Background
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by synovial inflammation. The global prevalence of RA ranges from 0.5% to 1% [
1]. The prevalence of RA in China is about 0.42% and affects 5 million people [
2]. RA often manifested as joint pain, stiffness, swelling, limitation of joint range of motion, and general fatigue [
3]. These symptoms may lead to limited daily activities and reduced work capacity, which negatively affects the quality of life in patients with RA [
4] and significantly increases healthcare costs [
5]. RA is incurable and the goal of treatment is to achieve treat-to-target, control disease, reduce disability, and optimize health outcomes and quality of life [
6].
Given the chronic and progressive nature of RA, several studies have demonstrated that a high level of self-management in RA patients can reduce patients’ symptoms (e.g., pain, stiffness, swelling, etc.), effectively improve the patients’ physical function and quality of life [
7,
8]. Self-management support provided by healthcare providers is an effective method to prompt patients’ self-management behaviours and health outcomes [
9]. Healthcare providers should learn patients’ level of self-management behaviours before providing self-management support. However, a reliable and valid scale to evaluate RA patients’ self-management behaviours is not currently available.
Lorig’s definition of self-management [
10] is that ‘Whether an individual is engaging in a health-promoting activity or is living with a chronic disease, he or she is responsible for day-to-day management’. Self-management shows potential as a useful tool for preventative health care [
11]. Although some RA patients are aware of the importance of medication adherence and joint exercises and following doctors’ advice on management, these self-management behaviours are not the only ones that should be taken into consideration [
12]. Other aspects of self-management behaviours are easily overlooked by patients, such as, underutilisation of healthcare resources, insufficient support from family and friends, and depression due to factors (e.g., long duration of illness, alternating symptoms of remission and onset of illness) [
13]. Effective self-management behaviours for RA patients play a crucial role in improving RA patients’ symptoms and health outcomes across the disease course [
14]. Self-management behaviours increase patients’ confidence, knowledge, and skills about their conditions, thereby assisting in managing their health problems [
15]. Engaging in self-management supports patients in taking responsibility for improving their health by engaging in positive health behaviours such as physical activity, fatigue management, medication adherence, and seeking support or advice from family and friends [
16].
Validated and reliable tools are needed to evaluate the level of self-management behaviours in RA patients. However, there is limited scales to evaluate self-management behaviours of RA patients. Chronic Disease Self-Management Study Measures (CDSMS) developed by Lorig et al. is the most commonly used scale for patients with chronic diseases in the world [
17,
18]. The CDSMS includes the self-efficacy scale and the self-management behaviours scale. The self-management behaviours scale includes three dimensions: stretching exercises, cognitive symptom management, and communication with the physician [
17,
18]. The Patient Activation Measure (PAM) assesses knowledge, skill, and confidence of self-management among patients with chronic conditions [
19]. The short self-management ability scale (SMAS-S) [
20] is more applicable for older adults, especially among frail elderly patients (e.g., the elderly shortly after discharge). The scale assesses patient initiatives, investment behaviours, self-efficacy, a positive frame of mind, and other aspects of self-management ability [
20]. Although these scales have good psychometric properties, the contents of these instruments are not specific for RA patients. Nadrian et al. developed Self-Care Behaviours Scale (SCBS) among patients with RA in 2019 [
21]. This is the only specific scale used for RA patients, but Cronbach's alpha coefficients for the SCBS subscale is lower than 0.3, indicating poor internal consistency [
21]. The scale also lacks a theoretical basis for self-management [
21]. Scale development through a rigorous approach should help to improve its psychometric properties and its suitability for use in target groups [
22]. The approach involves a literature review, expert consultation, careful consideration of the experience and perspectives of target groups, and a solid conceptual framework. The development of the existing scale did not incorporate the experience and perspectives of target groups and a solid conceptual framework. Although these scales can be used to evaluate RA patients’ self-management, they do not accurately reflect the muti-dimensions of RA patients’ self-management.
Given the lack of a specific scale to assess the multidimensional aspect of self-management among patients with RA, the study aimed to develop a scale to measure self-management behaviours among patients with RA and to evaluate the validity and reliability of this scale. The RA-SMBS we proposed was developed based on a solid conceptual framework, a literature review, in-depth reviews, the nominal group technique (NGT), and Delphi expert consultation.
