QOL Domains Research Articles

OP0262-HPR THE NEURO-QOL UPPER EXTREMITY FUNCTION SCALE: NEW OPPORTUNITIES TO MORE RELIABLY AND PRECISELY MEASURE SELF-REPORTED HAND FUNCTION AND SELF-CARE ACTIVITIES IN PEOPLE WITH RA

Background:RA is an inflammatory disease that results in pain and loss of function, especially in the hands and wrists. Brief self-assessment tools that can reliably and precisely quantify hand/wrist function are needed to assess inflammatory activity when a physical exam is not feasible and to capture day-to-day experience of living with RA. Neuro-QoL is part of the PROMIS family of self-report measures created using a patient-centred approach and IRT methodology. The Neuro-Qol Upper Extremity Function (UEF) scale measures ability across fine motor and ADLs involving digital, manual and reach-related function and self-care. Little is known about its performance in RA.Objectives:To evaluate the validity and responsiveness of the 8-item Neuro-QoL UEF in RA. We hypothesized scores would be strongly (r>.70) associated with MHAQ, MD-HAQ, and PROMIS PF, moderately (r=.4 to .7) to symptoms, disease activity, and QoL indicators, and be responsive to change in disease activity and PF.Methods:Data were from the 0 and 6-month visits of adults with early RA (sx <1 yr) enrolled in the Canadian Early Arthritis Cohort, a prospective real-world study at 16 sites across Canada. Participants completed the Neuro-QoL UEF, MHAQ, MDHAQ, PROMIS-29, and PT Global at each visit. Rheumatologists recorded joint counts and MD Global. To evaluate content validity, we examined descriptive statistics across CDAI disease activity levels, and Pearson correlations between the Neuro-QOL UEF, legacy measures, CRP & ESR. Responsiveness was assessed by correlating change scores from visits 0-6 between Neuro-QoL UEF, disease activity and legacy PF scores.Results:The 262 participants were mostly white (83%) women (71%) with a mean (SD) age of 55 (13). Summary statistics at 6-months are shown in Table 1. Neuro-QOL UEF was moderately-strongly correlated with MHAQ, MDHAQ, PROMIS-PF (|r|=.63-.75) and moderately correlated with pain and stiffness, (|r|=.59, -.64), and CDAI, SDAI, PT&MD Global, TJ & SJ (|r|=.39-.58). Neuro-QOL UEF was moderately correlated with PROMIS QoL domains Pain, Fatigue, Anxiety, Depression, Sleep & Participation (|r|=.39-.60).Table 1.Summary statistics of physical function and RA disease activity indices at 6 months.MeanSDMdn25%75%(Min, Max)Physical FunctionNeuro-Qol UEF46.59.753.837.553.8(21.8, 53.8)MHAQ (0-3)0.290.430.130.000.38(0.00, 2.25)MD-HAQ (0-10)1.391.640.700.002.00(0.00, 8.00)PROMIS-PF46.48.546.239.556.0(23.3, 56.0)RA Disease ActivityCDAI9.39.96.03.013.0(0.0, 56.0)SDAI10.710.96.83.115.2(0.0, 57.0)Patient Global3.02.5315(0, 10)MD Global1.82.2103(0, 9)Swollen Joints (28)2.13.7002(0, 20)Tender Joints (28)2.43.9103(0, 24)Neuro-QOL scores decreased in a dose-response manner across worsening CDAI DA states reflecting increasing impairment (Table 2). Persons with HDA reported the highest disability, scoring nearly 0.5 SD lower on the Neuro-QoL UEF than PROMIS PF. Change from baseline to 6 months in Neuro-QoL UEF was moderately correlated with changes in PROMIS PF, MHAQ, PT Global, and CDAI (|r|=.44-.65). The mean change and range from 0-6 months in Neuro-QoL was significantly larger than in PROMIS (8.9 [95% CI 7.5, 10.4] vs. 5.4 [95% CI 4.4, 6.4])(see Figure).Table 2.Mean scores (95% CI) at 6 months by CDAI level.REMLDAMDAHADNeuroQol UEF52.8 (51.8, 53.7)48.1 (46.6, 49.7)42.0 (39.4, 44.6)33.8 (30.5, 37.1)MHAQ (0-3)0.05 (0.02, 0.09)0.19 (0.14, 0.24)0.45 (0.34, 0.57)0.90 (0.63, 1.17)MD-HAQ (0-10)0.31 (0.17, 0.46)1.11 (0.90, 1.32)2.15 (1.71, 2.59)3.56 (2.56, 4.56)PROMIS-PF52.8 (51.4, 54.2)46.8 (45.3, 48.2)42.3 (40.4, 44.2)38.0 (34.4, 41.6)Conclusion:Clinicians, researchers, and patients benefit from practical self-report tools that reliably and precisely monitor hand function in RA. Results offer initial evidence of validity and responsiveness and support use of Neuro-QoL UEF to self-assess inflammatory activity in the hands and day-to-day experiences of living with RA.Acknowledgements:The CATCH study was designed and implemented by the investigators and financially supported through unrestricted research grants from: Amgen and Pfizer Canada - Founding sponsors since January 2007; AbbVie Corporation and Hoffmann-LaRoche since 2011; Medexus Inc. since 2013;, Merck Canada since 2017, Sandoz Canada, Biopharmaceuticals since 2019,Gilead Sciences Canada since 2020 and Fresenius Kabi Canada Ltd. since 2021. Previously funded by Janssen Biotech from 2011-2016, UCB Canada and Bristol-Myers Squibb Canada from 2011-2018, Sanofi Genzyme from 2016-2017, and Eli Lilly Canada from 2016-2020.Disclosure of Interests:None declared

