Literature DB >> 30098677

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 Burkhalter1, Thomas M Atkinson2, J Berry-Lawhorn1, Stephen Goldstone3, Mark H Einstein4, Timothy J Wilkin5, Jeannette Lee6, David Cella7, Joel M Palefsky1.   

Abstract

BACKGROUND: Anal 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).
OBJECTIVES: To 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.
METHODS: Expert 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.
RESULTS: Eighteen 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.
CONCLUSIONS: Using 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.
Copyright © 2018 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  ANCHOR trial; health-related quality of life; neoplasms; patient-reported outcomes

Mesh:

Year:  2018        PMID: 30098677      PMCID: PMC6093301          DOI: 10.1016/j.jval.2018.01.018

Source DB:  PubMed          Journal:  Value Health        ISSN: 1098-3015            Impact factor:   5.725


  19 in total

1.  Treatment of grade III anal intraepithelial neoplasia with photodynamic therapy: report of a case.

Authors:  Khaled A Hamdan; Iain S Tait; Valerie Nadeau; Miles Padgett; Frank Carey; Robert J Steele
Journal:  Dis Colon Rectum       Date:  2003-11       Impact factor: 4.585

2.  Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding.

Authors:  Donald L Patrick; Laurie B Burke; Chad J Gwaltney; Nancy Kline Leidy; Mona L Martin; Elizabeth Molsen; Lena Ring
Journal:  Value Health       Date:  2011-10-10       Impact factor: 5.725

3.  Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument.

Authors:  Donald L Patrick; Laurie B Burke; Chad J Gwaltney; Nancy Kline Leidy; Mona L Martin; Elizabeth Molsen; Lena Ring
Journal:  Value Health       Date:  2011-10-13       Impact factor: 5.725

4.  Cumulative Incidence of Cancer Among Persons With HIV in North America: A Cohort Study.

Authors:  Michael J Silverberg; Bryan Lau; Chad J Achenbach; Yuezhou Jing; Keri N Althoff; Gypsyamber D'Souza; Eric A Engels; Nancy A Hessol; John T Brooks; Ann N Burchell; M John Gill; James J Goedert; Robert Hogg; Michael A Horberg; Gregory D Kirk; Mari M Kitahata; Philip T Korthuis; William C Mathews; Angel Mayor; Sharada P Modur; Sonia Napravnik; Richard M Novak; Pragna Patel; Anita R Rachlis; Timothy R Sterling; James H Willig; Amy C Justice; Richard D Moore; Robert Dubrow
Journal:  Ann Intern Med       Date:  2015-10-06       Impact factor: 25.391

5.  The psychological impact of being screened for anal cancer in HIV-infected men who have sex with men.

Authors:  Jill Tinmouth; Janet Raboud; Michael Ali; Lindsay Malloch; Desheng Su; Marie Sano; Alice Lytwyn; Sean B Rourke; Linda Rabeneck; Irving Salit
Journal:  Dis Colon Rectum       Date:  2011-03       Impact factor: 4.585

Review 6.  Therapy for genital human papillomavirus-related disease.

Authors:  Charles J N Lacey
Journal:  J Clin Virol       Date:  2005-03       Impact factor: 3.168

Review 7.  Human papillomavirus type distribution in anal cancer and anal intraepithelial lesions.

Authors:  Brooke E Hoots; Joel M Palefsky; Jeanne M Pimenta; Jennifer S Smith
Journal:  Int J Cancer       Date:  2009-05-15       Impact factor: 7.396

8.  Health-Related Quality of Life and Sexual Functioning of HIV-Positive Men Who Have Sex With Men Who Are Treated for Anal Intraepithelial Neoplasia.

Authors:  Matthijs L Siegenbeek van Heukelom; Olivier Richel; Pythia T Nieuwkerk; Henry J C De Vries; Jan M Prins
Journal:  Dis Colon Rectum       Date:  2016-01       Impact factor: 4.585

9.  The Functional Assessment of Cancer Therapy scale: development and validation of the general measure.

Authors:  D F Cella; D S Tulsky; G Gray; B Sarafian; E Linn; A Bonomi; M Silberman; S B Yellen; P Winicour; J Brannon
Journal:  J Clin Oncol       Date:  1993-03       Impact factor: 44.544

10.  Anal Cancer Incidence in the United States, 1977-2011: Distinct Patterns by Histology and Behavior.

Authors:  Meredith S Shiels; Aimée R Kreimer; Anna E Coghill; Teresa M Darragh; Susan S Devesa
Journal:  Cancer Epidemiol Biomarkers Prev       Date:  2015-07-29       Impact factor: 4.254

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  4 in total

1.  Reliability and between-group stability of a health-related quality of life symptom index for persons with anal high-grade squamous intraepithelial lesions: an AIDS Malignancy Consortium Study (AMC-A03).

Authors:  Thomas M Atkinson; Joel Palefsky; Yuelin Li; Andrew Webb; J Michael Berry; Stephen Goldstone; Rebecca Levine; Timothy J Wilkin; Gary Bucher; David Cella; Jack E Burkhalter
Journal:  Qual Life Res       Date:  2019-01-07       Impact factor: 4.147

2.  Electrocautery ablation of anal high-grade squamous intraepithelial lesions: Effectiveness and key factors associated with outcomes.

Authors:  Michael M Gaisa; Yuxin Liu; Ashish A Deshmukh; Kimberly L Stone; Keith M Sigel
Journal:  Cancer       Date:  2020-01-24       Impact factor: 6.860

3.  DNA Methylation Analysis to predict Regression of high-grade anal Intraepithelial Neoplasia in HIV+ men (MARINE): a cohort study protocol.

Authors:  Fernando Dias Gonçalves Lima; Ramon P van der Zee; Stèfanie Dick; Carel J M van Noesel; Johannes Berkhof; Maarten F Schim van der Loeff; Jan M Prins; Renske D M Steenbergen; Henry J C de Vries
Journal:  BMJ Open       Date:  2022-08-03       Impact factor: 3.006

4.  Linguistic validation of the Spanish version of the Anal Cancer High-Grade squamous intraepithelial lesions outcomes Research Health-Related Symptom Index (A-HRSI): AMC-A04.

Authors:  Thomas M Atkinson; Kathleen A Lynch; Jacqueline Vera; Nuria Mendoza Olivares; Andrew Webb; Lisa C Diamond; Javier González; Erica I Lubetkin; Gary Bucher; Isabella Rosa-Cunha; J Michael Berry-Lawhorn; Rebecca Levine; David Aboulafia; Jeffrey Schouten; Susan M Holland; David Cella; Joel M Palefsky
Journal:  J Patient Rep Outcomes       Date:  2022-10-11
  4 in total

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