Life-5 Dimensions Questionnaire Research Articles

Arthroscopic treatment for femoroacetabular impingement yields favourable patient-reported outcomes and method survivorship at 10-year follow-up.

To compare the outcomes of hip arthroscopy for femoroacetabular impingement syndrome (FAIS) preoperatively and at minimum 10-year follow-up using patient-reported outcome measures (PROMs). A total of 128 patients with FAIS were prospectively included. The patients underwent arthroscopic surgery for FAIS between 2011 and 2013 and had a minimum of 10-year follow-up. The International Hip Outcome Tool short version (iHOT-12) was the primary outcome. Secondary outcomes were the Copenhagen Hip and Groin Outcome Score (HAGOS), the European Quality of Life-5 Dimensions Questionnaire (EQ-5D), the European Quality visual analogue scale (EQ VAS), the Hip Sports Activity Scale (HSAS) for physical activity level, the Visual Analogue Scale (VAS) for overall hip function and a single question regarding overall satisfaction with the surgery. The Wilcoxon signed rank test was used to compare pre- and postoperative PROMs. There was a significant improvement (p < 0.001) of iHOT-12, HAGOS subscales, EQ-5D, EQ VAS and VAS for overall hip function. A total of 83% of the patients were satisfied with their surgery. The survivorship of hip arthroscopy, defined as nonconversion to total hip arthroplasty (THA), at the end of the follow-up period was 77%. Patients undergoing arthroscopic treatment for FAIS reported statistically significant and clinically relevant improved outcomes at 10-year follow-up. Case series, level IV.

Role of tele-physical therapy in quality of life and satisfaction among patients with musculoskeletal disorders

Objectives: Previous research has shown telephysical therapy to be highly efficient, but it has shown vague results in terms of quality of life and satisfaction improvement in patients with musculoskeletal disorders (MSD). Hence, this study aimed to find the role of telephysical therapy in improving the quality of life of patients with MSD. Methods: The study was conducted using a pre- and post-study design, enrolling 327 patients with MSDs who contacted Marham for online physical therapy consultations. Participants filled out telehealth usability and European quality of life-5 dimensions questionnaires (EQ-5D-5L) in the priory. After tele-sessions, they were again requested to fill out questionnaires along with complete questionnaires and ten open-ended questions about their telephysical therapy experience. Any participant with cognitive dysfunction or inability to complete prescribed tele-sessions was excluded from the study. Results: Participants had a mean age of 41.80 (±14.84) years. One hundred and fifty-three were male and 174 were female. Thirty-nine distinct MSDs were diagnosed, with low back pain being the most prevalent among the participants. The Marham’s therapists prescribed a minimum of 3 and a maximum of 12 tele-sessions. The paired sample t-test showed statistically significant differences between pre- and post-scores of telehealth usability and EQ-5D-5L (P &lt; 0.001). According to multiple regression analysis, age, sex, and number of sessions were the most influencing variables, with a 35% variance in quality of life and 35.4% in satisfaction. Most participants, that is, 83% reported excellent experiences. Conclusion: The study concluded that telephysical therapy plays a positive role in improving the quality of life and satisfaction of MSD patients.

An Observational Multi-Center Study Protocol for Distribution of Pattern Identification and Clinical Index in Parkinson’s Disease

Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson’s disease (PD) for personalized diagnosis and treatment.Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed.Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved.Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD.

Medication adherence to obeticholic acid: a real-world experience using medication event monitoring systems

ObjectiveWe designed a clinical study to analyze patterns of adherence to obeticholic acid, factors influencing the adherence and potential correlation with treatment efficacy by using MEMS® cap in practice daily. MethodA multicenter prospective observational study of patients with primary biliary cholangitis. Adherence will be measured by MEMS® cap, pill count, and patient-reported outcomes during 3 months. The quality of life will be self-reported using the Chronic Liver Disease Questionnaire test, European Quality of Life 5-Dimension Questionnaire test and Itch Severity Scale. ConclusionsWe expect to clarify if there is correlation between adherence with treatment efficacy and to identify causes for poor compliance and introduce measures to reduce its prevalence.

