Physical Rehabilitation Core Outcomes In Critical illness (PRACTICE): protocol for development of a core outcome set.
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ABSTRACT: Background
Existing data on physical rehabilitation interventions in critical illness are challenged by outcome heterogeneity that limits data synthesis and translation of research findings into clinical practice. This protocol describes the PRACTICE study to develop a core outcome set (COS) for trials of physical rehabilitation interventions delivered across the continuum of a patient's recovery from the intensive care unit until reintegration in the community following hospital discharge.Methods
Mixed methods will be used including: systematic reviews of quantitative and qualitative literature; qualitative interviews with patients and caregivers; a modified Delphi consensus process with researcher, clinician and patient/caregiver stakeholder groups; and consensus meetings for ratification of findings, resolving uncertainty, or developing an action plan for COS implementation.Discussion
The PRACTICE COS will inform relevant stakeholders about important outcomes regarding physical rehabilitation in critical illness, and may enhance the future design and conduct of trials in this area.Trial registration
COMET database ( www.comet-initiative.org/ , Record ID 288, 01/03/13). PROSPERO database ( CRD42014008908 , CRD42017078549 ).
SUBMITTER: Connolly B
PROVIDER: S-EPMC5970518 | biostudies-literature | 2018 May
REPOSITORIES: biostudies-literature
Publications
Physical Rehabilitation Core Outcomes In Critical illness (PRACTICE): protocol for development of a core outcome set.
Connolly Bronwen B Denehy Linda L Hart Nicholas N Pattison Natalie N Williamson Paula P Blackwood Bronagh B
Trials 20180525 1
<h4>Background</h4>Existing data on physical rehabilitation interventions in critical illness are challenged by outcome heterogeneity that limits data synthesis and translation of research findings into clinical practice. This protocol describes the PRACTICE study to develop a core outcome set (COS) for trials of physical rehabilitation interventions delivered across the continuum of a patient's recovery from the intensive care unit until reintegration in the community following hospital dischar ...[more]
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Project description:ObjectivesMore children are surviving critical illness but are at risk of residual or new health conditions. An evidence-informed and stakeholder-recommended core outcome set is lacking for pediatric critical care outcomes. Our objective was to create a multinational, multistakeholder-recommended pediatric critical care core outcome set for inclusion in clinical and research programs.DesignA two-round modified Delphi electronic survey was conducted with 333 invited research, clinical, and family/advocate stakeholders. Stakeholders completing the first round were invited to participate in the second. Outcomes scoring greater than 69% "critical" and less than 15% "not important" advanced to round 2 with write-in outcomes considered. The Steering Committee held a virtual consensus conference to determine the final components.SettingMultinational survey.PatientsStakeholder participants from six continents representing clinicians, researchers, and family/advocates.Measurements and main resultsOverall response rates were 75% and 82% for each round. Participants voted on seven Global Domains and 45 Specific Outcomes in round 1, and six Global Domains and 30 Specific Outcomes in round 2. Using overall (three stakeholder groups combined) results, consensus was defined as outcomes scoring greater than 90% "critical" and less than 15% "not important" and were included in the final PICU core outcome set: four Global Domains (Cognitive, Emotional, Physical, and Overall Health) and four Specific Outcomes (Child Health-Related Quality of Life, Pain, Survival, and Communication). Families (n = 21) suggested additional critically important outcomes that did not meet consensus, which were included in the PICU core outcome set-extended.ConclusionsThe PICU core outcome set and PICU core outcome set-extended are multistakeholder-recommended resources for clinical and research programs that seek to improve outcomes for children with critical illness and their families.
