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Nevin Manimala Statistics

Longitudinal Cohort Study of Verbatim-Reported Postural Instability Symptoms as Outcomes for Online Parkinson’s Disease Trials

J Parkinsons Dis. 2022 Jun 6. doi: 10.3233/JPD-223274. Online ahead of print.

ABSTRACT

BACKGROUND: The Parkinson’s Disease Patient Report of Problems (PD-PROP) captures the problems and functional impact that patients report verbatim. Online research participation and advances in language analysis have enabled longitudinal collection and classification of symptoms as trial outcomes.

OBJECTIVE: Analyze verbatim reports longitudinally to examine postural-instability symptoms as 1) precursors of subsequent falling and 2) newly occurring symptoms that could serve as outcome measures in randomized controlled trials.

METHODS: Problems reported by >25,000 PD patients in their own words were collected online in the Fox Insight observational study and classified into symptoms by natural language processing, clinical curation, and machine learning. Symptoms of gait, balance, falling, and freezing and associated reports of having fallen in the last month were analyzed over three years of longitudinal observation by a Cox regression model in a cohort of 8,287 participants. New onset of gait, balance, falling, and freezing symptoms was analyzed by Kaplan-Meier survival techniques in 4,119 participants who had not previously reported these symptoms.

RESULTS: Classified verbatim symptoms of postural instability were significant precursors of subsequent falling among participants who were older, female, and had longer PD duration. New onset of symptoms steadily increased and informed sample size estimates for clinical trials to reduce the onset of these symptoms.

CONCLUSION: The tools to analyze symptoms reported by PD patients in their own words and capacity to enroll large numbers of research participants online support the feasibility and statistical power for conducting randomized clinical trials to detect effects of therapeutic interventions.

PMID:35694935 | DOI:10.3233/JPD-223274

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Nevin Manimala Statistics

Effects of an active hand exoskeleton on forearm muscle activity in industrial assembly grips

Work. 2022 Jun 10. doi: 10.3233/WOR-211272. Online ahead of print.

ABSTRACT

BACKGROUND: The Bioservo Ironhand ® is a commercially available active hand exoskeleton for reducing grip-induced stress.

OBJECTIVES: The study aimed at quantifying the effect of the Ironhand ® exoskeleton on the myoelectric muscle activity of forearm flexor and extensor muscles in three relevant assembly grip tasks: 2-Finger-grip (2Finger), 5-Finger-grip (5Finger) and Full grip (FullGrip).

METHODS: Twenty-two subjects were tested in three different exoskeleton conditions for each grip task (overall 3×3×10 = 90 repetitions in randomized order): Exoskeleton off (Off), Exoskeleton on, “locking tendency” 0% (On_LT0), and Exoskeleton on, “locking tendency” 85% (On_LT85). Muscle activity was measured at 25% of the participant’s maximum grip force using two EMG sensors at the M. flexor digitorum superficialis (M.FDS) and one at the M. extensor digitorum (M.ED).

RESULTS: The effect of the Ironhand ® exoskeleton varied depending on the grip task and the participant’s sex. A statistically significant reduction in muscle activity of the M.FDS was found only for male subjects in the FullGrip condition. No reduction of muscular activity in the M.FDS was found for the other grip tasks (2Finger, 5Finger). For the females in the 2Finger condition, mean muscle activity of M.FDS even increased significantly in On_LT0 compared to Off. Besides differences between grip tasks and sex, the current study revealed substantial individual differences.

CONCLUSIONS: In addition to testing for statistical significance, a detailed exploratory analysis of exoskeleton effects at subject level should be performed to evaluate these from a safety and regulatory perspective.

PMID:35694945 | DOI:10.3233/WOR-211272

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Evaluating the Use of Digital Biomarkers to Test Treatment Effects on Cognition and Movement in Patients with Lewy Body Dementia

J Parkinsons Dis. 2022 Jun 4. doi: 10.3233/JPD-213126. Online ahead of print.

ABSTRACT

BACKGROUND: PRESENCE was a Phase 2 trial assessing mevidalen for symptomatic treatment of Lewy body dementia (LBD). Participants received daily doses (10, 30, or 75 mg) of mevidalen (LY3154207) or placebo for 12 weeks.

