Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial.

BACKGROUND: Sleep problems are highly prevalent in people with dementia. Nevertheless, there is no "gold standard" intervention to prevent or reduce sleep problems in people with dementia. Existing interventions are characterized by a pronounced heterogeneity as well as insufficient knowledge about the possibilities and challenges of implementation. The aim of this study is to pilot and evaluate the effectiveness of a newly developed complex intervention to prevent and reduce sleep problems in people with dementia living in nursing homes. METHODS: This study is a parallel group cluster-randomized controlled trial. The intervention consists of six components: (1) the assessment of established sleep-promoting interventions and an appropriate environment in the participating nursing homes, (2) the implementation of two "sleep nurses" as change agents per nursing home, (3) a basic education course for nursing staff: "Sleep problems in dementia", (4) an advanced education course for nursing staff: "Tailored problem-solving" (two workshops), (5) workshops: "Development of an institutional sleep-promoting concept" (two workshops with nursing management and sleep nurses) and (6) written information and education material (e.g. brochure and "One Minute Wonder" poster). The intervention will be performed over a period of 16 weeks and compared with usual care in the control group. Overall, 24 nursing homes in North, East and West Germany will be included and randomized in a 1:1 ratio. The primary outcome is the prevalence of sleep problems in people with dementia living in nursing homes. Secondary outcomes are quality of life, quality of sleep, daytime sleepiness and agitated behavior of people with dementia, as well as safety parameters like psychotropic medication, falls and physical restraints. The outcomes will be assessed using a mix of instruments based on self- and proxy-rating. A cost analysis and a process evaluation will be performed in conjunction with the study. CONCLUSIONS: It is expected that the intervention will reduce the prevalence of sleep problems in people with dementia, thus not only improving the quality of life for people with dementia, but also relieving the burden on nursing staff caused by sleep problems. TRIAL REGISTRATION: Current controlled trials: ISRCTN36015309 . Date of registration: 06/11/2020.

An observational study found large methodological heterogeneity in systematic reviews addressing prevalence and cumulative incidence.

OBJECTIVES: The objective of this study was to assess reporting and methodological aspects of systematic reviews (SRs) on prevalence and cumulative incidence data. STUDY DESIGN AND SETTING: We searched PubMed up to 18 April, 2018, and drew a random sample of eligible SRs. RESULTS: The included 215 SRs were reported in 187 different journals. 58.1% were published between 2015 and 2018. Few SRs were registered with PROSPERO (5.6%). One-quarter considered articles without languages restrictions (25.1%). Regional restrictions of included studies were applied in 22.8%. A meta-analysis was carried out in 40.5% of the SRs. One hundred and six studies (49.3%) assessed risk of bias or study quality. A total of 41 different existing tools as well as 15 tools developed by the authors themselves were used. The most commonly applied tools were the Newcastle-Ottawa Scale (15.1%), STROBE (13.5%), and the Cochrane Collaboration's tool for assessing risk of bias (7.9%). CONCLUSION: We found large heterogeneity in characteristics, reporting, and methodological aspects of SRs on prevalence and cumulative incidence data, especially when compared with other types of SRs. Newly developed or revised guidance on how to conduct and report SRs as well as instruments for critical appraisal should consider the diversity of review types.