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Sakae Homma - One of the best experts on this subject based on the ideXlab platform.
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AMERICAN THORACIC SOCIETY DOCUMENTS An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis An Update of the 2011 Clinical Practice Guideline
2020Co-Authors: Ganesh Raghu, Bram Rochwerg, Yuan Zhang, Carlos Cuello A Garcia, Arata Azuma, J Behr, Jan Brozek, Harold R Collard, William Cunningham, Sakae HommaAbstract:Methods: Systematic reviews and, when appropriate, meta-analyses were performed to summarize all available evidence pertinent to our questions. The evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and then discussed by a multidisciplinary panel. Predetermined conflict-of-Interest Management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists. Results: After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications to health equity, recommendations were made for or against specific treatment interventions. Conclusions: The panel formulated and provided the rationale for recommendations in favor of or against treatment interventions for idiopathic pulmonary fibrosis. Contents Overview The purpose of this guideline is to analyze evidence reported since publication of the prior guideline in 2011 and to update the treatment recommendations accordingly. The guideline should empower clinicians to interpret these recommendations in the context of individual patient values and preferences and to make appropriate clinical decisions about treatment of patients with idiopathic pulmonary fibrosis (IPF). For each recommendation, it is important to consider both the summary of evidence reviewed and discussed by the nonconflicted members of the committee and remarks for each specific treatment question, including the values and preferences, before applying these recommendations to specific clinical situations or policy decisions. Clinicians, patients, third-party payers, and other stakeholders should never view these recommendations as dictates. No guideline or recommendations can take into account all of the often compelling unique individual clinical circumstances. Therefore, no one charged with evaluating clinicians' actions should attempt to apply the recommendations from this guideline by rote or in a blanket fashion. The implications of the strength of the recommendation for various stakeholders are described in This guideline does not provide recommendations for one treatment regimen over another. With the exception of the recommendation against using prednisone with azathioprine and Nacetylcysteine, the guideline does not provide suggestions for or against combination regimens or sequential therapies. Therefore, the strong or conditional rating for each recommendation must be weighed individually (i.e., two recommendations with the same strong or conditional rating should not by default be considered equivalent recommendations), factoring in all components used to determine the grade of the recommendation, including the confidence in effect estimates, outcomes studies, desirable and undesirable consequences of treatment, cost of treatment, implications of treatment on health equity, and feasibility of treatment. The methods used by guideline panels to appraise the evidence are different than those used by regulatory agencies when they review applications seeking market approval for the use of pharmacologic agents for treatment of IPF. The following recommendations are new or revised from the 2011 guideline, as shown in were not prioritized for an update in this guideline An evidence synthesis was also performed for a new question about single versus bilateral lung transplantation, but decisions regarding a recommendation were deferred until the next version of the guideline to gather additional information that was felt necessary before formulating a recommendation. Questions regarding newer treatments (e.g., antibiotics) were not addressed and were deferred until the next version of the guideline because of resource constraints. Introduction IPF is a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause occurring in adults. Radiologic and/or histopathologic patterns are consistent with usual interstitial pneumonia (1). Although the first guideline on Management of IPF, published in 2000, was based on the consensus of a group of international experts in the field (2), the 2011 guideline represented a rigorous joint effort by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT). It reviewed all available evidence, clarified the definition of IPF, provided precise diagnostic criteria, described the natural course of the disease, and provided evidence-based recommendations for treatment (3). The 2011 guideline also stated that updates would be provided based on pertinent new evidence. Although the 2011 guideline provided clear recommendations for several specific treatment regimens, new, important evidence for the treatment of IPF has become available since 2011. This document updates the treatment guideline with the reappraisal of previously assessed treatment options and new recommendations for novel agents. Evidence surrounding the clinical Management of IPF is rapidly evolving, and AMERICAN THORACIC SOCIETY DOCUMENTS American Thoracic Society Documents e5 it is intended that future iterations of the 2011 guideline dealing with questions related to diagnosis, genetics, and other new questions will be made available promptly. The ultimate goal for this guideline is for it to be a "living document," allowing new evidence to be incorporated as available, with periodic updates to guide clinical Management based on the best available evidence in a timely manner. Methods Committee Composition This guideline was developed by a multidisciplinary committee that consisted of pulmonologists with recognized IPF expertise (n = 8; G.R., F.J. M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.), general pulmonologists (n = 3; A.T., S.H., and H.H.), a pulmonologistmethodologist (n = 1; H.J.S.), an allergist-methodologist (n = 1; J.L.B.), a general internist (n = 1; D.R.), a chest radiologist (n = 1; T.J.), a pulmonary pathologist (n = 1; J.M.), an information scientist (n = 1; S.L.P.), and a patient with IPF (n = 1; W.C.), who was recommended for participation by the Coalition for Pulmonary Fibrosis and was not known to any of the committee members. The committee was chaired by G.R. and cochaired by H.J.S. and H.H. Committee members represented the ATS, ERS, JRS, and ALAT. The committee worked with the Methods Group (MG), which comprised five health research methodologists (B.R., C.A.C.G., Y.Z., J.L.B., and H.J.S.) from the MacGRADE Centre at McMaster University who had expertise in evidence synthesis and the guideline development process. Four of these methodologists are also clinicians (B.R., J.L.B., C.A.C.G., and H.J.S.). The MG conducted systematic reviews and prepared the systematic evidence summaries following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, as described here (4, 5). Confidentiality Agreement and Conflict-of-Interest Management Committee members signed a confidentiality agreement and disclosed all potential conflicts of Interest according to the ATS and ERS policies. Two of the co-chairs (G.R. and H.J.S.) reviewed all potential conflicts of Interest of committee members with the staff of the ATS conflictof-Interest and documents units. All of the eight pulmonologists with recognized IPF expertise (G.R., F.J.M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.) were considered to either have major financial or intellectual conflicts based on disclosures or participation in IPF clinical trials/studies (6); although they were permitted to participate in the discussions of the evidence with the rest of the committee, they were instructed to abstain from discussions related to the evidence to decision framework (described later), formulating and grading recommendations, and voting on recommendations if necessary. This approach was applied to all questions, not just those in which they had a perceived conflict of Interest. Conflicted members were allowed to stay in the same room while discussions among nonconflicted members took place to provide expert input; however, they could do so only when specifically requested by nonconflicted members. Adherence to the rules was strict, with one of the co-chairs (H.J.S.) responsible for monitoring the discussions for adherence to these rules. The remaining nine nonconflicted committee members (A.T., S.H., H.H., H.J.S., J.L.B., D.R., T.J., J.M., and W.C.) were allowed unrestricted participation. Two of the voting members were members of the MG; they are clinicians with extensive expertise in the guideline development process (H.J.S. and J.L.B.). The rest of the MG and the librarian also participated in discussions, but were nonvoting participants. Meetings Face-to-face planning meetings were held during the 2013 ATS International Conference in Philadelphia, Pennsylvania, at which the committee discussed the scope and objectives of the project, and during the 2014 ATS International Conference in San Diego, California, to go over the proceedings of the upcoming face-to-face meeting in June 2014 in Hamilton, Ontario, Canada (described here). Members who could not attend the actual face-to-face meetings participated in person live by teleconference. Additional planning meetings were held regularly over telephone between G.R., H.J.S., and the MG. Conference calls and email correspondence were used to discuss specific issues requiring input from others. The entire guideline committee met at the McMaster Health Forum in Hamilton, Ontario, Canada, on June 9-10, 2014, at which the evidence summaries were presented and discussed, and the recommendations were formulated. Three members participated through teleconference and webinar (H.H., M.S., and W.C.). The methodologists took notes of all matters and points discussed and documented all the recommendations and proceedings. Two follow-up teleconference webinars were held on June 23 and July 15, 2014, to complete the guideline development for two of the 12 treatment questions (questions on single versus bilateral lung transplantation and treatment of IPF-associated pulmonary hypertension [PH]). Three members (A.A., S.H., and T.J.) were not able to participate live during the first teleconference-webinar, and five members (A.A., S.H., T.J., M.S., and H.H.) were not able to join the second teleconference-webinar, but all provided feedback and discussion via emails. All meetings were attended by staff from the ATS documents