Suboptimal Treatment Research Articles

Racial and Ethnic Disparities in Epidural Blood Patch Utilization Among Obstetric Patients in the United States: A Nationwide Analysis, 2016–2020

BACKGROUND: Racial and ethnic disparities in health care delivery can lead to inadequate peripartum pain management and associated adverse maternal outcomes. An epidural blood patch (EBP) is the definitive treatment for moderate to severe postdural puncture headache (PDPH), a potentially debilitating neuraxial anesthesia complication associated with significant maternal morbidity if undertreated. In this nationwide study, we examine the racial and ethnic disparities in the inpatient utilization of EBP after obstetric PDPH in the United States. METHODS: In this retrospective observational study, we used the National Inpatient Sample, a nationally representative database of discharge records for inpatient admissions in the United States, from 2016 to 2020. We analyzed delivery hospitalizations of women of childbearing age (15–49 years) diagnosed with PDPH. Adjusting for maternal and hospitalization characteristics as confounders, we used a multilevel mixed-effects logistic regression model to compare the rates of EBP utilization by race and ethnicity. Secondarily, among hospitalizations with an EBP, we examined the association between race and ethnicity and the timing of the EBP procedure. RESULTS: We analyzed 49,300 delivery hospitalizations with a diagnosis of PDPH. An EBP was performed in 24,075 (48.8%; 95% confidence interval [CI], 47.8%–49.9%) of these hospitalizations. EBP was performed in 52.7% (95% CI, 51.3%–54.1%) of White non-Hispanic patients with PDPH. Compared to White non-Hispanic patients, Black non-Hispanic (adjusted odds ratio [aOR] = 0.69; 99% CI, 0.56–0.84), Hispanic (aOR = 0.80, 99% CI, 0.68–0.95), and Asian or Pacific Islander patients (aOR = 0.74, 99% CI, 0.58–0.96) were less likely to receive an EBP. The median (interquartile range [IQR]) time to perform an EBP was 2 (1–3) days after admission, with 90% of EBP procedures completed within 4 days of admission. There was no significant association between race and ethnicity and the timing of EBP placement. CONCLUSIONS: In this nationwide analysis of delivery hospitalizations from 2016 to 2020 in the United States with a diagnosis of PDPH, we identified racial and ethnic disparities in the utilization of EBP. Minoritized patients identified as Black non-Hispanic, Hispanic, or Asian or Pacific Islander were less likely to receive an EBP for the treatment of PDPH compared to White non-Hispanic patients. Suboptimal treatment of PDPH may be associated with adverse long-term outcomes such as postpartum depression, posttraumatic stress disorder, and chronic headaches. Racial and ethnic disparities in EBP utilization should be further investigated to ensure equitable health care delivery.

An approach to reduce inhaler errors using Donabedian's triad

Inhaler errors inversely affect the outcome of respiratory diseases. Inhaler devices, such as the metered-dose inhalers (MDI) and dry powder inhalers (DPI), are commonly used in treating respiratory diseases like asthma and chronic obstructive pulmonary disease (COPD), and incorrect use of these devices can result in suboptimal treatment outcomes, increased probabilities of hospitalizations or admissions, and poorer quality of life. Patient related factors to inhaler errors include age, cognitive and physical abilities, education, language barriers, and preferences. Device-related factors such as inhaler design and operational complexity can also lead to errors. Finally, factors related to healthcare professionals (HCP) such as competency, level of knowledge in disease and inhaler device and availability to educate patients, can play a role in inhaler error. Quality management is a potential solution to this problem. Quality improvement strategies towards addressing inhaler misuse can increase patient satisfaction and improve patient outcomes. Donabedian's triad, which includes structure, process, and outcome can be utilized in developing a framework for reducing inhaler errors. Institutional solutions are more towards the structural and process changes in the triad, such as HCP training, checklists on training efficacy, provision of action plans, and availability of staff to educate and train patients. Patient-centered solutions focus more on process and outcome domains, such as improvement in lung functions, patient education, re-assessment and re-education of inhaler techniques, and adherence to treatment regimen. By focusing on structural and process domains, the quality of care can be enhanced, resulting in improved outcomes.

