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The relationship between efficacy and methodology in studies investigating EMDR treatment of PTSD.

The controlled treatment outcome studies that examined the efficacy of EMDR in the treatment of posttraumatic stress disorder have yielded a range of results, with the efficacy of EMDR varying across studies. The current study sought to determine if differences in outcome were related to methodological differences. The research was reviewed to identify methodological strengths, weaknesses, and empirical findings. The relationships between effect size and methodology ratings were examined, using the Gold Standard (GS) Scale (adapted from Foa & Meadows, 1997). Results indicated a significant relationship between scores on the GS Scale and effect size, with more rigorous studies according to the GS Scale reporting larger effect sizes. There was also a significant correlation between effect size and treatment fidelity. Additional methodological components not detected by the GS Scale were identified, and suggestions were made for a Revised GS Scale. We conclude by noting that methodological rigor removes noise and thereby decreases error measurement, allowing for the more accurate detection of true treatment effects in EMDR studies.

Cognitive Behavioral Therapy↗

Specific laboratory methodologies achieve higher model for endstage liver disease (MELD) scores for patients listed for liver transplantation.

Priority for liver transplantation is currently based on the Model for Endstage Liver Disease (MELD) score, a mathematical function which includes the following objective variables: bilirubin, creatinine (Cr), and international normalized ratio (INR). We have noted that specific laboratory methodologies may yield consistently higher values of bilirubin, Cr, and INR. Therefore, we performed a study to determine if higher MELD scores could be obtained by utilizing laboratory methodologies selected to return higher laboratory values than standard methodologies used in our hospital's clinical laboratory. Phlebotomy was performed for routine clinical indications in 29 consecutive patients listed for liver transplantation. MELD scores were calculated using bilirubin, Cr, and INR from laboratory methods in our hospital's clinical laboratory (designated Lab #1) and from 2 other clinical laboratories (designated Lab #2 and Lab #3). The mean MELD score in our hospital's clinical laboratory (Lab #1) (13.6) was not significantly different than in Lab #2 (14.7), but in Lab #3, it was significantly higher by 20% (17.1), P <.03. Virtually all of the difference in MELD score between our hospital's clinical laboratory (Lab #1) and Lab #3 could be attributed to the INR, which was significantly higher by 26% in Lab #3 (1.9) vs. Lab #1 (1.4), P <.00002. Using MELD scores calculated from our hospital's clinical laboratory, the average change in priority for liver transplantation was from the 58th percentile to the 77th percentile (compared to Lab #3), P =.01. In conclusion, patients listed for liver transplantation at our center achieved significantly higher MELD scores and therefore a higher priority for liver transplantation by using laboratory methodologies that yield higher INR values than our hospital laboratory. The selection of laboratory methodologies may have a significant impact on MELD score.

Bilirubin↗

Toxicological risk assessment in the courtroom: are available methodologies suitable for evaluating toxic tort and product liability claims?

Courts are increasingly faced with the need to resolve claims by individuals that they have been injured by chemical exposures or that they have been put at sufficient risk by such exposures that their health status must be monitored to ensure the earliest possible detection of developing injuries or diseases. This paper offers the view that the principles and methods developed and applied by toxicologists, epidemiologists, and risk assessors to support regulatory and public health decision-making are inadequate to evaluate the types of claims that courts are called upon to resolve in such cases. No well-described alternative methodology appears to be available, and as a result, courts are exposed to a wide range of expert opinions based on diverse, conflicting, and sometimes baseless methodologies. It is suggested that there may be value in an effort by the community of professionals in toxicology, epidemiology, and risk assessment to devote attention to the types of data and scientific methodologies that might be appropriate for evaluating the technical questions that such claims provoke. Such an effort might assist trial judges in the role they have been assigned in the Supreme Court's 1993 Daubert decision, wherein they are asked to make a preliminary assessment of the admissibility of the scientific methodologies relied upon by various experts. Such an assessment, if based on an understanding of the types of data and methodologies suitable for evaluating claims of injury, offers the possibility of limiting the range of expert opinion that ultimately is heard in courtrooms to that which conforms to scientifically valid standards. Copyright 1998 Academic Press.

Journal Article↗

Process reengineering: the role of a planning methodology and picture archiving and communications system team building.