Psychometric properties of the WHOQOL-BREF(PT) in a sample of elderly citizens

BackgroundThe goal of this article was to research the psychometric properties of the WHOQOL-BREF(PT) instrument in a sample of elderly citizens residing in a rural area in their own homes or at family members’ or friends’ homes and to compare the results: (i) to those reported by the team of Portuguese researchers that undertaken the instrument's translation/validation to the Portuguese language and (ii) to those reported internationally by the World Health Organization Quality of Life group. An overall quality of life scoring (QOL24—all facets) is also proposed in this article as novelty. The correlation level between QOL24 and the instrument’s general facet was also investigated.MethodsThis was a cross-sectional study with a sample of 351 elderly citizens (46.4% males and 53.6% females) randomly selected from the official dataset of the Local Health Unit of Baixo Alentejo. All the data were collected by health professionals at the participants’ homes following the structured interview methodology and using the WHOQOL-BREF(PT) instrument. Three different structural equation models were developed: (i) a first-order confirmatory factor analysis, to assess the instrument’s psychometric properties; (ii) a hierarchical second-order confirmatory factor analysis model, to allow determining the QOL24 scoring; and (iii) a more generic structural equation model, to investigate the correlation level between QOL24 and the instrument’s general facet.ResultsThe WHOQOL-BREF(PT) showed an “almost very good” goodness of fit (comparative fit index of 0.949 and Tucker-Lewis index of 0.943), an adequate internal consistency (Cronbach’s alpha: from 0.64 to 0.90; composite reliability: from 0.59 to 0.88) and tolerable convergent validity (average variance extracted: from 0.374 to 0.614). However, discriminant validity was not reached because strong correlations between the first-order factors (four QOL domains) were obtained, together with low values of the average variance extracted. The scoring of QOL domains and QOL24, determined as weighted averages (proposed in this article as novelty) were significantly different than those determined as unweighted averages. The standardized correlation coefficient between QOL24 and the instrument’s general facet was of 0.89 (statistically highly significant).ConclusionsThe WHOQOL-BREF(PT) is a psychometrically sound instrument to assess the QOL of the considered population sample. However, the QOL domains were found strongly intertwined. More studies are necessary to validate the weighted average scoring strategy of QOL domains and QOL24. Concurrent validity between QOL24 and the instrument’s general facet was considered as “strong”.

Evaluation of perceived fears of COVID-19 virus infection and its relationship to health-related quality of life among patients with diabetes mellitus in Egypt during pandemic: a developing country single-center study.

Aims/introductionCOVID-19 pandemic and its associated circumstances had adversely affected patients with chronic diseases. This study aimed to assess the health-related quality of life (QoL), and identify its psychological and clinical correlates in patients with diabetes mellitus (DM) during pandemic in Egypt.Materials and methodsA cross-sectional study, using a convenience sampling technique, was conducted among patients with DM who were recruited from Zagazig University endocrinology outpatient clinics, Sharkia Province, Egypt from June 30 to September 29, 2020. A total of 200 consecutive patients were interviewed using a semistructured demographic and clinical checklist, the fear of COVID-19 scale (FCV-19S), the Hospital Anxiety and Depression Scale (HADS), and the short form 36 (SF-36) health survey.ResultsPoor physical and mental QoL was reported in 64% and 62% of patients with DM, respectively. Female gender, increased mean arterial pressure (MAP), associated physical comorbidities, and depressive symptoms were associated with lesser odds of physical QoL (OR 0.46, 0.96, 0.29, and 0.88, respectively). Besides, female gender, associated physical comorbidities, fear of COVID-19 virus infection (FCV), and depressive symptoms were associated with lesser odds of mental QoL (OR 0.41, 0.36, 0.91, and 0.84, respectively). The FCV was inversely correlated with all items of SF-36 among patients.ConclusionQoL, either physical or mental, was adversely affected among patients with DM during pandemic. FCV was negatively correlated with all QOL domains. Longitudinal studies are warranted to explore the long-term effect of pandemic on the physical and mental well-being of patients with DM.

Health-Related Quality of Life in Adults with Metabolic Syndrome

Introduction: As components of the metabolic syndrome (MetS), obesity, hypertension, and diabetes have been associated with decreased health-related quality of life (HQoL). The purpose of this study was to investigate the association of HQoL and MetS in Qazvin, Iran. Methods: In a cross-sectional design, 1071 people in Qazvin were identified via multi-stage cluster random sampling. MetS was defined based on the Adult Treatment Panel III criteria. HQoL was assessed using a 36-Item Short Form Health Survey (SF-36) questionnaire. Data were analyzed using the Chi-square test and analyses of covariance. Results: Of 1071 people, 328 participants had MetS. Mean scores of whole domains of the SF-36 scale in MetS participants was lower than subjects without MetS. Mean scores of physical functioning (74.0 ± 23.4 vs. 82.2 ± 20.1, P < 0.001), bodily pain (61.3 ± 22.7 vs. 65.1 ± 20.6, P = 0.009), and general health (59.4 ± 18.2 vs. 63.5 ± 17.3, P < 0.001) domains were statistically different between participants without MetS and those with MetS. The mean scores of mental domains were not significantly different between the two groups. After adjusting for age and gender, domains of HQoL were not significantly different between the two groups. Conclusion: After adjusting for age and gender, no association was observed between QoL domains and MetS. From a public health perspective, the increasing prevalence of MetS in the Iranian population requires effective health promotion policies and lifestyle modification to improve the patients' HQoL.

Health-related quality of life in children and adolescents with epilepsy in Enugu: Need for targeted intervention.

Epilepsy, a chronic brain disorder, predisposes children to low Health-Related Quality of Life (HRQOL). This study aimed at assessing the HRQOL in Nigerian children with epilepsy and compare it with that in healthy children. A cross-sectional study of 166 children with epilepsy (CWE), aged 5-18 years on anti-epileptic drugs (AEDs) for at least 6 months and 166 age and sex-matched apparently healthy children was conducted. A generic version of the Pediatric Quality of Life (Peds QoL version 4) scale was used to assess HRQOL. There were significant differences in Quality-of-Life mean scores in the domains of social functioning, psychosocial combination, and psychosocial plus physical activities between cases and controls. The school function scores of <50, indicating low QOL, were significantly more (Chi square = 35.37) (P = 0.0001) among the cases (32.5%) compared to the controls (6.3%). Similarly, low quality of life in the psychosocial combination were observed significantly (P_ = 0.042) more among the cases (12.7%) compared to the controls (6.3%). Low quality of life in emotional feeling domain were noted significantly (Chi square = 12.9) (P = 0.0002) more in subjects aged between 8 and 12 (20%). QOL scores of below 50 in the social function domain were observed significantly (Chi square = 6.49) (P = 0.039) more in subjects aged between 5 and 7 years (44.8%). There was significant gender difference in Quality-of-life index in school functioning domain in subjects. (Chi Square = 6.49) (P value = 0.039). Children in the upper social class scored higher in the social functioning domain, and social class was significantly associated with scores in the social domain of functioning. (F = 3.75 and P = 0.03). QOL scores below 50 in the emotional domain were significantly more among subjects aged 8-12 years/13-18 year, s and QOL scores of <50 in the school function domain were significantly more in subjects aged 5-7 years. (P = 0.0002) (P = 0.039), respectively. HRQOL is reduced in CWE in all domains of Peds QoL. Significant predictors of reduced HRQOL include age, gender, and socioeconomic class. Beyond seizure control, epilepsy management should be oriented towards ensuring the optimal health-related quality of life.

Heart Failure and Health-Related Quality of Life: Five Measures for Assessing Post-Implant Left Ventricular Assist Device Patients

PurposeAdult heart failure (HF) patients requiring left ventricular assist device (LVAD) implantation undergo life-altering experiences. The Mechanical Circulatory Support: Measures of Adjustment and Quality Of Life Study identified health-related QOL domains for monitoring post-implant LVAD patients. We present the psychometric development of five new measures of those domains.MethodsWe created five item pools: VAD Team Communication-6 items, VAD Self Care-12 items, Being Bothered by VAD Self Care-17 items, Satisfaction with Treatment-10 items, Stigma Mental Health-14 items. Next, we collected responses from a sample of LVAD patients 3 to 24+ months post implant. Then we evaluated item pool dimensionality using item/scale analysis (criterion: Pearson r adjusted-to-total score correlation ≥ .4); exploratory factor analysis (criteria: eigenvalue 1-to-2 ratio ≥ 4; eigenvalue 1 percent of variance accounted for ≥ 50); confirmatory factor analysis (criteria: factor loading ≥ .5; residual correlation ≤ .2; RMSEA < .1, CFI and TLI ≥ .95, SRMR < .08). Finally, for unidimensional item sets, we employed the graded response model to assess item fit (criterion: chi square-to-df ratio ≤ 3) and estimate item parameters.ResultsOur sample (N=678) included adult LVAD patients 3, 6, and > 12 months post implant (n=167, 167, and 344, respectively). After removing 12 non-conforming items, our analyses supported calibrated unidimensional item banks of: VAD Team Communication-6 items, VAD Self Care-12 items, Being Bothered by VAD Self Care-11 items, Satisfaction with Treatment-7 items, Stigma Mental Health-11 items) (see Table). Internal consistency reliability ranged from .88 to .92.ConclusionOur study supported the psychometric soundness of five new LVAD patient-related measures, appropriate for assessing post-implant adjustment to living with an LVAD. The new measures can be administered efficiently using computer adaptive testing and short forms. Adult heart failure (HF) patients requiring left ventricular assist device (LVAD) implantation undergo life-altering experiences. The Mechanical Circulatory Support: Measures of Adjustment and Quality Of Life Study identified health-related QOL domains for monitoring post-implant LVAD patients. We present the psychometric development of five new measures of those domains. We created five item pools: VAD Team Communication-6 items, VAD Self Care-12 items, Being Bothered by VAD Self Care-17 items, Satisfaction with Treatment-10 items, Stigma Mental Health-14 items. Next, we collected responses from a sample of LVAD patients 3 to 24+ months post implant. Then we evaluated item pool dimensionality using item/scale analysis (criterion: Pearson r adjusted-to-total score correlation ≥ .4); exploratory factor analysis (criteria: eigenvalue 1-to-2 ratio ≥ 4; eigenvalue 1 percent of variance accounted for ≥ 50); confirmatory factor analysis (criteria: factor loading ≥ .5; residual correlation ≤ .2; RMSEA < .1, CFI and TLI ≥ .95, SRMR < .08). Finally, for unidimensional item sets, we employed the graded response model to assess item fit (criterion: chi square-to-df ratio ≤ 3) and estimate item parameters. Our sample (N=678) included adult LVAD patients 3, 6, and > 12 months post implant (n=167, 167, and 344, respectively). After removing 12 non-conforming items, our analyses supported calibrated unidimensional item banks of: VAD Team Communication-6 items, VAD Self Care-12 items, Being Bothered by VAD Self Care-11 items, Satisfaction with Treatment-7 items, Stigma Mental Health-11 items) (see Table). Internal consistency reliability ranged from .88 to .92. Our study supported the psychometric soundness of five new LVAD patient-related measures, appropriate for assessing post-implant adjustment to living with an LVAD. The new measures can be administered efficiently using computer adaptive testing and short forms.

Clinical Pharmacist Approach towards Effectiveness of Pulmonary Rehabilitation of the Patient with COPD: A Randomized Controlled Study

Abstract: Background: COPD is characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible. Pulmonary rehabilitation is widely accepted as a best result outcome treatment for COPD patients. Clinical pharmacist play a very important role in patient prescription analysis, promoting the Quality of life, patient education, in developing the drug regimen, sensitivity and allergic condition of the patient to the drugs, finding out any ADRs. Objectives: To compare and assess the impact of pharmacist approach on Health related quality of Life of COPD patients undergoing pulmonary rehabilitation at two different time point. Results: Total 112 patients were screened as per study criteria, 70 were recruited and randomized into control and intervention groups of 35 each, respectively. Compared to baseline QOL score, it was improved at the follow-up in intervention group. Out of 35 subjects 33 subjects has shown good and very good QOL (94.28%). All the domains of QOL were improved compared to control group at the follow-up. Highest improved domain was physical health domain among all (difference 25.83) and lowest was socio-economic domain (difference 12.14) Mean total score of quality of life at follow-up has the significant difference 18.1 (p<0.0001). Conclusion: This study elaborated that quality of life of patients with COPD undergoing pulmonary rehabilitation was improved after the clinical pharmacists approach when compared to only standard treatment (control group). Key words: COPD, Pulmonary rehabilitation, Collaborative approach, Pharmacist’s intervention, Pharmaceutical care, Quality of life.

A poorer nutritional status impacts quality of life in a sample population of elderly cancer patients

RationaleQuality of Life (QoL) is impaired in cancer, and the elderly are particularly vulnerable to malnutrition. A diagnosis of cancer in elderly patients further exacerbates risks of negative health outcomes. Here we investigated associations between QoL and nutritional status in a sample population of mostly socially deprived elderly cancer patients.Method432 cancer patients were recruited for this cross-sectional study at point of admission to a tertiary referral hospital for cancer treatment. Patient-generated subjective global assessment (PG-SGA) assessed nutritional status. Functional assessment of cancer therapy- general (FACT-G) quantified QoL. Relationship between PG-SGA and QoL was assessed by Spearman correlation. PG-SGA outcomes were compared against FACT-G scores employing Mann–Whitney test. Bivariate Linear Regression Model was employed to investigate influences of sociodemographic, clinical and nutritional status upon QoL.Results37.5% of participants were malnourished or at risk. 39% were illiterate and 54.6% had family income lower than minimum wage. Malnourished patients showed lower FACT-G scores (76.8 vs. 84.7; p = 0.000). Poor nutritional diagnosis was inversely correlated with all QoL domains. Bivariate regression analysis showed that lower PG-SGA scores (βo = − 1.00; p = 0.000) contributed to FACT-G score deterioration, the male gender showed better QoL scores, and other clinical and sociodemographic variables did not show relationship.ConclusionPoorer nutritional status was significantly associated with worsened physical, social, emotional and functional well-being QoL domains in elderly cancer patients. Poorer nutritional status is an independent risk factor for worsened QoL. Future policies aimed at particularly vulnerable populations may improve QoL and health outcomes.

Quality of life of HIV-infected individuals: insights from a study of patients in Kermanshah, Iran

BackgroundQuality of life (QOL) is one of the major factors to assessing the health and wellbeing of People living with HIV (PLWH). Likewise, improved QOL is among the prominent goals of patient treatment. This study was conducted to investigate the QOL of PLWH in Kermanshah, Iran.MethodsThis cross-sectional study was conducted on 364 PLWH of Kermanshah between 2016 and 2017. Outpatients were selected as the sample through the convenience sampling method from HIV Positive Clients of Kermanshah Behavioral Diseases Counseling Center. The reasons for the selection of outpatients include: (a) some patients were substance users, homeless or did not have a fixed address to follow-up; (b) addresses and personal details that were registered on the first admission were incorrect or incomplete; (c) due to financial issues, some were forced to relocate frequently and were difficult to track; (d) some patients were convicts or prisoners, making it hard to find them after their release; (e) some of them were from other provinces, where managing access was not easy/possible. Data was collected using WHOQOL-HIV BREF questionnaire (Persian Version). Data also analyzed with STATA 14, and SPSS 23 using T-test and multiple regression.ResultsThis study showed that mean (SD) age of PLWH was 40.21 (10.45) years. Females had better QOL than males except for spirituality, religion and personal beliefs. The gender differences disappeared in multivariate results. A significant association was observed between education and the independence, environment, and spirituality domains of QOL. In addition, being married was correlated with overall QOL, psychological and social relationships domains of QOL of PLWH. Drug use was a behavioral factor with negative influence on the QOL.ConclusionThis study found that marital status and drug use were the main predictors of various domains of QOL. Drug use was a behavioral factor with a negative influence on the QOL. Hence, it is recommended that health professionals, planners, and policymakers take effective measures to improve the status quo.

Health-Related Quality of Life of Coronary Artery Disease Patients under Secondary Prevention: A Cross-Sectional Survey from South India.

Health-related quality of life (HRQOL) is emerging as an important outcome among patients with documented coronary artery disease (CAD). The primary objective of this study was to report the HRQOL of CAD patients under secondary prevention-related treatment and follow-up using the 36-Item Short Form (SF-36) tool. This was an analytical cross-sectional survey done in a hospital/clinic setting. We recruited CAD patients 30 to 80 years old with 1 to 6 years of follow-up. Patients self-reported HRQOL using SF-36. We recruited 1206 patients, among whom 879 (72.9%) were male. The mean age of patients was 61.3 (9.6) years. Mean (± standard deviation) scores for physical functioning, role limitations due to physical health, pain, and general health were 66.48 ± 29.41, 78.96 ± 28.01, 80.96 ± 21.15, and 51.49 ± 20.19, respectively. The scores for role limitations due to emotional problems, energy/fatigue, emotional well-being, and social functioning were 76.62 ± 28.0, 66.18 ± 23.92, 76.91 ± 20.47, and 74.49 ± 23.55. In subgroup analysis, age, sex, type of CAD, and treatment showed no significant association with any of the 8 domains of QOL. In addition, hypertension and diabetes showed no significant association with the individual domains of HRQOL. Patients with coronary artery disease under secondary prevention-related treatment have suboptimal HRQOL under both physical and mental domains. The role of demographic factors, comorbidities, disease subtypes, and treatment options in modifying HRQOL among patients with CAD appears to be minimal.

Quality of life among epileptic patients in Qassim Region, KSA

Objectives:To explore the influence of epilepsy on quality of life (QoL) among people with epilepsy in Saudi Arabia, and its association with sociodemographic and clinical characteristic aspects in the Qassim region.Methods:A cross-sectional multi-centered study done in the Qassim region from June 2018 to May 2019. A self-administered questionnaire was provided to 216 participants who attended the neurology clinic. We used a validated Arabic version of the QoL in Epilepsy (QOLIE-31) to measure the QoL.Results:The mean of the overall QOLIE-31 score was 64.23 ± 17.8. we found that employment status had a significant influence on the overall score (p<0.001) and all other QOL domains (rho ranged from -.136 for energy fatigue to -.193 for social function) Patients with focal seizures were significantly higher in emotional wellbeing (rho=-.159), seizure worry (rho=-.226), cognitive function (rho=-.166) and overall score (p=0.010) than patients with the generalized type. Monotherapy patients have higher scores in total (p<0.001) and all subscales except seizure worry and emotional wellbeing than those on polytherapy.Conclusion:Employment status, type of seizure, and AED number are the most important factors affecting Saudi patient’s QoL.

