EQ-5D VAS Research Articles

Impact of pharmacist counseling on health-related quality of life of patients with type 2 diabetes mellitus: a cluster randomized controlled study

PurposeThe quality of life (QoL) of patients with type 2 diabetes mellitus (T2DM) is a measure of the successful outcomes of therapy. The program of management of chronic diseases “Program Pengelolaan Penyakit Kronis” (Prolanis) among patients with hypertension and T2DM is a new strategy of the Badan Penyelenggara Jaminan Sosial (BPJS), which is the Indonesian national health insurance system. Here, we analyzed the impact of pharmacist counseling interventions on health-related QoL (HRQoL) in Prolanis T2DM patients.MethodsThis cluster randomized controlled trial was designed to include two groups [control (n = 111) and intervention (n = 109) groups], and pre- and post-test procedures. The participants were Prolanis T2DM patients who attended four primary health-care centers (Puskesmas) in Makassar City, South Sulawesi, Indonesia from August 2017 to August 2018. The intervention group received systematic counseling for 6 months. The data were collected using the Bahasa Indonesia version of the European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5 L) questionnaire and were analyzed using EQ-5D preference weight for each health state with the Indonesian EQ-5D-5 L value Set. Furthermore, the EQ-5D index and the EQ-5D VAS score were calculated and HbA1c levels were assessed.ResultsThe change in the EQ-5D-5 L index score (post-pre) was 0.01 in the control group and 0.04 in the intervention group (P = 0.041). The change in the VAS score was −0.07in the control group (post-pre) and 2.66 in the intervention group (P = 0.000).ConclusionPharmacist counseling may help improve the HRQoL of Prolanis T2DM patients.

Chronic Rhinosinusitis Patients With and Without Polyps Experience Different Symptom Perception and Quality of Life Burdens.

We sought to determine if chronic rhinosinusitis (CRS) patients with nasal polyps (CRSwNP) differentially perceived CRS symptom burden compared to patients without nasal polyps (CRSsNP) and to what extent CRS symptom severity was associated with quality of life (QOL) and patient-reported symptom control in the 2 groups. A total of 600 patients (266 CRSwNP and 334 CRSsNP) presenting with CRS were recruited. CRS symptom burden was assessed with the 22-item Sinonasal Outcome Test (SNOT-22). SNOT-22 nasal, sleep, ear/facial discomfort, and emotional subdomain scores were calculated. General health-related QOL was assessed with the visual analog scale of the 5-dimensional EuroQol questionnaire (EQ-5D VAS). Patients rated their CRS symptom control on a 5-point scale. SNOT-22 scores did not differ between CRSwNP (mean: 35.6) and CRSsNP (mean: 36.3). There were no differences in nasal, sleep, and emotional subdomains of the SNOT-22. CRSsNP had higher (P = .003) ear/facial subdomain scores than CRSwNP, while CRSwNP reported greater hyposmia (P < .001). EQ-5D VAS was significantly lower (P = .011) in CRSsNP (mean: 68.9) compared to CRSwNP (mean: 73.2). However, CRSwNP patients reported significantly less symptom control, compared to CRSsNP, in association with nasal and emotional symptoms. CRSwNP and CRSsNP have differences in symptom profile, effect on health-related QOL, and patient-perceived symptom control. CRSsNP experience significantly greater burden of ear/facial discomfort, while CRSwNP report greater hyposmia. Although CRSsNP reports lower general health-related QOL overall, CRSwNP patients had lower levels of CRS symptom control for every incremental increase in symptom burden suggesting greater sensitivity/intolerance to CRS symptoms.

Regaining a satisfactory quality of life and predicting functional decline after major cancer surgery in older adults: The Geriatric Oncology Surgical Assessment and Functional rEcovery after Surgery (GOSAFE) study.

