scholarly journals Study design guidelines

2020 ◽  
Vol 10 (3) ◽  
pp. 353-368
Author(s):  
Andrey P. Sereda ◽  
Marina A. Andrianova

Complying with certain requirements or, more precisely, following the guidelines for the design of a scientific publication helps to make it not only more comprehensible for reviewers and readers, but actually enhances the quality of work. For example, even if some aspects in design logic were fulfilled but not described, other researchers doing meta-analysis may wrongly but for a good reason downgrade such publication and exclude it from the analysis. understanding of the guidelines for study design ensures not only the proper description of the results but the initial planning of work. The CARE guidelines were established for reporting of clinical cases, STROBE for reporting observational studies (cohort and case-control studies), CONSORT for reporting randomized studies (these guidelines are often used also for other comparative and case series studies), STARD for reporting diagnostic studies, and PRISMa for reporting of systematic reviews and meta-analyses. The present paper describes the key aspects of those guidelines and provides templates for graphic display of study design in form of flow charts. evidently, we should not forget that each study is unique and there is always a place for a reasonable compromise between requirements and the real logic of the research in place. The article is the reprint published with the permission of the copyright holder. Original article: Sereda AP, Andrianova MA. Study Design Guidelines. Traumatology and Orthopedics of Russia. 2019;25(3):165-184. doi: 10.21823/2311-2905-2019-25-3-165-184

2019 ◽  
Vol 25 (3) ◽  
pp. 165-184 ◽  
Author(s):  
A. P. Sereda ◽  
M. A. Andrianova

Complying with certain requirements or, more precisely, following the guidelines for the design of a scientific publication helps to make it not only more comprehensible for reviewers and readers, but actually enhances the quality of work. For example, even if some aspects in design logic were fulfilled but not described, other researchers doing meta-analysis may wrongly but for a good reason downgrade such publication and exclude it from the analysis. Understanding of the guidelines for study design ensures not only the proper description of the results but the initial planning of work. The CA RE guidelines were established for reporting of clinical cases, STROBE — for reporting observational studies (cohort and case-control studies), CO NSORT — for reporting randomized studies (these guidelines are often used also for other comparative and case series studies), STARD — for reporting diagnostic studies, and PRISMA — for reporting of systematic reviews and meta-analyses. The present paper describes the key aspects of those guidelines and provides templates for graphic display of study design in form of flow charts. Evidently, we should not forget that each study is unique and there is always a place for a reasonable compromise between “requirements” and the real logic of the research in place.


2008 ◽  
Vol 11 (10) ◽  
pp. 1006-1014 ◽  
Author(s):  
RL Thompson ◽  
EV Bandera ◽  
VJ Burley ◽  
JE Cade ◽  
D Forman ◽  
...  

AbstractObjectiveDespite the increasing dependence on systematic reviews to summarise the literature and to issue public health recommendations, the formal assessment of the reliability of conclusions emerging from systematic reviews has received little attention. The main goal of the present study was to evaluate whether two independent centres, in two continents, draw similar conclusions regarding the association of food, nutrition and physical activity and endometrial cancer, when provided with the same general instructions and with similar resources.DesignThe assessment of reproducibility concentrated on four main areas: (1) paper search and selection; (2) assignment of study design; (3) inclusion of ‘key’ papers; and (4) individual studies selected for meta-analysis and the summary risk estimate obtained.ResultsIn total 310 relevant papers were identified, 166 (54 %) were included by both centres. Of the remaining 144 papers, 72 (50 %) were retrieved in the searches of one centre and not the other (54 in centre A, 18 in centre B) and 72 were retrieved in both searches but regarded as relevant by only one of the centres (52 in centre A, 20 in centre B). Of papers included by both centres, 80 % were allocated the same study design. Agreement for inclusion of cohort-type and case–control studies was about 63 % compared with 50 % or less for ecological and case series studies. The agreement for inclusion of 138 ‘key’ papers was 87 %. Summary risk estimates from meta-analyses were similar.ConclusionsTransparency of process and explicit detailed procedures are necessary parts of a systematic review and crucial for the reader to interpret its findings.


