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What is evidence-based medicine and the role of the systematic review: the revolution coming your way.

The practice of evidence-based medicine involves the critical application of current best evidence to the care of individual patients. This process requires clinicians to be able to efficiently locate, critically appraise and appropriately apply the best available evidence to particular clinical scenarios. The current volume of medical and scientific literature is unmanageable and traditional approaches to continuing education cannot fully address the information needs of practicing clinicians in the era of evidence-based medicine. Review articles are useful resources but traditional narrative reviews often include a selective summary of research findings mixed with personal opinion. Systematic reviews have many advantages over traditional narrative reviews; importantly, the use of systematic and explicit methods mean that bias in identifying, selecting and summarizing the evidence is minimized. For systematic reviews where meta-analysis can be performed, the quantitative synthesis of data from different studies can provide additional information. Systematic reviews are retrospective studies and like all research may be susceptible to bias. Furthermore some methodological issues related to meta-analysis have yet to be resolved. The strengths and limitations of systematic reviews are discussed in this article and useful resources for locating high quality systematic reviews are outlined. Clinical judgement and experience have a pivotal role in the practice of evidence-based medicine and clinicians must rely on this judgement when deciding how and when to apply the results of systematic reviews to particular patients.

Clinical Competence↗

Systematic review of the use of honey as a wound dressing.

OBJECTIVE: To investigate topical honey in superficial burns and wounds though a systematic review of randomised controlled trials. DATA SOURCES: Cochrane Library, MEDLINE, EMBASE, PubMed, reference lists and databases were used to seek randomised controlled trials. Seven randomised trials involved superficial burns, partial thickness burns, moderate to severe burns that included full thickness injury, and infected postoperative wounds. REVIEW METHODS: Studies were randomised trials using honey, published papers, with a comparator. Main outcomes were relative benefit and number-needed-to-treat to prevent an outcome relating to wound healing time or infection rate. RESULTS: One study in infected postoperative wounds compared honey with antiseptics plus systemic antibiotics. The number needed to treat with honey for good wound healing compared with antiseptic was 2.9 (95% confidence interval 1.7 to 9.7). Five studies in patients with partial thickness or superficial burns involved less than 40% of the body surface. Comparators were polyurethane film, amniotic membrane, potato peel and silver sulphadiazine. The number needed to treat for seven days with honey to produce one patient with a healed burn was 2.6 (2.1 to 3.4) compared with any other treatment and 2.7 (2.0 to 4.1) compared with potato and amniotic membrane. For some or all outcomes honey was superior to all these treatments. Time for healing was significantly shorter for honey than all these treatments. The quality of studies was low. CONCLUSION: Confidence in a conclusion that honey is a useful treatment for superficial wounds or burns is low. There is biological plausibility.

Anti-Bacterial Agents↗

Conservative interventions for treating distal radial fractures in adults.

BACKGROUND: Fracture of the distal radius is a common clinical problem particularly in elderly white women with osteoporosis, in whom the lifetime risk of this injury has been estimated as 15 per cent. OBJECTIVES: To determine the most appropriate conservative treatment for fractures (such as Colles') of the distal radius in adults. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group trials register, Medline and reference lists of trials. Date of the most recent search: April 1998. SELECTION CRITERIA: Randomised or quasi-randomised clinical trials involving skeletally mature patients with a fracture of the distal radius, which compared commonly applied conservative interventions for fracture fixation. These included the application of an external support (plaster cast or brace) and fracture manipulation. DATA COLLECTION AND ANALYSIS: All trials, judged as fitting the selection criteria by both reviewers, were independently assessed by both reviewers for methodological quality. Data were extracted for anatomical, functional and clinical, including complications, outcomes. The trials were grouped into categories relating to cast position, extent and duration of immobilisation, use of braces, cast material and fracture manipulation. Although quantitative data from some trials are presented, the lack of good quality trials and trial heterogeneity inhibited pooling of results. MAIN RESULTS: Over 50 randomised trials comparing treatment options for distal radial fractures were identified. Twenty nine trials of these, involving a total of 3199 mainly female and older patients, met the inclusion criteria for this review. Comprehensive details of the individual trials are provided in tabular form, and their results, grouped as indicated above, have been presented in text and analyses tables. The poor quality and heterogeneity in terms of patient characteristics, interventions compared and outcome measurement, of the included trials meant that no meta-analyses were undertaken. REVIEWER'S CONCLUSIONS: There is insufficient evidence from randomised trials to determine which methods of conservative treatment are the most appropriate for the more common types of distal radial fractures in adults. Therefore, at present, practitioners applying conservative management should use an accepted technique with which they are familiar, and which is cost-effective from the perspective of their provider unit. Whilst tempting, any call for further research to clarify the most appropriate conservative treatment for this common fracture must be resisted for now. Instead it is important to reflect on the issues raised in this review, to ascertain patient preferences, prioritise researchable questions and undertake a systematic programme of research after agreeing a core data set for classification of fractures and outcomes.

