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Original Article
Structural and Criterion Validity of a New 6-item Roland–Morris Disability Questionnaire (RMDQ-6) on Patients with Chronic Lower Back Pain Receiving Integrative Medicine
Yoon Jae Lee1orcid, Gyu Chan Shim2orcid, Changsop Yang3orcid, Chang-Hyun Han3,4,*orcid
Perspectives on Integrative Medicine 2023;2(3):182-189.
DOI: https://doi.org/10.56986/pim.2023.10.006
Published online: October 23, 2023

1Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, Republic of Korea

2College of Korean Medicine, Dongguk University, Seoul, Republic of Korea

3KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea

4Korean Convergence Medical Science, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea

*Corresponding author: Chang-Hyun Han, KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea, Email: chhan@kiom.re.kr
• Received: September 25, 2023   • Revised: October 6, 2023   • Accepted: October 6, 2023

©2023 Jaseng Medical Foundation

This is an open access article under the CC BY-NC license (http://creativecommons.org/licenses/by-nc/4.0/).

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  • Background
    Lower back pain (LBP) is a leading cause of disability worldwide. The Roland–Morris Disability Questionnaire (RMDQ) has been widely used to assess functional impairment in patients with LBP. However, its length and redundancy calls for a more concise and optimized version.
  • Methods
    We conducted a secondary analysis of data from two randomized controlled trials comparing pharmacopuncture and physical therapy for chronic LBP. We focused on 132 patients with moderate-to-severe symptoms and analyzed their baseline data to evaluate the structural validity of the RMDQ. We used R packages lavaan and semPlot for confirmatory factor analysis (CFA). Model fit were assessed through various indices, including comparative fit index, Tucker–Lewis index, root mean square error of approximation, and standardized root mean squared residual.
  • Results
    A total of 18 items were ultimately removed to produce a streamlined 6-item structure. Our model met the fit index criteria, yielding a one-domain, 6-item RMDQ structure. While the relative indices fell slightly short of the ideal values, the RMDQ-6 derived through CFA correlated well with the original version.
  • Conclusion
    This study developed a more concise version of RMDQ through CFA to optimize its structural configuration. This concise instrument can be proposed as an efficient tool to assess the functionality of patients with LBP.
In 2020, 619 million people worldwide suffered from lower back pain (LBP), and this is predicted to increase to 843 million cases by 2050 [1]. Furthermore, LBP ranks among the leading causes of Years Lived with Disability, with a global age-standardized rate of 843 per 100,000 people [1]. This condition progresses to a chronic state in approximately 40% of all individuals [2]. The lifetime prevalence of LBP is estimated to range from 60% to 85%, emphasizing its chronic and recurrent nature throughout an individual's lifetime [3]. Given the significant productivity losses associated with LBP [4], it is imperative to comprehensively assess both the pain intensity and the functional aspects of LBP.
Representative tools for evaluating disabilities related to LBP include the Oswestry Disability Index [5], Roland–Morris Disability Questionnaire (RMDQ) [6], and Back Pain Functional Scale [7]. The RMDQ, in particular, exhibits superior construct validity in terms of physical function and is widely employed in clinical research. Originating in the United Kingdom in 1983 [6], the RMDQ comprises 24 items and has been translated into multiple languages since then [812]. However, the extensive item count of the questionnaire poses challenges for respondents in that it becomes time-consuming and presents redundancy among items. Streamlining the questionnaire is essential to reduce the response time while maintaining the quality of the acquired information; such a simplification can also mitigate response errors.
When used to assess changes in clinical research or the progression of clinical conditions, the 24-item version of the RMDQ (RMDQ-24) may prove unwieldy and may not support frequent assessments, possibly impeding timely determination of the progress of patients’ health. Consequently, several studies have attempted to simplify the RMDQ. Stratford et al [13] proposed a modified version of the RMDQ, subsequently reducing it to 18 items. Stroud et al [14] presented an 11-item short version, whereas Friedman et al [15] proposed a concise 5-item version. Additionally, Frota et al [16] proposed a 15-item shortened version of the Brazilian version of the RMDQ. However, none of these studies conducted a factor analysis using the Korean version of the RMDQ, and no analysis, to our knowledge, has been based on research involving clinically problematic chronic moderate LBP.