Guduchi Ghanavati to Improve Immune Status and General Health in the Population at High Risk of COVID-19: Results of An Open-Label Non-Randomized Clinical Trial from India

Background: Ayurveda, the traditional system of Indian medicine, can offer prophylactic or therapeutic solutions for COVID-19. Govt of India recommended Guduchi Ghanavati (Ayurveda herbal formulation) as an Immunity enhancer and prophylaxis to SARS-CoV-2 during the COVID-19 pandemic. The study aimed to assess the effect of Guduchi Ghanavati as prophylaxis against SARS-CoV-2, as immunity enhancer and on Quality of life in adult volunteers who are at high risk of exposure to SARS-CoV-2.Materials & Methods: Non-randomized, multi-centric, controlled trial was conducted on the population of the community dwelling individuals having good health and were at moderate to very high risk of exposure to COVID 19 infection at five cities in Gujarat, India. Participants of the intervention arm received ‘Guduchi Ghana’ (GG) [extract of Tinospora cordifolia (Willd.) Miers] 1 g/day orally along with standard preventive guidelines (SPG) for SARS-CoV-2 infection (washing hand frequently, physical distancing, and covering the face). Participants of the control group followed standard preventive guidelines only. The outcome measures were the incidence of COVID-19, changes in Immune Status, WHOQOL-BREF, and preliminary safety.Results: a total of 41 incidences of COVID-19 were reported in GG+SPG group (n=15729 analyzed) whereas 16 incidences in SPG only group (n=4845 analyzed) indicating no significant association between the incidence of COVID-19 and Add-on GG intervention (OR, 0.79; CI, 0.44- 1.41 and Adjusted OR, 0.67; CI 0.37-1.21). Analyzing the effect on secondary outcomes, a significant difference (pConclusion: Data of the study supported the routine use of Guduchi Ghanavati to improve immune status and general health without any claim on COVID-19 as pre-exposure prophylaxis.

Quality of Life and Life Satisfaction among Persons with Alcohol Dependence Syndrome

Background: Quality of life plays a vital role to improve the life satisfaction of an individual. The increase in quality of life is related to the increase of subjective life satisfaction. There is an existing relationship between quality of life and life satisfaction for persons with alcohol dependence (Frisch et al., 2000). Aim: The aims of the present study was to assess and examine the relationship between Quality of life and life satisfaction among persons with alcohol dependence. Methodology: A total number 30 respondents with alcohol dependence syndrome were taken by using a purposive sampling technique. The samples were collected from MHI (COE), SCBMCH, Cuttack IPD and OPD. The scales such as WHOQOL-BREF questionnaire and Life Satisfaction were administered. Result: In this present study it was found that the persons with alcohol dependence scored the poor quality of life in all domains of WHO QOL, as well as life satisfaction scale and also statistically positive significant co-relationbetween quality of life and life satisfaction among persons with alcoholdependence.

Quality of Life and Complications in the Morbidly Obese Patient following Post-Bariatric Body Contouring.

With a growing obesity epidemic, an increasing number of patients are seeking body contouring procedures (BCP). The aim of this study was to assess the association of morbid obesity (BMI > 40kg/m2) with both clinical and health-related quality of life (H-RQOL) outcomes following BCP. Patients evaluated for post-bariatric BCP at a large academic hospital by one surgeon were retrospectively identified. Patients were surveyed using the BODY-Q© during initial and postoperative visits. Demographic, clinical, operative characteristics, and surgical outcomes data were extracted. BODY-Q domain scores were compared between morbidly obese (MO) and non-morbidly obese (NMO). The absolute change in HR-QOL scores for MO and NMO was also compared. Overall, 59 patients were included (MO 72.9% vs. NMO 27.1%). The median age was 50 years old (Interquartile range [IQR] ± 17); the majority were non-Hispanic (89.8%), non-diabetic (81.4%), non-smokers (67.8%). Assessment of surgical site occurrences, reoperations, and the complication composite outcome revealed no statistical differences between groups (p >0.05). MO patients showed lower net improvement in three HR-QOL domains: satisfaction with body (median 30 [IQR ± 53] vs. 65 [IQR ± 54]; p = 0.036), body image (median 39 [IQR ± 55] vs. 52 [IQR ± 44]; p = 0.025), and social function (median 12 [IQR ± 18] vs. 19 [IQR ± 35]; p = 0.015). Post-bariatric BCP can be safely performed in the MO patient without increased risk of complication. However, the benefit of truncal BCP is less in MO as it pertains to specific QOL domains: satisfaction with body, body image, and social function. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Gender differences in quality of life and psychological impact of facial burn scars in a tertiary care center

