bluuebunny/crossref_metadata_2025 huggingface dataset:
Language‐association cortex asymmetry in autism and specific language impairment
Authors: De Fossé Lies , Hodge Steven M. , Makris Nikos , Kennedy David N. , Caviness Verne S. , McGrath Lauren , Steele Shelley , Ziegler David A. , Herbert Martha R. , Frazier Jean A. , Tager‐Flusberg Helen , Harris Gordon J.
Published: October 2004

Language deficits are among the core impairments of autism. We previously reported asymmetry reversal of frontal language cortex in boys with autism. Specific language impairment (SLI) and autism share similar language deficits and may share genetic links. This study evaluated asymmetry of frontal language cortex in a new, independent sample of right‐handed boys, including a new sample of boys with autism and a group of boys with SLI. The boys with autism were divided into those with language impairment (ALI) and those with normal language ability (ALN). Subjects (right‐handed, aged 6.2–13.4 years) included 22 boys with autism (16 ALI and 6 ALN), 9 boys with a history of or present SLI, and 11 normal controls. MRI brain scans were segmented into grey and white matter; then the cerebral cortex was parcellated into 48 gyral‐based divisions per hemisphere. Group differences in volumetric asymmetry were predicted a priori in language‐related regions in inferior lateral frontal (Broca's area) and posterior superior temporal cortex. Language impaired boys with autism and SLI both had significant reversal of asymmetry in frontal language‐related cortex; larger on the right side in both groups of language impaired boys and larger on the left in both unimpaired language groups, strengthening a phenotypic link between ALI and SLI. Thus, we replicated the observation of reversed asymmetry in frontal language cortex reported previously in an independent autism sample, and observed similar reversal in boys with SLI, further strengthening a phenotypic link between SLI and a subgroup of autism. Linguistically unimpaired boys with autism had similar asymmetry compared with the control group, suggesting that Broca's area asymmetry reversal is related more to language impairment than specifically to autism diagnosis. Ann Neurol 2004
Norwegian version of the Canadian Occupational Performance Measure in patients with hand osteoarthritis: Validity, responsiveness, and feasibility
Authors: Kjeken Ingvild , Slatkowsky‐Christensen Barbara , Kvien Tore K. , Uhlig Till
Published: October 2004

Objective

To test the Norwegian version of the Canadian Occupational Performance Measure (COPM) for validity, responsiveness, and feasibility in patients with hand osteoarthritis.

Methods

Seventy‐nine patients completed a COPM interview and several self‐reported health status questionnaires, including Arthritis Impact Measurement Scales 2, modified Health Assessment Questionnaire; Western Ontario and McMaster Universities Osteoarthritis Index, and the Australian/Canadian Osteoarthritis Hand Index. Rescoring of the same instruments was performed 4 months later, after an intervention.

Results

The COPM detected a great variability of occupational performance problems. The hypotheses for testing validity were confirmed. Mean COPM change was 1.51 (P < 0.001) in performance score, and 2.22 (P < 0.001) in satisfaction score. The median time spent on the COPM interview was 30 minutes (range 10–70 minutes). The patients found the questions easy to understand, but 37% reported problems performing the scoring procedure.

Conclusions

The Norwegian version of the COPM is a valid and responsive instrument for use in clinical practice in osteoarthritis patients. It may serve as an instrument to promote a client‐centered approach and as a supplement to other health measures in the planning and evaluating of interventions. Feasibility regarding scoring needs to be improved.
High prevalence of symptomatic enthesopathy of the shoulder in ankylosing spondylitis: Deltoid origin involvement constitutes a hallmark of disease
Authors: Lambert Robert G. W. , Dhillon Sukhvinder S. , Jhangri Gian S. , Sacks Juliette , Sacks Herbert , Wong Benjamin , Russell Anthony S. , Maksymowych Walter P.
Published: October 2004

Objective

To examine the prevalence and characteristics of shoulder involvement in ankylosing spondylitis (AS). To analyze the sensitivity and specificity of shoulder lesions defined by magnetic resonance imaging (MRI) in patients with AS.

Methods

Prevalence of shoulder involvement was ascertained by chart review of 400 AS patients. One hundred of these patients and 285 controls were selected for clinical evaluation. AS patients with a clinically defined shoulder disorder (n = 15) and a control group of 91 patients (94 shoulders) with nonspecific shoulder pain were studied with MRI. Fifty‐four MRI‐defined variables per shoulder were analyzed by 2 observers. A third cohort of patients with AS (n = 76) was prospectively evaluated by clinical exam for AS‐specific shoulder lesions identified on MRI.

Results

Shoulder pain was recorded in 3.5% of patients by chart review. Shoulder involvement by clinical evaluation was noted in 24.7% of patients versus 14.2% of controls (odds ratio [OR] 8.17, 95% confidence interval [95% CI] 3.14–21.28, P < 0.001). Rotator cuff tendinitis was significantly more prevalent in patients (15.1%) than controls (3.5%; OR 8.17, 95% CI 2.66–25.14, P < 0.001). Acromioclavicular joint arthrosis was the most common lesion observed in AS shoulders (94%), although specificity was low (32%). Bone marrow edema at any entheseal site was noted in significantly more AS shoulders (70.6%) than in control (19.1%) shoulders (P < 0.001, corrected P = 0.02). Erosion of the greater tuberosity with or without adjacent bone edema had the best combination of sensitivity (58–65%) and specificity (86–92%). Intense acromial entheseal edema at the deltoid origin was observed only in AS shoulders (41.2%; P < 0.001). Evaluation of a prospective cohort of patients with AS showed that 22.4% had rotator cuff enthesopathy.

