22-1-2018 1 Datum Corporate presentatie Maastricht UMC+ (titel presentatie) Naam spreker (optioneel) Functie spreker (optioneel) Titel van de presentatie Onderwerpregel Presentatie Prof. Dr. Jan Jansen Patient-reported outcome measures (PROMs) in onderzoek: ontwikkeling en validatie. Prof. dr. Carmen Dirksen Head dept. Clinical Epidemiology and Medical Technology Assessment (KEMTA) Dr. Merel Kimman, postdoc/senior researcher KEMTA Content • What are PROMs • Toolbox PROMs • Relation with VBHC – Maastricht UMC+ • ICHOM and COMET – standard outcome sets/measures • Practical examples: - PESaM questionnaire - PROM-HISS Corporate presentatie | stafdienst Communicatie | maart 2011 | January 22, 2018 2
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Datum Corporate presentatie Maastricht UMC+ · Corporate presentatie | stafdienst Communicatie | maart 2011 | January 22, 2018 19 Corporate presentatie | stafdienst Communicatie |
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Toolbox PROMs (2017)
PROM cyclus
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Can also be used for
PREMS (e.g. CQ-
index)
Aim can also be
research
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1. Determine the objective: why, for whom, what setting
• Individual patient: to obtain insight in patient’s functioning/experienced health, to support in diagnostic process, choice for treatment, improve communication between patient and healthcare professional
• Internal quality: PROM data at aggregated level to get insight in quality of care, compare between HC professionals, organisations for quality improvement, info NOT available for patients or HC insurers
• External quality: PROM data at aggregated level, made publicly available to HC insurers (contracts) and patients (choose HC provider). Possibly also for HC Inspectorate.
• Research into effectiveness of treatments, HTA and policymaking
• Combination of the above; may be complex, conflicting goals
determine most important goal
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2. Selection of PROs
• Which PROs?
- Health is broad concept, can be measured on different levels (e.g. symptoms, functioning, health state, quality of life)
- Decision regarding at what level(s) to measure
• Identify relevant PROs
- Literature review (identification)
- Interviews/focus-groups (confirmation)
• Prioritise and select most relevant PROs
- Together with relevant stakeholders (depending on objective)
- PROs should fit objective, e.g.:
* individual patient: PRO should change through treatment
* internal quality: PRO should be influenced by health care (better care, better PROs)
* research: PRO should distinguish between comparative treatments
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3. Selection of PROMs (1)
• First explore which PROMs are already administered in patient group!! (especially in multidisciplinary treatment; reduce burden patient & HC provider)
• Determine requirements of PROM
- generic, disease-specific, etc.
- paper-pencil, interview, web-based, proxy
- psychometric properties
- feasibility/acceptance by stakeholders
• Identify existing PROMs
- literature review
- databases with PROMs
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3. Selection of PROMS (2)
• Selection of PROMs based on content
- does it measure the selected PROs?
face validity
• Determine psychometric properties of the PROMs
- Validity: does the PROM measure what it intends to measure?
- Reliability: does the PROM return the same results under the same conditions?
- COSMIN checklist (appraisal of articles investigating psychometric properties of PROMs)
• Determine feasibility, interpretability and acceptability of PROMs
- Feasibility: easy to use? (understandable, low burden, costs of usage, interpretability for HC professional)
- Interpretability: outcome meaningful? (score is low/high, minimally important change, etc.)
- Acceptability: support of PROM (e.g. already widely used)
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3. Selection of PROMS (3)
• Select most appropriate PROM
- involve relevant stakeholders in choice
e.g. through formal consensus method
• Determine trajectory:
- Testing selected PROM (step 4)
- Further development PROM (e.g. does not measure all selected PROs, not tested in target group, no Dutch version available)
- If not available/fit for purpose: develop new tool (part II Masterclass Merel Kimman)
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4. Testing PROM
• How depends on objective of PROM
• Always check if feasibility, validity and reliability (literature, other sources) also applies in target group
mix qualitative & quantitative research
practical and scientific value PROM
• Also applies in case of new PROM or further development existing PROM
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5. Define indicator
• An indicator gives meaning to results of a PROM
- e.g. average pain in adults in leg after hernia operation at 6 weeks FU (scale 0-10)
- proportion of patients that scores 10 or higher on PROM for anxiety
• Comparison with ‘norm score’
• Internal or external quality indicator: doing better or worse than norm score?
• Research: basis for sample size calculation (e.g. difference in proportions of patients above or below norm score/cut-off value)
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5. Define indicator (2)
Three steps in indicator definition:
1.Which outcome/indicator?
2.Comparability of measurement of indicator
- registration: procedures and analysis
- population characteristics: age, gender, education level, etc.
- representativeness respondents/sample
3.Define the (concept) norm of indicator, based on
- research, experts, average value
- can also be relative norm (deviation from mean)
- discriminative ability of norm more informative
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6. Testing indicator
Testing indicator in practice
• Do the requirements for comparability and discriminative ability hold?
• Are differences statistically different?
• Are statistically different scores relevant (for conclusions regarding e.g. quality)?
• Ongoing testing important to gain knowledge regarding value of indicator in relation to objective
• Adapt norm/ accept concept norm
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7. Actual use of PROM (in daily practice*)
• Define implementation strategy
- barriers and facilitators: HC professional, patient, organisation, culture, regulations
- tailored implementation strategy: educative meetings, educative materials, reminders, feedback on PROM use, adaptations in organisation, managerial support
• Helpful to integrate PROM within existing processes
• Beware of patient privacy and data anonymity
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* Step not relevant in research
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8. Maintenance and evaluation
• Evaluation of PROM and/or outcome indicator based on results (possibly return to PROM cycle)
• Structural financing necessary
• Questions:
- are chosen PROMs relevant for objective?
- does it measure intended outcomes?
- is the PROM being sufficiently used?
- does the outcome indicator still suffice?
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Many links to
relevant tools in
document!!
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PROMS and value-based health care (VBHC)
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Includes
PROMs!
Strategy conference November 2, 2017
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