AimTo compare the quality of life and psychological impact of cases of facial burn scar between male and female patients. Study typeAn observational cross sectional study done in a tertiary care university level teaching hospital, on a hospital based sample over a period ranging from January 2018 to July 2019. MethodologyThe study was carried out on 32 patients of facial burn scar, who were screened for psychiatric diagnoses by MINI International Neuropsychiatric Interview; severity of depression and anxiety assessed by HDRS and HAM A; assessed for QoL and scar ratings of both patient and observer. QoL was assessed using the WHO QOL BREF questionnaire. The scar assessment was done with the help of POSAS by interviewing the patient and examination of the scar. ResultsNone of other socio-demographic variables patient showed any significant association with the number of psychiatric diagnoses of the patient or QoL domains; barring years of schooling, which had a significant positive correlation with the psychological domain score of QoL. Being male or female also did not show any significant differences with the anxiety or depression severity. No burn or scar related variable could reach significant association, except scar itching, stiffness scores of POSAS P and overall scar opinion score of POSAS O, with the number of psychiatric diagnoses of the patient. Extent of scar had significant negative associations with the physical and psychological domains of QoL. Significant negative correlations were found between scar variables like stiffness, pigmentation, relief, pliability, and overall opinion and QoL domain scores. The total observer score of POSAS and the overall opinion of observer had much stronger negative correlation than the patient score; the latter having a significant association with the depression severity as well. ConclusionNo statistically significant gender difference in QoL and psychological impact of patients with facial burn scar were found. However educational level was found to positively influence the psychological well-being of the patients; whereas scar extent was found to negatively affect the physical and psychological domains of QoL.

Neuropathic Pain in Guillain-Barre Syndrome: Association with Rehabilitation Outcomes and Quality of Life.

Background:Neuropathic pain contributes significantly to the morbidity and affects the quality of life adversely in Guillain-Barre syndrome (GBS).Objective:To study neuropathic pain profile in GBS and association with rehabilitation outcomes and effect on the quality of life.Methods:Observational study conducted in rehabilitation setting of a tertiary care hospital among adult GBS patients of less than 3 months duration. Assessment was done at the time of admission and discharge with Pain-detect questionnaire (PD-Q), Neuropathic pain scale (NPS), SF 36 survey, Medical Research Council (MRC) score, INCAT sensory sum score (ISS), Overall Disability sum-score (ODSS), Hughes disability score (HDS), Hospital Anxiety and Depression scale (HADS), and Fatigue Severity scale (FSS). Neuropathic pain was managed as per routine protocol and rehabilitation program was individualized.Results:32 participants (26 males) with median age of 34.50 years were included. Eighteen (56.25%) patients had neuropathic pain on PD-Q at admission. The median intensity of pain on NPS scale was 47 at admission which decreased significantly to 14 at discharge. Pain group showed significant association with sensory impairment, CSF protein, and emotional domains of QOL while no association with disability.Conclusion:Neuropathic pain is associated with sensory impairment in GBS and markedly affects the quality of life, especially emotional, family, and social activities.

Patient-reported outcomes of non-pharmacological interventions for endometrial cancer survivors: a systematic review.

The objective of this review was to assess the efficacy of non-pharmacological interventions on endometrial cancer (EC) survivors' QOL, and their use of patient-reported outcome measures (PROMs). We conducted a systematic review of randomized controlled trials (RCTs) of non-pharmacological interventions that assessed the impact of intervention on EC survivors' general and domain-specific QOL (i.e., physical, psychological, and social well-being) using PROMs. Of the 3178 studies identified, 28 full-text articles were reviewed, and 10 were included in the review. Nine RCTs assessed at least one PROM as a primary outcome and six assessed a PROM as a secondary outcome, but few studies used validated PROMs. Significant improvements in general QOL were found in two studies, domain-specific QOL in three studies, and both general and domain-specific QOL in three studies; however, effect sizes ranged from small to large and no significant effects were found for social well-being and few were found for psychological well-being. Few non-pharmacological interventions for EC survivors targeted QOL, even though QOL was assessed as either a primary or secondary outcome of the RCT. Despite this, findings suggest that non-pharmacological interventions for EC survivors hold promise for improving general and domain-specific QOL. Use of validated PROMs would greatly enhance outcome reporting and facilitate comparisons across studies. More interventions are also needed that address social and psychological functioning in this population. Our review highlights a need to (1) expand non-pharmacological RCTs for EC survivors, (2) increase the use of validated PROMs measuring QOL, and (3) address psychosocial domains of QOL when developing interventions for this population.

Health related quality of life in chronic liver diseases.

