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The Cochrane Database of Systematic... Jan 2019People with cancer with febrile neutropenia are at risk of severe infections and mortality and are thus treated empirically with broad-spectrum antibiotic therapy.... (Meta-Analysis)
Meta-Analysis
BACKGROUND
People with cancer with febrile neutropenia are at risk of severe infections and mortality and are thus treated empirically with broad-spectrum antibiotic therapy. However, the recommended duration of antibiotic therapy differs across guidelines.
OBJECTIVES
To assess the safety of protocol-guided discontinuation of antibiotics regardless of neutrophil count, compared to continuation of antibiotics until neutropenia resolution in people with cancer with fever and neutropenia, in terms of mortality and morbidity. To assess the emergence of resistant bacteria in people with cancer treated with short courses of antibiotic therapy compared with people with cancer treated until resolution of neutropenia.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 10) in the Cochrane Library, MEDLINE, Embase, and LILACS up to 1 October 2018. We searched the metaRegister of Controlled Trials and the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov for ongoing and unpublished trials. We reviewed the references of all identified studies for additional trials and handsearched conference proceedings of international infectious diseases and oncology and haematology conferences.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared a short antibiotic therapy course in which discontinuation of antibiotics was guided by protocols regardless of the neutrophil count to a long course in which antibiotics were continued until neutropenia resolution in people with cancer with febrile neutropenia. The primary outcome was 30-day or end of follow-up all-cause mortality.
DATA COLLECTION AND ANALYSIS
Two review authors independently reviewed all studies for eligibility, extracted data, and assessed risk of bias for all included trials. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) whenever possible. For dichotomous outcomes with zero events in both arms of the trials, we conducted meta-analysis of risk differences (RDs) as well. For continuous outcomes, we extracted means with standard deviations (SD) from the studies and computed mean difference (MD) and 95% CI. If no substantial clinical heterogeneity was found, trials were pooled using the Mantel-Haenszel fixed-effect model.
MAIN RESULTS
We included eight RCTs comprising a total of 662 distinct febrile neutropenia episodes. The studies included adults and children, and had variable design and criteria for discontinuation of antibiotics in both study arms. All included studies but two were performed before the year 2000. All studies included people with cancer with fever of unknown origin and excluded people with microbiological documented infections.We found no significant difference between the short-antibiotic therapy arm and the long-antibiotic therapy arm for all-cause mortality (RR 1.38, 95% CI 0.73 to 2.62; RD 0.02, 95% CI -0.02 to 0.05; low-certainty evidence). We downgraded the certainty of the evidence to low due to imprecision and high risk of selection bias. The number of fever days was significantly lower for people in the short-antibiotic treatment arm compared to the long-antibiotic treatment arm (mean difference -0.64, 95% CI -0.96 to -0.32; I² = 30%). In all studies, total antibiotic days were fewer in the intervention arm by three to seven days compared to the long antibiotic therapy. We found no significant differences in the rates of clinical failure (RR 1.23, 95% CI 0.85 to 1.77; very low-certainty evidence). We downgraded the certainty of the evidence for clinical failure due to variable and inconsistent definitions of clinical failure across studies, possible selection bias, and wide confidence intervals. There was no significant difference in the incidence of bacteraemia occurring after randomisation (RR 1.56, 95% CI 0.91 to 2.66; very low-certainty evidence), while the incidence of any documented infections was significantly higher in the short-antibiotic therapy arm (RR 1.67, 95% CI 1.08 to 2.57). There was no significant difference in the incidence of invasive fungal infections (RR 0.86, 95% CI 0.32 to 2.31) and development of antibiotic resistance (RR 1.49, 95% CI 0.62 to 3.61). The data on hospital stay were too sparse to permit any meaningful conclusions.
AUTHORS' CONCLUSIONS
We could make no strong conclusions on the safety of antibiotic discontinuation before neutropenia resolution among people with cancer with febrile neutropenia based on the existing evidence and its low certainty. Results of microbiological outcomes favouring long antibiotic therapy may be misleading due to lower culture positivity rates under antibiotic therapy and not true differences in infection rates. Well-designed, adequately powered RCTs are required that address this issue in the era of rising antibiotic resistance.
