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Cardiology in the Young Jan 2022To determine the optimal antithrombotic agent choice, timing of initiation, dosing and duration of therapy for paediatric patients undergoing cardiac surgery with... (Review)
Review
OBJECTIVES
To determine the optimal antithrombotic agent choice, timing of initiation, dosing and duration of therapy for paediatric patients undergoing cardiac surgery with cardiopulmonary bypass.
METHODS
We used PubMed and EMBASE to systematically review the existing literature of clinical trials involving antithrombotics following cardiac surgery from 2000 to 2020 in children 0-18 years. Studies were assessed by two reviewers to ensure they met eligibility criteria.
RESULTS
We identified 10 studies in 1929 children across three medications classes: vitamin K antagonists, cyclooxygenase inhibitors and indirect thrombin inhibitors. Four studies were retrospective, five were prospective observational cohorts (one of which used historical controls) and one was a prospective, randomised, placebo-controlled, double-blind trial. All included were single-centre studies. Eight studies used surrogate biomarkers and two used clinical endpoints as the primary endpoint. There was substantive variability in response to antithrombotics in the immediate post-operative period. Studies of warfarin and aspirin showed that laboratory monitoring levels were frequently out of therapeutic range (variably defined), and findings were mixed on the association of these derangements with bleeding or thrombotic events. Heparin was found to be safe at low doses, but breakthrough thromboembolic events were common.
CONCLUSION
There are few paediatric prospective randomised clinical trials evaluating antithrombotic therapeutics post-cardiac surgery; most studies have been observational and seldom employed clinical endpoints. Standardised, validated endpoints and pragmatic trial designs may allow investigators to determine the optimal drug, timing of initiation, dosing and duration to improve outcomes by limiting post-operative morbidity and mortality related to bleeding or thrombotic events.
Topics: Cardiac Surgical Procedures; Cardiopulmonary Bypass; Child; Fibrinolytic Agents; Humans; Observational Studies as Topic; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies
PubMed: 34986908
DOI: 10.1017/S1047951121005205 -
The Cochrane Database of Systematic... Mar 2021Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Inhalation of the enzyme dornase alfa reduces sputum viscosity and improves clinical outcomes of people with cystic fibrosis. This is an update of a previously published Cochrane Review.
OBJECTIVES
To determine whether the timing of dornase alfa inhalation (in relation to airway clearance techniques or morning versus evening inhalation) has an impact on objective and subjective measures of clinical efficacy in people with cystic fibrosis.
SEARCH METHODS
Relevant randomised and quasi-randomised controlled trials were identified from the Cochrane Cystic Fibrosis Trials Register, the Physiotherapy Evidence Database (PEDro), clinical trial registries and international cystic fibrosis conference proceedings. Date of the most recent search: 12 October 2020.
SELECTION CRITERIA
Any trial of dornase alfa in people with cystic fibrosis where timing of inhalation was the randomised element in the trial with either: inhalation before compared to after airway clearance techniques; or morning compared to evening inhalation. DATA COLLECTION AND ANALYSIS: Both authors independently selected trials, assessed risk of bias and extracted data with disagreements resolved by discussion. Relevant data were extracted and, where possible, meta-analysed. We assessed the quality of the evidence using GRADE.
MAIN RESULTS
We identified 115 trial reports representing 55 trials, of which five trials (providing data on 122 participants) met our inclusion criteria. All five trials used a cross-over design. Intervention periods ranged from two to eight weeks. Four trials (98 participants) compared dornase alfa inhalation before versus after airway clearance techniques. Inhalation after instead of before airway clearance did not significantly change forced expiratory volume at one second (very-low quality evidence). Similarly, forced vital capacity (low-quality evidence) and quality of life (very-low quality evidence) were not significantly affected; forced expiratory flow at 25% was significantly worse with dornase alfa inhalation after airway clearance, mean difference -0.17 litres (95% confidence interval -0.28 to -0.05), based on the pooled data from two small trials in children (7 to 19 years) with well-preserved lung function. All other secondary outcomes were statistically non-significant. In one trial (25 participants), morning versus evening inhalation had no impact on lung function or symptoms (low-quality evidence).
AUTHORS' CONCLUSIONS
The current evidence derived from a small number of participants does not indicate that inhalation of dornase alfa after airway clearance techniques is more or less effective than the traditional recommendation to inhale nebulised dornase alfa 30 minutes prior to airway clearance techniques, for most outcomes. For children with well-preserved lung function, inhalation before airway clearance may be more beneficial for small airway function than inhalation after. However, this result relied on a measure with high variability and trials with variable follow-up. In the absence of strong evidence to indicate that one timing regimen is better than another, the timing of dornase alfa inhalation can be largely based on pragmatic reasons or individual preference with respect to the time of airway clearance and time of day. Further research is warranted.
