Patient education for adults with rheumatoid arthritis

Robert P Riemsma; John R Kirwan; Erik Taal; Hans, JJ Rasker

doi:10.1002/14651858.CD003688

. 2003 Apr 22;2003(2):CD003688. doi: 10.1002/14651858.CD003688

Patient education for adults with rheumatoid arthritis

Robert P Riemsma ^1,^✉, John R Kirwan ², Erik Taal ³, Hans, JJ Rasker ⁴

Editor: Cochrane Musculoskeletal Group

PMCID: PMC6991939 PMID: 12076505

Abstract

Background

Because of the unpredictability people with arthritis face on a daily basis, patient education programmes have become an effective complement to traditional medical treatment giving people with arthritis the strategies and the tools necessary to make daily decisions to cope with the disease.

Objectives

To assess the effectiveness of patient education interventions on health status in patients with rheumatoid arthritis.

Search methods

We searched MEDLINE, EMBASE and PsycINFO and the Cochrane Controlled Trials Register. A selection of review articles (see references) were examined to identify further relevant publications. There was no language restriction.

Selection criteria

Randomised controlled trials (RCT's) evaluating patient education interventions that included an instructional component and a non‐intervention control group; pre‐ and post‐test results available separately for RA, either in the publication or from the studies' authors; and study results presented in full, end‐of‐study report.

Data collection and analysis

Two reviewers examined and screened search results. Dichotomous items were summarized as relative risk. Standardized mean difference and weighted mean difference were calculated for continuous data. Heterogeneity was assessed using chi square.

Main results

Thirty‐one studies with relevant data were included.   We found significant effects of patient education at first follow‐up for scores on disability, joint counts, patient global assessment, psychological status, and depression. A trend favouring patient education was found for scores on pain. Physician global assessment was not assessed in any of the included studies. The dimensions of anxiety and disease activity showed no significant effects. At final follow up no significant effects of patient education were found, although there was a trend favouring patient education for scores on disability.

Authors' conclusions

Plain language summary

Patient education shows short‐term benefits for adults with rheumatoid arthritis.

The purpose was to examine the effectiveness of patient education interventions on health status (pain, functional disability, psychological well‐being and disease activity) in patients with rheumatoid arthritis (RA). Patient education had a small beneficial effect at first follow‐up for disability, joint counts, patient global assessment, psychological status, and depression. At final follow‐up (3‐14 months) no evidence of significant benefits was found.

Background

Rheumatoid arthritis (RA) is a common, chronic condition, which is characterised by uncertain disease progression and an unpredictable course of exacerbations and remissions. Approximately 1 to 2% of the UK population are affected by RA. Various interventions may alleviate its course, and patients come into contact with a large number and variety of health professionals. For many patients, pain, disability, deformity and reduced quality of life persist in spite of treatment. There is clearly room for new approaches to enhance current treatment effectiveness. Patient education is one such approach that is thought to be beneficial in helping patients to cope and co‐operate with their disease and its complex management (Kirwan 1990; Taal 1996).

As with other chronic diseases, there is no cure for most types of arthritis, including RA. Furthermore, the disease course is often unpredictable and the symptoms that patients experience can vary from day to day or even from hour to hour. Because of the unpredictability people with arthritis face on a daily basis, patient education programmes have become an effective complement to traditional medical treatment giving people with arthritis the strategies and the tools necessary to make daily decisions to cope with the disease (Hirano 1994; Taal 1997).

Patient education has been defined to be 'any set of planned educational activities designed to improve patients health behaviours and/or health status' (Lorig 1992). Lorig has further stated 'the purpose of patient education is to maintain or improve health, or, in some cases, to slow deterioration' (Lorig 1992). The focus of arthritis patient education programmes is to teach patients to adjust their daily activities as dictated daily by disease symptoms. In other words, in addition to teaching patients what they should do, patients are also instructed on how to approach situations and to make adjustments that are appropriate for each individual and his or her own needs.

Objectives

To examine the effectiveness of patient education interventions on health status (pain, functional disability and psychological well‐being) in patients with rheumatoid arthritis (RA).

Methods

Criteria for considering studies for this review

Types of studies

This review was preceded by a peer‐reviewed protocol, published in the Cochrane Library.   Randomised controlled trials (RCT's) which fulfilled the following criteria were entered in the review:   ‐ Confirmed diagnosis of RA. Studies with mixed populations were included, but only data for RA‐patients were included in the analyses.   ‐ Patient education interventions that include an instructional component.   ‐ Studies with a non‐intervention control group.   ‐ Patients had to be the unit of randomisation, cluster randomised studies were excluded.   ‐ Pre‐ and post‐test results available separately for RA, either in the publication or from the studies' authors.   ‐ Study results presented in full, end‐of‐study report.   ‐ All languages are included in the review.   ‐ Studies that did not include data on any of the outcome measures are reported, but excluded from the meta‐analysis. If data necessary for the calculation of weighted or standard mean differences were unavailable, either in the publication or from the studies' authors, the study was also excluded from the analysis. Studies that did include data on the relevant outcome measures, but only for specific parts of the body, e.g. pain in the hand, were also excluded.

Types of participants

Trials were included of adult participants over the age of 18 with clinical confirmation of the diagnosis of RA.

Types of interventions

We defined a patient education intervention as one that includes formal structured instruction on rheumatoid arthritis and on ways to manage arthritis symptoms. Studies that used modern psycho‐behavioural methods to promote changes in health behaviours were also included. As a complement to an instructional component, interventions could include exercise, biofeedback or psychosocial supports.

We excluded studies in which the intervention was only behavioural (e.g. biofeedback) without an educational component, or was only social support.

Types of outcome measures

A core set of outcome measures to be used in clinical trials in RA have been identified and agreed upon by OMERACT (Tugwell 1993). This set of outcome measures has been acknowledged as the gold standard for outcome measures in RA by the World Health Organization (WHO) and the International League for Associations for Rheumatology (ILAR) (Brooks 2001).

For RA, the preliminary core set of outcomes identified by OMERACT including validated measures of acute phase reactants, disability, joint pain/tenderness, joint swelling, pain, patient and physician global assessment were selected as outcome measures to be included in this review. Since psychological status is an important aspect of health status, we also included affect‐scores (psychological status, anxiety and depression).

The Arthritis Impact Measurement Scales (AIMS) are the most common used general measure of health status in patients with arthritis (Meenan 1980). The AIMS2 (Meenan 1992) is a more comprehensive and sensitive version of the Arthritis Impact Measurement Scales. For all AIMS and AIMS2 scales, scores range from 0 (good health status) to 10 (bad health status).

However, in most studies specific instruments will be used to measure the different aspects of health status.   For pain, the most common instrument besides the AIMS2‐pain scales is a visual analogue scale consisting of a 10‐cm horizontal line labeled 'no pain' on the right to 'pain as bad as it could be' on the left. Subjects are asked to place a dot on the line to describe the pain that they experienced in the past week.

Disability is most often measured using the Stanford Health Assessment Questionnaire (Fries 1980). The HAQ is self‐administered, and performance is measured in activities of daily living in 8 subscales: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities, which are averaged to create a disability index ranging from 0 (able without difficulty) to 3 (not able). The Modified‐HAQ (M‐HAQ) (Pincus 1989) is a shorter version of the HAQ containing 8 items, scores ranging from 1 (without any difficulty) to 4 (unable to do).

Joint counts are most often assessed by means of the Ritchie Articular Index (Ritchie 1968), this index scores joint tenderness on a 4‐grade scale (0‐3) combined to a maximum possible score of 78 (maximum tenderness). Other commonly used instruments are the ACR joint count for number of swollen and painful joints (ARA 1982) and Thompson's Articular Index (Thompson 1987). The ACR joint count uses the criteria of the American Rheumatism Association (ARA, now American College of Rheumatology, ACR).

Patient global assessment can be assessed by the Arthritis Impact‐scale of the original AIMS, or by a simple question: 'How do you rate your own health?'. Physician global assessment can be assessed by a similar global question or visual analogue scale.

There is a wide range of instruments to assess psychological status, anxiety and depression. Amongst the most common instruments used in arthritis education research are the Hospital Anxiety and Depression Scale (HAD) (Zigmond 1983), the Center for Epidemiological Studies‐Depression Scale (CES‐D) (Radloff 1977), and the Zung Self‐Rating Depression Scale (ZSRDS) (Zung 1964).

