patient reported outcomes: are they appropriate for ... · pdf fileassessing proms •...

Patient Reported Outcomes:

are they appropriate

for clinical practice?

Jose M Valderas

Clinical Lecturer

Key issues

• What are PROMs?

• Why PROMs?

• Assessing PROMs

• Interpreting PROMs

• Evidence for use in clinical practice

• Routine measurement of PROMs in the NHS

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

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

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)


What do PROMs measure?

SF-36

Health Related Quality of Life

Health statusFunctional status

Well being EQ-5D

Types of PROMs

Valderas JM, Alonso J. Qual Life Res 2008

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

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

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

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

EMPRO

Valderas JM et al. Val Health 2008

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

Interpreting PROMS

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



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



• 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



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



Barriers:

• 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

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


Next step:

• Patients with chronic conditions in Primary

Care

• Asthma, COPD, Diabetes, Epilepsy, Heart

failure, Stroke

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)

Web based resources

• Patient Reported Outcome Measures (PROMs): listening to patients(NHS)

http://www.nhs.uk/NHSEngland/PROMs

• PROQOLID

http://www.proqolid.org

• NCHOD at Oxford

http://nchod.uhce.ox.ac.uk

• EMPRO

http://www.ispor.org/publications/value/Supplements/ViH11.5/Valderas.pdf

Thank you for your attention

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