Evidence map›Paper›PMID 38641716›Full record

ArticleJournal of patient-reported outcomes2024

Qualitative interviews of patients with COPD and muscle weakness enrolled in a clinical trial evaluating a new anabolic treatment: patient perspectives of disease experience, trial participation and outcome assessments.

Maggie Tabberer, Nicola Williamson, Sophi Tatlock, Adam Gater, Rebecca Grimes, Chika Akinseye, David Neil, Aoife Mahon-Smith, Linda Nelsen

Registry-linked trialAbstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03359473 (A Randomized, Double-blind), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03359473 phase2completednot on this map

A Randomized, Double-blind (Sponsor Unblind), Placebo-controlled, Multi-centred Phase IIa Study to Evaluate the Safety and Efficacy of 13 Weeks of Once Daily Oral Dosing of the Selective Androgen Receptor Modulator (SARM) GSK2881078 in Older Men and Post Menopausal Women With COPD and Muscle Weakness, Participating in Home Exercise

TypeinterventionalSponsorGlaxoSmithKlineRan2018 to 2019Enrolled97ConditionsCachexiaArmsGSK2881078, Matching Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

9 authors.

Maggie Tabberer *GSK, Brentford, Middlesex, UK.
Nicola Williamson *PCO, Adelphi Values Ltd, Bollington, Cheshire, UK.
Sophi TatlockPCO, Adelphi Values Ltd, Bollington, Cheshire, UK.
Adam GaterPCO, Adelphi Values Ltd, Bollington, Cheshire, UK.
Rebecca Grimes *PCO, Adelphi Values Ltd, Bollington, Cheshire, UK.
Chika AkinseyeGSK R&D, Stevenage, Hertfordshire, UK.
David Neil *GSK R&D, 1250 S Collegeville Road, 19426, Collegeville, PA, USA.
Aoife Mahon-SmithPCO, Adelphi Values Ltd, Bollington, Cheshire, UK.
Linda NelsenGSK R&D, 1250 S Collegeville Road, 19426, Collegeville, PA, USA. linda.m.nelsen@gsk.com.ORCID 0000-0002-3929-4064

Funding

GSK GSK
6 · The paper itself

Abstract

backgroundChronic obstructive pulmonary disease (COPD) and muscle weakness can cause impaired physical function, significantly impacting patients' health-related quality of life (HRQoL). Loss of muscle strength is usually assessed through clinical and performance outcome (PerfO) assessments, which consists of tasks performed in a standardized manner, providing evidence of a patient's functional ability. However, evidence documenting the patient experience of COPD and muscle weakness is limited.

methodsThis two-stage qualitative study used semi-structured interviews in patients aged 45-80 years with COPD (post-bronchodilator forced expiratory volume in 1s [FEV

resultsIn Stage 1 (n = 20), most participants described their muscles as weak (83.3%). Difficulties with walking (100%) and lifting heavy objects (90%) were reported. In Stage 2, 60-minute interviews, all participants (n = 32) reported a positive trial experience. Most participants reported that the home exercise program was easy to fit into daily life (77.8%), the PROactive daily diary was easy to complete (100%) and wearable sensors were easy to use (65.6%). However, technical issues were reported (71%), and few participants (19.4%) found physical assessments easy to complete. Improvements in muscle strength and functional limitations were reported by most participants. The shorter 15-minute confirmatory interviews (n = 35) supported the in-depth interview results.

conclusionThe qualitative interviews generated in-depth evidence of key concepts relevant to patients with COPD and muscle weakness and support the assessments of patient strength and physical function as outcome measures in this population in future studies. TRIAL NUMBER: GSK Stage 1: 206869; Stage 2: 200182, NCT03359473; Registered December 2, 2017, https://clinicaltrials.gov/ct2/show/NCT03359473 .

Indexed as

Pulmonary Disease, Chronic ObstructiveQuality of LifeActivities of Daily LivingHumansMuscle WeaknessOutcome Assessment, Health CareParesisAnabolic treatmentChronic obstructive pulmonary diseaseExit interviewsMuscle weaknessPatient experiencePerformance outcome assessmentQualitative interviewTrial participation

Identifiers

PMID38641716
PMCPMC11031513

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Registered trials

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.