Conceptual framework
This scale was developed based on Lorig and Holman’s conceptual framework for self-management. Lorig and Holman’s framework reveals that self-management includes three tasks [
10]: medical management, role management, and emotional management. Medical management refers to the ability of patients to adopt behaviours beneficial to the disease in the process of disease management [
23]. Medication adherence, exercises, and joint protection are recognized as vital aspects of medical management for RA patients. Role management means that patients with chronic diseases can properly undertake more activities, such as housework, employment work, having good social interactions, etc. [
23]. Emotion management refers to the patient's ability to manage negative emotions (such as pain, sadness, depression, etc.) caused by the disease and reduce its negative life impact [
23]. Meanwhile, according to this framework, there are five self-management skills that are central to patient self-management, including solving problems, making decisions, utilizing potential resources, formatting a patient-provider partnership, and taking action. Thus, this scale initially includes three tasks and nine aspects based on Lorig and Holman’s conceptual framework, a literature review and RA patients’ characteristics. Medical management includes six aspects: reasonable medication, self-monitoring, joint protection, exercise, diet, and healthy lifestyle. Role and emotional management includes rest and work, social interaction, and emotional management.
Methods
Design
The study was conducted in two phases: (1) scale development, and (2) psychometric evaluation: refining the scale and evaluating the psychometric properties.
Phase 1 Scale development
Creating the item pool
The initial item pool of the scale was developed based on 2 sources: (1) a comprehensive literature review, and (2) findings from in-depth reviews.
In the literature review, we searched published articles in Web of Science, PubMed, Embase, EBSCO, CNKI, and WanFang Data. The keywords in the search were identified as “rheumatoid arthritis”, “self-care”, “self-care behaviour”, “self-management” and “self-management behaviour”. The inclusion criteria for the articles were: (1) relevant to RA patients’ self-management or focusing on self-management behaviours among patients with chronic disease; (2) quantitative and/or qualitative studies, and recommendations; and (3) published in English or Chinese. We retrieved a total of 2330 articles. After removing duplicates and screening by title and abstract, 356 articles (51 Chinese articles and 305 English articles) were included based on inclusion and exclusion criteria.
During the stage of the interview, face-to-face, semi-structured, in-depth individual interviews with 6 RA patients were performed. The primary questions in the interview asked were "How do you understand self-management behaviours?" and "What do you think is the content of self-management behaviours". The qualitative content analysis method was applied to analyse the review data.
Preliminarily evaluating the items
We used the NGT, Delphi expert consultation, and a pilot test to preliminarily evaluate and revise the items.
The NGT was used to evaluate and revise the initial item pool and dimensions by structuring face-to-face meetings with 9 experts to facilitate discussion and reach a consensus. The nine experts were invited from West China Hospital, Sichuan University. The inclusion criteria of the expert panel: (1) have practical experiences and/or theoretical knowledge of chronic diseases and rheumatic diseases self-management, (2) have intermediate or senior titles, (3) are willing to participate in our study. The NGT comprised 5 stages which included introducing and explaining the purpose and procedure of the meeting, carrying on a silent generation of ideas, presenting all ideas in a round-robin manner, clarification of any unclear ideas/items, and all participants voting on the importance of ideas [
24]. We conducted 2 rounds of NGT to revise the instrument.
Two rounds of Delphi expert consultation were used to revise the items and dimensions, and improve this scale. We invited 21 experts experienced in rheumatology disease management for at least 10 years from 15 tertiary hospitals, and received responses from 20 experts. The inclusion criteria of the experts were the same as the NGT experts. The anonymous consultation questionnaires were sent to the experts by email. The positive coefficient, degree of authority, and coordination coefficient of experts were used to evaluate the results of the expert consultation. The positive coefficient of experts was assessed by the response rate [
25]. An authority coefficient (Cr) of over 0.8 is considered a high expert authority coefficient [
26]. For the coordination coefficient of experts, Kendall’s coefficients of concordance (Kendall’s W) of 0.5 or above is considered a high correlation, and
P < 0.05 is considered statistically significant [
27]. The coefficient of variation (CV) is an important basis for index deletion. Meeting the following conditions were retained: mean ≥ 4, SD < 1, and CV < 0.2. Meanwhile, experts’ input were also incorporated to modify the items and formulate a draft scale.
A pilot test was conducted after Delphi expert consultation. We recruited 20 RA patients to complete the draft scale through face-to-face interviews to check comprehensibility, readability, and response errors. Then, the researchers communicated with the participants and formulated an original scale based on the participants’ feedback and advice.
Phase 2 Psychometric evaluation
In this stage, the original version of the Self-Management Behaviours Scale was used to evaluate the self-management behaviours of RA patients. We used item analysis, validity test and reliability to filter the items and evaluate the psychometric properties.
Item analysis
Item analysis was performed to determine whether each item in the original instrument should be retained or deleted. Low-quality items were removed from the scale.
