Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 11:19 PM
Study NCT ID:
NCT05237635
Status:
UNKNOWN
Last Update Posted:
2022-02-14
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defining Decision Thresholds for Judgments on Health Benefits and Harms: Study Protocol
Sponsor:
Organization:
Raw JSON
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Clinical Practice Guidelines We Can Trust. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK209539/'}, {'pmid': '21409613', 'type': 'BACKGROUND', 'citation': 'Schunemann HJ. Guidelines 2.0: do no net harm-the future of practice guideline development in asthma and other diseases. Curr Allergy Asthma Rep. 2011 Jun;11(3):261-8. doi: 10.1007/s11882-011-0185-8.'}, {'pmid': '15615589', 'type': 'BACKGROUND', 'citation': "Atkins D, Eccles M, Flottorp S, Guyatt GH, Henry D, Hill S, Liberati A, O'Connell D, Oxman AD, Phillips B, Schunemann H, Edejer TT, Vist GE, Williams JW Jr; GRADE Working Group. Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group. BMC Health Serv Res. 2004 Dec 22;4(1):38. doi: 10.1186/1472-6963-4-38."}, {'pmid': '27353417', 'type': 'BACKGROUND', 'citation': 'Alonso-Coello P, Schunemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. No abstract available.'}, {'pmid': '27365494', 'type': 'BACKGROUND', 'citation': 'Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schunemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. No abstract available.'}, {'pmid': '23943775', 'type': 'BACKGROUND', 'citation': 'Marcucci M, Sinclair JC. A generalised model for individualising a treatment recommendation based on group-level evidence from randomised clinical trials. BMJ Open. 2013 Aug 13;3(8):e003143. doi: 10.1136/bmjopen-2013-003143.'}, {'pmid': '18767894', 'type': 'BACKGROUND', 'citation': 'McCabe C, Claxton K, Culyer AJ. The NICE cost-effectiveness threshold: what it is and what that means. Pharmacoeconomics. 2008;26(9):733-44. doi: 10.2165/00019053-200826090-00004.'}, {'pmid': '1143303', 'type': 'BACKGROUND', 'citation': 'Pauker SG, Kassirer JP. Therapeutic decision making: a cost-benefit analysis. N Engl J Med. 1975 Jul 31;293(5):229-34. doi: 10.1056/NEJM197507312930505.'}, {'pmid': '31112801', 'type': 'BACKGROUND', 'citation': 'Hultcrantz M, Mustafa RA, Leeflang MMG, Lavergne V, Estrada-Orozco K, Ansari MT, Izcovich A, Singh J, Chong LY, Rutjes A, Steingart K, Stein A, Sekercioglu N, Arevalo-Rodriguez I, Morgan RL, Guyatt G, Bossuyt P, Langendam MW, Schunemann HJ. Defining ranges for certainty ratings of diagnostic accuracy: a GRADE concept paper. J Clin Epidemiol. 2020 Jan;117:138-148. doi: 10.1016/j.jclinepi.2019.05.002. Epub 2019 May 18.'}, {'pmid': '28529184', 'type': 'BACKGROUND', 'citation': 'Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Ostlund P, Tranaeus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schunemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18.'}, {'pmid': '19750051', 'type': 'BACKGROUND', 'citation': 'Faraone SV. Interpreting estimates of treatment effects: implications for managed care. P T. 2008 Dec;33(12):700-11. No abstract available.'}, {'pmid': '26428330', 'type': 'BACKGROUND', 'citation': 'Johnston BC, Ebrahim S, Carrasco-Labra A, Furukawa TA, Patrick DL, Crawford MW, Hemmelgarn BR, Schunemann HJ, Guyatt GH, Nesrallah G. Minimally important difference estimates and methods: a protocol. BMJ Open. 2015 Oct 1;5(10):e007953. doi: 10.1136/bmjopen-2015-007953.'}, {'pmid': '23303884', 'type': 'BACKGROUND', 'citation': 'Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.'}, {'pmid': '23116689', 'type': 'BACKGROUND', 'citation': 'Guyatt GH, Thorlund K, Oxman AD, Walter SD, Patrick D, Furukawa TA, Johnston BC, Karanicolas P, Akl EA, Vist G, Kunz R, Brozek J, Kupper LL, Martin SL, Meerpohl JJ, Alonso-Coello P, Christensen R, Schunemann HJ. GRADE guidelines: 13. Preparing summary of findings tables and evidence profiles-continuous outcomes. J Clin Epidemiol. 2013 Feb;66(2):173-83. doi: 10.1016/j.jclinepi.2012.08.001. Epub 2012 Oct 30.'}, {'pmid': '32503619', 'type': 'BACKGROUND', 'citation': 'Baldeh T, Saz-Parkinson Z, Muti P, Santesso N, Morgano GP, Wiercioch W, Nieuwlaat R, Grawingholt A, Broeders M, Duffy S, Hofvind S, Nystrom L, Ioannidou-Mouzaka L, Warman S, McGarrigle H, Knox S, Fitzpatrick P, Rossi PG, Quinn C, Borisch B, Lebeau A, de Wolf C, Langendam M, Piggott T, Giordano L, van Landsveld-Verhoeven C, Bernier J, Rabe P, Schunemann HJ. Development and use of health outcome descriptors: a guideline development case study. Health Qual Life Outcomes. 2020 Jun 5;18(1):167. doi: 10.1186/s12955-020-01338-8.'}, {'pmid': '21288353', 'type': 'BACKGROUND', 'citation': 'Abramson JH. WINPEPI updated: computer programs for epidemiologists, and their teaching potential. Epidemiol Perspect Innov. 2011 Feb 2;8(1):1. doi: 10.1186/1742-5573-8-1.'}, {'pmid': '31167868', 'type': 'BACKGROUND', 'citation': 'Alper BS, Oettgen P, Kunnamo I, Iorio A, Ansari MT, Murad MH, Meerpohl JJ, Qaseem A, Hultcrantz M, Schunemann HJ, Guyatt G; GRADE Working Group. Defining certainty of net benefit: a GRADE concept paper. BMJ Open. 2019 Jun 4;9(6):e027445. doi: 10.1136/bmjopen-2018-027445.'