The acquisition of a picture archiving and communications system (PACS) is an opportunity to reengineer business practices and should optimally consider the entire process from image acquisition to communication of results. The purpose of this presentation is to describe the PACS planning methodology used by the Department of Defense (DOD) Joint Imaging Technology Project Office (JITPO), outline the critical procedures for each phase, and review the military experience using this model. The methodology is segmented into four phases: strategic planning, clinical scenario planning, installation planning, and implementation planning. Each is further subdivided based on the specific tasks that need to be accomplished within that phase. By using this method, an institution will have clearly defined program goals, objectives, and PACS requirements before vendors are contacted. The development of an institution-specific PACS requirement should direct the process of proposal comparisons to be based on functionality and exclude unnecessary equipment. This PACS planning methodology is being used at more than eight DOD medical treatment facilities. When properly executed, this methodology facilitates a seamless transition to the electronic environment and contributes to the successful integration of the healthcare enterprise. A crucial component of this methodology is the development of a local PACS planning team to manage all aspects of the process. A plan formulated by the local team is based on input from each department that will be integrating with the PACS. Involving all users in the planning process is paramount for successful implementation.

Computer Systems↗

Analysis of methodological deficiencies of studies reporting surgical outcome following cemented total-joint arthroplasty of trapezio-metacarpal joint of the thumb.

Cemented total-joint arthroplasty has been increasingly used in the treatment of end stage arthritis of the thumb trapeziometacarpal joint. Evidence supporting its use in the treatment of trapeziometacarpal disorders in the literature is very limited. Most hand surgeons agree that there are concerns about the methodological quality of the limited literature available. In this study, we analysed the methodological quality of the outcome studies on cemented total-joint arthroplasty of the thumb. We included all the outcome studies published in the English literature on cemented total-joint arthroplasty of the trapeziometacarpal joint of thumb. We analysed these studies for methodological deficiencies and quality of outcome reporting based on the recommendations given by Coleman et al. Our study revealed that there were no uniform standards of outcome reporting. The mean Coleman score for the studies dealing with cemented total-joint arthroplasty of the thumb was 42.9. Major deficiencies were identified in areas like subject selection criteria (0/15), type of study (5.7/15), description of surgical procedure (3.7/5), description of the rehabilitation protocol (2/10), outcome measures (4.4/10) and outcome assessment (3.9/15). The methodological quality of the studies published within the last 10 years (49.9+/-9.7) was found to be slightly better than the studies published over 10 years ago (39.7+/-7.8). Our study highlights the need for more evidence in the form of randomised controlled prospective studies conducted with good methodological quality, comparing the cemented total-joint arthroplasty of the thumb to other procedures available for the treatment of disorders of the thumb. Further, to improve the standards of reporting, journal editors should try to standardise the outcome of the reporting by following the surgical procedures on the thumb.

Arthroplasty, Replacement↗

Operant conditioning methodology in the assessment of food preferences: introductory comments.

This paper provides a general introduction to the methodology used in the next three papers of this monograph to test dogs' food preferences. This "operant conditioning" methodology was developed in behavioral laboratories concerned with learning in animals. The logic of the methodology is described, some technical and practical aspects of the methodology are summarized, and its application in the hedonic-scaling of qualitatively different foods is discussed. The relation between this new methodology and the traditional two-bowl preference test is reviewed.

Animals↗

Bayesian methodology incorporating expert judgment for ranking countermeasure effectiveness under uncertainty: example applied to at grade railroad crossings in Korea.

