Physical SF-36 Research Articles

A Personalized Medicine Approach for the Management of Spinal Metastases with Cord Compression: Development of a Novel Clinical Prediction Model for Postoperative Survival and Quality of Life

Surgery should be considered for patients with metastatic epidural spinal cord compression (MESCC) with a life expectancy of ≥3 months. Given the heterogeneity of the clinical presentation and outcomes, clinical prognostic models (CPMs) can assist in tailoring a personalized medicine approach to optimize surgical decision-making. We aimed to develop and internally validate the first CPM of health-related quality of life (HRQoL) and a novel CPM to predict the survival of patients with MESCC treated surgically. Using data from 258 patients (AOSpine North America MESCC study and Nottingham MESCC registry), we created 1-year survival and HRQoL CPMs using a Cox model and logistic regression analysis with manual backward elimination. The outcome measure for HRQoL was the minimal clinical important difference in EuroQol 5-dimension questionnaire scores. Internal validation involved 200 bootstrap iterations, and calibration and discrimination were evaluated. Longer survival was associated with a higher SF-36 physical component score (hazard ratio [HR], 0.96). In contrast, primary tumor other than breast, thyroid, or prostate (unfavorable: HR, 2.57; other: HR, 1.20), organ metastasis (HR, 1.51), male sex (HR, 1.58), and preoperative radiotherapy (HR, 1.53) were not (c-statistic, 0.69; 95% confidence interval, 0.64-0.73). Karnofsky performance status <70% (odds ratio [OR], 2.50), living in North America (OR, 4.06), SF-36 physical component score (OR, 0.95) and SF-36 mental component score (OR, 0.96) were associated with the likelihood of achieving a minimal clinical important difference improvement in the EuroQol 5-Dimension Questionnaire score at 3 months (c-statistic, 0.74; 95% confidence interval, 0.68-0.79). The calibration for both CPMs was very good. We developed and internally validated the first CPMs of survival and HRQoL at 3 months postoperatively in patients with MESCC using the TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) guidelines. A web-based calculator is available (available at: http://spine-met.com) to assist with clinical decision-making.

Osteogenesis imperfecta: towards an individualised interdisciplinary care strategy to improve physical activity and quality of life.

This report describes a new strategy for the care of patients with osteogenesis imperfecta, based on an interdisciplinary team working. Thereby, we aim at fulfilling three main goals: offering thorough coordinated management for all, and improving physical activity and quality of life of the patients. With rare diseases such as osteogenesis imperfecta (OI), patients and their family often suffer from inadequate recognition of their disease, poor care coordination and incomplete information. A coordinated interdisciplinary approach is one possible solution for providing both comprehensive and cost-effective care, with benefits for patient satisfaction. Poor physical activity and impaired quality of life represent a considerable burden for these patients. To better address these issues, in 2012 we created an interdisciplinary team for the management of OI patients in our University Hospital Centre (CHUV, Lausanne University Hospital,). In this article we describe the implementation of this interdisciplinary care strategy for patients suffering from OI, and its impact on their physical activity and quality of life. All patients from the French part of Switzerland were invited to join us. We proposed two complementary evaluations: the initial interdisciplinary evaluation and a yearly follow-up during a special day &ndash; the &ldquo;OI day&rdquo;. This day features specialised medical appointments adapted to each patient&rsquo;s needs, as well as lectures and/or workshops dedicated to patients&rsquo; and families&rsquo; education. Our first aim was to propose for each patient the same management, from diagnosis to the bone health evaluation and physical therapy advice. Our second aim was to evaluate the evolution of physical activity, quality of life (measured by EQ-5D, SF-36 and a dedicated questionnaire) and satisfaction of patients and their families. Here we report both the initial and the long-term results. Since 2012, 50 patients from the French part of Switzerland received the personalised medical evaluation. All of the patients included in this study had the same initial evaluation and at least one participation in an OI Day. All patients had an adaptation of their bone acting drugs. Over a 7-year period, 62% of inactive patients started some physical activity, and 44% of patients who were not involved in any athletic activity started participating in sports. The mean EQ-5D increased from 0.73 to 0.75 (p = 0.59). The mean physical SF36 (musculoskeletal function) score was 59.09 &plusmn; 22.72 and improved to 65.79 &plusmn; 21.51 (p = 0.08), whereas it was 68.06 &plusmn; 20.05 for the mental SF36 without alteration during follow-up. The OI day was revealed to be useful, it contributed to improvement in continuity of care and helped families to better understand the OI patients&rsquo; health. Our interdisciplinary approach aimed at offering the same thorough management for all patients from the French part of Switzerland, and at improving both the physical activity and the satisfaction of the patients and their family. This report is a basis for future work focusing on the effect of bone fragility and the impact of OI on patients&rsquo; social relations.

