Assessment of presentation quality of the results of clinical trials in accordance with the standards of CONSORT

Randomized clinical trials (RCTs) are currently recognized as the gold standard for evaluating the efficacy and safety of medical interventions. However, often the presentation of the results of RCTs in reports and articles does not give a complete and reliable description of all the results of the test, which often leads to incorrect conclusions and guidelines. In order to comply with certain uniform requirements for reporting documents based on materials of the conducted RCT, a group of authors and editors of medical journals in the early 1990s came out with a proposal to the medical community about using common standards for presenting RCT results, which they called CONSORT (CONsolidated Standards Of Reporting). The first version of CONSORT, however, caused a lot of criticism from both authors and editors of journals. The accumulated critical comments were taken into account by the developers of the revised and published in 2010 version of CONSORT, which is currently accepted as a reference for presenting the results of RCT in the world's leading medical journals. CONSORT 2010 contains a statement, supplemented with a set of questions on the conducted RCT, requiring a clearly formalized answer, and a flowchart for visual presentation of the results. In addition, the CONSORT developers submitted a separate document to clarify the terms in order to clarify the cases of application of this methodology. It is important to understand that CONSORT does not include recommendations for developing, conducting and analyzing the trials. It contains only reports on what and how it was done, what was eventually established, and only indirectly affects the design and conduct of RCT. However, authors who are familiar with the requirements of CONSORT will strive to meet these requirements when planning and conducting RCTs. As an example, the article presents a case of assessing the quality of the presentation of one of the RCTs according to CONSORT 2010 standards.

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Quality of life measurements in major depression

European Psychiatry ◽

10.1016/0924-9338(96)85176-5 ◽

1996 ◽

Vol 11 (3) ◽

pp. 123-126 ◽

Cited By ~ 6

Author(s):

P Bech

Keyword(s):

Quality Of Life ◽

Clinical Trials ◽

Major Depression ◽

External Validity ◽

Randomized Clinical Trials ◽

Internal Validity ◽

Efficacy And Safety ◽

Quality Of Life Measurements

SummaryIn randomized clinical trials in patients with major depression quality of life is considered as an important dimension of treatment outcome in relation to clinical efficacy and safety. The internal validity, reliability, as well as external validity of quality of life scales have been analysed. It is concluded that such scales have their most appropriate applicability in medicine and long-term trials with antidepressants.

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Anti-hypertensive drugs deprescribing: an updated systematic review of clinical trials

BMC Family Practice ◽

10.1186/s12875-021-01557-y ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Salvatore Crisafulli ◽

Nicoletta Luxi ◽

Raffaele Coppini ◽

Annalisa Capuano ◽

Cristina Scavone ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Randomized Clinical Trials ◽

Experimental Studies ◽

Risk Of Bias ◽

Cochrane Library ◽

Efficacy And Safety ◽

Systematic Assessment ◽

Grade Approach

Abstract Background Polypharmacy is defined as the prescription of at least 5 different medicines for therapeutic or prophylactic effect and is a serious issue among elderly patients, who are frequently affected by multi-morbidity. Deprescribing is one of the proposed approaches to reduce the number of administered drugs, by eliminating those that are inappropriately prescribed. The aim of this systematic review is to provide an updated and systematic assessment of the benefit-risk profile of deprescribing of anti-hypertensive drugs, which are among the most commonly used drugs. Methods MEDLINE, EMBASE and The Cochrane Library were searched for studies assessing the efficacy and safety of anti-hypertensive drugs deprescribing in the period between January, 12,016 and December, 312,019. The quality of randomized clinical trials (RCTs) was assessed using the GRADE approach for the evaluation of the main outcomes. The risk of bias assessment was carried out using the Cochrane risk-of-bias tool. Results Overall, two RCTs were identified. Despite summarized evidence was in favor of anti-hypertensive deprescribing, the overall risk of bias was rated as high for each RCT included. According to the GRADE approach, the overall quality of the RCTs included was moderate regarding the following outcomes: systolic blood pressure < 150 mmHg after 12 weeks of follow-up, quality of life, frailty and cardiovascular risk. Conclusions This updated systematic review of the efficacy and safety of anti-hypertensive treatment deprescribing found two recently published RCTs, in addition to the previous guideline of the National Institute for Health and Care Excellence (NICE). Evidence points towards non-inferiority of anti-hypertensive deprescribing as compared to treatment continuation, despite the quality of published studies is not high. High quality experimental studies are urgently needed to further assess the effect of deprescribing for this drug class in specific categories of patients.

