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Abstract
Objective:
A comprehensive questionnaire designed to assess the full spectrum of potential human papillomavirus (HPV)-related psychosocial effects in women does not exist. The HPV Impact Profile (HIP) was developed to determine the psychosocial impact of HPV infection and related interventions.
Research design and methods:
Draft instrument items and domains were developed using a literature review and cognitive debriefing interviews with women who had experienced HPV-related conditions. An importance rating questionnaire guided item ranking and reduction. A draft questionnaire was pilot-tested for comprehension and ease of completion. Psychometric evaluation of the final HIP was conducted in a survey of 583 women. Data quality, item acceptability, scale acceptability, reliability, and discriminate construct validity were assessed.
Outcome measure:
The final HIP contained 29 items rated on a 0–10 point discretized visual analog scales grouped into seven hypothesized domains.
Results:
Total HIP scores ranged from 0 (no impact) to 100 (worst impact). Data quality was high, with missing data for items ranging from 0 to 0.7% and over 99% of the scores were computable. Cronbach's alpha ranged from 0.64 to 0.90 and was ≥0.7 for 5/7 domains. Discriminant construct validity was demonstrated. Appropriate modifications could potentially be made to improve some aspects of the HIP, including modification to include other HPV diseases such as head and neck, anal, and vulvovaginal cancers and HPV disease in men.
Conclusions:
The disease-specific HIP has favorable reliability and construct validity and a good ability to discriminate among disease severity.
Transparency
Declaration of funding
The study was funded by Merck Research Laboratories, Merck & Co., Inc.
Declaration of financial/other relationships
The authors are responsible for the work described in this paper. All authors were involved in at least one of the following: conception, design, acquisition, analysis, statistical analysis, interpretation of data, drafting the manuscript and/or revising the manuscript for important intellectual content. All authors provided final approval of the version to be published.
D.G.F. has disclosed that he has received honoraria from Merck for lectureships, consultation work and membership in the Phase III HPV Vaccine Steering and/or Registries Oversight Committees. D.G.F. has disclosed that he has led clinical sites that participated in the study and was compensated for all activities related to execution of the study. T.C.M., H.L.S., X.Z. and C.D-M. have disclosed that they are current or former employees of Merck and hold stock/stock options. H.W.C. was a student intern at Merck at the time of the study and is a stockholder.
Some peer reviewers receive honoraria from CMRO for their review work. Peer Reviewer 1 of this paper has disclosed that he/she has consulted for GlaxoSmithKline, Takeda, and Abbott.
The authors have disclosed that they had no outside editorial assistance in preparing this manuscript.
Acknowledgment
The authors acknowledge the following investigators (number enrolled) who participated in the study: B. Allen (27), R.S. Ashford, II (17), R. Edwards (68), D. Ferris (154), F. Fisk (12), S. Greer (28), R.M. Hamm (49), M. Jarratt (41), S. Kupersmith (45), D. Maizel (37), P. Whittaker (13), H. Wittenberg (9), P. Wright (50), and P. Zedler (33). The authors also thank all study participants.