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

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

Linking Physical Activity to Personal Values: Feasibility and Acceptability Randomized Pilot of a Behavioral Intervention for Older Adults with Osteoarthritis Pain

Background Osteoarthritis (OA) pain is common and leads to functional impairment for many older adults. Physical activity can improve OA outcomes for older adults, but few are appropriately active. Behavioral interventions can reduce barriers to physical activity. We developed and tested a brief, novel behavioral intervention for older adults combining values to enhance motivation and strategic activity pacing to improve arthritis-related pain and functioning and increase physical activity. Methods A randomized feasibility and acceptability pilot trial compared Engage-PA to treatment as usual plus fitness tracker (TAU+) in N=40 adults age 65+ with OA pain in the knee or hip. Engage-PA involved two 60-minute telephone sessions. All participants wore a fitness tracker to collect daily steps throughout the study and completed baseline and post-treatment assessments of secondary outcomes (arthritis-related pain and physical functioning, physical activity, psychological distress, psychological flexibility, and value-guided action). The impact of COVID-19 on general wellbeing and physical activity was also assessed. Descriptive statistics were conducted for feasibility and acceptability outcomes. Indicators of improvement in secondary outcomes were examined via change scores from baseline to post-treatment and performing independent samples t-tests to assess for between-group differences. Results Feasibility was high; 100% accrual, low (5%) attrition, and 100% completion of study sessions. Acceptability was high, with 89% finding the intervention “mostly” or “very” helpful. Engage-PA participants demonstrated improvements in arthritis pain severity (Mdiff=1.68, p<.05), arthritis-related physical functioning (Mdiff=.875, p=.056), and self-reported activity (Mdiff=.875, p<.05) from baseline to post-treatment as compared to TAU+. Sixty-three percent of participants provided useable objective daily steps data. Other secondary outcome patterns were not interpretable in this small sample. COVID-19 added additional burden to participants, such that 50% were exercising less, 68% were more sedentary, and 72% lost access to spaces and social support to be active. Conclusions Engage-PA is a promising brief, novel behavioral intervention that has potential to support older adults in improving arthritis-related pain and functioning and increasing physical activity. The feasibility and acceptability of the intervention is particularly notable as most participants reported COVID-19 added more barriers to physical activity, and Engage-PA may be appealing in future studies. Trial Registration: clinicaltrials.gov, NCT04490395, registered 7/29/2020, https://clinicaltrials.gov/ct2/show/NCT04490395.

Cardio-psycho-metabolic outcomes of bariatric surgery: design and baseline of the WAS trial

Obesity is a rapidly emerging health problem and an established risk factor for cardiovascular diseases. Bariatric surgery profoundly reduces body weight and mitigates sequelae of obesity. The open, randomized controlled WAS trial compares the effects of Roux-en-Y gastric bypass (RYGB) versus psychotherapy-supported lifestyle modification in morbidly obese patients. The co-primary endpoint addresses 1-year changes in cardiovascular function (peak VO2 during cardiopulmonary exercise testing) and quality of life (Short-Form-36 physical functioning scale). Prior to randomization, all included patients underwent a multimodal anti-obesity treatment for 6-12 months. Thereafter, patients were randomized and followed through month 12 to collect primary endpoints. Afterwards, patients in the lifestyle group could opt for surgery, and final visit was scheduled for all patients 24 months after randomization. Sample size calculation suggested to enroll 90 patients in order to arrive at minimally 22 patients per group evaluable for the primary endpoint. Secondary objectives were to quantify changes in body weight, left ventricular hypertrophy, systolic and diastolic function (by echocardiography and cardiac magnet resonance imaging [MRI]), functional brain MRI, psychometric scales, endothelial and metabolic function. WAS enrolled 93 patients (72 women, median age 38 years, BMI 47.5 kg/m2) exhibiting a relevantly compromised exercise capacity (median peakVO2 18.3 ml/min/kg) and quality of life (median physical functioning scale 50). WAS is the first randomized controlled trial focusing on the effects of RYGB on cardiovascular function beyond hypertension. In addition, it will provide a wealth of high-quality data on cerebral, psychiatric, hepatic, and metabolic function in obese patients after RYGB. The trial is registered at ClinicalTrials.gov (NCT01352403).

Psychometric Properties of the Barthel Index Used at Intensive Care Unit Discharge

Background The Barthel Index, originally developed and validated to assess activities of daily living in patients with neuromuscular disorders, is commonly used in research and clinical practice involving critically ill patients. Objectives To evaluate the internal consistency, reliability, measurement error, and construct validity of the Barthel Index used at intensive care unit discharge. Methods In this observational study, 2 physiotherapists measured the physical functioning of 122 patients at intensive care unit discharge, using the Barthel Index and other measurement instruments. Results The patients had a median (IQR) age of 56 (47-66) years, and 62 patients (51%) were male. The primary reason for intensive care unit admission was sepsis (28 patients [23%]), and 83 patients (68%) were receiving mechanical ventilation. The Cronbach α value indicating internal consistency was 0.81. For interrater reliability, the intraclass correlation coefficient for the total score was 0.98 (95% CI, 0.97-0.98; P &lt; .001) and the κ statistic for the individual items was 0.54 to 0.94. The standard error of measurement was 7.22, the smallest detectable change was 20.01, and the 95% limits of agreement were –10.3 and 11.8. The Barthel Index showed moderate to high correlations with the other physical functioning measurement instruments (ρ = 0.57 to 0.88; P &lt; .001 for all). Conclusion The Barthel Index is a reliable and valid instrument for assessing physical functioning at intensive care unit discharge.

