Relationship between subjectively-rated and objectively-tested physical function across six different medical diagnoses.

OBJECTIVE: To quantify and compare associations and relationships between self-rated and tested assessments of mainly mobility-related physical function in different diagnoses. DESIGN: Six longitudinal cohort studies before and after inpatient rehabilitation. PATIENTS: Patients with whiplash-associated disorder (n = 71), low back pain (n = 121), fibromyalgia (n = 84), lipoedema (n = 27), lymphoedema (n = 78), and post-acute coronary syndrome (n = 64). METHODS: Physical function was measured with the self-rated Short-Form 36 Physical functioning (SF-36 PF) and with the tested 6-Min Walk Distance (6MWD) and assessed by correlation coefficients. Across the 6 cohorts, the relationship between the 2 scores was compared using the ratio between them. RESULTS: The correlations between the 2 scores were mostly moderate to strong at baseline (up to r = 0.791), and weak to moderate for the changes to follow-up (up to r = 0.408). The ratios SF-36 PF to 6MWD were 1.143-1.590 at baseline and 0.930-3.310 for the changes, and depended on pain and mental health. CONCLUSION: Moderate to strong cross-sectional and moderate to weak longitudinal correlations were found between the 6MWD and the SF-36 PF. Pain and mental health should be considered when interpreting physical function. For a comprehensive assessment in clinical practice and research, the combination of self-rated and tested physical function measures is recommended.

Effects of Inpatient Rehabilitation in Leg Lymphedema: A Naturalistic Prospective Cohort Study With Intra-individual Control of Effects.

OBJECTIVE: To quantify therapy-attributable effects of a comprehensive inpatient rehabilitation program for lower limb lymphedema (LLL) and to compare the levels of health-related quality of life (HRQL) to population-based norms. DESIGN: Naturalistic prospective cohort study with intra-individual control of effects. SETTING: Rehabilitation hospital. PARTICIPANTS: Patients with LLL (N=67; 46 women). INTERVENTIONS: Comprehensive, multidisciplinary inpatient rehabilitation with 45-60 hours of therapy. MAIN OUTCOME MEASURES: Short Form 36 (SF-36) for HRQL, lymphedema-specific Freiburg Quality of Life Assessment for lymphatic disorders, Short Version (FLQA-lk), knee-specific Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), and Symptom Checklist-90Standard (SCL-90S). Observed pre/post rehabilitation effects were individually corrected by subtracting the home waiting-time effects and expressed as standardized effect sizes (ESs) and standardized response means (SRMs). Score differences to norms were quantified by standardized mean differences (SMDs). RESULTS: Participants were on average aged 60.5 years, not yet obese, and had 3 comorbidities (n=67). The greatest improvement was in HRQL on the FLQA-lk with ES=0.767/SRM=0.718, followed by improvements in pain and function with ES/SRM=0.430-0.495 on the SF-36, FLQA-lk, and KOS-ADL (all P<.001). Vitality, mental health, emotional well-being, and interpersonal sensitivity improved most by ES/SRM=0.341-0.456 on all 4 measures (all P≤.003). Post rehabilitation scores were significantly higher than population norms on SF-36 bodily pain (SMD=1.140), vitality (SMD=0.886), mental health (SMD=0.815), and general health (SMD=0.444) (all P<.001), and comparable on the other scales. CONCLUSIONS: Those affected by LLL stages II and III benefited substantially from the intervention, attaining equal or higher levels of HRQL than expected compared with the general population norms. Multidisciplinary, inpatient rehabilitation should be recommended for LLL management.

Comparison of Swiss versus Standard Acupuncture in Patients with Chronic Low Back Pain. A Study Protocol for a Randomized, Controlled, Single-Blind, Parallel Trial.

Introduction: Chronic low back pain (CLBP) cannot sufficiently be treated by pharmacological therapy and generates substantial health-care costs worldwide. Acupuncture, a cost-effective, safe and non-pharmacological therapy, has shown promising results in relieving acute low back pain; however, the optimal acupuncture therapy for CLBP remains controversial. This study will compare two acupuncture methods for pain relief in CLBP. Methods and Analysis: This randomized, controlled, single-blind, parallel trial will be conducted in patients with clinically diagnosed CLBP with a disease duration ≥3 months and an average pain intensity of ≥4 points on an 11-point Pain Intensity Numerical Rating Scale (pain-NRS) on the previous 7 days. Patients will be randomized to 9-week acupuncture therapy using Jiu Gong Points (termed Swiss low back acupuncture, SLBA) or standard acupuncture (SA) therapy (weeks 1-6: two sessions/week, weeks 7-9: one session/week, 15 sessions/patient in total). Measurements will be conducted before the first session (T1), at the end of the 9-week therapy (T2) and after 3- and 6-month follow-up (T3 and T4). The primary hypothesis is that 9 weeks of SLBA will be superior in reducing the pain severity assessed by the pain-NRS compared to SA therapy for CLBP. Secondary outcomes will be derived from the Short-Form 36, Oswestry Disability Index, Multidimensional Pain Inventory questionnaire, Symptom Checklist-90 - Revised questionnaire and a daily pain diary. Assuming a minimal clinically important difference in the pain-NRS of 0.39 and an effect size of ≥0.6 between SLBA and SA, 80% power, 0.05 alpha level and 20% dropouts, a total of 55 patients/arm will be required. The primary outcome will be analyzed in the intention-to-treat population using chained linear regression models. Patients, outcome assessors and data analysts will be blinded to the treatment arm. Trial Registration: Clinicaltrials.gov Identifier: NCT05232487.

