The role of mild systemic heat and physical activity on endothelial function in patients with increased cardiovascular risk: results from a systematic review.

BACKGROUND/AIMS: In various animal models the application of systemic heat and physical activity (PA) has induced an up-regulation of endothelial nitric oxide synthase. Several experts in the field suggest shear stress as the main mechanism. A review was performed to summarize the results from clinical studies investigating the effect of mild systemic heat (MSH) and PA on endothelium-dependent vasodilation (EDD) in persons at increased cardiovascular risk. METHODS: MEDLINE was searched from 1990 to 2008. Randomized controlled trials (RCTs) investigating the effect of MSH and/or PA on EDD in persons with at least one cardiovascular risk factor were included. RESULTS: For MSH, no RCTs were found, while for PA 12 RCTs could be identified (n = 383 participants). Besides one trial, EDD was assessed as percent flow-mediated dilation (% FMD). Three meta-analyses were performed depending on participants' age as well as type and length of PA intervention. All trials revealed effects in favor of PA compared to a non-intervention control. For example, in a meta-analysis of 3 PA trials including 106 participants and comparing 12-week aerobic exercise with a non-exercise control, EDD was statistically significantly improved (weighted mean difference: 2.14% FMD; 95% confidence interval: 1.12-3.15% FMD). CONCLUSION: The review provides clear evidence that PA improves endothelial function in persons at increased cardiovascular risk. For MSH, evidence from RCTs is lacking. However, because MSH and PA are assumed to be based on the same main mechanism, a comparable effect of MSH on endothelial function may be possible. This should be scrutinized in an RCT.

The future of physical & rehabilitation medicine as a medical specialty in the era of evidence-based medicine.

Ebenbichler G, Kerschan-Schindl K, Brockow T, Resch KL: The future of physical & rehabilitation medicine as a medical specialty in the era of evidence-based medicine.

Evaluation of the efficacy of subcutaneous carbon dioxide insufflations for treating acute non specific neck pain in general practice: A sham controlled randomized trial.

BACKGROUND: Subcutaneous carbon dioxide insufflations are a safe and inexpensive treatment modality in complementary medicine and are used mainly in musculoskeletal pain and vascular conditions. However, no rigorous trial exists on their efficacy. AIMS: To evaluate whether patients with acute non specific neck pain get pain free sooner, if treated with subcutaneous carbon dioxide insufflations compared to sham ultrasound. METHODS: One hundred and twenty-six persons from one German general practice with acute non specific neck pain less than 7 days and a current pain intensity 40 mm on a 100 mm visual analogue scale were included into the trial. Participants received either a maximum number of nine subcutaneous carbon dioxide insufflations or a maximum number of nine sham ultrasound administered by four therapists in a randomized order, thrice weekly. Main outcome measure was time to neck pain relief during a 28 days follow-up period from baseline analyzed by intention to treat. RESULTS: Twenty-seven of 63 patients (43%) got neck pain free in the subcutaneous carbon dioxide insufflations group compared to 29 of 63 (46%) in the sham ultrasound group. Median time to neck pain relief was 28 days in both groups (p=.77; logrank test). Secondary analyses yielded similar results. CONCLUSIONS: The study indicates that subcutaneous carbon dioxide insufflations are not superior to sham ultrasound for treating patients with acute non specific neck pain. Because course of pain did not differ from the one expected from self limitation, it is likely that non specific effects played only a minor role, if any, in both interventions.

A pragmatic randomized controlled trial on the effectiveness of highly concentrated saline spa water baths followed by UVB compared to UVB only in moderate to severe psoriasis.

