Clinical utility of ultra long-term subcutaneous electroencephalographic monitoring in drug-resistant epilepsies: a "real world" pilot study.

OBJECTIVE: This study was undertaken to assess the clinical utility, safety, and tolerability in epilepsy patients of ultra long-term monitoring with a novel subcutaneous electroencephalographic (EEG) device (sqEEG). METHODS: Five patients with drug-resistant focal epilepsy were implanted (one patient bilaterally) with sqEEG. In phase 1, we assessed sqEEG sensitivity for seizure recording by recording seizures simultaneously with scalp EEG in the epilepsy monitoring unit (EMU). sqEEG was scored either visually (v-sqEEG) or by using a semiautomatic algorithm (EpiSight; E-sqEEG). In phase 2, the patients were monitored as outpatients for 3-6 months. sqEEG data were analyzed monthly, evaluating concordance of data obtained by v-sqEEG, E-sqEEG, and patients' diaries. v-sqEEG data were used to guide treatment adjustments. sqEEG-related side effects were assessed throughout the study. RESULTS: In phase 1, v-sqEEG detected all seizures recorded in the EMU in all patients, whereas E-sqEEG was as effective in three patients. In the other two patients, E-sqEEG detected only a proportion or none of the seizures, respectively. Sensitivity of E-sqEEG depended on the ictal EEG features. In phase 2, a 100% concordance between E-sqEEG and v-sqEEG in seizure detection was observed for the same three patients as in phase 1. In the other two patients (one implanted bilaterally), effectiveness of E-sqEEG in detecting seizure as compared to v-sqEEG ranged from 0% to 83%. v-sqEEG showed that all patients reported in their diaries fewer seizures than they actually suffered. In four of five patients, v-sqEEG showed that the treatment adjustments had been ineffective or associated with a seizure increment. The only side effect was an infection at the implantation site in one patient. SIGNIFICANCE: The sqEEG system could collect reliable information on seizure activity, thus providing clinically relevant information. Sensitivity of EpiSight in detecting seizures varied across patients, depending on the ictal EEG features. sqEEG ultra long-term monitoring was feasible and well tolerated.

Personalized monitoring of ambulatory function with a smartphone 2-minute walk test in multiple sclerosis.

BACKGROUND: Remote smartphone-based 2-minute walking tests (s2MWTs) allow frequent and potentially sensitive measurements of ambulatory function. OBJECTIVE: To investigate the s2MWT on assessment of, and responsiveness to change in ambulatory function in MS. METHODS: One hundred two multiple sclerosis (MS) patients and 24 healthy controls (HCs) performed weekly s2MWTs on self-owned smartphones for 12 and 3 months, respectively. The timed 25-foot walk test (T25FW) and Expanded Disability Status Scale (EDSS) were assessed at 3-month intervals. Anchor-based (using T25FW and EDSS) and distribution-based (curve fitting) methods were used to assess responsiveness of the s2MWT. A local linear trend model was used to fit weekly s2MWT scores of individual patients. RESULTS: A total of 4811 and 355 s2MWT scores were obtained in patients (n = 94) and HC (n = 22), respectively. s2MWT demonstrated large variability (65.6 m) compared to the average score (129.5 m), and was inadequately responsive to anchor-based change in clinical outcomes. Curve fitting separated the trend from noise in high temporal resolution individual-level data, and statistically reliable changes were detected in 45% of patients. CONCLUSIONS: In group-level analyses, clinically relevant change was insufficiently detected due to large variability with sporadic measurements. Individual-level curve fitting reduced the variability in s2MWT, enabling the detection of statistically reliable change in ambulatory function.

[Outpatient long-term video EEG as new diagnostic approach in Germany: results of a feasibility study]. / Ambulantes Langzeit-Video-EEG als neuer diagnostischer Ansatz in Deutschland: Ergebnisse einer Machbarkeitsstudie.

In Germany, long-term video EEG as the gold standard for the diagnostics of epilepsy and other seizure disorders, is currently only available for inpatient monitoring in a limited number of specialized centers. These limited monitoring capacities and the large amount of associated time and work resources lead to a significant waiting time for this important diagnostic procedure nationwide. New portable sensor technology and automated data analysis methods are creating opportunities for gold standard long-term video EEG assessments in outpatient settings, which may help to resolve this barrier. Here, we report the results of a single-center feasibility study by implementing outpatient long-term video EEG (ALVEEG) as a diagnostic pathway in Germany. In the new diagnostic pathway, the use of innovative, portable video EEG monitoring systems along with artificial intelligence-assisted data analysis are intended to provide those patients affected by seizure disorders with a more rapid, efficient, and cross-sectoral access to gold standard diagnostics in the home environment. The diagnostics were well accepted by patients and clinicians and may represent a complementary option to inpatient monitoring to eliminate current bottlenecks in diagnostics and care.

The Use of Smartphone Keystroke Dynamics to Passively Monitor Upper Limb and Cognitive Function in Multiple Sclerosis: Longitudinal Analysis.

BACKGROUND: Typing on smartphones, which has become a near daily activity, requires both upper limb and cognitive function. Analysis of keyboard interactions during regular typing, that is, keystroke dynamics, could therefore potentially be utilized for passive and continuous monitoring of function in patients with multiple sclerosis. OBJECTIVE: To determine whether passively acquired smartphone keystroke dynamics correspond to multiple sclerosis outcomes, we investigated the association between keystroke dynamics and clinical outcomes (upper limb and cognitive function). This association was investigated longitudinally in order to study within-patient changes independently of between-patient differences. METHODS: During a 1-year follow-up, arm function and information processing speed were assessed every 3 months in 102 patients with multiple sclerosis with the Nine-Hole Peg Test and Symbol Digit Modalities Test, respectively. Keystroke-dynamics data were continuously obtained from regular typing on the participants' own smartphones. Press-and-release latency of the alphanumeric keys constituted the fine motor score cluster, while latency of the punctuation and backspace keys constituted the cognition score cluster. The association over time between keystroke clusters and the corresponding clinical outcomes was assessed with linear mixed models with subjects as random intercepts. By centering around the mean and calculating deviation scores within subjects, between-subject and within-subject effects were distinguished. RESULTS: Mean (SD) scores for the fine motor score cluster and cognition score cluster were 0.43 (0.16) and 0.94 (0.41) seconds, respectively. The fine motor score cluster was significantly associated with the Nine-Hole Peg Test: between-subject ß was 15.9 (95% CI 12.2-19.6) and within-subject ß was 6.9 (95% CI 2.0-11.9). The cognition score cluster was significantly associated with the Symbol Digit Modalities Test between subjects (between-subject ß -11.2, 95% CI -17.3 to -5.2) but not within subjects (within-subject ß -0.4, 95% CI -5.6 to 4.9). CONCLUSIONS: Smartphone keystroke dynamics were longitudinally associated with multiple sclerosis outcomes. Worse arm function corresponded with longer latency in typing both across and within patients. Worse processing speed corresponded with higher latency in using punctuation and backspace keys across subjects. Hence, keystroke dynamics are a potential digital biomarker for remote monitoring and predicting clinical outcomes in patients with multiple sclerosis. TRIAL REGISTRATION: Netherlands Trial Register NTR7268; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7268.

Unexpected high frequency of early mortality in COVID-19: a single-centre experience during the first wave of the pandemic.

We report the high frequency of early mortality in COVID-19 patients (48.6% of 72 deaths). Early deaths were not explained by differences in age, sex and comorbidities, but they had a more severe disease at hospital admission compared with late deaths. These data highlight the importance of outpatient monitoring for the early identification of COVID-19 patients who require hospital admission.

HOPES: An Integrative Digital Phenotyping Platform for Data Collection, Monitoring, and Machine Learning.

The collection of data from a personal digital device to characterize current health conditions and behaviors that determine how an individual's health will evolve has been called digital phenotyping. In this paper, we describe the development of and early experiences with a comprehensive digital phenotyping platform: Health Outcomes through Positive Engagement and Self-Empowerment (HOPES). HOPES is based on the open-source Beiwe platform but adds a wider range of data collection, including the integration of wearable devices and further sensor collection from smartphones. Requirements were partly derived from a concurrent clinical trial for schizophrenia that required the development of significant capabilities in HOPES for security, privacy, ease of use, and scalability, based on a careful combination of public cloud and on-premises operation. We describe new data pipelines to clean, process, present, and analyze data. This includes a set of dashboards customized to the needs of research study operations and clinical care. A test use case for HOPES was described by analyzing the digital behavior of 22 participants during the SARS-CoV-2 pandemic.

Front-Line innovation: Rapid implementation of a nurse-driven protocol for care of outpatients with COVID-19.

AIMS AND OBJECTIVES: Our objective was to rapidly adapt and scale a registered nurse-driven Coordinated Transitional Care (C-TraC) programme to provide intensive home monitoring and optimise care for outpatient Veterans with COVID-19 in a large urban Unites States healthcare system. BACKGROUND: Our diffuse primary care network had no existing model of care by which to provide coordinated result tracking and monitoring of outpatients with COVID-19. DESIGN: Quality improvement implementation project. METHODS: We used the Replicating Effective Programs model to guide implementation, iterative Plan-Do-Study-Act cycles and SQUIRE reporting guidelines. Two transitional care registered nurses, and a geriatrician medical director developed a protocol that included detailed initial assessment, overnight delivery of monitoring equipment and phone-based follow-up tailored to risk level and symptom severity. We tripled programme capacity in time for the surge of cases by training Primary Care registered nurses. RESULTS: Between 23 March and 15 May 2020, 120 Veterans with COVID-19 were enrolled for outpatient monitoring; over one-third were aged 65 years or older, and 70% had medical conditions associated with poor COVID-19 outcomes. All Veterans received an initial call within a few hours of the laboratory reporting positive results. The mean length of follow-up was 8.1 days, with an average of 4.2 nurse and 1.3 physician or advanced practice clinician contacts per patient. The majority (85%) were managed entirely in the outpatient setting. After the surge, the model was disseminated to individual primary care teams through educational sessions. CONCLUSION: A model based on experienced registered nurses can provide comprehensive, effective and sustainable outpatient monitoring to high-risk populations with COVID-19.

Duration of Electrocardiographic Monitoring of Emergency Department Patients With Syncope.

BACKGROUND: The optimal duration of cardiac rhythm monitoring after emergency department (ED) presentation for syncope is poorly described. We sought to describe the incidence and time to arrhythmia occurrence to inform decisions regarding duration of monitoring based on ED risk stratification. METHODS: We conducted a prospective cohort study with enrolled adult patients (≥16 years old) presenting within 24 hours of syncope at 6 EDs. We collected baseline characteristics, time of syncope and ED arrival, and the Canadian Syncope Risk Score (CSRS) risk category. We followed subjects for 30 days, and our adjudicated primary outcome was serious arrhythmic conditions (arrhythmias, interventions for arrhythmias, and unexplained death). After excluding patients with an obvious serious condition on ED presentation and those with missing CSRS predictors, we used Kaplan-Meier analysis to describe the time to serious arrhythmic outcomes. RESULTS: A total of 5581 patients (mean age, 53.4 years; 54.5% females; 11.6% hospitalized) were available for analysis, including 346 (6.2%) for whom the 30-day follow-up was incomplete and who were censored at the last follow-up time. A total of 417 patients (7.5%) experienced serious outcomes, 207 of which (3.7%; 95% CI, 3.3%-4.2%) were arrhythmic (161 arrhythmias, 30 cardiac device implantations, 16 unexplained deaths). Overall, 4123 (73.9%) were classified as CSRS low risk, 1062 (19.0%) medium risk, and 396 (7.1%) high risk. The CSRS accurately stratified subjects as low risk (0.4% risk for 30-day arrhythmic outcome), medium risk (8.7% risk), and high risk (25.3% risk). One-half of arrhythmic outcomes were identified within 2 hours of ED arrival in low-risk patients and within 6 hours in medium- and high-risk patients, and the residual risk after these cut points were 0.2% for low-risk, 5.0% for medium-risk, and 18.1% for high-risk patients. Overall, 91.7% of arrhythmic outcomes among medium- and high-risk patients, including all ventricular arrhythmias, were identified within 15 days. None of the low-risk patients experienced ventricular arrhythmia or unexplained death, whereas 0.9% of medium-risk patients and 6.3% of high-risk patients experienced them ( P<0.0001). CONCLUSIONS: Serious underlying arrhythmia was often identified within the first 2 hours of ED arrival for CSRS low-risk patients and within 6 hours for CSRS medium- and high-risk patients. Outpatient cardiac rhythm monitoring for 15 days for selected medium-risk patients and all high-risk patients discharged from the hospital should also be considered.