EXTH-51. ENHANCING GLIOBLASTOMA TREATMENT: ALLOGENEIC CAR-T CELLS OVERCOMES FUNCTIONAL DEFICITS OF PATIENT-DERIVED AUTOLOGOUS PRODUCTS

Abstract Glioblastoma (GBM) is the most common primary brain malignancy in adults, with a dismal prognosis despite an intensive standard of care. Recently, chimeric antigen receptor T-cell (CAR-T) therapy has shown promising outcomes in treating liquid malignancies. However, clinical trials targeting various tumor antigens in GBM failed to show durable clinical benefit. Though this may stem from various tumor-intrinsic immune evasion strategies typical of GBM, there has been little work investigating whether the problem lies in the quality of the CAR-T products treatment itself. Currently, CAR-T cells for clinical studies are produced in an autologous setting, where T-cells are extracted from patients, engineered ex-vivo, and then re-infused. However, peripheral T-cells taken from GBM patients have shown qualitative and functional deficits, which may contribute to suboptimal treatment outcomes. Thus, we aimed to explore whether CAR-Ts generated from GBM patients had any functional deficits in comparison to healthy donors, utilizing our previously validated CD133 CAR-T. In this study, we show pre-treatment exhaustion, poor tumor control, and reduced survival advantage in autologous, patient-derived CD133-targeting CAR-T cell products using an orthotopic xenograft model of human GBM. To address the functional and logistical considerations of autologous therapy, we also sought to generate an “off-the-shelf” allogeneic CD133 CAR-T. Using CRISPR gene editing technology, we generated TCR-knockout CAR-T cells with comparable pre-clinical efficacy to our healthy donor derived autologous models. Ultimately, this work highlights the need to reevaluate autologous CAR-T therapy for GBM and consider allogeneic approaches as biologically-informed therapeutic alternatives.

How to combat stigma surrounding mental health disorders: a scoping review of the experiences of different stakeholders

BackgroundThe stigma associated with mental health disorders (MHDs) results in delayed help-seeking, limited access to health services, suboptimal treatment, poor treatment outcomes, and an increased risk of human rights violations. This scoping review summarizes qualitative research on the lived experiences of different stakeholders regarding strategies and interventions to combat stigma for people with MHDs.MethodsThis study was a six-step scoping review using the Arksey and O’Malley framework. A comprehensive search of the following electronic databases was conducted to identify relevant records: PubMed, Scopus, Web of Science (WoS) and Google Scholar, as well as a manual search of the reference lists. All steps, including screening of eligible studies, data extraction, and analysis, were performed independently by multiple reviewers, with disagreements resolved by discussion. The data were synthesized based on the for-content synthesis guidelines.ResultsA total of 25 studies were included in this review of the 32,976 initial identified citations. The included studies were from all countries (low, middle, and high income), stigmatized disorders (e.g., schizophrenia, bipolar disorder, etc.) and target populations (e.g., people with MHDs and their families, health care providers, the general community, and students and school members). The thematic synthesis revealed six types of interventions and strategies and 17 themes related to reducing stigma in patients on MHDs. Strategies and interventions were classified by patient (self-stigma), family (family stigma), healthcare professionals’ stigma, workplace stigma, public/societal stigma, and structural type of stigma (institutional stigma).ConclusionsThis review contributes new evidence that should be considered in future interventions and policies to reduce stigma against MHDs. Multilevel and multistakeholder strategies and interventions are needed to reduce the stigmatization of MHDs.

Drug-related problems among pediatric intensive care units: prevalence, risk factors, and clinical pharmacists’ interventions

BackgroundDrug-related problems (DRPs) are frequently observed in intensive care units, resulting in a higher occurrence of drug side effects and increased treatment expenses. This study aimed to assess the prevalence of DRPs in pediatric patients admitted to the most prominent surgical and medical pediatric intensive care units (PICUs) in southern Iran, given the susceptibility of children to the effects of DRPs.MethodThis cross-sectional study was conducted at Namazi Hospital, which is affiliated with Shiraz University of Medical Sciences in Shiraz, Iran, from June 2022 to March 2023. The research focused on identifying and detecting drug-related problems (DRPs) among pediatric patients during their hospital stays across three medical wards, two pediatric intensive care units, and a surgical intensive care unit. The identification process occurred concurrently with patient treatment and utilized the Pharmaceutical Care Network of Europe’s data collection form for DRPs version 8.01. Before any documentation, all cases were thoroughly reviewed and validated by a professional focus group. The data gathered were then statistically analyzed using SPSS to evaluate the study’s outcomes.ResultDuring the study, 323 pediatric patients were involved, of whom 57% experienced at least one DRP. The primary issues identified during the study were suboptimal drug treatment, accounting for 41.13% of cases, followed by concerns related to treatment safety, which constituted 38.53% of cases. Drug-drug interactions were found to be the leading cause of DRPs, accounting for 36.26% of cases. Two significant factors associated with DRP occurrence were the number of prescribed drugs and the number of prescribed anticonvulsants. Out of all clinical pharmacist interventions, 97% were accepted.ConclusionPatients admitted to the PICUs experience a high occurrence of DRPs. It is essential to consider optimal dosage adjustment, particularly for pediatric patients with impaired kidney function.

