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      N-of-1 Trials as a Decision Support Tool in Clinical Practice: A Protocol for a Systematic Literature Review and Narrative Synthesis

      research-article
      1 , * , 2 , 1
      Healthcare
      MDPI
      n-of-1 trial, single case experimental design, personalized trial

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          Abstract

          The n-of-1 trial can utilized in clinical practice as a decision support tool, which may improve patient outcomes by providing both the patient and the clinician with objective evidence to inform personalized treatment decisions. As its use broadens, it will be important to study whether the added time and effort of an n-of-1 trial results in measurable improvements in important patient outcomes compared to usual clinical practice. Parallel-group randomized clinical trials testing the n-of-1 approach versus usual care have been undertaken in a number of medical settings. A systematic review will be performed according to PRISMA guidelines, using MEDLINE, Embase, Cochrane, CINAHL, PsycINFO, Scopus, and Web of Science to search for randomized clinical trials in humans, without date or language restriction. Reports from the gray literature and ongoing studies in trial registries will be included. Articles will be screened by two independent reviewers with a third reviewer consulted to adjudicate disagreement. The quality of included studies will be assessed using the Cochrane Collaboration’s tool for assessing risk of bias. A narrative synthesis will explore the differing methodological approaches of the included studies. The protocol will be registered in the PROSPERO registry, and the results of the review will be published in a peer-reviewed journal. To our knowledge, this systematic review will be the first to comprehensively assess the existing research on randomized trials testing the n-of-1 trial approach in clinical practice.

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          Most cited references6

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          Determining optimal therapy--randomized trials in individual patients.

          Although the treatment of an individual patient in routine clinical practice has been likened to an experiment, the method is so susceptible to bias that we have come to demand multi-patient, double-blind, randomized controlled trials on matters of efficacy. Unfortunately, such trials have not or cannot be carried out for many clinical disorders; even when they have been executed their results may be difficult to extrapolate to individual patients. To resolve this problem, we have begun to use double-blind randomized trials in which a single patient undergoes a series of pairs of treatments, consisting of one active and one placebo or alternative treatment per pair, with the order determined by random allocation. Appropriate treatment targets (signs, symptoms, or laboratory tests) are used as the measure of efficacy, and the trial is continued until efficacy is established or disproved. We describe such a trial, which resulted in a dramatically beneficial modification of treatment in a patient with partially reversible airflow limitation. We have established a clinical service that facilitates the widespread use of the method in our community.
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            Why Can't We Be More Idiographic in Our Research?

            Most psychological scientists make inferences about the relations among variables of interest by comparing aggregated data from groups of individuals. Although this method is unarguably a useful one that will continue to yield scientific advances, important limitations exist regarding the efficiency and flexibility of such designs, as well as with the generality of obtained results. Idiographic research strategies, which focus on the intensive study of individual organisms over time, offer a proficient and flexible alternative to group comparison designs; however, they are rarely taught in graduate training programs and are seldom used by psychological scientists. We highlight some of the unique strengths of idiographic methods, such as single case experimental designs, and suggest that psychological science will progress most efficiently with an increased use of such methods in both laboratory and clinical settings.
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              CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement.

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                Author and article information

                Journal
                Healthcare (Basel)
                Healthcare (Basel)
                healthcare
                Healthcare
                MDPI
                2227-9032
                06 November 2019
                December 2019
                : 7
                : 4
                : 136
                Affiliations
                [1 ]McGovern Medical School, The University of Texas Health Science Center at Houston, 6431 Fannin St, Houston, TX 77030, USA; donald.a.molony@ 123456uth.tmc.edu
                [2 ]Houston Academy of Medicine, The Texas Medical Center Library, 1133 John Freeman Blvd, Houston, TX 77030, USA; travis.holder@ 123456library.tmc.edu
                Author notes
                [* ]Correspondence: joyce.samuel@ 123456uth.tmc.edu ; Tel.: +1-713-500-6708
                Article
                healthcare-07-00136
                10.3390/healthcare7040136
                6955960
                31698713
                5ebd6ac7-5a77-48a7-8802-019d2dcb550e
                © 2019 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

                History
                : 29 August 2019
                : 02 November 2019
                Categories
                Protocol

                n-of-1 trial,single case experimental design,personalized trial

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