| S-EPMC7785252 | biostudies-literature
Project description:BackgroundUse of outcome measures (OMs) in adult neurologic physical therapy is essential for monitoring changes in a patient's status over time, quantifying observations and patient-reported function, enhancing communication, and increasing the efficiency of patient care. OMs also provide a mechanism to compare patient and organizational outcomes, examine intervention effectiveness, and generate new knowledge. This clinical practice guideline (CPG) examined the literature related to OMs of balance, gait, transfers, and patient-stated goals to identify a core set of OMs for use across adults with neurologic conditions and practice settings.MethodsTo determine the scope of this CPG, surveys were conducted to assess the needs and priorities of consumers and physical therapists. OMs were identified through recommendations of the Academy of Neurologic Physical Therapy's Evidence Database to Guide Effectiveness task forces. A systematic review of the literature on the OMs was conducted and additional OMs were identified; the literature search was repeated on these measures. Articles meeting the inclusion criteria were critically appraised by 2 reviewers using a modified version of the COnsensus-based Standards for the selection of health Measurement INstruments. (COSMIN) checklist. Methodological quality and the strength of statistical results were determined. To be recommended for the core set, the OMs needed to demonstrate excellent psychometric properties in high-quality studies across neurologic conditions.Results/discussionBased on survey results, the CPG focuses on OMs that have acceptable clinical utility and can be used to assess change over time in a patient's balance, gait, transfers, and patient-stated goals. Strong, level I evidence supports the use of the Berg Balance Scale to assess changes in static and dynamic sitting and standing balance and the Activities-specific Balance Confidence Scale to assess changes in balance confidence. Strong to moderate evidence supports the use of the Functional Gait Assessment to assess changes in dynamic balance while walking, the 10 meter Walk Test to assess changes in gait speed, and the 6-Minute Walk Test to assess changes in walking distance. Best practice evidence supports the use of the 5 Times Sit-to-Stand to assess sit to standing transfers. Evidence was insufficient to support use of a specific OM to assess patient-stated goals across adult neurologic conditions. Physical therapists should discuss the OM results with patients and collaboratively decide how the results should inform the plan of care.DisclaimerThe recommendations included in this CPG are intended as a guide for clinicians, patients, educators, and researchers to improve rehabilitation care and its impact on adults with neurologic conditions. The contents of this CPG were developed with support from the APTA and the Academy of Neurologic Physical Therapy (ANPT). The Guideline Development Group (GDG) used a rigorous review process and was able to freely express its findings and recommendations without influence from the APTA or the ANPT. The authors declare no competing interest.Video Abstract available for more insights from the authors (see Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A214.
| S-EPMC6023606 | biostudies-literature
Project description:INTRODUCTION:The number of inconclusive physical rehabilitation randomised controlled trials for patients with critical illness is increasing. Evidence suggests critical illness patient subgroups may exist that benefit from targeted physical rehabilitation interventions that could improve their recovery trajectory. We aim to identify critical illness patient subgroups that respond to physical rehabilitation and map recovery trajectories according to physical function and quality of life outcomes. Additionally, the utilisation of healthcare resources will be examined for subgroups identified. METHODS AND ANALYSIS:This is an individual participant data meta-analysis protocol. A systematic literature review was conducted for randomised controlled trials that delivered additional physical rehabilitation for patients with critical illness during their acute hospital stay, assessed chronic disease burden, with a minimum follow-up period of 3?months measuring performance-based physical function and health-related quality of life outcomes. From 2178 records retrieved in the systematic literature review, four eligible trials were identified by two independent reviewers. Principal investigators of eligible trials were invited to contribute their data to this individual participant data meta-analysis. Risk of bias will be assessed (Cochrane risk of bias tool for randomised trials). Participant and trial characteristics, interventions and outcomes data of included studies will be summarised. Meta-analyses will entail a one-stage model, which will account for the heterogeneity across and the clustering between studies. Multiple imputation using chained equations will be used to account for the missing data. ETHICS AND DISSEMINATION:This individual participant data meta-analysis does not require ethical review as anonymised participant data will be used and no new data collected. Additionally, eligible trials were granted approval by institutional review boards or research ethics committees and informed consent was provided for participants. Data sharing agreements are in place permitting contribution of data. The study findings will be disseminated at conferences and through peer-reviewed publications. PROSPERO REGISTRATION NUMBER:CRD42019152526.
| S-EPMC7223158 | biostudies-literature
Project description:IntroductionPrimary school-based physical activity interventions, such as The Daily Mile initiative, have the potential to increase children's physical activity levels over time, which is associated with a variety of health benefits. Comparing interventions or combining results of several studies of a single intervention is challenging because previous studies have examined different outcomes or used different measures that are not feasible or relevant for researchers in school settings. The development and implementation of a core outcome set (COS) for primary school-based physical activity interventions would ensure outcomes important to those involved in implementing and evaluating interventions are standardised.Methods and analysisOur aim is to develop a COS for studies of school-based physical activity interventions. We will achieve this by undertaking a four-stage process:(1) identify a list of outcomes assessed in studies through a systematic review of international literature; (2) establish domains from these outcomes to produce questionnaire items; (3) prioritise outcomes through a two-stage Delphi survey with four key stakeholder groups (researchers, public health professionals, educators and parents), where stakeholders rate the importance of each outcome on a 9-point Likert scale (consensus that the outcomes should be included in the COS will be determined as 70% or more of all stakeholders scoring the outcome 7%-9% and 15% or less scoring 1 to 3); (4) achieve consensus on a final COS in face-to-face meetings with a sample of stakeholders and primary school children.Ethics and disseminationWe have received ethical approval from Imperial College London (ref: 19IC5428). The results of this study will be disseminated via conference presentations/public health meetings, peer-reviewed publications and through appropriate media channels.Trial registration numberCore Outcome Measures in Effectiveness Trials Initiative (COMET) number: 1322.