Self-Reported Autonomic Dysregulation in Gulf War Illness

ABSTRACT Introduction Autonomic nervous system dysregulation is commonly observed in Gulf War illness (GWI). Using a new sample, we sought to replicate and extend findings from a previous study that found autonomic symptoms predicted physical functioning in Veterans with GWI. Materials and Methods A linear regression model was used to predict physical functioning (36-item Short Form Health Survey (SF-36); n = 73, 75% male). First, we examined the predictive value of independent variables individually in the model including: the 31-item Composite Autonomic Symptom Score (COMPASS-31) total score, body mass index (BMI), mental health burden (i.e., post-traumatic stress disorder [PTSD] and/or depression), and COMPASS-31 subscales: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor. Next, we estimated linear regression models containing the three variables (autonomic symptoms, BMI, and mental health burden) identified as predictors of physical functioning from the prior study. Results These linear regression models significantly predicted physical functioning and accounted for 15% of the variance with COMPASS-31, 36.6% of variance with COMPASS-31 and BMI, and 38.2% of variance with COMPASS-31, BMI, and mental health burden. Then, forward step-wise linear regressions were applied to explore new models including COMPASS-31 subscales. Two new models accounted for more of the variance in physical functioning: 39.3% with added gastrointestinal symptoms (β = −2.206, P = .001) and 43.4% of variance with both gastrointestinal (β = −1.592, P = .008) and secretomotor subscales (β = −1.533, P = .049). Unlike the previous study we intended to replicate, mental health burden was not a significant predictor in any of our models. Conclusions Treatments that address autonomic dysregulation should be prioritized for research and clinical recommendations for Veterans with GWI who experience chronic pain.

Mental and Psycho-social Health and Quality-of-Life Before and After Cardiac Rehabilitation: A Prospective Cohort Study With Comparison to Specific Population Norms

Background. Data on mental health improvement after cardiac rehabilitation (CR) are contradicting. The aim was to examine the mental and psycho-social health of patients admitted to our rehabilitation center following hospital treatment for acute coronary syndrome, before and after multidisciplinary CR.Methods. Outcome was measured at admission and discharge by the 36-Item Short Form Survey (SF-36), the Symptom Checklist-90 Revised (SCL-90R), the Coping Strategy Questionnaire (CSQ) and the 6-minute-walking distance test. The patients’ health status was compared with norms of sex-, age- and comorbidity-matched data from the German general population. Score differences from norms were measured by standardized mean differences (SMDs); health changes were quantified by standardized effect sizes (ESs). Their importance for comprehensive assessment was quantified by explorative factor analysis.Results. Of n=70 patients followed-up (male: 79%; mean age: 66.6 years), 79% had ≥3 comorbidities. At baseline, SF-36 Physical functioning (SMD=–0.75), Role physical (–0.90), Social functioning (SMD=–0.44), and Role emotional (SMD=–0.45) were significantly worse than the norm. After CR, almost all scores significantly improved by ES=0.23 (SCL-90R Interpersonal sensitivity) to 1.04 (SF-36 Physical functioning). The strongest factor (up to 41.1% explained variance) for health state and change was the mental health domain, followed by function&pain (up to 26.3%).Conclusions. Normative deficits in physical and psycho-social health were reported at baseline. After CR, at follow-up, all scores, except phobia, showed significant improvement. The comprehensive measurement of bio-psycho-social health should not be limited to depression and anxiety but include, especially, the somatization and social participation dimensions.

Health-related quality of life with idecabtagene vicleucel in relapsed and refractory multiple myeloma

Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy, showed deep, durable responses in patients with triple-class exposed (TCE) relapsed and refractory multiple myeloma (RRMM) in the phase 2 KarMMa trial. We assessed health-related quality of life (HRQoL) among KarMMa patients. EORTC QLQ-C30, EORTC QLQ-MY20, and EQ-5D-5L were given at screening, baseline (≤72 hours prior to or same day as lymphodepletion), day of ide-cel treatment, and after ide-cel treatment. Mean changes from baseline that exceeded the predetermined threshold of minimally important difference were deemed clinically meaningful. Proportions of patients experiencing clinically meaningful changes in HRQoL were assessed using within-patient change thresholds. Time to stable improvement (≥2 consecutive visits with clinically meaningful HRQoL improvements) was analyzed using the Kaplan-Meier method. 126/128 (98%) patients treated with ide-cel were included in the HRQoL analysis. Pretreatment baseline RRMM burden was high and meaningfully worse than the age- and sex-weighted general population. Statistically significant and clinically meaningful improvements from baseline were observed by month 1 for pain (−8.9) and disease symptoms (−10.2), and by month 2 for fatigue (−7.2), physical functioning (+6.1), cognitive functioning (+6.7), and global health status/QoL (+8.0). Clinically meaningful improvements in fatigue, pain, and physical functioning were most prominent at months 9, 12, and 18, respectively, and were sustained through 15 to 18 months after ide-cel treatment. For TCE patients with RRMM with a poor prognosis and few treatment options, a single ide-cel infusion provides early, sustained, statistically significant, and clinically meaningful improvements in HRQoL.