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Submit responseTo the Editor,
Because patients with chronic disease must be their own principal caretaker, education of patients for this task is essential for good health care. In evaluating education programs, there can be differences in selection of programs and in methods used for meta-analysis. However, as in this case, no contribution is made to improving health care by grouping and evaluating together widely different education programs delivered in widely different ways by people with widely different skills. What is needed is to identify successful programs and their components, and analyze the ways those components act and interact. In the process, rigorous longitudinal studies will be essential.
Halsted Holman, MD
Kate Lorig, DrPH
Conflict of Interest:
Federal, state and foundation grants, talk honoraria
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Re: Self-Management Education for Osteoarthritis
Submit responseWe thank Dr. Holman and Dr. Lorig for their interest in our paper. Regarding their concern about the effect size in one study, our calculated effect size is correct according to our methods, as it is based on the followup means for pain and function in the two groups. The effect size listed by Drs. Holman and Lorig in their letter is a "difference of difference" calculation that adjusts for baseline differences in pain and function between the two randomized groups in their study. While this is one valid method to analyze the results of an individual article, we do not prefer to combine "difference of difference" estimates with followup mean estimates in our meta-analyses because of reports that such an approach can increase susceptibility to bias.(1) On a practical level, combining just those studies which contain "difference of difference" estimates decreases the number of studies that can be included in a pooled analysis. In most circumstances, effect sizes calculated using the "difference of difference" method or using the followup means do not substantially differ. In this one particular study, they do. However, our pooled result is not very sensitive to which effect size is used from this study or similar studies; using the "difference of difference" effect size preferred by Drs. Holman and Lorig in their study only changes the pooled effect size for pain by 0.01. If we substitute a "difference of difference" effect size for all 6 studies where it is possible to do so in our pooled analysis of 14 studies, the effect for a decrease in pain diminishes to statistical insignificance (ES = -0.05, 95% CI -0.12, 0.03). Regarding the studies Drs. Holman and Lorig say we omitted, our study question of interest was the effect of chronic disease self-management programs on patients with osteoarthritis. All of the studies listed in their references were identified by us but rejected because they enrolled patients with mixed musculoskeletal conditions, and the proportion of patients with osteoarthritis was unacceptably low (about half of the patients in their references 3 and 4, as opposed to 77% of enrolled patients with osteoarthritis in their reference 2, which we did include in our analysis). Readers interested in a synthesis of evidence regarding self-management programs for patients with mixed diagnoses of arthritis are referred to the meta-analysis by Warsi and colleagues, which reported a pooled effect size very similar to our result (for pain = 0.12, for function = 0.07, (2)). In terms of the inclusion of different kinds of self-management programs, Dr. Holman and Dr. Lorig miss one the key points of our study - since there is no agreed upon definition of what constitutes a self-management program, we included a broad array of studies and used meta-regression in an attempt to identify components of particular significance. Unfortunately, our attempts were unrevealing, a result also echoed by Warsi and colleagues in another analysis, where meta -regression could not discern meaningful differences in the effectiveness of self-management programs as a function of a large number of different program components (3). There is simply an insufficient evidence base at present to conclude which components of a self-management program are most important in terms of effectiveness. We disagree with Dr. Holman and Dr. Lorig that longitudinal studies are "valid methods" to assess the effectiveness of interventions for a chronic disease with a variable clinical course, but do agree with Dr. Holman and Dr. Lorig that there are important outcomes other than pain and function, and we so stated this as a limitation of our analysis. Unfortunately, we could not include other outcomes because they were reported too infrequently and too variably to justify inclusion. Lastly, we did not conclude that self-management programs have "no clinically beneficial effect" for older adults with osteoarthritis, only that there are no data to suggest those benefits include clinically important improvements in pain and function. Future research is needed to determine which clinically and financially important outcomes are reproducibly improved by chronic disease self management programs for older adults with osteoarthritis, and which components are necessary in order to achieve these improvements.
1) Ray JA, Shadish WR. How interchangeable are different estimators of effect size? J Consulting and Clinical Psychology 1996;64:1316-25.
2) Warsi A, LaValley MP, Wang PS, Avorn J, Solomon DH. Arthritis self-management education programs: a meta-analysis of effects on pain and disability. Arthritis Rheum 2003;48:2207-13.
3) Warsi A, Wang PS, LaValley MP, Avorn J, Solomon DH. Self- management education programs in chronic disease. Arch Intern Med 2004;164:1641-49.