The Role of Fatty Acid Metabolism, the Related Potential Biomarkers, and Targeted Therapeutic Strategies in Gastrointestinal Cancers.

Gastrointestinal cancer has emerged as a significant global health concern due to its high incidence and mortality, limited effectiveness of early detection, suboptimal treatment outcomes, and poor prognosis. Metabolic reprogramming is a prominent feature of cancer, and fatty acid metabolism assumes a pivotal role in bridging glucose metabolism and lipid metabolism. Fatty acids play important roles in cellular structural composition, energy supply, signal transduction, and other lipid-related processes. Changes in the levels of fatty acid metabolite may indicate the malignant transformation of gastrointestinal cells, which have an impact on the prognosis of patients and can be used as a marker to monitor the efficacy of anticancer therapy. Therefore, targeting key enzymes involved in fatty acid metabolism, either as monotherapy or in combination with other agents, is a promising strategy for anticancer treatment. This article reviews the potential mechanisms of fatty acid metabolism disorders in the occurrence and development of gastrointestinal tumors, and summarizes the related potential biomarkers and anticancer strategies.

A Nation-Wide Evaluation of Suboptimal Lipid-Lowering Treatment Patterns Among Patients Undergoing Intervention for Acute Coronary Syndrome in Hungary.

Background/Objectives: A significant gap exists between guideline recommendations and everyday practice. Stringent treatment is needed for vulnerable patients with acute coronary syndrome (ACS). Methods: Data on the lipid-lowering therapy (LLT), including the adherence, persistence, and mortality of patients undergoing percutaneous coronary intervention or bypass surgery in Hungary in 2018 were followed up and analyzed based on the National Health Insurance Fund database until the end of 2020. Results: A total of 12,997 patients underwent revascularization for ACS in 2018, whose discharge therapy included any LLT, a high- or moderate-intensity statin, or ezetimibe at a proportion of 91%, 75%, 12%, and 4%, respectively. By the end of the observation period, the frequency of ezetimibe administration increased to 11%. Persistence decreased, reaching 50% for all therapeutic regimens by month 16. Patients on moderate statin doses had a significantly higher mortality rate at the end of follow-up than those receiving high-intensity statin with (20% vs. 9%, p < 0.0001) or without (20% vs. 14%, p = 0.00029) ezetimibe. Those taking less potent statin doses had higher rates of comorbidities; for example, a minimum of three comorbidities were present in 39% of patients taking medium statin doses and 23% among those on high-intensity statin therapy (p < 0.0001). Conclusions: LLT persistence decreased during follow-up. The administration of a higher-intensity lipid-lowering regimen was associated with better persistence and adherence, along with more favorable mortality rates. Multimorbidity was associated with the use of lower statin doses. The results suggest that more attention is needed in terms of lipid control of females, elderly people, and individuals with several comorbidities, and emphasis should be placed on improving persistence and increasing the frequency of combined LLT prescriptions.

Arterial hypertension-Current recommendations for action

Arterial hypertension (aHT) currently affects nearly 1 in every 3 persons in Germany and the number of those affected is steadily increasing. Only half of the patients treated show a controlled blood pressure in the follow-up. A suboptimal treatment involves the danger of cardiovascular and renal events that under certain circumstances can have a fatal course. The publication of the first national treatment guidelines (NVL) on hypertension and the new guidelines of the European Society of Hypertension (ESH) 2023 simultaneously represent two updates. Both emphasize the necessity to avoid hypertension-mediated organ damage (HMOD) and the identification of high blood pressure. The focussing on preventive measures and lifestyle recommendations as well as the simplification of target blood pressure values play important roles in the routine practice. This article provides a practical summary of the current recommendations of both guidelines on the diagnostics and treatment of aNT, discusses relevant differences and provides routinely applicable advice.

