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.

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.

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 Back Pain in Young and Middle-Aged Adults: A Longitudinal Population Cohort Survey From Age 27-50 Years.

BACKGROUND: Back pain is extremely common and a huge burden for both individuals and health care services. OBJECTIVE: The aim was to determine the prevalence and incidence of lumbar and cervical back pain over 23 years and to quantify associations with concomitant disorders. METHODS: Data on lumbar and cervical back pain, and mental disorders from the Zurich study, collected between 1986 (age men: 27/women: 28 years) and 2008 (age 49/50) were analyzed. Epidemiological parameters were representative rates for the general population. Associations were quantified by odds ratios (ORs). RESULTS: Of 499 subjects, 68.9% ever experienced lumbar pain and 60.7% ever experienced cervical back pain; the 23-year prevalences were 66.9% and 54.9% and the 23-year incidences 52.3% and 48.9% for lumbar and cervical back pain, respectively. Annual prevalences varied between 28.4% and 47.2% for lumbar and 18.3% and 54.7% for cervical back pain; the corresponding annual incidences varied by 5.8-13.3% (lumbar) and 7.8-12.6% (cervical). Lumbar back pain was significantly associated with cardiovascular disease (OR = 4.58), obesity (OR = 3.99), asthma spectrum (OR = 5.76), tranquillizer dependence (OR = 5.84), and other comorbidities (ORs = 1.47-3.27). Significant associations with cervical back pain were observed for specific phobia (OR = 5.10), panic attacks (OR = 4.79), and other comorbidities (ORs = 1.61-2.62). CONCLUSIONS: This study contributes to the refinement of epidemiological data on lumbar and cervical back pain. Some associations with treatable disorders were high, which may offer hope for the indirect management of lumbar and cervical back pain.

Quadriceps performance under activation of foot dorsal extension in healthy volunteers: an interventional cohort study.

BACKGROUND: The m. quadriceps femoris is the strongest muscle in the human body and plays an important role in sports, activities of daily living and independence. Two older studies showed increased electromyographic (EMG) activity of the quadriceps when the dorsal extensors of the foot were pre-activated. The aim was to physiologically replicate this finding by EMG and to verify it functionally by single leg hop. METHODS: EMG activity (root mean square, RMS) was tested on the leg press at the isometric load of the individual 12-repetition-maximum (12RM) weight (on average 79.7 kg) at 45° and 90° knee flexion. Single leg hop distance was measured between the tests. Intra-individual changes between with and without dorsal foot extension were quantified and compared by standardized response means (SRM). RESULTS: Thirty-five healthy subjects between 21 and 57 years were included. The m. vastus medialis was activated on average to an RMS of 32.4 µV without and 53.7 µV with dorsal foot extension (SRM = 1.39, p < 0.001) at 45° knee flexion and an RMS of 124.9 µV versus 152.8 µV (SRM = 1.08, p < 0.001) at 90°. The corresponding data for the rectus femoris were 9.4 µV versus 18.9 µV (SRM = 0.71, p < 0.001) at 45° and 77.8 µV versus 135.3 µV (SRM = 0.89, p < 0.001) at 90°. Mean single leg hop distance was 169.8 cm without versus 178.9 cm with dorsal foot extension (SRM = 1.09, p < 0.001). CONCLUSIONS: Pre-activation of dorsal foot extensors significantly increased EMG activity in the m. quadriceps femoris and single leg hop distance. It can therefore be used to improve functional quadriceps muscle performance and knee joint stability in training and rehabilitation.

Health and quality of life in patients with primary and secondary lymphedema of the lower extremity.