OBJECTIVE: To evaluate if frequent cognitive and motor tests using an iPad app and wrist-worn actigraphy to track activity and sleep could detect mevidalen treatment effects in LBD.

METHODS: Of 340 participants enrolled in PRESENCE, 238 wore actigraphy for three 2-week periods: pre-, during, and post-intervention. A subset of participants (n = 160) enrolled in a sub-study using an iPad trial app with 3 tests: digital symbol substitution (DSST), spatial working memory (SWM), and finger-tapping. Compliance was defined as daily test completion or watch-wearing ≥23 h/day. Change from baseline to week 12 (app) or week 8 (actigraphy) was used to assess treatment effects using Mixed Model Repeated Measures analysis. Pearson correlations between sensor-derived features and clinical endpoints were assessed.

RESULTS: Actigraphy and trial app compliance was > 90% and > 60%, respectively. At baseline, daytime sleep positively correlated with Epworth Sleepiness Scale score (p < 0.01). Physical activity correlated with improvement on Movement Disorder Society -Unified Parkinson Disease Rating Scale (MDS-UPDRS) part II (p < 0.001). Better scores of DSST and SWM correlated with lower Alzheimer Disease Assessment Scale -Cognitive 13-Item Scale (ADAS-Cog13) (p < 0.001). Mevidalen treatment (30 mg) improved SWM (p < 0.01), while dose-dependent decreases in daytime sleep (10 mg: p < 0.01, 30 mg: p < 0.05, 75 mg: p < 0.001), and an increase in walking minutes (75 mg dose: p < 0.001) were observed, returning to baseline post-intervention.

CONCLUSION: Devices used in the LBD population achieved adequate compliance and digital metrics detected statistically significant treatment effects.

PMID:35694933 | DOI:10.3233/JPD-213126

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Effects of Tianeptine Treatment on Depression and Cognitive Function in Patients with Alzheimer’s Disease: A 12-Month Retrospective Observational Study

J Alzheimers Dis. 2022 Jun 6. doi: 10.3233/JAD-215630. Online ahead of print.

ABSTRACT

BACKGROUND: Depression is a common manifestation in Alzheimer’s disease (AD). In clinical practice, antidepressant medication is often used for depression in AD.

OBJECTIVE: We explore the effectiveness of the atypical antidepressant tianeptine compared with other conventional antidepressants in AD patients with depression in a real-life setting.

METHODS: We retrospectively identified 126 AD patients who had received antidepressant treatment for 12 months with tianeptine or other antidepressants. Subjects were divided into two groups according to the treatment they had received: tianeptine group (n = 38) or other antidepressant group (n = 88). Drug effects on depression, cognition, behavior, and functional performance were evaluated at baseline, 6, and 12 months. A Mixed Effects Model Analysis was carried out to evaluate changes in performance scores.

RESULTS: Both tianeptine and other antidepressants showed an antidepressant effect after 12 months with significant improvement on the Cornell Scale for Depression in Dementia, the Hamilton Depression Rating Scale, and the Neuropsychiatric Inventory-Depression subscale. A statistically significant improvement at 12 months was shown in the tianeptine group versus the other antidepressants group on most of the cognitive measures such as the Mini-Mental State Examination, the Letter and Category Fluency Test, the Rey Auditory Verbal Learning Test, and the Boston Naming Test.

CONCLUSION: Our results suggest that tianeptine reduces depressive symptoms and improve cognition in AD patients. This could be considered clinically relevant and should inspire the design of future long-term randomized controlled trials that contribute to supporting the use of tianeptine for improving cognitive function in AD patients.

PMID:35694919 | DOI:10.3233/JAD-215630

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Nevin Manimala Statistics

Temporomandibular disorders, bite force and osseous changes of the temporomandibular joints in patients with hypermobile Ehlers-Danlos Syndrome compared to a healthy control group

J Oral Rehabil. 2022 Jun 13. doi: 10.1111/joor.13348. Online ahead of print.

ABSTRACT

BACKGROUND: Ehlers-Danlos syndrome (EDS) is a hereditary disorder that affects the connective tissue and collagen structures in the body characterized by joint hypermobility, skin hyperextensibility and tissue fragility.