Reliability analysis
The Cronbach's alpha coefficient and the split-half Spearman-Brown coefficient were used to assess the internal consistency and reliability of the scale and dimensions. The test–retest reliability was calculated to evaluate the stability of the scale. The test–retest reliability was evaluated by the intraclass correlation coefficients (ICC) and Pearson’s r. The ICC was assessed by a two-way mixed model with agreement.
Participants
All patients were recruited from the Department of Rheumatology and Immunology, West China Hospital, Sichuan University between July 2020 to January 2022. RA patients were recruited to participate in in-depth individual interviews (
n = 6), a pilot test (
n = 20), psychometric evaluation (
n = 561), and test–retest (
n = 20). The patients’ inclusion criteria in the in-depth individual interviews, a pilot test, psychometric evaluation, and test–retest stage were: (1) diagnosed with RA based on the 2010 American College of Rheumatology criteria (ACR) / European League Against Rheumatism (EULAR) classification criteria; (2) diagnosed with RA for six months or more; (3) ≥ 18 years, and (4) able to speak and understand Chinese. We excluded the patients who had psychosis or serious primary diseases (e.g., heart, brain, liver, etc.), or who had other rheumatic diseases (e.g., systemic lupus erythematosus, Sjogren's syndrome, etc.). The Individual and Family Self-management Theory demonstrates that self-management is a process by which individuals use knowledge, belief, skill, and ability to achieve outcomes (e.g., self-management behavior) [
30]. Self-management behaviour takes time to develop. Many previous studies selected RA patients with 6 months after diagnosis [
21,
31,
32]. In the current study, we selected patients diagnosed with RA for six months or more. For the in-depth individual interviews, we used purposive sampling to recruit 6 RA patients, and all patients completed our interviews and were included in the data analysis. For the pilot test, a convenience sample of 20 patients was recruited, and all of them completed the survey and were included in the data analysis.
In the psychometric evaluation stage, regarding the required sample size in factor analysis, the sample size of exploratory factor analysis was calculated to be 8 participants per item of scale, which is equivalent to 280 participants in our study. As for confirmatory factor analysis, the appropriate sample size was 200 or more. The final sample size was 534, allowing a 10% dropout. Finally, a total of 580 questionnaires were distributed by convenient sampling and 561 RA patients completed the questionnaires, with an effective return rate of 96.72%. For the test–retest, a convenience sample of 20 questionnaires was collected.
Data collection
Data were collected about the whole process. For the in-depth individual interviews, we recruited 6 RA patients and specified an appropriate place and date to conduct the interview. The interviews were recorded with a voice recorder. Each participant was interviewed once or twice and each interview lasted an average of 45–60 min. For the pilot study, we recorded patients’ comments about these items. In the psychometric test stage, the questionnaire took about 10–15 min to complete. The researchers explained the purpose of the study and the approach to completing the questionnaire. Participants completed the questionnaire independently or with the assistance of the researchers. Twenty participants who completed the questionnaire were invited to complete the questionnaire again after two weeks.
Statistical analysis
The data were analysed using NVivo for windows version 12, the Statistical Package for Social Sciences (SPSS) for Mac version 25.0 and AMOS for Windows version 21.0. Descriptive statistics were used to describe the demographic characteristics of the participants, including numbers, frequency (%), mean, and SD.
For item analysis, if the corrected item-total correlation (CITC) was less than 0.30 and Cronbach’s alpha increased if the item was deleted, then these items were respectively removed from the scale [
33].
For validity analysis, we conducted content validity and construct analysis. The I-CVI and S-CVI were calculated to determine the content validity of the scale items. The I-CVI value of more than 0.83, the S-CVI/UA value of more than 0.70 and the S-CVI/Ave value of more than 0.90 were considered as appropriate and acceptable [
34]. The construct analysis included EFA, CFA, and the convergent and discriminant validity. The total sample was split into two sub-sample using the SPSS random-assignment function. Subsample 1 (281 samples) was used for EFA and subsample 2 (280 samples) was used for CFA. For EFA, the criterion for appropriate factor extraction was an eigenvalue of 1.00 or more, and the result was considered good when there was at least 60.00% of variance [
35]. For CFA, model fit was considered acceptable if the χ
2/df ratio was lower than 3, and with the GFI, CFI, IFI, and TLI above 0.90 meaning good fit and 0.80 meaning reasonable fit, the PNFI and PGFI above 0.50 meaning good fit, and the RMSEA below 0.05 meaning good fit and 0.05 to 0.08 meaning reasonable fit [
36].
