SF-36 Physical Function Domain Research Articles

Abstract 4143239: Extracorporeal Shockwave Therapy Improves Physical Outcomes and Quality of Life In Patients With Symptomatic Peripheral Arterial Disease: Results from a Meta-analysis of Randomized Controlled Trials

Introduction: Extracorporeal shockwave therapy (ESWT) is a non-invasive procedure that may be useful to treat symptomatic peripheral arterial disease (PAD). Trials comparing ESWT with control groups have shown promising results. Methods: PubMed, Cochrane, EMBASE, and Google Scholar were searched for randomized controlled trials reporting the efficacy of extracorporeal shockwave therapy versus control in patients with symptomatic PAD. Data from eligible studies was analyzed using the Review Manager 5.4 software. Mean difference (MD) and 95% Confidence intervals (CI) were calculated for continuous outcomes. Inverse variance method and a random effects model were used for pooled estimates. A p-value < 0.05 (Z-test) was considered significant. Results: 5 randomized controlled trials with 264 patients were included in our analysis. A significant increase in the mean walking distance (MD: 54.13, 95% CI 9.34 to 98.92, p=0.02), pain-free walking distance (MD: 54.13, 95% CI 14.19, 57.88, p= 0.001), SF-36 physical component summary (MD: 11.97, 95% CI 0.26 to 23.69, p=0.05), EQ-5D-3L index score (MD; 0.08, 95% CI: 0.00 to 0.15, p=0.05) and VascuQoL index ((MD: 0.48, 95% CI 0.03 to 0.92, p= 0.04) was seen with ESWT. A slightly higher ankle brachial pressure index was seen in the control group (MD: -0.01, 95% CI: -0.02 to -0.00, p=0.04). There was no difference in SF-36 physical functioning domain score (MD: 18.58, 95% CI: -0.29 to 37.45, p=0.05) and SF-36 bodily pain score (MD: 9.17, 95% CI: -2.885 to 21.19, p=0.13). Conclusions: There was significant improvement in walking distances, exertional symptoms, and quality of life with ESWT. However, ESWT did not translate to an increase in post-treatment ankle-brachial index which was slightly higher in the control group. There is a need for larger randomized controlled trials to substantiate the efficacy of ESWT in treating symptomatic PAD.

Influence of a Concurrent Exercise Training Program on Health-Related Quality of Life During Advanced Pregnancy: The GESTAFIT Project.

Health-related quality of life (HRQoL) may be altered during pregnancy due to pregnancy-related changes in all domains of women's health. A supervised concurrent exercise-training program from the 17th gestational week until birth positively influences HRQoL. Randomized controlled trial. Level 1. Eighty-six pregnant women (age, 33.1 ± 4.6 years; prepregnancy body mass index, 23.5 kg/m2), divided into exercise (n = 41) and control (n = 45) groups, participated in this study (per-protocol basis). The exercise group followed a 60-min, 3 days/week, concurrent (aerobic + resistance) exercise training program. HRQoL was assessed with the 36-Item Short Form Health Survey (SF-36), where higher scores (0-100) indicate better HRQoL. After adjusting for potential confounders, the exercise group decreased 16.1 points less than the control group in the SF-36 physical functioning domain [between-group differences (B): 95% confidence interval (CI), 9.02 to 23.22; P < 0.01], and 4.5 points less in the SF-36 physical component summary than the control group (between-group differences (B): 95% CI, 0.65 to 8.28; P = 0.02). Intention-to-treat basis analyses depicted similar results, where the exercise group decreased 10.03 points less than the control group the in the SF-36 social functioning domain (between-group differences (B): 95% CI, 0.39 to 19.68; P = 0.04). A supervised concurrent exercise training program ameliorates HRQoL decreases along gestation. Although HRQoL decreased throughout pregnancy in both groups, this impact was less in the exercise group, especially in the SF-36 physical functioning, the SF-36 social functioning, and the SF-36 physical component summary. Healthcare providers may encourage pregnant women to exercise in this physiological stage for a better HRQoL throughout pregnancy. NCT02582567; Date of registration: 20/10/2015.

Ambulatory oxygen therapy in lung transplantation candidates with idiopathic pulmonary fibrosis referred for pulmonary rehabilitation.

