Transforming scientific evidence into better consumer choices

Translational research using evidence-based and comparative effectiveness research continues to evolve, becoming a useful tool in improving informed consent and decision-making in the clinical setting. While in development, emerging technologies, including cellular and molecular biology, are leading to establishing evidence-based dental practices. One emerging technology, which conjoins bench proteomic findings to clinical decision-making for treatment intervention, is the Translational Evidence Mechanism. This mechanism was developed to be a foundation for a compact between researcher, translational researcher, clinician, and patient. The output of such a mechanism is the clinical practice guideline (CPG), an interactive tool for dentists and patients to game evidence in reaching optimum clinical decisions that correspond to individual patient preferences and values. As such, the clinical practice guideline requires the vesting of decision, utility, and cost best evidence. Evidence-based research provides decision data, a first attempt at supporting decision-making by providing best outcome data. Since then comparative effectiveness research has emerged, using systematic review analysis to compare similar treatments or procedures in maximizing the choice of the most effective cost/benefit option within the context of best evidence. With innovation in the clinical practice guideline for optimizing efficacy and comparative effectiveness research, evidence-based practices will shape a new approach to health-based systems that adhere to shared decision-making between bench scientists, healthcare providers and patients.     

Transforming scientific evidence into better consumer choices

Translational research using evidence-based and comparative effectiveness research continues to evolve, becoming a useful tool in improving informed consent and decision-making in the clinical setting. While in development, emerging technologies, including cellular and molecular biology, are leading to establishing evidence-based dental practices. One emerging technology, which conjoins bench proteomic findings to clinical decision-making for treatment intervention, is the Translational Evidence Mechanism. This mechanism was developed to be a foundation for a compact between researcher, translational researcher, clinician, and patient. The output of such a mechanism is the clinical practice guideline (CPG), an interactive tool for dentists and patients to game evidence in reaching optimum clinical decisions that correspond to individual patient preferences and values. As such, the clinical practice guideline requires the vesting of decision, utility, and cost best evidence. Evidence-based research provides decision data, a first attempt at supporting decision-making by providing best outcome data. Since then comparative effectiveness research has emerged, using systematic review analysis to compare similar treatments or procedures in maximizing the choice of the most effective cost/benefit option within the context of best evidence. With innovation in the clinical practice guideline for optimizing efficacy and comparative effectiveness research, evidence-based practices will shape a new approach to health-based systems that adhere to shared decision-making between bench scientists, healthcare providers and patients.     

Reliability of Quality Assessments in Research Synthesis: Securing the Highest Quality Bioinformation for HIT

Current trends in bio-medicine include research synthesis and dissemination of bioinformation by means of health (bio) information technology (H[b] IT). Research must secure the validity and reliability of assessment tools to quantify research quality in the pursuit of the best available evidence. Our concerted work in this domain led to the revision of three instruments for that purpose, including the stringent characterization of inter-rater reliability and coefficient of agreement. It is timely and critical to advance the methodological development of the science of research synthesis by strengthening the reliability of existing measure of research quality in order to ensure H[b] IT efficacy and effectiveness.     

Dissemination of evidence-based standards of care

Standards of care pertain to crafting and implementing patient-centered treatment interventions. Standards of care must take into consideration the patient's gender, ethnicity, medical and dental history, insurance coverage (or socioeconomic level, if a private patient), and the timeliness of the targeted scientific evidence. This resolves into a process by which clinical decision-making about the optimal patient-centered treatment relies on the best available research evidence, and all other necessary inputs and factors to provide the best possible treatment. Standards of care must be evidence-based, and not merely based on the evidence - the dichotomy being critical in contemporary health services research and practice. Evidence-based standards of care must rest on the best available evidence that emerges from a concerted hypothesis-driven process of research synthesis and meta-analysis. Health information technology needs to become an every-day reality in health services research and practice to ensure evidence-based standards of care. Current trends indicate that user-friendly methodologies, for the dissemination of evidence-based standards of care, must be developed, tested and distributed. They should include approaches for the quantification and analysis of the textual content of systematic reviews and of their summaries in the form of critical reviews and lay-language summaries.     

