scholarly journals Clinical Trials Evaluating Drug Therapy: Types, Reliability of Results, Place in Modern Evidence-Based Medicine

2021 ◽  
Vol 17 (2) ◽  
pp. 249-255
Author(s):  
S. Yu. Martsevich ◽  
N. P. Kutishenko ◽  
Yu. V. Lukina ◽  
M. M. Lukyanov ◽  
O. M. Drapkina

The article discusses the main methods of evidence in modern medicine. Special attention is paid to randomized controlled trials and observational studies. The advantages of randomized controlled trials over observational studies are considered. A comparison of the informative value of randomized controlled trials and observational studies in assessing the effect of therapeutic interventions is made. Attention is drawn to situations when conducting randomized controlled trials is not possible and when they become the main source of information. It is emphasized that in order to verify the results of randomized controlled trials in real clinical practice, it is necessary to conduct observational studies. The basic principles of conducting observational studies are considered.

Nephrology ◽  
2020 ◽  
Vol 25 (10) ◽  
pp. 737-743
Author(s):  
Jizzo R. Bosdriesz ◽  
Vianda S. Stel ◽  
Merel van Diepen ◽  
Yvette Meuleman ◽  
Friedo W. Dekker ◽  
...  

2021 ◽  
Vol 20 (2) ◽  
Author(s):  
S. Yu. Martsevich ◽  
N. P. Kutishenko ◽  
Yu. V. Lukina ◽  
M. M. Lukyanov ◽  
O. M. Drapkina

The article describes the basic rules for conducting observational studies, in particular, registers. The principles of the assessment of its quality and impact on the results are discussed. The potential for evaluating therapeutic effect and side effects in randomized controlled trials (RCTs) and observational studies is compared. Effects of one drug identified in RCTs and observational studies are compared.


2021 ◽  
Vol 37 (1) ◽  
Author(s):  
Sameh M. Zamzam ◽  
Mosaad Abdel-Aziz ◽  
Ahmed Atef ◽  
Usama Abdel-Naseer ◽  
Mostafa Hamoda ◽  
...  

Abstract Background Randomized controlled trials (RCTs) are prospective comparative studies in which study groups are allocated randomly to intervention or serve as controls. RCT is the mainstay to achieve evidence in the literature in clinical research. A RCT is the main research design to study the effect of an intervention and the only way to confirm the value of a new treatment. Main body RCT also gives the way to generate meta-analyses and systematic reviews giving a stronger evidence for clinical practice. Evidence-based medicine (EBM) is crucial for safe, effective, and standardized patient care. Although there is an agreement on the importance of performing RCT, it can be challenging to do it efficiently including different aspects like study design, funding, randomization, blinding, follow-up, data analysis, statistics, generalization of results, and reporting of quality of the studies. Conclusion In this article, we gave a comprehensive review for RCT in otolaryngology discussing their importance, advantages, and drawbacks, types, steps, challenges, reporting their quality and their prevalence in the literature.


2022 ◽  
Author(s):  
John P.A. Ioannidis

Importance. COVID-19 has resulted in massive production, publication and wide dissemination of clinical studies trying to identify effective treatments. However, several widely touted treatments failed to show effectiveness in large well-done randomized controlled trials (RCTs). Objective. To evaluate for COVID-19 treatments that showed no benefits in subsequent large RCTs how many of their most-cited clinical studies had declared favorable results for these interventions. Methods. Scopus (last update December 23, 2021) identified articles on lopinavir-ritonavir, hydroxycholoroquine/azithromycin, remdesivir, convalescent plasma, colchicine or interferon (index interventions) that represented clinical trials and that had received >150 citations. Their conclusions were assessed and correlated with study design features. The ten most recent citations for the most-cited article on each index intervention were examined on whether they were critical to the highly-cited study. Altmetric scores were also obtained. Findings. 40 articles of clinical studies on these index interventions had received >150 citations (7 exceeded 1,000 citations). 20/40 (50%) had favorable conclusions and 4 were equivocal. Highly-cited articles with favorable conclusions were rarely RCTs while those without favorable conclusions were mostly RCTs (3/20 vs 15/20, p=0.0003). Only 1 RCT with favorable conclusions had sample size >160. Citation counts correlated strongly with Altmetric scores, in particular news items. Only 9 (15%) of 60 recent citations to the most highly-cited studies with favorable or equivocal conclusions were critical to the highly-cited study. Conclusion. Many clinical studies with favorable conclusions for largely ineffective COVID-19 treatments are uncritically heavily cited and disseminated. Early observational studies and small randomized trials may cause spurious claims of effectiveness that get perpetuated.