unit. McMaster University provided meeting facilities and logistical support, and the sponsoring societies provided the financial support for expenses resulting from the meeting and conference calls. The views and Interests of the ATS, ERS, JRS, and ALAT, as well as of any commercial entity that provided external funding for professional societies, had no influence on the topics discussed and recommendations made. Formulating Clinical Questions The committee used the treatment section of the 2011 guideline document (3) as a starting point. Twelve specific questions pertinent and relevant to current clinical practice were addressed to update the recommendations pertinent to treatment of IPF. Most of these questions were previously addressed, and formal recommendations had been provided in the 2011 document. Questions pertinent to the Management of patients with IPF with pulmonary rehabilitation, oxygen supplementation, antibiotics, palliative care, mechanical ventilation, and specific questions that had received a "strong against" or "strong for" in the 2011 AMERICAN THORACIC SOCIETY DOCUMENTS e6 American Journal of Respiratory and Critical Care Medicine Volume 192 Number 2 | July 15 2015 guideline were not readdressed in this update unless the literature search revealed new and pertinent evidence. The committee selected outcomes of Interest for each question, using the 2011 document as a guide in addition to following the approach suggested by the GRADE working group (5, 7). All outcomes were identified a priori, and the committee explicitly rated their relative importance (from the perspective of a patient with IPF) from not important to critical (7). Ranking outcomes by their relative importance helps focus attention on those that are most relevant to patients and helps resolve or clarify potential disagreements in decision making. Examples of critical outcomes include mortality or disease progression. Disease progression, defined in the 2011 document as increasing respiratory symptoms, worsening pulmonary function test (PFT) results, progressive fibrosis on highresolution computed tomography scan, acute respiratory decline, or death, can be measured using multiple outcome measures (3). Changes over time in FVC or diffusing capacity of the lung for carbon monoxide (DL CO ) were considered indirect measures of disease progression for the purpose of this guideline. Rankings of all outcomes were agreed on through consensus of the committee. Literature Search In collaboration with the MG, an information scientist (S.L.P.) designed a search strategy using medical subject heading keywords and text words (see online supplement) limited to human studies or nonindexed citations and articles in English or in any language with English abstracts. The Ovid platform was used to search MEDLINE, EMBASE, Cochrane Registry of Controlled Trials, Health Technology Assessment, and the Database of Abstracts of Reviews of Affects for May 2010 through May 2014. An update was performed in June 2014, immediately before the meeting at McMaster University. Reviewers contacted experts and reviewed previous meta-analyses for additional articles. The search retrieved 9,663 citations, minus duplicates. On the basis of predefined eligibility criteria, 54 citations were included for full text review, of which 34 were excluded with reasons and 20 were included in the evidence update (see online supplement). Evidence Review and Development of Clinical Recommendations Evidence summaries for each question were prepared by the McMaster methodology team, following the GRADE approach (4), using the GRADEpro Guideline Development Tool online software (8). All committee members reviewed the summaries of evidence, and corrections were made when appropriate. We based the evidence on the 2011 evidence summaries that had been produced for that document. These summaries were updated, if necessary, with additional recent randomized controlled trials (RCTs)
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AMERICAN THORACIC SOCIETY DOCUMENTS An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis An Update of the 2011 Clinical Practice Guideline
2020Co-Authors: Ganesh Raghu, Bram Rochwerg, Yuan Zhang, Carlos Cuello A Garcia, Arata Azuma, J Behr, Jan Brozek, Harold R Collard, William Cunningham, Sakae HommaAbstract:Methods: Systematic reviews and, when appropriate, meta-analyses were performed to summarize all available evidence pertinent to our questions. The evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and then discussed by a multidisciplinary panel. Predetermined conflict-of-Interest Management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists. Results: After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications to health equity, recommendations were made for or against specific treatment interventions. Conclusions: The panel formulated and provided the rationale for recommendations in favor of or against treatment interventions for idiopathic pulmonary fibrosis. Contents Overview The purpose of this guideline is to analyze evidence reported since publication of the prior guideline in 2011 and to update the treatment recommendations accordingly. The guideline should empower clinicians to interpret these recommendations in the context of individual patient values and preferences and to make appropriate clinical decisions about treatment of patients with idiopathic pulmonary fibrosis (IPF). For each recommendation, it is important to consider both the summary of evidence reviewed and discussed by the nonconflicted members of the committee and remarks for each specific treatment question, including the values and preferences, before applying these recommendations to specific clinical situations or policy decisions. Clinicians, patients, third-party payers, and other stakeholders should never view these recommendations as dictates. No guideline or recommendations can take into account all of the often compelling unique individual clinical circumstances. Therefore, no one charged with evaluating clinicians' actions should attempt to apply the recommendations from this guideline by rote or in a blanket fashion. The implications of the strength of the recommendation for various stakeholders are described in This guideline does not provide recommendations for one treatment regimen over another. With the exception of the recommendation against using prednisone with azathioprine and Nacetylcysteine, the guideline does not provide suggestions for or against combination regimens or sequential therapies. Therefore, the strong or conditional rating for each recommendation must be weighed individually (i.e., two recommendations with the same strong or conditional rating should not by default be considered equivalent recommendations), factoring in all components used to determine the grade of the recommendation, including the confidence in effect estimates, outcomes studies, desirable and undesirable consequences of treatment, cost of treatment, implications of treatment on health equity, and feasibility of treatment. The methods used by guideline panels to appraise the evidence are different than those used by regulatory agencies when they review applications seeking market approval for the use of pharmacologic agents for treatment of IPF. The following recommendations are new or revised from the 2011 guideline, as shown in were not prioritized for an update in this guideline An evidence synthesis was also performed for a new question about single versus bilateral lung transplantation, but decisions regarding a recommendation were deferred until the next version of the guideline to gather additional information that was felt necessary before formulating a recommendation. Questions regarding newer treatments (e.g., antibiotics) were not addressed and were deferred until the next version of the guideline because of resource constraints. Introduction IPF is a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause occurring in adults. Radiologic and/or histopathologic patterns are consistent with usual interstitial pneumonia (1). Although the first guideline on Management of IPF, published in 2000, was based on the consensus of a group of international experts in the field (2), the 2011 guideline represented a rigorous joint effort by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT). It reviewed all available evidence, clarified the definition of IPF, provided precise diagnostic criteria, described the natural course of the disease, and provided evidence-based recommendations for treatment (3). The 2011 guideline also stated that updates would be provided based on pertinent new evidence. Although the 2011 guideline provided clear recommendations for several specific treatment regimens, new, important evidence for the treatment of IPF has become available since 2011. This document updates the treatment guideline with the reappraisal of previously assessed treatment options and new recommendations for novel agents. Evidence surrounding the clinical Management of IPF is rapidly evolving, and Methods Committee Composition This guideline was developed by a multidisciplinary committee that consisted of pulmonologists with recognized IPF expertise (n = 8; G.R., F.J. M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.), general pulmonologists (n = 3; A.T., S.H., and H.H.), a pulmonologistmethodologist (n = 1; H.J.S.), an allergist-methodologist (n = 1; J.L.B.), a general internist (n = 1; D.R.), a chest radiologist (n = 1; T.J.), a pulmonary pathologist (n = 1; J.M.), an information scientist (n = 1; S.L.P.), and a patient with IPF (n = 1; W.C.), who was recommended for participation by the Coalition for Pulmonary Fibrosis and was not known to any of the committee members. The committee was chaired by G.R. and cochaired by H.J.S. and H.H. Committee members represented the ATS, ERS, JRS, and ALAT. The committee worked with the Methods Group (MG), which comprised five health research methodologists (B.R., C.A.C.G., Y.Z., J.L.B., and H.J.S.) from the MacGRADE Centre at McMaster University who had expertise in evidence synthesis and the guideline development process. Four of these methodologists are also clinicians (B.R., J.L.B., C.A.C.G., and H.J.S.). The MG conducted systematic reviews and prepared the systematic evidence summaries following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, as described here (4, 5). Confidentiality Agreement and Conflict-of-Interest Management Committee members signed a confidentiality agreement and disclosed all potential conflicts of Interest according to the ATS and ERS policies. Two of the co-chairs (G.R. and