SF-36 Domains Research Articles

Clinical meaningfulness of a British Isles Lupus Assessment Group-based Composite Lupus Assessment response in terms of patient-reported outcomes in moderate to severe systemic lupus erythematosus: a post-hoc analysis of the phase 3 TULIP-1 and TULIP-2 trials of anifrolumab

The British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) is a validated global measure of treatment response in systemic lupus erythematosus (SLE) clinical trials but does not include patient-reported outcomes. To evaluate the clinical meaningfulness of a BICLA response from the patient perspective, we aimed to analyse patient-reported outcomes by BICLA responses with anifrolumab or placebo in patients with moderate to severe SLE. We did a post-hoc analysis of pooled data from the phase 3 TULIP-1 (NCT02446912) and TULIP-2 (NCT02446899) trials of anifrolumab, which assessed health-related quality of life using the Short Form 36 Health Survey (SF-36; version 2) and Lupus Quality of Life, fatigue using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), pain using the Numerical Rating Scale, and disease activity using Patient Global Assessment. Changes from baseline and proportions of patients reporting improvements in patient-reported outcomes greater than or equal to the minimum clinically important differences and scores greater than or equal to the normative values were compared in BICLA responders and non-responders and by treatment group (intravenous anifrolumab 300 mg or placebo). 726 patients were included in the TULIP trials, of whom 366 received placebo (184 patients in TULIP-1 and 182 in TULIP-2) and 360 received anifrolumab 300 mg (180 patients in each trial). The mean patient age was 41·8 years (SD 11·9). 674 (93%) patients were female, 52 (7%) were male, and 479 (66%) were White; 283 (39%) were BICLA responders and 443 (61%) were BICLA non-responders. Compared with non-responders, BICLA responders reported greater mean improvements from baseline at week 52 in Patient Global Assessment, SF-36, Lupus Quality of Life, FACIT-F, and pain Numerical Rating Scale scores (all nominal p<0·0053). Compared with non-responders, a greater proportion of BICLA responders reported improvements greater than or equal to the minimum clinically important difference across all SF-36 domains; eg, Physical Component Summary (165 [60%] of 277 for responders vs 63 [15%] of 416 for non-responders), Mental Component Summary (140 [51%] of 276 vs 59 [15%] of 416), and role physical (184 [70%] of 264 vs 76 [19%] of 398); Lupus Quality of Life domains; eg, physical health (151 [58%] of 262 vs 60 [15%] of 396), and intimate relationships (77 [41%] of 187 vs 33 [11%] of 286), and FACIT-F (155 [56%] of 276 vs 66 [15%] of 439). Similarly, a greater proportion of BICLA responders had scores equal to or greater than the normative values across all SF-36 domains and FACIT-F compared with BICLA non-responders at week 52. Patients who received anifrolumab reported greater numerical improvements in Patient Global Assessment, SF-36, Lupus Quality of Life, FACIT-F, and pain Numerical Rating Scale scores than those who received placebo. BICLA responders reported significant and clinically meaningful improvements in Patient Global Assessment, health-related quality of life, fatigue, and pain compared with BICLA non-responders. More patients with moderate to severe SLE who received anifrolumab were BICLA responders and had improved health-related quality of life, fatigue, and pain than those who received placebo. AstraZeneca.

Quality of life and stress in mothers of preterm infant with feeding problems: A cross sectional study

BackgroundThe majority of preterm infants experience some oral feeding problems. The outcomes of preterm infants with feeding problems are not predictable. This study was conducted to determine the quality of life and stress among mothers of preterm infants with feeding problems. Materials and methodsParticipants consisted of mothers with preterm infants. The instruments used to measure infants' feedings, mothers' stress and quality of life, and mothers' and infants’ characteristics included: Infants Feeding Readiness Assessment Scale (POFRAS), Parental Stress Scale: Neonate Intensive Care Unit (PSS - NICU), quality of life questionnaire (SF-36), and a socio-demographic questionnaire. ResultsThere was no correlation between the subscales of the PSS - NICU and the POFRAS or between domains of SF-36 and POFRAS. There was no significant association between general physical health and stress. However, general mental health and overall quality of life of mothers were inversely correlated with all PSS-NICU subscales. ConclusionMost maternal stress was related to the infants' appearance and behaviors. The mental health dimension was affected more than the physical health dimension of quality of life. Health care professionals should teach mothers of premature infants about the NICU environment, parental role, and their infants’ appearance and behaviors.