Conclusion

Shoulder lesions in AS are common and characterized clinically by rotator cuff tendinitis and on MRI by intense bone edema localized to the supraspinatus/greater tuberosity and deltoid/acromial entheses. Intense acromial bone edema at the deltoid origin is a hitherto undescribed and highly specific feature of AS. Enthesopathy of the rotator cuff is underrecognized in AS and should be incorporated into instruments measuring enthesitis.
Pilot study of the effects of a heat‐retaining knee sleeve on joint pain, stiffness, and function in patients with knee osteoarthritis
Authors: Mazzuca Steven A. , Page Mark C. , Meldrum Russell D. , Brandt Kenneth D. , Petty‐Saphon Satham
Published: October 2004

Objective

To identify changes in joint pain, stiffness, and functional ability in patients with knee osteoarthritis (OA) after use of a knee sleeve that prevents loss of body heat by the joint.

Methods

Subjects with symptomatic knee OA (n = 52) were randomized to 2 treatment groups: verum sleeve (specially fabricated to retain body heat) or placebo sleeve (standard cotton/elastane sleeve). Subjects wore the sleeve over the more painful OA knee for at least 12 hours daily for 4 weeks. Pain, stiffness, and functional impairment (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) in the index knee were measured at baseline and after 4 weeks of wear, after which sleeve use was discontinued. Telephone followup interviews were conducted 2 and 4 weeks later.

Results

After 4 weeks of sleeve wear, subjects in the active treatment group reported a 16% decrease in mean WOMAC pain score relative to baseline (P = 0.001). Those who wore the placebo sleeve reported a 9.7% decrease from baseline (P = 0.002). The difference between treatment groups was not statistically significant (P = 0.12). However, it was found that the 12 subjects who believed correctly that they had received the verum sleeve reported a highly significant decrease in WOMAC pain score (−27.5% relative to baseline, P = 0.0001). In comparison, subjects who received the verum sleeve but believed they had received the placebo sleeve exhibited only a marginally significant improvement in pain (−13.0% relative to baseline, P = 0.07). In the placebo group, the modest improvement in pain scores appeared unrelated to the subject's impression of the type of sleeve worn.

Conclusion

This pilot study was insufficiently powered to be a definitive trial of the heat‐retaining sleeve. Given the magnitude of changes in knee pain in the active treatment group, heat retention merits further scientific investigation as a treatment modality for patients with knee OA.
Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: A randomized clinical trial
Authors: Hoeksma Hugo L. , Dekker Joost , Ronday H. Karel , Heering Annet , Van Der Lubbe Nico , Vel Cees , Breedveld Ferdinand C. , Van Den Ende Cornelia H. M.
Published: October 2004

Objective

To determine the effectiveness of a manual therapy program compared with an exercise therapy program in patients with osteoarthritis (OA) of the hip.

Methods

A single‐blind, randomized clinical trial of 109 hip OA patients was carried out in the outpatient clinic for physical therapy of a large hospital. The manual therapy program focused on specific manipulations and mobilization of the hip joint. The exercise therapy program focused on active exercises to improve muscle function and joint motion. The treatment period was 5 weeks (9 sessions). The primary outcome was general perceived improvement after treatment. Secondary outcomes included pain, hip function, walking speed, range of motion, and quality of life.

Results

Of 109 patients included in the study, 56 were allocated to manual therapy and 53 to exercise therapy. No major differences were found on baseline characteristics between groups. Success rates (primary outcome) after 5 weeks were 81% in the manual therapy group and 50% in the exercise group (odds ratio 1.92, 95% confidence interval 1.30, 2.60). Furthermore, patients in the manual therapy group had significantly better outcomes on pain, stiffness, hip function, and range of motion. Effects of manual therapy on the improvement of pain, hip function, and range of motion endured after 29 weeks.

Conclusion

The effect of the manual therapy program on hip function is superior to the exercise therapy program in patients with OA of the hip.
Patient‐reported health care utilization in rheumatoid arthritis: What level of detail is required?
Authors: Ruof Jörg , Huelsemann Jan L. , Mittendorf Thomas , Handelmann Silke , Von Der Schulenburg J. Matthias , Zeidler Henning , Aultman Rick , Merkesdal Sonja
Published: October 2004

Objective

To investigate the level of detail required in self‐reported health care utilization questionnaires for administration to patients with rheumatoid arthritis (RA).

Methods

A preliminary questionnaire was developed on the basis of existing tools for use in rheumatic conditions and in‐depth interviews with 10 RA patients. Data gathered over 1 year of administration in a clinical setting were then matched to a comprehensive database of payer‐reported information. Kappa statistics were calculated for each health care utilization domain. For domains where disaggregation into metric data was potentially preferable, histograms of difference were assessed visually and the strength of association examined using Spearman's rank correlation coefficient.

