Harmonizing guidelines and other clinical practice documents: A joint comprehensive methodology manual by the American Association for Thoracic Surgery (AATS), European Association for Cardio-Thoracic Surgery (EACTS), European Society of Thoracic Surgeons (ESTS), and Society of Thoracic Surgeons (STS)

Central Message A comprehensive pathway for creating multidisciplinary CPGs: encompassing research formulation and synthesis, development of evidence-based recommendations, rigorous validation, publication, and continuous updates to maintain relevance, accuracy, and trustworthiness. Perspective Governing bodies of the AATS, EACTS, ESTS, and STS chose a writing panel based on expertise in the development of clinical practice documents to establish uniform methodology for joint societies' projects. This document integrates existing independent methodologies into a singular collaborative methodology, further enriched by adopting the basic standards for development proposed by key stakeholders. Clinical practice guidelines (CPGs) are essential documents offering practical recommendations developed to enhance patient care and inform health care. Properly formulated through meticulous assessment of scientific evidence and medical expertise by multidisciplinary teams, CPGs strive to ensure an optimal balance between care benefits and potential risks. Because of the dynamic nature of medicine, health care professionals often balance delicate decisions with significant uncertainties. These professionals rely on scientific literature, personal skills and experience, patient preferences, and guidelines from different organizations. Yet, these sources can suggest different paths derived from the same evidence, as is the case in contemporary guidelines on the management of valvular heart disease. [1] No universally accepted standards for developing CPGs exist, even though multiple methodologies exist for evaluating and translating research evidence into treatment recommendations. [2–5] The Institute of Medicine (IOM) provides an authoritative and comprehensive guide for CPG development, introducing several pivotal characteristics regarded as essential for producing reliable documents: (1) transparency, (2) diversity in the writing group composition, (3) conflict of interest (COI) management, (4) thorough systematic literature reviews, (5) synthesis of evidence and evidence strength ratings, (6) clear communication in recommendation and supporting text, (7) external validation, and (8) regular updates. Although these criteria may seem straightforward, aligning with them can be challenging. [6] Many organizations have hesitated to embrace the IOM's criteria entirely, emphasizing the increase in expenses and publication delays without substantial added value. [7] In response to the critical demand for a standardized medical language with the exponential growth of medical knowledge and technology, leading organizations have taken significant steps with specific initiatives to enhance awareness among health care professionals and patients about the vital role of evidence-based practices in improving outcomes. These organizations include the American Association for Thoracic Surgery (AATS), the European Association for Cardio-Thoracic Surgery (EACTS), the European Society of Thoracic Surgeons (ESTS), and the Society of Thoracic Surgeons (STS). The organizations have achieved this awareness by developing, distributing, and extensively discussing clinical guidelines and other pertinent materials that serve to direct clinical decision-making and practices. A significant portion of guideline recommendations might extend beyond strictly empirical scientific arguments, as indicated by the minimal proportion of recommendations grounded in the most robust level of evidence. [8] In addition, the rapid proliferation of medical knowledge, anticipated to double at least every 73 days, [9] underscores the essential need for reliable practice guidelines in medicine. Moreover, in the light of disparate reported outcomes emerging from recent industry-sponsored versus investigator-initiated studies [10, 11] and growing demands for increased transparency and standardization, [12–14] these 4 cardiothoracic surgery associations are actively working to re-establish trust in CPGs within the medical community. Their objective is to produce guidelines and other practice documents with utmost clarity and rigor, ensuring that physicians, patients, and pertinent stakeholders can access and depend on this information. By adopting this methodology in future endeavors, this medical community aims to foster an environment in which decisions are evidence-based, transparent, unbiased, and focused on the safety and effectiveness of patient care. The governing bodies of the AATS, EACTS, ESTS, and STS chose a writing panel on the basis of their expertise in the development of clinical practice documents to establish a uniform methodology for joint societies’ projects. This document integrates existing independent methodologies into a singular collaborative methodology, [15, 16] further enriched by adopting the basic standards for development proposed by the key stakeholders [2, 5] (Table 1). The writing panel collaborated to draft all document sections that were reviewed and discussed during several committee meetings. Consensus was achieved in every phase throughout the development process. In the tables detailing relationships with industry, anonymous voting was applied, and the panel set a 75% approval threshold for finalizing decisions. The