Dataset Information

Do randomized controlled trials discuss healthcare costs?

ABSTRACT: BACKGROUND: Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs) routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs. METHODS AND FINDINGS: We randomly sampled 188 RCTs spanning three years (2003-2005) from six high impact journals. The sample size for RCTs was based on a calculation to estimate the inclusion of actual drug costs with a precision of +/-3%. Two reviewers independently extracted cost data and study characteristics. Frequencies were calculated and potential characteristics associated with the inclusion of costs were explored. Actual drug costs were included in 4.7% (9/188) of RCTs; any actual costs were included in 7.4% (14/188) of RCTs; and any mention of costs was included in 27.7% (52/188) of RCTs. As the amount of industry funding increased across RCTs, from non-profit to mixed to fully industry funded RCTs, there was a statistically significant reduction in the number of RCTs with any actual costs (Cochran-Armitage test, p = 0.005) and any mention of costs (Cochran-Armitage test, p = 0.02). Logistic regression analysis also indicated funding was associated with the inclusion of any actual cost (OR = 0.34, p = 0.009) or any mention of costs (OR = 0.63, p = 0.02). Journal, study conclusions, study location, primary author's country and product age were not associated with inclusion of cost information. CONCLUSION: While physicians are encouraged to consider costs when prescribing drugs for their patients, actual drug costs were provided in only 5% of RCTs and were not mentioned at all in 72% of RCTs. Industry funded trials were less likely to include cost information. No other factors were associated with the inclusion of cost information.

SUBMITTER: Allan GM

PROVIDER: S-EPMC2925897 | biostudies-literature | 2010

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Do randomized controlled trials discuss healthcare costs?

Allan G Michael GM Korownyk Christina C LaSalle Kate K Vandermeer Ben B Ma Victoria V Klein Douglas D Manca Donna D

PloS one 20100823 8

<h4>Background</h4>Healthcare costs, particularly pharmaceutical costs, are a dominant issue for most healthcare organizations, but it is unclear if randomized controlled trials (RCTs) routinely discuss costs. Our objective was to assess the frequency and factors associated with the inclusion of costs in RCTs.<h4>Methods and findings</h4>We randomly sampled 188 RCTs spanning three years (2003-2005) from six high impact journals. The sample size for RCTs was based on a calculation to estimate the ...[more]

PMID: 20808794

Similar Datasets

Project description:The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs) of patient education.On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health) and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers.We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%). The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47%) or active treatment (47%). A minority of records (17%, 95% CI 11 to 23%) reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention). Further, for most reports (59%), important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63%. Information about the caregivers was missing for 70% of trials. Most trials (73%) took place in the United States or United Kingdom, 64% involved only one centre, and participating centers were mainly tertiary-care, academic or university hospitals (51%).Educational interventions assessed in ongoing RCTs of educational interventions are poorly described in trial registries. The lack of adequate description raises doubts about the ability of trial registration to help patients and researchers know about the treatment evaluated in trials of education.

Project description:A growing number of randomized controlled trials (RCTs) have investigated the therapeutic value of yoga interventions. This bibliometric analysis aimed to provide a comprehensive review of the characteristics of the totality of available randomized yoga trials.All RCTs of yoga were eligible. Medline/PubMed, Scopus, the Cochrane Library, IndMED, and the tables of content of yoga specialty journals not listed in medical databases were screened through February 2014. Bibliometric data, data on participants, and intervention were extracted and analyzed descriptively.Published between 1975 and 2014, a total of 366 papers were included, reporting 312 RCTs from 23 different countries with 22,548 participants. The median study sample size was 59 (range 8-410, interquartile range?=?31, 93). Two hundred sixty-four RCTs (84.6%) were conducted with adults, 105 (33.7%) with older adults and 31 (9.9%) with children. Eighty-four RCTs (26.9%) were conducted with healthy participants. Other trials enrolled patients with one of 63 varied medical conditions; the most common being breast cancer (17 RCTs, 5.4%), depression (14 RCTs, 4.5%), asthma (14 RCTs, 4.5%) and type 2 diabetes mellitus (13 RCTs, 4.2%). Whilst 119 RCTs (38.1%) did not define the style of yoga used, 35 RCTs (11.2%) used Hatha yoga and 30 RCTs (9.6%) yoga breathing. The remaining 128 RCTs (41.0%) used 46 varied yoga styles, with a median intervention length of 9 weeks (range 1 day to 1 year; interquartile range?=?5, 12). Two hundred and forty-four RCTs (78.2%) used yoga postures, 232 RCTs (74.4%) used breath control, 153 RCTs (49.0%) used meditation and 32 RCTs (10.3%) used philosophy lectures. One hundred and seventy-four RCTs (55.6%) compared yoga with no specific treatment; 21 varied control interventions were used in the remaining RCTs.This bibliometric analysis presents the most complete up-to-date overview on published randomized yoga trials. While the available research evidence is sparse for most conditions, there was a marked increase in published RCTs in recent years.

Dataset Information

Do randomized controlled trials discuss healthcare costs?

Publications

Do randomized controlled trials discuss healthcare costs?

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets