Development of local clinical practice guidelines in the real world: an evolving scene in China.
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ABSTRACT:
SUBMITTER: Kwong JS
PROVIDER: S-EPMC5818048 | biostudies-literature | 2017
REPOSITORIES: biostudies-literature
Publications
Development of local clinical practice guidelines in the real world: an evolving scene in China.
Heart Asia 20170616 2
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Project description:BackgroundLittle is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment.MethodThis is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil.ResultsFOUR MAIN THEMES WERE IDENTIFIED: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision.DiscussionPhysicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration.
| S-EPMC2857648 | biostudies-literature
Project description:ObjectiveClinical practice guidelines can improve healthcare processes and patient outcomes; however, the quality of these guidelines varies greatly in China. The aim of this study was to construct a comprehensive instrument for the appraisal of clinical practice guidelines in China (AGREE-CHINA), and to validate its reliability as a tool for helping potential guideline users in assessing guideline quality.MethodsFirst, an interdisciplinary working group was established for developing the methods. They also created a checklist as a tool according to the Appraisal of Guidelines, Research and Evaluation II (AGREE II) standards, considering the particularity of Chinese clinical practice. Next, the first draft of AGREE-China was developed by vote, modification, preliminary trial, and cross-verification. To ensure the objectivity, credibility, and reproducibility of the draft assessment, all of the checklists and standards were cross-reviewed fairly widely. Finally, AGREE-CHINA and AGREE II were used to assess the Chinese guidelines published in the past five years, and the results were compared.ResultsThe presented AGREE-CHINA covered five main checkpoints (science and rigor, effectiveness and safety, economy, usability and feasibility, and conflicts of interest) with each point divided into several more specific checkpoints. Definitions and rationales for each main checkpoint appear in the Appendix. The quality ratings based on the total scores of AGREE-China and AGREE II were consistent (r = 0.508, P = 0.020). Compared with AGREE II, the study showed a higher level of interrater-reliability for AGREE-CHINA overall (ICC = 0.957, P < 0.001). The mean time required for AGREE-CHINA was less than that for AGREE II; this was approximately 30 minutes for every assessment. User satisfaction was generally high.ConclusionsThis paper has presented the first edition of the AGREE-CHINA appraisal tool for clinical guidelines. It is quick and easy to use; it assesses and performs well in comparison to AGREE II. This first version of AGREE-CHINA will require further development and validation.
| S-EPMC7305446 | biostudies-literature
Project description:ObjectivesTo characterize variations in real-world treatment patterns in multiple myeloma (MM) in Portugal over a 5-year period.MethodsA retrospective cohort multicenter study using secondary data of national hospital drug consumption database from 11 Portuguese public hospitals between 2017 and 2022.ResultsNumber of MM-treated patients increased 53% over 5 years (from 825 to 1266 patients). Constant slight predominance of male patients (55%), 82% over 60 years old (median age, 70 years), and half of newly diagnosed patients were transplant-eligible. The highest growth rate was in second-line treatments, with a sixfold increase in patients in fourth-line or beyond. First-line treatment pattern remained stable both in transplant-eligible (bortezomib, cyclophosphamide and dexamethasone (VCd_, bortezomib, thalidomide and dexamethasone (VTd), and bortezomib, lenalidomide and dexamethasone (VRd)) and noneligible patients (bortezomib, melphalan and prednisolone (VMP), VCd, and lenalidomide, dexamethasone (Rd)). Maintenance therapy increased from 5% to 16%, shifting from thalidomide to lenalidomide. Second and third lines were dominated by daratumumab-based regimens after 5 years. No standard of care in fourth-line treatment. Treatment duration increased in transplant-eligible due to maintenance therapy and in noneligible due to fourth-line treatments. Patients moved from first- to second-line more rapidly over time.ConclusionsThere was an increase in MM patients reaching advanced treatment lines and significant changes in the treatment patterns, driven by access to more effective frontline treatments and longer duration of treatment.