Efficacy of shortwave diathermy in ulnar nerve entrapment at the elbow: a double-blind randomized controlled clinical trial

Objective: To investigate the efficacy of shortwave diathermy in treatment of ulnar nerve entrapment at the elbow. Design: The study was a double blind, randomized controlled clinical trial. Setting, participants: A total of 76 adult patients diagnosed with ulnar nerve entrapment at the elbow clinically and electrophysiologically, were randomly assigned into two groups. Patients were evaluated at baseline, after completing treatment and 1 and 3 months after treatment. Physical examination, quick-DASH (disabilities of arm, shoulder, hand) and SF-36 (short form) questionnaires for daily life activities, dynamometer for grip strength, and visual analog scale for pain were used. Intervention: A total of 10 sessions of shortwave diathermy were applied to patients in treatment group as five sessions/week, 2 weeks. Control group was given placebo shortwave diathermy. Both groups were given elbow splints and informed to avoid symptom provoking activities. Main outcome measures: Visual analog scale, grip strength, SF-36, and quick-DASH results. Results: Out of 76 patients, 61 of them completed the study where n = 31 for treatment group and n = 30 for control group. Mean age was 46.18 ± 13.45 years. There were 32 (52.5%) women and 29 (47.5%) men. The p values between groups 3 months after intervention for visual analog scale, quick-DASH, SF-36 questionnaire, and dynamometer were 0.669, 0.277, 0.604, and 0.126, respectively (p > 0.05). Conclusion: Application of shortwave diathermy to patients with ulnar nerve neuropathy at the elbow was not associated with any difference in outcome.

Long-Term Symptom Improvement and Health-Related Quality of Life After Operative Management of Median Arcuate Ligament Syndrome

To investigate long-term patient-reported symptom improvement and health-related quality of life measures after operative interventions for median arcuate ligament syndrome (MALS). We reviewed the clinical data of all consecutive patients treated by operative management for symptomatic MALS from 1999 to 2018. Long-term outcomes were assessed using Visick score, Gastrointestinal Quality of Life Index and the Short Form (SF)-12v2 questionnaires. Physical and mental component scores and SF-12 health domains were compared to the average for the US general population. Freedom from symptomatic recurrence was analyzed. There were 100 patients treated for MALS (mean age 38 ± 18 years; 75% female) with open release in 81 and laparoscopic release in 19. Symptoms were abdominal pain in 99 patients with postprandial exacerbation in 85. There was no mortality. Major adverse events at 30 days occurred in 21 patients (open 19%, laparoscopic 2%), including myocardial infarction (1%), pancreatitis (2%), respiratory failure (4%), estimated blood loss of more than 1L (8%), and postoperative ileus (8%). One patient treated by laparoscopic release required conversion for an aortic injury, which was treated by primary repair and splenectomy (Table). At 10 years, freedom from recurrence was 64 ± 6%. A total of 46 patients responded to the survey with a mean follow-up of 8 ± 4 years. Symptom resolution or improvement was reported by 38 patients (83%), persistent unsatisfactory symptoms by 5 (11%) and unchanged or worsening symptoms by 3 (7%). The SF-12 scores were below the general population for the physical component scores, role–physical, bodily pain, vitality and social functioning domains (Fig). Forty patients (87%) reported that they would still like to undergo operative management if given the choice. Operative management for MALS can be performed with low rate of complications with freedom from symptom recurrent of 64% at 10 years. Patients with MALS had lower health-related quality of life physical component scores compared to the general population. The vast majority of patients (87%) would opt to have the operation again if given a choice.TableBaseline characteristics, clinical features, operative details, major adverse events, and follow-up symptoms in 100 patients surgically treated for median arcuate ligament syndrome (MALS)All patients (n = 100)Demographics Mean age, years38.1 ± 18.1 Female sex25 (25) BMI (kg/m2)22.6 ± 4.0Cardiovascular risk factors Tobacco use23 (23) Hypertension19 (19) Dyslipidemia14 (14)Gastrointestinal conditions Gastroesophageal reflux disease35 (35) Irritable bowel syndrome14 (14) Food intolerances12 (12) History of gastritis18 (18)Other conditions Coronary artery disease8 (8) Peripheral vascular disease8 (8) Migraines25 (25) History of mental illness37 (37)Clinical features Abdominal pain99 (99)Epigastric location75 (75)Constant pain35 (35)Postprandial exacerbation85 (85) Weight loss67 (67)Amount of weight loss, kg8.0 ± 8.7Period of weight loss, months6.8 ± 13.0 Epigastric bruits71 (71) Duration of symptoms, months35.2 ± 37.7Operative details Open procedure81 (81) Laparoscopic procedure19 (19) Conversion to open2 (2) Estimated blood loss, mL425.9 ± 1694.6 Blood transfusion8 (8) HDU admission6 (6) Length of hospital stay, days4.3 ± 3.3MAE Any MAE21 (21) EBL >1 L8 (8) Myocardial infarction1 (1) Respiratory failure4 (4) Pancreatitis2 (2) Postoperative ileus8 (8) Wound/incisional complications7 (7)Follow-up symptoms Immediate postoperative symptom improvement, n = 8150 (72)First clinical follow-up, months, n = 513.8 ± 8.2Symptoms improved or resolved35 (69)Symptoms unchanged or worsened17 (3)Latest follow-up, months, n = 8918.2 ± 28.5Symptoms improved or resolved22 (43)Symptoms recurred33 (37)Symptoms unchanged or worsened19 (16)Survey follow-up, years7.8 ± 4.3Symptoms improved or resolved29 (63)Symptoms recurred9 (20)Symptoms unchanged or worsened8 (17)MAE, Major adverse event.Values are number (%) or mean ± standard deviation. Open table in a new tab

Efficacy of Three Low-Intensity, Internet-Based Psychological Interventions for the Treatment of Depression in Primary Care: Randomized Controlled Trial.

