Outcomes Study 36-Item Short Form Research Articles

Abstract 12633: Factors Affecting Quality of Life Among Patients With Hypertrophic Cardiomyopathy

Background: Hypertrophic cardiomyopathy (HCM) is the most common genetically determined chronic condition with various clinical symptom and course. Recently, illness perceptions have been known to influence mental health outcomes in patients with HCM. However, limited studies exist on HRQoL and its determinant factors including psychosocial components in patients with HCM. This study aimed to identify factors affecting HRQoL in patients with HCM. Methods: A total of 101 patients with HCM (mean age, 59±12 years; men,74.3%; obstructive type, 43.6%) participated in the study at their regular visits to the outpatient clinic of a university affiliated hospital in Seoul, from July to December, 2020. A questionnaire including the Medical Outcomes Study 12-Item Short Form Health Survey (SF-12) as a measure of physical and mental HRQoL, Korean Illness Perception Questionnaire, Health Promoting Lifestyle II, Patient Health Questionnaire-9 (PHQ-9), and Korean activity scale index (KASI) was used. Multivariable linear regression analysis was conducted to assess determinants of HRQoL. Results: The mean physical component score (PCS) of HRQoL was 47.15±7.66 and mental component score (MCS) was 51.41±8.61. Lower physical functional capacity (β=-.398, p<.001) and higher cyclical timeline beliefs of illness perception (β=-.230, p=.039) were independently associated with lower PCS with 35.9% explanatory power (p<.001). Women (β=-.218, p=.032), depression (β=-.307, p=.004), and stress management (β=.240 p=.042) were identified as independent predictors of MCS with 39.7% explanatory power (p<.001). Conclusions: This study shows the important role of illness perception in determining the physical HRQoL in patients with HCM. Interventions aimed at changing Illness perception and reducing depression may be promising approaches to improve HCM patients’ HRQoL.

Health-related quality of life among persons with initial mild, moderate, and severe or critical COVID-19 at 1 and 12 months after infection: a prospective cohort study

BackgroundCurrently, there is limited evidence about the long-term impact on physical, social and emotional functioning, i.e. health-related quality of life (HRQL) after mild or moderate COVID-19 not requiring hospitalization. We compared HRQL among persons with initial mild, moderate or severe/critical COVID-19 at 1 and 12 months following illness onset with Dutch population norms and investigated the impact of restrictive public health control measures on HRQL.MethodsRECoVERED, a prospective cohort study in Amsterdam, the Netherlands, enrolled adult participants after confirmed SARS-CoV-2 diagnosis. HRQL was assessed with the Medical Outcomes Study Short Form 36-item health survey (SF-36). SF-36 scores were converted to standard scores based on an age- and sex-matched representative reference sample of the Dutch population. Differences in HRQL over time were compared among persons with initial mild, moderate or severe/critical COVID-19 using mixed linear models adjusted for potential confounders.ResultsBy December 2021, 349 persons were enrolled of whom 269 completed at least one SF-36 form (77%). One month after illness onset, HRQL was significantly below population norms on all SF-36 domains except general health and bodily pain among persons with mild COVID-19. After 12 months, persons with mild COVID-19 had HRQL within population norms, whereas persons with moderate or severe/critical COVID-19 had HRQL below population norms on more than half of the SF-36 domains. Dutch-origin participants had significantly better HRQL than participants with a migration background. Participants with three or more COVID-19 high-risk comorbidities had worse HRQL than part participants with fewer comorbidities. Participants who completed the SF-36 when restrictive public health control measures applied reported less limitations in social and physical functioning and less impaired mental health than participants who completed the SF-36 when no restrictive measures applied.ConclusionsTwelve months after illness onset, persons with initial mild COVID-19 had HRQL within population norms, whereas persons with initial moderate or severe/critical COVID-19 still had impaired HRQL. Having a migration background and a higher number of COVID-19 high-risk comorbidities were associated with worse HRQL. Interestingly, HRQL was less impaired during periods when restrictive public health control measures were in place compared to periods without.

The efficacy of brief strategic therapy in treating obsessive-compulsive disorder: a case series.

International guidelines indicate pharmacological therapy and cognitive-behavioral therapy (CBT) as gold standard treatments for obsessive-compulsive disorder (OCD). However, up to 40% patients do not fully respond to CBT, thus manifesting persistent symptomatology. Empirical research reported brief strategic therapy (BST) as a potential treatment for OCD. The aim of the present study is to evaluate the efficacy of BST in treating OCD and to identify the clinical characteristics associated to response. BST protocol was administered to patients with OCD. During a 24-weeks observational phase, the following scales have been administered at the baseline and every 4 weeks: Yale Brown Obsessive-Compulsive scale (Y-BOCS), Clinical Global Impression, Global Assessment of Functioning, Quality of Life Index, Medical Outcomes Study Short Form 12-item, Clinical Outcomes in Routine Evaluation-Outcome Measure, Generalized Anxiety Disorder Scale, Patient Health Questionnaire - 9 and Somatic Symptom Scale-8. eight patients completed the treatment and a subgroup of five patients obtained clinical remission, defined as Y-BOCS total score < 25. The repeated measures ANOVA performed showed a significant decreased of the Y-BOCS total scores (p<.001). Comparisons between the two subgroups (remitters vs. non-remitters) highlighted some potential baseline characteristics associated with remission: i.e., higher mean level of anxiety, quality of life, physical health, and lower mean level of somatic symptoms and lower prevalence of personality disorders comorbidity. BST could be a useful therapeutic strategy in treating OCD patients. Further studies with larger samples and with long-term follow-up are needed to assess the post-treatment maintenance of clinical effects.

