Short Form Health Survey Scores Research Articles

Health-Related Quality of Life May Predict Disease Staging in 10 Years in Parkinson Disease With Hoehn-Yahr Stage III.

Ten years ago, we examined 30 patients with Hoehn-Yahr stage III Parkinson disease (PD) to determine predictors related to falling, including walking speed, step number, and step time by using the originally designed narrowed paths. We verified the increased number of steps as greater risk for an upgrade of Hoehn-Yahr stage in a 6-year period. We further prospectively studied the same patients whether the step number on a sudden narrow path persists as a predictor of the severity of PD. The follow-up patients were divided into 2 groups-patients with and without an increase in Hoehn-Yahr stage. Variables with a significant relation to the development of Hoehn-Yahr stage on a single variable logistic regression analysis (p < 0.05) were entered into multiple logistic regression analysis, adjusting both age and disease duration. The significant variables between patients with and without an increase in Hoehn-Yahr stage were 36-item Short-Form Health Survey (SF-36) scores at 2, 4, 6, and 8 years. Multiple logistic regression analyses after adjusting both age and disease duration showed the SF-36 score at 2, 4, 6, and 8 years. The domain in social functioning significantly differed between patients with and without deterioration of Hoehn-Yahr stage in 10 years. This study demonstrated the capacity of low health-related quality of life (HR-QOL) to predict future developments of PD staging in 10 years. The lower HR-QOL, particularly in social functioning, may reflect the severity of both motor and nonmotor symptoms.

Intra-Articular Bone Marrow Aspirate Concentrate Injection in Patients with Knee Osteoarthritis

We aimed to evaluate the 5-year follow-up outcomes of an intra-articular bone marrow aspirate concentrate (BMAC) injection in patients with knee osteoarthritis. This is the first study to report the outcomes following BMAC injections over a 5-year follow-up period. Seventy knees of 37 patients, including 33 bilateral knees, were investigated. The primary outcome was the visual analogue scale (VAS) score for pain in the knee joint, and the secondary outcomes were the International Knee Documentation Committee score, the 36-Item Short Form Health Survey score, the Knee injury Osteoarthritis Outcome Score, Lysholm Knee Questionnaire/Tegner activity scale, BMAC injection-induced complications, and 5-year treatment success rate. The 5-year post-injection VAS scores (4.7 ± 0.5) were significantly lower than the preoperative scores (8.3 ± 1.2) (p = 0.01). Improvement in VAS scores was significantly greater in patients with Kellgren–Lawrence (K-L) Grade I or II than those in those with K-L Grade III or IV. Improvement in other clinical parameters and success rates were significantly low and the rates of secondary operation and failure were significantly higher in patients with K-L Grades III or IV. Intra-articular BMAC injections could be useful for managing patients with K-L Grades I or II osteoarthritis.

Laparoscopic Ventral Rectopexy for Obstructed Defecation: Functional Results and Quality of Life.

Laparoscopic ventral mesh rectopexy (LVR) is gaining wider acceptance as the preferred procedure to correct internal and external rectal prolapse with obstructed defecation syndrome (ODS) and/or fecal incontinence. The aim of our study was to analyze functional outcome and quality of life (Health-Related Quality of Life) after LVR for symptomatic internal prolapse and/or rectocele with ODS. Prospectively collected data on LVR for internal rectal prolapse were analyzed in 50 consecutive female patients operated between January 2011 and December 2018. In all cases, we performed a LVR according to the D'Hoore technique. Patients had ODS and internal rectal prolapse (grade 3 or 4) confirmed at the defecogram study. We registered only 1 major complication that required surgical treatment (Clavien-Dindo IIIb). The median hospital stay was 4 days [interquartile range (IQR): 2 to 5 d]. Functional results were measured with the Wexner Constipation Score and the 36-Item Short-Form Health Survey, and were analyzed before surgery and after 3, 6, or 12 months. After a median follow-up of 16.5 months (IQR: 10 to 44.25 mo), the Wexner Total Score was significantly improved in almost all items passing from 14 (IQR: 11 to 18) to 11 (IQR: 6.25 to 14.75) after surgery (P<0.0001). Incontinence was cured in 8 of 11 patients (P=0.036). Compared with the preoperative score, the 36-Item Short-Form Health Survey score improved, especially for physical activity, varying from 75 to 87.5 (P=0.0156). No worsening of continence status, constipation, or sexual function was observed. LVR appears to provide a sustained improvement in Health-Related Quality of Life, constipation, and incontinence in patients with ODS without worsening constipation with low morbidity and recurrence.

