Study protocol for two stepped-wedge interventional trials evaluating the effects of holistic information technology-based patient-oriented management in older multimorbid patients with cancer: The GERONTE trials.

INTRODUCTION: Current hospital-based care pathways are generally single-disease centred. As a result, coexisting morbidities are often suboptimally evaluated and managed, a deficiency becoming increasingly apparent among older patients who exhibit heterogeneity in health status, functional abilities, frailty, and other geriatric impairments. To address this issue, our study aims to assess a newly developed patient-centred care pathway for older patients with multimorbidity and cancer. The new care pathway was based on currently available evidence and co-designed by end-users including health care professionals, patients, and informal caregivers. Within this care pathway, all healthcare professionals involved in the care of older patients with multimorbidity and cancer will form a Health Professional Consortium (HPC). The role of the HPC will be to centralise oncologic and non-oncologic treatment recommendations in accordance with the patient's priorities. Moreover, an Advanced Practice Nurse will act as case-manager by being the primary point of contact for the patient, thus improving coordination between specialists, and by organising and leading the consortium. Patient monitoring and the HPC collaboration will be facilitated by digital communication tools designed specifically for this purpose, with the added benefit of being customisable for each patient. MATERIALS AND METHODS: The GERONTE study is a prospective international, multicentric study consisting of two stepped-wedge trials performed at 16 clinical sites across three European countries. Each trial will include 720 patients aged 70 years and over with a new or progressive cancer (breast, lung, colorectal, prostate) and at least one moderate or severe multimorbidity. The patients in the intervention group will receive the new care pathway whereas patients in the control group will receive usual oncologic care. DISCUSSION: GERONTE will evaluate whether this kind of holistic, patient-oriented healthcare management can improve quality of life (primary outcome) and other valuable endpoints in older patients with multimorbidity and cancer. An ancillary study will assess in depth the socio-economic impact of the intervention and deliver concrete implementation guidelines for the GERONTE intervention care pathway. TRIAL REGISTRATION: FRONE: NCT05720910 TWOBE: NCT05423808.

Imbalance of Iron Availability and Demand in Patients With Acute and Chronic Heart Failure.

BACKGROUND: Iron deficiency (ID) is a frequent comorbidity in patients with acute (AHF) and chronic heart failure (CHF) associated with morbidity and death. We aimed to better characterize iron homeostasis in patients with heart failure applying different biomarkers and to evaluate the accuracy of current ID definition by the European Society of Cardiology/American College of Cardiology/American Heart Association to indicate tissue iron availability and demand. METHODS AND RESULTS: We performed a retrospective cohort study investigating 277 patients with AHF and 476 patients with CHF between February 2021 and May 2022. Patients with AHF had more advanced ID than patients with CHF, reflected by increased soluble transferrin receptor and soluble transferrin receptor-ferritin index, and lower ferritin, serum iron, transferrin saturation, hepcidin, and reticulocyte hemoglobin. Decreased iron availability or increased tissue iron demand, reflected by increased soluble transferrin receptor-ferritin index and decreased reticulocyte hemoglobin, was found in 84.1% (AHF) and 28.0% (CHF) with absolute ID and in 50.0% (AHF) and 10.5% (CHF) with combined ID according to the current European Society of Cardiology/American College of Cardiology/American Heart Association-based ID definition. Low hepcidin expression as an indicator of systemic ID was found in 91.1% (AHF) and 80.4% (CHF) of patients with absolute ID and in 32.3% (AHF) and 18.8% (CHF) of patients with combined ID. ID definitions with higher specificity reduce the need for iron supplementation by 25.5% in patients with AHF and by 65.6% in patients with CHF. CONCLUSIONS: Our results suggest that the current European Society of Cardiology/American College of Cardiology/American Heart Association-based ID definition might overestimate true ID, particularly in CHF. More stringent thresholds for ID could more accurately identify patients with heart failure with reduced tissue iron availability who benefit from intravenous iron supplementation.

Effect modification of polypharmacy on incident frailty by chronic kidney disease in older adults.

