Study Designs in Epidemiology and Levels of Evidence

2010 ◽  
Vol 149 (3) ◽  
pp. 367-370 ◽  
Author(s):  
Jie Jin Wang ◽  
John Attia
Keyword(s):  
Levels Of Evidence ◽  
Study Designs

Analysis of the Quality of Prospective Randomized Controlled Trials for Treatment of Boxer’s Fractures

Hand ◽  
2021 ◽  
pp. 155894472110243
Author(s):  
Cole M. Patrick ◽  
Isaac Fernandez ◽  
Gilberto A. Gonzalez ◽  
Leon J. Nesti ◽  
John C. Dunn
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Levels Of Evidence ◽  
Randomized Controlled ◽  
Boxer’S Fracture ◽  
Neck Fracture ◽  
Level I ◽  
Study Designs ◽  
Coleman Methodology Score

Background This study aimed to review level I and II therapeutic studies on boxer’s fractures to measure variation in quality among the highest level study designs. Methods We used quantitative measures of study quality to evaluate prospective randomized controlled trials (RCTs) of treatments of boxer’s fractures. A search of PubMed, using terms “boxer’s fracture” and “fifth metacarpal neck fracture” identified 164 articles from 1961 to 2019. From this list, we identified 6 RCTs. Two observers classified each trial according to 3 systems: the Oxford Levels of Evidence, the modified Coleman Methodology Score, and the revised Consolidated Standards of Reporting Trials (CONSORT) score. Results The 2 reviewers were consistent in their use of the Oxford Levels of Evidence (100% agreement). The differences between the average modified Coleman Methodology scores and the average CONSORT scores assigned by the 2 observers were not significant (46.2 vs 45.3 points, κ = 0) and (13.7 vs 14.3 points, κ = 0.33), respectively. Both observers rated all the studies as level I and as unsatisfactory according to the Coleman Methodology Score (100% and 100%), and less than half as unsatisfactory according to the CONSORT score (50% and 17%). Areas of deficiency included randomization, blinding, group comparability, clinical effect measurements, and allocation into treatment arms. Conclusion Classifying orthopedic scientific reports according to the levels of evidence implies a degree of respect for level I and II studies that may not always be merited. Our data suggest that the quality of higher level studies, namely those involving boxer’s fractures, varies and may often be unsatisfactory when critically evaluated.

Clinical trials: A key tool in improving breast cancer survival in Nigeria.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18198-e18198
Author(s):  
Omolara A. Fatiregun ◽  
Olufunmilayo I. Olopade ◽  
Abiodun Popoola
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Clinical Trials ◽  
Cancer Treatment ◽  
Cancer Patients ◽  
Breast Cancer Treatment ◽  
Breast Cancer Patients ◽  
Levels Of Evidence ◽  
Level 1 ◽  
Study Designs

e18198 Background: Clinical trials has continued to sharpen the treatment guidelines in managing breast cancer in the United States. The trends in breast cancer management in developed countries and the shifts in treatment paradigms have impacted on breast cancer diagnosis from an incurable entity in the early 1900s’ to the situation today where most women are diagnosed in early stage and cured while advanced staged women are living with the disease for several years. Clinical research in breast cancer is in its infancy stage in Nigeria. There is an urgent need for more clinical trials in Nigeria geared towards developing treatment algorithms in a bid to increase survival in Breast cancer patients. Methods: A systematic review of all research published on breast cancer since 1963 till 2017 in Nigeria .We reviewed all articles found on PubMed and Google scholar search engines by searching “ Breast cancer in Nigeria”. Using the PRISMA and NIH guidelines, we reviewed classified them based on their study designs into different levels of evidence. Information extracted from studies include, year of publications, study designs and level of evidence. Studies selected were group into seven levels of evidence .Meta-analysis was not considered in the review due to vary study designs and difficulty n pooling then together. Results: Out of 430 published articles cited relating to Breast cancer, only 282 articles where eligible for the systematic review. 56.4%(159) of studies done on breast were cross sectional studies, followed by case – control studies 11.7% (33), then case reports & series 10.4%(29) ,2.8%(8) , only 1.1% (3)of studies cited were clinical trials registered on Clinical Trials.gov on breast cancer treatment. On Levels of Evidence, Level 6 accounted for 54.9 %( 155) followed by Level 7, 18.1 %( 51), level 1, 2, 3 were 0%, 1.1%, 8.9%.Conclusions: A vast majority of research done on Breast Cancer done in the Country are still at the Levels 4, 6 and 7 of Evidence. Clinical trials in Breast cancer treatment are rare in Nigeria, they however provide Level 1, 2 or 3 evidence which helps to develop treatment protocols for Breast cancer Treatment in Nigeria. , it is pertinent to develop more clinical trials so as to improve quality of care and life in breast cancer patients.

