{"corpus_id":39474846,"paper_sha":"2de19a39d313661c65accad438f777e3239c2da3","doi":"10.1097/MAT.0000000000000696","arxiv_id":null,"pmid":29076946,"pmcid":null,"mag_id":2766865996,"dblp_id":null,"acl_id":null,"title":"Mapping the Informed Consent Process for Left Ventricular Assist Devices","year":2017,"publication_date":"2017-10-01","venue":"ASAIO journal (1992)","journal":{"name":"ASAIO Journal","pages":"630–635","volume":"64"},"journal_issn":null,"journal_title":null,"publication_types":["JournalArticle"],"pubmed_pub_types":["Journal Article","Research Support, Non-U.S. Gov't"],"s2_fields_of_study":["Medicine"],"reference_count":32,"citation_count":9,"influential_citation_count":1,"is_open_access":false,"arxiv_categories":null,"arxiv_license":null,"arxiv_journal_ref":null,"mesh_headings":[{"d":"Decision Making","mj":false,"qs":[{"q":"ethics","mj":false,"ui":"Q000941"}],"ui":"D003657"},{"d":"Female","mj":false,"ui":"D005260"},{"d":"Heart Failure","mj":false,"qs":[{"q":"therapy","mj":false,"ui":"Q000628"}],"ui":"D006333"},{"d":"Heart-Assist Devices","mj":true,"qs":[{"q":"ethics","mj":false,"ui":"Q000941"}],"ui":"D006353"},{"d":"Humans","mj":false,"ui":"D006801"},{"d":"Informed Consent","mj":true,"ui":"D007258"},{"d":"Male","mj":false,"ui":"D008297"},{"d":"Middle Aged","mj":false,"ui":"D008875"},{"d":"United States","mj":false,"ui":"D014481"}],"chemicals":null,"comments_corrections":null,"source_flags":5,"s2_open_access_pdf_url":null,"s2_open_access_landing_url":null,"s2_open_access_license":null,"s2_open_access_status":null,"pmc_open_access_pdf_url":null,"pmc_open_access_landing_url":null,"pmc_open_access_license":null,"pmc_open_access_status":null,"unpaywall_open_access_pdf_url":null,"unpaywall_open_access_landing_url":null,"unpaywall_open_access_license":null,"unpaywall_open_access_status":null,"abstract":"Ethical, practical, and medical challenges affect decisions about left ventricular assist device (LVAD) implantation. The informed consent document (IC-Doc) is integral to the decision-making process and structures informed consent conversations. The objective of this study was to analyze IC-Docs to identify the information patients and their families receive about LVAD implantation to create a model IC-Doc. We requested IC-Doc for LVAD implantation from LVAD programs in the United States. We analyzed them in three areas: medical and technical content, patient knowledge gaps, and syntax. Nineteen IC-Docs representing all United Network of Organ Sharing regions were included. Seventeen (89.5%) mentioned the indications for LVAD implantation (bridge to transplant or destination therapy), and six indicated which category applied to the patient. Palliative care was mentioned as an alternative in nine (47.4%); no IC-Doc discussed nonsurgical palliative care. Eight forms (42.1%) specifically mentioned turning off the LVAD. Eighteen forms mention general bleeding, and four referred to long-term gastrointestinal bleeding. Two IC-Docs addressed driveline infections. One form was written at an 8th grade reading level. There is wide variation in LVAD IC-Docs and omission of some benefits and risks. We have written an IC-Doc that meets criteria for disclosure, fills many knowledge gaps, and has an acceptable readability score.","claims":[{"public_id":"cl_1471ff369a11f47597af3278a3de829d","status":"active","text":"A model LVAD informed consent document was written to meet disclosure criteria, fill knowledge gaps, and achieve acceptable readability.","confidence":0.97,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_1471ff369a11f47597af3278a3de829d"},{"public_id":"cl_e5ed3b35bbec45e0baead0b63cae48a5","status":"active","text":"LVAD informed consent documents vary widely across U.S. programs and omit some benefits and risks.","confidence":0.98,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_e5ed3b35bbec45e0baead0b63cae48a5"},{"public_id":"cl_a3b09ce1c83ba7c71be2846608316cb5","status":"active","text":"Many documents mention bleeding, but very few address long-term gastrointestinal bleeding, driveline infections, or turning off the LVAD.","confidence":0.95,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_a3b09ce1c83ba7c71be2846608316cb5"},{"public_id":"cl_7b2efa83cc6144dc12fb3231703afd98","status":"active","text":"Most