Synergistic Impact of Visual and Cognitive Impairments on Health-Related Quality of Life in a Multiethnic Asian Population

Introduction: The concomitant impact of visual impairment (VI) and cognitive impairment (CI) on health-related quality of life (HRQoL) in older adults is unclear. We aimed to determine the synergistic effect of baseline VI and CI on HRQoL decline at 6 years in multiethnic Asians. Methods: We included Chinese, Malay, and Indian adults aged ≥60 years who participated in baseline (2004–2011) and 6-year (2011–2017) follow-up visits of the Singapore Epidemiology of Eye Diseases Study, a population-based cohort study in Singapore. Visual acuity (VA) was objectively measured at both visits, with VI defined as presenting VA >0.3 LogMAR in the better eye. CI was defined as Abbreviated Mental Test scores of ≤6 and ≤8 for individuals with ≤6 and >6 years of formal education, respectively. HRQoL was measured using the European Quality of Life-5 Dimensions (EQ-5D) questionnaire. HRQoL decline was defined as the difference in the composite EQ-5D scores at baseline and 6-year follow-up and deemed clinically meaningful if the reduction was equal to or larger than the minimal clinically important difference. Multivariable linear regression assessed the independent associations and synergism (β interaction) between baseline VI and CI on EQ-5D decline. Results: Of the 2,433 participants (mean [SD] age: 67.6 [5.5]) at baseline, 559, 120, and 151 had VI only, CI only, and both impairments, respectively. HRQoL decline in individuals with baseline comorbid VI-CI was clinically meaningful and was 2.0 times (β = −0.044, 95% confidence interval: −0.077 to −0.010) and 3.7 times (β = −0.065, 95% confidence interval: −0.11 to −0.022) larger than those with VI only and CI only, respectively. Importantly, there was a significant synergism (β interaction = −0.048, 95% confidence interval: −0.095 to −0.001) between baseline VI and CI as predictors of HRQoL decline, suggesting that individuals having both conditions concurrently had a greater HRQoL reduction than the sum in those with VI alone and CI alone. The affected HRQoL domains included mobility and usual activities. Conclusions: Concomitant VI-CI potentiated HRQoL decline to a greater extent than the sum of individual contributions of VI and CI, suggesting synergism. Our results suggest that rehabilitative interventions such as the use of mobility aids and occupational therapy are needed to maintain HRQoL in older adults with concomitant VI-CI. Moreover, preventive interventions targeting at early detection and management of both VI and CI may also be beneficial.

Effect of Tai-chi on balance, mood, cognition, and quality of life in women with multiple sclerosis: A one-year prospective study

IntroductionOne of the most debilitating problems encountered by people with multiple sclerosis (MS) is the loss of balance and coordination. Our study aimed to comprehensively evaluate the effectiveness of one year of Tai-chi exercise in patients with MS using both subjective and objective methods, including posturography. MethodsThis was a single-group longitudinal one-year study performed from the 1st of January 2019 to the 1st of January 2020. The primary outcomes of interest were the Mini-Balance Evaluation Systems Test (Mini-BESTest) and static posturography measures as objective methods to detect subtle changes associated with postural control/balance impairment. Secondary outcomes were measures of depression, anxiety, cognitive performance, and quality of life. All objective and subjective parameters were assessed four times: at baseline, and after three, six and 12 months of regular Tai-chi training. The difference was calculated as a subtraction of baseline values from every timepoint value for each measurement. If the normality test was passed, parametric one-sample t-test was used, if failed, Wilcoxon signed ranks test was used to test the difference between the baseline and each timepoint. Alpha was set to 0.017 using Bonferroni correction for multiple comparisons. ResultsOut of 25 patients with MS enrolled, 15 women with MS (mean age 44.27 years) were included for statistical analyses after completing the 12-month program. After 12 months, significant improvements were found in all objective balance and gait tests: Mini-BESTest (p<0.001), static posturography measures (total area of the centre of foot pressure – TA; p = 0.015), 25 Feet Walk Test (25FWT; p = 0.001), anxiety (Beck Anxiety Inventory – BAI; p = 0.005) and cognition tests (Paced Auditory Serial Addition Test – PASAT; p = 0.003). Measures of depression (Beck Depression Inventory – BDI; p = 0.071), cognition (Symbol Digit Modalities Test – SDMT; p = 0.079), and health-related quality of life (European Quality of Life 5-Dimensions Questionnaire – EQ-5D-5L; p = 0.095) showed a trend of improvement but were not significant, which could be the result of a small sample and increased bias due the type II error. ConclusionAccording to these preliminary results, this study indicates the possible beneficial effects of long-term Tai-chi training on patients with MS. Although these findings need to be confirmed by further studies with a larger sample of participants of both genders and require more rigorous randomized controlled trials (RCT) design, our findings support the recommendation of regular and long-term Tai-chi exercise in patients with MS. ClinicalTrials.gov Identifier (retrospectively registered): NCT05474209