Conflict of Interest:
None declared
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Self-Management Education for Osteoarthritis
Submit responseSELF-MANAGEMENT EDUCATION FOR OSTEOARTHRITIS
This letter examines the article by Chodosh J et al. Meta-Analysis: Chronic Disease Self-Management Programs for Older Adults. Ann.Intern Med. 2005;143:427-438.
We respond first about our articles that were included, and then about the quality of the study. We do not know how our concerns apply to other articles that were analyzed. Also, we discuss only the data on pain, not physical disability, because self-management education for osteoarthritis, unlike that for diabetes and hypertension, does not intend to change the biologic abnormality. The goal is greater comfort and activity for the patient despite physical limitation. Disability may improve minimally but usually worsens over time.
A valid meta-analysis must be accurate in its use of data. Beyond that, it should search the relevant databases thoroughly, assess the methodological quality of the studies being analyzed, and interpret numerical results with common sense and due regard for the broader aspects of the problem.1 The study fails these requirements:
1. The authors describe the unbiased effect size for pain change in our study reference 602 as having a positive value that favors no benefit. In reality, the effect size is in the opposite direction, favoring treatment -0.31 as calculated by the method the authors used. (A similar error of direction is made for disability change).
2. The authors use 4 studies by us, one with two control-treatment comparisons with small sample sizes (27-29 persons per group). They omit 2 randomized studies by us with similar design done in the same time period with larger sample sizes (49-189 persons per group). These had effect sizes for pain clearly favoring treatment of about -0.36 and - 0.41 (depending on calculation method).3,4
On these grounds alone, a conclusion of no “clinically beneficial effect” from self-management programs for osteoarthritis is not legitimate. But there are more problems:
1. The included education programs differed widely: home-based reading with video demonstrations, computer programs, mailed information with audiotapes and telephone calls, and group meetings. Each intervention had different design, content and facilitators. Thus the programs are not comparable and the effectiveness of their teaching was not assessed as a condition for selection. . 2. The authors fail to mention that there are other valid methods to assess the benefits of a complex educational program. There are many examples including 2 longitudinal studies of ours with large sample sizes (113 and 263) that had benefits in pain and other outcomes persisting 3 to 4 years.5,6
3. While the goals of self-management have different definitions, none is restricted to pain and physical function.7,8 Just as osteoarthritis can have many consequences for a person, so self-management can have many benefits beyond pain reduction. Some that occur are mood improvement, enhanced perceived self-efficacy to cope with the consequences of chronic handicap, and reduced need for medical services. No mention is made of these benefits or the fact that benefits are additive to those of usual care.
Thus a conclusion from this study about the value of self-management in osteoarthritis would be invalid.
Why is all this important? Study integrity is only part of the answer. The impact of false conclusions can be substantial. Chronic disease is the dominant health care problem today and effective self- management is an essential part of the solution. We are just beginning to learn how best to instill and maintain patient’s self-management skills. As we devise and test different methods, it is crucial that we assess without error each approach in order to select the best ways to improve health care. Failure to do so properly undermines the effort and harms the public good.
References:
1.Greenhalgh T. How to read a paper: Papers that summarise other papers (systematic reviews and meta-analyses). BMJ. 1997; 315:672-675
2.Lorig K,Lubeck D, Kraines R, Seleznick M, Holman H.Outcomes of self -help education for patients with arthritis. Arthritis Rheum. 1985; 28:680 -5.
3.Lorig K, Chastain R, Ung E, Shoor S, Holman H. Development and evaluation of a scale to measure perceived self-efficacy in people with arthritis. Arthritis Rheum. 1989;32:37-44.
4.Lorig K, Gonzalez V, Ritter,P. Community-based Spanish language Arthritis education program. A randomized trial. Med.Care. 1999;37:957 -963.
5. Lorig K, Mazonson P, Holman H. Evidence suggesting that health education for self-management in patients with chronic arthritis has sustained health benefits while reducing health care costs. Arthritis Rheum. 1993;36:439-446.
6. Lorig K, Ritter P, Laurent D, Fries J. Long-term randomized controlled trials of tailored-print and small- group arthritis self- management interventions. Med.Care. 2004;42:346-354.
7. Barlow J, Wright C, Sheasby J, Turner A, Hainsworth J. Self- management approaches for people with chronic conditions: A review. Patient Educ. and Counselling. 2002;48:177-187.
8 Adams K, Greiner A, Corrigan J. Report of a summit. The 1st annual crossing the quality chasm summit - A focus on communities. 2004. Washington, DC: National Academies Press.
Conflict of Interest:
Federal, state and foundation grants, talk honoraria