists/gastroenterologists in diagnosing and treating patients with NASH.MethodsA United States population-based cross-sectional online survey was completed by 226 healthcare professionals (HCPs) who treat patients with NASH and 152 patients with NASH; this study focuses on the patient and 75 hepatologist/gastroenterologist HCP respondents. Tests of differences (chi square, t-tests) between respondent types were performed using SPSS.ResultsMost patients reported receiving their diagnosis of NASH from a hepatologist (37%) or gastroenterologist (26%). Hepatologists/gastroenterologists were more likely than other HCPs to use FibroScan (transient elastography) to diagnose NASH and were more likely to distinguish between NASH with or without fibrosis. Hepatologists/gastroenterologists (68%) and patients (52%) agree that hepatologists/gastroenterologists are the primary coordinators of NASH care. The majority of hepatologists/gastroenterologists (85%) are aware of American Association for the Study of Liver Diseases (AASLD) clinical practice guidance, and 86% of those aware consider them when diagnosing patients with NASH. Hepatologists/gastroenterologists most frequently recommended exercise (86%), diet (70%), and supplements (58%) for ongoing management of NASH. Pharmaceutical medications for comorbidities were prescribed by a minority of hepatologists/gastroenterologists for their patients with NASH. Hepatologists/gastroenterologists cite difficulty (67%) or unwillingness (64%) to adhere to lifestyle changes as primary reasons patients with NASH discontinue NASH treatment.ConclusionsHepatologists/gastroenterologists are considered the coordinators of NASH care. While recognizing that patient adherence to lifestyle changes is the basis for successful treatment, important barriers limit successful implementation.

Project description:ObjectiveThere was increasingly demand of participation in surgical decision-making among Chinese patients with prostate cancer. However, due to the complex healthcare system and advanced care settings, it is quite challenging for the patients to gain sufficient support from the institute and the government. This research aimed to investigate the factors that impact the degree of participation in surgical decision-making among Chinese prostate cancer patients.MethodsA phenomenological approach of qualitative research based on the results of semi-structured interviews was adopted, to explore the influencing factors which hinder the participation in surgical decision-making. Consolidated Criteria for Reporting Qualitative Research were utilized. Up to 160 post-operative patients who had undergone radical prostatectomy along with 68 medical and nursing staffs, were purposively recruited in this research. This retrospective study was carried out from September 2018 to August 2019. After recording and transcribing the interviews, the interview materials were evaluated via the Colaizzi's seven step approach and the NVivo Version 10 software to analyze the interview content.ResultsAccording to the analysis and summary of the interviews, there were three factors affecting the degree of participation in surgical decision-making. Firstly, insufficient information was provided by medical and nursing staffs because of their lack of time, proper communication skills, and career experience, as well as difficulties in the development of patient decision aid and inconsistent resource availability. Secondly, the cognitive level of decision-making among patients was relatively low due to poor psychological endurance, insufficient amount of education, senility, and less knowledge and information demand. Ultimately, decisions were constantly made by family members with/without patients.ConclusionsThe degree of participation of Chinese prostate cancer patients in the surgical decision-making had much space for improvement.

Project description:ImportancePayments from pharmaceutical and device manufacturers to physicians may influence the advice physicians give patients and peers.ObjectivesTo investigate the nature and amounts of monetary and other benefits that gastroenterologists received and to determine the participation of those receiving benefits in the formulation of clinical practice guidelines.Design, setting, and participantsThis cohort study analyzed information from the Centers for Medicare & Medicaid Services Open Payments database, including all reports about payments that pharmaceutical and device manufacturers gave to adult or pediatric gastroenterologists in 2016. PubMed was used to examine the professional affiliations and publication records of top payment recipients. Panelists of clinical guidelines who also received personal financial rewards listed in the Open Payments database were identified.Main outcomes and measuresPayments made to gastroenterologists by pharmaceutical company and device manufacturers.ResultsOf 15 497 gastroenterologists, 13 467 (86.9%) received a total of 432 463 payments accounting for a total expenditure of $67 144 862. Direct financial payments for consultations, talks, or other services were made to 2055 physicians and were responsible for 4.2% of payments (18 179 of 432 463), but for 62.7% of total expenditures ($42 086 207 of $67 144 862). Although a significant number of submissions were for food and beverages, they constituted only a small amount of total expenditure. For gastroenterologists treating adult patients, 10 products were linked to 63.8% of payments (11 221 of 17 588) related to direct financial rewards and 37.1% of the total expenditures ($24 892 643 of $67 144 862). Twenty-nine of 36 clinical practice guidelines included panelists who had received honoraria or consultation fees from industry sources, with amounts exceeding $10 000 in 8 of them (22%).Conclusions and relevanceMost gastroenterologists accept meals or gifts from industry, with 2055 of 15 497 gastroenterologists receiving direct payments and 8 of 36 clinical practice guidelines panelists having received more than $10 000. Considering the known impact of such benefits on prescribing patterns and other professional behaviors, policy makers should consider revising regulations governing interactions with industry and disclosure formats alerting others to their potential biasing impact.

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Factors influencing the participation of gastroenterologists and hepatologists in clinical research.

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Factors influencing the participation of gastroenterologists and hepatologists in clinical research.

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