Adult↗

[Critical analysis of a systematic review of the literature and a meta-analysis on exercise therapy and chronic low back pain].

OBJECTIVES: To determine wether the type of quality assessment scale used for evaluating the role of the physical training in chronic low back pain affects the conclusions of meta-analytic studies. DESIGN AND SETTING: Analysis of 20 trials assessing exercise therapy in chronic low back pain using 16 different scales to identify high-quality trials. Correlations between the scale scores were assessed using the Spearmans rank correlation coefficient. Inter-reader reliability was assessed with the intraclass correlation coefficient (ICC) and with the Bland and Altman technique. For the quality assessment scales allowing the classification in high quality or low quality trials, the degree of agreement between the two readers was calculated using the kappa coefficient. RESULTS: The range of the Spearman rank correlation coefficients between the different quality scales was wide (from 0.94 to 0.49). The quality scales inter-reader reliability were heterogeneous, ICC ranging from 0.86 to 0.39. The Bland and Altman analysis showed that with two scales the differences were not centered and that with 3 scales there was a systematic effect (r=0.32, 0.41, and 0.50). Finally, inter-reader agreement was low most of the time, the K coefficient being less than or equal to 0.60 for 8 of the 12 quality scales tested. CONCLUSIONS: Our data suggest that the use of summary scores to identify trials of high quality is problematic. Relevant methodological aspects should be assessed more specifically based on treatment strategies than on the own disease. A large reflexion on the elaboration and validation of specific quality scales is needed.

Humans↗

The quality of reports of critical care meta-analyses in the Cochrane Database of Systematic Reviews: an independent appraisal.

OBJECTIVE: To independently appraise the methodological quality of a sample of reports of meta-analyses that address critical care topics in the Cochrane Database of Systematic Reviews compared with the quality of reports published in regular journals, using a validated assessment instrument, the Overview Quality Assessment Questionnaire (OQAQ). DATA SOURCE: Studies were selected from a search of MEDLINE, EMBASE, and the Cochrane Database of Systematic Reviews from 1994 to 2003, using multiple search terms for critical care and sensitive filters to identify meta-analyses. STUDY SELECTION: Two authors independently selected meta-analyses that addressed topics pertinent to critical care medicine. DATA EXTRACTION: Two authors independently extracted the data. The proportion of reports that met each component of the OQAQ was determined, as was the overall quality score. Meta-analyses published in the Cochrane Database of Systematic Reviews were compared with those published in regular journals. DATA SYNTHESIS: There were 36 reports of meta-analyses in the Cochrane Database of Systematic Reviews and 103 reports of meta-analyses published in regular journals; 11 of these were reports of Cochrane reviews. The meta-analyses published in the Cochrane Database of Systematic Reviews were more likely to fulfill most components of the OQAQ. The median overall OQAQ scores indicated significant methodological problems in the reports regardless of the source of publication, although the reports in the Cochrane database scored higher than those in regular journals (five compared with two, p<.001). Major methodological flaws, notably failure to appropriately refer to the validity of included studies, were found in meta-analyses in both the Cochrane Database of Systematic Reviews and regular journals (44.4% and 79.3%, respectively). CONCLUSIONS: Although the quality of reports of meta-analyses published in the Cochrane Database of Systematic Reviews is superior to the quality of reports of meta-analyses published in regular journals, there is significant room for improvement. Clinicians should critically appraise all reports of meta-analyses before considering the results, regardless of the source of publication.

Critical Care↗

Improving the use of research evidence in guideline development: 10. Integrating values and consumer involvement.