A different outlook to consequences of anemia in older adults

ABSTRACT Objectives Anemia is a common health issue in older adults with crucial consequences. We aimed to investigate the relationship of anemia with various components of geriatric syndromes. Methods A total of 486 older individuals aged 65 and over admitted to a university hospital were included in this cross-sectional study. According to WHO criteria, we defined anemia as hemoglobin concentration lower than 13 g/dL in men and 12 g/dL in women. The Working Group on Sarcopenia in Older People (EWGSOP2) criteria were used to diagnose sarcopenia. Handgrip strength (HGS) was measured by a hand dynamometer. Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) questionnaires were used to evaluate functionality. Geriatric Depression Scale (GDS), Mini Nutritional Assessment (MNA), Mini-Mental State Examination (MMSE), and European Quality of Life-5 Dimensions (EQ-5D) questionnaires were also used. Results Participants’ mean age was 72.2 ± 6.4 years and 58.8% of them were female. Ninety-two of 486 patients were anemic and 64.1% of anemic patients were female. Anemic group had lower IADL, EQ-5D, HGS scores, and higher GDS scores. According to multivariate logistic regression analysis, age, and anemia were found to be independent risk factors for dependency in IADL in both genders. Anemia, age, and depression were found to be independent risk factors for low HGS in women. Conclusion Anemia and depression are independent factors for low HGS in women, and anemia and age are independent factors for dependency on instrumental daily activities in older persons. Treating depression and raising Hb to optimal levels may be critical interventions to improve the health and life quality of people aged 65 and over, particularly in the female gender.

A single relapse induces worsening of disability and health-related quality of life in patients with neuromyelitis optica spectrum disorder.

Cumulative damage from multiple relapses in neuromyelitis optica spectrum disorder (NMOSD) is associated with poor health-related quality of life (HRQoL) and long-term disability in patients positive for anti-aquaporin 4 antibodies (AQP4+). This study assessed the effect of an individual relapse on HRQoL and disability outcomes in AQP4+ NMOSD. Post hoc analyses of data pooled from the PREVENT study and its open-label extension, which evaluated the efficacy and safety of eculizumab in AQP4+ NMOSD, examined the effect of a single relapse on 3 disability and 4 HRQoL outcome measures. Assuming the effect of 1 relapse extends to multiple relapses, an extrapolation was done to assess the effect of 2 relapses on these outcomes. In 27 patients (placebo: n = 20; eculizumab: n = 7) experiencing an independently adjudicated relapse, 1 relapse led to significantly worse disability (modified Rankin Scale and Expanded Disability Status Scale [EDSS]) and HRQoL (36-item Short-Form Health Survey mental and physical component summaries; European Quality of Life 5-Dimension questionnaire 3-Level visual analogue scale and utility index) scores. In 4 of 7 outcomes, clinically meaningful worsening was more likely for relapsing versus non-relapsing patients (n = 116). Extrapolating the effect of 2 relapses predicted that clinically meaningful worsening was more likely in 6 out of 7 outcomes, including EDSS, for patients experiencing multiple relapses versus patients experiencing no relapses. Findings from these clinical trial data demonstrate that a single NMOSD relapse can worsen disability and HRQoL, underscoring the role of relapse prevention in improving long-term outcomes in patients with AQP4+ NMOSD.

Comparative efficacy of a day-stay hospital and telerehabilitation treatment: A retrospective study in 180 patients with COVID-19

