scholarly journals Quality of Adherence to the ARRIVE Guidelines in the Material and Methods Section in Studies Where Swine Were Used as Surgical Biomodels: A Systematic Review (2013–2018)

Animals ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. 947
Author(s):  
Jilma Alemán-Laporte ◽  
Gilbert Alvarado ◽  
Mariana SA Garcia-Gomes ◽  
Ana Tada Fonseca Brasil Antiorio ◽  
Marco Zúñiga-Montero ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sample Size ◽  
Animal Welfare ◽  
Sample Size Calculation ◽  
Surgical Techniques ◽  
Experimental Methods ◽  
Basic Information ◽  
Quality Reporting ◽  
Excellent Tool

Over the last two decades, pigs have become animal biomodels widely used for the investigation and practice of surgical techniques because of their great physiological and anatomical similarities to humans. Even though many of these studies must be carried out later in humans, the description of basic information is limited, making exact repetitions of the reported experimental methods impossible. In this review, 108 studies from 2013 to 2018 were considered to determine the quality of adherence to the ARRIVE guidelines in the reports of the methodologies. The majority of the studies lacked the details recommended in the ARRIVE guidelines regarding data directly related to the welfare of animals undergoing surgery and those about anesthetic protocols and analgesics. Information related to sample size calculation and housing and husbandry conditions was also very limited. We believe that the ARRIVE guidelines are an excellent tool for good-quality reporting. We encourage scientists to consistently use them as a tool to improve the quality of their scientific reports and, consequently, ensure animal welfare.

scholarly journals QUALITY OF SAMPLE SIZE ESTIMATION IN TRIALS OF MEDICAL DEVICES: HIGH-RISK DEVICES FOR NEUROLOGICAL CONDITIONS AS EXAMPLE

2017 ◽  
Vol 33 (1) ◽  
pp. 103-110 ◽  
Author(s):  
Britta Olberg ◽  
Matthias Perleth ◽  
Katja Felgentraeger ◽  
Sandra Schulz ◽  
Reinhard Busse
Keyword(s):  
Systematic Review ◽  
High Risk ◽  
Sample Size ◽  
Medical Devices ◽  
Sample Size Calculation ◽  
Data Availability ◽  
Principal Investigators ◽  
Research Protocols ◽  
Neurological Conditions

Background: The aim of this study was to assess the quality of reporting sample size calculation and underlying design assumptions in pivotal trials of high-risk medical devices (MDs) for neurological conditions.Methods: Systematic review of research protocols for publicly registered randomized controlled trials (RCTs). In the absence of a published protocol, principal investigators were contacted for additional data. To be included, trials had to investigate a high-risk MD, registered between 2005 and 2015, with indications stroke, headache disorders, and epilepsy as case samples within central nervous system diseases. Extraction of key methodological parameters for sample size calculation was performed independently and peer-reviewed.Results: In a final sample of seventy-one eligible trials, we collected data from thirty-one trials. Eighteen protocols were obtained from the public domain or principal investigators. Data availability decreased during the extraction process, with almost all data available for stroke-related trials. Of the thirty-one trials with sample size information available, twenty-six reported a predefined calculation and underlying assumptions. Justification was given in twenty and evidence for parameter estimation in sixteen trials. Estimates were most often based on previous research, including RCTs and observational data. Observational data were predominantly represented by retrospective designs. Other references for parameter estimation indicated a lower level of evidence.Conclusions: Our systematic review of trials on high-risk MDs confirms previous research, which has documented deficiencies regarding data availability and a lack of reporting on sample size calculation. More effort is needed to ensure both relevant sources, that is, original research protocols, to be publicly available and reporting requirements to be standardized.

2 Adiposity and Development of Dementia: A Systematic Review of Recently Published Longitudinal Studies

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i1-i6
Author(s):  
Y Xiang
Keyword(s):  
Systematic Review ◽  
Cohort Studies ◽  
Sample Size ◽  
Longitudinal Studies ◽  
Meta Analysis ◽  
Sample Size Calculation ◽  
Current Evidence ◽  
Reverse Causality ◽  
Socioeconomic Burden

