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Development of a core outcome set for oral health services research involving dependent older adults (DECADE): a study protocol.

ABSTRACT: BACKGROUND:Oral healthcare service provision for dependent older adults is often poor. For dental services to provide more responsive and equitable care, evidence-based approaches are needed. To facilitate future research, the development and application of a core outcome set would be beneficial. The aim of this study is to develop a core outcome set for oral health services research involving dependent older adults. METHODS:A multi-step process involving consensus methods and including key stakeholders will be undertaken. This will involve identifying potentially relevant outcomes through a systematic review of previous studies examining the effectiveness of strategies to prevent oral disease in dependent older adults, combined with semi-structured interviews with key stakeholders. Stakeholders will include dependent older adults, family members, carers, care-home managers, health professionals, researchers, dental commissioners and policymakers. To condense and prioritise the long list of outcomes generated by the systematic review and semi-structured interviews, a Delphi survey consisting of several rounds with key stakeholders, as mentioned above, will be undertaken. The 9-point Likert scale proposed by the GRADE Working Group will facilitate this consensus process. Following the Delphi survey, a face-to-face consensus meeting with key stakeholders will be conducted where the stakeholders will anonymously vote and decide on what outcomes should be included in the finalised core outcome set. DISCUSSION:Developing a core set of outcomes that are clinically and patient-centred will help improve the design, conduct and reporting of oral health services research involving dependent older adults, and ultimately strengthen the evidence base for high-quality oral health care for dependent older adults. TRIAL REGISTRATION:The study was registered with the COMET initiative on 9 January 2018 http://www.cometinitiative.org/studies/details/1081?result=true .

SUBMITTER: Watson S

PROVIDER: S-EPMC7329504 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Development of a core outcome set for oral health services research involving dependent older adults (DECADE): a study protocol.

Watson Sinead S McMullan Julie J Brocklehurst Paul P Tsakos Georgios G Watt Richard G RG Wassall Rebecca R RR Sherriff Andrea A Ramsay Sheena E SE Karki Anup J AJ Tada Sayaka S Lappin Caroline C Donaldson Michael M McKenna Gerald G

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<h4>Background</h4>Oral healthcare service provision for dependent older adults is often poor. For dental services to provide more responsive and equitable care, evidence-based approaches are needed. To facilitate future research, the development and application of a core outcome set would be beneficial. The aim of this study is to develop a core outcome set for oral health services research involving dependent older adults.<h4>Methods</h4>A multi-step process involving consensus methods and inc ...[more]

PMID: 32611443

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Project description:IntroductionCentralisation defined as the reorganisation of healthcare services into fewer specialised units serving a higher volume of patients is a potential measure for healthcare reforms aiming at reducing costs while improving quality. Research on centralisation of healthcare services is thus essential to inform decision-makers. However, so far studies on centralisation report a variability of outcomes, often neglecting outcomes at the health system level. Therefore, this study aims at developing a core outcome set (COS) for studies on centralisation of hospital procedures, which is intended for use in observational as well as in experimental studies.Methods and analysisWe propose a five-stage study design: (1) systematic review, (2) focus group, (3) interview studies, (4) online survey, (5) Delphi survey. The study will be conducted from March 2022 to November 2023. First, an initial list of outcomes will be identified through a systematic review on reported outcomes in studies on minimum volume regulations. We will search MEDLINE, EMBASE, CENTRAL, CINHAL, EconLIT, PDQ-Evidence for Informed Health Policymaking, Health Systems Evidence, Open Grey and also trial registries. This will be supplemented with relevant outcomes from published studies on centralisation of hospital procedures. Second, we will conduct a focus group with representatives of patient advocacy groups for which minimum volume regulations are currently in effect in Germany or are likely to come into effect to identify outcomes important to patients. Furthermore, two interview studies, one with representatives of the German medical societies and one with representatives of statutory health insurance funds, as well as an online survey with health services researchers will be conducted. In our analyses of the suggested outcomes, we will largely follow the categorisation scheme developed by the Cochrane EPOC group. Finally, a two-round online Delphi survey with all stakeholder groups using predefined score criteria for consensus will be employed to first prioritise outcomes and then agree on the final COS.Ethics and disseminationThis study has been approved by the Research Ethics Committee at the Brandenburg Medical School Theodor Fontane (MHB). The final COS will be disseminated to all stakeholders involved and through peer-reviewed publications and conferences.

