Study Short Form-36 Physical Component Summary Research Articles

Collaborative Care for Injured Older Adults

Older adults with recent injuries can have impaired long-term biopsychosocial function and may benefit from interventions adapted to their needs. To determine if a collaborative care intervention, Trauma Medical Home (TMH), improved the biopsychosocial function of older patients in the year after injury. This was a single-blinded, randomized clinical trial conducted at 4 level I trauma centers in Indianapolis, Indiana, and Madison, Wisconsin. Between October 2017 and October 2021, patients aged 50 years and older with an Injury Severity Score (ISS) of 9 or greater and without traumatic brain or spinal cord injury were enrolled. Exclusions were significant brain injury or a spinal cord injury with a persistent neurologic deficit at the time of enrollment, extensive burns, pregnancy, incarceration, neurodegenerative disease, visual or auditory impairment that would preclude study participation, a life expectancy of less than 1 year, significant alcohol or drug use history, and acute stroke during admission. Of 10 276 patients screened, 430 were randomized and 299 completed 12-month follow-up. Data were analyzed from March to July 2023. Intervention patients received 6 months of TMH delivered by a nurse care coordinator guided by an interdisciplinary team (trauma surgeon, pulmonary critical care and geriatrician physicians, nurses, and psychologist) in partnership with primary care. The care coordinator used standard protocols to monitor and treat biopsychosocial symptoms. Primary outcomes were Medical Outcome Study Short Form-36 (SF-36) score and Short Physical Performance Battery (SPPB) score at 12 months. Secondary outcomes were Patient Health Questionnaire-9 (PHQ-9) score, the Generalized Anxiety Disorder scale-7 (GAD-7) score, and health care utilization. A total of 429 participants (228 [53.1%] female; mean [SD] age, 69.3 [10.8] years; mean [SD] ISS, 12.3 [4.6]) completed baseline assessments and were randomized. Follow-up was 76% (n = 324) at 6 months and 70% (n = 299) at 12 months. There were no differences between the TMH and usual care groups at 12 months in SF-36 Physical Component Summary score (mean [SD], 40.42 [12.82] vs 39.18 [12.43]), SF-36 Mental Component Summary score (mean [SD], 53.92 [10.02] vs 53.21 [10.82]), or SPPB score (mean [SD], 8.00 [3.60] vs 8.28 [3.88]). Secondary outcomes were also no different. Planned subgroup analysis revealed patients with baseline symptoms of anxiety or depression (high GAD-7 and PHQ-9 scores) experienced improvement in the Mental Component Summary score when randomized to the TMH intervention. The TMH intervention did not significantly influence quality of life, depressive and anxiety symptoms, or physical function of older adults with injury at 12 months. Subgroup analysis showed positive impact in patients with a high burden of anxiety and depression symptoms at enrollment. Collaborative care interventions may improve long-term outcomes of select patients, but further research is needed. ClinicalTrials.gov Identifier: NCT03108820.

Comparisons between US norm-based two-component and Japanese norm-based three-component SF-36 summary scores in systemic lupus erythematosus patients.

We compared the US norm-based two-component vs. Japanese norm-based three-component summary scores of the Medical Outcomes Study Short Form-36 (SF-36) in patients with systemic lupus erythematosus (SLE). One hundred fourteen Japanese SLE patients were studied. SF-36 physical component summary (PCS) and mental component summary (MCS) scores were computed by the US norm-based two-component (US2) and Japanese norm-based three-component (JP3) models, respectively, and compared. Their association with demographics and disease characteristics was also analysed. The US2-PCS scores were significantly higher than the JP3-PCS scores (p < .001); however, the US2-MCS and JP3-MCS scores were not significantly different (p = .16). Bland-Altman analyses demonstrated that the US2-PCS scores were generally higher than the JP3-PCS scores, and their difference was larger in the subjects with lower PCS scores. However, the multiple linear regression analyses for the PCS and MCS scores computed by the different models demonstrated mostly equivalent standardized regression coefficients with the variables. Although the agreement between the US norm-based two-component and Japanese norm-based three-component models of the SF-36 was insufficient, their scores demonstrated similar associations with other variables. The application of the US original version could be acceptable in certain studies depending on the research question.

Family caregivers of rare disease: A survey on health-related quality of life in family caregivers for Gaucher disease patients in China.