Therefore, our study aimed to propose a shortened version of the RMDQ by conducting confirmatory factor analysis (CFA), specifically on data from Korean RMDQ responses, which were provided by patients experiencing moderate to severe back pain. This analysis may help identify the most suitable structure for simplifying the questionnaire.
2.1. Study design
This secondary analysis aimed to investigate the structural validity of the RMDQ in patients with chronic LBP who underwent pharmacopuncture or physical therapy (PT). In this secondary analysis, we used two clinical studies: a pilot clinical study (unpublished, NCT04576520) involving 32 participants and a clinical study involving 100 participants (NCT048333309). Both studies were reviewed and approved by the Institutional Review Board of the Jaseng Hospital of Korean Medicine, Seoul, Korea (JASENG 2020-08-009, JASENG 2020-08-018, JASENG 2020-08-014, JASENG 2020-08-013, JASENG 2021-02-012, JASENG 2021-02-032, JASENG 2021-02-013, and JASENG 2021-02-014). Informed consent was obtained from all subjects involved in the study.
Comprehensive details on the full-scale randomized controlled trial (RCT) (NCT0483333009) can be found elsewhere [17,18]. In brief, the trials were two-arm, parallel, multicenter RCTs conducted at four Korean medicine hospitals. The participants were randomly assigned to undergo 10 sessions of either pharmacopuncture or PT over a 5-week period. The inclusion and exclusion criteria and measurement outcomes were similar between the groups. The pilot and the full-scale studies had a follow-up period of 16 and 25 weeks, respectively.
The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines recommend that the sample size for factor analysis of health measurements should be at least five times the number of items for statistical adequacy [19]. Based on this criterion, the minimum sample size required for the RMDQ-24 was 120 participants. In the present study, we used baseline values of the RMDQ-24 from 132 patients who participated in the trial and received either pharmacopuncture (n = 66) or PT (n = 66).
2.2. Evaluation tools
The RMDQ measures disability in individuals with LBP and consists of 24 items that describe situations experienced by people with LBP, with scores ranging from 0 to 24 points. We used the validated Korean version of the RMDQ-24 to measure disability in patients with chronic LBP who received integrative medical treatments [8].
2.3. Statistical analysis
We performed a descriptive analysis to examine demographic and clinical variables. Continuous variables were presented as means and standard deviations, while categorical variables were presented as relative and absolute frequencies.
We used CFA to identify the best structure of the RMDQ via R Studio software (R Core Team, Vienna, Austria), using the lavaan and semPlot packages, with the implementation of a tetrachoric matrix and the robust diagonally weighted least squares extraction method. We considered adequate values of fit indices for the following cut-off values: chi-squared/degree of freedom (dF) < 3, comparative fit index (CFI) > 0.90, Tucker-Lewis index (TLI) > 0.85, root mean square error of approximation (RMSEA) < 0.9, and standardized root mean squared residual (SRMR) < 0.08.
For the comparison between models, the structure with the lowest Akaike information criterion (AIC) and Bayesian information criterion (BIC) values was considered more appropriate.
The method of reducing the number of items of the RMDQ takes modification indices (MIs) into consideration, which indicates redundant items in pairs and factor loadings. We considered redundant items as those with MI > 10. In each paired analysis, the redundant items with the lowest factor loadings were excluded.
We assessed criterion validity and considered the RMDQ-24 (long version) to be the gold standard. As the data did not present a normal distribution when analyzed using the Kolmogorov-Smirnov test, the Spearman’s correlation coefficient (rho) was used to correlate the long and short versions. A correlation magnitude > 0.70 was considered the appropriate cut-off point for criterion validity.
The study sample comprised 132 participants from the two original RCTs. Most participants were women (60.6%), and the mean age was 47.98 ± 12.13 years. All patients experienced moderate-to-severe pain (Table 1). The mean LBP intensity was 6.46 points and the mean radiating pain was 3.55 points on the Numeric Rating Scale (NRS). The mean RMDQ score was 14.59.
Table 2 [1214,2022] lists the RMDQ structures tested, including the newly proposed model. Table 3 summarizes the MIs and factor loadings for each pair with an MI of 10 or higher. Forty decisions were made, which excluded 18 items. Table 4 [1214,2022] presents the six models tested in this study, including the original 24-item RMDQ. Using our data, the only model with a CFI ≥ 0.9, TLI ≥ 0.85, and RMSEA ≤ 0.09 was Model 7 (RMDQ-6), which is the model suggested in this study. Regarding criterion validity, the correlation between the 24- and 6-item RMDQ versions was adequate (rho = 0.884, p < 0.001). The RMDQ-6 (including the Korean version) is available in Supplementary Material 1 and 2, and its path diagram is presented in Fig. 1.