Patient-reported outcomes, health-related quality of life, and acute medication use in patients with a\u2009\u2265\u200975% response to eptinezumab: subgroup pooled analysis of the PROMISE trials

BackgroundPROMISE-1 and PROMISE-2 evaluated the preventive efficacy, tolerability, and safety of eptinezumab, a calcitonin gene-related peptide–targeted monoclonal antibody, in adults with episodic (EM) and chronic migraine (CM), finding significant reductions in migraine frequency. This post hoc analysis compared patient-reported outcomes (PROs), health-related quality of life (HRQoL) and acute medication use in patients with a ≥ 75% migraine responder rate (MRR) after treatment with eptinezumab to patients with a ≥ 50– < 75% MRR.MethodsPROMISE-1 and PROMISE-2 were phase 3, randomized, double-blind, placebo-controlled studies. This analysis included patients from both studies treated with eptinezumab 100 mg or 300 mg who experienced ≥ 75% and ≥ 50–< 75% MRR over Weeks 1–12 (wks1–12). In both studies, HRQoL was measured by the 36-item Short-Form Health Survey (SF-36) and acute medication usage. PROMISE-2 also included the 6-item Headache Impact Test (HIT-6), patient-identified most bothersome symptom (PI-MBS), and Patient Global Impression of Change (PGIC).ResultsIn PROMISE-1, a total of 115/443 (26.0%; 100 mg, n = 49, 300 mg, n = 66) and 120/443 (27.0%; 100 mg, n = 61, 300 mg, n = 59) eptinezumab-treated patients achieved ≥ 75% and ≥ 50–< 75% MRR over wks1–12, respectively. In PROMISE-2, a total of 211/706 (30.0%; 100 mg, n = 95; 300 mg, n = 116) and 209/706 (29.6%; 100 mg, n = 110, 300 mg, n = 99) eptinezumab-treated patients achieved ≥ 75% and ≥ 50–< 75% MRR over wks1–12, respectively. EM and CM patients with ≥ 75% and ≥ 50–< 75% MRR over wks1–12 showed reduced use of acute headache medication and increased HRQoL to normative levels across SF-36 domains of bodily pain, social functioning, and physical functioning. In CM patients with ≥ 75% and ≥ 50–< 75% MRR over wks1–12, the mean change in HIT-6 total score with eptinezumab (pooled) was − 11.7 and − 7.6, respectively. “Very much” or “much” improvement responses were reported in 41.8% and 16.5% on PI-MBS and 36.2% and 20.0% on PGIC in ≥ 75% and ≥ 50–< 75% MRR, respectively.ConclusionEptinezumab treatment induced a ≥ 75% MRR over wks1–12 in the majority of patients. This patient subgroup reported substantial improvements in PROs associated with headache-related life impact and HRQoL, and reductions in acute headache medication use, which were more marked than those in the ≥ 50–< 75% responders. This study supports the clinical meaningfulness of ≥ 75% MRR for patients with either EM or CM.Trial registrationClinicalTrials.gov identifiers: NCT02559895 (PROMISE-1), NCT02974153 (PROMISE-2).

Validation and Psychometric Properties of the Minnesota Living With Heart Failure Questionnaire in Individuals With Coronary Artery Disease in Lithuania.

BackgroundHealth-related quality of life (HRQoL) is known to be impaired in individuals with coronary artery disease (CAD), especially in those after a recent acute coronary syndrome (ACS). Heart failure (HF) is a common burden in this population that significantly contributes to worsening HRQoL. To accurately measure the level of HRQoL in individuals with CAD after ACS, disease-specific scales, such as the Minnesota living with heart failure questionnaire (MLHFQ), are recommended. Nevertheless, to date, there has not been a study that would comprehensively evaluate the psychometric properties of the MLHFQ in a large sample of individuals with CAD after ACS. The debate regarding the internal structure of MLHFQ is also still present. Hence, this study aimed to translate the MLHFQ and evaluate its internal structure, reliability/precision, and validity in individuals with CAD following ACS in Lithuania.MethodsIn the cross-sectional study, 1,083 participants (70% men, age M = 58, SD = 9) were evaluated for sociodemographic and clinical characteristics. HRQoL was measured using the MLHFQ and the Short Form-36 health survey (SF-36). In addition, exercise capacity (EC) was also evaluated in the study patients, using a standardized computer-driven bicycle ergometer.ResultsThe internal consistency of the MLHFQ subscales (0.79−0.88) was found to be good. Confirmatory factor analysis (CFA) provided the support for the three-factor model (“physical domain,” “social domain,” and “emotional domain”) of the MLHFQ and showed acceptable fit [comparative fit indices (CFI) = 0.894; goodness-of-fit (GFI) = 0.898; non-normal fit index (NFI) = 0.879, and root mean square error of approximation (RMSEA) = 0.073]. Regarding convergent evidence, significant associations were found between the MLHFQ domains and the SF-36 domains and EC (r’s range 0.11−0.58).ConclusionThe current study completed cultural validation and provided further information on the psychometric characteristics of the MLHFQ in Lithuania, suggesting MLHFQ as a valid and reliable instrument to measure HRQoL. The Lithuanian version of MLHFQ is best described by a three-factor solution, measuring physical, social, and emotional dimensions of HRQoL among individuals with CAD following ACS.