Mental and psychosocial health and health related quality of life before and after cardiac rehabilitation: a prospective cohort study with comparison to specific population norms.

BACKGROUND: Data on mental health improvement after cardiac rehabilitation (CR) are contradictory. The aim was to examine the mental and psycho-social health of patients admitted to our rehabilitation center following hospital treatment for acute coronary syndrome, before and after multidisciplinary CR. METHODS: Outcome was measured at admission and discharge by the 36-Item Short Form Survey (SF-36), the Symptom Checklist-90 Revised (SCL-90R), the Coping Strategy Questionnaire (CSQ) and the 6-min-walking distance test. The patients' health status was compared with norms of sex-, age- and comorbidity-matched data from the German general population. Score differences from norms were measured by standardized mean differences (SMDs); health changes were quantified by standardized effect sizes (ESs). Their importance for comprehensive assessment was quantified by explorative factor analysis. RESULTS: Of n = 70 patients followed-up (male: 79%; mean age: 66.6 years), 79% had ≥ 3 comorbidities. At baseline, SF-36 Physical functioning (SMD = - 0.75), Role physical (- 0.90), Social functioning (SMD = - 0.44), and Role emotional (SMD = - 0.45) were significantly worse than the norm. After CR, almost all scores significantly improved by ES = 0.23 (SCL-90R Interpersonal sensitivity) to 1.04 (SF-36 Physical functioning). The strongest factor (up to 41.1% explained variance) for health state and change was the mental health domain, followed by function & pain (up to 26.3%). CONCLUSIONS: Normative deficits in physical and psycho-social health were reported at baseline. After CR, at follow-up, all scores, except phobia, showed significant improvement. The comprehensive measurement of bio-psycho-social health should not be limited to depression and anxiety but include, especially, the somatization and social participation dimensions.

Catastrophizing as a prognostic factor for pain and physical function in the multidisciplinary rehabilitation of fibromyalgia and low back pain.

BACKGROUND: Quantitative data on longitudinal associations between catastrophizing and pain or physical function are patchy. The study aimed to quantify the prognostic value of catastrophizing for pain and function in fibromyalgia and low back pain before and after rehabilitation. METHODS: The associations of state and change on the Multidimensional Pain Inventory (MPI) Pain severity scale, the Short Form 36 (SF-36) Physical functioning scale and the Six-Minute Walking Distance (6MWD) with the Coping Strategies Questionnaire (CSQ) Catastrophizing scale were quantified by multiple regression modelling to adjust for confounders. RESULTS: Sex- and age-matched cohorts (n = 71 each) were compared. Pain and catastrophizing were worse in fibromyalgia than in low back pain, whereas the function levels were comparable. Baseline catastrophizing predicted pain change by adjusted correlations of 0.552 (fibromyalgia) and 0.450 (low back pain), self-rated function by 0.403 and 0.308, and the 6MWD by 0.270 and - 0.072. The change in catastrophizing was associated to the change in pain by 0.440 (fibromyalgia) and 0.614 (low back pain), self-rated function by 0.122 and 0.465, and the 6MWD by 0186 and 0.162. CONCLUSIONS: Catastrophizing (pain-related worrying) was a potential prognostic factor, especially for pain and somewhat less for self-rated physical function but it was only weakly predictive for the walking distance in both conditions, independently of potential confounders, such as sex, age, baseline severity and others. Reduction of maladaptive coping should be integrated into the management of chronic pain. SIGNIFICANCE: Our study showed surprisingly high associations between state and change in catastrophizing to pain relief and functional improvement in chronic pain patients. This is supported by clinical experience and research data, even if the construct and measurement of catastrophizing is under debate. Our findings and those of literature point to more pessimistic self-rating of pain and catastrophizing in fibromyalgia when compared to other conditions. This might obscure positive effects on pain and function achieved by adaptive coping in fibromyalgia.