BACKGROUND: Frailty and polypharmacy are common conditions in older adults, especially in those with chronic kidney disease (CKD). Therefore, we analyzed the association of polypharmacy and incident frailty and the effect modification by CKD in very old adults. METHODS: In non-frail individuals within the Berlin Initiative (cohort) Study, polypharmacy (≥ 5 medications) was assessed according to multiple definitions based on the number of regular and on demand prescription and over the counter drugs, as well as vitamins and supplements. CKD was defined as an estimated glomerular filtration rate < 60 mL/min/1.73m2 and/or an albumin-creatinine ratio ≥ 30 mg/g. Incident frailty was assessed at follow-up using Fried criteria. Logistic regression was applied to assess (1) the association of different polypharmacy definitions with incident frailty and (2) effect modification by CKD. RESULTS: In this cohort study, out of 757 non-frail participants (mean age 82.9 years, 52% female, 74% CKD), 298 (39%) participants reported polypharmacy. Over the observation period of 2.1 years, 105 became frail. Individuals with polypharmacy had 1.96 adjusted odds (95% confidence interval (CI): 1.20-3.19) of becoming frail compared to participants without polypharmacy. The effect of polypharmacy on incident frailty was modified by CKD on the additive scale (relative excess risk due to interaction: 1.56; 95% CI 0.01-3.12). CONCLUSIONS: This study demonstrates an association of polypharmacy and incident frailty and suggests strong evidence for an effect modification of CKD on polypharmacy and incident frailty. Revision of prescriptions could be a target strategy to prevent frailty occurrence, especially in older adults with CKD.

Medical care priorities of community-dwelling older adults according to three dimensions of quality of life: Quality of daily living, satisfaction and happiness from birth to death, and human vitality.

AIM: Although the maintenance and improvement of quality of life (QoL) through holistic care are important in geriatric medical care, care priorities might differ depending on three essential aspects of QoL: the quality of daily living, satisfaction and happiness from birth to death, and human vitality, which are "Seikatsu," "Jinsei," "Seimei" in Japanese, respectively. We aimed to clarify these priorities in terms of medical care and examined how the definitions of QoL affected these priorities' rankings. METHODS: This cross-sectional study involved community-dwelling older adults aged ≥65 years living in Kashiwa City, Chiba Prefecture, Japan. The number of participants was 1550 (mean age, 76.1 ± 5.8 years; 699 women [45.1%]). A self-administered questionnaire distributed in advance was used to rank 12 items sought in medical care. Participants were randomly assigned to one of three groups and sent the corresponding questionnaire, which differed only in the definition of QoL. RESULTS: The top priorities for medical care were "effective treatment of illness," "improvement of physical function," and "maintaining a high level of activity." When QoL was defined as "the quality of daily living, satisfaction and happiness from birth to death, and human vitality," participants were significantly more likely to rank QoL improvement as one of the top three items (adjusted odds ratio, 1.46; 95% confidence interval, 1.03-2.05). CONCLUSIONS: As a medical care priority, older adults desire improvement of multidimensional elements of life, including human vitality. Health care providers should consider this when making medical care decisions. Geriatr Gerontol Int 2024; 24: 493-498.

Tai chi, irisin and cognitive performance: a clinical and biological investigation in older adults.

BACKGROUND: Skeletal muscle is the main source of circulating irisin, both at rest and during physical activity. Previous studies have suggested that irisin can improve cognitive abilities. AIMS: We explored whether six months of Tai Chi (TC) practice can modulate such a relationship in healthy older persons. METHODS: This is a prospective clinical study to evaluate the effects of TC practice as compared with low intensity exercise (LI) and no exercise (NE) control groups on plasmatic irisin levels and cognitive performance. Forty-two healthy older persons were stratified into three groups according to physical activities. Biochemical assay and cognitive functions were assessed at the baseline and after six months. RESULTS: A significant change was found in circulating irisin levels in TC as compared with NE group (p = 0.050) across time. At six months in TC group irisin levels significantly correlated with a verbal memory test (p = 0.013) controlled by age and education. CONCLUSION: Our results suggest the potential benefits for cognitive health of TC practice by irisin levels modulation.

The impact of sleep education, light intervention and relaxation on sleep and mood in the elderly.