BackgroundPrimary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches.ObjectiveThis study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]).MethodsA multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months’ follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages.ResultsA moderate decrease was detected in PHQ-9 scores from HLP (β=–3.05; P=.01) and MP (β=–3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment.ConclusionsThe low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions.Trial RegistrationISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279International Registered Report Identifier (IRRID)RR2-10.1186/s12888-015-0475-0

P0958THE EX-FRAIL CKD TRIAL: A PILOT RANDOMISED CONTROLLED TRIAL OF A HOME-BASED EXERCISE PROGRAMME FOR PRE-FRAIL AND FRAIL, OLDER ADULTS WITH CHRONIC KIDNEY DISEASE

Abstract Background and Aims Frailty is highly prevalent in adults with chronic kidney disease (CKD) and is associated with adverse health outcomes. However, exercise training may improve physical function leading to associated improvements in outcomes. The EX-FRAIL CKD trial (ISRCTN87708989) aimed to inform the design of a randomised controlled trial (RCT) that investigates the efficacy of a progressive home-based exercise programme in pre-frail and frail older adults with CKD. Methods Patients aged ≥65 years with CKD G3b-5 and a Clinical Frailty Scale score ≥4 were eligible for participation. Participants categorised as pre-frail or frail, following Frailty Phenotype (FP) assessment, were randomised to receive a tailored 12-week home-based exercise programme or usual care (UC). Primary outcome measures included recruitment, intervention adherence, outcome measure completion and participant attrition rate. Secondary outcome measures included frailty status (FP), physical function (walking speed, handgrip strength and Short Physical Performance Battery [SPPB]), fall concern (Falls Efficacy Scale-International tool [FESI]), symptom-burden (Palliative Care Outcome Scale-Symptoms RENAL [POS-S RENAL]) and health-related quality of life (Short Form-12v2 [SF-12]). Outcome measures are reported descriptively with 95% confidence intervals (CI) as recommended for pilot trials. Progression criteria to RCT stage were defined as: (1) eligibility: STOP &amp;lt;5%, GO &amp;gt;10%; (2) recruitment: STOP &amp;lt;10%, GO &amp;gt;30%; (3) exercise adherence: STOP: &amp;lt;30%, GO &amp;gt;70%; (4) outcome measure completion: STOP &amp;lt;70%, GO &amp;gt;80%; and (5) loss to follow-up: STOP &amp;gt;50%, GO &amp;lt;25%. Results Six hundred and sixty-five participants had an eligibility assessment with 201 (30% [95% CI 27-34]) patients eligible for enrolment. Thirty-five (17% [95% CI 12-23]) participants were recruited. Six participants were categorised as robust and therefore withdrawn prior to randomisation. Fifteen participants were randomised to exercise (mean age 77.0±8.3 years; mean eGFR 18.9±7.0 ml/min/1.73m2) and 14 to UC (mean age 78.8±7.0 years; mean eGFR 20.4±7.2 ml/min/1.73m2). Eleven (73% [95% CI 45-92]) exercise group participants completed an average of ≥2 exercise sessions/week. Eight (28% [95% CI 13-47]) participants were lost to follow-up. Retained participants (n=21, 100% [95% CI 84-100]) completed all outcome measures. There were 32 adverse events in the exercise group and 22 in the UC group. Within the exercise group, there were 2 hospitalisations (considered unrelated to exercise) and 12 adverse reactions: musculoskeletal pain (9), fall (1), nocturnal leg cramps (1) and postural dizziness (1). The odds ratio for improvement in frailty status with exercise was 5.50 (95% CI 0.46-65.16) and odds ratio for deterioration in frailty status was 0.63 (95% CI 0.05-8.20). The adjusted mean group difference in walking speed, grip strength and SPPB between exercise and UC groups were: 0.01 metres/second (95% CI -0.07-0.10), 3.6 kg (95% CI -0.6-7.9) and 0.5 (95% CI -0.9-1.8), respectively. The adjusted mean group difference in POS-S RENAL, FESI, SF-12 Physical Component Summary and SF-12 Mental Component Summary scores were: -1.4 (95% CI -6.6-3.7), 3.4 (95% CI -3.5-10.3), -3.9 (95% CI -9.3-1.5) and 0.2 (95% CI -6.2-6.6), respectively. Conclusion Eligibility, adherence and outcome measure progression criteria thresholds were exceeded; however, recruitment and loss to follow-up progression criteria thresholds were not achieved. Analysis of a nested qualitative study will explore perceived barriers to participation and retention. The EX-FRAIL CKD trial demonstrates that it is possible to progress to a definitive RCT with adaptations that address the barriers described. It has also provided preliminary evidence that frailty status and physical function may be improved with a home-based exercise programme in patients living with frailty and CKD.