BACKGROUND: Growing evidence indicates that coronavirus disease 2019 (COVID-19) is associated with long-term virus transmission by patients during the convalescence period. This fact required changes in the existing procedures of rehabilitation treatment while maintaining its staging. Particularly, the transformation of in-person rehabilitation to telerehabilitation is recommended. The previous experience allowed us to organize telerehabilitation for patients with COVID-19 in the early days of the pandemic. We have summarized the findings of our study in this article.&#x0D; AIM: to compare the effectiveness of two technologies for the rehabilitation treatment of patients with post-COVID: an in-person treatment (a day-stay hospital) and telerehabilitation&#x0D; MATERIALS AND METHODS: This retrospective single blind study included patients with post-COVID, who received day hospital or telerehabilitation treatment between May 2020 and February 2021. The efficacy was estimated by the intensity level of physical activity measured according to the Borg scale and by the generic quality of life by EQ-5 (European Quality of Life 5-Dimension Questionnaire). The choice of these metrics is justified by the possibility of their acquisition via a teleinterview.&#x0D; RESULTS: 180 patients in total, including those who received a day hospital (DH) rehabilitation treatment (n=97; 64 women and 33 men; 55.111.9 years) and those who underwent telerehabilitation (TR) (n=83; 52 women and 31 men; 54.412.76 years) were included in the study. In the DH group, the mean patient-day was 12.6, mean number of sessions achieved 10. In these patients, a high compliance to the treatment was noted: only 5 (4.9%) of participants visited 5 sessions. As a result of treatment in the DH and the TR groups, a statistically significant improvement both according to the Borg score and to the EQ-5 was observed (p 0.05 compared to the beginning of the treatment). The mean improvement by the Borg scale achieved 3.65 in the DH group and 1.43 in the TR group (p=0.001). The between-group differences in the effectiveness of therapy by the EQ-5 were not statistically significant (p=0.341). The clinical form of COVID did not affect the effectiveness of the rehabilitation treatment. We also assessed the TR-patients' perception of the absence of a physical contact during the therapy: all the participants reported a high quality of medical care. Neither a patients age nor the treatment time affected the level of satisfaction. 12 patients expressed their desire to repeat the TR course. No stop-signs or adverse effects were registered during the rehabilitation period in both treatment groups.&#x0D; CONCLUSIONS: The use of telerehabilitation in the medical rehabilitation care for post-COVID patients is not less effective than an in-person (day-stay hospital) treatment. Given the high risks of infection during the COVID pandemic, it is possible to use such a method of rehabilitation, without an in-person medical examination. However, we emphasize that in general practice a patient should be examined manually by specialists of a multidisciplinary team at least twice: at the beginning and at the end of the rehabilitation treatment course.

Arthroscopic iliopsoas tenotomy after total hip arthroplasty: safe method for the right patient

PurposeTo evaluate the outcome of arthroscopic treatment for iliopsoas impingement after total hip arthroplasty (THA) 2 years after surgery using patient reported outcomes (PROM).MethodsIn this study 12 patients (13 hips) were included from a local hip arthroscopy registry. Patients completed web-based PROMs preoperatively and at a minimum of 2 years postoperatively. The PROMs included the International Hip Outcome Tool short version (iHOT-12), the Copenhagen Hip and Groin Outcome Score (HAGOS), the European Quality of Life-5 Dimensions Questionnaire (EQ-5D), the Hip Sports Activity Scale (HSAS) for physical activity level, the Visual Analog Scale (VAS) for overall hip function and a single question regarding overall satisfaction with the surgery.ResultsThe mean age was 64.4 years (±15.1SD), mean body mass index (BMI) was 26.6 (±4.3SD), mean follow-up time was 49.8 months (±25SD). Comparing PROMs preoperatively with 2-year follow up showed an improvement for many of the PROMs used. The PROMs scores were iHOT-12 (24.9 vs 34.5, p = 0.13), HAGOS subscales (symptoms 38.2 vs 54.5, p = 0.05; pain 36 vs 53, p = 0.04; sport 14.1 vs 35.1, p = 0.03; daily activity 31 vs 47.5, p = 0.04; physical activity 21.8 vs 24, p = 0.76; quality of life 24 vs 35, p = 0.03), EQ-VAS (57.9 vs 58, p = 0.08), EQ-5D (0.34 vs 0.13, p = 0.07) and VAS for overall hip function (43.1 vs 46.2, p = 0.14). In total, 10 out of the 12 patients (83%) were satisfied with the intervention.ConclusionPatients undergoing surgery for iliopsoas impingement after previous THA showed improved self-reported hip function where most patients were satisfied with treatment.

Percutaneous coronary intervention improves quality of life of patients with chronic total occlusion and low estimated glomerular filtration rate.