To determine independent factors related to the use of oxygen and the oxygen flow rate in idiopathic pulmonary fibrosis (IPF) patients placed on a lung transplant waitlist and undergoing pulmonary rehabilitation (PR). This was a retrospective quasi-experimental study presenting functional capacity and health-related quality of life (HRQoL) data from lung transplant candidates with IPF referred for PR and receiving ambulatory oxygen therapy. The patients were divided into three groups on the basis of the oxygen flow rate: 0 L/min (the control group), 1-3 L/min, and 4-5 L/min. Data on functional capacity were collected by means of the six-minute walk test, and data on HRQoL were collected by means of the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), being collected before and after 36 sessions of PR including aerobic and strength exercises. The six-minute walk distance improved in all three groups (0 L/min: Δ 61 m, p < 0.001; 1-3 L/min: Δ 58 m, p = 0.014; and 4-5 L/min: Δ 35 m, p = 0.031). Regarding HRQoL, SF-36 physical functioning domain scores improved in all three groups, and the groups of patients receiving ambulatory oxygen therapy had improvements in other SF-36 domains, including role-physical (1-3 L/min: p = 0.016; 4-5 L/min: p = 0.040), general health (4-5 L/min: p = 0.013), social functioning (1-3 L/min: p = 0.044), and mental health (1-3 L/min: p = 0.046). The use of ambulatory oxygen therapy during PR in lung transplant candidates with IPF and significant hypoxemia on exertion appears to improve functional capacity and HRQoL.

Translation, cultural adaptation, and validation of the Manchester-Oxford Foot Questionnaire into Brazilian Portuguese

Objective: Translate, culturally adapt and validate the Manchester-Oxford Foot Questionnaire (MOXFQ) into Brazilian Portuguese. Methods: The translation followed the guidelines standardized in the literature, including initial translation, back-translation, committee review, pre-test phase, and application of the final questionnaire in 50 patients. Intraobserver reproducibility was evaluated by reapplying the final version of the questionnaire 14 days after the first application. The validation of the final MOXFQ translation was assessed by conjoint application with the SF-36 Quality of Life questionnaire; similar domain scores of the two questionnaires were compared and analyzed. Results: Excellent reproducibility was observed for three domains with statistical significance, the intra-class correlation coefficient (ICC) values were: pain 0.98, walking/standing 0.99, and social interaction 0.98. Internal consistency/reliability obtained excellent values: pain 0.992, walking/standing 0.997, and social interaction 0.992, all with statistical significance (p&lt;0.001). In the MOXFQ validation compared to the SF-36, the highest correlations of the study were found between the SF36 physical functioning domain and the MOXFQ walking/standing (-0.72) and social interaction domains (-0.73). Comparing the MOXFQ walking/standing domain, a good correlation was obtained with the SF-36 physical functioning (-0.41), bodily pain (-0.42), vitality (-0.45), and mental health (-0.40) domains. Also a good correlation was obtained on MOXFQ pain domain with the SF-36 physical functioning (-0.45) and social functioning (-0.43). Conclusion: The MOXFQ Brazilian version proved reliable, valid, and reproducible in measuring the symptoms and functional limitations of patients affected by foot and ankle diseases. Level of Evidence IV; Therapeutic Studies; Case Series.

Poor disease knowledge is associated with higher healthcare service use and costs among patients with cirrhosis: an exploratory study

BackgroundOptimal management of cirrhosis is complex, and patients often lack knowledge and skills, which can affect self-management. We assessed patient knowledge about cirrhosis and examined whether knowledge was associated with clinical outcomes, healthcare service use, and healthcare costs. A cross-sectional ‘knowledge survey’ was conducted during 2018–2020. We assessed patient knowledge about cirrhosis and explore whether knowledge was associated with clinical outcomes, healthcare service use, and costs.MethodsPatients with cirrhosis (n = 123) completed a ‘knowledge survey’. We calculated the proportion of correct answers to eight questions deemed to be “key knowledge” about cirrhosis by an expert panel, and dichotomized patients as ‘good knowledge’/‘poor knowledge’. Clinical data, healthcare costs, and health-related quality of life (SF-36) were available.Results58.5% of patients had ‘good knowledge’ about cirrhosis. Higher education level was associated with higher odds of having ‘good knowledge’ about cirrhosis (adjusted-OR = 5.55, 95%CI 2.40–12.84). Compared to patients with ‘poor knowledge’, those with ‘good knowledge’ had a higher health status in the SF-36 physical functioning domain (p = 0.011), fewer cirrhosis-related admissions (adjusted incidence rate ratio [IRR] = 0.59, 95%CI 0.35–0.99) and emergency presentations (adj-IRR = 0.34, 95%CI 0.16–0.72), and more planned 1-day cirrhosis admissions (adj-IRR = 3.96, 95%CI 1.46–10.74). The total cost of cirrhosis admissions was lower for patients with ‘good knowledge’ (adj-IRR = 0.30, 95%CI 0.29–0.30).ConclusionPoor disease knowledge is associated with increased use and total cost of healthcare services. Targeted educational interventions to improve patient knowledge may be an effective strategy to promote a more cost-effective use of healthcare services.