BackgroundRare diseases affect the health‐related quality of life (HRQoL) of patients and their family caregivers (FCs). However, limited evidence is available on the HRQoL of FCs of patients with Gaucher disease (GD). This study aimed to assess HRQoL and related factors among FCs of patients with GD in China.MethodsA cross‐sectional online survey was conducted with 49 FCs recruited by convenience sampling. Participants completed the Medical Outcome Study Short Form‐36 (SF‐36), Zung's Self‐Rating Anxiety Scale, Zung's Self‐Rating Depression Scale, the Multi‐dimensional Scale of Perceived Social Support, the Herth Hope Index, and a questionnaire about FCs’ and patients’ sociodemographic characteristics. Single‐sample t tests, one‐way analysis of variance, and multivariate linear regression analysis were used to analyze the data analysis.ResultsParticipating FCs had significantly lower scores in all eight SF‐36 domains compared with the general population in China (p < 0.01). FCs’ gender, education, daily care time, anxiety, and the perceived disease severity of patients were significant predictors of SF‐36 physical component summary scores. Caregiving help from others, anxiety, perceived disease severity, and medical insurance type were significant predictors of SF‐36 mental component summary scores.ConclusionThe findings showed FCs of patients with GD had lower HRQoL. There is an urgent need to address the health concerns of FCs of people with rare diseases including their HRQoL.

Use of Antimalarial Agents is Associated with Favourable Physical Functioning in Patients with Systemic Lupus Erythematosus.

Impaired health-related quality of life (HRQoL) is a major problem in patients with systemic lupus erythematosus (SLE). Antimalarial agents (AMA) are the cornerstone of SLE therapy, but data on their impact on HRQoL are scarce. We investigated this impact using baseline data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (n = 1684). HRQoL was self-reported using the Medical Outcomes Study short-form 36 (SF-36), functional assessment of chronic illness therapy (FACIT)-Fatigue and 3-level EuroQoL 5-Dimension (EQ-5D) questionnaires. Patients on AMA (n = 1098/1684) performed better with regard to SF-36 physical component summary, physical functioning, role physical, bodily pain, FACIT-Fatigue, EQ-5D utility index and EQ-5D visual analogue scale scores. The difference in SF-36 physical functioning (mean ± standard deviation (SD): 61.1 ± 24.9 versus 55.0 ± 26.5; p < 0.001) exceeded the minimal clinically important difference (≥5.0). This association remained significant after adjustment for potential confounding factors in linear regression models (standardised coefficient, β = 0.07; p = 0.002). Greater proportions of AMA users than non-users reported no problems in the mobility, self-care, usual activities and anxiety/depression EQ-5D dimensions. AMA use was particularly associated with favourable HRQoL in physical aspects among patients with active mucocutaneous and musculoskeletal disease, and mental aspects among patients with active renal SLE. These results provide support in motivating adherence to AMA therapy. Exploration of causality in the relationship between AMA use and favourable HRQoL in SLE has merit.

Impact of C-LEG on mobility, satisfaction and quality of life in a multicenter cohort of femoral amputees

In some countries, the microprocessor-controlled C-LEG knee joint is reimbursed by the national health insurance for transfemoral amputees under certain conditions. However, whether users really benefit from such a technology in their daily life is unknown. To observe the performance of active C-LEG users in terms of locomotor ability and activities, satisfaction and quality of life after 6 months of wearing the prosthesis in real-life conditions. This multicenter observational study investigated locomotor ability [Locomotor Capability Index 5 (LCI-5)], satisfaction [Quebec User Evaluation of Satisfaction with Assistive Device 2.0 (QUEST 2.0)] and quality of life [Medical Outcomes Study Short Form 36 (SF-36)] at the beginning (T0) and end (T1) of the C-LEG test period and at 6 months (T2) after the confirmed prescription of the C-LEG. Information was also collected on the use of walking aids, daily wear of the prosthesis, falls and adverse events. We enrolled 102 participants; 81 were assessed at T1 (62 had a previous prosthesis) and 56 were followed up after 6 months (45 had a previous prosthesis). For participants who had previously been fitted with a prosthetic knee, which was mechanical in almost all cases, as compared with baseline, the use of C-LEG significantly improved locomotor ability (LCI-5 52.6 vs. 46.7, P<0.001), satisfaction (QUEST score 4.6 vs. 3.7, P<0.001) and physical quality of life (SF-36 physical component summary score 51.1 vs. 45.3, P<0.001). In addition, daily use of the prosthesis was higher and use of walking aids and frequency of falls were lower as compared with the previous period. Active transfemoral amputees with prescription of the C-LEG knee joint showed improved function, satisfaction and physical quality of life after 6 months of wear as compared with their previous prosthesis.