Disease activity is generally measured by erythrocyte sedimentation rate (ESR), C‐reactive protein (CRP) or plasma viscosity. ESR is a widely used blood measure that parallels the levels of arthritis activity, particularly inflammation. CRP is an acute phase protein molecule that plays a role in the immune system and CRP levels are associated with disease activity. The plasma viscosity describes the thickness of the blood which is affected by the acute phase proteins, so it may also be used as a screening test to show disease activity in rheumatoid arthritis.

Search methods for identification of studies

We searched the following electronic databases MEDLINE, EMBASE and PsycINFO from 1966 forward to September 2002 and the Cochrane Controlled Trials Register. The search strategy was designed to achieve high recall of publications, which in turn resulted in inevitable low precision. An advanced boolean search strategy was used in MEDLINE to identify all publications on patient education interventions held within MEDLINE. The following format was used.

(rheumatoid arthritis OR arthritis) AND   (Clinical trial* OR study OR evaluation OR program OR experiment) AND   (health promotion OR patient education OR behavior therapy OR occupational therapy OR self care OR psychological adaptation OR counseling OR exercise therapy) NOT review

The format used in the searches for EMBASE and PsycINFO are in Appendix 1.

A similar search was performed in the Cochrane Controlled Trials Register and a selection of review articles (see references) were examined to identify further relevant publications.

Data collection and analysis

All identifiable RCT's comparing patient education interventions for people with RA were assessed particularly in relation to the outcome measures of pain reduction and improvements in functional abilities. The title and abstract of each citation were examined by two reviewers (RPR and ET), and the trials retrieved which, according to at least one of the reviewers, cited randomised controlled trials. If it was unclear from the title and abstract whether allocation of the intervention had been conducted in a randomised manner or whether the intervention included an educational component or whether RA patients were involved, the full report was retrieved.

Examination and screening for suitability for inclusion in the meta‐analysis followed. Both reviewers then examined the full reports. Disagreements regarding inclusion status were resolved by discussion. The details of the included reports were scrutinised by RPR and a standardised form was used for data abstraction. Only results at the end of the intervention were used for comparison of efficacy of the educational intervention, therefore statistically significant differences occurring between treatments throughout the trial but not at the end of the intervention were excluded.

To allow the reader to see any differences between the studies that were included in the meta‐analysis and the studies that were removed from consideration, tables are presented for the characteristics (population, size, intervention and treatment effect) of the trials included and excluded from the report.

The analysis was performed using Review Manager 4.1.

For continuous variables we calculated a weighted mean difference or a standard mean difference, in case the units of measurement were not comparable. If absolute values were reported, we calculated mean differences. The mean difference for each intervention group was weighted by the sample size of the group.

Dichotomous variables were summarised as relative risks. The summary relative risk was obtained by weighting each individual relative risk by the inverse of the variance of the estimate for each trial.

The results for each trial were tested for heterogeneity using the chi square statistic.   Effect estimates were analysed using fixed effects models, unless heterogeneity, due to differences in the outcome measures, was significant (at P < 0.05); in which case a random effects model was used.

Potential bias in meta‐analytic research is publication bias, which occurs when trials showing no effect are selectively not published (Felson 1992). One method used to detect publication bias is to plot study sample sizes versus effect sizes; a symmetric distribution of effect sizes, clustered around the effect sizes of the largest studies, would be expected in the absence of publication bias. We investigated whether publication bias existed among these studies by plotting sample sizes versus effect sizes for the outcomes that were most often reported: pain and disability.

Other sources of bias in the meta‐analysis were dealt with by several sensitivity analyses. The results are shown with and without use of quality scores to examine the effect of quality scores and we have run the analysis with only the larger studies to help determine the extent to which publication bias affected the conclusions. We also compared studies based on the end‐of‐study results, which was sometimes after 6 weeks and sometimes after 20 weeks, depending on the interventions, and we compared trials at a fixed time point.

Results

Description of studies

The search strategies identified 1423 publications, which were first examined on the basis of titles and abstracts. Eleven hundred and ninety‐three were excluded based on title and abstract. For 229 references the full report was retrieved. Eighty‐six publications turned out to be not RCT's, in 32 publications the patients involved were not RA‐patients, in 29 publications the intervention did not include an educational component, 11 publications involved secondary analysis, 8 publications did not include a non‐intervention control‐group, two publications only presented preliminary results, in one the intervention was education for health professionals and two turned out to be conference abstracts (so far we have not been able to find more information about these two studies) and one publication could not be retrieved (Sebro 1993). One publication is awaiting assessment because we need more information from the authors (Newman 2001). In 6 studies the outcome variables did not include any of the selected outcome measures, these studies will be described but they are excluded from the analyses (Darmawan 1992; Feinberg 1992; Linne 2001; Pope 1998; Van Deussen 1987; Young 1995). The remaining 50 publications are included in this analysis. Among the 50 references we found three studies with double publications, therefore 47 studies were included in the analysis.   We also searched for unpublished studies, and were able to retrieve data from three additional studies that have recently been completed. One of these has subsequently been published (Savelkoul 2001). In total 50 studies are included in this analysis.

Risk of bias in included studies

Methodological quality of the included trials was assessed independently by two assessors (RPR and JRK), using an adapted version (Arroll 1998) of the instrument developed by Jadad et al. (Jadad 1996). This was done by evaluating the methods and results of the reports without knowledge of the authors. Disagreement among the reviewers regarding the quality of the articles was readily resolved by discussion and consensus.   Our quality‐scale comprises the three criteria proposed by Jadad et al., which cover three out of four criteria outlined in the Cochrane Collaboration Handbook (Clarke 2000): selection bias, attrition bias and detection bias. We added one item concerning co‐interventions in order to cover the fourth criterion: performance bias as well.

One of the most important biases that may distort treatment comparisons is that which can result from the way that comparison groups are assembled (Kunz 1998). Using an appropriate method for preventing foreknowledge of treatment assignment is crucially important in trial design. When assessing a potential participant's eligibility for a trial, those who are recruiting participants and the participants themselves should remain unaware of the next assignment in the sequence until after the decision about eligibility has been made. Then, after assignment has been revealed, they should not be able to alter the assignment or the decision about eligibility. The ideal is for the process to be impervious to any influence by the individuals making the allocation. This will be most securely achieved if an assignment schedule generated using true randomisation is administered by someone who is not responsible for recruiting subjects, such as someone based in a central trial office or pharmacy. If such central randomisation cannot be organised, then other precautions are required to prevent manipulation of random assignment by those involved in recruitment.

Performance bias refers to systematic differences in care provided to comparison groups other than the intervention of interest. To protect against unintended differences in care and placebo effects, those providing and receiving care can be "blinded" so that they do not know the group to which the recipients of care have been allocated. Some research suggests that such blinding is indeed important in protecting against bias (Karlowski 1975; Colditz 1989; Schulz 1995). Studies have shown that contamination (provision of the intervention to the control group) and co‐intervention (provision of unintended additional care to either comparison group) can affect study results (CCSG 1978; Sackett 1979).

Attrition bias refers to systematic differences between groups in losses of participants from the study. It has sometimes been referred to as exclusion bias but here it is called attrition bias to prevent confusion with pre‐allocation exclusion and inclusion criteria for enrolling people. Because of inadequacies in reporting how losses of participants (e.g., withdrawals, dropouts, protocol deviations) are handled, reviewers should be cautious about implicit accounts of follow‐up. The approach to handling losses has great potential for biasing the results and reporting inadequacies cloud this problem.

Detection bias refers to systematic differences in outcome assessment. Trials that blind outcome assessors regarding treatment allocation should logically be less likely to be biased than trials that do not.

The scoring was as follows:

Scoring system   Selection   0. Randomisation reported but not specified, i.e. little effort to ensure proper randomisation.   1. On site computer, random number tables.   2. Centralised or in pre‐numbered/coded/identical boxes or containers.

Performance (co‐interventions)   0. Allowed but not reported   1. Allowed, reported   2. Allowed, reported, analysed or not allowed.

Attrition (Losses to follow up)   0. Follow‐up < 80% overall or not reported   1. Follow‐up > or equal to 80%   2. Intention‐to treat (ITT), explicit and clear.

Detection bias (Blinding)   0. Not reported.   1. Reported but not fully blinded.   2. Outcome assessment fully blinded.

Each criterion was scored from 0 to 2, therefore a maximum score of 8 and a minimum score of zero could be achieved for each trial.

Effects of interventions

Data abstraction.

