Evidence map›Paper›PMID 36302049›Full record

ArticlePloS one2022

Psychometric and biomedical outcomes of glycated haemoglobin target-setting in adults with type 1 and type 2 diabetes: Protocol for a mixed-methods parallel-group randomised feasibility study.

Samuel J Westall, Simon Watmough, Ram Prakash Narayanan, Greg Irving, Kevin Hardy

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 35% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Samuel J WestallFaculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.ORCID 0000-0003-1428-3681
Simon WatmoughFaculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.
Ram Prakash NarayananDepartment of Diabetes and Endocrinology, St Helens and Knowsley Teaching Hospitals NHS Trust, St Helens Hospital, St Helens, United Kingdom.
Greg IrvingFaculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, United Kingdom.
Kevin HardyDepartment of Diabetes and Endocrinology, St Helens and Knowsley Teaching Hospitals NHS Trust, St Helens Hospital, St Helens, United Kingdom.
Edge Hill University · GBSt Helens and Knowsley Teaching Hospitals NHS Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe disease burden of diabetes can have wide-ranging implications on patients' psychological well-being and health-related quality of life. Glycated haemoglobin targets are commonly used to guide patient management in diabetes to reduce the future risk of developing diabetes complications, but little is known of the psychological impact of glycated haemoglobin target-setting. This protocol describes a study to determine the feasibility of evaluating psychological outcomes when setting explicit glycated haemoglobin targets in people with diabetes.

methodsThis single-centre randomised feasibility study will follow a mixed-methods approach across four sub-studies. In sub-study A, eligible adults (aged 18 and over) with type 1 or type 2 diabetes will complete baseline validated psychometric questionnaires evaluating health-related quality of life (EuroQoL-5D-5L), diabetes-related distress (Problem Areas In Diabetes), self-care (Summary of Diabetes Self-Care Activities), well-being (Well-Being Quetionnaire-12) and diabetes-related psychosocial self-efficacy (Diabetes Empowerment Scale-Long Form). Participants will be randomised to receive explicit glycated haemoglobin intervention targets 5mmol/mol above or below current glycated haemoglobin readings. Rates of eligibility, recruitment, retention and questionnaire response rate will be measured. Psychometric outcomes will be re-evaluated 3-months post-intervention. Sub-studies B and C will use qualitative semi-structured interviews to evaluate experiences, views and opinions of diabetes patients and healthcare professionals in relation to the acceptability of study processes, the use of glycated haemoglobin targets, the impact of diabetes on psychological well-being and, in sub-study D, barriers to participation in diabetes research. DISCUSSION: This mixed-methods study aims to provide a novel insight into the psychological implications of glycated haemoglobin target-setting for people with diabetes in secondary care, alongside testing the feasibility of undertaking a larger project of this nature.

trial registrationThe study is registered with the ISRCTN (registration number: 12461724; date registered: 11th June 2021). Protocol version: 2.0.5, 26th February 2021.

Indexed as

Diabetes Mellitus, Type 2AdolescentAdultFeasibility StudiesGlycated HemoglobinHumansPsychometricsQuality of LifeRandomized Controlled Trials as TopicGlycated Hemoglobin

Identifiers

PMID36302049
PMCPMC9612465
OpenAlexW4307440665

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.