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SF-36 Scores (sf-36 + score)
Selected AbstractsDiabetes Care Protocol: effects on patient-important outcomes.DIABETIC MEDICINE, Issue 4 2010A cluster randomized, non-inferiority trial in primary care Diabet. Med. 27, 442,450 (2010) Abstract Aims, The Diabetes Care Protocol (DCP) combines task delegation, intensification of diabetes treatment and feedback. It reduces cardiovascular risk in Type 2 diabetes (T2DM) patients. This study determines the effects of DCP on patient-important outcomes. Methods, A cluster randomized, non-inferiority trial, by self-administered questionnaires in 55 Dutch primary care practices: 26 practices DCP (1699 patients), 26 usual care (1692 patients). T2DM patients treated by their general practitioner were included. Main outcome was the 1-year between-group difference in Diabetes Health Profile (DHP-18) total score. Secondary outcomes: DHP-18 subscales, general perceived health [Medical Outcomes Study 36-Items Short Form Health Survey (SF-36), Euroqol 5 Dimensions (EQ-5D) and Euroqol visual analogue scale (EQ-VAS)], treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire; DTSQ status) and psychosocial self-efficacy (Diabetes Empowerment Scale Short Form; DES-SF). Per protocol (PP) and intention-to-treat (ITT) analyses were performed: non-inferiority margin , = ,2%. At baseline 2333 questionnaires were returned and 1437 1 year thereafter. Results, Comparing DCP with usual care, DHP-18 total score was non-inferior: PP ,0.88 (95% CI ,1.94 to 0.12), ITT ,0.439 (95% CI ,1.01 to 0.08), SF-36 ,health change' improved: PP 3.51 (95% CI 1.23 to 5.82), ITT 1.91 (95% CI 0.62 to 3.23), SF-36 ,social functioning' was inconclusive: PP ,1.57 (95% CI ,4.3 to 0.72), ITT ,1.031 (95% CI ,2.52 to ,0.25). Other DHP and SF-36 scores were inconsistent or non-inferior. DHP-18 ,disinhibited eating' was significantly worse in PP analyses. For EQ-5D/EQ-VAS, DTSQ and DES-SF, no significant between-group differences were found. Conclusion, DCP does not seem to influence health status negatively, therefore diabetes care providers should not shrink from intensified treatment. However, they should take possible detrimental effects on ,social functioning' and ,disinhibited eating' into account. [source] Original article: Quality of life after esophagectomy and endoscopic therapy for Barrett's esophagus with dysplasiaDISEASES OF THE ESOPHAGUS, Issue 6 2010D. Schembre SUMMARY Esophagectomy (EG) and endoscopic therapy (ET) can eradicate Barrett's esophagus with early neoplasia. Their relative effect on quality of life is unknown. The 36-item Short Form Health Survey (SF-36) and Gastrointestinal Quality of Life Index (GIQLI) questionnaires were sent to all patients who underwent either EG or ET at our institution over the last 9 years. Groups were stratified by age and American Society of Anesthesia (ASA) class. Surveys were sent to 77 patients and completed by 14 EG (50%) and by 28 ET patients (57%). The average time between treatment and survey was 4 years in the ET group and 5 years in the EG group. There were no significant differences in SF-36 scores between EG and ET patients except for superior physical functioning among EG patients 65 and older QOL scores among EG and ET groups were not significantly different than sex age-matched controls. GIQLI scores were similar between ET and EG patients of all ages (P= 0.60). GIQLI scores were higher among younger ET patients than young EG patients (P= 0.049). GIQLI scores also tended to be higher among ASA 1 and 2 ET patients than ASA 1 and 2 EG patients, but this did not reach statistical significance (P= 0.09). EG and ET for early Barrett's neoplasia appear to have similar impact on QOL 1 year or more after treatment compared with age-matched controls. Negative QOL impact appears to be greater for younger patients undergoing EG than for ET. [source] Health Status among Emergency Department Patients Approximately One Year after Consecutive Disasters in New York CityACADEMIC EMERGENCY MEDICINE, Issue 10 2005William George Fernandez MD Abstract Objectives: Emergency department (ED) patients with disaster-related experiences may present with vague symptoms not clearly linked to the event. In 2001, two disasters in New York City, the World Trade Center disaster (WTCD) and the subsequent American Airlines Flight 587 crash, presented an opportunity to study long-term consequences of cumulative