12051 Background: Older cancer patients value quality of life (QoL) and functional outcomes as much as survival but surgical studies lack specific data. The international, multicenter GOSAFE study (ClinicalTrials.gov NCT03299270) aims to evaluate patients’ QoL and functional recovery (FR) after cancer surgery and to assess predictors of FR Methods: GOSAFE prospectively collected functional and clinical data before and after major elective cancer surgery on senior adults (≥70 years). Surgical outcomes were recorded (30, 90, and 180 days post-operatively) with QoL (EQ-5D-3L) and FR (Activities of Daily Living (ADL), Timed Up and Go (TUG) and MiniCog), 26 centers enrolled patients from February 2017 to April 2019. Results: 942 patients underwent a major cancer resection. Median age was 78 (range 70-95); 52.2% males, ASA III-IV 49%. 934 (99%) lived at home, 51% lived alone, and 87% were able to go out. Patients dependent (ADL &lt; 5) were 8%. Frailty was detected by means of G8 ≤14 in 68.8% and fTRST ≥2 in 37% of patients. Major comorbidities (CCI &gt; 6) were reported in 36% and 21% had cognitive impairment according to MiniCog (2.2% self-reported). 25% had &gt; 3 kg weight loss, 27% were hospitalized in the last 90 days, 54% had ≥3 medications (6% none). Postoperative overall morbidity was 39.1% (30 day) and 22.5% (90 day), but Clavien-Dindo III-IV complications were only 13.4% and 6.9% respectively. 30/90/180-day mortality was 3.6/6/8.9% (10/30/33% in patients with severe functional disability). At 3 months after surgery, QoL was stable/improved (mean EQ-5D index 0.78 was equivalent before vs. after surgery, while the EQ-5D VAS score &gt; 60 raised from 74.3% at baseline to 80.2%, p &lt; 0.01). 76.6% experienced postoperative FR/stability. Logistic regression analysis showed that ASA 3-4, CCI≥7 and CD III-IV complications are significantly associated with functional decline while a G8 &gt; 14 has a positive association with functional recovery. Age is not associated with functional outcomes. Conclusions: The largest prospective study on older patients undergoing structured frailty assessment before and after major elective cancer surgery has shown that QoL remains stable/improves after cancer surgery. The majority of patients return to independence and G8 can predict functional recovery. Older patients with multiple comorbidities, high ASA score or postoperative severe complications are likely to functionally deteriorate after oncologic surgery Clinical trial information: NCT03299270 .

Quality of Life Improves with Alemtuzumab Over 6Years in Relapsing-Remitting Multiple Sclerosis Patients with or without Autoimmune Thyroid Adverse Events: Post Hoc Analysis of the CARE-MS Studies.

IntroductionIn clinical trials of alemtuzumab, autoimmune thyroid adverse events (AEs) were frequent. Here, we assess the impact of thyroid AEs on health-related quality of life (HRQL) in alemtuzumab-treated patients with relapsing-remitting multiple sclerosis (RRMS).MethodsIn phase 3 CARE-MS I (NCT00530348) and II (NCT00548405) trials, patients with RRMS were administered alemtuzumab 12 mg/day on 5 consecutive days at baseline and on 3 consecutive days 12 months later. Patients could participate in an extension study (NCT00930553) through year 6. HRQL was assessed at baseline and annually using the Functional Assessment of Multiple Sclerosis (FAMS), EuroQoL-5 Dimension Visual Analog Scale (EQ-5D VAS), and 36-Item Short-Form Survey (SF-36) questionnaires. Outcomes were analyzed in patients with or without thyroid AEs (nonserious or serious). A subset of patients with thyroid AEs was analyzed to assess HRQL before and during the onset of thyroid AEs.ResultsA total of 811 CARE-MS patients were treated with alemtuzumab. Of these, 342 (42%) patients experienced thyroid AEs over 6 years; serious thyroid AEs occurred in 44 (5%) patients. At year 6, HRQL outcomes generally remained slightly improved or similar to core study baseline in alemtuzumab-treated patients with or without thyroid AEs: FAMS (least-squares mean change from baseline without thyroid AEs, 0.7; with nonserious thyroid AEs, 5.1; with serious thyroid AEs, − 5.3), EQ-5D VAS (2.0; 3.0; − 6.8), SF-36 mental component summary (MCS [0.6; 1.6; − 2.8]), SF-36 physical component summary (PCS [0.8; 1.0; 1.1]). Over 6 years, 63–82% of patients in each group had improved/stable SF-36 MCS and PCS scores. Among patients with thyroid AE onset in year 3 (peak incidence), there were minimal differences between HRQL outcomes before onset (year 2) and after onset (year 3).ConclusionAutoimmune thyroid AEs (serious and nonserious) had minimal impact on HRQL in alemtuzumab-treated patients. These data may aid therapeutic decisions in patients with relapsing MS.Electronic supplementary materialThe online version of this article (10.1007/s40120-020-00191-7) contains supplementary material, which is available to authorized users.