Assessment of anti-infective medication adherence in pediatric outpatients.

The objective of this pilot study was to assess the overall adherence rate of the pediatric population to anti-infective drugs prescribed for acute infection at hospital discharge and to identify risk factors for non-adherence behavior. Pediatric patients discharged from a French university hospital with at least one oral drug prescription for acute infection were included for 3 months. Medication adherence and antibiotic knowledge were assessed through data collected by calling the parents. Overall adherence was assessed according to seven items: medication order filling, administered dose, time of intake, frequency of doses, medication omission, dose modification, and length of treatment. Seventy-five patients were included, and 63 interviews were exploited. The median age was 1.4 years, IQR = [0.7; 3.3]. Overall adherence to anti-infective agents concerned 34.9% of patients. The most frequently prescribed antibiotics were amoxicillin (29.3%), amoxicillin associated with clavulanic acid (25.3%), cotrimoxazole (18.7%), and cefixime (12.0%). A lack of parents' anti-infective knowledge was associated with non-adherence to anti-infective drugs.Conclusion: Two-thirds of outpatients were non-adherent to anti-infectives in acute infectious diseases. The misunderstanding of anti-infective treatment could be a risk factor for non-adherence. Implementation of preventive actions such as therapeutic education or pharmaceutical counseling at hospital discharge could improve adherence to anti-infective agents. What Is Known: • Non-adherence to anti-infective drugs involves the emergence and spread of antibiotic resistance. • Very few studies have assessed medication adherence in acute infectious diseases in pediatrics after hospital discharge. What Is New: • Only 35% of children were overall adherent to anti-infective drugs in acute infectious disease after hospital discharge. • Most patients (89%) had a good primary adherence but very few (40%) had good secondary adherence mainly due to dose omission and dose modification.

Continuous LVAD monitoring reveals high suction rates in clinically stable outpatients.

Suction of the left ventricle can lead to potentially life-threatening events in left ventricular assist device (LVAD) patients. With the resolution of currently available clinical LVAD monitoring healthcare professionals are unable to evaluate patients' suction occurrences in detail. This study investigates occurrences and durations of suction events and their associations with tachycardia in stable outpatients. Continuous high-resolution LVAD data from HVAD patients were analyzed in the early outpatient period for 15 days. A validated suction detection from LVAD signals was used. Suction events were evaluated as suction rates, bursts of consecutive suction beats, and clusters of suction beats. The occurrence of tachycardia was analyzed before, during, and after suction clusters. Furthermore, blood work, implant strategy, LVAD speed setting, inflow cannula position, left ventricular diameters, and adverse events were evaluated in these patients. LVAD data of 10 patients was analyzed starting at 78 ± 22 postoperative days. Individuals' highest suction rates per hour resulted in a median of 11% (range 3%-61%). Bursts categorized as consecutive suction beats with n = 2, n = 3-5, n = 6-15, and n > 15 beats were homogenously distributed with 10.3 ± 0.8% among all suction beats. Larger suction bursts were followed by shorter suction-free periods. Tachycardia during suction occurred in 12% of all suction clusters. Significant differences in clinical parameters between individuals with high and low suction rates were only observed in left ventricular end-diastolic and end-systolic diameters (P < .02). Continuous high-resolution LVAD monitoring sheds light on outpatient suction occurrences. Interindividual and intraindividual characteristics of longitudinal suction rates were observed. Longer suction clusters have higher probabilities of tachycardia within the cluster and more severe types of suction waveforms. This work shows the necessity of improved LVAD monitoring and the implementation of an LVAD speed control to reduce suction rates and their concomitant burden on the cardiovascular system.