H.J.S.) reviewed all potential conflicts of Interest of committee members with the staff of the ATS conflictof-Interest and documents units. All of the eight pulmonologists with recognized IPF expertise (G.R., F.J.M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.) were considered to either have major financial or intellectual conflicts based on disclosures or participation in IPF clinical trials/studies (6); although they were permitted to participate in the discussions of the evidence with the rest of the committee, they were instructed to abstain from discussions related to the evidence to decision framework (described later), formulating and grading recommendations, and voting on recommendations if necessary. This approach was applied to all questions, not just those in which they had a perceived conflict of Interest. Conflicted members were allowed to stay in the same room while discussions among nonconflicted members took place to provide expert input; however, they could do so only when specifically requested by nonconflicted members. Adherence to the rules was strict, with one of the co-chairs (H.J.S.) responsible for monitoring the discussions for adherence to these rules. The remaining nine nonconflicted committee members (A.T., S.H., H.H., H.J.S., J.L.B., D.R., T.J., J.M., and W.C.) were allowed unrestricted participation. Two of the voting members were members of the MG; they are clinicians with extensive expertise in the guideline development process (H.J.S. and J.L.B.). The rest of the MG and the librarian also participated in discussions, but were nonvoting participants. Meetings Face-to-face planning meetings were held during the 2013 ATS International Conference in Philadelphia, Pennsylvania, at which the committee discussed the scope and objectives of the project, and during the 2014 ATS International Conference in San Diego, California, to go over the proceedings of the upcoming face-to-face meeting in June 2014 in Hamilton, Ontario, Canada (described here). Members who could not attend the actual face-to-face meetings participated in person live by teleconference. Additional planning meetings were held regularly over telephone between G.R., H.J.S., and the MG. Conference calls and email correspondence were used to discuss specific issues requiring input from others. The entire guideline committee met at the McMaster Health Forum in Hamilton, Ontario, Canada, on June 9-10, 2014, at which the evidence summaries were presented and discussed, and the recommendations were formulated. Three members participated through teleconference and webinar (H.H., M.S., and W.C.). The methodologists took notes of all matters and points discussed and documented all the recommendations and proceedings. Two follow-up teleconference webinars were held on June 23 and July 15, 2014, to complete the guideline development for two of the 12 treatment questions (questions on single versus bilateral lung transplantation and treatment of IPF-associated pulmonary hypertension [PH]). Three members (A.A., S.H., and T.J.) were not able to participate live during the first teleconference-webinar, and five members (A.A., S.H., T.J., M.S., and H.H.) were not able to join the second teleconference-webinar, but all provided feedback and discussion via emails. All meetings were attended by staff from the ATS documents unit. McMaster University provided meeting facilities and logistical support, and the sponsoring societies provided the financial support for expenses resulting from the meeting and conference calls. The views and Interests of the ATS, ERS, JRS, and ALAT, as well as of any commercial entity that provided external funding for professional societies, had no influence on the topics discussed and recommendations made. Formulating Clinical Questions The committee used the treatment section of the 2011 guideline document (3) as a starting point. Twelve specific questions pertinent and relevant to current clinical practice were addressed to update the recommendations pertinent to treatment of IPF. Most of these questions were previously addressed, and formal recommendations had been provided in the 2011 document. Questions pertinent to the Management of patients with IPF with pulmonary rehabilitation, oxygen supplementation, antibiotics, palliative care, mechanical ventilation, and specific questions that had received a "strong guide.medlive.cn guideline were not readdressed in this update unless the literature search revealed new and pertinent evidence. The committee selected outcomes of Interest for each question, using the 2011 document as a guide in addition to following the approach suggested by the GRADE working group (5, 7). All outcomes were identified a priori, and the committee explicitly rated their relative importance (from the perspective of a patient with IPF) from not important to critical (7). Ranking outcomes by their relative importance helps focus attention on those that are most relevant to patients and helps resolve or clarify potential disagreements in decision making. Examples of critical outcomes include mortality or disease progression. Disease progression, defined in the 2011 document as increasing respiratory symptoms, worsening pulmonary function test (PFT) results, progressive fibrosis on highresolution computed tomography scan, acute respiratory decline, or death, can be measured using multiple outcome measures (3). Changes over time in FVC or diffusing capacity of the lung for carbon monoxide (DL CO ) were considered indirect measures of disease progression for the purpose of this guideline. Rankings of all outcomes were agreed on through consensus of the committee. Literature Search In collaboration with the MG, an information scientist (S.L.P.) designed a search strategy using medical subject heading keywords and text words (see online supplement) limited to human studies or nonindexed citations and articles in English or in any language with English abstracts. The Ovid platform was used to search MEDLINE, EMBASE, Cochrane Registry of Controlled Trials, Health Technology Assessment, and the Database of Abstracts of Reviews of Affects for May 2010 through May 2014. An update was performed in June 2014, immediately before the meeting at McMaster University. Reviewers contacted experts and reviewed previous meta-analyses for additional articles. The search retrieved 9,663 citations, minus duplicates. On the basis of predefined eligibility criteria, 54 citations were included for full text review, of which 34 were excluded with reasons and 20 were included in the evidence update (see online supplement). Evidence Review and Development of Clinical Recommendations Evidence summaries for each question were prepared by the McMaster methodology team, following the GRADE approach (4), using the GRADEpro Guideline Development Tool online software (8). All committee members reviewed the summaries of evidence, and corrections were made when appropriate. We based the evidence on the 2011 evidence summaries that had been produced for that document. These summaries were updated, if necessary, with additional recent randomized controlled trials (RCTs)
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an official ats ers jrs alat clinical practice guideline treatment of idiopathic pulmonary fibrosis an update of the 2011 clinical practice guideline
American Journal of Respiratory and Critical Care Medicine, 2015Co-Authors: Ganesh Raghu, Bram Rochwerg, Yuan Zhang, Carlos Cuello A Garcia, Arata Azuma, J Behr, Jan Brozek, Harold R Collard, William Cunningham, Sakae HommaAbstract:Background: This document updates the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guideline on idiopathic pulmonary fibrosis treatment.Methods: Systematic reviews and, when appropriate, meta-analyses were performed to summarize all available evidence pertinent to our questions. The evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and then discussed by a multidisciplinary panel. Predetermined conflict-of-Interest Management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists.Results: After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications to health equity, recommendations were made for or against specific treatment interventions.Conclusion...
David D Gutterman - One of the best experts on this subject based on the ideXlab platform.
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accp evidence based guideline development a successful and transparent approach addressing conflict of Interest funding and patient centered recommendations
Chest, 2007Co-Authors: Michael H Baumann, Sandra Zelman Lewis, David D GuttermanAbstract:Evidence-based clinical practice guidelines (EBGs) can provide an invaluable distillation of knowledge regarding best practices based on the available evidence. EBGs, providing accurate and useful guidance to best clinical practices, require a rigorous development process. The American College of Chest Physicians (ACCP) has developed a process that embodies transparency, thoroughness, and timeliness, and effective conflict-of-Interest Management, and it continues to evolve. This process employs a quantitative and rigorous grading of the strength of recommendations and of the quality of evidence that incorporates sensitivity to health-care resource utilization and patient values and preferences. A review of this process is provided to inform the ACCP membership and those wishing to embark on EBG development.
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accp evidence based guideline development a successful and transparent approach addressing conflict of Interest funding and patient centered recommendations
Chest, 2007Co-Authors: Michael H Baumann, Sandra Zelman Lewis, David D GuttermanAbstract:Evidence-based clinical practice guidelines (EBGs) can provide an invaluable distillation of knowledge regarding best practices based on the available evidence. EBGs, providing accurate and useful guidance to best clinical practices, require a rigorous development process. The American College of Chest Physicians (ACCP) has developed a process that embodies transparency, thoroughness, and timeliness, and effective conflict-of-Interest Management, and it continues to evolve. This process employs a quantitative and rigorous grading of the strength of recommendations and of the quality of evidence that incorporates sensitivity to health-care resource utilization and patient values and preferences. A review of this process is provided to inform the ACCP membership and those wishing to embark on EBG development.
Ganesh Raghu - One of the best experts on this subject based on the ideXlab platform.