Inequalities in health-related quality of life and the contribution from socioeconomic status: evidence from Tibet, China

BackgroundThis study aimed to understand the association between socioeconomic status (SES) and Health Related Quality of Life (HRQoL) and the contribution of SES to health inequality among Tibetans of agricultural and pastoral areas (APA) in Tibet, China.MethodsThe data were from Health Survey of Tibetans in APA conducted in 2014. A total of 816 respondents were enrolled for the analysis Multiple linear regression was employed to examine the relationship between SES and HRQoL. Concentration index (CI) was used to measure the degree of health inequality and a Wagstaff-type CI decomposition method was applied to measure the contribution of SES to inequality.ResultsSES had significant association with HRQoL among the Tibetans in APA. The high SES group was more likely to have a higher Eq-5d index (0.77 vs. 0.67, P < 0.001) and VAS (72.94 vs. 62.41, P < 0.001) than the low SES group. The Concentration index of the Eq-5d index and VAS for total sample was 0.022 and 0.026 respectively, indicating a slight pro-rich inequality among this population. The decomposition analyses showed the SES is the main contributor to health inequality and contributed 45.50 and 41.39% to inequality for the Eq-5d index and VAS, respectively.ConclusionThe results showed SES is positively associated with HRQoL among Tibetans in APA. There was a slight pro-rich inequality in the health of the participants and most health inequality was attributable to SES. This study is helpful in gaining an insight into the HRQoL, health inequality and the relationship between SES and health inequality among Tibetans of APA in China.

Quality of life with pharmacological treatment in patients with benign prostatic enlargement: results from the Evolution European Prospective Multicenter Multi-National Registry Study.

Lower urinary tract symptoms due to benign prostate enlargement (LUTS/BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease specific and generic QOL measures. Evolution was a European prospective, multicenter multi-national, observational registry collecting real-life clinical data over 2years on the management of LUTS/BPE in primary and secondary care. This study investigated disease-specific QOL using questionnaires such as IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of 24months. Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons with lack of efficacy being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7years (0-26years). Medical management produced statistically significant improvement in QOL (disease specific and generic) in previously untreated patients and an insignificant change in generic QOL in previously treated patients. After 5-years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Earlier intervention with minimally invasive surgical techniques (MIT) should be considered in LUTS/BPE patients that do not show a significant improvement in QOL with medical therapy.

PNS192 PREDICTORS OF HEALTH RELATED QUALITY OF LIFE AMONG PRISONERS OF QUETTA CITY, PAKISTAN

We aimed to evaluate the Health Related Quality of Life (HRQOL) of prisoners of Quetta city, Pakistan. The study was cross sectional in nature and was conducted at central and district prison of Quetta city. Based on proportion, data from 389 prisoners were collected by using the EuroQol 5D-3L and was analyzed by using SPSS v. 20.0. Majority (56.8 %) of our respondents were from central prison and the cohort was dominated by participants of 21-30 years of age (28.3 %). Almost 94% of the inmates had been in prison for the first time and highest percentage (50.6 %) of crime reported was murder. Most frequently reported health condition among prisoners during imprisonment was stomach disorders (15.4 %). The EQ-5D descriptive and VAS score were 0.55 ± 0.29 and 49.1 ± 24.7 respectively depicted poor HRQOL. Majority of the participants reported no problem in mobility, self-care, usual activities, pain or discomfort but indicated severe and extreme anxiety or depression in the last domain (48.3 %). Overall, the prisoners reported 64 health states. Although age, locality, current years in prison, present illness during imprisonment, prison status and marital status were significantly associated with HRQOL, present illness during imprisonment (β=0.451) was rated as predictor of HRQOL in the current cohort. As expected, the prisoners of Quetta city, Pakistan reported poor health related quality of life. Findings of the current study demand the policymakers to take immediate steps in order to improve the prisoners’ HRQoL.

