Estimating the minimal clinically important difference for the Physical Component Summary of the Short Form 36 for patients with stroke

Objective To determine the Physical Component Summary (PCS) score's minimal clinically important difference (MCID) on the Short Form 36 (SF-36) for people with stroke. Methods We conducted secondary analysis of data from a large randomized controlled trial (N = 400) in the post-hospital discharge phase of stroke rehabilitation with outcome measurement 6 and 12 months following stroke. Three methods were used for estimating the MCID: two anchor and one distribution. Method 1 compared SF-36 PCS scores at 12 months for responses to the SF-36’s Perceived Health Change (PHC) question. Method 2 compared the change in PCS score between 6 and 12 months for responses to the PHC question. Method 3 used Cohen’s method to estimate the MCID from the PCS score distribution. Results Method 1: the mean PCS score increased by 3.0 units (95% confidence interval [CI] 2.2–3.9) for each unit change in the PHC question. Method 2: the mean change in PCS score increased by 2.1 units (95% CI 1.4–2.8) for each unit change in the PHC question. Method 3: the MCID was estimated to be 1.8 units. Conclusions Our estimate of the MCID for the PCS in patients with stroke was 1.8 to 3.0 units.

Cotyloid Fossa Coverage Percentages May Be Associated With Alpha Angle, Labral Tear, and Clinical Outcomes in Patients With Femoroacetabular Impingement

Background: Within the hip joint, the anatomy of the acetabulum and cotyloid fossa is well established. There is little literature describing the association between the size of the cotyloid fossa relative to the acetabulum and characteristics of patients with femoroacetabular impingement (FAI). Purpose/Hypothesis: The purpose was to calculate the cotyloid fossa coverage percentage in the acetabulum and determine its association with patient characteristics, radiographic parameters, intra-articular findings, and preoperative patient-reported outcomes in patients with FAI. We hypothesized there is an association between the cotyloid fossa coverage percentage of the acetabulum and characteristics of patients with FAI. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Patients were included who underwent standard clinical 3-T magnetic resonance imaging of the hip and primary arthroscopic FAI correction surgery during 2015 and 2016. Exclusion criteria were age <18 or >40 years, osteoarthritis, labral reconstruction, previous ipsilateral hip surgery, and hip dysplasia. Measurements of the cotyloid fossa and surrounding lunate cartilage were performed to calculate cotyloid fossa width (CFW) and cotyloid fossa height (CFH) coverage percentages. The relationships between coverage percentages and patient characteristics and intraoperative findings were assessed using independent t tests or Pearson correlations. Results: An overall 146 patients were included. Alpha angle negatively correlated with CFH coverage percentage ( r = −0.19; P = .03) and positively correlated with labral tear size ( r = 0.28; P < .01). CFH coverage percentage was negatively correlated with labral tear size ( r = −0.24; P < .01). Among patients with degenerative tears, CFH was negatively correlated with labral tear size ( r = −0.31; P < .01). However, this association was no longer significant after adjusting for sex (partial r = −0.10; P = .39). Cotyloid fossa coverage was not associated with the condition of the cotyloid fossa synovium (synovitis vs no synovitis). CFW coverage percentage was negatively correlated with the 12-Item Short Form Health Survey (SF-12) physical component summary score ( r = −0.23; P < .01). Conclusion: The CFW and CFH coverage percentages may be associated with alpha angle, labral tear size, and SF-12 physical component summary score in patients with FAI. We may be able to predict the labral condition based on preoperative measurements of CFH and CFW coverage percentages.

Terminal decline in objective and self-reported measures of motor function before death: 10 year follow-up of Whitehall II cohort study

