15-Dimensional Health-Related Quality of Life

Abstract

The 15-Dimensional Health-Related Quality of Life (15D) is a generic, preference-based instrument designed for measuring and valuing health-related quality of life (HRQoL). Developed primarily by H. Sintonen and M. Pekurinen, the 15D is unique in that it provides both a comprehensive profile across 15 dimensions of health and a single index score (or utility score) ranging from 0 (death/worst possible health) to 1 (full health). This structure makes the 15D highly valuable for use in health economic evaluations, clinical trials, and population health surveys, offering a nuanced assessment of health status that covers physical, mental, and social functioning.

Keywords

Health-Related Quality of Life, HRQoL, 15D, Sintonen, Pekurinen, Multi-dimensional, Utility score, Generic measure, Psychometrics, Health economics, Health status.

Authors

Harri Sintonen, Martti Pekurinen

Purpose

The primary purpose of the 15D instrument is to provide a standardized, robust, and comprehensive measure of health status that is applicable across various patient groups and general populations. It was developed to generate health state descriptions that could be valued using a preference-based method, yielding a single index score suitable for calculating Quality-Adjusted Life Years (QALYs) in health economic analysis.

Beyond economic evaluations, the 15D serves as a valuable clinical and research tool for tracking changes in health status over time, comparing the effectiveness of different medical interventions, and assessing the overall burden of disease on an individual’s daily life and well-being.

Construct

The 15D measures the multi-dimensional construct of Health-Related Quality of Life (HRQoL). This construct is operationalized through 15 distinct dimensions, each representing a critical area of human functioning. These dimensions collectively encompass physical well-being, sensory functions, psychological state, and social activities. Each dimension is assessed using a 5-level response scale, ranging from level 1 (no difficulty/problem) to level 5 (extreme difficulty/inability).

The 15 dimensions covered are: Mobility, Vision, Hearing, Breathing, Sleeping, Eating, Speech, Elimination, Usual Activities, Mental Function, Discomfort and Symptoms, Depression, Distress, Vitality, and Sexual Activity. This broad coverage ensures a holistic assessment of health impact.

Validity

The validity of the 15D has been established through numerous studies demonstrating strong construct and criterion validity. The instrument shows high correlation with other established generic HRQoL measures, such as the EQ-5D and the SF-36, particularly concerning related dimensions. Furthermore, it exhibits excellent known-groups validity, successfully distinguishing between groups known to differ in health status (e.g., patients with chronic conditions versus healthy controls).

The scale’s ability to capture subtle changes in health, often referred to as responsiveness or sensitivity, is a key aspect of its validity, making it highly effective for measuring outcomes in intervention studies. The valuation system, which generates the single index utility score, is based on the multi-attribute utility theory and has been rigorously validated using valuation methods like the standard gamble (SG) or visual analogue scale (VAS) in various national contexts.

Reliability

The 15D instrument demonstrates high reliability across diverse populations and settings. Studies assessing its psychometric properties consistently report good test-retest reliability, confirming that the scale provides stable results when health status remains unchanged between administrations. Although the internal consistency (as measured by Cronbach’s alpha) may be lower than in scales measuring a single construct, this is expected for a multi-dimensional profile measure where the dimensions are not necessarily highly intercorrelated.

The robustness of the scale’s measurement properties ensures that observed changes in scores genuinely reflect changes in the patient’s underlying health status rather than measurement error. Detailed reliability information is often published in academic literature, confirming its suitability for high-stakes research and clinical decision-making.

Factor Analysis

While the 15D is fundamentally structured around 15 specific domains, factor analytic techniques have been applied to understand the underlying structure of HRQoL captured by the scale. These analyses typically confirm the multi-dimensional nature of the instrument, supporting the retention of the 15 individual dimensions.

Importantly, factor analysis also supports the feasibility of aggregating these 15 dimensions into a single index score. The valuation system underpinning the 15D ensures that the weights assigned to each level within each dimension are based on societal preferences, allowing for the calculation of a single, standardized utility score, which is essential for cost-effectiveness analysis.

Instrument

Test Type: Generic, Multi-dimensional, Preference-based Measure of Health-Related Quality of Life (HRQoL)

Format: Self-administered questionnaire, consisting of 15 questions, each utilizing a 5-point ordinal scale.

Language Available: Available in numerous languages (e.g., Finnish, English, Swedish, German, Spanish, etc.). Information regarding official translations is available on the instrument’s website: http://www.15d-instrument.net

Population Group: General population, patients with various acute and chronic diseases.

