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Journal ArticleDOI

Presenting the results of clinical trials to participants.

01 Oct 2009-Clinical Medicine (Royal College of Physicians)-Vol. 9, Iss: 5, pp 415-416

TL;DR: The need for researchers to communicate their results to study participants is highlighted and suggestions for how the information collected could be used to inform further work in this area are made.

AbstractParticipants in clinical trials give their time and undergo procedures in the hope that they will obtain benefit for themselves and that they will be contributing to the advancement of medical science.[1][1] Traditionally little emphasis has been placed on informing participants of trial results,

Topics: Clinical trial (60%)

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Journal ArticleDOI
01 Jan 2012-BMJ Open
Abstract: Objective To identify the most appropriate format for results dissemination to maximise understanding of trial results. Design Qualitative. Setting Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. Participants All participants from these centres were eligible. All 343 participants were sent questionnaires. Primary and secondary outcome measures The low response rate meant that we were unable to make any firm conclusions about the patients9 preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. Results All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. Conclusions The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

8 citations


01 Jan 2012
TL;DR: The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres, and rapid dissemination of results is needed if it is to have any impact at all.
Abstract: Objective To identify the most appropriate format for results dissemination to maximise understanding of trial results. Design Qualitative. Setting Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. Participants All participants from these centres were eligible. All 343 participants were sent questionnaires. Primary and secondary outcome measures The low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. Results All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. Conclusions The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

6 citations


Journal ArticleDOI
24 May 2021-Trials
Abstract: There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the results of the trials they participated in. This scoping review aimed to identify, collate, and describe the available evidence relating to any aspect of disseminating trial results to participants. A scoping review was conducted employing a search of key databases (MEDLINE, EMBASE, PsycINFO, and the Cumulative Index to Nursing & Allied Health Literature (CINAHL) from January 2008 to August 2019) to identify studies that had explored any aspect of disseminating results to trial participants. The search strategy was based on that of a linked existing review. The evidence identified describes the characteristics of included studies using narrative description informed by analysis of relevant data using descriptive statistics. Thirty-three eligible studies, including 12,700 participants (which included patients, health care professionals, trial teams), were identified and included. Reporting of participant characteristics (age, gender, ethnicity) across the studies was poor. The majority of studies investigated dissemination of aggregate trial results. The most frequently reported mode of disseminating of results was postal. Overall, the results report that participants evaluated receipt of trial results positively, with reported benefits including improved communication, demonstration of appreciation, improved retention, and engagement in future research. However, there were also some concerns about how well the dissemination was resourced and done, worries about emotional effects on participants especially when reporting unfavourable results, and frustration about the delay between the end of the trial and receipt of results. This scoping review has highlighted that few high-quality evaluative studies have been conducted that can provide evidence on the best ways to deliver results to trial participants. There have been relatively few qualitative studies that explore perspectives from diverse populations, and those that have been conducted are limited to a handful of clinical areas. The learning from these studies can be used as a platform for further research and to consider some core guiding principles of the opportunities and challenges when disseminating trial results to those who participated.