Physical Functioning, Pain, and Health-Related Quality of Life in Adults With Juvenile Idiopathic Arthritis: A Longitudinal 30-Year Followup Study.

To describe physical functioning, pain, and health-related quality of life (HRQoL) in adults with juvenile idiopathic arthritis (JIA), investigate changes over time, and identify predictors of poorer HRQoL after 30 years of disease. Patients (n = 176) clinically examined after 15 years were reassessed using the Health Assessment Questionnaire disability index (HAQ DI), the visual analog scale pain subscale (VAS pain), and the Medical Outcomes Study Short Form 36 (SF-36) after 23 years and 30 years. Patients with signs of active disease after a minimum of 15 years were clinically examined again at 30 years. Patients were compared to matched controls. At the 30-year followup, 82 patients (47%) had HAQ DI scores >0, and the median VAS pain score in patients was 0.6 (range 0-10). Patients had lower SF-36 physical component summary (PCS) scores compared with controls (P < 0.001), and this was evident for patients both with and without clinical remission (P ≤ 0.01). No group differences were found in SF-36 mental component summary scores. Patients also scored worse than controls on all SF-36 subscales (P ≤ 0.01) except mental health. PCS scores worsened significantly between the 15- and 30-year followup time points (P = 0.001). Worse HAQ DI, VAS pain, and patient's global assessment of well-being scores, and receiving disability/social living allowance at 30 years, were correlated with lower PCS scores. Worse HAQ DI, patient's global assessment of well-being, and VAS fatigue scores at 15-year followup predicted lower PCS scores at 30-year followup. JIA had a detrimental effect on physical HRQoL as measured by the PCS of the SF-36. The strongest correlates were physical disability, pain, fatigue, well-being, and receiving disability/social living allowance.

Patient-Reported Allergies Predict Worse Outcomes After Hip and Knee Arthroplasty: Results From a Prospective Cohort Study

BackgroundRetrospective analyses have demonstrated correlation between patient-reported allergies and negative outcomes after total joint arthroplasty. We sought to validate these observations in a prospective cohort. MethodsOne hundred forty-four patients undergoing total hip arthroplasty and 302 patients undergoing total knee arthroplasty were prospectively enrolled. Preoperatively, patients listed their allergies and completed the Medical Outcomes Study Short Form 36 (SF-36) and the Charlson Comorbidity Index (CCI) Questionnaire. At a mean of 17 months (range 12-25 months) postoperatively, SF-36, CCI, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) were obtained by telephone survey. Regression analysis was used to determine the strength of correlation between patient age, comorbidity burden, and number of allergies and outcome measurements. ResultsIn 446 patients, 273 reported at least 1 allergy. The number of allergies reported ranged from 0 to 33. Penicillin or its derivative was the most frequently reported allergy followed by sulfa, environmental allergen, and narcotic pain medication. Patients reporting at least 1 allergy had a significantly lower postoperative SF-36 Physical Component Score compared to those reporting no allergies (51.3 vs 49.4, P = .01). The SF-36 postoperative Mental Component Score was no different between groups. Multivariate regression analysis showed that age and patient reported allergies, but not comorbidities, were independently associated with worse postoperative SF-36 Physical Component Summary (PCS) and WOMAC score. Patients with allergies experienced the same improvement in SF-36 PCS as those without an allergy. Comorbidities did not correlate with patient-reported function postoperatively. ConclusionPatients who report allergies have lower postoperative outcome scores but may experience the same increment in improvement after total joint arthroplasty.

Characteristics of chest wall injuries that predict postrecovery pulmonary symptoms: A secondary analysis of data from a randomized trial.