Topics: Adult; Anti-Bacterial Agents; Child; Drug Resistance, Bacterial; Febrile Neutropenia; Humans; Neoplasms; Randomized Controlled Trials as Topic; Treatment Outcome; Withholding Treatment
PubMed: 30605229
DOI: 10.1002/14651858.CD012184.pub2 -
Journal of Patient Safety Jun 2021Teach-back methods are reported to improve patient outcomes by encouraging patient understanding and participation and are increasingly being used in various clinical... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Teach-back methods are reported to improve patient outcomes by encouraging patient understanding and participation and are increasingly being used in various clinical settings. This study attempts to identify the effectiveness of discharge education using the teach-back method on 30-day readmission.
METHODS
MEDLINE, CINAHL, Embase, The Cochrane Library, and Web of Science were used to search experimental studies. The search terms were "discharged patient," "teach-back," and "30-day readmission" published in English up until July 2017. Two trained reviewers performed a critical appraisal of retrieved studies using the Risk of Bias Assessment tool for Nonrandomized Studies. Data were analyzed using Cochrane Review Manager (Revman) software 5.2.
RESULTS
A total of five studies were analyzed (3 studies on heart failure, 1 study on total joint replacement, and 1 study on a coronary artery bypass graft). The main content of the teach-back education was to confirm and reinforce the patients' comprehension of health-related information. Among the five studies, three studies were included in the meta-analysis. The odds ratio of 30-day readmission for discharge education with the teach-back method and usual care was 0.55 (95% confidence interval, 0.34-0.91; P = 0.02). The I2 score was 0%, which means that the analyzed studies are homogeneous.
CONCLUSIONS
The results indicate that discharge education with the teach-back method resulted in a 45% reduction in 30-day readmission. However, only a few studies were included in the analysis, and they showed a high risk of selection bias. Therefore, we suggest that well-designed randomized controlled trials be conducted.
Topics: Humans; Patient Discharge; Patient Readmission
PubMed: 30882616
DOI: 10.1097/PTS.0000000000000596 -
World Journal of Emergency Surgery :... Dec 2023To assess the efficacy of artificial intelligence (AI) models in diagnosing and prognosticating acute appendicitis (AA) in adult patients compared to traditional... (Review)
Review
BACKGROUND
To assess the efficacy of artificial intelligence (AI) models in diagnosing and prognosticating acute appendicitis (AA) in adult patients compared to traditional methods. AA is a common cause of emergency department visits and abdominal surgeries. It is typically diagnosed through clinical assessments, laboratory tests, and imaging studies. However, traditional diagnostic methods can be time-consuming and inaccurate. Machine learning models have shown promise in improving diagnostic accuracy and predicting outcomes.
MAIN BODY
A systematic review following the PRISMA guidelines was conducted, searching PubMed, Embase, Scopus, and Web of Science databases. Studies were evaluated for risk of bias using the Prediction Model Risk of Bias Assessment Tool. Data points extracted included model type, input features, validation strategies, and key performance metrics.
RESULTS
In total, 29 studies were analyzed, out of which 21 focused on diagnosis, seven on prognosis, and one on both. Artificial neural networks (ANNs) were the most commonly employed algorithm for diagnosis. Both ANN and logistic regression were also widely used for categorizing types of AA. ANNs showed high performance in most cases, with accuracy rates often exceeding 80% and AUC values peaking at 0.985. The models also demonstrated promising results in predicting postoperative outcomes such as sepsis risk and ICU admission. Risk of bias was identified in a majority of studies, with selection bias and lack of internal validation being the most common issues.
CONCLUSION
AI algorithms demonstrate significant promise in diagnosing and prognosticating AA, often surpassing traditional methods and clinical scores such as the Alvarado scoring system in terms of speed and accuracy.
Topics: Adult; Humans; Artificial Intelligence; Appendicitis; Prognosis; Algorithms; Machine Learning; Acute Disease
PubMed: 38114983
DOI: 10.1186/s13017-023-00527-2 -
European Journal of Oral Sciences Oct 2007In case-control studies the frequency of the exposure of interest is compared between a group of diseased subjects and a group of controls to determine whether an... (Review)
Review
In case-control studies the frequency of the exposure of interest is compared between a group of diseased subjects and a group of controls to determine whether an association exists between disease and exposure. Case-control studies are useful, but can be subject to several sources of bias if poorly conducted. Selection bias, which results in a lack of comparability between the groups being studied, is one of the most harmful types of bias. The aim of this study was to assess the information reported on case-control studies of periodontitis to identify sources of selection bias. We conducted an electronic search in PubMed, EMBASE, and Web of Science and evaluated the occurrence of sources of selection bias in case-control studies published in English during the year 2004. In relatively few studies did the authors provided information on recruitment periods for cases and controls (31.1% and 20%, respectively), sampling methods (26.7% and 31.1%, respectively), or participation rates (8.9% and 6.7%, respectively). The source of control subjects was appropriate in 15.6% of the studies, and the strategy used to select the controls was adequate in only 8.9% of the studies. It may be concluded that case-control studies on periodontitis are frequently inadequately conducted and reported.
