Clinical articleHypothesisPatient-Reported Outcomes in Studies of Complementary and Alternative Medicine: Problems, Solutions, and Future Directions
Introduction
As in studies of conventional medicine, therapeutic outcomes assessed in studies of complementary and alternative medicine (CAM) can be either objective or subjective. Objective outcomes are measurable without a perceptual interpretation (eg, blood pressure, respiration rate, time to illness progression, survival time). Objective biomedical markers have long been considered something of a “gold standard” in treatment studies. Conversely, subjective outcomes are usually reported by the patient or another person and involve some form of judgment.1 The status of subjectively assessed outcomes, such as those drawn from patient self-report, has risen considerably over the past 20 years. Scores from patient-reported outcome measures are now frequently used as endpoints in a host of clinical studies including CAM clinical studies.2, 3, 4, 5, 6, 7
Patient-reported outcomes (PROs) are essential to studying the effects of CAM given that the outcomes targeted by many therapies are best assessed by direct patient query. The intent of many CAM therapies and modalities is the alleviation of symptoms and promotion of overall well-being and quality of life (QOL).8 Furthermore, numerous surveys of CAM use show that patients often seek CAM for pragmatic reasons including relief from symptoms like pain, anxiety, and depression, relief from side effects of medical treatments, or to improve and maintain general physical and mental health,9, 10, 11, 12 all of which are amenable to assessment via self-report. General outcomes such as these are certainly not any more or less relevant for CAM than they are for conventional medicine. However, unlike conventional medicine interventions (eg, pharmaceuticals, surgery) that may focus more specifically on one or a few primary outcome domains, many CAM interventions have the potential to affect multiple aspects of health and well-being.13, 14 Hence, it is often important to measure the effects of an intervention on a number of health domains and symptoms. In this sense CAM is unique, not so much in terms of the types of outcomes it targets, but rather the number of different outcomes it has the potential to impact. Moreover, whereas PROs are often relegated to a secondary status in conventional medicine studies (behind objective indicators), they are typically of primary interest in CAM studies. In fact, prioritizing outcomes makes little sense in CAM as it fails to represent the complex nature of many CAM interventions.13
Presently, there are hundreds of measures available for use in CAM outcome studies. These include standardized (ie, off the shelf) assessments of general health or quality of life (eg, the SF-36),15 condition-specific measures of symptoms and disability (eg, the Arthritis Impact Measurement Scales, the Roland-Morris Disability Scale),16, 17 psychological measures (eg, the Profile of Mood States, the State-Trait Anxiety Inventory),18, 19 single-item, visual, or numerical analog rating scales,3, 7 and patient-generated instruments (eg, the Measure Yourself Medical Outcome Profile).20 Such measures have been used in a wide variety of healthcare studies, including studies of CAM. There are also a few self-report measures created and tested within CAM contexts like the Arizona Integrative Outcomes Scale21 and the Chinese Quality of Life Instrument.22 Although to date such outcome measures have seen more frequent usage in CAM studies, it is possible that they could prove useful in conventional medicine studies as well, or in studies that compare CAM with conventional medicine.