Continuous Cough Monitoring Using Ambient Sound Recording During Convalescence from a COPD Exacerbation.

PURPOSE: Cough is common in chronic obstructive pulmonary disease (COPD) and is associated with frequent exacerbations and increased mortality. Cough increases during acute exacerbations (AE-COPD), representing a possible metric of clinical deterioration. Conventional cough monitors accurately report cough counts over short time periods. We describe a novel monitoring system which we used to record cough continuously for up to 45 days during AE-COPD convalescence. METHODS: This is a longitudinal, observational study of cough monitoring in AE-COPD patients discharged from a single teaching hospital. Ambient sound was recorded from two sites in the domestic environment and analysed using novel cough classifier software. For comparison, the validated hybrid HACC/LCM cough monitoring system was used on days 1, 5, 20 and 45. Patients were asked to record symptoms daily using diaries. RESULTS: Cough monitoring data were available for 16 subjects with a total of 568 monitored days. Daily cough count fell significantly from mean ± SEM 272.7 ± 54.5 on day 1 to 110.9 ± 26.3 on day 9 (p < 0.01) before plateauing. The absolute cough count detected by the continuous monitoring system was significantly lower than detected by the hybrid HACC/LCM system but normalised counts strongly correlated (r = 0.88, p < 0.01) demonstrating an ability to detect trends. Objective cough count and subjective cough scores modestly correlated (r = 0.46). CONCLUSIONS: Cough frequency declines significantly following AE-COPD and the reducing trend can be detected using continuous ambient sound recording and novel cough classifier software. Objective measurement of cough frequency has the potential to enhance our ability to monitor the clinical state in patients with COPD.

A simple home-based self-monitoring tool for early detection of hand-foot syndrome in cancer patients.

OBJECTIVE: Development of hand-foot syndrome symptoms, which is a common adverse effect of several cancer chemotherapy agents, can result in patient withdrawal from treatment. Its early identification allows appropriate modification of chemotherapy regimens and can avert treatment withdrawal by minimizing the impact on quality of life and duration of discontinued therapy. We sought to develop a simple home-based self-monitoring tool to facilitate reliable early identification of hand-foot syndrome, based on the self-administered quality of life questionnaire hand-foot syndrome-14. METHODS: We modified the hand-foot syndrome-14 to create a simple tool with binary responses ('yes' or 'no') for patients to self-evaluate subjective hand-foot syndrome symptoms daily. We evaluated this tool with 187 consecutive, consenting, eligible adult patients attending four centers and treated with capecitabine, sorafenib or sunitinib for various cancers. Univariate and multivariate logistic regression analyses were used to select the items with the greatest discrimination for detecting Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or 3 reactions, which indicate the need to modify the treatment regimen. RESULTS: There were four items that were most strongly associated with Common Terminology Criteria for Adverse Events grade 2 or higher symptoms. 'Pain associated with hand-foot syndrome' was the most strongly associated with moderate hand-foot syndrome. For detecting moderate hand-foot syndrome symptoms, the sensitivity was 100.0%, specificity was 94.6%, positive predictive value was 82.6% and area under the curve was 0.98 by a sum of the scores of four-item self-monitoring tool with cut-off value. CONCLUSIONS: We present a simple self-monitoring tool that can be used at home with high sensitivity and specificity for identifying grade 2 hand-foot syndrome. In addition, this tool might facilitate self-care.