Maximizing the value of systematic reviews in ecology when data or resources are limited

Systematic reviews provide a rigorous, repeatable and quantitative method for assessing and synthesizing all available empirical evidence to evaluate a specific research, management, or policy question. They are particularly well suited for evaluating the effectiveness of environmental management actions, and thus for underpinning evidence‐based adaptive natural resource management. However, their current utility may be limited in countries like Australia, where both the amount of research relative to land area and of well‐monitored, active land management for environmental purposes are relatively low. Based on our experience conducting two of the first ecological systematic reviews in Australia, we have developed a number of recommendations for conducting systematic reviews in situations where resources and/or primary research data are limited. We discuss potential modification or augmentation of most aspects of the systematic review process including selection of a review team, question formulation, search strategy, data analysis, and the communication of results, as well as the inherent tradeoffs between systematic thoroughness and available resources that are involved in these changes. We hope that our recommendations will encourage more ecologists to undertake systematic reviews even if primary research and resources to conduct the review appear to be limited, as even a modified systematic review can provide more defensible evidence‐based guidelines for management of natural resources.     

Linking reductionist science and holistic policy using systematic reviews: unpacking environmental policy questions to construct an evidence-based framework

1. There is a mismatch between broad holistic questions typically posed in policy formation and narrow reductionist questions that are susceptible to scientific method. This inhibits the two-way flow of information at the science-policy interface and weakens the impact of applied ecology on environmental policy.
2. We investigate the approaches to building policy in the health services as a model to help establish a framework in applied ecology and environmental management by which reductionist science can underpin decision making at the policy level.
3. A comparison of policy documents in the health and environmental sectors reveals many similarities in identifying approaches and specific interventions that might achieve policy objectives. The difference is that in the health services, information on the effectiveness of potential interventions is far more readily available through the collaborative process of systematic review.
4. Synthesis and applications . Decision makers are increasingly looking to produce policies that are shaped by evidence through evidence-based policy making. The approach that we outline here provides a framework for structuring systematic reviews to deliver the evidence on key policy issues in a way that will see a faster return and provide better use of the systematic review methodology in environmental management.     

Evidence-Based Medicine,Clinical Practice Guidelines,and Common Sense in the Management of Osteoporosis

ObjectiveTo evaluate the benefits and limitations of randomized controlled trials (RCTs), clinical practice guidelines (CPGs), and clinical judgment in the management of osteoporosis.MethodsA review was conducted of the English-language literature on the origins and applications of RCTs, CPGs, evidence-based medicine, and clinical judgment in the management of osteoporosis.ResultsEvidence-based medicine is use of the currently available best evidence in making clinical decisions for individual patients. CPGs are recommendations for making clinical decisions based on research evidence, sometimes with consideration of expert opinion, health care policy, and costs of care. The highest levels of medical evidence are usually thought to be RCTs and meta-analyses of high-quality RCTs. Although it is desirable and appropriate for clinicians to consider research evidence from RCTs and recommendations presented in CPGs in making clinical decisions, other factors—such as patient preference, comorbidities, affordability, and availability of care—are important for the actual implementation of evidence-based medicine.ConclusionDecisions about who to treat, which drug to use, how best to monitor, and how long to treat require clinical skills in addition to knowledge of medical research. The necessity of integrating common sense and clinical judgment is highlighted by the fact that many patients treated for osteoporosis in clinical practice would not qualify for participation in the pivotal clinical trials that demonstrated efficacy and safety of the drugs used to treat them. (Endocr Pract. 2009;15:573-579)     

Endoscopic Vascular Harvest in Coronary Artery Bypass Grafting Surgery: A Consensus Statement of the International Society of Minimally Invasive Cardiothoracic Surgery (ISMICS) 2005

OBJECTIVE:: This purpose of this consensus statement was to compare endoscopic vascular graft harvesting (EVH) with conventional open vascular harvesting (OVH) in adults undergoing coronary artery bypass grafting (CABG) surgery and to determine which resulted in improved clinical and resource outcomes. METHODS:: Before the consensus conference, the consensus panel reviewed the best available evidence, whereby systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of importance. Evidence-based statements were created, and consensus processes were used to determine the ensuing statements. The AHA/ACC system was used to label the level of evidence and class of recommendation. RESULTS:: The consensus panel agreed upon the following statements: CONCLUSIONS:: Given these evidence-based statements, the consensus panel stated that EVH should be the standard of care for patients who require saphenous vein grafts for coronary revascularization (Class I, Level B). Future research should address long-term safety, cost-effectiveness, and endoarterial harvest.     

Implementing findings of research.

There are unacceptable delays in the implementation of many findings of research. This results in suboptimal care for patients. A number of approaches may be effective in speeding up implementation, including evidence based guidelines, the influence of opinion leaders, and computer based decision support systems. An integrated approach to speeding up this process by means of a number of mechanisms is likely to be most effective. The results of systematic reviews of the research literature should be incorporated into programmes of continuing medical education and clinical audit. Professional associations have an important role to play in ensuring that research based information is included in educational activities and clinical guidelines. Purchasers of health care could promote the uptake of research findings during contract negotiations. Improved methods of informing health care users and the public about evidence of effectiveness could also have an impact. Policy makers should take more account of the results of research when formulating recommendations. Methods of improving the implementation of research findings require further investigation and greater resources devoted to them.     

