Clinical Tool Research Articles

Assessment of drug utilization and potentially inappropriate medications in hemodialysis patients with end-stage renal dysfunction: A study in a tertiary care hospital in Bahrain.

Patients undergoing dialysis pose therapeutic challenges in terms of polypharmacy, administration of potentially inappropriate drugs, and drugs with the potential risk of toxicity. This study evaluated the use of drugs, potentially inappropriate medicines (PIM), drugs with risk of Torsades de Pointes (TdP), and the complexity of the prescribed regimen using the medication regimen complexity index scale in patients undergoing hemodialysis. A retrospective cohort study was carried out amongst patients receiving hemodialysis. Drugs were classified into one of four classes: (i) drugs used in managing renal complications, (ii) cardiovascular drugs, (iii) anti-diabetic drugs, (iv) drugs for symptomatic management, and (v) others. Drugs were considered as PIM according to the Can-SOLVE CKD working group from a network of Canadian nephrology health professionals. The study adhered to the CredibleMeds classification of drugs with known, possible, and conditional risk of TdP and the complexity of prescribed medicines was evaluated based on the pre-validated medication regimen complexity index scale based on form/route, frequency of dosing, and requirement of special instructions. Sixty-three participants were included in the study (49 males and 14 females) with the median (range) age of 45 (21-66) years. Cardiovascular drugs followed by drugs used for managing renal complications were the most common classes administered. Notably, 12 (19.1%) patients received one of the non-steroidal anti-inflammatory drugs, 21 (33.3%) received a proton pump inhibitor, three (4.8%) received pregabalin, two (3.2%) received opioid drugs, and one (1.6%) was administered celecoxib. Atorvastatin, furosemide, omeprazole, and allopurinol were the most common PIM drugs administered to the study participants followed by others. Drugs used for symptomatic management had significantly more PIM compared to other classes (p <0.0001). Six (9.5%) patients received drugs with known TdP risk, one with possible TdP risk, and 61 with conditional risk. Median (range) medical regimen complexity index score was 26.5 (2-62.5). A huge burden of drug therapy was observed in the hemodialysis patients in terms of higher proportions of PIM, complex medical regimen, and prescription of drugs with risk of TdP. Implementation of clinical decision support tools enhancing rational prescription and identification of drugs with TdP risk, introducing antimicrobial stewardship, and stepwise deprescription of the drugs with the least benefit-risk ratio are warranted.

The Effect of an Oxytocin Decision Support Checklist on Oxytocin Use and Maternal and Neonatal Outcomes: A Retrospective Cohort Study.

To assess the association between use of an oxytocin decision support checklist with oxytocin usage and clinical outcomes. We conducted a retrospective cohort study of patients with singleton gestations at 370/7 weeks or greater who received oxytocin during labor from October 2012 to February 2017 at an integrated community health care system during three exposure periods: (1) pre-checklist; (2) after paper checklist implementation; and (3) after checklist integration into the electronic medical record (EMR). The checklist was a clinical decision support tool to standardize the dosing and management of oxytocin. Thus, our primary outcomes included oxytocin infusion rates and cumulative dose. Secondary outcomes included maternal and neonatal outcomes. We controlled for maternal risk factors with multivariable regression analysis and stratified by mode of delivery. A total of 34,269 deliveries were included. Unadjusted analyses showed that compared with pre-checklist, deliveries during the paper and EMR-integrated periods had a lower cumulative dose (4,670 ± 6,174 vs. 4,318 ± 5,719 and 4,286 ± 5,579 mU, p < 0.001 for both), lower maximal infusion rate (9.9 ± 6.8 vs. 8.7 ± 5.8 and 8.4 ± 5.6 mU/min, p < 0.001 for both), and longer duration of oxytocin use (576 ± 442 vs. 609 ± 476 and 627 ± 488 minutes, p < 0.001 and p = 0.01, respectively). The unadjusted rates of cesarean, 5-minute Apgar <7, mechanical ventilation, and neonatal hospital length of stay were similar between periods. The adjusted mean difference in time from admission to delivery was longer during the EMR-integrated period compared with pre-checklist (3.0 [95% confidence interval: 2.7-3.3] hours, p < 0.001). Oxytocin checklist use was associated with decreased oxytocin use patterns at the expense of longer labor times. Findings were more pronounced with EMR integration. · An oxytocin decision support checklist is associated with reduced amounts of oxytocin used.. · However, checklists were associated with longer duration of oxytocin use and of labor.. · Results were more pronounced in the EMR-integrated checklist compared with paper checklist..