BACKGROUND: There is a lack of sufficiently large randomized trials evaluating the effectiveness of saline spa balneophototherapy compared to ultraviolet B (UVB) only. OBJECTIVE: The study aimed to evaluate whether highly concentrated saline spa water baths followed by UVB (HC-SSW-UVB) are superior to UVB only in moderate to severe psoriasis. METHODS: One hundred and sixty (160) adults with a Psoriasis Area and Severity Index (PASI) of >10 from 4 German spa centers were randomly allocated to HC-SSW-UVB (local sodium chloride concentration between 25% and 27%) or UVB only 3 a week until remission (PASI < 5) or for a maximum of 6 weeks. Reduction of PASI > or = 50% (PASI-50) at the end of the intervention period was defined as primary outcome. Only persons receiving at least 1 intervention were included into the primary analysis. RESULTS: Participants allocated to HC-SSW-UVB attained to a statistically significantly higher rate of PASI-50 than patients allocated to UVB only (68/79 [86%] versus 38/71 [54%]; p < 0.001; number needed to treat, 3.1; 95% confidence interval, 2.1-6.0). Postintervention analysis did not yield a clear hint of a persisting effect. CONCLUSIONS: The study indicates that HC-SSW-UVB are superior to routine UVB at the end of a 6-week treatment course.

Are the contents of treatment outcomes in fibromyalgia trials represented in the International Classification Of Functioning, Disability, and Health?

OBJECTIVES: To identify the concepts contained in treatment outcomes of randomized controlled trials (RCTs) for interventions in patients with fibromyalgia (FM) using the International Classification of Functioning, Disability, and Health (ICF) as external reference. METHODS: RCTs between 1992 and 2001 were located in MEDLINE and selected according to predefined eligibility criteria. The outcome measures were extracted and the concepts within the outcome measures were identified and linked to the ICF using a content-analytical approach. RESULTS: Forty-two trials on FM were included. Twenty-seven different questionnaires were extracted. Of all, 79.2% (N=236) of the clinical and physiologic outcomes could be linked to 31 different ICF categories and 84.7% (N=964) of the concepts contained in the health-status questionnaire to 113 ICF categories. CONCLUSIONS: The ICF provides a useful external reference to identify the concepts contained in outcome measures used in RCTs in FM.

Bath PUVA and saltwater baths followed by UV-B phototherapy as treatments for psoriasis: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of psoralens dissolved in a warm-water bath followed by exposure to UV-A irradiation (bath PUVA) or saltwater phototherapy (SW UV-B) compared with tap-water phototherapy (TW UV-B) or UV-B irradiation alone in psoriasis. DESIGN: Multisite, prospective, randomized, controlled trial with 4 parallel groups. SETTING: Total of 102 dermatologic outpatient clinics. PATIENTS: Total of 1241 patients with stable psoriasis vulgaris and a Psoriasis Area and Severity Index score of 7 or greater. INTERVENTIONS: Four-times-weekly UV-B, TW UV-B, SW UV-B, or bath-PUVA with baths preceding UV irradiation over a maximum of 8 weeks. The UV dose was adapted to erythemal response. MAIN OUTCOME MEASURES: Incidence of therapeutic success, defined as a reduction of the Psoriasis Area and Severity Index or affected body surface area of 50% or more. RESULTS: Patients who received TW UV-B had a significantly higher incidence of therapeutic success than did patients treated with UV-B alone (60.7% vs 43.3%; P<.001; number needed to treat, 5.8; 95% confidence interval [CI], 3.9-10.9). Patients who received SW UV-B or bath PUVA had a significantly higher incidence of therapeutic success than did patients treated with TW UV-B (74.9% vs 60.7%; P<.001; number needed to treat, 7.0; 95% CI, 4.6-14.9; and 78.4% vs 60.7%; P<.001; number needed to treat, 5.7; 95% CI, 4.0-9.7, respectively). Bath PUVA was not superior to SW UV-B (78.4% vs 74.9%; P = .34). CONCLUSION: Bath PUVA and SW UV-B are comparably effective treatments in psoriasis and superior to UV-B and TW UV-B.

A randomized controlled trial on the effectiveness of mild water-filtered near infrared whole-body hyperthermia as an adjunct to a standard multimodal rehabilitation in the treatment of fibromyalgia.