Abstract Background and Objectives The socioeconomic burden of dementia is very high and on the rise. Currently there is no cure for dementia; therefore, it is key to identify the modifiable risk factors for this condition. The association between adiposity and dementia is not yet convincingly established. This systematic review aimed to critically appraise the quality and to synthesise the findings of recently published longitudinal studies examining the association between adiposity and the development of dementia. Methods A comprehensive literature search on longitudinal studies published between 2013 and 2018 was conducted across MEDLINE, EMBASE, PsycINFO and SCOPUS. The quality of selected papers was assessed using the Newcastle-Ottawa Quality Assessment Scale for cohort studies (NOS) and PRISMA-IPD checklist. The results of the included studies were qualitatively synthesised. Results Of the 1,370 citations identified and reviewed, 10 completely met the inclusion criteria. Of the 10 included studies, 9 were high quality cohort studies, scoring an average of 8.4 out of 9 for NOS. One study was an individual patient data meta-analysis study (IPD). The IPD had high scientific rigour and largely adhered to the PRISMA-IPD checklist. In total, the 9 cohort studies included more than 2 million subjects, with 3 cohorts recruiting exclusively men. The IPD contained data from 39 cohorts and 1.3 million participants. 4 studies were conducted in highly selective cohorts. Apart from European male populations, the other populations were markedly under-represented. All studies used body mass index (BMI) as a proxy for adiposity. None of the included studies did a sample size calculation. Only half of the included studies were able to produce significant results, suggesting insufficient sample size and lack of power. The included studies reached contradictory results, with half of the studies favouring a protective effect of adiposity. Conclusions In view of the results and quality of the studies, this review found that there was insufficient evidence to establish the association between adiposity and dementia. Current evidence suggests an association between mid-life obesity and dementia development in late-life. Longer studies were more likely to conclude that adiposity was detrimental to health. The inconsistent conclusions could be the result of reverse causality. To conclusively establish the link between adiposity and dementia, more research with robust methodology is warranted.

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.

Quality of Patient-Reported Outcome Studies Utilizing the BREAST-Q: A Systematic Review

2021 ◽  
Author(s):  
Lior Har-Shai ◽  
Sar-El Ofek ◽  
Addy Brandstetter ◽  
Keren H Cohen ◽  
Tamir Shay ◽  
...  
Keyword(s):  
Systematic Review ◽  
Plastic Surgery ◽  
Survey Research ◽  
Breast Surgery ◽  
Sample Size Calculation ◽  
Patient Reported Outcome ◽  
Validated Questionnaire ◽  
Patient Reported ◽  
Current Guidance

Abstract Background Patient-reported outcome (PRO) studies are essential the assessment of surgical procedures in plastic surgery. An accepted and validated questionnaire is the Breast-Q. Objectives This study aims to assess the quality of PRO studies in plastic surgery utilizing the Breast-Q questionnaire. Methods This study included two steps: (1) A systematic review of 23 key-criteria assessing the quality of survey-research in studies utilizing the Breast-Q which were published between 2015-2018; (2) Review of current guidance for survey-research in journals related to Plastic Surgery and Breast Surgery which were included in the systematic review. Results 79 studies were included in the systematic review. Many key-criteria were poorly reported: 51.9% of the studies did not provide a defined response rate and almost 90% did not provide a method for analysis of non-response error. 67.1% lacked a description of the sample's representativeness of the population of interest, and 82.3% did not present a sample size calculation. 11.4% of papers failed to describe the data analyzing methods; in 27.8% the data analysis which was presented could not allow replication of the results. Of the 16 journals in Plastic Surgery and Breast Surgery that their "Instruction to Authors" were reviewed, 15 (93.7%) did not provide any guidance for survey reporting. Conclusions The majority of key criteria are under-reported by authors publishing their survey-research in peer-reviewed journals in the fields of plastic and breast surgery. There is an urgent need for constructing a well-developed reporting guideline for survey-research in plastic surgery and particularly in breast surgery.

scholarly journals Somatic Acupoint Stimulation for Cancer-Related Sleep Disturbance: A Systematic Review of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-12
Author(s):  
Xian-Liang Liu ◽  
Hui Lin Cheng ◽  
Simon Moss ◽  
Carol Chunfeng Wang ◽  
Catherine Turner ◽  
...  
Keyword(s):  
Systematic Review ◽  
Sleep Disturbance ◽  
Sample Size ◽  
Methodological Quality ◽  
Outcome Measurement ◽  
Small Sample ◽  
Large Sample Size ◽  
Intervention Protocol ◽  
Acupoint Stimulation

