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. 2021 Feb 5;11(2):e041318. doi: 10.1136/bmjopen-2020-041318

Table 3.

Inclusion and exclusion criteria

Inclusion criteria Exclusion criteria
Study focus
  • Studies reporting on the development, validation or user rating (feasibility, acceptability, appropriateness) of any version of the DEMQOL. DEMQOL versions include:

    • DEMQOL

    • DEMQOL-Proxy

    • DEMQOL-U

    • DEMQOL-Proxy-U

    • DEMQOL-CH

  • Studies using any of the DEMQOL versions to assess study outcomes—regardless of whether HRQoL was the main study outcome (dependent variable) or whether HRQoL was used as an independent variable or a covariate to adjust statistical models

  • Studies only mentioning a DEMQOL version without having used the tool to assess study outcomes

  • Studies using the C-DEMQOL which is a tool to assess the QoL of caregivers of people with dementia, not a dementia-specific HRQoL tool

  • Studies using QoL assessment tools other than any of the DEMQOL versions

Study design
  • Primary empirical quantitative research and research protocols, regardless of the research design:

    • Randomised trials

    • Non-randomised trials

    • On-group pre–post studies

    • Cohort studies

    • Case control studies

    • Cross-sectional studies

  • Qualitative studies:

    • Qualitative interviews

    • Focus groups

    • Ethnographic observations

    • Qualitative case studies

  • Mixed methods studies

  • Systematically conducted reviews:

    • Meta-analyses

    • Systematic reviews

    • Realist reviews

    • Integrative reviews

    • Scoping reviews

    • Narrative reviews if they report the search strategy, data bases searched, inclusion/exclusion criteria of references, screening process and analysis/synthesis methods

  • Non-empirical work (editorials, opinion texts, theoretical discussions)

  • Non-systematic (selective) reviews. We will, however, screen reference lists of those reviews for eligible studies

Study outcomes DEMQOL development
  • Studies reporting on the theoretical foundations, methods and processes used to develop any of the DEMQOL versions


DEMQOL reliability
  • Test re-test reliability: agreement (κ statistics, correlation coefficients, intraclass correlation coefficients) of DEMQOL scores obtained by the same person using the same DEMQOL version repeatedly to assess HRQoL of the same client25

  • Inter-rater reliability: agreement (κ statistics, correlation coefficients, intraclass correlation coefficients) of DEMQOL scores obtained by two independent raters, using the same DEMQOL version at the same time to assess HRQoL of the same client25

  • Internal consistency reliability: agreement among DEMQOL items thought to form a scale (Cronbach’s α)25

  • Multiple method reliability: agreement among DEMQOL scores obtained using different modes of administration (eg, correlations of self-report and proxy assessments or paper-based vs. electronic)25


DEMQOL validity
  • Content validity: experts’ quantitative or qualitative ratings of whether DEMQOL items are relevant and adequately reflect the construct of interest (dementia-specific HRQoL)25

  • Response process validity: qualitative rating based on cognitive interviews of whether DEMQOL users (persons with dementia, their proxies, data collectors) understand the DEMQOL stems, items and rating scales as intended; response and missing item patterns are quantitative proxy outcomes of participants’ response processes

  • Structural validity: evidence on whether items reflect an overall scale or subscales, based on based on confirmatory or exploratory factor analyses (factor loadings, model fit parameters)25

  • Item functioning: evidence on item difficulty and discrimination, based on item response theory models25

  • Construct validity: evidence on whether outcomes known to be associated with HRQoL are associated as hypothesised with DEMQOL items (correlation coefficients, regression parameters, results of structural equation models)25


DEMQOL feasibility
  • Quantitative or qualitative user ratings of whether either of the DEMQOL versions can be successfully used within an organisation or setting given existing resources (eg, effort, time to complete, costs of administration)26


DEMQOL acceptability
  • Quantitative or qualitative user ratings of whether any of the DEMQOL versions and their use are agreeable, palatable or satisfactory26


DEMQOL appropriateness
  • Quantitative or qualitative user ratings of whether any of the DEMQOL versions can effectively help achieve a common purpose giving existing conditions and whether that tool is consistent with users’ norms and values26


DEMQOL use
  • We will include any study that assessed outcomes other than those specified above (regardless of the outcomes) if any of the DEMQOL versions was used to assess HRQoL in that study, and HRQoL was included as one of the study outcomes

  • Studies reporting none of the outcomes listed as inclusion criteria

HRQoL, health-related quality of life.