Evidence-based Medicine Information Research Articles

Feasibility study on evidence-based medicine information services of hospital libraries in Hebei Province

To investigate the status of the evidence-based medicine （EBM） information services of the hospital libraries in Hebei Province. The preliminary survey data indicated that a certain objective needs exists for hospital libraries to offer the EBM information service to the medical staff. The lack of service consciousness and EBM knowledge of the librarians, as well as the insufficient EBM information in-house resources are the major restraining factors. However, the advantage exists on search capabilities and time. According to the survey, there is no condition to offer exacting clinical evidence searching services by the hospital libraries in Hebei province at the present. The hospital libraries should deepen the existing literature services to the physicians based on the concept of EBM and search the literature efficiently. Key words: Hospital library; Evidence-based medicine; Information service

How can observational trials inform and improve clinical practice?

Randomized controlled trials (RCTs) are rightly considered to provide the highest quality, first-level information in evidence-based medicine, because their inherent design limits bias and confounding. However, a number of aspects of their design and conduct mean that they do not always accurately reflect actual clinical practice [1]: these include highly selected patient populations, treatment in specialist centers, and intensive clinical supervision and follow-up. Observational studies include a wide range of study designs (cohort, case control, and cross-sectional), the common feature of which is that they are non-interventional, although the participants are often selected on the basis of having previously had a specific intervention in the course of routine clinical practice. Such observational studies may include prospective data ascertainment, and are often used to assess the performance of therapies in the post-licensing period. Here, ‘noninterventional’ means that people are only enrolled into the study once they have been started on a particular therapy. Because observational trials are not randomized, they are susceptible to bias and confounding, and, while likely biases can be compensated for in the design and/or the statistical analysis, unknown factors may also influence results [2]. Another limiting factor is that many prospective observational trials lack a control population. With these reservations, data from observational trials can complement those from RCTs by providing an insight into how treatments perform in dayto-day practice in more clinically representative patient populations. Because of cost and resource advantages they are also applicable to larger and more diverse populations. The first article in this supplement will examine the different types of observational trials, how they differ from RCTs, and the relevance of the information they provide. Additionally, the roles of healthcare professionals, health authorities, and industry in the planning and conduct of such studies will be examined [3].

Biomedical research competencies for osteopathic medical students

BackgroundWithout systematic exposure to biomedical research concepts or applications, osteopathic medical students may be generally under-prepared to efficiently consume and effectively apply research and evidence-based medicine information in patient care. The academic literature suggests that although medical residents are increasingly expected to conduct research in their post graduate training specialties, they generally have limited understanding of research concepts.With grant support from the National Center for Complementary and Alternative Medicine, and a grant from the Osteopathic Heritage Foundation, the University of North Texas Health Science Center (UNTHSC) is incorporating research education in the osteopathic medical school curriculum. The first phase of this research education project involved a baseline assessment of students' understanding of targeted research concepts. This paper reports the results of that assessment and discusses implications for research education during medical school.MethodsUsing a novel set of research competencies supported by the literature as needed for understanding research information, we created a questionnaire to measure students' confidence and understanding of selected research concepts. Three matriculating medical school classes completed the on-line questionnaire. Data were analyzed for differences between groups using analysis of variance and t-tests. Correlation coefficients were computed for the confidence and applied understanding measures. We performed a principle component factor analysis of the confidence items, and used multiple regression analyses to explore how confidence might be related to the applied understanding.ResultsOf 496 total incoming, first, and second year medical students, 354 (71.4%) completed the questionnaire. Incoming students expressed significantly more confidence than first or second year students (F = 7.198, df = 2, 351, P = 0.001) in their ability to understand the research concepts. Factor analyses of the confidence items yielded conceptually coherent groupings. Regression analysis confirmed a relationship between confidence and applied understanding referred to as knowledge. Confidence scores were important in explaining variability in knowledge scores of the respondents.ConclusionMedical students with limited understanding of research concepts may struggle to understand the medical literature. Assessing medical students' confidence to understand and objectively measured ability to interpret basic research concepts can be used to incorporate competency based research material into the existing curriculum.

Readily Available Work-Around Technology for Demonstrating PDA Products to a Group

Medical Informatics increasingly emphasizes evidence-based medicine information products taken with the practitioner to the point of care. The resulting explosion of products either adapted for PDAs or specifically developed for PDAs requires librarians to demonstrate such products to groups. However, the requisite small screen size of pocket devices (which may be easily transported to the point of care) severely hinders demonstrations. Fortunately, readily available and inexpensive solutions exist for the inventive librarian. These include live demonstrations using PC cameras and document cameras, “canned” demonstrations made with electronic cameras, live demonstrations with software device emulators, and live demonstrations using software to show an actual PDA screen on a computer.