Transportation professionals are sometimes required to make difficult transportation safety investment decisions in the face of uncertainty. In particular, an engineer may be expected to choose among an array of technologies and/or countermeasures to remediate perceived safety problems when: (1) little information is known about the countermeasure effects on safety; (2) information is known but from different regions, states, or countries where a direct generalization may not be appropriate; (3) where the technologies and/or countermeasures are relatively untested, or (4) where costs prohibit the full and careful testing of each of the candidate countermeasures via before-after studies. The importance of an informed and well-considered decision based on the best possible engineering knowledge and information is imperative due to the potential impact on the numbers of human injuries and deaths that may result from these investments. This paper describes the formalization and application of a methodology to evaluate the safety benefit of countermeasures in the face of uncertainty. To illustrate the methodology, 18 countermeasures for improving safety of at grade railroad crossings (AGRXs) in the Republic of Korea are considered. Akin to "stated preference" methods in travel survey research, the methodology applies random selection and laws of large numbers to derive accident modification factor (AMF) densities from expert opinions. In a full Bayesian analysis framework, the collective opinions in the form of AMF densities (data likelihood) are combined with prior knowledge (AMF density priors) for the 18 countermeasures to obtain 'best' estimates of AMFs (AMF posterior credible intervals). The countermeasures are then compared and recommended based on the largest safety returns with minimum risk (uncertainty). To the author's knowledge the complete methodology is new and has not previously been applied or reported in the literature. The results demonstrate that the methodology is able to discern anticipated safety benefit differences across candidate countermeasures. For the 18 at grade railroad crossings considered in this analysis, it was found that the top three performing countermeasures for reducing crashes are in-vehicle warning systems, obstacle detection systems, and constant warning time systems.

Accidents, Traffic↗

Trend in methodological quality of randomised clinical trials in low back pain.

During the past decades, the number of published randomised clinical trials evaluating the efficacy of conservative treatments for low back pain has substantially increased. At the same time several initiatives were undertaken in order to improve the methodological quality of published randomised clinical trials, also in the field of low back pain. We investigated how the methodological quality of randomised clinical trials in the field of low back pain developed over time since the first published trial in 1961. Methodological scores of 269 RCTs included in 15 Cochrane reviews of conservative treatment for low back pain were compared. Overall many trials showed methodological shortcomings. The median overall quality scores ranged from 36 to 82% depending on the type of intervention. There were no improvements in median overall methodological quality over time from 1960 to 2004. Improvements were apparent for a few validity criteria only.

Humans↗

Comparative study for the detection of peritubular capillary C4d deposition in human renal allografts using different methodologies.

Detection of peritubular capillary (PTC) C4d deposition in tissue sections of renal allograft biopsies became an important aid in the diagnosis of antibody-mediated rejection. Pathologists in many major transplant centers now routinely stain renal allograft biopsies for C4d. Currently, there are 3 commercially available antibodies. Two of these antibodies are monoclonal and are usually used with either a 3- or a 2-step indirect immunofluorescence (IF) methodology on frozen sections. A polyclonal antibody is used on formalin-fixed, paraffin-embedded tissue section with an immunoperoxidase detection system. The goal of our study was to compare these antibodies and methodologies in our renal allograft biopsy material. Twenty renal allograft biopsies with diffuse or focal PTC C4d staining, using immunofluorescence methods on frozen sections, were selected for this study. These biopsies were tested with the 3 commercially available anti-C4d antibodies (Biogenesis, Brentwood, Calif, cat no. 222-8004; Quidel Corporation, Santa Clara, Calif, cat no. A213; and ALPCO Diagnostic, Windham, NH, cat no. 004-BI-RC4D). Both monoclonal antibodies (Biogenesis and Quidel) were tested with a 3- and a 2-step indirect IF method on frozen sections. The polyclonal antibody (ALPCO) was applied to formalin-fixed paraffin sections using immunoperoxidase methodology. In selected cases, the polyclonal antibody was tested on frozen sections with a 3-step indirect IF method. To exclude possible false-negative staining with the IF method, we selected 10 additional biopsies that showed PTC margination of inflammatory cells, but were C4d-negative or only focally positive, and tested them with the ALPCO antibody on paraffin sections. We have found that all methodologies and antibodies tested provided adequate results with only minor differences between them. Perhaps the most sensitive method is the 3-step indirect IF on frozen sections using one of the monoclonal antibodies. We prefer the 2-step indirect IF method with the Quidel monoclonal antibody because of its simplicity, quick turnaround time, and relatively low cost. The advantages and disadvantages of the individual methodologies are discussed.

Antibodies↗

The AETL methodology as a potential solution to current challenges associated with the development and use of acute exposure levels in Seveso II applications.

