Ongoing Patient Management Research Articles

Safety study on adverse events of zanubrutinib based on WHO-VigiAccess and FAERS databases.

The study endeavors to elucidate AE signals associated with zanubrutinib data from the WHO-VigiAccess and FAERS databases. The aim is to furnish robust scientific evidence to inform clinical practice and regulatory decisions. We meticulously extracted all AE breports tied to zanubrutinib from the both databases, encompassing the period from the drug's market introduction until 30 April 2024. Retrospective quantitative analysis employing ROR, PRR, and BCPNN methodologies were utilized to analysis. The investigation unveiled 1,304 reports from WHO-VigiAccess and 1,141 reports from FAERS related to zanubrutinib. Among the top 30 reported PTs in both databases, those not recorded in the drug label included pyrexia, dizziness, and death. In the FAERS database, signals for zanubrutinib were detected across 19 SOCs. Systems not covered in the drug label included reproductive system and breast disorders, metabolism and nutrition disorders, ear and labyrinth disorders, among others. Unmentioned signals included intestinal perforation, onychoclasis, night sweats, etc. This study confirms common AEs of zanubrutinib and identifies new ones, highlighting the need for careful monitoring and personalized treatment. It also emphasizes the importance of ongoing drug safety surveillance and patient management to maximize therapeutic benefits and minimize risks.

Paradigms matter: why persistent pain is different and how dentists can help.

Dental professionals often expect, and are used to treating, pain that has a clear, organic and likely pathological cause. Patients visiting the dentist are also likely to share this expectation. However, in addition to potential organic contributions to the experience of pain, the nociceptive system (pain signalling system) also plays an important role. Alongside organic contributions, it is important to also consider that persistent pain is different to acute pain and requires different explanations and different management. Dental professionals need to be equipped to understand and explain persistent pain and to incorporate this understanding into their ongoing patient management so that patients can be educated in why the two are different and therefore require different approaches.

Achalasia Following SARS-CoV-2 Infection: A Case Report and Review of Literature.

The COVID-19 pandemic caused by the SARS-CoV-2 virus has led to health complications beyond respiratory symptoms, revealing multi-organ involvement, including potential gastrointestinal implications. We present a case of a 40-year-old female without any history of achalasia who developed symptoms of the condition following a confirmed SARS-CoV-2 infection. Unusually, multiple esophageal ulcers were identified, which are not typically associated with achalasia. Achalasia and esophageal ulcers were confirmed through a series of examinations, including barium swallow, CT scan, and upper endoscopy. Furthermore, immunohistochemical staining of esophageal biopsy specimens revealed the presence of the SARS-CoV-2 spike protein, suggesting direct viral involvement. The patient was treated with calcium channel blockers and proton pump inhibitors and later underwent a peroral endoscopic myotomy (POEM) procedure following the resolution of her COVID-19 infection. After the POEM procedure, the patient made a good recovery. This case underscores the potential for SARS-CoV-2 to trigger gastrointestinal complications and emphasizes the need for ongoing patient management and further research into the long-term implications of COVID-19. Despite the single-case nature of this report, it contributes to the expanding understanding of the diverse and multi-systemic impact of COVID-19.

Emergency Management System in Indonesia: An evaluation of emergency patient management in 2020

Indonesia has its emergency patient management system regulated in Public Safety Center (PSC) 119 as stated in Indonesia’s Health Ministry Regulation No. 19 (2016). An evaluation to assess the ongoing management of this system is a must to ensure its continuous development. This study assessed the ongoing emergency patient management system using instrument indicator questionnaires developed by the authors. The questionnaire consists of 28 indicators from 8 assessment aspects including: policy, planning, program implementation, communication, transportation, referral, management reviews, and emergency services. Questionnaires were distributed and completed questionnaires were received from 88 respondents from 21 provinces of Indonesia. Validity test results counted the coefficient correlation of all indicators above r value table (0.2096) and all Alpha Cronbach’s indicators value above 0,80. The value indicator is considered poor if its average score is below the average score of the overall indicators and is considered good if it is above the average overall indicator score. The assessment result there is twelve indicators from this study shows a below average value (66) . Data acquired in this study can be used as a preliminary reference for continuous improvement of Indonesia’s emergency management system operated by the PSC.