Section snippets
Problems with the Current State of Assessment of Pros
The availability of a wide variety of outcome measures provides CAM researchers with many options for assessment. This is crucial because many CAM interventions have the potential to impact many different health outcomes. Although having choice is certainly desirable in that it allows for the selection of outcome measures best suited to a particular study context, it can also be problematic. The sheer number of available PRO measures makes it difficult for researchers to know what the optimal
Direct Comparison of Outcome Measures in CAM Settings
Improving the quality of outcome assessment in future CAM studies can be accomplished by (1) pinpointing subsets of key outcomes that several CAM therapies have in common, (2) identifying frequently used PRO measures of these outcomes, and (3) conducting head-to-head comparisons of these measures in people receiving CAM. Identifying common outcomes and outcome measures can be accomplished in multiple ways. Literature reviews, especially systematic reviews, often provide data on PROs and
Future Directions for Outcomes Assessment in CAM
New initiatives in measurement have the potential to revolutionize outcomes assessment in CAM clinical research and practice. In 2004, the National Institutes of Health (NIH) established the PROMIS cooperative group (Patient-Reported Outcomes Measurement Information System), a component of the “Roadmap” for reengineering the medical research enterprise. The PROMIS Network was tasked with building, calibrating, and validating large pools of questionnaire items in selected outcome
Conclusion
Patient-reported outcome measures are an important means of assessing efficacy and effectiveness of CAM therapies. However, the large number of available instruments can make selection of the “right” instrument difficult. There is a pressing need for greater standardization of PRO measures in CAM.1 We have outlined an agenda for improving the quality of PRO assessment in CAM studies by (1) identifying optimal measures through direct, head-to-head performance comparison, and (2) specifying
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Cited by (15)
Rationale for routine collection of patient reported outcomes during integrative medicine consultation visits
2018, Complementary Therapies in MedicineCitation Excerpt :As a result, certain areas within healthcare, particularly oncology,8,9 have begun to adopt and integrate PRO data collection into routine clinical care as a means of establishing clinical effectiveness for individuals10–13 and supporting a learning health care environment.9 Since IM focuses heavily on whole-patient well-being,14 some have gone as far as suggesting that PRO measures be the primary indicator of treatment success and that PRO measures may reflect the primary outcome that patients are seeking to address with this line of treatment.15,16 This movement, paired with the shifting in the health care climate from fee-for-service to value-based reimbursement models, highlights an increasing criticality of exploring routine collection of PRO measures in most clinic settings17,18 including IM clinics.
Research methods in complementary and alternative medicine: an integrative review
2018, Journal of Integrative MedicineWell-Being and Self-Assessment of Change: Secondary Analysis of an RCT That Demonstrated Benefit of Inhaled Lavender and Sleep Hygiene in College Students with Sleep Problems
2016, Explore: The Journal of Science and HealingCitation Excerpt :The species of lavender that was most frequently studied for sleep was Lavandula angustifolia (L. angustifolia). L. angustifolia has multiple clinical properties and can impact well-being through its calming, sedating, pain relieving, immune system enhancing,14 and sleep-inducing properties.12,15 Significant side effects have not been reported with proper use of lavender.
The use of PROMIS and the RAND VSQ9 in chiropractic patients receiving care with the Webster Technique
2016, Complementary Therapies in Clinical PracticeCitation Excerpt :Our use of PROMIS as an outcome measure in such a situation provides a means of measuring the ability of this technique in maximizing overall functioning and life satisfaction. Eton et al. [19] lamented that the use of PROs in CAM research lacked guidance in selection and limited attention paid to their clinical meaningfulness. The authors offered as part of the solution the use of the National Institutes of Health's PROMIS instruments.
Exploring the prospect of a complementary and integrative medicine database for use in the Australian primary care setting
2014, Advances in Integrative MedicineCitation Excerpt :Potential PRO questionnaires need to be tested to ascertain their psychometric properties in the CIM primary care setting, their responsiveness to change as an outcome measure and the clinical relevance of the results. Simply choosing PRO questionnaires that are already known to the researchers or in common use, runs the risk of generating false negative results because the questionnaires may be unable to measure relevant changes in health status in the CIM population group under study [33]. As was highlighted by the interviews with patients and practitioners, it will be challenging to find ways to minimise responder burden whilst making an in-depth, holistic assessment.
Integrative medicine outcomes: What should we measure?
2013, Complementary Therapies in Clinical PracticeCitation Excerpt :Thousands of PRO questionnaires are available. When selecting PROs for health services research, the questionnaire must be well tested; acceptable and relevant to patients, practitioners and the health service; and sensitive to change.18,19 Similar to an outcomes project in four IM clinics in Canada,3 a primary care IM clinic in Sydney, Australia wanted to use PRO questionnaires to measure the longitudinal outcomes of patients attending the clinic.
Conflicts of Interest: None