Patient-reported quality of life and working status outcomes in ambulatory patients with idiopathic inflammatory myopathy.

OBJECTIVE: To investigate the health-related quality of life (HR-QoL), work productivity and activity impairment and associated factors among patients with idiopathic inflammatory myopathy (IIM). METHODS: This was an observational, cross-sectional study. The 189 ambulatory patients with IIM were recruited from May 2019 to May 2022. HR-QoL was measured by the European Quality of Life 5-Dimension (EQ-5D) questionnaire. The Work Productivity and Activity Impairment (WPAI) questionnaire was used to evaluate work productivity and activity impairment. The IIM-related parameters were assessed by the 8-item Manual Muscle Test (MMT-8), Myositis Disease Activity Assessment visual analogue scale (MYOACT), Myositis Damage Index (MDI), Disease Activity Score (DAS) and Physician/Patient Global Assessment (PhGA/PtGA). Quantile regression and ordinal logistic regression were performed to identify the factors, considering EQ-5D or WPAI scores as dependent variables, respectively. RESULTS: Of the 189 IIM patients enrolled, 60% had DM, 13% had PM and 27% had clinical amyopathic DM. The median EQ-5D score was 1.00 (95% CI 0.73, 1.00), 28% were employed and 45% of overall work was impaired due to health problems. EQ-5D values were positively associated with MMT-8 and negatively with MYOACT, DAS, MDI-global and PhGA/PtGA. For the WPAI, activity impairment was associated with a lower MMT-8 score, older onset age and higher PhGA only in 25th-75th percentile. Increased PtGA was associated with increased activity and overall working productivity impairment in most quantiles (P<0.05). CONCLUSION: Multiple disease characteristics were associated with reduced HR-QoL or working productivity impairment in patients with IIM, especially for PtGA.

Implementation of patient-reported outcome measures in a heart transplant recipient registry: First step toward a patient-centered approach.

BACKGROUND: Heart transplantation (HTX) is a well-established treatment for suitable patients with end-stage heart failure, intended to prolong their survival and improve their health-related quality of life (HR-QoL). No international consensus exists, however, about the preferred patient-reported outcomes (PROs) and their measures (PROMs) for heart transplant recipients. The purpose of this study, the first step in a mixed-method investigation, was to review the PROMs developed and used in this population to identify the instruments for measuring HR-QoL and adherence to immunosuppressive medications most appropriate for heart transplant patients. METHODS: This systematic search of the literature in the PubMed database focused on the assessment of PROMs for patients after HTX. We analyzed 66 studies with cross-sectional, 28 with longitudinal, and 2 with mixed-methods designs, as well as 6 literature reviews. RESULTS: These 102 articles used 115 different PROMs, which we categorized as generic HR-QoL instruments (n = 19), domain-specific instruments (n = 71), heart disease-specific instruments (n = 9), and heart transplant-specific instruments (n = 16). They cover different dimensions of HR-QoL and of immunosuppressive-drug experience, with diverse numbers of items, types of scales, and psychometric properties. CONCLUSIONS: Despite the abundance of instruments, PROMs for HTX can be improved to meet other patient expectations (i.e., by including important issues such as coping strategies, employment, social support, sexual relationships, spirituality, and beliefs), while paying attention to ease of use, reliability, validity, and the contribution of new technologies. A qualitative approach will complete our project of developing a patient-centered instrument for HTX patients.

Low prevalence of neuropathic-like pain symptoms in long-term controlled acromegaly.