For the 50 studies included in this review we found complete data on 24 studies (Barlow 1997; Barlow 2000; Bell 1998; Brus 1998; Geissner 1994; Hammond 1999; Helliwell 1999; Hewlett 1999; Hill 2001; Huiskes 1991; Leibing 1999; Lindroth 1997; Maisiak 1996b; Neuberger 1993; Parker 1988; Parker 1995; Radojevic 1992; Riemsma 1999; Rodriguez 1996; Savelkoul 2001; Scholten 1999; Sharpe 2001; Stenstrom 1994; Taal 1993), 7 other studies gave some data but not complete (Appelbaum 1988; Helewa 1991; Kaplan 1981; Maisiak 1996a; O'Leary 1988; Rhodes 1988; Shearn 1985), we are still waiting for replies from some of the authors to requests for more information. For 2 studies we have no data yet (Cohen 1986; Daltroy 1998), but the authors replied that the information requested will be send as soon as possible. On 8 studies we found no data relating to the outcomes under investigation in the report (Balmer 1989; Branch 1999; Cziske 1987; Lorig 1999a; Lorig 1999b; Maggs 1996; Strauss 1986; Wetstone 1985), and the authors have not yet replied to our requests. Finally on 9 studies the relevant data are not available according to the authors (Bradley 1987; Fries 1997; Goeppinger 1989; Lorig 1985; Lorig 1986; Lorig 1989; McEvoy‐DeVellis 1988; Oermann 1986; Parker 1984).

Publication bias

Potential bias in meta‐analytic research is publication bias, which occurs when trials showing no effect are selectively not published.   One method used to detect publication bias is to plot study sample sizes versus effect sizes in a so‐called funnel plot. A symmetric distribution of effect sizes, clustered around the effect sizes of the largest studies, would be expected in the absence of publication bias.   We have drawn funnel plots showing sample sizes versus effect sizes for the two outcomes that were assessed most often: pain and disability (see Figure 01 and 02).

Quality assessment.

The quality of all 50 studies was assessed (Table 5). For the studies on which we had two publications or more we used all available information from all publications to assess the quality of each study. If it was possible to retrieve additional information from the authors concerning the quality of the study, this was incorporated in the score as well. If it was not possible to retrieve additional information, the quality score reported reflects the quality of the study as it is reported in the paper. This may not reflect the true quality of the study.

1. Quality assessment for 50 included studies.

Study	Selection	Performance	Attrition	Blinding	Total score
Brus 1998	0	1	1	2	4
Barlow 1997	0	0	0	0	0
Lindroth 1997	0	1	2	0	3
Fries 1997	1	1	2	1	5
Maggs 1996	0	0	1	0	1
Maisiak 1996a	1	0	2	1	4
Parker 1995	0	1	1	1	3
Huiskes 1991	0	0	1	1	2
Stenstrom 1994	0	0	1	1	2
Geissner 1994	0	2	0	0	2
Neuberger 1993	0	0	0	0	0
Taal 1993	1	0	0	1	2
Helewa 1991	1	0	2	1	4
Goeppinger 1989	0	0	1	0	1
Lorig 1989	0	0	1	0	1
Parker 1988	1	0	1	0	2
O'Leary 1988	0	0	1	1	2
Bradley 1987	0	0	1	2	3
Strauss 1986	0	0	0	0	0
Lorig 1986	0	0	1	0	1
Cohen 1986	0	0	1	0	1
Wetstone 1985	0	0	1	1	2
Lorig 1985	0	0	1	0	1
Shearn 1985	0	0	0	0	0
Parker 1984	0	0	1	0	1
Kaplan 1981	0	0	1	1	2
McEvoy‐DeVellis 1988	0	0	1	0	1
Balmer 1989	0	0	1	0	1
Rhodes 1988	0	0	0	1	1
Oermann 1986	0	0	1	0	1
Appelbaum 1988	0	0	0	0	0
Radejovic 1992	0	1	1	0	2
Cziske 1987	0	0	0	0	0
Maisiak 1996b	0	1	1	2	4
Bell 1998	2	2	2	1	7
Riemsma 1999	0	0	2	1	3
Hewlett 1999	2	1	2	1	6
Savelkoul 2000	2	1	2	2	7
Rodriguez 1996	0	1	1	0	2
Barlow 2000	2	0	2	1	5
Branch 1999	0	0	0	0	0
Daltroy 1998	0	1	1	1	3
Hammond 1999	2	1	1	1	5
Helliwell 1999	2	2	2	1	7
Hill 2001	2	2	0	2	6
Leibing 1999	0	2	1	1	4
Lorig 1999a	0	0	2	2	4
Lorig 1999b	0	0	2	0	2
Scholten 1999	1	1	1	2	5
Sharpe 2001	2	0	2	1	5
Total of all 50 studies	22	22	52	34	130
Total of 31 studies with data	21	20	33	27	101

	Measure	Pain	Disability	Joint counts	Patient Global A.	Psychological status	Anxiety	Depression	Disease activity
Main analysis	SMD	(‐0.08)	‐0.17	‐0.13	‐0.28	‐0.15		‐0.14
SA: One instrument	WMD	‐0.38 ‐ VAS	(‐0.19 ‐ HAQ)	‐1.79 ‐ Ritchie		(‐0.45 ‐ AIMS‐Psy)		‐0.62 ‐ HAD‐Dep
SA: One experimental condition	SMD	(‐0.10)	‐0.23	‐0.15	‐0.30	(‐0.16)		‐0.18
SA: High Quality studies	SMD		‐0.20		‐0.32	‐0.18		‐0.21
SA: Large studies	SMD		‐0.15		‐0.31	(‐0.13)		‐0.13
SA: 2‐4 months results	SMD	(‐0.10)	‐0.14	(‐0.17)	(‐0.22)			‐0.11
SA: Information only	SMD	(‐0.15)				(‐0.24)
SA: Counselling	SMD					(‐0.25)
SA: Behavioral treatment	SMD	(‐0.09)	‐0.23		‐0.30			‐0.14

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain	39		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only
1.1 post‐treatment results	37	2219	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.08 [‐0.16, 0.00]
1.2 final follow‐up	19	1073	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.07 [‐0.19, 0.05]
2 Disability	38		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only
2.1 post‐treatment results	37	2275	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.17 [‐0.25, ‐0.09]
2.2 final follow‐up	23	1308	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.09 [‐0.20, 0.02]
3 Joint Counts	26		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
3.1 post‐treatment results	23	1158	Std. Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.24, ‐0.01]
3.2 final follow‐up	16	974	Std. Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.22, 0.07]
4 Patient Global Assessment	9		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only
4.1 post‐treatment results	6	358	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.28 [‐0.49, ‐0.07]
4.2 final follow‐up	8	618	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.06 [‐0.22, 0.10]
5 Physician Global Assessment	0		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only
5.1 post‐treatment results	0	0	Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 final follow‐up	0	0	Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
6 Psychological Status	19		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only
6.1 post‐treatment results	18	1138	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.15 [‐0.27, ‐0.04]
6.2 final follow‐up	13	794	Std. Mean Difference (IV, Fixed, 95% CI)	0.04 [‐0.10, 0.19]
7 Anxiety	19		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only
7.1 post‐treatment results	18	1328	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.04 [‐0.15, 0.07]
7.2 final follow‐up	16	990	Std. Mean Difference (IV, Fixed, 95% CI)	0.01 [‐0.12, 0.13]
8 Depression	30		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only
8.1 post‐treatment results	29	1770	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.14 [‐0.23, ‐0.05]
8.2 final follow‐up	20	1143	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.09 [‐0.21, 0.02]
9 Disease Activity	18		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only
9.1 post‐treatment results	15	647	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.03 [‐0.19, 0.12]
9.2 final follow‐up	11	718	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.05 [‐0.20, 0.10]

Methods	A 10 weeks, cross‐over study.   Assessments were done at baseline and after 10 weeks.   Quality: 0/0/0/0
Participants	19 RA patients recruited, 1 drop‐out before baseline assessment, 18 randomised (9/9) and analysed. Inclusion: outpatients with functional class Stage 2 or 3 RA according to the ARA‐criteria. Mean age: 62.2 yr, 11% female, 33% functional class 2.
Interventions	Active treatment: 10 sessions in 6 weeks, including: progressive relaxation training and thermal biofeedback (10 trials each) and instruction in cognitive pain management strategies.   Controls: symptom monitoring.
Outcomes	Included: McGill Pain Questionnaire, Daily Activities Questionnaire (personal hygiene, dressing, eating, household, communication).   Not reported: Beck Depression Inventory, State‐Trait Anxiety Inventory.   Others: Weekly Arthritis Diary (weekly pain index, weekly peak pain index), MMPI.
Notes	ARA = American Rheumatism Association   MMPI = Minnesota Multiphasic Personality Inventory