A low estimated glomerular filtration rate (eGFR <90 mL/min/1.73 m2) is widely recognized as a risk factor for major adverse cardiac events (MACE) after percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). However, the impact of successful CTO-PCI on quality of life (QOL) of patients with low eGFR remains unknown. The aim of this prospective study was to assess the QOL of CTO patients with low eGFR after successful PCI. Consecutive patients undergoing elective CTO-PCI were prospectively enrolled and subdivided into four groups: eGFR ≥90 mL/min/1.73 m2 (n = 410), 90 > eGFR ≥ 60 mL/min/1.73 m2 (n = 482), 60 > eGFR ≥ 30 mL/min/1.73 m2 (n = 161), and eGFR <30 mL/min/1.73 m2 (n = 23). The primary outcomes included QOL, as assessed with the European Quality of Life-5 Dimensions (EQ-5D) questionnaire, and symptoms, as assessed with the Rose Dyspnea Scale (RDS) and Seattle Angina Questionnaire (SAQ), at 1 month and 1 year after successful PCI. With the decline of eGFR, CTO patients were more likely to present with comorbidities of hypertension, diabetes, hyperuricemia, and previous stroke, in addition to lower hemoglobin levels and left ventricular ejection fraction (p < 0.05). Low eGFR was associated with greater incidences of in-hospital pericardiocentesis, major bleeding, acute renal failure, and subcutaneous hematoma, but not in-hospital MACE (p < 0.05). Symptoms of dyspnea and angina were alleviated in all CTO patients with eGFR ≥30 mL/min/1.73 m2 at 1 month and 1 year after successful CTO-PCI, but only at 1 month for those with eGFR <30 mL/min/1.73 m2 (p < 0.01). Importantly, QOL was markedly improved at 1 month and 1 year after successful PCI (p < 0.01), notably at a similar degree between patients with low eGFR and those with normal eGFR (p > 0.05). Successful PCI effectively improved symptoms and QOL of CTO patients with low eGFR.

90-Day Patient-Centered Outcomes after Totally Endoscopic Cardiac Surgery: A Prospective Cohort Study.

Over the past years, minimally invasive procedures have been developed to reduce surgical trauma after cardiac surgery. The value of patient-centered outcomes, including the quality of recovery after hospital discharge, is increasingly recognized. Identifying meaningful changes in postoperative function that might have a negative impact on patients without noticeable complications can provide a more comprehensive understanding of the impact on the patient’s life. In total, 209 patients were included in this trial. Of these, 193 patients underwent totally endoscopic cardiac surgery, 8 underwent cardiac surgery through a sternotomy, and 8 underwent transcatheter aortic valve implantation. Patients who previously underwent cardiac surgery were excluded. Quality of life was determined through the Short Form 36 and European Quality of Life-5 Dimensions questionnaires before the surgery and 14, 30, and 90 days afterward. In patients who underwent totally endoscopic cardiac surgery, the quality of life improved over the three time periods. The different domains of the questionnaire evolved in a positive manner. However, 14 days postoperatively, a decline in quality of life was noted, followed by a return to baseline at 30 days and an increase at 90 days. In conclusion, totally endoscopic cardiac surgery improves the quality of life 90 days after surgery.

Quality of life after the initial treatment of atrial fibrillation with cryoablation versus drug therapy.

The STOP AF First trial recently demonstrated that initial treatment with cryoballoon ablation (CBA) is safe and superior to antiarrhythmic drug (AAD) therapy for preventing atrial arrhythmia recurrence in patients with symptomatic atrial fibrillation (AF). The purpose of this study was to evaluate the change in quality of life (QoL) and symptoms after first-line CBA vs AAD therapy. Patients with symptomatic AF not previously receiving rhythm control therapy were randomized to AAD (class I or III) or CBA (Arctic Front Advance, Medtronic, Mounds View, MN). QoL was evaluated at baseline and at 6 and 12 months by using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Quality of Life-5 Dimensions questionnaires. A review of AF-associated symptoms was conducted at baseline and at 1, 3, 6, and 12 months. In total, 203 subjects received either CBA (n = 104 [51.2%]) or AAD therapy (n = 99 [48.8%]). Improvements in the AFEQT summary and subscale scores were significantly larger with CBA than with AAD therapy at 6 and 12 months (P < .02 for all). Clinically meaningful improvement (>5 points) in the AFEQT summary score from baseline to 12 months was observed in 96.0% (100) of patients in the CBA arm vs 72.2% (71) of patients in the AAD arm (P < .001). No significant between-group differences were observed in the change in the European Quality of Life-5 Dimensions index or visual analog scale scores. Overall, 54.4% (57) of the CBA group vs 29.7% (29) of the AAD group reported no AF-specific symptom recurrence after a 90-day blanking period (P = .0005). First-line CBA vs AAD therapy is associated with larger improvements in AF-specific QoL and a higher rate of symptom resolution.

