EQ-5D VAS Score Research Articles

Intracranial pressure monitoring in patients with spontaneous intracerebral hemorrhage.

The utility of ICP monitoring and its benefit with respect to outcomes after ICH is unknown. The aim of this study was to compare intracerebral hemorrhage (ICH) outcomes in patients who underwent intracranial pressure (ICP) monitoring to those who were managed by care-guided imaging and/or clinical examination alone. This was a retrospective analysis of data from the Ethnic/Racial variations of Intracerebral Hemorrhage (ERICH) study between 2010 and 2015. ICH patients who underwent ICP monitoring were propensity-score matched, in a 1:1 ratio, to those who did not undergo ICP monitoring. The primary outcome was 90-day mortality. Secondary outcomes were in-hospital mortality, hyperosmolar therapy use, ICH evacuation, length of hospital stay, and 90-day modified Rankin Scale (mRS) score, excellent outcome (mRS score 0-1), good outcome (mRS score 0-2), Barthel Index, and health-related quality of life (HRQoL; measured by EQ-5D and EQ-5D visual analog scale [VAS] scores). A secondary analysis for patients without intraventricular hemorrhage was performed. The ICP and no ICP monitoring cohorts comprised 566 and 2434 patients, respectively. The matched cohorts comprised 420 patients each. The 90-day and in-hospital mortality rates were similar between the matched cohorts. Shift analysis of 90-day mRS favored no ICP monitoring (p < 0.001). The rates of excellent (p < 0.001) and good (p < 0.001) outcome, Barthel Index (p < 0.001), EQ-5D score (p = 0.026), and EQ-5D VAS score (p = 0.004) at 90 days were lower in the matched ICP monitoring cohort. Rates of mannitol use (p < 0.001), hypertonic saline use (p < 0.001), ICH evacuation (p < 0.001), and infection (p = 0.001) were higher, and length of hospital stay (p < 0.001) was longer in the matched ICP monitoring cohort. In the secondary analysis, the matched cohorts comprised 111 patients each. ICP monitoring had a lower rate of 90-day mortality (p = 0.041). Shift analysis of 90-day mRS, Barthel Index, and HRQoL metrics were comparable between the matched cohorts. The findings of this study do not support the routine utilization of ICP monitoring in patients with ICH.

Outcomes that matter to patients: The Geriatric Oncology Surgical Assessment and Functional rEcovery after Surgery (GOSAFE) study—Analysis of 471 patients.

11511 Background: Older cancer patients value functional outcomes as much as survival but surgical studies lack functional recovery (FR) data. The international, multicenter GOSAFE study (ClinicalTrials.gov NCT03299270) aims to evaluate patients’ quality of life (QoL)and FR after cancer surgery and to assess predictors of FR. Methods: GOSAFE prospectively collects functional and clinical data before and after major elective cancer surgery on senior adults (≥70 years). Surgical outcomes are recorded (30 days, 90 days, and 180 dayspost-operatively) with QoL(EQ-5D-3L) and FR (Activities of Daily Living (ADL) + Timed Up and Go (TUG) + MiniCog), 28centers are prospectively enrolling patients; accrual ends February 2019. Results: 643 patients underwent major cancer surgery with curative(94%) or palliative (6%) intent (February 2017-September 2018). Median age was 78(range 70-94); 51.6% males, ASA III-IV 52%. Patients dependent (ADL &lt; 5) were 8%. Frailty was detected by G8 &gt; 14 in 32% and fTRST≥2 in 36% of patients. 639 (99%) lived at home, 32% lived alone, and 88% were able to go out. Major comorbidities (CCI &gt; 6) were detected in 36% and 22% had cognitive impairment according to MiniCog (5% self-reported). 26% had &gt; 3 kg weight loss, 30% were hospitalized in the last 90 days, 45% had ≥3 medications (6% none). For 471 patients, a 90-day comprehensive evaluation was available. Postoperative morbidity was 42% (30 day) and 63.3% (90 day), but Clavien-Dindo III-IV complications were only 11.2% and 17.6%. 90-day mortality was 7.4% (5% 30-day). QoL improved 90 days after surgery (mean EQ-5D index from 0.76 to 0.80). Patients with EQ-5D VAS score &gt; 60 raised from 73.9% at baseline to 82.8% at 90 days. 29% had complete FR (ADL score &gt; 4, MiniCog &gt; 2, TUG &lt; 20). Decreased functional capacity was seen in 23.4% of patients alive at 90-days. Conclusions: GOSAFE is the largest prospective study on older cancer patients undergoing major surgery. Interim analysis reports decreased functional capacity in a quarter of patients. The study will allow clinicians to associate clinical outcomes with individual factors of the preoperative assessment and create a user-friendly tool to predict outcomes that matter to patients.

