A post-trial survey to assess the impact of dissemination of results and unmasking on participants in a 13-year randomised controlled trial on age-related cataract

<p>Abstract</p> <p>Background</p> <p>The Italian-American Clinical Trial of Nutritional Supplements and Age-Related Cataract was designed to assess the impact of a multivitamin-mineral supplement on age-related cataract. Trial results showed evidence of a beneficial effect of the supplement on all types of cataract combined, opposite effects on two of the three types of cataract (beneficial for nuclear opacities and harmful for posterior sub-capsular opacities) and no statistically significant effect on cortical opacities. No treatment recommendations were made. A post-trial survey was conducted on 817 surviving elderly participants to assess their satisfaction, their understanding of treatment assignment to supplement or placebo and the success of masking.</p> <p>Methods</p> <p>Trial results were communicated by letter and the level of satisfaction and of understanding of the results was assessed by a questionnaire. Participants were offered the option of being unmasked: a second questionnaire was administered to this subset to assess their understanding of the randomisation process and the success of masking.</p> <p>Results</p> <p>610 participants (74.7%) responded to the survey:</p> <p>94.6% thought the description of the results was "very clear" or "quite clear", 5.4% "not clear" or "do not know"; 89.8% considered the results "very interesting" or "quite interesting", 10.2% "not interesting" or "do not know"; 60.3% expressed "satisfaction", 17.2% "both satisfaction and concern", 2.6% "concern", 19.9% "indifference" or "do not know".</p> <p>480 participants (78.7%) accepted the offer to be unmasked to their treatment assignment: 395 (82.3%) recalled/understood the possibility of assignment to vitamins or placebo, 85 (17.7%) did not. 68 participants (17.2%) thought they had taken vitamins (79.4% were correct; p = 0.0006), 47 (11.9%) thought they had taken placebo (59.6% were correct; p = 0.46) and 280 (70.9%) declared they did not know.</p> <p>Conclusions</p> <p>The results were made difficult to explain to study participants by the qualitatively different effect of treatment on the two most visually significant types of cataract. Although the study did not lead to a recommendation to use the dietary supplement, the vast majority of participants reported satisfaction after they received the results but almost 20% of the participants expressed some concern. Masking to treatment assignment was successful in the majority of participants.</p

Participants' uptake of clinical trial results: a randomised experiment

BJC OPENInternational audienceBACKGROUND: Participants are showing great interest these days in obtaining the results of clinical trials. The aim of this study was to assess patients' uptake and understanding of the results of the trial in which they have participated and the impact of a letter offering patients the possibility of consulting the trial results on a specific website. METHODS: Breast cancer patients participating in a trial on the efficacy of Trastuzumab were randomly subdivided into an Internet group (who received the letter of invitation) and a control group (who did not receive it). Among 115 HER2-positive women from 21 centres, 107 (93%) answered a self-administered questionnaire. RESULTS: Most of the patients in both groups had access to the Internet (72.0%). The majority (97.2%) stated that receiving information about the trial results would be useful, and the oncologist was the most frequently preferred information provider. The Internet group's declared uptake of the trial results was only slightly higher (47.1% vs 33.9%; P=0.166); however, they understood the results significantly more accurately (18.8% vs 5.6%; P=0.039). INTERPRETATION: Although Internet was not the respondents' preferred source of information, the possibility of using this source slightly increased the uptake and understanding of the results

Investing in the future: lessons learnt from communicating the results of HSV/ HIV intervention trials in South Africa

<p>Abstract</p> <p>Background</p> <p>Communicating the results of randomised controlled trials may present challenges for researchers who have to work with communities and policy-makers to anticipate positive outcomes, while being aware that results may show no effect or harm.</p> <p>Methods</p> <p>We present a case study from the perspective of researchers in South Africa about the lessons learnt from communicating the results of four trials evaluating treatment for herpes simplex virus type 2 (HSV-2) as a new strategy for HIV prevention.</p> <p>Results</p> <p>We show that contextual factors such as misunderstandings and mistrust played an important role in defining the communications response. Use of different approaches in combination was found to be most effective in building understanding, credibility and trust in the research process. During the communication process, researchers acted beyond their traditional role of neutral observers and became agents of social change. This change in role is in keeping with a global trend towards increased communication of research results and presents both opportunities and challenges for the conduct of future research.</p> <p>Conclusions</p> <p>Despite disappointing trial results which showed no benefit of HSV-2 treatment for HIV prevention, important lessons were learnt about the value of the communication process in building trust between researchers, community members and policy-makers, and creating an enabling environment for future research partnerships.</p

Institutional review board challenges related to community-based participatory research on human exposure to environmental toxins: A case study

<p>Abstract</p> <p>Background</p> <p>We report on the challenges of obtaining Institutional Review Board (IRB) coverage for a community-based participatory research (CBPR) environmental justice project, which involved reporting biomonitoring and household exposure results to participants, and included lay participation in research.</p> <p>Methods</p> <p>We draw on our experiences guiding a multi-partner CBPR project through university and state Institutional Review Board reviews, and other CBPR colleagues' written accounts and conference presentations and discussions. We also interviewed academics involved in CBPR to learn of their challenges with Institutional Review Boards.</p> <p>Results</p> <p>We found that Institutional Review Boards are generally unfamiliar with CBPR, reluctant to oversee community partners, and resistant to ongoing researcher-participant interaction. Institutional Review Boards sometimes unintentionally violate the very principles of beneficence and justice which they are supposed to uphold. For example, some Institutional Review Boards refuse to allow report-back of individual data to participants, which contradicts the CBPR principles that guide a growing number of projects. This causes significant delays and may divert research and dissemination efforts. Our extensive education of our university Institutional Review Board convinced them to provide human subjects protection coverage for two community-based organizations in our partnership.</p> <p>Conclusions</p> <p>IRBs and funders should develop clear, routine review guidelines that respect the unique qualities of CBPR, while researchers and community partners can educate IRB staff and board members about the objectives, ethical frameworks, and research methods of CBPR. These strategies can better protect research participants from the harm of unnecessary delays and exclusion from the research process, while facilitating the ethical communication of study results to participants and communities.</p