The effect of oral low molecular weight liquid hyaluronic acid combination with glucosamine and chondroitin on knee osteoarthritis patients with mild knee pain: An 8-week randomized double-blind placebo-controlled trial.

Background:The popularity of dietary supplements for knee osteoarthritis (OA) management is on the rise; however, their effects are still debated.Methods:This study aimed to investigate the effect of an oral low molecular weight liquid hyaluronic acid supplement in the treatment of knee OA patients with mild knee pain (visual analogue scale [VAS] ≤ 3) in Taiwan population. This was a randomized, double-blind, placebo-controlled study. Forty-seven subjects were enrolled and randomly allocated to either the A+HA or the placebo groups. The subjects were required to drink a bottle contained 20 mL of A+HA or placebo daily throughout an 8-week study period. The efficacy was assessed by using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the 36-item Short Form Survey (SF-36).Results:At Week 8, significant reductions from baseline in the WOMAC pain (–2.6 ± 1.68, P < .0001), stiffness (–1.2 ± 1.50, P = .007), physical function (–5.8 ± 4.39, P < .0001), and total (–9.4 ± 5.82, P < .0001) scores were observed in the A+HA group but not in the placebo group. Significant differences in the mean change of WOMAC scores from baseline at Week 8 between groups were detected (P < .01). At Week 8, the A+HA group also showed significant improvements in SF-36 physical functioning (2.7 ± 3.10, P = .001) and bodily pain (0.7 ± 1.50, P < .05) domains. Although the A+HA group had a higher increase in the SF-36 total score than the placebo group but the difference was not statistically significant (2.1 ± 12.75 vs 0.3 ± 19.66, P = .12).Conclusions:Oral administration of low molecular weight liquid HA appeared to be effective for knee OA patients with mild knee pain (VAS ≤ 3) in the relief of knee OA symptoms, particularly in pain and physical function.Clinical Trial Registration: NCT04352322.

Systematic early versus late mobilization or standard early mobilization in mechanically ventilated adult ICU patients: systematic review and meta-analysis

BackgroundThis systematic review and meta-analysis aimed to determine the effectiveness of systematic early mobilization in improving muscle strength and physical function in mechanically ventilated intensive care unit (ICU) patients.MethodsWe conducted a two-stage systematic literature search in MEDLINE, EMBASE and the Cochrane Library until January 2019 for randomized controlled trials (RCTs) examining the effects of early mobilization initiated within 7 days after ICU admission compared with late mobilization, standard early mobilization or no mobilization. Priority outcomes were Medical Research Council Sum Score (MRC-SS), incidence of ICU-acquired weakness (ICUAW), 6-min walk test (6MWT), proportion of patients reaching independence, time needed until walking, SF-36 Physical Function Domain Score (PFS) and SF-36 Physical Health Component Score (PCS). Meta-analysis was conducted where sufficient comparable evidence was available. We evaluated the certainty of evidence according to the GRADE approach.ResultsWe identified 12 eligible RCTs contributing data from 1304 participants. Two RCTs were categorized as comparing systematic early with late mobilization, nine with standard early mobilization and one with no mobilization. We found evidence for a benefit of systematic early mobilization compared to late mobilization for SF-36 PFS (MD 12.3; 95% CI 3.9–20.8) and PCS (MD 3.4; 95% CI 0.01–6.8), as well as on the proportion of patients reaching independence and the time needed to walking, but not for incidence of ICUAW (RR 0.62; 95% CI 0.38–1.03) or MRC-SS. For systematic early compared to standard early mobilization, we found no statistically significant benefit on MRC-SS (MD 5.8; 95% CI − 1.4 to 13.0), incidence of ICUAW (RR 0.90; 95% CI 0.63–1.27), SF-36 PFS (MD 8.1; 95% CI − 15.3 to 31.4) or PCS (MD − 2.4; 95% CI − 6.1 to 1.3) or other priority outcomes except for change in 6MWT from baseline. Generally, effects appeared stronger for systematic early compared to late mobilization than to standard early mobilization. We judged the certainty of evidence for all outcomes as very low to low.ConclusionThe evidence regarding a benefit of systematic early mobilization remained inconclusive. However, our findings indicate that the larger the difference in the timing between the intervention and the comparator, the more likely an RCT is to find a benefit for early mobilization.Study Registration: PROSPERO (CRD42019122555).