Evaluation of ChatGPT for Patient Counseling in Kidney Stone Clinic: A Prospective Study.

Introduction: The potential of large language models (LLMs) is to improve the clinical workflow and to make patient care efficient. We prospectively evaluated the performance of the LLM ChatGPT as a patient counseling tool in the urology stone clinic and validated the generated responses with those of urologists. Methods: We collected 61 questions from 12 kidney stone patients and prompted those to ChatGPT and a panel of experienced urologists (Level 1). Subsequently, the blinded responses of urologists and ChatGPT were presented to two expert urologists (Level 2) for comparative evaluation on preset domains: accuracy, relevance, empathy, completeness, and practicality. All responses were rated on a Likert scale of 1 to 10 for psychometric response evaluation. The mean difference in the scores given by the urologists (Level 2) was analyzed and interrater reliability (IRR) for the level of agreement in the responses between the urologists (Level 2) was analyzed by Cohen's kappa. Results: The mean differences in average scores between the responses from ChatGPT and urologists showed significant differences in accuracy (p < 0.001), empathy (p < 0.001), completeness (p < 0.001), and practicality (p < 0.001), except for the relevance domain (p = 0.051), with ChatGPT's responses being rated higher. The IRR analysis revealed significant agreement only in the empathy domain [k = 0.163, (0.059-0.266)]. Conclusion: We believe the introduction of ChatGPT in the clinical workflow could further optimize the information provided to patients in a busy stone clinic. In this preliminary study, ChatGPT supplemented the answers provided by the urologists, adding value to the conversation. However, in its current state, it is still not ready to be a direct source of authentic information for patients. We recommend its use as a source to build a comprehensive Frequently Asked Questions bank as a prelude to developing an LLM Chatbot for patient counseling.

A Review on Real Time Patient Health Monitoring System Using Cloud Technology

Abstract: The rising demand for advanced healthcare solutions has driven the development of innovative technologies aimed at improving patient care. This project introduces a Real-Time Patient Health Monitoring System, which utilizes cloud technology to its full potential. By incorporating cloud infrastructure, data science, and real-time analytics, the system offers continuous monitoring and analysis of crucial health metrics such as SpO2, temperature, and pulse rate. Designed with wearability in mind, the system's architecture ensures uninterrupted monitoring and instant feedback for both patients and healthcare professionals. Cloud technology enables seamless data storage, retrieval, and real-time analysis, thereby providing comprehensive insights into a patient's health status. The project's scalability guarantees its suitability for various healthcare environments, rendering it a versatile tool for hospitals, clinics, and remote healthcare scenarios.

The association between monocyte to high-density lipoprotein cholesterol ratio and chronic kidney disease in a Chinese adult population: a cross-sectional study

Background Monocyte to high-density lipoprotein cholesterol ratio (MHR) was confirmed as a novel inflammatory marker and strongly associated with the risk of several diseases. This study aimed to investigate the relationship between MHR and chronic kidney disease (CKD) in a Chinese adult population. Methods In this cross-sectional study, 232,775 community-dwelling adults in Binhai who completed health checkups in 2021 were enrolled. Participants were categorized based on the MHR quartiles. Clinical characteristics of participants across different groups were compared using one-way ANOVA, Kruskal-Wallis h-test, and Chi-squared test as appropriate. Univariate and multivariable logistic regression analyses were taken to assess the relationship between MHR and the presence of CKD, as well as its association with low estimated glomerular filtration rate (eGFR) and proteinuria. Subgroup analyses were further executed to confirm the reliability of this relationship. Results A total of 21,014 (9.0%) individuals were diagnosed with CKD. Characteristic indicators including waist circumference, body mass index (BMI), blood pressure (BP), serum uric acid (SUA), triglyceride, and fasting blood glucose (FBG) showed a gradual increase with higher MHR quartiles, whereas parameters such as age, total cholesterol, high-density lipoprotein cholesterol (HDL-C), and eGFR decreased (p < .001). In the multivariable logistic regression analysis, we observed independent associations between MHR (per 1 SD increase) and CKD, as well as low eGFR and proteinuria, with odds ratio (ORs) and 95% confidence intervals (95%CIs) of 1.206 (1.186–1.225), 1.289 (1.260–1.319), and 1.150 (1.129–1.171), respectively (p < .001). Similar conclusions were confirmed in subgroup analysis stratified by gender, age, BMI, central obesity, hypertension, and diabetes mellitus, after justification for confounding factors. Conclusion Elevated MHR level was independently associated with the presence of CKD, suggesting that it might serve as a useful clinical tool for risk stratification, offering valuable insights to inform preventive and therapeutic approaches for clinicians in their routine medical practice.