OBJECTIVE: The aim was to investigate temporomandibular disorders (TMD), bite force, teeth in occlusal contact and osseous changes of the temporomandibular joints (TMJs) in 26 patients with hypermobile EDS (hEDS), differentiated by a genetic test, compared to 39 healthy controls.

METHODS: Clinical examination according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), radiological examinations of the TMJs by cone-beam computed tomographic (CBCT) scans, registration of bite force and teeth in occlusal contact was performed. Statistical analyses included Fisher’s Exact Test, multiple logistic and linear regression models adjusted for age, gender and Body Mass Index (BMI).

RESULTS: Single symptoms and signs of TMD occurred significantly more often in hEDS (p=0.002; p=0.001; p=0.003; p=<0.0001; p=0.012) and maximum mouth opening was significantly smaller in hEDS compared to controls (p=<0.0001). The DC/TMD diagnosis myalgia, myofascial pain with referral, arthralgia, headache attributed to TMD, disc displacement disorders and degenerative joint disease occurred significantly more often in hEDS compared to controls (p=0.000; p=0.008; p=0.003; p=0.000; p=<0.0001; p=0.010, respectively). No significant differences were found in bite force and in teeth in occlusal contact between the groups (p>0.05). On CBCT of the TMJs, subcortical sclerosis occurred significantly more often in hEDS compared to controls (p=0.005).

CONCLUSION: Symptoms and signs of TMD and osseous changes of the TMJs occurred significantly more often in hEDS. Bite force and teeth in occlusal contact were comparable to controls.

PMID:35694904 | DOI:10.1111/joor.13348

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Nevin Manimala Statistics

Incidence, Risk Factors, and Reasons for 30-Day Hospital Readmission Among Healthy Late Preterm Infants

Hosp Pediatr. 2022 Jun 13:e2021006215. doi: 10.1542/hpeds.2021-006215. Online ahead of print.

ABSTRACT

OBJECTIVE: Late preterm infants have an increased risk of morbidity relative to term infants. We sought to determine the rate, temporal trend, risk factors, and reasons for 30-day readmission.

METHODS: This is a retrospective cohort study of infants born at 34 to 42 weeks’ gestation in California between January 1, 2011, and December 31, 2017. Birth certificates maintained by California Vital Statistics were linked to discharge records maintained by the California Office of Statewide Health Planning and Development. Multivariable logistic regression was used to identify risk factors and derive a predictive model.

RESULTS: Late preterm infants represented 4.3% (n = 122 014) of the study cohort (n = 2 824 963), of which 5.9% (n = 7243) were readmitted within 30 days. Compared to term infants, late preterm infants had greater odds of readmission (odds ratio [OR]: 2.34 [95% confidence interval (CI): 2.28-2.40]). The temporal trend indicated increases in all-cause and jaundice-specific readmission infants (P < .001). The common diagnoses at readmission were jaundice (58.9%), infections (10.8%), and respiratory complications (3.5%). In the adjusted model, factors that were associated with greater odds of readmission included assisted vaginal birth, maternal age ≥34 years, diabetes, chorioamnionitis, and primiparity. The model had predictive ability of 60% (c-statistic 0.603 [95% CI: 0.596-0.610]) in late preterm infants who had <5 days length of stay at birth.

CONCLUSION: The findings contribute important information on what factors increase or decrease the risk of readmission. Longitudinal studies are needed to examine promising hospital predischarge and follow-up care practices.

PMID:35694876 | DOI:10.1542/hpeds.2021-006215

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Nevin Manimala Statistics

A low-intensity behavioral intervention for depression in older adults delivered by lay coaches: proof-of-concept trial

Aging Ment Health. 2022 Jun 11:1-8. doi: 10.1080/13607863.2022.2084709. Online ahead of print.

ABSTRACT

OBJECTIVES: A broader workforce is necessary to expand U.S. geriatric mental health services. We examined (1) feasibility of training undergraduate students to deliver Do More, Feel Better (DMFB), an evidence-informed program for depression; and (2) feasibility, acceptability, and outcomes in a single-arm proof-of-concept trial.