Aim. The aim of this systematic review was to analyze and synthesize available evidence for the effects of somatic acupoint stimulation (SAS) on cancer-related sleep disturbance in adults with cancer. Methods. Nine databases and four clinical trial registries were searched from their inception to July 2019 to identify potential articles and registered trials. Two authors independently extracted data and appraised the methodological quality of the included studies. The included studies could not be subjected to meta-analysis due to the significant variations in SAS intervention protocols and outcome measurement instruments. This systematic review therefore reported the results of the included trials narratively. Results. Seven studies were identified, which involved 906 cancer patients. SAS protocols varied across trials without an optimal evidence-based standard intervention protocol to manage cancer-related sleep disturbance. Sanyinjiao (SP6) was the most commonly selected acupoint. Manual acupuncture was typically 15–30 min in duration and was conducted once a day or once a week for a period of 1–5 weeks, whereas self-administered acupressure was typically 1–3 min in duration per point and was conducted once a day, such as during night time before going to bed, for a period of 1–5 months. The results indicated that SAS could potentially relieve cancer-related sleep disturbance and improve quality of life. Mild adverse effects were reported in three of the included studies, but none of them performed a causality analysis to clarify the association between the reported adverse events and the intervention. Conclusions. This systematic review showed that SAS is a useful approach to relieving cancer-related sleep disturbance. However, research evidence on SAS for managing cancer-related sleep disturbance has not been fully conclusive due to the limited number of existing clinical studies with relatively small sample size and suboptimal methodological quality. Clinical trials with large sample size and robust methodology are warranted in future research.

scholarly journals Validation of a scale assessing the impact of periodontal diseases on patients' quality of life in Bulgaria (pilot research)

2012 ◽  
Vol 23 (5) ◽  
pp. 570-574 ◽  
Author(s):  
Nina Musurlieva ◽  
Maria Stoykova ◽  
Doychin Boyadjiev
Keyword(s):  
Quality Of Life ◽  
Sample Size ◽  
Periodontal Diseases ◽  
Sample Size Calculation ◽  
Discrimination Power ◽  
Related Quality ◽  
Health Related ◽  
Initial Interviews ◽  
The Impact

The aim of the paper is to present the validation of a scale for assessing the impact of periodontal diseases on individuals' quality of life in Bulgaria. A pilot research was made among 30 diagnosed patients with periodontitis visiting the Department of Periodontology, Faculty of Dental Medicine, Medical University of Plovdiv, Bulgaria. The minimum sample size of 30 people was established based on a power analysis for sample size calculation. The mean age of participants was 48.95 ± 11.85 years, being 56.67 ± 9.05 years for males and 43.33 ± 9.05 years for females. Standard interviews were conducted using a specific instrument: self-designed questionnaire and a 5-degree ranked scale, containing initially 11 questions. The interviews were repeated after 3 months with the same patients for retest analysis. The data was statistically processed using SPSS v.13 software. Results received after the initial interviews: Cronbach's coefficient (α=0.882), Spearman-Brown coefficient (r sb=0.998), average inter-item correlation coefficient (R=0.426), difficulty of the questions from 0.173 to 0.757 and discrimination power from 0.405 to 0.809. Results after the second interviews: α=0.883, r sb=0.998, R=0.507, difficulty from 0.287 to 0.757 and discrimination power from 0.524 to 0.809. In two of the questions, a low level of inter-item correlation with the rest of the items was found and they were excluded. The final version of the questionnaire contained 9 questions. The validation proved that the developed scale is sufficiently reliable and will be used in the final research, the first one to use such an instrument for measuring oral health-related quality of life in Bulgaria.

Quality of Split-Mouth Trials in Dentistry: 1998, 2008, and 2018

2020 ◽  
Vol 99 (13) ◽  
pp. 1453-1460
Author(s):  
D. Qin ◽  
F. Hua ◽  
H. He ◽  
S. Liang ◽  
H. Worthington ◽  
...  
Keyword(s):  
Sample Size ◽  
Methodological Quality ◽  
Linear Models ◽  
Sample Size Calculation ◽  
Reporting Quality ◽  
Treatment Groups ◽  
Item Checklist ◽  
The Mean ◽  
Over Time