Improved Innate Immune Function in Patients with Chronic Lymphocytic Leukemia Treated with Targeted Therapy in Clinical Trials.

Patients with chronic lymphocytic leukemia (CLL) have increased risk of severe infections. Although adaptive immune dysfunction is well described, clinical tools for identifying patients at risk are lacking, warranting investigation of additional immune components. In contrast to chemotherapy, targeted agents could spare or even improve innate immune function. Therefore, we investigated innate immune phenotypes and function in patients with CLL before and during targeted treatment. Baseline and consecutive blood samples were collected from patients with CLL treated with acalabrutinib (n = 17) or ibrutinib+venetoclax (n = 18) in clinical trials. Innate immune function was assessed by TruCulture, a whole-blood ligand-stimulation assay quantifying cytokine release in response to standardized stimuli. Innate immune phenotypes were characterized by flow cytometry. As a proxy for infections, we mapped antimicrobial use before and during treatment. At baseline, patients with CLL displayed impaired stimulated cytokine responses to the endotoxin lipopolysaccharide (LPS) along with deactivated monocytes, enrichment of myeloid-derived suppressor cells and metamyelocytes, and elevated (unstimulated) proinflammatory cytokines. Two/three cycles of acalabrutinib or ibrutinib normalized LPS-stimulated responses, in parallel with decreased duration of infections. Innate immune profiles and elevated proinflammatory cytokines further normalized during longer-term acalabrutinib or ibrutinib+venetoclax, paralleled by decreased infection frequency. Innate immune impairment and infection susceptibility in patients with CLL were restored in parallel during targeted therapy. Thus, targeted treatment may reduce the risk of infections in CLL, as currently under investigation in the PreVent-ACaLL phase 2 trial of acalabrutinib+venetoclax for high-risk CLL (NCT03868722).

Novel Strategies in Diagnosing Heart Failure with Preserved Ejection Fraction: A Comprehensive Literature Review.

Heart failure (HF) with preserved ejection fraction (HFpEF) is a prevalent global condition affecting approximately 50% of the HF population. With the aging of the worldwide population, its incidence and prevalence are expected to rise even further. Unfortunately, until recently, no effective medications were available to reduce the high mortality and hospitalization rates associated with HFpEF, making it a significant unmet need in cardiovascular medicine. Although HFpEF is commonly defined as HF with normal ejection fraction and elevated left ventricular filling pressure, performing invasive hemodynamic assessments on every individual suspected of having HFpEF is neither feasible nor practical. Consequently, several clinical criteria and diagnostic tools have been proposed to aid in diagnosing HFpEF. Overall, these criteria and tools are designed to assist healthcare professionals in identifying and evaluating patients who may have HFpEF based on a combination of signs, symptoms, biomarkers, and non-invasive imaging findings. By employing these non-invasive diagnostic approaches, clinicians can make informed decisions regarding the best pharmacological and rehabilitation strategies for individuals with suspected HFpEF. This literature review aims to provide an overview of all currently available methods for diagnosing and monitoring this disabling condition.

The Directional Effects of Marker Frequencies on Across-Channel Temporal Gap-Detection Tasks: An Experimental Study.

Gap detection tests are crucial clinical tools for identifying auditory processing disorders that result from abnormalities in the central auditory nervous system. These tests assess the ability to resolve temporal information in sounds, which aids in the diagnosis of auditory temporal processing issues. This study explores the directional effects of marker frequencies on gap detection tasks with respect to the conditions of long and short frequency disparity (separation). We measured the gap detection thresholds (GDTs) using four across-channel narrowband noise conditions (1-2, 2-1, 1-4, and 4-1 kHz). A within-subject study design involved 29 healthy individuals with normal hearing. Stimuli were presented monaurally using headphones routed via a calibrated audiometer. The condition with long frequency disparity and a low leading frequency (1-4 kHz) exhibited higher GDTs compared to the other across-channel conditions. However, we did not observe this effect in the other condition with long frequency disparity and a high leading frequency (4-1 kHz), which did not show significant differences from the two conditions with short frequency disparity. The study findings suggest that the combined effects of the spectral characteristics of the gap markers, including frequency disparity and order of presentation, influence the temporal resolution ability of auditory gap detection. Clinicians evaluating a patient suspected to have central auditory disorders should recognize that the across-channel GDTs may not consistently increase as the frequency separation between the markers increases.

