Table 1.

PICOTS (population, interventions, comparisons, outcomes, timing, and setting) criteria for the systematic literature review.

	Inclusion Criteria	Exclusion Criteria
Populations	People of any age, from any country, considered at high risk for HPV-related disease, including:∙ People with recurrent respiratory papillomatosis∙ Women with pre-existing HPV-related anogenital disease∙ Men who have sex with men∙ Immunocompromised or immunosuppressed individuals, including those positive for HIV or who have received immunosuppressive treatments (such as those receiving transplants)∙ Transgender and non-binary individuals∙ Sex workers	People not in one of the identified high-risk populations
Interventions	HPV vaccination	Use of 2vHPV in >50% of vaccinated subjects
Comparisons	No vaccine (effectiveness) Before vaccination programs implemented (impact)
Outcomes	Incidence or prevalence of genital warts or HPV-related precancer or cancer, including:∙ Genital warts∙ Precancers or cancer of the cervix (including low- and high-grade cervical lesions)∙ Precancers or cancer of other anogenital regions (including vulva, vagina, penis, or anus)∙ Precancers or cancer of the oral cavity, larynx, or oropharyngeal regions∙ Recurrent respiratory papillomatosis	Patient-reported outcomes (e.g., quality of life, satisfaction) Economic outcomes (e.g., cost-effectiveness, budget impact) Population level incidence/prevalence of Juvenile onset RRP (JoRRP vaccine impact studies)
Time	Conference abstracts: 1 January 2018 to present Articles: any time	Conference abstracts published before 2018
Study design	Observational studies using real-world data (e.g., longitudinal survey, medical records, registry) Systematic reviews (for identification of primary studies only)	Randomized trials, including long-term follow-up studies of clinical trial cohorts Decision Analytic and cost-effectiveness modeling/simulation studies Non-systematic reviews Editorials, comments, notes Case studies Clinical practice guidelines
Other	English language	Non-English language

HIV, human immunodeficiency virus; HPV, human papillomavirus; 2vHPV, bivalent HPV vaccine; 4vHPV, quadrivalent HPV vaccine; 9vHPV, nonavalent HPV vaccine.