Wen Dan Tang: A Potential Jing Fang Decoction for Headache Disorders?

BACKGROUND: Chinese herbal medicine is considered relatively safe, inexpensive, and easily accessible. Wen Dan Tang (WDT), a Jing Fang ancient classical Chinese herbal formula with a broad indication profile has been used for several centuries in China to treat various illnesses. QUESTION: Are there evidence-based clinical trials that show that WDT has a significant impact on the treatment of various diseases, especially in patients with migraine and tension-type headaches (TTH)? METHODS: This study is based on an online database search using PubMed, Medline, Cochrane Library, AcuTrials, Embase, Semantic Scholar, Jstor, internet research, and review of ancient and modern Chinese medical textbooks regarding WDT and its compounds. RESULTS: There were no studies on WDT in migraine and TTH; therefore, this work gathers and describes data for every single compound in the formula. CONCLUSION: This study suggests that the bioactive compounds found in WDT composition show potential in treating patients with neurological, psychiatric disorders, cardiovascular diseases, metabolic syndrome, and digestive disorders. Some coherence between WDT in headache reduction and improvements in the quality of life in patients with migraines and TTH could be evaluated, showing positive results of WDT in these patients.

Cultural adaption and multicenter validation of the German version of the LYMPH-Q Upper Extremity Module.

OBJECTIVE: Upper extremity lymphedema is a burdensome disease with significant effects on quality of life, underscoring the importance of quality of life measures for this patient population. Only recently, the LYMPH-Q Upper Extremity Module, a new patient-reported outcome measure, was developed. The aim of the present study was to translate the LYMPH-Q Upper Extremity Module from English to German and perform a comprehensive validation. METHODS: Translation was performed in accordance with the International Society for Pharmacoeconomics and Outcomes Research best practice guidelines. To validate the German LYMPH-Q, a multicenter study was conducted. Internal consistency was determined using Cronbach's α. Reliability was assessed using the intraclass correlation coefficient. To analyze construct validity, the Pearson correlation coefficient between the LYMPH-Q, quickDASH (disabilities of the arm, shoulder, and hand), and short-form 36-item health survey was calculated. Responsiveness was assessed by comparing the pre- and postoperative LYMPH-Q scores in five patients who had undergone lymphatic reconstructive surgery. RESULTS: Validation was performed using a cohort of 65 patients. The internal consistency of the different domains was good to excellent (α, 0.87-0.97). The intraclass correlation coefficient ranged from 0.74 to 0.92. The domains of the LYMPH-Q correlated significantly with the corresponding domains of the short-form 36-item health survey and quickDASH. Construct validity was good, with 8 of 10 hypotheses confirmed. Significant improvements in function (46.4 ± 13.3 vs 77.8 ± 11.5; P = .03), symptoms (42.0 ± 10.7 vs 70.6 ± 11.6; P = .02), and psychological well-being (40.4 ± 14.6 vs 78.0 ± 17.3; P = .03) were observed after lymphatic reconstructive surgery. CONCLUSIONS: The German version of the LYMPH-Q Upper Extremity Module was shown to be conceptually equivalent to the original English version. It was shown to be a reliable and valid patient-reported outcome measure to assess the physical and psychological impairments in patients with upper extremity lymphedema.

Myocardial involvement in children with post-COVID multisystem inflammatory syndrome: a cardiovascular magnetic resonance based multicenter international study-the CARDOVID registry.

BACKGROUND: Recent evidence shows an association between coronavirus disease 2019 (COVID-19) infection and a severe inflammatory syndrome in children. Cardiovascular magnetic resonance (CMR) data about myocardial injury in children are limited to small cohorts. The aim of this multicenter, international registry is to describe clinical and cardiac characteristics of multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19 using CMR so as to better understand the real extent of myocardial damage in this vulnerable cohort. METHODS AND RESULTS: Hundred-eleven patients meeting the World Health Organization criteria for MIS-C associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), having clinical cardiac involvement and having received CMR imaging scan were included from 17 centers. Median age at disease onset was 10.0 years (IQR 7.0-13.8). The majority of children had COVID-19 serology positive (98%) with 27% of children still having both, positive serology and polymerase chain reaction (PCR). CMR was performed at a median of 28 days (19-47) after onset of symptoms. Twenty out of 111 (18%) patients had CMR criteria for acute myocarditis (as defined by the Lake Louise Criteria) with 18/20 showing subepicardial late gadolinium enhancement (LGE). CMR myocarditis was significantly associated with New York Heart Association class IV (p = 0.005, OR 6.56 (95%-CI 1.87-23.00)) and the need for mechanical support (p = 0.039, OR 4.98 (95%-CI 1.18-21.02)). At discharge, 11/111 (10%) patients still had left ventricular systolic dysfunction. CONCLUSION: No CMR evidence of myocardial damage was found in most of our MIS-C cohort. Nevertheless, acute myocarditis is a possible manifestation of MIS-C associated with SARS-CoV-2 with CMR evidence of myocardial necrosis in 18% of our cohort. CMR may be an important diagnostic tool to identify a subset of patients at risk for cardiac sequelae and more prone to myocardial damage. CLINICAL TRIAL REGISTRATION: The study has been registered on ClinicalTrials.gov, Identifier NCT04455347, registered on 01/07/2020, retrospectively registered.

