-
Journal of Neurosurgery. Pediatrics Jun 2024Functional hemispherectomy is an effective surgical intervention for select patients with drug-resistant epilepsy. The last several decades have seen dramatic evolutions...
OBJECTIVE
Functional hemispherectomy is an effective surgical intervention for select patients with drug-resistant epilepsy. The last several decades have seen dramatic evolutions in preoperative evaluation, surgical techniques, and postoperative care. Here, the authors present a retrospective review of the medical records of 146 children who underwent hemispherectomy between 1987 and 2022 at The Hospital for Sick Children, providing a unique overview of the evolution of the procedure and patient outcomes over 35 years.
METHODS
The medical records of all children who underwent hemispherectomy at The Hospital for Sick Children between 1987 and 2022 were reviewed. Demographic information, preoperative clinical features, short-term and long-term seizure outcomes, and details regarding postoperative complications were recorded.
RESULTS
The seizure outcomes of 146 children were analyzed. There were 68 females and 78 males with a mean age of 5.08 years, 123 of whom demonstrated seizure freedom (Engel class IA) in the short-term postoperative follow-up period and 89 in the long term. The effectiveness of hemispherectomy in achieving long-term seizure control has improved over time (β = 0.06, p < 0.001). Factors associated with overall seizure freedom included younger age at the time of hemispherectomy and stroke as the etiology of seizures, as well as complete disconnection during the first surgery. Additionally, the etiologies of epilepsy for which hemispherectomy is performed have expanded over time, while complication rates have remained unchanged.
CONCLUSIONS
Hemispherectomy is an increasingly effective treatment for certain cases of drug-resistant epilepsy. The etiologies of epilepsy for which hemispherectomy is performed are broadening, with no change in its safety profile. Seizure outcomes are better when the etiology of epilepsy is an ischemic injury, and the most common complication after the procedure is hydrocephalus. These findings reinforce the ongoing use of hemispherectomy as a safe and effective treatment option for certain individuals with drug-resistant epilepsy, support its application to a broader range of etiologies, and highlight areas of future investigation.
PubMed: 38941627
DOI: 10.3171/2024.4.PEDS23475 -
JMIR Research Protocols Jun 2024Osteoarthritis (OA) is a disabling condition that affects more than one-third of people older than 65 years. Currently, 80% of these patients report movement...
Assessment of the Feasibility of Objective Parameters as Primary End Points for Patients Affected by Knee Osteoarthritis: Protocol for a Pilot, Open Noncontrolled Trial (:SMILE:).
BACKGROUND
Osteoarthritis (OA) is a disabling condition that affects more than one-third of people older than 65 years. Currently, 80% of these patients report movement limitations, 20% are unable to perform major activities of daily living, and approximately 11% require personal care. In 2014, the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) recommended, as the first step in the pharmacological treatment of knee osteoarthritis, a background therapy with chronic symptomatic slow-acting osteoarthritic drugs such as glucosamine sulfate, chondroitin sulfate, and hyaluronic acid. The latter has been extensively evaluated in clinical trials as intra-articular and oral administration. Recent reviews have shown that studies on oral hyaluronic acid generally measure symptoms using only subjective parameters, such as visual analog scales or quality of life questionnaires. As a result, objective measures are lacking, and data validity is generally impaired.
OBJECTIVE
The main goal of this pilot study with oral hyaluronic acid is to evaluate the feasibility of using objective tools as outcomes to evaluate improvements in knee mobility. We propose ultrasound and range of motion measurements with a goniometer that could objectively correlate changes in joint mobility with pain reduction, as assessed by the visual analog scale. The secondary objective is to collect data to estimate the time and budget for the main double-blind study randomized trial. These data may be quantitative (such as enrollment rate per month, number of screening failures, and new potential outcomes) and qualitative (such as site logistical issues, patient reluctance to enroll, and interpersonal difficulties for investigators).
METHODS
This open-label pilot and feasibility study is conducted in an orthopedic clinic (Timisoara, Romania). The study includes male and female participants, aged 50-70 years, who have been diagnosed with symptomatic knee OA and have experienced mild joint discomfort for at least 6 months. Eight patients must be enrolled and treated with Syalox 300 Plus (River Pharma) for 8 weeks. It is a dietary supplement containing high-molecular-weight hyaluronic acid, which has already been marketed in several European countries. Assessments are made at the baseline and final visits.