PURPOSE: Pain is a common symptom of acromegaly, impairing health-related quality of life (HR-QoL) significantly despite long-term disease remission. Neuropathic-like pain (NP-like) symptoms are invalidating, with great impact on HR-QoL. Studies characterizing or investigating the etiology of pain in acromegaly are scarce. Therefore, we aimed to assess NP-like symptoms in a cohort of controlled acromegaly patients. METHODS: Forty-four long-term controlled acromegaly patients (aged 62.6 ± 12.6 years; 56.8% female) were included in this cross-sectional study. NP-like symptoms were assessed using the validated painDETECT questionnaire. Patients were divided in three probability-based NP-like symptoms categories based on the total score (range 0-35): unlikely (≤ 12), indeterminate (13-18) and likely (≥ 19). HR-QoL (physical component score (PCS), and mental component score (MCS)), and self-reported pain were assessed using Short Form-36 (SF-36). Potential risk factors were determined using linear regression analyses. RESULTS: Self-reported pain was reported by 35 patients (79.5%). Likely NP-like symptoms were present in 4/44 patients (9.1%), and indeterminate NP-like symptoms in 6/44 patients (13.6%). All patients with likely NP-like symptoms were female. Higher painDETECT scores were negatively associated with HR-QoL (PCS: r = - 0.46, P = 0.003; MCS: r = - 0.37, P = 0.018), and SF-36 pain scores (r = - 0.63, P < 0.0001). Female sex was a risk factor for NP-like symptoms. CONCLUSIONS: Pain was prevalent in controlled acromegaly patients, whereas NP-like symptoms were relatively infrequent, and only observed in females. NP-like symptoms were associated with lower HR-QoL in acromegaly. Since specific analgesic therapy is available, awareness for characterization, increased understanding, and clinical trials regarding neuropathic pain identification and treatment in acromegaly patients are warranted.

'Quality of life at 90 days after stroke and its correlation to activities of daily living': A prospective cohort study.

BACKGROUND: The main goal of stroke rehabilitation is to improve the health-related quality of life (HRQoL). In developed countries, several studies evaluating the HRQoL among stroke survivors have been conducted. In India, HRQoL related to stroke as an important health care issue has not received sufficient attention. The study was conducted to encourage the professionals to use stroke-specific HRQoL scales in clinical practice as one of the measures of stroke outcome. OBJECTIVES: To study the correlation between activities of daily living (ADLs) and HRQoL at 90 days following an acute stroke. METHODS: In this prospective study, functional independence of patients admitted with stroke were measured using Barthel Index (BI). At 90 days post-stroke patients were assessed using two questionnaires. RESULTS: Significant improvement in BI total and domains scores at 90 days (p < .001) were seen. At follow-up, Stroke Specific Quality of Life Scale-12 (SS-QoL-12) score for 59 patients was 48 (high QoL). Individuals scored lowest for psychosocial subscale of HRQoL compared to physical subscale. All items and the total score of the BI showed a significant positive partial correlation (p< .001) with the HRQoL total score. The self-care domain of BI showed the highest correlation with QoL total score at 0.88. CONCLUSIONS: Patient dependent in ADL constantly scored less in all QoL domains. The psychosocial QoL was found to be most affected even in the presence of complete functional independence paving way for further studies on factors that impact psychosocial QoL of stroke survivors.

Effects of Low FODMAP Diet on Symptoms, Fecal Microbiome, and Markers of Inflammation in Patients With Quiescent Inflammatory Bowel Disease in a Randomized Trial.

BACKGROUND & AIMS: There is limited evidence that a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) reduces gut symptoms in quiescent inflammatory bowel disease (IBD). We performed a randomized, controlled trial to investigate the effects of a low FODMAP diet on persistent gut symptoms, the intestinal microbiome, and circulating markers of inflammation in patients with quiescent IBD. METHODS: We performed a single-blind trial of 52 patients with quiescent Crohn's disease or ulcerative colitis and persistent gut symptoms at 2 large gastroenterology clinics in the United Kingdom. Patients were randomly assigned to groups that followed a diet low in FODMAPs (n = 27) or a control diet (n = 25), with dietary advice, for 4 weeks. Gut symptoms and health-related quality of life were measured using validated questionnaires. Stool and blood samples were collected at baseline and end of trial. We assessed fecal microbiome composition and function using shotgun metagenomic sequencing and phenotypes of T cells in blood using flow cytometry. RESULTS: A higher proportion of patients reported adequate relief of gut symptoms following the low FODMAP diet (14/27, 52%) than the control diet (4/25, 16%, P=.007). Patients had a greater reduction in irritable bowel syndrome severity scores following the low FODMAP diet (mean reduction of 67; standard error, 78) than the control diet (mean reduction of 34; standard error, 50), although this difference was not statistically significant (P = .075). Following the low FODMAP diet, patients had higher health-related quality of life scores (81.9 ± 1.2) than patients on the control diet (78.3 ± 1.2, P = .042). A targeted analysis revealed that in stool samples collected at the end of the study period, patients on the low FODMAP diet had significantly lower abundance of Bifidobacterium adolescentis, Bifidobacterium longum, and Faecalibacterium prausnitzii than patients on control diet. However, microbiome diversity and markers of inflammation did not differ significantly between groups. CONCLUSIONS: In a trial of the low FODMAP diet vs a control diet in patients with quiescent IBD, we found no significant difference after 4 weeks in change in irritable bowel syndrome severity scores, but significant improvements in specific symptom scores and numbers reporting adequate symptom relief. The low FODMAP diet reduced fecal abundance of microbes believed to regulate the immune response, compared with the control diet, but had no significant effect on markers of inflammation. We conclude that a 4-week diet low in FODMAPs is safe and effective for managing persistent gut symptoms in patients with quiescent IBD. www.isrctn.com no.: ISRCTN17061468.