Topics: Administration, Inhalation; Adolescent; Child; Combined Modality Therapy; Cystic Fibrosis; Deoxyribonuclease I; Drug Administration Schedule; Forced Expiratory Volume; Humans; Quality of Life; Randomized Controlled Trials as Topic; Recombinant Proteins; Respiratory Therapy; Time Factors; Vital Capacity; Young Adult
PubMed: 33686652
DOI: 10.1002/14651858.CD007923.pub6 -
Exploration of Targeted Anti-tumor... 2023Coronavirus disease 2019 (COVID-19) became pandemic on 11th March 2020 and it deeply stressed the healthcare system. Cancer patients represent a vulnerable population,...
AIM
Coronavirus disease 2019 (COVID-19) became pandemic on 11th March 2020 and it deeply stressed the healthcare system. Cancer patients represent a vulnerable population, so many recommendations have been approved to ensure optimal management. Clinical research was notably impacted by COVID too. This review aims to analyze the challenges occurred during a pandemic for the management of enrolled patients (enrollment, use of telemedicine visits, study procedures) and for the clinical trials system (from feasibility to selection visit, site initiation visit, monitorings, use of e-signature, deviations and discontinuations).
METHODS
The studies included in the present review were selected from PubMed/Google Scholar/ScienceDirect databases.
RESULTS
During the first phase of pandemic many clinical trials were suspended in accrual and, as the pandemic progressed, recommendations were established to guarantee the safety and the continuity of care of enrolled patients. In addition, lot of new strategies was found during the pandemic to reduce the negative consequences on clinical trial performance and to guarantee new opportunities of care in the respect of good clinical practice (GCP) in a bad scenario.
CONCLUSIONS
Among all modifiers, investigators would prefer to maintain the positive ones such as pragmatic and simplified trial designs and protocols, reducing in-person visits when not necessary and to minimizing sponsor and contract research organizations (CROs) visits.
PubMed: 38023994
DOI: 10.37349/etat.2023.00183 -
PharmacoEconomics Jan 2021Recently, there has been an increase in use of the stepped wedge trial (SWT) design in the context of health services research, due to its pragmatic and methodological...
BACKGROUND
Recently, there has been an increase in use of the stepped wedge trial (SWT) design in the context of health services research, due to its pragmatic and methodological advantages over the parallel group design.
OBJECTIVE
Our objective was to summarise the statistical methods used when conducting economic evaluations alongside SWTs.
METHODS
A systematic literature search extending to February 2020 was conducted in the PubMed, Scopus, Cochrane and National Health Service Economic Evaluation Database (NHS-EED) databases to find and evaluate studies where there was an intention to conduct an economic evaluation alongside an SWT. Studies were assessed for their eligibility, findings, reporting of statistical methods and quality of reporting.
RESULTS
Of the 586 studies retrieved from the literature search, 69 studies were identified and included in this systematic review. A total of 54 studies were published protocols, with eight economic evaluations and seven studies reporting full trial results. Included studies varied in terms of their reporting of statistical methods, in both detail and methodology. There were 34 studies that did not report any statistical methods for the economic evaluation, and only 16 studies reported appropriate methods, mainly using some form of mixed/multilevel model, and two used seemingly unrelated regression. Twelve studies reported the use of generic bootstrap methods and other modelling techniques, whilst the remaining studies failed to appropriately account for clustering, correlation or adjustment for time.
CONCLUSIONS
The use of appropriate statistical methods that account for time, clustering and correlation between costs and outcomes is an important part of SWT health economics analysis, one that will benefit from an effort to communicate the methods available and their performance.
Topics: Cost-Benefit Analysis; Health Services Research; Humans; State Medicine
PubMed: 33015754
DOI: 10.1007/s40273-020-00963-x -
Pain Physician Sep 2023Extensive research into potential sources of thoracic pain with or without referred pain into the chest wall has demonstrated that thoracic facet joints can be a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Extensive research into potential sources of thoracic pain with or without referred pain into the chest wall has demonstrated that thoracic facet joints can be a potential source of pain confirmed by precise, diagnostic blocks.The objective of this systematic review and meta-analysis is to evaluate the effectiveness of medial branch blocks and radiofrequency neurotomy as a therapeutic thoracic facet joint intervention.
