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      A randomized clinical trial of a new perioperative practice model on anxiety and health‐related quality of life in arthroplasty patients

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          Abstract

          Aims

          To explore the effectiveness of a new perioperative practice model on anxiety and health‐related quality of life in patients undergoing total hip arthroplasty and total knee arthroplasty under spinal anaesthesia.

          Design

          A randomized clinical trial.

          Methods

          Control group participants ( N = 222) received standard perioperative care, meaning they were cared for by various nurses during their perioperative process without postoperative visits. Intervention group participants ( N = 231) were assigned one named anaesthesia nurse during their entire perioperative process who visited them postoperatively. Both groups responded to two self‐reported questionnaires: the generic 15D health‐related quality of life instrument and the State‐Trait Anxiety Inventory (STAI) measuring anxiety two to three weeks pre‐operatively and three months postoperatively.

          Results

          There were no statistically significant differences between the groups at baseline or at follow‐up in health‐related quality of life or anxiety.

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          Most cited references57

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          RoB 2: a revised tool for assessing risk of bias in randomised trials

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            CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials.

            Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials. Copyright © 2010 Moher et al/Ottawa Hospital Research Institute. Published by Elsevier Ltd.. All rights reserved.
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              The 15D instrument of health-related quality of life: properties and applications.

              The 15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL) that can be used both as a profile and single index score measure. This paper examines the acceptability, reliability, validity, discriminatory power and responsiveness to change of its health state descriptive system and valuation system and presents some examples of applications. As a profile measure on roughly comparable dimensions the 15D performs equally well as the Nottingham Health Profile (NHP) and SF-20, in some respects even better, and clearly better than EQ-5D. The remaining nine to ten dimensions of the 15D provide a large reserve in terms of discriminatory power and responsiveness to change. The valuation system is based on an application of the multiattribute utility theory. The single index score (15D score) on a 0-1 scale, representing the overall HRQoL, is calculated from the health state descriptive system by using a set of population-based preference or utility weights. The 15D scores are shown to be highly reliable, sensitive and responsive to change, generalisable at least in Western-type societies, and particularly valid for deriving quality-adjusted life years (QALYs) gained for resource allocation purposes. The instrument is recommended by the Washington Panel and is available in several languages for clinical economic evaluation and population studies.
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                Author and article information

                Contributors
                maria.pulkkinen@kolumbus.fi
                Journal
                Nurs Open
                Nurs Open
                10.1002/(ISSN)2054-1058
                NOP2
                Nursing Open
                John Wiley and Sons Inc. (Hoboken )
                2054-1058
                12 February 2021
                July 2021
                : 8
                : 4 ( doiID: 10.1002/nop2.v8.4 )
                : 1593-1605
                Affiliations
                [ 1 ] Helsinki University Hospital Helsinki University Helsinki Finland
                [ 2 ] Department of Nursing Science University of Turku Turku Finland
                [ 3 ] University of Eastern Finland Kuopio Finland
                [ 4 ] Department of Public Health University of Helsinki Helsinki Finland
                [ 5 ] Department of Mathematics and Statistics University of Turku Turku Finland
                [ 6 ] School of Economics University of Turku Turku Finland
                [ 7 ] Turku University Hospital Turku Finland
                [ 8 ] Nursing Research Center Helsinki University Hospital Helsinki Finland
                Author notes
                [*] [* ] Correspondence

                Maria Pulkkinen, Peijas Hospital, Operating Rooms, PO Box 900, FI00029 HUS, Sairaalakatu 1, 00140 Vantaa, Finland.

                Email: maria.pulkkinen@ 123456kolumbus.fi

                Author information
                https://orcid.org/0000-0003-4968-6173
                https://orcid.org/0000-0002-3541-601X
                Article
                NOP2776
                10.1002/nop2.776
                8186686
                33576579
                728eca9f-63f6-4bb1-8f07-5ccfee52c567
                © 2021 The Authors. Nursing Open published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 11 January 2021
                : 19 September 2020
                : 15 January 2021
                Page count
                Figures: 2, Tables: 4, Pages: 13, Words: 9640
                Funding
                Funded by: Research funding from the Hospital District of Helsinki and Uusimaa
                Funded by: State Funding for University Level Health Research in Finland
                Categories
                Research Article
                Research Articles
                Custom metadata
                2.0
                July 2021
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.2 mode:remove_FC converted:08.06.2021

                anxiety,continuity,health‐related quality of life,nursing,perioperative practice model,randomized clinical trial

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