Objective Measures Of Symptoms Research Articles

155: SYMPTOMATIC RESPONSE FOLLOWING TAVR: A CLINICAL INVESTIGATION

Introduction: Severe aortic valve stenosis (AS) is a progressive and insidious disease that causes rapid progression of debilitating symptoms. There are currently two treatment options that reduce mortality: surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). There are limited reports with a primary focus of symptom improvement following TAVR.The purpose of this study is to examine the AS-related symptoms over time, comparing baseline (pre-TAVR) to post-TAVR symptoms, using both objective and subjective reporting. Methods: This is a retrospective chart review, with descriptive and correlational aspects. It will also be a determination of feasibility for a larger study. A measure of both subjective and objective report of symptoms pre-TAVR and post-TAVR is a component of the charts. The objective measure of symptoms will be the New York Heart Association Functional Classification (NYHA), reported by providers. The shortened version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used to measure subjective symptoms; this survey is completed by patients pre-TAVR and post-TAVR at one month. A sample size of 80 charts from a single site will be used. Descriptive analyses will be used to describe the sample. Chi-square (NYHA class) and dependent t-tests (KCCQ-12 scores) will be used to determine whether changes in symptoms over time are significant. Spearman rank-order will be used to observe for associations between NYHA and KCCQ-12. Correlational statistics (chi-square and Pearson’s) will be used to investigate associations between patient characteristics and symptom scores at one month following TAVR. Results: Preliminary data shows trends towards improvement in self-reported symptoms and provider observed functional classification status post TAVR. Statistical analysis to support these findings is forthcoming. Conclusions: In this feasibility study, preliminary data supports improvement in quality signals status post TAVR. Further large-scale studies are needed to validate these findings.

Comparing symptom measurement tools in pediatric narcolepsy

Narcolepsy is a rare disabling neurological disease, affecting children and adults. The most recent development of measurement tools for narcolepsy were developed for adults; only a few tools are available for children without comparison on their validity. This research aims at comparing the validity of existing measurement tools in paediatric narcolepsy. From an ongoing randomized controlled trial, we extracted the data blind to the treatment of the 93 first terminating patients on which we compared the Paediatric Daytime Sleepiness Scale (PDSS), the Ullanlina Narcolepsy scale (UNS), the Child and Adolescent Sleepiness Questionnaire (CASS), the maintenance of wakefulness test (MWT), and the cataplexy episodes count (CEC).The comparison was carried out on reliability, internal consistency, sensitivity to change, minimum important difference, construct validity and concurrent validity.We provide evidence that the Ullanlina UNS score, currently used for screening purposes, constitutes a reliable and sensitive overall symptom measurement tool. Its subscore (UNS-CTP) based on the first four items permits a sensitive measurement of cataplexy, whereas the UNS-EDS subscore was found inferior to the PDSS scale. Compared with the objective measurement of symptoms (MWT, CEC), these scales better correlated with the clinical global impression of change in time, they are characterized by higher sensitivity, and they are much easier to use.

Remote patient-reported symptoms and passive activity monitoring to improve patient-clinician communication regarding symptoms and functional status: A randomized controlled trial (PROStep).