Common and Contrasting Characteristics of the Chronic Soft-Tissue Pain Conditions Fibromyalgia and Lipedema.

OBJECTIVE: To examine the common and specific characteristics of fibromyalgia and lipedema, two chronic soft-tissue pain syndromes without curative therapy options. METHODS: Diseases' characteristics were compared using the findings of extensive literature and the empiric data from two cohorts, both fulfilling standardized diagnostic criteria. Outcome was measured by various socio-demographics, the generic Short Form 36 (SF-36), the Fibromyalgia Severity Questionnaire (FSQ), and the 6-minute walk distance (6MWD). Empiric SF-36 data were compared to specific population-based norms and between the diagnostic groups, using standardized mean differences (SMD). RESULTS: Female participants with fibromyalgia (n = 77) and lipedema (n = 112) showed comparable education levels and living situations. Lipedema cases were, on average, 3.9 years younger and BMI 6.3kg/m2 more obese. Women with fibromyalgia smoked more, did less sport, had more comorbidities, and worked less. Compared to the norms, health in fibromyalgia was worse than expected by SMD = -1.60 to -2.35 and in lipedema by -0.44 to -0.82 on the SF-36. The score differences between the two conditions ranged from SMD = -0.96 to -1.34 (all p < 0.001) on the SF-36 and the FSQ. For the inpatients (n = 77 fibromyalgia, n = 38 lipedema), the 6MWD was comparable (SMD = -0.09, p = 0.640). These findings were consistent with detailed data from the literature reviewed. DISCUSSION: Fibromyalgia and lipedema share characteristics of clinical phenomenology and comorbid conditions. Disease perception is more pronounced in fibromyalgia than in lipedema, especially in social and role dysfunction, whereas the walking distance was similar for both syndromes. This difference may be explicable by limited coping skills in fibromyalgia.

Prognostic factors for the improvement of pain and disability following multidisciplinary rehabilitation in patients with chronic neck pain.

BACKGROUND: Recent clinical studies have demonstrated the effectiveness of specific, multidisciplinary, bio-psychosocial, rehabilitation programmes for chronic neck pain. However, prognostic factors for the improvement of pain and disability are mostly unknown. Therefore, the aim of this study was to explore prognostic factors associated with improvements in chronic neck pain following participation in a three-week, multidisciplinary, bio-psychosocial, rehabilitation programme. METHODS: In this observational, prospective cohort study, a total of 112 patients were assessed at the beginning, end, and 6 months following the completion of a multidisciplinary, bio-psychosocial, rehabilitation programme. Inclusion for participation in the rehabilitation programme depended upon an interdisciplinary pain assessment. The primary outcome was neck pain and disability, which was measured using the Northern American Spine Society questionnaire for pain+disability and was quantified with effect sizes (ES). Multivariable linear regression analyses were used to explore potential prognostic factors associated with improvements in pain and disability scores at discharge and at the 6-month follow-up period. RESULTS: The mean age of the patients was 59.7 years (standard deviation = 10.8), and 70.5% were female. Patients showed improvement in pain+disability at discharge (ES = 0.56; p < 0.001), which was sustained at the 6-month follow-up (ES = 0.56; p < 0.001). Prognostic factors associated with improvement in pain+disability scores at discharge included poor pain+disability baseline scores (partial, adjusted correlation r = 0.414, p < 0.001), older age (r = 0.223, p = 0.024), a good baseline cervical active range-of-motion (ROM) (r = 0.210, p < 0.033), and improvements in the Short-form 36 mental health scale (r = 0.197; p = 0.047) and cervical ROMs (r = 0.195, p = 0.048) from baseline values. Prognostic factors associated with improvements in pain+disability at the 6-month follow-up were similar and included poor pain+disability baseline scores (partial, adjusted correlation r = 0.364, p < 0.001), improvements in the Short-form 36 mental health scale (r = 0.232; p = 0.002), cervical ROMs (r = 0.247, p = 0.011), and better cervical ROM baseline scores. However, older age was not a factor (r = 0.134, p = 0.172). CONCLUSIONS: Future prognostic models for treatment outcomes in chronic neck pain patients should consider cervical ROM and mental health status. Knowledge of prognostic factors may help in the adoption of individualized treatment for patients who are less likely to respond to multidisciplinary rehabilitation.