Effects of the Graft Type Used for Anterior Cruciate Ligament Reconstruction on Isokinetic Muscle Strength and Quality of Life.

There is no consensus about which graft type should be used in patients who will undergo anterior cruciate ligament (ACL) reconstruction so far. In this study, it was aimed to compare the quality of life, knee functions, and isokinetic muscle strength of patients who underwent ACL reconstruction with hamstring tendon (HT) and bone-tendon-bone (BTB) autografts. Total 40 patients with ACL reconstruction (20 in HT group and 20 in BTB group), at least 1 year after the operation, all injured during sports activity were included in this study. Flexor and extensor muscle groups of both affected and unaffected knees at angular velocities of 60 and 180 degrees/s were recorded. Lysholm knee score questionnaire and Short Form (SF)-36 were administered to all patients before the isokinetic tests. No statistically significant differences were found between the groups at any angular velocity in isokinetic evaluation. Furthermore, there was no statistically significant difference between the groups in regard to Lysholm score. However, there was a statistically significant difference between the groups in SF-36 physical function domain score (p < 0.01). The results demonstrated that the SF-36 questionnaire can easily be applied to this patient population. There was only one significant difference in the SF-36 physical function component scores between the two groups. The quality of life, knee functions, and isokinetic muscle strength were similar in patients who underwent ACL reconstruction with HT and BTB.

Functional and quality of life assessment of patients with ankle ulcers subjected to complete Achilles tendon resection

Objective: To assess the quality of life and functional status of patients subjected to debridement of ulcers in the posterior ankle who required complete Achilles tendon resection without any type of reconstruction or tendon transfer. Method: This is a case series of 5 (mostly diabetic) patients who underwent complete Achilles tendon resection due to an ulcer in the posterior ankle region. Preservation of the Achilles tendon was prevented due to tendon exposure, extensive degeneration and the need for infection control. Patients answered the Brazilian Portuguese version of the Achilles Tendon Total Rupture Score (ATRS-BR) questionnaire and the 36-item Short-Form Health Survey (SF-36) during the postoperative period, and follow-up varied between 6 and 24 months. The ATRS-BR ranges from 0 to 100, and higher scores indicate fewer symptoms and limitations. The SF-36 consists of 36 questions comprising 8 domains, which are independently assessed and given a score of up to 100 points, with higher scores indicating better health status. Results: The mean age of patients was 70 years. The mean score on the SF-36 physical functioning domain was 70 (50-95) points. The mean value of the ATRS-BR was 54.6 (31-88) points; however, the patients had few complaints about their functional status. Conclusion: Non-reconstruction of the Achilles tendon in predominantly diabetic elderly patients with posterior ankle ulcers presents encouraging functional outcomes. This study suggests that complete Achilles tendon resection is a viable option for ulcer treatment in this population. Level of Evidence IV; Therapeutic Studies; Cases Series.

Motor Function and Perception of Health in Women with Provoked Vestibulodynia

Provoked vestibulodynia (PVD) is a prevalent and disabling condition in women that may be associated with reduced quality of life and impairment of physical functioning. To investigate whether women with PVD have different motor functions, posture and breathing patterns, and whether they perceive their physical health differently, compared with asymptomatic controls. The Standardized Mensendieck Test (SMT) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) were used to assess differences between 35 women with PVD and 35 healthy controls. There were no statistically significant differences in any of the 5 motor domains of the SMT between the women with PVD and those without PVD: standing posture, 4.0 (0.6) vs 5.0 (0.6); gait, 4.7 (0.6) vs 4.8 (0.6); movement, 4.8 (0.8) vs 5.1 (0.6); sitting posture, 4.7 (1.0) vs 4.9 (0.8); respiration, 4.7 (1.0) vs 4.7 (0.9). Women with PVD scored significantly lower in all domains on the SF-36 (adjusted Bonferroni P= .002) except physical functioning. Given the lack of difference in the SF-36 physical functioning domain and in all 5 domains of the SMT between women with PVD and those without PVD, the value of interventions focusing on general physical function is unclear. A study strength is the use of an assessor-blinded case-control design, trained physiotherapists to conduct the tests, and valid and reliable outcome measures. A limitation is the homogeneity of the sample of young nulliparous women, which limits the generalizability of our findings to other study populations. Young nulliparous women with PVD did not score differently from a group of healthy controls on assessment of overall physical functioning or on standing posture, gait, movement, sitting posture, and respiration. However, the score for perception of general health was lower in the women with PVD compared with controls. I. Næss, H.C. Frawley, K. Bø. Motor Function and Perception of Health in Women with Provoked Vestibulodynia. J Sex Med 2019;16:1060-1067.

