Evidence map›Paper›PMID 33346856›Full record

Trial reportEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2021

Improving quality of life through the routine use of the patient concerns inventory for head and neck cancer patients: main results of a cluster preference randomised controlled trial.

Simon N Rogers, Christine Allmark, Fazilet Bekiroglu, Rhiannon Tudor Edwards, Gillon Fabbroni, Robert Flavel, Victoria Highet, Michael W S Ho, Gerald M Humphris, Terry M Jones and 17 more

Abstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
–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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Speech and language therapy management of laryngotracheal stenosis - what has changed.Current opinion in otolaryngology & head and neck surgery · 2026
    Review
  6. Article
  7. Article
  8. Article
  9. Concerns raised by people treated for head and neck cancer: a secondary analysis of audiotaped consultations in a health services follow-up clinic.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Article
  10. Article
  11. The Patient Concerns Inventory in head and neck oncology: a structured review of its development, validation and clinical implications.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022
    Review
  12. Article
  13. Article
  14. Article
  15. Mapping of head and neck cancer patient concerns inventory scores on to Euroqol-Five Dimensions-Five Levels (EQ-5D-5L) health utility scores.The European journal of health economics : HEPAC : health economics in prevention and care · 2022
    Article
  16. Review
  17. 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

27 authors.

Simon N RogersFaculty of Health and Social Care, Edge Hill University, Ormskirk, Liverpool, L39 4QP, UK. simonn.rogers@aintree.nhs.uk.ORCID http://orcid.org/0000-0002-5989-6142
Christine AllmarkLeeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.
Fazilet BekirogluLiverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.
Rhiannon Tudor EdwardsCentre for Health Economics and Medicines Evaluation (CHEME), School of Health Sciences, College of Human Sciences, Ardudwy Hall, Normal Site, Bangor University, Bangor, Wales, UK.
Gillon FabbroniLeeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.
Robert Flavel, Southway, Guilford, Surrey, UK.
Victoria HighetLiverpool Head and Neck Clinical Trials, Clinical Sciences Building, University Hospital Aintree, Liverpool, UK.
Michael W S HoLeeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.
Gerald M HumphrisSchool of Medicine, Medical & Biological Sciences, North Haugh, St Andrews, UK.
Terry M JonesLiverpool Head and Neck Centre, University of Liverpool, Cancer Research Centre, University of Liverpool, 200 London Road, Liverpool, L3 9GA, UK.
Owais KhattakLiverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.
Jeffrey LancasterLiverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.
Christopher LohLiverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.
Derek LoweAstraglobe Ltd, Congleton, Cheshire, UK.
Cher LowiesLiverpool Head and Neck Clinical Trials, Clinical Sciences Building, University Hospital Aintree, Liverpool, UK.
Dominic MacareavyChair of the Head and Neck Patient and Carer Research Forum, Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.
James MoorLeeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.
T K OngLeeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.
A PrasaiLeeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.
Nicholas RolandLiverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.
Cherith SempleInstitute of Nursing and Health Research, Ulster University, Shore Road, Belfast, Newtownabbey, Co, BT37 0QB, Antrim, Belfast, UK.ORCID http://orcid.org/0000-0002-4560-7637
Llinos Haf SpencerCentre for Health Economics and Medicines Evaluation (CHEME), School of Health Sciences, College of Human Sciences, Ardudwy Hall, Normal Site, Bangor University, Bangor, Wales, UK.
Sank TandonLiverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.
Steven J ThomasOral and Maxillofacial Surgery Department, Bristol University, Lower Maudlin Street, Bristol, UK.
Andrew SchacheLiverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.
Richard J ShawLiverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK.
Anastasios KanatasLeeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK.

Funding

Department of Health PB-PG-0215-36047Research for Patient Benefit Programme PB-PG-0215-36047
6 · The paper itself

Abstract

purposeThe patient concerns inventory (PCI) is a prompt list allowing head and neck cancer (HNC) patients to discuss issues that otherwise might be overlooked. This trial evaluated the effectiveness of using the PCI at routine outpatient clinics for one year after treatment on health-related QOL (HRQOL).

methodsA pragmatic cluster preference randomised control trial with 15 consultants, 8 'using' and 7 'not using' the PCI intervention. Patients treated with curative intent (all sites, disease stages, treatments) were eligible.

resultsConsultants saw a median (inter-quartile range) 16 (13-26) patients, with 140 PCI and 148 control patients. Of the pre-specified outcomes, the 12-month results for the mean University of Washington Quality of Life (UW-QOLv4) social-emotional subscale score suggested a small clinical effect of intervention of 4.6 units (95% CI 0.2, 9.0), p = 0.04 after full adjustment for pre-stated case-mix. Results for UW-QOLv4 overall quality of life being less than good at 12 months (primary outcome) also favoured the PCI with a risk ratio of 0.83 (95% CI 0.66, 1.06) and absolute risk 4.8% (- 2.9%, 12.9%) but without achieving statistical significance. Other non-a-priori analyses, including all 12 UWQOL domains and at consultant level also suggested better HRQOL with PCI. Consultation times were unaffected and the number of items selected decreased over time.

conclusionThis novel trial supports the integration of the PCI approach into routine consultations as a simple low-cost means of benefiting HNC patients. It adds to a growing body of evidence supporting the use of patient prompt lists more generally.

Indexed as

Head and Neck NeoplasmsQuality of LifeEmotionsHumansReferral and ConsultationSurveys and QuestionnairesHead and neck cancerInterventionPatient concerns inventoryPatient-reported outcomesQuality of lifeRandomised trial

Identifiers

PMID33346856
PMCPMC7751263

What OpenQuestion holds

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Registered trials

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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.