Evidence map›Paper›PMID 37794275›Full record

ArticleDermatology and therapy2023

Evaluating the Appropriateness of Existing Health-Related Quality of Life Measures in Lichen Planus.

Aoife Mahon-Smith, George Skingley, Lara Ayala-Nunes, Anjali Batish, Rosie Sharp, Christel Naujoks, Eva Schruf, Nicolò Compagno, Santiago G Moreno

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Dermatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04300296 (A Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg Over 32 Weeks in Adult Patients With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies - PRELUDE), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 36% 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.

NCT04300296 phase2completednot on this map

A Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg Over 32 Weeks in Adult Patients With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies - PRELUDE

TypeinterventionalSponsorNovartis PharmaceuticalsRan2020 to 2022Enrolled111ConditionsLichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen PlanopilarisArmssecukinumab 300 mg Q4W, secukinumab 300 mg Q2W, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. 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 at 3 institutions in 3 countries.

Aoife Mahon-SmithPatient-Centered Outcomes, Adelphi Values Ltd, Bollington, Cheshire, UK. aoife.mahon-smith@adelphivalues.com.ORCID http://orcid.org/0000-0003-1167-7693
George SkingleyPatient-Centered Outcomes, Adelphi Values Ltd, Bollington, Cheshire, UK.ORCID http://orcid.org/0000-0002-7115-0394
Lara Ayala-NunesPatient-Centered Outcomes, Adelphi Values Ltd, Bollington, Cheshire, UK.ORCID http://orcid.org/0000-0001-5070-7731
Anjali BatishPatient-Centered Outcomes, Adelphi Values Ltd, Bollington, Cheshire, UK.ORCID http://orcid.org/0000-0002-1008-9710
Rosie SharpPatient-Centered Outcomes, Adelphi Values Ltd, Bollington, Cheshire, UK.ORCID http://orcid.org/0000-0002-4111-4181
Christel NaujoksNovartis Pharma AG, Basel, Switzerland.ORCID http://orcid.org/0000-0002-3799-6521
Eva SchrufNovartis Pharma GmbH, Nürnberg, Germany.ORCID http://orcid.org/0000-0002-1412-5141
Nicolò CompagnoNovartis Pharma AG, Basel, Switzerland.ORCID http://orcid.org/0000-0002-7590-4093
Santiago G MorenoNovartis Pharma AG, Basel, Switzerland.ORCID http://orcid.org/0000-0002-6341-7546
Adelphi Group (United Kingdom) · GBNovartis (Switzerland) · CHNovartis (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLichen planus (LP) is an inflammatory skin disorder that can present in various forms across the body, including lesions on the skin (cutaneous LP [CLP]), scalp (lichen planopilaris [LPP]) and mucosal regions (mucosal LP [MLP]). Several existing patient-reported outcome measures (PROMs) were identified for potential use in LP clinical development programs. This study aimed to assess the content validity and psychometric measurement properties of the Dermatology Life Quality Index (DLQI), Epworth Sleepiness Scale (ESS), Scalpdex and Oral Lichen Planus Symptom Severity Measure (OLPSSM) in an LP population.

methodsPatients completed the PROs at various time points as part of an international Phase 2 clinical study in adults with MLP (n = 37), LPP (n = 37) and CLP (n = 37). Test-retest reliability, construct validity and sensitivity to change were assessed. In addition, qualitative cognitive debriefing interviews were conducted with adults with MLP (n = 20), LPP (n = 19) and CLP (n = 19) in the USA and Germany to examine the PROM content validity.

resultsThe DLQI demonstrated adequate reliability and validity, although its ability to detect change was modest and most items were considered not relevant in qualitative interviews. The ESS had good reliability but limited evidence of validity and ability to detect change. Conceptual relevance varied according to the qualitative interview data. The Scalpdex was miscellaneous across domains, but the 'Symptoms' domain performed well overall. Overall, Scalpdex concepts were reported as relevant by most LPP patients interviewed. The OLPSSM demonstrated good psychometric properties and strong evidence of content validity.

conclusionsThe psychometric and qualitative findings support the use of the OLPSSM and Scalpdex within specific LP subtypes but cautioned use of the DLQI. Administration of the ESS is not recommended in LP because of its poor psychometric performance. Given these limitations, further validation of non-specific disease measures is needed and/or the development of additional LP-specific PROMs.

trial registrationNCT04300296.

Indexed as

Dermatology Life Quality IndexEpworth Sleepiness ScaleHealth-related quality of lifeLichen planusOral Lichen Planus Symptom Severity MeasurePatient-reported outcomesPsychometric evaluationQualitative evidenceScalpdex

Identifiers

PMID37794275
PMCPMC10613190
OpenAlexW4387357254

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.