The analysis was conducted on 132 individuals using data from two clinical studies involving integrative medicine. The RMDQ-6 model met the criteria for adequate values of fit. However, it did not have the smallest values in terms of the AIC and BIC. The RMDQ-6 did not fit the relative indices with smallest values.
As shown in Table 4, only the RMDQ-6 exhibited a CFI of 0.90 or higher, compared to models in other studies (RMDQ-11, RMDQ-15, RMDQ-16, and RMDQ-18). This discrepancy may arise from language differences or variations in the patient populations included in each study. Among the studies conducted thus far, Frota et al [16] targeted patients with LBP with NRS scores of 3 or higher, whereas our study focused on patients with an average NRS score of 6.47, which may account for the difference. Takara et al [20] targeted older adults, which differed from our study with an average age of 47.98 years. Williams and Myers [21] reported results for acute LBP, which could lead to differences due to variations in item responses or distribution, given the distinct prevalence periods between patients with acute and chronic LBP. Additionally, the differences might be attributed to the use of different language versions; Williams and Myers [21] and Stratford and Binkley [13] used the English version, whereas Takara et al [20] and Frota et al [16] used the Brazilian version. Various short versions of the RMDQ have been proposed; however, there are slight differences in the analytical methods employed. Stroud et al [14] proposed a method using the item response theory, whereas Frota et al [16] used a CFA similar to ours.
The items included in both the RMDQ-6 and other simplified RMDQs published so far were identified as items 3 (walking more slowly) and 16 (trouble putting on socks). These items could be viewed as representative of the functioning of low back pain patients, regardless of cultural and linguistic differences. Additionally, RMDQ-6 included more items related to sleeping or lying down compared to other simplified RMDQ versions (item 6, lie down to rest more often; item 18, sleep less well; and item 14, difficulty turning over in bed). Further research in the future may be necessary to ascertain whether this characteristic is exclusive to severe patients or indicative of cultural differences.
Our study performed an RMDQ analysis using clinical data; however, it had limitations with respect to the sample size used for factor analysis. The sample size may have been small compared to that of other studies [16]. However, some studies have suggested a minimum sample size of 100 individuals when conducting factor analyses using more than five factors [23]. In this context, our study exceeded this minimum threshold, and this could be considered an appropriate sample size [19]. Our proposed one-domain, 6-item model did not meet the fit index conditions we had set. Furthermore, this study only introduced a simplified version of the RMDQ-6, and further research is needed on its clinical applications, such as minimal clinically important differences and substantial clinical benefits.
Since the studies conducted in English-speaking countries were in English and those in Brazil were in Portuguese, the generalizability of our findings may be limited owing to cultural differences. However, future research should explore the use of the RMDQ-6 in various languages to determine whether similar results can be obtained.
Fewer items can make a questionnaire easier to administer. The RMDQ-6 has the fewest items among the proposed versions, making it highly suitable for clinical and research purposes. This facilitates the assessment of treatment efficacy in addressing back pain or measuring recurrence more quickly. Therefore, it can be widely used in clinical research. Future studies using the RMDQ-6 should explore aspects such as minimal clinically important differences and substantial clinical benefits. Additionally, our study may be more reliable than other studies because it used response data from clinical studies targeting patients with a demonstrated need for back pain treatment, based on their actual severity. Moreover, the RMDQ-6 demonstrated strong criterion validity, with a correlation of Rho = 0.884, thereby indicating a significant association with the full-length version.
The RMDQ-6 is a shortened version of the RMDQ instrument, developed using CFA, and it exhibited a significant correlation with the original RMDQ. Given its simplicity and validity, we expect that the RMDQ-6 can be widely used in future clinical studies.
Supplementary material 1(RMDQ 6 English) and 2 (RMDQ 6 Korean) are available at doi: https://doi.org/10.56986/pim.2023.10.006.