BACKGROUND: The World Health Organization (WHO), like many other organisations around the world, has recognised the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the 10th of a series of 16 reviews that have been prepared as background for advice from the WHO Advisory Committee on Health Research to WHO on how to achieve this. OBJECTIVES: We reviewed the literature on integrating values and consumers in guideline development. METHODS: We searched PubMed and three databases of methodological studies for existing systematic reviews and relevant methodological research. We reviewed the titles of all citations and retrieved abstracts and full text articles if the citations appeared relevant to the topic. We checked the reference lists of articles relevant to the questions and used snowballing as a technique to obtain additional information. We did not conduct a full systematic review ourselves. Our conclusions based on the available evidence, consideration of what WHO and other organisations are doing and logical arguments. KEY QUESTIONS AND ANSWERS: We did not find a systematic review of methods for integrating values in guidelines, but we found several systematic reviews that dealt with related topics. Whose values should WHO use when making recommendations? Values, the relative importance or worth of a state or consequences of a decision (outcomes relating to benefits, harms, burden and costs), play a role in every recommendation. Ethical considerations, concepts that determine what is right, also play a role. The values used in making recommendations should reflect those of the people affected. Judgements should be explicit and should be informed by input from those affected (including citizens, patients, clinicians and policy makers). When differences in values may lead to different decisions or there is uncertainty about values, this should also be explicit. If differences in values are likely to affect a decision, such that people in different setting would likely make different choices about interventions or actions based on differences in their values, global recommendations should be explicit in terms of which values were applied and allow for adaptation after incorporating local values. How should WHO ensure that appropriate values are integrated in recommendations? All WHO guideline groups should uniformly apply explicit, transparent and clearly described methods for integrating values. WHO should consider involving relevant stakeholders if this is feasible and efficient. WHO should develop a checklist for guidelines panels to help them to ensure that ethical considerations relevant to recommendations are addressed explicitly and transparently. How should users and consumers be involved in generating recommendations? Including consumers in groups that are making global recommendations presents major challenges with respect to the impossibility of including a representative spectrum of consumers from a variety of cultures and settings. Nonetheless, consideration should be given to including consumers in groups who are able to challenge assumptions that are made about the values used for making recommendations, rather than represent the values of consumers around the world. WHO should establish a network to facilitate involvement of users. Draft recommendations should be reviewed by consumers, who should be asked explicitly to consider the values that were used. How should values be presented in recommendations? Recommendations should include a description of how decisions were made about the relative importance of the consequences (benefits, harms and costs) of a decision. Values that influence recommendations should be reported along with the research evidence underlying recommendations. When differences in values would lead to different decisions or there is important uncertainty about values that are critical to a decision, this should be flagged and reflected in the strength of the recommendation. Adaptable guideline templates that allow for integration of different values should be developed and used when differences in values are likely to be critical to a decision.

Journal Article↗

The value of systematic reviews in research.

Nurses may be deterred from using research to inform their practice because of the huge numbers of papers available on some topics. Literature reviews on a topic of interest may make the task easier. A systematic review aims to discover all the research undertaken on a subject and review all the results in a scientific manner. Systematic reviews may highlight findings not available from individual studies and can thus help to inform and improve practice.

Nurses↗

Clinician's guide to systematic reviews and meta-analyses.

Systematic reviews answer clinical questions by finding and evaluating all available evidence. The systematic review is a powerful tool to help clinicians use evidence for patient care decisions. There are many sources for high-quality systematic reviews. Like all scientific studies there are potential biases, but systematic reviews have many benefits over narrative reviews. To ensure appropriate use of systematic reviews, clinicians must evaluate them in a logical, step-by-step manner. This article will review the benefits of systematic reviews, how to locate them, and how to evaluate their quality and results.

Decision Making↗

[A reproducibility and validity study of a systematic review on ischemic cardiopathy. The Study Group of the Quality of Care (GRECA)].

BACKGROUND: The systematic literature reviews have been proposed as a method of scientific evidence identification since they protect the final product from the subjectivity of each primary source reviewer. However, it is not known whether the different ways of evidence synthesis accomplish suitable criteria of objectivity, reliability and biases protection so as to be considered scientifically valid. An experiment of reliability and validity of a systematic literature review about coronary heart disease was carried out. MATERIAL AND METHODS: Study of blind concordance between two independent reviewers for the identification, selection, retrieval and quality evaluation of the articles by using the same protocol. The concordance was analysed by the kappa index for two observers in different categories. The validity was evaluated throughout the acceptability of the review users. RESULTS: The concordance for their identification capacity was poor although they used the same key words (869 versus 476). But the concordance improved when considering selection (26.6% versus 29.2%), retrieval (agreement = 76%) classification by kind of article (kappa = 0.60) and scoring by strength of the evidence (kappa = 0.87). The acceptability was high among review users. CONCLUSIONS: It would be assumed that, even under tight rules of performance, the systematic literature reviews are not completely protected against some biases which could damage their validity in a non easily controllable form. The implication of reviewers, experts in documentation and users of the literature, together with pilot studies performed previous to the review, seems to be the best way to yield better results.