Topics: Case-Control Studies; Control Groups; Humans; Patient Selection; Periodontitis; Selection Bias
PubMed: 17850421
DOI: 10.1111/j.1600-0722.2007.00476.x -
Cadernos de Saude Publica Nov 2015The proportion of non-participation in cohort studies, if associated with both the exposure and the probability of occurrence of the event, can introduce bias in the... (Meta-Analysis)
Meta-Analysis Review
The proportion of non-participation in cohort studies, if associated with both the exposure and the probability of occurrence of the event, can introduce bias in the estimates of interest. The aim of this study is to evaluate the impact of participation and its characteristics in longitudinal studies. A systematic review (MEDLINE, Scopus and Web of Science) for articles describing the proportion of participation in the baseline of cohort studies was performed. Among the 2,964 initially identified, 50 were selected. The average proportion of participation was 64.7%. Using a meta-regression model with mixed effects, only age, year of baseline contact and study region (borderline) were associated with participation. Considering the decrease in participation in recent years, and the cost of cohort studies, it is essential to gather information to assess the potential for non-participation, before committing resources. Finally, journals should require the presentation of this information in the papers.
Topics: Cohort Studies; Humans; Regression Analysis; Selection Bias
PubMed: 26840808
DOI: 10.1590/0102-311X00133814 -
The Science of the Total Environment Sep 2023As climate change exerts wide ranging health impacts, there is a surge of interest in the associations between climatic factors and mental and behavioral disorders... (Meta-Analysis)
Meta-Analysis Review
As climate change exerts wide ranging health impacts, there is a surge of interest in the associations between climatic factors and mental and behavioral disorders (MBDs). Existing quantitative syntheses focus mainly on heat and high temperature exposure, neglecting the effects of other climatic factors and their synergies. The objective of this study is to conduct a systematic review and meta-analysis of the evidence of associations between climatic exposure and combined mental and behavioral health conditions and specific mental disorders (e.g., schizophrenia, dementia). A systematic search was conducted April 11-16, 2022 using Web of Science, Medline, ProQuest, EMBASE, PsycINFO, CINAHL, and Environment Complete. Screening and eligibility screening followed inclusion criteria based on population, exposure, comparator, and outcome guidelines. Risk of bias assessment was performed, a narrative synthesis was first presented for all studies, and random-effect meta-analyses were performed when at least three studies were available for a specific exposure-outcome pair. Certainty of evidence was evaluated following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) tool. The search process yielded 7696 initial results, from which we identified 88 studies to include in the review set. Climatic factors reported included air temperature, solar radiation/sunshine, barometric pressure, precipitation, relative humidity, wind direction/speed, and thermal index. Outcomes including MBD incidences (e.g., schizophrenia, mood disorders, neurotic disorders), mental health-related mortality, and self-reported psychological states. Meta-analysis showed that heatwaves (pooled RR = 1.05, 95 % CI = 1.02-1.08) and extreme high temperatures (99th percentile: pooled RR = 1.18, 95 % CI = 1.08-1.29) were associated with higher risk of MBD. Cold extremes, however, were not associated with MBD risk. The findings further identified an association between increases in a thermal index (i.e., apparent temperature) and elevated risk of MBD (pooled RR = 1.06, 95 % CI = 1.03-1.12); specifically, a 99th percentile high temperature was associated with increased schizophrenia risk (pooled RR = 1.07, 95 % CI = 1.01-1.12). Risk of bias assessment showed most studies to have low or moderately low risks, while a few studies were rated probably high in confounding, selection bias, outcome measurement, and reporting bias. GRADE evaluation revealed moderate certainty of evidence on thermal comfort index and MBD, but low certainty related to air temperature or sunshine duration. These findings call attention to the heterogeneity of exposure measures and the utility of thermal indices that consider the synergistic effects of meteorological factors. Methodological concerns such as the linearity assumption and cumulative effects are discussed.