disaster exposure (CDE) on health-related quality of life (HRQOL) among ED patients. Methods: From July 15 to October 30, 2002, a systematic sample of stable, adult patients from two EDs in New York City were enrolled. Participants completed a self-administered questionnaire. The Short Form 36 (SF-36) was used to assess overall health status. Bivariate analyses were conducted to identify individual correlates of worsening health status. Multivariate regression was performed to identify the association between various factors and overall health status, while controlling for relevant sociodemographic variables. Results: Four hundred seventy-one patients (54.6% female) participated. The participation rate was 73.4%. One hundred sixty-one participants (36%) reported direct, indirect, or occupational exposure to the WTCD; 55 (13.3%) had direct, indirect, or occupational exposure to the plane crash; 33 (8.1%) had both exposures. In separate multivariate models, CDE predicted lower SF-36 scores for general health (p < 0.0096), mental health (p < 0.0033), and bodily pain (p < 0.0046). Conclusions: In the year following mass traumatic events, persons with CDE had lower overall health status than those with one or no disaster exposure. Clinicians should consider the impact that traumatic events have on the overall health status of ED patients in the wake of consecutive disasters. [source] Italian validation of INQoL, a quality of life questionnaire for adults with muscle diseasesEUROPEAN JOURNAL OF NEUROLOGY, Issue 9 2010V. A. Sansone Background and purpose:, A quality of life (QoL) questionnaire for neuromuscular diseases was recently constructed and validated in the United Kingdom in a sample of adult patients with a variety of muscle disorders. Preliminary results suggested it could be a more relevant and practical measure of QoL in muscle diseases than generic health measures of QoL. The purpose of our work was: (i) To validate INQoL in Italy on a larger sample of adult patients with muscle diseases (ii) to compare INQoL to SF-36. Methods:, We have translated into Italian and applied language adaptations to the original UK INQoL version. We studied 1092 patients with different muscle disorders and performed (i) test,retest reliability (n = 80); (ii) psychometric (n = 345), known-group (n = 1092), external criterion (n = 70), and concurrent validity with SF-36 (n = 183). Results:, We have translated and formally validated the Italian version of INQoL confirming and extending results obtained in the United Kingdom. In addition to good results in terms of reliability, known-group and criterion validity, a comparison with the SF-36 scales showed a stronger association between INQoL total index and SF-36 physical (r = ,0.72) than mental (r = ,0.38) summary health indexes. When considering comparable domains of INQoL and SF-36 with respect to an objective measure of muscle strength assessment (MMRC), regression analysis showed a stronger correlation using INQoL rather than SF-36 scores. Conclusions:, INQoL is recommended to assess QoL in muscle diseases because of its ability to capture physical limitations that are specifically relevant to the muscle condition. [source] Progression of dysautonomia in multiple system atrophy: a prospective study of self-perceived impairmentEUROPEAN JOURNAL OF NEUROLOGY, Issue 1 2007M. Köllensperger To assess severity and progression of self-perceived dysautonomia and their impact on health-related quality of life (Hr-QoL) in multiple system atrophy (MSA), twenty-seven patients were recruited by the European MSA Study Group (EMSA-SG). At baseline, all patients completed the Composite Autonomic Symptom Scale (COMPASS) and the 36 item Short Form Health Survey (SF-36), and they were assessed using the 3-point global disease severity scale (SS-3) and the Unified MSA Rating Scale (UMSARS). After 6 months follow-up, the self completed COMPASS Change Scale (CCS), the SF-36, SS-3, and UMSARS were obtained. MSA patients showed marked self-perceived dysautonomia at baseline visit and pronounced worsening of dysautonomia severity on the CCS at follow-up. Severity and progression of dysautonomia did not correlate with age, disease duration, motor impairment and overall disease severity at baseline. There were no significant differences between genders and motor subtypes. Baseline COMPASS scores were, however, inversely correlated with SF-36 scores. Progression of self-perceived