Expectations of treatment outcome in complex cases of patients with chronic pain: A study on the DATAPAIN cohort.

BACKGROUND: A better insight in how the biopsychosocial factors influence patient outcome(s) may provide information that helps selecting the optimal pain management for a specific group. METHODS: Categorization was made in the prospective DATAPAIN registry, in which patients with pain severity (Numeric Rating Scale [NRS]: 7-10), depression or anxiety (Hospital Anxiety and Depression Scale: > 10), and pain catastrophizing (Pain Catastrophizing Scale: > 31) were identified as complex cases. Patient outcomes; treatment satisfaction on the Patient Global Impression of Change (PGIC), pain relief (NRS), pain interference on the Brief Pain Inventory (BPI) and quality of life indicator General Perceived Health (GPH) were evaluated. Logistic regression analyzed if belonging to the complex cases showed modification in the outcome of the PGIC and GPH. Linear regression was observed if complex cases differed in average reduction in pain relief and interference compared to non-complex cases. RESULTS: 1637 patients were included, of which 345 (21.08%) were considered complex cases. The changes in scores of pain relief and BPI active subscale were not significantly different between groups. The BPI affective subscale had a different change in score (-0.509; p: 0.002). The complex cases had an odds ratio (OR) of 0.59 (95% confidence interval [CI]: 0.36-0.77) on treatment satisfaction compared to non-complex cases, and an OR of 0.28 (95% CI: 0.11-0.56) on the GPH. CONCLUSION: When treating patients with complex cases, desired treatment outcome(s) should be recognized by specialists and patients, as these may be less likely to occur.

Construct validity and reliability of the Bilateral Vestibulopathy Questionnaire (BVQ).

Background: The Bilateral Vestibulopathy Questionnaire (BVQ) is a recently developed 54-item Patient Reported Outcome Measure (PROM) that evaluates the clinically important symptoms of bilateral vestibulopathy (BVP) and its impact on daily life. This study aimed to assess the construct validity and reliability of the BVQ in a large BVP cohort. Methods: Patients diagnosed with BVP were asked to complete a set of questionnaires, including the BVQ, the EuroQol-5D-5L, the Health Utilities Index, the Dizziness Handicap Inventory, the Hospital Anxiety and Depression Scale, and the Oscillopsia Severity Questionnaire. The construct validity of the BVQ was evaluated by confirmatory and exploratory factor analyses (CFA and EFA), followed by hypotheses testing and known groups validity. Structural properties were explored for each individual item. Reliability was assessed by testing the internal consistency of the BVQ constructs (Cronbach's alpha) and test-retest reliability [intraclass correlation coefficients (ICCs)]. Results: A total of 148 patients with BVP (50% women, mean age 66 years) completed the set of questionnaires. The CFA did not show a satisfactory model in the original BVQ. However, the EFA showed a four-factor solution with 20 Likert-scale items related to oscillopsia, imbalance, emotion, and cognition. The succeeding CFA provided evidence for construct validity and an acceptable model of fit. Hypothesis testing confirmed that this shortened version validly measures the constructs to be measured. Statistically significant differences in scores between known groups were found, providing further support for good construct validity. The structural properties were acceptable. Cronbach's alpha confirmed good internal consistency for the four constructs, ranging from 0.80 to 0.89. The ICCs of the 20 Likert-scale items and four visual analog scale (VAS) items were interpreted as good (range 0.76-0.93). Conclusion: This study showed evidence of good construct validity of the new shortened version of the BVQ, consisting of four constructs with a total of 20 Likert-scale items and four VAS items. The final 24-item BVQ proved to be a reliable and valid multi-item PROM that captures the clinically important symptoms of BVP and evaluates its impact on daily life. Consequently, the BVQ enables the gathering of high-level evidence of treatment effectiveness in a systematic and quantitative manner.

Do Men and Women Have a Different Association between Fear-Avoidance and Pain Intensity in Chronic Pain? An Experience Sampling Method Cohort-Study.

BACKGROUND: Fear-avoidance is one of the factors associated with chronic pain. However, it remains unclear whether the association between fear-avoidance and pain depends on sex. The present study aimed to investigate whether the association between fear-avoidance and pain intensity differed between men and women in chronic pain patients. Additionally, the potential confounding effect of affective experiences on the association between fear-avoidance and pain intensity was analyzed. METHOD: This cohort study included hospital referred chronic pain patients (n = 45). Short momentary assessment questions according to the experience sampling method (ESM) were used to repeatedly assess patients' pain intensity, level of fear-avoidance and positive as well as negative affect during their daily life. Linear mixed-effects models were applied in the statistical analysis. Unadjusted and adjusted models were made, in which the latter corrected for statistically significant affective experiences and baseline variables, taking the Aikake Information Criterion into account to assess a better model of fit. RESULTS: The results demonstrated an association between fear-avoidance and pain intensity that differed for men and women. In men (n = 13), no association between these variables was found (-0.04 (95% CI: -0.14, 0.06) with a p-value of 0.48), whereas in women (n = 32), an increase in fear-avoidance was associated with a (slight) increase in pain intensity (0.18 (95% CI 0.06, 0.30) with a p-value of 0.003). Affect did not confound the above-mentioned findings. CONCLUSION: Our data supports previous research highlighting the importance of sex differences in pain experience. These findings may be relevant for clinicians to consider more personalized (i.e., gender specific) pain management in chronic pain patients.