Topics: Humans; Mental Disorders; Mental Health; Selection Bias; Hot Temperature; Risk
PubMed: 37257626
DOI: 10.1016/j.scitotenv.2023.164435 -
BMJ Evidence-based Medicine Apr 2019Following their evaluation in randomised controlled trials (RCTs), direct oral anticoagulants (DOACs) have replaced warfarin for stroke prevention in atrial fibrillation...
BACKGROUND
Following their evaluation in randomised controlled trials (RCTs), direct oral anticoagulants (DOACs) have replaced warfarin for stroke prevention in atrial fibrillation (AF), and treatment and prevention of venous thromboembolism (VTE). To avoid selection bias, it is recommended that RCTs use an intention-to-treat (ITT) analysis strategy.
OBJECTIVE
The objective of this study was to systematically review and compare reported analytical strategies, the proportion of randomised patients included in analyses and the reasons for participant exclusions.
STUDY SELECTION
A systematic search of PubMed, EMBASE and the Cochrane library for phase III trials of DOACs was conducted. Titles and abstracts were screened for relevance by two independent reviewers. Patient population, intervention studied, number of patients included in randomisation and analysis, reasons for exclusions from analysis and trial conclusions were extracted from each article.
FINDINGS
Twenty-nine studies were included, five were about stroke prevention in AF, 10 about VTE treatment and 14 about thromboprophylaxis. Trials of AF and VTE treatment had low proportions of postrandomisation exclusions (around 1%). In contrast, surgical and medical thromboprophylaxis trials excluded almost 30% of participants postrandomisation. This was in spite of authors' claims of using an ITT or modified ITT approach. Higher exclusion proportions in these trials were associated with non-clinically defined primary outcomes and incomplete outcome assessments.
CONCLUSIONS
Clinicians should be aware that the level of evidence in favour of DOAC use for thromboprophylaxis is weak due to high rates of postrandomisation exclusions and risks of selection bias.
Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Data Interpretation, Statistical; Humans; Intention to Treat Analysis; Selection Bias; Statistics as Topic; Stroke; Treatment Outcome
PubMed: 30745410
DOI: 10.1136/bmjebm-2018-111057 -
The Cochrane Database of Systematic... Nov 2021Topiramate is a newer broad-spectrum antiepileptic drug (AED). Some studies have shown the benefits of topiramate in the treatment of juvenile myoclonic epilepsy (JME).... (Review)
Review
BACKGROUND
Topiramate is a newer broad-spectrum antiepileptic drug (AED). Some studies have shown the benefits of topiramate in the treatment of juvenile myoclonic epilepsy (JME). However, there are no current systematic reviews to determine the efficacy and tolerability of topiramate in people with JME. This is an update of a Cochrane Review first published in 2015, and last updated in 2019.
OBJECTIVES
To evaluate the efficacy and tolerability of topiramate in the treatment of JME.
SEARCH METHODS
For the latest update, we searched the Cochrane Register of Studies (CRS Web) on 26 August 2021, and MEDLINE (Ovid 1946 to 26 August 2021). CRS Web includes randomized or quasi-randomized controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP), the Cochrane Central Register of Controlled Trials (CENTRAL), and the Specialized Registers of Cochrane Review Groups, including Cochrane Epilepsy.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) investigating topiramate versus placebo or other AED treatment for people with JME, with the outcomes of proportion of responders and proportion of participants experiencing adverse events (AEs).
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the titles and abstracts of identified records, selected studies for inclusion, extracted data, cross-checked the data for accuracy and assessed the methodological quality of the studies.
MAIN RESULTS
We included three studies with a total of 83 participants. For efficacy, a greater proportion of participants in the topiramate group had a 50% or greater reduction in primarily generalized tonic-clonic seizures (PGTCS), compared with participants in the placebo group (RR 4.00, 95% CI 1.08 to 14.75; 1 study, 22 participants; very low-certainty evidence). There were no significant differences between topiramate and valproate for participants responding with a 50% or greater reduction in myoclonic seizures (RR 0.88, 95% CI 0.67 to 1.15; one study, 23 participants; very-low certainty evidence) or in PGTCS (RR 1.22, 95% CI 0.68 to 2.21; one study, 16 participants, very-low certainty evidence), or participants becoming seizure-free (RR 1.13, 95% CI 0.61 to 2.11; one study, 27 participants; very-low certainty evidence). Concerning tolerability, we ranked AEs associated with topiramate as moderate to severe, while we ranked 59% of AEs linked to valproate as severe complaints (2 studies, 61 participants; very low-certainty evidence). Moreover, systemic toxicity scores were higher in the valproate group than the topiramate group. Overall we judged all three studies to be at high risk of attrition bias and at unclear risk of reporting bias. We judged the studies to be at low to unclear risk of bias for the remaining domains (selection bias, performance bias, detection bias and other bias). We judged the overall certainty of the evidence for the outcomes as very low using the GRADE approach.
