scholarly journals Do protocols for new randomised trials take previous similar trials into account? Cohort study of contemporary trial protocols

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e026661
Author(s):  
Asger Sand Paludan-Müller ◽  
Michelle C Ogden ◽  
Mikkel Marquardsen ◽  
Jonas Vive ◽  
Karsten Juhl Jørgensen ◽  
...  

ObjectiveTo investigate to what extent evidence from previous similar trials or systematic reviews was considered before conducting new trials.DesignCohort study of contemporary protocols for trials with ethical approval.MethodsAll protocols for randomised trials approved by the five ethical committees in Denmark between January 2012 and March 2013 were screened for eligibility. Included protocols were read in full to determine whether a systematic search had been conducted and references were checked to evaluate whether trial rationale and design could be challenged for not adequately considering previous evidence. To investigate whether protocols cited relevant trials, we used simple search strategies that could easily be conducted by researchers without experience with literature searches.ResultsSixty-seven protocols were included. Only two (3%) of the protocols explicitly stated to have conducted a literature search and only one (1%) provided information that allowed the search to be replicated. Eleven (16%) of the protocols described trials where we found the information insufficient to judge if the trial was ethically justified, either due to a comparator that was not supported by the presented evidence (six protocols), because they did not present a rationale for conducting the trial (two protocols), or for both reasons (three protocols). For eight (12%) of the protocols, our search identified trials that could have been relevant to cite as justification.ConclusionsWhile most protocols seem to adequately consider existing evidence, a substantial minority of trials might lack a sufficient evidence base. Very few trials seemed to have been based on a literature search which makes it impossible to know whether all relevant previous trials had been considered. Rules for ethical approval should include requirements for systematic literature searches to ensure that research participants are not exposed to sub-optimal treatments or unnecessary harms as well as to reduce research waste.

BMJ ◽  
2011 ◽  
Vol 342 (apr05 2) ◽  
pp. d1828-d1828 ◽  
Author(s):  
A. Blumle ◽  
J. J. Meerpohl ◽  
G. Rucker ◽  
G. Antes ◽  
M. Schumacher ◽  
...  

Author(s):  
Carmen Ricós ◽  
Pilar Fernández-Calle ◽  
Elisabet Gonzalez-Lao ◽  
Margarida Simón ◽  
Jorge Díaz-Garzón ◽  
...  

AbstractObjectivesNumerous biological variation (BV) studies have been performed over the years, but the quality of these studies vary. The objectives of this study were to perform a systematic review and critical appraisal of BV studies on glycosylated albumin and to deliver updated BV estimates for glucose and HbA1c, including recently published high-quality studies such as the European Biological Variation study (EuBIVAS).MethodsSystematic literature searches were performed to identify BV studies. Nine publications not included in a previous review were identified; four for glycosylated albumin, three for glucose, and three for HbA1c. Relevant studies were appraised by the Biological Variation Data Critical Appraisal Checklist (BIVAC). Global BV estimates were derived by meta-analysis of BIVAC-compliant studies in healthy subjects with similar study design.ResultsOne study received BIVAC grade A, 2B, and 6C. In most cases, the C-grade was associated with deficiencies in statistical analysis. BV estimates for glycosylated albumin were: CVI=1.4% (1.2–2.1) and CVG=5.7% (4.7–10.6), whereas estimates for HbA1c, CVI=1.2% (0.3–2.5), CVG=5.4% (3.3–7.3), and glucose, CVI=5.0% (4.1–12.0), CVG=8.1% (2.7–10.8) did not differ from previously published global estimates.ConclusionsThe critical appraisal and rating of BV studies according to their methodological quality, followed by a meta-analysis, generate robust, and reliable BV estimates. This study delivers updated and evidence-based BV estimates for glycosylated albumin, glucose and HbA1c.


2021 ◽  
Vol 9-10 (219-220) ◽  
pp. 44-51
Author(s):  
Abay Zhangabylov ◽  
◽  
Bakytzhan Bimbetov ◽  
Nurlan Jainakbayev ◽  
Каramyat Zordinova ◽  
...  