PMH63 A REAL WORLD ASSESSMENT OF OUTCOMES IN SCHIZOPHRENIA PATIENTS ACCORDING TO TREATMENT RESPONSE

To describe and compare demographics, outcomes and comorbidities amongst schizophrenia patients responding to treatment versus partial responders. A cross-sectional survey was conducted in USA from January to May 2014 through the Adelphi Schizophrenia Disease Specific Programme. Inclusion criteria comprised hospital/office-based psychiatrists who had been practicing for 2-40 years at time of study, saw ≥6 schizophrenia patients per week and were personally responsible for treatment decisions. Participating physicians provided information on their next 10 consulting schizophrenia patients aged ≥18, with the same patients invited to voluntarily complete a patient self-completion form (PSC). Patients were grouped for analysis as partial responders (PR) or responders (R) using physician reported CGI-Improvement scale on current treatment (minimally improved=PR and much-very much improved=R) (non-responders excluded). This study included 150 physicians providing data on 1489 patients (433 PR and 872 R), of which 680 completed a PSC. On average patients were age 41 and male (57% PR and 56% R) with PR more likely to be unemployed (68% vs 47% R p<0.001) and have a higher mean BMI (29.5 vs 28.6 R p=0.027). PR had 2.4 comorbidities on average compared to 2.0 for R (p=0.006) and 42% PR had history of hospitalization in the last twelve months vs. 21% R (p<0.001). PR patients reported a mean EQ5D VAS score of 59.4 compared with 69.9 R (p<0.001) and overall Q-LES-Q score of 44.5 vs. 56.8 (p<0.001) respectively. Overall life satisfaction from the Q-LES-Q was reported as poor-very poor 35% PR and 10% of R (p<0.001). Percentage daily activity impairment due to schizophrenia was calculated from WPAI scale as mean 56.1 PR vs 41.5 R (p<0.001) and 46.2 vs 28.3 (p<0.001) for percentage overall work impairment. Schizophrenia patients inadequately responding to treatment show significantly poorer outcomes and higher number of comorbidities when compared to treatment responders.

The clinical course of idiopathic pulmonary fibrosis and its association to quality of life over time: longitudinal data from the INSIGHTS-IPF registry

BackgroundQuality of life (QoL) is profoundly impaired in patients with idiopathic pulmonary fibrosis (IPF). However, data is limited regarding the course of QoL. We therefore analysed longitudinal data from the German INSIGHTS-IPF registry.MethodsClinical status and QoL were assessed at enrollment and subsequently at 6- to 12-months intervals. A range of different QoL questionnaires including the St. George’s Respiratory Questionnaire (SGRQ) were used.ResultsData from 424 patients were included; 76.9% male; mean age 68.7 ± 9.1 years, mean FVC% predicted 75.9 ± 19.4, mean DLCO% predicted 36.1 ± 15.9. QoL worsened significantly during follow-up with higher total SGRQ scores (increased by 1.47 per year; 95% CI: 1.17 to 1.76; p < 0.001) and higher UCSD-SOBQ scores and lower EQ-5D VAS and WHO-5 scores. An absolute decline in FVC% predicted of > 10% was associated with a significant deterioration in SGRQ (increasing by 9.08 units; 95% CI: 2.48 to 15.67; p = 0.007), while patients with stable or improved FVC had no significantly change in SGRQ. Patients with a > 10% decrease of DLCO % predicted also had a significant increase in SGRQ (+ 7.79 units; 95% CI: 0.85 to 14.73; p = 0.028), while SQRQ was almost stable in patients with stable or improved DLCO. Patients who died had a significant greater increase in SGRQ total scores (mean 11.8 ± 18.6) at their last follow-up visit prior to death compared to survivors (mean 4.2 ± 18.9; HR = 1.03; 95% CI: 1.01 to 1.04; p < 0.001). All QoL scores across the follow-up period were significantly worse in hospitalised patients compared to non-hospitalised patients, with the worst scores reported in those hospitalised for acute exacerbations.ConclusionsQoL assessments in the INSIGHTS-IPF registry demonstrate a close relationship between QoL and clinically meaningful changes in lung function, comorbidities, disease duration and clinical course of IPF, including hospitalisation and mortality.