Sleep and light education (SLE) combined with relaxation is a potential method of addressing sleep and affective problems in older people. 47 participants took part in a four-week sleep education program. SLE was conducted once a week for 60-90 minutes. Participants were instructed on sleep and light hygiene, sleep processes, and practiced relaxation techniques. Participants were wearing actigraphs for 6 weeks, completed daily sleep diaries, and wore blue light-blocking glasses 120 minutes before bedtime. Measures included scores of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISS), Beck Depression Inventory-II (BDI-II), State-Trait Anxiety Inventory (STAI) and actigraphy measurements of sleep latency, sleep efficiency, and sleep fragmentation. Sleep quality increased after SLE based on the subjective assessment and in the objective measurement with actigraphy. PSQI scores were statistically reduced indicating better sleep. Scores after the intervention significantly decreased in ESS and ISS. Sleep latency significantly decreased, whereas sleep efficiency and fragmentation index (%), did not improve. Mood significantly improved after SLE, with lower scores on the BDI-II and STAI. SLE combined with relaxation proved to be an effective method to reduce sleep problems and the incidence of depressive and anxiety symptoms.

Efficacy, safety and cost-effectiveness of 5-fluorouracil versus interferon α-2b as adjuvant therapy after surgery in ocular surface squamous neoplasia in a southern European tertiary hospital.

PURPOSE: To analyze the efficacy, safety and cost-effectiveness of adjuvant therapy with 5-fluorouracil (5-FU) compared to interferon α-2b (IFNα-2b) after surgery in ocular surface squamous neoplasia (OSSN). METHODS: Retrospective study that included patients diagnosed with OSSN, who underwent surgical excision followed by adjuvant therapy with IFN α-2b (Group A) or 5-FU (Group B), in a tertial referral hospital. Clinical data collected included: demographics, risk factors, appearance, size and location of the lesions, slit-lamp examination, anterior segment optical coherence tomography, iconography and histological classification of subtypes of OSSN. Costs derived from surgery and adjuvant therapy were noted. Resolution of the lesion, recurrences and adverse events were studied. Cost-effectiveness analysis was performed with the incremental cost-effectiveness index (CEI). RESULTS: 54 cases of 54 patients were included, with a mean age of 74.4 years (range 28-109). 30 were male (55.6%), and predominantly Caucasian (79.6%). The main risk factor was prolonged sun exposure (79.6%). Leukoplakic appearance (48.1%), location in bulbar conjunctiva (48.2%) and T3 (46.3%) stage were the most common clinical features. Histologically, the percentage of CIN I, CIN II, CIN III and SCC were 25.9%, 29.6%, 40.7% and 3.7%, respectively. Complete resolution was obtained in 74.1% and tolerance was overall positive. The cost was significantly higher for IFNα (1025€ ± 130.68€) compared to 5-FU (165.57€ ± 45.85 €) (p 0.001). The CEI was - 247.14€. CONCLUSIONS: Both 5-FU and IFN α-2b are effective and present a good security profile as adjuvant therapies after surgery in OSSN. Although presenting slightly more ocular complications, 5-FU can be considered more cost-effective than IFN α-2b.

Severe Coagulation Dysfunction caused by Vitamin K Deficiency in an Elderly Patient.

BACKGROUND: Vitamin K deficiency can lead to severe coagulation dysfunction, which may be dangerous and fatal, especially in patients undergoing surgery. METHODS: We report an 84-year-old male patient with gallstones and cholecystitis who had a severe coagulation disorder without bleeding symptoms after endoscopic papillary balloon dilation for removal of bile duct stones. After vitamin K supplementation, the coagulation dysfunction was corrected the next day. RESULTS: In this case, long-term antibiotic treatment, inadequate diet, and abnormal liver function led to coagulation dysfunction. After vitamin K supplementation, the blood coagulation disorder was corrected and serious consequences were prevented. Significantly elevated coagulation function was considered to be caused by vitamin K deficiency. CONCLUSIONS: This case indicates that coagulation dysfunction caused by vitamin K deficiency may occur within a few days. Laboratory personnel should fully understand the risks of vitamin K deficiency in elderly patients undergoing surgery with severely restricted diet, impaired absorption, and long-term use of cephalosporin anti-inflammatory therapy, and promptly remind clinical doctors.

Spurious Hyperphosphatemia in a Patient with Chronic Kidney Disease - a Rare Case of Alteplase Contamination.