RESULTS
Recruitment and treatment of the 8 patients began on February 15, 2018, and was completed on May 25, 2018. Data analysis was planned to be completed by the end of 2018. The study was funded in February 2019. We expect the results to be published in a peer-reviewed clinical journal in the last quarter of 2024.
CONCLUSIONS
The data from this pilot study will be used to assess the feasibility of a future randomized clinical trial in OA. In particular, the planned outcomes (eg, ultrasound and range of motion), safety, and quantitative and qualitative data must be evaluated to estimate in advance the time and budget required for the future main study. Finally, the pilot study should provide preliminary information on the efficacy of the investigational product.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03421054; https://clinicaltrials.gov/study/NCT03421054.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR1-10.2196/13642.
Topics: Humans; Osteoarthritis, Knee; Pilot Projects; Feasibility Studies; Hyaluronic Acid; Male; Female; Aged; Middle Aged; Quality of Life; Endpoint Determination
PubMed: 38941599
DOI: 10.2196/13642 -
Quality Management in Health Care
Topics: Humans; Patient Satisfaction
PubMed: 38941586
DOI: 10.1097/QMH.0000000000000479 -
Quality Management in Health CarePatient experience is a key factor in measuring hospital performance, and the Hospital Consumer Assessment of Healthcare Providers and Systems survey tool is used to...
BACKGROUND AND OBJECTIVES
Patient experience is a key factor in measuring hospital performance, and the Hospital Consumer Assessment of Healthcare Providers and Systems survey tool is used to assess patient perceptions. Hospitals with positive patient experience tend to have a better quality of clinical care, lower readmission and mortality rates, and an overall shorter inpatient length of stay. Studies have identified several organizational determinants of high- and low-rated patient experiences, including hospital size, type, staffing levels, and patient demographics.This study aims to explore the determinants of consistently high- and low-rated patient experience, as well as factors associated with positive and negative changes in patient experience over time.
METHOD
The 2014 to 2019 American Hospital Association annual survey and the Centers for Medicare and Medicaid Services Hospital Value-Based Purchasing database were used. A total of 2801 acute-care hospitals were included in this study. A series of multivariate logistic regressions were used to model the probability of "1" (being a superior hospital or an inferior hospital). In addition, a generalized linear mixed model for binary responses was used to analyze the change (probability of positive and negative change).
RESULTS
The results showed that most hospitals did not sustain superior or inferior performance, and competition decreased the likelihood of a hospital consistently performing well in terms of patient experience. Superior performance was associated with hospital ownership (P < .001), size (P = .026), location (P = .002), teaching status (P = .009), average Herfindahl-Hirschman Index value (P = .005), and Medicaid and Medicare patient population. On the other hand, inferior performance was associated with hospital ownership (P = .003), size (P < .001), teaching status (P = .003), safety net status (P = .020), and Medicaid and Medicare patient population.
CONCLUSION
This study aimed to examine the trends in hospital patient experience performance and the influence of hospital organizational characteristics on those trends. Our findings allow us to question the widely held belief that patient experience is a metric of differentiation and industry competition, suggesting that performance in this domain has not been utilized by most hospitals as a source of sustainable competitive advantage. The findings from this study highlight the importance of considering changes in performance over time and the need for significant organizational efforts to improve hospital performance in terms of patient experience.
Topics: Humans; United States; Patient Satisfaction; Hospitals; Quality of Health Care; Surveys and Questionnaires
PubMed: 38941580
DOI: 10.1097/QMH.0000000000000470 -
The Journal of Bone and Joint Surgery.... Jun 2024Radiostereometric analysis (RSA) provides highly accurate data about the migration of a total knee arthroplasty (TKA) component. However, patient-reported outcome...
Tibial Baseplate Migration Is Not Associated with Change in Patient-Reported Outcome Measures and Clinical Scores After TKA: A Secondary Analysis of 5 Radiostereometric Analysis Studies with 10-Year Follow-up.