Patient-centered outcomes of high-velocity, low-amplitude spinal manipulation for low back pain: A systematic review

Low back pain (LBP) is a well-recognized public health problem with no clear gold standard medical approach to treatment. Thus, those with LBP frequently turn to treatments such as spinal manipulation (SM). Many clinical trials have been conducted to evaluate the efficacy or effectiveness of SM for LBP. The primary objective of this paper was to describe the current literature on patient-centered outcomes following a specific type of commonly used SM, high-velocity low-amplitude (HVLA), in patients with LBP. A systematic search strategy was used to capture all LBP clinical trials of HVLA using our predefined patient-centered outcomes: visual analogue scale, numerical pain rating scale, Roland-Morris Disability Questionnaire, and the Oswestry Low Back Pain Disability Index. Of the 1294 articles identified by our search, 38 met our eligibility criteria. Like previous SM for LBP systematic reviews, this review shows a small but consistent treatment effect at least as large as that seen in other conservative methods of care. The heterogeneity and inconsistency in reporting within the studies reviewed makes it difficult to draw definitive conclusions. Future SM studies for LBP would benefit if some of these issues were addressed by the scientific community before further research in this area is conducted.     

Proteomic signature of periodontal disease in pregnancy: Predictive validity for adverse outcomes

The rate of preterm birth is a public health concern worldwide because it is increasing and efforts to prevent it have failed. We report a Clinically Relevant Complex Systematic Review (CSCSR) designed to identify and evaluate the best available evidence in support of the association between periodontal status in women and pregnancy outcome of preterm low birth weight. We hypothesize that the traditional limits of research synthesis must be expanded to incorporate a translational component. As a proof-of-concept model, we propose that this CSCSR can yield greater validity of efficacy and effectiveness through supplementing its recommendations with data of the proteomic signature of periodontal disease in pregnancy, which can contribute to addressing specifically the predictive validity for adverse outcomes. For this CRCSR, systematic reviews were identified through The National Library of MedicinePubmed, The Cochrane library, CINAHL, Google Scholar, Web of Science, and the American Dental Association web library. Independent reviewers quantified the relevance and quality of this literature with R-AMSTAR. Homogeneity and inter-rater reliability testing were supplemented with acceptable sampling analysis. Research synthesis outcomes were analyzed qualitatively toward a Bayesian inference, and converge to demonstrate a definite association between maternal periodontal disease and pregnancy outcome. This CRCSR limits heterogeneity in terms of periodontal disease, outcome measure, selection bias, uncontrolled confounders and effect modifiers. Taken together, the translational CRCSR model we propose suggests that further research is advocated to explore the fundamental mechanisms underlying this association, from a molecular and proteomic perspective.     

A Systematic Review of the Literature Addressing Veterinary Care for Underserved Communities

Currently, there is a care gap in veterinary medicine affecting low-income and underserved communities, resulting in decreased nonhuman-animal health and welfare. The use of low-price and community veterinary clinics in underserved populations is a strategy to improve companion-animal health through preventative care, spay/neuter, and other low-price care programs and services. Little research has documented the structure and effectiveness of such initiatives. This systematic review aimed to assess current published research pertaining to accessible health care, community-based veterinary medicine, and the use of community medicine in teaching programs. The review was an in-depth literature search identifying 51 publications relevant to the importance, benefits, drawbacks, and use of low-price and community clinics in underserved communities. These articles identified commonly discussed barriers to care that may prevent underserved clientele from seeking veterinary care. Five barriers were identified including the cost of veterinary care, accessibility of care, problems with or lack of veterinarian–client communication, culture/language, and lack of client education. The review also identified a need for additional research regarding evidence of effectiveness and efficiency in community medicine initiatives.     

Surgical treatment of osteoarthritis of the carpometacarpal joint of the thumb: a systematic review

