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Cureus Dec 2023Crohn's disease (CD) presents a formidable challenge as a chronic inflammatory condition. This systematic review aimed to comprehensively assess upadacitinib, a novel... (Review)
Review
Crohn's disease (CD) presents a formidable challenge as a chronic inflammatory condition. This systematic review aimed to comprehensively assess upadacitinib, a novel Janus kinase (JAK) inhibitor, regarding its efficacy, safety, and mechanistic insights in CD treatment. A thorough search of electronic databases identified studies investigating upadacitinib's impact on CD patients. Study characteristics, efficacy outcomes (clinical remission and endoscopic response), safety profiles, and mechanistic insights were extracted and qualitatively synthesized. Methodological quality was assessed using established tools. The synthesis of three studies consistently demonstrated improvements in clinical remission rates and endoscopic outcomes in upadacitinib-treated patients. Adverse events, such as herpes zoster, intestinal perforation, non-melanoma skin cancer, adjudicated cardiovascular events, and anemia, were reported, necessitating vigilant safety monitoring. Upadacitinib emerges as a promising therapeutic option for CD, supported by its observed clinical benefits and mechanistic implications. However, safety concerns underscore the importance of careful patient selection. These findings contribute to the ongoing discussion surrounding personalized treatment approaches for CD, emphasizing the need for further research to confirm its enduring efficacy and safety.
PubMed: 38229787
DOI: 10.7759/cureus.50657 -
International Journal of Medical... Dec 2023Identifying patient safety events using electronic health records (EHRs) and automated machine learning-based detection methods can help improve the efficiency and... (Review)
Review
INTRODUCTION
Identifying patient safety events using electronic health records (EHRs) and automated machine learning-based detection methods can help improve the efficiency and quality of healthcare service provision.
OBJECTIVE
This study aimed to systematically review machine learning-based methods and techniques, as well as their results for patient safety event management using EHRs.
METHODS
We reviewed the studies that focused on machine learning techniques, including automatic prediction and detection of patient safety events and medical errors through EHR analysis to manage patient safety events. The data were collected by searching Scopus, PubMed (Medline), Web of Science, EMBASE, and IEEE Xplore databases.
RESULTS
After screening, 41 papers were reviewed. Support vector machine (SVM), random forest, conditional random field (CRF), and bidirectional long short-term memory with conditional random field (BiLSTM-CRF) algorithms were mostly applied to predict, identify, and classify patient safety events using EHRs; however, they had different performances. BiLSTM-CRF was employed in most of the studies to extract and identify concepts, e.g., adverse drug events (ADEs) and adverse drug reactions (ADRs), as well as relationships between drug and severity, drug and ADEs, drug and ADRs. Recurrent neural networks (RNN) and BiLSTM-CRF had the best results in detecting ADEs compared to other patient safety events. Linear classifiers and Naive Bayes (NB) had the highest performance for ADR detection. Logistic regression had the best results in detecting surgical site infections. According to the findings, the quality of articles has non-significantly improved in recent years, but they had low average scores.
CONCLUSIONS
Machine learning can be useful in automatic detection and prediction of patient safety events. However, most of these algorithms have not yet been externally validated or prospectively tested. Therefore, further studies are required to improve the performance of these automated systems.