The impact of chronic liver diseases (CLDs) on health-related quality of life (HRQoL) is relevant to understand the burden of these conditions and inform decision-making processes related to their care. Studies simultaneously comparing the HRQoL of patients affected by the major CLDs to that of the general population are still lacking and are the subject of this study. Using the EQ-5D-3L questionnaire, we analysed and compared HRQoL data from 2962 Italian patients affected by CLDs and forming a representative sample of the general Italian population (6800 individuals). Exploratory analyses were conducted to investigate the effects of each CLD on HRQoL, using the general population as reference and adjusting for possible confounders. Patients with CLDs (HBV, HCV, PSC, PBC, AIH, NAFLD/NASH) in the chronic hepatitis stage and with compensated cirrhosis (CC) showed HRQoL similar to the general population. However, AIH were more likely to report problems in self-care and lower EQ-5D VAS score, while NAFLD/NASH and HCV showed an increased risk of anxiety/depression. On the other hand, with progression to more advanced stages of liver disease (DC or HCC), HRQoL decreased significantly with higher risk of reporting problems in the physical domains, and significant reductions in the VAS and utility index scores. Different subtypes of CLD affected different QoL domains. This study therefore provides a real estimate of the impact of CLDs on patients' HRQoL, and represents a much needed tool to inform decision-making while assessing the effectiveness and cost-effectiveness of the care of these patients.

Validity of the older people quality of life-7 domains (OQoL-7) scale

BackgroundThe Older people Quality of Life-7 domains (OQoL-7) is a 28-item multidimensional questionnaire developed to measure community-dwelling older people’s QoL. The OQoL-7 assesses both importance of and satisfaction in seven QoL domains (Material resources; Close entourage; Social and cultural life; Esteem and recognition; Health and mobility; Feeling of safety; and Autonomy). This study aimed to investigate concurrent and construct validity of the OQoL-7. A secondary aim was to compare different methods of weighting participants’ ratings of satisfaction according to their individual ratings of importance, as compared to the OQoL-7 total score (unweighted).MethodsData came from the first and second samples of the Lausanne cohort 65+ study, assessed at the same age of 72–77 years in 2011 (N = 1117) and 2016 (N = 1091), respectively. To assess concurrent validity, the OQoL-7 was compared to other measures of the same concept (single QoL item) or related concepts (self-rated health, SF-12). Construct validity was tested by comparing subscores in the seven QoL domains in the presence and absence of two stressful events during the preceding year (financial difficulties and relationship difficulties). The effect of importance weighting was assessed using moderated regression analysis.ResultsThe OQoL-7 total score was significantly associated with the single QoL item (Spearman’s rho 0.46), self-rated health (Spearman’s rho 0.34), SF-12 physical (Spearman’s rho 0.22) and mental (Spearman’s rho 0.28) component scores. Large differences (Cohen’s d > 0.8) were observed in the presence or absence of stressful events in the expected QoL domains: “Material resources” in the presence or absence of “Financial difficulties” (Cohen’s d 1.34), and “Close entourage” in the presence or absence of “Relationship difficulties” (Cohen’s d 0.84). Importance weighting resulted in a very small improvement in the prediction of the single QoL item (ΔR2 0.018). All results were highly consistent across 2011 and 2016 samples.ConclusionsThe OQoL-7 showed adequate concurrent and construct validity in two samples of older people. In future studies, the decision to use weighted or unweighted scores will depend on the priority given to either optimizing the prediction of QoL or limiting the burden on respondents and the amount of missing data.

ROLE OF SATVAVAJAYA CIKITSA IN STRESS, QUALITY OF LIFE, PSYCHOSO-CIAL WELL-BEING AND SEXUAL SATISFACTION IN WOMEN WITH POLYCYS-TIC OVARY SYNDROME

Polycystic ovary syndrome is a multisystem disorder having a great impact on psychological and social functioning. It may attribute poor QOL and reduced sexual satisfaction. A non-randomized controlled clin-ical trial to evaluate the add-on effect of Satvavajya Cikitsa in stress, QOL and Psychosocial wellbeing in 30 eligible women in the age group of 18-40 receiving treatment for PCOS from a tertiary care Ayurvedic hospital was tried. 30 participants were consecutively divided into trial group receiving counseling along with conventional treatment for PCOS symptoms and the control group receiving conventional treatment alone. The trial group underwent three sessions of supportive counseling incorporating Ayurvedic princi-ples, each of one-hour duration with 15 days gap. Main outcome measures included psychological stress, PCOS related QOL and general QOL in psycho-social domains and sexual satisfaction. Changes were sig-nificantly different in two groups in stress scores (p&lt;0.001), PCOS related QOL (p&lt;0.001) and general QOL in the Psychological (p&lt;0.01) and social (p&lt;0.05) domains and sexual satisfaction (p&lt;0.05) after the intervention. Better clinical efficacy was also noticed in the trial group.