In most cases of basal joint osteoarthritis, surgery becomes an option at stages II, III, and IV, as classified by Eaton. Controversy exists regarding which technique achieves the best outcome. This systematic review was undertaken to address the question of which technique, if any, offers the best outcome to patients with osteoarthritis of the first carpometacarpal joint greater than stage II. A thorough search of the electronic databases Cochrane, Cinahl, Healthstar, and MEDLINE/PubMed was undertaken to identify reviews and articles on primary comparative studies of the different surgical options. The methodological quality of the retrieved articles was assessed on the basis of specific criteria. Inclusion criteria were applied to 44 of 254 possibly relevant articles. Eight reviews and 18 comparative studies met the criteria and were reviewed. Each of the techniques, arthrodesis, trapeziectomy with or without biological/synthetic interposition, osteotomy, and joint replacement, was associated with unique benefits and risks. There was great variability in outcome measurements. The majority of retrieved review articles claim that ligamentous reconstruction and tendon interposition may represent the best option; however, validity assessment of these studies revealed methodological flaws. Furthermore, results from the articles on comparative studies indicate that ligamentous reconstruction and tendon interposition may provide no additional benefit when compared with arthrodesis and trapeziectomy alone or with tendon interposition. There is no consensus as to which clinical outcomes are most important in thumb basal joint surgery and how these should be measured. This renders the appraisal and comparison of such studies a challenging task. Until large randomized controlled trials that compare techniques in similar populations with respect to staging and prognostic factors are undertaken and the clinical outcomes are clearly defined, surgeons will continue to claim superiority of one technique over another without supporting evidence.     

The Contribution of Systematic Review and Meta-Analysis Methods to Human Health Risk Assessment: Neurobehavioral Effects of Manganese

Current methods of human health risk assessment may lack transparency in respect of identification, review, and synthesis of potentially relevant human and animal evidence. The nature, degree, and source of uncertainties are often unclear. This article aims to demonstrate the contribution that systematic review and meta-analysis methods can make to providing more structured, transparent, and systematic risk assessments. We focus on disparities between five risk assessments for neurobehavioral effects of manganese, and then illustrate advantages of a systematic approach. Fifty-five human epidemiological studies and 37 animal experiments were identified. Where appropriate, meta-analysis methods demonstrated consistent adverse effects associated with manganese exposure across species. In particular, there was reduced activity in subjects exposed to manganese, although exposed rats tended to be more active than controls. Limitations of exposure measurement and reporting restricted use of more quantitative methods of evidence synthesis. From a methodological viewpoint, we conclude that systematic review and meta-analysis methods can contribute to a more systematic and transparent human health risk assessment making more efficient use of available evidence, compared to current methods of risk assessment. More complex methods could encompass further differences between relevant studies and so further improve the risk assessment process.     

The impact of eHealth on the quality and safety of health care: a systematic overview

Background

There is considerable international interest in exploiting the potential of digital solutions to enhance the quality and safety of health care. Implementations of transformative eHealth technologies are underway globally, often at very considerable cost. In order to assess the impact of eHealth solutions on the quality and safety of health care, and to inform policy decisions on eHealth deployments, we undertook a systematic review of systematic reviews assessing the effectiveness and consequences of various eHealth technologies on the quality and safety of care.

Methods and Findings

We developed novel search strategies, conceptual maps of health care quality, safety, and eHealth interventions, and then systematically identified, scrutinised, and synthesised the systematic review literature. Major biomedical databases were searched to identify systematic reviews published between 1997 and 2010. Related theoretical, methodological, and technical material was also reviewed. We identified 53 systematic reviews that focused on assessing the impact of eHealth interventions on the quality and/or safety of health care and 55 supplementary systematic reviews providing relevant supportive information. This systematic review literature was found to be generally of substandard quality with regards to methodology, reporting, and utility. We thematically categorised eHealth technologies into three main areas: (1) storing, managing, and transmission of data; (2) clinical decision support; and (3) facilitating care from a distance. We found that despite support from policymakers, there was relatively little empirical evidence to substantiate many of the claims made in relation to these technologies. Whether the success of those relatively few solutions identified to improve quality and safety would continue if these were deployed beyond the contexts in which they were originally developed, has yet to be established. Importantly, best practice guidelines in effective development and deployment strategies are lacking.

Conclusions

There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated, despite being frequently promoted by policymakers and “techno-enthusiasts” as if this was a given. In the light of the paucity of evidence in relation to improvements in patient outcomes, as well as the lack of evidence on their cost-effectiveness, it is vital that future eHealth technologies are evaluated against a comprehensive set of measures, ideally throughout all stages of the technology''s life cycle. Such evaluation should be characterised by careful attention to socio-technical factors to maximise the likelihood of successful implementation and adoption. Please see later in the article for the Editors'' Summary     

On the lack of consensus over the meaning of openness: an empirical study

This study set out to explore the views and motivations of those involved in a number of recent and current advocacy efforts (such as open science, computational provenance, and reproducible research) aimed at making science and scientific artifacts accessible to a wider audience. Using a exploratory approach, the study tested whether a consensus exists among advocates of these initiatives about the key concepts, exploring the meanings that scientists attach to the various mechanisms for sharing their work, and the social context in which this takes place. The study used a purposive sampling strategy to target scientists who have been active participants in these advocacy efforts, and an open-ended questionnaire to collect detailed opinions on the topics of reproducibility, credibility, scooping, data sharing, results sharing, and the effectiveness of the peer review process. We found evidence of a lack of agreement on the meaning of key terminology, and a lack of consensus on some of the broader goals of these advocacy efforts. These results can be explained through a closer examination of the divergent goals and approaches adopted by different advocacy efforts. We suggest that the scientific community could benefit from a broader discussion of what it means to make scientific research more accessible and how this might best be achieved.     