EVALUATION OF PHYSICAL EXERCISE'S EFFECTS ON LOW BACK PAIN AMONG UNIVERSITY STUDENTS WITH SHORT FORM-36 AND OSWESTRY DISABILITY INDEX

Aims: This study aims to investigate the main effects of physical exercise on lower back pain with the Short Form-36 Health Survey and Oswestry Disability Index scores. Methods: University students between 18-25 years old who suffer from low back pain were enrolled in the study. Short Form-36 Health Survey and Oswestry Disability Index were used as the reference scales of lower back pain and quality of life, respectively. There are some questions in the questionnaire to scale the average comfort of the place they sleep and sit during the day, which is the result of the Personal Comfort Score. The Mann-Whitney U test was used for non-normal distributed variables. Correlation and Linear Regression were used to analyze data. SPSS 25.0 was used for all statistical analysis. Results: A total of 139 university students (94 females, 45 males) were included in the study. The median age was 20 years (IQR=2) for female students and 20 years (IQR=1) for male students. Oswestry Disability Index scores of fe- male students were higher, while Short Form-36 scores were lower than the male students. Male students' physical functioning scores were higher than female students. Each one-unit increase in Personal Comfort Score is associated with an increase in the rate between the energy/fatigue (3.34 units). Body Mass Index considerably affected the pain and Oswestry Disability Score, an increase in one unit of baseline BMI upsurged the Short Form-36 pain score to 0.13, and Oswestry disability score to 0.55. Conc- lusion: In our study, Body Mass Index is found to be associated with Oswestry Disability Index and Short Form-36 score, which are used for the severity of low back pain and defining the life quality and of patients. PCS had a positive correlation between energy/fatigue. In addition, There was a positive correlation between physical exercise and general health score.

Does anxiety influence the prognosis of percutaneous transforaminal endoscopic discectomy in the treatment of lumbar disc herniation? A preliminary propensity score matching analysis.

Previous reports revealed a correlation between psychological problems and spinal surgery. There is a lack of knowledge on the effect of anxiety on the percutaneous transforaminal endoscopic discectomy (PTED) outcome at the twoyear follow-up. The purpose of this study is to investigate changes in anxiety after PTED among patients with lumbar disc herniation (LDH), to compare the effect of anxiety on the prognosis using propensity score matching analysis, and to identify the related parameters of anxiety. A total of 145 patients with LDH requiring PTED surgery were included. Twenty-six LDH patients with anxiety were matched with 26 control patients utilizing propensity score matching analysis. The demographic and peri-operative data were collected and analyzed. A correlation analysis was utilized. Both groups achieved significant improvements in visual analogue scale (VAS) scores for pain, Japanese Orthopedic Association (JOA) scores for neurological deficit, and 36-item Short-Form Health Survey (SF-36) scores and Oswestry Disability Index (ODI) scores for quality of life. A statistical difference was detected between the pre-operative and the post-operative Zung Self-Rating Anxiety Scale scores in the anxiety cohort. However, the difference between the anxiety group and the control group was statistically significant in the aforementioned parameters. The VAS, JOA, ODI and the SF-36 scores, and the disease duration were associated with pre-operative anxiety. PTED may provide significant improvements in clinical outcomes and symptoms of anxiety. A negative impact on the patient's prognosis may be caused by the presence of anxiety. Pain severity, neurological deficit, disease duration, and quality of life were associated with anxiety.

Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study.