BACKGROUND: Little is known about comprehensively measured health and quality of life of lower limb lymphedema (LLL). The aim of this study was to determine health and quality of life of LLL patients stratified by primary and secondary lymphedema compared to a normative population-based data stratified by age, sex and comorbidity. PATIENTS AND METHODS: A cross-sectional study of patients after treatment at the department of angiology of a rehabilitation clinic was conducted. Self-assessment was performed by the Short Form 36 (SF-36) and two condition-specific measures. RESULTS: Primary LLL (n = 52) 75 % female, mean age 47.1 years) reported health comparable to normative values, e. g. SF-36 physical functioning 80.4 (norm 84.1, p = 0.512) and SF-36 vitality 62.7 (59.7, p = 0.117) (mean scores, 100 = best). Secondary LLL (n = 60, 68 % female, mean age 60.6 years) scored 68.1 (73.9, p = 0.049) and 55.2 (56.2, p = 0.800) on the corresponding scales. Mean symptoms and function scores on the specific measures ranged from 70.0 to 83.1 for primary LLL (100 = best) and from 63.3 to 80.6 for secondary LLL. Function, vitality and both SF-36 role dimensions were higher in primary LLL than in secondary LLL, (mean SF-36 vitality 62.7 versus 55.2, p = 0.035). CONCLUSIONS: Overall health and quality of life was high and comparable to the general population norms in primary LLL. The same was true for most psycho-social scales in secondary LLL whereas functionally some deficits were recorded. Cancer as the most frequent cause for secondary LLL may affect health in these dimensions. Reported negative effects of LLL seem to be well compensated, especially in primary LLL and under optimal treatment.

Multidimensional associative factors for improvement in pain, function, and working capacity after rehabilitation of whiplash associated disorder: a prognostic, prospective outcome study.

BACKGROUND: Whiplash associated disorders (WAD) have dramatic consequences for individual and public health. Risk factors for better and worse outcomes are important to optimize management. This study aimed to determine short- and mid-term associative co-factors of neck pain relief, improved physical functioning, and improved working capacity (dependent variables) in patients suffering from whiplash associated disorder who participated in a standardized, inpatient pain management program. METHODS: Naturalistic, observational, prospective cohort study. Outcome was measured by standardized assessment instruments. Co-factors covered sociodemographics, comorbidities, social participation, affective health, and coping abilities. Stepwise, multivariate linear regression analysis was performed at discharge and at the 6-month follow-up. RESULTS: All regression models explained high proportions of variance (53.3% - 72.1%). The corresponding baseline level was significantly associated with a change in every dependent variable (explained variances: 11.4%-56.7%). Pain relief significantly depended on improved function and vice-versa (3.4%-14.8%). Improved ability to decrease pain was associated with pain relief at discharge (9.6%). Functional improvement was associated with decreased catastrophizing (19.4%) at discharge and decreased depression (20.5%) at the 6 month follow-up. CONCLUSIONS: Pain relief, improved physical function and working capacity were associated with each other. Improved coping (catastrophizing and ability to decrease pain) and reduced depression may act as important predictors for pain relief and improved function. These findings offer toe-holds for optimized therapy of chronic WAD.

[Tratment of pain--the point of view of the rheumatologist]. / Traitement de la douleur du point de vue du rhumatologue.

From the point of view of the rheumatologist, the treatment of pain should be adjusted individually in accordance with medical principles based on the facts related to the relevant pathologies. This treatment includes conservative (medicinal and non-medicinal), interventional and surgical methods. The treatment does not just depend on the diagnosis, but also on the particular functional disability based on the ICF (International Classification of Functioning) and the level of polymorbidity. As rheumatology patients often have comorbidity, the choice of painkillers (NSAIDs, analgesics, opioids etc), immunosuppressants and physical therapy methods (physiotherapy, ergotherapy, etc) may be limited.

Effects of inpatient rehabilitation in hip and knee osteoarthritis: a naturalistic prospective cohort study with intraindividual control of effects.

OBJECTIVES: To quantify pain, function, and health-related quality of life in comparison with normative data, and to quantify intervention effects. DESIGN: Naturalistic cohort study without a control group. Correction of the effects observed during the intervention by those observed during waiting time prior to the intervention. SETTING: Inpatient rehabilitation clinic. PARTICIPANTS: Patients with hip (n=88) and knee (n=164) osteoarthritis. INTERVENTION: Comprehensive, multidisciplinary inpatient rehabilitation lasting 3 weeks. MAIN OUTCOME MEASURES: Medical Outcomes Study 36-Item Short-Form Health Survey and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). RESULTS: Four or more comorbid conditions had 45.3% of the hip and 51.8% of the knee patients on entry to and discharge from the clinic. On entry, physical health and some dimensions of psychosocial health were significantly diminished compared with population norms. At discharge, hip osteoarthritis had improved by a corrected effect size of .20 to .47 in pain, .04 to .39 in function, and -.04 to .32 in psychosocial health. Knee osteoarthritis showed a corrected effect size of .43 to .62 in pain, .19 to .51 in function, and .19 to .30 in psychosocial health. All but 1 effect in WOMAC pain and WOMAC function were higher than the minimal clinically important differences. CONCLUSIONS: Hip and knee osteoarthritis patients admitted to the inpatient intervention were affected by a substantial burden of disease and comorbidities. Inpatient rehabilitation resulted in small to moderate, statistically significant, and clinically important improvements in pain, function, and psychosocial health.

