So Much Data, So Little Knowledge: Using Formal Logic to Aggregate Data and Interpret Information

2018 ◽  
pp. e2-e5
Author(s):  
J. Russell Hoverman
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Retrospective Studies ◽  
Formal Logic ◽  
Competing Values ◽  
Professional Societies ◽  
Large Databases ◽  
Patient Values ◽  
Meta Analyses ◽  
Historical Controls

Formal logic is the use of symbols to structure how we make inferences such that the structure can be applied beyond specific cases. The structure of clinical trials and the values equation (value = outcomes/cost) lend themselves to evaluation using formal logic. Doing this demonstrates the unique position of randomized clinical trials as a defensible format for gathering information and identifies the shortcomings of historical controls and meta-analyses and retrospective studies using large databases. A practical example using literature on maintenance therapy in metastatic colorectal cancer is assessed. It is important to emphasize that value will be relative to a viewpoint, with many interested parties having competing values. This underscores the place of physicians and professional societies as putting patient values first.

scholarly journals Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for nonsystematic adverse events

2019 ◽  
Author(s):  
Evan Mayo-Wilson ◽  
Nicole Fusco ◽  
Hwanhee Hong ◽  
Tianjing Li ◽  
Joseph K. Canner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Selection Criteria ◽  
Randomized Clinical Trials ◽  
Bipolar Depression ◽  
Selective Reporting ◽  
Journal Articles ◽  
Multiple Sources ◽  
Study Results ◽  
Meta Analyses

Abstract Background: Adverse events (AEs) in randomized clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials, or across sources for a single trial, may produce inconsistent and confusing information about the adverse events associated with interventions Methods: We sought to compare the methods authors use to decide which AEs to include in a particular source (i.e., “selection criteria”) and to determine how selection criteria could impact the AEs reported. We compared sources (e.g., journal articles, clinical study reports [CSRs]) of trials for two drug-indications: gabapentin for neuropathic pain and quetiapine for bipolar depression. We identified selection criteria and assessed how criteria affected AE reporting. Results: We identified 21 gabapentin trials and 7 quetiapine trials. All CSRs (6 gabapentin, 2 quetiapine) reported all AEs without applying selection criteria; by comparison, no other source reported all AEs, and 15/68 (22%) gabapentin sources and 19/48 (40%) quetiapine sources reported using selection criteria. Selection criteria greatly affected the number of AEs that would be reported. For example, 67/316 (21%) AEs in one quetiapine trial met the criterion “occurring in ≥2% of participants in any treatment group,” while only 5/316 (2%) AEs met the criterion, “occurring in ≥10% of quetiapine-treated patients and twice as frequent in the quetiapine group as the placebo group.” Conclusions: Selection criteria for reporting AEs vary across trials and across sources for individual trials. If investigators do not pre-specify selection criteria, they might “cherry-pick” AEs based on study results. Even if investigators pre-specify selection criteria, selective reporting of AEs will produce biased meta-analyses and clinical practice guidelines. Data about all AEs identified in clinical trials should be publicly available; however, sharing data will not solve all the problems we identified in this study. Keywords: Harms, adverse events, clinical trials, reporting bias, selective outcome reporting, data sharing, trial registration

scholarly journals Application of Bee Products for Dermatological Problems

2020 ◽  
Vol 7 (1) ◽  
Author(s):  
Heidrun Männle ◽  
Karsten Münstedt
Keyword(s):  
Clinical Trials ◽  
Atopic Dermatitis ◽  
Randomized Clinical Trials ◽  
Case Control ◽  
Health Claims ◽  
Wound Infections ◽  
Herpes Viruses ◽  
Case Control Studies ◽  
Meta Analyses ◽  
Cutaneous Warts

Context: Bee products are frequently suggested as possible treatments for dermatological problems by protagonists of apitherapy, which is a discipline within the field of complementary and alternative medicine. Unfortunately, apitherapists do not support their health claims. This review was to identify potential uses of bee products in the field of dermatology. Evidence Acquisition: Randomized and non-randomized clinical trials, case-control studies, systematic reviews, and meta-analyses on the topics were identified using various search engines. Results: Evidence suggests that bee products may be a reasonable treatment option for wound infections, burns, radiodermatitis, infections with herpes viruses, atopic dermatitis, rosacea, scars, cutaneous warts, acne, psoriasis, facial wrinkles, and intertrigo. Conclusions: There are several applications for bee products in the field of dermatology, for instance treatment of wound infections with honey and herpes infections with propolis.