dysautonomia did not correlate with global disease progression. Hr-QoL scores were stable during follow-up. This is the first study to investigate self-perceived dysautonomia severity in MSA and its evolution over time. Our data suggest that dysautonomia should be recognized as a key target for therapeutic intervention in MSA. [source] Relationship of health-related quality of life to treatment adherence and sustained response in chronic hepatitis C patientsHEPATOLOGY, Issue 3 2002David Bernstein Interferon therapy may exacerbate health-related quality of life (HRQL) deficits associated with hepatitis C virus (HCV) early in the course of therapy. Treatment with polyethylene glycol,modified interferon (peginterferon) alfa-2a (40 kd) provides improved sustained response over interferon alfa-2a, but its effect on HRQL is unknown. The objective of this study was to (1) evaluate the effect of sustained virologic response on HRQL in patients with HCV and (2) determine whether impairment of HRQL during treatment contributes to early treatment discontinuation. Data consisted of a pooled secondary analysis of patients (n = 1,441) across 3 international, multicenter, open-label, randomized studies that compared peginterferon alfa-2a (40 kd) with interferon alfa-2a. ANCOVA was used to examine the effect of sustained virologic response on HRQL. Repeated-measures mixed-models ANCOVA was used to compare Fatigue Severity Scale (FSS) and SF-36 scores during treatment by treatment group. Logistic regression analysis was used to examine the association between changes at baseline in on-treatment HRQL and early treatment discontinuation. Sustained virologic response was associated with marked improvements from baseline to end of follow-up in all subjects, including patients with cirrhosis. During treatment, patients receiving peginterferon alfa-2a (40 kd) had statistically significantly better scores on both the SF-36 and FSS. Baseline to 24-week changes in fatigue and SF-36 mental and physical summary scores significantly predicted treatment discontinuation. In conclusion, sustained virologic response is associated with improvements in quality of life in patients with or without advanced liver disease. This parameter may be an important consideration in maximizing treatment adherence. [source] Patients' recovery after critical illness at early follow-upJOURNAL OF CLINICAL NURSING, Issue 5-6 2010Michelle A Kelly Aim., To determine the quality of life, particularly physical function, of intensive care survivors during the early recovery process. Background., Survivors of critical illness face ongoing challenges after discharge from the intensive care unit and on returning home. Knowledge about health issues during early phases of recovery after hospital discharge is emerging, yet still limited. Design., Descriptive study where the former critically ill patients completed instruments on general health and quality of life (SF-36) in the first six months of recovery. Methods., Participants responded to the SF-36 questionnaire and questions about problems, one to six months after intensive care, either face-to-face or by telephone. Results., Thirty-nine participants had a mean age of 60 years; of them, 59% were men and had been in intensive care for 1,69 days (median = 5). Most participants (69%) rated their health as good or fair, but 54% rated general health as worse than a year ago. Mean quality of life scores for all scales ranged from 25,65·5%, with particularly low scores for Role-Physical (25) and Pain (45·1). Half the participants reported difficulty with mobility, sleep and concentration, and 72% that their responsibilities at home had changed. No relationships were found between SF-36 scores and admission diagnosis, gender, age or length of intensive care stay. Conclusions., These survivors of critical illness and hospitalisation in an intensive care unit perceive their general health to be good despite experiencing significant physical limitations and disturbed sleep during recovery. Relevance to clinical practice., Knowledge of issues in these early phases of recovery and discussion and resolution of patient problems could normalise the experience for the patient and help to facilitate better quality of life. [source] Outcomes-based trial of an inpatient nurse practitioner service for general medical patientsJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 1 2001Mathilde H. Pioro MD Abstract