C5 palsy following posterior decompression and instrumentation in cervical stenosis: Single center experience and review

Causation and avoidance of C5 palsy after laminectomy have proven elusive, with multiple factors incriminated including width of the laminectomy, spinal cord migration, C5 neural foraminal stenosis, or intraoperative C5 root traction. In an attempt to identify risk factors for C5 palsy after decompression in cervical stenosis and myelopathy, the following review was conducted. This report is from a single center with consistent criteria for diagnosis and management of cervical stenosis and myelopathy. We retrospectively reviewed 63 patients with cervical stenosis and myelopathy who had been treated with laminectomy with instrumentation at the C4-6 level. Imaging studies reviewed included plain X-ray films, magnetic resonance imaging (MRI), and computed tomography (CT) scans of the cervical spine. Health-related outcomes were assessed before and at follow-up and included Visual Analog Scale (VAS) for pain (1-10), Japanese Orthopedic Association (JOA) score for myelopathy (0-18), and SF-36 physical functioning, energy and fatigue, and general health categories (0-100). In 53 patients (control group), decompression and instrumentation was accomplished without incident, but 5 patients developed lasting postoperative C5 palsy. At follow-up, there were overall significant improvements in VAS, JOA, and SF-36 physical functioning and general health domains. Subsequent to surgery, a loss of lordosis of 5° and an increase in C2 sagittal vertical axis (SVA) of 17 mm was significant. There was, however, no significant difference between control and C5 palsy patients in lordosis and C2 SVA, before or after surgery. Postoperative MRI studies were obtained in 15 of the control patients and 6 of the C5 palsy patients. Postoperative width of the laminectomy as well as the caliber of the C5 neural foramina in the control and C5 palsy cohorts were not statistically different. Though the posterior displacement of the cord in the C5 palsy cohort was larger than in controls, this difference was also not significant. The above findings suggest that the cause of C5 palsy remains elusive. Though our incidence of lasting C5 palsy subsequent to laminectomy and instrumentation was 8%, it is probably under-reported. In our experience, laminectomy and instrumentation failed to increase lordosis and, in fact, were associated with an increase in positive cervical balance. Complications with cervical laminectomy and instrumentation are not by any means rare, and need to be emphasized in counselling patients, and selecting the approach.

Physical function and health-related quality of life in young adults with unilateral congenital lower-limb deficiencies.

PurposeThe primary aim was to examine if there were differences in physical function and health-related quality of life (HRQoL) between young adults (18 to 35 years) with unilateral congenital lower-limb deficiency (CLLD) who had been surgically lengthened (Surg) and those using lengthening prostheses (Pros). Second, we wanted to compare their health status with an age- and gender-matched reference group (Ref) without CLLD.MethodsCross-sectional study including a study-specific questionnaire, clinical examination, two field tests evaluating physical function (the six-minute walk test and the Stair test) and HRQoL questionnaires (Short Form (SF)-36 and EuroQol (EQ)-5D-3L).ResultsPhysical function and HRQoL did not differ between the two treatment groups. The odds for having painful or disfiguring scars were 18 times higher in the Surg group (n = 16) compared with the Pros group (n = 14). The CLLD group showed significantly reduced physical function compared with the Ref group. HRQoL, measured by the EQ-5D-3L visual rating scale, was significantly reduced in the CLLD group compared with the Ref group, as was the SF-36 physical function domain in both genders. Men with CLLD also showed increased bodily pain and reduced general health (SF-36), while we found a reduction in the emotional role domain in women compared with Ref.ConclusionThere were no significant differences in physical function and quality of life in young adults with CLLD treated with surgical lengthening compared with those using lengthening prostheses. Compared with the general Norwegian population, young adults with CLLD had significantly lower physical function and reduced HRQoL in some domains.