Results

Patients (n = 136) included in the base case analysis determined the preferred levels of detail for each domain. Physician visits: occurrence of physician visits (yes/no; κ not applicable) and their number (r = 0.42, P < 0.001). Medication use of the following drug classes (yes/no): disease‐modifying antirheumatic drug (DMARD; κ = 0.68), nonsteroidal antiinflammatory drug (κ = 0.64), osteoporosis medication (κ = 0.56), analgesic (κ = 0.38), and steroid (κ = 0.83). Further disaggregation into different DMARD classes was recommended (κ ranging between 1 [use of biologics: yes/no] and 0.67 [use of azathioprine: yes/no]. Imaging: imaging of bones and chest (yes/no; κ = 0.20). Hospitalization: inpatient episodes (yes/no; κ = 0.64) and number of inpatient days (r = 0.80, P < 0.001). Transport: costs incurred (yes/no; κ = 0.13) and amount (r = 0.39, P < 0.001).

Conclusion

The use of highly aggregated items to assess health care utilization in RA is supported. Dichotomous assessment (yes/no) was the preferred level of detail for items in the domains covering medication and diagnostic procedures or tests. Metric data is appropriate in 3 areas: number of physician visits, number of inpatient days, and total expenditure on transportation.
Sex effects on heart rate variability in fibromyalgia and Gulf War illness
Authors: Stein Phyllis K. , Domitrovich Peter P. , Ambrose Kirsten , Lyden Angela , Fine Michael , Gracely Richard H. , Clauw Daniel J.
Published: October 2004

Objective

To investigate autonomic abnormalities in male and female fibromyalgia (FM) and Gulf War illness (GWI) patients by comparing heart rate variability (HRV) with that of age‐ and sex‐matched healthy controls.

Methods

Subjects included 26 (19 women, 7 men) with FM, 11 (6 men, 5 women) with GWI, and 36 (18 men,18 women) healthy controls. HRV was determined from Holter recordings obtained in the Clinical Research Center. Analysis of variance compared 24‐hour, daytime, and nighttime HRV by sex within groups and by group within sex.

Results

In women with FM or GWI, HRV was significantly lower than in men with FM or GWI. HRV was similar in male and female controls. When HRV was compared by group within sex, HRV was significantly decreased in women with FM or GWI and no significant differences were seen for men with these conditions.

Conclusion

Decreased HRV in FM and GWI appears to be sex dependent. Results suggest that different mechanisms may be operative in symptom expression in men and women with this spectrum of illness.
Comprehensive assessment of clinical outcome and quality of life after total shoulder arthroplasty: Usefulness and validity of subjective outcome measures
Authors: Angst Felix , Pap Géza , Mannion Anne F. , Herren Daniel B. , Aeschlimann André , Schwyzer Hans‐Kaspar , Simmen Beat R.
Published: October 2004

Objective

To explore the physiometric and psychometric properties of clinical, generic, and condition‐specific assessment instruments. To describe patients' outcome after total shoulder arthroplasty.

Methods

Forty‐three patients were assessed in a 5–6‐year cross‐sectional catamnesis.

Results

With regard to shoulder joint stability, pain, general physical health, and mental health, the patients showed scores comparative to normative scores. Significant functional limitation was evidenced by low mean scores on the specific function scales (e.g., Disability of the Arm, Shoulder and Hand questionnaire score = 64.0, normative score = 86.6). There were high correlations among the joint‐specific scales (up to 0.93) and moderate correlations between these and the generic and clinical scales. Factor analysis identified 3 different assessment domains.

Conclusion

The patients' quality of life (QOL) was high and not affected by impairment in some specific functional abilities. Physical QOL, mental QOL, clinical assessment, condition‐specific measures, and generic measures were identified as separate domains, all of which are required for a comprehensive and sophisticated assessment in practical clinical routine.
Health of children with chronic arthritis: Relationship of different measures and the quality of parent proxy reporting
Authors: Brunner Hermine I. , Klein‐Gitelman Marisa S. , Miller Michael J. , Trombley Michael , Baldwin Nicole , Kress Angela , Johnson Anne L. , Barron Andrea C. , Griffin Thomas A. , Passo Murray H. , Lovell Daniel J.
Published: October 2004

Objective

To examine the strength of the association between different measures of health‐related quality of life (HRQOL), disability, pain, and well‐being in children with chronic arthritis. To evaluate whether HRQOL scores vary as a function of disability status beyond chance. To assess the quality of the parent proxy report for HRQOL as compared with disability, pain, and well‐being.

Methods

Measures of HRQOL (visual analog scale [VAS] of health, Pediatric Quality of Life Inventory [PedsQL], Juvenile Arthritis Quality of Life Questionnaire (JAQQ), and modified standard gamble technique [SG]), disability (Childhood Health Assessment Questionnaire), VAS of pain, and VAS of well‐being (VAS‐well) were completed by the parents (n = 119) and patients ≥8 years (SG: ≥12 years).

Results

HRQOL was highest when measured by the SG, whose utilities were no more than weakly correlated with any of the other outcomes. The values of all other HRQOL measures were at least moderately correlated with each other and with the VAS‐well. Irrespective of the measure used, disability was associated with significantly decreased HRQOL. There was fair to good agreement and moderate consistency of the HRQOL ratings (SG: fair consistency) between patients and parents with marked differences between health domains.

Conclusion

HRQOL measured by the PedsQL, JAQQ, and VAS are moderately to highly correlated with each other in children with chronic arthritis. The children's HRQOL significantly decreases with increasing disability. Despite more pronounced differences for some health domains, parents are moderate to good proxy reporters of HRQOL, disability, and well‐being of children with chronic arthritis.
Identification of modifiable work‐related factors that influence the risk of work disability in rheumatoid arthritis
Authors: Lacaille Diane , Sheps Samuel , Spinelli John J. , Chalmers Andrew , Esdaile John M.
Published: October 2004

Objective

To define work‐related factors associated with increased risk of work disability (WD) in people with rheumatoid arthritis (RA).

