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Consort 2010 statement: extension to cluster randomised trials
Open accessAbstract
Abstract In age-related neurodegenerative disease, like Alzheimer’s and Parkinson’s disease, disease-specific proteins become aggregation-prone and form amyloid-like deposits. Depletion of SERF proteins ameliorates this toxic process in worm- and human cell models for disease. Whether SERF modifies amyloid pathology in mammalian brain, however, has remained unknown. Here, we generated SERF2 brain-specific knockout mice which, unlike full body knockout mice, were viable, and showed no major behavioral and cognitive abnormalities. We combined these knockout mice with the APPPS1 mouse model for human amyloid beta aggregation. Using structure-specific amyloid dyes, previously used to distinguish amyloid polymorphisms in human brain, we show that knockout of SERF2 alters the structure of amyloid fibrils and deposits. Moreover, scanning transmission electron microscopy revealed thicker, shorter and more densely packed amyloid in absence of SERF2. Altogether, our data reveal pleiotropic functions of SERF in development and aging and support a function as a modifier of amyloid aggregation in mammalian brain. Our results indicate that single cellular factors like SERF can determine the structural outcome of amyloid aggregation, offering possibilities for polymorphism-based disease interventions.
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“Both reporting and conduct might have improved in recent years with the use of the CONSORT statement extension for cluster randomized trials [5], but most evaluations of reporting and conduct suggest that improvements are minimal at best [6].”
From Cluster randomized trials of individual-level interventions were at high risk of bias (2021) · cites this paper as [5]
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“The design, conduct, and reporting of this trial follow the recommendations of the CONSORT statement [15].”
From Effects of a school-based physical activity intervention on academic performance in 14-year old adolescents: a cluster randomized controlled trial – the School in Motion study (2021) · cites this paper as [15]
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“Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions.”
From CONSORT 2025 statement: Updated guideline for reporting randomised trials (2025) · cites this paper as [34]
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“Whist we did not directly assess quality of reporting, despite the existence of specific reporting guidelines for cluster trials [5], we identified many elements were not well reported.”
From Cluster randomized trials of individual-level interventions were at high risk of bias (2021) · cites this paper as [5]
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“Cluster randomization is used in this study to reduce experimental contamination [47] and to minimize administrative burden and time spent on training the participating mental health counselors in the used treatment methods.”
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“Furthermore, due to the cluster-randomized design, more participants are needed to obtain equivalent statistical power as compared to an individually randomized trial [47].”
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“We report our trial findings according to the CONSORT guidelines31 and extensions for AI32, cluster-randomized trials33 and pragmatic trials34 (Supplementary Table 1).”
From Real-time surveillance system for patient deterioration: a pragmatic cluster-randomized controlled trial (2025) · cites this paper as [33]
In the citing paper
“Extensions to CONSORT have been developed to tackle the methodological issues associated with reporting different types of trial designs, data, and interventions.”
From CONSORT 2025 statement: updated guideline for reporting randomised trials (2025) · cites this paper as [34]
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Cites
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
Schulz, K. F., Altman, D. G., Moher, D., & for the CONSORT Group (2010) · BMJ · doi:10.1136/bmj.c332 · Cited by 9,329
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Self-citationThe Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
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“To facilitate discussion on presenting the flow of the number of clusters, cluster-period, and participants through a CRXO, we outline possible modifications to the flow diagram in the CONSORT 2012 cluster trials extension [12] and present a possible flow diagram in Fig.”
BackgroundMethodInfluentialMethodology reporting improved over time in 176,469 randomized controlled trials
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Metadata
- Authors
- Campbell, M. K., Piaggio, G., Elbourne, D. R., Altman, D. G., & for the CONSORT Group
- Affiliations
- University of Aberdeen (GB)
- London School of Hygiene & Tropical Medicine (GB)
- University of Oxford (GB)
- Corresponding author
- Campbell, M. K.
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2012-09-04
- Volume
- 345
- Issue
- sep04 1
- Pages
- e5661-e5661
- ISSN
- 1756-1833 (ISSN-L)
- OpenAlex
- W2102330235
- Cited by
- 3,510
- References
- 131
- Citations by year
- 2026: 194 · 2025: 227 · 2024: 211 · 2023: 221 · 2022: 248 · 2021: 264 · 2020: 249 · 2019: 172 · 2018: 197 · 2017: 174 · 2016: 172 · 2015: 201 · 2014: 166 · 2013: 165 · 2012: 109
- FWCI
- 137.68
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- BMJ (publishedVersion)
- PubMed (publishedVersion)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- Oxford University Research Archive (ORA) (University of Oxford) (submittedVersion)
- Funders
- U.S. Department of Health and Human Services
- Scottish Government
- Cancer Research UK (C5529)
- National Institutes of Health
- Chief Scientist Office, Scottish Government Health and Social Care Directorate
- Medical Research Council (MR/J004871/1)
- National Cancer Institute
- Topics
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Keywords
- amyloid fibril formation, amyloid fibril structure, Alzheimer's disease, Parkinson's disease, age-related neurodegenerative diseases, amyloid polymorphism, scanning transmission electron microscopy, genetic modifiers
- MeSH terms
- Data Interpretation, Statistical, Humans, Random Allocation, Cluster Analysis, Randomized Controlled Trials as Topic, Sample Size
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