The Swedish Quality Registry for Pain Rehabilitation (SQRP)
The SQRP is recognized by the Swedish Association of Local Authorities and Regions. Approximately 40 public and private clinics, equating to > 90% coverage of the clinical departments offering pain rehabilitation at the specialist level in Sweden, send data to the SQRP (28). The SQRP uses questionnaires to capture patients’ sociodemographic background, pain characteristics, psychological symptoms, function, activity/participation aspects, and Health-related Quality of Life (HRQoL). A more detailed description of the registry has been reported in previous publications (27). In 2010, the Boston Consulting Group ranked the SQRP as one of the ten high-quality national registries in Sweden (29).
Subjects
This cross-sectional study includes patients referred to pain rehabilitation clinics between August 2016 and February 2017 for clinical assessments, medical treatment, and rehabilitation. These patients were ≥ 18 years old and had non-malignant chronic pain (≥ 3 months) usually reported as part of complex chronic pain conditions that required a bio-psycho-social assessment as well as intervention.
Sociodemographic aspects and weight
The following sociodemographic characteristics were selected from the SQRP: age (years); sex (men or women); highest education levels (university/college, upper secondary school, and elementary school dichotomized into university/college and the other alternatives); place of birth (country outside Europe, Europe non-Nordic country, Nordic country and Sweden dichotomized into Europe vs. outside Europe); and work/study status (yes or no).
We calculated BMI (kg/m2) using self-reported weight and height in the SQRP and classified BMI according to the World Health Organization (WHO) criteria: <18.5 = underweight; 18.5-24.9 = normal range; 25.0-29.9 = overweight; 30.0-34.9 = obesity class I, mild obesity; and ≥35.0 = obesity class II-III, severe obesity.
Pain aspects
Pain duration was determined using the patients’ report of when they first experienced their current pain (days). The number of months were then calculated by dividing by 30. Pain intensity during latest seven days (NRS-7d) was determined using the patients’ report of their pain intensity during the previous week using a numeric rating scale (NRS) with 0 representing no pain and 10 representing worst possible pain. Pain frequency was determined using the patients’ report of their pain as either constant or recurrent. This variable was denoted as constant pain or no constant pain. Pain distribution was determined using the Pain Region Index (PRI). The PRI consists of 36 predefined anatomical areas (18 on the front and 18 on the back of the body). The number of areas with pain were calculated by adding all the patients’ marked anatomical areas that represent where they experience pain: 1) head/face, 2) neck, 3) shoulder, 4) upper arm, 5) elbow, 6) forearm, 7) hand, 8) anterior aspect of chest, 9) lateral aspect of chest, 10) belly, 11) sexual organs, 12) upper back, 13) low back, 14) hip/gluteal area, 15) thigh, 16) knee, 17) shank, and 18) foot.
Psychological aspects
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment questionnaire that measures anxiety and depression symptoms (30). HADS is divided into an anxiety subscale (HAD-A) and a depression subscale (HAD-D). Both subscales have seven items with a scoring range of 0 to 21; the lower score indicates a lower possibility of anxiety or depression. HADS has been validated in its Swedish translation (31).
The Insomnia Severity Index (ISI) is a reliable and valid instrument for detecting cases of insomnia and has excellent internal consistency (32). The seven items of the ISI are rated on a five-point Likert scale (0–4). The seven scores are summed to create the total ISI score (maximum 28).
The RAND 36-mental component summary (MCS) is one of the generic profile HRQoL measures used to compare the relative burden of chronic disease (32, 33). Comprising 36 items, RAND-36 assesses eight health dimensions with multi-item scales. Further calculation yields eight scale scores (range 0-100). Two summary scores, physical and mental health composites (PCS and MCS), were also derived from these eight scales. We used MCS in this study.
Two Multidimensional Pain Inventory (MPI) subscales – affective distress (MPI-distress, 0 = no distress and 6 = very distressed) and perceived life control (MPI-LifeCon, 0 = poor control and 6 = good control) – were chosen. MPI is a self-report instrument that assesses psychosocial, cognitive, and behavioural effects of chronic pain using 61 items (34 items in the Swedish version MPI-S) on a scale ranging from 0 to 6 (34, 35). The selected subscales reflect emotional functioning and the ability to cope with psychological distress (27, 36).
Physical activity aspects
The Swedish National Board of Health and Welfare recommends three PA questions (37), which are included in the registry. This study includes two of these questions:
- During a regular week, how much time do you spend exercising on a level that makes you short winded, for example, running, fitness class, or ball games? The following answer alternatives were provided: 0 minutes/none, less than 30 minutes, 30-60 minutes (0.5-1 hour), 60-90 minutes (1-1.5 hours), 90-120 minutes (1.5-2 hours), and more than 120 minutes (2 hours). A scale ranging from 1-6 (0 minute/none = 1 and more than 120 minutes = 6) was applied for this physical exercise variable and was denoted as PE.
