Data sharing: experience of accessing individual patient data from completed randomised controlled trials in vascular and cognitive medicine.

OBJECTIVES: Meta-analysis based on individual patient data (IPD) from randomised trials is superior to using published summary data since it facilitates subgroup and multiple variable analyses. Guidelines and funders expect that researchers share IPD for bona fide analyses, but in practice, this is done variably. Here, we report the experience of obtaining IPD for two collaborative analysis studies. SETTING: Two linked studies required IPD from published randomised trials. The leading researchers for eligible trials were approached and asked to share IPD including trial characteristics, patient demographics, baseline clinical data and outcome measures. PARTICIPANTS: Participants in eligible randomised controlled trials included patients with or at risk of cognitive decline/vascular events. PRIMARY AND SECONDARY OUTCOME MEASURES: Numbers (%) of trials where the leading researcher responded favourably/negatively or did not respond. If negative, reasons behind the response were collected. If positive, methods used to share IPD were recorded. RESULTS: Across the two studies, 391 completed trials were identified. Email addresses for researchers were found for 313 (80%) of the trials. One hundred and forty-eight (47%) researchers did not respond despite being sent multiple emails. Following contact, positive initial responses were received from 92 researchers, resulting in IPD being shared for 78 trials. Eighty-seven (28%) researchers declined to share data; justifications were recorded. The median time from first request to accessing data in one study was 241 (IQR 383.3) days. IPD sources included: direct from researcher, via academic trial funders repository and a website requiring remote analysis of commercial data. Where data were shared, a variety of methods were used to transfer data. CONCLUSION: Sharing of IPD from trials is desirable and a requirement of many funding bodies. However, accessing IPD faces multiple challenges including refusals to share, delays in access to data and having to perform analyses on a remote website. TRIAL REGISTRATION: Not applicable.

Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial.

INTRODUCTION: Mild cognitive impairment (MCI) is common in older adults and represents a high-risk group for progression to Alzheimer's disease (AD). Medication trials in MCI have generally failed, but new discoveries with brain plasticity in ageing have led to the study of cognitive training as a potential treatment to improve cognitive abilities. Computerised cognitive training (CCT) involves computerised cognitive exercises that target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity. METHODS AND ANALYSIS: In a two-site study (New York State Psychiatric Institute/Columbia University Medical Center and Duke University Medical Center), we will randomise 100 patients with MCI (Wechsler Memory Scale-III Logical Memory II score 0-11; Folstein Mini Mental State Examination ≥23) to home-based CCT (suite of exercises: memory, matching, spatial recognition, processing speed) or a home-based active control condition (computerised crossword puzzle training (CPT)) with 12 weeks of intensive training followed by regular booster sessions up to 78 weeks. All patients will receive standard neuropsychological and functional assessments in clinic as well as structural/functional brain MRI scans at study entry and endpoint. We will test if CCT, versus CPT, leads to improved cognitive functioning, transfers to functional ability and tasks of everyday life and impacts hippocampal volume changes and changes in the default mode network of the brain measured by resting-state functional MRI. ETHICS AND DISSEMINATION: The study will be conducted following ethics approval and written informed consent will be obtained from all subjects. Study results will be disseminated via publication, clinicaltrials.gov, media and conference presentations. This will be the first controlled long-term trial to evaluate the effects of home-based CCT versus computerised CPT on cognitive abilities and functional measures and neural outcomes as determined by MRI indices in patients with MCI. Positive results from trial may support further development of home-based CCT. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier (NCT03205709).

Developing assistive robots for people with mild cognitive impairment and mild dementia: a qualitative study with older adults and experts in aged care.

OBJECTIVES: This research is part of an international project to design and test a home-based healthcare robot to help older adults with mild cognitive impairment (MCI) or early dementia. The aim was to investigate the perceived usefulness of different daily-care activities for the robot, developed from previous research on needs. DESIGN: Qualitative descriptive analysis using semistructured interviews. Two studies were conducted. In the first study, participants watched videos of a prototype robot performing daily-care activities; in the second study, participants interacted with the robot itself. SETTING: Interviews were conducted at a university and a retirement village. PARTICIPANTS: In study 1, participants were nine experts in aged care and nine older adults living in an aged care facility. In study 2, participants were 10 experts in aged care. RESULTS: The themes that emerged included aspects of the robot's interactions, potential benefits, the appearance, actions and humanness of the robot, ways to improve its functionality and technical issues. Overall, the activities were perceived as useful, especially the reminders and safety checks, with possible benefits of companionship, reassurance and reduced caregiver burden. Suggestions included personalising the robot to each individual, simplifying the language and adding more activities. Technical issues still need to be fixed. CONCLUSION: This study adds to knowledge about healthcare robots for people with MCI by developing and testing a new robot with daily-care activities including safety checks. The robot was seen to be potentially useful but needs to be tested with people with MCI.

Evaluating the Impact of the Dementia Care in Hospitals Program (DCHP) on Hospital-Acquired Complications: Study Protocol.

Despite the increasing number of older people, many with cognitive impairment (CI), in hospitals, there is yet to be an evaluation of hospital-wide interventions improving the management of those with CI. In hospitalized patients with CI, there are likely to be associations between increased complications that impact on outcomes, length of stay, and costs. This prospective study will evaluate the effectiveness of an established hospital CI support program on patient outcomes, patient quality of life, staff awareness of CI, and carer satisfaction. Using a stepped-wedge, continuous-recruitment method, the pre-intervention patient data will provide the control data for usual hospital care. The intervention, the Dementia Care in Hospitals Program, provides hospital-wide CI awareness and support education, and screening for all patients aged 65+, along with a bedside alert, the Cognitive Impairment Identifier. The primary outcome is a reduction in hospital-acquired complications: urinary tract infections, pressure injuries, pneumonia and delirium. Secondary outcome measures include cost effectiveness, patient quality of life, carer satisfaction, staff awareness of CI, and staff perceived impact of care. This large-sample study across four sites offers an opportunity for research evaluation of health service functioning at a whole-of-hospital level, which is important for sustainable change in hospital practice.