Exploring health-related quality of life among non-Hodgkin's lymphoma survivors after completion of primary treatment: a cross-sectional study in Thailand.

PURPOSES: To investigate health-related quality of life (HR-QoL) and its influencing factors among non-Hodgkin's lymphoma (NHL) survivors after completion of primary treatment. METHODS: A cross-sectional study with 312 NHL survivors after completing primary treatment using self-reported data collected through face-to-face interviews or postal survey between May 2019 and December 2019. Sociodemographic factors, clinical characteristics, physical symptom distress, anxiety, depression, unmet supportive care needs, and adaptation (post-traumatic growth and post-traumatic stress disorder) were assessed. Data analysis included ANOVA tests to investigate HR-QoL among NHL survivors at different time points and GEE to assess predictors of HR-QoL. RESULTS: The mean score of HR-QoL was 136.05 (SD 19.12). HR-QoL scores reported by NHL survivors in phase I (6 months or less post-treatment) were significantly lower than those in phase II (> 6 months-4 years), phase III (> 4-9 years), and phase IV (over 9 years post-treatment). Regarding HR-QoL domains, NHL survivors in phase I had significantly lower physical well-being and functional well-being scores than those in phases II, III, and IV; and significantly lower lymphoma domain score than those in phase III. GEE analysis showed that physical symptom distress, anxiety, depression, unmet supportive care needs, poor adaptation, and receiving chemotherapy disrupted HR-QoL (all P < .001). CONCLUSIONS: Healthcare providers should re-prioritize intervention guidelines and survivorship care planning to promote HR-QoL among NHL survivors, particularly in phase I, through reducing physical and psychological symptom distress, addressing unmet needs, and enhancing adaptation outcomes.

Improving quality of life in vasculitis patients.

Systemic vasculitis are a complex cluster of diseases with high associated morbidity. As disease-related mortality diminishes, the cumulative impact of poor health-related quality of life becomes more pertinent to patients than the initial pathological insult. In this article we explore health-related quality of life in ANCA-associated vasculitis, large-vessel vasculitis and therapeutic strategies that may enhance this critical outcome.

Diet quality and well-being in children and adolescents: the UP&DOWN longitudinal study.

The present study examined the association between high-quality diet (using the Mediterranean diet (MD) as an example) and well-being cross-sectionally and prospectively in Spanish children and adolescents. Participants included 533 children and 987 adolescents at baseline and 527 children and 798 adolescents at 2-year follow-up, included in the UP&DOWN study (follow-up in schoolchildren and adolescents with and without Down's syndrome). The present study excluded participants with Down's syndrome. Adherence to an MD was assessed using the KIDMED index. Well-being was measured using the Positive and Negative Affect Schedule and the KIDSCREEN-10 questionnaire. Associations between MD adherence and well-being were assessed using multi-level, mixed-effects linear regression. At baseline, MD adherence was positively related to health-related quality of life in secondary school girls and boys (ß=0·41, se 0·10, P<0·001; ß=0·46, se 0·10, P<0·001, respectively) and to positive affect in secondary school girls and boys (ß=0·16, se 0·05, P=0·006; ß=0·20, se 0·05, P<0·001, respectively) and in primary school boys (ß=0·20, se 0·08, P=0·019). At 2-year follow-up, MD adherence was negatively related to negative affect in secondary school adolescent girls and boys (ß=-0·15, se 0·07, P=0·047; ß=-0·16, se 0·06, P=0·019, respectively), and MD adherence was associated with higher positive affect scores in secondary school girls (ß=0·30, se 0·06, P<0·001) and in primary school boys (ß=0·20, se 0·09, P=0·023). However, MD adherence at baseline did not predict well-being indicators at 2-year follow-up. In conclusion, higher MD adherence was found to behave as a protective factor for positive well-being in cross-sectional analysis.