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AMERICAN THORACIC SOCIETY DOCUMENTS An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis An Update of the 2011 Clinical Practice Guideline
2020Co-Authors: Ganesh Raghu, Bram Rochwerg, Yuan Zhang, Carlos Cuello A Garcia, Arata Azuma, J Behr, Jan Brozek, Harold R Collard, William Cunningham, Sakae HommaAbstract:Methods: Systematic reviews and, when appropriate, meta-analyses were performed to summarize all available evidence pertinent to our questions. The evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and then discussed by a multidisciplinary panel. Predetermined conflict-of-Interest Management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists. Results: After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications to health equity, recommendations were made for or against specific treatment interventions. Conclusions: The panel formulated and provided the rationale for recommendations in favor of or against treatment interventions for idiopathic pulmonary fibrosis. Contents Overview The purpose of this guideline is to analyze evidence reported since publication of the prior guideline in 2011 and to update the treatment recommendations accordingly. The guideline should empower clinicians to interpret these recommendations in the context of individual patient values and preferences and to make appropriate clinical decisions about treatment of patients with idiopathic pulmonary fibrosis (IPF). For each recommendation, it is important to consider both the summary of evidence reviewed and discussed by the nonconflicted members of the committee and remarks for each specific treatment question, including the values and preferences, before applying these recommendations to specific clinical situations or policy decisions. Clinicians, patients, third-party payers, and other stakeholders should never view these recommendations as dictates. No guideline or recommendations can take into account all of the often compelling unique individual clinical circumstances. Therefore, no one charged with evaluating clinicians' actions should attempt to apply the recommendations from this guideline by rote or in a blanket fashion. The implications of the strength of the recommendation for various stakeholders are described in This guideline does not provide recommendations for one treatment regimen over another. With the exception of the recommendation against using prednisone with azathioprine and Nacetylcysteine, the guideline does not provide suggestions for or against combination regimens or sequential therapies. Therefore, the strong or conditional rating for each recommendation must be weighed individually (i.e., two recommendations with the same strong or conditional rating should not by default be considered equivalent recommendations), factoring in all components used to determine the grade of the recommendation, including the confidence in effect estimates, outcomes studies, desirable and undesirable consequences of treatment, cost of treatment, implications of treatment on health equity, and feasibility of treatment. The methods used by guideline panels to appraise the evidence are different than those used by regulatory agencies when they review applications seeking market approval for the use of pharmacologic agents for treatment of IPF. The following recommendations are new or revised from the 2011 guideline, as shown in were not prioritized for an update in this guideline An evidence synthesis was also performed for a new question about single versus bilateral lung transplantation, but decisions regarding a recommendation were deferred until the next version of the guideline to gather additional information that was felt necessary before formulating a recommendation. Questions regarding newer treatments (e.g., antibiotics) were not addressed and were deferred until the next version of the guideline because of resource constraints. Introduction IPF is a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause occurring in adults. Radiologic and/or histopathologic patterns are consistent with usual interstitial pneumonia (1). Although the first guideline on Management of IPF, published in 2000, was based on the consensus of a group of international experts in the field (2), the 2011 guideline represented a rigorous joint effort by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT). It reviewed all available evidence, clarified the definition of IPF, provided precise diagnostic criteria, described the natural course of the disease, and provided evidence-based recommendations for treatment (3). The 2011 guideline also stated that updates would be provided based on pertinent new evidence. Although the 2011 guideline provided clear recommendations for several specific treatment regimens, new, important evidence for the treatment of IPF has become available since 2011. This document updates the treatment guideline with the reappraisal of previously assessed treatment options and new recommendations for novel agents. Evidence surrounding the clinical Management of IPF is rapidly evolving, and AMERICAN THORACIC SOCIETY DOCUMENTS American Thoracic Society Documents e5 it is intended that future iterations of the 2011 guideline dealing with questions related to diagnosis, genetics, and other new questions will be made available promptly. The ultimate goal for this guideline is for it to be a "living document," allowing new evidence to be incorporated as available, with periodic updates to guide clinical Management based on the best available evidence in a timely manner. Methods Committee Composition This guideline was developed by a multidisciplinary committee that consisted of pulmonologists with recognized IPF expertise (n = 8; G.R., F.J. M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.), general pulmonologists (n = 3; A.T., S.H., and H.H.), a pulmonologistmethodologist (n = 1; H.J.S.), an allergist-methodologist (n = 1; J.L.B.), a general internist (n = 1; D.R.), a chest radiologist (n = 1; T.J.), a pulmonary pathologist (n = 1; J.M.), an information scientist (n = 1; S.L.P.), and a patient with IPF (n = 1; W.C.), who was recommended for participation by the Coalition for Pulmonary Fibrosis and was not known to any of the committee members. The committee was chaired by G.R. and cochaired by H.J.S. and H.H. Committee members represented the ATS, ERS, JRS, and ALAT. The committee worked with the Methods Group (MG), which comprised five health research methodologists (B.R., C.A.C.G., Y.Z., J.L.B., and H.J.S.) from the MacGRADE Centre at McMaster University who had expertise in evidence synthesis and the guideline development process. Four of these methodologists are also clinicians (B.R., J.L.B., C.A.C.G., and H.J.S.). The MG conducted systematic reviews and prepared the systematic evidence summaries following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, as described here (4, 5). Confidentiality Agreement and Conflict-of-Interest Management Committee members signed a confidentiality agreement and disclosed all potential conflicts of Interest according to the ATS and ERS policies. Two of the co-chairs (G.R. and H.J.S.) reviewed all potential conflicts of Interest of committee members with the staff of the ATS conflictof-Interest and documents units. All of the eight pulmonologists with recognized IPF expertise (G.R., F.J.M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.) were considered to either have major financial or intellectual conflicts based on disclosures or participation in IPF clinical trials/studies (6); although they were permitted to participate in the discussions of the evidence with the rest of the committee, they were instructed to abstain from discussions related to the evidence to decision framework (described later), formulating and grading recommendations, and voting on recommendations if necessary. This approach was applied to all questions, not just those in which they had a perceived conflict of Interest. Conflicted members were allowed to stay in the same room while discussions among nonconflicted members took place to provide expert input; however, they could do so only when specifically requested by nonconflicted members. Adherence to the rules was strict, with one of the co-chairs (H.J.S.) responsible for monitoring the discussions for adherence to these rules. The remaining nine nonconflicted committee members (A.T., S.H., H.H., H.J.S., J.L.B., D.R., T.J., J.M., and W.C.) were allowed unrestricted participation. Two of the voting members were members of the MG; they are clinicians with extensive expertise in the guideline development process (H.J.S. and J.L.B.). The rest of the MG and the librarian also participated in discussions, but were nonvoting participants. Meetings Face-to-face planning meetings were held during the 2013 ATS International Conference in Philadelphia, Pennsylvania, at which the committee discussed the scope and objectives of the project, and during the 2014 ATS International Conference in San Diego, California, to go over the proceedings of the upcoming face-to-face meeting in June 2014 in Hamilton, Ontario, Canada (described here). Members who could not attend the actual face-to-face meetings participated in person live by teleconference. Additional planning meetings were held regularly over telephone between G.R., H.J.S., and the MG. Conference calls and email correspondence were used to discuss specific issues requiring input from others. The entire guideline committee met at the McMaster Health Forum in Hamilton, Ontario, Canada, on June 9-10, 2014, at which the evidence summaries were presented and discussed, and the recommendations were formulated. Three members participated through teleconference and webinar (H.H., M.S., and W.C.). The methodologists took notes of all matters and points discussed and documented all the recommendations and proceedings. Two follow-up teleconference webinars were held on June 23 and July 15, 2014, to complete the guideline development for two of the 12 treatment questions (questions on single versus bilateral lung transplantation and treatment of IPF-associated pulmonary hypertension [PH]). Three members (A.A., S.H., and T.J.) were not able to participate live during the first teleconference-webinar, and five members (A.A., S.H., T.J., M.S., and H.H.) were not able to join the second teleconference-webinar, but all provided feedback and discussion via emails. All meetings were attended by staff from the ATS documents unit. McMaster University provided meeting facilities and logistical support, and the sponsoring societies provided the financial support for expenses resulting from the meeting and conference calls. The views and Interests of the ATS, ERS, JRS, and ALAT, as well as of any commercial entity that provided external funding for professional societies, had no influence on the topics discussed and recommendations made. Formulating Clinical Questions The committee used the treatment section of the 2011 guideline document (3) as a starting point. Twelve specific questions pertinent and relevant to current clinical practice were addressed to update the recommendations pertinent to treatment of IPF. Most of these questions were previously addressed, and formal recommendations had been provided in the 2011 document. Questions pertinent to the Management of patients with IPF with pulmonary rehabilitation, oxygen supplementation, antibiotics, palliative care, mechanical ventilation, and specific questions that had received a "strong against" or "strong for" in the 2011 AMERICAN THORACIC SOCIETY DOCUMENTS e6 American Journal of Respiratory and Critical Care Medicine Volume 192 Number 2 | July 15 2015 guideline were not readdressed in this update unless the literature search revealed new and pertinent evidence. The committee selected outcomes of Interest for each question, using the 2011 document as a guide in addition to following the approach suggested by the GRADE working group (5, 7). All outcomes were identified a priori, and the committee explicitly rated their relative importance (from the perspective of a patient with IPF) from not important to critical (7). Ranking outcomes by their relative importance helps focus attention on those that are most relevant to patients and helps resolve or clarify potential disagreements in decision making. Examples of critical outcomes include mortality or disease progression. Disease progression, defined in the 2011 document as increasing respiratory symptoms, worsening pulmonary function test (PFT) results, progressive fibrosis on highresolution computed tomography scan, acute respiratory decline, or death, can be measured using multiple outcome measures (3). Changes over time in FVC or diffusing capacity of the lung for carbon monoxide (DL CO ) were considered indirect measures of disease progression for the purpose of this guideline. Rankings of all outcomes were agreed on through consensus of the committee. Literature Search In collaboration with the MG, an information scientist (S.L.P.) designed a search strategy using medical subject heading keywords and text words (see online supplement) limited to human studies or nonindexed citations and articles in English or in any language with English abstracts. The Ovid platform was used to search MEDLINE, EMBASE, Cochrane Registry of Controlled Trials, Health Technology Assessment, and the Database of Abstracts of Reviews of Affects for May 2010 through May 2014. An update was performed in June 2014, immediately before the meeting at McMaster University. Reviewers contacted experts and reviewed previous meta-analyses for additional articles. The search retrieved 9,663 citations, minus duplicates. On the basis of predefined eligibility criteria, 54 citations were included for full text review, of which 34 were excluded with reasons and 20 were included in the evidence update (see online supplement). Evidence Review and Development of Clinical Recommendations Evidence summaries for each question were prepared by the McMaster methodology team, following the GRADE approach (4), using the GRADEpro Guideline Development Tool online software (8). All committee members reviewed the summaries of evidence, and corrections were made when appropriate. We based the evidence on the 2011 evidence summaries that had been produced for that document. These summaries were updated, if necessary, with additional recent randomized controlled trials (RCTs)
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AMERICAN THORACIC SOCIETY DOCUMENTS An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis An Update of the 2011 Clinical Practice Guideline