Clinical Trial Evaluating Quality of Life in Patients with Intra-Oral Halitosis.

Halitosis is considered to be extremely unattractive in the context of social interactions. The main research objective of this study was to evaluate whether intra-oral halitosis may impact patients’ quality of life (QOL). One hundred generally healthy adult participants complaining about oral malodor and diagnosed with intra-oral halitosis were enrolled in this study. For halitosis diagnosis, a gas chromatography (GC) analysis by the Oral Chroma portable device was used. QOL assessment was based on the Short Form 36-item Health Survey (SF-36). The respondents had the highest scores in the physical functioning (PF), activity limitations caused by emotional problems (RE) and activity limitations caused by physical problems (RP) domains, and the weakest in the general health perception (GH), vitality (VT) and emotional wellbeing (MH) ones. The total volatile sulfur compounds (VSCs) level was negatively correlated with SF-36 domains. The SF-36 domains’ scores decreased the higher the level of VSC was. The respondents assessed their QOL to be at its best in physical functioning and activity limitations caused by emotional and physical problems and the worst in general health perception, vitality and emotional wellbeing. The strongest correlation between halitosis and decreased QOL was found in the social functioning (SF), vitality, emotional wellbeing and general health perception domains.

Simplified Chinese Version of the Back Pain Function Scale (BPFS) for Patients with Low Back Pain: Cross-Cultural Adaptation and Validation.

A cross-sectional study. To translate and cross-culturally adapt back pain function scale (BPFS) into a simplified Chinese version (SC-BPFS), and evaluate the reliability and validity of SC-BPFS in patients with low back pain. The BPFS is a reliable and valid evaluation instrument for low back pain. However, simplified Chinese version of BPFS has not been validated. Cross-cultural adaptation was performed according to the internationally recognized guidelines of the American Academy of Orthopaedic Surgeons Outcome Committee. One-hundred and sixty-two participants with low back pain (LBP) were included in this study. Reliability was tested based on test-retest reliability and internal consistency. We calculated Cronbach alpha and intra-class correlation coefficient (ICC). Construct validity was analyzed by evaluating the correlations between SC-BPFS and the Oswestry disability index (ODI), the visual analogue scale (VAS), and the short form (36) health survey (SF-36). The original version of the BPFS was cross-culturally well adapted and translated into simplified Chinese. Each item of the SC-BPFS was properly responded and correlated with the total items. SC-BPFS had good reliability (Cronbach alpha = 0.847, intra-class correlation coefficient [ICC] = 0.891, 95% confidence interval [CI] 0.864-0.914). Elimination of any one item in all did not result in a value of Cronbach alpha of <0.80. SC-BPFS had a high correlation with ODI (0.712, P < 0.01) and a moderate correlation with VAS (0.484, P < 0.01). And it was also fairly to very well correlated with physical domains of SF-36 (0.334-0.632, P < 0.01), and not correlated with mental domains of SF-36 (0.022-0.119, P > 0.05). SC-BPFS demonstrated outstanding acceptability, internal consistency, reliability, and construct validity, and could be recommended for patients with LBP in Mainland China.Level of Evidence: 3.

Pulmonary function and Quality of Life in a prospective cohort of (non-) hospitalized COVID-19 pneumonia survivors up to six months.

A decrease of both diffusion capacity (DLCO) and Quality of Life (QoL) was reported after discharge in hospitalized COVID-19 pneumonia survivors. We studied three and 6month outcomes in hospitalized and non-hospitalized patients. COVID-19 pneumonia survivors (n = 317) were categorized into non-hospitalized "moderate" cases (n = 59), hospitalized "severe" cases (n = 180) and ICU-admitted "critical" cases (n = 39). We studied DLCO and QoL (Short Form SF-36 health survey) 3 and 6months after discharge. Data were analyzed using (repeated measures) ANOVA, Kruskal-Wallis or Chi-square test (p < .05). At 3months DLCO was decreased in 44% of moderate-, 56% of severe- and 82% of critical cases (p < .003). Mean DLCO in critical cases (64±14%) was lower compared to severe (76 ± 17%) and moderate (81±15%) cases (p < .001). A total of 159/278 patients had a decreased DLCO (<80%), of whom the DLCO improved after 6months in 45% (71/159). However the DLCO did not normalize in the majority (89%) of the cases (63 ± 10% vs 68±10%; p < .001). At 3months, compared to critical cases, moderate cases scored lower on SF-36 domain "general health" (p < .05); both moderate and severe cases scored lower on the domain of "health change" (p < .05). At 6months, there were no differences in SF-36 between the subgroups. Compared to 3months, in all groups "physical functioning" improved; in contrast all groups scored significantly lower on "non-physical" SF-36 domains. Three months after COVID-19 pneumonia, DLCO was still decreased in the more severely affected patients, with an incomplete recovery after 6months. At 3months QoL was impaired. At 6months, while "physical functioning" improved, a decrease in "non-physical" QoL was observed but did not differ between the moderate and severely affected patients.