| S-EPMC11647699 | biostudies-literature
Project description:UnlabelledThe American Association for the Study of Liver Diseases (AASLD) practice guidelines provide recommendations in diagnosing and managing patients with liver disease from available scientific evidence in combination with expert consensus opinions. The aim was to systematically review the evolution of recommendations from AASLD guidelines and identify gaps limiting the evidence-based foundations of these guidelines. Initial and current AASLD guidelines published from January 1998 to August 2012 were reviewed. The AGREE II instrument was used to evaluate rigor and transparency of guideline development. The number of recommendations, distribution of grades (strength or certainty), classes (benefit versus risk), and types of recommendations were evaluated. Whenever possible, multiple versions were evaluated for evolving scientific evidence. A total of 991 recommendations from 28 guidelines on 17 topics were evaluated. From initial to current guidelines, the total number of recommendations increased by 36% (512 to 699). The largest increases were from chronic hepatitis B virus (HBV) (+71), liver transplantation (+53), and autoimmune hepatitis (AIH) (+27). Most current recommendations are grade II (44%) and less than 20% are grade I. The AGREE II evaluation showed global improvement in guideline quality. Both HBV and chronic hepatitis C guidelines had greatest increases in grade I recommendations (+383% and +67%, respectively). The greatest increases in treatment recommendations were from HBV (grade I, +1,150%), liver transplantation (grade II, +112%), and AIH (grade III, +105%).ConclusionDespite significant increases in the numbers of recommendations within AASLD practice guidelines over time, only a minority are supported by grade I evidence, highlighting the need for developing well-designed investigations to provide evidence for areas of uncertainty and improving the quality of future guidelines in hepatobiliary diseases.
| S-EPMC4613804 | biostudies-literature
Project description:IntroductionClinical trials provide the "gold standard" evidence for advancing the practice of medicine, even as they evolve to integrate real-world data sources. Modern clinical trials are increasingly incorporating real-world data sources - data not intended for research and often collected in free-living contexts. We refer to trials that incorporate real-world data sources as real-world trials. Such trials may have the potential to enhance the generalizability of findings, facilitate pragmatic study designs, and evaluate real-world effectiveness. However, key differences in the design, conduct, and implementation of real-world vs traditional trials have ramifications in data management that can threaten their desired rigor.MethodsThree examples of real-world trials that leverage different types of data sources - wearables, medical devices, and electronic health records are described. Key insights applicable to all three trials in their relationship to Data and Safety Monitoring Boards (DSMBs) are derived.ResultsInsight and recommendations are given on four topic areas: A. Charge of the DSMB; B. Composition of the DSMB; C. Pre-launch Activities; and D. Post-launch Activities. We recommend stronger and additional focus on data integrity.ConclusionsClinical trials can benefit from incorporating real-world data sources, potentially increasing the generalizability of findings and overall trial scale and efficiency. The data, however, present a level of informatic complexity that relies heavily on a robust data science infrastructure. The nature of monitoring the data and safety must evolve to adapt to new trial scenarios to protect the rigor of clinical trials.
| S-EPMC10514684 | biostudies-literature
Project description:ObjectivesAccording to the 10th revision of the International Classification of Diseases, the main categories of tic disorders (F95.0, F95.1, and F95.2) follow a diagnostic hierarchy based on the duration and diversity of tic symptoms. The present study investigated the use of this diagnostic hierarchy in real-world clinical practice.MethodsBased on the National Health Insurance Service-National Health Information Database, the diagnosis of transient tic disorder (F95.0) made after a diagnosis of chronic motor or vocal tic disorder (F95.1) or Tourette's syndrome (F95.2) and diagnosis of chronic motor or vocal tic disorder (F95.1) made after a diagnosis of Tourette's syndrome (F95.2) were referred to as type A errors. The diagnosis of transient tic disorder (F95.0) repeated after a period of >12 months was referred to as type B error. Demographic and clinical differences according to the diagnostic error types were analyzed using analysis of variance, Student's t-tests, and chi-squared tests.ResultsMost participants (96.5%) were without errors in the diagnosis of tic disorders. Higher proportions of males (p=0.005) and antipsychotic prescriptions (p<0.001) were observed in patients with type A or B diagnostic errors. A higher proportion of health insurance holders was observed among those with type A errors (p=0.027).ConclusionErrors were absent in majority of the tic diagnoses in real-world clinical practice in terms of the diagnostic hierarchy.
| S-EPMC10568186 | biostudies-literature
Project description:Fingolimod is a multiple sclerosis treatment licensed in Europe since 2011. Its efficacy has been demonstrated in three large phase III trials, used in the regulatory submissions throughout the world. As usual, in these trials the inclusion and exclusion criteria were designed to obtain a homogeneous population, with interchangeable characteristics in the different treatment arms. Although this is the best strategy to achieve a robust answer to the investigation question, it does not guaranty the treatment efficacy in the clinical practice, since in the real world there are concomitant treatments, comorbidities, adherence, and persistence challenges. But, to make informed treatment decision for a real life patient, we need to have evidence of the treatment efficacy, what has been called treatment effectiveness. This work aims to review fingolimod effectiveness, using, as source of information, abstracts, posters, and manuscripts. This unorthodox strategy was developed because more than half of the published experience with fingolimod is still on abstracts and posters. Only a small part of the studies reviewed are already published in peer reviewed journals. Fingolimod seems to be, at least, as effective and safe as it was on clinical trials, and with its long-term experience no new safety signals were observed.