1506 Background: Oncologists suboptimally assess patient symptoms and functional status, possibly leading to poor symptom management or over-treatment. Remote patient-reported symptoms and passive activity monitoring may provide objective measures of symptoms and functional status to improve patient-clinician communication and symptom understanding. We assessed the impact of a clinician-centered dashboard of longitudinal patient-reported symptoms and step counts on patient-clinician communication regarding symptoms and functional status. Methods: This randomized trial enrolled 108 patients with incurable GI or lung cancers treated with chemotherapy at a large academic health center. Patients were randomized to either of Arms A) control, B) weekly patient-reported symptoms via text message + step tracking from a wearable activity monitor, with summary dashboards given to clinicians at each visit, or C) arm B plus text message-based prompts to patients encouraging discussion of symptoms and functional status prior to each visit. We used Kruskal Wallis tests to compare co-primary outcomes (patient-reported perceptions of clinician symptom and functional status understanding at 6 months after enrollment) between control (A) and intervention (B+C) arms on a 5-point scale (1 = Not at all; 2 = Slightly; 3 = Moderately; 4 = Considerably; 5 = Completely). Results: 33, 37, and 38 patients were enrolled in arms A, B, and C, respectively. Patients were 54.6% male, mean age was 58.9 years, 77% had GI cancer, and 23% had lung cancer. At six months, there was no difference between control and intervention arms in patient perception of clinician understanding of symptoms (Arm A: 4.5, Arm B/C: 4.5, p = 0.85) or functional status (Arm A: 4.5, Arm B/C: 4.3, p = 0.59). Patients reported that their oncology team seldom discussed PROstep data during appointments (mean 2.3 on 5-point scale where 2 = seldom). Hospitalization rates were 42% and 45% for Arms A and B/C (p = 0.8), respectively, and new palliative care referrals were 9% and 10% (p = 0.8), respectively. Mean adherence to weekly patient reports and Fitbit data (at least 4 of 7 days in a week) was 64% and 53%, respectively. Net promoter score was 8.3 on a 10-point scale. Conclusions: Clinician and patient-directed dashboards based on patient-generated health data did not lead to higher patient-perceived clinician understanding of symptoms and functional status, although this was limited by moderate adherence to remote symptom and step count collection and low frequency of clinician discussion of PROStep data with patients, highlighting challenges to clinical application of these data sources. Further efforts are needed to improve patient-clinician communication about symptoms and functional status. Clinical trial information: NCT04616768.

Convolutional neural network ensemble for Parkinson's disease detection from voice recordings

The computerized detection of Parkinson's disease (PD) will facilitate population screening and frequent monitoring and provide a more objective measure of symptoms, benefiting both patients and healthcare providers. Dysarthria is an early symptom of the disease and examining it for computerized diagnosis and monitoring has been proposed. Deep learning-based approaches have advantages for such applications because they do not require manual feature extraction, and while this approach has achieved excellent results in speech recognition, its utilization in the detection of pathological voices is limited. In this work, we present an ensemble of convolutional neural networks (CNNs) for the detection of PD from the voice recordings of 50 healthy people and 50 people with PD obtained from PC-GITA, a publicly available database. We propose a multiple-fine-tuning method to train the base CNN. This approach reduces the semantical gap between the source task that has been used for network pretraining and the target task by expanding the training process by including training on another dataset. Training and testing were performed for each vowel separately, and a 10-fold validation was performed to test the models. The performance was measured by using accuracy, sensitivity, specificity and area under the ROC curve (AUC). The results show that this approach was able to distinguish between the voices of people with PD and those of healthy people for all vowels. While there were small differences between the different vowels, the best performance was when/a/was considered; we achieved 99% accuracy, 86.2% sensitivity, 93.3% specificity and 89.6% AUC. This shows that the method has potential for use in clinical practice for the screening, diagnosis and monitoring of PD, with the advantage that vowel-based voice recordings can be performed online without requiring additional hardware.

The mental health and lifestyle impacts of COVID-19 on bipolar disorder

BackgroundIt is unclear how those with bipolar disorder (BD) have been affected by the coronavirus (COVID-19) pandemic. This study aimed to obtain a more detailed understanding of the current mental health needs of these individuals, which is important for both the development of intervention strategies to better manage patient distress and to better prepare for similar circumstances in future. MethodsThe sample comprised 43 individuals with a verified diagnosis of BD and 24 healthy controls. Data about pandemic-related mental health support use, socio-demographics, mood, lifestyle, social rhythm and subjective cognitive dysfunction data were collected and compared between groups. Inter-relationships between scores were also examined. ResultsNo between-group differences were found in terms of age, sex, living situation, job loss or reduced work hours due to COVID-19. Most patients with BD reported a history of ongoing formal psychological support (68.3%), with most continuing this support throughout the pandemic (82.1%). A large, statistically significant pandemic-related increase in subjective cognitive dysfunction was evident in the BD group. Subjective cognitive dysfunction was significantly associated with negative symptomology, suicidal thoughts, and quality of life ratings. LimitationsData was collected in self-report format in an online survey and objective symptom measures were not used at this time ConclusionThe absenceof substantial differences between patients and controls in terms of mood symptoms, COVID-19 fear or lifestyle factors and social rhythms suggests a degree of resilience in BD patients; despite large pandemic related increases in subjective cognitive dysfunction.