Psychiatric Morbidity in Migraine and its Impact on Quality of Life: A Hospital-based Cross-sectional Study

Introduction: Migraine is a disabling headache disorder. Many psychiatric disorders co-exist with migrainous headache which largely remain undiagnosed leading to greater risk of morbidity and significantly impacts quality of life. Migraine patients are particularly at risk for mood and anxiety disorders which negatively impact the prognosis and poor headache outcome. Hence, defining the exact nature of underlying psychiatric conditions in migraine are relevant issues in the clinical practice. Aim: To find the association of psychiatric morbidity and quality of life in migrainous (with and without aura) and non-migrainous subjects and to assess the correlation between severity of migraine and quality of life. Materials and Methods: It was a hospital based cross-sectional study conducted amongst the patients and their healthy attendants visiting the Psychiatry OPD of Rajindra Hospital, Patiala from May 2018 to April 2019, after obtaining ethical clearance. A total of 392 subjects of both gender and in the age group 18-65 years, who gave informed consent were enrolled. Group 1 (n=196) consisted of cases i.e., migrainous patients as per International Classification of Headache Disorders 3rd Edition, β version (ICHD-3) criteria and Group 2 (n=196) consisted non-migrainous controls. Psychiatric morbidity was assessed using Mini International Neuropsychiatric Interview (MINI) and confirmed on International Classification of Diseases 10th edition (ICD-10). Severity of migraine was assessed on Migraine Disability Assessment Test (MIDAS) and its impact on quality of life (QOL) by using 36 Item Short Form questionnaire (SF-36 questionnaire). Variables were compared using the independent t-test and chi-square test. Pearson correlation was used to study the relationship between severity of migraine with QOL in subjects with and without psychiatric morbidity. Results: Psychiatric morbidity was found among 65.3% (n=128) and 19.9% (n=39) subject in Group 1 and Group 2, respectively. Major Depressive Disorder (37.2%, n=73) was the most common psychiatric morbidity, followed by Generalized Anxiety Disorder (8.7%, n=17), Manic episode and Panic disorder each (5.1%, n=10), Hypomanic episode &amp; Obsessive Compulsive Disorder each (3.1%, n=6), Dysthymia (2%, n=4) and Post Traumatic Stress disorder (1%, n=2). Between groups, the association of migraine with Major Depressive Disorder (p≤0.001), General Anxiety Disorder (GAD) (p=0.024), Manic episode (p=0.005), Hypomanic episode (p=0.048) was statistically significant but more in migrainous patients than non-migrainous subjects. Migrainous patients had lower QOL in physical and psychological health domains of SF-36 than in non-migrainous subjects. Furthermore, migrainous patients with or without psychiatric morbidity had significantly negative correlation in all domains of SF-36. Conclusion: Psychiatric morbidity was significantly higher in migrainous patients than non-migrainous subjects with poor quality of life in migrainous patients causing significant disability with an increase in severity of migraine.

Health-related quality of life and associated factors in people with diabetes at high risk of foot ulceration

BackgroundThe health-related quality of life (HRQoL) of people with diabetes-related foot complications has been increasingly reported, mostly from studies of people with a foot ulcer. The aim of this study was to assess HRQoL and determine factors associated with HRQoL in people with diabetes at high risk of foot ulceration.MethodsIn all, 304 participants enrolled in the Diabetic Foot Temperature Trial (DIATEMP) were included in the cross-sectional analysis. HRQoL was measured by the RAND® 36-Item Short Form Health Survey (SF-36) at baseline. Potential factors associated with HRQoL were analysed using multiple linear regression analyses for the eight domains of the SF-36.ResultsParticipants were predominantly male (72%), mean age 64.6 (±10.5) years, 77% type 2 diabetes and mean duration of diabetes 20 (±14) years. Mean SF-36 domain scores for the General Health (49.2 ± 20.1), Role Physical (50.9 ± 44.7), Physical Function (58.5 ± 27.9) and Vitality domains (59.8 ± 21.6) were lower compared to the Mental Health (78.4 ± 18.0), Social Functioning (75.3 ± 24.2), Role Emotional (73.5 ± 38.9) and Bodily Pain (67.0 ± 27.0) domains. HRQoL was lower than Dutch population-based and general diabetes samples, but higher than in samples with an ulcer. Use of a walking aid was associated with lower HRQoL across all 8 SF-36 domains (β range − 0.20 to − 0.50), non-Caucasian descent was associated with lower HRQoL in 5 domains (β range − 0.13 to − 0.17). Not working, higher BMI and younger age were associated with lower HRQoL in 3 domains.ConclusionsPeople at high risk of diabetes-related foot ulceration have reduced HRQoL that varies across domains, with the physical domains most affected. Assessing mobility, ethnicity, BMI and job status may be useful in daily practice to screen for people who might benefit from interventions targeting HRQoL.Trial registrationNetherlands Trial Registration: NTR5403. Registered on 8 September 2015.