Phospholipids (PL) – lipids that are not involved in accumulation of fatty deposits play a significant role and serve various functions. Firstly, as a component of cell membranes of all cells in the organism. In clinical practice, for the past decades, phospholipids were primarily used as hepaprotective substances, going by the name of “essential phospholipids (EPL)”. Becoming a popular, demanded, well-promoted remedy for the treatment of liver diseases. However, despite the many years of approbation, the existing and sufficientclinicalexperience, discussions regarding their benefits, effectiveness, safety and reliability are still underway and have brought up diametrically opposed views. From complete rejection of EPL as medicinal means, to full recognition of the advertised properties of EPL drugs based on the given manufacturer’s descriptions. For this reason, to clarify the issuing situation, we have conducted a literature search on the object of investigation. Purpose of the study. Search and critical analysis of modern literature sources on the topic of work using the principles of evidence-based medicine. Material and Methods. A critical online review of the literature sources chosen for the research has been carried out in the Web of Science Thompson Reuters, Springer Link and Pubmed databases, as well as in research works and online articles 10 years deep. Inclusion criteria: research papers with a high index of evidence base. Exclusion criteria: literature sources with no evidence, low quality works. Results and Discussion. The articleoutlines the natural role of proteins, lipids and the function of the cytolemma of intracellularorganoids in the restoration of damaged membranes of hepatocytes - de novo. Substantiating the obvious uselessness of using essential phospholipids in the treatment of liver diseases in general, fatty hepatosis in particular. The inability of penetration into liver cells for phospholipids in their native form and their alignment in thehepacyte membrane is indicated, since they belong to different biological species and have a mutually closed genetic system. In the literature search undertaken by us on this issue, the analytical and critical review of scientific literature have also shown that when ingested, essential phospholipids have low bioavailability, as the phospholipids in the chylomicrons do not directly enter the liver, but first the lymphatic system through which they are transported to the adipose tissue of the organism, where they are accumulated and metabolized. With parenteral administration, EPL spreading through the bloodstream can accumulate in other organs, systems, without reaching the liver tissue. For example, the largest amounts of EPL are usually found in the cell membranes of the nervous tissue and the brain. Conclusion. Essential phospholipids in the form of soy lecithin products cannot replace the endogenous phospholipids of the human body - in principle. Keywords: essentialphospholipids, liver cell membranes, hepaprotectors.


2015 ◽  
Vol 10 (1) ◽  
pp. 95
Author(s):  
Elizabeth Margaret Stovold

A Review of: Perrier, L., Farrell, A., Ayala, A. P., Lightfoot, D., Kenny, T., Aaronson, E., . . . Weiss, A. ( 2014). Effects of librarian-provided services in healthcare settings: A systematic review. Journal of the American Medical Informatics Association, 21(6), 1118-1124. http://dx.doi.org/10.1136/amiajnl-2014-002825 Abstract Objective – To assess the effects of librarian-provided services, in any healthcare setting, on outcomes important to patients, healthcare providers, and researchers. Design – Systematic review and narrative synthesis. Setting – MEDLINE, CINAHL, ERIC, LISA, and CENTRAL databases; library-related websites, conference proceedings, and reference lists of included studies. Subjects – Twenty-five studies identified through a systematic literature search. Methods – In consultation with the review team, a librarian designed a search to be run in MEDLINE that was peer-reviewed against a published checklist. The team then conducted searches in the five identified databases, adapting the search as appropriate for each database. Authors also checked the websites of library and evidence based healthcare organisations, along with abstracts of relevant conference proceedings, to supplement the electronic search. Two authors screened the literature search results for eligible studies, and reached agreement by consensus. Studies of any librarian-delivered service in a healthcare setting, directed at either patients, clinicians of any type, researchers, or students, along with studies reporting outcomes relevant to clinicians, patients, or researchers, were eligible for inclusion. The authors assessed results initially on the titles and abstracts, and then on the full-text of potentially relevant reports. The data from included studies were then extracted into a piloted data extraction form, and each study was assessed for quality using the Cochrane EPOC risk of bias tool or the Newcastle-Ottawa scale. The results were synthesised narratively. Main Results – The searches retrieved a total of 25 studies that met the inclusion criteria, comprised of 22 primary papers and 3 companion reports. Authors identified 12 randomised trials, 4 controlled before-and-after studies, 3 cohorts, 2 non-randomised trials, and 1 case-control study. They identified three main categories of intervention: librarians teaching search skills; providing literature searching as a service; and a combination of the teaching and provision of search services. The interventions were delivered to a mix of trainees, clinicians, and students. None of the studies examined services delivered directly to patients or to researchers. The quality assessment found most of the studies had a mid- to high-risk of bias due to factors such as lack of random sequence generation, a lack of validated tools for data collection, or a lack of statistical analysis included in the study. Two studies measured patient relevant outcomes and reported that searches provided by librarians to clinicians had a positive impact on the patient’s length of stay in hospital. Five studies examined the effect of librarian provided services on outcomes important to clinicians, such as whether a literature search influenced a clinical decision. There was a trend towards a positive effect, although two studies found no significant difference. The majority of studies investigated the impact of training delivered to trainees and students on their literature search skills. Twelve of these studies found a positive effect of training on the recipients’ search skills, while three found no difference. The secondary outcomes considered by this review were satisfaction with the service (8 studies), relevance of the answers provided by librarians (2), and cost (3). The majority reported good satisfaction, and relevance. A cost benefit was found in 2 of 3 studies that reported this outcome. Conclusion – Authors report a positive effect of training on the literature search skills of trainees and students, and identified a benefit in the small number of studies that examined librarian services to clinicians. Future studies should use validated data collection tools, and further research should be conducted in the area of services provided to clinicians. Research is needed on the effect of librarian-provided services to patients and researchers as no studies meeting the inclusion criteria examining these two groups were identified by the literature search.


