Dec 31, 2009
Choosing Patient-Based Outcomes
Published In: Acupuncture in Modern Medicine / Chen, Lucy L, Cheng, Tsung O. (eds) ( March 6, 2013), Chapter 17, p. 349-370
Posted on RAND.org on March 01, 2013
In this chapter, we present the patient-based outcome assessment (PBOA) instruments that have been used to determine outcomes in acupuncture clinical research, and highlight measures that are feasible, practical, economical, reliable, valid, and responsive to clinical change. The material in this chapter has been previously published in the Journal of Alternative and Complementary Medicine (Khorsan R, York A, Coulter ID, Wurzman R, Walter JA, Coeytaux RR. Patient-Based Outcome Assessment Instruments in Acupuncture Research. J Altern Complement Med. 2010 Jan;16(1):27-35.). This chapter has been edited to reflect and enhance, in particular, recent discussions on measures that cover issues of specific concern to the patient (i.e. health and wellbeing). It must be noted that often patient reported outcomes are measured by questionnaires that cover issues of specific concern to the patient. However, patient reported outcomes should be distinguished from PBOAs. Patient reported outcomes connotes patient-provided (rather than clinician observed) information; however, the information sought may or may not be focused on what the patients consider the most important health-related outcomes. An example of a patient-reported outcome is a sleep diary, in which patients track and report hours of sleep during a trial of a sleep medication. On the other hand, patient based outcomes explore the patient's health from her own perspective, and include measures of health that may lie outside of traditional medical surveys. An example of a PBOA related to a sleep medication trial is a self-report sleep diary in which the patient rates how refreshed she feels following medication-induced sleep. For the purposes of this chapter we define PBOA as any questionnaire, interview schedule and other related method or that assesses the patient's health, illness and benefits of health care interventions from the patient's perspective. Acupuncture researchers, like all clinical researchers, should assess the appropriateness of their treatment approach defined and measured by clinically significant change and determine patient satisfaction with the intervention. We found in this review that acupuncture research includes a combination of validated instruments, such as common standardized questionnaires that assess functional status or health-related QoL before and after the administration of a therapeutic intervention for a specific condition. Examples include the VAS, NRS, and SF-36 and disease specific QoL instrument such as the WOMAC, BDI, and RM used to quantify change over time. However, acupuncture research also included a wide variety of unvalidated instruments like the 10-point Likert scale on subjective experience and global well-being and Symptom Diary. Both types of measures were used to capture particular health and wellbeing information from the study participants in relationship to a specific health event or an experience based on a particular research question that no single instrument and no combination of validated scales alone could achieve. The large number of unvalidated PBOA instruments in acupuncture research may be associated with the paradigm of whole systems medicine. Therefore, instruments such as MYMOP may be most useful for assessing clinical change in patients who present for acupuncture treatment with a variety of symptoms, clinical conditions, and therapeutic objectives. Further research is needed to determine whether these results apply across other whole medical system therapies compared more so than to conventional therapy research.