Age Group: Adults (versions for children and adolescents are also available, though the listed items are for the adult version).

Population Details: Suitable for use across a wide demographic spectrum due to its generic nature and focus on fundamental aspects of functioning.

Test Methodology: The respondent selects one of the five health state options for each of the 15 dimensions that best describes their current health condition. Scoring involves calculating a profile of 15 scores, or aggregating these scores using preference weights to derive a single utility index score.

Keywords

Health measurement, Sintonen, Quality of life assessment, Preference-based, Psychometric properties, Health outcomes, QALY, Generic health instrument, 15D instrument, Health status index.

Authors

Author ORCID Identifier: Not provided in source content.

Affiliation Email addresses: Not provided in source content.

Correspondence Address: Correspondence regarding the instrument should be directed via the official website: http://www.15d-instrument.net

Permissions & Fee and Test Year

The 15D was first published in 1989 by Sintonen and Pekurinen. Use of the 15D instrument, especially for commercial or large-scale research projects, typically requires permission and may involve a licensing fee. Detailed information concerning permissions and fees can be obtained directly from the developers or the organization managing the instrument (see official website).

Reference’s

• Sintonen H, Pekurinen M. (1989) A generic 15 dimensional measure of health-related quality of life (15D). Journal of Social Medicine 26, 85-96.
• Sintonen H, Pekurinen M. (1993) A fifteen dimensional measure of health-related quality of life (15D) and its applications. In Walker SR, Rosser RM. (Eds.) Quality of life assessment. Key issues in the 1990s. Kluwer, Dordrecht, 185-195, 467-470.
• Sintonen, H. (1995). The 15D-measure of health-related quality-of-life, II. Feasibility, reliability, and validity of its valuation system. National Centre for Health Program Evaluation, Working Paper 42, Melbourne.
• Sintonen, H. (2001). The 15D instrument of health-related quality of life: Properties and applications. Annuals of Medicine, 33, 328-336.
• Sintonen, H. (2001). 15Dimentional Health-Related Quality of Life. In: Simmons C. A., Lehmann P. (eds). Tools for strengths-based assessment and evaluation, New York, NY: Springer, pp. 100-104. (2013). Google Scholar
• Additional resources are available on ResearchGate and Google Scholar.

Items of the 15- Dimensional Health-Related Quality of Life

QUESTION 1: MOBILITY

1. I am able to walk normally (without difficulty) indoors‚ outdoors‚ and on stairs.
2. I am able to walk without difficulty indoors‚ but outdoors and/or on stairs I have slight difficulties.
3. I am able to walk without help indoors (with or without an appliance)‚ but outdoors and/or on stairs only with considerable difficulty or with help from others.
4. I am able to walk indoors only with help from others.
5. I am completely bed-ridden and unable to move about.

QUESTION 2: VISION

1. I see normally‚ that is‚ I can read newspapers and TV text without difficulty (with or without glasses).
2. I can read papers and/or TV text with slight difficulty (with or without glasses).
3. I can read papers and/or TV text with considerable difficulty (with or without glasses).
4. I cannot read papers or TV text either with glasses or without‚ but I can see enough to walk about without guidance.
5. I cannot see enough to walk about without a guide‚ that is‚ I am almost or completely blind.

QUESTION 3: HEARING

1. I can hear normally‚ that is‚ normal speech (with or without a hearing aid).
2. I hear normal speech with a little difficulty.
3. I hear normal speech with considerable difficulty; in conversation I need voices to be louder than normal.
4. I hear even loud voices poorly; I am almost deaf.
5. I am completely deaf.

QUESTION 4: BREATHING

1. I am able to breathe normally‚ that is‚ with no shortness of breath or other breathing difficulty.
2. I have shortness of breath during heavy work or sports‚ or when walking briskly on flat ground or slightly uphill.
3. I have shortness of breath when walking on flat ground at the same speed as others my age.
4. I get shortness of breath even after light activity‚ for example‚ washing or dressing myself.
5. I have breathing difficulties almost all the time‚ even when resting.

QUESTION 5: SLEEPING

1. I am able to sleep normally‚ that is‚ I have no problems with sleeping.
2. I have slight problems with sleeping‚ for example‚ difficulty falling asleep at night.
3. I have moderate problems with sleeping‚ for example‚ disturbed sleep or feeling I have not slept enough.
4. I have great problems with sleeping‚ for example‚ having to use sleeping pills often or routinely‚ or usually waking at night and/or too early in the morning.
5. I suffer severe sleeplessness‚ for example‚ sleep is almost impossible even with full use of sleeping pills or staying awake most of the night.