Intra-articular knee injections in patients with primary osteoarthritis in a tertiary clinical setting: a best practice implementation project.

This project aimed to improve physicians' adherence to evidence-based practices regarding the selection and administration of intra-articular knee injections for patients with osteoarthritis. The project also aimed to empower patients by increasing their awareness of these evidence-based practices. In the management of knee osteoarthritis, intra-articular injections are commonly used when initial treatments prove inadequate. However, issues such as patients' demand for rapid relief and variability in physicians' familiarity with optimal practices often lead to suboptimal treatment decisions and potential adverse outcomes. This project followed the JBI Evidence Implementation Framework, which is grounded in an audit, feedback, and re-audit process. Initially, physicians were surveyed on the topic under consideration, and hospital records were reviewed. Subsequently, targeted interventions were implemented, including briefings and the distribution of informative flyers. The baseline audit indicated low adherence with all audit criteria. Various parameters, such as adherence to best clinical practices, informed decision-making by patients, and the recommendation of alternative treatment modalities, were significantly lacking. Following the interventions, substantial improvements were observed, including higher rates of adherence to best clinical practices by physicians for multiple criteria, such as stepwise referral to conservative therapy options and the content of intra-articular injections. Adherence to best clinical practices can be improved through educational briefings for physicians on the most current evidence-based treatment practices for injectable substances in knee osteoarthritis. The active engagement of patients, facilitated by informative flyers and physician assistance, contributed to better involvement in their treatment choices. However, the participation of health care institutions and providers as well as lifelong education practices may be necessary for more comprehensive and sustainable changes. http://links.lww.com/IJEBH/A277.

Residual risk post acute coronary syndroms after 1 year of cardiac rehabilitation. Can we improve it?

Abstract How much do we reduce residual risk with a cardiac rehabilitation program? What is left to do? Which would be the impact of a lower cholesterol threshold for the use of more potent lipid lowering drugs on residual risk? We explored these issues. Methods We retrospectively analyzed clinical and biochemical data from patients after 1 year of cardiac rehabilitation following an acute coronary event. Changes in residual risk of combined myocardial infarction, stroke and cardiovascular death, and its modification with optimization of treatment in patients with suboptimal lipid control, and with the use of PCSK9 inhibitors in those with a LDL-cholesterol over 70 mg/dl, were estimated using the SMART-REACH model calculator. Wilcoson and McNemar tests for paired-samples were used in the statistical análisis. Results 262 consecutive patients were included. Median age was 63.5 years, 80.5% men, 89.3% stented. Baseline use of high intensity statins was 90.8%. After 1 year, the use of Ezetimibe was doubled to 77.1%, empaglifozin to 26%, and PCSK inhibitors were used only in 5%, with a residual use of colchicine. Blood pressure and Cholesterol profile improved after 1 year, with no change in HbA1c. Absolute 10- years and life-long residual risk were reduced 4.8% (95%CI:3.6-5.9) and 6% (95%IC: 4.5-7.5) respectively (both p&amp;lt;0.001). LDL-cholesterol was &amp;gt;55 mg/dl with a suboptimal lipid lowering treatment in 29.8% of patients: an optimization to higher dose of rosuvastatin/atorvastatin plus ezetimibe would decrease absolute 10-years and life-long residual risk in 7.2% (95%CI: 4.9-9.4) and 9.9% (95%CI: 6.4-13.5%) respectively (both p&amp;lt;0.001). LDL-cholesterol remained &amp;gt; 70 mg/dl after higher dose of statin plus ezetimibe in 13.7% of patients: use of PCSK9 inhibitors in this group would reduce absolute 10-year and life-long residual risk in an additional 5.4% (95%CI:2.4-7,6;p=0,018) and 7% (95%CI: 3,8-10,1) compared to maximal dose of statins plus ezetimibe. Conclusions Cardiac rehabilitation programs reduce cardiac risk 1 year after an acute coronary event. Residual risk remain very high, and a significant proportion of patients do not reach recommended targets and optimal lipid lowering treatment. Optimization of lipid lowering drugs, and a lower LDL-cholesterol threshold for the use of PCSK9 inhibitors, would have a significant impact on residual risk.Changes in residual riskPCSK9-inhibitors in LDLchol &amp;gt;70 mg/dl