Development and Validation of Models to Predict Poor Health-Related Quality of Life Among Adult Survivors of Childhood Cancer

Risk prediction models are important to identify survivors of childhood cancer who are at risk of experiencing poor health-related quality of life (HRQOL) as they age. To develop and validate prediction models for a decline in HRQOL among adult survivors of childhood cancer. This prognostic study included 4755 adults from the Childhood Cancer Survivor Study (CCSS) diagnosed between January 5, 1970, and December 31, 1986, who completed baseline (time 0 [November 3, 1992, to August 28, 2003]) and 2 follow-up (time 1 [February 12, 2002, to May 21, 2005] and time 2 [January 6, 2014, to November 30, 2016]) surveys. Data were analyzed from June 19, 2019, to February 2, 2022. Sociodemographic, lifestyle, and emotional factors, and chronic health conditions (CHCs) were assessed at time 0 and time 1, and neurocognitive factors were assessed at time 1 to predict HRQOL at time 2 and a decline in HRQOL between time 1 and time 2. Impaired health states were defined as CHC grades 2 to 4 using the modified Common Terminology Criteria for Adverse Events, version 4.03, and mental and neurocognitive status as 1 SD or more below reference levels. Health-related quality of life was operationalized using the Medical Outcomes Study 36-Item Short Form Health Survey Physical (PCS) and Mental (MCS) Component Summary and classified by optimal (≥40) or suboptimal (<40) at each point (main outcome). A decline in HRQOL was defined as a change from optimal to suboptimal between time 1 and time 2. Multivariable logistic regression identified factors associated with HRQOL decline. The cohort was randomly split into training (80%) and test (20%) data sets for model development and validation; the area under the receiver operating characteristic curve was used to evaluate prediction performance. A total of 4755 adults (mean [SD] age at time 0, 24.3 [7.6] years; 2623 [55.2%] women) were included in the analysis. Between time 1 and time 2, 285 of 3294 survivors (8.7%) had declining PCS and 278 of 3294 (8.4%) had declining MCS. Risk factors associated with PCS decline included female sex (odds ratio [OR], 1.67 [95% CI, 1.25-2.24]), family income less than $20 000 vs $80 000 or more (OR, 2.00 [95% CI, 1.21-3.30]), presence of CHCs (OR for neurological, 2.16 [95% CI, 1.51-3.10]; OR for endocrine, 2.25 [95% CI, 1.44-3.52]; OR for gastrointestinal tract, 1.89 [95% CI, 1.32-2.69]; OR for respiratory, 1.66 [95% CI, 1.06-2.59]; OR for cardiovascular, 1.53 [95% CI, 1.14-2.06]), and depression (OR, 1.79 [95% CI, 1.20-2.67]). Risk factors associated with MCS decline included unemployment vs full-time employment (OR, 1.68; [95% CI, 1.19-2.38]), current vs never cigarette smoking (OR, 2.03 [95% CI, 1.37-3.00]), depression (OR, 4.29 [95% CI, 2.44-7.55]), somatization (OR, 1.63 [95% CI, 1.05-2.53]), impaired task efficiency (OR, 1.90 [95% CI, 1.34-2.68]), and impaired organization (OR, 1.67 [95% CI, 1.12-2.48]). The areas under the receiver operating characteristic curve for the test models were 0.74 (95% CI, 0.67-0.81) for declining PCS and 0.68 (95% CI, 0.60-0.75) for declining MCS. In this prognostic study of adult survivors of childhood cancer who experienced declining HRQOL, CHCs were associated with a decline in physical HRQOL, whereas current smoking and emotional and neurocognitive impairment were associated with a decline in mental HRQOL. These findings suggest that interventions targeting modifiable risk factors are needed to prevent poor HRQOL in this population.

Humanistic and economic burden associated with depression in the United States: a cross-sectional survey analysis