Methods	A 6 months counselling intervention.   Assessments were done at baseline and after 6 months.   Quality: 0/0/1/0
Participants	30 RA‐patients randomised (20 couns/10 contr) 1 drop‐out (couns) before start of sessions. No inclusion criteria mentioned. Mean age: 56 yr, 73% female.
Interventions	Counselling: 2 groups (10 persons) received weekly (1 hr) counselling sessions over 6 months by different counselors.   Controls: no‐intervention
Outcomes	Included: None.   Not reported: McGill Pain Questionnaire, VAS‐pain, AIMS, Ritchie Articular Index, Beck Depression Inventory, ESR.   Others: Arthritis Helplessness Index, Multidimensional Health Locus of Control.
Notes	VAS = Visual Analogue Scale   AIMS = Arthritis Impact Measurement Scale   ESR = Erythrocyte Sedimentation Rate

Methods	A 3 weeks, cross‐over design.   Assessments were done at baseline, after 3 weeks and after 6 months.   Quality: 0/0/0/0
Participants	Consecutive patients with definite RA were asked to participate, 142 agreed, 34 were lost to follow‐up (no reasons stated), 108 RA‐patients were used for T1‐T2 analysis. Mean age was 59.3 yr and 81% were female.
Interventions	Experimental group: Mailed RA‐leaflets from the ARC, to be read at home during a three week period.   Control group: no intervention.
Outcomes	Included: VAS‐pain, HADS (Anxiety and Depression).   Others: HAQ (only at baseline), VAS‐fatigue, ASE (pain and other symptoms).
Notes	ARC = Arthritis and Rheumatism Council (UK)   VAS = Visual Analogue Scale   HADS = Hospital Anxiety and Depression Scale   HAQ = Health Assessment Questionnaire   ASE = Arthritis Self‐Efficacy

Methods	A pragmatic randomised controlled study. Assessments were done at baseline and 4 months follow‐up. The intervention group completed a 12‐month follow‐up.   Quality: 2/0/2/1
Participants	602 people with arthritis recruited (I: 344; C: 258).   58 were ineligible or non‐consenting (I: 33; C: 25).   544 people were consenting and returned baseline questionnaires (I: 311; C: 233; RA‐patients: I: 115 (37%); C: 77 (33%)).   423 returned the 4 month follow‐up (I: 234; C: 189).   602 (I: 344; C: 258) randomised.   544 analysed at 4 months (I:311; C: 233). At 4 months follow‐up 423 (I: 234; C: 189) respondents remaining, intention‐to‐treat analyses with corresponding baseline value replacing missing values at both follow‐ups.   Course attendance was not dependent on participation in the evaluation. Entry criteria were: age 18 or older; ability to complete the questionnaire and a diagnosis of arthritis from the participant's GP.   Mean age for all respondents at baseline (n=544): 58.1y (SD: 12.8), 84% female. Type of arthritis: 35% RA, 52% OA, 13% other. Disease duration for all respondents at baseline (n=544): Mean: 11.0y (SD: 11.1). Comorbidities for all respondents at baseline (n=544): 56%.
Interventions	The ASMP comprises 6 weekly sessions, each lasting approximately 2h, delivered by pairs of lay leaders, most of whom have arthritis themselves. Leaders are trained by Arthritis Care and course delivery is guided by a manual to ensure consistency of content. The ASMP is multi‐component and topics include: information about arthritis, an overview of self‐management principles, exercise, cognitive symptom management (e.g. distraction, visualization and guided imagery), dealing with depression, nutrition, communication with family and health professionals, and contracting. The last of these involves the setting of realistic goals to be achieved during the forthcoming week. Participants report back to their group on their achievements at the next weekly session. Participants are given a copy of the Arthritis Helpbook (Lorig and Fries, 1995), which is an accompanying guide to the course. The format of the ASMP is largely interactive, with short 'lecturettes' to introduce topics, group discussion, problem solving, role plays and mastery experience (i.e. trying out the skills introduced on the ASMP).   Controls: a 4 months waiting list control group.
Outcomes	Included: VAS‐pain, health status (Modified Health assessment Questionnaire (M‐HAQ), Hospital Anxiety and Depression Scale (HADS) and a subsample completed the EuroQol (EQ‐5D).   Others: Arthritis self‐efficacy, health behaviours (exercise, cognitive symptom management, diet and relaxation) and VAS‐fatigue, and the Positive and Negative Affect Scales (PANAS).
Notes	ASMP = Arthritis Self‐Management Programme.   VAS = Visual Analogue Scale

Methods	A 6 week, outcome assessor blinded, cross‐over study, no co‐interventions allowed.   Assessments were done at baseline and after 6 weeks.   Quality: 2/2/2/1
Participants	150 RA patients randomised (76 EG/74 CG), 23 drop‐outs (7/16), leaving 127 (69/59) for analysis. Inclusion: RA according to ARA‐criteria; referral for PT (first to CTS); disease onset after 18 yr; ability to read, write, speak English; understand purpose of study and informed consent; requires > 3 visits or > 2 h of PT; available for follow‐up; at least 3 of 12 improvement areas, 6 tender and painful joints, 45 min morning stiffness; functional class 2 or 3. Exclusion: involvement in pilot study, require urgent care; current or past participatation in similar programme.
Interventions	EG: 4 visits (3h) of physical therapy over 6 weeks, including: total evaluation of disease activity, and level of function; review of 5 brochures, RA disease management, medications, nutrition and exercise and access to community resources and individual goal setting.   CG: Waiting list controls (after 6 weeks)
Outcomes	Included: VAS‐pain, tender joint count.   Others: Stanford Arthritis Self‐Efficacy Scales.
Notes	ARA = American Rheumatism Association   PT = Physical Therapy   CTS = Consultation and Therapy Service   VAS = Visual Analogue Scale

Methods	A study of 15 sessions of Cognitive Behavioural group therapy compared to 15 sessions of structured group social support therapy with a no adjunct treatment control group.   Assessments were done at baseline, immediately after the intervention, and 1 year after the intervention.   Quality: 0/0/1/2
Participants	68 RA patients randomised, 2 drop‐outs before first assessment, 11 (6 CBT/3 SGT/2 NAT) before treatment and 2 (0/1/1) during treatment. 53 analysed (17/18/18), 5 patients (1/1/3) excluded because of incomplete data at 1 yr follow‐up. Inclusion: definite or classis RA according to the 1987 ARA criteria. Mean age: 50.09 (SD: 12.44); 81% female; 9% functional class 1, 53% class 2, 38% classs 3.
Interventions	CBT: Biofeedback assisted cognitive behavioural group therapy: 5 sessions of individual thermal biofeedback training to promote increased skin temperature at most painful joints and 10 small group meetings (with family and friends) including education, relaxation training and instruction in behavioural goalsetting and use of self‐rewards.   NAT: no adjunct treatment control group
Outcomes	Included: None.   Not reported: VAS‐pain (unpleasentness and intensity), M‐HAQ, tender joints count, patient's rating of disaese activity, physician's rating of disease activity, STAI‐Trate Form; Depression Adjective Scale, ESR.   Others: Health Locus‐of‐control Scale; Arthritis Helplessness Index.
Notes	ARA = American Rheumatology Association.   VAS = Visual Analogue Scale   M‐HAQ = Modified Health Assessment Questionnaire   STAI = State‐Trate Anxiety Inventory   ESR = Erythrocyte sedimentation rate