The Transmural Trauma Care Model (TTCM) for the rehabilitation of trauma patients is effective in improving patient related outcome measures: a non-randomized controlled trial.

BACKGROUND: The Transmural Trauma Care Model (TTCM) is a refined post-clinical rehabilitation approach, in which a multidisciplinary hospital-based team guides a network of primary care physical therapists in the treatment of trauma patients. The objective of this study was to assess the effectiveness of the TTCM compared to regular care. METHODS: A controlled-before-and-after study was performed in a level 1 trauma center. The TTCM includes four elements: 1) a multidisciplinary team at the outpatient clinic, 2) coordination and individual goal setting for each patient by this team, 3) a network of primary care physical therapists, 4) E-health support for transmural communication. Intervention group patients were prospectively followed (3, 6 and 9 months). The control group consisted of 4 clusters of patients who either had their first consultation at the outpatient clinic 0, 3, 6 or 9 months ago. Outcomes included generic- and disease-specific health-related quality of life (HR-QOL), pain, functional status, patient satisfaction, and perceived recovery. Between-group comparisons were made using linear regression analyses. The recovery pattern of intervention group patients was identified using longitudinal data analysis methods. RESULTS: A total of 83 participants were included in the intervention group. In the control group, 202 participants were included (68 in the baseline cluster, 26 in the 3-month cluster, 51 in the 6-month cluster, 57 in the 9-month cluster). Between-group differences were statistically significant in favor of the intervention group for disease-specific HR-QOL at 9 months, pain at 6 and 9 months, functional status at 6 and 9 months, patient satisfaction at 3, 6 and 9 months, and perceived recovery at 6 months. No significant differences were found between groups for generic HR-QOL at any time point. Generic HR-QOL, disease-specific HR-QOL, pain, and functional status significantly improved in a linear fashion among intervention group patients during the nine-month follow-up period. CONCLUSIONS: This study provides preliminary evidence that the TTCM is effective in improving patient related outcome measures, such as disease-specific HR-QOL, pain and functional status. A multicenter, and ideally randomized controlled trial, is required to confirm these results. TRIAL REGISTRATION: The trial is registered at the Dutch Trial Register (NTR5474). Registered 12 October 2015. Retrospectively registered.

Cost-Effectiveness of the Transmural Trauma Care Model (TTCM) for the Rehabilitation of Trauma Patients.

OBJECTIVES: To assess the societal cost-effectiveness of the Transmural Trauma Care Model (TTCM), a multidisciplinary transmural rehabilitation model for trauma patients, compared with regular care. METHODS: The economic evaluation was performed alongside a before-and-after study, with a convenience control group measured only afterward, and a 9-month follow-up. Control group patients received regular care and were measured before implementation of the TTCM. Intervention group patients received the TTCM and were measured after its implementation. The primary outcome was generic health-related quality of life (HR-QOL). Secondary outcomes included disease-specific HR-QOL, pain, functional status, and perceived recovery. RESULTS: Eighty-three trauma patients were included in the intervention group and fifty-seven in the control group. Total societal costs were lower in the intervention group than in the control group, but not statistically significantly so (EUR-267; 95 percent confidence interval [CI], EUR-4,175-3011). At 9 months, there was no statistically significant between-group differences in generic HR-QOL (0.05;95 percent CI, -0.02-0.12) and perceived recovery (0.09;95 percent CI, -0.09-0.28). However, mean between-group differences were statistically significantly in favor of the intervention group for disease-specific HR-QOL (-8.2;95 percent CI, -15.0--1.4), pain (-0.84;95CI, -1.42--0.26), and functional status (-20.1;95 percent CI, -29.6--10.7). Cost-effectiveness acceptability curves indicated that if decision makers are not willing to pay anything per unit of effect gained, the TTCM has a 0.54-0.58 probability of being cost-effective compared with regular care. For all outcomes, this probability increased with increasing values of willingness-to-pay. CONCLUSIONS: The TTCM may be cost-effective compared with regular care, depending on the decision-makers willingness to pay and the probability of cost-effectiveness that they perceive as acceptable.