- During a regular week, how much time are you physically active in ways that are not exercise, for example, walks, bicycling, or gardening? Added together, all activities should last for at least 10 minutes. The following answer alternatives were provided: 0 minutes/none, less than 30 minutes, 30-60 minutes (0.5-1 hour), 60-90 minutes (1-1.5 hours), 90-150 minutes (1.5 -2.5 hours), 150-300 minutes (2.5-5 hours), and more than 300 minutes (5 hours). Hence, the scale – denoted as EPA – ranged between 1 (0 minutes/none) and 7 (more than 300 minutes).
The first question refers to physical exercise (PE) and the second one to everyday physical activity (EPA). These categories were found to have the strongest validity comparison to open-end questions or to the time spent on daily PA (38). Following the national recommendations (37), we also generated an outcome of PA volume by converting categorical options to activity minutes, denoted as PA time. The midpoints of intervals in each given answer option (i.e., less than 30 minutes converted to 15 minutes, 30-60 minutes converted to 45 minutes, more than 120 minutes or 300 minutes converted to 120 and 300 minutes, respectively) were used. The PA time was calculated by multiplying PE by two and adding the product to EPA (PE minutes × 2 + EPA minutes). Less than 150 minutes per week indicate insufficient physical active (in the following denoted as insufficient PA time) (37, 39). The questionnaire has been validated for use in Sweden (40).
Statistics
Traditional statistical analyses were performed with SPSS Statistics (IBM Corporation, Somers, NY, version 26.0). Mean with standard deviations (Mean ± SD) or median with interquartile range for continuous variables and number with percentage (n, %) for categorical variables were used to report descriptive data. The criteria for testing normality was ≥±2.00 for the skewness and ≥±7.00 for the kurtosis, since the typical use of the Kolmogorov-Smirnov and the Shapiro-Wilk tests is not recommended for large sample sizes (41). The chi-square test was used to compare values of the categorical variables, and one-way ANOVA (Bonferroni method for post hoc test) was used for continuous data fulfilled both normality and homogeneity of variance. Kruskal-Wallis test and the Mann-Whitney U test with Bonferroni method for post hoc test were used when the assumption of homogeneity of variance among the groups were rejected by Levene’s test (P<0.05). A P-value below 0.05 was regarded as significant. A P-value of less than 0.017 was used for Mann-Whitney U test, which served as a post hoc test to control for risk of mass significance (42). Logistic regression (Likelihood ratio method) was used to determine the dichotomous parameter – i.e., sufficient/insufficient PA time. We also defined PA time as a tetrachotomous variable (1st-4th quartile) and ordinal regression was subsequently used. Covariates were removed from the models if P-value was less than 0.1 from the prior model. Pearson’s chi-square test (goodness of fit) and test of parallel lines (assumption of proportional odds) were calculated so that the models were not violated (P > 0.05). Multicollinearity was assessed by examining tolerance and the variance inflation factor (VIF); a VIF less than 2.5 might also indicate a multicollinearity problem (43).
The logistic regressions suffer some disadvantages, such as assumptions of variable independence, meeting power, and missing data (44-46). Therefore, we also performed confirmatory analyses using advanced Principal Component Analysis (PCA) for the multivariate correlation analyses to detect outliers and Orthogonal Partial Least Square Regressions (OPLS) for the multivariate regressions. Analyses were conducted using SIMCA-P+ (version 15, Umetrics, Sartorius Stedim Biotech, Umeå). The confirmatory analyses were used in a larger proportion of the whole study sample because SIMCA-P+ uses the Nonlinear Iterative Partial Least Squares algorithm (NIPALS algorithm) to compensate for missing data. Detailed information about this statistical method is described in Appendix A.
We investigated the relative importance of BMI, socio-demographic characteristics, pain, and psychological aspects (X-variables) for insufficient PA and PA time quartiles (Y-variables) using OPLS. The importance of the X-variables was measured as a Variable Influence on Projection (VIP) value. VIP indicates the relevance of each X-variable pooled over all dimensions and Y-variables – i.e., the group of variables that best explain Y. VIP ³ 1.0 was considered significant if the VIP value had a 95% jack-knife uncertainty confidence interval non-equal to zero (45). P(corr) was used to note the direction of the relationship (positive or negative). P(corr) depicts the loading of each variable scaled as a correlation coefficient, standardizing the range from -1 to +1. An absolute P(corr) > 0.4-0.5 is generally considered significant (47). For each regression, we report the R2, Q2, and the result (i.e., P-value) of a cross-validated analysis of variance (CV-ANOVA). In addition, we required significant CV-ANOVA for a regression to be significant. A certain variable was considered significant when VIP > 1.0 and absolute p(corr) > 0.40.