Objectives To examine multiple objective and self-reported measures of motor function for their associations with mortality. Design Prospective cohort study. Setting UK based Whitehall II cohort study, which recruited participants aged 35-55 years in 1985-88; motor function component was added at the 2007-09 wave. Participants 6194 participants with motor function measures in 2007-09 (mean age 65.6, SD 5.9), 2012-13, and 2015-16. Main outcome measures All cause mortality between 2007 and 2019 in relation to objective measures (walking speed, grip strength, and timed chair rises) and self-reported measures (physical component summary score of the SF-36 and limitations in basic and instrumental activities of daily living (ADL)) of motor function. Results One sex specific standard deviation poorer motor function in 2007-09 (cases/total, 610/5645) was associated with an increased mortality risk of 22% (95% confidence interval 12% to 33%) for walking speed, 15% (6% to 25%) for grip strength, 14% (7% to 23%) for timed chair rises, and 17% (8% to 26%) for physical component summary score over a mean 10.6 year follow-up. Having basic/instrumental ADL limitations was associated with a 30% (7% to 58%) increased mortality risk. These associations were progressively stronger when measures were drawn from 2012-13 (mean follow-up 6.8 years) and 2015-16 (mean follow-up 3.7 years). Analysis of trajectories showed poorer motor function in decedents (n=484) than survivors (n=6194) up to 10 years before death for timed chair rises (standardised difference 0.35, 95% confidence interval 0.12 to 0.59; equivalent to a 1.2 (men) and 1.3 (women) second difference), nine years for walking speed (0.21, 0.05 to 0.36; 5.5 (men) and 5.3 (women) cm/s difference), six years for grip strength (0.10, 0.01 to 0.20; 0.9 (men) and 0.6 (women) kg difference), seven years for physical component summary score (0.15, 0.05 to 0.25; 1.2 (men) and 1.6 (women) score difference), and four years for basic/instrumental ADL limitations (prevalence difference 2%, 0% to 4%). These differences increased in the period leading to death for timed chair rises, physical component summary score, and ADL limitations. Conclusion Motor function in early old age has a robust association with mortality, with evidence of terminal decline emerging early in measures of overall motor function (timed chair rises and physical component summary score) and late in basic/instrumental ADL limitations.

Therapeutic Effect of Large Channel Endoscopic Decompression in Lumbar Spinal Stenosis

Background: Percutaneous endoscopic decompression (PED) is a minimally invasive surgical technique that is now used for not only disc herniation but also lumbar spinal stenosis (LSS). However, few studies have reported endoscopic surgery for LSS. Therefore, we conducted this study to evaluate the outcomes and safety of large channel endoscopic decompression.Methods: Forty-one patients diagnosed with LSS who underwent PED surgery were included in the study. The estimated blood loss, operative time, length of hospital stay, hospital costs, reoperations, complications, visual analogue scale (VAS) score, Oswestry Disability Index (ODI) score, Japanese Orthopaedic Association (JOA) score and SF-36 physical-component summary scores were assessed. Preoperative and postoperative continuous data were compared through paired-samples t-tests. The significance level for all analyses was defined as p &lt; 0.05.Results: A total of 41 consecutive patients underwent PED, including 21 (51.2%) males and 20 (48.8%) females. The VAS and ODI scores decreased from preoperatively to postoperatively, but the JOA and SF-36 physical component summary scores significantly increased. The VAS (lumbar) score decreased from 5.05 ± 2.33 to 0.45 ± 0.71 (P = 0.000); the VAS (leg) score decreased from 5.51 ± 2.82 to 0.53 ± 0.72 (P = 0.000); the ODI score decreased from 52.80 ± 20.41 to 4.84 ± 3.98 (P = 0.000), and the JOA score increased from 11.73 ± 4.99 to 25.32 ± 2.12 (P = 0.000). Only 1 patient experienced an intraoperative complication (2.4%; dural tear), and 1 patient required reoperation (2.4%).Conclusions: Surgical treatment for LSS is to sufficiently decompress and minimize the trauma and complications caused by surgery. This study did not reveal any obvious shortcomings of PED and suggested PED is a safe and effective treatment for LSS.

Exercise programme to improve quality of life for patients with end-stage kidney disease receiving haemodialysis: the PEDAL RCT

