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Physicians' Understanding of Clinical Trial Data in Professional Prescription Drug Promotion.

ABSTRACT: BACKGROUND:Prescription drug marketing to physicians often includes clinical trial data. Prior research has shown that physicians may not have the necessary knowledge to understand all clinical trial results and they can be influenced by how these results are reported. This study focused on physicians' reactions to and evaluations of clinical trial data presented in professional prescription drug promotion. METHODS:We conducted 60-minute interviews with practicing physicians across the United States (50 primary care physicians and 22 endocrinologists). Physicians viewed prescription drug promotional materials that contained clinical trial data and answered follow-up questions. RESULTS:Physicians demonstrated low to moderate knowledge about clinical trial-related terms found in promotional prescription drug materials. DISCUSSION:Results from this qualitative analysis underscore a need to determine how clinical trial data in prescription drug promotional materials affect physicians' attitudes and decision making.

SUBMITTER: Moynihan CK

PROVIDER: S-EPMC6112155 | biostudies-literature | 2018 Jul-Aug

REPOSITORIES: biostudies-literature

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Physicians' Understanding of Clinical Trial Data in Professional Prescription Drug Promotion.

Moynihan Caitlin K CK Burke Panne A PA Evans Sarah A SA O'Donoghue Amie C AC Sullivan Helen W HW

Journal of the American Board of Family Medicine : JABFM 20180701 4

<h4>Background</h4>Prescription drug marketing to physicians often includes clinical trial data. Prior research has shown that physicians may not have the necessary knowledge to understand all clinical trial results and they can be influenced by how these results are reported. This study focused on physicians' reactions to and evaluations of clinical trial data presented in professional prescription drug promotion.<h4>Methods</h4>We conducted 60-minute interviews with practicing physicians acros ...[more]

PMID: 29986991

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Project description:BackgroundLittle is known about how physicians interpret data displays that depict preliminary or exploratory clinical data in physician-targeted sales aids for oncology drugs. Using three factorial experiments, we examined whether disclosures of data limitations and clinical uncertainty adequately communicate the limitations and practical utility of this type of data.Subjects, materials, and methodsThe studies used a 2 (disclosure of data limitations: technical, nontechnical) × 2 (disclosure of clinical uncertainty: present, absent) + 1 (control: no disclosure) between-subjects experimental design to examine the impact of disclosures as they relate to presentations of preliminary or exploratory data in promotional communications for oncology products. In each experiment, we randomized oncologists and primary care physicians with oncology experience to view one version of a two-page sales aid. Following this exposure, physicians completed a web-based survey. The design was replicated in three concurrently conducted experiments using sales aids for different fictitious oncology drugs, each featuring one of three common data displays: a forest plot (n = 495), a Kaplan-Meier curve (n = 504), or a bar chart (n = 532).ResultsResults provide initial evidence that in some contexts disclosures can improve understanding of the clinical utility of certain information about a drug and the limitations of results presented in a data display. Disclosures can also temper perceptions of how much evidence is presented that supports a conclusion that the drug is an appropriate treatment. In terms of the language used in the disclosure of data limitations, physicians in all three experiments strongly preferred the nontechnical disclosures.ConclusionThe findings from the three experiments in this study suggest that disclosures have the potential to increase relevant knowledge, but more research is needed to establish best practice recommendations for using disclosures to convey contextual information relevant for interpreting data displays in promotional communications.Implications for practiceThis article reports the results from three large, online experimental studies that address a growing concern that drug companies often share favorable clinical trial results with physicians in promotional materials that lack important context for physicians to interpret the data. This series of studies investigates whether strategic use of two types of disclosures (disclosure of data limitations and a disclosure of clinical uncertainty) improves understanding and reduces misinterpretations among physicians. The results from these studies help identify communication factors that impact how physicians critically appraise preliminary or exploratory clinical trial data to inform policy and regulatory efforts.