Topics: Humans; Electronic Health Records; Bayes Theorem; Patient Safety; Machine Learning; Algorithms
PubMed: 37837710
DOI: 10.1016/j.ijmedinf.2023.105246 -
Cureus Nov 2023Inflammatory bowel disease (IBD) is a group of chronic disorders, including Crohn's disease (CD) and ulcerative colitis (UC), that contribute to inflammation of the... (Review)
Review
Inflammatory bowel disease (IBD) is a group of chronic disorders, including Crohn's disease (CD) and ulcerative colitis (UC), that contribute to inflammation of the gastrointestinal tract, manifesting as bloody diarrhea, fecal urgency, bloating, cramping, and weight loss. IBD manifests as an exacerbation of these symptoms, which medications with high side effect profiles can manage; consequently, many novel therapies, including biologics such as ustekinumab and vedolizumab, have been developed over the years. This systematic review aims to assess the safety and efficacy of ustekinumab and vedolizumab in treating inflammatory bowel disease based on a comprehensive analysis of relevant studies. A thorough literature search was conducted to identify randomized controlled trials, post hoc analyses, case reports, observational cohorts, and meta-analyses involving ustekinumab and vedolizumab as treatment in IBD patients. The selected studies were critically evaluated for their methodology, patient characteristics, and outcomes. The analysis involved twelve distinct studies investigating the impact of ustekinumab and vedolizumab on individuals afflicted with inflammatory bowel disease (IBD). The findings revealed a notable trend: ustekinumab displayed a propensity for yielding higher rates of clinical remission in patients with ulcerative colitis (UC). Moreover, one study underscored substantial reductions in endoscopic disease activity in patients with Crohn's disease (CD) who were on ustekinumab. Similarly, ustekinumab exhibited promising outcomes in CD patients, including swift ultrasound responses and the achievement of transmural remission, particularly among those who were new to biologic treatments. In line with this, vedolizumab demonstrated early and considerable symptomatic improvements when used to treat both UC and CD patients. While both biologics showed promising results in inducing and maintaining remission, cautious monitoring is warranted due to the potential adverse events observed in some cases. Further research with larger sample sizes and longer follow-up periods is needed to establish a comprehensive understanding of the medications' effects on IBD patients.
PubMed: 38060699
DOI: 10.7759/cureus.48338 -
Cancer Treatment Reviews Nov 2023PARP inhibitors (PARPi) are a standard-of-care (SoC) treatment option for patients with metastatic castration-resistant prostate cancer (mCRPC). Several clinical trials... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
PARP inhibitors (PARPi) are a standard-of-care (SoC) treatment option for patients with metastatic castration-resistant prostate cancer (mCRPC). Several clinical trials have shown the potential of combining PARPi with other anticancer agents. Therefore, we conducted a systematic review and meta-analysis to comprehensively evaluate the efficacy and safety of PARPi in patients with metastatic prostate cancer.
METHODS
MEDLINE, Cochrane CENTRAL, EMBASE, CINAHL, and Web of Science were searched on March 22nd, 2023, for phase 2 or 3 clinical trials. Efficacy (progression-free survival [PFS], overall survival [OS], PSA decline >50% [PSA50], and objective response rate [ORR]) and safety outcomes were assessed in the included studies.
RESULTS
Seventeen clinical trials (PARPi monotherapy [n = 7], PARPi + androgen-receptor signaling inhibitors [ARSI] [n = 6], and PARPi + immune checkpoint inhibitors [ICI] [n = 4]) were included in the quantitative analyses. PARPi monotherapy improved radiographic PFS and OS over SoC in mCRPC patients with alterations in BRCA1 or BRCA2 genes but not in those with alterations in the ATM gene. Higher rates of PSA50 and ORR were reported in participants treated with PARPi + ARSI than in single-agent PARPi or PARPi + ICI. Although the rate of high-grade adverse events was similar across all groups, treatment discontinuation was higher in patients treated with PARPi-based combinations than PARPi monotherapy.
CONCLUSION
The efficacy of PARPi is not uniform across mCRPC patients with alterations in DNA damage repair genes, and optimal patient selection remains a clinical challenge. No unexpected safety signals for this class of agents emerged from this analysis.
Topics: Male; Humans; Poly(ADP-ribose) Polymerase Inhibitors; Prostatic Neoplasms, Castration-Resistant; Immune Checkpoint Inhibitors; Patient Selection; Progression-Free Survival
PubMed: 37716332
DOI: 10.1016/j.ctrv.2023.102623 -
Health Policy (Amsterdam, Netherlands) May 2024Pay-for-performance (p4p) has been tried in all healthcare settings to address ongoing deficiencies in the quality and outcomes of care. The evidence for the effect of... (Review)
Review
Pay-for-performance (p4p) has been tried in all healthcare settings to address ongoing deficiencies in the quality and outcomes of care. The evidence for the effect of these policies has been inconclusive, especially in acute care. This systematic review focused on patient safety p4p in the hospital setting. Using the PRISMA guidelines, we searched five biomedical databases for quantitative studies using at least one outcome metric from database inception to March 2023, supplemented by reference tracking and internet searches. We identified 6,122 potential titles of which 53 were included: 39 original investigations, eight literature reviews and six grey literature reports. Only five system-wide p4p policies have been implemented, and the quality of evidence was low overall. Just over half of the studies (52 %) included failed to observe improvement in outcomes, with positive findings heavily skewed towards poor quality evaluations. The exception was the Fragility Hip Fracture Best Practice Tariff (BPT) in England, where sustained improvement was observed across various evaluations. All policies had a miniscule impact on total hospital revenue. Our findings underscore the importance of simple and transparent design, involvement of the clinical community, explicit links to other quality improvement initiatives, and gradual implementation of p4p initatives. We also propose a research agenda to lift the quality of evidence in this field.
