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Direct-to-consumer Internet promotion of robotic prostatectomy exhibits varying quality of information.

ABSTRACT: Robotic surgery to remove a cancerous prostate has become a popular treatment. Internet marketing of this surgery provides an intriguing case study of direct-to-consumer promotions of medical devices, which are more loosely regulated than pharmaceutical promotions. We investigated whether the claims made in online promotions of robotic prostatectomy were consistent with evidence from comparative effectiveness studies. After performing a search and cross-sectional analysis of websites that mentioned the procedure, we found that many sites claimed benefits that were unsupported by evidence and that 42 percent of the sites failed to mention risks. Most sites were published by hospitals and physicians, which the public may regard as more objective than pages published by manufacturers. Unbalanced information may inappropriately raise patients' expectations. Increasing enforcement and regulation of online promotions may be beyond the capabilities of federal authorities. Thus, the most feasible solution may be for the government and medical societies to promote the production of balanced educational material.

SUBMITTER: Mirkin JN

PROVIDER: S-EPMC3897330 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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Direct-to-consumer Internet promotion of robotic prostatectomy exhibits varying quality of information.

Mirkin Joshua N JN Lowrance William T WT Feifer Andrew H AH Mulhall John P JP Eastham James E JE Elkin Elena B EB

Health affairs (Project Hope) 20120401 4

Robotic surgery to remove a cancerous prostate has become a popular treatment. Internet marketing of this surgery provides an intriguing case study of direct-to-consumer promotions of medical devices, which are more loosely regulated than pharmaceutical promotions. We investigated whether the claims made in online promotions of robotic prostatectomy were consistent with evidence from comparative effectiveness studies. After performing a search and cross-sectional analysis of websites that mentio ...[more]

PMID: 22492893

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Project description:BACKGROUND:US Food and Drug Administration (FDA) regulations state that any prescription drug promotion that presents drug benefits to consumers must also disclose certain information about the drug's risks in a similar manner. Nearly three-quarters of all US mobile phone subscribers use a smartphone, and over half report receiving mobile advertisements on their device. OBJECTIVE:The objective of this project was to investigate how prescription drugs are being promoted to consumers using mobile technologies. We were particularly interested in the presentation of drug benefits and risks, with regard to presence, placement, and prominence. METHODS:We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. RESULTS:Of the 51 mobile communications we coded, 41% (21/51) were product claim communications (includes the drug name, benefits, and risks), 22% (11/51) were reminder communications (includes drug name only), and 37% (19/51) were help-seeking communications (includes information about the medical condition but not the drug name). Some of the product claim communications (5/21, 24%) required scrolling to see all the benefit information; in contrast, 95% (20/21) required scrolling to see all the risk information. Of the 19 product claim communications that presented both benefits and risks, 95% (18/19) presented benefits before risks and 47% (9/19) used a bigger font for benefits than for risks. Most mobile communications (35/51, 69%) linked to branded drug websites with both benefits and risks, 25% (13/51) linked to a landing page with benefits but no visible risks, and 6% (3/51) linked to a landing page with risks but no visible benefits. Few landing pages (4/51, 8%) required scrolling to see all the benefit information; in contrast, 51% (26/51) required scrolling to see all the risk information. Of the 35 landing pages with both benefit and risk information, 71% (25/35) presented benefits before risks and 51% (18/35) used a bigger font for benefits than for risks. CONCLUSIONS:These results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not equally prominent and accessible. This has implications for compliance with FDA fair balance regulations.

Project description:ObjectiveTo describe the technical aspects and outcomes of robotic-assisted radical prostatectomy (RARP) following abandoned open radical prostatectomy (ORP).Patients and methodsA retrospective review was performed of patients who underwent RARP following abandonment of ORP between 2016 and 2020. RARP was undertaken by two highly experienced robotic surgeons. Analysis of patient and operative characteristics, outcomes, and reasons for abandonment of ORP were described.ResultsSix patients were included for analysis with a median age of 63.5 years [50.3-67.5]. The median body mass index (BMI) was 34.7 [27.8-36.2]. All patients had intermediate-risk prostate cancer. Small prostate and deep pelvis were given as reasons for abandoning ORP in five cases (83.3%), with four of these also attributing increased BMI as a factor. Extensive mesh from previous bilateral inguinal hernia repair was cited as the reason for abandonment in the remaining patient. One patient had commenced androgen deprivation therapy following abandoned ORP. Extensive retropubic adhesions were noted at the time of RARP in five of six patients, with intraoperative complication of small bladder lacerations encountered in the patient with prior mesh hernia repair. The median time from abandoned ORP to RARP was 128 days [40-216]. Median operating time was 160 minutes [139-190] and estimated blood loss was 225 mL [138-375]. Negative margins were obtained in four of six cases, with further salvage treatment being required in one case at a median follow-up duration of 10.5 months [6.5-25.3].ConclusionAbandonment of ORP is an uncommonly reported event, however, in this small case series, we demonstrate that, in the hands of experienced surgeons, RARP is a safe and technically feasible alternative in such cases. Increased BMI, small prostate size and pelvic anatomical constraints appear to be common catalysts for abandonment of open surgery in this cohort. Identifying these high-risk patients early and considering referral to robotic centers may be preferred.

Project description:BACKGROUND:Direct-to-consumer information (DTCI) campaign is a new medium to inform and empower patients in their decision-making without directly promoting specific drugs. However, little is known about the impact of DTCI campaigns, expanding rapidly in developed countries, on changes in prescription patterns. We sought to determine whether a DTCI campaign on overactive bladder increases the prescription rate for overactive bladder treatment drugs. METHODS:We performed a 3-year retrospective cohort study of 1332 participants who were diagnosed overactive bladder but not prescribed treatment drugs prior to the examined DTCI campaign (exposure), using the health insurance claims dataset of the Japan Medical Data Center (November 19, 2010 to November 18, 2013). The DTCI campaign for overactive bladder included television, Internet, and print advertising (November 19, 2011 to December 22, 2011). We divided the study period into Pre-Campaign Year (2010-2011), Year 1 (2011-2012), and Year 2 (2012-2013). Each year began on November 19 and included Period 1 (weeks 1-5) through Period 10 (weeks 46-50). The main outcome was first-time prescription of the treatment drug for each patient, measured by 5-week periods. Using Period 10 in the Pre-Campaign Year as the referent period, we applied the Cox proportional hazard model for each period. Additionally, we performed the interrupted time series analysis (ITSA) for the first-time prescription rate per 5-week period. RESULTS:Following the DTCI campaign, patients were about seven times more likely to receive a first prescription of a treatment drug during Period 4 in Year 1 (hazard ratio 7.09; 95% CI, 2.11-23.8; p-value<.01) compared with the reference period. Similar increases were also observed for subsequent Periods 5 and 6 in Year 1. The ITSA confirmed the DTCI campaign impact on the level of prescription rate (one-time increase in the regression-intercept) that increased by 1128.1 [per standardized 100,000 persons] (p < .05) during Period 4 in Year 1. CONCLUSIONS:The examined DTCI campaign appeared to increase the prescription rate among patients with overactive bladder for 15 weeks with a 15-week delay. Clinical outcomes of the patients with targeted diseases need to be monitored after DTCI campaigns by a future study.

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Direct-to-consumer Internet promotion of robotic prostatectomy exhibits varying quality of information.

Publications

Direct-to-consumer Internet promotion of robotic prostatectomy exhibits varying quality of information.

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