Measuring outcomes

Any clinical trial requires that relevant changes in patients are measured in a reliable and valid manner. Case studies and series also will be stronger when appropriate outcomes measures are used, and they may be required for audit and service evaluation. There are very many different measures available (Bowling, 2001; 2004). Established measure have usually been validated, i.e. testing them with samples of people and against existing valid measures, to check that they do what they are meant to do. Validation is a good reason in favour of using established tools. It also dictates that you should not change anything in a questionnaire without permission, even just the odd word. If there is nothing close to your requirements then you may need to write your own, but this is usually difficult and time-consuming.

Access

Some measures are freely accessible, some require payment (usually small) and some are available only to institutions or for particular sorts of research.

What outcomes to measure?

The IN-CAM Outcomes Database (http://www.outcomesdatabase.org/) is a comprehensive collection of measures that may be useful for CAM research, classified across 9 different domains. It is searchable and interactive and it is being continually updated.

To simplify the choice you could decide whether you want to employ a global measure or one that is condition-specific. If you were researching only patients with back pain then it would be appropriate to use a tool designed for that, such as the Oswestry Disability Index http://www.ncor.org.uk/wp-content/uploads/2012/12/Oswestry-Disability-questionnairev2.pdf  or the Bournemouth Questionnaire http://www.ncor.org.uk/wp-content/uploads/2012/12/The-Bournemouth-Questionnaire.pdf . In more general terms you could use a simple pain scale such as a Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS)(Mannion et al 2007; Lund and Lunderberg 2006; White 1998).
Nowdays clinical trials usually specify at least one global outcome even if it is only accorded secondary status. The most frequently used such measure in healthcare has been the SF36 (http://www.sf-36.org/tools/sf36.shtml), a 36-question survey that produces functional health and well-being scores organized into 8 domains: they can be reported separately and/or combined to give one overall score. The SF12 is a shorter version and there are several other well-used measures of general wellbeing (see IN-CAM for more examples).
Another category of outcomes measures is the patient-centred ones. The most well known, used broadly in CAM research, is MYMOP (Measure Yourself Medical Outcomes Profile: http://www.bris.ac.uk/primaryhealthcare/resources/mymop/). The patient defines their main symptom in their own words, rather than being shoe-horned into standard medical categories. They also score changes in a second symptom (if significant), an activity most affected and wellbeing. MYMOP is quite short and easy to complete, ideal for practice-based research, though not without some drawbacks (most of which are presented and discussed on the MYMOP web site). For a good introduction to patient-centred outcomes, aimed at CAM professionals, see Paterson (2010a).

The references below provide further examples from theory and practice.

References

General

  • Bowling A. "Measuring Health: A Review of Quality of Life Measurement Scales", 3rd Edition. Open University Press / McGraw Hill, 2004
  • Bowling A. "Measuring disease : a review of disease-specific quality of life measurement scales", 2nd Edition. Open University Press, 2001
  • The International Consortium for Health Outcomes Management (ICHOM) http://www.ichom.org/
  • Local Government Improvement and Development. Measuring impact in health improvement: a guide for health practitioners. Local Government Improvement and Development, January 2011 http://www.local.gov.uk/web/guest/health/-/journal_content/56/10180/3510402/ARTICLE


Pain

  • Lund I, Lundeberg T. Aspects of pain, its assessment and evaluation from an acupuncture perspective. Acupuncture in  Medicine 2006;24(3):109-117.
  • Mannion AF, Balague F, Pellise F, Cedraschi C. Pain measurement in patients with low back pain. Nat Clin Pract Rheumatol. 2007 Nov;3(11):610-8
  • White A. Measuring pain. Acupuncture in Medicine 1998; 16(2):83-7

Wellbeing

CAM: general

IN-CAM Outcomes Database (http://www.outcomesdatabase.org/

CAM: complex interventions

  • Paterson C Baarts C Launsø L Verhoef MJ. Evaluating complex health interventions: a critical analysis of the 'outcomes' concept. BMC Complementary and Alternative Medicine 2009, 9:18
  • Complexity, Whole Systems Research, and Complementary Therapies. Forsch Komplementmed 2012;19(suppl 1):1-2
  • This is the contents list for a special supplement of 8 articles on applying complex systems theory to CAM, which includes cutting-edge ideas on defining and measuring outcomes. Freely available online: http://www.karger.com/Journal/Issue/256740

CAM: patient-centred

  • Paterson C. Evaluating the Effect of Treatment from the Patient's Perspective. Europ J Oriental Med 2010a;6(4):36-9
  • Verhoef MJ Vanderheyden LC Dryden T Mallory D  Ware MA. Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures.  BMC Complementary and Alternative Medicine 2006, 6:38    http://www.biomedcentral.com/1472-6882/6/38

CAM: empathy

  • Mercer SW. An empathy-based consultation quality measure for use in CAM and conventional care settings. 9th Annual Symposium on Complementary Health Care, December 2002, Exeter, UK

Acupuncture examples

  • Fixler M, Ogden C, Moir F, Polley MJ. Patient experience of acupuncture provision in a GP practice. Complement Ther Clin Pract. 2012 Aug;18(3):140-4
  • Paterson C, Unwin J, Joire D. Outcomes of traditional Chinese medicine (traditional acupuncture) treatment for people with long-term conditions. Complement Ther Clin Pract. 2010b Feb;16(1):3-9
  • Paterson C. Measuring changes in self-concept: a qualitative evaluation of outcome questionnaires in people having acupuncture for their chronic health problems. BMC Complementary and Alternative Medicine 2006, 6:7
  • Shaw J, Bidgood P, Saebi N. Exploring acupuncture outcomes in a college clinic: Patient profile and evaluation of overall treatment benefit. Europ J Oriental Med. 2007;5(4):

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