scholarly journals A systematic review of the quality of conduct and reporting of survival analyses of tuberculosis outcomes in Africa

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Moses M. Ngari ◽  
Susanne Schmitz ◽  
Christopher Maronga ◽  
Lazarus K. Mramba ◽  
Michel Vaillant
Keyword(s):  
Systematic Review ◽  
Sample Size ◽  
Survival Function ◽  
Sample Size Estimation ◽  
Size Estimation ◽  
Survival Curves ◽  
Survival Analyses ◽  
Survival Regression

Abstract Background Survival analyses methods (SAMs) are central to analysing time-to-event outcomes. Appropriate application and reporting of such methods are important to ensure correct interpretation of the data. In this study, we systematically review the application and reporting of SAMs in studies of tuberculosis (TB) patients in Africa. It is the first review to assess the application and reporting of SAMs in this context. Methods Systematic review of studies involving TB patients from Africa published between January 2010 and April 2020 in English language. Studies were eligible if they reported use of SAMs. Application and reporting of SAMs were evaluated based on seven author-defined criteria. Results Seventy-six studies were included with patient numbers ranging from 56 to 182,890. Forty-three (57%) studies involved a statistician/epidemiologist. The number of published papers per year applying SAMs increased from two in 2010 to 18 in 2019 (P = 0.004). Sample size estimation was not reported by 67 (88%) studies. A total of 22 (29%) studies did not report summary follow-up time. The survival function was commonly presented using Kaplan-Meier survival curves (n = 51, (67%) studies) and group comparisons were performed using log-rank tests (n = 44, (58%) studies). Sixty seven (91%), 3 (4.1%) and 4 (5.4%) studies reported Cox proportional hazard, competing risk and parametric survival regression models, respectively. A total of 37 (49%) studies had hierarchical clustering, of which 28 (76%) did not adjust for the clustering in the analysis. Reporting was adequate among 4.0, 1.3 and 6.6% studies for sample size estimation, plotting of survival curves and test of survival regression underlying assumptions, respectively. Forty-five (59%), 52 (68%) and 73 (96%) studies adequately reported comparison of survival curves, follow-up time and measures of effect, respectively. Conclusion The quality of reporting survival analyses remains inadequate despite its increasing application. Because similar reporting deficiencies may be common in other diseases in low- and middle-income countries, reporting guidelines, additional training, and more capacity building are needed along with more vigilance by reviewers and journal editors.

scholarly journals Correction to: Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Stephen J. Walters ◽  
Richard M. Jacques ◽  
Inês Bonacho dos Anjos Henriques-Cadby ◽  
Jane Candlish ◽  
Nikki Totton ◽  
...  
Keyword(s):  
Sample Size ◽  
Randomised Controlled Trials ◽  
Patient Reported Outcomes ◽  
Sample Size Estimation ◽  
Controlled Trials ◽  
Size Estimation ◽  
Patient Reported ◽  
Randomised Controlled ◽  
Repeated Assessment

Following publication of the original article [1], we have been notified that one of an error in the Conclusions section of the Abstract.

scholarly journals Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Stephen J. Walters ◽  
Richard M. Jacques ◽  
Inês Bonacho dos Anjos Henriques-Cadby ◽  
Jane Candlish ◽  
Nikki Totton ◽  
...  
Keyword(s):  
Sample Size ◽  
Randomised Controlled Trials ◽  
Sample Size Estimation ◽  
Controlled Trials ◽  
Size Estimation ◽  
Time Points ◽  
Patient Reported ◽  
Randomised Controlled ◽  
Post Randomisation

Abstract Background Patient-reported outcome measures (PROMs) are now frequently used in randomised controlled trials (RCTs) as primary endpoints. RCTs are longitudinal, and many have a baseline (PRE) assessment of the outcome and one or more post-randomisation assessments of outcome (POST). With such pre-test post-test RCT designs there are several ways of estimating the sample size and analysing the outcome data: analysis of post-randomisation treatment means (POST); analysis of mean changes from pre- to post-randomisation (CHANGE); analysis of covariance (ANCOVA). Sample size estimation using the CHANGE and ANCOVA methods requires specification of the correlation between the baseline and follow-up measurements. Other parameters in the sample size estimation method being unchanged, an assumed correlation of 0.70 (between baseline and follow-up outcomes) means that we can halve the required sample size at the study design stage if we used an ANCOVA method compared to a comparison of POST treatment means method. So what correlation (between baseline and follow-up outcomes) should be assumed and used in the sample size calculation? The aim of this paper is to estimate the correlations between baseline and follow-up PROMs in RCTs. Methods The Pearson correlation coefficients between the baseline and repeated PROM assessments from 20 RCTs (with 7173 participants at baseline) were calculated and summarised. Results The 20 reviewed RCTs had sample sizes, at baseline, ranging from 49 to 2659 participants. The time points for the post-randomisation follow-up assessments ranged from 7 days to 24 months; 464 correlations, between baseline and follow-up, were estimated; the mean correlation was 0.50 (median 0.51; standard deviation 0.15; range − 0.13 to 0.91). Conclusions There is a general consistency in the correlations between the repeated PROMs, with the majority being in the range of 0.4 to 0.6. The implications are that we can reduce the sample size in an RCT by 25% if we use an ANCOVA model, with a correlation of 0.50, for the design and analysis. There is a decline in correlation amongst more distant pairs of time points.