Objective Measurement of Cough Frequency During COPD Exacerbation Convalescence.

Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Cough and sputum production are associated with adverse outcomes in COPD and are common during COPD exacerbation (AE-COPD). This study of objective cough monitoring using the Hull Automated Cough Counter and Leicester Cough Monitor software confirms that this system has the ability to detect a significant decrease in cough frequency during AE-COPD convalescence. The ability to detect clinically meaningful change indicates a potential role in home monitoring of COPD patients.

Postoperative monitoring with a mobile application after ambulatory lumbar discectomy: an effective tool for spine surgeons.

BACKGROUND: The rise of eHealth, with the increasing use of a Mobile application provides a new perspective for outpatient spine surgery follow-up. OBJECTIVE: Assess the feasibility of Mobile app for postoperative monitoring after outpatient lumbar discectomy. PATIENTS AND METHODS: Sixty consecutive patients, who underwent an ambulatory lumbar discectomy, were proposed the use of Mobile app to optimize their home monitoring for 15 days. Contact was maintained with the clinic based on the level of symptom severity: pain, temperature, deficit, bleeding, to provide a suitable solution. Use of Mobile app compared to the standard follow-up procedure was evaluated daily and a satisfaction survey was carried-out 3 months after surgery. RESULTS: Thirty-six patients (60.0 %) completed the initial checklist within 48 h, with no triggered severity. Five patients (8.3 %) triggered a non-response alarm; no action was required in the follow-up of 41 patients. However, 19 patients (31.7 %) triggered a total of 29 alarms, automatically resulting in a neurosurgeon contact for: postoperative pain management and optimization of analgesics, 21 cases (72.4 %), low-grade fever <38.5°, 4 cases (13.8 %), voiding delay, 2 cases (6.9 %) and a problem related to dressing, 2 cases (6.9 %). The scale ranged from 1 (poor) to 4 (excellent), with a 3.5/4 overall satisfaction mean score for the mobile handheld-device. Most patients (91.6 %) responded that they would agree to repeat the postoperative experience. CONCLUSION: Overall patient satisfaction was excellent. Mobile app provides an effective useful tool for outpatient spine surgery monitoring and minimizes the need for in-person visits for postoperative patients.

Surveillance of fetal arrhythmias in the outpatient setting: current limitations and call for action.

Surveillance of fetal arrhythmias in the outpatient setting remains limited by lack of monitoring modalities. Despite technological advances made in the field of obstetrics, existing devices are not currently suitable to monitor fetal arrhythmias. In this report, the author describes the current and developing fetal heart rate monitoring technologies including the recent introduction of hand-held Doppler monitors for outpatient surveillance of fetal arrhythmias.

Digital outcome measures are associated with brain atrophy in patients with multiple sclerosis.

BACKGROUND: Digital monitoring of people with multiple sclerosis (PwMS) using smartphone-based monitoring tools is a promising method to assess disease activity and progression. OBJECTIVE: To study cross-sectional and longitudinal associations between active and passive digital monitoring parameters and MRI volume measures in PwMS. METHODS: In this prospective study, 92 PwMS were included. Clinical tests [Expanded Disability Status Scale (EDSS), Timed 25 Foot Walk test (T25FW), 9-Hole Peg Test (NHPT), and Symbol Digit Modalities Test (SDMT)] and structural MRI scans were performed at baseline (M0) and 12-month follow-up (M12). Active monitoring included the smartphone-based Symbol Digit Modalities Test (sSDMT) and 2 Minute Walk Test (s2MWT), while passive monitoring was based on smartphone keystroke dynamics (KD). Linear regression analyses were used to determine cross-sectional and longitudinal relations between digital and clinical outcomes and brain volumes, with age, disease duration and sex as covariates. RESULTS: In PwMS, both sSDMT and SDMT were associated with thalamic volumes and lesion volumes. KD were related to brain, ventricular, thalamic and lesion volumes. No relations were found between s2MWT and MRI volumes. NHPT scores were associated with lesion volumes only, while EDSS and T25FW were not related to MRI. No longitudinal associations were found for any of the outcome measures between M0 and M12. CONCLUSION: Our results show clear cross-sectional correlations between digital biomarkers and brain volumes in PwMS, which were not all present for conventional clinical outcomes, supporting the potential added value of digital monitoring tools.