reviewed documents mention the indications for LVAD implantation, but only a minority specify which indication applies to the patient.","confidence":0.93,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_7b2efa83cc6144dc12fb3231703afd98"},{"public_id":"cl_68c2f66ef6e024514685b9fb30e4cf70","status":"active","text":"Palliative care is mentioned as an alternative in fewer than half of the documents, and nonsurgical palliative care is not discussed.","confidence":0.95,"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/claims/cl_68c2f66ef6e024514685b9fb30e4cf70"}],"concepts":[{"public_id":"co_10d77639ae13aa1bd2a37f98d1e2fae6","status":"active","name":"disclosure criteria","description":"Standards for what information should be included in informed consent.","types":["standard"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_10d77639ae13aa1bd2a37f98d1e2fae6"},{"public_id":"co_131ee9d7a2629e1d1d1243a2e4c87034","status":"active","name":"model informed consent document","description":"A proposed consent document developed from the review to better disclose relevant LVAD information.","types":["document"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_131ee9d7a2629e1d1d1243a2e4c87034"},{"public_id":"co_2d74932f1d33630659301ca0c68bb098","status":"active","name":"readability score","description":"A measure of how easy a document is to read and understand.","types":["metric"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_2d74932f1d33630659301ca0c68bb098"},{"public_id":"co_453168e56fb5b411ace6883e0032fbcc","status":"active","name":"gastrointestinal bleeding","description":"Bleeding originating in the gastrointestinal tract.","types":["complication"],"aliases":["long-term gastrointestinal bleeding"],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_453168e56fb5b411ace6883e0032fbcc"},{"public_id":"co_4ac1a85be03bbd1068b161f480e864e0","status":"active","name":"palliative care","description":"Care focused on symptom relief and quality of life for serious illness.","types":["care approach"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_4ac1a85be03bbd1068b161f480e864e0"},{"public_id":"co_4d746fa2dd26110e94e0ab9ab578afe0","status":"active","name":"turning off the LVAD","description":"The option of deactivating the implanted left ventricular assist device.","types":["management option"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_4d746fa2dd26110e94e0ab9ab578afe0"},{"public_id":"co_6568309c8a09cbb264ba315c1ec6a793","status":"active","name":"nonsurgical palliative care","description":"Palliative care options that do not involve surgical intervention.","types":["care approach"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_6568309c8a09cbb264ba315c1ec6a793"},{"public_id":"co_719ceadb23ef0ee580ece3b34af5df6b","status":"active","name":"driveline infections","description":"Infections involving the external cable connecting the implanted LVAD to its controller.","types":["complication"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_719ceadb23ef0ee580ece3b34af5df6b"},{"public_id":"co_892ffe4e40ec3f71d4b8e19b7bcdc5f9","status":"active","name":"benefits and risks","description":"Potential positive outcomes and adverse effects associated with LVAD implantation.","types":["clinical content"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_892ffe4e40ec3f71d4b8e19b7bcdc5f9"},{"public_id":"co_8a5058f5237c6795bfb7bfcc05d5f15d","status":"active","name":"bleeding","description":"Loss of blood discussed as a complication in LVAD consent materials.","types":["complication"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous (12632b8b5f)","roles":["extraction"],"url":"https://sah.borca.ai/u/12632b8b5f"}],"url":"https://sah.borca.ai/concepts/co_8a5058f5237c6795bfb7bfcc05d5f15d"},{"public_id":"co_a074e8d26f7b25f39607eb0623d75e27","status":"active","name":"indications for LVAD implantation","description":"The clinical reasons or intended therapeutic goals for placing an LVAD.","types":["clinical content"],"aliases":[],"contributors":[{"id":1,"public_id":"12632b8b5f","public_label":"Anonymous 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