Assessment of Health-Related Quality of Life Among Patients Management Program of Chronic Diseases Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus (T2DM) has significant adverse effects on health-related quality of life. PROLANIS program is a system of governance of health services and health education for social health insurance participants who suffer from type 2 diabetes mellitus to achieve the optimal quality of life independently. This research aims to measure quality of life in T2DM patient. The research was an analytical non-experimental study according to the patient’s perspective using prospective data collection techniques. The subjects are PROLANIS patient T2DM who comply inclusion and exclusion criteria.The data were collected by using the European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) Indonesian questionnaire. Data analysis using EQ-5D preference weight for each health state using Indonesian EQ-5D-5L Value Set. Furthermore, the percentage of the patients’ problems, EQ-5D index (utility) and EQ-5D VAS were calculated. A total of 220 patients were included. Seventy-two different EQ-5D index values were described by the patients. Obtained 37 subjects (16.82%) had no problems. The EQ-5D index value highest is 1,000 (n = 32, 14,54%) and EQ-5D index value lowest is -0,384 (n = 1, 0,45%). EQ-5D index value has an average is 0.57 (SD 0,32) and EQ VAS value has an average is 72.19 (SD 14.73). This study also confirmed that T2DM remains a critical predictor of health outcomes among patients. Results from this study could be constructive in clinical practice, particularly in the early treatment of T2DM patients where improving HRQoL is still possible.

Two-year weight, risk and health factor outcomes of a weight-reduction intervention programme: Primary prevention for overweight in a multicentre primary healthcare setting

Objective: To study the long-term effects of weight reduction, quality of life and sense of coherence in a primary health care (PHC)-based programme with two different intensities.Design: Prospective two-armed randomised intervention.Setting: Three PHC centres in south west of Sweden.Subjects: In total, 289 women and men aged 40-65 years with a BMI of 28-35 were recruited for a two-year weight-reduction programme. Participants were randomized to high-intensity or low-intensity groups. Blood samples, physical measurements and questionnaires were analysed. Participants received cookbooks and dietary lectures. The high-intensity group also received Motivational interviewing (MI), dietary advice on prescription (DAP- advice), a grocery store lecture, a website and weekly e-mails.Main outcome measures: Weight, quality of life, risks and health factors.Results: In total, 182 (64%) participants completed the 2-year follow-up. The total sample reduced their weight by 1 kg (p = 0.006). No significant differences regarding weight were found between the groups. Anxiety/depression decreased in EQ5-D (p = 0.021), EQ5-D VAS (p = 0.002) and SOC (p = 0.042). Between the groups, there were significant differences in EQ5-D usual activities (p = 0.004), anxiety/depression (p = 0.013), pain/discomfort (p = 0.041), fruit and vegetables (p = 0.005), HLV anxiety (p = 0.005), and visits to nurses (p = 0.012).Conclusion: The total population lost weight, and the high-intensity and low-intensity programmes did not result in significant differences in terms of weight. The high-intensity programme reported health benefits linked to lower levels of anxiety and depression, increased activity and intake of greens and reduced visits to physicians and nurses.Key pointsBoth groups had a consisting weight- reduction after two years.High intensity did not lead to a significant difference in weight reduction between the groups.The high-intensity group reported more health effects, such as better quality of life, reduced anxiety, and increased greenery intake. It is unknown how much support patients in a weight- reduction programme in PHC require to succeed with weight loss and a healthy lifestyle