Association of the sense of coherence with physical and psychosocial health in the rehabilitation of osteoarthritis of the hip and knee: a prospective cohort study.

BACKGROUND: According to Antonovsky's salutogenic concept, a strong sense of coherence is associated with physical and psychological health. The goal of this study was to analyze the association of Antonovsky's sense of coherence with physical and psychosocial health components in patients with hip and knee osteoarthritis before and after in- and outpatient rehabilitation. METHODS: Prospective cohort study with 335 patients, 136 (41%) with hip and 199 (59%) with knee osteoarthritis. The outcome was measured by Short Form-36 (SF-36), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Sense of Coherence (SOC-13). Baseline scores of the SF-36 and WOMAC scales and the observed effect sizes after rehabilitation were correlated with the baseline SOC-13. These correlations of the SF-36 scales were compared to the Factor Score Coefficients for the Mental Component Summary of SF-36, which quantify the factor load on the psychosocial dimension. Predictive impact of the baseline SOC-13 for the SF-36 and WOMAC scales (baseline scores and effect sizes) was then determined by multivariate linear regression controlled for possible confounders. RESULTS: At baseline, the SOC-13 correlated with the WOMAC scores between r = 0.18 (stiffness) and r = 0.25 (pain) and with the SF-36 scores between r = 0.10 (physical functioning) and r = 0.53 (mental health). The correlation of these SF-36 correlation coefficients to the Factor Score Coefficient of the SF-36 Mental Component Summary was r = 0.95. The correlations for the effect sizes (baseline → discharge) with the baseline SOC-13 global score were all negative and varied between r = 0.00 (physical functioning) and r = -0.19 (social functioning). In the multivariate linear regression model, the explained variance of the SF-36 scores by the baseline SOC-13 increased continuously from physical to psychosocial health dimensions (from 12.9% to 29.8%). This gradient was consistently observed for both the baseline scores and the effect sizes. The results of the WOMAC were consistent with the physical health scales of SF-36. CONCLUSIONS: The sense of coherence was associated with psychosocial health dimensions but hardly with physical health. The higher the load of a scale on the psychosocial dimension the higher was its correlation to the sense of coherence. This is in contrast to the idea of Antonovsky who predicted high associations with both mental and physical health.

Responsiveness of the cervical Northern American Spine Society questionnaire (NASS) and the Short Form 36 (SF-36) in chronic whiplash.

OBJECTIVE: To determine and compare the sensitivity to change of the condition-specific cervical Northern American Spine Society (NASS) and the generic Short Form 36 (SF-36). DESIGN: Prospective cohort study. SUBJECTS: One hundred and seventy five patients after whiplash injury. INTERVENTIONS: Four-week inpatient interdisciplinary pain management programme. MAIN MEASURES, ANALYSIS: Responsiveness of the NASS and the SF-36 was quantified by effect size and standardized response mean and compared within the same construct by the modified Jacknife test. Ability to detect improvement was compared using sensitivities determined from receiver operating characteristics curves. RESULTS: In pain, the NASS was comparable responsive to the SF-36 at the one-month follow-up (n = 175): effect sizes: 0.62 (NASS) versus 0.61 (SF-36), P = 0.914. The NASS was less responsive than the SF-36 in function: 0.23 versus 0.63, P < 0.001 and in pain+function: 0.35 versus 0.58 (P = 0.001). These relationships remained consistent using standardized response means, at the six-month follow-up (n = 103), and in the comparison of the sensitivities. Sensitivities at one month, pain: 70% (NASS) versus 62% (SF-36), P = 0.234; function: 65% versus 80%, P = 0.002; pain+function: 68% versus 78%, P = 0.035. The six-month data were similar. CONCLUSIONS: The generic SF-36 was more responsive in function and equally responsive in pain when compared to the condition-specific NASS. The SF-36 can be recommended as a responsive instrument for measurement of pain and function in chronic whiplash syndrome.