Methods

Questionnaires were mailed to all RA patients who used a province‐wide arthritis treatment program between 1991 and 1998 (n = 1,824). The association between risk factors and WD (defined as no paid work due to RA for at least 6 months) was assessed using multiple logistic regression analysis, controlling for significant sociodemographic and disease‐related variables.

Results

Of the original 1,824 patients, 581 were eligible and responded to the questionnaire. Work survival analysis revealed a steady rate of WD starting early, with 7.5%, 18%, and 27% work disabled at 1, 5, and 10 years, respectively. Significant determinants in multiple logistic regression were physical function (Health Assessment Questionnaire), pain (visual analog scale), and 6 work‐related factors: self employment, workstation modification, work importance, family support toward employment, commuting difficulty, and comfort telling coworkers about RA.

Conclusion

Work disability occurs early in RA. Novel work‐related factors were identified, which are potentially modifiable, to help RA patients stay employed.
Psychosocial and geriatric correlates of functional status after total hip replacement
Authors: Bischoff‐Ferrari H. A. , Lingard E. A. , Losina E. , Baron J. A. , Roos E. M. , Phillips C. B. , Mahomed N. N. , Barrett J. , Katz J. N.
Published: October 2004

Objective

To determine whether psychosocial factors, chronic diseases, and common geriatric problems are associated with poor physical function 3 years after primary total hip replacement (THR).

Methods

We studied a sample of Medicare recipients in Ohio, Pennsylvania, and Colorado (n = 922) who underwent primary THR in 1995 (mean ± SD age 73.1 ± 5.6 years, 32% men). Participants completed a questionnaire regarding lifestyle factors, medical history, and quality of life ∼3 years after the surgery. Physical function was measured using the function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index. We assessed the relationship between functional outcome 3 years postsurgery and 4 predictor domains: pain or complications in the operated hip, other musculoskeletal comorbidity, medical factors (obesity, chronic medical comorbidity, rheumatoid arthritis, and such common geriatric problems as falls, poor balance, or incontinence), and psychosocial factors (mental health, regular alcohol consumption, smoking, provider role, living alone, and education).

Results

Ten percent of subjects had poor functional status. In a logistic regression model controlling for sex and age, the following factors were associated with an increased risk for poor functional status (in order of importance): pain in the back or lower extremity, severe pain in the operated hip, poor mental health, more than 1 common geriatric problem, obesity, and less than college education.

Conclusion

Pain in the operated hip was strongly associated with poor functional status 3 years after THR. However, other factors associated with poor functional status were not related to the hip. Our results suggest that a comprehensive assessment of functional status in elderly THR patients should include assessment of common geriatric problems, mental health status, and weight.
Reliability and validity of the proposed American College of Rheumatology neuropsychological battery for systemic lupus erythematosus
Authors: Kozora Elizabeth , Ellison Misoo C. , West Sterling
Published: October 2004

Objective

To examine the reliability and validity of the proposed American College of Rheumatology (ACR) neuropsychological battery for patients with systemic lupus erythematosus (SLE).

Methods

Thirty‐one SLE patients with a history of neuropsychiatric symptoms (NPSLE), 22 SLE patients without a history of neuropsychiatric symptoms (non‐NPSLE), and 25 healthy controls completed measures of cognition at baseline and after 1 month. The 1‐hour proposed ACR‐SLE battery was compared with a 4‐hour comprehensive battery (CB).

Results

Seven of 12 measures from the ACR‐SLE battery were lower in SLE patients compared with controls. Overall agreement between impairment on the ACR‐SLE battery and the CB was 90%. This was established using previously defined impairment on the CB and 4 of 12 scores impaired on the ACR‐SLE battery. Almost perfect agreement between the 2 batteries was found for non‐NPSLE patients and healthy controls (95–96%) and moderate agreement was reported for NPSLE patients (81%). Intraclass correlation coefficients for ACR‐SLE tests ranged from 0.40 to 0.90, indicating adequate reliability.

Conclusion

Reliability and validity of the ACR‐SLE battery was established in this study. Agreement regarding classification for impairment was almost perfect for non‐NPSLE and moderate for the NPSLE patients. The ACR battery is well designed for general classification of cognitive impairment in SLE. However, comprehensive testing may be useful in identifying specific deficits in NPSLE.
Are there more than cross‐sectional relationships of social support and support networks with functional limitations and psychological distress in early rheumatoid arthritis? The European Research on Incapacitating Diseases and Social Support Longitudinal Study
Authors: Demange V. , Guillemin F. , Baumann M. , Suurmeijer T. P. B. M. , Moum T. , Doeglas D. , Briançon S. , van den Heuvel W. J. A.
Published: October 2004

Objective

To investigate whether greater social support and support network are cross‐sectionally associated with less functional limitations and psychological distress in patients with early rheumatoid arthritis (RA); whether this association is constant over time; and whether increases in social support or support network are associated with less functional limitations and psychological distress.

Methods

Subjects were from the European Research on Incapacitating Diseases and Social Support cohort and had early RA. Social support, support network, functional limitations (Health Assessment Questionnaire), and psychological distress (General Health Questionnaire) were assessed annually. Variance and covariance analyses with repeated measures were performed.