Patient-reported outcomes of upadacitinib versus abatacept in patients with rheumatoid arthritis and an inadequate response to biologic disease-modifying antirheumatic drugs: 12- and 24-week results of a phase 3 trial

BackgroundIn previous clinical trials, patients with active rheumatoid arthritis (RA) treated with upadacitinib (UPA) have improved patient-reported outcomes (PROs). This post hoc analysis of SELECT-CHOICE, a phase 3 clinical trial, evaluated the impact of UPA vs abatacept (ABA) with background conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on PROs in patients with RA with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARD-IR).MethodsPatients in SELECT-CHOICE received UPA (oral 15 mg/day) or ABA (intravenous). PROs evaluated included Patient Global Assessment of Disease Activity (PtGA) by visual analog scale (VAS), patient’s assessment of pain by VAS, Health Assessment Questionnaire Disability Index (HAQ-DI), morning stiffness duration and severity, 36-Item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Impairment (WPAI), and EQ-5D 5-Level (EQ-5D-5L) index score. Least squares mean (LSM) changes from baseline to weeks 12 and 24 were based on an analysis of covariance model. Proportions of patients reporting improvements ≥ minimal clinically important differences (MCID) were compared using chi-square tests.ResultsData from 612 patients were analyzed (UPA, n=303; ABA, n=309). Mean age was 56 years and mean disease duration was 12 years. One-third received ≥2 prior bDMARDs and 72% received concomitant methotrexate at baseline. At week 12, UPA- vs ABA-treated patients had significantly greater improvements in PtGA, pain, HAQ-DI, morning stiffness severity, EQ-5D-5L, 2/4 WPAI domains, and 3/8 SF-36 domains and Physical Component Summary (PCS) scores (P<0.05); significant differences persisted at week 24 for HAQ-DI, morning stiffness severity, SF-36 PCS and bodily pain domain, and WPAI activity impairment domain. At week 12, significantly more UPA- vs ABA-treated patients reported improvements ≥MCID in HAQ-DI (74% vs 64%) and SF-36 PCS (79% vs 66%) and 4/8 domain scores (P<0.05).ConclusionsAt week 12, UPA vs ABA treatment elicited greater improvements in key domains of physical functioning, pain, and general health and earlier improvements in HAQ-DI. Overall, more UPA- vs ABA-treated patients achieved ≥MCID in most PROs at all timepoints; however, not all differences were statistically significant. These data, however, highlight the faster response to UPA treatment.Trial registrationNCT03086343, March 22, 2017.

Health-related quality of life in patients with long-standing ulcerative colitis in remission.

Introduction:Ulcerative colitis (UC) contributes to impaired health-related quality of life (HRQoL). Although disease activity is the most important factor, reduced HRQoL has been reported even in quiescent UC. We aimed to determine HRQoL, and identify predictors thereof, in patients with long-standing UC in remission.Methods:In total, 66 patients with inactive UC were included 10 years after the disease onset. Clinical assessment including rigid sigmoidoscopy was performed to ensure remission. Data on demographic, clinical, treatment-related, and psychological determinants of HRQoL were obtained with a structured interview and self-assessment questionnaires measuring gastrointestinal (GI) and psychological symptoms and fatigue. HRQoL was measured with the Short Form Health Survey (SF-36).Results:The SF-36 domains were comparable to the general Swedish population, except for Vitality, where UC patients scored lower. Gender, smoking, comorbidity, or disease phenotype had no impact on HRQoL. In contrast, corticosteroid use and sick leave during the previous year were independently associated with Physical Functioning and Bodily Pain domains of SF-36; persisting GI symptoms during remission with Bodily Pain; and fatigue with Role Physical, General Health and Vitality. For all other SF-36 domains reflecting mental HRQoL (Social Function, Role Emotional, Mental Health), only psychological distress contributed uniquely.Conclusions:Although overall HRQoL in long-standing UC in remission is comparable to the general population, previous disease activity as well as persisting GI symptoms, fatigue, and psychological distress are associated with a lower HRQoL among these patients. Improved HRQoL may allow for better UC patient health and reduced costs for health care.