The Impact of Photopigment Bleaching on the Human Rod Photoreceptor Subretinal Space Measured Via Optical Coherence Tomography.

The purpose of this study was to investigate rod photopigment bleaching-driven intrinsic optical signals (IOS) in the human outer retina and its measurement repeatability based on a commercial optical coherence tomography (OCT) platform. The optical path length of the rod photoreceptor subretinal space (SRS), that is, the distance between signal bands of rod outer segment tips and retinal pigment epithelium, was measured in 15 healthy subjects in ambient light and during a long-duration bleaching white-light exposure. On 2 identical study days (day 1 and day 2 [D1 and D2]), light stimulation resulted in a significant decrease in rod SRS by 21.3 ± 7.6% and 19.8 ± 8.5% (both P<0.001), respectively. The test-retest reliability of the SRS maximum change of an individual subject was moderate for single measures (intraclass correlation coefficient [ICC] = 0.730, 95% confidence interval [CI] = 0.376, 0.900, P<0.001) and good for average measures (ICC = 0.844, 95% CI = 0.546, 0.947, P<0.001). The mean area under the stimulus response curve with values of 14.8 ± 9.4 and 15.5 ± 7.5µm × minutes (P=0.782) showed excellent agreement between the stimulus response on D1 and D2. Intermittent dark adaptation of the retina led to an initial increase of the SRS by 6.1% (P=0.018) and thereafter showed a decrease toward baseline, despite continued dark adaptation. The data indicate the potential of commercial OCT in measuring slow IOS in the outer retina suggesting that the rod SRS could serve as a biomarker for photoreceptor function. The presented approach could provide an easily implementable clinical tool for the early detection of diseases affecting photoreceptor health.

Precision dosing for patients on tricyclic antidepressants.

We aim to develop a personalized dosing tool for tricyclic antidepressants (TCAs) that integrates CYP2D6 and CYP2C19 gene variants and their effects while also considering the polypharmacy effect. The study first adopted a scoring system that assigns weights to each genetic variant. A formula was then developed to compute the effect of both genes' variants on drug dosing. The output of the formula was assessed by a comparison with the clinical pharmacogenetics implementation consortium recommendation. The study also accounts for the effect of the co-administration of inhibitors and inducers on drug metabolism. Accordingly, a user-friendly tool, Clinical Dosing Tool ver.2, was created to assist clinicians in dosing patients on TCAs. The study provides a comprehensive list of all alleles with corresponding activity values and phenotypes for both enzymes. The tool calculated an updated area under the curve ratio that utilizes the effects of both enzymes' variants for dose adjustment. The tool provided a more accurate individualized dosing that also integrates the polypharmacy effect. To the best of our knowledge, the literature misses such a tool that provides a numerical adjusted dose based on continuous numerical activity scores for the considered patients' alleles and phenoconversion.

Mindfulness and Religiosity: Four Propositions to Advance a More Integrative Pedagogical Approach

AbstractIn this commentary article, we critically discuss the need for greater understanding of intercultural and interreligious competence when teaching and applying the practice of mindfulness and contemplative meditation. We start by considering the predominant religious and belief systems that exist worldwide, how each system utilises meditation, and how this meditative practice can be linked to the experience of mindfulness. We then consider how mindfulness can be discussed when taught, through the cultivation of intercultural and interreligious competence. To create a clearer direction in the teaching of mindfulness within the context of interreligious competence, we present four propositions or considerations. We have also put forward a model that suggests mindfulness is a means to achieving greater understanding of self and, thus, more than a clinical tool for ameliorating observable malaise. Moreover, we assert that mindfulness and contemplative meditation practices lie on a continuum that provides the opportunity for self-realisation and optimal states of wellbeing. Our aim is to extend previous discussions on intercultural and interreligious competence as this relates to the practice of meditation. In addition, we continue the philosophical and pedagogical debate to enable teachers and students to optimise the full potential of meditation. In doing so, we create an expansive dialogue to enable teachers and students to engage in a richer and more accepting learning landscape.