Health-Related Quality of Life in Waldenstrom Macroglobulinemia (WM) and IgM Monoclonal Gammopathy of Undeterminated Significance (IgM-MGUS)

The clinical course of WM widely differs among patients, with some manifesting symptoms as a consequence of the monoclonal IgM component or lymphoma infiltration. IgM-MGUS is generally asymptomatic while, in some cases, paraprotein-related manifestations may occur. Patients with IgM-MGUS should perform a regular follow-up as they are at risk of developing WM or other B-cell lymphoproliferative disorders (1.5-2% per year).Although WM typically afflicts the elderly, there are no studies addressing the impact of ECOG performance status and comorbidities on patients' outcome. Furthermore, to our knowledge health-related quality of life (HRQOL) has never been evaluated in this category. The aim of this study is to analyze the impact of diagnosis and patients' characteristics on quality of life.From October 2017, HRQOL was assessed in 103 patients (37 WM with previous or ongoing treatment [tWM]; 29 asymptomatic MW [aWM]; 37 IgM-MGUS) by the administration of EORTC QLQ-C30, HADS, FACT-GOG neurotoxicity and EQ-5D-5L questionnaires. Demographic anamnestic and disease-related data were also collected for each patient. The same questionnaires continue to be administered every 6 months for 3 years, in order to capture changes in HRQOL over time.Patients features are reported in table 1. No significant differences in terms of age, sex distribution, age at diagnosis, months from diagnosis, ECOG performance status, CIRS or number of concomitant medications, were detected among the 3 groups (table 1).As regards CIRS, the organ systems mainly involved resulted: vascular and genitourinary for tWM, genitourinary for aWM and vascular, respiratory and genitourinary for IgM-MGUS.Among the 3 groups no statistical differences were reported when analyzing: EORTC QLQ-C30 global health status, functional scales (physical, role, emotional, cognitive and social functioning) and symptoms scale, EQ-5D VAS score, HADS anxiety and depression scores or FACT-GOG neurotoxicity score.Males had higher global health status and emotional function when compared to females both in IgM-MGUS and WM patients. Higher CIRS score and ECOG status negatively impacted on global health status, physical function, EQ-5D VAS score and anxiety both in WM and IgM-MGUS. WM patients with longer time from diagnosis showed a significantly worse emotional function.Patients-reported symptoms that could be referred to peripheral neuropathy (PN, 39 patients) resulted the only significant parameter negatively impacting on HRQOL (global health status, functional and symptoms scales according to EORTC QLQ-C30 and EQ-5D VAS score) and also affecting HADS anxiety score.The diagnosis of PN was confirmed by neurologic tests only in 16/39 subjects that, compared with the rest of the population, showed older age (p .019), older age at diagnosis (p . 015) and higher ECOG status (p .005). In these patients, EORTC QLQ-C30 detected a reduced cognitive function (p .0031), while HADS a greater perception of anxiety (p .0015). No differences were recorded for EQ-5D VAS score or HADS depression scale.In conclusion, in our series diagnosis per se didn't seem to affect HRQOL which was negatively influenced by high ECOG status and comorbidities. Emotional function meaningfully deteriorated as the time lapse from diagnosis became longer. Quality of life was significantly altered in patients reporting symptoms of PN and this was confirmed by all the questionnaires. Longer follow up is needed to confirm these preliminary data. [Display omitted] DisclosuresMontillo:Roche: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Speakers Bureau; Gilead: Consultancy, Honoraria, Speakers Bureau. Tedeschi:Janssen: Consultancy, Speakers Bureau; AbbVie: Consultancy; Gilead: Consultancy.

Early outcomes and radiographic alignment of the Infinity total ankle replacement with a minimum of two year follow-up data

BackgroundThe Infinity total ankle replacement (Wright Medical Technology, Memphis, TN) is a low profile, fluoroscopically navigated, fixed-bearing device. We hypothesised that the fluoroscopic navigation would allow more accurate alignment of the prosthesis than conventional techniques. We present our minimum two year follow up data of Infinity ankle replacements. MethodsAll total ankle replacements (TARs) performed at our institution were prospectively followed-up with EQ5-D and MOx-FQ scores as well as intra-operative radiation exposure and radiographic alignment data. Post-operative radiographs were used to measure the alignment of the prostheses. We identified 20 implants with minimum of two year follow up which were compared to a control group of 20 Zenith TAR’s (Corin, Cirencester, UK). ResultsIntra-operative fluoroscopic navigation has allowed excellent alignment of all prostheses. Median deviations from 90° alignment to the anatomical axis of the tibia were 1.5° and 1.2° in the anterior-posterior (AP) and lateral planes respectively, compared to 2.8° and 3.1° in the Zenith group. This difference reached significance (p=<0.05) using the Mann–Whitney U test. At 2 years, MOx-FQ scores had fallen from pre-operative mean of 63.9∓17.1 to 15∓12.7. EQ-5D VAS scores had improved from 71.3∓17.3 to 81.4∓9.7 points. Radiation exposure had a mean screening time of 82∓29.4s and a decrease in exposure per patient was observed over time. No patients have undergone, or are awaiting, revision surgery. Complications include one intraoperative medial malleolar tip avulsion fracture, one medial malleolar stress fracture, and one patient who developed CRPS. ConclusionsWe present evidence that this system achieves better anatomical alignment of the components when compared to techniques without fluoroscopic navigation. The implant survival and complication profile at a minimum of two years is satisfactory.

