BACKGROUND: Clinical decisions are made based on Cochrane reviews, but the implementation of results of evidence syntheses such as Cochrane reviews is problematic if the evidence is not prepared consistently. All systematic reviews should assess the risk of bias (RoB) in included studies, and in Cochrane reviews, this is done by using Cochrane RoB tool. However, the tool is not necessarily applied according to the instructions. In this study, we aimed to determine the types of bias and their corresponding judgements noted in the 'other bias' domain of Cochrane RoB tool. METHODS: We analyzed Cochrane reviews that included randomized controlled trials (RCTs) and extracted data regarding 'other bias' from the RoB table and accompanying support for the judgment. We categorized different types of other bias. RESULTS: We analyzed 768 Cochrane reviews that included 11,369 RCTs. There were 602 (78%) Cochrane reviews that had 'other bias' domain in the RoB tool, and they included a total of 7811 RCTs. In the RoB table of 337 Cochrane reviews for at least one of the included trials it was indicated that no other bias was found and supporting explanations were inconsistently judged as low, unclear or high RoB. In the 524 Cochrane reviews that described various sources of other bias, there were 5762 individual types of explanations which we categorized into 31 groups. The judgments of the same supporting explanations were highly inconsistent. We found numerous other inconsistencies in reporting of sources of other bias in Cochrane reviews. CONCLUSION: Cochrane authors mention a wide range of sources of other bias in the RoB tool and they inconsistently judge the same supporting explanations. Inconsistency in appraising risk of other bias hinders reliability and comparability of Cochrane systematic reviews. Discrepant and erroneous judgments of bias in evidence synthesis may hinder implementation of evidence in routine clinical practice and reduce confidence in otherwise trustworthy sources of information. These results can help authors of Cochrane and non-Cochrane reviews to gain insight into various sources of other bias that can be found in trials, and also to help them avoid mistakes that were recognized in published Cochrane reviews.
- MeSH
- Anti-Bacterial Agents therapeutic use MeSH
- Benzoxazines * administration & dosage adverse effects therapeutic use MeSH
- Cholinergic Antagonists therapeutic use MeSH
- Pulmonary Disease, Chronic Obstructive * diagnosis etiology drug therapy MeSH
- Drug Therapy methods trends utilization MeSH
- Drug Combinations MeSH
- Drug Evaluation trends utilization MeSH
- Adrenal Cortex Hormones therapeutic use MeSH
- Quality of Life MeSH
- Humans MeSH
- Disease Progression MeSH
- Randomized Controlled Trials as Topic methods standards MeSH
- Statistics as Topic MeSH
- Tiotropium Bromide * administration & dosage adverse effects therapeutic use MeSH
- Outcome and Process Assessment, Health Care MeSH
- Check Tag
- Humans MeSH
In December of 2016, a Consensus Conference on unruptured AVM treatment, involving 24 members of the three European societies dealing with the treatment of cerebral AVMs (EANS, ESMINT, and EGKS) was held in Milan, Italy. The panel made the following statements and general recommendations: (1) Brain arteriovenous malformation (AVM) is a complex disease associated with potentially severe natural history; (2) The results of a randomized trial (ARUBA) cannot be applied equally for all unruptured brain arteriovenous malformation (uBAVM) and for all treatment modalities; (3) Considering the multiple treatment modalities available, patients with uBAVMs should be evaluated by an interdisciplinary neurovascular team consisting of neurosurgeons, neurointerventionalists, radiosurgeons, and neurologists experienced in the diagnosis and treatment of brain AVM; (4) Balancing the risk of hemorrhage and the associated restrictions of everyday activities related to untreated unruptured AVMs against the risk of treatment, there are sufficient indications to treat unruptured AVMs grade 1 and 2 (Spetzler-Martin); (5) There may be indications for treating patients with higher grades, based on a case-to-case consensus decision of the experienced team; (6) If treatment is indicated, the primary strategy should be defined by the multidisciplinary team prior to the beginning of the treatment and should aim at complete eradication of the uBAVM; (7) After having considered the pros and cons of a randomized trial vs. a registry, the panel proposed a prospective European Multidisciplinary Registry.
- MeSH
- European Union MeSH
- Intracranial Arteriovenous Malformations surgery MeSH
- Congresses as Topic MeSH
- Consensus * MeSH
- Humans MeSH
- Neurosurgical Procedures standards MeSH
- Randomized Controlled Trials as Topic standards MeSH
- Registries standards MeSH
- Practice Guidelines as Topic * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
Evidence based medicine has preferably been based on prospective randomized controlled trials (PRCT's) and subsequent meta-analyses in many fields including nutrition and metabolism. These meta-analyses often yield convincing, contradictory or no proof of effectiveness. Consequently recommendations and guidelines of varying validity and quality have been published, often failing to convince the medical, insurance and government worlds to support nutritional care. Causes for lack of adequate proof of effectiveness are manifold. Many studies and meta-analyses lacked pathophysiological depth in design and interpretation. Study populations were not homogenous and endpoints not always clearly defined. Patients were included not at nutritional risk, unlikely to benefit from nutritional intervention. Others received nutrients in excess of requirements or tolerance due to organ failure. To include all available studies in a meta-analysis, study quality and homogeneity were only assessed on the basis of formal study design and outcome rather than on patient characteristics. Consequently, some studies showed benefit but included patients suffering harm, other studies were negative but contained patients that benefited. Recommendations did not always emphasize these shortcomings, confusing the medical and nutritional community and creating the impression that nutritional support is not beneficial. Strong reliance on meta-analyses and guidelines shifts the focus of education from studying clinical and nutritional physiology to memorizing guidelines. To prevent or improve malnutrition more physiological knowledge should be acquired to personalize nutritional practices and to more correctly value and evaluate the evidence. This also applies to the design and interpretation of PRCT's and meta-analyses.
