Evidence-based medicine

Author(s):  
Raghbir Khakha ◽  
Adam Hill

The aim of research is to faithfully observe and describe, predict, determine causation, explain the hitherto unexplained, and conjure further questions. Medical research is concerned with the application of the scientific method to investigating both our population at risk, and our patients. However, it is often impossible to study entire populations. Therefore, many studies are undertaken to analyse representative cohorts before extrapolating the data to the population of interest. Every study is susceptible to bias and error. It is important to determine whether the evidence from an individual or groups of studies is strong or weak. In other words, are these data sets truly representative of the entire population of interest, or are the data distorted due to potential confounding factors? Furthermore, have the investigators presented a measured interpretation of their results in the context of the potential errors within their experimental system? It is these questions that have led to the concept of research evidence, or the hierarchical system in which the strength of the argument within some studies is simply better, or more persuasive, than others. When planning a research study, design is the first consideration. The highest possible level of evidence is a systematic review or meta-analysis of randomized controlled trials (RCTs), or an individual RCT. These are considered the ‘gold standard’ of clinical research. The design of RCTs allows exclusion of confounding factors and bias as much as possible. These studies work very well for certain interventions, such as drug trials. However, where the control and sample groups cannot be blinded, (e.g. ‘sham acupuncture’ or ‘sham manipulation’ as the control), RCTs may be less appropriate. Meta-analyses are considered as type 1 evidence. The more data is pooled, the more valid the results. However, the data may be less relevant to individual patients. Therefore, although potentially the most powerful type of evidence, meta-analyses can have some important limitations. A meta-analysis takes a number of trials from the literature, e.g. 10 trials of 100 patients each.

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Stefano Granieri ◽  
Francesco Sessa ◽  
Alessandro Bonomi ◽  
Sissi Paleino ◽  
Federica Bruno ◽  
...  

Abstract Background Entero-colovesical fistula is a rare complication of various benign and malignant diseases. The diagnosis is prominently based on clinical symptoms; imaging studies are necessary not only to confirm the presence of the fistula, but more importantly to demonstrate the extent and the nature of the fistula. There is still a lack of consensus regarding the if, when and how to repair the fistula. The aim of the study is to review the different surgical treatment options, focus on surgical indications, and explore cumulative recurrence, morbidity, and mortality rates of entero-vesical and colo-vesical fistula patients. Methods A systematic review of the literature was conducted according to PRISMA guidelines. Random effects meta-analyses of proportions were developed to assess primary and secondary endpoints. I2 statistic and Cochran’s Q test were computed to assess inter-studies’ heterogeneity. Results Twenty-two studies were included in the analysis with a total of 861 patients. Meta-analyses of proportions pointed out 5, 22.2, and 4.9% rates for recurrence, complications, and mortality respectively. A single-stage procedure was performed in 75.5% of the cases, whereas a multi-stage operation in 15.5% of patients. Palliative surgery was performed in 6.2% of the cases. In 2.3% of the cases, the surgical procedure was not specified. Simple and advanced repair of the bladder was performed in 84.3% and 15.6% of the cases respectively. Conclusions Although burdened by a non-negligible rate of complications, surgical repair of entero-colovesical fistula leads to excellent results in terms of primary healing. Our review offers opportunities for significant further research in this field. Level of Evidence Level III according to ELIS (SR/MA with up to two negative criteria).


Author(s):  
Paul Harrison ◽  
Philip Cowen ◽  
Tom Burns ◽  
Mina Fazel

‘Evidence-based approaches to psychiatry’ describes the application of evidence-based medicine (EBM) to psychiatric practice. The chapter covers the key processes in EBM, including the formulation of a clinically relevant question, the systematic search for high-quality evidence and the meta-analytic synthesis of data. It demonstrates how evidence-based approaches to psychiatry have led to important developments showing quantitative effects of different treatments through advanced meta-analysis of data from randomized trials. This has underpinned the development of clinical guidelines that have the aim of improving the reliability and quality of treatments that patients receive. The chapter also describes how meta-analyses should be critically reviewed, as well as their problems and limitations. Not all relevant questions in psychiatric research are susceptible to the quantitative approach offered by EBM, and the chapter also outlines how qualitative methodologies can play a key role in answering important questions related, for example, to the patient experience.