Comprehensiveness and validity of a multidimensional assessment in patients with chronic low back pain: a prospective cohort study.

BACKGROUND: Chronic low back pain is a multidimensional syndrome affecting physical activity and function, health-related quality of life and employment status. The aim of the study was to quantify the cross-sectional and longitudinal validity of single measurement scales in specific construct domains and to examine how they combine to build a comprehensive outcome, covering the complex construct of chronic low back pain before and after a standardized interdisciplinary pain program. METHODS: This prospective cohort study assessed 177 patients using the Short Form 36 (SF-36), the Multidimensional Pain Inventory (MPI), the Symptom Checklist-90-Revised (SCL-90-R), the Oswestry Disability Index (ODI), and 2 functional performance tests, the Back Performance Scale (BPS) and the 6-Minute Walking Distance (6MWD). The comprehensiveness and overlap of the constructs used were quantified cross-sectionally and longitudinally by bivariate correlations, exploratory factor analysis, and effect sizes. RESULTS: The mean age of the participants was 48.0 years (+/- 12.7); 59.3% were female. Correlations of baseline scores ranged from r = - 0.01 (BPS with MPI Life control) to r = 0.76 (SF-36 Mental health with MPI Negative mood). SF-36 Physical functioning correlated highest with the functional performance tests (r = 0.58 BPS, 0.67 6MWD) and ODI (0.56). Correlations of change scores (difference of follow-up - baseline score) were consistent but weaker. Factor analysis revealed 2 factors: "psychosocial" and "pain & function" (totally explained variance 44.0-60.9%). Psychosocial factors loaded strongest (up to 0.89 SCL-90-R) on the first factor, covering 2/3 of the explained variance. Pain and function (ing) loaded more strongly on the second factor (up to 0.81 SF-36 Physical functioning at follow-up). All scales showed improvements, with effect sizes ranging from 0.16-0.67. CONCLUSIONS: Our results confirm previous findings that the chronic low back pain syndrome is highly multifactorial and comprises many more dimensions of health and quality of life than merely back-related functioning. A comprehensive outcome measurement should include the predominant psychosocial domain and a broad spectrum of measurement constructs in order to assess the full complexity of the chronic low back syndrome. Convergence and divergence of the scales capture the overlapping contents and nuances within the constructs.

High molecular weight Intraarticular hyaluronic acid for the treatment of knee osteoarthritis: a network meta-analysis.

BACKGROUND: The 2013 American Academy of Orthopaedic Surgeons (AAOS) guidelines made strong recommendations against intraarticular hyaluronic acid (IAHA) for patients with knee osteoarthritis (OA), as evidence supporting improvements in pain did not meet the minimal clinically important improvement (MCII) threshold. However, there may be important distinctions based on IAHA molecular weight (MW). Hence our objective was to evaluate the efficacy of IAHAs in knee OA based on molecular weight. METHODS: Randomized controlled trials were searched within MEDLINE, Embase, and CENTRAL and selected based on AAOS criteria. A pain measure hierarchy and longest follow-up were used to select one effect size from each trial. Mean differences between interventions were converted to standardized mean differences (SMDs) and incorporated into a random-effects Bayesian network meta-analysis. High MW (HMW) was defined as ≥6000 kDa, and low MW (LMW) as < 750 kDa. RESULTS: HMW IAHA was associated with a statistically significant and possibly clinically significant improvement in pain (SMD - 0.57 (95% credible interval [Crl]: - 1.04, - 0.11), exceeding the - 0.50 MCII threshold. LMW IAHA had a lesser, non-significant improvement (- 0.23, 95% Crl: - 0.67, 0.20). Back-transforming SMDs to the WOMAC pain scale indicated a 14.65 (95% CI: 13.93, 15.62) point improvement over IA placebo, substantially better than the 8.3 AAOS MCII threshold. CONCLUSIONS: Unlike LMW IAHA, HMW IAHA exceeded the MCII threshold for pain relief, suggesting that improvements can be subjectively perceived by the treated patient. Amalgamation of LMW and HMW may have blurred the benefits of IAHA in the past, leading to negative recommendations. Differentiation according to MW offers refined insight for treatment with IAHA.

Cross-sectional validity and specificity of comprehensive measurement in lymphedema and lipedema of the lower extremity: a comparison of five outcome instruments.