Short-term health-related quality of life in patients with ischaemic stroke after PFO closure

Abstract Funding Acknowledgements Type of funding sources: None. Introduction/Purpose: Patent foramen ovale (PFO) is common in asymptomatic adults and is associated with cryptogenic stroke (CS). We sought to evaluate the impact of PFO closure in health-related quality of life (HRQoL) in PFO patients with CS. Method In this pilot study, 19 patients (mean age 47 ± 7.7; 13 male) who underwent PFO closure at our center were invited to a short-term clinical follow up (mean follow-up period 6-10 months). All patients had suffered an ischaemic stroke and their disability level was assessed using the Modified Rankin Scale (MRS, no significant disability 63%). HRQoL was assessed using the 36-Item Short Form Survey (SF-36) and the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) preoperatively and at follow-up. Results Both SF36 and EQ-5D scores improved after the operation as shown by the self-rating scores (20,67% and 40,52% higher scores, respectively). Patients with major mobility problems were more likely to be current smokers (r = 0.481) and those who had lower scores on the MRS scale (r=-0.571) rated higher their scale diagram. The categories of energy/fatigue (r = 0.459; p = 0.048), social functioning (r = 0.547; p = 0.015) and pain (r = 0.550; p = 0.015) were positively correlated with physical function. Finally, there was a positive correlation between role limitations due to emotional problems and energy/fatigue (r = 0,519; p = 0.023), and between energy/fatigue and emotional well-being (r = 0.519; p = 0,023). Conclusions The results of our study indicate that shortly after PFO, subjects perceive improvements in their QoL. However, it seems that poorly rated physical function was more common in active smokers, and affects patients" social life and their emotional state. Health care professionals should encourage these patients to participate in rehabilitation and psychological support programs postoperatively.

Long-term health-related quality of life in patients treated with subcutaneous C1-inhibitor replacement therapy for the prevention of hereditary angioedema attacks: findings from the COMPACT open-label extension study

BackgroundLong-term prophylaxis with subcutaneous C1-inhibitor (C1-INH[SC]; HAEGARDA, CSL Behring) in patients with hereditary angioedema (HAE) due to C1-INH deficiency (C1-INH-HAE) was evaluated in an open-label extension follow-up study to the international, double-blind, placebo-controlled COMPACT study. The current analysis evaluated patient-reported health-related quality of life (HRQoL) data from 126 patients in the open-label extension study randomized to treatment with C1-INH(SC) 40 IU/kg (n = 63) or 60 IU/kg (n = 63) twice weekly for 52 weeks. HRQoL was evaluated at the beginning of the open-label study and at various time points using the European Quality of Life-5 Dimensions Questionnaire (EQ-5D), the Hospital Anxiety and Depression Scale (HADS), the Work Productivity and Activity Impairment Questionnaire (WPAI), and the Treatment Satisfaction Questionnaire for Medication. The disease-specific Angioedema Quality of Life Questionnaire (AE-QoL) and HAE quality of life questionnaire (HAE-QoL) instruments were administered in a subset of patients. Statistical significance was determined by change-from-baseline 95% confidence intervals (CIs) excluding zero. No adjustment for multiplicity was done.ResultsMean baseline EQ-5D scores (Health State Value, 0.90; Visual Analog Scale, 81.32) were slightly higher (better) than United States population norms (0.825, 80.0, respectively) and mean HADS anxiety (5.48) and depression (2.88) scores were within “normal” range (0–7). Yet, patients using C1-INH(SC) 60 IU/kg demonstrated significant improvement from baseline to end-of-study on the EQ-5D Health State Value (mean change [95% CI], 0.07 [0.01, 0.12] and Visual Analog Scale (7.45 [3.29, 11.62]). In the C1-INH(SC) 60 IU/kg group, there were significant improvements in the HADS anxiety scale (mean change [95% CI], − 1.23 [− 2.08, − 0.38]), HADS depression scale (− 0.95 [− 1.57, − 0.34]), and WPAI-assessed presenteeism (mean change [95% CI], − 23.33% [− 34.86, − 11.81]), work productivity loss (− 26.68% [− 39.92, − 13.44]), and activity impairment (− 16.14% [− 26.36, − 5.91]). Clinically important improvements were achieved in ≥ 25% of patients for all domains except WPAI-assessed absenteeism (which was very low at baseline). Mean AE-QoL total score by visit ranged from 13.39 to 17.89 (scale 0–100; lower scores = less impairment). Mean HAE-QoL global scores at each visit (115.7–122.3) were close to the maximum (best) possible score of 135.ConclusionsLong-term C1-INH(SC) replacement therapy in patients with C1-INH-HAE leads to significant and sustained improvements in multiple measures of HRQoL.Trial registration A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema, NCT02316353. Registered December 12, 2014, https://clinicaltrials.gov/ct2/show/NCT02316353.