IntroductionChronic pain assessment and post-treatment evaluation continues to be challenging due to a lack of validated, objective tools to measure patient outcomes. Validation of mechanistic pain biomarkers would allow clinicians to objectively identify abnormal biochemistry contributing to painful symptoms.MethodsWe describe the clinical validation of a multi-biomarker assay with algorithmic analysis known as the Foundation Pain Index (FPI) in diverse cohorts of chronic pain patients in a prospective, cross-sectional, observational validation study. Levels of 11 urinary pain biomarkers were measured and tabulated using a proprietary algorithm to generate FPI scores for chronic pain subjects (N = 153) and age- and sex-matched pain-free controls (N = 334).ResultsFPI scores were significantly correlated with the 36-Item Short Form Health Survey (SF-36) scores among chronic pain subjects (P value < 0.015) and specific components of SF-36, including emotional well-being, limitations due to emotional problems, and general health (P value < 0.05). Area under ROC analysis (AUROC) revealed FPI to accurately distinguish biomarker profiles between pain-free and chronic pain cohorts (AUROC: 0.7490, P value < 0.0001) as well as the SF-36 scores between chronic pain subjects with low vs. high FPI scores (AUROC: 0.7715, P value < 0.01).ConclusionsOur findings establish the validity and discriminatory power of a novel multi-biomarker test that evaluates the role of biochemistry in chronic pain and correlates with clinical assessments of patients. This test provides novel, reproducible, objective data which may pave the way for non-opioid therapeutic strategies to treat chronic pain.

Efficacy of yokukansan compared with clonazepam for rapid eye movement sleep behaviour disorder: a preliminary retrospective study.

Rapid eye movement sleep behaviour disorder (RBD) is characterized by abnormal behaviours accordant with nightmares during rapid eye movement sleep and is considered a prodromal marker of dementia with Lewy body. Most common in the elderly population, RBD is generally treated with clonazepam (CZP), a long-term acting benzodiazepine antiepileptic. As such, alternative drugs for RBD are urgently needed to minimize the adverse effects peculiar to benzodiazepines. The efficacy of yokukansan (YKS), a traditional Japanese herbal medicine, on RBD was initially reported by Shinno et al. in 2008. However, no study has compared YKS with CZP. Therefore, this study aimed to clarify the possibility of using YKS as an alternative to CZP. This was a retrospective cohort study conducted at Jikei University Affiliated Hospital. The subjects were selected from 36 outpatients who had been diagnosed with RBD based on the International Classification of Sleep Disorders, third edition. Of the 23 who met the inclusion criteria but not the exclusion criteria, 11 were treated with YKS monotherapy, and 12 were treated with CZP monotherapy. The primary outcome was the total score on the Japanese version of the Rapid Eye Movement Sleep Behaviour Disorder Questionnaire (RBDQ-JP), and the secondary outcomes were the scores from the eight-item Short-Form Health Survey and factors 1 and 2 of the RBDQ-JP. The mean total RBDQ-JP score significantly improved from 52.5 to 21.7 (P = 0.002) after treatment with YKS (mean dosage: 3.0 g/day), which was similar to the change after CZP treatment (from 43.8 to 21.3). On RBDQ-JP factor 1 (dream content), the mean score on five of six items significantly improved after treatment with YKS. There was no significant change in Short-Form Health Survey scores after treatment with either drug. Potassium concentrations were within the normal range in patients treated with YKS. The present results suggest that a small amount of YKS may be an alternative to CZP for RBD, without remarkable adverse events. Further study is needed to prospectively clarify the efficacy and safety of YKS in more detail.