2020Co-Authors: Ganesh Raghu, Bram Rochwerg, Yuan Zhang, Carlos Cuello A Garcia, Arata Azuma, J Behr, Jan Brozek, Harold R Collard, William Cunningham, Sakae HommaAbstract:Methods: Systematic reviews and, when appropriate, meta-analyses were performed to summarize all available evidence pertinent to our questions. The evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and then discussed by a multidisciplinary panel. Predetermined conflict-of-Interest Management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists. Results: After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications to health equity, recommendations were made for or against specific treatment interventions. Conclusions: The panel formulated and provided the rationale for recommendations in favor of or against treatment interventions for idiopathic pulmonary fibrosis. Contents Overview The purpose of this guideline is to analyze evidence reported since publication of the prior guideline in 2011 and to update the treatment recommendations accordingly. The guideline should empower clinicians to interpret these recommendations in the context of individual patient values and preferences and to make appropriate clinical decisions about treatment of patients with idiopathic pulmonary fibrosis (IPF). For each recommendation, it is important to consider both the summary of evidence reviewed and discussed by the nonconflicted members of the committee and remarks for each specific treatment question, including the values and preferences, before applying these recommendations to specific clinical situations or policy decisions. Clinicians, patients, third-party payers, and other stakeholders should never view these recommendations as dictates. No guideline or recommendations can take into account all of the often compelling unique individual clinical circumstances. Therefore, no one charged with evaluating clinicians' actions should attempt to apply the recommendations from this guideline by rote or in a blanket fashion. The implications of the strength of the recommendation for various stakeholders are described in This guideline does not provide recommendations for one treatment regimen over another. With the exception of the recommendation against using prednisone with azathioprine and Nacetylcysteine, the guideline does not provide suggestions for or against combination regimens or sequential therapies. Therefore, the strong or conditional rating for each recommendation must be weighed individually (i.e., two recommendations with the same strong or conditional rating should not by default be considered equivalent recommendations), factoring in all components used to determine the grade of the recommendation, including the confidence in effect estimates, outcomes studies, desirable and undesirable consequences of treatment, cost of treatment, implications of treatment on health equity, and feasibility of treatment. The methods used by guideline panels to appraise the evidence are different than those used by regulatory agencies when they review applications seeking market approval for the use of pharmacologic agents for treatment of IPF. The following recommendations are new or revised from the 2011 guideline, as shown in were not prioritized for an update in this guideline An evidence synthesis was also performed for a new question about single versus bilateral lung transplantation, but decisions regarding a recommendation were deferred until the next version of the guideline to gather additional information that was felt necessary before formulating a recommendation. Questions regarding newer treatments (e.g., antibiotics) were not addressed and were deferred until the next version of the guideline because of resource constraints. Introduction IPF is a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause occurring in adults. Radiologic and/or histopathologic patterns are consistent with usual interstitial pneumonia (1). Although the first guideline on Management of IPF, published in 2000, was based on the consensus of a group of international experts in the field (2), the 2011 guideline represented a rigorous joint effort by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT). It reviewed all available evidence, clarified the definition of IPF, provided precise diagnostic criteria, described the natural course of the disease, and provided evidence-based recommendations for treatment (3). The 2011 guideline also stated that updates would be provided based on pertinent new evidence. Although the 2011 guideline provided clear recommendations for several specific treatment regimens, new, important evidence for the treatment of IPF has become available since 2011. This document updates the treatment guideline with the reappraisal of previously assessed treatment options and new recommendations for novel agents. Evidence surrounding the clinical Management of IPF is rapidly evolving, and Methods Committee Composition This guideline was developed by a multidisciplinary committee that consisted of pulmonologists with recognized IPF expertise (n = 8; G.R., F.J. M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.), general pulmonologists (n = 3; A.T., S.H., and H.H.), a pulmonologistmethodologist (n = 1; H.J.S.), an allergist-methodologist (n = 1; J.L.B.), a general internist (n = 1; D.R.), a chest radiologist (n = 1; T.J.), a pulmonary pathologist (n = 1; J.M.), an information scientist (n = 1; S.L.P.), and a patient with IPF (n = 1; W.C.), who was recommended for participation by the Coalition for Pulmonary Fibrosis and was not known to any of the committee members. The committee was chaired by G.R. and cochaired by H.J.S. and H.H. Committee members represented the ATS, ERS, JRS, and ALAT. The committee worked with the Methods Group (MG), which comprised five health research methodologists (B.R., C.A.C.G., Y.Z., J.L.B., and H.J.S.) from the MacGRADE Centre at McMaster University who had expertise in evidence synthesis and the guideline development process. Four of these methodologists are also clinicians (B.R., J.L.B., C.A.C.G., and H.J.S.). The MG conducted systematic reviews and prepared the systematic evidence summaries following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, as described here (4, 5). Confidentiality Agreement and Conflict-of-Interest Management Committee members signed a confidentiality agreement and disclosed all potential conflicts of Interest according to the ATS and ERS policies. Two of the co-chairs (G.R. and H.J.S.) reviewed all potential conflicts of Interest of committee members with the staff of the ATS conflictof-Interest and documents units. All of the eight pulmonologists with recognized IPF expertise (G.R., F.J.M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.) were considered to either have major financial or intellectual conflicts based on disclosures or participation in IPF clinical trials/studies (6); although they were permitted to participate in the discussions of the evidence with the rest of the committee, they were instructed to abstain from discussions related to the evidence to decision framework (described later), formulating and grading recommendations, and voting on recommendations if necessary. This approach was applied to all questions, not just those in which they had a perceived conflict of Interest. Conflicted members were allowed to stay in the same room while discussions among nonconflicted members took place to provide expert input; however, they could do so only when specifically requested by nonconflicted members. Adherence to the rules was strict, with one of the co-chairs (H.J.S.) responsible for monitoring the discussions for adherence to these rules. The remaining nine nonconflicted committee members (A.T., S.H., H.H., H.J.S., J.L.B., D.R., T.J., J.M., and W.C.) were allowed unrestricted participation. Two of the voting members were members of the MG; they are clinicians with extensive expertise in the guideline development process (H.J.S. and J.L.B.). The rest of the MG and the librarian also participated in discussions, but were nonvoting participants. Meetings Face-to-face planning meetings were held during the 2013 ATS International Conference in Philadelphia, Pennsylvania, at which the committee discussed the scope and objectives of the project, and during the 2014 ATS International Conference in San Diego, California, to go over the proceedings of the upcoming face-to-face meeting in June 2014 in Hamilton, Ontario, Canada (described here). Members who could not attend the actual face-to-face meetings participated in person live by teleconference. Additional planning meetings were held regularly over telephone between G.R., H.J.S., and the MG. Conference calls and email correspondence were used to discuss specific issues requiring input from others. The entire guideline committee met at the McMaster Health Forum in Hamilton, Ontario, Canada, on June 9-10, 2014, at which the evidence summaries were presented and discussed, and the recommendations were formulated. Three members participated through teleconference and webinar (H.H., M.S., and W.C.). The methodologists took notes of all matters and points discussed and documented all the recommendations and proceedings. Two follow-up teleconference webinars were held on June 23 and July 15, 2014, to complete the guideline development for two of the 12 treatment questions (questions on single versus bilateral lung transplantation and treatment of IPF-associated pulmonary hypertension [PH]). Three members (A.A., S.H., and T.J.) were not able to participate live during the first teleconference-webinar, and five members (A.A., S.H., T.J., M.S., and H.H.) were not able to join the second teleconference-webinar, but all provided feedback and discussion via emails. All meetings were attended by staff from the ATS documents unit. McMaster University provided meeting facilities and logistical support, and the sponsoring societies provided the financial support for expenses resulting from the meeting and conference calls. The views and Interests of the ATS, ERS, JRS, and ALAT, as well as of any commercial entity that provided external funding for professional societies, had no influence on the topics discussed and recommendations made. Formulating Clinical Questions The committee used the treatment section of the 2011 guideline document (3) as a starting point. Twelve specific questions pertinent and relevant to current clinical practice were addressed to update the recommendations pertinent to treatment of IPF. Most of these questions were previously addressed, and formal recommendations had been provided in the 2011 document. Questions pertinent to the Management of patients with IPF with pulmonary rehabilitation, oxygen supplementation, antibiotics, palliative care, mechanical ventilation, and specific questions that had received a "strong guide.medlive.cn guideline were not readdressed in this update unless the literature search revealed new and pertinent evidence. The committee selected outcomes of Interest for each question, using the 2011 document as a guide in addition to following the approach suggested by the GRADE working group (5, 7). All outcomes were identified a priori, and the committee explicitly rated their relative importance (from the perspective of a patient with IPF) from not important to critical (7). Ranking outcomes by their relative importance helps focus attention on those that are most relevant to patients and helps resolve or clarify potential disagreements in decision making. Examples of critical outcomes include mortality or disease progression. Disease progression, defined in the 2011 document as increasing respiratory symptoms, worsening pulmonary function test (PFT) results, progressive fibrosis on highresolution computed tomography scan, acute respiratory decline, or death, can be measured using multiple outcome measures (3). Changes over time in FVC or diffusing capacity of the lung for carbon monoxide (DL CO ) were considered indirect measures of disease progression for the purpose of this guideline. Rankings of all outcomes were agreed on through consensus of the committee. Literature Search In collaboration with the MG, an information scientist (S.L.P.) designed a search strategy using medical subject heading keywords and text words (see online supplement) limited to human studies or nonindexed citations and articles in English or in any language with English abstracts. The Ovid platform was used to search MEDLINE, EMBASE, Cochrane Registry of Controlled Trials, Health Technology Assessment, and the Database of Abstracts of Reviews of Affects for May 2010 through May 2014. An update was performed in June 2014, immediately before the meeting at McMaster University. Reviewers contacted experts and reviewed previous meta-analyses for additional articles. The search retrieved 9,663 citations, minus duplicates. On the basis of predefined eligibility criteria, 54 citations were included for full text review, of which 34 were excluded with reasons and 20 were included in the evidence update (see online supplement). Evidence Review and Development of Clinical Recommendations Evidence summaries for each question were prepared by the McMaster methodology team, following the GRADE approach (4), using the GRADEpro Guideline Development Tool online software (8). All committee members reviewed the summaries of evidence, and corrections were made when appropriate. We based the evidence on the 2011 evidence summaries that had been produced for that document. These summaries were updated, if necessary, with additional recent randomized controlled trials (RCTs)
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an official ats ers jrs alat clinical practice guideline treatment of idiopathic pulmonary fibrosis an update of the 2011 clinical practice guideline
American Journal of Respiratory and Critical Care Medicine, 2015Co-Authors: Ganesh Raghu, Bram Rochwerg, Yuan Zhang, Carlos Cuello A Garcia, Arata Azuma, J Behr, Jan Brozek, Harold R Collard, William Cunningham, Sakae HommaAbstract:Background: This document updates the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guideline on idiopathic pulmonary fibrosis treatment.Methods: Systematic reviews and, when appropriate, meta-analyses were performed to summarize all available evidence pertinent to our questions. The evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and then discussed by a multidisciplinary panel. Predetermined conflict-of-Interest Management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists.Results: After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications to health equity, recommendations were made for or against specific treatment interventions.Conclusion...