2019 ◽  
Vol 39 (9) ◽  
pp. 927-942 ◽  
Author(s):  
Andrew A Jacono ◽  
A Sean Alemi ◽  
Joseph L Russell

AbstractBackgroundSub-superficial musculo-aponeurotic system (SMAS) rhytidectomy techniques are considered to have a higher complication profile, especially for facial nerve injury, compared with less invasive SMAS techniques. This results in surgeons avoiding sub-SMAS dissection.ObjectivesThe authors sought to aggregate and summarize data on complications among different SMAS facelift techniques.MethodsA broad systematic search was performed. All included studies: (1) described a SMAS facelifting technique categorized as SMAS plication, SMASectomy/imbrication, SMAS flap, high lateral SMAS flap, deep plane, and composite; and (2) reported the number of postoperative complications in participants. Meta-analysis was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.ResultsA total 183 studies were included. High lateral SMAS (1.85%) and composite rhytidectomy (1.52%) had the highest rates of temporary nerve injury and were the only techniques to show a statistically significant difference compared with SMAS plication (odds ratio [OR] = 2.71 and 2.22, respectively, P < 0.05). Risk of permanent injury did not differ among techniques. An increase in major hematoma was found for the deep plane (1.22%, OR = 1.67, P < 0.05) and SMAS imbrication (1.92%, OR = 2.65, P < 0.01). Skin necrosis was higher with the SMAS flap (1.57%, OR = 2.29, P < 0.01).ConclusionsThere are statistically significant differences in complication rates between SMAS facelifting techniques for temporary facial nerve injury, hematoma, seroma, necrosis, and infection. Technique should be selected based on quality of results and not the complication profile.Level of Evidence: 2


2019 ◽  
Vol 80 (11) ◽  
pp. 636-641 ◽  
Author(s):  
Shahjahan Khan ◽  
Breda Memon ◽  
Muhammed A Memon

Meta-analysis has become an integral part of evidence-based decision-making processes and is being increasingly used in medical and non-medical disciplines. Aggregate data or summary statistics continue to be the mainstay of meta-analysis and are used by many professional societies to support clinical practice guidelines. Meta-analyses synthesize the summary statistics from independent trials by pooling them to estimate the underlying common effect size. The results represent the highest level of evidence but only if the chosen studies are of high quality and the selection criteria are fully satisfied. It is important to address the issues of defining an explicit and relevant question, exhaustively searching for the totality of evidence, meticulous and unbiased data transfer or extraction, assessment of between study heterogeneity and the use of appropriate statistical methods for estimating summary effect measures. This article reviews the methodology, benefits and drawbacks of performing a meta-analysis.


2020 ◽  
pp. jnnp-2020-323706
Author(s):  
Lillian Wieder ◽  
Richard Brown ◽  
Trevor Thompson ◽  
Devin B. Terhune

ObjectiveResponsiveness to direct verbal suggestions (suggestibility) has long been hypothesised to represent a predisposing factor for functional neurological disorder (FND) but previous research has yielded conflicting results. The aim of this study was to quantitatively evaluate whether patients with FND display elevated suggestibility relative to controls via meta-analysis.MethodsFour electronic databases were searched in November 2019, with the search updated in April 2020, for original studies assessing suggestibility using standardised behavioural scales or suggestive symptom induction protocols in patients with FND (including somatisation disorder) and controls. The meta-analysis followed Cochrane, Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Meta-analyses Of Observational Studies in Epidemiology (MOOSE) guidelines. Data extraction and study quality coding were performed by two independent reviewers. Standardised suggestibility scores and responsiveness to symptom induction protocols were used to calculate standardised mean differences (SMDs) between groups.ResultsOf 26 643 search results, 19 articles presenting 11 standardised suggestibility data sets (FND: n=316; control: n=360) and 11 symptom suggestibility data sets (FND: n=1285; control: n=1409) were included in random-effect meta-analyses. Meta-analyses revealed that patients with FND displayed greater suggestibility than controls on standardised behavioural scales (SMD, 0.48 (95% C, 0.15 to 0.81)) and greater responsiveness to suggestive symptom induction (SMD, 1.39 (95% CI 0.92 to 1.86)). Moderation analyses presented mixed evidence regarding the extent to which effect sizes covaried with methodological differences across studies. No evidence of publication bias was found.ConclusionsThese results corroborate the hypothesis that FND is characterised by heightened responsiveness to verbal suggestion. Atypical suggestibility may confer risk for FND and be a cognitive marker that can inform diagnosis and treatment of this condition.