C1 INHIBITOR ADMINISTRATION IN PEDIATRIC PATIENTS WITH HEREDITARY ANGIOEDEMA: PATIENT COMPLIANCE WITH INTRAVENOUS THERAPY

Introduction Adherence in a pediatric population can be a barrier to therapy. Here we report compliance, safety, efficacy and QoL outcomes in patients aged 6-11years who received intravenous (IV) C1-INH for routine prevention of angioedema attacks. Methods In a single blind, crossover design, patients received IV 500U and 1000U of C1-INH every 3-4 days for 12 weeks. Endpoints assessed were the monthly normalized number of attacks (NNA), adverse event reporting, completion of the youth version of the EQ-5D-Y descriptive system/VAS questionnaire, and C1 INH treatment adherence. Results Of 12 enrolled patients, 7 (58.3%) were female with a median (range) age 10.0 (7-11) years. All 12 patients were administered ≥90% of all C1-INH doses. Ten (83.3%) patients were 100% compliant with receiving all doses (n=480 doses) across both treatment arms. Overall, 58.3% and 91.7% of patients achieved a ³70% reduction from baseline with 500U and 1000U C1-INH, respectively. No patients discontinued due to an AE and few injection site reactions were noted; one patient (8.3%) who received 1000U C1-INH reported 1 related TEAE of mild pruritus and 1 related TEAE of mild erythema. The mean (SD) change in the EQ-5D VAS score from baseline to week 9 of treatment with 500U and 1000U C1-INH was 10.4 (19.0) and 21.6 (13.4), respectively. Conclusions This study demonstrated that high levels of compliance with IV administration of C1-INH can be achieved in a pediatric population. IV administration of C1 INH is well tolerated, efficacious and indicative of improved QoL.

Patient-Reported Outcome Measures of Long-Term Swallowing Function after Oropharyngeal Radiation Therapy: A Cross-Sectional Methods Comparison

Definitive radiation therapy (RT) plays an important role in the curative treatment of many patients with oropharyngeal cancer (OPC), but carries a risk of long-term toxicity including the development of severe dysphagia. Here we characterize the relationship of patient-reported outcomes (PRO) of swallowing to quality of life (QOL) and radiation dose in long-term OPC survivors following definitive RT. Patients with non-metastatic OPC treated with definitive RT at a single institution between January 2000 and April 2014 were examined. All patients completed the MD Anderson Symptom Inventory—Head and Neck (MDASI-HN), the MD Anderson Dysphagia Inventory (MDADI), and the EuroQol five dimension questionnaire (EQ-5D VAS) 12 months or more following end of RT in a cross-sectional survivorship survey. A single dysphagia question from MDASI-HN (designated MDASI-HN-S) was used. An MDASI-HN-S score ≥6 and composite MDADI score <60 were considered representative of moderate-severe swallowing dysfunction. The Bayesian information criteria (BIC) were used to test the predictive power of MDASI-HN-S and composite MDADI with QOL as measured by EQ-5D VAS. The modified Breiman recursive partitioning analysis (RPA) was used to identify an MDASI-HN-S cut off score for poor QOL. To assess validity of PRO cutpoints, the mean dose to candidate regions of interest (ROI) were compared in patients with and without moderate/severe dysphagia symptoms. A total of 714 patients met criteria for inclusion, with 91.9% treated with intensity modulated radiotherapy (IMRT) and a mean time from treatment of 6.7 years. Moderate/severe dysphagia was reported by 17% and 16% of respondents by MDASI-HN-S and composite MDADI, respectively. QOL as measured by EQ-5D VAS was lower in those with moderate/severe dysphagia per both MDASI-HN-S (63.4 vs 83.5, p<0.001) and composite MDADI scores (64.5 vs 83.2, p< 0.001). Although both inventories were predictive of QOL, the model including MDASI-HN-S was slightly more parsimonious for discrimination of EQ-5D VAS scores compared to composite MDADI (BIC of 6062 vs 6076). Recursive partitioning analysis showed that an MDASI-HN-S cutoff score of ≥6 correlated best with EQ-5D VAS decline (LogWorth 2.7, p<0.001). Among 320 patients with available DICOM-RT plans, a higher mean dose to the contralateral anterior digastric muscle, intrinsic tongue muscles, and larynx was associated with moderate-severe dysphagia by both MDASI-HN-S and composite MDADI (all p <0.05). In long-term survivors of OPC following definitive RT, the single item dysphagia MDASI-HN-S question performed as well as the 20-item MDADI for discrimination of patient-reported dysphagia and QOL. Dose-response relationships to candidate ROIs were similar for the two questionnaires.