Background Whether or not clinically implementable exercise interventions in haemodialysis patients improve quality of life remains unknown. Objectives The PEDAL (PrEscription of intraDialytic exercise to improve quAlity of Life in patients with chronic kidney disease) trial evaluated the clinical effectiveness and cost-effectiveness of a 6-month intradialytic exercise programme on quality of life compared with usual care for haemodialysis patients. Design We conducted a prospective, multicentre randomised controlled trial of haemodialysis patients from five haemodialysis centres in the UK and randomly assigned them (1 : 1) using a web-based system to (1) intradialytic exercise training plus usual-care maintenance haemodialysis or (2) usual-care maintenance haemodialysis. Setting The setting was five dialysis units across the UK from 2015 to 2019. Participants The participants were adult patients with end-stage kidney disease who had been receiving haemodialysis therapy for > 1 year. Interventions Participants were randomised to receive usual-care maintenance haemodialysis or usual-care maintenance haemodialysis plus intradialytic exercise training. Main outcome measures The primary outcome of the study was change in Kidney Disease Quality of Life Short Form, version 1.3, physical component summary score (from baseline to 6 months). Cost-effectiveness was determined using health economic analysis and the EuroQol-5 Dimensions, five-level version. Additional secondary outcomes included quality of life (Kidney Disease Quality of Life Short Form, version 1.3, generic multi-item and burden of kidney disease scales), functional capacity (sit-to-stand 60 and 10-metre Timed Up and Go tests), physiological measures (peak oxygen uptake and arterial stiffness), habitual physical activity levels (measured by the International Physical Activity Questionnaire and Duke Activity Status Index), fear of falling (measured by the Tinetti Falls Efficacy Scale), anthropometric measures (body mass index and waist circumference), clinical measures (including medication use, resting blood pressure, routine biochemistry, hospitalisations) and harms associated with intervention. A nested qualitative study was conducted. Results We randomised 379 participants; 335 patients completed baseline assessments and 243 patients (intervention, n = 127; control, n = 116) completed 6-month assessments. The mean difference in change in physical component summary score from baseline to 6 months between the intervention group and control group was 2.4 arbitrary units (95% confidence interval –0.1 to 4.8 arbitrary units; p = 0.055). Participants in the intervention group had poor compliance (49%) and very poor adherence (18%) to the exercise prescription. The cost of delivering the intervention ranged from £463 to £848 per participant per year. The number of participants with harms was similar in the intervention (n = 69) and control (n = 56) groups. Limitations Participants could not be blinded to the intervention; however, outcome assessors were blinded to group allocation. Conclusions On trial completion the primary outcome (Kidney Disease Quality of Life Short Form, version 1.3, physical component summary score) was not statistically improved compared with usual care. The findings suggest that implementation of an intradialytic cycling programme is not an effective intervention to enhance health-related quality of life, as delivered to this cohort of deconditioned patients receiving haemodialysis. Future work The benefits of longer interventions, including progressive resistance training, should be confirmed even if extradialytic delivery is required. Future studies also need to evaluate whether or not there are subgroups of patients who may benefit from this type of intervention, and whether or not there is scope to optimise the exercise intervention to improve compliance and clinical effectiveness. Trial registration Current Controlled Trials ISRCTN83508514. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 40. See the NIHR Journals Library website for further project information.

MO500A NEW INDEX BASED ON THE DIFFERENCE BETWEEN CREATININE-BASED EGFR AND CYSTATIN-C EGFR ASSOCIATES WITH THE PHYSICAL COMPONENT OF THE SF-36 AND PREDICTS CARDIOVASCULAR EVENTS AND PROGRESION TO KIDNEY FAILURE IN CKD