The convergent and discriminant validity of the scale was determined by calculating AVE, CR, and root AVE square. The formula is [
37]:
-
AVE = (sum of squared standardized loadings) / (sum of squared standardized loadings + sum of oberved variable measurement error).
-
CR = (sum of standardized loadings)2 / ((sum of standardized loadings)2 + (sum of oberved variable measurement error)).
The convergent validity tests of AVE (> 0.5) [
37] and CR (> 0.7) [
38] confirmed that items of each factor were in agreement and accurately measured. The square root of AVE being greater than all the possible two-factor correlation coefficients (Ф) (AVE > Ф
2) determined the discriminant validity between the two factors [
37].
For reliability analysis, Cronbach’s alpha coefficients, and test–retest reliability coefficients were calculated by the total sample (561 samples) and the test–retest sample (20 samples). Cronbach’ s alpha coefficient above 0.80 indicates acceptable internal consistency reliability [
39]. The ICC value of 0.70–1.00 was considered to have excellent stability, 0.60–0.70 as good stability, and 0.40–0.60 as reasonable stability, but below 0.40 as poor stability [
40]. The Pearson’s r of more than 0.30 indicated good stability [
41].
Ethical considerations
The research was approved by West China Hospital Medical Ethics Committee in China (ID 2020997). Written informed content was obtained from participants in the in-depth individual interviews, pilot test, and psychometric test. The researchers informed the participants of the purpose and content of this study and obtained consent from all participants before the data collection. Participation was voluntary, and participants were guaranteed that they could withdraw from the study without stating any reasons. Data were ensured to be confidential and used for research purposes only.
Discussion
This study aimed to develop and evaluate the psychometric properties of a self-reported RA-SMBS. The results showed that this questionnaire had good validity, reliability, and internal consistency, indicating this scale can be used to evaluate RA patients’ self-management behaviours. In general, the psychometric properties of RA-SMBS are more reliable compared to other self-management scales for RA patients [
17,
19‐
21]. It may be that this scale was developed based on Lorig and Holman’s conceptual framework, a literature review, in-depth reviews, the NGT, and Delphi expert consultation.
The distribution of demensions is roughly the same as the three tasks and of Lorig’s self-management. Medication management, symptom management, exercise and joint protection reflect the first task of medical management. RA patients are often present with joint pain, swelling, and morning stiffness [
3], required long-term medication to achieve remission or near remission, and required self-monitoring of symptoms, as well as synovitis erosion of joints that could lead to joint damage and functional limitations [
42]. Thus, the three dimensions are of major importance in patients with RA. Resource utilization and emotional management reflect tasks of role management, and emotional management. Based on the three tasks, the Lorig and Holman’s five self-management skills complement other content such as utilizing social resource, seeking help with doctors, family and friends, and furthering efforts to protect joints.
According to RA disease characteristics, the three aspects of medication management, symptom monitoring, and joint exercise are critical aspects to address in the treatment, they are also significant indicators of the ability of self-management behaviours. Meanwhile, access to medical and social support, building partneiships, and emotion regulation are also intergral to their self-management abilities. Long-term treatment increases the psychological and economic burden of patients [
43,
44]. Studies show that the prevalence of depression among RA patients varies between 9.5–41.5% [
45], which would become a stumbling block in the treatment process. Besides, emotional management is an essential component of support for patients with chronic diseases. Reasonable utilization of medical and social resources could enhance patients’ confidence in treatment adherence [
46], which is also a manifestation of patients’ improved self-management ability.
The dimension of medication management with six items addresses patients’ knowledge of medication use and their medication adherence. The SCBS among patients with RA was developed by Nadrian, et al. in 2019. It included the dimension of medication (three items), but while two items are inverse to each other, the three items do not reflect well on the ability of patients to manage medications. The items of joint protection were not grouped into the same dimension but were assigned to ‘nutrition/joints protection’ and ‘stress management/others’, respectively [
21]. There is a lack of reasonable explanations for such a distribution of dimensions, and that is considered a weakness of their study. Also, the researchers relied solely on a literature review and expert consultation when developing the items of the SCBS without consideration of the experience and perspectives of patients. Our study, however, had a more comprehensive process of item development with the integration of Lorig and Holman’s conceptual framework, the NGT, and in-depth interviews. Strengths of the present study specifically included using face-to-face expert consultations and gathering participants' feedback, which further contributed to the successful development of items and increased reliability of the results. Additionally, the items of the RA-SMBS were developed according to the characteristics of patients, the scale demonstrates good psychological properties which also make it very practical.
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.