Evidence map›Paper›PMID 30098677›Full record

ArticleValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research2018

Initial Development and Content Validation of a Health-Related Symptom Index for Persons either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions.

Jack E Burkhalter, Thomas M Atkinson, J Berry-Lawhorn, Stephen Goldstone, Mark H Einstein, Timothy J Wilkin, Jeannette Lee, David Cella, Joel M Palefsky, ANCHOR HRQOL Implementation Group

Registry-linked trialAbstract read
In one paragraph

Article in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06156566 (European Randomised Clinical Trial on mPOX Infection), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.5field-weighted citation impact, top 34% 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.

NCT06156566 phase4recruitingnot on this mapstarted 2024, after this paper: background citation

European Randomised Clinical Trial on mPOX Infection

TypeinterventionalSponsorMiquel EkkelenkampRan2024 to 2026Enrolled150ConditionsMonkeypoxArmsTecovirimat Oral Capsule, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Construct validity and responsiveness of a health-related symptom index for persons either treated or monitored for anal high-grade squamous intraepithelial lesions (HSIL): AMC-A01/-A03.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023
    Trial
  4. Article
  5. Review
  6. Article
  7. Article
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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 at 6 institutions in 1 country.

Jack E BurkhalterUniversity of California, San Francisco, CA, USA.
Thomas M AtkinsonMemorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: atkinsot@mskcc.org.
J Berry-LawhornUniversity of California, San Francisco, CA, USA.
Stephen GoldstoneLaser Surgery Care, New York, NY, USA.
Mark H EinsteinRutgers-New Jersey Medical School, Newark, NJ, USA.
Timothy J WilkinWeill Cornell Medicine, New York, NY, USA.
Jeannette LeeUniversity of Arkansas for Medical Sciences, Little Rock, AR, USA.
David CellaNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Joel M PalefskyUniversity of California, San Francisco, CA, USA.
ANCHOR HRQOL Implementation Group
University of California, San Francisco · USCornell University · USMemorial Sloan Kettering Cancer Center · USNorthwestern University · USRutgers, The State University of New Jersey · USUniversity of Arkansas for Medical Sciences · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Consortium for Advancing Management and Prevention of Cancer in People with HIVUM1CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Joseph A. Sparano · 2015 to 2026
$253.7M
University of Southern CaliforniaU01CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI KROWN, SUSAN E · 2006 to 2014
$54.7M
Training and Career Development CoreU54CA132378 · NCI · CITY COLLEGE OF NEW YORK · PI Tim Alan Ahles, ADRIANA ESPINOSA · 2008 to 2026
$28.9M
Training and Career Development and Education CoreU54CA137788 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI Daniel Alan Heller · 2008 to 2026
$28.1M
NCI NIH HHS P30 CA008748NCI NIH HHS U01 CA121947NCI NIH HHS U54 CA132378NCI NIH HHS U54 CA137788NCI NIH HHS UM1 CA121947
6 · The paper itself

Abstract

backgroundAnal cancer, caused by oncogenic types of human papillomavirus, is a growing problem in the United States. A key focus of anal cancer prevention has been screening for and treating precancerous high-grade squamous intraepithelial anal lesions (HSILs).

objectivesTo develop a health-related symptom index for HSIL using qualitative techniques because anal HSIL and its treatment may have a negative impact on health-related quality of life (HRQOL), and no HRQOL measure specific to this condition and treatment currently exists.

methodsExpert consultation was used to guide one-on-one concept elicitation interviews with participants to identify HRQOL aspects they attribute to their anal HSIL and its treatment. This resulted in a draft instrument, which was administered to an independent participant sample, where cognitive interview techniques assessed comprehension.

resultsEighteen anal HSIL-related concepts were identified by the expert panel. Across the 41 concept elicitation interviews, 23 items representing physical symptoms, physical impacts, and psychological symptoms were identified to comprise the initial measure, which was then evaluated during three rounds of cognitive interviews (n = 45). Several questionnaire aspects were refined on the basis of participant input, with three additional items added per expert/participant recommendation. One item was removed because of poor comprehension, resulting in a 25-item measure.

conclusionsUsing state-of-the-art qualitative methodology, we have established the content validity of this new instrument, the ANCHOR Anal HSIL Health-Related Symptom Index. Quantitative validation efforts are currently underway. The participant-driven process of developing this tool will facilitate a participant-centered evaluation of the impact on morbidity for treatment of anal HSIL or observation without treatment.

Indexed as

AdultAnus NeoplasmsFemaleHIV InfectionsHumansMaleMiddle AgedPsychometricsQuality of LifeSquamous Intraepithelial Lesions of the CervixSurveys and QuestionnairesANCHOR trialhealth-related quality of lifeneoplasmspatient-reported outcomes

Identifiers

PMID30098677
PMCPMC6093301
OpenAlexW2797416871

What OpenQuestion holds

Textmetadata
LicenceTDM
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.