Although thoracic trauma is common, little is known about which factors lead to poor functional outcomes. We sought to determine which characteristics of chest wall injury predict postrecovery pulmonary symptoms or health-related quality of life. We conducted a secondary analysis of data from a randomized trial involving patients with chest wall injuries at a Level I trauma center between December 2007 and July 2012. We evaluated the overall severity of the chest wall injury-characterized primarily by the number of fractured ribs-and rib fracture location (upper, middle, and lower; anterior, lateral, and posterior) as predictors of patient-reported outcomes 60 days after injury: dyspnea burden (0-40), Modified Medical Research Council Dyspnea Scale (MMRC) (0-4), St. George's Respiratory Questionnaire (SGRQ), and normalized Medical Outcomes Study Short-Form 36 (SF-36) scores. Of 189 evaluable subjects, the mean (SD) number of fractured ribs was 5 (4). The number of fractured ribs was not associated with dyspnea burden, MMRC, or SGRQ scores. After adjustment for confounders, each additional fractured rib was associated with worse SF-36 Physical Functioning and Bodily Pain scores (-0.6 units [95% confidence interval (CI), -1.1 to 0.0] and -0.8 units [95% CI, -1.3 to -0.2], respectively). Lower rib fractures were associated with worse dyspnea burden (3.4 units; 95% CI, 1.0-5.9), MMRC score (0.4 units; 95% CI, 0.0-0.8), and SF-36 Physical Functioning, Role-Physical, Role-Emotional, and Physical Component Summary scores (-4 units [95% CI, -8 to 0], -5 units [95% CI, -8 to -1], -4 units [95% CI, -8 to 0], and -4 units [95% CI, -7 to -1], respectively). The overall anatomic severity of chest wall injuries does not predict worse dyspnea symptoms 60 days after injury, but it does predict increased patient perceptions of pain and physical function limitations. Lower rib fractures predict both persistent respiratory symptoms and perception of decreased overall health. Prognostic/epidemiologic study, level III.

Health-related quality of life in young adults with congenital central hypoventilation syndrome due to PHOX2B mutations: a cross-sectional study.

BackgroundCongenital central hypoventilation syndrome (CCHS) is a rare genetic disease due to PHOX2B mutations. CCHS patients suffer from many autonomic disorders, dominated clinically by defective ventilatory automatisms. From birth, the life of CCHS patients depends on ventilatory support during sleep, involving a high burden of care. Whether or not this impairs the quality of life of these patients during adulthood remains unknown.MethodsWe applied the medical outcome study short form-36 (SF-36) to 12 CCHS patients aged 15–33 (9 women) at the time of their passage from pediatric to adult care. Scores for the SF-36 dimensions were compared to the age- and gender-matched French reference population after transformation into standardized Z-scores. The SF-36 physical component summary score (PCS) and mental component summary score (MCS) were compared to American reference values.ResultsMedian Z-scores were significantly different from zero for PF (physical functioning, p = 0.020) and GH (general health perception, p = 0.0342) and for PCS (p = 0.020). The other physical dimensions (RP, role limitation due to physical function; BP, bodily pain) and the mental dimensions (VT, vitality; SF, social functioning; RE, role limitation due to emotional function; MH, mental health) and MCS were not altered.ConclusionsWe conclude that, despite the physical constraints imposed by CCHS and its anxiogenic nature, this disease is associated with an impairment of health-related quality of life in young adults that remains moderate. Whatever the underlying explanations, these results convey hope to parents with a child diagnosed with CCHS and for patients themselves.

The Effects of Respiratory Muscle Weakness and Pulmonary Involvement on Functional Status, Fatigue and Health Related Quality of Life in Patients With Systemic Sclerosis

Objectives: The aim of this study is to investigate the effects of respiratory muscle strength and pulmonary involvement on functional status, fatigue, and health related quality of life (HRQoL) in patients with systemic sclerosis. Patients and methods: Thirty-three patients (2 males, 31 females; mean age 46.2±13.4 years; range 27 to 77 years) with systemic sclerosis and 34 healthy volunteers (3 males, 31 females; mean age 40.9±12.8 years; range18 to 65 years) were included in the study. Pulmonary involvement and respiratory muscle strength were evaluated by measuring forced vital capacity, vital capacity, maximum voluntary ventilation, high resolution computed tomography, pulmonary artery systolic pressure, and visual analog scale for dyspnea. Functional status, HRQoL and fatigue were measured with Health Assessment Questionnaire Disability Index, Medical Outcomes Study Short Form-36 (SF-36), and Fatigue Severity Scale, respectively. Results: Compared to healthy controls, our patients had lower functional status and HRQoL, and a higher fatigue level. Respiratory muscle strength had significant contribution on functional status and SF-36 physical component summary scores. Pulmonary arterial hypertension had significant predictive value for SF-36 physical component summary. Interstitial lung disease affected the functional status only. Dyspnea had significant predictive value for fatigue and mental component summary of SF-36. Conclusion: Since a significant association is present between pulmonary involvement, respiratory muscle strength, functional status, HRQoL, and fatigue in patients with systemic sclerosis, these parameters should also be evaluated in the early period of the disease. Once respiratory muscle weakness and pulmonary involvement are detected in this population with limited treatment options, a comprehensive pulmonary rehabilitation program including respiratory muscle exercises should be designed to improve functional status, HRQoL, and fatigue.

Longitudinal evaluation of PROMIS-29 and FACIT-dyspnea short forms in systemic sclerosis.