Spurious hyperphosphatemia, a rare occurrence, typically arises from substances in a patient's blood interfering with the colorimetric method for serum phosphate measurement. We present a case of factitious hyperphosphatemia caused by alteplase-contaminated blood samples in an 88-year-old CKD patient on hemodialysis, leading to misleadingly high phosphorus levels. Thorough investigations ruled out other etiologies, highlighting the necessity of stringent adherence to blood collection protocols to prevent sample contamination and avert erroneous laboratory results. This unique cause of hyperphosphatemia should be considered in the differential diagnosis when encountering unexplained elevations in phosphorus levels, particularly in the context of normal blood calcium levels.

A preliminary, quantitative study on the use of traditional and complementary medicine by cancer patients seen at the Senkatana oncology clinic, Maseru, Lesotho.

BACKGROUND: The use of traditional and complementary medicine (TCM) by cancer patients remains common in several countries especially in the Sub-Saharan Africa. However, the reasons for use are complex and change with time and geographic location, they may vary from therapy to therapy, and they are different from one individual to another. The use of TCM has been associated with active coping behaviour and a way through which patients take control of their own health. However, cancer patients do not disclose their use of TCM to the attending healthcare professionals and therefore the effects of these medicines on the patients may not be ascertained. AIM: To investigate the use of traditional and complementary medicines among patients diagnosed with cancer. METHODS: A cross-sectional, quantitative study was conducted at Senkatana Oncology clinic in May to June 2023. Cancer patients underwent standardized, quantitative interviews using structured questionnaires about their use of TCM. Descriptive statistics were used to analyse the data. Logistic regression analysis was also used to identify factors associated with satisfaction with the performance of TCM. RESULTS: All interviewed patients (n = 50, 100%) reported to be using TCM. Patients consisted of 24 females (48%) and 26 males (52%) in the age range 14 to 82 years old. The majority of the study population was in the age group 35-44 years old. The most prevalent cancer among participating males was prostate cancer and among females was cervical cancer. Biological products use was the most prominent with the highest average percentage usage (14.7%). The majority of patients (66%, n = 33) indicated that they just wanted to try everything that could help. Patients (n = 47, 94%) further reported that they had been using complementary medicine during the same period as they were using conventional treatment so that both may work to help each other. Neither gender nor age predicted satisfaction with the performance of traditional and complementary medicine. CONCLUSIONS: It is concluded that all interviewed cancer patients use TCM. Patients indicated that one of the reasons for using TCM was that they wanted to try everything that could help in their cancer care. Patients further reported that they did not inform their oncologist of their concurrent use of TCM because they had been advised not to use other medicines besides what they are given at the clinic.

Expression analysis of zinc-metabolizing enzymes in the saliva as a new method of evaluating zinc content in the body: two case reports and a review of the literature.

BACKGROUND: The activity level of alkaline phosphatase, a zinc-requiring enzyme in the serum, is used to indicate zinc nutritional status; however, it does not correlate with serum zinc levels or subjective symptoms of taste disorder in many cases. Hence, this study focused on the total activity of alkaline phosphatase, a zinc-requiring enzyme. The total alkaline phosphatasa activity level in the saliva was measured before and after zinc supplementation, and the results were compared with serum zinc levels. CASE PRESENTATION: This study included patients with hypozincemia, specifically a patient with zinc-deficient taste disorder (patient 1: a 69-year-old Japanese woman) and a patient with glossodynia with zinc deficiency (patient 2: an 82-year-old Japanese woman). Saliva samples were collected, and blood tests were performed before and after zinc supplementation. Subjective symptoms and serum zinc levels were simultaneously evaluated. Zinc supplementation was performed using zinc acetate hydrate or Polaprezinc. CONCLUSIONS: Total alkaline phosphatase activity levels were found to be associated with serum zinc levels and subjective symptoms. A further study with a higher number of patients is necessary to confirm whether total alkaline phosphatase activity levels more accurately reflect the amounts of zinc in the body than serum zinc levels.

Cross-cultural adaptation and psychometric evaluation of the social frailty scale in Iranian older adults.