Topics: Humans; Reimbursement, Incentive; Patient Safety; Quality Improvement; Delivery of Health Care; Hospitals
PubMed: 38547664
DOI: 10.1016/j.healthpol.2024.105051 -
The Lancet. Rheumatology Dec 2023Sex-related differences in clinical manifestations and disease outcomes exist in psoriatic arthritis, however, there is limited information on sex-related differences in... (Meta-Analysis)
Meta-Analysis
Sex-related differences in patient characteristics, and efficacy and safety of advanced therapies in randomised clinical trials in psoriatic arthritis: a systematic literature review and meta-analysis.
BACKGROUND
Sex-related differences in clinical manifestations and disease outcomes exist in psoriatic arthritis, however, there is limited information on sex-related differences in randomised controlled trials of psoriatic arthritis. We aimed to compare patient characteristics and efficacy and safety of advanced therapies (including biological and targeted synthetic therapies) between male and female patients with psoriatic arthritis participating in randomised controlled trials.
METHODS
In this systematic review and meta-analysis, we searched Medline, Embase, and Central databases, and conference abstract archives, from their inception to June 10, 2022, for randomised controlled trials that assessed the efficacy of advanced therapies in psoriatic arthritis. Two reviewers extracted information on participants' characteristics and rates of American College of Rheumatology (ACR) 20 and ACR50 response and minimal disease activity (MDA) by sex. Random-effects models were used to calculate pooled effects of ACR20, ACR50, and MDA in male versus female patients by drug class.
FINDINGS
We included 54 trials (11 514 [50·9%] of 22 621 participants were female and 11 107 [49·1%] were male). Sex-disaggregated results were reported in a minority of studies (nine [17%] of 54 reported baseline characteristics by sex, 18 [33%] reported efficacy by sex, and two [4%] reported safety endpoints by sex). At baseline, male patients had lower baseline tender joint count (mean difference -3·01 [95% CI -3·83 to -2·18], health assessment questionnaire scores (-0·28 [-0·33 to -0·24]), pain scores (-4·58 [-6·86 to -2·30]), patient global assessment (-3·22 [-5·27 to -1·17]), and physician global assessment (-1·34 [-2·08 to -0·08]) than did female patients. Male patients had higher baseline psoriasis area and severity index scores (mean difference 1·95 [95% CI 0·78 to 3·11]) and C-reactive protein concentrations (2·57 [0·40 to 4·74]) than did female patients. ACR20 response by sex varied across drug classes, with higher rates in males than females with interleukin (IL)-17 inhibitors (odds ratio [OR] 1·70 [95% CI 1·38-2·11]), IL-23 inhibitor (1·46 [1·20-1·78]), IL-12 and IL-23 inhibitor (2·67 [1·39-5·09]), and tumour necrosis factor (TNF) inhibitors (1·55 [1·11-2·18]), but no difference with JAK and TYK2 inhibitors (1·10 [0·87-1·38]). Similarly, ACR50 response rates were higher in male patients versus female patients in all drug classes, with exception of JAK and TYK2 inhibitors (TNF inhibitors, OR 2·17 [95% CI 1·62-2·90]; IL-17 inhibitors, 1·93 [1·56-2·38]; IL-23 inhibitor, 1·71 [1·25-2·34]; IL-12 and 23 inhibitor, 2·43 [1·14-5·20]; and JAK and TYK2 inhibitors, 1·09 [0·73-1·62]). Male patients were more likely to reach MDA with most drug classes, including IL-17 inhibitors (OR 1·99 [95% CI 1·50-2·63]), IL-23 inhibitors (1·79 [1·29-2·50]), TNF inhibitors (2·62 [1·54-4·44]), and JAK and TYK2 inhibitors (1·77 [1·15-2·73]). Risk of bias was low for most studies.
