title: Confidence in outcome estimates from systematic reviews used in informed consent.
abstract: Evidence-based dentistry now guides informed consent in which clinicians are obliged to provide patients with the most current, best evidence, or best estimates of outcomes, of regimens, therapies, treatments, procedures, materials, and equipment or devices when developing personal oral health care, treatment plans. Yet, clinicians require that the estimates provided from systematic reviews be verified to their validity, reliability, and contextualized as to performance competency so that clinicians may have confidence in explaining outcomes to patients in clinical practice.
  
  
  
  The purpose of this paper was to describe types of informed estimates from which clinicians may have confidence in their capacity to assist patients in competent decision-making, one of the most important concepts of informed consent.
  
  
  
  Using systematic review methodology, researchers provide clinicians with valid best estimates of outcomes regarding a subject of interest from best evidence. Best evidence is verified through critical appraisals using acceptable sampling methodology either by scoring instruments (Timmer analysis) or checklist (grade), a Cochrane Collaboration standard that allows transparency in open reviews. These valid best estimates are then tested for reliability using large databases. Finally, valid and reliable best estimates are assessed for meaning using quantification of margins and uncertainties.
  
  
  
  Through manufacturer and researcher specifications, quantification of margins and uncertainties develops a performance competency continuum by which valid, reliable best estimates may be contextualized for their performance competency: at a lowest margin performance competency (structural failure), high margin performance competency (estimated true value of success), or clinically determined critical values (clinical failure).
  
  
  
  Informed consent may be achieved when clinicians are confident of their ability to provide useful and accurate best estimates of outcomes regarding regimens, therapies, treatments, and equipment or devices to patients in their clinical practices and when developing personal, oral health care, treatment plans.
authors.affiliation: Division of General Dentistry, Center of Dental Research, Loma Linda University School of Dentistry, Loma Linda, CA, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Fritz
authors.affiliation: Advanced Education Services, Center of Dental Research, Loma Linda University School of Dentistry, Loma Linda, CA, USA. Electronic address: jbauer@llu.edu.
authors.forename: Janet G
authors.initials: JG
authors.lastname: Bauer
authors.affiliation: Division of General Dentistry, Center of Dental Research, Loma Linda University School of Dentistry, Loma Linda, CA, USA.
authors.forename: Sue S
authors.initials: SS
authors.lastname: Spackman
authors.affiliation: Center of Dental Research, Loma Linda University School of Dentistry, Loma Linda, CA, USA.
authors.forename: Amanjyot K
authors.initials: AK
authors.lastname: Bains
authors.affiliation: Center of Dental Research, Loma Linda University School of Dentistry, Loma Linda, CA, USA.
authors.forename: Jeanette
authors.initials: J
authors.lastname: Jetton-Rangel
mesh_terms: D000066491:Clinical Decision-Making; D003657:Decision Making; D055094:Evidence-Based Dentistry; D058015:Health Communication; D006801:Humans; D007258:Informed Consent; D015203:Reproducibility of Results; D057170:Translational Research, Biomedical; D016896:Treatment Outcome
keywords: Outcomes; Performance margins; QMU; Quantification of margins and uncertainties; Reliable best estimates; True value; Valid best estimates