}, {'pmid': '23163976', 'type': 'BACKGROUND', 'citation': 'Puhan MA, Singh S, Weiss CO, Varadhan R, Boyd CM. A framework for organizing and selecting quantitative approaches for benefit-harm assessment. BMC Med Res Methodol. 2012 Nov 19;12:173. doi: 10.1186/1471-2288-12-173.'}, {'pmid': '402576', 'type': 'BACKGROUND', 'citation': 'Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health and medical practices. N Engl J Med. 1977 Mar 31;296(13):716-21. doi: 10.1056/NEJM197703312961304.'}, {'pmid': '35273045', 'type': 'DERIVED', 'citation': 'Morgano GP, Mbuagbaw L, Santesso N, Xie F, Brozek JL, Siebert U, Bognanni A, Wiercioch W, Piggott T, Darzi AJ, Akl EA, Verstijnen IM, Parmelli E, Saz-Parkinson Z, Alonso-Coello P, Schunemann HJ. Defining decision thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks: a protocol for a randomised methodological study (GRADE-THRESHOLD). BMJ Open. 2022 Mar 10;12(3):e053246. doi: 10.1136/bmjopen-2021-053246.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is an approach to derive and use decision-thresholds for judgments on health benefits and harms using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) frameworks.', 'detailedDescription': 'The objective of this study is to derive decision-thresholds (DTs) for Evidence to Decision (EtD) judgments on the magnitude of health benefits and harms. The study hypothesis is that DTs could discriminate between the four categories for EtD judgments. Explicit DTs, providing an indication for which could be the appropriate judgment for a given scenario, might have the potential to support panels of decision-makers in their work, facilitate a common understanding, and promote consistency and transparency in judgments.\n\nStudy investigators will conduct a methodological randomized controlled trial to collect the data that allow deriving the decision-thresholds. They will invite clinicians, epidemiologists, decision scientists, health research methodologists, experts in Health Technology Assessment (HTA), members of guideline development groups and the public to participate in the trial. Then, investigators will investigate the validity of decision-threshold by measuring the agreement between judgments that were made in the past by guideline panels and the judgments that the DTs approach would suggest if applied on the same guideline data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe target population of the survey will include:\n\n* clinicians\n* epidemiologist\n* decision scientists\n* health research methodologists\n* experts in health technology assessment (HTA)\n* and members of guideline working groups\n* members from the general public\n\nExclusion Criteria:\n\n• Prior participation in the survey'}, 'identificationModule': {'nctId': 'NCT05237635', 'briefTitle': 'Defining Decision Thresholds for Judgments on Health Benefits and Harms: Study Protocol', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Defining Decision Thresholds for Judgments on Health Benefits and Harms Using the GRADE Evidence to Decision (EtD) Frameworks: Protocol for a Randomized Methodological Study (GRADE-THRESHOLD)', 'orgStudyIdInfo': {'id': 'GRADETHRESHLD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Threshold estimates', 'description': 'Descriptive case-scenarios', 'interventionNames': ['Other: descriptive case-scenarios']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Alternative threshold estimates', 'description': 'Descriptive case-scenarios', 'interventionNames': ['Other: descriptive case-scenarios']}], 'interventions': [{'name': 'descriptive case-scenarios', 'type': 'OTHER', 'description': "Each case-scenario will include: (1) a GRADE Summary of Finding (SoF) table providing information about the Population, Intervention, Comparator, Outcome (PICO), the relative and absolute anticipated effects of the intervention, and the certainty in the evidence; (2) a Health Outcome Descriptor describing key attributes of the outcome under consideration including symptoms, time horizon, testing and treatment, and consequences; a measure of the impact on health of the outcome (also known as 'value' of the outcome or 'health utility' in health economics).", 'armGroupLabels': ['Alternative threshold estimates', 'Threshold estimates']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4K1', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Holger J Schunemann, MD, PhD', 'role': 'CONTACT', 'email': 'schuneh@mcmaster.ca', 'phone': '+19055259140', 'phoneExt': '24699'}, {'name': 'Gian Paolo Morgano, PhD', 'role': 'CONTACT', 'email': 'morganog@mcmaster.ca', 'phone': '+393498125719'}, {'name': 'Holger J Schunemann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gian Paolo Morgano, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wojtek Wiercioch, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Holger J Schunemann, MD, PhD', 'role': 'CONTACT', 'email': 'schuneh@mcmaster.ca', 'phone': '+19055259140', 'phoneExt': '24699'}, {'name': 'Gian Paolo Morgano, PhD', 'role': 'CONTACT', 'email': 'morganog@mcmaster.ca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}