Although teaching hospitals are increasingly using nurse practitioners (NPs) to provide inpatient care, few studies have compared care delivered by NPs and housestaff or the ability of NPs to admit and manage unselected general medical patients. In a Midwest academic teaching hospital 381 patients were randomized to general medical wards staffed either by NPs and a medical director or medical housestaff. Data were obtained from medical records, interviews and hospital databases. Outcomes were compared on both an intention to treat (i.e. wards to which patients were randomized) and actual treatment (i.e. wards to which patients were admitted) basis. At admission, patients assigned randomly to NP-based care (n = 193) and housestaff care (n = 188) were similar with respect to demographics, comorbidity, severity of illness and functional parameters. Outcomes at discharge and at 6 weeks after discharge were similar (P > 0.10) in the two groups, including: length of stay; charges; costs; consultations; complications; transfers to intensive care; 30-day mortality; patient assessments of care; and changes in activities of daily living, SF-36 scores and symptom severity. However, after randomization, 90 of 193 patients (47%) assigned to the NP ward were actually admitted to housestaff wards, largely because of attending physicians and NP requests. None the less, outcomes of patients admitted to NP and housestaff wards were similar (P > 0.1). NP-based care can be implemented successfully in teaching hospitals and, compared to housestaff care, may be associated with similar costs and clinical and functional outcomes. However, there may be important obstacles to increasing the number of patients cared for by NPs, including physician concerns about NPs' capabilities and NPs' limited flexibility in managing varying numbers of patients and accepting off-hours admissions. [source] Validity of the Spanish version of the Chronic Liver Disease Questionnaire (CLDQ) as a standard outcome for quality of life assessment,LIVER TRANSPLANTATION, Issue 1 2006Montserrat Ferrer The Chronic Liver Disease Questionnaire (CLDQ) measures the impact on quality of life of chronic liver diseases, regardless of underlying etiology. The aim of this study was to develop a Spanish version of the CLDQ, and to assess its acceptability, reliability, validity, and sensitivity to change. The forward and back-translation method by bilingual translators, with expert panel and pilot testing on patients, was used for the adaptation. The final version was self-administered, together with the Short Form-36 Health Survey (SF-36), on 149 consecutive patients with chronic liver disease. Child-Turcotte-Pugh scores were evaluated by a physician. To assess reproducibility and responsiveness the CLDQ was readministered to a subsample of stable patients and to those who had received a liver transplant. Validity was evaluated via exploratory factor analysis, the CLDQ pattern across severity groups, and correlation coefficients with "itching" and SF-36 scores. Cronbach's alpha and Intraclass Correlation Coefficient for CLDQ global score were 0.93 and 0.90, respectively, demonstrating good reliability. Validity was supported by correlations of the CLDQ with SF-36 and "itching," and CLDQ severity gradient (global score means were 5.5, 5.2, 5.0, and 4.5 in patients with no cirrhosis, cirrhosis Child-Turcotte-Pugh A, B, and C, respectively; P = 0.012). Responsiveness was shown by a high CLDQ improvement in patients who had received liver transplant (mean change = ,1.4; P < 0.001). In conclusion, the Spanish CLDQ is reliable, valid, responsive, and equivalent to the original. These findings support its use as a standard outcome for patients with chronic liver diseases within the whole severity range, from "no cirrhosis" to transplant recipients, both in Spanish and international studies. Liver Transpl 12:95,104, 2006. © 2005 AASLD. [source] CONTROLLED-RELEASE OXYCODONE RELIEVES MODERATE TO SEVERE PAIN IN A 3-MONTH STUDY OF PERSISTENT MODERATE TO SEVERE BACK PAINPAIN MEDICINE, Issue 2 2002Article first published online: 4 JUL 200 Patricia Richards, MD, PhD; Pinggao Zhang, PhD; Michael Friedman, PhD; Rahul Dhanda, PhD. (Purdue Pharma L.P.) Introduction: Opioids are frequently prescribed for management of persistent low back pain, however, efficacy has not been well documented, and concerns are that opioids may impair physical functioning. Objective: To compare controlled-release oxycodone (CRO) with placebo in controlling pain and to observe the effect of CRO on quality of life and functionality. Methods: A double-blind, randomized, placebo-controlled, parallel-group study of 3 months duration was conducted in 110 subjects (49 males, 61 females), mean age 48 years (19,80 years). Subjects had a 3- to 12-month history of moderate to severe persistent low back pain and were previously unresponsive to therapeutic doses of NSAIDs, and/or low dose combination opioid analgesics. At baseline 4% of subjects were on opioids, 39% on NSAIDs, and 57% both NSAIDs and opioids. Subjects were treated with 10 mg CRO tablet or 10 mg oral placebo q12h, titrated to stable pain control. Existing treatment regimens of acetaminophen, NSAIDs, or oral steroids were allowed to continue. The Brief Pain Inventory (BPI), the Roland Morris Functionality Questionnaire, and the MOS 36-Item Short-Form Health Survey (SF-36) were the measures of pain intensity, functionality, and quality of life. Treatments were compared using repeated measures ANCOVA with baseline value as covariate. Results: CRO treatment was significantly superior to placebo on the BPI average pain intensity and average percent pain relief scores overall (4.6 vs 5.4, P = .03, and 47.2 vs 36.3, P = .05, respectively). Fewer CRO subjects discontinued because of inadequate pain control (P < .001). No significant differences between treatments were observed in either Roland Morris or SF-36 scores. Common adverse events for CRO were nausea, constipation, somnolence, headache, and pruritus, consistent with opioid use. Conclusions: Three-month treatment with CRO provides significant pain relief for subjects with persistent moderate to severe back pain, without significantly impairing functionality and quality of life. The support of Purdue Pharma L.P. for this research project is gratefully acknowledged. [source] (647) Evaluation of the Long-Term Efficacy and Safety of Transdermal Fentanyl in the Treatment of Noncancer Pain: The Interim AnalysisPAIN MEDICINE, Issue 2 2000Article first published online: 25 DEC 200 Authors: K Milligan, South Cleveland Hospital, L Haazen and L Bijnens, Janssen Research Foundation Aim of Investigation: To document long-term efficacy and safety of transdermal (TTS) fentanyl for the management of noncancer pain. Methods: The study was an open-label, international, multi-center, phase III trial in 532 patients (mean age 51.5 years) with a median pain duration of 6 years. Two hundred sixty-two patients (50%) had neuropathic pain and 367 (70%) had predominantly somatic, nociceptive pain. TTS-fentanyl was started at an equi-analgesic dose to the pretrial opioid, and given for 12 months. Main outcome measures were weekly assessment of pain control, global treatment satisfaction and quality of life scores. Results: At interim analysis, 120 patients had completed the trial, 211 were continuing treatment, and 201 patients had discontinued. The mean dose of TTS-fentanyl increased from 48 ,g/h to 105 ,g/h over 12 months, with most increases occurring in the first months. During treatment the number of subjects reporting very good, good, or moderate pain control remained stable at 65% (range 61% to 75%). Global satisfaction (very good or good) was also stable at 42% (range 38% to 46%). Eighty-six percent of patients reported preference for TTS-fentanyl over their previous treatment, stating the main reason as better pain relief. SF-36 scores improved from baseline for physical pain and physical summary measurements. The most frequently occurring adverse events were nausea (28%), sonmolence (17%), constipation (15%), vomiting (15%), and increased sweating (14%). Conclusions: Long-term treatment with TTS-fentanyl provides a stable degree of pain control in the majority of patients with moderate-to-severe noncancer pain. It was preferred by the majority of subjects to their previous medication and favorably improved their quality of life. Acknowledgments: Supported by the Janssen Research Foundation. [source] Health status and life satisfaction among breast cancer survivor peer support volunteersPSYCHO-ONCOLOGY, Issue 3 2002B. Alex Matthews Two measures of health-related quality of life (HRQOL), the Medical Outcomes Survey Short Form 36 (SF-36) and the Satisfaction with Life Domains Scale for Cancer (SLDS-C), were compared to examine the relationship between health status and life satisfaction