Intravascular Volume Derangement and Value of Blood Volume Analysis in Stable Ambulatory Patients with Advanced Heart Failure Supported with Left Ventricular Assist Device

<h3>Purpose</h3> Heart failure is associated with elevated filling pressures and significant volume expansion. Durable left ventricular assist devices (LVAD) have been shown to improve survival and quality of life in patients with advanced heart failure. There is strong evidence suggesting structural, neurohormonal and hemodynamic improvement after LVAD implantation. The data on normalization of plasma volume is lacking. We sought to describe blood volume parameters in stable outpatient LVAD recipients. <h3>Methods</h3> We performed blood volume analysis (BVA) on 33 stable consecutive patients supported with LVADs in the outpatient setting. All BVAs were obtained as part of routine outpatient follow up. Results of the test were provided to clinicians for ongoing patient management. BVA is clinically approved and utilizes the Iodine131-tagged albumin tracer to provide quantitative measurement of total blood volume (TBV), plasma volume (PV) and red blood cell volume (RBC). The BVA-report provides absolute values (ml) and deviation from ideal TBV, PV, and RBC. A TBV deviation ≥±8% was considered to be either an excess or deficit of volume. <h3>Results</h3> Only 9% of stable ambulatory LVAD patients had normal blood volume results. 18/33 (54%) had significant anemia, 4/33 (12%) had polycythemia. Polycythemia in all of the patients was masked on complete blood count analysis, due to significant hypervolemia. One of the patients with masked polycythemia had fatal pump thrombosis. Plasma volume abnormality was found in 75% of patients (39% were hypervolemic, 36% were hypovolemic). 6 patients had repeat BVA after medical interventions and all of them were unsuccessful in normalizing plasma volume. <h3>Conclusion</h3> BVA is useful tool in outpatient management of patients with LVADs. As with advanced heart failure, correction of clinically unsuspected and undetected derangements in intravascular volume and red blood cell volumes likely have an impact on device and patient outcomes. These deviations may be recalcitrant to correction and further investigation is ongoing. Underdiagnosed polycythemia in LVAD patients may further contribute to hemo-compatibility issues and thrombosis. Measurement and treatment of derangements of intravascular volumes likely will improve performance and survival of patients and devices.

Introduction of structured record keeping in age-related macular degeneration: a before and after study

ABSTRACT Clinical relevance Structured record keeping improves documentation in age-related macular degeneration; however, it may have a more limited effect on the management decisions of a group of already highly trained clinicians, especially in the context of other well-embedded clinical decision support tools. Background Structured record keeping has been associated with a range of advantages including improved history taking and communication, reduced number of unnecessary referrals, and enhanced diagnostic accuracy. The aim of this study was to examine the impact of a structured record keeping, quality improvement tool on recording, reporting and management congruency. Methods A before and after retrospective record review study was performed in a single academic, intermediate-tier care institute in New South Wales, Australia. The structured record keeping tool intervention captured 31 items in addition to the prior pre-existing medical record: six items relating to historical risk factors, two items relating to patient activation, 13 items signifying core clinical signs, five items for change analysis and five items regarding the ongoing patient management plan. Results Two hundred medical records from 151 patients with age-related macular degeneration were analysed. There was a statistically significant improvement in the number of reports that explicitly specified the number of clinical structural risk factors (from 24 to 75%; Fisher’s exact p < 0.001) and risk of progression to advanced disease (from 71 to 84%; p = 0.041); however, this documentation had no statistically significant effect on the report-recommended management plan and/or the final report-recommended review period. Conclusion Disease-specific, structured record keeping improves the outgoing documentation of key clinical signs and is effective in prompting the transposition of these signs into a quantified risk progression score. It has limited value in improving management consistency among a group of highly trained eye care staff.

Clinical presentation and natural history of Barth Syndrome: An overview.

Barth Syndrome is a rare X-linked disorder caused by pathogenic variants in the gene TAFAZZIN, which encodes for an enzyme involved in the remodeling of cardiolipin, a phospholipid primarily localized to the inner mitochondrial membrane. Barth Syndrome is characterized by cardiomyopathy, skeletal myopathy, neutropenia, and growth abnormalities, among other features. In this review, we will discuss the clinical presentation and natural history of Barth Syndrome, review key features of this disease, and introduce less common clinical associations. Recognition and understanding of the natural history of Barth Syndrome are important for ongoing patient management and developing endpoints for the demonstration of efficacy of new and emerging therapies.

Development of antibody response to SARS‐CoV‐2 following asymptomatic infection in patients with plasma cell disorders on immunomodulatory therapy

Development of antibody response to SARS‐CoV‐2 following asymptomatic infection in patients with plasma cell disorders on immunomodulatory therapy

Validation of a prospective mortality prediction score for hip fracture patients.