fundamental principle proposed for the development of joint clinical practice documents AATS, American Association for Thoracic Surgery; EACTS, European Association for Cardio-Thoracic Surgery; ESTS, European Society of Thoracic Surgeons; STS, Society of Thoracic Surgeons. The fundamental principle proposed for the development of joint clinical practice documents AATS, American Association for Thoracic Surgery; EACTS, European Association for Cardio-Thoracic Surgery; ESTS, European Society of Thoracic Surgeons; STS, Society of Thoracic Surgeons. This document does not address the cost-effectiveness or cost-benefit of specific patient care recommendations as the result of 2 factors: the substantial variability in economic parameters and the absence of standardized cost-effectiveness and cost-benefit data in Europe and globally. Instead, it concentrates on the processes guiding the development of best practice recommendations to provide the best patient care, which aligns with physicians’ primary roles in taking care of patients. The document received unanimous approval from the writing committee members before its submission for external review. It was then presented to 8 expert reviewers appointed by the involved associations. Once declared suitable for publication, it was sent for final review and approval to the 4 societies’ governing bodies. After final approval, it was concurrently published in the Journal of Thoracic and Cardiovascular Surgery, the European Journal of Cardio-Thoracic Surgery, and the Annals of Thoracic Surgery. The writing panel proposes the creation of an array of specialized documents, each designed to meet particular surgical needs within the cardiothoracic community. All clinical practice documents, of their to the fundamental of developing clinical practice These include (1) systematic literature (2) synthesis of evidence, and (3) with and The documents are into primary each characteristics as in with on the of clinical practice documents of clinical practice documents CPGs are documents that address a of these guidelines as that include recommendations to patient care that are by a systematic review of evidence and an assessment of the benefits and of care The guidelines recommendations that are with the primary of improving patient care. recommendations be derived on the basis of a thorough of evidence, with clinical to and the evidence, treatment potential benefits and risks. The formulation of clinical guidelines a joint from a multidisciplinary writing committee of This committee is by its diversity in and its in medical the of clinical the committee evidence review clinical and with knowledge in the development of clinical practice In addition, the writing committee may include research physicians, and from a medical to a rigorous and thorough ensuring that the guidelines are to a of patient and the in medical The key of guidelines depend on from and patient ensuring a robust evidence the primary data from or the writing committee the of the evidence, on and of each may not be for as further research the absence of between 2 treatment these and case studies with the clinical a role in clinical These the basis for recommendations, by expert to enhance patient outcomes. The writing committee its expertise to guidelines that the of patient care. This is critical in with data and treatment practices. The committee further the for continuous in health care and research its each guideline a thorough review by the of the and guideline The guideline be for the writing committee to review and all This review phase the have from anonymous reviewers and final approval from the reviewers and Once the governing of the approval and the guideline is and for documents by significant in practice and the absence of rigorous studies the development of a guideline of recommendations, provide clinical through not by a level of evidence or of recommendation and are as The with the clinical and expert writing committee an literature review and the evidence. This committee is the same as for the CPG ensuring diversity and balance to a of and These documents with the a comprehensive that the for the at of the for the specific of practice a critical of the evidence and expert the knowledge to further for publication, the documents a comprehensive review and approval to the The is these documents are not to be for their to A clinical or is a comprehensive guide or on specific or by leading or authoritative within medical associations. It as and recent or proposed health documents in which may be and to These to the existing literature and potential treatment offering for further clinical practice and The objective is to societies’ on critical clinical and of or for patient The formulation of CPGs is a comprehensive into critical The or phase the by the and the writing committee to ensure the of the document and scientific The or writing the meticulous and synthesis of evidence, which is formulated into recommendations. The validation, thorough and to ensure accuracy, relevance, and before the guidelines are and to the health care community. phase on the to authoritative and practical The of multiple is fundamental in developing knowledge and expertise from these collaborative guidelines that are evidence-based, and of the in medical multidisciplinary a to patient care, the creation of guidelines that are to health care The phase for clinical guidelines is the that a clear and a writing committee of practical as and A CPG document with an and focused on the or of a or The and