Methods	An 8‐week randomised controlled trial with an intervention by a arthritis patient educator as well as standard rheumatologic care compared with standard rheumatologic care.   Assessments were done at baseline and 8 weeks later.   Quality: 0/0/0/0
Participants	537 patients were randomised. The authors state: "Of the 537 patients randomised to enter this study, 108 had their referral diagnosis confirmed by a rheumatologist, had sufficient time to complete the initial questionnaires, and were enrolled in the study." 58 (I: 27; C: 31) analysed. Probably all 537 patients recruited were randomised, 429 of these dropped‐out at baseline assessment. Intervention group: 20 patients (43%) did not complete the entire protocol. Controls: 30 patients (49%) did not complete the entire protocol. Inclusion: All newly referred (August‐December 1994) arthritis patients to the clinic, meeting the ACR criteria for rheumatoid arthritis, osteoarthritis, or fybromyalgia and were not excluded on the basis of length of disease or because of current use of medication. Exclusion criteria regarding 'length of disease' or 'current use of medication' not specified. Mean age and percentage female: not stated.
Interventions	Intervention: A 10‐30 minutes face‐to‐face interaction with an arthritis patient educator during a routine clinic visit. During the encounter, the arthritis patient educator utilised a standard protocol as a guide to ascertain the diagnosis of the patient, if known, as well as whether the patient had specific concerns about his or her condition. The arthritis patient educator then provided peer support, education and/or referral to the social worker if the patient needed additional help. Arthritis Foundation pamphlets were used as an adjunct to the educational component. One week after the appointment, the arthritis patient educator provided a follow‐up phone call to determine whether the patient had any questions since his or her rheumatologist's appointment.Arthritis patient educators are persons with arthritis, selected by their rheumatologists to participate in the above‐described training course. Additional training was given during an intensive 2‐day training programme prepared by a panel of experts. Topics included: rheumatic disease pathophysiology, nutritional guidelines, psychosocial aspects of chronic illness, components of physical therapy including exercise and pain management, and components of occupational therapy including exercise, joint protection, and energy conservation; and discussions of cultural diversity and cross cultural differences in disease perceptions and interviewing and listening skills.   Controls: Standard rheumatologic care.
Outcomes	Included: None.   Not reported: AIMS2 (pain, physical, arthritis impact, affect, anxiety and depression).   Others: Arthritis Self‐Efficacy Scales, a basic arthritis knowledge test, and satisfaction with services questionnaire.
Notes	ACR = American College of Rheumatology   AIMS = Arthritis Impact Measurement Scales

Methods	An assessor blinded, one year study. 65 RA‐ patients were selected, results presented of 25 experimental and 30 controls who finished the study.   Assessments were done at baseline and after 3, 6 and 12 months.   Quality: 0/1/1/2
Participants	65 RA‐patients randomised (32 exp/33 contr), 5 drop‐outs (3/2) at baseline, 2 at 6 months (1 each) and 3 exp at 12 months, leaving 55 (25/30) for analysis. Inclusion: less than 3 years RA, active disease (ESR > 28 mm/h and > 5 painful and > 3 swollen joints) and on DMARD therapy with sulphasalazine. DMARDs other than hydroxychloroquine were excluded. Mean age: 59.2 yrs, 80% female and mean number of ACR criteria: 4.7.
Interventions	Experimental Group: Four (2 h) goup meetings in the first month, with reinforcement meetings after 4 and 8 months, partners were invited. Focus on compliance with sulphalazine therapy, physical exercises, endurance activities, advice on energy conservation and joint protection. One instructor (HB) provided information on RA, attendant problems and basic treatment. Sessions included discussion of problems and solutions, training in physical exercises, treatment planning, use of contracts and feedback.   Controls: no intervention
Outcomes	Included: Dutch‐AIMS (pain, anxiety and depression), M‐HAQ, Ritchie Articular Index, ESR.   Not reported: Dutch‐AIMS (mobility, physical activity, dexterity and household activities).   Others: CRP,   number of swollen joints, number of painful joints, DAS.
Notes	ESR = erythrocyte sedimentation rate   DMARD = disease modifying anti‐rheumatic drug   ACR = American College of Rheumatology   AIMS = Arthritis Impact Measurement Scales   M‐HAQ = Modified Health Assessment Questionnaire   DAS = Disease Activity Score

Methods	A 3 months Randomised Controlled Trial.   Assessments were done at baseline, after 6 weeks (experimental groups only) and after 12 weeks.   Quality: 0/0/1/0
Participants	96 arthritis patients randomised (28 prof/32 lay/36 contr), 10 drop‐outs (4/4/2), leaving 86 (24/28/34) for analysis, 15% RA (n=14). Volunteers through public service announcements. Diagnosis determined by patient's physician. Mean age: 65.5 yr, 78% female.
Interventions	Professional‐instructed: 6 weekly (2 hr) sessions (10 persons) of arthritis self‐management course (modeled after Lorig). Including: exercise techniques, relaxation, joint protection, heat therapy, massage, medications, diets, physician‐patient communication and solving social/functional problems. Led by 2 health professionals who acted as expert authorities rather than equals.   Controls: no intervention.
Outcomes	Included: None.   Not reported: VAS‐pain, M‐HAQ, CES‐D.
Notes	VAS = Visual Analogue Scale   M‐HAQ = Modified‐Health Assessment Questionnaire   CES‐D = Center for Epidemiologic Studies‐Depression Scale

Methods	A 4 week intervention with 4 rheumatic conditions.   Assessments were done at baseline and immediately after the 4 weeks intervention period.   Quality: 0/0/0/0
Participants	44 arthritis patients randomised and analysed (25 exp/19 contr); 9 RA (4/5). Inclusion: considerable pain, disease duration at least 6 months, no other relevant comorbidities, having RA, OA, ankylosing spondylitis or low‐back pain.
Interventions	Pain‐management training: 4 sessions (90 min, 4 persons with same disease) including: gate‐control theory of pain, presentation of and training in breathing techniques, distraction and visualisation; and how to incorporate techniques in daily life.   Controls: lecture (90 min) on pain management
Outcomes	Included: None.   Not reported: Revidierte Mehrdimensionale Schmerz‐Skala (pain‐RMSS), Befindlichkeitsskala (disability), Trait Anxiety (State‐Trait Anxiety Inventory).
Notes

Methods	A 4‐days randomised controlled prospective study of two interventions, information and relaxation training, in a 2x2 factorial design. Assessments were done at baseline and 4 days post intervention.   Quality: 0/1/1/1
Participants	From March 1985 until December 1987 letters were mailed to 329 eligible patients of 8 orthopaedic surgeons. Of these, 247 (82%) agreed to participate. In 25 cases surgery was cancelled, leaving 222 patients with completed baseline data and exposure to the intervention (I1: 58, I2: 58, I3: 52, C: 54). One patient was excluded from analyses (outlier for all outcomes), 5 patients were excluded due to incomplete data.   Number randomised: not stated, nor for total nor for RA.   Number analysed: 216 patients. (19% RA‐patients = 42). Inclusion: Eligible patients were those scheduled for total hip or knee replacement surgery. Patients were excluded if they could not speak English, fill out the questionnaires, or if they had previously had surgery on the contralateral joint. Mean age: 64 years (SD: 12). Range: 20‐88 years, 66% female. 19% RA; 73% OA; 8% other. One or more comorbidities: 33%. Uses pain medication 5‐7 days per week: 78%.
Interventions	Information only ‐ The informational intervention consisted of a 12‐min audiotape slide programme presented by a research assistant at the patient's bedside the day before surgery. The audiotape oriented the patient to the hospital, to staff and their roles, to the events of surgery and rehabilitation, and to life in the hospital. Patients were told of various stressful aspects of the hospitalisation., including postoperative pain, immobility, the work involved in rehabilitation, lights and noises, an altered sleep schedule, and dietary and smoking restrictions. They were reassured that various sensations, emotions and difficulties were normal and would pass.   Controls: no intevention.
Outcomes	Included: none.   Not reported: Pain (assessed by taking the mean of 3 5‐point Likert scales assessing pain (not at all to extremely painful) at night, resting and when active); State anxiety (Spielberger's 20‐item anxiety inventory).
Notes

Methods	A 6 months cross‐over study.   Assessments were done at baseline and 6 months later.   Quality: 1/1/2/1
Participants	1099 respondents from three groups were recruited and seperately randomised (557 exp/542 contr): Physician diagnosed OA and RA‐patients from a HMO, Physician referrals from 3 rheumatology practices and self‐reported arthritis from a general health education programme. 809 (375/434) patients analysed at 6 months and 392 (248/144) at 12 months.
Interventions	Mail delivered intervention at 3 months intervals. HAQs lead directly to computer generated recommendation letters with physician signature and graphic reports of progress. Positive change is reinforced and additional change encouraged every 3 months. Including exercise video and relaxation audiotape. Recommendations were tailored for age, diagnosis, level of disability, education level, medication schedule, side‐effects, pain, self‐efficacy, etc. Advice given is closely similar to that in Lorig's 'The Arthritis Helpbook'.   Controls: not reported (no‐intervention).
Outcomes	Included: None.   Not reported: VAS‐pain, HAQ, joint count, VAS‐global vitality.   Others: confidence (self‐efficacy).
Notes	HMO = Health Maintenance Organization   VAS = Visual Analogue Scale   HAQ = Health Assessment Questionnaire