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Meta-analysis of randomized clinical trials of Riamilovir eﬃcacy in etiotropic therapy of inﬂuenza

Antibiotics and Chemotherapy ◽

10.37489/0235-2990-2021-66-5-6-58-71 ◽

2021 ◽

Vol 66 (5-6) ◽

pp. 58-71

Author(s):

A. U. Sabitov ◽

O. P. Kovtun ◽

N. A. Batskalevich ◽

N. I. Lvov ◽

K. V. Zhdanov ◽

...

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Clinical Symptoms ◽

Meta Analysis ◽

Initial Therapy ◽

Adult Patients ◽

Quality Of Information ◽

Medical Interventions ◽

Late Stages

The aim of the study was to carry out a meta-analysis of randomized clinical trials in order to combine the results of clinical trials on Triazavirin® (Riamilovir) eﬃcacy in etiotropic therapy of inﬂuenza.Materials and methods. The analysis was carried out in accordance with the PRISMA principles regarding the quality of information presentation on the results of systematic reviews and meta-analyzes of works assessing medical interventions. The study included 471 patients with a conﬁrmed diagnosis of inﬂuenza (with laboratory conﬁrmed presence of inﬂuenza virus antigens).Results. The conducted meta-analysis showed that the use of Triazavirin® (Riamilovir) has a statistically signiﬁcant eﬀect on the severity of clinical symptoms in patients with inﬂuenza, therefore Riamilovir can be used in the initial therapy of adult patients with inﬂuenza.Conclusion. Clinical studies have shown that the use of Triazavirin® (Riamilovir) is eﬀective both in the initial and late stages of the disease, and therefore Riamilovir can be used in the treatment of adult patients with respiratory diseases of viral etiology, in particular, those diagnosed with inﬂuenza. The meta-analysis of the collected data showed that therapy with Triazavirin® (Riamilovir) has statistically signiﬁcant advantages in various aspects both in comparison with the placebo group and with the Tamiﬂu® (Oseltamivir) group.

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Faculty Opinions recommendation of Efficacy and safety of topical clascoterone cream, 1%, for treatment in patients with facial acne: two phase 3 randomized clinical trials.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.737803133.793575042 ◽

2020 ◽

Author(s):

Joel Gelfand ◽

John Barbieri

Keyword(s):

Clinical Trials ◽

Randomized Clinical Trials ◽

Efficacy And Safety ◽

Phase 3 ◽

Two Phase ◽

Facial Acne

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Efficacy and Safety of Intravenous rtPA in Ischemic Strokes Due to Small-Vessel Occlusion: Systematic Review and Meta-Analysis

Translational Stroke Research ◽

10.1007/s12975-021-00890-9 ◽

2021 ◽

Author(s):

Bartosz Karaszewski ◽

Adam Wyszomirski ◽

Bartosz Jabłoński ◽

David J. Werring ◽

Dominika Tomaka

Keyword(s):

Clinical Trials ◽

Ischemic Stroke ◽

Randomized Clinical Trials ◽

Small Vessel Disease ◽

Small Vessel ◽

Efficacy And Safety ◽

Eligibility Criteria ◽

Vessel Occlusion ◽

Excellent Outcome ◽

Symptomatic Intracerebral Hemorrhage

AbstractIntravenous recombinant tissue plasminogen activator (iv-rtPA) has been routinely used to treat ischemic stroke for 25 years, following large clinical trials. However, there are few prospective studies on the efficacy and safety of this therapy in strokes attributed to cerebral small vessel disease (SVD). We evaluated functional outcome (modified Rankin scale, mRS) and symptomatic intracerebral hemorrhage (sICH) using all available data on the effects of iv-rtPA in SVD-related ischemic stroke (defined either using neuroimaging, clinical features, or both). Using fixed-effect and random-effects models, we calculated the pooled effect estimates with regard to excellent and favorable outcomes (mRS=0–1 and 0–2 respectively, at 3 months), and the rate of sICH. Twenty-three studies fulfilled the eligibility criteria, 11 of which were comparative, and there were only 3 randomized clinical trials. In adjusted analyses, there was an increased odds of excellent outcome (adjusted OR=1.53, 95% CI: 1.29–1.82, I2: 0%) or favorable outcome (adjusted OR=1.68, 95% CI: 1.31–2.15,I2: 0%) in patients who received iv-rtPA compared with placebo. Across the six studies which reported it, the incidence of sICH was higher in the treatment group (M-H RR = 8.83, 95% CI: 2.76–28.27). The pooled rate of sICH in patients with SVD administered iv-rtPA was only 0.72% (95% CI: 0.12%–1.64%). We conclude that when ischemic stroke attributed to SVD is considered separately, available data on the effects of iv-rtPA therapy are insufficient for the highest level of recommendation, but it seems to be safe. Although further therapeutic trials in SVD-related ischemic stroke appear to be justified, our findings should not prevent its continued use for this group of patients in clinical practice.

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