PSY212 - TREATMENT CHARACTERISTICS, QUALITY OF LIFE AND SLEEP PERFORMANCE OF LOCALISED NEUROPATHIC PAIN PATIENTS IN THE PRIMARY CARE SETTING

To describe clinical characteristics, treatment patterns, quality of life (QoL) and sleep performance of localized neuropathic pain (LNP) patients. Cross-sectional study in primary care of 4 EU countries. Patients were identified using a screening tool for LNP. At screening, clinical and treatment information was collected, and patients completed the EQ-5D and CPSI (sleep performance) questionnaires. Results are presented overall and by type of analgesia at screening (topical and systemic monotherapies, combinations of topical-systemic and systemic-systemic). Of 1102 patients that screened positive for LNP, 1030 were included in the study. Despite 97% of patients were under pain treatment, they presented moderate pain (median pain intensity 6.0) with a median duration of 30.9 months. Main sites of pain were the limbs (62% upper/58% lower) and spine (41%). Main etiologies were: neuropathic low back pain (47%), post-surgery neuropathic pain (17%), and diabetic poly-neuropathy (12%). In the previous 6 months 40% switched treatment. At screening, 32% were receiving a single analgesic (2% topical), while combinations comprised: 43% systemic-systemic, 24% topical-systemic, 1% topical-topical. Most frequent medications were NSAIDs (45%), anticonvulsants (38%), WHO step II opioids (35%) and topical treatments (26%). The mean (SD) EQ-5D VAS score was 58 (22.3), significantly lower than in general population, and the mean (SD) EQ-5D summary score (UK tariff) was 0.62 (0.25). Patients showed sleeping problems of mild severity (CPSI mean index=41/100), however sleeping pills were used by 33% of patients. The results provide a better understanding of clinical characteristics and current pain management strategies for LNP in the primary care setting. Many LNP patients suffered from moderate pain intensity for long durations, with QoL and sleep performance affected. Combinations and switches were frequent. This highlights the need for early diagnosis of LNP and use of appropriate treatment regimens to relieve pain in LNP.

Treatment history and association between allergic rhinitis symptoms and quality of life.

Recalcitrance of allergic rhinitis (AR) to medical management may be reflective of patient-specific impact of AR symptoms. To understand the relationship between AR symptoms and general health-related quality of life (QOL) or AR control, based on treatment status. Cross-sectional cohort study of 130 adult participants-65 using no allergy medications and 65 consistently using intranasal corticosteroid sprays (ICS) in the last 3months-presenting with persistent AR. General health-related QOL was measured using the EuroQol 5-dimensional visual analog scale (EQ-5D VAS). Severity and control of AR symptoms were measured using the 22-item Sinonasal Outcome Test (SNOT-22) and the Rhinitis Control Assessment Test (RCAT), respectively. We compared associations between AR symptoms and general health-related QOL and AR control in patients presenting with persistent AR with and without ICS use. Severity of AR symptoms was similar between cohorts. In participants using no allergy medications, extranasal AR symptom severities were most dominantly associated with decreased EQ-5D VAS and RCAT score. In participants using ICS, only nasal symptom severities were associated with decreased EQ-5D VAS and RCAT scores. Consistently, only in participants on ICS was a deviated septum associated with decreased EQ-5D VAS (β = - 12.1, 95% CI - 21.1 to - 3.1, p = 0.011) and poorly controlled AR (OR = 4.27, 96% CI 1.27 to 14.33; p = 0.019). In persistent AR despite consistent ICS use, nasal symptoms may be the dominant drivers of AR-associated decreased general health-related QOL in contrast to persistent AR on no medication, when extranasal symptoms of AR are most significant. Longitudinal study is needed to investigate whether these results are predictive of responsiveness to ICS.

Hopelessness and Quality of Life Levels in Hemodialysis Patients

Objective: Hemodialysis treatment causes psychosocial problems like restrictions on social life, hopelessness, role changes, sadness, depression, anxiety and uncertainty about the future. So this problems may threat the quality of life. The purpose of this study was to determine the hopelessness and quality of life of the hemodialysis patients and the effective factors. Methods: The sample of the study consisted of 320 hemodialysis patients from four hemodialysis centers in the province of Ankara. The data were collected by using Patient Information Form, Beck Hopelessness Scale and EQ-5D General Quality of Life Scale and EQ-5D Visual Analog Scale (EQ-5D VAS) in 2016. Results: Mean scale score was 9.63±5.56 for Beck Hopelessness Scale,0.57±0.32 for EQ-5D Index, and 57.0±22.20 for EQ-5D VAS. Most of the patient experienced physical, mental or social problems. The patients, who were widowed/divorced, were literate, and had another chronic disease, had higher Beck Hopelessness Scale mean score and lower EQ-5D VAS mean score. It was found that there was a positive correlation between Beck Hopelessness Scale scores and age, number of children, and treatment duration; and a negative correlation between EQ-5D VAS scores and age, number of children, and treatment duration. There was a negative correlation between Beck Hopelessness Scale scores and EQ-5D VAS scores. Conclusion: The patients who were divorced/widowed, were literate and had another chronic disorder experienced more hopelessness and had lower level of general health. Increasing age, number of children, and treatment duration increased hopelessness and decreased general health. The increased hopelessness level also had a negative effect on the level of health.