Effect of pomegranate fruit supplementation on performance and various markers in athletes and active subjects: a systematic review

2019 ◽  
pp. 1-15
Author(s):  
Alicja Urbaniak ◽  
Anna Skarpańska-Stejnborn
Keyword(s):  
Vessel Diameter ◽  
Whole Body ◽  
Double Blind Study ◽  
Double Blind ◽  
Physically Active ◽  
Highly Active ◽  
Body Strength ◽  
Rate Of Increase ◽  
Study Designs ◽  
Pomegranate Fruit

Abstract. The aim of the study was to review recent findings on the use of POM supplements in athletes of various disciplines and physically active participants. Eleven articles published between 2010 and 2018 were included, where the total number of investigated subjects was 176. Male participants constituted the majority of the group (n = 155), as compared to females (n = 21). 45% of research described was conducted on athletes, whereas the remaining studies were based on highly active participants. Randomised, crossover, double-blind study designs constituted the majority of the experimental designs used. POM supplementation varied in terms of form (pills/juice), dosage (50 ml–500 ml) and time of intervention (7 days–2 months) between studies. Among the reviewed articles, POM supplementation had an effect on the improvement of the following: whole body strength; feeling of vitality; acute and delayed muscle fatigue and soreness; increase in vessel diameter; blood flow and serum level of TAC; reduction in the rate of increase for HR, SBP, CK and LDH; support in the recovery of post-training CK, LDH, CRP and ASAT to their baseline levels; reduction of MMP2, MMP9, hsCRP and MDA; and increased activity of antioxidant enzymes (glutathione peroxidase and superoxide dismutase). In the majority of reviewed articles POM supplementation had a positive effect on a variety of parameters studied and the authors recommended it as a supplement for athletes and physically active bodies.

Patientenbezogene Komplexität in der Pflege – Kollektive Case Studies im Akutspital

Pflege ◽  
2018 ◽  
Vol 31 (5) ◽  
pp. 237-244 ◽  
Author(s):  
Caroline Gurtner ◽  
Rebecca Spirig ◽  
Diana Staudacher ◽  
Evelyn Huber
Keyword(s):  
Case Studies ◽  
Study Designs

Zusammenfassung. Hintergrund: Die patientenbezogene Komplexität der Pflege ist durch die Merkmale „Instabilität“, „Unsicherheit“ und „Variabilität“ definiert. Aufgrund der reduzierten Aufenthaltsdauer und der steigenden Zahl chronisch und mehrfach erkrankter Personen erhöht sich die Komplexität der Pflege. Ziel: In dieser Studie untersuchten wir das Phänomen patientenbezogener Komplexität aus Sicht von Pflegefachpersonen und Pflegeexpertinnen im Akutspital. Methode: Im Rahmen eines kollektiven Case-Study-Designs schätzten Pflegefachpersonen und Pflegeexpertinnen die Komplexität von Pflegesituationen mit einem Fragebogen ein. Danach befragten wir sie in Einzelinterviews zu ihrer Einschätzung. Mittels Within-Case-Analyse verdichteten wir die Daten induktiv zu Fallgeschichten. In der Cross-Case-Analyse verglichen wir die Fallgeschichten hinsichtlich deduktiv abgeleiteter Merkmale. Ergebnisse: Die Ausprägung der Komplexität hing in den vier Cases im Wesentlichen davon ab, ob klinische Probleme kontrollierbar und prognostizierbar waren. Je nach individuellen Ressourcen der Patientinnen und Patienten stieg bzw. sank die Komplexität. Schlussfolgerungen: Komplexe Patientensituationen fordern von Pflegefachpersonen Fachwissen, Erfahrung, kommunikative Kompetenzen sowie die Fähigkeit zur Reflexion. Berufsanfänger und Berufsanfängerinnen werden zur Entwicklung dieser Fähigkeiten idealerweise durch erfahrene Berufskolleginnen oder -kollegen unterstützt und beraten.