Author Contributions

Conceptualization: YC and CHH. Methodology: YJL. Formal analysis: GCS. Investigation: GCS and CY. Writing original draft: YJL. Writing - review and editing: YCY and HCC.

Conflicts of Interest

The authors have no conflicts of interest to declare.

Funding

This study was funded by the Korea Institute of Oriental Medicine, Republic of Korea (grant no.: KSN1823211).

Ethical Statement

Both studies were reviewed and approved by the Institutional Review Board of the Jaseng Hospital of Korean Medicine, Seoul, Korea (JASENG 2020-08-009, JASENG 2020-08-018, JASENG 2020-08-014, JASENG 2020-08-013, JASENG 2021-02-012, JASENG 2021-02-032, JASENG 2021-02-013, and JASENG 2021-02-014).

The data presented in this study are available upon request from the corresponding author.
Fig. 1
Path diagram of the 6-item Roland-Morris Disability Questionnaire.
F = function.
pim-2023-10-006f1.jpg
pim-2023-10-006f2.jpg
Table 1
Characteristics of Patients with Chronic Low Back Pain.
Variable Total (N = 132) Pharmacopuncture (N = 66) PT (N=66) P-value
Sex Male 52 (39.4%) 24 (36.4%) 28 (42.4%) 0.593
Female 80 (60.6%) 42 (63.6%) 38 (57.6%)

Age (y) 47.98 ± 12.13 51.39 ± 10.64 44.56 ± 12.63 0.001

Age category 20s 12 (9.1%) 3 (4.5%) 9 (13.6%) 0.011
30s 26 (19.7%) 7 (10.6%) 19 (28.8%)
40s 32 (24.2%) 17 (25.8%) 15 (22.7%)
50s 35 (26.5%) 23 (34.8%) 12 (18.2%)
60s 27 (20.5%) 16 (24.2%) 11 (16.7%)

Symptom severity Moderate 64 (48.5%) 32 (48.5%) 32 (48.5%) 0.766
Severe (not requiring treatment) 37 (28.0%) 20 (30.3%) 17 (25.8%)
Severe (requiring treatment) 31 (23.5%) 14 (21.2%) 17 (25.8%)

Height 165.52 ± 8.99 164.69 ± 8.39 166.35 ± 9.55 0.292

Weight 66.34 ± 13.55 65.93 ± 11.55 66.74 ± 15.37 0.734

BMI (kg/m2) 24.04 ± 3.33 24.17 ± 2.65 23.91 ± 3.90 0.653

NRS score LBP 6.47 ± 0.93 6.50 ± 0.96 6.44 ± 0.90 0.709
Radiating leg pain 3.55 ± 2.85 3.58 ± 2.78 3.52 ± 2.94 0.903

VAS score LBP 66.84 ± 8.98 67.29 ± 9.36 66.39 ± 8.63 0.570
Radiating leg pain 36.49 ± 29.41 37.61 ± 29.00 35.38 ± 29.99 0.665