BACKGROUND: Literature on the validity of outcome measurement in lymphedema and lipedema is very sparse. This study aimed to examine the convergent, divergent and discriminant validity of a set of 5 instruments in both conditions. METHODS: Cross-sectional outcome was measured by the generic Short Form 36 (SF-36), the lymphedema-specific Freiburg Quality of Life Assessment for lymphatic disorders, Short Version (FLQA-lk), the knee-specific Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), the Symptom Checklist-90-revised (SCL-90R), and the Six-Minute Walk Test (6 MWT). Construct convergent/divergent validity was quantified by bivariate correlations and multivariate factor analysis, and discriminant validity by standardized mean differences (SMDs). RESULTS: Health was consistently better in lymphedema (n = 107) than in lipedema (n = 96). The highest construct convergence was found for physical health between the SF-36 and KOS-ADL (bivariate correlations up to 0.78, factor loads up to 0.85, explained variance up to 56.8%). The second most important factor was mental health (bivariate correlations up to 0.79, factor loads up to 0.86, explained variance up to 13.3%). Discriminant validity was greatest for the FLQA-lk Physical complaints (adjusted SMD = 0.93) followed by the SF-36 Bodily pain (adjusted SMD = 0.83), KOS-ADL Function (adjusted SMD = 0.47) and SF-36 Vitality (adjusted SMD = 0.39). CONCLUSIONS: All five instruments have specific strengths and can be implemented according to the scope and aim of the outcome examination. A minimum measurement set should comprise: the SF-36 Bodily pain, SF-36 Vitality, FLQA-lk Physical complaints, FLQA-lk Social life, FLQA-lk Emotional well-being, FLQA-lk Health state, KOS-ADL Symptoms, KOS-ADL Function, and the SCL-90R Interpersonal sensitivity.

Extended overview of the longitudinal pain-depression association: A comparison of six cohorts treated for specific chronic pain conditions.

BACKGROUND: The aim was to quantify and to compare the associations between longitudinal changes in pain and depression in different chronic pain conditions. METHODS: Data were retrieved from 6 observational cohort studies. From baseline to the 6-month follow-up, the score changes on the Short Form (36) Health Survey (SF-36) bodily pain (pain) and the SF-36 mental health (depression) scales (0=worst, 100=best) were quantified, using partial correlations obtained by multiple regression. Adjustment was performed by age, living alone/with partner, education level, number of comorbidities, baseline pain and baseline depression. RESULTS: Stronger associations were found between changes in levels of pain and depression for neck pain after whiplash (n = 103, mean baseline pain=21.4, mean baseline depression=52.5, adjusted correlation r = 0.515), knee osteoarthritis (n = 177, 25.4, 64.2, r = 0.502), low back pain (n = 134, 19.0, 49.4, r = 0.495), and fibromyalgia (n = 125, 16.8, 43.2, r = 0.467) than for lower limb lipedema (n = 68, 40.2, 62.6, r = 0.452) and shoulder arthroplasty (n = 153, 35.0, 76.4, r = 0.292). Those correlations were somewhat correlated to baseline pain (rank r=-0.429) and baseline depression (rank r=-0.314). LIMITATIONS: The construct of the full range of depressive symptoms is not explicitly covered by the SF-36. CONCLUSIONS: Moderate associations between changes in pain and depression levels were demonstrated across 5 of 6 different chronic pain conditions. The worse the pain and depression scores at baseline, the stronger those associations tended to be. Both findings indicate a certain dose-response relationship - an important characteristic of causal interference. Relieving pain by treatment may lead to the relief of depression and vice versa.

Comparison of short- and mid-term outcomes of Italian- and German-speaking patients after an interdisciplinary pain management programme in Switzerland: A prospective cohort study.

OBJECTIVE: To quantify and compare the course of health-related quality of life of immigrant native Italian-speaking and German-speaking patients before and after an interdisciplinary pain programme. DESIGN: Prospective cohort study with 1-12 month follow-up. SUBJECTS: Fibromyalgia, generalized widespread pain, and chronic non-specific back pain patients (Italian-speaking n = 96, German-speaking n = 199). METHODS: Score changes measured with the Short Form 36 (SF-36) were compared with multivariate analysis using standardized mean differences (SMD), adjusted for sex, education and the baseline score. RESULTS: At baseline, health of the Italian-speaking patients was worse than for the German-speaking patients. Adjusted SMDs showed significantly better improvements in the German group compared with the Italian group: SF-36 Physical functioning SMD = 0.54 (at discharge) and 0.49 (at 12 months), General health SMD = 0.71 and 0.44, Vitality SMD = 0.43 and 0.48 in one sample. In the other sample, the corresponding SMDs were 0.06 (discharge), 0.50 (3 months) and 0.47 (6 months) for Bodily pain. CONCLUSION: State of health was better and health improvements were greater in German-speaking patients compared with Italian-speaking patients. Patients with a migration background may have special needs in therapeutic management, and addressing these might enhance the positive outcome in the short- and mid-term.

Differences between unipolar mania and bipolar-I disorder: Evidence from nine epidemiological studies.