PD33-01 QUALITY OF LIFE WITH PHARMACOLOGICAL TREATMENT IN PATIENTS WITH BENIGN PROSTATIC ENLARGEMENT

INTRODUCTION AND OBJECTIVE: Lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. There is variability in the relationship between individual symptom severity and the bother reported by patients as symptom scores alone, may not capture their actual impact on men. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease-specific and generic QoL measures. METHODS: Evolution was a European prospective, multicenter multi-national, observational registry collecting real life clinical data over two years on the management of LUTS/BPE in primary and secondary care. This study investigated disease specific QOL using questionnaires like IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. RESULTS: The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of the study period (24 months). Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons, lack of efficacy of medication being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7 years (0-26 years). Medical management produced statistically successful improvement in QOL (disease specific and generic), albeit significantly better in previously untreated patients. CONCLUSIONS: At an average of five years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Medical management was successful in producing improvement in QOL when first started in previously untreated patients, but was much less significant in the previously treated patients. We need to rethink how we treat LUTS/BPE in clinical practice in line with emerging evidence, it is imperative to offer other options like Minimally Invasive Therapy (MIT) early, especially in patients previously treated with medical therapy.Source of Funding: Financial disclosure: The Evolution registry was supported by a restricted Grantfrom GlaxoSmithKline© (GSK).

Caregiver Comorbidities and Anxiety are Related to Caregiver Quality of Life: Findings from the Sustaining QualIty of Life of the Aged: HT or MCS Study

Involvement of caregivers (CGs) is crucial to successful outcomes of patients (PTs) awaiting heart transplantation (HT) and scheduled for durable mechanical circulatory support (MCS). Importantly, CG quality of life (QOL) may be impacted by providing care for older PTs with advanced heart failure (HF) awaiting these surgeries. We sought to identify both PT and CG factors related to QOL for CGs providing care to pts (60-80 years old (yo)) awaiting HT (with and without MCS) and destination therapy (DT) MCS. Between 10/1/15-12/31/18, we enrolled 302 CGs of HF PTs from 13 U.S. sites: 193 awaiting HT (92 HT with MCS [HT BTT] and 101 HT without MCS [HT non BTT]), and 109 DT MCS. At baseline, CGs completed the EQ-5D-3L (Visual Analog Scale [VAS]: 0 [worst] to 100 [best] imaginable health state); STAI-State (range=20-80, higher score=more anxiety); PHQ-8 (range=0-24; score >10=significant depressive symptoms); and Oberst Caregiving Burden Scale (OCBS): 15 items (2 subscales, 1-5 range each): (1) time: higher score=more time spent on task, and (2) difficulty: higher score=more difficulty of task. CG demographics and clinical history (medical and surgical) were also collected. PTs completed the KCCQ-12 (an HF-specific QOL measure) and all above measures except the OCBS. Analyses included multivariable logistic regression models in which the binary outcome was whether the CG EQ-5D-3L VAS score was less than the cohort median value of 90. CGs (n=302) were 61.1±9.7 yo, 85% white, 85% female, and 85% spouses. CGs reported high overall QOL at baseline (mean/median VAS=83.8±14.0 and 90) with no significant differences between groups. CG EQ-5D VAS score less than 90 was correlated with number of CG comorbidities (p=0.001) and STAI-state (p=0.002) after adjusting for other covariates in the model. See table. CG- and not PT-specific factors were related to CG QOL prior to HT and DT MCS. Awareness of these factors may foster support of CGs.

Endoscopic Argon Plasma Coagulation vs. Multidisciplinary Evaluation in the Management of Weight Regain After Gastric Bypass Surgery: a Randomized Controlled Trial with SHAM Group.