How non-functioning pituitary adenomas can affect health-related quality of life: a conceptual model and literature review.

After treatment for a non-functioning pituitary adenoma (NFA) health-related quality of life (HR-QoL) improves considerably. However, the literature about the normalization of HR-QoL after treatment is inconclusive. Some researchers described a persistently decreased HR-QoL compared to reference data, while others did not. Considering this variety in observed HR-QoL outcomes, the aim of the present review was to provide a literature overview of health outcomes in patients with a NFA, using a conceptual HR-QoL model. A concrete conceptualization of the health outcomes of patients with a NFA can be helpful to understand the observed variety in HR-QoL outcomes and to improve clinical care and guidance of these patients. For this conceptualization, the Wilson and Cleary model was used. This model has a biopsychosocial character and has been validated in several patient populations. In the present review, health outcomes of patients with a NFA were described at each stage of the model e.g. biological and physiological variables, symptom status, functional status, general health perceptions and overall HR-QoL. The Wilson-Cleary model elucidates that elements at each stage of the model can contribute to the impairment in HR-QoL of patients with a NFA, which explains the reported variety in the literature. Furthermore, by applying the model, potential interventions targeting these elements can be identified. While optimal biomedical treatment has always been the focus, it is clearly not sufficient for good HR-QoL in patients with a NFA. Further improvement of HR-QoL should be supported by a pituitary specific care trajectory, including psychosocial care (e.g. self-management training), to beneficially affect characteristics of the patient and the (healthcare) environment, with the utmost goal to optimize HR-QoL in patients after treatment.

Using Rasch Analysis to Evaluate the Reliability and Validity of the Swallowing Quality of Life Questionnaire: An Item Response Theory Approach.

The Swallowing Quality of Life questionnaire (SWAL-QOL) is widely used clinically and in research to evaluate quality of life related to swallowing difficulties. It has been described as a valid and reliable tool, but was developed and tested using classic test theory. This study describes the reliability and validity of the SWAL-QOL using item response theory (IRT; Rasch analysis). SWAL-QOL data were gathered from 507 participants at risk of oropharyngeal dysphagia (OD) across four European countries. OD was confirmed in 75.7% of participants via videofluoroscopy and/or fiberoptic endoscopic evaluation, or a clinical diagnosis based on meeting selected criteria. Patients with esophageal dysphagia were excluded. Data were analysed using Rasch analysis. Item and person reliability was good for all the items combined. However, person reliability was poor for 8 subscales and item reliability was poor for one subscale. Eight subscales exhibited poor person separation and two exhibited poor item separation. Overall item and person fit statistics were acceptable. However, at an individual item fit level results indicated unpredictable item responses for 28 items, and item redundancy for 10 items. The item-person dimensionality map confirmed these findings. Results from the overall Rasch model fit and Principal Component Analysis were suggestive of a second dimension. For all the items combined, none of the item categories were 'category', 'threshold' or 'step' disordered; however, all subscales demonstrated category disordered functioning. Findings suggest an urgent need to further investigate the underlying structure of the SWAL-QOL and its psychometric characteristics using IRT.

Effects of progressive resistance training combined with a protein-enriched lean red meat diet on health-related quality of life in elderly women: secondary analysis of a 4-month cluster randomised controlled trial.

Resistance training (RT) and increased dietary protein are recommended to attenuate age-related muscle loss in the elderly. This study examined the effect of a lean red meat protein-enriched diet combined with progressive resistance training (RT+Meat) on health-related quality of life (HR-QoL) in elderly women. In this 4-month cluster randomised controlled trial, 100 women aged 60-90 years (mean 73 years) from self-care retirement villages participated in RT twice a week and were allocated either 160 g/d (cooked) lean red meat consumed across 2 meals/d, 6 d/week or ≥1 serving/d (25-30 g) carbohydrates (control group, CRT). HR-QoL (SF-36 Health Survey questionnaire), lower limb maximum muscle strength and lean tissue mass (LTM) (dual-energy X-ray absorptiometry) were assessed at baseline and 4 months. In all, ninety-one women (91 %) completed the study (RT+Meat (n 48); CRT (n 43)). Mean protein intake was greater in RT+Meat than CRT throughout the study (1·3 (sd 0·3) v. 1·1 (sd 0·3) g/kg per d, P<0·05). Exercise compliance (74 %) was not different between groups. After 4 months there was a significant net benefit in the RT+Meat compared with CRT group for overall HR-QoL and the physical component summary (PCS) score (P<0·01), but there were no changes in either group in the mental component summary (MCS) score. Changes in lower limb muscle strength, but not LTM, were positively associated with changes in overall HR-QoL (muscle strength, ß: 2·2 (95 % CI 0·1, 4·3), P<0·05). In conclusion, a combination of RT and increased dietary protein led to greater net benefits in overall HR-QoL in elderly women compared with RT alone, which was because of greater improvements in PCS rather than MCS.