The Influence of the Inflammatory Bowel Diseases on the Perceived Stress and Quality of Life in a Sample of the South-Western Romanian Population.

Background: Inflammatory bowel diseases (IBD) represent a category of chronic diseases of gastrointestinal tract with a long-term evolution which includes flares and periods of remission. The aim of the study is to identify and quantify the relationship between IBD status, perceived stress, coping mechanisms, and patients QOL. Methods: Cross-sectional study on two samples consisting of 70 IBD patients monitored in the Gastroenterology Department of the Emergency Clinical County Hospital Craiova, Romania, respectively 70 healthy volunteers. Collected data include socio-demographic details, personal and familial medical history, clinical status, presumed risk factors, perceived stress (Perceived Stress Scale-PSS), coping strategies (COPE questionnaire) and Health-Related Quality of Life (HRQOL-SF-36 scale). Results: Perceived stress was considerably higher on IBD subjects (p<0.0001). The assessment of HRQOL has shown that patients had the best perception over their physical and emotional domains of SF-36 (p<0.0001), while the most often coping mechanisms used are those from the problem-focused category. Conclusions: There is a significant relationship between increased activity of IBD and higher level of stress, that led to the development of problem-focused coping strategies. We did not find a strong correlation between lower HRQOL levels and the items considered as potential risk factors.

Validation of the Individualized Neuromuscular Quality of Life Questionnaire in Korean Patients With Genetic Neuromuscular Diseases.

Background and PurposeThe Individualized Neuromuscular Quality of Life questionnaire (INQoL) is a widely used measure of the quality of life in patients with neuromuscular diseases. The purpose of this study was to translate and validate the Korean version of INQoL in Korean patients with neuromuscular diseases.MethodsWe translated the original INQoL version into Korean while applying appropriate language adaptations. The internal consistency, known-group validity, and test-retest reliability were also assessed. Construct validity was measured using the modified Rankin Scale (mRS) score and the manual muscle testing (MMT)-sum score based on the Medical Research Council scale, and concurrent validity was measured using the 36-item Short Form Survey (SF-36) questionnaire.ResultsThis study enrolled 193 patients. The coefficients for internal consistency (Cronbach’s α=0.805 to 0.987) and test-retest reliability (Spearman’s ρ=0.453 to 0.886) were adequately high for all subscales except in the ‘treatment effects’ dimension. INQoL subscales other than those for locking, droopy eyelids, double vision, and swallowing difficulties were significantly associated with their relevant SF-36 domains (Spearman’s ρ=-0.274 to -0.833). Functional status and muscle strength were most strongly associated with independence (Spearman’s ρ=0.753 and p<0.001 for mRS score, Spearman’s ρ=-0.741 and p<0.001 for MMT-sum score).ConclusionsThe Korean INQoL is a reliable and validated measurement tool for Korean patients with neuromuscular diseases.

Transcutaneous electrical stimulation therapy and genetic analysis in Dercum's disease: A pilot study.

Dercum's disease (DD), or adiposis dolorosa, is a rare condition of unknown etiology characterized by growth of painful subcutaneous adipose tissue. No specific treatment exists. Pain is often invalidating and resistant to analgesic drugs. We tested the efficacy of Frequency Rhythmic Electrical Modulation System (FREMS) therapy on pain relief. Subcutaneous biopsies were performed for genetic analysis.Nine DD patients were enrolled. Five cycles of FREMS at 3-month intervals during 1 year were administered. Visual analogue scale (VAS), Bartel Index Questionnaire and Short Form 36 questionnaire were used to measure pain and general health status at baseline, 6 and 12 months. Dual-energy X-ray absorptiometry (DEXA) quantified fat mass. Next-Generation Sequencing (NGS) was performed on adipose tissue biopsies and peripheral blood sample to search for somatic variants and specific protein pathway mutation.Seven patients were included in the final analysis. FREMS induced a reduction in VAS score (from 92 to 52.5, P = .0597) and a significant improvement in SF-36 domains (Physical functioning, Role limitation due to physical health, Body pain, Vitality, Social functioning, P < .05). No modification in anthropometrics and DEXA values was observed. The analysis of the mitochondrial Displacement loop (D-loop) region confirmed the clonality of all lipomatous lesions. The presence of the mitochondrially encoded tRNA-Lysine (MT-TK) m.8344A>G variant, occasionally identified in patients with multiple symmetric lipomatosis, was excluded in all subjects. On the other hand, we observed variants in genes belonging to signaling pathways involved in cell cycle and proliferation (Phosphoinositide 3-kinase/AKT/mTOR, MAPK/ERK, and Hippo).FREMS can be a useful tool to alleviate pain and improve overall quality of life in patients with DD. Genetic analysis highlighted the molecular heterogeneity of lipomas.