Thyroid function status in patients with hypothyroidism on thyroxine replacement and associated factors: a retrospective cohort study in primary care.

BACKGROUND: Long-term management of patients with hypothyroidism on thyroxine replacement requires thyroid function test (TFT) monitoring once every six-12 months as recommended by clinical practice guidelines. This study determined their thyroid function status during two-year follow-up visits in primary care, and the factors influencing their thyroid status, and assessed the optimal interval for TFTs. METHODS: A retrospective cohort study was conducted on adults with a clinical diagnosis code for hypothyroidism in their electronic health records taken from a group of polyclinics in Singapore between July 2017 and June 2020. The follow-up thyroid status was categorized as under-replacement (TSH ≥ 3.70mIU/L), over-replacement (TSH ≤ 0.65mIU/L) or euthyroid (TSH 0.65-3.70mIU/L). The patients' demographic, clinical and TFT data were analyzed using appropriate statistical tests during the two-year follow-up. Stepwise logistic regression analysis identified the factors associated with suboptimal thyroid control. Kaplan-Meier analysis was used to compare their thyroid function status in association with the interval between TFT monitoring. RESULTS: Data from 5,749 eligible subjects (mean age 62.1 ± 13.29 years; 79% female; 79.7% Chinese) were analyzed. After a two-year follow-up, 61.9% (n = 3558) of all subjects were euthyroid, with 29.5% (n = 1694) being under-replaced and 8.6% (n = 497) over-replaced. However, thyroid status did not differ significantly with the various dose regimen (daily, segmented, or alternate days) (p = 0.193). Stepwise logistic regression showed that thyroxine under-replacement was significantly associated with the male gender (AOR = 1.25,95%CI = 1.03-1.51,p = 0.02) and obesity (AOR = 1.34,95%CI = 1.08-1.66,p = 0.008). Every unit (µg/kg body weight) increase in the mean daily thyroxine dose was associated with 2.72 times greater odds of over-replacement. When comparing thyroid function monitoring at intervals of 13-24 months, monitoring at shorter intervals (≤ 12 months) was less likely to detect thyroxine under-replacement (AOR = 0.57,95%CI = 0.44-0.74,p < 0.001) and over-replacement (AOR = 0.62,95%CI = 0.41-0.97,p = 0.033). Among the 3,312 adults who were euthyroid at baseline, 22.2%, 41.7% and 59.6% had suboptimal thyroid control at 6, 12 and 24 months respectively (Kaplan-Meier analysis). CONCLUSION: Around six in ten patients were euthyroid with thyroxine replacement for hypothyroidism in primary care over two years. Thyroxine under-replacement was associated with male gender and obesity. The proportion of euthyroid patients developing abnormal thyroid function doubled with TFTs at six, 12 and 24-month intervals.

The telephone-based application of the modified fatigue impact scale in individuals with multiple sclerosis: An investigation of measurement properties.

