Methodology checklist: diagnostic studies

CriterionMeaning
(1) Well coveredClear description of good methodology.
(2) Adequately addressedDescription OK and methodology meets minimum criteria.
(3) Poorly addressedDescription OK, but methodology does not meet minimum criteria.
(4) Not addressedNo description of methodology.
(5) Not reported adequatelyDescription is insufficient to allow assessment to be made.
(6) Not applicable
Study ID:
Checklist completed by:
SECTION 1: INTERNAL VALIDITY
In a well-conducted diagnostic studyIn this study this criterion is: (circle one option for each question)
1.1The nature of the test being studied is clearly specified.
  1. Well covered
  2. Adequately addressed
  3. Poorly addressed
  4. Not addressed
  5. Not reported adequately
1.2The test is compared with an appropriate gold standard.
  1. Well covered
  2. Adequately addressed
  3. Poorly addressed
  4. Not addressed
  5. Not reported adequately
1.3Where no gold standard exists, a validated reference standard is used as a comparator.
  1. Well covered
  2. Adequately addressed
  3. Poorly addressed
  4. Not addressed
  5. Not reported adequately
1.4Patients for testing are selected either as a consecutive series or randomly, from a clearly defined population.
  1. Well covered
  2. Adequately addressed
  3. Poorly addressed
  4. Not addressed
  5. Not reported adequately
1.5The test and gold standard are measured independently (blind) of each other.
  1. Well covered
  2. Adequately addressed
  3. Poorly addressed
  4. Not addressed
  5. Not reported adequately
1.6The test and gold standard are applied as close together in time as possible.
  1. Well covered
  2. Adequately addressed
  3. Poorly addressed
  4. Not addressed
  5. Not reported adequately
1.7Results are reported for all patients that are entered into the study.
  1. Well covered
  2. Adequately addressed
  3. Poorly addressed
  4. Not addressed
  5. Not reported adequately
ASSESSMENT
1.8A pre-diagnosis is made and reported.
  1. Well covered
  2. Adequately addressed
  3. Poorly addressed
  4. Not addressed
  5. Not reported adequately
SECTION 2: OVERALL ASSESSMENT OF THE STUDY
2.1How reliable are the conclusions of this study? Code + +, + or −
2.2Is the spectrum of patients assessed in this study comparable with the patient group targeted by this guideline in terms of the proportion with the disease, or the proportion with severe versus mild disease?

From: Appendix 11, Quality checklists for clinical studies and reviews

Cover of Depression in Adults with a Chronic Physical Health Problem
Depression in Adults with a Chronic Physical Health Problem: Treatment and Management.
NICE Clinical Guidelines, No. 91.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2010.
Copyright © 2010, The British Psychological Society & The Royal College of Psychiatrists.

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