Quality of Life and Burden of Disease in Italian Patients with Transfusion-Dependent Beta-Thalassemia.

Lifespan treatment in transfusion-dependent β-thalassemia (TDT) is expected to impact quality of life. This study aimed at evaluating health-related quality of life (HRQoL), well-being, and the burden of TDT on Italian patients. Patients (≥14 years) were invited to complete a cross-sectional, online volunteer survey. HRQoL was measured by the 36-item short-form health survey (SF-36) and wellbeing was measured by the Italian version of the Psychological General-Well-Being-Index (PGWBI). A total of 105/167 completed questionnaires were analyzed (46% males; median age 44, (IQR = 11)). Patients reported lower HRQoL compared with the general population in all SF-36 domains (except for emotional well-being (p = 0.7024) and role limitations due to emotional problems (p = 0.1389)). PGWBI domains general health and vitality and the total PGWBI score were all significantly lower (p = 0.0001) compared with the general population. On average, patients spent 16.62 h/month engaged in care activities that were additional to the time required for completing transfusions. Of the 16.62 h/month, 11.7 h/month were required for therapy management and 4.92 h/month for family management. This study found lower HRQoL and well-being in physical and psychological domains compared with the general population. Further, patients were found to have a high perceived burden of disease.

P-P33 Quality of Life Assessment in Patients undergoing Robot Assisted Pancreaticoduodenectomy

Abstract Background Robot-assisted pancreaticoduodenectomy has recently gained attention as there is evidence from high volume centres suggests better outcomes and quick recovery. This study aimed to evaluate the quality of life after robotic-assisted pancreaticoduodenectomy Methods The study included the first 12 consecutive patients who underwent robotic pancreaticoduodenectomy. The RAND SF 36-Item health survey form was used to assess the quality of life through a one-hour face-to-face interview carried out by a junior doctor from a different team with no prior involvement in patient care. The interview was carried out at least three months postoperative period. Each item in the subscale was recorded with a pre-coded numeric value. The comparison was made between preoperative periods' scores defined by the onset of disease symptoms to surgery and the postoperative follow-up score. The SF-36 survey questions were supplemented with additional items such as postoperative pain, emotional wellbeing, and fatigue status. Results Analysis of SF-36 domains showed better quality of life postoperatively than the baseline, as evidenced by the mean physical functioning score from 82.91 to 90 and mean general health score from 37.9 to 69.5 postoperatively. 91.66% of the patients reported that they felt better at the time of study and were happy overall. Conclusions Robotic-assisted pancreaticoduodenectomy shows a better quality of life than in the preoperative period, which can be attained in a brief postoperative period.

One-Anastomosis and Roux-en-Y Gastric Bypass Promote Similar Weight Loss, Patient Satisfaction, Quality of Life, Inflammation Grade, and Cellular Damage in the Esophagus and Gastric Pouch in a Short-term Follow-up.

BackgroundOne-anastomosis gastric bypass (OAGB) is a simpler procedure than Roux-en-Y gastric bypass (RYGB); however, biliary reflux can occur and impair outcomes. This study aimed to compare outcomes of OAGB and RYGB.MethodsTwenty patients with morbid obesity were randomized prospectively into two groups: OAGB (n=10) or RYGB (n=10). Quality of life (36-item short-form health survey [SF-36]), satisfaction (Visick scale), and body mass index (BMI) were evaluated before and 6 months after the operation. All patients underwent esophagogastroduodenoscopy with gastric and esophageal mucosal biopsies at 3 and 6 months after their operation.ResultsThe study found no significant difference in BMI before surgery (OAGB, 43.2 kg/m2; RYGB, 43.1 kg/m2; P=0.90) or at 6 months postoperative (OAGB, 32.1 kg/m2; RYGB, 31.8 kg/m2; P=0.91). There was no significant difference in improvement of quality of life (four SF-36 domains) or satisfaction (P=0.08) between groups at 6 months. There was no statistical difference between gastric (P=0.10) and esophageal (P=0.76) inflammation grade at three or 6 months between the two groups.ConclusionOAGB and RYGB are equally effective in terms of weight loss, patient satisfaction, and quality of life improvement at 6 months after the procedures. Inflammation grade and cellular damage in the gastric pouch and in the esophagus were similar.

