PATIENT-REPORTED OUTCOMES

A patient-reported outcome (PRO), as discussed at length in Chapter 12, is a measurement and assessment of a patient’s health status coming directly from the patient rather than from a physician or any other healthcare provider [37, 38]. The Food and Drug Administration refers to a PRO as any report coming from patients about a health condition and its treatment [37, 38]. An important feature that differentiates a PRO from any other measurement is that the measurement is done directly from the patient. A PRO thus provides a patient’s perspective on treatment effectiveness [39, 40], adverse events, and so on. Health-related quality of life (HRQoL), a term closely related to PRO, specifically refers to measures that are not only patient reported, but also include the impact of the disease and its treatment on the patient’s well-being and functioning (see Chapter 12 on PROs) [39, 40]. A PRO measure includes various facets of disease treatment and its effectiveness as reported directly by the patient. These include, among others, reports of symptoms such as pain, fatigue, physical functioning, and well-being in the physical, mental, and social domains of life [41]. Many health behaviors, including use of tobacco and alcohol, participation in exercise programs, and so on, are also included in a typical PRO. Other end points captured in a PRO include patient preferences for a particular treatment and treatment satisfaction [41]. A PRO measure can include patient satisfaction with treatment, medication adherence, and other aspects of disease treatment, functional status, psychological well-being, and health status in addition to HRQoL [42, 43].

Use of PRO Instruments in Pharmacoeconomic Studies: Focus on HPV Vaccine Studies

Although PROs usually consist of specific health-related questionnaires or instruments, providing a simple survey questionnaire for patient response also makes up a simpler form of PRO. This section provides examples of how such PRO questionnaires have been used in HPV vaccine-related issues and studies. Gerend and Magloire assessed the awareness, knowledge, and beliefs about HPV in a racially diverse sample of young adults [44]. The authors used a survey to obtain respondent-reported responses among 124 students aged 18-26 years from two southeastern universities. The survey assessed demographics, sexual history, awareness and knowledge of HPV, HPV-related beliefs, and interest in the HPV vaccine (women only). This study reported some interesting findings that could be used for further economic studies on HPV vaccine, including great knowledge of HPV, greater awareness among women of HPV as compared with men, and a greater interest in HPV education among blacks and sexually active respondents. Another study examined the stage of adoption of the HPV vaccine among college women aged 18-22 years at a New England University [45]. This study used an online survey as a means to complete the PRO instrument. The survey examined knowledge of HPV, perceived susceptibility, severity, vaccine benefits or barriers, and stage of vaccine adoption. The use of such PRO measures provides a useful means to obtain responses directly from patients (in this case, women) who have had HPV vaccines or have potential to have one in the future. The analyzed results indicated that the acceptance of the vaccine was high among the study respondents and that the importance of Pap smears was also high [45]. Yet another study analyzed the acceptance of HPV vaccine among mid-adult women [46]. This particular study used a convenience sample of 472 mid-adult women who completed a survey that examined the demographic, knowledge, and behavioral variables associated with HPV vaccine acceptance. The study assumed clinical significance, as some of the variables that were found to be associated with vaccination among the study respondents could be useful to clinicians to identify potential female patients who might be more receptive to the vaccine. These variables included women who were younger than 55 years, had had an abnormal Pap test, understood the association of HPV and cervical cancer, and those who felt at risk for HPV infection.

Though HPV-related diseases are more common among women, men are also exposed to the virus in varying forms and severity. A study similar to the previous study based on women and by the same authors examined the variables associated with HPV vaccine acceptance among men [47]. Similar results were obtained from this study in that the (male) respondents with a higher education and knowledge about HPV were more likely to accept HPV vaccination than others.

 
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