Michael H Baumann - One of the best experts on this subject based on the ideXlab platform.
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accp evidence based guideline development a successful and transparent approach addressing conflict of Interest funding and patient centered recommendations
Chest, 2007Co-Authors: Michael H Baumann, Sandra Zelman Lewis, David D GuttermanAbstract:Evidence-based clinical practice guidelines (EBGs) can provide an invaluable distillation of knowledge regarding best practices based on the available evidence. EBGs, providing accurate and useful guidance to best clinical practices, require a rigorous development process. The American College of Chest Physicians (ACCP) has developed a process that embodies transparency, thoroughness, and timeliness, and effective conflict-of-Interest Management, and it continues to evolve. This process employs a quantitative and rigorous grading of the strength of recommendations and of the quality of evidence that incorporates sensitivity to health-care resource utilization and patient values and preferences. A review of this process is provided to inform the ACCP membership and those wishing to embark on EBG development.
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accp evidence based guideline development a successful and transparent approach addressing conflict of Interest funding and patient centered recommendations
Chest, 2007Co-Authors: Michael H Baumann, Sandra Zelman Lewis, David D GuttermanAbstract:Evidence-based clinical practice guidelines (EBGs) can provide an invaluable distillation of knowledge regarding best practices based on the available evidence. EBGs, providing accurate and useful guidance to best clinical practices, require a rigorous development process. The American College of Chest Physicians (ACCP) has developed a process that embodies transparency, thoroughness, and timeliness, and effective conflict-of-Interest Management, and it continues to evolve. This process employs a quantitative and rigorous grading of the strength of recommendations and of the quality of evidence that incorporates sensitivity to health-care resource utilization and patient values and preferences. A review of this process is provided to inform the ACCP membership and those wishing to embark on EBG development.
Bram Rochwerg - One of the best experts on this subject based on the ideXlab platform.
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AMERICAN THORACIC SOCIETY DOCUMENTS An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis An Update of the 2011 Clinical Practice Guideline
2020Co-Authors: Ganesh Raghu, Bram Rochwerg, Yuan Zhang, Carlos Cuello A Garcia, Arata Azuma, J Behr, Jan Brozek, Harold R Collard, William Cunningham, Sakae HommaAbstract:Methods: Systematic reviews and, when appropriate, meta-analyses were performed to summarize all available evidence pertinent to our questions. The evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and then discussed by a multidisciplinary panel. Predetermined conflict-of-Interest Management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists. Results: After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications to health equity, recommendations were made for or against specific treatment interventions. Conclusions: The panel formulated and provided the rationale for recommendations in favor of or against treatment interventions for idiopathic pulmonary fibrosis. Contents Overview The purpose of this guideline is to analyze evidence reported since publication of the prior guideline in 2011 and to update the treatment recommendations accordingly. The guideline should empower clinicians to interpret these recommendations in the context of individual patient values and preferences and to make appropriate clinical decisions about treatment of patients with idiopathic pulmonary fibrosis (IPF). For each recommendation, it is important to consider both the summary of evidence reviewed and discussed by the nonconflicted members of the committee and remarks for each specific treatment question, including the values and preferences, before applying these recommendations to specific clinical situations or policy decisions. Clinicians, patients, third-party payers, and other stakeholders should never view these recommendations as dictates. No guideline or recommendations can take into account all of the often compelling unique individual clinical circumstances. Therefore, no one charged with evaluating clinicians' actions should attempt to apply the recommendations from this guideline by rote or in a blanket fashion. The implications of the strength of the recommendation for various stakeholders are described in This guideline does not provide recommendations for one treatment regimen over another. With the exception of the recommendation against using prednisone with azathioprine and Nacetylcysteine, the guideline does not provide suggestions for or against combination regimens or sequential therapies. Therefore, the strong or conditional rating for each recommendation must be weighed individually (i.e., two recommendations with the same strong or conditional rating should not by default be considered equivalent recommendations), factoring in all components used to determine the grade of the recommendation, including the confidence in effect estimates, outcomes studies, desirable and undesirable consequences of treatment, cost of treatment, implications of treatment on health equity, and feasibility of treatment. The methods used by guideline panels to appraise the evidence are different than those used by regulatory agencies when they review applications seeking market approval for the use of pharmacologic agents for treatment of IPF. The following recommendations are new or revised from the 2011 guideline, as shown in were not prioritized for an update in this guideline An evidence synthesis was also performed for a new question about single versus bilateral lung transplantation, but decisions regarding a recommendation were deferred until the next version of the guideline to gather additional information that was felt necessary before formulating a recommendation. Questions regarding newer treatments (e.g., antibiotics) were not addressed and were deferred until the next version of the guideline because of resource constraints. Introduction IPF is a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause occurring in adults. Radiologic and/or histopathologic patterns are consistent with usual interstitial pneumonia (1). Although the first guideline on Management of IPF, published in 2000, was based on the consensus of a group of international experts in the field (2), the 2011 guideline represented a rigorous joint effort by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT). It reviewed all available evidence, clarified the definition of IPF, provided precise diagnostic criteria, described the natural course of the disease, and provided evidence-based recommendations for treatment (3). The 2011 guideline also stated that updates would be provided based on pertinent new evidence. Although the 2011 guideline provided clear recommendations for several specific treatment regimens, new, important evidence for the treatment of IPF has become available since 2011. This document updates the treatment guideline with the reappraisal of previously assessed treatment options and new recommendations for novel agents. Evidence surrounding the clinical Management of IPF is rapidly evolving, and AMERICAN THORACIC SOCIETY DOCUMENTS American Thoracic Society Documents e5 it is intended that future iterations of the 2011 guideline dealing with questions related to diagnosis, genetics, and other new questions will be made available promptly. The ultimate goal for this guideline is for it to be a "living document," allowing new evidence to be incorporated as available, with periodic updates to guide clinical Management based on the best available evidence in a timely manner. Methods Committee Composition This guideline was developed by a multidisciplinary committee that consisted of pulmonologists with recognized IPF expertise (n = 8; G.R., F.J. M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.), general pulmonologists (n = 3; A.T., S.H., and H.H.), a pulmonologistmethodologist (n = 1; H.J.S.), an allergist-methodologist (n = 1; J.L.B.), a general internist (n = 1; D.R.), a chest radiologist (n = 1; T.J.), a pulmonary pathologist (n = 1; J.M.), an information scientist (n = 1; S.L.P.), and a patient with IPF (n = 1; W.C.), who was recommended for participation by the Coalition for Pulmonary Fibrosis and was not known to any of the committee members. The committee was chaired by G.R. and cochaired by H.J.S. and H.H. Committee members represented the ATS, ERS, JRS, and ALAT. The committee worked with the Methods Group (MG), which comprised five health research methodologists (B.R., C.A.C.G., Y.Z., J.L.B., and H.J.S.) from the MacGRADE Centre at McMaster University who had expertise in evidence synthesis and the guideline development process. Four of these methodologists are also clinicians (B.R., J.L.B., C.A.C.G., and H.J.S.). The MG conducted systematic reviews and prepared the systematic evidence summaries following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, as described here (4, 5). Confidentiality Agreement and Conflict-of-Interest Management Committee members signed a confidentiality agreement and disclosed all potential conflicts of Interest according to the ATS and ERS policies. Two of the co-chairs (G.R. and H.J.S.) reviewed all potential conflicts of Interest of committee members with the staff of the ATS conflictof-Interest and documents units. All of the eight pulmonologists with recognized IPF expertise (G.R., F.J.M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.) were considered to either have major financial or intellectual conflicts based on disclosures or participation in IPF clinical trials/studies (6); although they were permitted to participate in the discussions of the evidence with the rest of the committee, they were instructed to abstain from discussions related to the evidence to decision framework (described later), formulating and grading recommendations, and voting on recommendations if necessary. This approach was applied to all questions, not just those in which they had a perceived conflict of Interest. Conflicted members were allowed to stay in the same room while discussions among nonconflicted members took place to provide expert input; however, they could do so only when specifically requested by nonconflicted members. Adherence to the rules was strict, with one of the co-chairs (H.J.S.) responsible