among breast cancer survivors (BCSs). A total of 586 BCSs, all of whom were volunteers in peer support programs, met inclusion criteria and completed the self-report measures. Significant correlation coefficients were shown between life satisfaction and measures of health status. SF-36 scores were significantly higher for physical functioning, emotional well-being, and vitality subscales compared to population norms. BCSs expressed greatest dissatisfaction with their sexual ability, physical strength, and bodies in general. Small age differences were found. Results suggest that incorporating multiple measures of HRQOL contribute to the understanding and measurement of the effects of cancer on perceived health status and life satisfaction. Copyright © 2002 John Wiley & Sons, Ltd. [source] Botulinum Toxin Type A,A Novel Treatment for Provoked Vestibulodynia?THE JOURNAL OF SEXUAL MEDICINE, Issue 9 2009Double Blinded Study, Placebo Controlled, Results from a Randomized ABSTRACT Introduction., Vestibulodynia is an increasingly recognized problem among women and is often difficult to treat. Aim., This randomized, double blinded, placebo-controlled study aimed to evaluate the efficacy of Botox in the treatment of vestibulodynia. Methods., Sixty-four women were randomized to receive Botox (N = 32) or saline placebo (N = 32). Botulinum toxin A (20 I.E.) diluted in 0.5 mL saline or 0.5 mL saline was injected in the musculus bulbospongiosus at baseline. Main Outcome Measures., Pain was measured monthly on a visual analog scale (VAS) Likert scale. Sexual function was measured using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale at baseline and at 3 and 6 months follow up. Quality of life was measured using the 36-item short-form (SF-36). Results., Sixty women (94%) completed the 6 months follow up. Both Botox and placebo produced significantly pain reduction (P < 0.001). There was no significant difference in the median VAS score between the groups at 6 months follow up (P = 0.984). An improvement on the FSFI full score from baseline until 6 months was not significantly different between the groups (P = 0.635). In the placebo group a statistical significant larger reduction in sexual distress was observed from baseline until 6 months follow up compared to the Botox group (P = 0.044). No statistical significant differences were observed between the B- and P-groups in regard to the SF-36 scores. Conclusion., Injection of 20 I.E. Botox in the vestibule of women diagnosed with vestibulodynia does not reduce pain, improve sexual functioning, or impact the quality of life compared to placebo and evaluated at 3 and 6 moths follow up. Both the Botox group and the placebo groups experienced a reduction in pain on the VAS Likert scale at 6 months follow up. Women with vestibulodynia have difficulty with sexual function and present with sexual distress, which has to be addressed in conjunction with pain to eliminate the disorder. Petersen CD, Giraldi A, Lundvall L, and Kristensen E. Botulinum toxin Type A,A novel treatment for provoked vestibulodynia? Results from a randomized, placebo controlled, double blinded study. J Sex Med 2009;6:2523,2537. [source] Health-related quality of life in multiple sclerosis: effects of natalizumabANNALS OF NEUROLOGY, Issue 4 2007Richard A. Rudick MD Objective To report the relationship between disease activity and health-related quality of life (HRQoL) in relapsing multiple sclerosis, and the impact of natalizumab. Methods HRQoL data were available from 2,113 multiple sclerosis patients in natalizumab clinical studies. In the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study, patients received natalizumab 300mg (n = 627) or placebo (n = 315); in the Safety and Efficacy of Natalizumab in Combination with Interferon Beta-1a in Patients with Relapsing Remitting Multiple Sclerosis (SENTINEL) study, patients received interferon beta-1a (IFN-,-1a) plus natalizumab 300mg (n = 589), or IFN-,-1a plus placebo (n = 582). The Short Form-36 (SF-36) and a subject global assessment visual analog scale were administered at baseline and weeks 24, 52, and 104. Prespecified analyses included changes from baseline to week 104 in SF-36 and visual analog scale scores. Odds ratios for clinically meaningful improvement or worsening on the SF-36 Physical Component Summary (PCS) and Mental Component Summary were calculated. Results Mean baseline SF-36 scores were significantly