| S-EPMC6937029 | biostudies-literature
Project description:BackgroundSeveral hundred core outcome set (COS) projects have been systematically identified to date which, if adopted, ensure that researchers measure and report those outcomes that are most likely to be relevant to users of their research. The uptake of a COS by COS users will depend in part on the transparency and robustness of the methods used in the COS development study, which would be increased by the use of a standardised protocol. This article describes the development of the COS-STAP (Core Outcome Set-STAndardised Protocol Items) Statement for the content of a COS development study protocol.MethodsThe COS-STAP Statement was developed following the Enhancing the Quality and Transparency Of Health Research (EQUATOR) Network's methodological framework for guideline development. This included an initial item generation stage, a two-round Delphi survey involving more than 150 participants representing three stakeholder groups (COS developers, journal editors and patient and public involvement researchers interested in COS development), followed by a consensus meeting with eight voting participants.ResultsThe COS-STAP Statement consists of a checklist of 13 items considered essential documentation in a protocol, outlining the scope of the COS, stakeholder involvement, COS development plans and consensus processes.ConclusionsJournal editors and peer reviewers can use the guidance to assess the completeness of a COS development study protocol submitted for publication. By providing guidance for key content, the COS-STAP Statement will enhance the drafting of high-quality protocols and determine how the COS development study will be carried out.
| S-EPMC6371434 | biostudies-literature
Project description:IntroductionVelopharyngeal dysfunction (VPD) is present in up to 40% of patients following cleft palate repair. Children with VPD display hypernasal speech, nasal air emission and are at a high risk for developing articulation disorders. The overall result is decreased intelligibility and acceptability of speech, as well as significant functional and social impairments. Although there are several surgical approaches for the management of children with VPD, standard treatment protocols have not been well defined. There is a need for a core outcome set (COS) to reduce outcome reporting bias and heterogeneity across studies of VPD. The COS-VPD Initiative is an international effort to establish a COS for the reporting of studies of the management of VPD.Methods and analysisThe study has been developed according to the Core Outcome Set-STAandards for Development standards for the design of a COS study and will be carried out according to the guidance of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. A long list of clinical and patient-reported outcomes will be identified from a systematic review of the literature. A two-stage Delphi consensus process will be used to refine this list into a COS. An international panel of key stakeholders including patients, parents and multidisciplinary clinical and academic experts will be invited to participate in this process. Consensus criteria will be specified a priori and the steering group will ratify the final COS.Ethics and disseminationThe study has ethical approval through Children's Health Ireland at Crumlin Research and Ethics Committee, Ref: GEN/683/18. The study is registered with the COMET Initiative (http://www.cometinitiative.org/studies/details/1146?result=true). The COS will be disseminated by publication in the peer-reviewed literature, presentation at international research meetings and distribution to patient-representative organisations. This will facilitate the application of the COS in future studies of the management of VPD.
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Project description:Purpose of reviewGiven the growing body of critical care clinical research publications, core outcome sets (COSs) are important to help mitigate heterogeneity in outcomes assessed and measurement instruments used, and have potential to reduce research waste. This article provides an update on COS projects in critical care medicine, and related resources and tools for COS developers.Recent findingsWe identified 28 unique COS projects, of which 15 have published results as of May 2020. COS topics relevant to critical care medicine include mechanical ventilation, cardiology, stroke, rehabilitation, and long-term outcomes (LTOs) after critical illness. There are four COS projects for coronavirus disease 2019 (COVID-19), with a 'meta-COS' summarizing common outcomes across these projects. To help facilitate COS development, there are existing resources, standards, guidelines, and tools available from the Core Outcome Measures in Effectiveness Trials Initiative (www.comet-initiative.org/) and the National Institutes of Health-funded Improve LTO project (www.improvelto.com/).SummaryMany COS projects have been completed in critical care, with more on-going COS projects, including foci from across the spectrum of acute critical care, COVID-19, critical care rehabilitation, and patient recovery and LTOs. Extensive resources are accessible to help facilitate rigorous COS development.