Patients' health related quality of life after massive weight loss reconstruction in the Netherlands.

OBJECTIVES: The present study aimed to evaluate the impact of undergoing massive weight loss reconstruction (MWR) on health-related quality of life (HR-QoL) in the Netherlands. METHOD: A retrospective study was performed among 131 Dutch bariatric patients, divided into two groups: an intervention group (93 patients who had undergone MWR) and a control group (38 patients who had not undergone MWR). HR-QoL was assessed by the validated BODY-q questionnaire. The sign test was used to measure the difference between the 0 and 12 months' measurements of HR-QoL in both groups, whereas multiple regression analysis was conducted to assess whether undergoing MWR significantly predicted participants' incremental HR-QoL. RESULTS: Whereas the intervention group showed a significance improvement on all parameters of the BODY-q between 0 and 12 months (all parameters p < .001), the control group did not. The multiple regression analysis showed that having undergone a MWR significantly and positively predicted incremental HR-QoL on all scales on the BODY-q (all parameters p < 0.05). CONCLUSION: The present study suggests a positive impact of MWR on the HR-QoL of bariatric patients.

A comparative cross-sectional study on the quality of life in Grave's disease patients: urban vs. rural perspectives.

Grave's disease affects numerous patients globally, but its impact on health-related quality of life (HR-QoL) in relation to geographical disparities remains under-explored. This cross-sectional study aimed to assess the influence of urban versus rural residence on HR-QoL among patients diagnosed with Graves' Disease in Rajasthan, India. One hundred seven Graves' disease patients from rural and urban endocrine centers were analyzed. The rural group included 52 patients (24 males, 28 females), averaging 38.9 ± 10.9 years of age, while the urban group had 55 (13 males, 42 females) with an average age of 39.1 ± 14.2 years. We found differences between rural and urban patients in terms of gender ratio, BMI, smoking habits, and obesity. Multivariable linear regression was used in both groups to determine the association between the baseline characteristics of Graves' patients from both areas and HR-QOL. Health-related quality of life, assessed via the SF-36 questionnaire, indicated higher general health and role emotional scores among urban patients. Our study found that the duration of Graves' disease in rural centers negatively impacted physical health scores. In urban patients, age and BMI influenced physical health, while gender and disease duration affected mental health scores in rural patients. Age impacted mental health in urban patients. Rural patients had a poorer quality of life compared to urban patients. Differences in gender distribution, BMI, smoking habits, and obesity rates revealed disparities in Graves' disease between rural and urban patients in India, highlighting the need for better healthcare infrastructure and awareness in rural areas.

Effectiveness of Exercise on Fatigue for Patients With Heart Failure: A Systematic Review and Meta-Analysis.

Exercise is the standard treatment for fatigue in heart failure (HF) patients. However, no study has investigated the effect of exercise on improving fatigue and HR-QoL in HF patients. Our study adhered to the Cochrane Handbook for Systematic Reviews of Interventions and followed the PRISMA statement. The date of the last search was October 31, 2021. We included randomized controlled trials (RCTs) using exercise to improve fatigue and HR-QoL. The combined exercise training studies showed improvement in fatigue (SMD = -.51, 95% CI = -.89 to -.12, p = .001, I2 = 48%). The IMT studies showed significantly improved fatigue (MD = -11.36, 95%CI = -15.30 to -7.41, p < .00001, I2 = 54%). However, three studies, with moderate heterogeneity (p = .10, I2 = 56%), showed non-significant changes in HR-QoL (SMD = -0.04, 95% CI = -.45 to .37, p = .83).

