Evidence map›Paper›PMID 27473371›Full record

Trial reportTrials2016

Hepatitis C - Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial.

Kirsty Roberts, John Macleod, Chris Metcalfe, Joanne Simon, Jeremy Horwood, William Hollingworth, Sharon Marlowe, Fiona H Gordon, Peter Muir, Barbara Coleman and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
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

15 authors.

Kirsty RobertsSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
John MacleodSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Chris MetcalfeSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Joanne SimonSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Jeremy HorwoodSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
William HollingworthSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Sharon MarloweUniversity Hospitals Bristol, Bristol Royal Infirmary, Marlborough Street, Bristol, UK.
Fiona H GordonUniversity Hospitals Bristol, Bristol Royal Infirmary, Marlborough Street, Bristol, UK.
Peter MuirPublic Health Laboratory Bristol, Public Health England, Myrtle Road, Bristol, UK.
Barbara ColemanPublic Health Commissioning and Performance, Avonquay, Merchants Road, Cumberland Basin, Bristol, UK.
Peter VickermanSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
Graham I HarrisonNIHR Nottingham Digestive Diseases Biomedical Research Unit, University Hospital Nottingham, Nottingham, UK.
Cherry-Ann WaldronSchool of Social and Community Medicine, University of Bristol, Bristol, UK.
William IrvingNIHR Nottingham Digestive Diseases Biomedical Research Unit, University Hospital Nottingham, Nottingham, UK.
Matthew HickmanSchool of Social and Community Medicine, University of Bristol, Bristol, UK. Matthew.Hickman@bristol.ac.uk.

Funding

Department of Health RP-DG-0610-10055Medical Research Council MR/K023233/1Medical Research Council MR/K025643/1Medical Research Council MR/N005953/1
6 · The paper itself

Abstract

backgroundPublic Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. METHODS/

designA total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients' and health care workers' experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. DISCUSSION: This trial has the potential to make an important impact on patient care and will provide high-quality evidence to help general practitioners make important decisions on HCV testing and onward referral. If found to be effective and cost-effective the intervention is readily scalable and can be used to support the implementation of NICE recommendations on HCV case-finding.

trial registrationISRCTN61788850 . Registered on 24 April 2015; Protocol Version: 2.0, 22 May 2015.

Indexed as

Clinical ProtocolsPrimary Health CareHepatitis C, ChronicHumansOutcome Assessment, Health CarePatient Education as TopicReferral and ConsultationCase-findingComplex interventionHCVHepatitis CPrimary careRCT

Identifiers

PMID27473371
PMCPMC4966763

What OpenQuestion holds

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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.