AUTHORS' CONCLUSIONS
We have found no new studies since the last version of this review was published in 2019. This review does not provide sufficient evidence to support topiramate for the treatment of people with JME. Based on the current limited available data, topiramate seems to be better tolerated than valproate, but has no clear benefits over valproate in terms of efficacy. Well-designed, double-blind RCTs with large samples are required to test the efficacy and tolerability of topiramate in people with JME.
Topics: Anticonvulsants; Humans; Myoclonic Epilepsy, Juvenile; Randomized Controlled Trials as Topic; Seizures; Topiramate; Valproic Acid
PubMed: 34817852
DOI: 10.1002/14651858.CD010008.pub5 -
Medical Decision Making : An... 2012Economic studies funded by the pharmaceutical industry are more likely to report favorable results and recommendations for the sponsor's product than are studies funded... (Review)
Review
BACKGROUND
Economic studies funded by the pharmaceutical industry are more likely to report favorable results and recommendations for the sponsor's product than are studies funded by nonindustry establishments.
PURPOSE
To determine whether clinical outcome data obtained from the same meta-analyses are used differently in various economic studies of oral triptans and whether there is an association between the study sponsorship and the choice of clinical outcome measure.
DATA SOURCES
Economic studies of triptans were identified by updating a previously published systematic review.
STUDY SELECTION
Twelve studies that used the same meta-analyses as the source of clinical outcome data were identified.
DATA EXTRACTION
Two independent reviewers extracted the essential data from the identified studies.
DATA SYNTHESIS
In the 12 appraised studies, 9 alternative measures of effectiveness were derived from the same meta-analyses. Eleven studies were industry-related, and in these the selected clinical outcome consistently favored the sponsor's product. Also the reported results suggested that the sponsor's product was more cost-effective than the competitors' products.
LIMITATIONS
The cost-effectiveness of triptans is dependent on both the definition of clinical effectiveness and the treatment-related costs. Only bias related to the selection of the clinical outcome measure has been taken into account in this review.
CONCLUSIONS
The results of published economic studies of triptans are conflicting and biased. There is a tendency to select clinical outcome measures that support the sponsor's product. This leads to concern about the possible poor applicability of these results in decision making.
Topics: Administration, Oral; Conflict of Interest; Cost-Benefit Analysis; Decision Support Techniques; Drug Costs; Drug Industry; Finland; Humans; Outcome Assessment, Health Care; Publication Bias; Research Support as Topic; Tryptamines
PubMed: 21490308
DOI: 10.1177/0272989X11403834 -
Journal of Clinical Epidemiology Feb 2015To assess the current practice of propensity score (PS) analysis in the medical literature, particularly the assessment and reporting of balance on confounders. (Review)
Review
OBJECTIVES
To assess the current practice of propensity score (PS) analysis in the medical literature, particularly the assessment and reporting of balance on confounders.
STUDY DESIGN AND SETTING
A PubMed search identified studies using PS methods from December 2011 through May 2012. For each article included in the review, information was extracted on important aspects of the PS such as the type of PS method used, variable selection for PS model, and assessment of balance.
RESULTS
Among 296 articles that were included in the review, variable selection for PS model was explicitly reported in 102 studies (34.4%). Covariate balance was checked and reported in 177 studies (59.8%). P-values were the most commonly used statistical tools to report balance (125 of 177, 70.6%). The standardized difference and graphical displays were reported in 45 (25.4%) and 11 (6.2%) articles, respectively. Matching on the PS was the most commonly used approach to control for confounding (68.9%), followed by PS adjustment (20.9%), PS stratification (13.9%), and inverse probability of treatment weighting (IPTW, 7.1%). Balance was more often checked in articles using PS matching and IPTW, 70.6% and 71.4%, respectively.
CONCLUSION
The execution and reporting of covariate selection and assessment of balance is far from optimal. Recommendations on reporting of PS analysis are provided to allow better appraisal of the validity of PS-based studies.
Topics: Analysis of Variance; Data Interpretation, Statistical; Humans; Patient Selection; Propensity Score; Research Design; Selection Bias
PubMed: 25433444
DOI: 10.1016/j.jclinepi.2014.08.011