Although mortality prediction tools are the subject of significant interest as components of comprehensive hip fracture protocols, few have been applied or validated to prospectively inform ongoing patient management. Five regional hospitals are currently generating real-time mortality risk scores for all adults at the time of admission using available laboratory and comorbidity data (Cowen et al. J Hosp Med 9(11):720-726, 2014). Although results for aggregated conditions have been published, the primary aim of this study is to determine how well prospectively calculated scores predict mortality for hip fracture patients specifically. Using a five-hospital database, 1376 patients who were prospectively scored on admission were identified from January 2013 to April 2017, cross-referencing ICD9/10 diagnosis and procedure codes for AO/OTA 31A1 through 31B3 fractures. Prospective mortality scores have been previously divided into 5 risk categories to facilitate ease of clinical use. Vital status was determined from hospital data, Social Security and Michigan Death Indices. Prospective scores demonstrated good mortality prediction, with AUCs of 0.80, 0.73, 0.74 and 0.74 for in hospital, 30-, 60- and 90-day mortality, respectively. Patients in the top 2 mortality risk categories represented 30% (410/1376) of the cohort and accounted for 78% (25/32) of the inpatient and 59% (57/97) of the 30day deaths. Implementation of this real-time mortality risk tool is feasible and valid for the prediction of short- to medium-term mortality risk for hip fracture patients, and potentially offers valuable information to guide ongoing patient management decisions such as admitting service or level of care.

Nurses as substitutes for doctors in primary care

Pressures on the health care system are a stimulus for innovation, including workforce changes such as substitution. A common approach to substitution in primary care is where nurses replace medical staff in roles traditionally filled by physicians. However, questions regarding the safety and effectiveness of substitution remain. The objective of this systematic review was to evaluate outcomes from nurse substitution in primary health care settings. The review of randomised controlled trials used Cochrane methods to evaluate study quality (risk of bias) and select papers focused on nurse substitution in primary care. Two independent reviewers were used for each key step, following a comprehensive search in this high quality systematic review. Eighteen studies were included, showing clinical outcomes were comparable (and not worse) when nurses substituted for medical staff. While nurses were reliably found to spend more time per consult, this was the only significant difference between nurses and physicians; with data on patient outcomes being similar. Nurses in primary care are safe, effective first contact providers who can sustain ongoing patient management without adversely effecting healthcare outcomes.

The Development of Remote Speech Recognition Tests for Adult Cochlear Implant Users: The Effect of Presentation Mode of the Noise and a Reliable Method to Deliver Sound in Home Environments

The number of cochlear implant (CI) users is increasing annually, resulting in an increase in the workload of implant centers in ongoing patient management and evaluation. Remote testing of speech recognition could be time-saving for both the implant centers as well as the patient. This study addresses two methodological challenges we encountered in the development of a remote speech recognition tool for adult CI users. First, we examined whether speech recognition in noise performance differed when the steady-state masking noise was presented throughout the test (i.e. continuous) instead of the standard clinical use for evaluation where the masking noise stops after each stimulus (i.e. discontinuous). A direct coupling between the audio port of a tablet computer to the accessory input of the sound processor with a personal audio cable was used. The setup was calibrated to facilitate presentation of stimuli at a predefined sound level. Finally, differences in frequency response between the audio cable and microphones were investigated.

Letter to the Editor: The Emerging Role of Pharmacists in the Multidisciplinary Care of Patients with Multiple Sclerosis.

Letter to the Editor: The Emerging Role of Pharmacists in the Multidisciplinary Care of Patients with Multiple Sclerosis.

Appropriate pathology ordering? Troponin testing within an Australian Emergency Department.

Cardiac Troponin I and Troponin T are both very sensitive and specific, with the troponin pathology test recommended for the diagnosis of myocardial infarction. The diagnosis of myocardial infarction, in conjunction with electrocardiogram myocardial infarction, is based on a rise or fall of troponin with at least one value above the 99th percentile for the population. Troponin levels are regularly ordered within hospitals, especially in emergency medicine. It has been suggested that much of this testing is ordered despite the absence of clinical suspicion for acute coronary syndrome. This study examined the appropriateness of troponin testing within one Australian teaching hospital. A retrospective chart review was conducted of 111 randomly selected patients who received a troponin assay within the hospital's Emergency Department. To determine appropriateness, the troponin test needed to reflect Australian clinical guidelines, and inform the ongoing management of the patient. Results demonstrate that the majority (76.6 %) of troponin testing was appropriate, with the remainder (23.4 %) deemed inappropriate due to not altering the ongoing patient management (n = 26), and not being informed by clinical guidelines (n = 26). Troponin testing is important in the diagnosis of myocardial infarction, although should not be ordered routinely, or unnecessary. This study has determined that using clinical guidelines can promote rational ordering, and that testing should ultimately benefit patient management. Reducing inappropriate pathology test ordering is important to maximize productive clinical time, reduce false positives, maximize patient care, and to reduce financial waste.