ODI 29.22 ± 11.76 28.95 ± 11.52 29.48 ± 12.06 0.793

RMDQ score 14.59 ± 16.03 14.41 ± 15.95 14.77 ± 16.23 0.897

EQ-5D-5L score 0.72 ± 0.13 0.71 ± 0.14 0.74 ± 0.12 0.348

BMI = body mass index; EQ-5D-5L = European Quality of Life 5 Dimension 5 Level; LBP = lower back pain; NRS = numeric rating scale; ODI = Oswestry disability index; PT = physical therapy; RMDQ = Roland–Morris Disability Questionnaire; VAS = visual analog scale.

Table 2
Item Comparison from the Roland–Morris Disability Questionnaire Tested in This Study.
Items 24 Items [12] 18 Items [22] 18 Items [13] 11 Items [21] 15 Items [14] 16 Items [20] 6 Items*
1. I stay at home most of the time because of my back Yes Yes Yes No Yes Yes No
2. I change position frequently to try and get my back comfortable Yes No No No No No No
3. I walk more slowly than usual because of my back Yes Yes Yes Yes Yes Yes Yes
4. Because of my back, I am not doing any of the jobs that I usually do around the house Yes Yes Yes No Yes Yes No
5. Because of my back, I use a handrail to get upstairs Yes Yes Yes Yes Yes Yes No
6. Because of my back, I lie down to rest more often Yes Yes Yes No No Yes Yes
7. Because of my back, I have to hold onto something to get out of an easy chair Yes Yes Yes Yes No Yes No
8. Because of my back, I try to get other people to do things for me Yes Yes Yes Yes Yes Yes No
9. I get dressed more slowly than usual because of my back Yes Yes Yes Yes Yes Yes No
10. I only stand up for short periods of time because of my back Yes Yes Yes Yes Yes No No
11. Because of my back, I try not to bend or kneel down Yes Yes Yes Yes No Yes No
12. I find it difficult to get out of a chair because of my back Yes Yes Yes Yes Yes No No
13. My back is painful almost all the time Yes Yes Yes No Yes No No
14. I find it difficult to turn over in bed because of my back Yes Yes Yes No No Yes Yes
15. My appetite is not very good because of my back pain Yes No Yes No No No No
16. I have trouble putting on my socks (or stockings) because of the pain in my back Yes Yes Yes Yes Yes Yes Yes
17. I only walk short distances because of my back pain Yes No Yes Yes Yes Yes No
18. I sleep less well because of my back Yes Yes Yes No No No Yes
19. Because of my back pain, I get dressed with help from someone else Yes No No No Yes Yes No
20. I sit down for most of the day because of my back Yes No No No Yes Yes No
21. I avoid heavy jobs around the house because of my back Yes Yes Yes Yes No Yes Yes
22. Because of my back pain, I am more irritable and bad tempered with people than usual Yes Yes No No Yes No No
23. Because of my back, I go upstairs more slowly than usual Yes Yes Yes Yes No Yes No
24. I stay in bed most of the time because of my back Yes No No No Yes No No

* Structure proposed in this study.

Table 3
Reduction of the Roland–Morris Disability Questionnaire Items Based on Modification Indices and Factor Loadings from Confirmatory Factor Analysis.
Redundant items MI Factor loading Item deleted
Decision1 Item 1 10.693 0.39 Item 2
Item 2 0.367