Project description:Importance:Burnout symptoms among physicians are common and have potentially serious ramifications for physicians and their patients. Randomized studies testing interventions to address burnout have been uncommon. Objective:To explore the effect of individualized coaching on the well-being of physicians. Design, Setting, and Participants:A pilot randomized clinical trial involving 88 practicing physicians in the departments of medicine, family medicine, and pediatrics who volunteered for coaching was conducted between October 9, 2017, and March 27, 2018, at Mayo Clinic sites in Arizona, Florida, Minnesota, and Wisconsin. Statistical analysis was conducted from August 24, 2018, to March 25, 2019. Interventions:A total of 6 coaching sessions facilitated by a professional coach. Main Outcomes and Measures:Burnout, quality of life, resilience, job satisfaction, engagement, and meaning at work using established metrics. Analysis was performed on an intent-to-treat basis. Results:Among the 88 physicians in the study (48 women and 40 men), after 6 months of professional coaching, emotional exhaustion decreased by a mean (SD) of 5.2 (8.7) points in the intervention group compared with an increase of 1.5 (7.7) points in the control group by the end of the study (P?<?.001). Absolute rates of high emotional exhaustion at 5 months decreased by 19.5% in the intervention group and increased by 9.8% in the control group (-29.3% [95% CI, -34.0% to -24.6%]) (P?<?.001). Absolute rates of overall burnout at 5 months also decreased by 17.1% in the intervention group and increased by 4.9% in the control group (-22.0% [95% CI, -25.2% to -18.7%]) (P?<?.001). Quality of life improved by a mean (SD) of 1.2 (2.5) points in the intervention group compared with 0.1 (1.7) points in the control group (1.1 points [95% CI, 0.04-2.1 points]) (P?=?.005), and resilience scores improved by a mean (SD) of 1.3 (5.2) points in the intervention group compared with 0.6 (4.0) points in the control group (0.7 points [95% CI, 0.0-3.0 points]) (P?=?.04). No statistically significant differences in depersonalization, job satisfaction, engagement, or meaning in work were observed. Conclusions and Relevance:Professional coaching may be an effective way to reduce emotional exhaustion and overall burnout as well as improve quality of life and resilience for some physicians. Trial Registration:ClinicalTrials.gov identifier: NCT03207581.

Project description:IntroductionSome patients with rheumatoid arthritis (RA) using tumor necrosis factor inhibitors (TNFi) experience inefficacy or lack of tolerability and hence switch to another TNFi (cycling) or to a therapy with another mode of action (switching). This study examined patient characteristics, prescribing patterns and treatment practice for RA in the United States.MethodsData were from the Adelphi Disease Specific Programme (Q2-Q3 2016). Rheumatologists completed a survey and patient record forms for adult patients with RA who had received ≥ 1 targeted therapy. Patients were grouped by class of first-used targeted therapy, and monotherapy vs. combination therapy. TNFi patients who received ≥ 1 targeted therapy were classified as cyclers or switchers. Univariate analyses compared patient characteristics and physician factors across the analysis groups.ResultsOverall, 631 patients received ≥ 1 targeted therapy; 535 were prescribed a TNFi as first targeted therapy, 53 a nonTNFi biologic disease-modifying antirheumatic drug (bDMARD), and 43 tofacitinib. Of 577 patients with known conventional synthetic (cs) DMARD status, 18.7% were prescribed monotherapy and 81.3% combination therapy. Combination therapy patients received significantly more concomitant medications prior to initiation of first targeted therapy than monotherapy patients (P < 0.05). The top reason for physicians to prescribe first use targeted therapy was strong overall efficacy (79.9%). Of 163 patients who progressed to second targeted therapy, 60.7% were cyclers. A lower proportion of cyclers persisted on their first use targeted therapy versus switchers (P = 0.03). The main reason physicians gave for switching patients at this stage was worsening condition (46.6%).ConclusionsMost patients were prescribed a TNFi as their first targeted therapy; over half then cycled to another TNFi. This suggests other factors may influence second use targeted treatment choice and highlights the need for greater understanding of outcomes associated with subsequent treatment choices and potential benefits of switching.

Dataset Information

Physicians' Understanding of Clinical Trial Data in Professional Prescription Drug Promotion.

Publications

Physicians' Understanding of Clinical Trial Data in Professional Prescription Drug Promotion.

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