METHOD: In Study 1, we taught DMFB to 18 upper-level undergraduate students and assessed fidelity using role plays. In Study 2, four students delivered six weekly DMFB sessions to 12 community-dwelling older adults (M = 66.83 years old, SD = 10.39) with depression (PHQ ≥ 10). Patient outcomes were change in pre- to post-treatment depressive symptoms, disability, and the target mechanism of increased activity.

RESULTS: Fidelity was high in the course (Study 1; 82.4% of role plays rated as ‘passing’) and the trial (Study 2; 100% of 24 sessions rated as ‘passing’). The majority (83.3%) of patients were retained and evidenced statistically and clinically significant improvement in depressive symptoms (Hamilton Rating Scale for Depression [HAM-D]), disability (World Health Organization’s Disability Assessment Schedule 2.0 [WHODAS 2.0], and activity (Behavioral Activation for Depression Scale [BADS]).

CONCLUSION: It is feasible to train bachelor’s-level students to deliver a brief, structured intervention for depression. Future research should consider implementation strategies and stakeholder feedback.

PMID:35694856 | DOI:10.1080/13607863.2022.2084709

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A Proactive Behavioral Activities Program (EWA) and the Influence of COVID-19 among Seniors in Congregate Living Communities

J Appl Gerontol. 2022 Jun 13:7334648221108279. doi: 10.1177/07334648221108279. Online ahead of print.

ABSTRACT

Older adults in affordable housing are at risk for mental health problems, physical vulnerability, and isolation. We examine the role of an activities program in buffering the influence of life stressors on the mental health of seniors in congregate housing, using a non-experimental pretest-posttest study design. Results based upon repeated measures analyses (N = 29), found statistically significant (p < .05) program by time effects for depression, coping strategies, positive affect, isolation, and resident satisfaction. Analyses based upon independent samples of pretest and posttest measures (N = 60) were considerably less strong, but consistent in yielding similar patterns to those of the longitudinally gathered data. Our longitudinal findings substantiate the positive impact of the Engage with Age program in supporting older adults living in congregate housing. Researchers need to develop strategies to assess and support the mental health of older persons in low-income urban congregate living in the larger context of COVID-19.

PMID:35694870 | DOI:10.1177/07334648221108279

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Nevin Manimala Statistics

How to evaluate fixed clinical QC limits vs. risk-based SQC strategies

Clin Chem Lab Med. 2022 Jun 14. doi: 10.1515/cclm-2022-0539. Online ahead of print.

NO ABSTRACT

PMID:35694816 | DOI:10.1515/cclm-2022-0539

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Nevin Manimala Statistics

Is reduced health-related quality of life a primary manifestation of fibromyalgia? A comparative study with Rheumatoid arthritis

Psychol Health. 2022 Jun 11:1-19. doi: 10.1080/08870446.2022.2085705. Online ahead of print.

ABSTRACT

BACKGROUND: Fibromyalgia syndrome (FMS) is a chronic pain condition associated with a significant reduction in health-related quality of life (HRQoL). This study compared the different components of HRQoL between FMS and rheumatoid arthritis (RA) patients, and evaluated the relationships between HRQoL and clinical and emotional factors in FMS and RA patients.

METHOD: Women with FMS (n = 80), RA (n = 43) and healthy women (n = 67) participated in the study. HRQoL was assessed by the SF-36 survey. Associations between HRQoL and symptom severity were assessed by correlation and multiple linear regression analyses.

RESULTS: FMS patients displayed lower values for all SF-36 variables than RA patients and healthy participants, while RA patients showed lower values for all SF-36 variables than healthy participants. These group differences persisted after statistically controlling for demographic, clinical and emotional variables. Clinical and emotional factors were inversely associated with SF-36 scores in the overall FMS + RA sample. Depression and fatigue were the strongest negative predictors. However, after the statistical control of the effect of diagnosis (FMS vs. RA) in the regression analysis, most of the associations disappear.

CONCLUSIONS: The fact that group differences in HRQoL remained highly significant after statistically controlling of group differences in clinical symptom severity, and that associations between clinical symptoms and HRQoL disappear when the type of diagnosis was considered in the regression analysis, suggest that impairment of HRQoL could be considered a primary feature of FMS.

PMID:35694814 | DOI:10.1080/08870446.2022.2085705