2020 ◽  
pp. 977-1096
Author(s):  
Edward H. Livingston

The Study Design and Statistics chapter of the 11th edition of the AMA Manual of Style begins with a description of the parts of a scientific manuscript and the role of each part: Abstract, Introduction, Methods, Results, and Discussion. The features unique to different study types are outlined: randomized clinical trials, parallel-design double-blind trials, crossover trials, equivalence and noninferiority trials, cluster trials, observational studies, cohort studies, case-control studies, case series, comparative effectiveness research, meta-analyses, cost-effectiveness/cost-benefit analyses, quality improvement studies, and survey studies. Because correct treatment depends on accurate diagnosis, attention is given to various types of diagnostic tests. A large glossary of statistical terms indicates the appropriate applications of commonly used statistical techniques, providing definitions, presentation, and tips and guidelines for correct usage. Many new terms have been added to this glossary since the previous edition.


2019 ◽  
Vol 12 (3) ◽  
pp. 400-407 ◽  
Author(s):  
Karolinny Borinelli de Aquino Moura ◽  
Paula Marques Prates Behrens ◽  
Rafaela Pirolli ◽  
Aimee Sauer ◽  
Dayana Melamed ◽  
...  

Abstract Background The aim of this study was to report the prevalence and mortality associated with anticoagulant-related nephropathy (ARN) through a systematic review of the literature. Methods Electronic searches were conducted in the Medline and EMBASE databases, and manual searches were performed in the reference lists of the identified studies. The studies were selected by two independent researchers, first by evaluating the titles and abstracts and then by reading the complete texts of the identified studies. Case series, cross-sectional studies, cohort studies and case–control studies reporting the prevalence and factors associated with ARN were selected. The methodological quality was assessed using the Newcastle–Ottawa scale. Meta-analyses of the prevalence of ARN and 5-year mortality using the random effects model were performed when possible. Heterogeneity was assessed using the I2 statistic. Results Five studies were included. Prevalence of ARN ranged from 19% to 63% among the four included cohort studies. Meta-analysis of these resulted in high heterogeneity [I2 96%, summary effect 31%; 95% confidence interval (CI) 22–42%]. Subgroup meta-analysis yielded an ARN prevalence of 20% among studies that included patients with fewer comorbidities (I2 12%; 95% CI 19–22%). In a direct comparison, meta-analysis of the 5-year mortality rate between anticoagulated patients who had experienced ARN and anticoagulated patients without ARN, patients with ARN were 91% more likely to die (risk ratio = 1.91; 95% CI 1.22–3; I2 87%). Risk factors for ARN that were reported in the literature included initial excessive anticoagulation, chronic kidney disease, age, diabetes, hypertension, cardiovascular disease and heart failure. Conclusions ARN studies are scarce and heterogeneous, and present significant methodological limitations. The high prevalence of ARN reported herein suggests that this entity is underdiagnosed in clinical practice. Mortality in patients with ARN seems to be high compared with patients without this condition in observational studies.


Dose-Response ◽  
2020 ◽  
Vol 18 (1) ◽  
pp. 155932582090235
Author(s):  
Shih-Wei Lai ◽  
Cheng-Chan Yu ◽  
Cheng-Li Lin ◽  
Kuan-Fu Liao

Background/Objective: Some case series and case report have shown the association between the risk of acute pancreatitis and use of selective serotonin reuptake inhibitors. The results of systematic studies were not consistent. Methods: A meta-analysis was performed to investigate the risk of acute pancreatitis associated with use of selective serotonin reuptake inhibitors. Results: There was no statistical association between the risk of acute pancreatitis and selective serotonin reuptake inhibitors use (odds ratio: 1.19, 95% confidence interval: 0.93-1.51). Conclusions: Despite reaching no statistical significance, the possibility of the association between the risk of acute pancreatitis and selective serotonin reuptake inhibitors use cannot be totally excluded.