Registries as a tool in evidence‐based medicine: example of KIMS (Pfizer International Metabolic Database)

To evaluate the value of a registry, set in 'real-life practice', as a contribution to evidence-based medicine and to estimate the impact of information collected in such a registry, on the up to date knowledge in growth hormone (GH)-related disorders. Analysis of data collected prospectively for a pharmacoepidemiological registry--KIMS (Pfizer International Metabolic Database)--in assessing long-term clinical and safety outcomes of GH treatment (Genotropin) in patients with GH deficiency. The study was based on 11,374 treated (40,000 patient-years of observation) and 263 untreated adult GH deficient patients from 30 countries, in whom background characteristics, clinical values such as lipids and body composition, quality of life (QoL) and GH dosage as well as safety profile were evaluated. Citation analysis for the published papers was also performed. The study depicts the clinical picture of adult patients with GH deficiency managed in current clinical settings. It confirms the features previously detected such as increased cardiovascular risk, mostly dyslipidemia and abnormal body composition as well as impaired QoL. There was considerable heterogeneity of conditions resulting in GH deficiency. The large database also enabled study of rare causes of the condition. The 31 out of 36 KIMS papers were cited 544 times, in 125 different journals. These findings and the further insight into the response to GH replacement therapy show that the registry methodology is valuable for filling the gaps of information in evidence-based medicine that cannot be addressed by clinical trials.

Searching for evidence-based medicine in the literature. Part 3: Assessment.

After composing a pointed question for an evidence-based medicine (EBM) search and then selecting appropriate resources for its execution, the final step requires an assessment of the information gleaned: what is substantive material and what is not? Unless one is especially adept at statistics and/or EBM methodology, it may appear that one study is as good as another and, consequently, the researcher can feel muddled by the retrieval. Critical appraisal in EBM generally centers around three questions: 1) is it valid?, 2) what are the results?, and 3) is it applicable to the patient? One is trying to determine if the study’s evidence demonstrates enough rigor within its methodology to impact the course of a particular patient’s care. It may be tempting to view critical appraisal as an invitation to negate or castigate clinical study efforts but, in a real world, no study can be perfectly designed or executed. The main purpose of critical appraisal is to “assess not whether a paper is ‘rubbish’, but whether there is so much potential bias that the results are no longer valid”.1 While the determination of validity is not easy and relevance to patient care is sometimes obscured, two resources that can assist in the evaluation of good, better, and best EBM information can be accessed electronically. At the Critical Appraisal Skills Programme (CASP) section of the United Kingdom’s National Health Service web site (http://www.phru.nhs.uk/casp/appraisa.htm), a wealth of resources provides a rich repository. Especially useful are forms described as critical appraisal tools for various types of articles including systematic reviews, randomized controlled trials, cohort studies, case control studies, diagnostic test studies and economic evaluation studies. Each form consists of ten questions about each specific type of article, which are supplemented with prompts that assist in the assessment of each question topic. The questions derive from a notable series titled “Users’ Guides to the Medical Literature,” which appeared in the Journal of the American Medical Association (JAMA) from 1993 through 20002 – 34 and, as such, constitute a solid approach to evidence-based assessment. In terms of function, the forms demonstrate attention to clarity in font size, strong contrast in design, and an efficient screening section in each article type that determines whether one should proceed through all ten questions or stop. While the roomy, clear forms may be used only for an individual’s personal use, the web site also provides a method to obtaining copyright permission if one wanted to use them in a group practice or other setting. Another useful web site that offers a step-by-step approach to critical appraisal can be found at the Centre for Evidence-Based Medicine in Oxford, England (http://www.cebm.net/critical_appraisal.asp). Worksheets provided for the assessment of articles relating to diagnosis, harm, etiology, therapy and systematic reviews of therapy can be accessed separately or downloaded as a group. Each type of article evaluation requires a different approach to determination of validity; critical questions and demonstrations of specific calculations are customized for each worksheet set. The addition of statistics can be daunting, but the authors supply understandable sample calculations and then provide a practice section for the user’s skill development. The last section of the form consists of patient-related questions to focus the results of the inquiry and, as such, cinches the usefulness of the worksheets. The aim of the worksheet exercise is to determine the article’s relevance to an individual patient’s care, and these worksheets provide an effective and cogent methodology to do so. While there are many evidence-based medicine resources, it is more difficult to find those with an easy and efficient approach to a rather complex area. Without compromising quality or exhausting time, one can find respectable EBM web resources to compose a suitable question, execute a viable literature search, and then assess the trustworthiness of the materials gleaned. Certainly more time and resources are needed for extended systematic assessments, but the busy practitioner can use evidence-based medicine in daily practice and still feel comfortable about the results for specific patient care.