Reliability and validity of the Chinese version of Narcolepsy Severity Scale in adult patients with narcolepsy type 1

ObjectiveTo evaluate reliability and validity of the Chinese version of Narcolepsy Severity Scale (NSS) in adult patients with narcolepsy type 1 (NT1). MethodsOne hundred and fifty-one adult patients (≥18 years) with NT1 were recruited. All filled out the 15-item Chinese version of NSS. Item analysis included critical ratio and correlation analysis. The validity of NSS was assessed by exploratory factor analysis, discriminant validity and convergent validity. Reliability of NSS was assessed by Cronbach's α coefficient, spilt-half reliability and test-retest reliability. ResultsCritical value of all 15 items ranged from 3.01 to 13.36. Each item was significantly correlated with the total score by a correlation coefficient (r) ranging from 0.219 to 0.700. Three common domains were extracted and 15 items explained 54.86% of the total variance. There was a shift in domains compared to the English version likely due to cultural differences. Cronbach's α coefficient for the total scale of 15 items was 0.821 and for three factors was 0.726, 0.748 and 0.760 respectively. The NSS had good correlation with Epworth sleepiness scale scores, Insomnia severity index scores and moderate correlation with mean the sleep latency of polysomnographic recording, and European Quality of Life-5 Dimensions Questionnaire. The Chinese version of NSS showed good spilt-half reliability and test-retest reliability. ConclusionThe Chinese version of NSS shows satisfactory psychometric properties with good validity and reliability. It is applicable to evaluate the severity and consequences of symptoms in Chinese adult patients with NT1.

Impact of overweight and obesity on patient-reported health-related quality of life in systemic lupus erythematosus.

ObjectivesAssociations between BMI and health-related quality of life (HRQoL) in SLE have been implied, but data are scarce. We determined the impact of overweight and obesity on HRQoL in a large SLE population.MethodsWe pooled cross-sectional baseline data from the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials (N = 1684). HRQoL was evaluated using the 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale and the European Quality of Life 5-dimension questionnaire (EQ-5D). Comparisons between BMI groups were conducted using the Mann–Whitney U test and adjustments using linear regression. Clinical relevance was determined by minimal clinically important differences (MCIDs).ResultsIn total, 43.2% of the patients had BMI above normal and 17.4% were obese. Overweight and obese patients reported worse SF-36 physical component summary (PCS), physical functioning, role physical, bodily pain and FACIT-Fatigue scores than normal weight patients. Divergences were greater than corresponding MCIDs and more prominent with increasing BMI. Despite no clinically important difference in SF-36 mental component summary scores across BMI categories, patients experienced progressively diminished vitality and social functioning with increasing BMI. In linear regression analysis, BMI above normal and obesity were associated with worse PCS (standardized coefficient β = −0.10, P < 0.001 and β = −0.17, P < 0.001, respectively), FACIT-Fatigue (β = −0.11, P < 0.001 and β = −0.16, P < 0.001) and EQ-5D (β = −0.08, P = 0.001 and β = −0.12, P < 0.001) scores, independently of demographic and disease-related factors. The impact of BMI on the PCS and FACIT-Fatigue was more pronounced than that of SLE activity.ConclusionPatients with SLE and BMI above normal experienced clinically important HRQoL diminutions in physical aspects, fatigue and social functioning. A survey of potential causality underlying this association is warranted.

Cognitive function and health-related quality of life 1 year after acute brain injury: An observational study.