scholarly journals Effectiveness of e-cigarettes in smoking cessation: a systematic review and meta-analysis

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
M Oberndorfer ◽  
I Grabovac ◽  
S Haider ◽  
T E Dorner
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Meta Analysis ◽  
Current Evidence ◽  
Promising Alternative ◽  
Quality Of Evidence ◽  
Different Populations ◽  
Meta Analyses

Abstract Background Reports of the effectiveness of e-cigarettes (ECs) for smoking cessation vary across different studies making implementation recommendations hard to attain. We performed a systematic review and meta-analysis to synthesise the current evidence regarding the effectiveness of ECs for smoking cessation. Methods PubMed, PsycInfo and Embase databases were searched for randomized controlled trials comparing nicotine ECs with non-nicotine ECs or with established smoking cessation interventions (nicotine replacement therapy (NRT) and or counselling) published between 01/01/2014 and 01/05/2019. Data from eligible studies were extracted and used for random-effects meta-analyses. Results Our literature review yielded 13190 publications with 10 studies being identified as eligible for systematic review, covering 8362 participants, and 8 for meta-analyses (n = 30 - 6006). Using the last follow-up of eligible studies, the proportion of smokers achieving abstinence was 1.67 [95CI:0.99 - 2.81] times higher in nicotine EC users compared to non-nicotine EC users. The proportion of abstinent smokers was 1.69 [95CI:1.25 - 2.27] times higher in EC users compared to participants receiving NRT. EC users showed a 2.70 [95CI:1.15 - 6.30] times higher proportion of abstinent smokers in comparison to participants solely receiving counselling. Conclusions Our analysis showed modest effects of nicotine-ECs compared to non-nicotine ECs. When compared to NRT or counselling, results suggest that nicotine EC may be more effective for smoking cessation. As ECs also help maintaining routinized behaviour and social aspects of smoking, we hypothesise that this may explain their advantage as a tool for smoking cessation. However, given the small number of included studies, different populations, heterogeneous designs, and the overall moderate to low quality of evidence, it is not possible to offer clear recommendations. More comparable data is needed to strengthen confidence in the quality of evidence. Key messages The number of previous studies assessing the effectiveness of ECs for smoking cessation is limited. Further, comparability of these studies is restricted, weakening the quality of evidence. Although current evidence on the effectiveness of ECs for smoking cessation is inconclusive, our meta-analyses suggest that ECs could be a promising alternative tool in attempts to achieve abstinence.

Criteria for Return to Play After Hip Arthroscopy in the Treatment of Femoroacetabular Impingement: A Systematic Review

2021 ◽  
pp. 036354652110389
Author(s):  
Martin S. Davey ◽  
Eoghan T. Hurley ◽  
Matthew G. Davey ◽  
Jordan W. Fried ◽  
Andrew J. Hughes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Femoroacetabular Impingement ◽  
Hip Arthroscopy ◽  
Operative Management ◽  
Return To Play ◽  
Return To Sports ◽  
Level Of Evidence ◽  
The Mean

Background: Femoroacetabular impingement (FAI) is a common pathology in athletes that often requires operative management in the form of hip arthroscopy. Purpose: To systematically review the rates and level of return to play (RTP) and the criteria used for RTP after hip arthroscopy for FAI in athletes. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review of the literature, based on the PRISMA guidelines, was performed using PubMed, Embase, and Scopus databases. Studies reporting outcomes after the use of hip arthroscopy for FAI were included. Outcomes analyzed were RTP rate, RTP level, and criteria used for RTP. Statistical analysis was performed using SPSS software. Results: Our review found 130 studies, which included 14,069 patients (14,517 hips) and had a mean methodological quality of evidence (MQOE) of 40.4 (range, 5-67). The majority of patients were female (53.7%), the mean patient age was 30.4 years (range, 15-47 years), and the mean follow-up was 29.7 months (range, 6-75 months). A total of 81 studies reported RTP rates, with an overall RTP rate of 85.4% over a mean period of 6.6 months. Additionally, 49 studies reported the rate of RTP at preinjury level as 72.6%. Specific RTP criteria were reported in 97 studies (77.2%), with time being the most commonly reported item, which was reported in 80 studies (69.2%). A total of 45 studies (57.9%) advised RTP at 3 to 6 months after hip arthroscopy. Conclusion: The overall rate of reported RTP was high after hip arthroscopy for FAI. However, more than one-fourth of athletes who returned to sports did not return at their preinjury level. Development of validated rehabilitation criteria for safe return to sports after hip arthroscopy for FAI could potentially improve clinical outcomes while also increasing rates of RTP at preinjury levels.