2021 ◽  
Vol 12 ◽  
Author(s):  
Dana Abdelrahim ◽  
MoezAlIslam E. Faris ◽  
Mohamed Hassanein ◽  
Ayman Z. Shakir ◽  
Ayesha M. Yusuf ◽  
...  

Ramadan is the 9th month of the lunar calendar during which Muslims abstain from food and drink between dawn and sunset for 30 consecutive days. Ramadan fasting is observed by all healthy Muslim adults, as well many Muslims with type 2 diabetes (T2DM). Hypoglycemic events (HE) are a serious complication associated with diabetes management and are associated with increased cardiovascular disease risk. Conflicting results have been reported concerning the incidence of HE among people with T2DM observing Ramadan fasting. This review summarizes available scientific evidence on the occurrence of HE and the effects of different moderators on the incidence of HE among patients with T2DM during Ramadan. We conducted a systematic review of available observational studies and randomized controlled trials (RCTs) for patients with T2DM who fasted during Ramadan, with HE as the primary outcome. Ten databases were searched for relevant studies from inception until October 31, 2020. In total, 68 studies (35 RCTs and 33 observational studies) met the inclusion criteria. Non-sulfonylureas hypoglycemic medications showed superior effects in lowering the incidence of HE over sulfonylureas hypoglycemic medications. Variable moderators were associated with experiencing HE during Ramadan in both observational studies and RCTs, including sex, geographical location, body anthropometric indicators, season, dietary behaviors, fasting duration, time since diagnosis, and pre-fasting education. This comprehensive systematic review covered the largest number of observational and clinical studies investigating the impact of Ramadan on HE among patients with T2DM. The study highlights the significance of different moderators that influence the effect of Ramadan fasting on HE, including dietary behaviors, fasting time duration, sex, season, country, pre-fasting education, age, and time since diagnosis. The study also highlighted the impact of different hypoglycemic medications on HE and noted the superiority of non-sulfonylureas over sulfonylureas hypoglycemic medications in lowering the risk for hypoglycemia in people with T2DM during Ramadan fasting.


2021 ◽  
pp. 384-390
Author(s):  
Omolara A. Fatiregun ◽  
Temiloluwa Oluokun ◽  
Nwamaka N. Lasebikan ◽  
Emmanuella Nwachukwu ◽  
Abiola A. Ibraheem ◽  
...  

PURPOSE Breast cancer is the most common malignancy in women worldwide. In Nigeria, it accounts for 22.7% of all new cancer cases among women. Evidence-based medicine (EBM) entails using the results from healthcare research to enhance the clinical decision-making process and develop evidence-based treatment guidelines. Level 1 and 2 studies, such as randomized controlled trials, meta-analyses, and systematic reviews of randomized controlled trials, yield more robust types of evidence. This study reviewed the levels of evidence of breast cancer publications in Nigeria. METHODS We conducted an electronic literature search of all studies published on breast cancer in Nigeria from January 1961 to August 2019. We reviewed all the articles found under the search term “Breast Cancer in Nigeria” on medical databases. RESULTS Our search identified 2,242 publications. One thousand two hundred fifty duplicates were removed, and 520 were excluded. A total of 472 articles were considered eligible for this review. Most of these articles were case series or reports (30.7%), qualitative studies (15.7%), followed by cross-sectional studies (13.3%), laboratory studies (12.9%), case-control studies (6.1%), case reports (7%), and cohort (5.7%). CONCLUSION Breast cancer research in Nigeria is yet to produce much evidence of the types considered to best support EBM. The scarcity of data hampers the implementation of EBM in Nigeria. Currently, most treatment guidelines are adapted from those developed in other countries, despite genetic differences among populations and different environmental influencing factors.


2010 ◽  
Vol 88 ◽  
pp. S3-S9 ◽  
Author(s):  
Wenying Yang ◽  
Alexey Zilov ◽  
Pradana Soewondo ◽  
Ole Molskov Bech ◽  
Fawzia Sekkal ◽  
...  

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