BACKGROUND: Social frailty is a holistic concept encompassing various social determinants of health. Considering its importance and impact on health-related outcomes in older adults, the present study was conducted to cross-culturally adapt and psychometrically evaluate the Social Frailty Scale in Iranian older adults in 2023. METHODS: This was a methodological study. The translation and cross-cultural adaptation of the Social Frailty Scale 8-item (SFS-8) was conducted according to Wild's guideline. Content and face validity were assessed using qualitative and quantitative methods. Then, 250 older adults covered by comprehensive health centers were selected using multistage random sampling. Participants completed the demographic questionnaire, the Abbreviated Mental Test score, the SFS-8, and the Lubben Social Network Scale. Construct validity was assessed by principal component analysis (PCA) and known-group comparisons. The Mann‒Whitney U test was used to compare social frailty scores between the isolated and non-isolated older adults. Internal consistency, equivalence, and stability were assessed using the Kuder-Richardson method, the intraclass correlation coefficient (ICC), the standard error of measurement (SEM), and the minimum detectable change (MDC). The ceiling and floor effects were also assessed. The data were analyzed using JASP 0.17.3. RESULTS: The ratio and index of content validity and the modified kappa coefficient of all the items were 1.00. The impact score of the items was greater than 4.6. PCA identified the scale as a single component by removing two questions that could explain 52.9% of the total variance in the scale score. The Persian version of the Social Frailty Scale could distinguish between isolated and non-isolated older adults (p < 0.001). The Kuder-Richardson coefficient, ICC, SEM, and MDC were 0.606, 0.904, 0.129, and 0.358, respectively. The relative frequencies of the minimum and maximum scores obtained from the scale were 34.8 and 1.2, respectively. CONCLUSIONS: The Persian version of the Social Frailty Scale (P-SFS) can be used as a valid and reliable scale to assess social frailty in Iranian older adults.

Patterns of comorbidities in patients with atrial fibrillation and impact on management and long-term prognosis: an analysis from the Prospective Global GLORIA-AF Registry.

BACKGROUND: Clinical complexity, as the interaction between ageing, frailty, multimorbidity and polypharmacy, is an increasing concern in patients with AF. There remains uncertainty regarding how combinations of comorbidities influence management and prognosis of patients with atrial fibrillation (AF). We aimed to identify phenotypes of AF patients according to comorbidities and to assess associations between comorbidity patterns, drug use and risk of major outcomes. METHODS: From the prospective GLORIA-AF Registry, we performed a latent class analysis based on 18 diseases, encompassing cardiovascular, metabolic, respiratory and other conditions; we then analysed the association between phenotypes of patients and (i) treatments received and (ii) the risk of major outcomes. Primary outcome was the composite of all-cause death and major adverse cardiovascular events (MACE). Secondary exploratory outcomes were also analysed. RESULTS: 32,560 AF patients (mean age 70.0 ± 10.5 years, 45.4% females) were included. We identified 6 phenotypes: (i) low complexity (39.2% of patients); (ii) cardiovascular (CV) risk factors (28.2%); (iii) atherosclerotic (10.2%); (iv) thromboembolic (8.1%); (v) cardiometabolic (7.6%) and (vi) high complexity (6.6%). Higher use of oral anticoagulants was found in more complex groups, with highest magnitude observed for the cardiometabolic and high complexity phenotypes (odds ratio and 95% confidence interval CI): 1.76 [1.49-2.09] and 1.57 [1.35-1.81], respectively); similar results were observed for beta-blockers and verapamil or diltiazem. We found higher risk of the primary outcome in all phenotypes, except the CV risk factor one, with highest risk observed for the cardiometabolic and high complexity groups (hazard ratio and 95%CI: 1.37 [1.13-1.67] and 1.47 [1.24-1.75], respectively). CONCLUSIONS: Comorbidities influence management and long-term prognosis of patients with AF. Patients with complex phenotypes may require comprehensive and holistic approaches to improve their prognosis.

Multicomponent Intervention on Improving the Cognitive Ability of Older Adults with Mild Cognitive Impairment: A Pilot Randomized Controlled Trial.