PRO91 REDUCTION IN HRQOL WITH INCREASING VOC FREQUENCY AMONG PATIENTS WITH SCD

Objectives: Sickle cell disease (SCD) is one of the most prevalent inherited diseases, with approximately 300,000 affected children born each year worldwide. A major cause of morbidity among patients with SCD is the occurrence of severely painful episodes, known as vaso-occlusive crisis (VOCs), which can impact quality of life and cause organ damage or even death. This study assessed the impact of VOC events on health-related quality of life (HRQoL) and associated utility of patients with SCD. Methods: The LEGACY registry (CICL670AUS38) is a prospective, multicenter, observational study that documented the outcomes of 498 SCD patients living in the United States. For the cohort of 181 adult patients (≥18 years), Short Form-36 (SF-36) Health Survey scores and VOCs were evaluated every 6 months for 3 years or until patient discontinuation. SF-36 scores were mapped to the EuroQoL five-dimension (EQ-5D) questionnaire. For each patient, the annualized rate of VOC events was calculated from first visit to each visit with HRQoL measures reported, and annualized VOC rates were subsequently grouped (<1, ≥1 to <3, ≥3 VOCs/year). Mean EQ-5D scores were compared between annualized VOC groups using generalized estimating equations to account for within-patient correlation across visits. Differences between the groups on the SF-36 component scores and SF-36 domains were also assessed. Results: Patients with ≥3 VOCs/year reported, on average, a mapped EQ-5D score 0.0697 lower (p = 0.014) than patients with <1 VOCs/year (0.6213 vs. 0.6910). Furthermore, patients who had ≥3 VOCs/year also showed, on average, a SF-36 Physical Component Score 2.480 lower (p = 0.025) compared to patients with <1 VOCs/year (48.684 vs. 51.164). Conclusions: This analysis demonstrates the long-term impact of VOC frequency on HRQoL. SCD patients who had a higher number of annual VOCs were shown to have a worse HRQoL compared to patients with <1 VOCs/year.

Assessment of the association between paraspinal muscle degeneration and quality of life in patients with degenerative lumbar scoliosis.

The present study aimed to determine the characteristics of multifidus, erector spinae and psoas major degeneration in elderly patients with degenerative lumbar scoliosis (DLS) and the correlation between asymmetric changes and patient quality of life. A total of 49 patients with lumbar scoliosis (DLS group) and 38 healthy individuals (control group) were prospectively examined. The functional cross-sectional area, cross-sectional area difference index (CDI) and fat infiltration rate (FIR) of the multifidus, erector spinae and psoas major at the apical vertebral level were measured using MRI. The visual analogue scale (VAS) score, Oswestry Disability Index (ODI) and 36-item Short Form Health Survey (SF-36) score were used to evaluate patient quality of life. Correlations between the degree of asymmetric muscular degeneration and quality of life were analysed. The CDI of the multifidus, erector spinal and psoas major was higher in the DLS group compared with that in the control group. The CDI of the multifidus was found to be positively associated with the Cobb angle of lumbar scoliosis. Similar results were obtained for fat infiltration between the two groups. In addition, the CDI and FIR difference index of the multifidus was positively correlated with the VAS score and ODI but negatively correlated with the SF-36 score. The quality of life significantly decreased with increasing asymmetric atrophy and fat infiltration in the multifidus. Thus, strategies to enhance the function of the multifidus may have a positive impact on quality of life (Chinese Clinical Trial Registry, registration date, 2018.11.12; registration no. ChiCTR1800019459.).

Pharmacological treatment for familial amyloid polyneuropathy.

Pharmacological treatment for familial amyloid polyneuropathy.

Use of a Closed Diurnal Indwelling Catheter for Patients With Spinal Cord Disorders: A Pilot Study

ObjectivesTo evaluate an alternative to clean intermittent catheterization (CIC) for individuals with neurogenic bladder for its effects on independence, privacy, and convenience. This prospective cohort study provides an initial assessment of quality of life, safety, and efficacy of closed diurnal indwelling catheterization (CDIC). Materials and MethodsIndividuals with spinal cord disorders using CIC were prospectively screened at multidisciplinary clinic appointments. During the 24-week intervention, a foley was placed each morning and capped between scheduled bladder drainage each 3-4 hours. After a maximum of 8 hours of CDIC use, CIC was resumed. Quality of life outcome measures (the Short Form Health Survey, King's Health Questionnaire, and Pediatric Quality of Life InventoryTM (PedsQL) questionnaires), clinic evaluations, labs, imaging, and urodynamics were obtained at specified interval visits planned after 4-, 12-, and 24 weeks of study participation and compared to baseline. ResultsA total of 11 subjects enrolled; 8 completed the 24-week intervention. No significant difference with CDIC was observed in the Short Form Health Survey or PedsQL summary scores as compared to baseline. For the King's Health Questionnaire, physical limitations secondary to bladder function decreased significantly from baseline to the 4-week and 12-week (P = .02) but not 24-week visits. All 8 subjects who completed the 24-week intervention requested continued use. Early discontinuation occurred in 3 male participants due to urethral trauma (1) and incontinence (2). No increase in bacteriuria, urinary tract infections, or renal anatomic changes was observed. ConclusionThis prospective study demonstrates that CDIC may be safe and effective for short-term use. This alternative to CIC for scheduled daytime bladder drainage for neurogenic bladder warrants further consideration.

