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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 -
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 -
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 -
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 -
The Cochrane Database of Systematic... Jun 2019Frequent consumption of excess amounts of sugar-sweetened beverages (SSB) is a risk factor for obesity, type 2 diabetes, cardiovascular disease and dental caries....
BACKGROUND
Frequent consumption of excess amounts of sugar-sweetened beverages (SSB) is a risk factor for obesity, type 2 diabetes, cardiovascular disease and dental caries. Environmental interventions, i.e. interventions that alter the physical or social environment in which individuals make beverage choices, have been advocated as a means to reduce the consumption of SSB.
OBJECTIVES
To assess the effects of environmental interventions (excluding taxation) on the consumption of sugar-sweetened beverages and sugar-sweetened milk, diet-related anthropometric measures and health outcomes, and on any reported unintended consequences or adverse outcomes.
SEARCH METHODS
We searched 11 general, specialist and regional databases from inception to 24 January 2018. We also searched trial registers, reference lists and citations, scanned websites of relevant organisations, and contacted study authors.
SELECTION CRITERIA
We included studies on interventions implemented at an environmental level, reporting effects on direct or indirect measures of SSB intake, diet-related anthropometric measures and health outcomes, or any reported adverse outcome. We included randomised controlled trials (RCTs), non-randomised controlled trials (NRCTs), controlled before-after (CBA) and interrupted-time-series (ITS) studies, implemented in real-world settings with a combined length of intervention and follow-up of at least 12 weeks and at least 20 individuals in each of the intervention and control groups. We excluded studies in which participants were administered SSB as part of clinical trials, and multicomponent interventions which did not report SSB-specific outcome data. We excluded studies on the taxation of SSB, as these are the subject of a separate Cochrane Review.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened studies for inclusion, extracted data and assessed the risks of bias of included studies. We classified interventions according to the NOURISHING framework, and synthesised results narratively and conducted meta-analyses for two outcomes relating to two intervention types. We assessed our confidence in the certainty of effect estimates with the GRADE framework as very low, low, moderate or high, and presented 'Summary of findings' tables.
MAIN RESULTS
We identified 14,488 unique records, and assessed 1030 in full text for eligibility. We found 58 studies meeting our inclusion criteria, including 22 RCTs, 3 NRCTs, 14 CBA studies, and 19 ITS studies, with a total of 1,180,096 participants. The median length of follow-up was 10 months. The studies included children, teenagers and adults, and were implemented in a variety of settings, including schools, retailing and food service establishments. We judged most studies to be at high or unclear risk of bias in at least one domain, and most studies used non-randomised designs. The studies examine a broad range of interventions, and we present results for these separately.Labelling interventions (8 studies): We found moderate-certainty evidence that traffic-light labelling is associated with decreasing sales of SSBs, and low-certainty evidence that nutritional rating score labelling is associated with decreasing sales of SSBs. For menu-board calorie labelling reported effects on SSB sales varied.Nutrition standards in public institutions (16 studies): We found low-certainty evidence that reduced availability of SSBs in schools is associated with decreased SSB consumption. We found very low-certainty evidence that improved availability of drinking water in schools and school fruit programmes are associated with decreased SSB consumption. Reported associations between improved availability of drinking water in schools and student body weight varied.Economic tools (7 studies): We found moderate-certainty evidence that price increases on SSBs are associated with decreasing SSB sales. For price discounts on low-calorie beverages reported effects on SSB sales varied.Whole food supply interventions (3 studies): Reported associations between voluntary industry initiatives to improve the whole food supply and SSB sales varied.Retail and food service interventions (7 studies): We found low-certainty evidence that healthier default beverages in children's menus in chain restaurants are associated with decreasing SSB sales, and moderate-certainty evidence that in-store