ArticleAlzheimer's & dementia (New York, N. Y.)2021
Impact of the COVID-19 pandemic on statistical design and analysis plans for multidomain intervention clinical trials: Experience from World-Wide FINGERS.
Article in Alzheimer's & dementia (New York, N. Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 27 citations in OpenAlex.
- Baseline characteristics of the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER): Successful enrollment of a diverse clinical trial cohort at risk for cognitive decline.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Trial
- The cost effectiveness of a multidomain intervention on physical, cognitive, vascular, dietary and psychosocial outcomes among community dwelling older adults with cognitive frailty in Malaysia: The AGELESS Trial.Alzheimer's research & therapy · 2025Trial
- Effects of a multidomain intervention against cognitive decline on dementia risk profiles - Results from the AgeWell.de trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024Trial
- Japan-Multimodal Intervention Trial for the Prevention of Dementia: A randomized controlled trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024Trial
- A multidomain intervention against cognitive decline in an at-risk-population in Germany: Results from the cluster-randomized AgeWell.de trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024Trial
- Lessons on Resilient Research: Adapting the Tribal Turning Point Study to COVID-19.American Indian and Alaska native mental health research (Online) · 2022Trial
- Multidomain interventions for prevention of dementia: Achievements, challenges and future perspectives.Geriatrics & gerontology international · 2025Review
- Adapting epidemiological research through unexpected environmental events: COVID-19 and bushfires impacts on the administration of the PATH cohort study.Archives of public health = Archives belges de sante publique · 2025Article
- Estimating treatment effects from a randomized controlled trial with mid-trial design changes.Clinical trials (London, England) · 2025Article
- Article
- Social activities in multidomain dementia prevention interventions: insights from practice and a blueprint for the future.Frontiers in psychiatry · 2024Article
- Challenges and solutions in clinical research during the COVID-19 pandemic: A narrative review.Health science reports · 2023Article
- Intensive assessment of executive functions derived from performance in cognitive training games.iScience · 2023Article
- Article
- Effects of the COVID-19 pandemic on recruitment for the working women walking program.Research in nursing & health · 2022Article
- Changes in Brain-Health Related Modifiable Risk Factors in Older Adults After One Year of COVID-19-Restrictions.Frontiers in psychiatry · 2022Article
- Impact of the COVID-19 pandemic on statistical design and analysis plans for multidomain intervention clinical trials: Experience from World-Wide FINGERS.Alzheimer's & dementia (New York, N. Y.) · 2021Article
- Rationale, design, and cohort characteristics of the Action for Health in Diabetes Aging study.Alzheimer's & dementia (New York, N. Y.)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 8 institutions in 7 countries.
Funding
Abstract
introductionThe coronavirus disease-19 (COVID-19) pandemic presents challenges to the conduct of randomized clinical trials of lifestyle interventions.
methodsWorld-Wide FINGERS is an international network of clinical trials to assess the impact of multidomain lifestyle intervention on cognitive decline in at-risk adults. Individual trials are tailoring successful approaches from the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) to local cultures and environments. The network convened a forum for researchers to discuss statistical design and analysis issues they faced during the pandemic. We report on experiences of three trials that, at various stages of conduct, altered designs and analysis plans to navigate these issues. We provide recommendations for future trials to consider as they develop and launch behavioral intervention trials.
resultsThe pandemic led researchers to change recruitment plans, interrupt timelines for assessments and intervention delivery, and move to remote intervention and assessment protocols. The necessity of these changes add emphasis to the importance, in study design and analysis, of intention to treat approaches, flexibility, within-site stratification, interim power projections, and sensitivity analyses. DISCUSSION: Robust approaches to study design and analysis are critical to negotiate issues related to the intervention. The world-wide network of similarly oriented clinical trials will allow us to evaluate the effectiveness of responses to the pandemic across cultures, local environments, and phases of the pandemic.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.