Decision2 Item 1 24.393 0.39 Item 4
Item 4 0.372

Decision3 Item 1 15.268 0.39 Item 1
Item 23 0.507

Decision4 Item 1 47.066 0.39 Item 1
Item 24 0.52

Decision5 Item 2 15.410 0.367 Item 2
Item 21 0.529

Decision6 Item 2 13.361 0.367 Item 2
Item 23 0.507

Decision7 Item 3 10.626 0.541 Item 4
Item 4 0.372

Decision8 Item 3 13.665 0.541 Item 17
Item 17 0.526

Decision9 Item 3 13.634 0.541 Item 19
Item 19 0.375

Decision10 Item 3 10.260 0.541 Item 22
Item 22 0.5

Decision11 Item 3 58.361 0.541 Item 23
Item 23 0.507

Decision12 Item 3 18.668 0.541 Item 24
Item 24 0.52

Decision13 Item 4 10.326 0.372 Item 4
Item 11 0.47

Decision14 Item 4 22.313 0.372 Item 15
Item 15 0.28

Decision15 Item 4 70.579 0.372 Item 4
Item 19 0.375

Decision16 Item 4 16.434 0.372 Item 4
Item 23 0.507

Decision17 Item 4 15.669 0.372 Item 4
Item 24 0.52

Decision18 Item 5 24.141 0.27 Item 5
Item 7 0.34

Decision19 Item 5 10.790 0.27 Item 5
Item 16 0.45

Decision20 Item 5 21.609 0.27 Item 5
Item 20 0.35

Decision21 Item 5 14.892 0.27 Item 5
Item 23 0.507

Decision22 Item 5 12.307 0.27 Item 5
Item 24 0.52

Decision23 Item 6 19.902 0.59 Item 11
Item 11 0.47

Decision24 Item 6 14.751 0.59 Item 19
Item 19 0.375

Decision25 Item 7 15.565 0.335 Item 7
Item 23 0.507

Decision26 Item 8 16.167 0.509 Item 8
Item 21 0.529

Decision27 Item 8 16.219 0.509 Item 22
Item 22 0.497

Decision28 Item 9 57.010 0.448 Item 9
Item 16 0.455

Decision29 Item 10 50.540 0.455 Item 10
Item 17 0.526

Decision30 Item 10 11.034 0.455 Item 10
Item 21 0.529

Decision31 Item 11 12.593 0.47 Item 11
Item 18 0.536

Decision32 Item 11 49.788 0.47 Item 11
Item 21 0.529

Decision33 Item 12 13.116 0.275 Item 12
Item 16 0.455

Decision34 Item 13 22.392 0.498 Item 13
Item 18 0.536

Decision35 Item 15 75.749 0.276 Item 15
Item 19 0.375

Decision36 Item 17 10.737 0.526 Item 17
Item 21 0.529

Decision37 Item 17 12.543 0.526 Item 23
Item 23 0.507

Decision38 Item 19 12.616 0.375 Item 20
Item 20 0.349

Decision39 Item 19 12.044 0.375 Item 19
Item 23 0.507

Decision40 Item 23 20.912 0.507 Item 23
Item 24 0.52

MI = modification index.

Table 4
Confirmatory Factor Analysis of the Seven Versions of the Roland–Morris Disability Questionnaire.
Chi-squared/dF CFI TLI RMSEA SRMR AIC BIC
Model 1 [12] 4.73 0.66 0.63 0.084 (0.079, 0.089) 0.075 3,783.18 3,987.82
Model 2 [22] 4.61 0.74 0.70 0.083 (0.076, 0.09) 0.068 5,415.99 5,569.48
Model 3 [13] 4.74 0.74 0.70 0.084 (0.078, 0.091) 0.069 5,563.54 5,717.02
Model 4 [21] 6.34 0.75 0.69 0.101 (0.091, 0.111) 0.073 4,656.78 4,759.10
Model 5 [14] 5.6 0.70 0.65 0.094 (0.086, 0.102) 0.073 605.34 733.24
Model 6 [20] 5.68 0.70 0.65 0.094 (0.087, 0.102) 0.076 3,034.83 3,171.26
Model 7* 4.75 0.92 0.87 0.084 (0.06, 0.111) 0.044 2,683.32 2,734.48

AIC = Akaike information criterion; BIC = Bayesian information criterion; CFI = comparative fit index; dF = degree of freedom; RMSEA = root mean square error of approximation; SRMR = standardized root mean squared residual; TLI = Tucker–Lewis index.

* Structure proposed in this study.

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