The objectives of this study were to assess the reporting quality and methodological quality of split-mouth trials (SMTs) published during the past 2 decades and to determine whether there has been an improvement in their quality over time. We searched the MEDLINE database via PubMed to identify SMTs published in 1998, 2008, and 2018. For each included SMT, we used the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 guideline, CONSORT for within-person trial (WPT) extension, and a new 3-item checklist to assess its trial reporting quality (TRQ), WPT-specific reporting quality (WRQ), and SMT-specific methodological quality (SMQ), respectively. Multivariable generalized linear models were performed to analyze the quality of SMTs over time, adjusting for potential confounding factors. A total of 119 SMTs were included. The mean overall score for the TRQ (score range, 0 to 32), WRQ (0 to 15), and SMQ (0 to 3) was 15.77 (SD 4.51), 6.06 (2.06), and 1.12 (0.70), respectively. The primary outcome was clearly defined in only 28 SMTs (23.5%), and only 27 (22.7%) presented a replicable sample size calculation. Only 45 SMTs (37.8%) provided the rationale for using a split-mouth design. The correlation between body sites was reported in only 5 studies (4.2%) for sample size calculation and 4 studies (3.4%) for statistical results. Only 2 studies (1.7%) performed an appropriate sample size calculation, and 46 (38.7%) chose appropriate statistical methods, both accounting for the correlation among treatment groups and the clustering/multiplicity of measurements within an individual. Results of regression analyses suggested that the TRQ of SMTs improved significantly with time ( P < 0.001), while there was no evidence of improvement in WRQ or SMQ. Both the reporting quality and methodological quality of SMTs still have much room for improvement. Concerted efforts are needed to improve the execution and reporting of SMTs.

scholarly journals Randomized controlled trials and neurosurgery: the ideal fit or should alternative methodologies be considered?

2016 ◽  
Vol 124 (2) ◽  
pp. 558-568 ◽  
Author(s):  
Alireza Mansouri ◽  
Benjamin Cooper ◽  
Samuel M. Shin ◽  
Douglas Kondziolka
Keyword(s):  
Randomized Controlled Trials ◽  
Sample Size ◽  
English Language ◽  
Sample Size Calculation ◽  
Median Number ◽  
Controlled Trials ◽  
Quality Of Reporting ◽  
Randomized Controlled ◽  
Mesh Terms

OBJECT Randomized-controlled trials (RCTs) are advocated to provide high-level medical evidence. However, in neurosurgery, there are barriers to conducting RCTs. The authors of this study sought to analyze the quality of neurosurgical RCTs since 2000 to determine the adequacy of their design and reporting. METHODS A search of the MEDLINE and EMBASE databases (2000–2014) was conducted. The medical subject heading (MeSH) terms used in the search included: “neurosurgery” OR “neurosurgical procedure,” “brain neoplasms,” “infarction” and “decompression,” “carotid stenosis,” “cerebral hemorrhage,” and “spinal fusion.” These studies were limited to RCTs, in humans, and in the English language. The Consolidated Standards for Reporting of Trials (CONSORT) and Jadad scales were used to assess the quality of RCT design and reporting. The standardized median times cited (median citations divided by years since publication) were used to assess impact. A pragmatic-explanatory continuum indicator summary-based scale was used to assess the design of the studies as primarily pragmatic or explanatory. RESULTS Sixty-one articles were identified, and the following subspecialties were the most common: vascular (23, 37%), followed by functional neurosurgery and neurooncology (both 13, 21%). The following nations were the primary leaders in RCTs: US (25 studies, 41%), Germany (8 studies, 13%), and the United Kingdom (7 studies, 11%). Median sample size was 100 (interquartile range [IQR] 41.5–279). The majority of the studies (40, 66%) had pragmatic objectives. The median number of times cited overall was 69 (IQR 20.5–193). The combined median CONSORT score was 36 (IQR 27.5–39). Blinding was most deficiently reported. Other areas with a relatively low quality of reporting were sample size calculation (34.2% of surgical, 38.5% of drug, and 20% of device studies), allocation concealment (28.9% of surgical, 23.1% of drug, and 50% of device studies), and protocol implementation (18.4% of surgical, 23% of drug, and 20% of device studies). The quality of reporting did not correlate with the study impact. All studies had a median Jadad score ≤ 3. Thirty-three pragmatic studies (83%) and 5 explanatory studies (25%) met the design objectives. All pragmatic studies based on drug and device trials met their objectives, while 74% of pragmatic surgical trials met their objectives. CONCLUSIONS The prevalence of neurosurgical RCTs is low. The quality of RCT design and reporting in neurosurgery is also low. Many study designs are not compatible with stated objectives. Pragmatic studies were more likely to meet design objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting.

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