INTERPRETATION
Biological sex of patients with psoriatic arthritis influences their response to advanced therapies, but the effect varies by drug class. Selective reporting might have influenced these results. Future trials should report baseline characteristics and endpoint results by sex.
FUNDING
Canadian Rheumatology Association.
Topics: Humans; Female; Male; Arthritis, Psoriatic; Interleukin-17; Tumor Necrosis Factor Inhibitors; Canada; Interleukin-12; Interleukin Inhibitors; Interleukin-23; Randomized Controlled Trials as Topic
PubMed: 38251562
DOI: 10.1016/S2665-9913(23)00264-3 -
Journal of Medical Internet Research Nov 2023Telehealth has been used for health care delivery for decades, but the COVID-19 pandemic greatly accelerated the uptake of telehealth in many care settings globally.... (Review)
Review
BACKGROUND
Telehealth has been used for health care delivery for decades, but the COVID-19 pandemic greatly accelerated the uptake of telehealth in many care settings globally. However, few studies have carried out a direct comparison among different telehealth modalities, with very few studies having compared the effectiveness of telephone and video telehealth modalities.
OBJECTIVE
This study aimed to identify and synthesize randomized controlled trials (RCTs) comparing synchronous telehealth consultations delivered by telephone and those conducted by video with outcomes such as clinical effectiveness, patient safety, cost-effectiveness, and patient and clinician satisfaction with care.
METHODS
PubMed (MEDLINE), Embase, and CENTRAL were searched via the Cochrane Library from inception until February 10, 2023, for RCTs without any language restriction. Forward and backward citation searches were conducted on included RCTs. The Cochrane Risk of Bias 2 tool was used to assess the quality of the studies. We included studies carried out in any health setting-involving all types of outpatient cohorts and all types of health care providers-that compared synchronous video consultations directly with telephone consultations and reported outcomes specified in the objective. We excluded studies of clinician-to-clinician telehealth consults, hospitalized patients, and asynchronous consultations.
RESULTS
Sixteen RCTs-10 in the United States, 3 in the United Kingdom, 2 in Canada, and 1 in Australia involving 1719 participants-were included in the qualitative and quantitative analyses. Most of the telehealth interventions were for hospital-based outpatient follow-ups, monitoring, and rehabilitation (n=13). The 3 studies that were conducted in the community all focused on smoking cessation. In half of the studies, nurses delivered the care (n=8). Almost all included studies had high or unclear risk of bias, mainly due to bias in the randomization process and selection of reported results. The trials found no substantial differences between telephone and video telehealth consultations with regard to clinical effectiveness, patient satisfaction, and health care use (cost-effectiveness) outcomes. None of the studies reported on patient safety or adverse events. We did not find any study on telehealth interventions for diagnosis, initiating new treatment, or those conducted in a primary care setting.
CONCLUSIONS
Based on a small set of diverse trials, we found no notable differences between telephone and video consultations for the management of patients with an established diagnosis. There is also a significant lack of telehealth research in primary care settings despite its high uptake.
Topics: Humans; Telephone; Telemedicine; Personal Satisfaction; Australia; Canada; Randomized Controlled Trials as Topic
PubMed: 37976100
DOI: 10.2196/49942 -
Scandinavian Journal of Medicine &... Jan 2024This systematic review evaluated the safety and efficacy of blood flow restriction exercise (BFRE) on skeletal muscle size, strength, and functional performance in... (Review)
Review
OBJECTIVES
This systematic review evaluated the safety and efficacy of blood flow restriction exercise (BFRE) on skeletal muscle size, strength, and functional performance in individuals with neurological disorders (ND).
METHODS
A literature search was performed in PubMed, CINAHL, and Embase. Two researchers independently assessed eligibility and performed data extraction and quality assessments.
ELIGIBILITY CRITERIA
Study populations with ND, BFRE as intervention modality, outcome measures related to safety or efficacy.
