Patient Reported Outcomes: are they appropriate for clinical practice? Jose M Valderas Clinical Lecturer
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1 Patient Reported Outcomes: are they appropriate for clinical practice? Jose M Valderas Clinical Lecturer
2 Key issues What are PROMs? Why PROMs? Assessing PROMs Interpreting PROMs Evidence for use in clinical practice Routine measurement of PROMs in the NHS
3 What is a Patient Reported Outcome? A measurement of any aspect of a patient s health status that comes directly from the patient (i.e., without the interpretation of the patient s responses by a physician or anyone else). Valderas JM et al. MJA 2008
4 Measure vs Measurement? Measure: a standard unit used to express size, amount, or degree; a measuring device marked with such units; (a measure of) a certain amount or degree of Measurement: the action of measuring; an amount, size, or extent found by measuring; a standard unit used in measuring Oxford English Dictionary 2009
5 Examples of PROMs Self reported health status: In general, how would you rate your health? Excellent, very good, good, fair, poor Medical Outcomes Study short-form health surveys (SF- 36, SF-12, SF-6D) EuroQol (EQ-5D) McGill Pain Questionnaire KIDSCREEN Patient Health Questionnaire (PHQ-9) Schedule for the Evaluation of Individual Quality of Life (SEIQoL) Therapy Outcome Measure (TOM) Valderas JM et al. MJA 2008
6 What do PROMs measure? Health status Health Related Quality of Life SF-36 Well being Functional status EQ-5D
7 Types of PROMs Valderas JM, Alonso J. Qual Life Res 2008
8 Types of PROMs Construct: symptoms, functional status, health perceptions, HRQoL, other Population: age, gender, condition, culture Measurement: Metric: psychometric, econometric, clinimetric Dimensionality: index, profile Adaptability: standardized, individualized Valderas JM, Alonso J. Qual Life Res 2008
9 Why PROMS? Research: outcome, adjustement (case-mix) measure Quality of health care: estimating health gains, audit, benchmarking providers, rewarding performance, informing patient choice Individualized clinical care: screening, diagnosing, identification of vulnerable patients, assessing response to treatment, disease monitoring, facilitating patient-clinician communication Greenhalgh J. Qual Life Res 2009; Valderas JM et al. Med J Aust 2008
10 Assessing PROMS Conceptual and measurement model Reliability Validity Responsiveness Interpretability Burden Alternative modes of administration Cross-cultural and linguistic adaptations SAC Medical Outcomes Trust Qual Life Res 2002
11 Assessing PROMS EMPRO: tool for standardized assessment of PROMs (39 items, 2-4 reviewers) Domain scores (0-100) Overall recommendation: Strongly recommended, Recommended with provisos or alterations, Would not recommend, Unsure Pilot tested with generic measures (SF-36, NHP, COOP charts, EQ-5D, EORTC QLQ 30) and heart failure specific measures Valderas JM et al. Val Health 2008
12 Valderas JM et al. Val Health 2008 EMPRO
13 Interpreting PROMS Absolute scores Norms (population based) Anchor based: prediction of relevant events, association with relevant variables Content based Change scores (clinical trials): clinically significant change (difference score that is large enough to have an implication for the patient s treatment or care) Minimal Important Difference (MID): the smallest change in instrument score that patients perceive as important Standard Error of Measurement (SEM) (function of reliability coefficient) Valderas JM et al. Qual Life Res 2004
14 Interpreting PROMS
15 Interpreting PROMS
16 Routine use of PROMS in clinical practice Impact of feedback on PROMs to health professionals Systematic review (2008, 2000): international team (10 reviewers) 28 RCT Significant heterogeneity: setting, populations, interventions (PROMs, frequency, ), endpoints Methodological limitations: unit rnd/analysis, contamination Valderas JM et al. Qual Life Res 2008
17 Routine use of PROMS in clinical practice Increased frequency with which cancer clinics doctors discuss quality of life and symptoms with their patients, without an increase in the visit duration Physicians informed by PROs had greater agreement with their patients about functioning PRO reports of mental health status in a variety of settings resulted in a higher likelihood of diagnostic notations Valderas JM et al. Qual Life Res 2008; Marshall S et al. J Eval Clin Pract 2006
18 Routine use of PROMS in clinical practice Valderas JM et al. Qual Life Res 2008
19 Routine use of PROMS in clinical practice Feedback of PROMs to health professionals may have an impact on the process of care (specifically in improving diagnosis and recognition of problems and in patient physician communication), with a less evident impact on health outcomes. Contexts and interventions that will yield important benefits remain to be clearly defined Considerable work is still required before clinicians can invest resources in the process and confidently anticipate benefits for their patients. Valderas JM et al. Qual Life Res 2008; Marshall S et al. J Eval Clin Pract 2006
20 Routine use of PROMS in clinical practice Lack of impact vs lack of theory: The influence of PROMs on clinical decision making depends on a large number of factors related to the design of the intervention, patients and clinicians desire to discuss HRQoL issues within the consultation and the legitimacy that clinicians give to HRQoL instruments. Greenhalgh J et al. Soc Sci Med 2005
21 Routine use of PROMS in clinical practice Valderas JM et al. MJA 2008
22 Routine use of PROMS Barriers: in clinical practice skepticism about the validity and potential utility unfamiliarity with the interpretation of the information paucity of direct face-to-face instrument comparisons costs of data collection need for rapid data manipulation and processing Valderas JM et al. Med J Aust 2008
23 Routine use of PROMS in the NHS
24 Routine use of PROMS in the NHS Starting 2009 All patients Pre- and post-elective surgery Unilateral Hip Replacements (Primary and Revisions): Oxford Hip Score + EQ-5D Unilateral Knee Replacements (Primary and Revisions): Oxford Knee Score + EQ-5D Groin Hernia Surgery: EQ-5D Varicose Vein Surgery: Aberdeen Varicose Vein Questionnaire + EQ-5D
25 Routine use of PROMS in the NHS Next step: Patients with chronic conditions in Primary Care Asthma, COPD, Diabetes, Epilepsy, Heart failure, Stroke
26 Take home messages PROMs are measurements of patient s health status that come directly from the patient Well established assessment criteria Great potential for research, clinical care and for improving quality of health care Limited evidence for impact on clinical care Are here (NHS) to stay (for a while)
27 Web based resources Patient Reported Outcome Measures (PROMs): listening to patients (NHS) PROQOLID NCHOD at Oxford EMPRO deras.pdf Thank you for your attention
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