BackgroundDepression (major depressive disorder [MDD]) affects the functioning of patients in many facets of life. Very few large-scale studies to date have compared health and economic related outcomes of those with versus without depression, and across various depression severity groups. We aimed to evaluate humanistic and economic burden in respondents with and without depression diagnosis, and across symptom severity groups.MethodsData from the 2017 US National Health and Wellness Survey (NHWS) were utilized. Of the adult respondents (N = 75,004), 59,786 were < 65 years old. Respondents not meeting eligibility criteria were excluded (e.g., those self-reporting bipolar disorder or experiencing depression in past 12 months but no depression diagnosis). Overall, data from 39,331 eligible respondents (aged 18–64 years) were analyzed; and comprised respondents ‘with depression diagnosis’ (n = 8853; self-reporting physician diagnosis of depression and experiencing depression in past 12 months) and respondents ‘without depression diagnosis’ (n = 30,478; no self-reported physician diagnosis of depression and not experiencing depression). Respondents with depression were further examined across depression severity based on Patient Health Questionnaire-9 (PHQ-9). Outcome measures included health-related quality-of-life (HRQoL; Medical Outcomes Study 36-item Short Form [SF-36v2]: mental and physical component summary [MCS and PCS]; Short-Form 6 Dimensions [SF-6D]; and EuroQol 5 Dimensions [EQ-5D]), work productivity and activity impairment (WPAI), and health resource utilization (HRU). Multivariate analysis was performed to examine group differences after adjusting covariates.ResultsRespondents with depression diagnosis reported significantly higher rates of diagnosed anxiety and sleep problems versus those without depression (for both; P < 0.001). Adjusted MCS, PCS, SF-6D, and EQ-5D scores were significantly lower in respondents with depression versus those without depression (all P < 0.001). Consistently, respondents with depression reported higher absenteeism, presenteeism, and overall WPAI, as well as greater number of provider visits, emergency room visits, and hospitalizations compared with those without depression (all P < 0.001). Further, burden of each outcome increased with an increase in disease severity.ConclusionsDiagnosed depression was associated with lower health-related quality-of-life and work productivity, and higher healthcare utilization than those without depression, and burden increased with an increase in symptom severity. The results show the burden of depression remains high even among those experiencing minimal symptoms.

Salivary Dysfunctions and Consequences After Radioiodine Treatment for Thyroid Cancer: Protocol for a Self-Controlled Study (START Study).

BackgroundFollowing radioiodine (131I) therapy of differentiated thyroid cancer, the salivary glands may become inflamed, leading to dysfunctions and decreases in patients’ nutritional status and quality of life. The incidence of these dysfunctions after 131I-therapy is poorly known, and no clinical or genetic factors have been identified to date to define at-risk patients, which would allow the delivered activity to be adapted to the expected risk of salivary dysfunctions.ObjectiveThe aims of this study are to estimate the incidence of salivary dysfunctions, and consequences on the quality of life and nutritional status for patients after 131I-therapy; to characterize at-risk patients of developing posttreatment dysfunctions using clinical, biomolecular, and biochemical factors; and to validate a dosimetric method to calculate the dose received at the salivary gland level for analyzing the dose-response relationship between absorbed doses to salivary glands and salivary dysfunctions.MethodsThis prospective study aims to include patients for whom 131I-therapy is indicated as part of the treatment for differentiated thyroid cancer in a Paris hospital (40 and 80 patients in the 1.1 GBq and 3.7 GBq groups, respectively). The follow-up is based on three scheduled visits: at inclusion (T0, immediately before 131I-therapy), and at 6 months (T6) and 18 months (T18) posttreatment. For each visit, questionnaires on salivary dysfunctions (validated French tool), quality of life (Hospital Anxiety and Depression scale, Medical Outcomes Study 36-Item Short Form Survey), and nutritional status (visual analog scale) are administered by a trained clinical research associate. At T0 and T6, saliva samples and individual measurements of the salivary flow, without and with salivary glands stimulation, are performed. External thermoluminescent dosimeters are positioned on the skin opposite the salivary glands and at the sternal fork immediately before 131I administration and removed after 5 days. From the doses recorded by the dosimeters, an estimation of the dose received at the salivary glands will be carried out using physical and computational phantoms. Genetic and epigenetic analyses will be performed to search for potential biomarkers of the predisposition to develop salivary dysfunctions after 131I-therapy.ResultsA total of 139 patients (99 women, 71.2%; mean age 47.4, SD 14.3 years) were enrolled in the study between September 2020 and April 2021 (45 and 94 patients in the 1.1 GBq and 3.7G Bq groups, respectively). T6 follow-up is complete and T18 follow-up is currently underway. Statistical analyses will assess the links between salivary dysfunctions and absorbed doses to the salivary glands, accounting for associated factors. Moreover, impacts on the patients’ quality of life will be analyzed.ConclusionsTo our knowledge, this study is the first to investigate the risk of salivary dysfunctions (using both objective and subjective indicators) in relation to organ (salivary glands) doses, based on individual dosimeter records and dose reconstructions. The results will allow the identification of patients at risk of salivary dysfunctions and will permit clinicians to propose a more adapted follow-up and/or countermeasures to adverse effects.Trial RegistrationClinicalTrials.gov NCT04876287; https://clinicaltrials.gov/ct2/show/NCT04876287International Registered Report Identifier (IRRID)DERR1-10.2196/35565

Problematic substance use in midwives registered with the United Kingdom’s Nursing and Midwifery Council: A pragmatic mixed methods study