promotion of healthier beverages in supermarkets is associated with decreasing SSB sales. We found very low-certainty evidence that urban planning restrictions on new fast-food restaurants and restrictions on the number of stores selling SSBs in remote communities are associated with decreasing SSB sales. Reported associations between promotion of healthier beverages in vending machines and SSB intake or sales varied.Intersectoral approaches (8 studies): We found moderate-certainty evidence that government food benefit programmes with restrictions on purchasing SSBs are associated with decreased SSB intake. For unrestricted food benefit programmes reported effects varied. We found moderate-certainty evidence that multicomponent community campaigns focused on SSBs are associated with decreasing SSB sales. Reported associations between trade and investment liberalisation and SSB sales varied.Home-based interventions (7 studies): We found moderate-certainty evidence that improved availability of low-calorie beverages in the home environment is associated with decreased SSB intake, and high-certainty evidence that it is associated with decreased body weight among adolescents with overweight or obesity and a high baseline consumption of SSBs.Adverse outcomes reported by studies, which may occur in some circumstances, included negative effects on revenue, compensatory SSB consumption outside school when the availability of SSBs in schools is reduced, reduced milk intake, stakeholder discontent, and increased total energy content of grocery purchases with price discounts on low-calorie beverages, among others. The certainty of evidence on adverse outcomes was low to very low for most outcomes.We analysed interventions targeting sugar-sweetened milk separately, and found low- to moderate-certainty evidence that emoticon labelling and small prizes for the selection of healthier beverages in elementary school cafeterias are associated with decreased consumption of sugar-sweetened milk. We found low-certainty evidence that improved placement of plain milk in school cafeterias is not associated with decreasing sugar-sweetened milk consumption.
AUTHORS' CONCLUSIONS
The evidence included in this review indicates that effective, scalable interventions addressing SSB consumption at a population level exist. Implementation should be accompanied by high-quality evaluations using appropriate study designs, with a particular focus on the long-term effects of approaches suitable for large-scale implementation.
Topics: Adolescent; Adult; Animals; Artificially Sweetened Beverages; Child; Commerce; Controlled Before-After Studies; Drinking Behavior; Drinking Water; Environment; Fast Foods; Food Supply; Fruit; Humans; Interrupted Time Series Analysis; Milk; Nutritive Value; Product Labeling; Randomized Controlled Trials as Topic; Schools; Selection Bias; Social Environment; Sugar-Sweetened Beverages; Young Adult
PubMed: 31194900
DOI: 10.1002/14651858.CD012292.pub2 -
Updates in Surgery Oct 2023Laser-assisted resection (LAR) of pulmonary metastases offers several potential advantages compared to conventional surgical techniques. However, the technical details,... (Review)
Review
Laser-assisted resection (LAR) of pulmonary metastases offers several potential advantages compared to conventional surgical techniques. However, the technical details, indications and outcomes of LAR have not been extensively reviewed. We conducted a systematic literature search to identify all original articles reporting on LAR of pulmonary metastases. All relevant outcomes, including morbidity rate, R0 rate, pulmonary function tests, overall- (OS) and relapse-free survival (RFS) rates were collected. Additionally, a comparison between outcomes obtained by laser-assisted and conventional resection techniques was provided. Of 2629 articles found by the initial search, 12 were selected for the systematic review. Following LAR, the R0 rate ranged between 72 and 100% and the morbidity rate ranged from 0 to 27.5%. The postoperative decline in forced expiratory volume in 1 s varied between 3.4 and 11%. Median OS and RFS were 42-77.6 months and 9-34.1 months, respectively. Compared with patients treated by other resection techniques, patients treated by LAR frequently had a higher number of metastases and a higher rate of bilateral disease. Despite this, no significant differences were observed in R0 rate, morbidity rate, and median OS rate, while only 1 study found a lower RFS rate in the LAR cohort. Although selection bias limits the comparability of outcomes, the findings of this review suggest that LAR is a valid alternative to conventional procedures of lung metastasectomy. The main difficulties of this technique consist in the adoption of a video-assisted thoracoscopic approach, and in the pathologic assessment of resection margins.