Health-Related Quality of Life in Patients After Surgically Treated Midface Fracture: A Comparison with the Croatian Population Norm.

AimTo evaluate the health-related life quality of patients after surgically treated midface fractures.Patients and MethodsThis retrospective cohort study compared the 36-Item Short Form Health Survey (SF-36) scores of 42 male patients following surgically treated maxillary or zygomatic fractures with the reported normative data of the SF-36 for the Croatian population.ResultsThe current study showed that the health-related life quality of surgically treated patients was comparable to similar age, gender, and regional demographics in the Croatian population norm. However, we revealed a significant deterioration of the “Emotional wellbeing” domain in younger patients (P = 0.03) and a severely affected domain of “Physical functioning” in older patients (P = 0.049).ConclusionThere was a significant negative psychological impact from facial trauma on younger patients. In contrast, older patients were more prone to physical impairment. Therefore, follow-up visits are an opportunity to screen and refer younger patients to mental health services in a timely manner to prevent severe psychological difficulties and an opportunity to identify older patients who require physical therapy.

Performance of the Patient-Reported Outcome Measurement Information System in Patients With Patellofemoral Instability.

Background:The Patient-Reported Outcome Measurement Information System (PROMIS) was developed to improve patient-reported outcome measures (PROMs) and administration through a computer adaptive test (CAT). The PROMIS physical function-CAT (PF-CAT) has not been investigated in patients with patellofemoral instability (PFI).Purpose/Hypothesis:The purpose of this study was to evaluate the construct validity of the PROMIS PF-CAT with previously validated tools for measuring PROMs in patients with a diagnosis of PFI. We hypothesized that the PF-CAT will have the strongest correlations with other PROMs that evaluated PF as well as moderate correlations with PROMs that measured other health domains.Study Design:Cohort study (diagnosis); Level of evidence, 2.Methods:Patients enrolled in this study who underwent operative intervention for PFI completed the following evaluations preoperatively: PROMIS PF-CAT, 36-Item Short Form Health Survey (SF-36), Knee injury and Osteoarthritis Outcome Score (KOOS), EuroQol-5 dimensions (EQ-5D), and Kujala Anterior Knee Pain Scale (AKPS). Correlation coefficients and the percentage of patients achieving the highest and lowest possible outcome score of each instrument were calculated to assess floor and ceiling effects. Statistical significance was defined as P < .05.Results:In total, 91 participants (63.7% females; mean age, 20.1 ± 7.2 years) completed the questionnaires. PF-CAT had the lowest number of questions (4.3 ± 1.1). The strongest correlations were between the PF-CAT and SF-36 PF subscale (r = 0.78; P < .01), AKPS (r = 0.68; P < .01), and KOOS Activities of Daily Living subscale (r = 0.68; P < .01). Correlation was moderate between the PF-CAT and the KOOS subscales of Sports/Recreation (r = 0.58; P < .01), Quality of Life (r = 0.53; P < .01), and Symptoms (r = 0.47; P < .01). The PROMIS PF-CAT demonstrated no floor or ceiling effects.Conclusion:In patients with PFI, construct validity of the PROMIS PF-CAT was supported by strong correlations demonstrated between the PF-CAT and PROMs evaluating PF and moderate correlations with those assessing other health domains. Our results demonstrated a low respondent burden and no floor or ceiling effects associated with the PROMIS PF-CAT. The PROMIS PF-CAT may be considered a beneficial alternative to previously established PF PROMs for preoperative evaluation of patients with PFI.

Augmenting posterolateral fusion with transforaminal lumbar interbody fusion cage improves clinical outcome, but not fusion rate, of posterior decompression.