METHODS
Systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies of medial branch blocks and the radiofrequency neurotomy in managing thoracic pain utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was performed. A comprehensive literature search of multiple databases of RCTs and observational studies of medial branch blocks and radiofrequency neurotomy in managing chronic thoracic pain were identified from 1996 to December 2022 with inclusion of manual searches of the bibliography of known review articles and multiple databases. Methodologic quality and risk of bias assessment was also conducted. Evidence was synthesized utilizing principles of quality assessment and best evidence synthesis, with conventional and single meta-analysis. The primary outcome measure of success was 3 months of pain reduction for medial branch blocks and 6 months for radiofrequency thermoneurolysis for a single treatment. Short-term success was defined as up to 6 months and long-term was more than 6 months.
RESULTS
This literature search yielded 11 studies meeting the inclusion criteria, of which 3 were RCTs and 8 were observational studies. Of the 3 RCTs, 2 of them assessed medial branch blocks and one trial assessed radiofrequency for thoracic pain. The evidence for managing thoracic pain with qualitative analysis and single-arm meta-analysis and GRADE system of appraisal, with the inclusion of 2 RCTs and 3 observational studies for medial branch blocks was Level II. For radiofrequency neurotomy, with the inclusion of one RCT of 20 patients in the treatment group and 5 observational studies, the evidence was Level III in managing thoracic pain.
LIMITATIONS
There was a paucity of literature with RCTs and real-world pragmatic controlled trials. Even observational studies had small sample sizes providing inadequate clinically applicable results. In addition, there was heterogeneity of the available studies in terms of their inclusion and exclusion criteria, defining their endpoints and the effectiveness of the procedures.
CONCLUSION
This systematic review and meta-analysis show Level II evidence of medial branch blocks and Level III evidence for radiofrequency neurotomy on a long-term basis in managing chronic thoracic pain.
KEY WORDS
Chronic spinal pain, thoracic facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks, diagnostic accuracy, radiofrequency neurotomy.
Topics: Humans; Nerve Block; Pain Management; Chronic Pain; Denervation; Anesthesia, Local; Chest Pain; Zygapophyseal Joint; Treatment Outcome
PubMed: 37774177
DOI: No ID Found -
Journal of Medical Internet Research Aug 2023Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video... (Review)
Review
BACKGROUND
Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video recording patients for direct care purposes.
OBJECTIVE
We aimed to synthesize empirical studies published internationally to explore the extent to which video recording patients is acceptable and effective in supporting direct care and, for the United Kingdom, to summarize the relevant guidance of professional and regulatory bodies.
METHODS
Five electronic databases (MEDLINE, Embase, APA PsycINFO, CENTRAL, and HMIC) were searched from 2012 to 2022. Eligible studies evaluated an intervention involving video recording of adult patients (≥18 years) to support diagnosis, care, or treatment. All study designs and countries of publication were included. Websites of UK professional and regulatory bodies were searched to identify relevant guidance. The acceptability of video recording patients was evaluated using study recruitment and retention rates and a framework synthesis of patients' and clinical staff's perspectives based on the Theoretical Framework of Acceptability by Sekhon. Clinically relevant measures of impact were extracted and tabulated according to the study design. The framework approach was used to synthesize the reported ethico-legal considerations, and recommendations of professional and regulatory bodies were extracted and tabulated.
RESULTS
Of the 14,221 abstracts screened, 27 studies met the inclusion criteria. Overall, 13 guidance documents were retrieved, of which 7 were retained for review. The views of patients and clinical staff (16 studies) were predominantly positive, although concerns were expressed about privacy, technical considerations, and integrating video recording into clinical workflows; some patients were anxious about their physical appearance. The mean recruitment rate was 68.2% (SD 22.5%; range 34.2%-100%; 12 studies), and the mean retention rate was 73.3% (SD 28.6%; range 16.7%-100%; 17 studies). Regarding effectiveness (10 studies), patients and clinical staff considered video recordings to be valuable in supporting assessment, care, and treatment; in promoting patient engagement; and in enhancing communication and recall of information. Observational studies (n=5) favored video recording, but randomized controlled trials (n=5) did not demonstrate that video recording was superior to the controls. UK guidelines are consistent in their recommendations around consent, privacy, and storage of recordings but lack detailed guidance on how to operationalize these recommendations in clinical practice.
CONCLUSIONS
Video recording patients for direct care purposes appears to be acceptable, despite concerns about privacy, technical considerations, and how to incorporate recording into clinical workflows. Methodological quality prevents firm conclusions from being drawn; therefore, pragmatic trials (particularly in older adult care and the movement disorders field) should evaluate the impact of video recording on diagnosis, treatment monitoring, patient-clinician communication, and patient safety. Professional and regulatory documents should signpost to practical guidance on the implementation of video recording in routine practice.