Prevalence of anxiety and depression symptoms and their associated factors in mild COPD patients from community settings, Shanghai, China: a cross-sectional study

BackgroundChronic obstructive pulmonary disease (COPD) is a serious disease frequently accompanied by anxiety and depression. Few studies have focused on anxiety and depression for mild COPD patients in China. This study aimed to assess the prevalence and associated factors for anxiety and depression among patients with mild COPD in urban communities.MethodsA cross-sectional survey of 275 mild COPD patients was conducted in 6 communities randomly sampled from Pudong New Area of Shanghai, China, in 2016. Data on socioeconomic factors and health conditions were acquired through a face-to-face interview as well as a physical examination. The Hospital Anxiety and Depression Scale (HAD) and EQ-5D visual analogue (EQ-5Dvas) were applied to evaluate their mental health and quality of life, respectively. Logistic regression model was used to estimate adjusted odds ratios (aORs) and their 95% confidential intervals (CI) for risk factors associated with anxiety or depression.ResultsAmong 275 subjects, 8.1% had anxiety and 13.4% had depression. Logistic regression analysis indicated that female patients were more likely to suffer from anxiety than male patients (aOR = 6.41, 95% CI:1.73-23.80). Poor health status (EQ-5Dvas score < 70) was significantly associated with increased risks of anxiety (aOR = 5.99, 95% CI: 2.13-16.82) and depression (aOR = 2.67, 95% CI: 1.29-5.52).ConclusionsThere were increased risks of anxiety and depression in mild COPD patients living in urban communities. Female sex and poor health status were significantly correlated to anxiety or depression. More interventions should be developed to reduce the risks of anxiety and depression at the early stage of COPD.

Factors affecting the return to work of total hip arthroplasty due to of developmental hip dysplasia in in young patients

IntroductionThe aim of this study was to examine the factors affecting return to work after Total hip arthroplasty (THA) applied for coxarthrosis due to developmental hip dysplasia (DDH). MethodsThe study included 51 patients aged <60 years in the period 2004–2010. The demographic information was recorded for all patients and the pre-postoperative Modified Harris score, EQ-5D, EQ-5D VAS and Grimby activity score. With an evaluation of the current employment status at the final follow-up examination. ResultsPreoperatively, 21 patients were employed, 16 were unemployed and 14 were housewives, none of whom were able to perform housework tasks. Postoperatively, 30 patients were employed and 10 were unemployed. One of the previously employed patients decided preoperatively to retire and was therefore not employed postoperatively. Of the 14 housewives, 9 were able to undertake the housework themselves postoperatively. The mean time of return to work was 13.4 weeks. Factors affecting finding work postoperatively were determined to be body mass index, National Occupational Level, whether or not osteotomy was applied and the preoperative duration of unemployment. ConclusionsAs coxarthrosis associated with DDH develops earlier than primary coxarthrosis, these patients undergo surgery at a younger age and the vast majority are of working age. THA applied for coxarthrosis on the basis of DDH enables most patients to return to their preoperative work and offers the opportunity of finding work to some of those who were unemployed. This increases the contribution of these patients to the national economy.

Association of Socioeconomic Status, Race and Insurance Status with Chronic Rhinosinusitis Patient-Reported Outcome Measures.

Objective Disparities in health and health care access are widely prevalent. However, disparities among patients with chronic rhinosinusitis (CRS) are poorly understood. We investigated if CRS severity at presentation according to socioeconomic factors. Study Design Cross-sectional study. Setting Tertiary rhinology center. Subjects and Methods Three hundred prospectively recruited patients presenting with CRS were included. Outcome variables included CRS symptomatology, as reflected by the 22-item Sinonasal Outcome Test (SNOT-22); general health status, as reflected by the EuroQol 5-dimensional visual analog scale (EQ-5D VAS); and CRS-related antibiotic and systemic corticosteroid use. Race/ethnicity, zip code income bracket, education level, and insurance status were used as predictor variables. Regression, controlling for clinical and demographic characteristics, was used to determine associations between predictor and outcome variables. Results Mean SNOT-22 score was 33.8 (SD, 23.2), and mean EQ-5D VAS score was 74.2 (SD, 18.9). On multivariable analysis, presenting SNOT-22 and EQ-5D VAS scores were not associated with nonwhite patient race/ethnicity ( P = .634 and P = .866), education ( P = .106 and P = .586), or the percentage of households in zip code with incomes <$50,000 per year ( P = .917 and P = .979, respectively). SNOT-22 scores did not differ by insurance type, but patients receiving Medicare reported worse general health status. Use of oral antibiotics or oral steroids for CRS was not associated with predictor variables. Conclusion Patients with CRS presented to a tertiary rhinology center with similar metrics for CRS severity and pre-presentation medical management regardless of race/ethnicity, education status, or zip code income level. Patients with Medicare had worse general health status. Further research should investigate potential disparities in diagnosis of CRS, specialist referral, and treatment outcomes.