OBJECTIVES: To evaluate whether mild water-filtered near infrared whole-body hyperthermia (NI-WBH) produces an additional benefit when applied as an adjunct to a standard multimodal rehabilitation (MR) compared with MR only in patients with fibromyalgia (FM). METHODS: One hundred thirty-nine patients of a German inpatient rehabilitation hospital meeting the ACR 1990 criteria for FM were randomly allocated to NI-WBH (heating-up to 38.1 degrees C body core temperature followed by a 15 min heat retention period) and MR or MR only, twice a week over 3 weeks. Main outcome measures were affective and sensory pain assessed by a German version of the McGill Pain Questionnaire, measured at baseline, postintervention, 3 and 6 months postintervention and analyzed by intention to treat. RESULTS: Repeated measures analysis of covariance showed significant differences between groups for both primary outcome measures in favor of NI-WBH and MR compared with MR only (P<0.001 for affective pain, P=0.001 for sensory pain). Secondary analyses on pain intensity, FM-related quality of life and tender point assessment yielded similar results. Moderate effect sizes were observed for all outcome measures considered (range, 0.41 to 0.75). NI-WBH related side effects were observed in 14 of 69 participants (20%) but all disappeared in less than 30 minutes. DISCUSSION: The study indicates that NI-WBH is a worthwhile adjunct to MR in the treatment of FM.

Content comparison of low back pain-specific measures based on the International Classification of Functioning, Disability and Health (ICF).

OBJECTIVES: The objective of this study was to compare the content covered by the North American Spine Society Lumbar Spine Outcome Assessment Instrument, the Oswestry Low Back Disability Questionnaire, and the Roland-Morris Disability Questionnaire based on the International Classification of Functioning, Disability and Health (ICF). METHODS: The linkage of items of the three measures to the ICF involved three steps, which were performed by two different health professionals and in which 10 different linking rules were applied. RESULTS: In the 48 items of the three instruments, a total of 123 concepts were identified and linked to the ICF. The concepts contained in the items were linked to 10 ICF categories of the component "body functions," 27 of the component "activities and participation," and 4 of the component "environmental factors." The estimated kappa coefficients ranged from 0.67 to 1.00. CONCLUSION: Comparison based on the ICF provides insight into both the breadth of health dimensions measured as well as the thoroughness and depth of measurement. Therefore, it can be a useful tool when selecting specific measures for a study. Compared with other types of qualitative review, the most important advantage of the content comparison of measures based on the ICF is the use of an external and independent reference to which all the instruments can be linked and by which all the instruments can be compared. The three back-specific measures are comparable, with their common focus on physical aspects of body functions and activities and participation.

Identifying the concepts contained in outcome measures of clinical trials on musculoskeletal disorders and chronic widespread pain using the International Classification of Functioning, Disability and Health as a reference.

OBJECTIVES: To systematically identify and compare the concepts contained in outcome measures of clinical trials on low back pain, chronic widespread pain, osteoarthritis, osteoporosis and rheumatoid arthritis using the International Classification of Functioning, Disability and Health (ICF) as a reference. METHODS: Randomized controlled trials carried out between 1991 and 2000 were identified using MEDLINE and selected according predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked to the ICF. RESULTS: One hundred and twenty-nine trials on low back pain, 42 trials on chronic widespread pain, 176 trials on osteoarthritis, 107 trials on osteoporosis and 382 trials on rheumatoid arthritis were included. Fifty-nine different health status questionnaires were extracted in low back pain, 29 in chronic widespread pain, 29 in osteoarthritis, 3 in osteoporosis and 48 in rheumatoid arthritis. Across conditions at least 77% (range 77-88%) of the extracted concepts could be linked to the ICF. In low back pain, chronic widespread pain and osteoarthritis the most used ICF-categories were sensation of pain (b280), in osteoporosis structure of trunk (s760) and in rheumatoid arthritis additional musculoskeletal structures related to movement (s770). The most used category across conditions was sensation of pain (b280) except for osteoporosis. CONCLUSION: The ICF provides a useful reference to identify and quantify the concepts contained in outcome assessment used in clinical trials.