Cognitive impairment and reduced health-related quality of life (HRQoL) are well-established sequelae of critical illness. Studies on survivors of critical illness have found delirium to be a predictor of these conditions, but evidence regarding survivors of acute brain injury is sparse. We aimed to explore if delirium duration was associated with 1-year cognitive impairment and reduced HRQoL in patients with acute brain injury. Intensive care unit (ICU) delirium was assessed using the Intensive Care Delirium Screening Checklist. Cognitive status was assessed using the Repeatable Battery for Neuropsychological Status (RBANS) and HRQoL using the European Quality of Life 5-dimension questionnaire (EQ-5D). We used a multiple linear regression for testing the association of delirium duration with cognitive impairment and quality of life, respectively. Forty-seven survivors of acute brain injury participated in follow-up and 35 completed RBANS. Delirium was present in 39 of 47 (83%) with a median duration of 4days. Delirium duration did not predict cognitive impairment (95% CI -4.1 to 0.5) or lower HRQoL (95% CI -1.4 to 2.7). Moderate-to-severe cognitive impairment was present in 17 of 35 (49%) participants, and they had a mean EQ-5D health visual analogue scale of 70.9 vs 81.6 for the Danish age-matched norm. Our sample did not demonstrate an association between delirium and 1-year cognitive impairment or reduced HRQoL. Still, a large proportion of the participants were cognitively impaired, and their quality of life was lower compared to norm. Larger studies are necessary to explore these associations further.

Health-related quality of life and sleep quality among North Indian type 2 diabetes mellitus patients: evidence from a cross-sectional study

ObjectiveThe objective of this study is to measure the relationship between sleep quality and health-related quality of life (HRQOL), in Indian population with type 2 diabetes mellitus (T2DM). MethodsA cross-sectional study, included a total of 300 patients with T2DM. All participants were responding to the Pittsburgh Sleep Quality Index (PSQI) and European Quality of Life-5 Dimensions Questionnaire (EQ-5D). A PSQI global score ≥5 was defined as poor sleep quality. EQ-5D visual analogue scale (VAS), determining the overall health status. Logistic regression analysis was used to examine the association between PSQI and EQ-5D. All the study data were analysed using the SPSS software version 20.0. Values of p < 0.05 were considered statistically significant. ResultsThe mean age of included participants were 55.29. Majority of the participants (55.3%) were identified as “poor sleepers” and female (31.3%) contributing higher proportion. Poor sleepers had significantly lower the HRQoL (p < 0.001). After adjustment, poor sleep quality was significantly associated with a lower HRQoL; EQ-5D index (OR = 1.080, 95%, CI: 1.015–1.148, p < 0.05), and EQ-5D VAS (OR = 1.092, 95%, CI: 1.021–1.176, p < 0.01). Overall, the EQ-5D index and EQ-5D VAS were found to be an independent predictors of sleep quality. ConclusionsPoor sleep quality is prevalent in Indian T2DM population, and it imparts negative impact on several dimensions of EQ-5D that characterising the daily activities performance. Therefore, further real-world studies are needed to determine the causal relationship between T2DM patients and measure of objective sleep and their impact on health.

Quality of life among patients with left ventricular assist device: Comparison of two populations.

This study aims to evaluate quality of life among patients with an implanted left ventricular assist device in two different populations. This cross-sectional study included a total of 20 patients (15 males, 5 females; mean age 41.8±13.4 years; range, 20 to 65 years) from Turkey and 40 patients (33 males, 7 females; mean age 55.1±11.6 years; range, 21 to 76 years) from Germany who underwent left ventricular assist device implantation and reached their third month of treatment between January 2016 and August 2016. The Euro Quality of Life-5 Dimension Questionnaire and Kansas City Cardiomyopathy Questionnaire-12 were used to assess quality of life of both groups. Sixty-five percent of the German patients returned to work, while none of the Turkish patients returned after implantation (p=0.000). The Turkish (70%) and German (40%) patients reported that they had difficulty in living with a left ventricular assist device (p=0.028). The mean Euro Quality of Life-5 Dimension Questionnaire visual analog scale scores of the Turkish and German patients were 70.50% and 62.38%, respectively. The mean Kansas City Cardiomyopathy Questionnaire-12 scores of the Turkish patients were significantly higher than those of the German patients (p=0.01). Left ventricular assist device implantation improved the quality of life of both Turkish and German patients. Turkish patients with left ventricular assist device should be encouraged to adopt a more independent life, not to limit their lives to home and to return to work according to their functional capacity.