scholarly journals Vaccines to prevent COVID-19: a protocol for a living systematic review with network meta-analysis including individual patient data (The LIVING VACCINE Project)

2020 ◽  
Vol 9 (1) ◽  
Author(s):  
Steven Kwasi Korang ◽  
Sophie Juul ◽  
Emil Eik Nielsen ◽  
Joshua Feinberg ◽  
Faiza Siddiqui ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Individual Patient Data ◽  
Viral Vector ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Serious Adverse Events ◽  
Meta Analyses ◽  
Harmful Effects

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19) which has rapidly spread worldwide. Several human randomized clinical trials assessing potential vaccines are currently underway. There is an urgent need for a living systematic review that continuously assesses the beneficial and harmful effects of all available vaccines for COVID-19. Methods/design We will conduct a living systematic review based on searches of major medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from their inception onwards to identify relevant randomized clinical trials. We will update the literature search once a week to continuously assess if new evidence is available. Two review authors will independently extract data and conduct risk of bias assessments. We will include randomized clinical trials comparing any vaccine aiming to prevent COVID-19 (including but not limited to messenger RNA; DNA; non-replicating viral vector; replicating viral vector; inactivated virus; protein subunit; dendritic cell; other vaccines) with any comparator (placebo; “active placebo;” no intervention; standard care; an “active” intervention; another vaccine for COVID-19) for participants in all age groups. Primary outcomes will be all-cause mortality; a diagnosis of COVID-19; and serious adverse events. Secondary outcomes will be quality of life and non-serious adverse events. The living systematic review will include aggregate data meta-analyses, trial sequential analyses, network meta-analyses, and individual patient data meta-analyses. Within-study bias will be assessed using Cochrane risk of bias tool. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) and Confidence in Network Meta-Analysis (CINeMA) approaches will be used to assess certainty of evidence. Observational studies describing harms identified during the search for trials will also be included and described and analyzed separately. Discussion COVID-19 has become a pandemic with substantial mortality. A living systematic review assessing the beneficial and harmful effects of different vaccines is urgently needed. This living systematic review will regularly inform best practice in vaccine prevention and clinical research of this highly prevalent disease. Systematic review registration PROSPERO CRD42020196492

scholarly journals Fibromyalgia and Shoulder Surgery: A Systematic Review and a Critical Appraisal of the Literature

2019 ◽  
Vol 8 (10) ◽  
pp. 1518 ◽  
Author(s):  
Riccardo Compagnoni ◽  
Roberta Gualtierotti ◽  
Francesco Luceri ◽  
Fabio Sciancalepore ◽  
Pietro Simone Randelli
Keyword(s):  
Randomized Clinical Trials ◽  
Retrospective Studies ◽  
Case Series ◽  
Chronic Widespread Pain ◽  
Shoulder Surgery ◽  
Postoperative Outcomes ◽  
Open Label ◽  
Opioid Prescription ◽  
Meta Analyses ◽  
The Impact

Fibromyalgia is a common musculoskeletal syndrome characterized by chronic widespread pain and other systemic manifestations, which has demonstrated a contribution to higher postoperative analgesic consumption to other surgeries such as hysterectomies and knee and hip replacements. The aim of this review is to search current literature for studies considering the impact of fibromyalgia on clinical outcomes of patients undergoing shoulder surgery. A systematic literature review was conducted in PubMed/Medline, Embase, and ClinicalTrials.gov in February 2019. Studies were selected based on the following participants, interventions, comparisons, outcomes, and study design criteria: adult patients undergoing surgery for shoulder pain (P); diagnosis of fibromyalgia (I); patients without fibromyalgia (C); outcome of surgery in terms of pain or analgesic or non-steroidal anti-inflammatory drugs consumption (O); case series, retrospective studies, observational studies, open-label studies, randomized clinical trials, systematic reviews and meta-analyses were included (S). Authors found 678 articles, of which four were found eligible. One retrospective study showed that patients with fibromyalgia had worse clinical postoperative outcomes; two retrospective studies reported a higher opioid prescription in patients with fibromyalgia and one prospective observational study found that a higher fibromyalgia survey score correlated with lower quality of recovery scores two days after surgery. The scarce and low-quality evidence available does not allow confirming that fibromyalgia has an impact on postoperative outcomes in shoulder surgery. Future studies specifically focusing on shoulder surgery outcomes may help improvement and personalization of the management of patients with fibromyalgia syndrome (PROSPERO 2019, CRD42019121180).