2018 ◽  
Vol 64 (10) ◽  
pp. 942-951 ◽  
Author(s):  
Mohammad Zare ◽  
Jamal Jafari-Nedooshan ◽  
Mohammadali Jafari ◽  
Hossein Neamatzadeh ◽  
Seyed Mojtaba Abolbaghaei ◽  
...  

SUMMARY OBJECTIVE: There has been increasing interest in the study of the association between human mutL homolog 1 (hMLH1) gene polymorphisms and risk of colorectal cancer (CRC). However, results from previous studies are inconclusive. Thus, a meta-analysis was conducted to derive a more precise estimation of the effects of this gene. METHODS: A comprehensive search was conducted in the PubMed, EMBASE, Chinese Biomedical Literature databases until January 1, 2018. Odds ratio (OR) with 95% confidence interval (CI) was used to assess the strength of the association. RESULTS: Finally, 38 case-control studies in 32 publications were identified met our inclusion criteria. There were 14 studies with 20668 cases and 19533 controls on hMLH1 −93G>A, 11 studies with 5,786 cases and 8,867 controls on 655A>G and 5 studies with 1409 cases and 1637 controls on 1151T>A polymorphism. The combined results showed that 655A>G and 1151T>A polymorphisms were significantly associated with CRC risk, whereas −93G>A polymorphism was not significantly associated with CRC risk. As for ethnicity, −93G>A and 655A>G polymorphisms were associated with increased risk of CRC among Asians, but not among Caucasians. More interestingly, subgroup analysis indicated that 655A>G might raise CRC risk in PCR-RFLP and HB subgroups. CONCLUSION: Inconsistent with previous meta-analyses, this meta-analysis shows that the hMLH1 655A>G and 1151T>A polymorphisms might be risk factors for CRC. Moreover, the −93G>A polymorphism is associated with the susceptibility of CRC in Asian population.


Author(s):  
C Dandurand ◽  
AA Sepehry ◽  
MH Asadi Lari ◽  
R Akagami ◽  
PA Gooderham

Background: The optimal therapeutic approach for adult craniopharyngioma remains controversial. Some advocate for gross total resection (GTR), while others support subtotal resection followed by adjuvant radiotherapy (STR + XRT). Methods: MEDLINE (1946 to July 1st 2016) and EMBASE (1980 to June 30th 2016) were systematically reviewed. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline was followed. At our institution, from 1975 to 2013, 33 patients were treated with initial surgical resection for adult onset craniopharyngioma. 22 patients were included in the present case series. Results: Eligible studies (n=21) were identified from the literature in addition to a case series of our institutional experience. Three groups were available for analysis: GTR, STR + XRT, and STR. The rates of recurrence were 17 %, 27 % and 45%, respectively. This differs from childhood population. The difference in risk of recurrence after GTR vs. STR + XRT did not reach significance (OR: 0.63, 95% confidence interval: 0.33-1.24, P=0.18). This maybe because of low pooled sample size (n=99) who underwent STR+XRT. Conclusions: This is the first and largest meta-analysis examining rate of recurrence in adult craniopharyngioma. Thus, when safe and feasible, a goal of gross total resection should be favored. Each patient should be considered on a case-by-case basis.


2021 ◽  
pp. 219256822110668
Author(s):  
Kenney K. L. Lau ◽  
Karlen K. P. Law ◽  
Kenny Y. H. Kwan ◽  
Jason P. Y. Cheung ◽  
Kenneth M. C. Cheung ◽  
...  

Study Design Systematic review and meta-analysis Objectives The present review aimed to summarize the evidence regarding differences in proprioception between children with and without adolescent idiopathic scoliosis (AIS). Methods Seven electronic databases were searched from their inception to April 10, 2021. Articles were included if they involved: (1) AIS patients aged between 10 and 18 years, (2) measurements of proprioceptive abilities, and (3) comparisons with non-AIS controls. Animal studies, case reports, commentaries, conference proceedings, research protocols, and reviews were excluded. Two reviewers independently conducted literature screening, data extraction, risks of bias assessments, and quality of evidence evaluations. Relevant information was pooled for meta-analyses. Results From 432 identified citations, 11 case-control studies comprising 1121 participants were included. The meta-analyses showed that AIS participants displayed proprioceptive deficits as compared to non-AIS controls. Moderate evidence supported that AIS participants showed significantly larger repositioning errors than healthy controls (pooled mean difference = 1.27 degrees, P < .01). Low evidence substantiated that AIS participants had significantly greater motion detection threshold (pooled mean difference = 1.60 degrees, P < .01) and abnormal somatosensory evoked potentials (pooled mean difference = .36 milliseconds, P = .01) than non-AIS counterparts. Conclusions Consistent findings revealed that proprioceptive deficits occurred in AIS patients. Further investigations on the causal relationship between AIS and proprioception, and the identification of the subgroup of AIS patients with proprioceptive deficit are needed.