Reliability of the Multidimensional Pain Inventory and stability of the MPI classification system in chronic back pain.

BACKGROUND: This cross validation study examined the reliability of the Multidimensional Pain Inventory (MPI) and the stability of the Multidimensional Pain Inventory Classification System of the empirically derived subgroup classification obtained by cluster analysis in chronic musculoskeletal pain. Reliability of the German Multidimensional Pain Inventory was only examined once in the past in a small sample. Previous international studies mainly involving fibromyalgia patients showed that retest resulted in 33-38% of patients being assigned to a different Multidimensional Pain Inventory subgroup classification. METHODS: Participants were 204 persons with chronic musculoskeletal pain (82% chronic non-specific back pain). Subgroup classification was conducted by cluster analysis at 4 weeks before entry (=test) and at entry into the pain management program (=retest) using Multidimensional Pain Inventory scale scores. No therapeutic interventions in this period were conducted. Reliability was quantified by intraclass correlation coefficients (ICC) and stability by kappa coefficients (κ). RESULTS: Reliability of the Multidimensional Pain Inventory scales was least with ICC = 0.57 for the scale life control and further ranged from ICC = 0.72 (negative mood) to 0.87 (solicitous responses) in the other scales. At retest, 82% of the patients in the Multidimensional Pain Inventory cluster interpersonally distressed (κ = 0.69), 80% of the adaptive copers (κ = 0.58), and 75% of the dysfunctional patients (κ = 0.70) did not change classification. In total, 22% of the patients changed Multidimensional Pain Inventory cluster group, mainly into the adaptive copers subgroup. CONCLUSION: Test-retest reliability of the German Multidimensional Pain Inventory was moderate to good and comparable to other language versions. Multidimensional Pain Inventory subgroup classification is substantially stable in chronic back pain patients when compared to other diagnostic groups and other examiner-based subgroup Classification Systems. The MPI Classification System can be recommended for reliable and stable specification of subgroups in observational and interventional studies in patients with chronic musculoskeletal pain.

Horticultural therapy for patients with chronic musculoskeletal pain: results of a pilot study.

CONTEXT: Therapists can use horticultural therapy as an adjuvant therapy in a non threatening context, with the intent of bringing about positive effects in physical health, mental health, and social interaction. Very few experimental studies exist that test its clinical effectiveness. OBJECTIVE: To determine whether the addition of horticultural therapy to a pain-management program improved physical function, mental health, and ability to cope with pain. DESIGN: The research team designed a prospective, nonrandomized, controlled cohort study, enrolling all patients consecutively referred to the Zurzach Interdisciplinary Pain Program (ZISP) who met the studys criteria. The team divided them into two cohorts based on when medical professionals referred them: before (control group) or after (intervention group) introduction of a horticultural therapy program. SETTING: The setting was the rehabilitation clinic (RehaClinic) in Bad Zurzach, Switzerland. PARTICIPANTS: Seventy-nine patients with chronic musculoskeletal pain (fibromyalgia or chronic, nonspecific back pain) participated in the study. INTERVENTIONS: The research team compared a 4-week, inpatient, interdisciplinary pain-management program with horticultural therapy (intervention, n = 37) with a pain-management program without horticultural therapy (control, n = 42). The horticultural therapy program consisted of seven sessions of group therapy, each of 1-hour duration. OUTCOME MEASURES: The research team assessed the outcome using the Medical Outcome Study Short Form-36 (SF-36), the West Haven-Yale Multidimensional Pain Inventory (MPI), the Hospital Anxiety and Depression Scale (HADS), the Coping Strategies Questionnaire (CSQ ), and two functional performance tests. The team tested participants on entry to and discharge from the 4-week pain-management program. RESULTS: Between-group differences in sociodemographic and outcome variables were not significant on participants entry to the pain-management program. On discharge, the research team measured small to moderate outcome effects (effect size [ES] up to 0.71) within both groups. The study found significantly larger improvements for the horticultural therapy group vs the control group in SF-36 role physical (ES = 0.71 vs 0.22; P = .018); SF-36 mental health (ES = 0.46 vs 0.16; P = .027); HADS anxiety (ES = 0.26 vs 0.03; P = .043); and CSQ pain behavior (ES = 0.30 vs -0.05; P = .032). CONCLUSION: The addition of horticultural therapy to a pain management program improved participants' physical and mental health and their coping ability with respect to chronic musculoskeletal pain.