Methods	Parallel treatment during 4 to 6 weeks rheumatology clinic admission. Co‐interventions not allowed.   Assessments were done at baseline and after the 4 to 6 weeks intervention period.   Quality: 0/2/0/0
Participants	60 RA patients recruited, 14 drop‐outs before randomisation, 46 (12 MPM/10 VT/ 12 RT/ 12 Contr) randomised and analysed. Inclusion: definite diagnose of RA and chronic pain during at least 6 months. Mean age 47.5 yr and 78% female.
Interventions	Multimodal Pain Management (MPM): 6 sessions (90 min) icluding pain information, presentation of coping strategies and training.   Controls: medical treatment alone.
Outcomes	Included: AES (pain), Behinderungserleben (disability), Gelenkstatus (joint count), HDA (psychological status), ESR.   Others: Beck‐hopelessness scale; Optimismusskala (Optimism).
Notes	AES = Affektiv‐evaluative Schmerzangabe   HDA = Schmerz bezogene Hilflosigkeit, Depression und Angst   ESR = erythrocyte sedimentation rate

Methods	A 4 months cross‐over study. Assessments were done at baseline and after 4 months. Quality: 0/0/1/0
Participants	459 arthritis patients randomised, 85 drop‐outs, leaving 374 (121 HS/100 SG/153 Contr) for analysis, 16% RA (N=60). Inclusion: 18 yr or older, medically verified diagnosis of arthritis, sixth grade reading level or above, non‐housebound and resident in 1 of 9 selected rural counties. Mean age total group: 62.44 (sd 11.25), 87% female.
Interventions	SG ‐ small group: 6 sessions (2hr each) in community sites led by 2 trained lay leaders. Contents: encourage active pratice of self‐care, contracts and feedback and problem‐solving. Topics: exercise, energy conservation and joint protection, depression, medications, nutrition and diet, sleep, family relationships, community resources, folk or popular medicines and working with physicians. WLC ‐ Waiting list controls
Outcomes	Included: None. Not reported: Pain Index, HAQ, CES‐D). Others: AHI.
Notes	HAQ = Health Assessment Questionnaire CES‐D = Center for Epidemiologic Studies Depression Scale AHI = Arthritis Helplessness Index

Methods	A single blind cross‐over trial with 12‐week cross‐over. Assessments were done at baseline and 12‐weeks later.   Quality: 2/1/1/1
Participants	175 out‐patients were contacted by mail, of whom 79 (46%) responded.   Number randomised: 35 (I: 17; C: 18)   Number analysed: 33 (I: 16; C: 17). Inclusion: Out‐patients diagnosed with RA by consultant rheumatologists. Participants had wrist and/or MCP involvement, no other medical condition affecting hand function, and had some restriction in ability to perform daily activities (American College of Rheumatology Revised Functional Classification III: able to perform usual self‐care activities (e.g. dressing, feeding, bathing, toileting) but limited in vocational (homemaking, school, work) and avocational (recreational) activities.   Mean age: 55.17y (SD: 9.39), range: 33‐69, 83 % female (29 women and 6 men). Mean disease duration: 9.83y (SD: 8.06). All were in functional class III, and had moderate functional difficulties; 13 had already developed some degree of hand deformity.
Interventions	Intervention: Four weekly 2hr sessions, plus an optional home visit within 2 weeks of the end of the programme, led by an experienced rheumatology occupational therapist. Partners or significant others were invited to attend. Between 4 and 8 people attended each programme. A teaching manual was followed throughout to standardise the programme content and delivery. Patients were provided with a workbook "Managing Your Arthritis: Joint Care Workbook', "Coping with Rheumatoid Arthritis" and patient education leaflets produced by the Arthritis and Rheumatism Council (ARC). The ARC videotape 'Help is at hand ‐ getting the better of your arthritis' is shown at the first meeting to promote discussion of members' own alternate methods and gadgets they found useful, as well as on the impact of living with arthritis. The programme used the Health Belief Model and Self‐efficacy Theory as a basis. The programme focussed on barriers to adhering with JP such as: poor self‐efficacy for using JP (modelling on other group members' JP performance and verbal persuasion), limited perceived susceptibility to the effects of RA (educating about the effects of RA on joints, etc.), poor recall of JP methods (advance organisers, simplification, explicit categorisation, specific advice and repetition), limited skill (motor learning strategies) and difficulty with habit formation (self‐management strategies such as contracting and goal‐setting).   Controls: waiting list control group.
Outcomes	Included: HAQ, HAQ Pain Scale (patients are asked to rate their perceived pain during performance of 8 activities derived from the HAQ).   Others: Joint Protection Behaviour Assessment, Self‐reported JP homework practice, Joint Protection Knowledge Assessment, Arthritis Helplessness Index, Arthritis Self‐efficacy Scale, Hand Pain Visual Analogue Scale, Hand Joint Count, Hand Joint Alignment and Motion Scale, Grip strength.
Notes	HAQ = Health Assessment Questionnaire   JP = Joint Protection.

Methods	A 6 week, cross‐over study.   Assessments were done at baseline and after 6 weeks.   Quality: 1/0/2/1
Participants	105 RA‐patients randomised (53 exp/52 contr), 3 (1/2) drop‐outs after 6 weeks. Inclusion: age: 18‐70 yr, definite or classical RA according to 1987 ARA criteria, limitations in physical function, no other sources of disability, stable clinical status, no intra‐articular treatment last 2 months, no joint surgery for RA last 3 months and coming 6 weeks. Exclusion: pregnant or disease onset before age 16. Mean age: 54 yr (sd: 12.2), 87% female.
Interventions	A 6 week programme of occupational therapy: total evaluation of disease activity and level of function + physical examination + functional evaluation of daily tasks. Formulation of a problem list and treatment plan. More detailed evaluations of hand and feet if required. Enhancement of ADL by provision of aids, home adaptations, wheelchair prescription, education, joint protection and energy conservation. If appropriate: vocational assessment, ehancement of leisure activities, psychosocial counselling and socialising skills.   Waiting List Controls.
Outcomes	Included: HAQ, Beck‐depression.   Not reported: VAS‐pain, Active joints count, ESR.
Notes	ARA = American Rheumatology Association   ADL = Activities of Daily Living   VAS = Visual Analogue Scale   HAQ = Health Assessment Questionnaire   ESR = erythrocyte sedimentation rate

Methods	A 12‐months randomised controlled trial in people with rheumatoid arthritis of < 5yr duration. Control patients could attend education classes after the 12‐month study if such classes were found of benefit. Assessments were done at baseline, 4 weeks and 12 months.   Quality: 2/2/2/1
Participants	79 patients were randomised, 77 analysed (I: 43; C: 34). Inclusion: Patients from routine out‐patient clinic appointments, with a diagnosis of rheumatoid arthritis (using the 1987 ARA criteria) of <5yr duration who were able to read and speak English.No previous participation in a group patient education programme.   Mean age: 53.2yr, range: 23‐78, 66% (51/77) female. Mean duration of disease: 3.2yr.
Interventions	A 4‐week education programme, with 2h weekly sessions. Participants were encouraged to bring a partner. The format of the sessions was a talk from a non‐medical health professional using overhead projection, a discussion period and the distribution of supporting literature. The content of the sessions included the pathophysiology of rheumatoid arthritis, drug treatments, local treatments, mechanisms and control of pain, stress, exercise and rest, joint protection, task allocation, splinting and assistive equipment.   Controls: Usual care, control patients could attend education classes after the 12‐month study if such classes were found of benefit.
Outcomes	Included: SF‐36 (at baseline and 12‐months: Bodily pain, General health perception, and Mental health), HAQ, Ritchie Articular Index, and Plasma viscosity (PV).   Others: The modified Larsen radiological score for the hands and wrists, Patient Knowledge Questionnaire (PKQ), Compliance Questionnaire (CQ), pharmaceutical changes and consulting behaviour.
Notes	ARA = American Rheumatology Association   HAQ = Health Assessment Questionnaire   SF‐36 = Medical Outcome Survey ‐ Short Form 36‐item version

Methods	A 36 weeks study.   Assessments were done at baseline, after 8 weeks and after 36 weeks.   Quality: 2/1/2/1
Participants	79 RA‐patients were randomised (34 education/34 controls/11 declined education and were followed as an observation group for ITT analysis). 11 drop‐outs (4/6/1), leaving analysis on 68 (30/28/10). Inclusion: age 18‐70, positive RA‐factor, evidence of current inflammation (CRP > 10 and/or 5+ swollen joints). Exclusion: previous education programme.   Mean age: 56.79 y (SD:10.63), 69% female.
Interventions	Group Education: 5 sessions (2.5 hr), including joint protection, relaxation, pain management, stress and mood management. Run by nurses, occupational therapists, physiotherapists and a psychologis.   Controls: No additional intervention.
Outcomes	Included: VAS‐pain, HAQ, Thompson‐score (joints count), HADS (anxiety and depression), CRP.
Notes	VAS = Visual Analogue Scale   HAD = Hospital Anxiety and Depression Scale   CRP = C‐reactive protein

PERMALINK

Patient education for adults with rheumatoid arthritis

Robert P Riemsma

John R Kirwan

Erik Taal

Hans, JJ Rasker

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Background

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Search methods for identification of studies

Data collection and analysis

Results

Description of studies

Risk of bias in included studies

Effects of interventions

1. Quality assessment for 50 included studies.

Discussion

2. Summary of significant results at first follow‐up (trends in brackets).

3. Summary of significant results at final follow‐up (trends in brackets).

Authors' conclusions

Implications for practice.