Association of objectively measured sedentary behavior and physical activity levels with health-related quality of life in middle-aged women: The FLAMENCO project

The aim of the study was to analyze the association of objectively measured sedentary time and physical activity with health-related quality of life in middle-aged women. The present cross-sectional analyses were performed in a total of 182 middle-aged women (52.6 ± 4.6 years old) from the Fitness League Against MENopause COst (FLAMENCO) project. Sedentary time and physical activity were objectively measured through accelerometry. Participants' health-related quality of life was assessed with the Short-Form Health Survey 36 (SF-36). Lower sedentary time was associated with a better SF-36 emotional role (B: -0.03; 95% confidence interval: -0.07 to -0.00). Greater light physical activity was associated with a better SF-36 emotional role (B: 0.04; 95% confidence interval: 0.00-0.08). Greater moderate-vigorous physical activity was associated with a greater SF-36 physical function (B: 0.01; 95% confidence interval: 0.00-0.02) and SF-36 vitality (B: 0.02; 95% confidence interval: 0.00-0.03). Greater vigorous physical activity was associated with a better SF-36 physical function (B: 0.34; 95% confidence interval: 0.02-0.66), SF-36-bodily pain (B: 0.63; 95% confidence interval: 0.02-1.25), and the SF-36 physical component scale (B: 0.20; 95% confidence interval: 0.00-0.39). Greater total physical activity was associated with a better SF-36 emotional role (B: 0.03; 95% confidence interval: 0.00-0.07). Moderate physical activity was not associated with any SF-36 dimension (all, P > 0.05). Spending less time in sedentary behavior and greater physical activity levels, especially vigorous physical activity, are associated with better health-related quality of life in middle-aged women. Vigorous physical activity is associated with a better SF-36 physical component scale, which might mean a reduction in exercise time with similar improvements for women's quality of life.ClinicalTrials.gov Identifier: NCT02358109. Date of registration: 05/02/2015.

Role of depressive symptoms in the health-related quality of life of Venezuelan patients with rheumatoid arthritis. Results from a tertiary care center.

To examine the effect of depressive symptoms on health-related quality of life (HR-QoL) in Venezuelan patients with rheumatoid arthritis (RA). HR-QoL was assessed in a cross-sectional, single-center study of 212 consecutive Venezuelan patients with RA (1987 American College of Rheumatology criteria) using the Medical Outcomes Study Short Form (SF-36), which includes a Physical Composite Scale (PCS) and a Mental Composite Scale (MCS); depressive symptoms were assessed using the Center for Epidemiologic Studies Depression Scale. Covariates included socio-demographics, comorbidities, disease characteristics, body mass index, and disability. Unadjusted and multivariable linear regression analysis were used to determine the effect of depressive symptoms on HR-QoL. Mean age was 50.2years and 89.6% were female. Twenty-five percent of patients had depressive symptoms. In the multivariable regression analysis, the presence of depressive symptoms changed the mental SF-36 scores by -4.81 (p = 0.0052) and the physical SF-36 scores by -3.33 (p = 0.0527). Other factors significantly associated with scores on the PCS of the SF-36 were functional class, disability and job loss due to RA. The presence of depressive symptoms negatively affected the HR-QoL in our patients, with a predominant effect on the MCS of the SF-36. The PCS of the SF-36 was mainly affected by those symptoms related to the functional impairment and inflammatory activity of the disease. The routine assessment and early treatment of depressive symptoms, targeting mental and mood manifestations, may improve the HR-QoL and thus contribute to healthier outcomes in Venezuelan RA patients.

Validation of the Australian Treatment Outcomes Profile for use in clients with cannabis dependence

The Australian Treatment Outcomes Profile (ATOP) was developed as a clinical tool for monitoring the substance use, health and wellbeing of clients in alcohol and other drug treatment. This is the first psychometric validation of the ATOP in a cannabis-dependent treatment population. A total of 128 individuals with cannabis dependence enrolled in an outpatient randomised controlled trial were administered the ATOP and gold-standard health and wellbeing questionnaires once by clinicians and once by researchers at baseline. Concurrent validity was assessed by testing ATOP Psychological Health, Physical Health and Quality of Life questions against concurrently administered gold-standard questionnaires: the Short Form 36 Health Survey (SF-36), the 21-item Depression, Anxiety and Stress Scale (DASS-21) and the Sheehan Disability Scale (SDS). Interrater reliability was tested by comparing clinician-administered ATOP items at the medical screening interview to the same ATOP items administered by researchers at baseline. ATOP Psychological Health showed moderate to strong correlations with SF-36 Mental Components, SF-36 Mental Health and DASS-21 scores (r = 0.40-0.52) and ATOP Physical Health with SF-36 Physical Components and SF-36 General Health scores (r = 0.36-0.67). The ATOP Quality of Life scale showed moderate agreement with the SDS and six-dimensional health state short form scales (r = 0.38-0.40). ATOP substance use, employment, education and child care items showed good to excellent interrater reliability (Krippendorff's α = 0.62-0.81), and tobacco use, Psychological Health, Physical Health and Quality of Life showed fair to moderate interrater reliability (Krippendorff's α = 0.42-0.53). The ATOP appears to be valid and reliable when tested in a population with cannabis-dependence, justifying its widespread use in clinical settings.

The quality of acute intensive care and the incidence of critical events have an impact on health-related quality of life in survivors of the acute respiratory distress syndrome - a nationwide prospective multicenter observational study.