Long-Term Results of Deep Brain Stimulation of the Anterior Cingulate Cortex for Neuropathic Pain.

Deep brain stimulation (DBS) of the anterior cingulate cortex (ACC) is a recent technique that has shown some promising short-term results in patients with chronic refractory neuropathic pain. Three years after the first case series, we assessed its efficacy on a larger cohort, with longer follow-up. Twenty-four patients (19 males; average age, 49.1 years) with neuropathic pain underwent bilateral ACC DBS. Patient-reported outcome measures were collected before and after surgery, using the Numerical Rating Scale (NRS), Short-Form 36 quality of life (SF-36), McGill Pain Questionnaire (MPQ), and EuroQol 5-domain quality of life (EQ-5D) questionnaire. Twenty-two patients after a trial week were fully internalized and 12 had a mean follow-up of 38.9 months. Six months after surgery the mean NRS score decreased from 8.0 to 4.27 (P= 0.004). There was a significant improvement in the MPQ (mean,-36%; P= 0.021) and EQ-5D score significantly decreased (mean,-21%; P= 0.036). The physical functioning domain of SF-36 was significantly improved (mean,+54.2%; P= 0.01). Furthermore, in 83% of these patients, at 6 months, NRS score was improved by 60% (P < 0.001) and MPQ decreased by 47% (P < 0.01). After 1 year, NRS score decreased by 43% (P < 0.01), EQ-5D was significantly reduced (mean,-30.8; P= 0.05) and significant improvements were also observed for different domains of the SF-36. At longer follow-ups, efficacy was sustained up to 42 months in some patients, with an NRS score as low as3. Follow-up results confirm that ACC DBS alleviates chronic neuropathic pain refractory to pharmacotherapy and improves quality of life in many patients.

PROMIS PF CAT Outperforms the ODI and SF-36 Physical Function Domain in Spine Patients.

The Oswestry Disability Index v2.0 (ODI), SF36 Physical Function Domain (SF-36 PFD), and PROMIS Physical Function CAT v1.2 (PF CAT) questionnaires were prospectively collected from 1607 patients complaining of back or leg pain, visiting a university-based spine clinic. All questionnaires were collected electronically, using a tablet computer. The aim of this study was to compare the psychometric properties of the PROMIS PF CAT with the ODI and SF36 Physical Function Domain in the same patient population. Evidence-based decision-making is improved by using high-quality patient-reported outcomes measures. Prior studies have revealed the shortcomings of the ODI and SF36, commonly used in spine patients. The PROMIS Network has developed measures with excellent psychometric properties. The Physical Function domain, delivered by Computerized Adaptive Testing (PF CAT), performs well in the spine patient population, though to-date direct comparisons with common measures have not been performed. Standard Rasch analysis was performed to directly compare the psychometrics of the PF CAT, ODI, and SF36 PFD. Spearman correlations were computed to examine the correlations of the three instruments. Time required for administration was also recorded. One thousand six hundred seven patients were administered all assessments. The time required to answer all items in the PF CAT, ODI, and SF-36 PFD was 44, 169, and 99 seconds. The ceiling and floor effects were excellent for the PF CAT (0.81%, 3.86%), while the ceiling effects were marginal and floor effects quite poor for the ODI (6.91% and 44.24%) and SF-36 PFD (5.97% and 23.65%). All instruments significantly correlated with each other. The PROMIS PF CAT outperforms the ODI and SF-36 PFD in the spine patient population and is highly correlated. It has better coverage, while taking less time to administer with fewer questions to answer. 2.

Validity of the German Version of the Continuous-Scale Physical Functional Performance 10 Test.