Collaborative research between clinicians and researchers: a multiple case study of implementation

<p>Abstract</p> <p>Background</p> <p>Bottom-up, clinician-conceived and directed clinical intervention research, coupled with collaboration from researcher experts, is conceptually endorsed by the participatory research movement. This report presents the findings of an evaluation of a program in the Veterans Health Administration meant to encourage clinician-driven research by providing resources believed to be critical. The evaluation focused on the extent to which funded projects: maintained integrity to their original proposals; were methodologically rigorous; were characterized by collaboration between partners; and resulted in sustained clinical impact.</p> <p>Methods</p> <p>Researchers used quantitative (survey and archival) and qualitative (focus group) data to evaluate the implementation, evaluation, and sustainability of four clinical demonstration projects at four sites. Fourteen research center mentors and seventeen clinician researchers evaluated the level of collaboration using a six-dimensional model of participatory research.</p> <p>Results</p> <p>Results yielded mixed findings. Qualitative and quantitative data suggested that although the process was collaborative, clinicians' prior research experience was critical to the quality of the projects. Several challenges were common across sites, including subject recruitment, administrative support and logistics, and subsequent dissemination. Only one intervention achieved lasting clinical effect beyond the active project period. Qualitative analyses identified barriers and facilitators and suggested areas to improve sustainability.</p> <p>Conclusions</p> <p>Evaluation results suggest that this participatory research venture was successful in achieving clinician-directed collaboration, but did not produce sustainable interventions due to such implementation problems as lack of resources and administrative support.</p

The considerations, experiences and support needs of family members making treatment decisions for patients admitted with major stroke:a qualitative study

BACKGROUND: Treatment decision-making by family members on behalf of patients with major stroke can be challenging because of the shock of the diagnosis and lack of knowledge of the patient's treatment preferences. We aimed to understand how, and why, family members made certain treatment decisions, and explored their information and support needs.METHOD: Semi-structured interviews with family members (n = 24) of patients with major stroke, within 2 weeks of hospital admission. Data were analysed thematically.RESULTS: Families' approach to treatment decision-making lay on a spectrum according to the patient's state of health pre-stroke (i.e. patient's prior experience of illness and functional status) and any views expressed about treatment preferences in the event of life-threatening illness. Support and information needs varied according to where they were on this spectrum. At one extreme, family members described deciding not to initiate life-extending treatments from the outset because of the patients' deteriorating health and preferences expressed pre-stroke. Information from doctors about poor prognosis was merely used to confirm this decision. In the middle of the spectrum were family members of patients who had been moderately independent pre-stroke. They described the initial shock of the diagnosis and how they had initially wanted all treatments to continue. However, once they overcame their shock, and had gathered relevant information, including information about poor prognosis from doctors, they decided that life-extending treatments were no longer appropriate. Many reported this process to be upsetting and expressed a need for psychological support. At the other end of the spectrum were family members of previously independent patients whose preferences pre-stroke had not been known. Family members described feeling extremely distressed at such an unexpected situation and wanting all treatments to continue. They described needing psychological support and hope that the patient would survive.CONCLUSION: The knowledge that family members' treatment decision-making approaches lay on a spectrum depending on the patient's state of health and stated preferences pre-stroke may allow doctors to better prepare for discussions regarding the patient's prognosis. This may enable doctors to provide information and support that is tailored towards family members' needs.</p

Toxic ignorance and right-to-know in biomonitoring results communication: a survey of scientists and study participants

<p>Abstract</p> <p>Background</p> <p>Exposure assessment has shifted from pollutant monitoring in air, soil, and water toward personal exposure measurements and biomonitoring. This trend along with the paucity of health effect data for many of the pollutants studied raise ethical and scientific challenges for reporting results to study participants.</p> <p>Methods</p> <p>We interviewed 26 individuals involved in biomonitoring studies, including academic scientists, scientists from environmental advocacy organizations, IRB officials, and study participants; observed meetings where stakeholders discussed these issues; and reviewed the relevant literature to assess emerging ethical, scientific, and policy debates about personal exposure assessment and biomonitoring, including public demand for information on the human health effects of chemical body burdens.</p> <p>Results</p> <p>We identify three frameworks for report-back in personal exposure studies: clinical ethics; community-based participatory research; and citizen science 'data judo.' The first approach emphasizes reporting results only when the health significance of exposures is known, while the latter two represent new communication strategies where study participants play a role in interpreting, disseminating, and leveraging results to promote community health. We identify five critical areas to consider in planning future biomonitoring studies.</p> <p>Conclusion</p> <p>Public deliberation about communication in personal exposure assessment research suggests that new forms of community-based research ethics and participatory scientific practice are emerging.</p

Promoting advance planning for health care and research among older adults: A randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making.</p> <p>Methods/Design</p> <p>Dyads (<it>n </it>= 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled <it>My Preferences </it>that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about <it>My Preferences</it>. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments.</p> <p>Discussion</p> <p>This study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system.</p> <p>Trial Registration</p> <p><a href="http://www.controlled-trials.com/ISRCTN89993391">ISRCTN89993391</a></p