Getting the measures you need: the Canadian IN-CAM Outcomes Database

Outcomes assessment is a crucial part of any type of research that aims to evaluate a treatment or a healthcare intervention. The discussion about appropriate and relevant outcomes has heightened with the increasing use of CAM and the rise of integrative medicine. These interventions are often complex and multidimensional and are part of whole systems of treatment and care. Investigators evaluating CAM will therefore need a range of outcome measures to capture the complexity of the treatment response. Further, such interventions are often used for reasons other than to relieve physical symptoms or to cure a disease, which means that the causal relationship between intervention and outcome is not always simple and direct. Again, this means that it might be helpful to explore a range of outcomes. Moreover, we need to be aware of the philosophical assumptions underlying many CAM interventions and integrative medicine so that we use outcome measures that are appropriate to the system under study. At a practical level, it is often difficult to get a good overview of the outcome measures that are currently available and to assess their psychometric qualities, in particular for outcomes that are not commonly used in biomedicine.

At a strategic planning meeting of the Canadian Interdisciplinary Network for CAM Research (IN-CAM, <www.incamresearch.ca>), the need for easy access to a wide range of outcome measures was identified as a priority issue. A web database application was felt to be the best medium to gather and disseminate such information. Based on the responses to an online questionnaire sent to all IN-CAM members to assess their views and feedback on this initiative, the team held a consensus meeting to develop a framework of outcome domains that would guide database development.¹ Nine domains were identified, seven of which range from specific to general measures. These include (1) individualised outcomes that assess unique patient-centred outcomes for each participant, (2) physical, (3) psychological, (4) social and (5) spiritual outcomes, (6) quality of life measures that encompass any two or more aspects related to the physical, psychological, social or spiritual domains, and (7) holistic outcomes which include measures that assess outcomes on a global level and encompasses all of the other domains defined within the database framework. Clearly there are some outcomes, such as pain or function, which fit in more than one domain. The last two domains are (8) the process and (9) the context of healing. Although these last two domains do not represent outcomes of an intervention per se, they were identified as being of great importance in intervention research, and in need of future instrument development. Process measures assess factors related to the process of healing, such as the process of adjusting to an illness, unsticking from a troublesome life trajectory, transforming to a new way of being in the world or engaging more fully in life. If we are able to measure such processes, we might be able to facilitate outcomes such as adjustment, unstuckness, transformation and engagement that have been identified as important to patients. We defined the context of healing as the circumstances encompassing the intervention or healing experience, which may include the patient–provider relationship, therapeutic intent, patient beliefs or patient expectations. For several context-related concepts, instruments are already available.

The IN-CAM Outcomes Database is currently under development, with an anticipated launch date of September 2007. There are four main ways of accessing the database for a specific instrument or groups of instruments. These include browsing by domain or alphabetically by instrument name, and two search methods (quick and advanced). The database includes outcome measures in each of the nine domains discussed above. Information provided for each instrument includes (among others) a description of the instrument, the intended target group, time to administer the instrument, sample instrument items, number of items and whether translations are available. If the instrument has been psychometrically tested, two key references containing psychometric information are included. A link to the full instrument is provided if it is in the public domain, otherwise there are instructions on how and where to access the instrument. If this information is in the public domain, it will again be hyperlinked. If the instrument has been used in CAM research, a sample reference to an example of such a study will also be included.

The intent of the website is to be as interactive as possible. Comments, suggestions and contributions will be vital to the ongoing development of the IN-CAM Outcomes Database. Access to the site will be free but people who wish to post comments or submit ideas will need to become IN-CAM members (which is quick and free at <www.incamresearch.ca>). Database users will be encouraged to use the website as an interactive tool by posting comments specific to instruments and to engage in discussions regarding CAM-specific outcomes and instruments on the discussion board. This could include comments regarding specific information that is missing, suggestions for other existing or new outcome measures/instruments, or additional information relating to a specific instrument’s validity or use with respect to CAM research and practice.

Anyone wishing to recommend an outcome measure that is not included in the database will be able to send an e-mail (address provided on the ‘Contact Us’ web page) indicating the title of the outcome measure and one key reference (preferably the psychometric reference). Submissions will then be reviewed by the IN-CAM Outcomes Database team. If the team finds the instrument to be relevant, the submitter will be asked to submit an ‘Instrument Proposal Form’. Recommendations will be reviewed and added to the database if the proposed instrument is felt to be of importance to CAM research and practice.

Anyone interested in being informed of the formal website launch and the formal website address can send an email to <outcomes@ucalgary.ca>.

We gratefully acknowledge the support and advice received from our advisers: Iris Bell, MD, MD(H), PhD; George Lewith, MA, DM, FRCP, MRCGP; Andrew Long, MSc, MPhil; Stewart Mercer, MSc, PhD, MBChB, MRCGP; Charlotte Patterson, PhD, MBChB; and Cheryl Ritenbaugh, PhD, MPH. We also acknowledge the Lotte & John Hecht Memorial Foundation which is funding this project and Centennial College for technical support.

Reference

1. Verhoef MJ, Vanderheyden L, Dryden T et al. Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures. BMC Complement Altern Med 2006; 6: 6–38.