Evidence map›Paper›PMID 34932192›Full record

Trial reportQuality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation2022

Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting.

Stacie Hudgens, Amy Howerter, Ela Polek, Fredrik L Andersson

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03201419 (A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults), 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
0.2field-weighted citation impact, top 43% 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.

NCT03201419 phase2completednot on this map

A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults

TypeinterventionalSponsorFerring PharmaceuticalsRan2017 to 2019Enrolled302ConditionsNocturiaArmsFE 201836, Desmopressin, Placebo oral solution, Placebo ODT
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Observational
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

4 authors at 2 institutions in 2 countries.

Stacie HudgensClinical Outcomes Solutions, Tucson, AZ, USA. stacie.hudgens@clinoutsolutions.com.ORCID http://orcid.org/0000-0002-7350-1549
Amy HowerterClinical Outcomes Solutions, Tucson, AZ, USA.ORCID http://orcid.org/0000-0003-0012-3951
Ela PolekClinical Outcomes Solutions, Folkestone, UK.ORCID http://orcid.org/0000-0003-1405-2269
Fredrik L AnderssonFerring Pharmaceuticals A/S, Copenhagen, Denmark.ORCID http://orcid.org/0000-0001-6304-5781
Health Outcomes Solutions (United States) · USFerring Pharmaceuticals (Denmark) · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePsychometric evaluation of the Nocturia Impact (NI) Diary was conducted to support its use as a trial endpoint.

methodsAs part of a randomized, controlled Phase 2 clinical trial investigating a novel drug candidate for nocturnal polyuria, adult nocturia patients completed the NI Diary and a voiding diary for three nights preceding their clinic visit at Baseline and Weeks 1, 4, 8, and 12 (end of treatment). Exit interviews were conducted to obtain patient impressions of the NI Diary.

resultsA total of N = 302 participants were included. Confirmatory factor analysis (CFA) indicated that the 11-item measure is unidimensional with values of CFI, TLI, and RMSEA meeting relevant thresholds. Good internal consistency (Cronbach's α 0.941) and test-retest reliability (intra-class correlation coefficients 0.730-0.880). Convergent validity with two reference measures was demonstrated with strong correlations of 0.573-0.730 were shown. Significant differences (P = 0.0018, standardized effect size = 0.372) between groups defined by number of night-time voids supported known-groups validity. Exit interviews in 66 patients indicated all participants experienced improvement in at least 1 NI Diary item and that a 1-point improvement on the item response scale and 1-void reduction per night (associated with an average best cut point on ROC analysis of - 11.6) constituted meaningful improvement. Anchor and distribution-based analyses identified a meaningful change threshold of - 15 to - 18 points on the NI Diary.

conclusionThe NI Diary is a reliable and valid patient-reported psychometric instrument which is fit-for-purpose to evaluate the impact of nocturia on patient quality of life in the clinical trial setting. Trial registration number and registration date NCT03201419; June 28, 2017.

Indexed as

NocturiaAdultEnvironmentHumansPsychometricsQuality of LifeReproducibility of ResultsSurveys and QuestionnairesAnchor-basedMeaningful change thresholdNI DiaryNocturiaPatient-reported outcomesQuality of life

Identifiers

PMID34932192
PMCPMC9098619
OpenAlexW4200194689

What OpenQuestion holds

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LicenceCC BY
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.