This paper analyses current trends in the development and use of acute exposure levels in Europe for the implementation of the Seveso II Directive [Council Directive 96/82/EC of December 9, 1996 on the control of major-accident hazards involving dangerous substances. Official Journal of the European Communities, vol. L 10, January 14, 1997, Luxembourg, pp. 13-33]. It also describes a new initiative to develop a European methodology for deriving acute exposure threshold levels that responds to emerging needs in this area. The need for acute exposure values to predict human health effects of potential accidents on exposed populations has burgeoned in recent years. As the driving legislation for managing industrial hazards in Europe, the Seveso II Directive has particularly influenced this trend. Yet at this time it is questionable whether the availability and range of acute exposure values for toxic substances has kept apace with the growing need. Results of a survey of Seveso II competent authorities in the EU-15 revealed that a variety of different types of acute exposure values (AEGLs, EPRGs, etc.) are used for Seveso II applications. Moreover, a comparison of these values indicates gaps in coverage of substances as well as inconsistencies in terms of how health effects and exposure periods are defined for each type. These findings highlight an opportunity for greater collaboration on scientific inputs to application of the Directive in Europe. The ACUTEX project is an EU-funded research project aimed at furthering scientific exchange and collaboration in support of the development of acute exposure levels for toxic substances in Europe. Its goal is to develop a European methodology for deriving acute exposure threshold levels (AETLs). In particular, it provides the possibility for a common European platform for developing additional acute exposure values to meet emerging needs and cover more chemical substances. To maximise success, the work plan is designed to meet two very important challenges, the need to complement and add value to the existing array of acute exposure methodologies and the necessity of meeting requirements of a diverse range of European stakeholders. As such the project will draw on collaboration among European scientists and process of deliberation among stakeholders to deliver the following key results: (1) to facilitate wide acceptance of the methodology in Europe by both the scientific community and communities of different end-users; (2) to provide greater equivalence and transparency in implementation of the Seveso II Directive across the Member States, specifically through the development of common scientific bases for assessing risks and making risk management decisions related to toxic releases; (3) to produce a methodology that remains open to future collaboration on derivation of acute exposure levels on a European and a global basis.

Accident Prevention↗

A methodology for solid waste characterization based on diminishing marginal returns.

A methodology is developed for estimating the number of waste sorts for characterizing solid wastes into categories based on diminishing minimum incremental information. Convergence in the square of the coefficient of variation with successive waste sorts is used to indicate cost-efficient termination of sampling at substantially reduced numbers of sorts in comparison with existing methodologies. These findings indicate that the numbers of waste sorts beyond that determined using the proposed methodology do not add substantial marginal gains in information and/or reduction in the confidence interval of the estimate. The methodology is demonstrated using waste composition analyses from the Greater Vancouver Regional District where 22 waste sorts are examined. The proposed methodology is simple, and the number of waste sorts can be estimated with a hand-held calculator and utilized in the field.

Confidence Intervals↗

Methodology citations and the quality of randomized controlled trials in obstetrics and gynecology.

OBJECTIVES: Randomized controlled trials offer the best chance for valid treatment comparisons, yet most trials are of poor quality. This may reflect a lack of awareness of the requirements for conducting and reporting this type of research. If so, then citation of methodology references might indicate knowledge of how to conduct these studies and vice versa. Our study tests the hypothesis that the methodologic quality of published trials is related to citation of methodology references. STUDY DESIGN: We performed a hand search of the American Journal of Obstetrics and Gynecology, the British Journal of Obstetrics and Gynaecology, the Journal of Obstetrics and Gynaecology, and Obstetrics and Gynecology to identify all randomized controlled trials published in 1990 and 1991 (N = 206). We reviewed the reference lists of all reports of randomized controlled trials and evaluated the adequacy of randomization methods by accepted criteria. RESULTS: Most reports (81.6%) cited no methodology text or article. Although lack of any methodology reference was not significantly related to failure to report an adequate random method of sequence generation, this was highly related (p < 0.001) to failure to report adequate allocation concealment. Scanning the reference list of reports took a mean of 16 seconds and identified most poorly done trials. CONCLUSIONS: Investigators who conduct randomized controlled trials should be thoroughly familiar with this type of research or should get expert help. Poorly done trials are wasteful and often misleading.

Bibliographies as Topic↗

US EPA's acute reference exposure methodology for acute inhalation exposures.