QUESTION 6: EATING

1. I am able to eat normally‚ that is‚ with no help from others.
2. I am able to eat by myself with minor difficulty (e.g.‚ slowly‚ clumsily‚ shakily‚ or with special appliances).
3. I need some help from another person in eating.
4. I am unable to eat by myself at all‚ so I must be fed by another person.
5. I am unable to eat at all‚ so I am fed either by tube or intravenously.

QUESTION 7: SPEECH

1. I am able to speak normally‚ that is‚ clearly‚ audibly‚ and fluently.
2. I have slight speech difficulties‚ for example‚ occasional fumbling for words‚ mumbling‚ or changes of pitch.
3. I can make myself understood‚ but my speech is‚ for example‚ disjointed‚ faltering‚ stuttering‚ or stammering.
4. Most people have great difficulty understanding my speech.
5. I can only make myself understood by gestures.

QUESTION 8: ELIMINATION

1. My bladder and bowel work normally and without problems.
2. I have slight problems with my bladder and/or bowel function‚ for example‚ difficulties with urination‚ or loose or hard bowels.
3. I have marked problems with my bladder and/or bowel function‚ for example‚ occasional “accidents” or severe constipation or diarrhea.
4. I have serious problems with my bladder and/or bowel function‚ for example‚ routine “accidents” or need of catheterization or enemas.
5. I have no control over my bladder and/or bowel function.

QUESTION 9: USUAL ACTIVITIES

1. I am able to perform my usual activities (e.g.‚ employment‚ studying‚ housework‚ free-time activities) without difficulty.
2. I am able to perform my usual activities slightly less effectively or with minor difficulty.
3. I am able to perform my usual activities much less effectively‚ with considerable difficulty‚ or not completely.
4. I can only manage a small proportion of my previously usual activities.
5. I am unable to manage any of my previously usual activities.

QUESTION 10: MENTAL FUNCTION

1. I am able to think clearly and logically‚ and my memory functions well.
2. I have slight difficulties in thinking clearly and logically‚ or my memory sometimes fails me.
3. I have marked difficulties in thinking clearly and logically‚ or my memory is somewhat impaired.
4. I have great difficulties in thinking clearly and logically‚ or my memory is seriously impaired.
5. I am permanently confused and disoriented in place and time.

QUESTION 11: DISCOMFORT AND SYMPTOMS

1. I have no physical discomfort or symptoms‚ for example‚ pain‚ ache‚ nausea‚ itching‚ and so on.
2. I have mild physical discomfort or symptoms‚ for example‚ pain‚ ache‚ nausea‚ itching‚ and so on.
3. I have marked physical discomfort or symptoms‚ for example‚ pain‚ ache‚ nausea‚ itching‚ and so on.
4. I have severe physical discomfort or symptoms‚ for example‚ pain‚ ache‚ nausea‚ itching‚ and so on.
5. I have unbearable physical discomfort or symptoms‚ for example‚ pain‚ ache‚ nausea‚ itching‚ and so on.

QUESTION 12: DEPRESSION

1. I do not feel at all sad‚ melancholic‚ or depressed.
2. I feel slightly sad‚ melancholic‚ or depressed.
3. I feel moderately sad‚ melancholic‚ or depressed.
4. I feel very sad‚ melancholic‚ or depressed.
5. I feel extremely sad‚ melancholic‚ or depressed.

QUESTION 13: DISTRESS

1. I do not feel at all anxious‚ stressed‚ or nervous.
2. I feel slightly anxious‚ stressed‚ or nervous.
3. I feel moderately anxious‚ stressed‚ or nervous.
4. I feel very anxious‚ stressed‚ or nervous.
5. I feel extremely anxious‚ stressed‚ or nervous.

QUESTION 14: VITALITY

1. I feel healthy and energetic.
2. I feel slightly weary‚ tired‚ or feeble.
3. I feel moderately weary‚ tired‚ or feeble.
4. I feel very weary‚ tired‚ or feeble‚ almost exhausted.
5. I feel extremely weary‚ tired‚ or feeble‚ totally exhausted.

QUESTION 15: SEXUAL ACTIVITY

1. My state of health has no adverse effect on my sexual activity.
2. My state of health has a slight effect on my sexual activity.
3. My state of health has a considerable effect on my sexual activity.
4. My state of health makes sexual activity almost impossible.
5. My state of health makes sexual activity impossible.