Patient-Reported Outcome Measures
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1 Medication Safety in Older People Network & Citizen Senate Event: Working together for Medication Safety - 6 th March 2018 Patient-Reported Outcome Measures Sam Salek School of Life & Medical Sciences University of Hertfordshire
2 Outcomes Clinical Humanistic Economic
3 Areas of Patient-Reported Outcomes Application in Health Care - Clinical trials - Clinical practice - Pharmacoeconomic studies
4 Рatient-Reported Outcome (PRO) PRO is an umbrella term encompassing a number of patient self-reported parameters related to a patient s health status and perception of treatment side effects.
5 PRO PRO is a measurement based on a report that comes directly from the patient about the status of a patient s condition without amendment or interpretation of the patient s response by a clinician or anyone else US Food and Drug Administration: Patient-Reported Outcome Measures Guidelines, 2009.
6 Why Measure PRO - A unique indicator of disease impact - Essential for evaluating treatment efficacy - Useful for interpreting clinical outcomes - A key element in treatment decision-making
7 Challenges of Measuring PRO Awareness & Knowledge Barriers beyond our control Motivation Challenges Practicalities Acceptance and beliefs Skills
8 Benefits of Measuring PRO in Routine Clinical Practice Inform clinical decisions Clinician-patient communication Awareness of the burden of haematological conditions Informing the consultation Clinical service administration
9 Including the Patient Voice when Choosing a Treatment The patient voice is important when defining the most appropriate balance between benefits and risks of a medical product Laurie Burke, Office of New Drugs, CDER, FDA, 2009
10 Including the Patient Voice when Choosing a Treatment Expectation and Choice of Treatment B-R of medicines at population level must be clearly translated into its use at individual level B-R balance must always be clearly communicated Simple B-R of medicines should be presented alongside scientific data
11 Including the Patient Voice when Choosing a Treatment Expectation and Choice of Treatment (cont.) Even small improvements in the pharmacovigilance system will have a major impact on public health and society Risk Communication : Allows users of medicines a choice Can reduce risk and increase benefit of medicines thereby promoting public health
12 Treatment Outcomes in Patients With Chronic Conditions Physician-Reported Outcomes Patient-Reported Outcomes Quality of Life Symptoms
13
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15 Most Common PROs QoL and symptoms are PROs that are most frequently used in clinical trials and are of major importance in clinical practice
16 What is Quality of Life? Quality of life is a multi-dimensional construct that represents a patient s overall perception of the impact of an illness and its treatment on the patient s functioning and well-being. Quality of life is the integral characteristics of physical, psychological, and social functioning of a patient based upon his / her perception.
17 Multidimensionality of QoL A QoL measure captures, at minimum, physical, psychological (including emotional and cognitive), and social functioning.
18 Subjectivity of QoL - QoL is considered to be subjective - It is not subjective in the usual sense of the term, but in that it derives from a human subject of research or clinical practice - Subjectivity should never be confused with lack of validity.
19 Variability of QoL QoL of a patient may change at different time-points of treatment and at follow-up, and these changes may be captured by means of standardized self-reported instruments.
20 Signs and Symptoms A symptom is any subjective evidence of a disease, health condition, or treatment-related effect that can be noticed and recognized only by the patient. Examples of symptoms are pain, fatigue, loss of appetite, etc. A sign is any objective evidence of a disease, health condition, or treatment-related effect which is usually observed and interpreted by a clinician but may be noticed and reported by a patient. Examples are lymph node enlargement, weight loss, icterus, etc.
21 Key Issues to be Considered when Planning Clinical Studies with a PRO Component Developing an end-point model Choosing an appropriate PRO instrument(s) Timing for administering PRO instruments Data collection Handling of missing data Using proper approaches to analyze and interpret PRO data.
22 Standardized PRO Instruments
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24 The Use of PROs in Clinical Practice
25 The Use of PROs in Clinical Practice
26 The Use of PROs in Clinical Practice
27 The Use of PROs in Clinical Practice
28 Quality of Life and Pharmacoeconomic Studies Measuring effectiveness and cost effectiveness: the QALY
29 Quality of Life and Pharmacoeconomic Studies How a QALY is calculated: Patient x has a serious, life-threatening condition If he continues receiving standard treatment he will live for 1 year and his quality of life will be 0.4 (0 or below = worst possible health, 1= best possible health) If he receives the new drug he will live for 1 year 3 months (1.25 years), with a quality of life of 0.6 The new treatment is compared with standard care in terms of the QALYs gained: Standard treatment: 1 (year's extra life) x 0.4 = 0.4 QALY New treatment: 1.25 (1 year, 3 months extra life) x 0.6 = 0.75 QALY Therefore, the new treatment leads to 0.35 additional QALYs (that is: QALY = 0.35 QALYs) The cost of the new drug is assumed to be 10,000, standard treatment costs 3000 The difference in treatment costs ( 7000) is divided by the QALYs gained (0.35) to calculate the cost per QALY. So the new treatment would cost 20,000 per QALY.
30 Quality of Life and Pharmacoeconomic Studies
31
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