Background: Initial treatment (ventilator settings, rescue therapy, supportive measures), and prevention of critical events improve survival in ARDS patients, but little data exists on its effect on health-related quality of life (HRQOL) and return to work (RtW) in survivors. We analyzed the association of the intensity of treatment at ARDS onset and the incidence of critical events on HRQOL and RtW a year after ICU discharge.Methods: In a prospective multi-centre cohort study, the intensity of treatment and the incidence of critical events were determined at 61 ICUs in Germany. At 3, 6, and 12 months, 396 survivors reported their HRQOL (Short-Form 12) and RtW. The parameters of the intensity of acute management (lung protective ventilation, prone position, hemodynamic stabilization, neuromuscular blocking agents), and critical events (hypoxemia, hypoglycemia, hypotension) were associated with HRQOL and RtW.Results: Patients ventilated at ARDS onset with a low tidal volume (VT≤7 ml/kg) had higher arterial carbon dioxide levels (PaCO2=57.5±17 mmHg) compared to patients ventilated with VT>7ml/kg (45.7±12, p=0.001). In a multivariate adjusted dichotomized analysis, a better mental 3-month SF-12 was observed in the higher VT-group (mean 43.1±12) compared to the lower VT-group (39.5±9, p=0.042), while a dichotomized analysis for driving pressures (≤14 mbar vs >14 mbar) did not show any difference neither in PaCO2 levels nor in HRQOL parameters. A decrease in the mental (6-month: 40.0±11 vs 44.8±13, p=0.038) and physical SF-12 (12-month: 38.3±11 vs 43.0±13, p=0.015) was reported from patients with hypoglycemia (blood glucose <70 mg/dl) compared to those without hypoglycemic episodes. More frequent vasopressor use with mean arterial pressure ≥65 mmHg was associated with an impaired physical SF-12 (6-month: 38.8±10) compared to less vasopressor use (43.0±11, p=0.019).Conclusions: In acute management of ARDS, a lower VT strategy associated with hypercapnia, as well as the frequent usage of catecholamines and the management of blood glucose may influence short-term HRQOL of survivors. The awareness of these findings is of clinical importance for the acute and post-ICU care.

Effectiveness of a housing support team intervention with a recovery-oriented approach on hospital and emergency department use by homeless people with severe mental illness: a randomised controlled trial.

Many people who are homeless with severe mental illnesses are high users of healthcare services and social services, without reducing widen health inequalities in this vulnerable population. This study aimed to determine whether independent housing with mental health support teams with a recovery-oriented approach (Housing First (HF) program) for people who are homeless with severe mental disorders improves hospital and emergency department use. We did a randomised controlled trial in four French cities: Lille, Marseille, Paris and Toulouse. Participants were eligible if they were 18 years or older, being absolutely homeless or precariously housed, with a diagnosis of schizophrenia (SCZ) or bipolar disorder (BD) and were required to have a high level of needs (moderate-to-severe disability and past hospitalisations over the last 5 years or comorbid alcohol or substance use disorder). Participants were randomly assigned (1:1) to immediate access to independent housing and support from the Assertive Community Treatment team (social worker, nurse, doctor, psychiatrist and peer worker) (HF group) or treatment as usual (TAU group) namely pre-existing dedicated homeless-targeted programs and services. Participants and interviewers were unmasked to assignment. The primary outcomes were the number of emergency department (ED) visits, hospitalisation admissions and inpatient days at 24 months. Secondary outcomes were recovery (Recovery Assessment Scale), quality of life (SQOL and SF36), mental health symptoms, addiction issues, stably housed days and cost savings from a societal perspective. Intention-to-treat analysis was performed. Eligible patients were randomly assigned to the HF group (n = 353) or TAU group (n = 350). No differences were found in the number of hospital admissions (relative risk (95% CI), 0.96 (0.76-1.21)) or ED visits (0.89 (0.66-1.21)). Significantly less inpatient days were found for HF v. TAU (0.62 (0.48-0.80)). The HF group exhibited higher housing stability (difference in slope, 116 (103-128)) and higher scores for sub-dimensions of S-QOL scale (psychological well-being and autonomy). No differences were found for physical composite score SF36, mental health symptoms and rates of alcohol or substance dependence. Mean difference in costs was €-217 per patient over 24 months in favour of the HF group. HF was associated with cost savings in healthcare costs (RR 0.62(0.48-0.78)) and residential costs (0.07 (0.05-0.11)). An immediate access to independent housing and support from a mental health team resulted in decreased inpatient days, higher housing stability and cost savings in homeless persons with SCZ or BP disorders.

IMPORTANCE OF DIAGNOSTIC IMAGING FOR INTERPRETATION OF SELF-REPORTED SURVEYS OF SHOULDER FUNCTION

Rotator cuff (RC) tear is highly prevalent in older adults. The American Shoulder and Elbow Surgeon (ASES) survey, which quantifies subjective self-reported shoulder function, was originally validated in adults <60 years, and more recently is suggested to be valid in adults ≥60 years. We tested the hypothesis that ASES score (1) discriminates between adults 60—85 years with and without RC tear and (2) correlates with self-reported health quality and objective shoulder measures. Cross-sectional study: forty-two community-dwelling-older-adult volunteers (mean age, 69.4 ± 5.7 years; range, 61-84 years; male, 45%) with no history of RC surgery completed shoulder magnetic resonance imaging (MRI), shoulder forward flexion (FF) and abduction (ABD) range-of-motion (ROM) testing; and ASES, shoulder-pain and SF-36 (pain/physical function) surveys. Four groups (group-1:-pain,-tear,n=14; group-2:+pain,-tear,n=4; group-3:-pain,+tear,n=12; group-4:+pain,+tear,n=12) were compared using one-way ANOVA with ad hoc pairwise comparisons and Spearman Rank Order Correlation (rho). Age, Charlson co-morbidity index, and SF-36 pain/physical function were not appreciably different among all groups. ASES score (p<0.001), FF-ROM (p=0.032) and ABD-ROM (p=0.018) comparing all groups. ASES score: group-1 versus group-4 (p<0.001); but no difference between group-1 versus group-3 (p=0.999), and group-2 had lowest ASES score. ASES score correlated with SF-36 physical function (rho=0.47,p=0.002), SF-36 pain (rho=0.34,p=0.028), FF-ROM (rho=0.63,p<0.001), and ABD-ROM (rho=0.66,p<0.001). Our results suggest that additional research on ASES score in older adults is needed. Although valid, interpretation of ASES score in older adults should be approached cautiously in studies without shoulder diagnostic imaging tests, since painless RC tears and painful shoulders without RC tear are not rare.