1 citations


Journal ArticleDOI
Abstract: Background Sharing trial results with participants is an ethical imperative but often does not happen. We tested an Enhanced Webpage versus a Basic Webpage, Mailed Printed Summary versus no Mailed Printed Summary, and Email List Invitation versus no Email List Invitation to see which approach resulted in the highest patient satisfaction with how the results were communicated. Methods and findings We carried out a cluster randomised, 2 by 2 by 2 factorial, nonblinded study within a trial, with semistructured qualitative interviews with some patients (ISRCTN96189403). Each cluster was a UK hospital participating in the ICON8 ovarian cancer trial. Interventions were shared with 384 ICON8 participants who were alive and considered well enough to be contacted, at 43 hospitals. Hospitals were allocated to share results with participants through one of the 8 intervention combinations based on random permutation within blocks of 8, stratified by number of participants. All interventions contained a written plain English summary of the results. The Enhanced Webpage also contained a short video. Both the Enhanced Webpage and Email contained links to further information and support. The Mailed Printed Summary was opt-out. Follow-up questionnaires were sent 1 month after patients had been offered the interventions. Patients' reported satisfaction was measured using a 5-point scale, analysed by ordinal logistic regression estimating main effects for all 3 interventions, with random effects for site, restricted to those who reported receiving the results and assuming no interaction. Data collection took place in 2018 to 2019. Questionnaires were sent to 275/384 randomly selected participants and returned by 180: 90/142 allocated Basic Webpage, 90/133 Enhanced Webpage; 91/141 no Mailed Printed Summary, 89/134 Mailed Printed Summary; 82/129 no Email List Invitation, 98/146 Email List Invitation. About 3 patients opted out of receiving the Mailed Printed Summary; no patients signed up to the email list. Patients' satisfaction was greater at sites allocated the Mailed Printed Summary, where 65/81 (80%) were quite or very satisfied compared to sites with no Mailed Printed Summary 39/64(61%), ordinal odds ratio (OR) = 3.15 (1.66 to 5.98, p Conclusions Nearly all respondents wanted to know the results and were glad to receive them. Adding an opt-out Mailed Printed Summary alongside a webpage yielded the highest reported satisfaction. This study provides evidence on how to share results with other similar trial populations. Further research is needed to look at different results scenarios and patient populations. Trial registration ISRCTN: ISRCTN96189403.

References
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Journal ArticleDOI
Abstract: The “deficit model” of public attitudes towards science has led to controversy over the role of scientific knowledge in explaining lay people’s attitudes towards science. In this paper we challenge the de facto orthodoxy that has connected the deficit model and contextualist perspectives with quantitative and qualitative research methods respectively. We simultaneously test hypotheses from both theoretical approaches using quantitative methodology. The results point to the clear importance of knowledge as a determinant of attitudes toward science. However, in contrast to the rather simplistic deficit model that has traditionally characterized discussions of this relationship, this analysis highlights the complex and interacting nature of the knowledge— attitude interface.

893 citations


Journal ArticleDOI
TL;DR: The addition of biphasic or prandial insulin aspart reduced levels more than the addition of basal insulin detemir but was associated with greater risks of hypoglycemia and weight gain.
Abstract: A b s t r ac t At 1 year, mean glycated hemoglobin levels were similar in the biphasic group (7.3%) and the prandial group (7.2%) (P = 0.08) but higher in the basal group (7.6%, P<0.001 for both comparisons). The respective proportions of patients with a gly- cated hemoglobin level of 6.5% or less were 17.0%, 23.9%, and 8.1%; respective mean numbers of hypoglycemic events per patient per year were 5.7, 12.0, and 2.3; and respective mean weight gains were 4.7 kg, 5.7 kg, and 1.9 kg. Rates of adverse events were similar among the three groups. Conclusions A single analogue-insulin formulation added to metformin and sulfonylurea resulted in a glycated hemoglobin level of 6.5% or less in a minority of patients at 1 year. The addition of biphasic or prandial insulin aspart reduced levels more than the addition of basal insulin detemir but was associated with greater risks of hypogly- cemia and weight gain. (Current Controlled Trials number, ISRCTN51125379.)

677 citations


Journal ArticleDOI
Abstract: Over the last four decades, a substantial body of national survey material has been collected in the US concerning the public understanding of science and technology. Using this body of research, this analysis outlines the major trends from 1957 to 1999 and discusses their implications for public understanding of, and attitudes toward, scientific research. The analysis found that although the rate of civic scientific literacy in the US is only now approaching 20 percent, there is a strong and continuing public belief in the value of scientific research for economic prosperity and for the quality of life. Even though there are some continuing reservations about the pace of change engendered by science and technology and the relationship between science and faith, the public consistently reconciles these differing perceptions in favor of science.

486 citations


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17 Jul 2002-JAMA

140 citations