The US Environmental Protection Agency (EPA) National Center for Environmental Assessment is engaged in the development of a methodology for Agency use to perform risk assessments for non-cancer effects due to acute inhalation exposures. The methodology will provide general guidance for deriving chemical-specific acute exposure benchmarks called acute reference exposures (AREs). Chemical-specific AREs are analogous to reference concentra tions (RfCs) for chronic non-cancer effects and will be incorporated in chemical-specific files in the US EPA's Integrated Risk Information System (IRIS) as they are developed and reviewed. AREs will have wide applicability in assessing the potential health risks of accidental and routine acute releases of chemicals to the environment. The proposed methodology for ARE development provides a framework for choosing an optimal derivation approach, depending on the type of data available, from the no-observed-adverse-effect level (NOAEL), benchmark concentration (BMC), or categorical regression approaches. Uncertainty factors are applied to the point of departure, determined by one of the recommended approaches, to derive the ARE. Due to the capability to use more exposure-response information than the NOAEL approach allows, exposure-response analyses such as BMC and categorical regression are favored as methods to develop the point of departure when the available database will support such analyses. The NOAEL approach is suitable when the data are insufficient to support exposure-response modeling. Applications of the proposed ARE methodology are illustrated by the derivation of example AREs for hydrogen sulfide and hexachlorocyclopentadiene, which showcase the categorical regression and NOAEL approaches, respectively. In addition, a recent review of the proposed ARE methodology by the US EPA Risk Assessment Forum is discussed.

Air Pollutants↗

The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist.

The "Consolidated Standards of Reporting Trials" (CONSORT) was developed to improve the suboptimal reporting of randomized controlled trials (RCTs). However, little is known about the quality of reporting since this publication. We undertook an observational study to determine the quality of reporting key methodological factors in RCTs since the publication of the CONSORT statement and if a journal policy to promote adherence to the CONSORT checklist was associated with superior reporting. We recorded the reporting of 11 key methodological factors in 105 RCTs from 29 medical journals published subsequent to the CONSORT statement. We examined the quality of reporting in relation to whether a journal was a "CONSORT promoter" as defined by inclusion of the CONSORT checklist in a journal's "information to authors" section or a requirement that authors, manuscript reviewers, or copy editors complete the CONSORT checklist. Multivariate analysis controlled for journal impact factor, study outcome, and time of publication. Six of the 11 methodological factors were reported <50% of the time. The number of methodological factors reported was greater in CONSORT promoters than in journals not promoting CONSORT in both unadjusted (6.0 and 5.1, respectively, p-value = 0.03) and adjusted (6.4 and 4.8 of the 11 methodological factors, respectively, p-value = 0.0001) analyses. While journals that promote CONSORT demonstrate superior reporting of RCTs, persistent inadequacies in reporting remain. Until these inadequacies are resolved health-care providers will remain limited in their ability to make informed inferences about the validity of the studies upon which they base their clinical practice.

Guideline Adherence↗

Evaluation of the research methodology in genetic, molecular and proteomic tests.

INTRODUCTION: The advances in genomic analysis technologies have conducted to the development of new diagnostic tests in the clinical practice. As well as it happened in other diagnostic fields, the knowledge of the main flaws affecting genetic investigation will facilitate the application of the results. METHODS: We included 44 original articles that evaluate diagnostic exactitude of genetic and molecular tests (including proteomic), published from 2002 to June 2005 in five international publications: JAMA, Lancet, New England Journal of Medicine, Cancer Research and Clinical Cancer Research. We examined adherence to 24 methodological criteria included in the guide STARD (Standards for Reporting of Diagnostic Accuracy. RESULTS: The mean number of methodological criteria satisfied was 9.8 (95% CI 8.8-10.6); the greater deficiencies were in aspects related to the description of patient's selection 9 (20%), the treatment of indeterminate results 5 (11%) and the determination of test reproducibility 6 (13%). It was observed a high fulfillment in the description of the gold standard 39 (87%) and in the methodology of the test 28 (62%). DISCUSSION: The methodologic quality of the evaluated articles is lower than the quality observed in other research fields. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied and the reproducibility of the tests. The research and development of new genetic-molecular technologies requires a better fulfillment of the epidemiological and clinical criteria already followed by other diagnostic fields.

Genetic Testing↗

Trace gas emissions from German agriculture as obtained from the application of simpler or default methodologies.