BACKGROUND: Fatigue is one of the most common symptoms reported by individuals with multiple sclerosis and it contributes to the reduction of the functionality. Therefore, it is important to assess the impact of fatigue on daily living of individuals with multiple sclerosis. The Modified Fatigue Impact Scale (MFIS) is an instrument to assess the perception of the impact of fatigue. However, there have been no investigations about the measurement properties of this instrument administered over the telephone for individuals with multiple sclerosis. OBJECTIVES: To verify the concurrent validity, the test-retest reliability, the standard error of measurement (SEM) and the minimal detectable change (MDC) of the MFIS applied over the telephone to assess the perception of the impact of fatigue of individuals with multiple sclerosis. METHODS: The MFIS, composed of 21 items covering three domains: physical, cognitive and psychosocial, was applied at three different moments with an interval of 5-7 days. To establish the concurrent criterion validity, the face-to-face application and the first evaluation by telephone were used. The two telephone assessments were used to assess the test-retest reliability The intraclass correlation coefficient (ICC) with 95 % confidence interval (CI) and the Bland-Altman method were used. The standard error of measurement (SEM) and the MDC was calculated according to reliability results. RESULTS: Thirty individuals (40.83 ± 10.61, 60 % female) were included. The median score on the Expanded Disability Status Scale was 2.00 (±4.00). The majority of participants experienced fatigue (n = 17; 56.67 %). A significant and high magnitude correlation (0.70 ≤ ICC ≤ 0.87, p < 0.001) was found in the investigation of concurrent criterion validity. The Bland-Altman method showed a mean difference between 0.70 to 2.17 points between face-to-face and telephone-based application of the MFIS. For test-retest reliability, a significant and very high magnitude correlation (0.91 ≤ ICC ≤ 0.97, p < 0.001) was found. The Bland-Altman method showed a mean difference between -0.03 and -0.77 points between two telephone-based applications. The SEM and the MDC were 0.71 and 1.97 points. CONCLUSION: The telephone-based application of the MFIS to assess the perceived impact of fatigue in individuals with multiple sclerosis demonstrated adequate measurement properties, and may be a valuable tool to assess patients in clinical practice.

Chimeric Antigen Receptor T-Cell Therapy in the Outpatient Setting: An Expert Panel Opinion from the American Society for Transplantation and Cellular Therapy.

The first series of chimeric antigen receptor T (CAR-T) cell therapy products were approved in 2017 to 2019 and have shown remarkable efficacy in both clinical trials and the real-world setting, but at the cost of prolonged patient hospitalization. As the toxicity management protocols were refined, the concept of cellular therapy administered in the outpatient setting gained steam, and single institutions began to perform certain aspects of CAR-T monitoring in the outpatient setting for select patients. However, there are many considerations for a successful outpatient program. In anticipation of increasing use of CAR-T-cell therapy in the outpatient setting as a mechanism to overcome frequent hospital bed shortages and high cost of inpatient care, the American Society for Transplantation and Cellular Therapy convened a group of experts in hematology, oncology, and cellular therapy to provide a comprehensive review of the existing publications on outpatient CAR-T cell therapy, discuss selected ongoing clinical trials of outpatient CAR-T, and describe strategies to optimize safety without compromising efficacy for patients treated and monitored in the outpatient setting.

Evaluation of a remote monitoring app in head and neck cancer follow-up care.

BACKGROUND: A remote monitoring app was developed for head and neck cancer (HNC) follow-up during the SARS-CoV-2 pandemic. This mixed-methods study provides insight in the usability and patients' experiences with the app to develop recommendations for future use. METHODS: Patients were invited to participate if they were treated for HNC, used the app at least once and were in clinical follow-up. A subset was selected for semi-structured interviews through purposive sampling considering gender and age. This study was conducted between September 2021-May 2022 at a Dutch university medical center. RESULTS: 135 of the 216 invited patients completed the questionnaire, resulting in a total mHealth usability score of 4.72 (± 1.13) out of 7. Thirteen semi-structured interviews revealed 12 barriers and 11 facilitators. Most of them occurred at the level of the app itself. For example, patients received no feedback when all their answers were normal. The app made patients feel more responsible over their follow-up, but could not fulfill the need for personal contact with the attending physician. Patients felt that the app could replace some of the outpatient follow-up visits. CONCLUSIONS: Our app is user-friendly, makes patients feel more in control and remote monitoring can reduce the frequency of outpatient follow-up visits. The barriers that emerged must be resolved before the app can be used in regular HNC follow-up. Future studies should investigate the appropriate ratio of remote monitoring to outpatient follow-up visits and the cost-effectiveness of remote monitoring in oncology care on a larger scale.