less than the general US population and correlated with Expanded Disability Status Scale scores, sustained disability progression, relapse number, and increased volume of brain magnetic resonance imaging lesions. Natalizumab significantly improved SF-36 PCS and Mental Component Summary scores at week 104 in AFFIRM. PCS changes were significantly improved by week 24 and at all subsequent time points. Natalizumab-treated patients in both studies were more likely to experience clinically important improvement and less likely to experience clinically important deterioration on the SF-36 PCS. The visual analog scale also showed significantly improved HRQoL with natalizumab. Interpretation HRQoL was impaired in relapsing multiple sclerosis patients, correlated with severity of disease as measured by neurological ratings or magnetic resonance imaging, and improved significantly with natalizumab. Ann Neurol 2007 [source] Rituximab for rheumatoid arthritis refractory to anti,tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeksARTHRITIS & RHEUMATISM, Issue 9 2006Stanley B. Cohen Objective To determine the efficacy and safety of treatment with rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to anti,tumor necrosis factor (anti-TNF) therapies and to explore the pharmacokinetics and pharmacodynamics of rituximab in this population. Methods We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the Randomized Evaluation of Long-Term Efficacy of Rituximab in RA (REFLEX) Trial, a 2-year, multicenter, randomized, double-blind, placebo-controlled, phase III study of rituximab therapy. Patients with active RA and an inadequate response to 1 or more anti-TNF agents were randomized to receive intravenous rituximab (1 course, consisting of 2 infusions of 1,000 mg each) or placebo, both with background MTX. The primary efficacy end point was a response on the American College of Rheumatology 20% improvement criteria (ACR20) at 24 weeks. Secondary end points were responses on the ACR50 and ACR70 improvement criteria, the Disease Activity Score in 28 joints, and the European League against Rheumatism (EULAR) response criteria at 24 weeks. Additional end points included scores on the Functional Assessment of Chronic Illness Therapy,Fatigue (FACIT-F), Health Assessment Questionnaire (HAQ) Disability Index (DI), and Short Form 36 (SF-36) instruments, as well as Genant-modified Sharp radiographic scores at 24 weeks. Results Patients assigned to placebo (n = 209) and rituximab (n = 311) had active, longstanding RA. At week 24, significantly more (P < 0.0001) rituximab-treated patients than placebo-treated patients demonstrated ACR20 (51% versus 18%), ACR50 (27% versus 5%), and ACR70 (12% versus 1%) responses and moderate-to-good EULAR responses (65% versus 22%). All ACR response parameters were significantly improved in rituximab-treated patients, who also had clinically meaningful improvements in fatigue, disability, and health-related quality of life (demonstrated by FACIT-F, HAQ DI, and SF-36 scores, respectively) and showed a trend toward less progression in radiographic end points. Rituximab depleted peripheral CD20+ B cells, but the mean immunoglobulin levels (IgG, IgM, and IgA) remained within normal ranges. Most adverse events occurred with the first rituximab infusion and were of mild-to-moderate severity. The rate of serious infections was 5.2 per 100 patient-years in the rituximab group and 3.7 per 100 patient-years in the placebo group. Conclusion At 24 weeks, a single course of rituximab with concomitant MTX therapy provided significant and clinically meaningful improvements in disease activity in patients with active, longstanding RA who had an inadequate response to 1 or more anti-TNF therapies. [source] Differences in mail and telephone responses to self-rated health: use of multiple imputation in correcting for response biasAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 2 2005J. R. Powers Objectives: To estimate differences in self-rated health by mode of administration and to assess the value of multiple imputation to make self-rated health comparable for telephone and mail. Methods: In 1996, Survey 1 of the Australian Longitudinal Study on Women's Health was answered by mail. In 1998, 706 and 11,595 mid-age women answered Survey 2 by telephone and mail respectively. Self-rated health was measured by the physical and mental health scores of the SF-36. Mean change in SF-36 scores