BACKGROUND
Radiostereometric analysis (RSA) provides highly accurate data about the migration of a total knee arthroplasty (TKA) component. However, patient-reported outcome measures (PROMs) reflect the patients' perspective of their functional status, pain, and overall health after TKA. The aim of this study was to evaluate the association between tibial implant migration and change in postoperative PROMs and clinical scores, using data pooled from long-term follow-up RSA studies.
METHODS
Individual implant migration data were collected from 5 randomized RSA studies, including a total of 300 patients with 6 distinct TKA implant designs (all Stryker). Tibial implant migration (maximum total point motion [MTPM]) was evaluated with RSA at 3 months, 1 year, and 2, 5, 7, and 10 years postoperatively. The Knee Society Score (KSS)-Knee and KSS-Function and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales were collected in all studies at the same follow-up times. Linear mixed-effects models, with adjustment for TKA implant design and patient characteristics, were used to analyze the data. The 3-month follow-up visit was used as the baseline to assess the association between implant migration and PROMs across the 10-year follow-up.
RESULTS
No association between tibial implant migration and change in KSS-Knee (p = 0.384), KSS-Function (p = 0.737), KOOS-Symptoms (p = 0.398), KOOS-Pain (p = 0.699), KOOS-Activities of Daily Living (p = 0.205), KOOS-Sport and Recreation (p = 0.702), or KOOS-Quality of Life (p = 0.368) was found across the entire follow-up. Similar results were found when using the 2-year follow-up as the baseline, after which both cemented and uncemented implants are expected to have stabilized.
CONCLUSIONS
Tibial baseplate migration was not associated with postoperative worsening in PROMs or clinical scores in patients who underwent TKA. These findings suggest that implant migration, as measured with RSA, measures a different parameter (i.e., implant-bone fixation) than PROMs (i.e., patient perception) and clinical scores. Therefore, to assess the performance and safety of TKA implant designs, RSA and PROMs cannot be used interchangeably during the postoperative follow-up of patients and evaluation of the fixation of knee implants.
LEVEL OF EVIDENCE
Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.
PubMed: 38941476
DOI: 10.2106/JBJS.23.00957 -
Journal of Primary Health Care Jun 2024
Substitution of regulated health professionals such as doctors and nurses with unregulated health professionals such as physician assistants gives rise to concerns around patient safety and accountability issues: Yes.
Topics: Humans; Patient Safety; Physician Assistants; Social Responsibility; Physicians; Nurses
PubMed: 38941250
DOI: 10.1071/HC24075 -
Journal of Primary Health Care Jun 2024
Substitution of regulated health professionals, such as doctors and nurses, with unregulated health care workers, such as physician assistants, gives rise to concerns around patient safety and accountability issues: No.
Topics: Humans; Patient Safety; Physician Assistants; Social Responsibility; Physicians; Nurses
PubMed: 38941249
DOI: 10.1071/HC24077 -
Journal of Primary Health Care Jun 2024Introduction New Zealand's health care system faces significant shortages in health care workers. To address workforce challenges and meet the population's health needs,...
Introduction New Zealand's health care system faces significant shortages in health care workers. To address workforce challenges and meet the population's health needs, health care systems around the world have introduced new clinical roles, such as physician associates/assistants (PAs) into existing health care teams. Aim This article aims to examine the benefits, challenges, and broader implications of regulating PAs in the context of New Zealand's primary care sector, with a specific emphasis on how it may impact general practice. Methods A range of literature surrounding the role, impact, and perception of PAs were selected and included in this article. Results The PA profession can significantly strengthen New Zealand's primary care workforce, improving patient access and continuity of care. However, the global deployment of PAs has faced scrutiny due to concerns about its potential risks to patient safety and the overall viability of such a role. Discussion If regulated, the PA profession can reshape New Zealand's primary care, offering a partial solution to current medical staff shortages. Trained under a generalised medical model similar to doctors, PAs possess the necessary skills to perform both routine and non-routine medical tasks. This dual capability can significantly improve primary care service provision, reduce existing workloads, and allow for a more efficient deployment of doctor expertise. However, medico-legal issues and the supervisory burden can impede widespread integration into general practice. Despite challenges, the success of the PA role relies on mutual trust, respect, and support from other clinical team members within primary health care.