ObjectiveThis study was performed to compare fusion rates and clinical outcomes of posterior decompression by posterolateral fusion (PLF) versus transforaminal lumbar interbody fusion (TLIF) for treatment of lumbar spinal stenosis.MethodsThis retrospective cohort study involved 157 patients with lumbar spinal stenosis treated with instrumented PLF alone or instrumented PLF combined with TLIF from 2010 to 2018. The patients were divided into two groups: the PLF group (Group A), in which posterior decompression with instrumented PLF was performed, and the cage-augmented group (Group B), in which TLIF was added to the procedures described for the PLF group. Patient outcomes (Oswestry Disability Index, visual analog scale score, and 36-Item Short-Form Health Survey scores) and fusion rates were compared.ResultsThe fusion rate was similar between the two groups. Among patients with two- and three-level fusion, improvements in the clinical outcome scores were significantly greater in Group B than Group A.ConclusionCombining TLIF with PLF provides better clinical outcomes than PLF alone when multilevel fusion is indicated. TLIF augmentation does not improve the fusion rates in either single- or multi-level surgery.

Injections of concentrated bone marrow aspirate as treatment for Discogenic pain: a retrospective analysis

BackgroundThere are an overwhelming number of patients suffering from low back pain (LBP) resulting from disc pathology. Although several strategies are being developed pre-clinically, simple strategies to treat the large number of patients currently affected is still needed. One option is to use concentrated bone marrow aspirate (cBMA), which may be effective due to its intrinsic stem cells and growth factors.MethodsThirty-three patients who received intradiscal injections of cBMA to relieve LBP were followed up based on Numeric Rating Scale (NRS), Oswestry Low Back Pain Disability Index (ODI), and Short Form-36 Health Survey (SF-36) scores. Patients were also subdivided into those with a pre-injection NRS > 5 and pre-injection NRS ≤ 5. The proportion of patients demonstrating at least 50% improvement (and 95% confidence intervals) from baseline at five follow-up visits for each outcome was evaluated.ResultsAt least 50% improvement in NRS was observed for 13.8, 45.8, 41.1, 23.5, and 38.9% of patients across five follow-up visits, out to 1 year. When stratified by high (> 5) versus low (≤ 5) baseline NRS scores, the values were 14.3, 45.5, 71.4, 22.2, and 44.4% among those with high baseline pain, and 13.3, 46.2, 20.0, 25.0, and 33.3% among those with low baseline pain. The 50% improvement rates across visits were 4.3, 28.6, 30.0, 22.2, and 30.8% for SF-36, and 4.2, 26.7, 36.4, 55.6, and 30.8% for ODI.ConclusionsIntradiscal cBMA injections may be effective to reduce pain and improve function. Patients with relatively higher initial pain may have potential for greatest improvement.

Midterm outcomes of arthroscopic rotator cuff repair in patients aged 75 years and older

Full-thickness rotator cuff tears remain a significant cause of pain and dysfunction in the elderly. Substantial improvement in pain and functional outcomes with arthroscopic cuff repair is possible. Recent data has shown that patients older than 70-75 years still have clinical improvement with operative rotator cuff repair. This is a retrospective study of patients aged ≥75 years undergoing arthroscopic rotator cuff repair at a minimum of 24 months after surgery. Outcome measurements included range of motion (ROM), visual analog scale (VAS) pain scores, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) scores, Single Assessment Numeric Evaluation (SANE) scores, and Short Form Health Survey (SF-12) scores. Reoperation and rates of conversion to reverse shoulder arthroplasty (RSA) were determined. Eighty-three patients were included with an average follow-up of 56.9 ± 25.9 months (range 24-127 months). Six (7.2%) patients had additional surgery, including 3 revision rotator cuff repairs for retear, 2 conversion to RSA, and 1 capsular release and loose anchor removal. There were statistically significant improvements in shoulder ROM, ASES, SANE, VAS, and SF-12 scores postoperatively. Rotator cuff repair in select patients aged ≥75 yearsresults in reliable improvements in pain and function. There was a low reoperation rate or conversion to RSA (7.2%) at midterm follow-up. This study indicates a role for rotator cuff repair in an elderly population and argues against the routine use of reverse arthroplasty for repairable rotator cuff tears in this population.