Project description:IntroductionThe incidence of anal squamous cell carcinoma (ASCC) has increased threefold in the last 30 years. Initial treatment is chemoradiotherapy, associated with short-term and long-term side effects. Future therapy innovations aim to reduce morbidity in treatment of early tumours while maintaining treatment efficacy, and to escalate treatment intensity in locally advanced tumours with acceptable quality of life (QoL). However, all phase III randomised controlled trials to-date have utilised different primary outcomes, which hinders evidence synthesis and presents challenges to the selection of optimal outcomes in future trials. No trial comprehensively assessed long-term side effects and QoL, suggesting outcomes reflecting issues important to patients are under-represented. This project aims to determine the priority outcomes for all stakeholders and reach agreement on a standardised core set of outcomes to be measured and reported on in all future ASCC trials.Methods and analysisA systematic review will identify all outcomes reported in trials and observational studies of chemoradiotherapy as primary treatment for ASCC. Outcomes of importance to patients will be identified through patient interviews. The long list of outcomes generated from the systematic review and interviews will be used to create a two-round Delphi process, including key stakeholders (patients and healthcare professionals). The results of the Delphi will be discussed at a face-to-face consensus meeting. Discussion will focus on outcomes that did not achieve consensus through the Delphi process and conclude with anonymous voting to ratify the final core outcome set (COS).Ethics and disseminationThe final COS will feed directly into the PersonaLising Anal cancer radioTherapy dOse (PLATO) national anal cancer trials and the Association of coloproctologists of Great Britain and Ireland (ACPGBI) supported national anal cancer database. Utilisation of the COS will increase the relevance of research output to all stakeholders and increase the capacity for data synthesis between trials. This study has ethical approval and is registered with the Core Outcome Measures in Effectiveness Trials (COMET) initiative.Trial registration numberPROSPERO registration ID: CRD42016036540.

Project description:BackgroundThe development of a standardised reporting set is important to ensure that research is directed towards the most important outcomes and that data is comparable. To ensure validity, the set must be agreed by a consensus of stakeholders including patients, healthcare professionals and lay representatives. There is currently no agreed core outcome set for patients undergoing major lower limb amputation for peripheral arterial disease (PAD) for either short- or medium-term research outcomes. By developing these sets we aim to rationalise future trial outcomes, facilitate meta-analysis and improve the quality and applicability of amputation research.Methods/designWe will undertake a comprehensive systematic review of studies of patients undergoing major lower limb amputation for PAD. Data regarding all primary and secondary outcomes reported in relevant studies will be extracted and summarised as outcome domains. We will then undertake focus groups with key stakeholders (patients, carers, health and social care workers) to collect qualitative data to identify the main short- and medium-term research outcomes for patients undergoing major lower limb amputation. Results of the systematic review and focus groups will be combined to create a comprehensive list of potential key outcomes. Stakeholders (patients, researchers and health and social care workers) will then be polled to determine which of the outcomes are considered to be important in a general context using a three-phase Delphi process. After preliminary analysis, results will be presented at a face-to-face meeting of key stakeholders for discussion and voting on the final set of core outcomes. This project is being run in parallel with a feasibility trial assessing perineural catheters in patients undergoing lower limb amputation (the PLACEMENT trial). Full ethical approval has been granted for the study (Wales REC 3 reference number 16/WA/0353).DiscussionCore outcome sets will be developed for short- and medium-term outcomes of research involving patients undergoing major lower limb amputation for PAD. This will help with the design of future trials and facilitate meta-analyses of trial data.Trial registrationPROSPERO: CRD42017059329 . Registered on 30 March 2017.Comet975 . Registered on 5 April 2017.

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Development of a core outcome set for oral health services research involving dependent older adults (DECADE): a study protocol.

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Development of a core outcome set for oral health services research involving dependent older adults (DECADE): a study protocol.

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