Optimizing aldosterone receptor antagonist therapy by sodium zirconium cyclosilicate in heart failure - OPRA-HF trial

Abstract Background Heart failure remains a significant health burden, characterized by disabling symptoms and mortality rates comparable to cancer. Mineralocorticoid antagonists (MRAs), pivotal in treating heart failure with reduced ejection fraction (HFrEF), are underutilized due to concerns of hyperkalemia. Sodium Zirconium Cyclosilicate (SZC) enables optimized MRA therapy by reducing hyperkalemia. However, prospective studies on the efficacy and safety of SZC in patients with HFrEF and high hyperkalemia risk are lacking, particularly in the context of contemporary heart failure quadruple-therapy including angiotensin receptor neprilysin inhibitor (ARNI) and Sodium-Glucose Transport Protein 2 (SGLT2) Inhibitors. Purpose The OPRA-HF trial aims to assess the efficacy and safety of SZC in optimizing MRA treatment in symptomatic patients with HFrEF with risk for hyperkalemia on top of optimal guideline-directed medical therapy including ARNI and SGLT2 Inhibitors. Methods This investigator-initiated multicentred, randomized, placebo-controlled, and double-blinded trial include patients with HFrEF on suboptimal MRA treatment due to (1) history of hyperkalemia due to MRA, or (2) risk of hyperkalemia due to reduced renal function (eGFR 30-45 ml/min/m2) and current potassium 4.5-5-0 mmol/L. Patients undergo a Run-In phase with SZC, initiating or up-titrating MRA to target doses for 4-7 weeks and SZC was initiated in those patients that became hyperkalemic (K+&amp;gt;5 mEq/L. Those normokalemic and tolerating MRA ≥ 25 mg daily or at least 25 mg dose increase vs before run-in were randomized to SZC (5g or 10g) or placebo for 6 months. Study is powered to randomize 110 patients. Primary outcomes include maintaining daily MRA dose ≥ 25 mg or dose increase by 25 mg with normal potassium levels without rescue therapy. Secondary outcomes include evaluating the safety and tolerability of SZC as well as impact of SZC on quality of life. Results In this ongoing trial, so far 40 patients have been randomized. Of these, mean age was 74.3 years, 88.9% men. Most patients had ischemic etiology (54.2%), 36.1% had diabetes mellitus, 52.8% had hypertension.n. At screening 94.4% had beta-blockers, 35% ACEI/ARB, 60% ARNI and 72.2% had SGLT2 inhibitors, 33.3% had no MRAs and 35,6% of patients had less than 25 mg MRA daily,62,2% had 25 mg MRA daily, mean p-potassium was 4.7+0.4 mmol/L, and eGFR was 57.3 ml/min/1.73m². After run-in, 85.2% were on 50 mg MRA daily. A substantial number (51.2%) of eligible patients with previous hyperkalemia had Run-In failure as they now successfully tolerated target dose of MRA at 50 mg daily without recurrent hyperkalemia. SZC dosing was 5g once daily in 78.9% of patients. Conclusion This ongoing trial will provide evidence for the use of SZC to optimize MRA treatment in contemporary HFrEF patients. Preliminary findings suggest SZC effectively maintains normokalemia, enabling MRA optimization, potentially improving patients’ otcome.

Intratumoral microbiota: a new force in the development and treatment of esophageal cancer.

Esophageal cancer (EC) ranks among the most prevalent cancers worldwide, with a particularly high incidence in the Asian population. Due to the inconspicuous nature of early symptoms, patients with esophageal cancer are typically diagnosed in the middle to late stages, resulting in suboptimal overall treatment outcomes. Consequently, there is an urgent need to explore and refine therapeutic strategies. Microorganisms have been identified in numerous tumor tissues, including EC, and these microorganisms are referred to as the intratumoral microbiome. Intratumoral microbiota and their metabolic byproducts can influence the progression and treatment of esophageal cancer through various mechanisms, such as modulating tumor cell metabolism and local immune responses. Therefore, the intratumoral microbiota may potentially serve as a target for the treatment of esophageal cancer. This review delineates the composition, origin, and diagnostic significance of intratumoral microbiota in esophageal cancer tissue, and discusses the mechanisms by which intratumoral microbiota contribute to the onset of esophageal cancer. In addition, the impact of intratumoral microbiota on the treatment of esophageal cancer and its intervention measures are also addressed.

Enhancing Cytoplasmic Expression of Exogenous mRNA Through Dynamic Mechanical Stimulation.