Randomized controlled trials as sources of information in evidence based medicine

Physicians are constantly challenged by their patients themedia, and the rapid pace of technological advance to keep abreast of new diagnostic and therapeutic developments. Evidence-based medicine (EBM) is the practice of making updated medical decisions through the judicious identification, evaluation and application of the most relevant published information. RCTs are one of the best primary sources used in EBM. Thus, evaluation of the strength and validity of the RCTs that supports the discussion on making medical decisions seems to be necessary. In this paper, main types of biases occurred during the course of an RCT as well as Assessment of RCTs as sources of information in evidence-based medicine are discussed. Key Words: RANDOMIZED CONTROLLED TRIAL, EVIDENCE BASED MEDICINE, ASSESSMENT

Systematic overview of quality of life studies for breast cancer.

The concept of quality of life (QOL) is essentially subjective, determined from the patient's point of view. Thus, an appropriate investigation and analysis of QOL as an indicator of medical treatment outcome is a task of some difficulty. The physician-led QOL assessment studies to date in Japan have suffered from insufficient knowledge and understanding of the diverse factors contributing to QOL, thereby contributing to a dearth of quality studies. Given this background, the Japanese Breast Cancer Society has established a Task Force for the development of guidelines to properly conduct QOL assessment studies. The present article reports the results of a large-scale systematic overview of QOL assessment studies for breast cancer patients that was undertaken as one part of this project. Six databases were used in this overview: MEDLINE, CINAHL, CANCERLIT, EMBASE, PsychINFO, and Japan Centra Revuo Medicina. The search period was 1982-1999 for CINAHL, and 1990-1999 for the others. Following a check of the titles, important information was recorded on relevance and data collection forms. A systematic search was conducted of the literature on QOL assessment studies for breast cancer patients, and 1,954 articles were extracted from a check of titles. Using the relevance and data collection forms, the number of articles was further narrowed to 126. These articles were then classified according to the type and design of the study, the number of QOL and psychological measures used, frequency of use of each measure, and study focus and type of intervention. The results were then compiled. To date there have been almost no appropriate systematic overviews or guidelines issued for QOL assessment studies related to breast cancer, even on the international level. The results of the present study may contribute high-quality QOL information for evidence-based medicine, as it continues to gain global prevalence.

Which coding system for therapeutic information in evidence-based medicine

The coding of information in the computer representation of clinical trials is essential both for the rationalisation of the activities involved in the production of therapeutic information for evidence-based decision support and for the integration of the messages produced by these activities with clinical information and electronic patient record systems. There is no standard coding system available, however, so building on existing evaluations, we performed a simple semi-quantitative evaluation of ICD-10, CDAM, MEDDRA, MESH, READ, SNOMED and UMLS to provide objective criteria for the choice of a coding system. Inclusion and exclusion criteria for four clinical trials recorded in TriSum constituted the corpus of evaluation texts. Criteria included coding coverage, size, integration and language coverage. The results of the comparison lead us to choose SNOMED as the most appropriate coding system for our needs. The absence of a European Medical Language System project is observed, as is the need for combinatorial as opposed to enumerative systems.

Evidence-based medicine and randomized double-blind clinical trials: a study of flawed implementation.

The randomized double-blind clinical trial (RDBCT) is a key source of information for evidence-based medicine. However, anomalous and unexplainable results have prompted suggestions that 'unknown and unidentifiable biases' may exist. This paper identifies that a possible flaw in the implementation of RDBCTs may account for these biases. The flaw relates to the breaking of the double blind through the generation of beliefs and expectations in experimenters. These, in turn, may lead to unconscious biases in assessment and cues to patients. It is then uncertain how much of an observed effect is due to such expectations or the treatment itself. Therefore, any RDBCT in which the maintenance of blinding is not monitored throughout its course is at risk of its conclusions being compromised. It is not sufficient to assert that blinding must have been maintained through arguments based on design features. The burden of proof is on the researchers to demonstrate, through data, that blinding has been maintained. The need to address social psychological issues in implementing RDBCTs is discussed and it is recommended that to avoid this confound, methods of monitoring and accounting for experimenter beliefs and expectations should be routinely included in future RDBCTs.