ObjectiveUse a pragmatic mixed methods approach to provide a rich understanding of the perceptions of Problematic Substance Use (PSU) and the influences of PSU on the mental and physical health of midwives registered with the Nursing and Midwifery Council (NMC). DesignA confidential and anonymous self-administered online survey was employed to encourage wider participation. SettingUnited Kingdom ParticipantsMidwives (n=623) registered with the NMC MeasurementsOpen text responses were invited throughout the survey. Along with the collection of brief demographic data, PSU was also measured using the Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse (TAPS) Tool whilst mental and physical health was measured via version 2 of the Medical Outcomes Study Short-Form 12-Item Health Survey. All qualitative open text responses were analysed inductively using reflexive thematic analysis. Multiple regression was used to test whether health outcomes in the sample as a whole were predicted by PSU and Mann-Whitney U tests to compare the health dimensions between participants who met the criteria for PSU and those who did not. FindingsPSU significantly predicted poorer general health, physical functioning, and mental functioning. Additionally, those who met criteria for PSU experienced significantly poorer general, mental, and physical health than those who did not. The influence of PSU was captured via 3 themes and 10 subthemes. Though the signs and symptoms of PSU identified remained broadly consistent, approaches to management did not. Many midwives were conflicted in how they might seek support without facing professional, personal and practical reprisal. Key conclusions and implications for practicePSU in midwifery populations poses professional, personal, and occupational risks. Congruence between policies and approaches to identification and management may reduce risk overall. Future interventions including educational and practitioner health programmes could also be usefully co-created with midwives, policy, and decision makers to reduce stigmatising attitudes and encourage greater awareness, compassion and help seeking to appropriate sources.

Association between serum β-oestradiol and health-related quality of life in postmenopausal women with degenerative lumbar scoliosis.

Degenerative lumbar scoliosis (DLS) is an age-related spinal disease. It is an important cause of low back pain, lower limb painand intermittent claudication, which seriously affects the quality of life of middle-aged and elderly people. This article aims to study the changes in serum oestrogen levels in postmenopausal women with DLS and its relationship. One hundred and sixty-eightpostmenopausal women diagnosed with DLS (DLS group) and 140 healthy postmenopausal women (control group) were recruited. Lumbar spinal bone mineral density (LSBMD) was measured by dual-energy X-ray absorptiometryand a chemiluminescence immunoassay analyser was used to detect serum β-oestradiol (E2) levels. The severity of lower back painwas assessed by the visual analogue scalescore and dysfunction was evaluated by Oswestry Disability Index (ODI). The quality of life was evaluated by Medical Outcomes Study 36-item Short Form Health Survey (SF-36). Diagnostic efficiency was evaluated by the receiver-operating characteristics curve (ROC). LSBMD and the level of E2 in the serum in DLS patients were significantly reduced when compared with the control group. The levels of E2 in the serum of postmenopausal women are reliable for predicting DLS revealed by ROC (p < .001). Serum E2 levels were negatively correlated with Cobb angle, VASand ODIand were positively correlated with LSBMD and SF-36 scores. In postmenopausal women, serum E2 levels in DLS patients are significantly reduced and low levels of E2 are associated with lower bone density and poorer quality of life.

Health-related quality of life in people receiving opioid agonist treatment and treatment for hepatitis C virus infection

Background In people with chronic hepatitis C virus (HCV) infection, viral eradication is associated with improved health-related quality of life (HRQOL). Objective To assess changes in HRQOL among participants receiving opioid agonist therapy undergoing treatment for HCV infection Methods COSTAR (NCT02251990) was a randomized, double-blind, placebo-controlled study. Adults with HCV infection on opioid agonist therapy received elbasvir (50 mg)/grazoprevir (100 mg) or placebo for 12 weeks. HRQOL was evaluated using the Medical Outcomes Study 36-Item Short Form Health Survey version 2 (SF-36v2) Acute Form. Participants remained blinded until 4 weeks after end of treatment. Results Overall, 201 participants received elbasvir/grazoprevir and 100 participants received placebo. Treatment difference mean change from baseline scores (elbasvir/grazoprevir minus placebo) indicated an improvement in HRQOL at 4 weeks after end of treatment in participants receiving elbasvir/grazoprevir versus those receiving placebo, driven by declining HRQOL in those receiving placebo and improved HRQOL in certain domains among participants receiving elbasvir/grazoprevir. Notable differences in SF-36v2 scores were evident in the general health (mean treatment difference [MTD], 6.00; 95% CI, 1.37–10.63), vitality (MTD, 6.81; 95% CI, 1.88–11.75), and mental health (MTD, 5.17; 95% CI, 0.52–9.82) domains and in the mental component summary score (mean, 2.83; 95% CI, 0.29–5.37). No notable between-treatment differences were evident at treatment weeks 4 or 12. Conclusion HRQOL in patients receiving medication for opioid dependence was improved following treatment for HCV infection with elbasvir/grazoprevir, suggesting that eradication of HCV infection with direct-acting antivirals is associated with improved HRQOL. Trial registration number ClinicalTrials.gov, NCT02251990

Spiritually oriented therapy approach applying in complex rehabilitation of patients with mental disorders