抑郁症治疗的循证医学研究进展

循证医学是近年来国际上临床医学领域迅速发展起来的新学科,已成为当前国际医学研究中的热点之一,是指对病人的诊 断、治疗、预防、康复和其他决策应建立在当前最佳临床研究证据,是遵循证据的临床医学,强调收集最佳证据。其理念的科学性 和有效性迅速渗透到医学领域的众多学科,循证精神卫生也相继提出并发展。抑郁症是由各种原因引起的以抑郁为主要症状的 一组心境障碍或情感性障碍,近几年能够有效运用循证医学方法为治疗抑郁症寻找最佳临床证据,制定循证诊疗指南成为了临 床医生的迫切要求。本文就抑郁症治疗方面的循证医学研究进展做一综述。     

The assessment and management of insomnia: an update

Insomnia poses significant challenges to public health. It is a common condition associated with marked impairment in function and quality of life, psychiatric and physical morbidity, and accidents. As such, it is important that effective treatment is provided in clinical practice. To this end, this paper reviews critical aspects of the assessment of insomnia and the available treatment options. These options include both non‐medication treatments, most notably cognitive behavioral therapy for insomnia, and a variety of pharmacologic therapies such as benzodiazepines, “z‐drugs”, melatonin receptor agonists, selective histamine H1 antagonists, orexin antagonists, antidepressants, antipsychotics, anticonvulsants, and non‐selective antihistamines. A review of the available research indicates that rigorous double‐blind, randomized, controlled trials are lacking for some of the most commonly administered insomnia therapies. However, there are an array of interventions which have been demonstrated to have therapeutic effects in insomnia in trials with the above features, and whose risk/benefit profiles have been well characterized. These interventions can form the basis for systematic, evidence‐based treatment of insomnia in clinical practice. We review this evidence base and highlight areas where more studies are needed, with the aim of providing a resource for improving the clinical management of the many patients with insomnia.     

Gene-chip studies of adipogenesis-regulated microRNAs in mouse primary adipocytes and human obesity

Background

Research has investigated whether communication technologies (e.g. mobile telephony, forums, email) can be used to transfer digital information between healthcare professionals and young people who live with diabetes. The systematic review evaluates the effectiveness and impact of these technologies on communication.

Methods

Nine electronic databases were searched. Technologies were described and a narrative synthesis of all studies was undertaken.

Results

Of 20,925 publications identified, 19 met the inclusion criteria, with 18 technologies assessed. Five categories of communication technologies were identified: video-and tele-conferencing (n = 2); mobile telephony (n = 3); telephone support (n = 3); novel electronic communication devices for transferring clinical information (n = 10); and web-based discussion boards (n = 1). Ten studies showed a positive improvement in HbA1c following the intervention with four studies reporting detrimental increases in HbA1c levels. In fifteen studies communication technologies increased the frequency of contact between patient and healthcare professional. Findings were inconsistent of an association between improvements in HbA1c and increased contact. Limited evidence was available concerning behavioural and care coordination outcomes, although improvement in quality of life, patient-caregiver interaction, self-care and metabolic transmission were reported for some communication technologies.

Conclusions

The breadth of study design and types of technologies reported make the magnitude of benefit and their effects on health difficult to determine. While communication technologies may increase the frequency of contact between patient and health care professional, it remains unclear whether this results in improved outcomes and is often the basis of the intervention itself. Further research is needed to explore the effectiveness and cost effectiveness of increasing the use of communication technologies between young people and healthcare professionals.     

Gezamenlijke besluitvorming zorgt voor een betere toepassing van evidence-based medicine in de geriatrische patiënt

Evidence based medicine (EBM) is the integration of the best research evidence, clinical expertise and patient values in the decision making process for patient care. However, elderly people are often excluded from participating in scientific studies and they often have multiple morbidities, which complicates the application of EBM. Shared decision making (SDM), a process where clinicians and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options, to achieve appropriate treatment can help to shape EBM for this group of patients.In this article, we provide tools for finding relevant literature for the geriatric patient population and for shaping the SDM process to achieve personalized care.