To assess the sensitivity of the Patient-Reported Outcomes Measurement Information System 29-item Health Profile (PROMIS-29) and the Functional Assessment of Chronic Illness Therapy-Dyspnea 10-item short form (FACIT-Dyspnea) for measuring change in health status and dyspnea in systemic sclerosis (SSc). One hundred patients with SSc completed the PROMIS-29, FACIT-Dyspnea, and traditional instruments [Medical Research Council Dyspnea Score, St. George's Respiratory Questionnaire (SGRQ), Health Assessment Questionnaire-Disability Index (HAQ-DI), and Medical Outcomes Study Short Form-36 (SF-36)] at baseline and 1-year visits. PROMIS-29, FACIT-Dyspnea, and traditional instrument change scores were compared across composite modified Medsger Disease Severity and modified Rodnan Skin score (mRSS) change groups. Moderately high Spearman correlation coefficients were observed between FACIT-Dyspnea and SGRQ (r = 0.57), FACIT-Dyspnea functional limitations and SF-36 physical component summary (PCS; r = 0.51), PROMIS-29 physical functioning and HAQ-DI (r = 0.50), and SF-36 PCS (r = 0.52) change scores. In most validity comparisons, PROMIS-29, FACIT-Dyspnea, HAQ-DI, and SF-36 scores performed similarly. While PROMIS-29 covers more content areas than SF-36 (e.g., sleep), it may do so at the expense of responsiveness of its 4-item physical function scale as compared to the multiitem-derived SF-36 PCS. Statistically significant increases in SF-36 role physical (p = 0.01) and physical component scale (p = 0.016), but not PROMIS-29, were observed in patients with mRSS improvement. PROMIS-29 and FACIT-Dyspnea are valid instruments to measure health status and dyspnea in patients with SSc. In physical function assessment, longer PROMIS short forms or computer adaptive testing should be considered to improve responsiveness to the effect of skin disease changes on physical function in patients with SSc.

Comparative Effectiveness of Anti–Tumor Necrosis Factor Drugs on Health‐Related Quality of Life Among Patients With Inflammatory Arthritis

To compare the relative effectiveness of anti-tumor necrosis factor (anti-TNF) therapies on health-related quality of life (HRQOL) by inflammatory arthritis types. Patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) who had anti-TNF therapy (etanercept, adalimumab, or infliximab) in the Australian Rheumatology Association Database during 2001-2011 were assessed using the Medical Outcomes Study Short Form 36 (SF-36), Assessment of Quality of Life (AQoL), and Health Assessment Questionnaire (HAQ) disability index (DI) on a biannual basis. Linear regression was used for the analysis; the lack of independence in outcomes for multiple assessments in the same patient was taken into account using generalized estimating equations. There were 18,119 assessments (first-time drug use n = 12,274, subsequent use n = 3,098, and no use n = 2,747) provided by 3,033 patients (2,240 RA, 507 AS, and 286 PsA patients) with the anti-TNF therapies. The effects of subsequent use versus first-time use were reduced on the SF-36 physical component summary, AQoL, and HAQ DI scores among RA patients. After adjusting for therapy order, calendar year, sex, age, smoking status, and various medication uses, the 3 anti-TNF preparations had similar effects on the HRQOL measures for patients with RA, AS, or PsA. However, differences between anti-TNF therapies were observed in the AQoL score among PsA patients (infliximab versus etanercept: -0.06 [95% confidence interval (95% CI) -0.12, -0.004]) and in the SF-36 mental component summary score among RA patients (adalimumab versus etanercept: -1.17 [95% CI -1.88, -0.46]). This study revealed similar effectiveness of etanercept, adalimumab, and infliximab on the HRQOL measures among Australians with RA, AS, and PsA.

Patient-based outcomes and quality of life after salvageable wartime extremity vascular injury