IntroductionNumerous studies point to a high effectiveness of psychosocial rehabilitation using psychopharmacological treatment, psychosocial methods and spiritually oriented care technologies.ObjectivesDescription of the experience of using a spiritually oriented approach in complex rehabilitation of patients with mental disorders.MethodsClinical, pathopsychological, statistic. The study involved two groups of patients with illness (ICD-10 F 20.04 – F 20.05, F25.х, F21.3-21.4, F 33.4, F31.7, F32.2 – 18 patients) and comorbid addictive disorders (ICD-10 F10.2х1- F10.2х2 - 17 patients). “The Social Adjustment Scale–Self-Report SAS-SR” (М. Weissman, S. Bothwell, 1976); “Medical Outcomes Study 36-item short form health survey” (SF-36, John E.Ware, 1992); “Methodology of the severity of anti-drug potential” (Kopeyko G.I. et al, 2018); “The Scale of Religiosity” (Kaz’mina O.Y., 2000) were used to assess the effectiveness.ResultsAll patients received psychopharmacological treatment and participated in rehabilitation work in patient community organizations using psychosocial and spiritually oriented therapy. The rehabilitation program included psychoeducation, skills training, group and individual psychotherapy, social activity. Spiritually oriented assistance was realized in the tradition of dialogical approach (Florenskaya T.A., 1992) and included conversations on Evangelical topics, work in therapeutic groups on the principles of a religious community. Longer remission times, a social functioning improvement, a tendency to change lifestyle based on the values of religious worldview, anti-drug potential increase and a higher understanding of religious life with an orientation towards internal religiosity were revealed among the participants of complex rehabilitation program.ConclusionsPerspective of using biopsychosociospiritual approach in psychiatry in work with patients with schizophrenia and patients with comorbid addictive disorders was shown.DisclosureNo significant relationships.

Development of the quality of life of family caregivers of advanced cancer patients scale in Japan: Psychometric properties

ObjectiveWe aimed to develop a new scale for use in Japan, called the “Quality of Life of Family Caregivers of Advanced Cancer Patients Scale (QFCS)” and to examine its psychometric properties. MethodsA draft scale was extracted based on qualitative inductive and deductive analyses, and its content validity and surface validity were investigated. Its psychometric properties were examined. ResultsThe QFCS consists of 30 items comprising four factors. Cronbach's α was 0.92 and the intraclass correlation coefficient was 0.90. Correlation coefficients between the total QFCS score and eight subscale scores of the revised Medical Outcomes Study 12-Item Short Form Survey Instrument were rs ​= ​0.22–0.65 (P ​< ​0.01–0.05). The Physical Component Summary was r ​= ​0.29 (P ​< ​0.01), and the Mental Component Summary was r ​= ​0.67 (P ​< ​0.01). Correlation coefficients between the QFCS total score and four subscale scores of the Caregiver Quality of Life Index-Cancer (CQOLC) were r ​= ​0.27–0.59 (P ​<0 ​.01) and the CQOLC total score was r ​= ​0.65 (P ​<0 ​.01). ConclusionsOur results suggest that the QFCS exhibited acceptable psychometric properties in measuring the quality of life of family caregivers of patients with advanced cancer. Future research is needed to evaluate the effectiveness and quality of family support using the QFCS.

Poke Not Prod: Improving Quality of Life Through Non-Invasive Rejection Surveillance for Heart Transplant Recipients

<h3>Purpose</h3> Gene expression profiling (GEP) and donor-derived cell-free DNA (dd-cfDNA) provide effective non-invasive rejection surveillance for heart transplant (HT) recipients with a trend toward improved quality of life. During the COVID-19 pandemic, rejection monitoring and titration of mediations in HT patients was difficult due to limited health-care resources for endomyocardial biopsy (EMBx). This is the first Canadian study to assess non-invasive rejection surveillance in improving patient satisfaction and reducing anxiety during HT rejection screening. <h3>Methods</h3> Adult HT recipients, at least 6 months post-transplant, were enrolled to have surveillance EMBx replaced by non-invasive rejection testing with GEP and dd-cfDNA. Patients with multiorgan transplant, dialysis, or high rejection risk (recent acute cellular rejection ≥ grade 2R, new graft dysfunction, or heart failure) were excluded. All patients completed the Medical Outcomes Study 12-item Short Form Health Survey (SF-12) and a patient satisfaction survey. Thematic analysis was performed for open-ended responses. <h3>Results</h3> Out of 90 patients screened, 31 had their routine EMBx replaced by non-invasive rejection testing. Based on test results, 89% of EMBx were safely eliminated. On the SF-12, participants had a median physical health score of 43 (40-53) and mental health score of 53 (46-58) out of 100 . Patients' self-reported satisfaction was 90%. Median self-reported anxiety score prior to EMBx was 50 (10-71) versus 2.5 (0-7.5) out of 100 prior to GEP/dd-cfDNA. Four codes ("emotions" (pain, anxiety, fear), "time", "biopsy", "accuracy") were used to uncover two themes of "Superiority to Biopsy" and "Mental or Physical Stress". Patients described feeling much more satisfied and less emotionally distressed with the non-invasive screening compared to EMBx. HT patients reported less fear and anxiety, reduced pain, and enjoyed the simplicity of non-invasive testing. <h3>Conclusion</h3> Non-invasive rejection surveillance screening can positively impact patients' mental health. In this study, non-invasive rejection surveillance eliminated the recovery time and risk of an invasive procedure for HT recipients while reducing anxiety, improving patient satisfaction, and providing an alternative way to screen patients during a period of limited resources due to a global pandemic.

