Framework of Health Outcome Domains
Recognizing health as a "state of complete physical, mental and social well-being and not merely the absence of disease or infirmity" (WHO), we acknowledge the importance of addressing health outcomes from whole person perspective. We also appreciate the need for a wide range of outcome measures to assess the impact of health interventions, particularly CAM therapies.
As a means to identify and categorize a wide range of outcome measures relevant to CAM research, we have developed a unique and comprehensive Framework of Health Outcome Domains, as pictured below.
- 1 Framework Description
The framework is intended to integrate seven measurable aspects (or ˜domains) of health into a unified scheme. Two additional components are included in the framework - context and process. It is important to consider that outcomes are not isolated events related only to a specific intervention. Outcomes take place within a certain context. In addition, whether and how change takes place is part of the process of the intervention. Therefore, although process and context of the intervention do not represent outcomes or domains of health, they have been identifed as being of an important consideration in outcome assessment in CAM research. As such, they are included in the framework.
The framework can be used to search for outcome measures of interest within our database or to facilitate planning of a research study to ensure that all relevant domains are addressed.
For more information on the development of our unique Framework of Outcome Domains, please refer to:
Verhoef MJ, Vanderheyden LC, Dryden T, Mallory D, Ware MA. (2006). Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures. BMC Complementary and Alternative Medicine, 6, 38. (link to http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1661594)
Verhoef MJ, Ware MA, Dryden T, Gignac P, Weeks L, Kania A, Ferguson L, Mallory D, Xu T, Brazier A. (2007). Getting the measures you need: the IN-CAM Outcomes Database. Focus on Alternative and Complementary Medicine, 12, 170-171. (link to: http://www.medicinescomplete.com/journals/fact/current/fact1203a06d01.htm).
- 2 Domain Descriptions
Context of the Intervention
Context is the set of circumstances within which an intervention takes place, which may include the patient provider relationship and patient and provider characteristics and the health care system.
Process of the Intervention
A process is a series of actions, changes, reactions or functions that happen over time as an individual moves from one state of health to another. Where an outcome measure can determine if change happened specific to a particular symptom, process focuses on not only whether change occurred, but how the change occurred. Some common examples include unsticking and transforming.
The holistic domain includes health outcomes related to the interaction between mind, body, spirit and the individual patient context, and therefore considers the whole person perspective. Holistic health outcome measures do not distinguish between specific domains as they provide a global measure of an individuals overall sense of well being.
Health-Related Quality of Life
The health-related QOL domain includes outcomes that are related to an individuals experience and appraisal of their current health state in relation to their health-specific goals, expectations, standards and concerns. They often assess multiple health outcome domains, such as those listed above.
The spiritual domain includes health outcomes related to meaningful connections with the self, others, the environment and a higher power. These can be experienced as: faith, beliefs and spiritual/soulful practices AND/OR interconnectedness (with others and the environment). Some common examples include spiritual wellbeing, awareness and self-transcendence.
The psychological domain includes health outcomes related to cognitive and emotional status, and a sense of being . Some common examples include coping, hope, stress, anxiety and depression.
The physical domain includes health outcomes related to physical function, from the ability to carry out daily self care tasks to activities that require a greater degree of mobility, strength and endurance. Some common examples include disability, activity levels (related to work, leisure, etc), sleep, energy (as experienced physically) and pain. Physical health outcomes are separate from biological markers (e.g., cortisol levels, blood pressure) which are directly measurable and therefore are not included in this database.
The social domain includes health outcomes related to a sense of participation and belonging in various social relationships, and development of personal potential within those roles. Some common examples include attachment, family relationships, friendship, work-related relationships, and community-oriented relationships.
Individualized health outcome measures include items selected by the individual receiving the intervention, rather than items that are pre-standardized. These outcome measures provide an opportunity for the individual to identify goals and symptoms that are important to them, based on their personal experiences and values. Therefore they may also be labeled patient-centered outcomes.
- 3 Directly and Indirectly Measurable Health Outcomes
The Database includes only indirectly measurable health outcomes and not directly measurable outcomes. Given the number of questions we received regarding this issue we clarify these concepts below.
Directly measurable health outcomes
These are defined as outcomes that do not require a standardized, pre-tested scale to be assessed, such as: cost, biological markers or number of days of work lost. Our database does NOT include information on such measures. We reasoned that blood pressure, for example, can be measured by taking a direct reading using a sphygmomanometer or cost can be be measured directly by adding up the dollars spent on an intervention. The information we aim to provide does not apply to such measures, and thus we have excluded them from our database.
Indirectly measurable health outcomes
Outcomes that require a standardized, pre-tested scale to be assessed in a valid and reliable manner. These outcomes are more theoretical or complex in nature (compared to directly measurable health outcomes) and cannot be directly measured. They require a theoretical perspective to guide the development of a set of items that can be answered to approximate their measurement. For example, outcomes such as satisfaction, empowerment, well-being and pain require a set of questions or proxy measurements to determine the value of the outcome.
We acknowledge that there are global assessments that use one question to assess outcomes such as satisfaction, pain and quality of life which are based on the idea that the respondent will take various aspects into account when responding. These are however not directly assessed outcomes as identified above.
Our database only contains information on indirectly measurable health outcomes.