To date, contemporary studies on wartime vascular trauma have focused on acute management strategies and early results, with no characterization of enduring functional limb salvage or its relation to quality of life. The objective of this study was to describe long-term, patient-based quality of life and function after extremity vascular injury (EVI). The Joint Theater Trauma Registry was queried for U.S. troops with EVI. Injury and management data was obtained and the Medical Outcomes Study Short Form 36 (SF-36) Health Survey administered after patient contact and consent. Demographic, injury, and management variables were analyzed and examined for correlation with the primary end points of favorable or unfavorable outcome defined by SF-36 Mental (MCS) or Physical Component Summary (PCS) scores of >42 or <42 (effect size ≥ 0.8). Surveys were completed by 214 patients, who were a median age of 25 years (range, 19-52 years). The Injury Severity Score was 15.3 ± 8.6 and the Mangled Extremity Severity Score was 5.65 ± 1.4. Amputation-free survival was 84% at mean follow-up of 61 ± 24 months. Overall SF-36 PCS and MCS scores were 43.0 ± 9.2 and 46.6 ± 12.4, respectively, with 92 respondents (43%) reporting favorable outcomes on both MCS and PCS. On multivariate analysis, older age, severe extremity injury (Mangled Extremity Severity Scores ≥ 7), and chronic pain were predictive of unfavorable physical outcomes (P < .05). Presence of pain, nerve injury, and junior rank (<E7) were predictive of unfavorable MCS scores (P < .05). Higher educational background (baccalaureate or above) was associated with favorable outcome (P < .05). This study reports the first long-term patient-centered outcomes data after wartime EVI. At 5 years after injury, quality-of-life measures are reduced compared with national norms. Understanding high-risk characteristics, both demographic- and injury-specific, that are associated with unfavorable outcomes will help guide future acute management and long-term recovery strategies.

Disease Course, Outcome, and Predictors of Outcome in a Population-based Juvenile Chronic Arthritis Cohort Followed for 17 Years

To investigate disease course, outcome, and predictors of outcome in an unselected population-based cohort of individuals diagnosed with juvenile chronic arthritis (JCA) followed for 17 years. The cohort consisted of 132 incidence JCA cases identified 1984-1986 according to EULAR criteria. At 5-year followup, 129 individuals underwent joint assessment, laboratory measurements, radiographic examination, and medication and functional assessment. At 17-year followup, 86 were examined with joint assessment, laboratory measurements, medication assessment, Health Assessment Questionnaire (HAQ), Keitel functional test (KFT), and Medical Outcomes Study Short Form-36 (SF-36). At 17-year followup, 40% were in remission, 44% changed subgroups, median HAQ score was 0.0 (range 0.0-1.5), and median KFT was 100 (range 54-100). SF-36 scores were significantly lower compared to a reference group. Thirty-nine percent of those in remission at 5-year followup were not in remission at 17-year followup. In multivariate analyses of variables from the 17-year followup: remission was predicted by remission at 5-year followup (OR 4.8); HAQ > 0 by rheumatoid factor (RF)-positivity at 5-year followup (OR 3.6); KFT < 100 by nonremission (OR 11.3); and RF-positivity (OR 5.6) at 5-year followup; and the SF-36 physical component summary score above average of the reference group by remission at 5-year followup (OR 5.8). This longterm study of 86 individuals with JCA showed large variability of disease courses and of impaired health-related quality of life. Sixty percent were not in remission at 17-year followup. Longterm outcome was best predicted by and associated with characteristics at 5-year followup rather than those at onset.

Improved Health-related Quality of Life and Physical Function in Patients with Refractory Chronic Gout Following Treatment with Pegloticase: Evidence from Phase III Randomized Controlled Trials

To assess the efficacy of pegloticase on pain, physical function, and health-related quality of life (HRQOL) in patients with refractory chronic gout. Subjects in 2 replicate, 6-month, randomized controlled phase III trials received intravenous infusions of pegloticase 8 mg twice monthly (biweekly group), pegloticase alternating with placebo (8-mg monthly group), or placebo. Medical Outcomes Study Short Form-36 (SF-36), Health Assessment Questionnaire-Disability Index (HAQ-DI), patient global assessment of disease activity (PtGA), and pain by visual analog scale were completed at weeks 1 (baseline), 13, 19, and 25. Prespecified pooled analyses of patient-reported outcomes were performed by combining values for each treatment group (biweekly treatment, monthly treatment, and placebo) at Week 25. Of 212 patients enrolled, 157 (74.1%) completed treatment. At entry, mean age was 55.4 years (range 23-89 yrs) and mean plasma uric acid was 9.7 mg/dl; most were male (81.6%) and white (67.5%). Subjects reported an average of 9.8 flares in the previous 18 months. Baseline SF-36 physical component summary (PCS) scores were > 1.5 SD below US normative values. At Week 25, mean changes from baseline in PtGA, pain, HAQ-DI, and PCS scores were statistically significant and exceeded minimum clinically important differences (MCID) in the biweekly treatment group, compared with little to no improvement in placebo group. Statistically significant improvements greater than or equal to MCID were reported in 6 of 8 SF-36 domains. Monthly pegloticase resulted in significantly improved PtGA, HAQ-DI, PCS, and 3 SF-36 domains. Pegloticase therapy resulted in statistically significant and clinically meaningful improvements in PtGA, pain, physical function, and HRQOL.