Results

A total of 542 subjects were assessed for 3 years. On average, patients with a greater amount of specific social support or a stronger specific support network experienced less functional limitation and less psychological distress. Changes in a given subject's functional limitations and psychological distress did not depend on his or her baseline social support or support network. Neither social support nor support network change over time.

Conclusion

There may be a cross‐sectional link between specific social support or support network and functional limitations and psychological distress, but no longitudinal association could be evidenced.
Longitudinal comparison of the Health Assessment Questionnaire (HAQ) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Authors: Bruce Bonnie , Fries James
Published: October 2004

Objective

To compare the measurement properties of the generic Health Assessment Questionnaire (HAQ) and the disease‐specific Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Methods

Physical function, pain, and radiographic progression were assessed in knee or hip osteoarthritis patients (n = 271) who had 2 radiographs that were at least 6 months apart from 6 ARAMIS (Arthritis, Rheumatism, and Aging Medical Information System) databanks. Data were compared at baseline and after a mean of 3.2 (SE 0.10) years. Correlation coefficients and standardized effect sizes (SES) were used to assess their relationship and responsiveness.

Results

The majority of items in the 2 function and pain scales overlapped and were highly and significantly correlated with each other at baseline and last assessments (function at baseline rs = 0.71 and function at last assessment rs = 0.79, P < 0.0001; pain at baseline rs = 0.70 and pain at last assessment rs = 0.76, P < 0.0001). The HAQ disability index and total knee score were more sensitive to detection of disease progression than the WOMAC (SES for HAQ = 0.27; SES for WOMAC = −0.05).

Conclusion

Both instruments showed favorable measurement properties, with the HAQ having the advantages of being more sensitive to change and adaptable to a wide variety of diseases and conditions, which contribute to the generalizability of findings.
Serum levels of matrix metalloproteinase 3 and macrophage colony‐stimulating factor 1 correlate with disease activity in ankylosing spondylitis
Authors: Yang Chunhua , Gu Jieruo , Rihl Markus , Baeten Dominique , Huang Feng , Zhao Miansong , Zhang Hanwei , Maksymowych Walter P. , De Keyser Filip , Veys Eric M. , Yu David T. Y.
Published: October 2004

Objective

To assess the usefulness of measuring serum matrix metalloproteinase 3 (MMP‐3) and macrophage colony‐stimulating factor (M‐CSF) in patients with ankylosing spondylitis (AS).

Methods

Serum levels of MMP‐3 and M‐CSF were measured in AS patients who did and did not receive infliximab treatment. These were compared with those of 28 healthy subjects.

Results

In the group of AS patients not treated with biologics, both M‐CSF and MMP‐3 correlated with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) values, but not with each other. Logistic regression analysis showed that MMP‐3 values were high in those with severely active disease. Infusions of infliximab in AS patients led to a significant decrease in the values of the BASDAI as well as the serum MMP‐3, but no change in the serum M‐CSF values.

Conclusion

MMP‐3 and M‐CSF are potentially useful markers of AS disease activity.
Randomized, double‐blind, placebo‐controlled glucosamine discontinuation trial in knee osteoarthritis
Authors: Cibere Jolanda , Kopec Jacek A. , Thorne Anona , Singer Joel , Canvin Janice , Robinson David B. , Pope Janet , Hong Paul , Grant Eric , Esdaile John M.
Published: October 2004

Objective

To assess the efficacy of glucosamine sulfate in knee osteoarthritis (OA).

Methods

A 4‐center, 6‐month, randomized, double‐blind, placebo‐controlled glucosamine discontinuation trial was conducted in 137 current users of glucosamine with knee OA who had experienced at least moderate improvement in knee pain after starting glucosamine. Study medication dosage was equivalent to the dosage of glucosamine taken prior to the study (maximum 1,500 mg/day). Followup continued for 6 months or until disease flare, whichever occurred first. The primary outcome was the proportion of disease flares in the glucosamine and placebo groups using an intent‐to‐treat analysis. Secondary outcomes included time to disease flare; analgesic medication use; severity of disease flare; and change in pain, stiffness, function and quality of life in the glucosamine and placebo groups.

Results

Disease flare was seen in 28 (42%) of 66 placebo patients and 32 (45%) of 71 glucosamine patients (difference −3%; 95% confidence interval [95% CI] −19, 14; P = 0.76). In the Cox regression analysis, after adjustment for sex, study site, and OA radiographic severity, time to disease flare was not significantly different in the glucosamine compared with placebo group (hazard ratio of flare = 0.8; 95% CI 0.5, 1.4; P = 0.45). At final study visit, acetaminophen was used in 27% and 21% of placebo and glucosamine patients, respectively (P = 0.40), nonsteroidal antiinflammatory drugs were used in 29% and 30% (P = 0.92), and both were used in 20% and 21% (P = 0.84). No differences were found in severity of disease flare or other secondary outcomes between placebo and glucosamine patients.