Factors predicting the self‐evaluated health of hidradenitis suppurativa patients recruited from an outpatient clinic

In recent years, Hidradenitis suppurativa has received increased attention but still lack well-defined, robust patient-reported outcome measures. Such measures are likely to be influenced by contextual factors. We, therefore, aim to describe the association of biological and other factors with HS patient's self-evaluated health as reflected by the EQ5D VAS score. This cross-sectional study measured basic information, Dermatology Life Quality Index, Major Depression Inventory and Euro-QoL-5D. Information obtained through questionnaires was used to create a model showing the relation between biological factors, questionnaire results and self-evaluated health using the stepwise method for linear regression. Patients with HS (n=805) registered at our department were invited to participate. A total of 503 (62.5%) patients replied to this survey. There was no difference in basic demographics between responders and non-responders. Possible predictors for this study were DLQI, MDI, BMI, smoking, gender. A final model for correlation with self-evaluated health was obtained. Significant predictors for the model were DLQI (P<0.05), BMI points above 25 and active smoking (both: P<0.01) and MDI (P<0.001). As this is a cross-sectional study, it reveals several clinically relevant correlations. Smoking appears to correlate with the highest change in VAS score, but an MDI of 10 (lower than study average) or a BMI of 40 influences the results more. This study provides an assessment of how much BMI and smoking, in relation to other factors, correlate to the self-evaluated health state of patients with HS. These may, therefore, be relevant contextual factors to the construction and interpretation of specific patient-reported outcome measures. To improve QoL, we advocate smoking cessation and weight loss, and advice active screening for depression as over 10% of our patients qualify for a depressive diagnosis according to ICD-10.

Reversal of Smoking Effects on Chronic Rhinosinusitis after Smoking Cessation.

Objective To understand whether the impact of smoking on chronic rhinosinusitis (CRS) is reversible after smoking cessation. Study Design Cross-sectional study. Setting Academic tertiary care rhinology clinic. Subjects and Methods A total of 103 former-smoker CRS patients and 103 nonsmoker CRS patients were prospectively recruited. The primary outcome measure was sinonasal symptom severity measured with the 22-item Sinonasal Outcomes Test (SNOT-22), and secondary outcome measures were general health-related quality of life (QOL) measured with the 5-dimensional EuroQol visual analog scale (EQ-5D VAS) and patient-reported CRS-related antibiotic and oral corticosteroid usage in the past year. Outcome measures were compared between cohorts and checked for association with time since cessation of smoking for former smokers. Results Compared with nonsmokers, former smokers had worse SNOT-22 score ( P = .019) and EQ-5D VAS score ( P = .001) and reported using more CRS-related antibiotics ( P = .003) and oral corticosteroids in the past year ( P = .013). In former smokers, every year was associated with a statistically significant improvement in SNOT-22 score (β = -0.48; 95% CI, -0.91 to -0.05; P = .032), EQ-5D VAS score (β = 0.46; 95% CI, 0.02-0.91; P = .046), and CRS-related oral corticosteroid use (relative risk = 0.95; 95% CI, 0.91-0.98; P = .001). Given the differences in our study outcome measures between former smokers and nonsmokers, we estimate that the reversible impacts of smoking on CRS may resolve after 10 to 20 years. Conclusions CRS patients who are former smokers have worse sinonasal symptomatology, QOL, and CRS-related medication usage than nonsmokers. Every year since cessation of smoking is associated improvements in sinonasal symptomatology, QOL, and CRS-related oral corticosteroid use, potentially reaching nonsmoker levels after 10 to 20 years.

Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial

BackgroundThe effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naïve men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument.MethodsPatients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted.ResultsWith enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (−0.042 vs. –0.070; P < .0001) and EQ-5D VAS (−1.3 vs. –4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P ≤ .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions.ConclusionsThis in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type.Trial registrationNCT01212991

Patient-reported quality of life (QOL) following CTL019 in pediatric and young adult patients (pts) with relapsed/refractory (r/r) b-cell acute lymphoblastic leukemia (B-ALL).