For the assessment of emission inventories matching pairs of activities (emission explaining variables) and emission factors are used. Simpler and detailed methodologies are proposed within the emission inventory handbooks. The data sets needed to serve the detailed methodologies have not been at public disposal so far. Therefore, this paper investigates the applicability of simpler methodologies to the statistical data sets of activities officially available in Germany. The statistical data base for the assessment of emissions from fertilised soils is adequate if one assumes that fertilisers sold in one financial year are applied in the same year. For grassland, statistical data describing the actual management do not exist. Lack of nitrogen inputs with crop residues and due to nitrogen fixation make it impossible to deduce the respective emissions. The assessment of indirect emissions due to reactions of leached nitrogen is also impossible. For extensively managed grasslands, data concerning fertiliser application or grazing are missing when calculating emissions. The determination of emissions from organic soils presupposes the knowledge of both the area concerned and the degree of mineralisation which has been attained at the time of the inventory. The results of the biennial animal census meet the requirements of the simpler methodologies. However, the assumptions made to evaluate the mean emission factors are not correct in many cases, as far as animal performance, housing, storage and application of animal excreta are concerned. The simpler methodologies are biassed, as the emission factors are (Northwest) European means. Changes in the raising of statistical data make the construction of meaningful time-series difficult.

Agrochemicals↗

Economic analyses of radiological procedures: a methodological evaluation of the medical literature.

OBJECTIVE: Increasing pressure to curb health care costs has led to considerable interest in economic analyses, including both cost-effectiveness and cost-benefit analyses. Numerous economic analyses of radiological procedures have appeared in both the radiology and non-radiology literature. The objective of this study was to evaluate the methodological quality of economic analyses of radiological procedures published in the non-radiology medical literature during the years 1990 1995. METHODS: Original investigations from the medical (non-radiological) literature that include economic analyses of radiological interventions were identified from a computerized literature search. Each economic analysis article was evaluated by two independent reviewers for adherence to ten methodological criteria. The criteria were derived from review of the medical and radiological economic analysis methodology literature and consisted of the following: (1) Comparative options stated; (2) perspective of analysis defined; (3) outcome measure identified; (4) cost data included; (5) source of cost data stated; (6) long term costs included; (7) discounting employed; (8) summary measure provided; (9) incremental computation method used; and (10) sensitivity analysis performed. The results were compared to a previous study that evaluated the radiological literature. RESULTS: Of the 56 articles in the medical literature that included economic analyses of radiological procedures, only eight (14%) conformed to all ten methodological criteria. The cost data (98%) and comparative options (89%) criteria exhibited high compliance, while the perspective of analysis (25%) and discounting (32%) criteria had relatively low compliance. Agreement between the reviewers was excellent (kappa = 0.88). CONCLUSIONS: Published economic analyses of radiology procedures usually do not meet accepted methodological standards.

Bibliometrics↗

Comparing methodological quality and consistency of international guidelines for the management of patients with chronic heart failure.

BACKGROUND: Guidelines (GLs) for the management of heart failure (HF) are of great importance in order to define and disseminate therapeutic recommendations based on scientific evidence. The aim was to analyse and to compare the methodological quality of HF GLs as well as to evaluate the consistency of therapeutic recommendations. METHODS: Eleven international GLs for the management of chronic HF were identified by search of the internet, electronic databases and references of published literature. Their methodological quality was assessed by two different appraisal instruments: (1) according to the US National Guideline Clearinghouse (NGC) on a scale from 0 to 17 points, (2) according to the German Guideline Clearinghouse (Agency for Quality in Medicine, AQUMED) on a scale from 0 to 44 points. Clinical criteria for assessment of the consistency of the recommendations included diagnostic testing, pharmacological and non-pharmacological treatment. RESULTS: The quality scores of the GLs varied substantially with a range of 1.5-15.5 points (NGC) and 8-30 points (AQUMED). The greatest variation was found in the dimensions "development" and "evidence". Only 3 of the 11 GLs (approximately 30%) were rated as methodologically well prepared. The recommendations on diagnostic procedures and medical management were rather consistent among the different GLs. CONCLUSIONS: Published international GL recommendations on medical management of patients with chronic HF are broadly consistent. The methodological quality of the GLs, however, varies to a great extent. Improvement is needed in most methodological aspects, especially in the dimensions "evidence" and "applicability".

Chronic Disease↗