TRIAL REGISTRATION
PROSPERO CRD42022331825: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=331825.
Topics: Humans; Aged; Patient Participation; Empirical Research; Communication; Narration; Clinical Decision-Making
PubMed: 37585249
DOI: 10.2196/46478 -
Frontiers in Neurology 2020Given the limited healthcare resources in low and middle income countries (LMICs), effective rehabilitation strategies that can be realistically adopted in such...
Given the limited healthcare resources in low and middle income countries (LMICs), effective rehabilitation strategies that can be realistically adopted in such settings are required. A systematic review of literature was conducted to identify pragmatic solutions and outcomes capable of enhancing stroke recovery and quality of life of stroke survivors for low- and middle- income countries. PubMed, HINARI, and Directory of Open Access Journals databases were searched for published Randomized Controlled Trials (RCTs) till November 2018. Only completed trials published in English with non-pharmacological interventions on adult stroke survivors were included in the review while published protocols, pilot studies and feasibility analysis of trials were excluded. Obtained data were synthesized thematically and descriptively analyzed. One thousand nine hundred and ninety six studies were identified while 347 (65.22% high quality) RCTs were found to be eligible for the review. The most commonly assessed variables (and outcome measure utility) were activities of daily living [75.79% of the studies, with Barthel Index (37.02%)], motor function [66.57%; with Fugl Meyer scale (71.88%)], and gait [31.12%; with 6 min walk test (38.67%)]. Majority of the innovatively high technology interventions such as robot therapy (95.24%), virtual reality (94.44%), transcranial direct current stimulation (78.95%), transcranial magnetic stimulation (88.0%) and functional electrical stimulation (85.00%) were conducted in high income countries. Several traditional and low-cost interventions such as constraint-induced movement therapy (CIMT), resistant and aerobic exercises (R&AE), task oriented therapy (TOT), body weight supported treadmill training (BWSTT) were reported to significantly contribute to the recovery of motor function, activity, participation, and improvement of quality of life after stroke. Several pragmatic, in terms of affordability, accessibility and utility, stroke rehabilitation solutions, and outcome measures that can be used in resource-limited settings were found to be effective in facilitating and enhancing post-stroke recovery and quality of life.
PubMed: 32695058
DOI: 10.3389/fneur.2020.00337 -
Biomedicines Feb 202110 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials... (Review)
Review
10 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials supporting its use, has accumulated over the last decade. This systematic review aims to summarize the retrospective literature with reference to the efficacy and safety of 10 kHz SCS. We performed a systematic literature search of PubMed between 1 January 2009 and 21 August 2020 for English-language retrospective studies of ≥3 human subjects implanted with a Senza 10 kHz SCS system and followed-up for ≥3 months. Two independent reviewers screened titles/abstracts of 327 studies and 46 full-text manuscripts. In total, 16 articles were eligible for inclusion; 15 reported effectiveness outcomes and 11 presented safety outcomes. Follow-up duration ranged from 6-34 months. Mean pain relief was >50% in most studies, regardless of follow-up duration. Responder rates ranged from 67-100% at ≤12 months follow-up, and from 46-76% thereafter. 32-71% of patients decreased opioid or nonopioid analgesia intake. Complication incidence rates were consistent with other published SCS literature. Findings suggest 10 kHz SCS provides safe and durable pain relief in pragmatic populations of chronic pain patients. Furthermore, it may decrease opioid requirements, highlighting the key role 10 kHz SCS can play in the medium-term management of chronic pain.
PubMed: 33670252
DOI: 10.3390/biomedicines9020180 -
Frontiers in Cardiovascular Medicine 20232-dimensional Speckle-Tracking Echocardiography, to obtain longitudinal layer specific strain (LSS), has recently emerged as a novel and accurate non-invasive imaging... (Review)
Review
The clinical application of longitudinal layer specific strain as a diagnostic and prognostic instrument in ischemic heart diseases: A systematic review and meta-analysis.
BACKGROUND
2-dimensional Speckle-Tracking Echocardiography, to obtain longitudinal layer specific strain (LSS), has recently emerged as a novel and accurate non-invasive imaging technique for diagnosis as well as for prediction of adverse cardiac events. This systematic review and meta-analysis aimed to give an overview of the possible clinical implication and significance of longitudinal LSS.
