Evidence map›Paper›PMID 36633810›Full record

ArticleOncology and therapy2023

A Mixed-Methods Study to Better Measure Patient-Reported Pain and Fatigue in Soft Tissue Sarcoma.

Louise Barrett, Emma Elliott, Maarten Voorhaar, Anders Ingelgård, Ingolf Griebsch, Brendon Wong, Jessica Mills, Phoebe Heinrich, Stefan Cano

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Article in Oncology and therapy, 2023. 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
–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

4 citing papers in PubMed.

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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

9 authors.

Louise BarrettModus Outcomes, a Division of THREAD, Cheltenham, UK. louise.barrett@threadresearch.com.ORCID http://orcid.org/0000-0002-3299-4412
Emma ElliottModus Outcomes, a Division of THREAD, Cheltenham, UK.
Maarten VoorhaarBoehringer Ingelheim, Ingelheim am Rhein, Germany.
Anders IngelgårdBoehringer Ingelheim, Ingelheim am Rhein, Germany.
Ingolf GriebschBoehringer Ingelheim, Ingelheim am Rhein, Germany.
Brendon WongBoehringer Ingelheim, Ingelheim am Rhein, Germany.
Jessica MillsModus Outcomes, a Division of THREAD, Cheltenham, UK.
Phoebe HeinrichModus Outcomes, a Division of THREAD, Cheltenham, UK.
Stefan CanoModus Outcomes, a Division of THREAD, Cheltenham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPain and fatigue are commonly reported by patients with soft tissue sarcoma (STS) as distressing symptoms, yet no patient-reported outcome (PRO) measures have been validated or developed specifically for STS. This study aimed to develop novel PRO scales using existing item banks to measure pain and fatigue in STS.

methodsA three-stage mixed-methods approach was used. Stage 1: a literature review examined the development and validation of the European Organization for Research and Treatment of Cancer (EORTC) library, Patient-Reported Outcomes Measurement Information System (PROMIS) pain/fatigue item banks, Functional Assessment of Cancer Therapy-General, and FACIT-Fatigue. Conceptual models were developed for pain and fatigue. Stage 2: semi-structured interviews were conducted with clinical experts (n = 3) and STS patients (n = 28) to ensure conceptual coverage and cognitively debrief the selected PRO items. Stage 3: exploratory Rasch measurement theory (RMT) analyses were performed to examine the measurement properties of the proposed scales.

resultsStage 1: The conceptual model for fatigue was organized into two overarching domains: fatigability and fatigue, further split into two subdomains: symptoms and impact. The conceptual model for pain had one overarching domain split into two subdomains: descriptors and impact. Pain (n = 56) and fatigue (n = 40) items were selected from the EORTC item library. Stage 2: qualitative findings ensured conceptual coverage, provided insight into the relevance and comprehension of the items, and informed subsequent item reduction. Stage 3: The total item number was reduced to 43 (pain n = 18, fatigue n = 25). Exploratory RMT analyses supported the final scales' psychometric properties.

conclusionsThis mixed-methods research generated important information on the experience of pain and fatigue in specific subtypes of STS. Five novel PRO scales have been developed through careful item selection in consultation with experts and supported by qualitative and quantitative evidence. These scales may be of value to future clinical trials for STS.

Indexed as

EORTCFatigueMixed-methods researchOncologyPainPatient-centered outcome measurementPatient-reported outcomesRare diseaseRasch measurement theorySoft tissue sarcoma

Identifiers

PMID36633810
PMCPMC9935765

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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.