2020 ◽  
Vol 50 (5) ◽  
pp. 574-580
Author(s):  
Munehisa Kito ◽  
Akira Ogose ◽  
Masahiro Yoshida ◽  
Yoshihiro Nishida

Abstract Objective The purpose of this systematic review is to assess and compare the efficacy of surgical treatment for patients with asymptomatic extra-peritoneal desmoid-type fibromatosis to the wait-and-see policy by evaluating (1) the exacerbation rate (exacerbation; recurrence after surgery or progressive disease following non-surgical treatment) and (2) treatment-associated complications in extra-peritoneal desmoid-type fibromatosis. Methods We evaluated documents published between 1 January 1990 and 31 August 2017. The risk of bias in the selected literature was analyzed using the Cochrane Collaboration Risk of Bias Tool. Quality of evidence was evaluated using Grading of Recommendation, Assessment, Development and Evaluation approach. Results One prospective cohort study, four case–control studies and five case series studies were identified. Meta-analysis was performed to evaluate the exacerbation rate after treatment on one prospective cohort study and four case–control studies. In comparing surgical and non-surgical treatments, the exacerbation rate was significantly higher in the surgical treatment group (odds ratio: 1.32, 95% confidence interval 1.01–1.73, P = 0.05). However, in the case series study, the recurrence rate was 23.4% for the surgical treatment group, while the progressive disease rate was 28.1% for the non-surgical treatment group. The postoperative complication rates associated with surgical treatment in the two studies were 20.8 and 17.2%, respectively. Conclusions When considering the exacerbation rate, non-surgical treatment might be appropriate for asymptomatic patients with extra-peritoneal desmoid-type fibromatosis. However, if patients with tumor-related symptoms opt for surgery, including those who face difficulties due to the presence of tumors, it is important to fully explain to them the possibility that the recurrence rate and treatment-associated functional failures may increase depending on the site of occurrence.


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Tomoya Ohno ◽  
Dagfinn Aune ◽  
Alicia K. Heath

Abstract Several studies have investigated associations between overweight/obesity and risk of developing rheumatoid arthritis, however, the evidence is not entirely consistent, and previous meta-analyses mainly included case–control studies, which can be affected by various biases. We therefore conducted a systematic review and meta-analysis of cohort studies on adiposity and risk of rheumatoid arthritis. Relevant studies were identified by searching PubMed and Embase databases. Random effects models were used to estimate summary relative risks (RRs) and 95% confidence intervals (CIs) for rheumatoid arthritis in relation to different measures of adiposity. Thirteen cohort studies (10 publications) were included. The summary RR per 5 kg/m2 increase in body mass index (BMI) was 1.11 (95% CI 1.05–1.18, I2 = 50%), but the association was restricted to women (1.15, 95% CI 1.08–1.21, I2 = 17%) and not observed in men (0.89, 95% CI 0.73–1.09, I2 = 58%). The summary RR per 5 kg/m2 increment in BMI at age 18 years was 1.17 (95% CI 1.01–1.36, I2 = 26%, n = 3), and per 10 cm increase in waist circumference was 1.13 (95% CI 1.02–1.25, I2 = 44%, n = 2). Higher BMI in middle age, BMI at age 18 years, and waist circumference were associated with increased rheumatoid arthritis risk, suggesting adiposity could be targeted for primary prevention.


Sign in / Sign up

Export Citation Format

Share Document