This pilot randomized controlled trial aimed to evaluate the feasibility and potential outcomes of an innovative 16-session multicomponent intervention model to improve cognitive abilities in older adults with mild cognitive impairment (MCI) by promoting healthy lifestyle, cognitive skills, tai chi and mindfulness practices. This study was a multicentre, randomized controlled, two-arm, parallel-group, unblinded trial in Hong Kong. 57 Chinese older adults with MCI recruited from three local elderly centers were randomly assigned to either the control or intervention group. The study results support the feasibility and efficacy of the multicomponent intervention, and recommend future larger-scale randomized control trials.

Factors Contributing to Non-Concordance Between End-of-Life Care and Advance Care Planning.

CONTEXT: Despite making do-not-resuscitate or comfort care decisions during advance care planning, terminally ill patients sometimes receive life-sustaining treatments as they approach end of life. OBJECTIVES: To examine factors contributing to nonconcordance between end-of-life care and advance care planning. METHODS: In this longitudinal retrospective cohort study, terminally ill patients with a life expectancy shorter than six months, who had previously expressed a preference for do-not-resuscitate or comfort care, were followed up after palliative shared care intervention. An instrument with eight items contributing to non-concordant care, developed through literature review and experts' consensus, was employed. An expert panel reviewed electronic medical records to determine factors associated with non-concordant care for each patient. Statistical analysis, including descriptive statistics and the chi-square test, examines demographic characteristics, and associations. RESULTS: Among the enrolled 7871 patients, 97 (1.2%) received non-concordant care. The most prevalent factor was "families being too distressed about the patient's deteriorating condition and therefore being unable to let go" (84.5%) followed by "limited understanding of medical interventions among patients and surrogates" (38.1%), and "lack of patient participation in the decision-making process" (25.8%). CONCLUSIONS: This study reveals that factors related to relational autonomy, emotional support, and health literacy may contribute to non-concordance between advance care planning and end-of-life care. In the future, developing an advance care planning model emphasizes respecting relational autonomy, providing emotional support, and enhancing health literacy could help patients receiving a goal concordant and holistic end-of-life care.

Monitorización de la glucemia en el paciente crítico adulto: tipo de muestra y método de análisis. Revisión sistemática y metanálisis / Blood glucose monitoring in critically ill adult patients: Type of sample and method of analysis. Systematic review and meta-analysis

IntroducciónLa guía clínica para el manejo de la sepsis recomienda usar muestras de sangre arterial para el control glucémico. Un estudio multicéntrico en 86 unidades de cuidados intensivos españolas reveló que el 85,4% de estas utilizaban punción capilar.ObjetivoAnalizar la fiabilidad de la glucemia comparando diferentes muestras sanguíneas (arterial, venosa, capilar) e instrumentos (glucómetros, gasómetros, laboratorio central). Secundariamente, estimar el efecto de variables confusoras y el rendimiento de los instrumentos de medición determinados por las diferentes normas de calidad.MetodologíaRevisión sistemática y metanálisis con búsqueda en las bases de datos PubMed, CINAHL y Embase en septiembre-2021 y septiembre-2022, sin límites temporales ni idiomáticos. Fuentes de literatura gris: DART-Europe, OpenGrey y Google Académico. Resultados resumidos mediante síntesis cualitativa (descripción de resultados, características de los estudios) y cuantitativa (metanálisis para evaluar la diferencia de medias estandarizadas). Calidad metodológica de artículos evaluada con Quality Assessment of Diagnostic Accuracy Studies-2. Protocolo: https://osf.io/ DOI 10.17605/OSF.IO/T8KYP.ResultadosSe incluyeron un total de 32 artículos y 5.451 pacientes. No se obtuvieron discrepancias entre muestras arteriales con glucómetro vs. laboratorio (sesgo [IC95%]: 0,01 [−0,12 a 0,14] mg/dL). En cambio, muestras arteriales con gasómetro sí sobreestimaron de forma significativa (sesgo [IC95%]: 0,12 [0,01 a 0,24] mg/dL). La misma tendencia presentan capilares con glucómetro, aunque no de forma significativa (sesgo [IC95%]: 0,07 [−0,02 a 0,15] mg/dL). Hay discrepancia entre los estudios sobre el efecto del hematocrito y el equilibrio ácido-base. El mayor consenso se da en la poca concordancia del glucómetro con muestras capilares vs. laboratorio en presencia de shock y soporte vasopresor, situación de fallo renal o durante el tratamiento con vitamina C.Conclusiones... (AU)