Randomized Controlled Trial of Isha Kriya versus Observation to Improve Quality of Life in Hematopoietic Cell Transplantation Recipients.

Hematopoietic cell transplantation (HCT) impacts recipients' quality of life (QoL). Few mindfulness-based interventions (MBI) in HCT recipients have shown feasibility, but heterogeneous practices and outcome measures have called into question the actual benefit. We hypothesized that self-guided isha kriya, a 12-minute guided meditation based on the principles of yoga focusing on breathing, awareness, and thought, as a mobile app would improve QoL in the acute HCT setting. This single-center, open-label, randomized controlled trial was conducted in 2021 to 2022. Autologous and allogeneic HCT recipients age ≥18 years were included. The study was approved by our Institutional Ethics Committee and registered at the Clinical Trial Registry of India, and all participants provided written informed consent. HCT recipients without access to smartphones or regular practitioners of yoga, meditation, or other mind-body practices were excluded. Participants were randomized to the control arm or the isha kriya arm at a 1:1 ratio stratified by type of transplantation. Patients in the isha kriya arm were instructed to perform the kriya twice daily from pre-HCT to day +30 post-HCT. The primary endpoint was QoL summary scores as assessed by the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) and the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) questionnaires. The secondary endpoints were the differences in QoL domain scores. The validated questionnaires were self-administered before the intervention and at days +30 and +100 post-HCT. The analysis of endpoints was done on an intention-to-treat basis. Domain and summary scores were calculated for each instrument as recommended by the developers. A P value < .05 was considered to indicate statistical significance, and Cohen's d effect size was used to determine clinical significance. A total of 72 HCT recipients were randomized to the isha kriya and control arms. Patients in the 2 arms were matched for age, sex, diagnosis, and type of HCT. The 2 arms showed no differences in pre-HCT QoL domain, summary, and global scores. At day +30 post-HCT, there was no difference between the arms in the mean FACT-BMT total score (112.9 ± 16.8 for the isha kriya arm versus 101.2 ± 13.9 for the control arm; P = .2) or the mean global health score (global mental health, 45.1 ± 8.6 versus 42.5 ± 7.2 [P = .5]; global physical health, 44.1 ± 6.3 versus 44.1 ± 8.3 [P = .4]) in the 2 groups. Similarly, there were no differences in physical, social, emotional, and functional domain scores. However, the mean bone marrow transplantation (BMT) subscale scores, which addresses BMT-specific QoL concerns, were statistically and clinically significantly higher in the isha kriya arm (27.9 ± 5.1 versus 24.4 ± 9.2; P = .03; Cohen's d = .5; medium effect size). This effect was transient; mean day +100 scores showed no difference (28.3 ± 5.9 versus 26.2 ± 9.4; P = .3). Our data indicate that the isha kriya intervention did not improve the FACT-BMT total and global health scores in the acute HCT setting. However, practicing isha kriya for 1 month was associated with transient improvement in the FACT-BMT subscale scores on day +30 but not on day +100 post-HCT.

Health-related quality of life and long-term symptoms among patients with non-severe covid-19 - a prospective cohort study.

BACKGROUND: The vast majority of covid-19 patients experience non-severe disease. Nonetheless, long-term symptoms may be common and the impact on quality of life is uncertain. This study aims to examine these aspects in a prospective, longitudinal cohort. METHODS: Non-hospitalised patients with PCR-confirmed covid-19 were prospectively invited to self-report assessments of background data, symptoms and recovery, illness perception (BIPQ) and health-related quality of life (HR-Qol) measured by EQ5D-VAS. RESULTS: 154 patients were included (mean age 46 years, 69% female). The majority of participants (65%) had symptoms for 1-4 weeks and 12% more than 6 months. The most common symptoms were initially malaise, fatigue, headache, fever and cough and the most common long-term symptoms were impaired physical condition, fatigue, anosmia and headache. The BIPQ index had a negative correlation with the EQ5D-VAS score after the infection, but not with long-term symptoms. Mean differences in the EQ5D-VAS score were significantly lower after the infection and patients with long-term symptoms had a more pronounced negative effect in EQ5D-VAS scores. CONCLUSION: We found that most patients with non-severe covid-19 reported symptoms for 1-4 weeks and approximately 10% developed long-term symptoms. Non-severe covid-19 seems to have a negative influence on HR-Qol, especially in patients with long-term symptoms and with a greater burden from the disease. None of the initial symptoms could predict the presence of long-term symptoms.