Dynamics of quality of life parameters and echocardiography depending on adherence to treatment in patients with chronic rheumatic heart disease at 5-year follow-up

Aim. To assess the dynamics of quality of life indicators and echocardiography parameters depending on adherence to treatment in patients with chronic rheumatic heart disease at 5-year follow-up. Material and methods . A total of 180 patients with RHD were examined. According to the Moriski-Green test 60% were not adherent to treatment; 28,9% are not sufficiently adherent; 11,1% — adherent to treatment. Echocardiography was performed on a Philips Affinity 50 machine, the quality of life was assessed using SF-36, KCCQ, MHFLQ. Results. Both at baseline and after 5 years of observation, the maximum linear dimensions of left atrium — 4,90 [4,62;5,22] cm, left ventricle end-diastolic dimension — 5,55 [4,39;6,69] cm and left ventricle end-systolic dimension 3,70 [4,63;5,23] cm were in a group of adherent to treatment patients. The maximum dimensions of the right atrium (4,80 [4,55;5,15] cm) and of the right ventricle (2,70 [2,40;2,94]) cm at baseline and, after 5 years, were observed in group not adherent to treatment. Differences in the area of mitral valve between groups are not received. On the scales of quality of life, initially, the best value was in group of not sufficiently adherent: MHFLQ — 34,29 [26,97;40,3]; KCCQ functional status — 25,20 [19,28;31,18], KCCQ clinical summary score — 55,00 [47Д67.0]; SF-36 physical health — 34,26 [26,05;45,36], SF-36 mental health — 43,36 [37,49;48,60]. In the group of treatment adherents, the worst values of physical health SF-36 were 33,62 [32,5;36,92] and KCCQ clinical summary score was 37,50 [21,5;56,5]. After 5 years, in group of not sufficiently adherent patients maintained the best quality of life values: MHFLQ - 30,5 [11,5;48,5]; SF-36 physical health is 37,81 [31,51;45,91 ], KCCQ overall summary score — 24,85 [18,55;33,95]. Group of adherents to treatment had the best indicators of quality of life only for SF-36 mental health — 44,29 [30,47;58,33] and KCCQ clinical summary score — 67,50 [48,8;87,5]. Conclusion. In the study with RHD, there was no unambiguous effect of adherence to drug therapy on indicators of heart remodeling and quality of life. The data obtained on the greater severity of dilatation of left heart in adherents to treatment and dilatation of right in non-adherents require a comparison with patients who did not receive drug therapy and, possibly, a longer follow-up period.

Efficacy of Stabilization Exercise for Neck Pain: A Narrative Review and Meta-Analysis of Randomized Controlled Studies

Abstract Introduction Stabilization exercise may be an important approach to alleviate neck pain. However, its use has not been well established. We conduct a narrative review and meta-analysis to evaluate the efficacy of stabilization exercise to control neck pain. Methods PubMed, Embase, and the Cochrane Central Register of Controlled Trials are searched. Randomized controlled trials (RCTs) assessing the influence of stabilization exercise on neck pain are included. Two investigators independently have searched articles, extracted data, and assessed the quality of included studies. Meta-analysis is performed using the random-effect model. Results Five RCTs involving 217 patients are included in the meta-analysis. Compared with control intervention for neck pain, stabilization exercises has no notable impact on pain intensity (Std. MD=−0.55; 95% CI=−1.24 to 0.14; P=0.12), neck disability index (Std. MD=−0.44; 95% CI=−1.01 to 0.13; P=0.13), SF-36 physical health (Std. MD=−0.18; 95% CI=−0.61 to 0.26; P=0.43), SF-36 mental health (Std. MD=−0.03; 95% CI=−0.47 to 0.41; P=0.89), but can remarkably decrease depression scale (Std. MD=−1.05; 95% CI=−1.59 to −0.50; P=0.0002). Conclusions Stabilization exercises shows similar impact on pain intensity, neck disability index, SF-36 physical health and SF-36 mental health, but significant reduced depression scale compared with control intervention in patients with neck pain.

Quality of life, pain, and psychological factors in patients undergoing surgery for primary tumors of the spine.