Subjective and Objective Measures of Symptoms, Function, and Outcome in Patients With Degenerative Spine Disease.

Subjective and Objective Measures of Symptoms, Function, and Outcome in Patients With Degenerative Spine Disease.

Clinical Guidance on the Identification and Management of Treatment-Resistant Schizophrenia.

Treatment-resistant schizophrenia (TRS) occurs in approximately 30% of individuals diagnosed with schizophrenia. The identification and management of TRS in clinical practice are inconsistent and not evidence based. No established clinically relevant criteria for defining and treating TRS exist, although guidelines have been promulgated for clozapine use among TRS patients. This report summarizes the consensus from a roundtable that focused on defining and identifying TRS, pathways to treatment resistance, current treatments, unmet needs, and disease burden. Nine clinical experts in schizophrenia and TRS participated in a closed meeting on June 23, 2017, sponsored by Lundbeck, at which published literature in key areas of TRS research was reviewed. The findings from published studies were synthesized by experts in each area and presented to the group for review and discussion. It was agreed that inadequate response to 2 different antipsychotics, each taken with adequate dose and duration, is required to establish TRS. This recommendation is consistent with guidelines for clozapine use. For each trial, objective symptom measures should be used to assess treatment response, with medication adherence ensured. Once nonresponse is established (after ≥ 12 weeks for positive symptoms [2 trials of ≥ 6 weeks]), the treatment plan should be reevaluated and alternative pharmacologic or nonpharmacologic treatments considered. With increased awareness, those involved in the care of patients with schizophrenia will be able to identify TRS earlier in its course, thus supporting more informed treatment decisions by clinicians, patients, and caregivers to reduce the overall disease burden.

Postural Stability Assessment in Patients with Mild Traumatic Brain Injury Complaining of Dizziness

We compared subjective and objective measurements of symptoms of dizziness and postural stability in patients with mild traumatic brain injury (mTBI) during the first week following the injury. We recruited 244 patients with mTBI and 105 controls. The Dizziness Handicap Inventory (DHI) and modified Clinical Test of Sensory Integration and Balance were used as the subjective and objective measures of dizziness and ability to perform daily activities, respectively. All four DHI subscores significantly differed among the three mTBI subgroups (low, middle, and high; P = 0.00). The predictor of postural stability and sensory integration in all three DHI subgroups was the eyes closed while standing on a firm surface (ECFIS) condition (P = 0.03). A significant relationship was observed between the emotional (r = 0.14, P = 0.028) and total (r = 0.13, P = 0.048) aspects of the DHI and sensory integration indices (ECFIS). Compared with the healthy controls, balance, postural stability, and sensory integration were considerably impaired in the patients with mTBIs. However, a low correlation was observed between subjective (DHI) and objective balance measurements.

Practical Evaluation and Handling of Patients with Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a functional bowel disorder by unknown aetiology. Several reviews are written about pharmacological and psychological treatment of the disease. Nevertheless, healthcare professionals consider these patients difficult to handle in daily practice. There is an uncertainty about how to measure symptoms and to evaluate the effect of any given treatment. In the absence of objective markers, professionals feel unsure of how to manage the condition and the patients do not feel that they are taken seriously. The development of the short, self-reported questionnaire, Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS), offers a practical guide to objective measurement of symptoms and effect of given treatments into numerical values in the daily practice.