scholarly journals An overview of treatment options for COVID-19

2020 ◽  
Vol 9 (11) ◽  
pp. 1770
Author(s):  
Madhusmita Mohanty Mohapatra ◽  
Manju Rajaram ◽  
Dharm Prakash Dwivedi ◽  
Vishnukant Govindraj ◽  
Pratap Upadhya
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Treatment Options ◽  
Unknown Origin ◽  
The Novel ◽  
Clinical Trial Registry ◽  
Repurposed Drugs ◽  
Novel Coronavirus ◽  
Meta Analyses ◽  
Effective Drugs

Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2) which emerged in Wuhan initially as pneumonia of unknown origin in December 2019, later spread to whole world and became pandemic on 11th March, 2020. Many drugs have been proposed but are backed without clinical evidence. Scientific bodies are in the row to discover a reliable vaccine and effective drugs against the novel coronavirus. Many antiviral and anti-parasitic drugs which were thought to have some effect on Coronavirus disease 2019 (COVID-19) have been tried during the crisis but none have shown concrete evidence of action. Randomized clinical trials on the repurposed drugs are now registered under clinical trial registry to look at the safety profile and efficacy of the drugs to be used against SARS-CoV-2. Many meta-analyses are being conducted worldwide to frame evidence for the fight against this novel coronavirus. We are providing below a review of various drugs that have been tried for treatment of COVID-19 as well as different clinical trials which are underway.

scholarly journals Review of properties and mechanisms of action of hepatoprotective drugs

2020 ◽  
pp. 36-44
Author(s):  
Е.В. Кардаш ◽  
Е.М. Григорьева ◽  
А.Г. Емельянова ◽  
С.А. Тарасов
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Side Effects ◽  
Randomized Clinical Trials ◽  
Evidence Base ◽  
Mechanisms Of Action ◽  
New Drugs ◽  
Simultaneous Administration ◽  
Essential Phospholipids ◽  
Meta Analyses

В медицинской практике достаточно часто возникает необходимость в одновременном приеме нескольких лекарственных средств. Иногда это оказывается невозможным в силу наличия у препаратов гепатотоксических свойств, поэтому актуальными задачами фармакологии являются как поиск и разработка новых препаратов, так и оптимизация уже существующих с целью уменьшения побочных эффектов при их приеме. В настоящем обзоре были проанализированы данные о фармакологических препаратах класса гепатопротекторов, разобраны механизмы их действия и потенциал поиска новых препаратов. В заключение отмечено, что в настоящее время в клинической практике наибольшей популярностью пользуются препараты, содержащие эссенциальные фосфолипиды и препараты, улучшающие рециркуляцию и выведение желчных кислот. Существуют теоретические обоснования механизмов действия этих препаратов и перспектива накопления доказательной базы для них в виде рандомизированных клинических исследований и мета-анализов. Medical practice quite often requires simultaneous administration of several drugs. Sometimes it is impossible due to their hepatotoxicity; therefore, urgent tasks of pharmacology include searching for and developing new drugs as well as optimizing already existing products in order to reduce side effects during their administration. This review focused on pharmacological drugs of the hepatoprotector class and their mechanisms of action and evaluated the prospects of searching for new medicines. In conclusion, drugs containing essential phospholipids and those improving recirculation and removal of bile acids are currently the most popular agents in clinical practice. Mechanisms of action of these drugs are theoretically justified and there is a prospect for building an evidence base for them by randomized clinical trials and meta-analyses.

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