METHODS
We conducted a systematic review and meta-analysis with all the studies involving layer specific strain in patients with ischemic heart disease (IHD). Of 40 eligible studies, 9 met our inclusion criteria. Studies that were included either investigated the prognostic value ( = 3) or the diagnostic value ( = 6) of longitudinal LSS.
RESULTS
The pooled meta-analysis showed that longitudinal LSS is a significant diagnostic marker for coronary artery disease (CAD) in patients with IHD. Endocardial LSS was found to be a good diagnostic marker for CAD in IHD patients (OR: 1.28, CI95% [1.11-1.48], < 0.001, per 1% decrease). Epicardial (OR: 1.34, CI95% [1.14-1.56], < 0.001, per 1% decrease), Mid-Myocardial (OR: 1.24, CI95% [1.12-1.38], < 0.001, per 1% decrease) and endocardial (OR: 1.21, CI95% [1.09-1.35], < 0.001, per 1% decrease) LSS all entailed diagnostic information regarding CAD, with epicardial LSS emerging as the superior diagnostic marker for CAD in patients with SAP. Endocardial LSS proved to be the better diagnostic marker of CAD in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). LSS was shown to be a good prognostic maker of adverse cardiac events in IHD patients. Two studies found endocardial circumferential strain to be the good predictor of outcome in CAD patients and when added to baseline characteristics. Epicardial LSS emerged as best predictor in acute coronary syndrome (ACS) patients.
CONCLUSION
In patients with SAP, epicardial LSS was the stronger diagnostic marker while in NSTE-ACS patients, endocardial LSS was the stronger diagnostic marker. In addition, endocardial circumferential strain is the better predictor of adverse outcome in CAD patients whilst in ACS patients, epicardial LSS was found to be a better predictor of outcome.
PubMed: 37051064
DOI: 10.3389/fcvm.2023.980626 -
PloS One 2023To systematically evaluate the empirical evidence on the impact of community-based health insurance (CBHI) on healthcare utilization and financial risk protection in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
To systematically evaluate the empirical evidence on the impact of community-based health insurance (CBHI) on healthcare utilization and financial risk protection in low- and middle-income countries (LMIC).
METHODS
We searched PubMed, CINAHL, Cochrane CENTRAL, CNKI, PsycINFO, Scopus, WHO Global Index Medicus, and Web of Science including grey literature, Google Scholar®, and citation tracking for randomized controlled trials (RCTs), non-RCTs, and quasi-experimental studies that evaluated the impact of CBHI schemes on healthcare utilization and financial risk protection in LMICs. We assessed the risk of bias using Cochrane's Risk of Bias 2.0 and Risk of Bias in Non-randomized Studies of Interventions tools for RCTs and quasi/non-RCTs, respectively. We also performed a narrative synthesis of all included studies and meta-analyses of comparable studies using random-effects models. We pre-registered our study protocol on PROSPERO: CRD42022362796.
RESULTS
We identified 61 articles: 49 peer-reviewed publications, 10 working papers, 1 preprint, and 1 graduate dissertation covering a total of 221,568 households (1,012,542 persons) across 20 LMICs. Overall, CBHI schemes in LMICs substantially improved healthcare utilization, especially outpatient services, and improved financial risk protection in 24 out of 43 studies. Pooled estimates showed that insured households had higher odds of healthcare utilization (AOR = 1.60, 95% CI: 1.04-2.47), use of outpatient health services (AOR = 1.58, 95% CI: 1.22-2.05), and health facility delivery (AOR = 2.21, 95% CI: 1.61-3.02), but insignificant increase in inpatient hospitalization (AOR = 1.53, 95% CI: 0.74-3.14). The insured households had lower out-of-pocket health expenditure (AOR = 0.94, 95% CI: 0.92-0.97), lower incidence of catastrophic health expenditure at 10% total household expenditure (AOR = 0.69, 95% CI: 0.54-0.88), and 40% non-food expenditure (AOR = 0.72, 95% CI: 0.54-0.96). The main limitations of our study are the limited data available for meta-analyses and high heterogeneity persisted in subgroup and sensitivity analyses.
CONCLUSIONS
Our study shows that CBHI generally improves healthcare utilization but inconsistently delivers financial protection from health expenditure shocks. With pragmatic context-specific policies and operational modifications, CBHI could be a promising mechanism for achieving universal health coverage (UHC) in LMICs.
Topics: Humans; Developing Countries; Community-Based Health Insurance; Delivery of Health Care; Health Expenditures; Universal Health Insurance; Insurance, Health
PubMed: 37368882
DOI: 10.1371/journal.pone.0287600