Background The Continuous-Scale Physical Functional Performance 10 Test (CS-PFP 10) quantitatively assesses physical functional performance in older adults who have a broad range of physical functional ability. This study assessed the validity and reliability of the CS-PFP 10 German version. Methods Forward-translations and backtranslations as well as cultural adaptions of the test were conducted. Participants were German-speaking Swiss community-dwelling adults aged 64 and older. Concurrent validity was assessed using Pearson correlation coefficients between CS-PFP 10 and gait velocity, Timed Up and Go Test, hand grip strength, SF-36 physical function domain, and Freiburger Physical Activity Questionnaire. Internal consistency was calculated by Cronbach's alpha. Results Backtranslation and cultural adaptions were accepted by the CS-PFP 10 developer. CS-PFP 10 total score and subscores (upper body strength, upper body flexibility, lower body strength, balance and coordination, and endurance) correlated significantly with all measures of physical function tested. Internal consistency was high (Cronbach's alpha 0.95–0.98). Conclusion The CS-PFP 10 German version is valid and reliable for measuring physical functional performance in German-speaking Swiss community-dwelling older adults. Quantifying physical function is essential for clinical practice and research and provides meaningful insight into physical functional performance of older adults. This trial is registered with ClinicalTrials.gov NCT01539200.

Determining the Minimal Clinically Important Difference for 6-Minute Walk Distance in Fibromyalgia.

The aim of this study was to estimate the minimal clinically important difference (MCID) for 6-min walk distance (6MWD) in patients with fibromyalgia. Data from a recently completed trial that included 187 patients who completed the 6-min walk test, Fibromyalgia Impact Questionnaire (FIQ), and Short-Form 36 (SF36) at 12 and 36 wks were used to examine longitudinal changes in 6MWD. An anchor-based approach that used linear regression analyses was used to determine the MCID for 6MWD, using the total FIQ score (FIQ-Total) and SF36-physical function domain as clinical anchors. The mean (SD) change in 6MWD from baseline to week 36 was 34.4 (65.2) m (P < 0.001). The anchor-based MCIDs for the 6MWD were 156 and 167 m for the FIQ and SF36-physical function domain, respectively. These MCIDs correspond with clinically meaningful improvements in FIQ (14% reduction) and SF36-physical function domain (10-point increase). The MCID for 6MWD in patients with fibromyalgia was 156 to 167 m. These findings provide the first evidence of the change in 6MWD that is perceived by patients to be clinically meaningful. Further research using other MCID calculation methods is needed to refine estimates of the MCID for 6MWD in patients with fibromyalgia.

Validation of the Chinese Western Ontario and McMaster Universities Osteoarthritis Index in Patients From Mainland China With Osteoarthritis of the Knee.

To establish the reliability, validity, and sensitivity to change of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) among Chinese subjects with osteoarthritis (OA) of the knee, living in mainland China. A multicenter, randomized, double-blind, placebo-controlled, parallel-group study was conducted for validation of the electronic personal digital assistant version of the WOMAC Numerical Rating Scale (NRS) 3.1 Index in China. A total of 287 subjects with OA of the knee were randomized to receive either meloxicam (15 mg) or placebo. Psychometric properties of the WOMAC were evaluated by estimating the reliability, validity, and sensitivity to change. Equivalence of the electronic version was also compared with the paper version. Intraclass correlation coefficients for the WOMAC pain, stiffness, and physical function subscales were 0.81, 0.76, and 0.85, respectively, indicating good test-retest reliability. Similarly, internal consistency was strong (Cronbach's alpha for the 3 WOMAC subscales was 0.84, 0.86, and 0.96, respectively). Pearson's correlation coefficients for WOMAC pain and Short Form 36 health survey (SF-36) bodily pain, as well as WOMAC physical function and SF-36 physical functioning domains were >0.4, indicating convergent validity, whereas the coefficients for all 3 WOMAC domains with SF-36 mental health and mental health component scores were <0.4, indicating divergent validity. There was strong discriminant validity between healthy volunteers and OA patients. The effect sizes of change from baseline to week 12 in WOMAC subscale scores were large, demonstrating sensitivity to change. Equivalence between paper and electronic versions was very high. The culturally and linguistically validated Chinese version of the WOMAC NRS 3.1 for mainland China is psychometrically robust in its validity, reliability, and sensitivity to change for patients with OA of the knee.

Outcome 5years after surgical treatment of acetabular fractures: a prospective clinical and radiographic follow-up of 101 patients.