Differences in pain, function and coping in Multidimensional Pain Inventory subgroups of chronic back pain: a one-group pretest-posttest study.

BACKGROUND: Patients with non-specific back pain are not a homogeneous group but heterogeneous with regard to their bio-psycho-social impairments. This study examined a sample of 173 highly disabled patients with chronic back pain to find out how the three subgroups based on the Multidimensional Pain Inventory (MPI) differed in their response to an inpatient pain management program. METHODS: Subgroup classification was conducted by cluster analysis using MPI subscale scores at entry into the program. At program entry and at discharge after four weeks, participants completed the MPI, the MOS Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS), and the Coping Strategies Questionnaire (CSQ). Pairwise analyses of the score changes of the mentioned outcomes of the three MPI subgroups were performed using the Mann-Whitney-U-test for significance. RESULTS: Cluster analysis identified three MPI subgroups in this highly disabled sample: a dysfunctional, interpersonally distressed and an adaptive copers subgroup. The dysfunctional subgroup (29% of the sample) showed the highest level of depression in SF-36 mental health (33.4 ± 13.9), the interpersonally distressed subgroup (35% of the sample) a modest level of depression (46.8 ± 20.4), and the adaptive copers subgroup (32% of the sample) the lowest level of depression (57.8 ± 19.1). Significant differences in pain reduction and improvement of mental health and coping were observed across the three MPI subgroups, i.e. the effect sizes for MPI pain reduction were: 0.84 (0.44-1.24) for the dysfunctional subgroup, 1.22 (0.86-1.58) for the adaptive copers subgroup, and 0.53 (0.24-0.81) for the interpersonally distressed subgroup (p = 0.006 for pairwise comparison). Significant score changes between subgroups concerning activities and physical functioning could not be identified. CONCLUSIONS: MPI subgroup classification showed significant differences in score changes for pain, mental health and coping. These findings underscore the importance of assessing individual differences to understand how patients adjust to chronic back pain.

A concept for comprehensively measuring health, function and quality of life following orthopaedic interventions of the upper extremity.

The view that subjective complaints rather than "objective" measurements decide on whether to consult the doctor or allow for an intervention to be carried out, should contribute to the decision-making process. This is especially true in diseases with multiple joint impairments. Although a variety of patient self-assessment scores exists, no gold standard is available to measure function and quality of life (QoL) after interventions at the upper extremity. The goal of our concept is to establish a comprehensive score set where patients should rate their generic health resp. quality of life (QoL), function of the upper extremity and specific joint function including activities of daily living, function and pain. A comparison with normative data should be possible in order to estimate how the subjective results of the patient when compared to "healthy" people in the general population. Score sets for measuring intervention effect at the shoulder, elbow and the hand were established after previous methodological testing within an interdisciplinary research project. The provisional sets were defined following a systematic literature search. Each set received a score of measuring the quality of life (SF-36), the whole function of the arm (DASH) and the specific joint function (SPADI/ASES for shoulder, PREE/mASES for the elbow and PRWE/custom for the hand). Individual scores were translated, if necessary according to AAOS-guidelines, and tested for reliability and construct validity. All three score sets were then systematically tested in cross-sectional studies. In addition, characteristic values such as minimal detectable difference and effect size could already be determined in the shoulder set in a long-term study. Definite score sets were defined, which allow quantification of the intervention effect at the upper extremity on function and quality of life after.

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.

Responsiveness of five condition-specific and generic outcome assessment instruments for chronic pain.

