Dataset Information

Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus.

ABSTRACT:

Background

It is increasingly accepted that insufficient attention has been given to the patient health outcomes that are important to measure in comparative effectiveness research that will inform decision-making. The relationship between outcomes chosen for comparative effectiveness research, outcomes used in decision-making in routine care, and outcome data recorded in electronic health records (EHR) is also poorly understood. The COMET Initiative (http://www.comet-initiative.org/. Accessed 3 Apr 2020) supports and encourages the development and use of 'core outcome sets' (COS), which represent the minimum set of patient health outcomes that should be measured and reported for a specific condition. There is growing interest in identifying how COS might fit into the different stages of the healthcare research and delivery ecosystem, and whether inclusion in the EHR might facilitate this.

Methods

We sought to determine the degree of overlap between outcomes within COS for research and routine care, EMA, FDA and NICE guidelines, NICE quality statements/indicators, EHR and a point-of-care randomised clinical trial, using type 2 diabetes (T2D) as a case study.

Results

There is substantial agreement about important patient outcomes for T2D for research and healthcare, with associated coverage within the UK general practice EHR.

Conclusions

This case study has demonstrated the potential for efficient research and value-based healthcare when the EHR can include COS for both research and care, where the COS comprises outcomes of importance to all relevant stakeholders. However, this concordance may not hold more generally, as the focus on patient-centred outcomes may well be greater in T2D than in other conditions. Work is ongoing to examine other clinical areas, in order to highlight any current inefficiencies when health outcomes in research and healthcare do not agree with core outcomes identified by patients, clinicians and other key stakeholders.

SUBMITTER: Dodd S

PROVIDER: S-EPMC7318375 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus.

Dodd Susanna S Harman Nicola N Taske Nichole N Minchin Mark M Tan Toni T Williamson Paula R PR

Trials 20200625 1

<h4>Background</h4>It is increasingly accepted that insufficient attention has been given to the patient health outcomes that are important to measure in comparative effectiveness research that will inform decision-making. The relationship between outcomes chosen for comparative effectiveness research, outcomes used in decision-making in routine care, and outcome data recorded in electronic health records (EHR) is also poorly understood. The COMET Initiative (http://www.comet-initiative.org/. Ac ...[more]

PMID: 32586349

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Project description:ObjectivesAmblyopia, strabismus and ocular motility disorders are common conditions with significant impact on visual function, appearance and quality of life. We aimed to establish a core set of outcomes for each of the three conditions for use in clinical trials and routine clinical practice.DesignA comprehensive databank of outcomes was developed from a systematic review of the literature and a series of focus groups with healthcare professionals, researchers, patients and carers. The databank of outcomes was scored in a two-round Delphi Survey completed by two stakeholder groups: healthcare professionals/researchers and patients/carers. Results of the online Delphi were discussed at a face-to-face consensus meeting where the core outcome sets were finalised.SettingUK-wide consultation.ParticipantsResearchers, clinicians, patients and carers.Outcome measuresCore outcome sets.ResultsFor amblyopia, strabismus and ocular motility, 40/42/33 participants contributed to both rounds of the Delphi; six/nine/seven members attended consensus meetings, respectively. Consensus was reached on ten core outcomes for both amblyopia and ocular motility and nine for strabismus. All three conditions shared the core outcomes: adverse events, cost, vision-related quality of life and ocular alignment. The strabismus and ocular motility disorder core sets included, in addition, measuring the deviation, binocular vision, ocular movement, patient satisfaction and symptoms. The amblyopia set, distinct from the sets for the other two conditions, included best corrected distance and near visual acuity, spherical and cylindrical refraction, compliance and treatment-related and functionality/long-term impacts.ConclusionsThe study used robust consensus methods to develop a core outcome set for three ophthalmic conditions. Implementation of these core outcome sets in clinical trials and routine clinical practice will ensure that the outcomes being measured and reported are relevant to all stakeholders. This will enhance the relevance of study findings and enable comparison of results from different studies.

Project description:AIMS/HYPOTHESIS:The aim of this systematic review was to develop core outcome sets (COSs) for trials evaluating interventions for the prevention or treatment of gestational diabetes mellitus (GDM). METHODS:We identified previously reported outcomes through a systematic review of the literature. These outcomes were presented to key stakeholders (including patient representatives, researchers and clinicians) for prioritisation using a three-round, e-Delphi study. A priori consensus criteria informed which outcomes were brought forward for discussion at a face-to-face consensus meeting where the COS was finalised. RESULTS:Our review identified 74 GDM prevention and 116 GDM treatment outcomes, which were presented to stakeholders in round 1 of the e-Delphi study. Round 1 was completed by 173 stakeholders, 70% (121/173) of whom went on to complete round 2; 84% (102/121) of round 2 responders completed round 3. Twenty-two GDM prevention outcomes and 30 GDM treatment outcomes were discussed at the consensus meeting. Owing to significant overlap between included prevention and treatment outcomes, consensus meeting stakeholders agreed to develop a single prevention/treatment COS. Fourteen outcomes were included in the final COS. These consisted of six maternal outcomes (GDM diagnosis, adherence to the intervention, hypertensive disorders of pregnancy, requirement and type of pharmacological therapy for hyperglycaemia, gestational weight gain and mode of birth) and eight neonatal outcomes (birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, neonatal hypoglycaemia, neonatal death and stillbirth). CONCLUSIONS/INTERPRETATION:This COS will enable future GDM prevention and treatment trials to measure similar outcomes that matter to stakeholders and facilitate comparison and combination of these studies. TRIAL REGISTRATION:This study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/studies/details/686/.

Project description:IntroductionThis study aimed to assess the adherence to guidelines by practitioners working in the Mediterranean region and to identify the reasons for non-compliance.MethodsA opportunistic self-administered questionnaire was circulated among members of the Mediterranean Group for the Study of Diabetes (MGSD) and regional diabetic associations. The study was limited to the Mediterranean region; 2841 medical practitioners participated in the study. Intervention involved a self-administered questionnaire enabling demographic and personal details to be correlated to relevant information related to practice and continuing health professional education (CHPE) attitudes, perceptions related to diabetes and healthcare systems in the community, and physicians' attitudes to healthcare practices and target goals relevant to type 2 diabetes mellitus (T2DM). The main outcome measure was adherence to evidence-based guidelines.ResultsWhile the majority of respondents (69.9%) reported being confident in managing these patients, and 79.2% reported being aware of the availability of local guidelines; only a fifth opted to manage patients by strictly targeting an HbA1c value below 6.5%, while 3.3% were happy to maintain an HbA1c value of up to 8.0%. These goals appeared to be tempered by fear of eliciting hypoglycaemia in the belief that patients and their families do not have the skills to manage the complication. Endocrinologists/internists preferred more rigid control.ConclusionIt is clear that the promulgation of evidence-based guidelines cannot assume automatic adoption in clinical practice since adoption is tempered by on-the-ground practice circumstances that make the practitioner reluctant to fully endorse and adopt the targets defined by the guidelines. The evidence-based guidelines need to be modified for local or regional circumstances.FundingThis study and the Rapid Service Fee were supported by a financial grant from the Mediterranean Group for the Study of Diabetes which is supported by an unrestricted educational grant from Servier.

Dataset Information

Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus.

Background

Methods

Results

Conclusions

Publications

Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus.

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