Relationship between the number of comorbidities, quality of life, and cardiac autonomic modulation in patients with coronary disease: a cross-sectional study.

The aim of this study was to evaluate if there is a relationship between the number of comorbidities, autonomic modulation, and quality of life in patients diagnosed with coronary artery disease. A cross-sectional study was conducted at an outpatient rehabilitation center in Presidente Prudente-SP, Brazil. A total of 27 participants (65.33±9.23 years) diagnosed with coronary artery disease were assessed, from a cardiac rehabilitation program, independent of sex or age. The number of comorbidities was evaluated using the Self-Administered Comorbidity Questionnaire, and quality of life was evaluated using the Medical Outcome Study 36-Item Short Form Health Survey (SF-36) (eight domains: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects, and mental health). To evaluate the cardiac autonomic modulation, the heart rate was registered beat to beat using an heart rate monitor in the supine position during rest for 30 min. A total of 1000 RR intervals were considered to calculate linear (time domain: RMSSD, SDNN; frequency domain: LF, HF, LF/HF) and nonlinear indices (SD1, SD2, SD1/SD2) of heart rate variability. A negative correlation was observed between the aggregation of comorbidities and the pain domain of the SF-36 (r=-0.427; p=0.03). No significant correlations were observed between other variables (p>0.05). The number of comorbidities is inversely related to the pain domain of the SF-36, suggesting that a higher pain level is related to a higher number of comorbidities in coronary artery disease patients.

Health-related quality of life (HRQoL) from HIV patients\u2019 perspective: comparison of patient-reported outcome (PRO) measures among people living with hiv (PLWH) and other chronic clinical conditions

BackgroundPeople living with HIV (PLWH) are generally known to suffer from a lower quality of life compared to the one of general population, but still very few is known about the self-perception of quality of life when comparing HIV to non-communicable diseases. We performed a comprehensive assessment of patient’s reported outcomes measures (PROMs) among PLWH and patients affected by other chronic conditions (OC) such as diabetes mellitus type 1, rheumatoid arthritis, breast cancer in hormonal therapy, in order to investigate differences in PROMs outcomes between PLWH and other pathologies.MethodsA cross-sectional observational study was performed by using questionnaires investigating health-related quality of life (Medical Outcomes Study Short Form 36-item Health Survey), work productivity (WPI), and global health status (EQ-5D-3L). They were administered to patients affected by chronic diseases consecutively observed at a single University Hospital during a 10 months period, with comparable disease related aspects. Logistic regression analysis was used to analyze the association between disease group (HIV vs OC) and PROMs.Results230 patients were enrolled (89 PLWH, 143 OC). Mean age: 49 years (SD 10), mean time of disease 12 years (10), 96% were Caucasian, 35% assumed polypharmacy, 42% of male were PLWH versus 16% OC (p < 0.001), 19% PLWH versus 6% OC had clinical complications (p < 0.001). HIV infection was independently associated to a better health-related quality of life in several domains compared with the other conditions, except in mental health, whereas a worst health-related quality of life in most domains was reported by older patients and those experiencing polypharmacy.ConclusionsIn this cohort of patients with chronic conditions followed within the same health setting, PLWH showed better self-reported health outcomes compared to other chronic conditions with comparable characteristics of chronicity. The potential detrimental role of older age and polypharmacy in most outcomes suggests the need of longitudinal assessment of PROMs in clinical practice.

Association between Treatment for Localized Prostate Cancer and Mental Health Outcomes.

We aimed to compare patient-reported mental health outcomes for men undergoing treatment for localized prostate cancer longitudinally over 5 years. We conducted a prospective population-based analysis using the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study. Patient-reported depressive symptoms (Centers for Epidemiologic Studies Depression [CES-D]) and domains of the Medical Outcomes Study 36-item Short Form survey evaluating emotional well-being and energy/fatigue were assessed through 5 years after treatment with surgery, radiotherapy (with or without androgen deprivation therapy) and active surveillance. Regression models were adjusted for outcome-specific baseline function, demographic and clinicopathological characteristics, and treatment approach. A total of 2,742 men (median [quartiles] age 64 [59-70]) met inclusion criteria. Baseline depressive symptoms, as measured by the CES-D, were low (median 4, quartiles 1-8) without differences between groups. We found no effect of treatment modality on depressive symptoms (p=0.78), though older age, poorer health, being unmarried and baseline CES-D score were associated with declines in mental health. There was no clinically meaningful association between treatment modality and scores for either emotional well-being (p=0.81) or energy/fatigue (p=0.054). This prospective, population-based cohort study of men with localized prostate cancer showed no clinically important differences in mental health outcomes including depressive symptoms, emotional well-being, and energy/fatigue according to the treatment received (surgery, radiotherapy, or surveillance). However, we identified a number of characteristics associated with worse mental health outcomes including: older age, poorer health, being unmarried, and baseline CES-D score which may allow for early identification of patients most at risk of these outcomes following treatment.

