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Cited by 3,510Alzheimer's disease research and treatmentsStatistical Methods in Clinical TrialsDementia and Cognitive Impairment Research

Consort 2010 statement: extension to cluster randomised trials

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Campbell, M. K., Piaggio, G., Elbourne, D. R., Altman, D. G., for the CONSORT Group·2012·BMJ
DOI 10.1136/bmj.e5661
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Abstract

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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Crossref · 10.1136/bmj.e5661

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124 of 124 references verified0 citation errors · 0 not checkable

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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, but most evaluations of reporting and conduct suggest that improvements are minimal at best.

    “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]

    The Additional information section says the authors expect routine use of the extension to improve reporting of cluster trials, and the Interpretation section describes some evidence of improved reporting over time. The Quality of reporting of cluster trials section also notes improvement in methods in one study, but our copy does not link improved conduct to use of the extension. The separate claim about evaluations finding minimal improvement is attached to citation [6], not this source. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • The design, conduct, and reporting of this trial follow the recommendations of the CONSORT statement.

    “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]

    The 'Extension of CONSORT 2010 to cluster trials' section presents a reporting checklist, and 'Additional information' says the statement can help researchers design future trials. The paper does not establish that the citing trial followed those recommendations in its design, conduct, or reporting; its guidance focuses on reporting rather than trial conduct. (LLM, conf=0.83)

    Experimental — accuracy not yet measured

  • Extensions to CONSORT have been developed to address methodological issues in reporting different types of trial designs, data, and interventions.

    “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]

  • We did not directly assess quality of reporting, despite the existence of specific reporting guidelines for cluster trials, and we identified many elements were not well reported.

    “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]

  • Cluster randomization reduces experimental contamination.

    “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.”

    From An Internet-based Acceptance and Commitment Therapy intervention for older adults with anxiety complaints: study protocol for a cluster randomized controlled trial. (2018) · cites this paper as [47]

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Cites

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7 of the 131 references couldn’t be matched to a known paper.

Research works printed but not linked: 11

  1. [24]24. Campbell MJ, Donner A, Klar N. Developments in cluster randomized trials. Stat Med 2007;26:2-19.
  2. [35]35. Calhoun AW, Guyatt GH, Cabana MD, Lu D, Turner DA, Valentine S, et al. Addressing the unit of analysis in medical care studies: a systematic review. Med Care 2008;46:635-43.
  3. [49]49. Donner A, Brown KS, Brasher P. A methodological review of non-therapeutic intervention trials employing cluster randomization, 1979-1989. Int J Epidemiol 1990;19:795-800.
  4. [75]75. Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, et al. The Ottawa Consensus Statement on the ethical design and conduct of CRTs. PloS Med (in press).
  5. [79]79. Taljaard M, McRae A, Weijer C, Bennett C, Dixon S, Taleban J, et al. Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of a representative sample of published trials. BMJ 2011;342:d2496.
  6. [85]85. For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
  7. [89]89. Moher D, Turner L, Shamseer L, Plint A, Weeks L, Peters J, et al. The influence on CONSORT on the quality of RCTs: an updated review. Clin Trials 2011;8:485.
  8. [90]90. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA 2006;295:1152-60.
  9. [93]93. Klar N, Donner A. The merits of matching in community intervention trials. Stat Med 1997;16:1753-64.
  10. [104]104. Spiegelhalter DJ. Bayesian methods for cluster randomized trials with continuous response. Stat Med 2001;20:435-52. 104
  11. [105]105. Turner RM, Omar RZ, Thompson SG. Bayesian methods of analysis for cluster randomized trials with binary outcome data. Stat Med 2001;20:453-72. 105

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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.
ORCID
Venue
BMJ
Publisher
BMJ
Published
2012-09-04
Volume
345
Issue
sep04 1
Pages
e5661-e5661
ISSN
1756-1833 (ISSN-L)
DOI
10.1136/bmj.e5661
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
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
  • Health Sciences › Medicine › Physiology › 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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