IntroductionThe clinical guideline for the management of sepsis recommends using arterial blood samples for glycaemic control. A multicentre study in 86 Spanish intensive care units revealed that 85.4% of these used capillary puncture.ObjectiveTo analyse the reliability of glycaemia by comparing different blood samples (arterial, venous, capillary) and instruments (glucometers, gasometers, central laboratory). Secondarily, to estimate the effect of confounding variables and the performance of measuring instruments as determined by different quality standards.MethodologySystematic review and meta-analysis with search in PubMed, CINAHL and Embase databases in September-2021 and September-2022, with no time or language limits. Grey literature sources: DART-Europe, OpenGrey and Google Scholar. Results summarised by qualitative (description of results, study characteristics) and quantitative (meta-analysis to assess standardised mean difference) synthesis. Methodological quality of articles assessed with Quality Assessment of Diagnostic Accuracy Studies-2. Protocol: https://osf.io/ DOI 10.17605/OSF.IO/T8KYP.ResultsA total of 32 articles and 5451 patients were included. No discrepancies were obtained between arterial glucometer vs. laboratory samples (bias [95%CI]: 0.01 [−0.12 to 0.14] mg/dL). In contrast, arterial samples with a gasometer did significantly overestimate (bias [95%CI]: 0.12 [0.01 to 0.24] mg/dL). The same trend is seen in capillaries with a glucometer, although not significantly (bias [95%CI]: 0.07 [−0.02 to 0.15] mg/dL). There is discrepancy between studies on the effect of haematocrit and acid-base balance. The greatest consensus is on the poor agreement of glucometer with capillary vs. laboratory samples in the presence of shock and vasopressor support, renal failure or during vitamin C treatment.Conclusions... (AU)

Measuring patients' medical treatment preferences in advance care planning: development and validation of the Treat-Me-ACP instrument - a secondary analysis of a cluster-randomized controlled trial.

BACKGROUND: Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated early stage outcome instruments are lacking. Therefore, the Treatment-Preference-Measure-Advance Care Planning (Treat-Me-ACP) instrument was developed and validated as part of the cluster-randomized controlled trial STADPLAN (Study on Advance Care Planning in care-dependent community-dwelling older persons) to assess the effects of Advance Care Planning interventions on patients' medical treatment preferences. METHODS: The design of Treat-Me-ACP is based on the Emanuel Medical Directive and the Life Support Preferences Questionnaires. Using a multi-stage team approach a preliminary version of the Treat-Me-ACP was developed and pre-tested. The pre-tested instrument consists of one global medical care goal-item, five hypothetical scenarios with five hypothetical treatments, and one how would you feel-item within each scenario. A total of five scenario preference scores and five treatment preference scores can be formed. This version was subsequently applied to a subsample of the STADPLAN project (n = 80) to assess patient's preferences at baseline (T0) and at 12-month follow-up (T2). The further validation steps were based on this subsample and included: (1) acceptance by using completion rate and frequencies of missing data, (2) internal consistency by using Cronbach's α to test whether it was possible to create preference scores by scenario and treatment, (3) concurrent validation examining the association between the global medical care goal-item and the preference scores and the association between the how would you feel-items and the scenario preference scores, and (4) responsiveness of the instrument to changes in preferences for life-sustaining treatments by comparing preference scores from T0 to T2 between study groups. RESULTS: Acceptance of the instrument was high. Results of concurrent validation indicate that the five scenarios represent the global medical care goal well. The preference scores showed an average tendency for decreasing preferences for life-sustaining treatments across all scales for the intervention group during study follow-up. CONCLUSIONS: The Treat-Me-ACP can be used to evaluate the dynamics of patients' medical treatment preferences in Advance Care Planning. It has been validated for care-dependent community-dwelling older persons and can be used as an additional outcome measure in evaluating the effectiveness of ACP interventions. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 on 04/06/2019.

Assessing brain involvement in Fabry disease with deep learning and the brain-age paradigm.