Roux-en-Y gastric bypass is one of the most widely performed bariatric surgeries. However, the relapse of obesity occurs in approximately 20% of patients and enlargement of the anastomosis is one of the factors associated with this relapse. Endoscopic treatment of the anastomosis has been proposed to assist in renewed weight loss. One endoscopic technique is the narrowing of the anastomosis argon plasma coagulation (APC). Evaluate the effectiveness and safety of the endoscopic treatment of an enlarged anastomosis with APC. A randomized controlled study was conducted comparing APC to exclusive multidisciplinary management after weight regain. Forty-two patients were divided into two groups: APC (n = 22) and control (n = 20). After 14months of follow-up with a crossover at 6months, significant improvement in satiety and greater weight loss were found in the APC group and after crossover. APC was associated with significant weight loss [9.73 (7.46, 12) vs. + 1.38 (- 1.39, 2.15)], a reduction in the anastomosis diameter [p < 0.001], early satiation [0.77 (0.44, 1.11) vs. - 0.59 (- 0.95, - 0.23), p < 0.001], and increased quality of life measured using the EQ5D index [p = 0.04] and EQ5D VAS scale [p = 0.04]. Considering total mean weight loss throughout the entire follow-up, weight loss was similar in both groups (13.02kg in the APC and 11.52kg in the control). Treatment of the gastrojejunal anastomosis with APC was effective and safe, with significant weight loss, the return of early satiation, and an improvement in quality of life.

Evaluation of the patient acceptable symptom state following hip arthroscopy using the 12 item international hip outcome tool

BackgroundThe International Hip Outcome Tool 12 (iHOT-12) is a shorter version of the iHOT-33 which measures health related quality of life following treatment of hip disorders in young, active patients. The purpose of this study was identify a PASS threshold for a UK population undergoing hip arthroscopy for intra-articular hip pathology.MethodsData was identified retrospectively from a prospective database of patients undergoing hip arthroscopy under the care of a single surgeon within the date range January 2013 to March 2017. All patients with a diagnosis of femoroacetabular impingment (FAI) undergoing arthroscopic treatment were included. iHOT-12, EuroQol 5D-5 L (EQ-5D-5 L) and a satisfaction questionnaire were available pre and post-operatively. PASS was calculated using an anchor-based approach and receiver operator characteristic (ROC) analysis.Results171 patients underwent hip arthroscopy in the study period. Linked longitudinal follow-up data was available for 122 patients (71.3%) at a median of 24.3 months (740 days, interquartile range 576–1047). The PASS threshold for the iHOT-12 was 59.5 (sensitivity 81.1%, specificity 83.9%; area under the curve (AUC) 0.92, 95% CI 0.87–0.97). 64% of patients achieved this score. The median postoperative iHOT-12 score was 72.5 (IQR 44) and the mean change in score was 35 (SD 25, p < 0.001). The EQ-5D Index improved by 0.18 (SD 0.25, p < 0.001) and there was a mean change of 7.67 (SD 24.82) on the EQ-5D VAS (p = 0.001).ConclusionsWe report a PASS threshold of the iHOT-12 following hip arthroscopy for FAI as a measurable benchmark for clinicians using this outcome measure.

Validity of systemic antibiotics and systemic corticosteroid usage for chronic rhinosinusitis as metrics of disease burden.

The frequencies of systemic antibiotics and oral corticosteroids taken for chronic rhinosinusitis (CRS) indicate poor CRS disease control. We sought to determine the validity and responsiveness of these metrics as reflections of CRS disease burden. One hundred and eighty-seven patients undergoing medical management for CRS were recruited. Participants were assessed at two time points: enrollment and a follow-up appointment three to nine months later. At each time point, CRS related antibiotic and oral corticosteroid usage in the previous three months was measured, while general and disease-specific quality of life (QOL) was measured using the visual analog scale of the 5-dimension EuroQol questionnaire (EQ-5D VAS) and the 22-item Sinonasal Outcome Test (SNOT-22), respectively. The frequency of CRS-related antibiotics and oral corticosteroids use was cross-sectionally correlated with EQ-5D VAS and SNOT-22 at the corresponding time points. For participants reporting usage of these medications at enrollment, there was a decrease of 1 course per 3 months for both CRS-related antibiotics and oral corticosteroids. Change in CRS-related antibiotics from enrollment to follow-up was correlated with change in both EQ-5D and SNOT-22 over the same timeframe. The change in CRSrelated oral corticosteroids was correlated with change in both EQ-5D VAS and SNOT-22). These correlations were stronger in the subset of patients who had a change in these metrics over the study period. The frequencies of CRS-related antibiotic use and oral corticosteroid use are valid and responsive measures of CRS disease burden.