Humans↗

Effectiveness and efficiency of search methods in systematic reviews of complex evidence: audit of primary sources.

OBJECTIVE: To describe where papers come from in a systematic review of complex evidence. Method Audit of how the 495 primary sources for the review were originally identified. RESULTS: Only 30% of sources were obtained from the protocol defined at the outset of the study (that is, from the database and hand searches). Fifty one per cent were identified by "snowballing" (such as pursuing references of references), and 24% by personal knowledge or personal contacts. CONCLUSION: Systematic reviews of complex evidence cannot rely solely on protocol-driven search strategies.

Data Collection↗

Does the non-randomized controlled study have a place in the systematic review? A pilot study.

BACKGROUND: A major issue in any systematic review is deciding which trials or studies to include and which to exclude. The Cochrane Collaboration and similar respected organizations have traditionally viewed the randomized trial (RCT) as the only acceptable evidence on treatment outcome. However, many systematic reviews are indeterminate because they include insufficient RCTs whilst they reject large numbers of non-randomized controlled studies. This is particularly true in forensic mental health, a domain where RCT methodology can be problematic. Systematic reviews could become more informative if reviewers knew when, and under what circumstances, non-randomized designs are acceptable for inclusion alongside RCTs. METHOD: This pilot study explores whether good-quality, controlled, non-randomized studies can be reliable surrogates for RCTs. We examined two published reviews from the Cochrane Schizophrenia Group. We compared outcomes between (a) randomized trials (that had been included) and non-randomized studies (that had been excluded), and (b) between high- and low-quality studies using an established quality checklist. RESULTS: In the first review, effect scores were similar for randomized and non-randomized studies and relatively insensitive to study quality. In the second review, the treatment effect was considerably lower for the RCT group - here, however, studies of high-quality showed much smaller effect scores than those of low-quality on two separate outcomes. CONCLUSIONS: Non-randomized controlled studies of high quality can produce outcomes that approximate to those found in RCTs. Trial quality may have a greater impact on treatment effect size than randomization alone, suggesting that randomization should not be seen as a reliable proxy for overall quality. The problems and issues still to be resolved are discussed with recommendations for future research.

Humans↗

Overview of evidence-based medicine: challenges for evidence-based laboratory medicine.

Evidence-based medicine (EBM) has been driven by the need to cope with information overload, by cost-control, and by a public impatient for the best in diagnostics and treatment. Clinical guidelines, care maps, and outcome measures are quality improvement tools for the appropriateness, efficiency, and effectiveness of health services. Although they are imperfect, their value increases with the quality of the evidence they incorporate. Laboratory professionals must direct more effort to demonstrating the impact of laboratory tests on a greater variety of clinical outcomes. Laboratory and clinical practitioners must be familiar with many of the accessible electronic and paper tools for searching for evidence. Detailed statistical and epidemiologic knowledge is not essential, but critical appraisal skills and a competent understanding of the strengths and weaknesses of systematic review and metaanalysis are necessary. Overemphasis on complexity and failure to recognize time limitations are major barriers to translating EBM into everyday practice. Emphasizing and practicing the role of the laboratory professional as a skilled clinical consultant strongly grounded in evidence as well, in addition to better integration of laboratory and clinical information and improved laboratory reports will overcome most barriers. There is a poverty of good, primary studies of test evaluations. Institution of more consistent standards for the design and reporting of studies on diagnostic accuracy should improve the situation. If nothing else, systematic reviews have demonstrated the need for more good-quality primary research in laboratory medicine.

Chemistry, Clinical↗

Nerve blocks (subcostal, lateral cutaneous, femoral, triple, psoas) for hip fractures.

BACKGROUND: Various nerve blocks using local anaesthetic agents have been used in order to reduce pain after hip fracture. OBJECTIVES: To determine the effects of nerve blocks (inserted either pre-operatively, operatively or post-operatively) as part of the treatment for a hip fracture. SEARCH STRATEGY: The Cochrane Musculoskeletal Injuries Group trials register, MEDLINE, and bibliographies of trial reports were searched. Date of the most recent search: April 1998. SELECTION CRITERIA: Randomised and quasi-randomised trials involving the use of nerve blocks as part of the care of a hip fracture patient. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, by use of an eight item scale, and extracted data. Wherever appropriate, results of outcome measures were pooled. MAIN RESULTS: Six randomised or quasi-randomised trials involving 229 patients were included. One trial related to insertion of a nerve block pre-operatively and the remaining five, to peri-operative insertion. Nerve blocks resulted in a reduction of the quantity of parental or oral analgesia administered to control pain from the fracture/operation or during surgery. It was not possible to demonstrate if this reduction in analgesia use was associated with any clinical benefit. REVIEWER'S CONCLUSIONS: Because of the small number of patients included in this review and the differing type of nerve blocks and timing of insertion, it is not possible to determine if nerve blocks confer any benefit when compared with other analgesic methods as part of the treatment of a hip fracture. Further trials with larger numbers of patients and full reporting of clinical outcomes would be justified.