10523 Background: The global ELIANA trial (NCT02435849) evaluates the efficacy and safety of CTL019, a single infusion of genetically modified autologous chimeric antigen receptor–expressing T cells targeting CD19+ cells in pediatric and young adult r/r B-ALL pts. Analyses show a complete response rate of 82% with or without complete blood count recovery ≤ 3 months. A serious adverse event rate of 71% was observed in ≤ 8 weeks of infusion, decreasing to 17% at &gt; 8 weeks (Grupp S, et al. Blood. 2016;128(22) [abstract 221].). This analysis further evaluates the clinical benefit of CTL019. QOL was assessed before and after CTL019 infusion. Methods: Infused pts were 3-23 y/o with CD19+ B-ALL who were chemo refractory, relapsed after allogeneic stem cell transplant (SCT), or otherwise ineligible for SCT. Pts ≥ 8 y completed the Pediatric Quality of Life Inventory (PedsQL) and EuroQol EQ-5D at baseline and following CTL019 infusion. Minimal clinically important differences are estimated to be 4.4 and 7 to 10 for PedsQL and EQ-5D, respectively. Results: 62 of 81 enrolled pts were infused; 56% had relapsed after SCT with median of 3 prior therapies. At interim analysis, 50 pts were treated ≥ 3 months prior to data cutoff and eligible for primary efficacy analysis. A total of 39 pts were ≥ 8 y. Mean PedsQL total and EQ-5D VAS scores, respectively, were 58.4 and 69.4 at baseline. Mean changes from baseline for the PedsQL total and EQ VAS scores, respectively, were 13.9 and 13.7 at month 3 and 12.8 and 10.9 at month 6, supporting clinically meaningful improvements in QOL. Similar trends were observed with each PedsQL subscale. With EQ-5D, the proportions of pts reporting problems with mobility, self-care, usual activities, anxiety/depression, or pain/discomfort were notably decreased at months 3 and 6 compared with baseline. Conclusions: Clinically meaningful improvements in QOL were observed at 3 and 6 months after CTL019 therapy in pediatric and young adult r/r B-ALL pts, including fewer problems in each EQ-5D domain. These results suggest improved QOL after this one-time immunocellular therapy beyond the period of acute toxicities. Clinical trial information: NCT02435849.

Health-related quality of life associated with systemic corticosteroids.

Systemic corticosteroids (SCS) are commonly used but are associated with adverse effects. Given their prevalent use, the potential impact of SCS use on health-related quality of life (HRQoL) is important to characterize. To assess the HRQoL of patients taking SCS. The 2000-2003 Medical Expenditure Panel Survey was used to examine EQ-5D and SF-6D scores associated with SCS use in adults. The study sample was restricted to those with a condition for which SCS are prescribed. SCS use was categorized into three levels: none; 1-3; and ≥4 prescriptions per year. HRQoL scores were regressed on SCS use (1-3 or ≥4 annual prescriptions) controlling for age, gender, race, ethnicity, education, income category, geographic region, number of ER visits, number of outpatient visits, total number of chronic conditions (for which SCS are not used) and conditions for which SCS are clinically indicated. There were 54,856 individuals with no SCS exposure, 2245 with 1-3 and 624 with ≥4 annual SCS prescriptions. In adjusted analyses, use of ≥4 annual SCS prescriptions appeared to be associated with significantly lower EQ-5D (US), EQ-5D (UK), SF-6D and EQ-5D VAS scores compared to no exposure: -0.032, -0.047, -0.036, and -7.58. While SCS are efficacious and widely used for numerous conditions, results suggest that their use may be associated with a substantial deleterious impact on HRQoL. This potential negative effect should be considered in balance with the cost and efficacy of comparable treatments.

A Novel Use of Arthroereisis in the Adult Flat Foot

Category: Hindfoot Introduction/Purpose: The use of an arthroereisis screw is well described in the paediatric population for the correction of flexible flat feet. Here we present a case comparison series involving the use of an arthroereisis screw to augment reconstruction in adult patients with Tibialis Posterior Insufficiency. Methods: All patients (36 feet in 34 patients) underwent flexor digitorum longus transfer, reefing of the spring ligament and a translational medialising calcaneal osteotomy. In 23 cases the reconstruction was augmented with an arthroereisis screw (Kalix, Integra), which was removed 6 months later in all cases. The mean age was 58 years and most patients were female. Weight bearing radiographs were taken after removal of the implant and assessed using previously published parameters. Patients were evaluated at follow up using validated functional outcome questionnaires (MOXFQ, EQ-5D and a health VAS). Results: One patient in the group without augmentation went on to have a triple fusion 13 months after reconstruction. In both cohorts the calcaneal pitch was raised, Meary’s angle decreased, the medial cuneiform height increased and the talonavicular coverage angle improved post-operatively compared to pre-operative measurements (p &lt; 0.05, Wilcoxon Signed Rank tests). There was a trend towards better radiographic correction in the augmented group and the difference in correction of the talonavicular coverage angle was statistically significant (p &lt; 0.05, Students T test). There was however no difference between the MOXFQ, EQ-5D and heath VAS scores between the two groups at mean follow up of 4 years. Conclusion: We conclude that the use of an arthroereisis screw is a promising adjunct to conventional reconstruction in tibialis posterior insufficiency.