for monitoring the discussions for adherence to these rules. The remaining nine nonconflicted committee members (A.T., S.H., H.H., H.J.S., J.L.B., D.R., T.J., J.M., and W.C.) were allowed unrestricted participation. Two of the voting members were members of the MG; they are clinicians with extensive expertise in the guideline development process (H.J.S. and J.L.B.). The rest of the MG and the librarian also participated in discussions, but were nonvoting participants. Meetings Face-to-face planning meetings were held during the 2013 ATS International Conference in Philadelphia, Pennsylvania, at which the committee discussed the scope and objectives of the project, and during the 2014 ATS International Conference in San Diego, California, to go over the proceedings of the upcoming face-to-face meeting in June 2014 in Hamilton, Ontario, Canada (described here). Members who could not attend the actual face-to-face meetings participated in person live by teleconference. Additional planning meetings were held regularly over telephone between G.R., H.J.S., and the MG. Conference calls and email correspondence were used to discuss specific issues requiring input from others. The entire guideline committee met at the McMaster Health Forum in Hamilton, Ontario, Canada, on June 9-10, 2014, at which the evidence summaries were presented and discussed, and the recommendations were formulated. Three members participated through teleconference and webinar (H.H., M.S., and W.C.). The methodologists took notes of all matters and points discussed and documented all the recommendations and proceedings. Two follow-up teleconference webinars were held on June 23 and July 15, 2014, to complete the guideline development for two of the 12 treatment questions (questions on single versus bilateral lung transplantation and treatment of IPF-associated pulmonary hypertension [PH]). Three members (A.A., S.H., and T.J.) were not able to participate live during the first teleconference-webinar, and five members (A.A., S.H., T.J., M.S., and H.H.) were not able to join the second teleconference-webinar, but all provided feedback and discussion via emails. All meetings were attended by staff from the ATS documents unit. McMaster University provided meeting facilities and logistical support, and the sponsoring societies provided the financial support for expenses resulting from the meeting and conference calls. The views and Interests of the ATS, ERS, JRS, and ALAT, as well as of any commercial entity that provided external funding for professional societies, had no influence on the topics discussed and recommendations made. Formulating Clinical Questions The committee used the treatment section of the 2011 guideline document (3) as a starting point. Twelve specific questions pertinent and relevant to current clinical practice were addressed to update the recommendations pertinent to treatment of IPF. Most of these questions were previously addressed, and formal recommendations had been provided in the 2011 document. Questions pertinent to the Management of patients with IPF with pulmonary rehabilitation, oxygen supplementation, antibiotics, palliative care, mechanical ventilation, and specific questions that had received a "strong against" or "strong for" in the 2011 AMERICAN THORACIC SOCIETY DOCUMENTS e6 American Journal of Respiratory and Critical Care Medicine Volume 192 Number 2 | July 15 2015 guideline were not readdressed in this update unless the literature search revealed new and pertinent evidence. The committee selected outcomes of Interest for each question, using the 2011 document as a guide in addition to following the approach suggested by the GRADE working group (5, 7). All outcomes were identified a priori, and the committee explicitly rated their relative importance (from the perspective of a patient with IPF) from not important to critical (7). Ranking outcomes by their relative importance helps focus attention on those that are most relevant to patients and helps resolve or clarify potential disagreements in decision making. Examples of critical outcomes include mortality or disease progression. Disease progression, defined in the 2011 document as increasing respiratory symptoms, worsening pulmonary function test (PFT) results, progressive fibrosis on highresolution computed tomography scan, acute respiratory decline, or death, can be measured using multiple outcome measures (3). Changes over time in FVC or diffusing capacity of the lung for carbon monoxide (DL CO ) were considered indirect measures of disease progression for the purpose of this guideline. Rankings of all outcomes were agreed on through consensus of the committee. Literature Search In collaboration with the MG, an information scientist (S.L.P.) designed a search strategy using medical subject heading keywords and text words (see online supplement) limited to human studies or nonindexed citations and articles in English or in any language with English abstracts. The Ovid platform was used to search MEDLINE, EMBASE, Cochrane Registry of Controlled Trials, Health Technology Assessment, and the Database of Abstracts of Reviews of Affects for May 2010 through May 2014. An update was performed in June 2014, immediately before the meeting at McMaster University. Reviewers contacted experts and reviewed previous meta-analyses for additional articles. The search retrieved 9,663 citations, minus duplicates. On the basis of predefined eligibility criteria, 54 citations were included for full text review, of which 34 were excluded with reasons and 20 were included in the evidence update (see online supplement). Evidence Review and Development of Clinical Recommendations Evidence summaries for each question were prepared by the McMaster methodology team, following the GRADE approach (4), using the GRADEpro Guideline Development Tool online software (8). All committee members reviewed the summaries of evidence, and corrections were made when appropriate. We based the evidence on the 2011 evidence summaries that had been produced for that document. These summaries were updated, if necessary, with additional recent randomized controlled trials (RCTs)
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AMERICAN THORACIC SOCIETY DOCUMENTS An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis An Update of the 2011 Clinical Practice Guideline
2020Co-Authors: Ganesh Raghu, Bram Rochwerg, Yuan Zhang, Carlos Cuello A Garcia, Arata Azuma, J Behr, Jan Brozek, Harold R Collard, William Cunningham, Sakae HommaAbstract:Methods: Systematic reviews and, when appropriate, meta-analyses were performed to summarize all available evidence pertinent to our questions. The evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and then discussed by a multidisciplinary panel. Predetermined conflict-of-Interest Management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists. Results: After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications to health equity, recommendations were made for or against specific treatment interventions. Conclusions: The panel formulated and provided the rationale for recommendations in favor of or against treatment interventions for idiopathic pulmonary fibrosis. Contents Overview The purpose of this guideline is to analyze evidence reported since publication of the prior guideline in 2011 and to update the treatment recommendations accordingly. The guideline should empower clinicians to interpret these recommendations in the context of individual patient values and preferences and to make appropriate clinical decisions about treatment of patients with idiopathic pulmonary fibrosis (IPF). For each recommendation, it is important to consider both the summary of evidence reviewed and discussed by the nonconflicted members of the committee and remarks for each specific treatment question, including the values and preferences, before applying these recommendations to specific clinical situations or policy decisions. Clinicians, patients, third-party payers, and other stakeholders should never view these recommendations as dictates. No guideline or recommendations can take into account all of the often compelling unique individual clinical circumstances. Therefore, no one charged with evaluating clinicians' actions should attempt to apply the recommendations from this guideline by rote or in a blanket fashion. The implications of the strength of the recommendation for various stakeholders are described in This guideline does not provide recommendations for one treatment regimen over another. With the exception of the recommendation against using prednisone with azathioprine and Nacetylcysteine, the guideline does not provide suggestions for or against combination regimens or sequential therapies. Therefore, the strong or conditional rating for each recommendation must be weighed individually (i.e., two recommendations with the same strong or conditional rating should not by default be considered equivalent recommendations), factoring in all components used to determine the grade of the recommendation, including the confidence in effect estimates, outcomes studies, desirable and undesirable consequences of treatment, cost of treatment, implications of treatment on health equity, and feasibility of treatment. The methods used by guideline panels to appraise the evidence are different than those used by regulatory agencies when they review applications seeking market approval for the use of pharmacologic agents for treatment of IPF. The following recommendations are new or revised from the 2011 guideline, as shown in were not prioritized for an update in this guideline An evidence synthesis was also performed for a new question about single versus bilateral lung transplantation, but decisions regarding a recommendation were deferred until the next version of the guideline to gather additional information that was felt necessary before formulating a recommendation. Questions regarding newer treatments (e.g., antibiotics) were not addressed and were deferred until the next version of the guideline because of resource constraints. Introduction IPF is a specific form of chronic, progressive fibrosing interstitial pneumonia of unknown cause occurring in adults. Radiologic and/or histopathologic patterns are consistent with usual interstitial pneumonia (1). Although the first guideline on Management of IPF, published in 2000, was based on the consensus of a group of international experts in the field (2), the 2011 guideline represented a rigorous joint effort by the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT). It reviewed all available evidence, clarified the definition of IPF, provided precise