What’s Important to the Patient? Informational Needs of Patients Making Decisions About Hepatitis C Treatment

Evon, Donna M.; Golin, Carol E.; Stoica, Teodora; Jones, Rachel E.; Willis, Sarah J.; Galanko, Joseph A.; Fried, Michael

doi:10.1007/s40271-016-0207-7

Cited by 13 publications

(17 citation statements)

References 24 publications

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“…Not surprisingly, the most important treatment attributes were efficacy (i.e., cure rate) and safety/tolerability (i.e., risks of common mild side effects). Cure rate identified as the attribute of a DAA that CHC patients value the most is in line with previous studies [16, 25–28].…”

Section: Discussionsupporting

confidence: 91%

Assessing Patient Preferences for Treatment Decisions for New Direct Acting Antiviral (DAA) Therapies for Chronic Hepatitis C Virus Infections

et al. 2019

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IntroductionThe new direct acting antiviral (DAA) therapies are able to effectively treat chronic hepatitis C (CHC). This study elicited the preferences of CHC patients for treatment attributes of new DAAs.MethodsAn online discrete choice experiment survey was designed to collect data from adult CHC patients in the USA, UK, France, Germany, Spain, and Italy. Patients were asked to choose from alternative hypothetical DAA options, defined by differing levels of nine attributes [i.e., treatment duration, tablet count and packaging, cure rate, required office visits when on treatment, modifications to statins or to proton pump inhibitors (PPIs), and risks of diarrhea, headache and nausea]. Logistic regression was used to assess preference for the treatment options.ResultsA total of 328 patients with CHC completed the survey (USA, n = 227; European countries, n = 101), with a mean age of 47.7 years (SD = 14.4) and an average 11.2 years since CHC diagnosis; 51% of patients were female. More than half (60%) of the patients had treatment for CHC. Patients significantly preferred a DAA regimen with higher cure rate, shorter treatment duration, lower risks of diarrhea, headache, and nausea (all p < 0.001), reduced need for office visits when on treatment (p = 0.044), and without requiring dose reduction or timing change in PPIs (p = 0.032). Tablet counts were not found to be statistically significant.ConclusionGiven the overall high cure rates of new DAAs, CHC patients’ preferences for therapy may be influenced by treatment attributes other than cure rates and tolerability. Treatments that are more convenient and require less disruption to their daily life (e.g., shorter treatment duration, no modification in PPI use, and fewer office visits when on treatment) are important to patients with CHC and should be considered when making treatment decisions.FundingAbbVie.

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Section: Discussionsupporting

confidence: 91%

Assessing Patient Preferences for Treatment Decisions for New Direct Acting Antiviral (DAA) Therapies for Chronic Hepatitis C Virus Infections

et al. 2019

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“…However, qualitative studies are absolutely essential to deepen our understanding of patient experiences, perspectives, needs, and priorities; this is especially true in the setting of studying different medical treatments. (37)(38)(39) Toward this end, clinical investigators are encouraged to familiarize themselves with the systematic, step-by-step approaches for conducting formative, qualitative work needed to develop or modify accompanying PRO instruments. In 2019, the FDA published a series of four guidance documents to facilitate patient-focused drug development.…”

Section: Discussionmentioning

confidence: 99%

A Systematic Review of Patient‐Reported Outcomes in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis

et al. 2020

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Primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) are associated with decreased health-related quality of life and debilitating symptoms. These experiences can be defined as patient-reported outcome (PRO) concepts and measured using PRO instruments. We identified all PRO concepts and instruments used in the PBC and PSC literature. This systematic review identified PBC and/or PSC studies from January 1, 1990, to May 6, 2019, that measured at least one PRO concept. Study population, design, PRO concept, PRO instrument, and validation data for PRO instruments were investigated. We provided descriptive statistics of PRO concepts and instruments used, stratified by population type. Use of PRO concepts and instruments were assessed over time. The search yielded 318 articles (69% in PBC, 18% in PSC, 13% in both, and 24% in drug trials). Forty-nine unique PRO concepts were identified. The five most common PRO concepts included pruritus (25%), fatigue (19%), broad health-related quality of life (16%), gastrointestinal adverse events (6%), and physical adverse events (6%). Only 60% of PRO concepts were measured with a PRO instrument, most of which were nonvalidated visual analogue or numeric rating scales. Only three of 83 PRO instruments were developed with feedback from the target populations (one for PBC, one for PSC, and one for both), and only six documented any psychometric testing in the target populations. Use of PRO instruments increased over time from 30% in the 1990s to 67% by 2019. Conclusion: The overwhelming majority of PRO instruments used in PBC/PSC were nonspecific and lacked patient validation or empirical justification. Significant opportunities exist to use qualitative methods to better understand patient experiences, and translate this knowledge into meaningful, patient-driven study outcomes. (Hepatology Communications 2020;4:1502-1515). P rimary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) are chronic cholestatic liver diseases associated with significant morbidity, including decreased quality of life, (1-6) pruritus, (7-9) and fatigue, (10-14) among other symptoms. The primary outcomes of most clinical trials include disease endpoints or surrogates (e.g., alkaline phosphatase), rather than patient-reported outcomes (PROs), which capture how patients feel or function. PROs reflect a patient's health status, as it comes directly from the patient, without interpretation by anyone else including the clinician. (15) Patient experiences and perceptions are best evaluated using validated PRO instruments that were developed with Abbreviations: FDA, Food and Drug Administration; HRQOL, health-related quality of life; NOS, not otherwise specified; PBC, primary biliary cholangitis; PRO, patient-reported outcome; PSC, primary sclerosing cholangitis.

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“…In the year before proposal submission, we conducted a formative content analysis of 45 patient interviews with patients being evaluated by clinicians for HCV treatment 32 . Participants were asked to free-list all potential types of information they felt were important to them for making an informed treatment decision or choosing between hypothetical treatment options.…”

Section: 0 Methodsmentioning

confidence: 99%

Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment

Evon¹,

Golin²,

Stewart³

et al. 2017

Contemporary Clinical Trials

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Background New highly efficacious direct-acting antiviral (DAA) therapies are available to treat chronic hepatitis C viral (HCV) infection. Real-world, patient-centered data on harms and benefits associated with these therapies are needed. Methods PROP UP is a multi-center prospective observational study that plans to enroll 1,600 patients starting treatment with recently-approved DAA regimens. Informed by extensive input from a HCV patient engagement group who prioritized outcomes most important to them, patient-reported outcomes will be characterized using surveys at five time points: Baseline (T1), treatment week 4 (T2), end of treatment (T3), 12 weeks post-treatment (T4), 12 months post-treatment (T5). Outcomes (1) Changes in side effects, functioning, pre-existing conditions, and out-of-pocket costs during therapy (T1 vs T2/T3); (2) Medication adherence in relation to a history of mental health/substance abuse, treatment regimens, pill burden, reasons for missed doses, and cure rates; (3) Short term impact of cure on functioning and amelioration of symptoms (T1 vs T4); (4) Long-term treatment harms or benefits of cure on symptoms, side effects, pre-existing conditions, and functioning (T1 vs T5). Similarities between regimens will be examined where comparisons are appropriate and meaningful. Conclusion PROP UP complements previous clinical trials by focusing on patient-reported outcomes in a representative sample of patients treated in clinical practice, by collaborating with a patient engagement group, by characterizing the experiences of vulnerable subgroups, and by investigating long-term harms and benefits of treatments. PROP UP is designed to provide novel and detailed information to support informed decision-making for patients and providers contemplating HCV treatment (PCORI CER-1408-20660; NCT02601820).

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What’s Important to the Patient? Informational Needs of Patients Making Decisions About Hepatitis C Treatment

Cited by 13 publications

References 24 publications

Assessing Patient Preferences for Treatment Decisions for New Direct Acting Antiviral (DAA) Therapies for Chronic Hepatitis C Virus Infections

Assessing Patient Preferences for Treatment Decisions for New Direct Acting Antiviral (DAA) Therapies for Chronic Hepatitis C Virus Infections

A Systematic Review of Patient‐Reported Outcomes in Primary Biliary Cholangitis and Primary Sclerosing Cholangitis

Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment

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