Limited Health Literacy and Its Associated Health Outcomes Among Adults With at Least 2 Atopic Diseases.

BACKGROUND: Health literacy (HL) is essential for patients with multiple atopic diseases to improve their health, given the complexity of their disease and treatment regimens. OBJECTIVE: To estimate the proportion of adults with multiple atopic diseases (at least 2 of atopic dermatitis, asthma, allergic rhinitis, and food allergy) in the Dutch general population and to evaluate the prevalence of limited HL, and its association with socioeconomic status (SES), lifestyle factors, and health-related quality of life (HR-QoL) in this patient population. METHODS: This cross-sectional study was conducted within the Lifelines Cohort Study via sending an add-on digital questionnaire, including (among others) questions on atopic dermatitis, to all adult participants (n = 135,950) between February and May 2020. Data on asthma, allergic rhinitis, lifestyle factors, HR-QoL, and SES were extracted from baseline assessment between 2006 and 2013. Functional, communicative, and critical HL were measured by validated items from Chew and the Dutch Functional Communicative and Critical Health Literacy questionnaires between 2012 and 2016. Food allergy was measured by the Food Allergy Questionnaire between 2014 and 2016. RESULTS: In total, 11.8% of the overall study population reported ever having multiple atopic diseases; of those, 23.6% reported having limited functional HL, with a higher prevalence among those with a low SES. Limited functional HL showed positive associations with smoking, obesity, chronic stress, a low diet quality, and decreased HR-QoL among subjects with multiple atopic diseases. CONCLUSIONS: We identified an HL deficit, and its association with a low SES and poor health outcomes among patients with multiple atopic diseases. Further research is warranted to utilize a more extensive assessment to measure HL and include more health outcomes, such as treatment adherence and disease control.

Prevalence of global spinal malalignment and the influence on LBP and HR-QOL in a healthy, nonelderly population. A cross sectional analysis, including bone mineral density, skeletal muscle mass index, and back muscle extensor strength.

Background: In healthy, nonelderly populations, prevalence of 3 modifiers of global spinal malalignment (GS-MalAlign) (PT ≧20°, PI-LL≧10°, SVA≧40 mm) remains unknown. The clinical significance has not been determined. The purposes are to disclose the prevalence of the 3 modifiers of GS-MalAlign, and evaluate the influence on LBP, and HR-QOL related to bone mineral density (BMD), skeletal muscle mass index (SMI), and back muscle extensors strength (BMES) in a healthy, nonelderly population. Methods: A mono-centric, cross-sectional survey. Three hundred and 2 participants (18< age <65 years) without ADL disturbance were consecutively enrolled. Sagittal parameters of the spine and the pelvis were measure on whole spine radiograms. BMD and SMI were determined using DEXA. BMES was defined as a maximum extension force at the T4 to T7 level and measured by a strain-gauge dynamotor. LBP was checked through interview. HR-QOL was ascertained by score of Medical Outcome Study Short-Form 36-Health Survey (SF-36v2). Results: The final analysis could be done in 84 females and 179 males. PT≧20°, PI-LL≧10°, and SVA≧40 mm were found in 12% (31/263), 11% (31/263), and 6% (16/263), and each mean value was 25.0 ± 4.0°, 15.3 ± 5.9°, and 52.7 ± 12.2 mm (Mean ± S.D.). Prevalence of LBP was significantly higher in the participants with PI-LL≧10° than with PI-LL<10°; 43% (12/28) versus 21% (49/235) (p<.05). PI-LL≧10° only had an association with LBP (OR: 3.0435, 95% CI, 1.1378-8.141, p<.05). Four 2% of participants (4/263) associated with all 3 modifiers had LBP and a significantly lower mental component summary score of SF-36v2 (p<.05). Conclusions: Some of individuals are associated with GS-MalAlign even in healthy, nonelderly populations. There is a possibility that PI-LL ≧10° results in LBP within a degree of no ADL disturbance, and it is speculated that coexistence of all 3 modifiers of GS-MalAlign would lead to a poor mental HR-QOL.