| S-EPMC4674597 | biostudies-literature
Project description:Objective: The principal aim of this study was to identify, systematically and transparently, clinical practice guidelines (CPGs) on palliative sedation from around the world. Methods: A systematic search was performed using 5 databases, grey literature search tools, citation tracking, and contact with palliative care experts across the world. Current CPGs accredited by an international, national, or regional authority, published in English, German, French, or Italian, were subjected to content analysis. Results: In total, 35 CPGs from 14 countries and 1 international CPG were included in the analysis. The CPGs had diverse formal characteristics. Their thematic scope was difficult to analyze and compare because of differences in the terms and definitions of palliative sedation in those texts. We identified 3 main situations: (1) CPGs with a fully explicit thematic scope; (2) CPGs with a partially explicit thematic scope; and (3) CPGs without an explicit thematic scope. Several CPGs explicitly stated what forms of sedation were excluded from the text. However, this presentation was often confusing. Conclusion: Our review provides several pieces of information that could guide international reflections in this field, and be used to develop or update CPGs at all levels. Efforts should be made to clarify the thematic scope of each CPG on palliative sedation, in order to generate an understanding of the forms of this therapy addressed in the text.
| S-EPMC11568653 | biostudies-literature
Project description:PurposeThis study aimed to evaluate the current clinical practice patterns regarding the utilization of "Urolithiasis Guidelines" in Turkey and to identify critical factors influencing their application by urologists.MethodsThe study targeted practicing urologists in Turkey, primarily those involved in the management of urolithiasis, to assess their perspectives and experiences regarding the clinical application of established guidelines. A total of 415 urology specialists were invited to participate in a survey-based study conducted via Google Forms. Participation was voluntary, and 65.08% of the invited urologists completed the survey.ResultsAmong the respondents, 84.7% reported utilizing the available guidelines in their routine clinical practice, with varying frequencies of reference. The primary motivations for guideline use were the prevention of potential complications and the avoidance of legal risks, as indicated by 90.5% of respondents. While 56.9% of participants adhered to the guidelines as a clinically standardized practice, 41.6% reported applying the recommendations on a case-by-case basis. Notably, 41.0% of respondents emphasized the need for locally adapted versions of guideline texts. Additionally, nearly half of the participants reported receiving no formal education or training on the significance, content, and practical application of these guidelines. Furthermore, 12.7% expressed skepticism about the evidence-based foundation of the guidelines, questioning whether the recommendations were derived from rigorously conducted studies.ConclusionThe available urolithiasis guidelines are recognized as valuable resources offering key recommendations for the effective and safe management of urolithiasis. However, findings from this survey highlight significant variability in clinical practice patterns due to local conditions and the individual experience and attitudes of practicing urologists. The application of guideline recommendations is further influenced by perceptions regarding their development, content, and practicality. Insights gathered from this study may contribute to improving the preparation, dissemination, and implementation of urolithiasis guidelines, particularly in adapting them to local clinical settings.
| S-EPMC11790800 | biostudies-literature
Project description:OBJECTIVE:To evaluate the quality of clinical practice guidelines (CPGs) for otorhinolaryngology in China. MATERIALS AND METHODS:A systematic search of relevant literature databases (CBM, WANFANG, VIP, CNKI, China Guideline Clearinghouse) published between 1978 and March 2012 was undertaken to identify and select CPGs related to otorhinolaryngology. Four independent reviewers assessed the eligible guidelines using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. Their degree of agreement was evaluated using the intraclass correlation coefficient (ICC). RESULT:From 170 citations, 21 relevant guidelines were included. The overall agreement among reviewers was moderate (ICC?=?0.87; 95% confidence interval [CI], 0.78-0.91). The scores for each of the AGREE domains were the following: "scope and purpose" (mean ± standard error [SE]?=?45.4±4.4; ICC?=?0.92), "stakeholder involvement" (mean ± SE?=?30.4±3.1; ICC?=?0.81), "rigor of development" (mean ± SE?=?20.9±2.8; ICC?=?0.87), "clarity of presentation" (mean ± SE?=?48.8±3.7; ICC?=?0.80), "applicability" (mean ± SE?=?12.6±1.7; ICC?=?0.72), and "editorial independence" (mean ± SE?=?6.2±0.8; ICC?=?0.76). Three guidelines (14%) mentioned updates, and the average update frequency was 7 years. None used the GRADE system. CONCLUSION:The quality of otorhinolaryngology guidelines in China is low. Greater efforts are needed to provide high-quality guidelines that serve as a useful and reliable tool for clinical decision-making in this field.
| S-EPMC3548820 | biostudies-literature