Identifying the concepts contained in outcome measures of clinical trials on four internal disorders using the International Classification of Functioning, Disability and Health as a reference.

OBJECTIVES: To systematically identify and compare the concepts contained in outcome measures of clinical trials on chronic ischaemic heart disease, diabetes mellitus, obesity, and obstructive pulmonary disease, including asthma using the International Classification of Functioning, Disability and Health (ICF) as a reference. METHODS: Randomized controlled trials between 1993 and 2003 were located in MEDLINE and selected according predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked to the ICF. RESULTS: 166 trials on chronic ischaemic heart disease, 227 trials on diabetes mellitus, 428 trials on obesity, and 253 trials on obstructive pulmonary disease were included. Ten different health status questionnaires (fulfilling the inclusion criteria) were extracted in chronic ischaemic heart disease, 19 in diabetes mellitus, 47 in obesity, and 39 in obstructive pulmonary disease. Across conditions at least 75% (range 75-92%) of the extracted concepts could be linked to the ICF. In diabetes mellitus and obesity the most used ICF categories were general metabolic functions (b540), in obstructive pulmonary disease respiration functions (b440) and in chronic ischaemic heart disease heart functions (b410). CONCLUSION: In all 4 health conditions the majority of studies were drug trials focusing on clinically relevant parameters and not on functioning. The ICF provides a useful reference to identify and quantify the concepts contained in outcome assessment used in clinical trials.

Identifying the concepts contained in outcome measures of clinical trials on breast cancer using the International Classification of Functioning, Disability and Health as a reference.

OBJECTIVES: To systematically identify and quantify the concepts contained in outcome measures of clinical breast cancer trials using the International Classification of Functioning, Disability and Health (ICF) as a reference. METHODS: Randomized controlled trials between 1991 and 2000 were located in MEDLINE and selected according predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked to the ICF. RESULTS: A total of 640 trials were included. Ninety-four different health status questionnaires were extracted. Three questionnaires were breast cancer-specific and 12 cancer-specific. Of 19,692 extracted concepts, 88% could be linked to the ICF. The most used ICF categories within the components body structures, body functions, and activities and participation were structure of the reproductive system (s630), sensations associated with the digestive system (b535), and looking after one's health (d570) with frequencies of 64%, 46% and 14%, respectively. No category of the environmental factors component reached a frequency of 10%. CONCLUSION: The ICF provides a useful reference to identify and quantify the concepts contained in outcome assessment used in clinical breast cancer trials. There seems to be a lack of health concepts evaluating specific aspects of disability and participation in breast cancer. Similarly, environmental factors with an impact on individual life of breast cancer survivors seem to be poorly represented.

Identifying the concepts contained in outcome measures of clinical trials on depressive disorders using the International Classification of Functioning, Disability and Health as a reference.

OBJECTIVES: First, to systematically identify the concepts contained in outcome measures of trials on depressive disorders using the International Classification of Functioning, Disability and Health (ICF) as a reference. Secondly, to explore differences in the use of ICF categories across different intervention types. Thirdly, to examine which and how often health status measures have been applied in trials on depressive disorders. METHODS: Randomized controlled trials between 1991 and 2000 were located in MEDLINE and selected according to predefined criteria. The outcome measures were extracted and the concepts contained in the outcome measures were linked to the ICF. RESULTS: A random sample of 203 (50%) of 406 eligible studies were included. The 5 most used ICF categories (range 88-94%) were sleep functions (b134), emotional functions (b152), energy and drive functions (b130), thought functions (b160) and higher-level cognitive functions (b164), all belonging to the body functions component. The use of ICF categories did not vary across different intervention types. A total of 126 different health status measures were extracted. The Hamilton Rating Scale for Depression was the most used health status measure applied in 80% of the studies. CONCLUSION: Concepts about execution of tasks/actions, participation in life situations, and the influence of the environment were under-represented in the outcome assessment of trials on depressive disorders. These observations indicate that most trials were limited in their ability to assess more global individual outcomes.