Comparison of Tightly Controlled Dose Reduction of Biologics With Usual Care for Patients With Psoriasis

Biologics revolutionized the treatment of psoriasis. Biologics are given in a fixed dose, but lower doses might be possible. To investigate whether dose reduction (DR) of biologics in patients with stable psoriasis is noninferior to usual care (UC). This pragmatic, open-label, prospective, controlled, noninferiority randomized clinical trial was conducted from March 1, 2016, to July 22, 2018, at 6 dermatology departments in the Netherlands. A total of 120 patients with plaque psoriasis and stable low disease activity who were receiving treatment with adalimumab, etanercept, or ustekinumab were studied. Patients were randomized 1:1 to DR (n = 60) or UC (n = 60). In the DR group, injection intervals were prolonged stepwise, leading to 67% and 50% of the original dose. The primary outcome was between-group difference in disease activity corrected for baseline at 12 months compared with the predefined noninferiority margin of 0.5. Secondary outcomes were Psoriasis Area and Severity Index (PASI) score and health-related quality of life (including Dermatology Life Quality Index [DLQI] and Medical Outcomes Study 36-Item Short Form Health Survey scores), proportion of patients with short and persistent flares (defined as PASI and/or DLQI scores >5 for ≥3 months), and proportion of patients with successful dose tapering. Of 120 patients (mean [SD] age, 54.0 [13.2] years; 82 [68%] male), 2 patients were lost to follow-up, 2 patients had a protocol violation, and 5 patients had a protocol deviation, leaving 111 patients for the per-protocol analysis (53 in the DR group and 58 in the UC group). The median PASI scores at month 12 were 3.4 (interquartile range [IQR], 2.2-4.5) in the DR group and 2.1 (IQR, 0.6-3.6) in the UC group (mean difference, 1.2; 95% CI, 0.7-1.8). This indicates that noninferiority was not demonstrated for DR compared to UC. The median DLQI score at month 12 was 1.0 (IQR, 0.0-2.0) in the DR group and 0.0 (IQR, 0.0-2.0) in the UC group (mean difference, 0.8; 95% CI, 0.3-1.3), indicating noninferiority for DR compared with UC. No significant difference was found regarding persistent flares between groups (n = 5 in both groups). Twenty-eight patients (53%; 95% CI, 39%-67%) in the DR group tapered their dose successfully at 12 months. No severe adverse events related to the intervention occurred. In this trial, noninferiority was not demonstrated for DR of adalimumab, etanercept, and ustekinumab based on the PASI in patients with psoriasis compared with UC with the chosen noninferiority margin. However, the strategy was noninferior based on the DLQI. Dose tapering did not lead to persistent flares or safety issues. ClinicalTrials.gov Identifier: NCT02602925.

Effects of Exercise and an Integrated Neuromuscular Inhibition Technique Program in the Management of Chronic Mechanical Neck Pain: A Randomized Controlled Trial

ObjectiveThe aim of this study was to evaluate the effect of adding the integrated neuromuscular inhibition technique (INIT) to therapeutic exercise (TE) in individuals with chronic mechanical neck pain (CMNP). MethodsIn this 34-week, assessor-blind randomized controlled trial, 40 participants (men and women) with CMNP with active or latent myofascial trigger points on the neck muscles were divided into 2 groups. The participants followed 4 treatments per week for 10 weeks. The intervention group followed a TE program in combination with the INIT, whereas the control group followed the same program without the INIT. Both protocols were applied by physiotherapists. Pain, disability, pressure pain threshold, active range of motion, and health-related quality of life were evaluated before, during, and after the intervention, whereas patients were followed for 6 months after completion of treatment. Repeated-measures ANOVA was applied. ResultsBoth groups showed a significant improvement in all dependent measures after the intervention (P < .05). However, the intervention group showed greater improvement in the visual analog scale and neck disability index score, in the neck muscles pressure pain threshold, in the range of motion, and in the 36-Item Short Form Health Survey score, than the control group. In many of the above variables this improvement was seen from the second week and was maintained for 6 months after the intervention. ConclusionThe results of this preliminary study suggest that the addition of the INIT to a TE program had a positive effect on pain, functionality, and the quality of life in individuals with CMNP.