PubMed: 37347356
DOI: 10.1007/s13304-023-01564-x -
The Cochrane Database of Systematic... Nov 2021Hypertension is considered to be a serious health problem worldwide. Controlling and lowering blood pressure are of significant benefit to people with hypertension... (Review)
Review
BACKGROUND
Hypertension is considered to be a serious health problem worldwide. Controlling and lowering blood pressure are of significant benefit to people with hypertension because hypertension is a risk factor for stroke, heart disease, and cardiovascular disease. Roselle, the tropical plant Hibiscus sabdariffa, also commonly called sour tea or red tea, has been used as both a thirst-quenching drink and for medicinal purposes.
OBJECTIVES
To assess the effect of Roselle on blood pressure in people with primary hypertension.
SEARCH METHODS
For this update, the Cochrane Hypertension Information Specialist searched the following databases and trials registers for randomised controlled trials (RCTs): the Cochrane Hypertension Specialised Register (to 6 August 2021), Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 7), MEDLINE Ovid (1946 to 5 August 2021), Embase Ovid (1974 to 5 August 2021), ProQuest Dissertations & Theses (to 6 August 2021), Web of Science Clarivate (to 7 August 2021), Food Science and Technology Abstracts Clarivate (to 7 August 2021), the WHO International Clinical Trials Registry Platform (to 6 August 2021), and the US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (to 6 August 2021). We searched Google Scholar and OpenSIGLE. We also handsearched local and regional Chinese databases: CBM, CMCC, TCMLARS, CNKI, CMAC, and the Index to Chinese Periodical Literature (to 14 September 2020), as well as Thai databases (ThaiJO, CUIR, TDC, CMU e-Theses, TCTR) (to 3 October 2020). There were no language or publication date restrictions.
SELECTION CRITERIA
We sought RCTs evaluating the use of any forms of Roselle with placebo or no treatment in adults with hypertension. Our primary outcome was change in trough and/or peak systolic and diastolic blood pressure (SBP, DBP). Secondary outcomes were withdrawals due to adverse effects, change in pulse pressure, and change in heart rate.
DATA COLLECTION AND ANALYSIS
All search results were managed using Covidence and re-checked for the number of records, inclusion and exclusion of studies with Mendeley reference management software. We used standard methodological procedures expected by Cochrane. Two review authors worked independently in parallel for screening (titles and abstracts, and full reports), data extraction, risk of bias assessment, and assessment of the certainty of the evidence using the GRADE approach. Any disagreements were resolved by discussion or by consultation with the third review author if necessary. We presented mean difference (MD) of change in SBP and DBP with their corresponding 95% confidence interval (CI).
MAIN RESULTS
For this update, only one RCT with a parallel-group design involving 60 participants with type 2 diabetes mellitus fulfilled the inclusion criteria. This study investigated the effect of Roselle extract capsules (total dose of 5600 mg) compared with placebo (lactose) at eight weeks. The study was at low risk of selection bias, performance bias, and detection bias. Conversely, it was at high risk of attrition bias, reporting bias, and other bias (baseline imbalance). We have very little confidence in the effect estimate of Roselle on change-from-baseline in both SBP and DBP between the two groups. The MD of change in SBP was 1.65, 95% CI -7.89 to 11.19 mmHg, 52 participants, very low-certainty evidence. The MD of change in DBP was 4.60, 95% CI -1.38 to 10.58 mmHg, 52 participants, very low-certainty evidence. Our secondary outcomes of withdrawals due to adverse effects, change in pulse pressure, and change in heart rate were not reported. Due to the limited available data, no secondary analyses were performed (subgroup and sensitivity analysis).
AUTHORS' CONCLUSIONS
The evidence is currently insufficient to determine the effectiveness of Roselle compared to placebo for controlling or lowering blood pressure in people with hypertension. The certainty of evidence was very low due to methodological limitations, imprecision, and indirectness. There is a need for rigorous RCTs that address the review question.