clinical be and to contemporary medical with significant in clinical and outcomes and a clear need for standardized the development of a document is a substantial of evidence to its ensuring that the is and In this the working by guideline critical clinical and them to the governing bodies for the of and the of care to patients and to provide robust and recommendations, the associations publication enhance transparency and ensure that the and of all members are and members from each are to suggest and for in the process. The guideline committee of the primary an of these the basis of the the guideline committee a about to to the this phase are with to the other guideline for further These a be developed into a expert or clinical and with the the is to or of as a an expert or a the to the governing bodies of all associations for final The is with the of all involved and the of a of which the practical of each involved in the and other the and is pivotal in developing Although surgical management is a the guidelines often critical of care, as and treatment through multidisciplinary as as the care to ensure to and clinical The of guideline is to provide an ensure and practical for the guidelines have a of and and provide an of the a and set of recommendations. The in creating a CPG a writing committee of published in the clinical and on the of professionals in of guideline development, as systematic reviews, research and ensure a comprehensive the the of encompassing a of practice and and the and for of of key stakeholders that an to is not In addition, patient from organizations is to the and decision-making process. The of writing committee members not and research physicians, to ensure an All members are to provide substantial into document development, the clinical and evaluating evidence guideline actively in group and document and in and ensuring that all members to the process. A roles and of writing committee members be before members are each involved in the guideline its In the guideline a pivotal leading the and as a to the writing and governing bodies of the involved associations. The have several critical in the of writing committee members in with the guideline the of to the of the research and writing potential and writing committee and the review and the document before the final for external In addition, the the review between reviewers and the writing and the creation of The are for the clinical a of the review and voting and the guideline committee on other writing committee it is critical to for their substantial to the and in research It is to as as and research or The members be for their and which are essential for collaborative the of the the associations an for ensuring that all have an to This be through to a of potential be by the societies' in with the the assessment the This transparency and a to the the CPG the committee and in the review and of evidence to ensure that have to the development are and for in future This the of and to the standards of collaborative The that the CPGs are developed by and to produce a evidence-based document that the of practical in health care in and potential is critical for developing A to that or to an or and include for which or in These include in or direct of or and with or This to guideline their or and include roles or that research or an and of interest that the members of the guidelines committee review to in of the decisions with management or of committee and about in the writing medical of AATS, American Association for Thoracic Surgery. appointed with management clear the on their These may their in sections of the or recommendations, or voting on to specific a may be for approval from substantial that further on the Once each a writing committee the the specific of their of the of or relationships a is from document development through writing committee a from the before in the The final of the writing group include have and other members have or are as in which a proposed on the basis of the standards of the American of with the publication, the of interest for each be as a of of recommendation and of evidence. of the writing committee a before the communication of to the and development before its the document is published the of the be to the the of other writing committee members and reviewers the publication to the potential of their during the development process. writing committee through of to external may be from all and future to this of to is critical may of this review. the of the the the publication of the document not beyond ensuring the and of the information. The with the systematic literature review. The writing which creation of the submission and evidence is a to ensure and in a robust of the the to the and publication for which a of is This final that the document rigorous and to the of and expert in the before it its A be for and the and and each guideline A is essential for and to the writing committee and by and and This the and writing leading external through the and regular communication to the governing bodies of the involved associations about significant throughout the The associations the development without or to to the ensure transparency and the leading the and for guideline development and this for approval with all involved the include expenses for as and The during the final phase of the development recommendations are can to and the The the expenses for an medical and a publication and other that may during the After all steps of the the writing phase of CPGs This the comprehensive