- MeSH
- Biomarkers metabolism MeSH
- Biomedical Research education methods trends MeSH
- Dietetics * trends MeSH
- Energy Metabolism MeSH
- Humans MeSH
- Evidence-Based Medicine * MeSH
- Meta-Analysis as Topic * MeSH
- Nutritional Support adverse effects trends MeSH
- Nutritional Sciences education methods trends MeSH
- Malnutrition diet therapy metabolism prevention & control therapy MeSH
- Randomized Controlled Trials as Topic standards MeSH
- Reproducibility of Results MeSH
- Practice Guidelines as Topic MeSH
- Patient Selection MeSH
- Diet, Healthy * MeSH
- Animals MeSH
- Check Tag
- Humans MeSH
- Animals MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
BACKGROUND: Randomized controlled trials (RCTs) are the best tool to evaluate the effectiveness of clinical interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement is an evidence-based approach to improve the quality of RCTs reporting. OBJECTIVE: To evaluate the reporting quality of published RCTs concerning multiple sclerosis from 2000 to 2015 according to a checklist based on the CONSORT statement. METHODS: Electronic databases were searched for English-language RCTs involving patients with multiple sclerosis (MS). Trials were considered eligible when participants were randomly assigned to at least two medicinal treatment arms and included patients with MS. Quality of reporting was assessed using a 39-item questionnaire based on the CONSORT checklist. Articles were grouped in three 5-year periods and comparisons were made using descriptive statistics. RESULTS AND CONCLUSION: The search identified 102 eligible articles for analysis. 20 of the 38 items of the checklist (52.6%) were addressed in 75% or more of the studies. Reporting of more than 75% of CONSORT items (>75% CONSORT compliance) was increased during the three five-year time periods from 2000 to 2015 (p<0.05). CONCLUSIONS: Quality of reporting in RCTs focusing on multiple sclerosis is showing improvement over time, but still remains unsatisfactory. Further improvement of reporting is necessary to assess the validity of clinical research.
- MeSH
- Journal Impact Factor MeSH
- Humans MeSH
- Periodicals as Topic MeSH
- Publishing standards MeSH
- Randomized Controlled Trials as Topic standards MeSH
- Multiple Sclerosis therapy MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: In clinical trials, the use of intermediate time-to-event end points (TEEs) is increasingly common, yet their choice and definitions are not standardized. This limits the usefulness for comparing treatment effects between studies. The aim of the DATECAN Kidney project is to clarify and recommend definitions of TEE in renal cell cancer (RCC) through a formal consensus method for end point definitions. MATERIALS AND METHODS: A formal modified Delphi method was used for establishing consensus. From a 2006-2009 literature review, the Steering Committee (SC) selected 9 TEE and 15 events in the nonmetastatic (NM) and metastatic/advanced (MA) RCC disease settings. Events were scored on the range of 1 (totally disagree to include) to 9 (totally agree to include) in the definition of each end point. Rating Committee (RC) experts were contacted for the scoring rounds. From these results, final recommendations were established for selecting pertinent end points and the associated events. RESULTS: Thirty-four experts scored 121 events for 9 end points. Consensus was reached for 31%, 43% and 85% events during the first, second and third rounds, respectively. The expert recommend the use of three and two endpoints in NM and MA setting, respectively. In the NM setting: disease-free survival (contralateral RCC, appearance of metastases, local or regional recurrence, death from RCC or protocol treatment), metastasis-free survival (appearance of metastases, regional recurrence, death from RCC); and local-regional-free survival (local or regional recurrence, death from RCC). In the MA setting: kidney cancer-specific survival (death from RCC or protocol treatment) and progression-free survival (death from RCC, local, regional, or metastatic progression). CONCLUSIONS: The consensus method revealed that intermediate end points have not been well defined, because all of the selected end points had at least one event definition for which no consensus was obtained. These clarified definitions of TEE should become standard practice in all RCC clinical trials, thus facilitating reporting and increasing precision in between trial comparisons.
- MeSH
- Delphi Technique MeSH
- Guideline Adherence standards MeSH
- Carcinoma, Renal Cell mortality therapy MeSH
- Humans MeSH
- Neoplasm Recurrence, Local mortality therapy MeSH
- Kidney Neoplasms mortality therapy MeSH
- Disease-Free Survival MeSH
- Randomized Controlled Trials as Topic methods standards MeSH
- Endpoint Determination methods standards MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Review MeSH
- Keywords
- CRF (Case Report Form) a EDC (Electronic Data Capture), query (dotaz),
- MeSH
- Biomedical Research * methods standards trends MeSH
- Data Management MeSH
- Data Interpretation, Statistical MeSH
- Clinical Protocols * standards MeSH
- Humans MeSH
- Randomized Controlled Trials as Topic methods standards utilization MeSH
- Data Collection methods standards utilization MeSH
- Statistics as Topic MeSH
- Database Management Systems standards utilization MeSH
- Computer Security standards legislation & jurisprudence MeSH
- Check Tag
- Humans MeSH
- MeSH
- Double-Blind Method * MeSH
- Clinical Trials as Topic * methods statistics & numerical data MeSH
- Humans MeSH
- Randomized Controlled Trials as Topic * ethics methods standards MeSH
- Statistics as Topic MeSH
- Case-Control Studies MeSH
- Planning Techniques MeSH
- Investigative Techniques MeSH
- Check Tag
- Humans MeSH
- Geographicals
- Czech Republic MeSH