Knowledge about quality of life (QOL), pain, and psychological factors in patients with primary tumors of the spine is limited, but is important in planning rehabilitation after surgery. Aims of this study were to assess the preoperative levels and improvement after surgery of these factors, and to identify the predictors of postoperative pain and QOL. Patients with primary tumors undergoing spine surgery were matched for sex and age with patients with metastatic tumors. QOL was measured at baseline and three months after surgery with the physical (PCS) and mental (MCS) components SF-12 subscales, pain intensity with a numeric rating scale (NRS), depression with the Beck Depression Inventory (BDI). Preoperative SF-12, NRS, and BDI levels and differences in follow-up improvement in SF-12 and NRS were compared across samples. LASSO regressions were performed to find predictors of follow-up SF-12 and NRS. Patients with primary tumors showed better PCS and NRS, and similar BDI and MCS than patients with metastatic tumors. At follow-up, they showed stronger improvement in the MCS and no improvement in the PCS. All QOL scores were below those of the general population. Follow-up PCS was predicted by baseline PCS and BDI; MCS by baseline MCS; pain intensity by baseline pain intensity and BDI. Patients with primary tumors of the spine suffer from moderate levels of physical and mental impairment. Depression influences surgical outcomes.

457 – On Demand Vs Continuous Use of Proton Pump Inhibitors (PPI) on Symptom Burden and Quality of Life: Results of a Real-World Rct in Primary Care Patients with Gastroesophageal Reflux Disease (GORD)

Introduction The aim in the study was to investigate if prescription of on demand vs continuous use of PPI influenced symptom burden, health related quality of life and selfrated health in primary care. Previous trials in this area have used 'willingness to continue' as a proxy outcome measure. The use of an innovative trials platform integrating the electronic record and patient outcomes via smartphone enables symptoms and quality of life profile to be captured. Methods 36 primary care centres participated in the study: 8 in Greece, 10 in Poland, 8 in the Netherlands and 10 in UK. Eligible patients were adults 18 to 65 years of age with GORD, either current or former PPI users, and identified based on primary care electronic health records data. Patients were randomized to either on demand (when the patient experiences bothersome reflux symptoms) or continuous use of PPI. Patient reported demographics, drug use, symptom burden, quality of life and self-rated health at the first visit and the follow-up visit after 8 weeks. The trial was registered with EudraCT as nr 2014-001314-25. The effect of on demand vs continuous PPI use on PPI intake and patient reported outcomes (reflux symptom burden, assessed with RDQ; Health related quality of life, assessed with SF-12) was tested using mixed effect regression model with treatment allocation (on demand vs continuous PPI use), visit and an interaction term between treatment allocation and visit as exposure variables. Change in PPI dose was correlated with change in patient reported outcomes using Spearman correlation. Results A total of 488 patients (median age 51 years, 58 % women) completed the first visit and 360 completed the follow-up visit. There was no significant difference in baseline PPI use, reflux symptom burden or QoL, or in study completion, between treatment allocation. There was no difference between continuous or on-demand advice on PPI use (b=.57, 95 %CI: -.40-1.53), however, PPI use increased between baseline and follow-up in both groups (b=1.33, 95 %CI: .65-2.01). There was no difference between continuous or on-demand on either of the patient reported outcomes. However, symptom burden (b=-.61, 95%CI:-.73- -.49) and health related quality of life (b= 3.31, 95 %CI: 2.17-4.45) improved significantly between baseline and follow up in both groups (Table 2). An increased PPI intake correlated significantly with a reduced reflux symptom score (n=347, rho= -0.12, p=.02) and an improved physical SF-12 subscale score (n=217, rho=0.16, p=0.02), while no significant association was found for SF-12 mental subscale or self-rated health. Conclusion Both continuous and on-demand dosing increase PPI consumption in real-world settings. Reaching a sufficient dose of PPI to reduce reflux symptom burden improves quality of life in patients with GORD.

Gait analysis related to functional outcome in patients operated for ankle fractures.

ABSTRACTAnkle fractures are among the most common lower limb fractures. Associations between postoperative radiographic results and clinical outcome have been found, but less is known about the relevant ankle biomechanics. This study analyzed ankle kinematics, radiographic findings, and patient‐reported outcome measures (PROM) in patients treated for ankle fractures. The hypothesis was that patients after ankle fracture surgery had less flexion/extension in the ankle compared to healthy subjects and that fracture severity had significant influence on kinematics and patient satisfaction. Thirty‐three patients (n = 33 feet) operated for ankle fractures were recruited. Ankle kinematics were analyzed using the Oxford Foot model, and results were compared with an age‐matched healthy control group (11 patients, 20 feet). In addition, patients were divided by fracture (severity) classification and kinematic results were correlated with PROM and radiographic findings. Patients treated for ankle fracture showed lower walking speed (p < 0.001) when asked to walk in preferred normal speed. When compared at equal speed, significantly less range of motion (ROM) between the hindfoot and tibia in the sagittal plane (flexion/extension) during loading and push‐off phases (p = 0.003 and p < 0.001) was found in patients after ankle fractures compared to healthy subjects. Lowest ROM and poorest PROM results were found for patients with trimalleolar ankle fractures. There was a significant correlation between ROM (flexion/extension) during the push‐off phase and SF‐36 physical functioning (r 2 = 0.403, p = 0.027) and SF‐36 general health (r 2 = 0.473, p = 0.008). Fracture severity was significantly correlated with flexion/extension ROM in the ankle during both loading and push‐off phases (r 2 = −0.382, p = 0.005, and r 2 = −0.568, p < 0.001) and was also significantly correlated with PROM. This study found that patients with ankle fractures had significantly altered ankle kinematics compared to healthy subjects. The poorest results were found among patients with trimalleolar fractures. Weak to strong significant correlations were found between fracture severity, ankle kinematics, and PROM. © 2019 The Authors. Journal of Orthopaedic Research® Published by Wiley Periodicals, Inc. on behalf of Orthopaedic Research Society. J Orthop Res 37:1658–1666, 2019.

