| Types & Uses of HRQL Measures | Design | Assessment |
|---|---|---|
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Health-related Quality of Life (HRQL)
What measurement is commonly used to measure quality of life in clinical trials in a health or medical perspective?
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- Those with functional limitations (e.g., hearing or vision problems) may need administration accommodations
- Ethnically diverse groups require measures that have been validated across several different cultures and/or languages - Children need age appropriate instruments and/or may need a family proxy - The health status of the participant at baseline needs to be considered in regards to trial duration
How does the study population influence the choice and administration of HRQL measures?
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SF-36, EQ-5D, PROMIS, RedsQL, KidsSCREEN, PROMIS, PHQ9, etc.
What are some examples of generic HRQL instruments?
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Physical, social and psychological functioning, and participants’ overall assessment of their life quality and/or perceptions of their health status
What specific dimensions does HRQL measure?
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- Venue
- Who's giving the intervention - Number of participants - Number of assessments - Data collection method (telephone, computer, paper forms, interview)
What additional factors should be considered when developing HRQL collection procedures?
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The favorable and adverse effects of intervention, the time course of the effects, and if the interventions’ outcomes are affected by existing medications and pre-existing health conditions
What are the three major intervention-related factors relevant to the assessment of HRQL?
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- Sleep disturbance
- Neuropsychological functioning - Sexual Functioning - Work-Related impacts
What are some additional measures and what do they encompass?
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- Nature of the condition (e.g., Acute or chronic)
- Expected effects of the intervention - Expected time course of effects on the participants - Specific aims of the trial
What determines the timing of the HRQL assessments?
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Depending on population and contextual characteristics, the difference is defined as the smallest score or change in scores that is perceived by participants as improving or decreasing their HRQL, which would lead a clinician to consider a change in treatment or follow-up
When assessing the significance of HRQL Measures, what does the minimal clinically important difference refer to?
|
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Life expectancy and quality of life
What are the two primary outcomes that are most important to most subjects?
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Modifying factors are those variables that can modify the effect of an intervention on an outcome, while mediating factors are any changes, improvements or impairments to a participant’s wellbeing that are induced by the study intervention.
What are modifying and mediating factors?
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Utility scores reflect a person’s preferences and values for specific health states and allow morbidity and mortality changes to be combined into a single summary score representing the net change in quality of life (the gains from the intervention minus adverse effects and burden)
What are utility measures?
|
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Can determine how the person’s life is influenced by both the disease and its intervention, and whether the effects are better or worse than the effects of the untreated course of the underlying disease
What is the benefit of using HRQL measures?
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Multiple questionnaire items provide greater information and have higher content validity and reliability (by reducing
measurement error), but can also increase participant and staff burden and study costs
What are the benefits and consequences of multiple questionnaire items?
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They are useful in decision-making regarding competing treatments and/or for the allocation of limited resources
When are utility measures useful?
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