| S-EPMC8314715 | biostudies-literature
Project description:BACKGROUND:Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Whilst surgery is the mainstay of curative treatment, it is associated with significant risks. Surgical strategies for treating gastric cancer should be based on evidence from systematic reviews of well-designed randomised controlled trials. However, inconsistencies in the reporting of outcomes from these trials makes evidence synthesis unreliable. We present a protocol for an international consensus study to develop a standardised set of outcomes and measurement tools - a 'core outcome set' (COS) - to be used by all future trials examining therapeutic surgical interventions for gastric cancer. The GASTROS study aims to standardise the reporting of outcomes in gastric cancer surgery trials through an international consensus process of key stakeholders including health care professionals and patients. METHODS:The first of three stages in the study will identify a 'long-list' of potentially important outcomes to be prioritised. These will be extracted from a systematic review of relevant academic literature and patient interviews. Stage 2 will comprise an eDelphi survey which will consider the views of patients, nurse specialists and surgeons to prioritise the most important outcomes. A meeting of stakeholder representatives will ratify the COS. Stage 3 will focus on identifying appropriate instruments to measure the prioritised outcomes by means of quality assessment of available measurement instruments and stakeholder consultation. DISCUSSION:This study aims to standardise the reporting of outcomes in future trials examining therapeutic surgical interventions for gastric cancer. It is anticipated that standardisation of outcome reporting in these surgical effectiveness trials will enhance the evidence base for clinical practice. Highlighting outcomes of greatest importance to patients will ensure that their perspectives are central to research in this field.
| S-EPMC5550993 | biostudies-other
Project description:IntroductionLimb fractures in children are common yet there are few trials that compare treatments for these injuries. There is significant heterogeneity in the outcomes reported in the paediatric orthopaedic literature, which limits the ability to compare study results and draw firm conclusions. The aim of the CORE-Kids Study is to develop a core outcome set for use in research studies of childhood limb fractures. A core outcome set will provide a minimum set of outcomes to be measured in all trials to minimise the heterogeneity of outcomes reported and minimise reporting bias. A core outcome set ensures that outcomes are reported that are relevant to families as well as clinicians. The core outcome set will include additional upper and lower limb modules.MethodsThe development of the core outcome set will require four phases to evaluate:What are the outcomes that are relevant to professionals?What are the outcomes that are relevant to families?What are the most important of these outcomes?Which outcomes should be included in the core outcome set?This will be completed through a systematic review of trials to identify the outcomes domains that are relevant to trialists. A series of semi-structured interviews will be completed with families to identify the outcome domains that are relevant to families. These outcome domains will be used in a three-round Delphi Study to analyse the importance of these outcome domains to a range of stakeholders including parents, clinicians and researchers. Following this, the core outcome set will be decided at a consensus meeting.Ethics and disseminationEthical approval has been awarded HRA/REC IRAS number 262503. Date of approval 06/08/2019. Dissemination will be through scientific literature and international societies.Trial registrationCore Outcome Measures in Effectiveness Trials Initiative, registration number: 1274. Date of registration 13/12/2018.Prospero registration numberCRD42018106605.
| S-EPMC7050303 | biostudies-literature
Project description:ObjectiveMenopause is the natural cessation of menstruation and may be accompanied by troublesome symptoms including hot flushes and night sweats (vasomotor symptoms) and genitourinary symptoms. Randomized trials evaluating the safety and effectiveness of interventions for these symptoms have reported a wide range of outcomes and used inconsistent measures. This variation precludes comparing and combining data from different trials. To overcome this limitation, we will develop a Core Outcome Set for Menopausal Symptoms.MethodsWe will systematically review the literature to identify the outcomes reported in the interventional trials for vasomotor and genitourinary symptoms. This list will be entered into a two-round modified Delphi survey to be completed by clinicians, researchers, and consumers (women who have experienced menopause). Participants will score outcomes on a nine-point scale from "not important" to "critically important." Representatives from each stakeholder group will then meet to discuss the results and finalize the Core Outcome Set. Ethics approval was not required as this was considered service evaluation and development. The study is registered with the Core Outcome Measures in Effectiveness Trials Initiative (http://www.comet-initiative.org/studies/details/917).ResultsAn agreed upon set of minimum outcomes and outcome measures will facilitate combining and comparing findings from future trials of treatments for menopausal symptoms.ConclusionsThis Core Outcome Set will better enable women and clinicians to select effective treatments, improve the quality of trial reporting, reduce research wastage, and improve care for women with troublesome menopausal symptoms. VIDEO SUMMARY:: http://links.lww.com/MENO/A633.
| S-EPMC7709924 | biostudies-literature