Background and Aims Analyses in a large clinical trial in hypertensive patients (SPRINT) and in the Cardiovascular Health study cohort coherently showed that the difference between the GFR as estimated by serum cystatin and creatine (eGFRDiff) associates with frailty and predicts a lower risks for adverse outcomes including frailty, falls, cardiovascular events and mortality. Whether eGFRdiff in CKD patients associates with frailty metrics like the physical component summary (PCS) of the SF-36 and cardiovascular (CV) and kidney outcomes has not been studied. Method In a cohort of 757 with stages 2-5 CKD we tested the relationship between eGFRDiff with PCS (n=582) and in the whole cohort investigated the relationship between the same indicator with the incidence rate of two combined endpoint: non fatal CV events/death and renal events (dialysis/transplantation/eGFR reduction &gt;30%)/death over a median follow up of 35.6 months (inter-quartile range 21.3-36.2months). Results The eGFRDiff was strongly related to PCS (rho=0.25, P&lt;0.001) and physical functioning (rho=0.26, P&lt;0.001) emerged as the strongest correlate of eGFRDiff among PCS sub-domains. At baseline, eGFRDiff had a median value of 7.0 ml/min/1.73m2 (interquartile range: 2.2-13.0 ml/min/1.73m2) and h P=0.001), serum phosphate (β=-0.11, P=0.003), and BMI (β=-0.08, P=0.043) had an independent relationship with the eGFRDiff. During follow-up, 118 patients had fatal (n=29) and non fatal (n=89) CV events and 13 died of causes other than CV. Overall, 131 patients had the combined endpoint of non fatal CV event/death. Furthermore, 246 patients had renal outcomes and 276 patients had the combined end-point renal events/death. On univariate Cox regression analyses, 1 unit increase in eGFRdiff associated with a 3% reduction of the HR of non fatal CV events/death (hazard ratio: 0.965, 95% CI: 0.951-0.978, P&lt;0.001) and a 2% reduction of the HR of renal events/death ( 0.979, 95% CI: 0.969-0.990, P&lt;0.001). Data adjustment for potential confounders (age, gender, smoking, diabetes, cardiovascular comorbidities, antihypertensive therapy, BMI, systolic BP, haemoglobin, albumin total cholesterol, 24h urinary protein, phosphate, and C-reactive protein) did not materially modify the eGFRdiff- non fatal CV events-death (HR: 0.958, 95% CI: 0.939-0.977, P&lt;0.001) as well as the eGFRdiff- renal events-death (HR: 0.984, 95% CI: 0.971-0.997, P=0.014). Conclusion The eGFRDiff, a new biomarker of frailty, associates with the Physical Component summary of SF36 and predicts cardiovascular events, progression to kidney failure and death independently of other risk factors in CKD patients. Considering eGFRDiff as a marker of patients’ functional status may be helpful to nephrologists as an indicator of poor prognosis.

Upadacitinib improves patient-reported outcomes vs placebo or adalimumab in patients with rheumatoid arthritis: results from SELECT-COMPARE

ABSTRACT Objective To evaluate the impact of upadacitinib vs placebo and adalimumab treatment, on patient-reported outcomes (PROs) in SELECT-COMPARE in an active RA population with inadequate responses to methotrexate (MTX-IR). Methods PROs in patients receiving upadacitinib (15 mg QD), placebo, or adalimumab (40 mg EOW) while on background MTX were evaluated over 48 weeks. PROs included PtGA and pain by VAS, HAQ-DI, 36-Item Short Form Survey (SF-36), morning (AM) stiffness duration and severity, FACIT-F, and work instability. Least squares mean (LSM) changes and proportions of patients reporting improvements ≥ minimal clinically important differences (MCID) and scores ≥ normative values were evaluated. Results Upadacitinib and adalimumab resulted in greater LSM changes from baseline vs placebo across all PROs (p &lt; 0.05) at week 12, and pain and AM stiffness severity (p &lt; 0.05) at week 2. More upadacitinib- vs placebo-treated (p &lt; 0.05) and similar percentages of upadacitinib- vs adalimumab-treated patients reported improvements ≥ MCID across all PROs at week 12. Upadacitinib vs adalimumab resulted in greater LSM changes from baseline in PtGA, pain, HAQ-DI, stiffness severity, FACIT-F, and SF-36 Physical Component Summary (PCS) (all p &lt; 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients reported scores ≥ normative values in HAQ-DI and SF-36 PCS (p &lt; 0.05) at week 12. More upadacitinib- vs adalimumab-treated patients maintained clinically meaningful improvements in PtGA, pain, HAQ-DI, FACIT-F, and AM stiffness through 48 weeks. Conclusion In MTX-IR patients with RA, treatment with upadacitinib resulted in statistically significant and clinically meaningful improvements in PROs equivalent to or greater than with adalimumab.