of the creating submission of the document and its and evidence It is a by systematic group and the meticulous of recommendations. This that the guidelines are evidence-based and in contemporary clinical The phase with a writing committee and with the document for external The of a for the composition, detailing the primary sections and their the It the for specific research and practice recommendations. The the text, and and It critical knowledge medical community response and key with for clinical practice The the which is then on the basis of the during the Once discussed and the of is it may external validation, with or on the basis of authoritative from the an essential it a by to for the of literature review and This provides and to and A literature review a and to systematic literature for research This is for developing recommendations or clinical in practice documents and with the need for rapid between and provides with an of the rigor, decision-making in clinical guideline The writing committee members for each recommendations and to the and the specific group of patients by the or of The of the patient be the treatment or and its is In the case of the may be on the of versus an to the proposed often the of care or which include a or an the might be not to outcomes most to the patient with a on direct patient care and supporting the proposed treatment effectiveness and or on improving or outcomes. to the for an to or the of and the developed set of medical can focused for the clinical The teams, of and a research or with the of evidence review a literature review without publication for the development and of ensuring the of for review aligns with the be based on studies published in with the that the writing committee the evidence synthesis without beyond and reported in the The literature be and a methodology in with for and by In with the research an evidence comprehensive on and specific data on the basis of the formulated The tables to the of and its of The writing committee is for a final literature This the evidence of and a all of which be as The thorough assessment of is in clinical research that practice for in recommendation tables a meticulous of potential and The 2 be for to that might outcomes. studies be through the In of to the of in the absence of from evidence in systematic with the as a guideline to the and In addition, other may be as the of evidence to a be as and not as their may not of research as This underscores the of and to for all and significant are the of as that and be without the supporting language and is for the patient specific medical and for the The language to the of and include the as in The provides and a these to the of the recommendations. A comprehensive pathway for creating multidisciplinary clinical practice encompassing research formulation and synthesis, development of evidence-based recommendations, rigorous validation, publication, and continuous updates to maintain and of and A fundamental principle of evidence-based is the of evidence, as the of evidence. Although designed and are the level of evidence, not all are designed and and their be The the strength of evidence-based recommendations to the of the level of evidence an increased of in the or evidence between them In the level of evidence be from A to which is on with The same principle to of an of or significant the universally accepted recommendations are based on or by substantial evidence to and further The writing role in developing clinical guidelines is a dynamic and through all of guideline This continuous and through and and potential recommendations with the of evidence. are for draft recommendations, which are then to and during group meetings. The a critical role in among in evidence and the of each The writing committee members with from discussing and voting on recommendations their an anonymous with for each by a of recommendation and level of evidence. response and 75% among voting with a recommendation or from voting provide a for their that the for further and of the recommendation in for of This is all recommendations a The same to all proposed treatment other or that provides different of clinical the writing committee from finalizing recommendations is a significant in expert or recommendations to by members of the committee the of these the different and for future research to the in evidence and clinical is of among the writing committee be indicated in the of the recommendations. In addition, even is achieved a members of the writing committee in have an to the for their The include these After on the recommendations, and the is to with these decisions and the for The recommendations that have achieved are all are to review the draft and to clarity and throughout the The are for the final which is then among the for their and it by unanimous and the the voting is is the document for external A robust phase is essential in practice guideline this the document draft is the a rigorous to ensure it aligns with clinical standards and The a thorough review to establish the and of the in their Central to this are the and are critical to the This review meticulous to and of to a uniform and comprehensive of the The phase the and of the their for and patients. The primary of this phase is to the guidelines into their most practical and ensuring are for and within clinical the of the writing the governing in with the in a review and to anonymous reviewers from each to to the external process. In to the reviewers a pivotal role in ensuring the and of the