OBJECTIVES: Although clinical evidence suggests important differences between unipolar mania and bipolar-I disorder (BP-I), epidemiological data are limited. Combining data from nine population-based studies, we compared subjects with mania (M) or mania with mild depression (Md) to those with BP-I with both manic and depressive episodes with respect to demographic and clinical characteristics in order to highlight differences. METHODS: Participants were compared for gender, age, age at onset of mania, psychiatric comorbidity, temperament, and family history of mental disorders. Generalized linear mixed models with adjustment for sex and age as well as for each study source were applied. Analyses were performed for the pooled adult and adolescent samples, separately. RESULTS: Within the included cohorts, 109 adults and 195 adolescents were diagnosed with M/Md and 323 adults and 182 adolescents with BP-I. In both adult and adolescent samples, there was a male preponderance in M/Md, whereas lifetime generalized anxiety and/panic disorders and suicide attempts were less common in M/Md than in BP-I. Furthermore, adults with mania revealed bulimia/binge eating and drug use disorders less frequently than those with BP-I. CONCLUSIONS: The significant differences found in gender and comorbidity between mania and BP-I suggest that unipolar mania, despite its low prevalence, should be established as a separate diagnosis both for clinical and research purposes. In clinical settings, the rarer occurrence of suicide attempts, anxiety, and drug use disorders among individuals with unipolar mania may facilitate successful treatment of the disorder and lead to a more favorable course than that of BP-I disorder.

Multidisciplinary biopsychosocial rehabilitation in chronic neck pain: a naturalistic prospective cohort study with intraindividual control of effects and 12-month follow-up.

BACKGROUND: In contrast to the large evidence of the effectiveness of multidisciplinary biopsychosocial rehabilitation (MBR) in chronic low back pain, little is known about the effects of MBR in chronic neck pain (CNP). AIM: To quantify short-term and 12-month effects of a 3-week CNP-specific MBR program. DESIGN: Naturalistic prospective observational cohort study with intraindividual control of effects. SETTING: Outpatient clinic at a tertiary physical medicine and rehabilitation center. POPULATION: Consecutive patients with CNP (N.=81) who participated in a CNP-specific MBR. METHODS: The intervention was a MBR outpatient clinic program. Primary Outcome was the North American Spine Society (NASS) questionnaire pain/function scale. Secondary outcomes included the NASS scale neurogenic symptoms, Short-Form 36 Health Survey (SF-36) and numerical rating scales (NRS) for maximum and average pain. Short-term changes of health were quantified using effect sizes (ES), which were corrected by the change during waiting time before MBR. RESULTS: At the end of treatment, the NASS pain/function scale showed significant improvement (P<0.001) by a moderate corrected ES (ES=0.59). Moderate significant improvements were also found for the NASS scale neurogenic symptoms (ES=0.65), the SF-36 scales bodily pain (ES=0.56) and mental health (ES=0.54), and the NRS maximum pain (ES=0.59). Significant small corrected ES were found for the SF-36 scales physical functioning (ES=0.32), physical role (ES=0.41), vitality (ES=0.42), social functioning (ES=0.41), emotional role (ES=0.41) and the NRS average pain (ES=0.48). The improvement on the SF-36 scale general health was not significant (ES=0.19). At the follow-up after 12 months, the NASS pain/function scale remained its moderate ES (ES=0.52, P value <0.001). Also, the NASS Scale neurogenic symptoms, the SF-36 scales bodily pain, general health, social functioning and mental health and both NRS pain scales showed significant benefits. CONCLUSIONS: This study showed that MBR may be effective in patients with CNP. Maintenance of moderate benefits in pain and function seems possible for at least 12 months. CLINICAL REHABILITATION IMPACT: The findings support the concept of CNP-specific MBR.

Multidimensional minimal clinically important differences in knee osteoarthritis after comprehensive rehabilitation: a prospective evaluation from the Bad Zurzach Osteoarthritis Study.

