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Cited by 1,715Health Systems, Economic Evaluations, Quality of LifeDelphi Technique in ResearchHealth Education and Validation

Evaluating patient-based outcome measures for use in clinical trials.

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Fitzpatrick, Davey, Buxton, Jones·1998·Health Technology Assessment
DOI 10.3310/hta2140
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Abstract

NHS R&D HTA ProgrammeT he overall aim of the NHS R&D Health Technology Assessment (HTA) programme is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and work in the NHS.Research is undertaken in those areas where the evidence will lead to the greatest benefits to patients, either through improved patient outcomes or the most efficient use of NHS resources.The Standing Group on Health Technology advises on national priorities for health technology assessment.Six advisory panels assist the Standing Group in identifying and prioritising projects.These priorities are then considered by the HTA Commissioning Board supported by the National Coordinating Centre for HTA (NCCHTA).This report is one of a series covering acute care, diagnostics and imaging, methodology, pharmaceuticals, population screening, and primary and community care.It was identified as a priority by the Methodology Panel and funded as project number 93/47/09.The views expressed in this publication are those of the authors and not necessarily those of the Standing Group, the Commissioning Board, the Panel members or the Department of Health.The editors wish to emphasise that funding and publication of this research by the NHS should not be taken as implicit support for the recommendations for policy contained herein.In particular, policy options in the area of screening will, in England, be considered by the National Screening Committee.This Committee, chaired by the Chief Medical Officer, will take into account the views expressed here, further available evidence and other relevant considerations.Reviews in Health Technology Assessment are termed 'systematic' when the account of the search, appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.

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  • Only studies using depression outcome measurements with at least acceptable internal consistency and test-retest reliability at Cronbach's alpha ≥0.70 will be included.

    “In order to ensure the quality of the outcome measurements concerning the primary outcome of depression only studies using depression outcome measurements with at least acceptable internal consistency and test–retest reliability at Cronbach’s alpha ≥0.70 (as reported in outcome measurement validation studies) will be included.62”

    From Effectiveness and acceptability of cognitive-behavioural therapy based interventions for maternal peripartum depression: A systematic review, meta-analysis and thematic synthesis protocol (2019) · cites this paper as [62]

    The Internal consistency section suggests Cronbach’s alpha above 0.70 for internal consistency, and the Reproducibility section describes 0.7 as a commonly cited minimum reliability coefficient for group data. But the paper treats test–retest reliability separately and says it is assessed through agreement between repeated measurements, not Cronbach’s alpha. It does not establish the cited sentence’s combined alpha-based criterion for depression measures. (LLM, conf=0.89)

    Experimental — accuracy not yet measured

  • To capture the patient's perspective, it is essential that patients are involved in PROM development.

    “To capture the patient's perspective, it is essential that patients are involved in PROM development”

    From Patient involvement in the development of patient‐reported outcome measures: a scoping review (2017) · cites this paper as [6]

  • Patient involvement is not only recommended by many researchers, it has also become a requirement if the PROM is used in medical product development.

    “This is especially surprising because patient involvement is not only recommended by many researchers,5, 6, 7, 8, 9 a few years ago it has also become a requirement if the PROM is used in medical product development.26”

    From Patient involvement in the development of patient‐reported outcome measures: a scoping review (2017) · cites this paper as [6]

    The citation to this paper is attached to the claim that patient involvement became a requirement when a PROM is used in medical product development. The paper’s “Face and content validity” section emphasizes involving patients in developing questionnaires, but it does not state that such involvement became a requirement for medical product development. Searches for a regulatory or mandatory requirement found no passage addressing it; no page number was available in our copy. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

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Cites

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Authors
Fitzpatrick, Davey, Buxton, & Jones
Venue
Health Technology Assessment
Publisher
National Institute for Health and Care Research
Published
1998
Volume
2
Issue
14
Pages
i-iv, 1
ISSN
  • 1366-5278 (ISSN-L)
  • 2046-4924
DOI
10.3310/hta2140
OpenAlex
W3141544461
Cited by
1,715
References
349
Citations by year
2026: 28 · 2025: 31 · 2024: 53 · 2023: 50 · 2022: 62 · 2021: 71 · 2020: 79 · 2019: 84 · 2018: 84 · 2017: 75 · 2016: 85 · 2015: 88 · 2014: 81 · 2013: 83 · 2012: 96
FWCI
33.59
Type
journal article
Language
en
Open access
Licence
www.nationalarchives.gov.uk/doc/non-commercial-government-licence/non-commercial-government-licence.htm (unspecified)
Locations
  • Health Technology Assessment (publishedVersion)
  • PubMed (publishedVersion)
  • OpenGrey (Institut de l'Information Scientifique et Technique) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Figshare (submittedVersion, cc-by)
  • Leicester Research Archive (University of Leicester) (submittedVersion)
Funders
Health Technology Assessment Programme (10/51/01)
Topics
  • Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
  • Social Sciences › Sociology and Political Science › Delphi Technique in Research
  • Social Sciences › Education › Health Education and Validation
Keywords
clinical trials, outcome measurement, patient-reported outcomes
MeSH terms
Clinical Trials as Topic, Health Status Indicators, Humans, Quality of Life, Surveys and Questionnaires, Reproducibility of Results, Patient Satisfaction, Outcome Assessment, Health Care, Cost of Illness

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