Association between muscle strength and health-related quality of life in a Chinese rural elderly population: a cross-sectional study

ObjectiveTo investigate the relationship between upper and lower limb muscle strength and the health-related quality of life (HRQoL) of a Chinese rural, elderly population.DesignA population-based, cross-sectional study.SettingMiyun, Beijing, China.ParticipantsThe participants...

The burden of osteoarthritis: self-reported severity in the KHOALA population-based cohort.

Lay descriptions of mild, moderate and severe disease states have been utilized in Global Burden of Disease studies in the calculation of years lived with disability, and may be a useful brief starting point for clinical care. The primary aims of this study were to estimate the proportion of an OA cohort within each severity level, and to assess the validity of lay descriptions of OA. During 2014 to 2016, participants in the KHOALA population-based cohort completed questionnaires including pain, function, and quality of life, in addition to indicating which of the lay descriptions devised for presenting to populations in GBD2010 they felt best described their current condition. 569 participants comprising 152 with hip OA, 384 knee OA and 33 with both hip+knee OA participated. 10% of hip OA and 17% of knee OA participants classified themselves as having severe OA, a considerably higher proportion than the 2% reported for high-income countries in GBD2010.The lay descriptions showed significant convergent and divergent validity: pain, function and stiffness scores increased as the rating of severity increased, with a significant trend for EQ5D and EUROQOL VAS to decline, also indicating worse health state, as level of severity increased. Lay descriptions of levels of severity are understandable by participants and show convergent validity with standardized measure of physical and functional outcomes. The proportion of people with OA who align themselves with the severe category is considerably larger than that used in GBD estimates to estimate the impact of OA.

What to expect after open heart valve surgery? Changes in health-related quality of life.

To (i) describe changes in health-related quality of life (HRQoL) pre-operatively, at discharge, and 4 weeks after discharge following open heart surgery, (ii) compare the performance of the EuroQol Questionnaire (EQ-5D 5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) against an anchor-based approach, and to (iii) investigate the association between HRQoL and 180-day readmission. A prospective, consecutive cohort (single-center study) of 291 patients completed the EQ-5D 5L and KCCQ pre-operatively, at discharge and 4 weeks post-discharge. Changes in HRQoL over time were evaluated, and the performance of the instruments was investigated. The association between HRQoL and readmission were investigated with Cox Proportional Hazard models. Scores of the EQ-5D Index and VAS decreased significantly from the pre-operative assessment to discharge and improved from discharge to 4 weeks after. The KCCQ scores significantly improved from baseline to 4 weeks after. Minimal clinically important improvements from before surgery to 4 weeks after were seen among 24% (EQ-5D Index), 45% (EQ-5D VAS), and 57% (KCCQ). More than one-third experienced worse HRQoL 1 month after discharge. Area under the curve (AUC) (performance of the instruments) demonstrated the following: EQ-5D Index AUC 0.622 (95% CI 0.540-0.704), VAS AUC 0.674 (95% CI 0.598-0.750), and KCCQ AUC 0.722 (95% CI 0.65-0.792). None of the HRQoL measurements were associated with 180-day readmission. This study revealed that HRQoL measured with the EQ-5D is significantly worse at discharge compared to before surgery, but scores increases within the first month measured with the EQ-5D and the KCCQ. The EQ-5D and KCCQ have a moderate correlation with an anchor-based approach but were not associated with readmission.

An add-on training program involving breathing exercises, cold exposure, and meditation attenuates inflammation and disease activity in axial spondyloarthritis - A proof of concept trial.