OBJECTIVE: To determine minimal clinically important differences (MCIDs) for improvement and worsening in various health dimensions in knee osteoarthritis under conservative therapy. METHODS: Health, symptoms and function were assessed by the generic Short Form 36 and the condition-specific Western Ontario and McMaster Universities Osteoarthritis Index in n=190 patients with knee osteoarthritis before and after comprehensive rehabilitation intervention (3-month follow-up). By means of construct-specific transition questions, MCIDs were defined as the difference between the 'slightly better/worse' and the 'almost equal' transition response categories according to the 'mean change method'. The bivariate MCIDs were adjusted for sex, age and baseline score to obtain adjusted MCIDs by multivariate linear regression. They were further standardised as (baseline) effect sizes (ESs), standardised response means (SRMs) and standardised mean differences (SMDs) and compared with the minimal detectable change with 95% confidence (MDC95). RESULTS: Multivariate, adjusted MCIDs for improvement ranged from 2.89 to 16.24 score points (scale 0-100), corresponding to ES=0.14 to 0.63, SRM=0.17 to 0.61 and SMD=0.18 to 0.72. The matching results for worsening were -5.80 to -12.68 score points, ES=-0.30 to -0.56, SRM=-0.35 to -0.52 and SMD=-0.35 to -0.58. Almost all MCIDs were larger than the corresponding MDC95s. CONCLUSIONS: This study presents MCIDs quantified according to different methods over a comprehensive range of health dimensions. In most health dimensions, multivariate adjustment led to higher symmetry between the MCID levels of improvement and worsening. MCIDs expressed as standardised effect sizes (ES, SRM, SMD) and adjusted by potential confounders facilitate generalisation to the results of other studies.

Translation, cross-cultural adaptation and reliability of the German version of the migraine disability assessment (MIDAS) questionnaire.

BACKGROUND: The Migraine Disability Assessment (MIDAS) is a brief questionnaire and measures headache-related disability. This study aimed to translate and cross-culturally adapt the original English version of the MIDAS to German and to test its reliability. METHODS: The standardized translation process followed international guidelines. The pre-final version was tested for clarity and comprehensibility by 34 headache sufferers. Test-retest reliability of the final version was quantified by 36 headache patients completing the MIDAS twice with an interval of 48 h. Reliability was determined by intraclass correlation coefficients and internal consistency by Cronbach's α. RESULTS: All steps of the translation process were followed, documented and approved by the developer of the MIDAS. The expert committee discussed in detail the complex phrasing of the questions that refer to one to another, especially exclusion of headache-days from one item to the next. The German version contains more active verb sentences and prefers the perfect to the imperfect tense. The MIDAS scales intraclass correlation coefficients ranged from 0.884 to 0.994 and was 0.991 (95% CI: 0.982-0.995) for the MIDAS total score. Cronbach's α for the MIDAS as a whole was 0.69 at test and 0.67 at retest. CONCLUSIONS: The translation process was challenged by the comprehensibility of the questionnaire. The German version of the MIDAS is a highly reliable instrument for assessing headache related disability with moderate internal consistency. Provided validity testing of the German MIDAS is successful, it can be recommended for use in clinical practice as well as in research.

Epidemiology of gastrointestinal symptoms in young and middle-aged Swiss adults: prevalences and comorbidities in a longitudinal population cohort over 28 years.

BACKGROUND: Although subacute and chronic gastrointestinal symptoms are very common in primary care, epidemiological date are sparse. The aim of the study was to examine and quantify the prevalence of subacute and chronic gastrointestinal symptoms and their associations with somatic and mental disorders in the general population. METHODS: Data were collected prospectively between 1981 (age m = 22, f = 23) and 2008 (age 49/50) from the Zurich Cohort Study (n = 292 men, 299 women), a representative general population survey. The participants were assessed using a semi-structured interview, the "Structured Psychopathological Interview and Rating of the Social Consequences of Psychological Disturbances for Epidemiology" (SPIKE). Prevalence rates were computed to be representative of the general population aged 22-50. Associations were quantified by odds ratios (ORs) and their 99% confidence intervals (CI). RESULTS: The prevalences of intestinal and of gastric symptoms were significantly higher among women in all categories examined. For example, any gastric symptoms: f. 26.4% vs m.15.2%; any intestinal symptoms: 27.6% vs 14.6%; nausea/vomitus: 19.1% vs 4.5%; constipation: 15.8% vs 6.5% (all p < 0.001). Strong associations (all p < 0.0001) were found between fatigue (1 month) and chronic stomach (OR = 9.96, 99%-CI: 5.53-17.94) and chronic intestinal symptoms (OR = 9.02, 99%-CI: 4.92-16.54). Panic attacks were associated with subacute intestinal symptoms (OR = 4.00, 99%-CI: 2.43-6.59). Anxiety was more strongly associated with subacute intestinal symptoms (OR = 3.37, 99%-CI: 2.23-5.08) than with subacute stomach symptoms (OR = 1.85, 1.20-2.86). Bipolar disorders were associated with subacute stomach symptoms (OR = 1.83, 1.18-2.17) and unipolar depression with subacute intestinal symptoms (OR = 2.05, 1.34-3.15). CONCLUSIONS: Remarkably high prevalence rates of gastric and intestinal complaints were observed in women (over 1/4; men 1/7). Fatigue/neurasthenia was the strongest co-factor in both conditions. Various syndromes related to anxiety, phobia, and panic disorders showed further significant associations. The integration of psychiatric and/or psychological treatment could help address the functional part of gastric and intestinal syndromes.