between Surveys 1 and 2 were compared for telephone and mail respondents to Survey 2, before and after adjustment for socio-demographic and health characteristics. Missing values and SF-36 scores for telephone respondents at Survey 2 were imputed from SF-36 mail responses and telephone and mail responses to socio-demographic and health questions. Results: At Survey 2, self-rated health improved for telephone respondents but not mail respondents. After adjustment, mean changes in physical health and mental health scores remained higher (0.4 and 1.6 respectively) for telephone respondents compared with mail respondents (-1.2 and 0.1 respectively). Multiple imputation yielded adjusted changes in SF-36 scores that were similar for telephone and mail respondents. Conclusions and Implications: The effect of mode of administration on the change in mental health is important given that a difference of two points in SF-36 scores is accepted as clinically meaningful. Health evaluators should be aware of and adjust for the effects of mode of administration on self-rated health. Multiple imputation is one method that may be used to adjust SF-36 scores for mode of administration bias. [source] Posterior tibial nerve stimulation in patients with intractable interstitial cystitisBJU INTERNATIONAL, Issue 1 2004Jimao Zhao OBJECTIVE To evaluate the efficacy of intermittent percutaneous posterior tibial nerve stimulation (PPTNS) in patients with refractory interstitial cystitis. PATIENTS AND METHODS One man and 13 women (mean age 58.3 years) with suprapubic or perineal pain were enrolled in a prospective open study, in which they had 10 weekly sessions of PPTNS. Their mean duration of symptoms was 8.3 years. All patients were previously diagnosed as having interstitial cystitis according to the National Institute of Diabetes and Digestive and Kidney Diseases criteria. The response to the treatment were assessed using voiding diary, visual analogue scale diary for a pain index, and the Interstitial Cystitis Problem Index (ICPI), O'Leary/Sant Interstitial Cystitis Symptom Index (ICSI) and the 36-item short-form health survey (SF-36) quality-of-life questionnaire. RESULTS Of the 14 patients, 13 completed the 10 weeks of treatment with no complications; 12 continued treatment for a short period after the study. There were no statistically significant changes in pain scores, voiding frequency and volumes, or in the ICPI, ICSI and SF-36 scores. However, there was an improvement in some patients, with one having complete resolution of the pain. CONCLUSION Intermittent PPTNS in patients with refractory interstitial cystitis has no significant clinical effect over 10 weeks of treatment. [source] The relationship of pain and health-related quality of life in Korean patients with Parkinson's diseaseACTA NEUROLOGICA SCANDINAVICA, Issue 6 2009J. H. Roh Background,,, Parkinson's disease (PD) is a chronic progressive neurodegenerative disorder. Increasing attention has been focused on the pain and health-related quality of life (HrQOL) in patients with PD. Objective,,, To evaluate the relationship between pain and the HrQOL in patients with PD. Methods,,, Eighty-two patients with PD were included and classified into two groups according to the presence of pain. The Hoehn and Yahr scale, the Unified Parkinson's Disease Rating Scale (UPDRS), the Modified Somatic Perception Questionnaire (MSPQ), the Zung Depression Inventory , Self-rating Depression Scale (SDS), the Visual Analogue Scale and the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) were administered. The factors influencing the pain, HrQOL and parkinsonian manifestations were evaluated. Results,,, The PD with pain group had higher UPDRS part III scores, lower SF-36 scores, higher SDS scores and higher MSPQ scores than the PD without pain group. The presence of pain, high Hoehn and Yahr stage, advanced age and somatic perception were the factors that had a negative effect on the physical component of the HrQOL. Depression and somatic perception were the most important predictive factors for the mental component of the HrQOL. Depression and poor parkinsonian motor abilities were the leading factors contributing to pain. Conclusion,,, Pain and depression were major detrimental factors affecting the physical and mental aspects of the HrQOL respectively. Therefore, the treatment of pain and depression can be important to improve the HrQOL. [source] | ||||||||||