Ionizable lipid nanoparticles (LNPs) are pivotal in combating COVID-19, and numerous preclinical and clinical studies have highlighted their potential in nucleic acid-based therapies and vaccines. However, the effectiveness of endosomal escape for the nucleic acid cargos encapsulated in LNPs is still low, leading to suboptimal treatment outcomes and side effects. Hence, improving endosomal escape is crucial for enhancing the efficacy of nucleic acid delivery using LNPs. Here, a mechanical oscillation (frequency: 65Hz) is utilized to prompt the LNP-mediated endosomal escape. The results reveal this mechanical oscillation can induce the combination and fusion between LNPs with opposite surface charges, enhance endosomal escape of mRNA, and increase the transfection efficiency of mRNA. Additionally, cell viability remains high at 99.3% after treatment with oscillation, which is comparable to that of untreated cells. Furthermore, there is no obvious damage to mitochondrial membrane potential and Golgi apparatus integrity. Thus, this work presents a user-friendly and safe approach to enhancing endosomal escape of mRNA and boosting gene expression. As a result, this work can be potentially utilized in both research and clinical fields to facilitate LNP-based delivery by enabling more effective release of LNP-encapsulated cargos from endosomes.

Addressing bladder and bowel challenges in dutch multiple sclerosis patients: Symptom prevalence and patient referral pathways.

Nerve damage and/or spinal cord injury in individuals with multiple sclerosis (MS) may result in the development of bladder and bowel problems. We wanted to gain insight into two issues: the prevalence of bladder and bowel problems among individuals with MS and the referral pathways for these problems to various physicians treating patients with MS. In the autumn of 2021, we undertook a nationwide cross-sectional study. We used a comprehensive questionnaire comprising 63 questions covering aspects such as MS diagnosis, disease progression, bladder and bowel issues, and consultations with healthcare professionals. Individuals with MS were invited to participate through social media or by direct mail. The study included 1,082 validated respondents (81.5% female) with an average age of 53.3 years at participation, and an average age of 38.3 years at MS-diagnosis. Among the respondents, 91% experienced bladder problems while 73% indicated they had bowel problems. Within these respective groups, 42% and 47% were not aware of the connection between these issues and MS. Bladder and bowel related complaints disrupted daily life for 45% and 28% of the respondents, respectively. The patients consulted various healthcare providers for their complaints. Most respondents expressed dissatisfaction with the time it took to resolve their problems and 9% of those with bladder complaints and 60% of those with bowel complaints had not yet found a satisfactory solution. In the Netherlands, bladder and bowel symptoms in individuals with MS are highly prevalent and have a considerable impact on quality of life. Lack of awareness of these symptoms frequently leads to inadequate recognition, both by the patient and healthcare professional. Patients often consult various healthcare professionals for these complaints, which can potentially result in suboptimal treatment due to a lack of specialized expertise.

Phenotyping Adherence Through Technology-Enabled Reports and Navigation (the PATTERN Study): Qualitative Study for Intervention Adaptation Using the Exploration, Preparation, Implementation, and Sustainment Framework.

Older adults with multiple chronic conditions (MCC) and polypharmacy often face challenges with medication adherence. Nonadherence can lead to suboptimal treatment outcomes, adverse drug events, and poor quality of life. To facilitate medication adherence among older adults with MCC and polypharmacy in primary care, we are adapting a technology-enabled intervention previously implemented in a specialty clinic. The objective of this study was to obtain multilevel feedback to inform the adaptation of the proposed intervention (Phenotyping Adherence Through Technology-Enabled Reports and Navigation [PATTERN]). We conducted a formative qualitative study among patients, clinicians, and clinic administrators affiliated with a large academic health center in Chicago, Illinois. Patient eligibility included being aged 65 years or older, living with MCC, and contending with polypharmacy. Eligibility criteria for clinicians and administrators included being employed by any primary care clinic affiliated with the participating health center. Individual semistructured interviews were conducted remotely by a trained member of the study team using interview guides informed by the Exploration, Preparation, Implementation, and Sustainment Framework. Thematic analysis of interview audio recordings drew from the Rapid Identification of Themes from Audio Recordings procedures. In total, we conducted 25 interviews, including 12 with clinicians and administrators, and 13 with patients. Thematic analysis revealed participants largely found the idea of technology-based medication adherence monitoring to be acceptable and appropriate for the target population in primary care, although several concerns were raised; we discuss these in detail. Our medication adherence monitoring intervention, adapted from specialty care, will be implemented in primary care. Formative interviews, informed by the Exploration, Preparation, Implementation, and Sustainment Framework and conducted among patients, clinicians, and administrators, have identified intervention adaptation needs. Results from this study could inform other interventions using the patient portal with older adults.