Significant Improvement In Quality Of Life (QoL) In Patients With Chronic Myeloproliferative Neoplasms and Myelofibrosis Treated With JAK-1 and JAK-2 Inhibitor Ruxolitinib. A Single Institution Experience In Mexico

IntroductionMyeloproliferative Neoplasms can shorten the life of patients and affect severely their quality of life as a result of constitutional symptoms mediated by cytokines and from massive splenomegaly characteristic of these diseases. The objective measurement of symptoms in Myelofibrosis is essential for the presence of general constitutional symptoms as fatigue and is considered adverse prognostic value for survival. The systematic measurement of symptoms in Myelofibrosis is essential for assessing the outcome of treatment with JAK-2 inhibitors. Material and MethodsTo assess the impact on quality of life in patients with Myeloproliferative Neoplasms treated with the inhibitor Ruxolitinib, there was applied the questionnaire Myelofibrosis Symptom Assessment Form (Mesa et al. Leukemia Research. 2009: 33; 1199-1203) to 16 patients included in the Compassionate Use of Ruxolitinib Program: 8 men and 8 women were included with a median age of 63 years; 4 patients with primary Myelofibrosis, 3 with Myelofibrosis post Polycitemia vera and 9 with Myelofibrosis post essential Thrombocythemia. The median patient follow-up was 9 months. The patients started with a dose of 20 mg Ruxolitinib orally every 12 hours. ResultsThe questionnaire was administered to all patients at each visit and the results of the ratings of the patients were presented as median of each answer at baseline, 3, 6 and 12 months of follow-up (table 1). By comparing the differences of each parameter measured between the start and at 3, 6 and 12 months were statistically significant for all variables (P <0.001, CI: 95%). The most significant changes were observed when comparing data at baseline and follow-up to the maximum time, however were obvious from the first quarter of observation on fatigue and symptoms dependent splenomegaly in most general symptoms, which actually disappeared completely after 3 months of treatment and not relapsed during the track and in the perception of the quality of life of patients. The variables with lower proportional change recorded were general activity, mood, walking tolerance and everyday work. [Display omitted] Discussion and conclusionsThe treatment of Myeloproliferative Neoplasms with Ruxolitinib represents a major advance in the management of malignant Myeloproliferative and achieved excellent improvement in overall constitutional symptom control, splenomegaly and the general perception of the quality of life of these patients. The objective measurement of symptoms of Myelofibrosis is essential, since the presence of general constitutional symptoms as fatigue is considered adverse prognostic value for survival and systematic measurement of symptoms in Myelofibrosis is essential for assessing the outcome of treatment with inhibitors JAK-2. Disclosures:No relevant conflicts of interest to declare.

Use of Image Analysis to Assess Color Response on Plants Caused by Herbicide Application

In herbicide-selectivity experiments, response can be measured by visual inspection, stand counts, plant mortality, and biomass. Some response types are relative to nontreated control. We developed a nondestructive method by analyzing digital color images to quantify color changes in leaves caused by herbicides. The range of color components of green and nongreen parts of the plants and soil in Hue, Saturation, and Brightness (HSB) color space were used for segmentation. The canopy color changes of barley, winter wheat, red fescue, and brome fescue caused by doses of a glyphosate and diflufenican mixture, cycloxydim, diquat dibromide, and fluazifop-p-butyl were described with a log-logistic dose–response model, and the relationship between visual inspection and image analysis was calculated at the effective doses that cause 50% and 90% response (ED50 and ED90, respectively). The ranges of HSB components for the green and nongreen parts of the plants and soil were different. The relative potencies were not significantly different from one, indicating that visual and image analysis estimations were about the same. The comparison results suggest that image analysis can be used to assess color changes of plants in response to some herbicides and may have the potential to provide an objective measurement of symptoms.