Conclusion

In patients with knee OA with at least moderate subjective improvement with prior glucosamine use, this study provides no evidence of symptomatic benefit from continued use of glucosamine sulfate.
A comparison of the efficacy and safety of nonsteroidal antiinflammatory agents versus acetaminophen in the treatment of osteoarthritis: A meta‐analysis
Authors: Lee Chin , Straus Walter L. , Balshaw Robert , Barlas Suna , Vogel Suzanne , Schnitzer Thomas J.
Published: October 2004

Objective

To perform a meta‐analysis comparing the efficacy and safety of recommended dosages of nonsteroidal antiinflammatory drugs (NSAIDs), including cyclooxygenase 2 inhibitors, versus acetaminophen in the treatment of symptomatic hip and knee osteoarthritis.

Methods

Medline and EMBASE searches were performed for original clinical trials directly comparing NSAIDs with acetaminophen. A standardized form was used to abstract all data, including outcome measures of pain at rest, walking pain, and dropouts due to adverse effects. Inverse‐variance‐weighted mean differences (WMDs) and 95% confidence intervals (95% CI) for pain measures were determined for treatment groups. Odds ratios (ORs) and 95% CIs were calculated for withdrawals due to adverse events. Results were compared using a random effects model.

Results

Seven articles met inclusion criteria with sufficient data for analysis. Participants had a mean age of 61.1 years and 71.1% were women. Test of heterogeneity was not significant for either rest (P = 0.73) or walking (P = 0.76) pain. The scores for overall pain at rest (WMD −6.33 mm on a 100‐mm visual analog scale [VAS], 95% CI −9.24, −3.41) and walking pain (WMD –5.76 mm on a 100‐mm VAS, 95% CI –8.99, –2.52) favored the NSAID‐treated group. Although NSAIDs elevated the risk of withdrawals due to adverse events, the difference was not statistically significant (OR 1.45, 95% CI 0.93, 2.27).

Conclusion

NSAIDs are statistically superior in reducing rest and walking pain compared with acetaminophen for symptomatic osteoarthritis. Safety, measured by discontinuation due to adverse events, was not statistically different between NSAID‐ and acetaminophen‐treated groups.
A crossover trial of custom‐made and commercially available wrist splints in adults with inflammatory arthritis
Authors: Haskett Sandra , Backman Catherine , Porter Barbara , Goyert Jill , Palejko Gillian
Published: October 2004

Objective

To compare the effect of 3 wrist splints (2 prefabricated commercial splints and 1 custom made) on perceived wrist pain, hand function, and perceived upper extremity function in adults with inflammatory arthritis.

Methods

Subjects (n = 45, mean age 49 years, mean disease duration 8.6 years) were randomly assigned to treatment order in a 3‐phase crossover trial. Splints were worn for 4 weeks, separated by 1‐week washouts. Outcomes were assessed at baseline, after each splint phase and washout period, and at 6 months' followup using a pain visual analog scale (VAS), the Arthritis Hand Function Test, and McMaster‐Toronto Arthritis Patient Function Preference questionnaire. Data were analyzed with multivariate analyses of variance (MANOVAs), t‐tests, and chi‐square tests.

Results

There did not appear to be order or carryover effects. MANOVA indicated that wrist splints significantly reduced pain (P = 0.007). The custom leather splint was most effective in reducing pain, from 4.1 cm to 2.8 cm on the VAS (P = 0.001). All splints improved hand strength, and the commercial Rolyan splint provided significantly stronger grip than the Anatech commercial splint (P = 0.04). In contrast to previous studies, splints did not compromise dexterity. There were several significant differences among splints, depending on the outcome measure. Improvements were maintained at 6 months.

Conclusion

After 4 weeks' use, wrist splints reduce pain, improve strength, and do not compromise dexterity. Similar improvements were achieved with the custom leather splint and Rolyan commercial splint, which were superior to the Anatech commercial splint.
Utilization of low‐volume hospitals for total hip replacement
Authors: Losina Elena , Barrett Jane , Baron John A. , Levy Matthew , Phillips Charlotte B. , Katz Jeffrey N.
Published: October 2004

Objective

To identify factors associated with utilization of low‐volume hospitals for total hip replacement (THR) and to estimate differences in the distances that Medicare beneficiaries had to travel to reach low‐ or high‐volume hospitals.

Methods

We studied a population‐based sample of 1,146 Medicare beneficiaries who underwent elective THR in 1995. Using multiple data sources including medical record review, Medicare claims data, 1990 Census data, and a patient survey, we examined factors independently associated with utilization of low‐volume hospitals for elective THR. We estimated the magnitude of difference in distances for patients undergoing THR in low‐ and high‐volume hospitals. We determined the distance between each patient's residence and the treating hospital using MapQuest.

Results

Rural residency, low income, and low educational attainment, as well as belief in the importance of convenient location in the choice of hospital, were associated with higher utilization of low‐volume hospitals. Rural and suburban patients who went to low‐volume hospitals traveled much less than patients operated upon in high‐volume centers.

Conclusion

Policies aimed at restricting THR to high‐volume centers would differentially affect poor, less educated, and rural patients. Voluntary efforts to shift THR to high‐volume centers should involve educating these patients and their referring physicians about differences in both short‐term and longer‐term outcomes between high‐ and low‐volume centers.
Reliability and validity of the Duruöz Hand Index in persons with systemic sclerosis (scleroderma)
Authors: Brower Lisa M. , Poole Janet L.
Published: October 2004

Objective

To examine the test–retest reliability and concurrent validity of the Duruöz Hand Index (DHI) in persons with scleroderma.