2002 ◽  
Vol 17 (3) ◽  
pp. 115-119 ◽  
Author(s):  
Emmanuel Stip

SummaryGiven that we are celebrating the 50th birthday of neuroleptics introduction in psychiatry, the author proposes to take a look at certain results related to therapeutic practice. After a brief chronological literature review of the clinical practices and theoretical models that have controlled drug treatment of schizophrenia, the author presents a critical review of four meta-analyses. Since Delay, Deniker and Harl’s initial report, the story of neuroleptics comprises several periods. In 1963, the hyper-dopaminergic theory of psychoses was proposed. Another period began with models mainly based on the serotonin/dopamine relative blockade receptor hypothesis. More recently, a new framework to understand the differential effect of antipsychotics is related to the appropriate modulation (e.g., fast dissociation) of the D2 receptor alone. The concept of atypicality has become a new vista for research and to market new compounds. However, after 50 years of neuroleptic drugs, are we able to answer the following simple questions: Are neuroleptics effective in treating schizophrenia? Is there a difference between atypical and conventional neuroleptics? How do the efficacy and safety of newer antipsychotic drugs compare with those of clozapine? Actually, the answers yielded by these simple questions by meta-analysis should elicit in us a good deal of humility. If we wish to base psychiatry on evidence-based medicine, we run a genuine risk in taking a closer look at what has long been considered fact. Each psychiatrist must continue to be critical, sceptical, optimistic (not overoptimistic) and to learn in order to integrate the positive aspects of our growing knowledge base.


2012 ◽  
Vol 21 (2) ◽  
pp. 151-153 ◽  
Author(s):  
A. Cipriani ◽  
C. Barbui ◽  
C. Rizzo ◽  
G. Salanti

Standard meta-analyses are an effective tool in evidence-based medicine, but one of their main drawbacks is that they can compare only two alternative treatments at a time. Moreover, if no trials exist which directly compare two interventions, it is not possible to estimate their relative efficacy. Multiple treatments meta-analyses use a meta-analytical technique that allows the incorporation of evidence from both direct and indirect comparisons from a network of trials of different interventions to estimate summary treatment effects as comprehensively and precisely as possible.


2016 ◽  
Vol 16 (2) ◽  
pp. 135-146 ◽  
Author(s):  
Tae-Young Choi ◽  
Jong In Kim ◽  
Hyun-Ja Lim ◽  
Myeong Soo Lee

Background. Insomnia is a prominent complaint of cancer patients that can significantly affect their quality of life and symptoms related to sleep quality. Conventional drug approaches have a low rate of success in alleviating those suffering insomnia. The aim of this systematic review was to assess the efficacy of acupuncture in the management of cancer-related insomnia. Methods. A total of 12 databases were searched from their inception through January 2016 without language restriction. Randomized controlled trials (RCTs) and quasi-RCTs were included if acupuncture was used as the sole intervention or as an adjunct to another standard treatment for any cancer-related insomnia. The data extraction and the risk of bias assessments were performed by 2 independent reviewers. Results. Of the 90 studies screened, 6 RCTs were included. The risk of bias was generally unclear or low. Three RCTs showed equivalent effects on the Pittsburgh Sleep Quality Index and 2 RCTs showed the similar effects on response rate to those of conventional drugs at the end of treatment. The other RCT showed acupuncture was better than hormone therapy in the numbers of hours slept each night and number of times woken up each night. The 3 weeks of follow-up in 2 RCTs showed superior effects of acupuncture compared with conventional drugs, and a meta-analysis showed significant effects of acupuncture. Two RCTs tested the effects of acupuncture on cancer-related insomnia compared with sham acupuncture. One RCT showed favourable effects, while the other trial failed to do so. Conclusion. There is a low level of evidence that acupuncture may be superior to sham acupuncture, drugs or hormones therapy. However, the number of studies and effect size are small for clinical significance. Further clinical trials are warranted.