Quality of Life After Open Abdominal Treatment With Vacuum-Assisted Wound Closure and Mesh-Mediated Fascial Traction

ABSTRACT Introduction Little is known about the long-term outcome of open abdomen treatment with vacuum-assisted wound closure and mesh-3. Therefore, this study’s purpose is to evaluate this with a particular focus on incisional hernia development and quality of life (QoL). Materials and Methods Fifty-five patients who underwent vacuum-assisted wound closure and mesh-mediated fascial traction at our institution from 2006 to 2013 were prospectively enrolled in this study. After a median follow-up period of 3.8 years, 34 patients attended a follow-up examination, including the SF-36 QoL questionnaire. Results The fascial closure rate was 74% (intention-to-treat) and 89% (per-protocol). Enteroatmospheric fistulae occurred in 1.8%. In-hospital mortality was 16.4%, and during the follow-up period, it was 27.4%. Incisional hernias developed in 35% of the cases. The SF-36 physical role (54.6 ± 41.0 (0-100), P &lt; 0.01), physical functioning (68.4 ± 29.5 (0-100), P = 0.01), and physical component summary (41.6 ± 13.0 (19-62), P = 0.01) scores for the patient population were significantly lower than normative scores. The mental dimensions of QoL showed no differences. A subgroup analysis revealed that the lower scores for physical role, physical functioning, and physical component summary only existed in the subgroup of incisional hernia patients. In contrast, physical and mental SF-36 scores of patients without incisional hernias did not differ from the normative scores. Conclusions Vacuum-assisted wound closure and mesh-mediated fascial traction seems to result in low complication rates. However, incisional hernias occur in 35%, which are the leading cause of reduced QoL. Measures to further improve this rate, such as prophylactic meshes, have to be evaluated.

The validation of the measurement of the mental and physical components of SF-12 in Iranian elderly

This study aimed to assess the validity and reliability of the mental component summary (MCS) and physical component summary (PCS) of SF-12. 140 Iranian elderly aged 60 years and older from the general population (100 male vs 40 female) of the Shiraz city were recruited by convenient sampling. The questionnaire on quality of life (SF-12, two dimensions: the physical component α = 0.68; and the mental component α = 0.71) was used to collect the data analyzed with the AMOS software. According to the structural equation model (SEM), four subscales of SF-12 (emotional role, social function, vitality and mental health) can predict mental component summary (respectively: coefficient = 0.65, 0.57, 0.78 and 0.90) and four subscales of SF-12 (general health, physical function, bodily pain and physical role) can predict physical component summary (respectively: coefficient = 0.58, 0.70, 0.74 and 0.88). The goodness-of-fit indices showed that the model for predicting mental and physical components in the elderly was excellent (X2 / df = 1.61, RMSEA= 0.07, CFI = 0.96 and NFI=0.92).

Relationship Between Tibiotalar Joint Space and Ankle Function Following Ankle Surgery

Background: Joint-preserving procedures of the ankle may postpone the need for ankle arthrodesis (AA) or total ankle replacement (TAR). The challenge for the surgeon is to determine which patients may benefit from these joint-preserving procedures. We hypothesized that patents with less than 2 mm of ankle joint space on preoperative radiographs would report inferior outcomes following joint-preserving surgery compared with those with 2 mm or greater joint space. Methods: Patients 18 years of age or older treated with joint-preserving ankle surgery with a minimum of 2 years of follow-up were considered for study inclusion. The ankle joint space was measured on standardized weightbearing preoperative radiographs. At follow-up, patients completed questionnaires including the Foot and Ankle Ability Measure (FAAM) Activities of Daily Living (ADL) and Sports subscales, the Short Form-12 (SF-12) Physical Component Summary and Mental Component Summary, the Tegner Activity Scale, and satisfaction with outcome. Results: A total of 251 patients were included in the study. Forty-three patients had an ankle joint space of less than 2 mm. Compared with the 208 patients with an ankle joint space of 2 mm or greater, they had inferior FAAM ADL, FAAM Sports, and SF-12 Physical Component Summary scores ( P = .001, P = .001, and P = .006, respectively). Additionally, a statistically significant positive correlation between joint space distance and the FAAM ADL ( P = .012, r = 0.158), FAAM Sports ( P < .001, r = 0.301), and SF-12 Physical Component Summary ( P < .010, r = 0.163) scores was found. Conclusion: Patients with a preoperatively narrowed ankle joint space of less than 2 mm had significantly lower outcome scores following joint-preserving ankle surgery compared with patients with preserved ankle joint space. These results may assist clinicians in selecting patients who may benefit from ankle joint–preserving procedures, as well as counseling patients with a narrowed ankle joint space regarding expected outcome after joint-preserving ankle surgery. Level of Evidence: Level II, prognostic comparative study.