Evidence map›Paper›PMID 32720113›Full record

ArticleBreast cancer research and treatment2020

The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer.

Helena Harder, Valerie M Shilling, Shirley F May, David Cella, Peter Schmid, Lesley J Fallowfield

Open access · hybridAbstract read
In one paragraph

Article in Breast cancer research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 43% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Clinical experience and satisfaction in patients with advanced breast cancer participating in the abemaciclib patient support program in Spain: a prospective observational study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Observational
  2. Observational
  3. Article
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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

6 authors at 3 institutions in 2 countries.

Helena HarderSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK. h.harder@sussex.ac.uk.ORCID http://orcid.org/0000-0002-7296-8227
Valerie M ShillingSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.
Shirley F MaySussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.
David CellaDepartment of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
Peter SchmidCentre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University London, London, UK.
Lesley J FallowfieldSussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK.
Brighton and Sussex Medical School · GBNorthwestern University · USQueen Mary University of London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeChemotherapy-induced diarrhoea (CID) is a common, but often underreported problem in patients with breast cancer that has a profound effect on quality of life. It is best measured from a patient's perspective, but tools are limited. The aim of this study was to develop and evaluate the Diarrhoea Management Diary (DMD), a self-report measure to assess CID, use of self-management strategies and treatment adherence.

methodsThe DMD was constructed using an iterative process of instrument development: concept elicitation (literature review), item generation and reduction (cognitive debriefing), and pilot testing in the target population. After translation into eight languages, the DMD was used in an international randomised trial for women receiving lapatinib and capecitabine for metastatic breast cancer with or without prophylactic octreotide. Patterns of missing data and sensitivity to change were examined.

resultsThe understandability and completeness of the 8-item DMD was confirmed in cognitive interviews and pilot testing. Practicability of the DMD was evaluated in 62 women with metastatic breast cancer (median age 57). Up to 68% reported CID at any given time-point, and 19% had diarrhoea at each time-point. Patients also described efficacy of different strategies for diarrhoea management. Missing data were associated with study discontinuation. DMD missing item response was 0.9%. Sensitivity to change was good at most assessment points.

conclusionsAlthough further psychometric testing is recommended, initial evaluation of the DMD showed good content validity and practicability in international research with cancer patients.

Indexed as

Breast NeoplasmsDiarrheaFemaleHumansLapatinibMiddle AgedQuality of LifeSelf ReportLapatinibAdverse effectsChemotherapy-induced diarrhoeaMeasurementPatient-reported outcomesQuality of lifeSelf-managementSupportive care

Identifiers

PMID32720113
PMCPMC7497672
OpenAlexW3044047520

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.