The aim of this study was to evaluate functional outcome after surgically treated acetabular fracture using radiography and patient-reported outcome measures, and to determine predictors of hip joint failure 5years post-surgery. All patients with acetabular fractures treated with open reduction and internal fixation (ORIF) at our unit are prospectively entered into a local register. 101 acetabular fractures in 112 patients treated from 2004 to 2007 were eligible for analysis 5years after surgery. Radiographs and questionnaires regarding physical function (Short Form[SF]-36) and pelvic discomfort index (PDI, 100%=worst outcome) were obtained. The primary outcome measure was "joint failure" defined as either secondary total hip arthroplasty (THA) or a Girdlestone situation. Univariable analysis was used to compare patients with joint failure to those without, and binary logistic regression analysis was performed to identify risk factors of joint failure. 77% of 101 followed patients had a preserved hip joint 5years after surgery, and failure of the hip joint most often occurred within the first 2years after injury. Patients with preserved hip joints had higher scores in the SF-36 physical function domain (median 75 vs. 48; p=0.004) and better PDI (28 vs. 43%, p=0.03). Femoral head impaction was associated with an increased risk of joint failure [relative risk (RR)=15.2, 95% CI 3-95; p=0.002], as was an age of ≥60years at the time of injury (RR=4.2, CI 1.3-15; p=0.02). Patients with failed hip joints after surgery for acetabular fracture have inferior global and disease-specific functional outcomes, even after secondary arthroplasty surgery. We suggest that patients with predictors of joint failure could benefit from other treatment strategies than ORIF, and primary insertion of THA may be an alternative treatment strategy for this subgroup.

Temporal Dissociation between Disease Activity Reduction and Improvements in Fatigue and Physical Function After Infliximab in Rheumatoid Arthritis

Objective: To evaluate the temporal responses to infliximab in fatigue and other selected parameters of physical function, inflammation, disease activity, and QOL in a cohort of rheumatoid arthritis patients. Methods: A prospective study was conducted. At baseline (PRE), after two (POST 2) and six (POST 6) months of treatment with infliximab (3 mg/Kg), fatigue, muscle function and strength, quality of life, disease activity, and markers of inflammation were assessed in 25 consecutive patients. Results: Infliximab treatment resulted in a significant reduction in fatigue at POST 2 and POST 6 when evaluated by both Chalder and the Global Fatigue VAS scale. Similarly, improvements in physical function at POST 2 and POST 6 as assessed by both the timed-stands test and SF-36 physical functioning domain was also observed. Conversely, disease activity, as assessed by DAS-28, remained unchanged at POST 2 and improved only at POST 6. The reduction in clinical markers of inflammation (i.e. CRP and ERS) did not reach significance at POST 2 or at POST 6, except for a trend in CRP after 6 months of treatment. Muscle strength remained unchanged throughout the trial. Additionally, no significant correlations were found between delta changes of either disease activity or inflammation parameters and physical function and fatigue parameters. Conclusion: These findings clearly reveal a temporal dissociation between the improvements in fatigue, physical function, and quality of life and the reduction in disease activity in response to infliximab in rheumatoid arthritis patients. The predictive value of these early response factors merits further investigations.

Effects of functional electrical stimulation on gait function and quality of life for people with multiple sclerosis taking dalfampridine.

Multiple sclerosis (MS) can adversely affect gait, causing gait slowing, loss of balance, decreased functional mobility, and gait deficits, such as footdrop. Current treatments for gait dysfunction due to MS are pharmacologic, using dalfampridine, or orthotic, using an ankle-foot orthosis. Functional electrical stimulation (FES) to the fibular nerve stimulates active dorsiflexion and provides an alternative treatment for gait dysfunction caused by footdrop. The objective of this study was to determine the effect of FES on gait function and the impact of MS on walking and quality of life for people with MS taking a stable dalfampridine dose. Participants demonstrating gait slowing and footdrop completed the Timed 25-Foot Walk (T25FW) test, 6-Minute Walk (6MW) test, GaitRite Functional Ambulation Profile, 12-item Multiple Sclerosis Walking Scale (MSWS-12), and 36-item Short Form Health Status Survey (SF-36) at screening without FES; the measures were repeated with FES at baseline, 1 month, and 3 months. Twenty participants (8 men and 12 women) completed this unblinded case series study. The mean age, duration of MS, and time taking dalfampridine were 51.7, 15.8, and 1.4 years, respectively. Changes from screening to baseline and screening to 3 months were analyzed. Significant improvement was noted from screening to baseline for the MSWS-12 (P = .024) and SF-36 Physical Function domain (P = .028) and from screening to 3 months for the T25FW (P = .015), MSWS-12 (P = .003), and SF-36 Physical Function (P = .032) and Role Limitation-Physical Health (P = .012) domains. Improvements above those induced pharmacologically suggest that FES can augment pharmacologic intervention and significantly improve gait function, decrease the impact of MS on walking, and improve quality of life for people with MS.