Patient reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS): Development, reliability and construct validity.

AIM: Haemorrhoidal disease (HD) is a frequently occurring disorder with a significant negative impact on a patient's quality of life. Here, we describe the development and validation of the Dutch patient reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS). METHODS: The development of the PROM-HISS followed recommended guidelines. Face and content validity, structural properties, reliability and construct validity were evaluated in a HD population. Reliability was tested by assessing the test-retest reliability, defined by the intraclass correlation coefficient (ICC), and internal consistency measured with Cronbach's alpha. Construct validity was evaluated using confirmatory factor analysis (CFA) and hypotheses testing. RESULTS: The PROM-HISS consists of three domains: (1) HD symptoms (blood loss; pain; prolapse; soiling; itching), (2) impact of symptoms on daily activities, and (3) satisfaction with treatment. The PROM-HISS showed good face and content validity. The PROM-HISS was completed by 102 patients (65% male), with a mean age of 58 years (23-81 years). The ICCs of the different items in the domain HD symptoms ranged between 0.56 and 0.79 and were interpreted as good. The Cronbach's alpha value was 0.80 and considered satisfactory. The CFA provided further evidence for construct validity with a good model fit. A high score on the symptoms of HD correlated with a high impact of HD on daily activities (Pearson's r = 0.632, p < 0.01) and a low degree of satisfaction (Pearson's r = 0.378, p < 0.01). CONCLUSION: The PROM-HISS is a reliable and valid instrument to evaluate symptoms of HD, impact on daily activities and satisfaction with treatment.

Clinical important improvement of chronic pain patients in randomized controlled trials and the DATAPAIN cohort.

BACKGROUND: Change on the Numeric Rating Scale (NRS) is based on subjective pain experience, hampering the establishment of clinically important improvement. An anchor-based method, the Patients' Global Impression of Change (PGIC), is often added to determine whether a patient has improved. A two-point change on the NRS has been shown to be equivalent to a moderate clinically important improvement in randomized controlled trials (RCT's) on medication effects. We contemplated whether these findings could be reproduced in cohort and data and in non-drug interventional RCT's. METHODS: The NRS change was quantified by subtracting the NRS of baseline from the NRS at 6-month follow-up. Categorization of success/nonsuccess was applied on the PGIC, and their average NRS raw changes were calculated. The Spearman correlation coefficient quantified the overall relationship, while the discriminative ability was explored through the receiver operating characteristic curve. Data were stratified on design, sex, and pain intensity at baseline. Besides, the cohort evaluated treatment status at follow-up. RESULTS: The records of 1661 patients were examined. Overall, the observed NRS change needed for moderate clinically important improvement was larger than the average two points. Yet, the changes in the cohort were smaller compared with the RCT's. Moreover, it modified with pain intensity at baseline and treatment statuses indicated differences in mean clinical importance of -4.15 (2.70) when finalized at 6 months and -2.16 (2.48) when treatment was ongoing. CONCLUSION: The moderate clinically important improvement varied substantially, representing heterogeneity in pain relief and its relation to treatment success in chronic pain patients.

Biopsychosocial baseline values of 15 000 patients suffering from chronic pain: Dutch DataPain study.

BACKGROUND AND OBJECTIVES: Chronic pain affects many adults. To improve our daily practice, we need to understand multidisciplinary approaches, integrated treatment plans and the biopsychosocial context of these patients. To date, almost 15 000 chronic pain patients have been referred to the Maastricht University Pain Center in the Netherlands. METHODS: This study describes 11 214 of these patients suffering from chronic pain. Chronic pain was analyzed using relevant Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials instruments. RESULTS: Most patients were female (59.3%). The prevalence of low education was 59%, and unemployment/disability was 35.9%. The mean age was 55.6 years. Severe pain (Numerical Rating Sale score 7-10) was reported by 71.9% of the patients; psychological and quality of life values deteriorated when pain severity increased. Approximately 36% of patients showed severe signs of depression or anxiety, and 39% displayed high pain catastrophizing. Of all patients, 17.8% reported high values for pain severity, catastrophizing and anxiety or depression. CONCLUSIONS: Based on baseline biopsychosocial values, this study shows the complexity of patients referred to pain centers. Pain management with a biopsychosocial approach in an integrated multidisciplinary setting is indispensable. Above all, adjusted education on chronic pain and attention to its biopsychosocial aspects are deemed necessary.