diagnostic criteria, described the natural course of the disease, and provided evidence-based recommendations for treatment (3). The 2011 guideline also stated that updates would be provided based on pertinent new evidence. Although the 2011 guideline provided clear recommendations for several specific treatment regimens, new, important evidence for the treatment of IPF has become available since 2011. This document updates the treatment guideline with the reappraisal of previously assessed treatment options and new recommendations for novel agents. Evidence surrounding the clinical Management of IPF is rapidly evolving, and Methods Committee Composition This guideline was developed by a multidisciplinary committee that consisted of pulmonologists with recognized IPF expertise (n = 8; G.R., F.J. M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.), general pulmonologists (n = 3; A.T., S.H., and H.H.), a pulmonologistmethodologist (n = 1; H.J.S.), an allergist-methodologist (n = 1; J.L.B.), a general internist (n = 1; D.R.), a chest radiologist (n = 1; T.J.), a pulmonary pathologist (n = 1; J.M.), an information scientist (n = 1; S.L.P.), and a patient with IPF (n = 1; W.C.), who was recommended for participation by the Coalition for Pulmonary Fibrosis and was not known to any of the committee members. The committee was chaired by G.R. and cochaired by H.J.S. and H.H. Committee members represented the ATS, ERS, JRS, and ALAT. The committee worked with the Methods Group (MG), which comprised five health research methodologists (B.R., C.A.C.G., Y.Z., J.L.B., and H.J.S.) from the MacGRADE Centre at McMaster University who had expertise in evidence synthesis and the guideline development process. Four of these methodologists are also clinicians (B.R., J.L.B., C.A.C.G., and H.J.S.). The MG conducted systematic reviews and prepared the systematic evidence summaries following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, as described here (4, 5). Confidentiality Agreement and Conflict-of-Interest Management Committee members signed a confidentiality agreement and disclosed all potential conflicts of Interest according to the ATS and ERS policies. Two of the co-chairs (G.R. and H.J.S.) reviewed all potential conflicts of Interest of committee members with the staff of the ATS conflictof-Interest and documents units. All of the eight pulmonologists with recognized IPF expertise (G.R., F.J.M., H.R.C., A.U.W., J.B., L.R., A.A., and M.S.) were considered to either have major financial or intellectual conflicts based on disclosures or participation in IPF clinical trials/studies (6); although they were permitted to participate in the discussions of the evidence with the rest of the committee, they were instructed to abstain from discussions related to the evidence to decision framework (described later), formulating and grading recommendations, and voting on recommendations if necessary. This approach was applied to all questions, not just those in which they had a perceived conflict of Interest. Conflicted members were allowed to stay in the same room while discussions among nonconflicted members took place to provide expert input; however, they could do so only when specifically requested by nonconflicted members. Adherence to the rules was strict, with one of the co-chairs (H.J.S.) responsible for monitoring the discussions for adherence to these rules. The remaining nine nonconflicted committee members (A.T., S.H., H.H., H.J.S., J.L.B., D.R., T.J., J.M., and W.C.) were allowed unrestricted participation. Two of the voting members were members of the MG; they are clinicians with extensive expertise in the guideline development process (H.J.S. and J.L.B.). The rest of the MG and the librarian also participated in discussions, but were nonvoting participants. Meetings Face-to-face planning meetings were held during the 2013 ATS International Conference in Philadelphia, Pennsylvania, at which the committee discussed the scope and objectives of the project, and during the 2014 ATS International Conference in San Diego, California, to go over the proceedings of the upcoming face-to-face meeting in June 2014 in Hamilton, Ontario, Canada (described here). Members who could not attend the actual face-to-face meetings participated in person live by teleconference. Additional planning meetings were held regularly over telephone between G.R., H.J.S., and the MG. Conference calls and email correspondence were used to discuss specific issues requiring input from others. The entire guideline committee met at the McMaster Health Forum in Hamilton, Ontario, Canada, on June 9-10, 2014, at which the evidence summaries were presented and discussed, and the recommendations were formulated. Three members participated through teleconference and webinar (H.H., M.S., and W.C.). The methodologists took notes of all matters and points discussed and documented all the recommendations and proceedings. Two follow-up teleconference webinars were held on June 23 and July 15, 2014, to complete the guideline development for two of the 12 treatment questions (questions on single versus bilateral lung transplantation and treatment of IPF-associated pulmonary hypertension [PH]). Three members (A.A., S.H., and T.J.) were not able to participate live during the first teleconference-webinar, and five members (A.A., S.H., T.J., M.S., and H.H.) were not able to join the second teleconference-webinar, but all provided feedback and discussion via emails. All meetings were attended by staff from the ATS documents unit. McMaster University provided meeting facilities and logistical support, and the sponsoring societies provided the financial support for expenses resulting from the meeting and conference calls. The views and Interests of the ATS, ERS, JRS, and ALAT, as well as of any commercial entity that provided external funding for professional societies, had no influence on the topics discussed and recommendations made. Formulating Clinical Questions The committee used the treatment section of the 2011 guideline document (3) as a starting point. Twelve specific questions pertinent and relevant to current clinical practice were addressed to update the recommendations pertinent to treatment of IPF. Most of these questions were previously addressed, and formal recommendations had been provided in the 2011 document. Questions pertinent to the Management of patients with IPF with pulmonary rehabilitation, oxygen supplementation, antibiotics, palliative care, mechanical ventilation, and specific questions that had received a "strong guide.medlive.cn guideline were not readdressed in this update unless the literature search revealed new and pertinent evidence. The committee selected outcomes of Interest for each question, using the 2011 document as a guide in addition to following the approach suggested by the GRADE working group (5, 7). All outcomes were identified a priori, and the committee explicitly rated their relative importance (from the perspective of a patient with IPF) from not important to critical (7). Ranking outcomes by their relative importance helps focus attention on those that are most relevant to patients and helps resolve or clarify potential disagreements in decision making. Examples of critical outcomes include mortality or disease progression. Disease progression, defined in the 2011 document as increasing respiratory symptoms, worsening pulmonary function test (PFT) results, progressive fibrosis on highresolution computed tomography scan, acute respiratory decline, or death, can be measured using multiple outcome measures (3). Changes over time in FVC or diffusing capacity of the lung for carbon monoxide (DL CO ) were considered indirect measures of disease progression for the purpose of this guideline. Rankings of all outcomes were agreed on through consensus of the committee. Literature Search In collaboration with the MG, an information scientist (S.L.P.) designed a search strategy using medical subject heading keywords and text words (see online supplement) limited to human studies or nonindexed citations and articles in English or in any language with English abstracts. The Ovid platform was used to search MEDLINE, EMBASE, Cochrane Registry of Controlled Trials, Health Technology Assessment, and the Database of Abstracts of Reviews of Affects for May 2010 through May 2014. An update was performed in June 2014, immediately before the meeting at McMaster University. Reviewers contacted experts and reviewed previous meta-analyses for additional articles. The search retrieved 9,663 citations, minus duplicates. On the basis of predefined eligibility criteria, 54 citations were included for full text review, of which 34 were excluded with reasons and 20 were included in the evidence update (see online supplement). Evidence Review and Development of Clinical Recommendations Evidence summaries for each question were prepared by the McMaster methodology team, following the GRADE approach (4), using the GRADEpro Guideline Development Tool online software (8). All committee members reviewed the summaries of evidence, and corrections were made when appropriate. We based the evidence on the 2011 evidence summaries that had been produced for that document. These summaries were updated, if necessary, with additional recent randomized controlled trials (RCTs)
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an official ats ers jrs alat clinical practice guideline treatment of idiopathic pulmonary fibrosis an update of the 2011 clinical practice guideline
American Journal of Respiratory and Critical Care Medicine, 2015Co-Authors: Ganesh Raghu, Bram Rochwerg, Yuan Zhang, Carlos Cuello A Garcia, Arata Azuma, J Behr, Jan Brozek, Harold R Collard, William Cunningham, Sakae HommaAbstract:Background: This document updates the American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guideline on idiopathic pulmonary fibrosis treatment.Methods: Systematic reviews and, when appropriate, meta-analyses were performed to summarize all available evidence pertinent to our questions. The evidence was assessed using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach and then discussed by a multidisciplinary panel. Predetermined conflict-of-Interest Management strategies were applied, and recommendations were formulated, written, and graded exclusively by the nonconflicted panelists.Results: After considering the confidence in effect estimates, the importance of outcomes studied, desirable and undesirable consequences of treatment, cost, feasibility, acceptability of the intervention, and implications to health equity, recommendations were made for or against specific treatment interventions.Conclusion...