review process. are for the of the review their and ensuring that all are by the writing The reviewers have the to an of the review all are ensuring that the review is and of are 2 review an review is as are and a review the document is of review at the writing for to The may an of the review to ensure all are in recommendations and a before The the reviewers are with the to their and the writing committee members the the document is for 2 of The and the reviewers to significant to the document are The an of by the reviewers and the writing are by their as in the final can anonymous in the publication, between the writing committee and the the a process. This to with the expertise to the These with the and reviewers to in and a collaborative Their is to a ensuring that the clinical guidelines are evidence-based and Once the have their final approval, the document is sent to the language for final and then to the for and the of the the document for final These bodies serve as the of review. The writing committee address these final with the same as for The document is for publication it received the of all involved the writing The publication the of the clinical development and often aligns with a scientific This the guidelines are presented to a and to address and in Once the guidelines be to foster from the medical community. In the case of joint are to their and ensure and other and uniform of the a and of the recommendations within the medical community. In the interest of transparency, all be and on to joint review and approval, the of the These and to the document development process. medical practices the regular and of clinical guidelines to include and are A ensure CPG at least every or the evidence significant This regular review CPGs with research and its on and practices. be critical evidence, from robust clinical These updates may or comprehensive The of these updates and the for a writing committee are by the of the as by the governing bodies. health care professionals the as contemporary an or guideline or clinical specific clinical is The development of clinical guidelines is from other clinical practice documents in several vital evidence nature of recommendations, review and as presented in Clinical guidelines a and thorough on patient care by robust evidence from and studies ensuring a for recommendations. clinical documents with a address specific patient care or clinical by practices on document on evidence strength can be recommendations for health care and with of recommendations and of evidence. In other documents clinical or to serve as The for guidelines is from a array of reviewers and by authoritative bodies. clinical documents are to a review the of a review panel and the approval of the the for guidelines is ensuring the evidence. In other clinical practice documents is with that to evidence and for without significant of the document a systematic comprehensive literature reviews, meticulous development, and achieved to these and transparency about the to all clinical practice The and phase of CPGs is critical and can result in not the guidelines the health care and patients. publication in scientific and into materials and clinical can ensure all these to the practical of the guidelines in clinical as to guideline include the of guideline documents and the of or recommendations. often a to by health care professionals in the clinical include and the of guidelines into health guideline to provide on the to which the guidelines are and their on clinical practice is critical during this derived from and and can inform the and of and and for Moreover, the the that may the of guidelines into as to of or these often to health care and organizations in the to with the best practices. and to ensure that CPGs to health of care, and patient safety by translating the best evidence into clinical and knowledge is a dynamic and in clinical practice with emerging research and guidelines be and in guideline development on medicine, recommendations to and The development of clinical guidelines a multidisciplinary patient clinical and and are to patient and into the heart of guideline development, evidence-based, care. and data for the of guidelines and to specific patient guidelines the need for and ensuring into clinical to guidelines is not and might be of future it to and guidelines into health care This include and that recommendations and into and to them to maintain their pivotal role in clinical decisions and patient care outcomes. The of CPGs as the result of transparency of multidisciplinary potential and all of which have health care and patients to their In the AATS, EACTS, ESTS, and STS have reviewed and discussed the critical for creating clinical practice This collaborative in a for joint guidelines with to standards the emphasizing fundamental development systematic literature comprehensive evidence evidence and This document for and guidelines and health care decisions. This collaborative the and transparency in guideline physicians’ in their recommendations, and the for future that to patient care. The reported of The Journal and reviewers to of interest and to or for which may have a conflict of The and reviewers of this have of The and for the The and for their during the development process. The expert external reviewers are and American Association for Thoracic Surgery conflict of interest clinical practice guideline European Association for Cardio-Thoracic Surgery European Society of Thoracic Surgeons Institute of Medicine and Society of Thoracic Surgeons