Methods

Forty patients with scleroderma and no other major medical problems completed the DHI at 2 points in time to assess test–retest reliability. To assess validity, participants were administered the Arthritis Hand Function Test (AHFT), the Hand Mobility in Scleroderma Test (HAMIS), and the Keital Function Test (KFT), all performance‐based tests. In addition, participants completed the Health Assessment Questionnaire (HAQ), a self report of functional ability.

Results

Test–retest reliability intraclass correlation coefficients for the DHI ranged from 0.81 to 0.97. Scores on the DHI did not correlate with HAMIS scores, but were significantly correlated with scores from the KFT (rs = 0.48, P < 0.01), HAQ (rs = 0.79, P < 0.01), and all sections of the AHFT (rs = 0.34–0.60, P < 0.05–0.01).

Conclusion

The results from this study show the DHI to be a reliable and valid test for persons with scleroderma.
Anti–tumor necrosis factor agents for rheumatoid arthritis in the setting of chronic hepatitis C infection
Authors: Parke Frank A. , Reveille John D.
Published: October 2004

Objective

To examine the safety of using anti–tumor necrosis factor (TNF) therapy in patients with rheumatoid arthritis (RA) in the setting of hepatitis C virus (HCV) infection.

Methods

The charts of 5 patients known to have RA requiring anti‐TNF therapy as well as established HCV infection were reviewed retrospectively for laboratory data of hepatic parenchymal inflammation and viral proliferation while taking these agents.

Results

In a mean ± SD followup period of 41 months (± 28.2 months), no patient displayed evidence of sustained elevation of serum aminotransferases during therapy with anti‐TNF. Additionally, 1 patient was observed to have a decreased HCV viral load after extended treatment with only anti‐TNF (no therapy for HCV).

Conclusion

Anti‐TNF therapy for RA in the setting of HCV appears to be safe and well tolerated without apparent influence on the underlying HCV infection. Therefore, this approach should be further evaluated prospectively for longterm safety.
Measuring the consequences of osteoarthritis and joint pain in population‐based studies: Can existing health measurement instruments capture levels of participation?
Authors: Wilkie R. , Peat G. , Thomas E. , Croft P. R.
Published: October 2004

Objective

To identify health measurement instruments to investigate levels of participation associated with joint pain in a population survey questionnaire.

Method

A comprehensive electronic search of the published literature was performed to identify potential instruments that could measure participation. All items from identified instruments were assessed for the ability to measure participation by 2 experienced and 2 inexperienced assessors. Agreement was determined in terms of actual agreement (%) and agreement beyond chance (κ).

Results

Twenty‐seven instruments (912 items) were identified. Agreement between the experienced assessors occurred in 86% of items (κ = 0.70, 95% confidence interval [95% CI] 0.65–0.75) and between the inexperienced assessors in 72% (κ = 0.40, 95% CI 0.34–0.46). The greatest proportion of participation items in one instrument was 82%.

Conclusion

None of the identified instruments consisted entirely of participation items. The concept of participation and its translation into measurement for use in the general population is likely to need further development.
Wärmedämmstoffe in Deutschland nach europäischen Normen: Nicht nur ein Problem für Sachverständige
Authors: Cziesielski Erich
Published: October 2004

Die harmonisierten europäischen Produktnormen für werkmäßig hergestellte Wärmedämmstoffe EN 13162 bis EN 13171 sind auf der Grundlage der vom europäischen Rat 1989 erlassenen Bauproduktenrichtlinie erarbeitet worden. Das Deutsche Institut für Normung (DIN) hat diese Normen im Oktober 2001 veröffentlicht. Nach der Koexistenzperiode, während der in Deutschland die Dämmstoffe sowohl mit dem CE‐ als auch mit dem Ü‐Zeichen in den Verkehr gebracht werden konnten, gilt seit dem 15.05.2003, daß nationale Normen, die den hamonisierten Normen entgegenstehen, zurückgezogen werden müssen. Die nationalen Normen, die den harmonisierten Normen nicht entgegenstehen, bleiben aber einschließlich der dazugehörigen Prüfnormen weiterhin gültig.

Der folgende Beitrag soll dazu dienen, den am Bau Tätigen die neuen harmonisierten Produktnormen bezüglich der Wärmedämmstoffe und vor allem die neue Methodik und Symbolik von Produkteigenschaften zu erläutern. Weiterhin soll die von der Dämmstoffindustrie zum Teil vorgenommene Qualitätssicherung durch CE‐ und Ü‐Zeichen begründet werden.
Modelling Heterogeneous Dispersion in Marginal Models for Longitudinal Proportional Data
Authors: Song Peter X.‐K. , Qiu Zhenguo , Tan Ming
Published: October 2004

Continuous proportional data is common in biomedical research, e.g., the pre‐post therapy percent change in certain physiological and molecular variables such as glomerular filtration rate, certain gene expression level, or telomere length. As shown in (Song and Tan, 2000) such data requires methods beyond the common generalised linear models. However, the original marginal simplex model of (Song and Tan, 2000) for such longitudinal continuous proportional data assumes a constant dispersion parameter. This assumption of dispersion homogeneity is imposed mainly for mathematical convenience and may be violated in some situations. For example, the dispersion may vary in terms of drug treatment cohorts or follow‐up times. This paper extends their original model so that the heterogeneity of the dispersion parameter can be assessed and accounted for in order to conduct a proper statistical inference for the model parameters. A simulation study is given to demonstrate that statistical inference can be seriously affected by mistakenly assuming a varying dispersion parameter to be constant in the application of the available GEEs method. In addition, residual analysis is developed for checking various assumptions made in the modelling process, e.g., assumptions on error distribution. The methods are illustrated with the same eye surgery data in (Song and Tan, 2000) for ease of comparison. (© 2004 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)
Nonparametric Modeling of the Mean Survival Time in a Multi‐factor Design Based on Randomly Right‐Censored Data
Authors: Rahbar M. H. , Gardiner J. C.
Published: October 2004