314 Spinal Versus General Anesthesia for Lumbar Spine Surgery: Prospective Analysis of Quality of Life, Postoperative Fatigue and Cognitive Dysfunction

INTRODUCTION: Low back pain is the leading cause of years lost to disability worldwide, and this burden is increasing as our population ages. Postoperative fatigue and postoperative cognitive dysfunction (POCD) commonly affect patients during their recovery period and diminish their quality of life. There has recently been increasing interest in the use of spinal anesthesia (SA) for lumbar spine surgery. To date the literature that has compared spine surgery under SA versus general anesthesia (GA) has been focused exclusively on safety, perioperative outcomes and costs. METHODS: We conducted a prospective non-randomized study in patients undergoing elective lumbar spine surgery under SA or GA by a single surgeon. Fatigue was assessed with a fatigue VAS scale (0-10) and with Chalder Fatigue Scale (CFQ); quality of life with the Medical Outcomes Study 12-item Short Form (SF-12); differences in cognition with the Mini-Mental State Exam(MMSE). Patients were assessed before the surgery to acquire their baseline and again 1 month after surgery. RESULTS: Fifty patients completed the study, 25 underwent surgery under spinal and 25 under general anesthesia. The groups were homogeneous for baseline clinical characteristics; with no differences in preoperative baseline fatigue, quality of life and cognition, and physical and mental components of the SF-12 between the SA and GA groups. At 1-month after surgery spinal anesthesia when compared to general anesthesia had better fatigue scores: i) fatigue VAS (2.9 ± 1.5 versus 5.6 ± 2.3, (p &lt; 0.0001)); ii) fatigue CFQ (11.2 ± 3.1 versus 16.5 ± 3.9 (p &lt; 0.0001)). At 1-month after surgery we observed a significant difference in the physical component of SF-12, spinal anesthesia having 38.8 ± 8.9 versus 29.4 ± 10.3 (p = 0.002). We did not observe significant postoperative differences in mental component of SF-12. There was no significant difference in MMSE at 1-month follow-up. CONCLUSION: At 1 month postop patients that underwent surgery under spinal anesthesia had less postoperative fatigue and better quality of life.

Neurofilament Light Chain as a Biomarker for Monitoring the Efficacy of Transcranial Magnetic Stimulation on Alcohol Use Disorder.

ObjectiveThis study assessed the effects of repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (DLPFC) on serum neurofilament light chain (NfL) levels, alcohol consumption, craving, and psychological impairment in participants with alcohol use disorder (AUD).MethodsParticipants with AUD were randomly assigned to receive one of two treatments (active or sham rTMS). All participants received 10 daily active or sham rTMS sessions over the left DLPFC for 2 weeks, with follow-up visits at baseline and immediately after the completion of the treatments. Serum samples were obtained before and after the intervention. Days of heavy drinking, visual analog scale (VAS) scores, and mental health component scores (MCSs) of the Medical Outcomes Study 36-Item Short Form Health Survey were used to assess the effects of rTMS.ResultsActive rTMS had a significant effect on reducing days of heavy drinking, alcohol craving, and serum NfL levels, and improved social functioning and mental health. The improvement with active rTMS was significantly greater than that with sham rTMS. Correlation analysis revealed that the reduction in the baseline drinking level was positively correlated with declines in the VAS and NfL levels but not with psychological scores.ConclusionRepetitive transcranial magnetic stimulation of the left DLPFC was associated with reducing alcohol consumption and craving in patients with AUD and positively impacted neuropsychological and social function. Serum NfL levels may be useful as an early serological indicator of alcohol-induced brain injury.

A non-interventional cross-sectional re-contact study investigating the relationship between overactive bladder and frailty in older adults in Japan

BackgroundIncreasing age is associated with frailty and a higher prevalence of overactive bladder (OAB). Given the rapidly increasing proportion of older adults in Japan, a better understanding of the relationship between frailty and OAB is needed to inform future healthcare planning. This study assessed the association between frailty and OAB in older adults in Japan and evaluated the impact on their health-related quality of life (HRQoL).MethodsThis was a cross-sectional re-contact study of respondents who previously completed the National Health and Wellness Survey 2018 in Japan. Participants were aged ≥65 years and Japanese speakers and readers. As part of a customized online survey, participants were screened for frailty using the Kihon Checklist (frail = scores ≥8 points) and OAB using the overactive bladder symptom score (OAB = total score ≥ 3 points and ≥ 2 points on question 3). The primary endpoint was the odds ratio of frailty in older adults with and without OAB assessed using a multivariable logistic regression model. Secondary endpoints were the prevalence rates of OAB and frailty. Exploratory endpoints assessed HRQoL using the Medical Outcomes Study 12-Item Short Form Survey Instrument version 2 (SF-12v2).ResultsOverall, 2953 participants were included: 150 (5.1%) were frail OAB, 416 (14.1%) non-frail OAB, 287 (9.7%) frail non-OAB, and 2100 (71.1%) non-frail non-OAB. There was a statistically significant correlation between frailty and OAB demonstrated by an adjusted odds ratio (95% CI) of 2.78 (2.18–3.54; p < 0.001). The prevalence (95% CI) of OAB was 34.3% (29.9–38.8) in frail and 16.5% (15.1–18.0) in non-frail older adults; the prevalence of frailty was 26.5% (22.9–30.1) and 12.0% (10.7–13.3) in older adults with and without OAB. HRQoL was assessed in 150 participants per group. The adjusted HRQoL analyses showed significantly lower scores in participants who were frail OAB vs. frail non-OAB for most of the SF-12v2 scores/sub-component scores.ConclusionsThese data highlight the statistically significant positive correlation between frailty and OAB among older adults in Japan and may provide valuable information on the burden of OAB and frailty on older adults to healthcare professionals when considering future healthcare planning.