Long-term functional and psychological recovery in a population of acute respiratory distress syndrome patients treated with VV-ECMO and in their caregivers.

Acute respiratory distress syndrome (ARDS) survivors are affected with long-term physical/mental impairments, with improvements limited mostly to the first year after intensive care (ICU) discharge. Furthermore, caregivers of ICU patients exhibit psychological problems after family-member recovery. We evaluated the long-term physical and mental recovery of ARDS survivors treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO), and the long-term psychological impact on their caregivers. Single-center prospective evaluation of a retrospective cohort of 75 ARDS patients treated with VV-ECMO during a seven-year period (25.10.2009-11.08.2016). Primary outcomes were the 36-Item Short-Form Health-Survey (SF-36, patients only), and risks of depression, anxiety or post-traumatic stress disorder (PTSD), both for patients and their caregivers. We investigated correlations between outcomes and population characteristics. Of 50 ICU-survivors, seven died later and five were not contactable. Among 38 living patients, 33 participated (87%, 31 with their caregiver) with 2.7 years of median follow-up. Physical and mental SF-36 component scores were 42 (inter-quartile range, IQR:22) and 52 (IQR:18.5), respectively. The worst domains of the SF-36 were physical-role limitations (25, IQR:100) and general-health perception (56, IQR:42.5). Psychological tests highlighted high risk of depression (39-42%, patients; 39-52%, caregivers), anxiety (42%, patients; 39%, caregivers), and PTSD (47%, patients; 61%, caregivers). Patient depression or anxiety scores were correlated to age and to the outcome reported by caregivers. At almost three-year follow-up, ARDS survivors treated with VV-ECMO showed reduced health-related quality-of-life and high risk of psychological impairment, in particular PTSD. Caregivers of this population were at high psychological risk as well.

The Systemic Sclerosis Questionnaire (SySQ): Validation of the Translation of the Original German Version Into Spanish and Its Relationship to the Disease and to Quality of Life

ObjectiveTranslation, transculturation and validity of the self-administered questionnaire for functionality (Systemic Sclerosis Questionnaires [SySQ]) for use in Spanish patients with systemic sclerosis and its relationship to the severity of the disease and to quality of life. Patients and methodsWe conducted an observational analytical study to perform a cross-cultural validation of the self-administered questionnaire on functionality in scleroderma. The validity of the form and content was evaluated by an expert panel. The method included: (a) adaptation into Spanish of the construct for translation and back translation, and transculturation; (b) internal consistency with the SySQ (Cronbach's alpha), and (c) reproducibility was assessed taking into account all occasions in which the test was performed with Cohen's kappa. Additionally, we calculated the Spearman correlation coefficient with the Medsger severity scale, Health Assessment Questionnaire score and SF-36 score. ResultsWe included 70 patients with systemic sclerosis: age 17–78 (51±12) years, 65 (93%) were women, diffuse/limited subtype 64/36%, disease duration of .5–40 years. Optimal internal consistency for all categories of the final version of SySQ (Cronbach's α of .961) and intraobserver reliability in 2 tests over a 2-week interval (Cohen's kappa coefficient .618) and optimal interobserver reliability in 2 tests on the same day (Cohen's kappa coefficient .911). Moderate correlation between functionality by SySQ and by Health Assessment Questionnaire (r=.573, P<.0001). Inverse correlation between SySQ and quality of life mental health domain SF-36 (r=−.435, P<.001) and physical domain SF-36 (r=−.638, P<.001). Medsger severity scale (tendon, heart, lung, vascular) also showed significant correlation with SySQ. ConclusionsSySQ in this validated Spanish version is a suitable instrument to measure functional status in patients with systemic sclerosis. Reduced functionality is related to greater tendon and peripheral vascular involvement and to a poorer quality of life.

Study on correlation between fatigue status and self-management behavior and quality of life in maintenance hemodialysis patients

Objective To explore the relationship between status of maintenance hemodialysis patients, self-management behavior and quality of life, and provide theoretical basis for clinical individualized care and improvement of patients' quality of life. Methods The Fatigue Assessment Instrument (FAI), the self-management scale of hemodialysis patients and the MOS 36-item short-form health survey (SF-36) were used to investigate 140 patients who received long-term hemodialysis treatment in the hospital from June 2014 to June 2016. Results According to the score of FAI rating scale factor 1, there were 45 cases of mild fatigue , 73 cases of moderate fatigue and 22 cases of severe fatigue . There was no significant difference in the total score of self-management behavior between mild fatigue and moderate fatigue patients(P>0.05). The total scores of self-management behaviors, SF-36 physical health and SF-36 mental health of patients with mild fatigue , moderate fatigue and severe fatigue all showed a downward trend, with statistically significant differences (P<0.05). Spearman correlation analysis showed that the factor of maintenance hemodialysis patients were negatively correlated with the total score of self-management behavior, SF-36 physical health score and SF-36 mental health score (P<0.05). Conclusions Fatigue is common in maintenance hemodialysis patients.Severe is not conducive to the maintenance of patients' self-management behavior and can reduce their quality of life. Key words: Hemodialysis; Fatigue; Self-management; Quality of life