Topics: Adult; Blood Pressure; Cardiovascular Diseases; Hibiscus; Humans; Hypertension; Systole
PubMed: 34837382
DOI: 10.1002/14651858.CD007894.pub3 -
The Cochrane Database of Systematic... Jun 2020Pitavastatin is the newest statin on the market, and the dose-related magnitude of effect of pitavastatin on blood lipids is not known. (Meta-Analysis)
Meta-Analysis
BACKGROUND
Pitavastatin is the newest statin on the market, and the dose-related magnitude of effect of pitavastatin on blood lipids is not known.
OBJECTIVES
Primary objective To quantify the effects of various doses of pitavastatin on the surrogate markers: LDL cholesterol, total cholesterol, HDL cholesterol and triglycerides in participants with and without cardiovascular disease. To compare the effect of pitavastatin on surrogate markers with other statins. Secondary objectives To quantify the effect of various doses of pitavastatin on withdrawals due to adverse effects. SEARCH METHODS: The Cochrane Hypertension Information Specialist searched the following databases for trials up to March 2019: the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 2, 2019), MEDLINE (from 1946), Embase (from 1974), the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. The searches had no language restrictions.
SELECTION CRITERIA
RCT and controlled before-and-after studies evaluating the dose response of different fixed doses of pitavastatin on blood lipids over a duration of three to 12 weeks in participants of any age with and without cardiovascular disease.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed eligibility criteria for studies to be included, and extracted data. We entered data from RCT and controlled before-and-after studies into Review Manager 5 as continuous and generic inverse variance data, respectively. Withdrawals due to adverse effects (WDAE) information was collected from the RCTs. We assessed all included trials using the Cochrane 'Risk of bias' tool under the categories of allocation (selection bias), blinding (performance bias and detection bias), incomplete outcome data (attrition bias), selective reporting (reporting bias), and other potential sources of bias.
MAIN RESULTS
Forty-seven studies (five RCTs and 42 before-and-after studies) evaluated the dose-related efficacy of pitavastatin in 5436 participants. The participants were of any age with and without cardiovascular disease, and pitavastatin effects were studied within a treatment period of three to 12 weeks. Log dose-response data over doses of 1 mg to 16 mg revealed strong linear dose-related effects on blood total cholesterol and LDL cholesterol and triglycerides. There was no dose-related effect of pitavastatin on blood HDL cholesterol, which was increased by 4% on average by pitavastatin. Pitavastatin 1 mg/day to 16 mg/day reduced LDL cholesterol by 33.3% to 54.7%, total cholesterol by 23.3% to 39.0% and triglycerides by 13.0% to 28.1%. For every two-fold dose increase, there was a 5.35% (95% CI 3.32 to 7.38) decrease in blood LDL cholesterol, a 3.93% (95% CI 2.35 to 5.50) decrease in blood total cholesterol and a 3.76% (95% CI 1.03 to 6.48) decrease in blood triglycerides. The certainty of evidence for these effects was judged to be high. When compared to other statins for its effect to reduce LDL cholesterol, pitavastatin is about 6-fold more potent than atorvastatin, 1.7-fold more potent than rosuvastatin, 77-fold more potent than fluvastatin and 3.3-fold less potent than cerivastatin. For the placebo group, there were no participants who withdrew due to an adverse effect per 109 subjects and for all doses of pitavastatin, there were three participants who withdrew due to an adverse effect per 262 subjects.
AUTHORS' CONCLUSIONS
Pitavastatin lowers blood total cholesterol, LDL cholesterol and triglyceride in a dose-dependent linear fashion. Based on the effect on LDL cholesterol, pitavastatin is about 6-fold more potent than atorvastatin, 1.7-fold more potent than rosuvastatin, 77-fold more potent than fluvastatin and 3.3-fold less potent than cerivastatin. There were not enough data to determine risk of withdrawal due to adverse effects due to pitavastatin.
