Abstract
Objectives
This article describes the Grading of Recommendations Assessment, Development and
Evaluation (GRADE) Working Group's framework of moving from test accuracy to patient
or population-important outcomes. We focus on the common scenario when studies directly
evaluating the effect of diagnostic and other tests or strategies on health outcomes
are not available or are not providing the best available evidence.
Study Design and Setting
Using practical examples, we explored how guideline developers and other decision
makers can use information from test accuracy to develop a recommendation by linking
evidence that addresses downstream consequences. Guideline panels should develop an
analytic framework that summarizes the actions that follow from applying a test and
the consequences.
Results
We describe GRADE's current thinking about the overall certainty of the evidence (also
known as quality of the evidence or confidence in the estimates) arising from consideration
of the often complex pathways that involve multiple tests and management options.
Each link in the evidence can—and often does—lower the overall certainty of the evidence
required to formulate recommendations and make decisions about tests. The frequency
with which an outcome occurs and its importance will influence whether or not a particular
step in the linked evidence is critical to decision-making.
Conclusions
Overall certainty may be expressed by the weakest critical step in the linked evidence.
The linked approach to addressing optimal testing will often require the use of decision
analytic approaches. We present an example that involves decision modeling in a GRADE
Evidence to Decision framework for cervical cancer screening. However, because resources
and time of guideline developers may be limited, we describe alternative, pragmatic
strategies for developing recommendations addressing test use.
Keywords
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References
- GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health.J Clin Epidemiol. 2016; 76: 89-98
- Current methods of the US Preventive Services Task Force: a review of the process.Am J Prev Med. 2001; 20: 21-35
- The efficacy of diagnostic imaging.Med Decis Making. 1991; 11: 88-94
- GRADE: assessing the quality of evidence for diagnostic recommendations.ACP J Club. 2008; 149: 2
- Grading quality of evidence and strength of recommendations for diagnostic tests and strategies.BMJ. 2008; 336: 1106-1110
- [Diagnostic accuracy and linked evidence--testing the chain].Z Evid Fortbild Qual Gesundhwes. 2012; 106: 153-160
- Assessing the value of diagnostic tests: a framework for designing and evaluating trials.BMJ. 2012; 344: e686
- GRADE guidelines: 14. Going from evidence to recommendations: the significance and presentation of recommendations.J Clin Epidemiol. 2013; 66: 719-725
- GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength.J Clin Epidemiol. 2013; 66: 726-735
- How to read the new recommendation statement: methods update from the U.S. Preventive Services Task Force.Ann Intern Med. 2007; 147: 123-127
- A capture-recapture analysis demonstrated that randomized controlled trials evaluating the impact of diagnostic tests on patient outcomes are rare.J Clin Epidemiol. 2012; 65: 282-287
- Systematic reviews and meta-analyses of benefits and harms of cryotherapy, LEEP, and cold knife conization to treat cervical intraepithelial neoplasia.Int J Gynaecol Obstet. 2016; 132: 266-271
- Application of GRADE: making evidence-based recommendations about diagnostic tests in clinical practice guidelines.Implement Sci. 2011; 6: 62
- Diagnosis and Rationale for action against Cow's milk allergy (DRACMA): a summary report.J Allergy Clin Immunol. 2010; 126: 1119-1128.e12
- Commercial Serodiagnostic Tests for Diagnosis of Tuberculosis.World Health Organization, Geneva2011 (ISBN 978 92 4 150205 4)
- World Health Organization Guidelines for treatment of cervical intraepithelial neoplasia 2-3 and screen-and-treat strategies to prevent cervical cancer.Int J Gynaecol Obstet. 2016; 132: 252-258
- Systematic reviews and meta-analyses of the accuracy of HPV tests, visual inspection with acetic acid, cytology, and colposcopy.Int J Gynaecol Obstet. 2016; 132: 259-265
- World health organization guidelines: use of cryotherapy for cervical intraepithelial neoplasia.Int J Gynaecol Obstet. 2012; 118: 97-102
- (Available at)http://globocan.iarc.fr/factsheets/cancers/cervix.aspDate accessed: October 13, 2016
- World allergy organization (WAO) diagnosis and Rationale for action against Cow's milk allergy (DRACMA) guidelines.Pediatr Allergy Immunol. 2010; 21: 1-125
- Decision-making about healthcare related tests and diagnostic strategies: User testing of GRADE evidence tables.PLoS One. 2015; 10: e0134553
- Uncertainties in baseline risk estimates and confidence in treatment effects.BMJ. 2012; 345: e7401
- Use of GRADE for assessment of evidence about prognosis: rating confidence in estimates of event rates in broad categories of patients.BMJ. 2015; 350: h870
- Model based economic evaluations of diagnostic point of care tests were rarely fit for purpose.J Clin Epidemiol. 2018; ([Epub ahead of print])https://doi.org/10.1016/j.jclinepi.2018.11.003
- When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials?.Ann Intern Med. 2006; 144: 850-855
- Transparent development of the WHO rapid advice guidelines.PLoS Med. 2007; 4: e119
- Developing and evaluating Communication strategies to Support informed decisions and practice based on evidence (DECIDE): protocol and preliminary results.Implement Sci. 2013; 8: 6
- GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: clinical practice guidelines.BMJ. 2016; 353: i2089
- GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction.BMJ. 2016; 353: i2016
- Diagnosis of DVT: Antithrombotic therapy and Prevention of Thrombosis, 9th ed.: American College of chest Physicians evidence-based clinical practice guidelines.Chest. 2012; 141: e351S-e418S
Article info
Publication history
Published online: February 07, 2019
Accepted:
February 4,
2019
Footnotes
Conflict of interest statement: The authors are members of the GRADE Working Group. J.A.S. has received research grants from Takeda and Savient and consultant fees from Savient, Takeda, Regeneron, Merz, Iroko, Bioiberica, Crealta/Horizon and Allergan pharmaceuticals, WebMD, UBM LLC and the American College of Rheumatology. J.A.S. serves as the principal investigator for an investigator-initiated study funded by Horizon pharmaceuticals through a grant to DINORA, Inc., a 501 (c) (3) entity. J.S. is a member of the executive of OMERACT, an organization that develops outcome measures in rheumatology, and receives arms-length funding from 36 companies; a member of the American College of Rheumatology's (ACR) Annual Meeting Planning Committee (AMPC); Chair of the ACR Meet-the-Professor, Workshop and Study Group Subcommittee; and a member of the Veterans Affairs Rheumatology Field Advisory Committee. J.S. is the editor and the Director of the UAB Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis. The other authors declared no financial conflict of interest.
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Copyright
© 2019 Published by Elsevier Inc.