Hip Fractures↗

[Evidence-based medicine and the systematic review in perioperative medicine].

The aim of Evidence-based medicine (EBM) is the unbiased and systematic identification and synthesis of valid scientific data. These best-evidence data may then be used for clinical decision-making. The systematic review is the most important tool of EBM and gives a specific answer to a specific question. More than 200 systematic reviews have been published in perioperative medicine. They treat complications and risks related to anaesthesia, postoperative and labour analgesia, nausea and vomiting, regional anaesthesia, blood transfusion and fluids replacement, and resuscitation. The majority of these systematic reviews are of good quality. In the specific settings of perioperative medicine the number of systematic reviews has become so important that recommendations for evidenced-based strategies of prevention and therapy can be formulated.

Anesthesiology↗

A guide to systematic reviews.

Systematic reviews have become widely used for evaluating evidence across all fields of biomedicine. The objective of a systematic review is to provide a comprehensive and contemporary appraisal of research using transparent methods whilst aiming to minimize bias. In essence, research methodology is employed in the conduct of the review. Such reviews are therefore fundamentally different from traditional 'narrative' review articles in their purpose and in their potential to aid clinical decision-making. This paper is a guide to the rationale and nature of systematic reviews and will provide a background to understanding their use in clinical practice.

Dental Research↗

Thermotherapy for treating rheumatoid arthritis.

BACKGROUND: Heat and cold therapy are often used as adjuncts in the treatment of rheumatoid arthritis by rehabilitation specialists. OBJECTIVES: To evaluate the effects of heat and cold on objective and subjective measures of disease activity in patients with rheumatoid arthritis. SEARCH STRATEGY: We searched Medline, Embase, PEDro, Current Contents, Sports Discus and CINAHL up to June 2000. The Cochrane Field of Rehabilitation and related therapies and the Cochrane Musculoskeletal Review Group were also contacted for a search of their specialized registers. Handsearching was conducted on all retrieved articles for additional articles. SELECTION CRITERIA: Randomized or controlled clinical trials of ice or heat compared to placebo or active interventions in patients with rheumatoid arthritis and case-control and cohort studies were eligible. No language restrictions were applied. Abstracts were accepted. DATA COLLECTION AND ANALYSIS: Two independent reviewers identified potential articles from the literature search. These reviewers extracted data using pre-defined extraction forms. Consensus was reached on all data extraction. Quality was assessed by two reviewers using a 5 point scale that measured the quality of randomization, double-blinding and description of withdrawals. MAIN RESULTS: Three studies (79 subjects) met the inclusion criteria. There was no effect on objective measures of disease activity (including inflammation, pain and x-ray measured joint destruction) of either ice versus control or heat versus control. Patients reported that they preferred heat therapy to no therapy (94% like heat therapy better than no therapy). There was no difference in patient preference for heat or ice. No harmful effects of ice or heat were reported. REVIEWER'S CONCLUSIONS: Since patients enjoy thermotherapy, and there are no harmful effects, thermotherapy should be recommended as a therapy which can be applied at home as needed to relieve pain. There is no need for further research on the effects of heat or cold for RA.

Arthritis, Rheumatoid↗

Screening for suicide risk: recommendation and rationale.

This statement summarizes the current U.S. Preventive Services Task Force (USPSTF) recommendations on screening for suicide risk and the supporting scientific evidence and updates the 1996 recommendations on this topic. The complete information on which this statement is based, including evidence tables and references, is available in the accompanying article in this issue and in the systematic evidence review on this topic, which is available through the USPSTF Web site (www.preventiveservices.ahrq.gov) and through the National Guideline Clearinghouse (www.guideline.gov). The complete recommendation statement and the summary of the evidence are also available from the Agency for Healthcare Research and Quality Publications Clearinghouse (telephone, 800-358-9295; e-mail, ahrqpubs@ahrq.gov).

Adolescent↗