Statistical procedures and methodology for assessment of interventions or treatments based on medical data often involves complexities due to incompleteness of the available data as a result of drop out or the inability of complete follow up until the endpoint of interest. In this article we propose a nonparametric regression model based on censored data when we are concerned with investigation of the simultaneous effects of the two or more factors. Specifically, we will assess the effect of a treatment (dose) and a covariate (e.g., age categories) on the mean survival time of subjects assigned to combinations of the levels of these factors. The proposed method allows for varying levels of censorship in the outcome among different groups of subjects at different levels of the independent variables (factors). We derive the asymptotic distribution of the estimators of the parameters in our model, which then allows for statistical inference. Finally, through a simulation study we assess the effect of the censoring rates on the standard error of these types of estimators. (© 2004 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)
Use of Covariates and Survey Wave to Adjust for Nonresponse
Authors: Rao R. Sowmya , Glickman Mark E. , Glynn Robert J.
Published: October 2004

Using covariates available on all sampled individuals along with an intensive follow‐up of nonrespondents is a useful approach to reduce the impact of nonresponse. We examined the performance of several different nonresponse models to account for such covariates and multiple survey waves to estimate the prevalence of birth control use in 106463 women taking the teratogenic drug Accutane. Nonrespondents to a first mailing were followed with two more mailings and then a telephone call. The first mailing had a response rate of 59.7 percent; the overall nonresponse rate was 15.2 percent. Age was available on all women and was strongly associated with both response and birth control use. We considered both multiple imputation and weighting strategies using information on age and time to response assuming that nonrespondents were: (i) like all respondents conditional on age, (ii) like reluctant respondents conditional on age, and (iii) projected from a model which includes trend. Simulation studies were used to examine the potential bias in this setting and we compared models under different assumptions about the missing data mechanism. Results describe the extent to which availability of covariate information and use of multiple waves improves estimation. (© 2004 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)
K‐Sample Test and Sample Size Calculation for Comparing Slopes in Data with Repeated Measurements
Authors: Jung Sin‐Ho , Ahn Chul
Published: October 2004

Sample size calculations based on two‐sample comparisons of slopes in repeated measurements have been reported by many investigators. In contrast, the literature has paid relatively little attention to the design and analysis of K‐sample trials in repeated measurements studies where K is 3 or greater. Jung and Ahn (2003) derived a closed sample size formula for two‐sample comparisons of slopes by taking into account the impact of missing data. We extend their method to compare K‐sample slopes in repeated measurement studies using the generalized estimating equation (GEE) approach based on independent working correlation structure. We investigate the performance of the sample size formula since the sample size formula is based on asymptotic theory. The proposed sample size formula is illustrated using a clinical trial example. (© 2004 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)
Centre‐effect on Survival after Bone Marrow Transplantation: Application of Time‐dependent Frailty Models
Authors: Wintrebert Claire M. A. , Putter Hein , Zwinderman Aeilko H. , van Houwelingen J.C.
Published: October 2004

In many biomedical investigations, multivariate or clustered failure time data are encountered. They arise for instance, when the sample consists of centres and each centre contains several patients. For this kind of data, frailty models can be used to take into account the possible correlation within centres. Most common are centre‐specific frailty models in which the centre‐effect on failure time is assumed to be constant with follow‐up. But with many applications this assumption is too restrictive. More realistic are models with time‐varying frailties. Therefore, we studied ways to extend the constant centre‐specific frailty model to allow time dependence of the frailties. To begin, we followed and adapted Paik et al. (1994) who generalized the shared frailty model by introducing additional random frailty terms for different time‐intervals. Although, the model allows the frailty to vary between intervals, it is very cumbersome to calculate and difficult to fit. We developed two much simpler centre‐specific frailty models. First, we proposed a model with a power parameter in which the “effect” of the centre‐specific frailty is allowed to vary between intervals. And secondly, we extended the model permitting the centre‐specific frailty to vary with time. Although the convenience of the gamma and positive stable frailty models is lost in both extensions of the frailty model, the computations of these models are much easier than of the adapted Paik's model. We applied these time‐dependent frailty models to a data set from the European Blood Marrow Transplant (EBMT) registry, where a decaying centre‐effect was found. (© 2004 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)
A New Testing Approach for Comparing the Overall Homogeneity of Survival Curves
Authors: Lin Xun , Wang Hongkun
Published: October 2004

The assessment of overall homogeneity of time‐to‐event curves is a key element in survival analysis. The currently commonly used methods, e.g., log‐rank and Wilcoxon tests, may have a significant loss of statistical testing power under certain circumstances. In this paper a new statistical testing approach is developed to compare the overall homogeneity of survival curves. The proposed new method has greater power than the commonly used tests to detect overall differences between crossing survival curves. The small‐sample performance of the new test is investigated under a variety of situations by means of Monte Carlo simulations. Furthermore, the applicability of the proposed testing approach is illustrated by a real data example from a kidney dialysis trial. (© 2004 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)