Reporting standards for studies of diagnostic test accuracy in dementia

Objective: To provide guidance on standards for reporting studies of diagnostic test accuracy for dementia disorders. Methods: An international consensus process on reporting standards in dementia and cognitive impairment (STARDdem) was established, focusing on studies presenting data from which sensitivity and specificity were reported or could be derived. A working group led the initiative through 4 rounds of consensus work, using a modified Delphi process and culminating in a face-to-face consensus meeting in October 2012. The aim of this process was to agree on how best to supplement the generic standards of the STARD statement to enhance their utility and encourage their use in dementia research. Results: More than 200 comments were received during the wider consultation rounds. The areas at most risk of inadequate reporting were identified and a set of dementia-specific recommendations to supplement the STARD guidance were developed, including better reporting of patient selection, the reference standard used, avoidance of circularity, and reporting of test-retest reliability. Conclusion: STARDdem is an implementation of the STARD statement in which the original checklist is elaborated and supplemented with guidance pertinent to studies of cognitive disorders. Its adoption is expected to increase transparency, enable more effective evaluation of diagnostic tests in Alzheimer disease and dementia, contribute to greater adherence to methodologic standards, and advance the development of Alzheimer biomarkers.

[1]  P. Bossuyt,et al.  Reporting the accuracy of diagnostic tests: the STARD initiative 10 years on. , 2013, Clinical chemistry.

[2]  Nick C Fox,et al.  Revising the definition of Alzheimer's disease: a new lexicon , 2010, The Lancet Neurology.

[3]  C. Brayne,et al.  Political drive to screen for pre-dementia: not evidence based and ignores the harms of diagnosis , 2013, BMJ : British Medical Journal.

[4]  D. Moher,et al.  A catalogue of reporting guidelines for health research , 2010, European journal of clinical investigation.

[5]  D. Rennie,et al.  Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative , 2003, BMJ : British Medical Journal.

[6]  Johannes B Reitsma,et al.  Evidence of bias and variation in diagnostic accuracy studies , 2006, Canadian Medical Association Journal.

[7]  F. Hasson,et al.  Research guidelines for the Delphi survey technique. , 2000, Journal of advanced nursing.

[8]  Nick C. Fox,et al.  The diagnosis of mild cognitive impairment due to Alzheimer's disease: Recommendations from the National Institute on Aging and Alzheimer's Association workgroup , 2011 .

[9]  D. Moher,et al.  Guidelines for Reporting Health Research: The EQUATOR Network's Survey of Guideline Authors , 2008, PLoS medicine.

[10]  D. Moher,et al.  CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials , 2011, BMJ : British Medical Journal.

[11]  J. Morris,et al.  The diagnosis of dementia due to Alzheimer’s disease: Recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer's disease , 2011, Alzheimer's & Dementia.

[12]  Chris Hyde,et al.  Neuropsychological tests for the diagnosis of Alzheimer's disease dementia and other dementias: a generic protocol for cross-sectional and delayed-verification studies. , 2013, The Cochrane database of systematic reviews.

[13]  Manjit,et al.  Neurology , 1912, NeuroImage.

[14]  Luca Pani,et al.  Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: Cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden — Regulatory considerations by European Medicines Agency focusing in improving benefit/risk in regulatory trials , 2011, European Neuropsychopharmacology.

[15]  Denise C. Park,et al.  Toward defining the preclinical stages of Alzheimer’s disease: Recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease , 2011, Alzheimer's & Dementia.

[16]  J. Cummings,et al.  The Montreal Cognitive Assessment, MoCA: A Brief Screening Tool For Mild Cognitive Impairment , 2005, Journal of the American Geriatrics Society.

[17]  P. Bossuyt,et al.  Empirical evidence of design-related bias in studies of diagnostic tests. , 1999, JAMA.

[18]  M. Carrillo,et al.  CSF biomarker variability in the Alzheimer's Association quality control program , 2013, Alzheimer's & Dementia.

[19]  G. Mead,et al.  Systematic review of the body of evidence for the use of biomarkers in the diagnosis of dementia , 2013, Alzheimer's & Dementia.

[20]  P. Glasziou,et al.  Avoidable waste in the production and reporting of research evidence , 2009, The Lancet.

[21]  Keith A. Johnson,et al.  Appropriate Use Criteria for Amyloid PET: A Report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer’s Association , 2013, The Journal of Nuclear Medicine.

[22]  D. Moher,et al.  CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trialsqqq , 2018 .

[23]  Keith A. Johnson,et al.  Update on appropriate use criteria for amyloid PET imaging: Dementia experts, mild cognitive impairment, and education , 2013, Alzheimer's & Dementia.

[24]  Leslie M. Shaw,et al.  Global standardization measurement of cerebral spinal fluid for Alzheimer's disease: An update from the Alzheimer's Association Global Biomarkers Consortium , 2013, Alzheimer's & Dementia.

[25]  Trish Groves,et al.  Enhancing the quality and transparency of health research , 2008, BMJ : British Medical Journal.

[26]  References , 1971 .

[27]  D. Moher,et al.  The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration , 2001, Annals of Internal Medicine.

[28]  Leslie M. Shaw,et al.  Standardization of preanalytical aspects of cerebrospinal fluid biomarker testing for Alzheimer's disease diagnosis: A consensus paper from the Alzheimer's Biomarkers Standardization Initiative , 2012, Alzheimer's & Dementia.

[29]  P. Bossuyt,et al.  The quality of diagnostic accuracy studies since the STARD statement , 2006, Neurology.

[30]  F. Goodyear-Smith Government’s plans for universal health checks for people aged 40-75 , 2013, BMJ.

[31]  John R Hodges,et al.  The Addenbrooke's Cognitive Examination Revised (ACE‐R): a brief cognitive test battery for dementia screening , 2006, International journal of geriatric psychiatry.

[32]  Johannes B Reitsma,et al.  Quality of reporting of diagnostic accuracy studies. , 2005, Radiology.

[33]  W. M. van der Flier,et al.  A worldwide multicentre comparison of assays for cerebrospinal fluid biomarkers in Alzheimer's disease , 2009, Annals of clinical biochemistry.

[34]  Malaz Boustani,et al.  Alzheimer's Association recommendations for operationalizing the detection of cognitive impairment during the Medicare Annual Wellness Visit in a primary care setting , 2013, Alzheimer's & Dementia.

[35]  K. Davis,et al.  A new rating scale for Alzheimer's disease. , 1984, The American journal of psychiatry.

[36]  J. Ioannidis,et al.  Why Current Publication Practices May Distort Science , 2008, PLoS medicine.