Implications for research.

What's new

Acknowledgements

Appendices

Appendix 1. EMBSE and PsycINFO search strategy

Data and analyses

Comparison 1. Patient Education versus Controls.

1.1. Analysis.

1.2. Analysis.

1.3. Analysis.

1.4. Analysis.

1.6. Analysis.

1.7. Analysis.

1.8. Analysis.

1.9. Analysis.

Comparison 2. Information Only versus Controls.

2.1. Analysis.

2.2. Analysis.

2.3. Analysis.

2.4. Analysis.

2.6. Analysis.

2.7. Analysis.

2.8. Analysis.

2.9. Analysis.

Comparison 3. Counselling versus Controls.

3.1. Analysis.

3.2. Analysis.

3.3. Analysis.

3.4. Analysis.

3.6. Analysis.

3.7. Analysis.

3.8. Analysis.

3.9. Analysis.

Comparison 4. Behavioural Treatment versus Controls.

4.1. Analysis.

4.2. Analysis.

4.3. Analysis.

4.4. Analysis.

4.6. Analysis.

4.7. Analysis.

4.8. Analysis.

4.9. Analysis.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Appelbaum 1988.

Methods	A 6‐months randomised controlled study comprising 100 patients with rheumatoid arthritis requiring D‐penicillamine (DPA).Patients were stratified into bands of low, medium or high knowledge of their RA.   Assessments were done at baseline and after 24 weeks.   Quality: 2/2/0/2
Participants	100 patients, referred by their rheumatologist, were recruited and randomised (I: 51; C: 49); 63 patients completed the full 24 weeks of the study and were analysed (I: 33; C: 30).   Inclusion: Patients with active RA from an outpatient clinic. All were deemed to require DPA as their slow acting antirheumatic drug (SAARD). Age: 18 years or above; a positive diagnosis of RA using the American Rheumatism Association criteria, a plasma viscosity >= 1.75 mPa.s or a CRP > 10mg/l. In addition: two out of three clinical features: an articular index > 15, morning stiffness > 45 minutes, a minimum of moderate levels of pain.   Patients were excluded if they had received DPA previously, had a contraindication such as kidney impairment or pregnancy, or were receiving incompatible concomitant drugs; or awaiting hospital admission.   Median age: 63 years, range: 22 to 79 years, 73 females (73%). Median duration of RA: 13 years (range: 0‐45 years).
Interventions	Intervention: 7x30 minute one‐to‐one sessions of patient education over a 6 months period. The programme was based on the theory of self‐efficacy and taught by a rheumatology nurse practitioner. The programme comprised information about the types drugs use for RA, the disease process, physical; exercise, joint protection, pain control, and coping strategies. Written information, including a DPA drug information leaflet developed specially for the study, was provided as back up.   Controls: Standard management and received the same drug information leaflet. Control patients were invited for 7 sessions of 30 minutes over a 6 months period to talk about their social lives and families.
Outcomes	Included: Pain score (daily diary card, 1=no pain, 5=very severe), Ritchie articular index, C reactive protein (CRP).   Others: Measure of adherence: Pharmacological marker (phenobarbitone)., Plasma viscosity, and morning stiffness.
Notes	DPA = D‐penicillamine

Methods	An 8 months, waiting‐list control and outcome assessor blinded study.   Assessments were done at baseline, after 10 weeks and 6 months after the 10 weeks patient education period.   Quality: 0/0/1/1
Participants	105 RA‐patients randomised ( 21 CT/24 CBT/28 OT/19 WLC), 13 drop‐outs (3/3/3/4). Inclusion: minimum age of 20 yr, diagnose of RA according to 1987 ACR‐criteria for at least 1 yr. Exclusion: difficulty ambulating due to aging or medical problems, and class 4 RA. Mean age 57 yr (sd: 12.7) and 68% female.
Interventions	CT ‐ Combination of Cognitive Behavioral Therapy and Occupational Therapy.   WLC ‐ Waiting List Controls.
Outcomes	Included: IRGL (pain, mobility, mood, anxiety, depression), Thompson‐score (joint count), ESR.   Others: IRGL (self‐care), CRP.
Notes	WLC = Waiting List Controls   CT = Combination Therapy   IRGL = Impact of Rheumatic diseases on Health and Lifestyle   ESR = Erythrocyte Sedimentation Rate   CRP = C‐reactive protein

Methods	A 16 week, outcome assessor blinded, group counselling programme.   Assessments were done before the patient education session for all respondents, 2 weeks later (baseline) and 16 weeks later (post‐test).   Quality: 0/0/1/1
Participants	34 female RA patients randomised (17 each), 6 drop‐outs (exp): 4 non‐compliant, 1 moved, 1 refused final test). Inclusion: definite or classical RA according to ARA criteria, age between 21 and 65 yr and willingness and ability to attend 20 weekly sessions. Mean age: 49 yr; 100% female;21% ARA‐class 1, 50 % class 2 and 29% class 3.
Interventions	All: patient education session (2.5 hr). Including: pathophysiology, treatment and complications by rheumatologist; physical and occupational therapeutic modalities plus demonstrations by OT; eligibility and availability of programmes for chronic patients by social worker.   EG ‐ 12 weekly (1‐2 hr) group counselling sessions, free discussion encouraged, but emphasis on problems caused by arthritis. Led by a patient counsellor and psychiatrist.   CG ‐ No additional meetings.
Outcomes	Included: Zung self‐rating depression scale.   Not reported: Joint counts, joint tenderness (dolorimeter), subjective impression of disease activity by rheumatologist.
Notes	ARA = American Rheumatism Association   OT = Occupational Therapist   EG = Experimental Group   CG = Control Group   Test 2 (after first education session, before randomisation) = Pre‐test; Test 3 (after 12 weeks counseling) = post‐test

Methods	A 9‐months prospective randomised controlled trial. Change in medication during treatment was controlled by matching therapy and control group participants according to this change in medication, sex, age, duration of disease and functional class. Medication was not prescribed during treatment. Assessments were done at baseline, and after 3 and 9 months.   Quality: 0/2/1/1
Participants	118 consecutive outpatients were seen. 63 met the criteria and were included. 55 patients were randomised (although not explicitly stated; could also be 63). 55 patients finished the study and were analysed (I: 19, C: 36). Inclusion: Diagnosis of rheumatoid arthritis (ACR criteria). Exclusion criteria: duration of disease of 0.5 years or less, another severe disease, planned hospitalisation, organic brain syndrome, no pain, or advanced disability (functional class IV). Mean age: 52.7 years (SD: 11.9), 74.5% female. Mean duration of disease: 9.4 years (SD: 9.3). 26 patients (67%) were functional class II and 8 (21%) functional class III.
Interventions	Intervention: Routine care by the rheumatologist and adjunctive standardised cognitive‐behavioural group treatment (5‐7 patients) with 12 weekly 90‐minute manual based sessions, designed after the approach by Turk and Rudy, a common basis for cognitive‐behavioural therapies for pain. The following strategies were included: information an education about the gate‐control theory of pain, the vicious circle of pain, muscular tension, demoralisation, and the rational of the treatment methods; relaxation and imagery; cognitive‐behavioural treatment interventions and pain management strategies; and pleasant activity scheduling. Sessions were led by 2 experienced instructors (> 5 years of psychotherapeutic experience)   Controls: Routine care by the rheumatologist and routine medical treatment (n=36, "change‐in‐medication‐matched control group": n=20)
Outcomes	Included: Pain intensity, Functional capacity (Hannover Functional Ability Questionnaire), Number of swollen joints, State‐Trait Anxiety Inventory, Depression scale, ESR.   Others: Affective pain, CRP, grip strength, Arthritis Helplessness Index, Bernese Coping Modes.
Notes	ACR = American College of Rheumatology   ESR = Erythrocyte Sedimentation Rate   CRP = C‐reactive protein