Inappropriate wrist MRI: did guidelines have an impact?

To assess the national prevalence and cost of inappropriate MRI in patients with wrist pain prior to and following American College of Radiology (ACR) guidelinepublication. We used administrative claims from the IBM MarketScan Research Databases to evaluate the appropriateness of wrist MRI in a national cohort of patients with commercial insurance or Medicare Advantage. Adult patients with a diagnosis of wrist pain between 2016 and 2019 were included and followed for 1year. We made assessments of appropriateness based on ACR guidelines for specific wrist pain etiologies. We tabulated the total costs and out-of-pocket expenses associated with inappropriate MRI studies using weighted mean payments for facility and professional fees. We performed segmented logistic regression on interrupted time series data to identify predictors of receiving inappropriate imaging and the impact of guideline publication on MRI use. The study cohort consisted of 867,119 individuals. Of these, 40,164 individuals (4.6%) had MRI, of whom 52.6% received an inappropriate study. Inappropriate studies accounted for $44,493,234 in total payments and $8,307,540 in out-of-pocket expenses. The interrupted time series found an approximately 1% monthly decrease in the odds of receiving an inappropriate study after guidelinedissemination. MRI as a diagnostic tool for wrist pain is often inappropriate and expensive. Our findings support interventions to increase guideline adherence, such as integrated clinical decision support tools.

Digitalization and clinical decision tools

Digitalization in cardiovascular emergencies is rapidly evolving, analogous to the development in medicine, driven by the increasingly broader availability of digital structures and improved networks, electronic health records and the interconnectivity of systems. The potential use of digital health in patients with acute chest pain starts even in the prehospital phase with the transmission of adigital electrocardiogram (ECG) as well as telemedical support and digital emergency management, which facilitate optimization of the rescue pathways and reduce critical time intervals. The increasing dissemination and acceptance of guideline apps and clinical decision support tools as well as integrated calculators and electronic scores are anticipated to improve guideline adherence, translating into abetter quality of treatment and improved outcomes. Implementation of artificial intelligence to support image analysis and also the prediction of coronary artery stenosis requiring interventional treatment or impending cardiovascular events, such as heart attacks or death, have an enormous potential especially as conventional instruments frequently yield suboptimal results; however, there are barriers to the rapid dissemination of corresponding decision aids, such as the regulatory rules related to approval as amedical product, data protection issues and other legal liability aspects, which must be considered.

AI-luminating Artificial Intelligence in Inflammatory Bowel Diseases: A Narrative Review on the Role of AI in Endoscopy, Histology, and Imaging for IBD.

Endoscopy, histology, and cross-sectional imaging serve as fundamental pillars in the detection, monitoring, and prognostication of inflammatory bowel disease (IBD). However, interpretation of these studies often relies on subjective human judgment, which can lead to delays, intra- and interobserver variability, and potential diagnostic discrepancies. With the rising incidence of IBD globally coupled with the exponential digitization of these data, there is a growing demand for innovative approaches to streamline diagnosis and elevate clinical decision-making. In this context, artificial intelligence (AI) technologies emerge as a timely solution to address the evolving challenges in IBD. Early studies using deep learning and radiomics approaches for endoscopy, histology, and imaging in IBD have demonstrated promising results for using AI to detect, diagnose, characterize, phenotype, and prognosticate IBD. Nonetheless, the available literature has inherent limitations and knowledge gaps that need to be addressed before AI can transition into a mainstream clinical tool for IBD. To better understand the potential value of integrating AI in IBD, we review the available literature to summarize our current understanding and identify gaps in knowledge to inform future investigations.

Circulating tumor DNA methylation: a promising clinical tool for cancer diagnosis and management.

Cancer continues to pose significant challenges to the medical community. Early detection, accurate molecular profiling, and adequate assessment of treatment response are critical factors in improving the quality of life and survival of cancer patients. Accumulating evidence shows that circulating tumor DNA (ctDNA) shed by tumors into the peripheral blood preserves the genetic and epigenetic information of primary tumors. Notably, DNA methylation, an essential and stable epigenetic modification, exhibits both cancer- and tissue-specific patterns. As a result, ctDNA methylation has emerged as a promising molecular marker for noninvasive testing in cancer clinics. In this review, we summarize the existing techniques for ctDNA methylation detection, describe the current research status of ctDNA methylation, and present the potential applications of ctDNA-based assays in the clinic. The insights presented in this article could serve as a roadmap for future research and clinical applications of ctDNA methylation.