The effectiveness of pulsed electrical stimulation in the management of osteoarthritis of the knee: Results of a double‐blind, randomized, placebo‐controlled, repeated‐measures trial

To determine the effectiveness of subsensory, pulsed electrical stimulation (PES) in the symptomatic management of osteoarthritis (OA) of the knee. This was a double-blind, randomized, placebo-controlled, repeated-measures trial in 70 participants with clinical and radiographically diagnosed OA of the knee who were randomized to either PES or placebo. The primary outcome was change in pain score over 26 weeks measured on a 100-mm visual analog scale (VAS). Other measures included pain on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), function on the WOMAC, patient's global assessment of disease activity (on a 100-mm VAS), joint stiffness on the WOMAC, quality of life on the Medical Outcomes Study Short-Form 36 (SF-36) health survey, physical activity (using the Human Activity Profile and an accelerometer), and global perceived effect (on an 11-point scale). Thirty-four participants were randomized to PES and 36 to placebo. Intent-to-treat analysis showed a statistically significant improvement in VAS pain score over 26 weeks in both groups, but no difference between groups (mean change difference 0.9 mm [95% confidence interval -11.7, 13.4]). Similarly, there were no differences between groups for changes in WOMAC pain, function, and stiffness scores (-5.6 [95% confidence interval -14.9, 3.6], -1.9 [95% confidence interval -9.7, 5.9], and 3.7 [95% confidence interval -6.0, 13.5], respectively), SF-36 physical and mental component summary scores (1.7 [95% confidence interval -1.5, 4.8] and 1.2 [95% confidence interval -2.9, 5.4], respectively), patient's global assessment of disease activity (-2.8 [95% confidence interval -13.9, 8.4]), or activity measures. Fifty-six percent of the PES-treated group achieved a clinically relevant 20-mm improvement in VAS pain score at 26 weeks compared with 44% of controls (12% [95% confidence interval -11%, 33%]). In this sample of subjects with mild-to-moderate symptoms and moderate-to-severe radiographic OA of the knee, 26 weeks of PES was no more effective than placebo.

Impaired Health-related Quality of Life in Patients Treated for Wegener’s Granulomatosis

To investigate whether patients with Wegener's granulomatosis (WG) experience reduced health-related quality of life (HRQOL) after accomplishment of remission, and to study the influence of WG-associated organ damage on HRQOL. Sixty-eight patients with inactive WG and 680 randomly selected, age- and sex-matched controls of the Danish background population completed the Medical Outcomes Study Short-Form 36 (SF-36) survey for evaluation of HRQOL. Irreversible organ damage attributable to WG and/or its treatment was assessed using the Vasculitis Damage Index (VDI). The median disease duration was 7.5 (range 1-26) years in the WG group, and the median total VDI score was 2.0 (range 0-7). Compared to controls, WG patients reported impaired HRQOL reflected by significantly lower SF-36 physical component summary scores (PCS) and mental component summary scores (MCS) (p < 0.001) and by significantly lower scores in 7 out of 8 SF-36 subscales (p ≤ 0.001). In the WG group, no statistically significant correlations were found between the different SF-36 scores and the total VDI score, number of organ systems affected by damage, disease duration, or number of WG relapses. Patients with organ failure or other major forms of damage did not report significantly lower HRQOL than less severely affected patients. WG patients experience significantly reduced HRQOL even in phases with no apparent vasculitis disease activity. Our data indicate that the level of HRQOL does not correlate well with the extent of vasculitis-associated organ damage in WG.

After patients are diagnosed with knee osteoarthritis, what do they do?

To learn more about the health services and products that patients use after receiving a diagnosis of knee osteoarthritis (OA), as well as the trajectory of their health-related quality of life (HRQOL). Using a simple screening survey, community pharmacists identified 194 participants with previously undiagnosed knee OA. Of these participants, 190 were confirmed to have OA on further investigation. At baseline and 1, 3, and 6 months after diagnosis, a survey was administered to assess health services, product use, and HRQOL, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Medical Outcomes Study Short Form 36 (SF-36) health survey, the Paper Adaptive Test (PAT-5D-QOL), and the Health Utilities Index Mark 3. With a mean age of 63 years, participants were mostly women, white, and overweight. By 6 months, more than 90% of the participants had visited their family physician to discuss their OA, and more than 50% of participants took either prescription or nonprescription analgesics. In addition, three-quarters of the participants started exercising, one-third initiated activity aids, and one-third had started natural medicine products. At 6 months compared with baseline, significant improvements were seen in the SF-36 physical component summary (P = 0.001) and bodily pain domain scores (P = 0.02), the PAT-5D-QOL overall, pain, and usual daily activities scores (P < 0.001 for all), and the WOMAC total, pain, and function scores (P < 0.001 for all). Within 6 months of receiving a diagnosis of knee OA, participants made several lifestyle interventions, often without the advice of a health professional, and saw improvements in their pain and function.