Methods	A one year study with waiting list controls.   Assessments were done at baseline and 3 and 12 months after the intervention.   Quality: 0/1/2/0
Participants	100 consecutive patients with RA according to 1987 ACR criteria. All patients completed the intervention, 4 patients were lost to follow‐up (2 refused, 1 death, 1 ill). Mean age: 55 yr; 83% female.
Interventions	8 weekly (2,5 h) group discussions led by a team (doctor, nurse, PT, OT, social worker and dietitian). First session: introduction, leisure priorities and main problems. Folowing sessions: problem solving; therapy; diets; pain management, rest, exercise and relaxation; pain relief, home exercises; hand function and aids; social problems; daily problems and tools; discussion with family and friends. One yr later informal meeting (problems with feet).
Outcomes	Included: VAS‐pain, HAQ.   Others: AHI.
Notes	ACR = American College of Rheumatology   PT = Physiotherapist   OT = Occupational therapist   VAS = Visual Analogue Scale   HAQ = Health Assessment Questionnaire   AHI = Arthritis Helplessness Index

Methods	A 4 months, community based, cross‐over study.   Assessments were done at baseline and after 4 months.   Quality: 0/0/1/0
Participants	199 arthritis patients randomised (134 exp/65 contr), 9 drop‐outs (5/4), 10.7% RA (N=31). Diagnosis confirmed by their physician. Recruited by public service announcements. Mean age 67.4 (SD=11.84), 83% female.
Interventions	Arthritis Self‐Management Programme: 6 sessions (15‐20 persons, plus family) in 4 months, taught by 2 lay leaders. Including: nature of arthritis, use of medications, range of motion and isometric exercises, relaxation techniques, joint protection, nutrition, patient‐physician interaction and evaluation of non‐traditional treatments. Based on group discussion, practice, use of contracts and diaries to improve compliance and weekly feedback.   Controls: waiting list controls.
Outcomes	Included: None.   Not reported: VAS‐pain, Ordinale pain scale (mild, moderate, severe), HAQ.   Others: Wallston Health Locus of Control.
Notes	VAS = Visual Analogue Scale   HAQ = Health Assessment Questionnaire

Methods	A 4 months, cross‐over study.   Assessments were done at baseline and after 4 months.   Quality: 0/0/1/0
Participants	100 arthritis patients randomised (34 HP/34 Lay/32 Contr), 15 drop‐outs after 4 months (5/7/3). From the final sample of 85 patients, 12 had RA (3/4/5). Diagnoses confirmed by their physician. Inclusion: Volunteers recruited by use of public service. Mean age: 64.4 yr, 73% female.
Interventions	HP‐led: 6 weekly (2hr) sessions (15‐20 persons) ASM course at community sites, including: types of arthritis, ROM and isometric exercises, relaxation techniques, use of medication, nutrition, problem‐solving, joint protection, evaluation of non‐traditional therapies and patient‐physician communication. Led by rheumatologist and physical therapist, who attended an 18 hr ASM leaders training programme and worked by a protocol.   Controls: no intervention.
Outcomes	Included: None.   Not reported: VAS‐pain; HAQ.
Notes	HP = Health professional   ASM = Arthritis Self‐Management   ROM = Range of Motion   VAS = Visual Analogue Scale.   HAQ = Health Assessment Questionnaire

Methods	A 4 moths, cross‐over study.   Assessments were done at baseline and after 4 months.   Quality: 0/0/1/0
Participants	854 arthritis patients randomised (501 exp/206 contr), 147 drop‐outs after 4 months: 707 analysed, 14% RA (N=99). Inclusion: Volunteers through public service announcements, with a physician's confirmation of the diagnosis. Mean age total group: 64 yr, 84% female.
Interventions	ASMC: 6 weekly (2 hr) sessions (15‐20 persons, sometimes including family and friends), taught by 2 trained lay‐leaders. Content: pathophysiology of RA/OA, design of individual exercise and relaxation programme, medication effects and treatment, joint protection, nutrition, decision making about non‐traditional remedies, physician‐patient communication and problem‐solving.   WLC: waiting list control group
Outcomes	Included: None.   Not reported: VAS‐pain, HAQ, CES‐D.
Notes	ASMC = Arthritis Self‐Management Course   VAS = Visual Analogue Scale   HAQ = Health Assessment Questionnaire   CES‐D = Center for Epidemiologic Studies Depression Scale

Methods	A 6‐month randomised controlled trial at community based sites comparing treatment patients with waiting list control patients. Control patients received the programme after 6 months.   Assessments were done at baseline and after 6 months.   Quality: 0/0/2/2
Participants	1,140 patients responding to public service announcements in the mass media, referrals from flyers left in physician's offices and community clinics, posters at senior citizen centres, announcements in health maintenance organisation (HMO) patient newsletters, and referrals from county government employers were recruited and randomised (I: 664; C: 476). 952 (83%) completed the 6‐month study and were analysed (I: 561; C: 391). Arthritis patients: 521 (I: 314; C: 207).   Inclusion: patients 40 years of age or older with a physician‐confirmed diagnosis of heart disease, lung disease, stroke or arthritis.   Patients with compromised mentation, and cancer patients who received chemotherapy or radiation within the past year were excluded.   Mean age: 65.4yr, range: 40‐90yr, 65% female.
Interventions	Intervention: The Chronic Disease Self‐management Program (CDSMP) is a community‐based patient self‐management education course. Sessions are led by two trained lay persons with chronic conditions. The programme was given in 7 weekly 2.5h sessions. Topics included: exercise; use of cognitive symptom management techniques; nutrition; fatigue and sleep management; use of community resources; use of medications; dealing with the emotions of fear, anger and depression; communication with others including health professionals; problem‐solving; and decision‐making. The book: "Living a Healthy Life with Chronic Conditions" was used as a text for participants and details the content of the course. The process of teaching is based on Self‐Efficacy Theory. Strategies include: weekly action planning, and feedback, modelling of behaviours and problem‐solving by participants for one another, reinterpretation of symptoms by giving many possible causes for each symptom as well as several different management techniques, group problem‐solving, and individual decision‐making. Each course had 10‐15 participants of mixed ages and diagnoses, including family members if they wished to attend. Controls: waiting list control group.
Outcomes	Included: none.   Not reported: the pain and discomfort scale (an adaption of the Medical Outcomes Study (MOS) pain scale), HAQ, the psychological well‐being scale from the SF‐36 (MHI‐5), and the health distress scale (adapted from the MOS health distress scale).   Others: a self‐rated health scale used in the National Health Interview Survey, the energy/fatigue scale from the MOS, social/role activity limitations, shortness of breath, duration of exercise, use of cognitive symtom management, communication with physicians, visits to physicians, visits to hospitals during the past 6 months, and the number of nights spent in a hospital.
Notes

Methods	A 4‐months randomised controlled trial comparing a community‐based arthritis self‐management programme for Spanish speaking participants with a waiting list control group. Control patients received the programme after 4 months.   Assessments were done at baseline and 4 months.   Quality: 0/0/2/0
Participants	Respondents were recruited in cohorts every 4 months for 2 years. Number recruited not specified; probably 331, as authors state: 'All patients were included in the analyses'. 331 patients randomised (I: 219; C: 112), RA‐patients: 25 (I: 14; C: 11). 86% of 331 patients completed the 4‐month data. (Number of RA‐patients not specified). Inclusion: not stated. Mean age: 62.5 years, range: 18‐93y. 84% female. 25 RA (I: 14, C:11); 117 OA (I: 116, C:51); 19 other arthritis (I: 10, C: 9); 120 undiagnosed musculoskeletal symptoms (I: 79, C: 41). Patients' diagnoses were verified in most cases by their physician.
Interventions	Intervention: The Spanish Arthritis Self‐Management Programme (SASMP) is a 12‐hour, community based programme given in 2‐hour sessions over 6 weeks. It is taught in community settings by trained lay leaders, many of whom have arthritis. The leaders teach from a standardised protocol which details botyh the course content and process. Class sizes range from 10‐15, including participants' familyand friends. Participants received a book: 'Una guia para una vida activa y saludable', an audio exercise tape and illustrated booklet of the exercises routines, and an audio relaxation tape. The programme is taught using techniques to enhance self‐efficacy.   Controls: waiting list control group.
Outcomes	Included: none.   Not reported: a visual numeric scale for pain, HAQ, a self‐rated health item from the Medical Outcomes Study, and the CES‐Depression scale.   Others: Self‐management behaviour (physical activities scale), Number of visits to physicians during the past 4 months, Medication use and Self‐efficacy.
Notes	HAQ = Health Assessment Questionnaire