Strain Echocardiography Parameters Correlate With Disease Severity in Children and Infants With Sepsis.

In the progression of severe sepsis, sepsis-induced myocardial dysfunction contributes to severity of illness and ultimate mortality. Identification of sepsis-induced myocardial dysfunction causing depressed cardiac function during critical illness has implications for ongoing patient management. However, assessing pediatric cardiac function traditionally relies on echocardiographic qualitative assessment and measurement of left ventricular ejection fraction or fractional shortening. These metrics are often insensitive for detecting early or regional myocardial dysfunction. Strain echocardiography is a contemporary echocardiographic modality that may be more sensitive to perturbations in cardiac function. This investigation hypothesizes that strain echocardiography metrics correlate with severity of illness in pediatric sepsis despite normal fractional shortening. Single-center retrospective observational study. Tertiary 36-bed medical/surgical PICU. Pediatric patients admitted with sepsis. None. Twenty-three children with sepsis received an echocardiogram in the study period. Patients with sepsis demonstrated abnormal peak systolic longitudinal strain for age (mean = -0.13 ± 0.07; p < 0.01) and low normal peak systolic circumferential strain (mean = -0.17 ± 0.14; p = 0.02) compared with internal controls as well as previously published normal values. Depressed strain was demonstrated in the septic patients despite having normal fractional shortening (mean = 0.41; 95% CI, 0.38-0.43). On initial echocardiographic imaging, worsening peak systolic longitudinal strain was associated with increasing lactate (p = 0.04). Pediatric patients with sepsis demonstrate evidence of depressed strain echocardiography parameters not shown by fractional shortening that correlate with clinical indices of sepsis severity. Whether strain echocardiography could eventually assist in grading pediatric sepsis severity and affect management is an area for potential future investigation.

Patient selection and treatment response assessment in radium-223 therapy

Learning objectives Radium-223 is an alpha emitter, licensed in 2013 for treatment of symptomatic bone metastases in metastatic castration resistant prostate cancer. The treatment consists of 6 intravenous administrations and ongoing patient management before, during and after treatment. In our institution, this service is led by the nuclear medicine department The ALSYMPCA trial, published in 2013, demonstrated improved overall survival (14.9 vs 11.3 months) and prolonged time to first symptomatic skeletal event (15.6 vs 9 months) for patients administered Radium-223 vs placebo Imaging plays a key role in the selection criteria and response assessment for this new therapeutic modality. We present an educational review of the spectrum of multimodality imaging techniques employed for pretherapeutic assessment and also for therapeutic response assessment

Accuracy of rapid disposition by emergency clinicians.

Objectives Rapid disposition protocols are increasingly being considered for implementation in emergency departments (EDs). Among patients presenting to an adult tertiary referral hospital, this study aimed to compare prediction accuracy of a rapid disposition decision at the conclusion of history and examination, compared with disposition following standard assessment. Methods Prospective observational data were collected for 1 month between October and November 2012. Emergency clinicians (including physicians, registrars, hospital medical officers, interns and nurse practitioners) filled out a questionnaire within 5min of obtaining a history and clinical examination for eligible patients. Predicted patient disposition (representing 'rapid disposition') was compared with final disposition (determined by 'standard assessment'). Results There were 301 patient episodes included in the study. Predicted disposition was correct in 249 (82.7%, 95% confidence interval (CI) 78.0-86.8) cases. Accuracy of predicting discharge to home appeared highest among emergency physicians at 95.8% (95% CI 78.9-99.9). Overall accuracy at predicting admission was 79.7% (95% CI 67.2-89.0). The remaining 20.3% (95% CI 11.0-32.8) were not admitted following standard assessment. Conclusion Rapid disposition by ED clinicians can predict patient destination accurately but was associated with a potential increase in admission rates. Any model of care using rapid disposition decision making should involve establishment of inpatient systems for further assessment, and a culture of timely inpatient team transfer of patients to the most appropriate treating team for ongoing patient management. What is known about the topic? In response to the National Emergency Access Targets, there has been widespread adoption of rapid-disposition-themed care models across Australia. Although there is emerging data that clinicians can predict disposition accurately, this data is currently limited. What does this paper add? Results of this study support the previously limited evidence that ED practitioners can accurately predict disposition early in the patient journey through ED, and that accuracy is similar across clinician groups. In addition to overall prediction accuracy, admission, discharge and treating team predictions were separately measured. These additional outcomes lend insight into safety and performance aspects relating to a rapid disposition model of care. What are the implications for practitioners? This study offers practical insights that could aid safe and efficient implementation of a rapid disposition model of care.