Design of thermally programmable 3D shape memory polymer-based devices tailored for endovascular treatment of intracranial aneurysms

Despite recent technological advancements in endovascular embolization devices for treating intracranial aneurysms (ICAs), incomplete occlusion and aneurysm recanalization remain critical challenges. Shape memory polymer (SMP)-based devices, which can be manufactured and tailored to patient-specific aneurysm geometries, possess the potential to overcome the suboptimal treatment outcome of the gold standard: endovascular coiling. In this work, we propose a highly porous patient-specific SMP embolic device fabricated via 3D printing to optimize aneurysm occlusion, and thus, improve the long-term efficacy of endovascular treatment. To facilitate device deployment at the aneurysm via Joule-heating, we introduce a stable, homogeneous coating of poly-pyrrole (PPy) to enhance the electrical conductivity in the SMP material. Using an in-house pulse width modulation circuit, we induced Joule-heating and characterized the shape recovery of the PPy-coated SMP embolic devices. We found that the employed PPy coating enables enhanced electrical and thermal conductivity while only slightly altering the glass transition temperature of the SMP material. Additionally, from a series of parametric studies, we identified the combination of catalyst concentration and pyrrole polymerization time that yielded the shape recovery properties ideal for ICA endovascular therapy. Collectively, these findings highlight a promising material coating for a future coil-free, personalized shape memory polymer (SMP) embolic device, designed to achieve long-lasting, complete occlusion of aneurysms.

Remote monitoring of rheumatoid arthritis (REMORA): study protocol for a stepped wedge cluster randomized trial and process evaluation of an integrated symptom tracking intervention

BackgroundManagement of rheumatoid arthritis (RA) relies on symptoms reported by patients during infrequent outpatient clinic visits. These reports are often incomplete and inaccurate due to poor recall, leading to suboptimal treatment decisions and outcomes. Asking people to track symptoms in-between visits and integrating the data into clinical pathways may improve this. However, knowledge on how to implement this into practice and its impact on services and outcomes remains scarce in RA. Therefore, we evaluate the comparative effectiveness and cost-effectiveness of integrated symptom tracking in people with RA over and above usual care, while generating insights on factors for successful implementation.MethodsIn this superiority stepped wedge cluster-randomized controlled trial with continuous recruitment short exposure design, 16 rheumatology outpatient departments (clusters) recruit a total of 732 people with active RA. They initially offer clinic visits according to standard of care before switching in pairs to visits with integrated symptom tracking. Clusters switch in randomized order every 3 weeks. Integrated symptom tracking consists of (1) a mobile app for patients to track their symptoms daily and other RA aspects weekly/monthly, and (2) an interactive dashboard visualizing the app data, which healthcare professionals access from their electronic health record system. Clinic visits happen according to usual practice, with tracked symptom data only reviewed during visits. Our primary outcome is a difference in marginal mean disease activity score at 12 ± 3 months between standard of care and integrated symptom tracking, after accounting for baseline values, cluster, and other covariates. Secondary outcomes include patient-reported disease activity, quality of life and quality-adjusted life-years, medication/resource use, consultation and decision-making experience, self-management, and illness perception. We also conduct interviews and observations as part of a parallel process evaluation to gather information on implementation.DiscussionOur trial will generate high-quality evidence of comparative and cost-effectiveness of integrated symptom tracking compared to standard of care in people with RA, with our process evaluation delivering knowledge on successful implementation. This optimizes the chances of integrated symptom tracking being adopted more widely if we find it is (cost-) effective.Trial registrationRegistered 4-Jun-2024 on https://www.isrctn.com/, ISRCTN51539448.Trial open science framework repositoryhttps://osf.io/sj9ha/.

