title: Assessing Patient-Reported Outcomes in Pediatric Populations With Vaccine-Preventable Infectious Diseases: A Systematic Review of the Literature (the PROCHID Study).
abstract: OBJECTIVE
  To investigate the use of patient-reported outcomes (PROs) in pediatric populations with vaccine-preventable infectious diseases in high-income Western countries.
  
  
  METHODS
  Systematic review of PRO use in populations younger than 18 years with any of 17 infectious diseases for which vaccines are available or in development. The search was limited to studies performed in Europe, North America, Australia, and New Zealand and published between January 1, 1990, and July 31, 2013. Searches were conducted in Scopus and PsycINFO, and reference lists were manually searched. Results are reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
  
  
  RESULTS
  Of 6410 titles and abstracts and 174 full-text articles reviewed, 17 full-text articles were included for data extraction. The largest number of PRO studies was carried out in patients with anogenital warts and rotavirus gastroenteritis. No PRO studies were identified for nine conditions. A total of 24 PRO measures (12 generic and 12 disease-specific) were used in the studies reviewed. Most of the instruments used were of high quality. Proxy responses were occasionally obtained when self-report would have been feasible. No validated disease-specific instruments for children with any of the conditions studied were found.
  
  
  CONCLUSIONS
  The paucity of studies and PRO instruments to assess pediatric health status in vaccine-preventable infectious diseases, and the lack of a standardized approach to measurement, makes it difficult to capture the impact of disease and the benefit of vaccination and could potentially hinder decision making. Guidelines from relevant bodies to steer research in this area would be useful.
authors.affiliation: Office of Health Economics, London, UK. Electronic address: mherdman@ohe.org.
authors.forename: Michael
authors.initials: M
authors.lastname: Herdman
authors.affiliation: Office of Health Economics, London, UK.
authors.forename: Christopher K
authors.initials: CK
authors.lastname: Hoyle
authors.affiliation: Sanofi Pasteur MSD, Berkshire, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: Coles
authors.affiliation: Sanofi Pasteur MSD, Berkshire, UK.
authors.forename: Stuart
authors.initials: S
authors.lastname: Carroll
authors.affiliation: Office of Health Economics, London, UK.
authors.forename: Nancy
authors.initials: N
authors.lastname: Devlin
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003141:Communicable Diseases / Q000628:therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D063868:Patient Outcome Assessment; D057566:Self Report; D014612:Vaccines
chemical_list: D014612:Vaccines
keywords: infectious diseases; literature review; patient-reported outcomes; pediatric