Evidence map›Paper›PMID 41257214›Full record

ArticleJournal of pain research2025

Evaluating the Content Validity of the Modified Neuropathy Total Symptom Score-6 Self-Administered (mNTSS-6-SA) in a Painful Diabetic Peripheral Neuropathy Population.

Heather Gerould, Rikki Mangrum, Rebecca L Robinson, Karolina Schantz, Alexandra Bryant, Laure Delbecque, Benjamin Behrend, Karen L Price, Virginia L Stauffer, Ekin Seçinti

Registry-linked trialAbstract read
In one paragraph

Article in Journal of pain research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07708233 (A 12-Week Double-blind Randomized Controlled Study; Comparing the Efficacy of Benfotiamine and Vitamin b1-6-12 in Alleviating Numbness, Sensory Neuropathy Symptoms and Pain in Patients With Diabetic Peripheral Neuropathy), which is not on this map. Not yet cited in PubMed.

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

NCT07708233 phase4recruitingnot on this mapstarted 2026, after this paper: background citation

A 12-Week Double-blind Randomized Controlled Study; Comparing the Efficacy of Benfotiamine and Vitamin b1-6-12 in Alleviating Numbness, Sensory Neuropathy Symptoms and Pain in Patients With Diabetic Peripheral Neuropathy

TypeinterventionalSponsorThammasat UniversityRan2026 to 2027Enrolled66ConditionsDiabetic Peripheral Neuropathy (DPN)ArmsBenfotiamine, Vitamin B1-6-12
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Heather GerouldVector Psychometric Group, LLC, Chapel Hill, NC, USA.
Rikki MangrumVector Psychometric Group, LLC, Chapel Hill, NC, USA.ORCID 0000-0001-6231-5890
Rebecca L RobinsonEli Lilly and Company, Indianapolis, IN, USA.ORCID 0000-0003-1490-0491
Karolina SchantzVector Psychometric Group, LLC, Chapel Hill, NC, USA.
Alexandra BryantVector Psychometric Group, LLC, Chapel Hill, NC, USA.ORCID 0000-0003-3650-9346
Laure DelbecqueEli Lilly and Company, Indianapolis, IN, USA.ORCID 0009-0008-0547-6645
Benjamin BehrendEli Lilly and Company, Indianapolis, IN, USA.
Karen L PriceEli Lilly and Company, Indianapolis, IN, USA.
Virginia L StaufferEli Lilly and Company, Indianapolis, IN, USA.
Ekin SeçintiEli Lilly and Company, Indianapolis, IN, USA.ORCID 0000-0001-7794-8500

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: People with diabetes often develop painful diabetic peripheral neuropathy (pDPN). Symptoms of pDPN vary and often lead to impairments in basic daily activities and negative impacts on quality of life. The Neuropathy Total Symptom Score-6 (NTSS-6) assesses the frequency and intensity of six neuropathic sensory symptoms. Validity of the NTSS-6 for neuropathic populations has been evaluated for a 24-hour clinician-reported version and 4-week self-administered (SA) version. The aim of this study was to evaluate the content validity of the Neuropathy Total Symptom Score-6 self-administered (NTSS-6-SA) modified for use with a 7-day recall period in a sample of people with pDPN. Methods: This was an observational qualitative study consisting of concept elicitation and cognitive debriefing interviews. The study included 25 US-based, English-speaking adults who had a physician-confirmed diagnosis of DPN and who self-reported moderate-to-severe pain in their feet or legs. Participants were asked to describe their experiences with pDPN and to review the NTSS-6-SA with a 7-day recall period. Based on findings from the first 13 interviews (Wave 1), the NTSS-6-SA was modified to address minor comprehension problems and incorporate patient feedback. The modified NTSS-6-SA (mNTSS-6-SA) was then reviewed in 11 interviews (Wave 2). Results: The measure was interpreted as intended, well-understood, and included content relevant to the experiences that study participants found important. Conclusion: The evidence from this study supported the content validity of the mNTSS-6-SA for the pDPN population.

Indexed as

cognitive debriefingcontent validitydiabetic peripheral neuropathyneuropathic painqualitative research

Identifiers

PMID41257214
PMCPMC12620620

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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.