Quality of Life in GERD and Barrett's Esophagus Is Related to Gender and Manifestation of Disease

Gastroesophageal reflux disease (GERD) is a common condition that affects patients' health-related quality of life (HRQoL). The HRQoL of Barrett's esophagus (BE) has been less well studied. Furthermore, it is unknown to what extent BE patients suffer from psychological distress as a result of carrying a diagnosis of a premalignant condition. We sought to compare BE and GERD (stratified by erosive reflux disease (ERD) and non-erosive reflux disease (NERD)) with regard to HRQoL and psychological impact. In this single-center study of subjects presenting for elective upper endoscopy, consecutive patients with BE and GERD were enrolled. Participants completed questionnaires assessing generic HRQoL (medical outcomes study short form-36 (SF-36)), disease-specific HRQoL (gastrointestinal quality of life index (GIQLI)), a measure of psychological distress (the Revised Hopkins Symptom Checklist: SCL-90R), and a patient-centered assessment of the impact of disease severity (the GERD health-related quality of life measure (GERD HRQL)). Patients with BE had the lowest symptom severity compared with those suffering from NERD or ERD (GERD HRQL: 13.7 vs. 18 and 15.9, respectively, P<0.01). Those with BE also had better disease-specific quality of life compared with NERD or ERD patients (GIQLI: 137.2 vs. 124.3 and 131.0, respectively, P<0.001). After adjusting for potential confounding variables including symptom severity and gender, BE patients continued to demonstrate better disease-specific HRQoL, scoring 12.2 points higher on the GIQLI than NERD patients (95% confidence interval (CI) 5.1-19.3) and 16.3 points higher than ERD patients (95% CI 5.4-27.3), as well as better generic HRQoL, scoring 4.8 points higher on the SF-36 physical component summary than NERD patients (95% CI 0.8-8.8) and 7.1 points higher than ERD patients (95% CI 1.2-13.1). There were no significant differences between groups in psychological distress, as demonstrated by the SCL-90R global severity index, although BE patients scored lower on the somatization domain compared with NERD and ERD patients. When stratified by gender, females with NERD and BE had worse disease-specific HRQoL than males. Patients with BE have better generic and disease-specific HRQoL when compared with patients suffering from NERD and ERD. This difference is only partially attributable to lower symptom severity amongs BE patients. Psychological distress did not differ significantly amongs groups. Female gender was associated with worsened HRQoL regardless of GERD disease manifestation. Though more precise instruments may aid in detecting any HRQoL decrements in BE patients because of perceived cancer risk or fear of developing or dying from cancer, we were unable to demonstrate an additional decrement in HRQoL because of cancer risk in subjects with BE.

Quality of life in systemic sclerosis: Psychometric properties of the World Health Organization Disability Assessment Schedule II

To determine the validity of the World Health Organization Disability Assessment Schedule II (WHODAS II) in systemic sclerosis (SSc). Patients enrolled in the Canadian Scleroderma Research Group registry participated in a standardized evaluation and completed the WHODAS II. Criterion validity was assessed by comparing the WHODAS II with the Medical Outcomes Study Short Form 36 (SF-36), construct validity was assessed by examining how it relates to common measures of outcome in SSc, and discriminative validity was assessed by examining how it distinguishes patients with more severe disease from those with less severe disease. A total of 402 patients with SSc were included (mean +/- SD age 55 +/- 13 years, 87% women, mean +/- SD disease duration 11 +/- 9 years). The mean +/- SD WHODAS II score was 24.6 +/- 17.4, and the greatest impairments were in life activities and mobility. There were moderate to good correlations between the WHODAS II and the SF-36 Physical Component Summary score (r = -0.44), the SF-36 Mental Component Summary score (r = -0.41), and measures of function (r = 0.54), depression (r = 0.44), pain (r = 0.40), and fatigue (r = -0.49, P < 0.0001 for all). The WHODAS II was able to consistently distinguish patients with milder disease from those with more severe disease. The WHODAS II had good psychometric properties in patients with SSc and should be considered a valid measure of health-related quality of life in SSc.