Dataset Information

Consent processes in cluster-randomised trials in residential facilities for older adults: a systematic review of reporting practices and proposed guidelines.

ABSTRACT:

Objective

To assess the quality of reported consent processes of cluster-randomised trials conducted in residential facilities for older people and to explore whether the focus on improving the general conduct and reporting of cluster-randomised trials influenced the quality of conduct and reporting of ethical processes in these trials.

Design

Systematic review of cluster-randomised trials reports, published up to the end of 2010.

Data sources

National Library of Medicine (Medline) via PubMed, hand-searches of BMJ, Journal of the American Medical Association, BMC Health Services Research, Age and Ageing and Journal of the American Geriatrics Society, reference search in Web of Knowledge and consultation with experts.

Eligibility for selecting studies

Published cluster-randomised trials where the unit of randomisation is a part or the whole of a residential facility for older people, without language or year of publication restrictions.

Results

We included 73 trials. Authors reported ethical approval in 59, obtaining individual consent in 51, and using proxies for this consent in 37, but the process to assess residents' capacity to consent was clearly reported in only eight. We rated only six trials high for the quality of consent processes. We considered that individual informed consent could have been waived legitimately in 14 of 22 trials not reporting obtaining consent. The proportions reporting ethical approval and quality of consent processes were higher in recent trials.

Conclusions

Recently published international recommendations regarding ethical conduct in cluster-randomised trials are much needed. In relation to consent processes when cognitively impaired individuals are included in these trials, we provide a six-point checklist and recommend the minimum information to be reported. Those who lack capacity in trials with complex designs should be afforded the same care in relation to consent as competent adults in trials with simpler designs.

SUBMITTER: Diazordaz K

PROVIDER: S-EPMC3710983 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectivesTo investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association's Declaration of Helsinki and the International Committee of Medical Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices.DesignReview of a random sample of published cluster randomised trials from an electronic search in Medline.SettingCluster randomised trials in health research published in English language journals from 2000 to 2008. Study sample 300 cluster randomised trials published in 150 journals.Results77 (26%, 95% confidence interval 21% to 31%) trials failed to report ethics review. The proportion reporting ethics review increased significantly over time (P<0.001). Trials with data collection interventions at the individual level were more likely to report ethics review than were trials that used routine data sources only (79% (n=151) v 55% (23); P=0.008). Trials that accounted for clustering in the design and analysis were more likely to report ethics review. The median impact factor of the journal of publication was higher for trials that reported ethics review (3.4 v 2.3; P<0.001). 93 (31%, 26% to 36%) trials failed to report consent. Reporting of consent increased significantly over time (P<0.001). Trials with interventions targeting participants at the individual level were more likely to report consent than were trials with interventions targeting the cluster level (87% (90) v 48% (41); P<0.001). Trials with data collection interventions at the individual level were more likely to report consent than were those that used routine data sources only (78% (146) v 29% (11); P<0.001).ConclusionsReporting of research ethics protections in cluster randomised trials is inadequate. In addition to research ethics approval, authors should report whether informed consent was sought, from whom consent was sought, and what consent was for.

Project description:BackgroundPrevious reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this review, our aim was to assess the quality of cluster randomised trials conducted in residential facilities for older people, and to determine whether (1) statistician involvement in the trial and (2) strength of journal endorsement of the Consolidated Standards of Reporting Trials (CONSORT) statement influence quality.MethodsWe systematically identified trials randomising residential facilities for older people, or parts thereof, without language restrictions, up to the end of 2010, using National Library of Medicine (Medline) via PubMed and hand-searching. We based quality assessment criteria largely on the extended CONSORT statement for cluster randomised trials. We assessed statistician involvement based on statistician co-authorship, and strength of journal endorsement of the CONSORT statement from journal websites.Results73 trials met our inclusion criteria. Of these, 20 (27%) reported accounting for clustering in sample size calculations and 54 (74%) in the analyses. In 29 trials (40%), methods used to identify/recruit participants were judged by us to have potentially caused bias or reporting was unclear to reach a conclusion. Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials. Trials with statistician/epidemiologist co-authors were more likely to account for clustering in sample size calculations (unadjusted odds ratio 5.4, 95% confidence interval 1.1 to 26.0) and analyses (unadjusted OR 3.2, 1.2 to 8.5). Journal endorsement of the CONSORT statement was not associated with trial quality.ConclusionsDespite international attempts to improve methods in cluster randomised trials, important quality limitations remain amongst these trials in residential facilities. Statistician involvement on trial teams may be more effective in promoting quality than further journal endorsement of the CONSORT statement. Funding bodies and journals should promote statistician involvement and co-authorship in addition to adherence to CONSORT guidelines.

Project description:BackgroundThe provision of residential aged care is underpinned by information, and is reliant upon systems that adequately capture and effectively utilise and communicate this information. The aim of this study was to explicate and quantify the volume and method by which information is collected, exchanged within facilities and with external providers, and retrieved from facility information systems and hospitals.MethodsA survey of staff (n = 119), including managers, health informatics officers (HIOs), quality improvement staff, registered nurses (RNs), enrolled nurses (ENs)/endorsed enrolled nurses (EENs) and assistants in nursing (AINs) was carried out in four residential aged care facilities in New South Wales and Victoria, Australia. Sites varied in size and displayed a range of information technology (IT) capabilities. The survey investigated how and by whom information is collected, retrieved and exchanged, and the frequency and amount of time devoted to these tasks. Descriptive analysis was performed using SPSS, and open responses to questions were coded into key themes.ResultsStaff completed a median of six forms each, taking a median of 30 min per shift. 68.8% of staff reported transferring information from paper to a computer system, which took a median of 30 min per shift. Handover and face-to-face communication was the most frequently used form of information exchange within facilities. There was a large amount of faxing and telephone communication between facility staff and General Practitioners and community pharmacists, with staff reporting sending a median of 2 faxes to pharmacy and 1.5 faxes to General Practitioners, and initiating 2 telephone calls to pharmacies and 1.5 calls to General Practitioners per shift. Only 38.5% of respondents reported that they always had information available at the point-of-care and only 35.4% of respondents reported that they always had access to hospital stay information of residents after hospital discharge.ConclusionsThis survey identified a high volume of information exchange activities, as well as inefficient procedures, such as the transfer of information from paper to computer systems and the reliance upon faxes for communication with external providers. These findings contribute to evidence for the need for interoperable IT systems to allow more efficient and reliable information exchange between facilities and external providers.