RESULTS
Out of 443 studies identified, 16 were deemed eligible for review. Three studies examined the efficacy and safety of BFRE, one study focused on efficacy results, and 12 studies investigated safety. Disease populations included spinal cord injury (SCI), inclusion body myositis (sIBM), multiple sclerosis (MS), Parkinson's disease (PD), and stroke. A moderate-to-high risk of bias was presented in the quality assessment. Five studies reported safety concerns, including acutely elevated pain and rating of perceived exertion levels, severe fatigue, muscle soreness, and cases of autonomic dysreflexia. Two RCTs reported a significant between-group difference in physical function outcomes, and two RCTs reported neuromuscular adaptations.
CONCLUSION
BFRE seems to be a potentially safe and effective training modality in individuals with ND. However, the results should be interpreted cautiously due to limited quality and number of studies, small sample sizes, and a general lack of heterogeneity within and between the examined patient cohorts.
Topics: Humans; Blood Flow Restriction Therapy; Multiple Sclerosis; Myalgia; Nervous System Diseases; Parkinson Disease
PubMed: 38268066
DOI: 10.1111/sms.14561 -
Cureus Dec 2023Psychotherapy has many forms, such as cognitive behavioral therapy (CBT), mindfulness therapy (MFT), and hypnotherapy, to name a few. Cognitive behavioral therapy is the... (Review)
Review
Psychotherapy has many forms, such as cognitive behavioral therapy (CBT), mindfulness therapy (MFT), and hypnotherapy, to name a few. Cognitive behavioral therapy is the gold standard in therapy-based treatment and is used for cognitive restructuring to reduce safety-seeking and avoidant behaviors. While the main application of psychotherapy is psychological disorders, recent studies have found that it is beneficial for somatic and physiological symptoms such as chronic pain or even irritable bowel syndrome (IBS). Irritable bowel syndrome is a common but debilitating gastrointestinal condition that has a prevalence of 12% in the United States and costs the average patient $9,776 annually in 2023. Irritatable bowel syndrome is a condition of exclusion but consists of abdominal discomfort or pain and must be associated with altered bowel habits as stated in the Rome IV criteria. At least half of these patients also exhibit extracolonic symptoms, most commonly psychological disorders like anxiety and stress. The true etiology of IBS is not understood, but ideas such as the brain-gut axis, stress response system, and gut microbiota have been evaluated. Treatment of IBS is extensive and heavily relies on the patient-physician interaction, but pharmacologic therapies have been employed and are sometimes unsuccessful. Irritable bowel syndrome impacts an individual as a whole, making them hesitate whether or not they eat a particular food or even go out to do an activity because of the unpredictable bowel pattern. Finding a better solution is essential to improving the patient's quality of life (QoL), especially by addressing how they perceive the illness, how they adjust to it, and even how they determine what foods to consume. This paper aims to evaluate whether or not psychotherapy can be employed to improve all aspects of IBS, as well as if it can reduce the cost of IBS treatment.
PubMed: 38259396
DOI: 10.7759/cureus.51003 -
International Clinical... Nov 2023To date, the role of valbenazine (VAL) in a dose-dependent increase in efficacy for tardive dyskinesia (TD) and in the worsening of acceptability and tolerability in a...
To date, the role of valbenazine (VAL) in a dose-dependent increase in efficacy for tardive dyskinesia (TD) and in the worsening of acceptability and tolerability in a dose-dependent manner remains to be elucidated. Thus, in this systematic review and frequentist network meta-analysis, we compared 16 outcomes of VAL80 mg/d (VAL80) with VAL40 mg/d (VAL40) related to the efficacy, acceptability, tolerability, and safety in the treatment of patients with TD. Using a 95% confidence interval, we calculated the standardized mean difference for continuous variables and the risk ratio for dichotomous variables. Our results demonstrated that both VAL80 and VAL40 were superior to the placebo in terms of Abnormal Involuntary Movement Scale (AIMS) total score, Clinical Global Impression of Change-TD, and response to treatment, but VAL80 outperformed VAL40 in terms of AIMS score and response to treatment. However, any active therapy and placebo treatment groups did not have significant differences in acceptability, tolerability, and safety outcomes and similarly between VAL80 and VAL40 in any other outcomes. In conclusions, VAL could be increased from VAL40 to VAL80 if a patient with TD adequately tolerates VAL40 but treatment response is poor.
PubMed: 37694845
DOI: 10.1097/YIC.0000000000000485