Biomarkers for acute kidney injury: is NGAL ready for clinical use?

The RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) criteria were introduced in 2004, defining the clinical stage of acute kidney injury (AKI) and outcome measures based on serum creatinine, glomerular filtration rate, and urine output. However, a growing body of evidence suggests that these markers are insufficient in drawing an accurate illustration of kidney injury. Indeed, mortality and morbidity remain high in AKI, suggesting that accuracy and speed of patient evaluation are lacking. A great deal of evidence indicates that neutrophil gelatinase-associated lipocalin (NGAL) is a sensitive and specific early marker of various etiological classes of AKI and would be highly valuable in conjunction with existing markers of AKI for better classifying renal injury as well as dysfunction (kidney attack). Improvements in diagnosis, risk identification, stratification, prognosis, and therapeutic monitoring will benefit clinical decision-making in the individualized bundling of therapies and ongoing patient management. In particular, kidney protection and AKI prevention may become feasible if an earlier and more accurate diagnosis is made for AKI. Here, we discuss the opportunity to consider whether NGAL is ready for routine clinical use in a number of etiologies of AKI.

Significance of histology in determining management of lesions regrowing after radiosurgery

Brain metastases treated with stereotactic radiosurgery may show delayed enlargement on post-treatment imaging that is of ambiguous etiology. Histopathologic interpretation of brain specimens is often challenging due to the presence of significant radiation effects admixed with irradiated residual tumor of indeterminate viability. The purpose of this study was to assess the impact of histologic findings on clinical outcomes following resection of these lesions. Between 2004 and 2010, 690 patients with brain metastases were enrolled in a prospective gamma knife data repository, and lesions requiring excision were identified. Tissue specimens were divided into four groups based on the ratio of treatment related inflammatory changes (TRIC) to tumor cells, and subsequently patient outcomes were assessed. Of 2,583 metastases treated, 36 were excised due to symptomatic enlargement. Only TRIC, without residual evidence of tumor, was seen in 36% (13/36) of specimens. Resection of these lesions resulted in 100% local control in follow-up. Of the remaining 23 lesions that contained any viable-appearing tumor within the resected specimen, 8 recurred after resection. Lesions that enlarged in the first 6months were more likely to contain higher amounts of residual tumor cells. Patients with even <2% tumors cells on excision had significantly worse local control (75 vs. 100%, p=0.024) and survival (HR 0.27, p=0.029) compared with those patients with exclusively TRIC. In summary, our findings underscore the importance of surgically obtaining tissue in a method that facilitates complete lesional interpretive histology in order to accurately guide ongoing patient management.

Gender and survival in cystic fibrosis

Survival for patients with cystic fibrosis (CF) continues to improve. The proportion of CF patients over the age of 18 years is nearly 50%, and care providers will need to better understand this patient population. Despite these improvements, young females continue to have a worse prognosis and lower median survival compared with their male counterparts. Contributing factors to the difference in survival remain uncertain. The 'gender gap' remains an area of controversy. Recent data suggest that it still exists, though exact reasons remain unclear. For those patients diagnosed in adulthood, outcomes are also improving. Some evidence suggests persistence of the gender gap. Other data suggest a reversal of this effect. Additional work and study are needed. This review finds supporting evidence for persistence of the gender gap and outlines the effect of age and sex on survival in CF. The majority of patients with CF will now be adults; thus, care providers must be aware of the impact this will have on ongoing patient management.

Integrating Health Information Technology and Electronic Health Records Into the Management of Fibromyalgia

Fibromyalgia (FM) is a widespread chronic pain condition that represents a significant economic burden for patients and health care systems. Effective treatment of FM requires a multidisciplinary management strategy that incorporates pharmacologic and nonpharmacologic therapy. Steps such as reducing the time to diagnosis and improving treatment decisions can result in significant cost savings and improved patient outcomes. An FM management framework, based on patient education and goal setting, has emphasized the need for ongoing care of patients with FM. In this article, we discuss how this framework could be further improved through the use of health information technology, including electronic health records. Health information technology/electronic health records can be incorporated at every stage of patient care, from initial presentation to diagnosis, through to making treatment decisions and maintaining ongoing patient management. This can lead to a number of potential benefits for patients with FM (by improving their level of care), primary care providers (by creating greater efficiencies), and the health care system (by reducing costs). Ultimately, the treatment and care of patients with FM need be no more burdensome to primary care providers than any other chronic illness. Through the greater efficiencies and optimized treatment approaches facilitated by health information technology/electronic health records, it should be possible to drive best-practice care for patients with FM and improve patient outcomes.