Topics: Atorvastatin; Cardiovascular Diseases; Cholesterol, HDL; Cholesterol, LDL; Controlled Before-After Studies; Drug Administration Schedule; Female; Fluvastatin; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Lipids; Male; Pyridines; Quinolines; Randomized Controlled Trials as Topic; Rosuvastatin Calcium; Sex Factors; Triglycerides
PubMed: 32557581
DOI: 10.1002/14651858.CD012735.pub2 -
CNS Spectrums Feb 2023The aim of this paper is to review evidence on Interpersonal Psychotherapy (IPT) administered via telephone (IPT-T). (Review)
Review
BACKGROUND
The aim of this paper is to review evidence on Interpersonal Psychotherapy (IPT) administered via telephone (IPT-T).
METHODS
We conducted a systematic review of studies published between January 1, 1990 and June 30, 2020, assessing the efficacy of IPT administered by phone, using PubMed.
RESULTS
Originally, we found 60 papers; the final selection led to 13 papers. Six studies were performed using a randomized clinical trial methodology (6/13, 46.2%), three were prospective open-label not randomized studies (3/13, 15.7%), three were pilot studies (3/13, 23.1%), and one was a feasibility/acceptance study (1/13, 7.7%). The number of subjects included in the studies ranged between 14 and 442 (mean: 140.0 ± 124.9), for a total of 1850 patients. The mean age of the enrolled subjects was 47.8 ± 9.3 years (range: 27.4-70.4). Thirty-four different instruments were utilized. Qualitative synthesis was conducted only on randomized controlled trials (RCTs), namely on six studies. RCTs were almost all of good quality (mean score/standard deviation of the RCT-Psychotherapy Quality Rating Scale omnibus rating: 5.6 ± 1.2 points; range: 3-7).
CONCLUSIONS
IPT-T showed response rates similar to IPT administered in the usual way. Results are limited by small samples sizes, selection bias of the less severe depressed patients, and the heterogeneity of rating scales.
Topics: Humans; Adult; Middle Aged; Aged; Interpersonal Psychotherapy; Psychotherapy; Depression; Telephone; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 34657641
DOI: 10.1017/S1092852921000948 -
The Journal of Hand Surgery Jun 2022Inappropriately reported or conducted studies may decrease the quality of care due to under- or overestimation of the benefits or harms of interventions. Our aim was to...
PURPOSE
Inappropriately reported or conducted studies may decrease the quality of care due to under- or overestimation of the benefits or harms of interventions. Our aim was to evaluate how often hand surgical randomized controlled trials (RCTs) use and report adequate methods to ensure internal validity, and whether inadequate reporting or methods are associated with the magnitude of treatment effect estimates.
METHODS
Data Sources were the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase databases until November 2020. We included published RCTs investigating the effects of any surgical intervention in the hand and wrist region. We assessed internal validity using the Cochrane Risk of Bias (RoB) tool for 6 domains: selection, performance, detection, attrition, selective reporting, and "other" bias. We extracted the primary outcome and calculated the effect size for each study. We used mixed-effect meta-regression to assess whether the RoB modified the magnitude of the effects.
RESULTS
For 207 assessed trials, the RoB was unclear or high for 72% in selection, 93% in performance, 88% in detection, 25% in attrition, 22% in selective reporting, and 34% in the "other" bias domain. Trials with a high or unclear risk of selection bias yielded 0.28 standardized mean difference (95% confidence interval, 0.02-0.55) larger effect sizes compared to studies with a low risk. Risks of bias for other domains did not modify the intervention effects. The risk for selection bias declined over time: the odds ratio for a high or unclear RoB was 0.90 (95% confidence interval, 0.85-0.95) per additional year of publication CONCLUSIONS: The internal validity and credibility of hand surgical RCTs can be improved by using established methods to achieve true randomization, blinding of the participants and study personnel, publishing the trial protocol and avoiding selective reporting of the outcomes, and reporting the trial as recommended in the Consolidated Standards of Reporting Trials statement.
CLINICAL RELEVANCE
Clinicians should be aware that RCTs that do not use or report proper randomization and allocation concealment may overestimate the treatment effects.
Topics: Bias; Epidemiologic Studies; Humans; Odds Ratio; Randomized Controlled Trials as Topic
PubMed: 35341627
DOI: 10.1016/j.jhsa.2022.01.027