Evidence map›Paper›PMID 35622190›Full record

ArticleJournal of patient-reported outcomes2022

Development and validation of a disease-specific quality of life questionnaire for patients with peripheral artery disease (QOLPAD).

Ebru-Berrin Arman, Matthias Augustin, Nicole Mohr, Sebastian E Debus, Peter Breuer, Christine Blome

Registry-linked trialAbstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06061211 (Treadmill Training with TENS Impact on Walking Distance, Pain and Peak Velocity in Patients with Peripheral Arterial Disease), which is not on this map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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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.

NCT06061211 nacompletednot on this mapstarted 2023, after this paper: background citation

Treadmill Training with TENS Impact on Walking Distance, Pain and Peak Velocity in Patients with Peripheral Arterial Disease

TypeinterventionalSponsorCairo UniversityRan2023 to 2024Enrolled50ConditionsPeripheral Arterial DiseaseArmsTREADMILL(SIDEA-Germany treadmill ) with TENS
3 · Its place in the literature

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0 citing papers in PubMed.

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

6 authors.

Ebru-Berrin ArmanInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Martinistraße 52, 20246, Hamburg, Germany.
Matthias AugustinInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Martinistraße 52, 20246, Hamburg, Germany.ORCID http://orcid.org/0000-0002-4026-8728
Nicole MohrInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Martinistraße 52, 20246, Hamburg, Germany.ORCID http://orcid.org/0000-0003-0628-9717
Sebastian E DebusDepartment of Vascular Medicine, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Peter BreuerDepartment of Vascular and Endovascular Surgery, Asklepios Klinik Wandsbek, Hamburg, Germany.
Christine BlomeInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Martinistraße 52, 20246, Hamburg, Germany. c.blome@uke.de.ORCID http://orcid.org/0000-0002-1163-1639

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to develop and validate a short and feasible questionnaire to measure health-related quality of life (HRQoL) in patients with peripheral artery disease (PAD). The content of the new instrument is intended to correspond with the simultaneously developed instrument Patient Benefit Index for PAD (PBI-PAD), which evaluates treatment goals and benefits in this patient group.

methodsFifty patients stated their disease burden on free-text questionnaires, which was used by an interdisciplinary expert panel to develop 12 items for the new instrument, named Quality of Life questionnaire for patients with peripheral artery disease (QOLPAD). The validity of the instrument was tested in patients from Germany with PAD stages I to IV who completed the QOLPAD, EuroQol questionnaire (EQ-5D-3L; EuroQol visual analogue scale (EQ VAS)), and Vascular Quality of Life questionnaire (VascuQoL) before (baseline) and three months after (follow-up) treatment.

resultsOne hundred and three patients were included at baseline (mean age: 68.6 years; 68% male), among whom, 57 provided data at follow-up. Most patients (86.4%) rated the completion of QOLPAD as being easy. Internal consistency was satisfactory, with a Cronbach's alpha of 0.74 (baseline) and 0.84 (follow-up). Convergent validity was indicated by significant correlations with the EQ-5D-3L (baseline: - 0.62; follow-up: - 0.81), EQ VAS (baseline: - 0.44, follow-up: - 0.79), VascuQoL global score (baseline: - 0.77; follow-up: - 0.87), global rating of impairment (baseline: 0.64; follow-up: 0.71), and PAD stage (baseline: 0.40; follow-up: 0.67). Sensitivity to change was confirmed by significant correlations of change in the QOLPAD with changes in convergent criteria; however, the high number of dropouts limits the generalizability of this finding.

conclusionThis study provided evidence that the QOLPAD is internally consistent and valid in patients receiving treatment for PAD in Germany.

Indexed as

Health-related quality of lifePatient-reported outcomesPeripheral artery diseaseQuestionnaireValidation

Identifiers

PMID35622190
PMCPMC9142721

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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.