Ambulatory and Social Performance Status After Transfemoral Prosthetic Rehabilitation Regarding Age, Gender, and Marital Status

Objectives: This study aims to determine the association of ambulatory and social performance status of transfemoral prosthetic users with their age, gender, and marital status. Methods: A cross-sectional study was conducted on 400 transfemoral prosthesis users. A sample was recruited from both genders aged 10-60 years using the prosthesis for at least one year. They were selected using the non-probability convenience sampling method from the Pakistan Institute of Prosthetic and Orthotic Sciences from July 2019 to December 2019. Lower extremity functional scale and short form-36 health survey questionnaire (SF-36) were used for data collection, followed by statistical analysis. Results: Ambulatory status (as measured by the total lower extremity functional scale) revealed significant association (P&lt;0.001) with age. The highest score belonged to the 10-30 years age group. Also, there was a significant association (P=0.003) with marital status with the highest scores for unmarried ones. However, no significant (P=0.705) gender association was noted though scores were higher for the male gender. As regards, the social performance was measured by SF-36. The findings revealed a significant association (P&lt;0.05) of most domains of SF-36 with age groups, with the highest scores for the age group of 10-30 years. Also, a significant association with the gender with higher scores in females was noted in most domains. In contrast, no significant association with marital status was reported in most domains. Discussion: Ambulatory status has a significant association with age and marital status with no significant gender association. While social performance has a significant association with gender, most domains had significant associations with age groups. However, no association with marital status was present.

The impact of poor medication knowledge on health-related quality of life in people with Parkinson\u2019s disease: a mediation analysis

PurposeThis study aimed to determine how limited medication knowledge as one aspect of health literacy contributes to poorer health-related quality of life (HRQoL) in people with Parkinson’s disease (PD).MethodsDemographical data, PD-specific data (MDS-Unified Parkinson’s Disease-Rating Scale, Nonmotor symptom scale), and data about depressive symptoms (Beck’s depression inventory), cognition (Montreal cognitive assessment), HRQoL (Short-Form Health Questionnaire-36, SF-36), and medication knowledge (names, time of taking, indication, dosage) were assessed in 193 patients with PD. Multivariate analysis of variance (MANOVA), multivariate analysis of covariance, and mediation analyses were used to study the relationship between medication knowledge and HRQoL in combination with different mediators and covariates.ResultsOverall, 43.5% patients showed deficits in at least one of the 4 knowledge items, which was associated with higher age, number of medications per day and depression level, and poorer cognitive function, motor function, and lower education level. Using one-way MANOVA, we identified that medication knowledge significantly impacts physical functioning, social functioning, role limitations due to physical problems, and role limitations due to emotional problems. Mediation models using age, education level, and gender as covariates showed that the relationship between knowledge and SF-36 domains was fully mediated by Beck’s Depression Inventory but not by Montreal Cognitive Assessment.ConclusionsPatients who expressed unawareness of their medication did not necessarily have cognitive deficits; however, depressive symptoms may instead be present. This concomitant depressive symptomatology is crucial in explaining the contribution of nonadherence and decreased medication knowledge to poor quality of life.

Tadalafil improves erectile dysfunction and quality of life in men with cirrhosis: a randomized double blind placebo controlled trial.

Patients with cirrhosis have high prevalence of erectile dysfunction (ED). The aim of this study was to study the efficacy and safety of tadalafil for ED in patients with cirrhosis. 140 cirrhotic males with ED were randomized into tadalafil 10mg daily (n = 70) or placebo (n = 70) for 12weeks. ED was diagnosed if erectile function (EF) domain score was < 25 in International Index of Erectile Function (IIEF) questionnaire. The erectile function domain consists of six questions concerning erection frequency, erection firmness, frequency of partner penetration, frequency of maintaining erection after penetration, ability to maintain erection to completion of intercourse and confidence in achieving and maintaining erection. Primary outcome was proportion of patients having an increase in > 5 points in EF domain of the IIEF. Generalized Anxiety Disorder 7(GAD-7) questionnaire was used for screening and severity measuring of GAD. The presence of depression was screened using the Patient Health Questionnaire (PHQ-9) and the assessment of health related quality of life was done using the Short Form (36) Health Survey. At the end of 12weeks, more patients in tadalafil group achieved > 5 points increase in the EF domain of the IIEF when compared with the placebo group [44(62.9%) vs. 21(30%), p < 0.001]. At the end of 12weeks, patients receiving tadalafil had significantly more change in scores on the erectile function domain, orgasmic function domain, intercourse satisfaction domain, overall satisfaction domain, erection vaginal penetration rates and successful intercourse; significantly more decline in the GAD-7 and PHQ-9 scores; significantly more improvement in scores of five of the eight domains of SF-36 (general health perception, vitality score, social functioning, role emotional and mental health) and the mental component summary rates when compared with placebo. The development of side effects and the changes in HVPG were not significantly different between the two groups. Tadalafil therapy may enhance erectile function, improve anxiety, depression and quality of life; and is well tolerated by men with cirrhosis (CTP score < 10) and ED. However, further larger and long-term studies are needed to confirm these results and look for rarer side effects of using tadalafil in patients with cirrhosis. ClinicalTrials.gov identifier number NCT03566914; first posted date: June 25, 2018.