2018 ◽  
Vol 42 (4) ◽  
pp. 361 ◽  
Author(s):  
Richard Olley ◽  
Andrea Morales

Objective Dementia is one of the most common illnesses worldwide, and is one of the most important causes of disability in older people. Currently, dementia affects over 35 million people around the globe. It is expected that this number will increase to 65.7 million by 2030. Early detection, diagnosis and treatment to control the principal behaviour symptoms may help reduce these numbers and delay the progression to more advanced and dangerous stages of this disorder with resultant increase quality of life for those affected. The main goal of the present systematic literature review was to examine contemporary evidence relating to non-pharmacological therapy in the treatment of dementia. Methods To achieve the study goal, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used. Results This study identified the five most common behaviours in patients with dementia as aggression, wandering, agitation, apathy and sleep disturbances. Two non-pharmacological therapies were the most studied treatment: music therapy and aromatherapy. Ten other non-pharmacological therapies were also identified, but these lack a sufficient evidence-base. Conclusion Although all the therapies identified could be used as part of the treatment of behavioural symptoms, there is insufficient evidence relating to the indications, appropriate use and effectiveness of these therapies to apply in each behavioural treatment. Thus, the present study has demonstrated a significant research gap. What is known about the topic? Despite the widespread use of many different types of therapies, there is limited evidence regarding the efficacy of non-pharmaceutical therapies deployed in the management of behaviours of concern manifested by some people who suffer with dementia in all its forms. What does this paper add? This systematic review examines contemporary evidence from the literature to determine whether there is an evidence base available that would underpin the use of these therapies. This report on a PRISMA systematic review of the available literature demonstrates that only two therapies have some evidence to underpin the use of these non-pharmaceutical therapies and that a significant research gap is exists. What are the implications for practitioners? The implications for practitioners is that significant research effort is required to determine the efficacy of many of the therapies that are currently deployed, and thus many of the therapies used lack an evidence base at this time.


2016 ◽  
Author(s):  
Hannah Moshontz

A complete description of the literature search, including the criteria used for the inclusion of reports after they have been located, used in a research synthesis or meta-analysis is critical if subsequent researchers are to accurately evaluate and reproduce a synthesis' methods and results. Based on previous guidelines and new suggestions, we present a set of focused and detailed standards for reporting the methods used in a literature search. The guidelines cover five search strategies: reference database searches, journal and bibliography searches, searches of the reference lists of reports, citation searches, and direct contact searches. First, we bring together all the unique recommendations made in existing guidelines for research synthesis. Second, we identify gaps in reporting standards for search strategies. Third, we address these gaps by providing new reporting recommendations. Our hope is to facilitate successful evaluation and replication of research synthesis results.


BMJ ◽  
1996 ◽  
Vol 313 (7053) ◽  
pp. 342-343 ◽  
Author(s):  
P. Spoor ◽  
M. Airey ◽  
C. Bennett ◽  
J. Greensill ◽  
R. Williams

2021 ◽  
pp. 76-83
Author(s):  
S. V. Tikhonov ◽  
V. D. Dekkanova ◽  
S. A. Vinnichuk ◽  
T. S. Fil ◽  
N. V. Bakulina

The pandemic of COVID-19 is changing the usual clinical practice. Most of the drugs used for the etiotropic and pathogenetic therapy of COVID-19 do not have a sufficient evidence base, approaches to therapy of liver, gastrointestinal tract and other body systems damage in the structure of COVID-19 and post COVID-19 syndrome are under development. Coronavirus infection is more severe in  obese patients with associated diseases; the  liver plays an important role in  this process. Retrospective analysis of  the  medical histories of  patients with a  new coronavirus infection hospitalized in  the  clinic of North-Western State Medical University named after I.I. Mechnikov identified that 34.7% of patients were overweight, 51.3% obese, 77% abdominal obesity (alanine aminotransferase (ALAT) was on average 76.2 ± 58.8 U/L, aspartate aminotransferase (ACAT) 60.7 ± 48.6 U/L). At the time of hospitalization, increased transaminases was detected in 71% of patients and correlated with markers of the severe course of COVID-19 (the level of C-reactive protein, ferritin, % of blood oxygen saturation). In patients with severe new coronavirus infection, receiving therapy with JAK-kinase inhibitors and/or biological drugs, often was a  significant increase of  ALAT and ASAT up to 5–10  upper limits of  the  norm. In  the  process of  histological examination of the liver tissue of patients who died of extremely severe course of infection, characteristic fatty degeneration of hepatocytes was revealed. Therapy with a multicomponent drug containing inosine, meglumine, methionine, nicotinamide and succinic acid contributed to a dynamic decrease of transaminases and an improvement in the course of the new coronavirus infection. 


BMJ ◽  
2005 ◽  
Vol 330 (7495) ◽  
pp. 821 ◽  
Author(s):  
Li Wei ◽  
Shah Ebrahim ◽  
Christopher Bartlett ◽  
Peter D Davey ◽  
Frank M Sullivan ◽  
...  

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