While neurological manifestations are core features of Fabry disease (FD), quantitative neuroimaging biomarkers allowing to measure brain involvement are lacking. We used deep learning and the brain-age paradigm to assess whether FD patients' brains appear older than normal and to validate brain-predicted age difference (brain-PAD) as a possible disease severity biomarker. MRI scans of FD patients and healthy controls (HCs) from a single Institution were, retrospectively, studied. The Fabry stabilization index (FASTEX) was recorded as a measure of disease severity. Using minimally preprocessed 3D T1-weighted brain scans of healthy subjects from eight publicly available sources (N = 2160; mean age = 33 years [range 4-86]), we trained a model predicting chronological age based on a DenseNet architecture and used it to generate brain-age predictions in the internal cohort. Within a linear modeling framework, brain-PAD was tested for age/sex-adjusted associations with diagnostic group (FD vs. HC), FASTEX score, and both global and voxel-level neuroimaging measures. We studied 52 FD patients (40.6 ± 12.6 years; 28F) and 58 HC (38.4 ± 13.4 years; 28F). The brain-age model achieved accurate out-of-sample performance (mean absolute error = 4.01 years, R2 = .90). FD patients had significantly higher brain-PAD than HC (estimated marginal means: 3.1 vs. -0.1, p = .01). Brain-PAD was associated with FASTEX score (B = 0.10, p = .02), brain parenchymal fraction (B = -153.50, p = .001), white matter hyperintensities load (B = 0.85, p = .01), and tissue volume reduction throughout the brain. We demonstrated that FD patients' brains appear older than normal. Brain-PAD correlates with FD-related multi-organ damage and is influenced by both global brain volume and white matter hyperintensities, offering a comprehensive biomarker of (neurological) disease severity.

A Potential Therapeutic Approach According to Traditional Thai Medicine Theory for Post-COVID-19 Syndrome Treatment: An Observational Retrospective Clinical Study.

Background: Most post-COVID-19 patients had physiological health problems, which differed for each patient. The potential treatment for post-COVID-19 syndrome must require multi-disciplinary approaches that focus on individualized treatment. Therefore, traditional Thai Medicine (TTM) clinical practice guidelines for post-COVID-19 treatment are developed by the Traditional Thai Medicine Hospital, Prince of Songkla University, to care for post-COVID-19 patients. Objective: This current study aimed to investigate the effect of the guidelines on post-COVID-19 patient's physical health. Methods: This research was a retrospective clinical study, carried out from June 2022 to July 2022. Setting: The study was conducted at the Traditional Thai Medicine Hospital, Prince of Songkla University, and La Flora Khao Lak TTM clinic, Thailand. Participants: Data (n=17) were collected from the medical record. They were included if they met the following criteria: patients were more than 18 years old, had a medical history of COVID-19 disease, had fully recovered from the disease (ATK for COVID-19 is negative) at least a week before starting the guideline, and had complete medical information such as post-COVID-19 symptoms, vital signs, pain score, cough severity score, and quality of life examination. Intervention: Approaches for post-COVID-19 treatment included herbal Thai medicine recipes, Thai massage, herbal steam inhalation, herbal hot steam, herbal hot water immersion, acupressure massage for breathing stimulation, and a breathing exercise. All procedures were applied for 7 days continually or until they have recovered. Primary Outcome Measures: The effects of TTM approaches on the symptoms of post-COVID-19 patients on pain score, quality of life, cough severity were measured using a visual analog score (VAS), SF-36 questionnaire, and cough severity index (CSI), respectively. Results: The average duration time of post-COVID-19 syndrome was 25.76 days, and the most common symptom was muscle pain/stress (10; 71.43%). Yahom-Navakot (6; 42.86%) is the most common recipe used for the treatment. Interestingly, the pain score was significantly reduced by 3 days of the treatment (4.88±2.03 vs 2.29±2.08 ). Moreover, the cough severity index (12.86±11.55 vs 3.31±6.38) was significantly lessened by 7 days of the treatment. Remarkably, most symptoms vanished entirely after 7 days of the intervention, leading to a better quality of life for the patients (53.24±22.15 vs 65.59±23.64). Conclusions: The TTM clinical practice guideline for treating post-COVID-19 syndrome effectively improved the overall physical health capacity and symptoms associated with post-COVID-19 syndrome. Therefore, the implementation of this guideline, together with other approaches, could strengthen the treatment for post-COVID-19 to be more effective.