The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies

BackgroundThe effects of filgotinib on patient-reported outcomes (PROs) from 3 trials in patients with active rheumatoid arthritis were investigated.MethodsMethotrexate (MTX)-naïve patients received filgotinib 200 or 100 mg plus MTX (FIL200+MTX, FIL100+MTX), filgotinib 200 mg monotherapy (FIL200), or MTX monotherapy through 52 weeks (NCT02886728). Patients with inadequate response (IR) to MTX (MTX-IR) received FIL200+MTX, FIL100+MTX, adalimumab 40 mg +MTX (ADA+MTX), or placebo (PBO)+MTX (rerandomized to FIL200+MTX or FIL100+MTX at week 24) through 52 weeks (NCT02889796). Patients with IR to biologic disease-modifying antirheumatic drugs (bDMARD-IR) received FIL200 or FIL100 or PBO with background stable conventional synthetic (cs) DMARDs for up to 24 weeks (NCT02873936). PROs included Health Assessment Questionnaire-Disability Index (HAQ-DI), Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) physical/mental component summary (PCS/MCS), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis (WPAI-RA), and Patient Global Assessment of Disease Activity (PtGA). Data are reported as least-squares mean changes from baseline with standard error to the timepoint representing each study’s primary endpoint. All statistical comparisons are of filgotinib groups vs their respective control groups.ResultsAt week 24, among MTX-naïve patients, change from baseline (standard deviation) in HAQ-DI was − 1.00 (0.03; P < 0.001) with FIL200+MTX, − 0.94 (0.04; P < 0.01) with FIL100+MTX, and − 0.91 (0.04; P < 0.05) with FIL200 alone compared with − 0.81 (0.03) with MTX alone. At week 12, among MTX-IR patients, change from baseline in HAQ-DI was − 0.69 (0.04; P < 0.001 vs PBO+MTX, P < 0.05 vs ADA) with FIL200+MTX, − 0.57 (0.04; P < 0.001 vs placebo) with FIL100+MTX, and − 0.60 (0.04) with ADA vs − 0.40 (0.04) with PBO+MTX. At week 12, among bDMARD-IR patients, change from baseline in HAQ-DI was − 0.50 (0.06; P < 0.001) with FIL200+csDMARD and − 0.46 (0.05; P < 0.001) with FIL100+csDMARD vs − 0.19 (0.06) with placebo+csDMARD. Changes in SF-36 PCS and MCS, FACIT-Fatigue, WPAI, and PtGA tended to favor filgotinib over PBO, MTX, and ADA. Greater proportions of patients experienced clinically meaningful differences with either dosage of FIL in combination with csDMARDs (including MTX) and with FIL200 monotherapy vs comparators.ConclusionsFilgotinib provided improvements in PROs across patient populations. These findings suggest filgotinib can be an effective treatment option for patients with insufficient response to MTX or bDMARDs and patients who are MTX-naïve.Trial registrationClinicalTrials.gov, FINCH 1, NCT02889796, first posted September 7, 2016; FINCH 2, NCT02873936, first posted August 22, 2016, retrospectively registered; FINCH 3, NCT02886728, first posted September 1, 2016, retrospectively registered.

Real-Time Exercise Feedback through a Convolutional Neural Network: A Machine Learning-Based Motion-Detecting Mobile Exercise Coaching Application

PurposeMobile applications are widely used in the healthcare market. This study aimed to determine whether exercise using a machine learning-based motion-detecting mobile exercise coaching application (MDMECA) is superior to video streaming-based exercise for improving quality of life and decreasing lower back pain.Materials and MethodsThe same 14-day daily workout program consisting of five exercises was performed by 104 participants using the MDMECA and another 72 participants using video streaming. The Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) and lower back pain scores were assess as pre- and post-workout measurements. Scores for the treatment-satisfaction subscale of the visual analog scale (TS-VAS), intention to use a disease-oriented exercise program, intention to recommend the program to others, and available expenses for a disease-oriented exercise program were determined after the workout.ResultsThe MDMECA group showed a higher increase in SF-36 score (MDMECA, 9.10; control, 1.09; p<0.01) and a greater reduction in lower back pain score (MDMECA, -0.96; control, -0.26; p<0.01). Scores for TS-VAS, intention to use a disease-oriented exercise program, and intention to recommend the program to others were all higher (p<0.01) in the MDMECA group. However, the available expenses for a disease-oriented program were not significantly different between the two groups.ConclusionThe MDMECA is more effective than video streaming-based exercise in increasing exercise adherence, improving QoL, and reducing lower back pain. MDMECAs could be promising tools of use to achieve better medical outcomes and higher treatment satisfaction.