Characteristics of patients with somatoform pain disorder

AbstractBackgroundPatients with somatoform pain experience physical pain that cannot be attributed to any underlying medical or physiological cause, and it is often thought to be related to psychological factors. Health professionals encounter difficulties identifying this specific type of chronic pain, leading to suboptimal treatment strategies. Therefore, we aimed to describe the characteristics of patients with somatoform pain, to support the identification of affected patients.MethodsWe collected and analyzed a cross‐sectional survey data from 200 patients with somatoform pain admitted to one of three psychosomatic centers in Germany between August 2013 and July 2014. The survey contains 10 different categories, all of them referring to pain‐related topics. Within the survey, we analyzed validated as well as non‐validated questionnaires. Here, we present the following five: Personal data, Body: Pain perception, Cognition: Pain processing, Pain behavior, and Physical complaints.ResultsOur results highlight that most patients with somatoform pain experience it in several body parts and as persisting, lasting &gt;12 h/day (50%), and constantly changing (71%). Furthermore, patients indicate feelings of helplessness, by agreeing to the expressions the pain controls me (70%). Finally, we found that pain is predominantly seen as suffering, failing to convey emotional pain, despite cognitively acknowledging the dependency of emotional and physical pain.ConclusionThe study identified specific and distinctive characteristics in the emotional and behavioral responses of patients with somatoform pain, potentially distinguishing them from other patients with chronic pain.

Organizational readiness to implement bundled interventions to increase HIV linkage and retention in care and treatment: results from the Black Women First (BWF) initiative

BackgroundEvidence-based and evidence-informed interventions designed to address gaps in the HIV care continuum have the potential to improve HIV care and treatment. However, inadequate organizational readiness can derail intervention uptake, prevent the integration of interventions, and contribute to suboptimal HIV treatment outcomes. This study sought to understand organizational readiness to implement bundled interventions for Black women with HIV and inform facilitators and barriers to implementation.MethodsWe conducted a mixed methods readiness assessment across 12 sites participating in the Black Women First (BWF) initiative to gauge preparedness to implement bundled interventions. Readiness was assessed using the organizational readiness for implementing change (ORIC) scale, and two open-ended questions examined facilitators and barriers. Associations between participant and organizational level factors were evaluated using linear models with clustering by site at baseline, 6- and 12-months. Pre-implementation interviews were conducted with staff virtually and transcripts were managed in NVivo. Directed content analysis was used to explore implementation barriers and facilitators.FindingsSites demonstrated high levels of organizational readiness at baseline; overall organizational readiness for implementing change (ORIC) (mean 56.4, median 59, interquartile range [IQR] 5) and subscales of the ORIC change efficacy (mean 32.4, median 35, IQR 4), change commitment (mean 24, median 25, IQR 1), which is consistent with willingness and capability to implement bundled interventions for Black women with HIV. Organizational readiness remained high at 6- and 12-month follow-up periods. Staff role was significantly associated with organizational readiness (p = 0.007), change efficacy (p = 0.006), and change commitment (p = 0.020) at 6 months. Qualitative analysis indicated strategic planning and assessment (e.g., team coordination and the development of workflows to support implementation); organizational change through network weaving across silos within the organization, and communications systems that engage external partners, as well as resources available for hiring and training, supported readiness. Collaborative leadership and organizational buy-in, staff motivation, and partnerships facilitated implementation processes.ConclusionsOrganizations in the BWF initiative have high levels of organizational readiness reflecting willingness and capability to implement bundled interventions for Black women with HIV. Future research should examine the relationship between readiness and clinical outcomes.

Current Diagnosis of Bleeding Disorders in Lower Income Countries.

There have been considerable advances in diagnosing and treating bleeding disorders. But the scenario remains dismal in resource-constrained settings in low and lower-middle-income countries (LMICs). Seventy-five percent of the patients with inherited bleeding disorders do not get diagnosed in LMICs. In resource-constrained settings, infectious disease and malignancies take the major focus. Bleeding disorders do not get prioritised in LMICs, and this leads to underdiagnoses and suboptimal treatment. There are various challenges like financial status, inadequacy of health care infrastructure, lack of patient registry and lack of awareness across medical staff, general population and government stakeholders. The lack of skilled laboratory personnel and laboratory infrastructure for optimal bleeding disorder diagnosis adds on to the problem. World Federation of Hemophilia (WFH) has been at the forefront in developing strategies to overcome some of these inadequacies; however, more active participation of the stakeholders including patients, medical professionals and policy makers is the need of the hour. This review highlights the different challenges in LMICs in diagnosing bleeding disorders, the gap between high-income countries and LMICs and the possible strategies in closing the gap.