Sample Size Estimation

2008 ◽  
pp. 1278-1278
Keyword(s):  
Sample Size ◽  
Sample Size Estimation ◽  
Size Estimation

Sample Size Estimation

2020 ◽  
pp. 1945-1947
Author(s):  
J. Rick Turner
Keyword(s):  
Sample Size ◽  
Sample Size Estimation ◽  
Size Estimation

scholarly journals Tamaño óptimo de la muestra

2017 ◽  
Vol 5 (9) ◽  
Author(s):  
M. H. Badii ◽  
J. Castillo ◽  
A. Guillen
Keyword(s):  
Sample Size ◽  
Normal Distribution ◽  
Key Words ◽  
Sample Size Estimation ◽  
Size Estimation ◽  
Bias Estimation ◽  
Population Variance ◽  
Population Proportion ◽  
Estimation Process ◽  
The Mean

Key words: Bias, estimation, population, sampleAbstract. The basics of sample size estimation process are described. Assuming the normal distribution, the procedures for estimation of sample size for the mean; with and without knowledge of the population variance, and population proportion are noted. Sample size for more than one population feature is also given.Palabras clave: Estimación, muestra, población, sesgoResumen. Se describen los fundamentos del proceso de la estimación del tamaño óptimo de la muestra. Suponiendo una distribución normal para una población, se notan los procedimientos de la estimación del tamaño óptimo de la muestra para la media muestral con y sin el conocimiento de la varianza poblacional. Se presenta el tamaño óptimo de la muestra con más de una característica poblacional.

scholarly journals Effectiveness of acute geriatric unit care on functional decline and process outcomes among older adults admitted to hospital with acute medical complaints: a protocol for a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e050524
Author(s):  
Íde O’Shaughnessy ◽  
Katie Robinson ◽  
Margaret O'Connor ◽  
Mairéad Conneely ◽  
Damien Ryan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Older Adults ◽  
Meta Analysis ◽  
Functional Decline ◽  
Index Admission ◽  
Research Centre ◽  
Cochrane Library ◽  
Process Outcomes

IntroductionOlder adults are clinically heterogeneous and are at increased risk of adverse outcomes during hospitalisation due to the presence of multiple comorbid conditions and reduced homoeostatic reserves. Acute geriatric units (AGUs) are units designed with their own physical location and structure, which provide care to older adults during the acute phase of illness and are underpinned by an interdisciplinary comprehensive geriatric assessment model of care. This review aims to update and synthesise the totality of evidence related to the effectiveness of AGU care on clinical and process outcomes among older adults admitted to hospital with acute medical complaints.DesignUpdated systematic review and meta-analysisMethods and analysisMEDLINE, Cumulative Index of Nursing and Allied Health Literature, Controlled Trials in the Cochrane Library and Embase electronic databases will be systematically searched from 2008 to February 2021. Trials with a randomised design that deliver an AGU intervention to older adults admitted to hospital for acute medical complaints will be included. The primary outcome measure will be functional decline at discharge from hospital and at follow-up. Secondary outcomes will include length of stay, cost of index admission, incidence of unscheduled hospital readmission, living at home (the inverse of death or institutionalisation combined; used to describe someone who is in their own home at follow‐up), mortality, cognitive function and patient satisfaction with index admission. Title and abstract screening of studies for full-text extraction will be conducted independently by two authors. The Cochrane risk of bias 2 tool will be used to assess the methodological quality of the included trials. The quality of evidence for outcomes reported will be assessed using the Grading of Recommendations Assessment, Development and Evaluations framework. A pooled meta-analysis will be conducted using Review Manager, depending on the uniformity of the data.Ethics and disseminationFormal ethical approval is not required as all data collected will be secondary data and will be analysed anonymously. The authors will present the findings of the review to a patient and public involvement stakeholder panel of older adults that has been established at the Ageing Research Centre in the University of Limerick. This will enable the views and opinions of older adults to be integrated into the discussion section of the paper.PROSPERO registration numberCRD42021237633.

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