2015 ◽  
Vol 29 (4) ◽  
pp. 433-444 ◽  
Author(s):  
Fuschia M. Sirois ◽  
Ryan Kitner

Despite the theoretical and empirical accounts of trait procrastination as reflecting avoidance of aversive tasks as a means of mood repair, research documenting its links to coping is scarce and inconsistent. There is also little if any research to date examining whether coping strategies might explain the procrastination–stress relationship. The current research aimed to address these issues by integrating current research on procrastination and coping with our own data into a first meta–analysis of the associations of procrastination with adaptive and maladaptive coping and then testing the potential role of coping for understanding the procrastination–stress relationship. In Study 1, a literature search yielded five published papers and three theses, which were supplemented by seven unpublished data sets comprising 15 samples ( N = 4357). Meta–analyses revealed that procrastination was positively associated with maladaptive coping (average r = .31) and negatively associated with adaptive coping (average r = −.24). In Study 2, a meta–analysis of the indirect effects through coping across four samples revealed that the average indirect effects for maladaptive but not adaptive coping explained the link between procrastination and stress. These findings expand the nomological network of procrastination and highlight the role of maladaptive coping for understanding procrastinators‘ stress. Copyright © 2015 European Association of Personality Psychology


2008 ◽  
Vol 5;12 (5;9) ◽  
pp. 819-850
Author(s):  
Laxmaiah Manchikanti

Observational studies provide an important source of information when randomized controlled trials (RCTs) cannot or should not be undertaken, provided that the data are analyzed and interpreted with special attention to bias. Evidence-based medicine (EBM) stresses the examination of evidence from clinical research and describes it as a shift in medical paradigm, in contrast to intuition, unsystematic clinical experience, and pathophysiologic rationale. While the importance of randomized trials has been created by the concept of the hierarchy of evidence in guiding therapy, much of the medical research is observational. The reporting of observational research is often not detailed and clear enough with insufficient quality and poor reporting, which hampers the assessment of strengths and weaknesses of the study and the generalizability of the mixed results. Thus, in recent years, progress and innovations in health care are measured by systematic reviews and meta-analyses. A systematic review is defined as, “the application of scientific strategies that limit bias by the systematic assembly, clinical appraisal, and synthesis of all relevant studies on a specific topic.” Meta-analysis usually is the final step in a systematic review. Systematic reviews and meta-analyses are labor intensive, requiring expertise in both the subject matter and review methodology, and also must follow the rules of EBM which suggests that a formal set of rules must complement medical training and common sense for clinicians to integrate the results of clinical research effectively. While expertise in the review methods is important, the expertise in the subject matter and technical components is also crucial. Even though, systematic reviews and meta-analyses, specifically of RCTs, have exploded, the quality of the systematic reviews is highly variable and consequently, the opinions reached of the same studies are quite divergent. Numerous deficiencies have been described in methodologic assessment of the quality of the individual articles. Consequently, observational studies can provide an important complementary source of information, provided that the data are analyzed and interpreted in the context of confounding bias to which they are prone. Appropriate systematic reviews of observational studies, in conjunction with RCTs, may provide the basis for elimination of a dangerous discrepancy between the experts and the evidence. Steps in conducting systematic reviews of observational studies include planning, conducting, reporting, and disseminating the results. MOOSE, or Meta-analysis of Observational Studies in Epidemiology, a proposal for reporting contains specifications including background, search strategy, methods, results, discussion, and conclusion. Use of the MOOSE checklist should improve the usefulness of meta-analysis for authors, reviewers, editors, readers, and decision-makers. This manuscript describes systematic reviews and meta-analyses of observational studies. Authors frequently utilize RCTs and observational studies in one systematic review; thus, they should also follow the reporting standards of the Quality of Reporting of Meta-analysis (QUOROM) statement, which also provides a checklist. A combined approach of QUOROM and MOOSE will improve reporting of systematic reviews and lead to progress and innovations in health care. Key words: Observational studies, evidence-based medicine, systematic reviews, metaanalysis, randomized trials, case-control studies, cross-sectional studies, cohort studies, confounding bias, QUOROM, MOOSE


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