Identifying the concepts contained in outcome measures of clinical trials on stroke using the International Classification of Functioning, Disability and Health as a reference.

OBJECTIVES: To systematically identify and quantify the concepts contained in outcome measures in stroke trials using the International Classification of Functioning, Disability and Health (ICF) as a reference. METHODS: Randomized controlled trials between 1992 and 2001 were located in MEDLINE and selected according to predefined criteria. Outcome measures were extracted and concepts contained in the outcome measures were linked to the ICF. RESULTS: A random sample of 160 (50%) of 320 eligible studies was included. A total of 148 standardized health status measures were identified. Of 11,283 extracted concepts, 91% could be linked to the ICF. The most used ICF categories for each component were d450 walking (70%) for activities and participation, b525 defecation functions (62%) for body functions, and e399 support and relationships, unspecified (30%) for environmental factors. CONCLUSION: The ICF provides a useful reference to identify and quantify the concepts contained in outcome measures used in stroke trials. Outcome measurement in stroke refers to an enormous variety of concepts; for comparability of research findings agreement on what should be measured is needed.

Cross-cultural adaption of the Manniche questionnaire for German-speaking low back pain patients.

OBJECTIVE: To develop and validate a cross-cultural version of the Manniche Low Back Pain Rating Scale (MRS) for use in German-speaking low back pain patients. BACKGROUND: Clinical intervention research in back pain would be enormously facilitated if a small number of relevant, patient-centred questionnaires became internationally used. MRS seems to be particularly suitable for cross-cultural adaptation due to its coverage of multidimensional back pain-specific health domains. METHODS: MRS was translated and back-translated, pretested and reviewed by a committee. The German version was tested in 126 patients with low back pain from all countries of German-speaking Europe. Reliability (subsample n = 20), dimensionality and construct validity was assessed. Single-dimensionality, higher correlations of MRS with the physical scales compared with the mental scales of the MOS SF-36, a moderate to good correlation with the Roland Morris Questionnaire and a low correlation with the Finger Floor Distance were hypothesized. RESULTS: Spearman's Rho for test-retest reliability was 0.98 (p < 0.001); Cronbach's alpha 0.95. Factor analysis revealed only 1 factor with an Eigenvalue >1 [3.25]. MRS was strongly correlated with the Roland Morris Questionnaire (r = 0.91), and slightly correlated with the Finger Floor Distance (r = 0.23). Correlations of MRS with domains of the SF-36 "Physical Functioning", "Role Physical" and "Bodily Pain" were higher (r -0.66 to -0.72) than with "Role Emotional", "Mental Health" and "Social Functioning" (r -0.34 to -0.61). CONCLUSION: The German version of the MRS seems to be reliable, uni-dimensional and construct valid for the assessment of functional status in German-speaking low back pain patients.

Linking health-status measurements to the international classification of functioning, disability and health.

With the approval of the International Classification of Functioning, Disability and Health by the World Health Assembly in May 2001, the concurrent use of both health-status measures and the International Classification of Functioning, Disability and Health is expected. It is therefore important to understand the relationship between these two concepts. The objective of this paper is to provide a systematic and standardized approach when linking health-status measures to the International Classification of Functioning, Disability and Health. The specific aims are to develop rules, to test their reliability and to illustrate these rules with examples. Ten linking rules and an example of their use are presented in this paper. The percentage agreement between two health professionals for 8 health-status instruments tested is also presented. A high level of agreement between the health professionals reflects that the linking rules established in this study allow the sound linking of items from health-status measures to the International Classification of Functioning, Disability and Health.