Topics: New Zealand; Primary Health Care; Humans; Professional Role; Physician Assistants
PubMed: 38941244
DOI: 10.1071/HC23134 -
International Clinical... Jun 2024Schizophrenia is a chronic, complex mental health disorder requiring effective management to mitigate its broad personal and societal impacts. This narrative review...
BACKGROUND AND OBJECTIVES
Schizophrenia is a chronic, complex mental health disorder requiring effective management to mitigate its broad personal and societal impacts. This narrative review assesses the efficacy, effectiveness, and side effects of third-generation antipsychotics (TGAs) like aripiprazole, brexpiprazole, and cariprazine, focusing on their use in first-episode schizophrenia. These drugs aim to reduce side effects typical of earlier antipsychotics while more effectively addressing positive and cognitive symptoms.
METHODS
Our extensive literature review, using PubMed and Scopus, includes randomized controlled trials and observational studies, showing TGAs may match older antipsychotics in efficacy with fewer side effects, notably in reducing extrapyramidal symptoms and enhancing cognitive outcomes.
RESULTS
Aripiprazole appears effective in both acute and maintenance phases of schizophrenia, while brexpiprazole and cariprazine show potential in managing negative symptoms and improving social functioning, essential for patient recovery.
CONCLUSIONS
This review emphasizes the need for personalized treatment and further research to fully determine the long-term benefits and safety of TGAs. These findings can inform clinical decisions and underline the ongoing need for innovation in schizophrenia pharmacotherapy.
PubMed: 38941160
DOI: 10.1097/YIC.0000000000000559 -
JMIR Research Protocols Jun 2024Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have...
BACKGROUND
Artificial intelligence (AI) medical devices have the potential to transform existing clinical workflows and ultimately improve patient outcomes. AI medical devices have shown potential for a range of clinical tasks such as diagnostics, prognostics, and therapeutic decision-making such as drug dosing. There is, however, an urgent need to ensure that these technologies remain safe for all populations. Recent literature demonstrates the need for rigorous performance error analysis to identify issues such as algorithmic encoding of spurious correlations (eg, protected characteristics) or specific failure modes that may lead to patient harm. Guidelines for reporting on studies that evaluate AI medical devices require the mention of performance error analysis; however, there is still a lack of understanding around how performance errors should be analyzed in clinical studies, and what harms authors should aim to detect and report.
OBJECTIVE
This systematic review will assess the frequency and severity of AI errors and adverse events (AEs) in randomized controlled trials (RCTs) investigating AI medical devices as interventions in clinical settings. The review will also explore how performance errors are analyzed including whether the analysis includes the investigation of subgroup-level outcomes.
METHODS
This systematic review will identify and select RCTs assessing AI medical devices. Search strategies will be deployed in MEDLINE (Ovid), Embase (Ovid), Cochrane CENTRAL, and clinical trial registries to identify relevant papers. RCTs identified in bibliographic databases will be cross-referenced with clinical trial registries. The primary outcomes of interest are the frequency and severity of AI errors, patient harms, and reported AEs. Quality assessment of RCTs will be based on version 2 of the Cochrane risk-of-bias tool (RoB2). Data analysis will include a comparison of error rates and patient harms between study arms, and a meta-analysis of the rates of patient harm in control versus intervention arms will be conducted if appropriate.
RESULTS
The project was registered on PROSPERO in February 2023. Preliminary searches have been completed and the search strategy has been designed in consultation with an information specialist and methodologist. Title and abstract screening started in September 2023. Full-text screening is ongoing and data collection and analysis began in April 2024.
CONCLUSIONS
Evaluations of AI medical devices have shown promising results; however, reporting of studies has been variable. Detection, analysis, and reporting of performance errors and patient harms is vital to robustly assess the safety of AI medical devices in RCTs. Scoping searches have illustrated that the reporting of harms is variable, often with no mention of AEs. The findings of this systematic review will identify the frequency and severity of AI performance errors and patient harms and generate insights into how errors should be analyzed to account for both overall and subgroup performance.
TRIAL REGISTRATION
PROSPERO CRD42023387747; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=387747.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/51614.
Topics: Humans; Randomized Controlled Trials as Topic; Artificial Intelligence; Algorithms; Systematic Reviews as Topic; Patient Harm; Equipment and Supplies; Research Design
PubMed: 38941147
DOI: 10.2196/51614