BACKGROUND: Changes of health and quality-of-life in chronic conditions are mostly small and require specific and sensitive instruments. The aim of this study was to determine and compare responsiveness, i.e. the sensitivity to change of five outcome instruments for effect measurement in chronic pain. METHODS: In a prospective cohort study, 273 chronic pain patients were assessed on the Numeric Rating Scale (NRS) for pain, the Short Form 36 (SF-36), the Multidimensional Pain Inventory (MPI), the Hospital Anxiety and Depression Scale (HADS), and the Coping Strategies Questionnaire (CSQ). Responsiveness was quantified by effect size (ES) and standardized response mean (SRM) before and after a four week in-patient interdisciplinary pain program and compared by the modified Jacknife test. RESULTS: The MPI measured pain more responsively than the SF-36 (ES: 0.85 vs 0.72, p = 0.053; SRM: 0.72 vs 0.60, p = 0.027) and the pain NRS (ES: 0.85 vs 0.62, p < 0.001; SRM: 0.72 vs 0.57, p = 0.001). Similar results were found for the dimensions of role and social interference with pain. Comparison in function was limited due to divergent constructs. The responsiveness of the MPI and the SF-36 was equal for affective health but both were better than the HADS (e.g. MPI vs HADS depression: ES: 0.61 vs 0.43, p = 0.001; SF-36 vs HADS depression: ES: 0.54 vs 0.43, p = 0.004). In the "ability to control pain" coping dimension, the MPI was more responsive than the CSQ (ES: 0.46 vs 0.30, p = 0.011). CONCLUSION: The MPI was most responsive in all comparable domains followed by the SF-36. The pain-specific MPI and the generic SF-36 can be recommended for comprehensive and specific bio-psycho-social effect measurement of health and quality-of-life in chronic pain.

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.

Effectiveness of subgroup-specific pain rehabilitation: a randomized controlled trial in patients with chronic back pain.

BACKGROUND: Prospective classification of patients with nonspecific chronic back pain into homogeneous subgroups might be an important objective in order to tailor interventions and improve treatment outcomes. AIM: This study investigated the effect of a subgroup-specific pain rehabilitation program based on the Multidimensional Pain Inventory (MPI) Classification System compared to standard care. DESIGN: Single blinded, parallel group, pragmatic randomized controlled trial. SETTING: Inpatient subjects of a rehabilitation clinic. POPULATION: A total of 139 patients with chronic back pain. METHODS: Patients in both the experimental group and control group received during their 4-week in-house stay at the rehabilitation clinic on average four daily sessions of therapy. The patients in the experimental group received specific interventions, which were tailored to their subgroup classification profile. The patients in the control group participated in state-of-the-art care. The primary outcome was self-reported disability measured at 1, 3 and 12 months after randomization with the Oswestry Disability Index (ODI). Secondary outcomes were pain intensity, examiner-reported disability, anxiety and depression, catastrophizing, self-efficacy and global perceived effect. RESULTS: Groups were comparable under demographic and clinical characteristics. No significant differences between the experimental group and the control group for any of the outcomes and follow-up times were found in the intention-to-treat analysis. Compared to the 8-10 points considered as minimal clinically important difference for the ODI, effects within groups were small, e.g. the experimental group improved by 2.2 points at 1-month follow-up, 3.7 points at 3 months and 5.3 points at 12 months. CONCLUSIONS: This study failed to demonstrate that a subgroup-specific program was more effective than standard care. CLINICAL REHABILITATION IMPACT: Since the subgroup-specific interventions were equally effective as standard pain rehabilitation, subgroup classification and tailoring interventions may be an alternative in clinical care.

The minimal clinically important difference raised the significance of outcome effects above the statistical level, with methodological implications for future studies.

OBJECTIVE: To illustrate and discuss current and proposed new concepts of effect size (ES) quantification and significance, with a focus on statistical and clinical/subjective interpretation and supported by empirical examples. STUDY DESIGN AND SETTINGS: Different methods for determining minimal clinically important differences (MCIDs) are reviewed, applied to practical examples (pain score differences in knee osteoarthritis), and further developed. Their characteristics, advantages, and disadvantages are illustrated and discussed. RESULTS: Empirical score differences between verum and placebo become statistically significant if sample sizes are sufficiently large. MCIDs, by contrast, are defined by patients' perceptions. MCIDs obtained by the most common "mean change method" can be expressed as absolute or relative scores, as different ES parameters, and as the optimal cutoff point on the receiver operating characteristic curve. They can further be modeled by linear and logistic regression, adjusting for potential confounders. CONCLUSION: Absolute and relative MCIDs are easy to interpret and apply to data of investigative studies. MCIDs expressed as effect sizes reduce bias, which mainly results from dependency on the baseline score. Multivariate linear and logistic regression modeling further reduces bias. Anchor-based methods use clinical/subjective perception to define MCIDs and should be clearly differentiated from distribution-based methods that provide statistical significance only.