Multispectral Optoacoustic Tomography Enables In Vivo Anatomical and Functional Assessment of Human Tendons.

Tendon injuries resulting from accidents and aging are increasing globally. However, key tendon functional parameters such as microvascularity and oxygen perfusion remain inaccessible via the currently available clinical diagnostic tools, resulting in disagreements on optimal treatment options. Here, a new noninvasive method for anatomical and functional characterization of human tendons based on multispectral optoacoustic tomography (MSOT) is reported. Healthy subjects are investigated using a hand-held scanner delivering real-time volumetric images. Tendons in the wrist, ankle, and lower leg are imaged in the near-infrared optical spectrum to utilize endogenous contrast from Type I collagen. Morphology of the flexor carpi ulnaris, carpi radialis, palmaris longus, and Achilles tendons are reconstructed in full. The functional roles of the flexor digitorium longus, hallicus longus, and the tibialis posterior tendons have been visualized by dynamic tracking during toe extension-flexion motion. Furthermore, major vessels and microvasculature near the Achilles tendon are localized, and the global increase in oxygen saturation in response to targeted exercise is confirmed by perfusion studies. MSOT is shown to be a versatile tool capable of anatomical and functional tendon assessments. Future studies including abnormal subjects can validate the method as a viable noninvasive clinical tool for tendinopathy management and healing monitoring.

Limited total arc range of motion increases sheer stress in the shoulder while pitching in collegiate baseball pitchers.

Upper extremity injuries in baseball pitchers cause significant time-loss from competing and decreased quality of life. Although shoulder range of motion (ROM) is reported as a key factor to prevent potential injury, it remains unclear how limited glenohumeral ROM affects pitching biomechanics which may contribute to upper extremity injuries. To investigate how pitchers with decreased total arc glenohumeral ROM of the throwing arm differed in upper extremity pitching kinematics and kinetics as well as ball velocity compared to pitchers with greater levels of glenohumeral ROM. Cross-sectional Study. Laboratory. Fifty-seven baseball pitchers (ages 18-24) were divided into either control (≧160° total arc) or lower ROM (<160° total arc) groups. The mean glenohumeral ROM deficits, pitching kinematic and kinetic outcomes, and ball velocity were compared between groups. The control group demonstrated significantly less deficit in total arc ROM between arms than the lower ROM (Control: -1.5±10.0°, Lower ROM: -12.4±13.9°, p<.001). While, the lower ROM group displayed less maximal shoulder external rotation (ER) while pitching, the control group had significantly less difference in ROM between maximal shoulder ER while pitching and clinically-measured ER (Lower ROM: 64.4±12.1°, Control: 55.8±16.6°, p=.025). The control group had significantly faster ball velocity compared to the lower ROM group (Control: 85.0 ± 4.3mph, Lower ROM: 82.4 ± 4.8mph, p=.024). Pitchers with decreased total arc glenohumeral ROM (<160° total arc) may undergo over-stretching toward ER in the shoulder during the late cocking phase. Pitchers with higher total arc ROM can pitch the same or faster ball without increasing loading in the upper extremity. Total arc glenohumeral ROM measurement can be a clinical screening tool to monitor shoulder condition over the time, and pitchers with limited total arc ROM might be at higher risk of shoulder injury.

Development and validation of a brain fog scale for coeliac disease.

Brain fog is a subjective cognitive impairment commonly reported in coeliac disease. A standardised tool to define and assess it is an important unmet need. To develop a patient-informed tool to assess brain fog in coeliac disease to support clinical care, research and drug development. A pilot online study defined patient descriptors of brain fog. A second study evaluated the factor structure and performance of the scale across two-time points ('Now' and in the 'Past week'). One month later, participants were invited to repeat the study with two online cognitive processing tests, the Stroop task and the trail making test. Among adults with treated coeliac disease, 37 (91.9% F) participated in the pilot study and 510 (88.8% F) in the second study of whom 99 repeated the study 1 month later with 51 completing cognitive testing. The most common brain fog descriptors were 'difficulty focusing', 'difficulty thinking' and 'difficulty finding the right words and communicating'. The 12-item scale reflects 'cognitive impairment' and 'somatic and affective experience' and demonstrates strong psychometric properties. It tracked with patients report of brain fog being present or absent across two-time points. It did not significantly correlate with the cognitive tests. The brain fog assessment and severity scale is the first patient-informed clinical outcomes assessment tool measuring brain fog in coeliac disease. It is brief and validated for two time-based formats. Further research coupling it with biomarker discovery is needed to confirm its validity as a predictor of cognitive performance.