ObjectivesThe primary objective of this trial was to assess safety and anti-inflammatory effects of an add-on training program involving breathing exercises, cold exposure, and meditation in patients with axial spondyloarthritisMethodsThis study was an open-label, randomised, one-way crossover clinical proof-of-concept trial. Twenty-four patients with moderately active axial spondyloarthritis(ASDAS >2.1) and hs-CRP ≥5mg/L were included and randomised to an intervention (n = 13) and control group (n = 11) group that additionally received the intervention after the control period. The intervention period lasted for 8 weeks. The primary endpoint was safety, secondary endpoints were change in hs-CRP, serum calprotectin levels and ESR over the 8-week period. Exploratory endpoints included disease activity measured by ASDAS-CRP and BASDAI, quality of life (SF-36, EQ-5D, EQ-5D VAS), and hospital anxiety and depression (HADS).ResultsWe found no significant differences in adverse events between groups, with one serious adverse event occurring 8 weeks after end of the intervention and judged ‘unrelated’. During the 8-week intervention period, there was a significant decline of ESR from (median [interquartile range] to 16 [9–26.5] to 9 [5–23] mm/hr, p = 0.040, whereas no effect was found in the control group (from 14 [8.3–27.3] to 16 [5–37] m/hr, p = 0.406). ASDAS-CRP declined from 3.1 [2.5–3.6] to 2.3 [1.9–3.2] in the intervention group (p = 0.044). A similar trend was observed for serum calprotectin (p = 0.064 in the intervention group versus p = 0.182 in the control group), but not for hs-CRP.ConclusionsThis proof-of-concept study in axial spondyloarthritis met its primary endpoint with no safety signals during the intervention. There was a significant decrease in ESR levels and ASDAS-CRP upon the add-on training program in the intervention group. These findings warrant full-scale randomised controlled trials of this novel therapeutic approach in patients with inflammatory conditions.Trial registrationClinicalTrials.gov; NCT02744014

Patient characteristics and valuation changes impact quality of life and satisfaction in total knee arthroplasty \u2013 results from a German prospective cohort study

BackgroundEvaluation of variations in pre- and postoperative patient reported outcomes (PRO) and the association between preoperative patient characteristics and health and satisfaction outcomes after total knee arthroplasty (TKA) may support shared decision-making in Germany. Since previous research on TKA health outcomes indicated valuation differences in longitudinal data, experienced-based population weights were used for the first time as an external valuation system to measure discrepancies between patient and average population valuation of HRQoL.MethodsBaseline data (n = 203) included sociodemographic and clinical characteristics and PROs, measured by the EQ-5D-3 L and WOMAC. Six-month follow-up data (n = 161) included medical changes since hospital discharge, PROs and satisfaction. A multivariate linear regression analysis was performed to evaluate the relationship between preoperative patient characteristics and PRO scores. Patient acceptable symptom state (PASS) was calculated to provide a satisfaction threshold. Patient-reported health-related quality of life (HRQoL) valuations were compared with average experienced-based population values to detect changes in valuation.ResultsOne hundred thirty-seven subjects met inclusion criteria. All PRO measures improved significantly. Preoperative WOMAC and EQ-5D VAS, housing situation, marital status, age and asthma were found to be predictors of postoperative outcomes. 73% of study participants valued their preoperative HRQoL higher than the general population valuation, indicating response shift. Preoperatively, patient-reported EQ-5D VAS was substantially higher than average experienced-based population values. Postoperatively, this difference declined sharply.Approximately 61% of the patients reported satisfactory postoperative health, being mainly satisfied with results if postoperative WOMAC was ≥82.49 (change ≥20.25) and postoperative EQ-5D VAS was ≥75 (change ≥6).ConclusionOn average, patients benefited from TKA. Preoperative WOMAC and EQ-5D VAS were predictors of postoperative outcomes after TKA. Particularly patients with high absolute preoperative PRO scores were more likely to remain unsatisfied. Therefore, outcome prediction can contribute to shared-decision making. Using general population valuations as a reference, this study underlined a discrepancy between population and patient valuation of HRQoL before, but not after surgery, thus indicating a potential temporary response shift before surgery.

Real-World Treatment Patterns and Clinical Outcomes in Multiple Myeloma in the Asia-Pacific Region: Methodology and Preliminary Results of the Asia-Pacific Myeloma and Related Diseases Registry (APAC MRDR)

Real-World Treatment Patterns and Clinical Outcomes in Multiple Myeloma in the Asia-Pacific Region: Methodology and Preliminary Results of the Asia-Pacific Myeloma and Related Diseases Registry (APAC MRDR)