Prospective patterns and correlates of quality of life among women in substance abuse treatment

BackgroundQuality of life (QOL) is increasingly recognized as central to the broad construct of recovery in substance abuse services. QOL measures can supplement more objective symptom measures, identify specific service needs and document changes in functioning that are associated with substance use patterns. To date however, QOL remains an under investigated area in the addictions field, especially in the United States. MethodsThis study examines patterns and predictors of QOL at 1 and 6 months post treatment intake among 240 women enrolled in substance abuse treatment in Cleveland, Ohio. The World Health Organization Quality of Life (WHOQOL-BREF) measure was used to assess physical, psychological, social and environmental domains. Hierarchical multiple regressions were conducted to identify correlates of QOL at 6 months post treatment intake. ResultsAll QOL domains across the follow up time points improved significantly. However, QOL scores across domains remained below those of healthy population norms. Trauma symptoms significantly predicted Physical and Psychological QOL. Among treatment process variables, alcohol use was the sole significant factor associated with QOL and only for Environmental QOL. Recovery support and friends support for abstinence were consistently associated with QOL across all four domains.Implications: This study suggests the usefulness of the WHOQOL measure as an indicator of functioning in substance abusing populations. Findings underline the importance of helping women deal with trauma symptoms and develop support for recovery. Further research is needed on the longitudinal relationship between QOL and substance use patterns.

The use of the fluorescein disappearance test in the management of childhood epiphora

PURPOSE . The fluorescein disappearance test (FDT) is reported to be an objective measure of lacrimal outflow in congenital non-canalisation of the nasolacrimal system. We introduced FDT into our evaluation of children with epiphora to investigate its sensitivity/specificity with regard to symptoms in a prospective study. We also examined the FDT against findings at syringing and probing (S&P) and persistence or resolution of symptoms on follow-up. METHODS . Over a period of 16 months, 88 consecutive children (median age 12 months; range 2.5–192) with epiphora were reviewed and FDT measured at 5 and 10 minutes; 66 FDT were evaluated for inter-observer variation in a masked fashion. S&P were scheduled on the basis of symptoms, abnormal FDT and age „1 year. Normal FDT prompted review. Younger children were observed for natural history and possible resolution with repeat FDT. Equivocal symptoms and normal FDT initiated discharge and telephone review. RESULTS . Inter-observer correlation coefficient = 0.86. Sensitivity/specificity of FDT was 76/76% at 5 minutes and 63/89% at 10 minutes, respectively. In patients under 1 year of age undergoing follow-up (29 patients; 38 eyes) FDT at 10 minutes correctly predicted persistence of symptoms in 65% and resolution in 66% of eyes (follow-up 3–14 months; mean 6); 23 patients (mean age 27 months; range 12–72) underwent S&P with positive surgical findings in 20 (87%). On review, symptoms had improved in 64% eyes (20/31). CONCLUSION . FDT at 5 minutes is an objective measure of symptoms with high inter-observer agreement and agreement with surgical findings. FDT read at 10 minutes may be useful to indicate the persistence or resolution of symptoms and guide patient management.

Exercise echocardiographic assessment in severe mitral regurgitation.

In chronic severe mitral regurgitation, minimum morbidity and mortality is achieved by applying surgical correction before left ventricular dysfunction becomes irreversible. This requires detection of subtle signs of early ventricular decompensation, for which isotonic stress echocardiography is more accurate than is use of resting indices of contractile function alone. We perform serial 6-monthly stress echocardiography for patients with severe mitral regurgitation, and recommend surgery when the exercise end-systolic volume index or ejection fraction reaches the cutoff values in Table 4 or if there is a clear adverse trend. Exercise echocardiography is more accurate than is exercise electrocardiography for detecting concomitant coronary disease prior to revascularization. Stress testing is also an objective measure of symptoms. Color-Doppler stress echocardiography can detect those patients whose mitral regurgitation worsens (or even develops de novo) with exercise, which can explain unexpected symptoms. Stress echocardiography, therefore, provides a comprehensive and cost-effective evaluation of patients with mitral regurgitation that combines functional, diagnostic, and prognostic information.