Investigating Digital Patient-Reported Outcome Measures in Patient-Centered Diabetes Specialist Outpatient Care (DigiDiaS): Protocol for a Multimethod Prospective Observational Study.

Living with type 1 diabetes is challenging, and to support self-management, repeated consultations in specialist outpatient care are often required. The emergence of new digital solutions has revolutionized how health care services can be patient centered, providing unprecedented opportunities for flexible, high-quality care. However, there is a lack of studies exploring how the use of digital patient-reported outcome measures (PROMs) for flexible specialist care affects diabetes self-management. To provide new knowledge on the relevance of using PROMs in standard care, we have designed a multimethod prospective study. The overall aim of this protocol is to describe our prospective multimethod observational study designed to investigate digital PROMs in a routine specialist outpatient setting for flexible patient-centered diabetes care (DigiDiaS). This protocol outlines the design of a multimethod prospective observational cohort study that includes data from electronic health records, self-reported questionnaires, clinical consultation field observations, and individual in-depth interviews with patients and diabetes health care personnel. All patients with type 1 diabetes at a designated outpatient clinic were invited to participate and use the digital PROM implemented in clinical care. Both users and nonusers of the digital PROM were eligible for the prospective study, allowing for a comparison of the two groups. Data were collected at baseline and after 12 months, including self-management as the primary outcome assessed using the Patient Activation Measure, along with the secondary outcomes of digital health literacy, quality of life, health economy, and clinical variables such as glycated hemoglobin. The digital solution was implemented for routine clinical care in the department in November 2021, and data collection for the prospective study started in October 2022. As of September 6, 2023, 84.6% (186/220) of patients among those in the digital PROM and 15.5% (34/220) of patients among the nonusers have consented to participate. We expect the study to have enough participants by the autumn of 2023. With 1 year of follow-up, the results are expected by spring 2025. In conclusion, a multimethod prospective observational cohort study can offer valuable insights into the relevance, effectiveness, and acceptability of digital tools using PROMs in diabetes specialist care. Such knowledge is crucial for achieving broad and successful implementation and use of these tools in a large diabetes outpatient clinic. DERR1-10.2196/52766.

Unveiling quality, clinical, and financial Impacts of Pulmonary Tuberculosis Clinical Pathway Implementation in Magelang Public Hospital, Indonesia

Tuberculosis (TB) is a popular endemic disease in Indonesia with increased risk outcomes. The clinical pathway (CP) is crucial to enhancing healthcare services and resource efficiency despite discrepancies in service variability reduction, clinical outcomes improvement, and cost saving. Therefore, this study aimed to assess pulmonary TB CP and evaluate its impacts on clinical and financial results, as well as barriers to implementation at Tidar Hospital in Magelang, Indonesia. A sequential explanatory mixed-method design was used from July 2022 to January 2023. The study began with a retrospective analysis of medical records of TB patients (total sampling, n=92). In-depth interviews (IDIs) were conducted with healthcare workers including the quality and medical committee, case manager, CP team, inpatient and non-inpatient nursing sub-coordinators, and pulmonary specialists. In addition, eight multidiscipline healthcare professionals attended the focus group discussions (FGDs). The audio recordings were transcripted verbatim and subjected to thematic analysis. The results showed that the quality and content of CP based on TB evaluation using the Integrated Clinical Pathway Assessment Tool (ICPAT) was 62.6%. Four themes were obtained: 1) CP implementation techniques, 2) supportive factors in the success of CP, 3) organization support in CP implementation, and 4) TB patient outcomes. Furthermore, procedure compliance after CP implementation was 33%. There were no significant differences in the length of stay (p=0.77), diagnosis investigation and therapy appropriateness (100%), mortality (4 vs 3 patients; p=0.589), and cost efficiency with an average cost of care (Rp 6.994.508,- vs Rp 5.521.091,-; p=0.083) before and after CP implementation. Readmission rates were low before and after deployment (1 vs. 2 patients). This study found no significant clinical or financial benefits in TB CP implementation. These results imply the need for hospital leadership and a multidisciplinary team to overcome CP implementation hurdles.