P699 The concordance of Short Form-36 Health Survey scores with Mayo scores in the tofacitinib ulcerative colitis clinical programme

Abstract Background The Short Form-36 Health Survey version 2 (SF-36v2) is a generic health-related quality-of-life (HRQoL) instrument [1]. Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). In these exploratory analyses the concordance between total and partial Mayo scores and SF-36v2 scores was evaluated in patients with UC in the Phase 3 tofacitinib 8-week OCTAVE Induction 1&amp;2 (NCT01465763; NCT01458951) and 52-week OCTAVE Sustain (NCT01458574) studies. Methods A repeated measures regression model was used to evaluate the relationship between total and partial Mayo scores (as predictor) and SF-36v2 component and domain scores. A sensitivity analysis to assess the linearity assumption was performed using Mayo score as a categorical anchor (represented by integer values 0–12 [total] or 0–9 [partial]). Previous analyses identified clinically important differences (CIDs) in total and partial Mayo scores as changes of 3 points and 2.25 points, respectively [2]. Mean differences in SF-36v2 component and domain scores were compared with their recommended group-level CID thresholds [3]. Results Clinically meaningful differences of 3 points and 2.25 points in total and partial Mayo scores, respectively, were generally associated with clinically meaningful differences in SF-36v2 component and domain scores, with the exception of Role-Emotional with partial Mayo score in the pooled induction studies and with total Mayo score in the maintenance study. In the induction studies, a 3-point difference in total Mayo score was associated with a mean difference exceeding CIDs in both the SF-36v2 Physical Component Summary score (mean improvement 4.5; 95% confidence interval [CI] 4.2, 4.7) and Mental Component Summary score (mean improvement 5.0; 95% CI 4.6, 5.3). Results were closely aligned when Mayo score was used as a categorical or continuous anchor, supporting a linear relationship between Mayo score and SF-36v2 scores (Figure). Similar results were observed in the maintenance study, and when assessing the relationship of partial Mayo score with SF-36v2 scores. Conclusion Clinically meaningful decreases in disease activity, as measured by Mayo score, were associated with clinically meaningful benefits in HRQoL, as measured by SF-36v2 component and domain scores. These findings highlight the impact that disease activity has on HRQoL and may assist with articulating the treatment effect of tofacitinib on specific domains. References

Minimally invasive spine surgery: evaluation of clinical and functional outcomes and their correlation with the return to work.

BackgroundIntervertebral disc changes are a multi-factorial problem whose main clinical feature is pain. Studies show that when clinical treatments fail, the proposed surgical treatments frequently present unsatisfactory results. Traditional lumbar arthrodesis causes important clinical and functional changes that can result in complications and jeopardize the patients’ quality of life.ObjectivesThis study aims to investigate the clinical and functional results of minimally invasive spine surgery in patients with a clinical diagnosis of low-back or sciatic pain and segmental instability, finally correlating these results with the patients’ return to work.MethodsPatients signed an informed consent form and were clinical and radiographically re-evaluated by independent professionals in the pre- and postoperative periods. Evaluation methods used the Oswestry disability index, as well as visual analog scale and Medical Outcomes Short Form Health Survey (SF-36) scores. We also retrieved epidemiological data, information on work resumption, and bone consolidation evaluations from the medical records.ResultsWe evaluated 19 patients who had been operated on 33 levels; visual analog scale and Oswestry disability index scores were initially reduced from 10% to 2% and from 64% to 28%, respectively. SF-36 scores were significantly higher in 5 of the 7 questionnaire scales at the end of the follow-up period. Most patients (68.4%) did not return to work after surgery; the others returned 2 to 67 months after the procedure. All patients received social security benefits after the surgery.ConclusionAlthough the procedure presented positive results, it did not result in a satisfactory return-to-work rate. Our results should be analyzed in view of the low educational level and income of the patients, the manual nature of their labor, and the validity of social security benefits.