Elsevier

EXPLORE

Volume 7, Issue 5, September–October 2011, Pages 314-319
EXPLORE

Clinical article
Hypothesis
Patient-Reported Outcomes in Studies of Complementary and Alternative Medicine: Problems, Solutions, and Future Directions

https://doi.org/10.1016/j.explore.2011.06.002Get rights and content

Patient-reported outcome (PRO) measures are frequently used to assess therapeutic efficacy and effectiveness of complementary and alternative medicine (CAM). Although CAM investigators are increasingly making use of valid, self-report instruments to assess patient-relevant outcomes, the sheer number of available instruments poses challenges. Two of the more pressing issues are discussed: the lack of guidance for selecting measures and the limited attention paid to the clinical meaningfulness of PRO results. Solutions are offered that may support selection and standardization of outcome measures for future CAM studies. This includes testing of tools from the National Institutes of Health's Patient-Reported Outcomes Measurement Information System (PROMIS). Increased standardization of outcome measurement in CAM studies will allow for more cross-study comparisons and facilitate the statistical pooling of results, ultimately leading to a more informative evidence base.

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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    Conflicts of Interest: None

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