METHODS: Eleven databases were searched without date or language restrictions for systematic reviews of public and patient involvement (PPI) in clinical trials design. This systematic overview of PPI included 27 reviews from which areas of good and bad practice were identified. Strengths, weaknesses, opportunities, and threats of PPI were explored through use of meta-narrative analysis.
RESULTS: Inclusion criteria were met by 27 reviews ranging in quality from high (n = 7), medium (n = 14) to low (n = 6) reviews. Reviews were assessed using CERQUAL NICE, CASP for qualitative research and CASP for systematic reviews. Four reviews report risk of bias. Public involvement roles were primarily in agenda setting, steering committees, ethical review, protocol development, and piloting. Research summaries, follow-up, and dissemination contained PPI, with lesser involvement in data collection, analysis, or manuscript authoring. Trialists report difficulty in finding, retaining, and reimbursing volunteers. Respectful inclusion, role recognition, mutual flexibility, advance planning, and sound methods were reported as facilitating public involvement in research. Public involvement was reported to have increased the quantity and quality of patient relevant priorities and outcomes, enrollment, funding, design, implementation, and dissemination. Challenges identified include lack of clarity within common language, roles, and research boundaries, while logistical needs include extra time, training, and funding. Researchers report struggling to report involvement and avoid tokenism.
CONCLUSIONS: Involving patients and the public in clinical trials design can be beneficial but requires resources, preparation, training, flexibility, and time. Issues to address include reporting deficits for risk of bias, study quality, and conflicts of interests. We need to address these tensions and improve dissemination strategies to increase PPI and health literacy.
OBJECTIVES: To review the literature on trials conducted among older adults residing in care homes within the UK and collate evidence on their methodological characteristics and outcomes.
METHODS: A systematic rapid review methodology was employed. MEDLINE, EMBASE and CENTRAL were searched in two incremental stages: stage 1 searched for oral health-related trials conducted within the UK care homes up to July 2021, whereas stage 2 sought for general health-related trials in the same setting from 2011 to 2021. The quality of included studies was assessed using Cochrane's RoB 2 and ROBINS-I tools. Findings were summarised descriptively.
RESULTS: Five oral health and 33 general health-related trials involving care home residents were included for analysis. The most common trial design was parallel group with two arms (n = 25) involving individual randomisation (n = 21). Consent was mainly obtained from residents and/or their proxies (n = 24), followed by residents only (n = 13) and care homes only (n = 1). Based on available data, the number needed to screen to recruit one participant ranged from 2 to 40 (median: 3; Q1-Q3: 2-9). Attrition rates ranged from 0% to 73% (median: 21%; Q1-Q3: 13%-32%) for follow-up periods between 1 and 52 weeks. The studies were of mixed methodological quality.
CONCLUSION: This rapid review outlines the methodological characteristics and outcomes of trials conducted among older adults in UK care homes. The findings of this review provide valuable information to assist in navigating and designing future research in this complex setting.
BACKGROUND: FPE is a cost-effective and helpful tool for reducing fall occurrences.
EVALUATION: This is a systematic review study using electronic searches via EBSCOHost® platform, ScienceDirect, Scopus and Google Scholar in March 2021. The review protocol was registered with PROSPERO (CRD42021232102). The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement flow chart guided the search strategy. Articles published from January 2010 to March 2021 were included for quality appraisal using the 'Transparent Reporting of Evaluations with Non-randomised Designs' (TREND) and the 'Consolidated Standards of Reporting Trials' (CONSORT) statement for randomised controlled trial studies.
KEY ISSUES: Six FPE studies selected emphasised on personal health status, exercise and environmental risk factors. These studies reported an increase in fall risk awareness or knowledge and a positive change in fall preventive behaviours. Two studies included nurses as educators in FPE.
CONCLUSION: FPE evidently improved awareness or knowledge and preventive fall behaviour change among older adults. Nurses are in great potential in planning and providing FPE for older adults in community settings.
IMPLICATIONS FOR NURSING MANAGEMENT: Expand nurses' roles in fall prevention programmes in community settings by using high-quality and evidence-based educational tools. Highlight the nurse's role and collaborative management in FPE.
METHODS: Neonatal trials including ≥100 participants/arm published between 2015 and 2020 with at least 1 primary outcome from a neonatal core outcome set were eligible. Raters recruited from Cochrane Neonatal were trained to evaluate the trials' primary outcome reporting completeness using relevant items from Consolidated Standards of Reporting Trials 2010 and Consolidated Standards of Reporting Trials-Outcomes 2022 pertaining to the reporting of the definition, selection, measurement, analysis, and interpretation of primary trial outcomes. All trial reports were assessed by 3 raters. Assessments and discrepancies between raters were analyzed.
RESULTS: Outcome-reporting evaluations were completed for 36 included neonatal trials by 39 raters. Levels of outcome reporting completeness were highly variable. All trials fully reported the primary outcome measurement domain, statistical methods used to compare treatment groups, and participant flow. Yet, only 28% of trials fully reported on minimal important difference, 24% on outcome data missingness, 66% on blinding of the outcome assessor, and 42% on handling of outcome multiplicity.
CONCLUSIONS: Primary outcome reporting in neonatal trials often lacks key information needed for interpretability of results, knowledge synthesis, and evidence-informed decision-making in neonatology. Use of existing outcome-reporting guidelines by trialists, journals, and peer reviewers will enhance transparent reporting of neonatal trials.
AIMS: This research project aims to identify attitudes towards cancer and associated information and communication needs of Chinese patients and their relatives in Sydney, thereby providing a framework for the provision of culturally appropriate cancer care for Chinese-Australians.
METHODS: A qualitative data collection strategy was selected as the most appropriate method, because no validated measures are available and no previous research has examined attitudes and needs of Chinese-Australian cancer patients. Patients were recruited from three major teaching hospitals in Sydney and from a Chinese cancer support organisation. Sampling was discontinued when informational redundancy was achieved. Four focus groups and 26 individual telephone interviews were conducted with a total of 36 cancer patients and 12 relatives born in China, Singapore and Malaysia.
RESULTS: While individual differences were observed, a majority view was expressed on a range of issues. Non-disclosure of a poor prognosis was favoured, and the role of the family in liaising between health professionals and the patient was emphasised. Patients preferred a confident and clear diagnosis and treatment recommendation. Most patients wished to incorporate Chinese culture-specific treatments into their care. The need for interpreters and psychological and spiritual support was emphasised.
CONCLUSIONS: Providing information in a culturally sensitive manner will assist doctors in providing optimum care and support for ethnic minority groups in this country.
RECOMMENDATIONS: This is a narrative opinion piece on the design of clinical trials in youth-onset type 2 diabetes prepared by researchers who undertake this type of study in different countries. The review addresses possible ways to enhance trial designs in youth-onset type 2 diabetes to meet regulatory requirements, while minimizing the barriers to patients' participation. The definition of adolescence, recruitment of sufficient patient numbers, increasing flexibility in selection criteria, improving convenience of trial visits, requirements of a control group, possible endpoints, and trial compliance are all considered. The authors recommend allowing extrapolation from adult data, using multiple interventional arms within future trials, broadening inclusion criteria, and focusing on endpoints beyond glucose control, among others, in order to improve the successful completion of more trials in this population.
CONCLUSIONS: Improvements in trial design will enable better recruitment and retention and thereby more evidence for treatment outcomes for youth-onset type 2 diabetes.