Innovative study designs and methods for optimizing and implementing behavioral interventions to improve health.

2018 ◽  
Vol 37 (12) ◽  
pp. 1081-1091 ◽  
Author(s):  
Sylvie Naar ◽  
Susan M. Czajkowski ◽  
Bonnie Spring
Keyword(s):  
Behavioral Interventions ◽  
Study Designs ◽  
Improve Health

A historical cohort of temporal lobe surgery for medically refractory epilepsy: a systematic review and meta-analysis to guide future nonrandomized controlled trial studies

2020 ◽  
Vol 133 (1) ◽  
pp. 71-78 ◽  
Author(s):  
Anthony T. Lee ◽  
John F. Burke ◽  
Pranathi Chunduru ◽  
Annette M. Molinaro ◽  
Robert Knowlton ◽  
...  
Keyword(s):  
Systematic Review ◽  
Temporal Lobe ◽  
Epilepsy Surgery ◽  
Refractory Epilepsy ◽  
Meta Analysis ◽  
Small Sample ◽  
Seizure Freedom ◽  
Level I ◽  
Study Designs ◽  
Medically Refractory Epilepsy

OBJECTIVERecent trials for temporal lobe epilepsy (TLE) highlight the challenges of investigating surgical outcomes using randomized controlled trials (RCTs). Although several reviews have examined seizure-freedom outcomes from existing data, there is a need for an overall seizure-freedom rate estimated from level I data as investigators consider other methods besides RCTs to study outcomes related to new surgical interventions.METHODSThe authors performed a systematic review and meta-analysis of the 3 RCTs of TLE in adults and report an overall surgical seizure-freedom rate (Engel class I) composed of level I data. An overall seizure-freedom rate was also collected from level II data (prospective cohort studies) for validation. Eligible studies were identified by filtering a published Cochrane meta-analysis of epilepsy surgery for RCTs and prospective studies, and supplemented by searching indexed terms in MEDLINE (January 1, 2012–April 1, 2018). Retrospective studies were excluded to minimize heterogeneity in patient selection and reporting bias. Data extraction was independently reverified and pooled using a fixed-effects model. The primary outcome was overall seizure freedom following surgery. The historical benchmark was applied in a noninferiority study design to compare its power to a single-study cohort.RESULTSThe overall rate of seizure freedom from level I data was 72.4% (55/76 patients, 3 RCTs), which was nearly identical to the overall seizure-freedom rate of 71.7% (1325/1849 patients, 18 studies) from prospective cohorts (z = 0.134, p = 0.89; z-test). Seizure-freedom rates from level I and II studies were consistent over the years of publication (R2< 0.01, p = 0.73). Surgery resulted in markedly improved seizure-free outcomes compared to medical management (RR 10.82, 95% CI 3.93–29.84, p < 0.01; 2 RCTs). Noninferiority study designs in which the historical benchmark was used had significantly higher power at all difference margins compared to using a single cohort alone (p < 0.001, Bonferroni’s multiple comparison test).CONCLUSIONSThe overall rate of seizure freedom for temporal lobe surgery is approximately 70% for medically refractory epilepsy. The small sample size of the RCT cohort underscores the need to move beyond standard RCTs for epilepsy surgery. This historical seizure-freedom rate may serve as a useful benchmark to guide future study designs for new surgical treatments for refractory TLE.

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