July 9, 2018
The symptoms of decompensated cirrhosis are well documented and understood. The more common symptoms of chronic hepatitis C (HCV) can dramatically vary from patient to patient. Patients want their symptoms to be understood, validated and treated, and their medical providers want to have scientific data to help guide them when they treat their patients. The current study was conducted to evaluate the reliability and validity of several survey instruments that will be used in the PROP UP study to understand patient-reported symptoms before, during and after HCV treatment.
A study conducted by D. M. Evon, et. al.1 assessed and validated the NIH PROMIS short form measures and the HIT-6 (Head Impact Test). PROMIS and HIT-6 are patient self-reported symptom instruments.
Nine-hundred-sixty-one (961) patients with chronic HCV at 11 U.S. liver centers completed the PROMIS and HIT-6 instruments before treatment with direct-acting antiviral medications. Surveys were conducted over the phone or taken through a data website.
The study was a non-pharmaceutical funded clinical study. It was funded by The Patient Centered Outcomes Research Institute (PCORI) whose mission is to include patients with the disease as patient partners during the research studies. For the PROP UP study, a UNC Patient Engagement Group2 was instrumental in the development of the study design and selection of the study outcomes and surveys used to capture patients' experiences. For disclosure purposes, I have been a member of the UNC Patient Engagement Group since its inception in 2013.
The short-form surveys evaluate fatigue, depression, anxiety, anger, pain interference, sleep disturbance, cognition concerns, belly pain, diarrhea, and nausea/vomiting (some of the most common symptoms of HCV or side effects of DAA therapy). A higher score equals worse symptoms.
A 6-item questionnaire to score headaches, which are not covered by the PROMIS measures. The score ranges from "Never to Always." A higher score equals a worse headache. The patient characteristics were mean age 57 years old (23-82 yo); male 55%; white 61%; Hispanic 4%; married 38%; high school or equivalent 55%; employed/disabled/applying 49%; cirrhosis 50%.
The PROMIS and the HIT-6 performed well and were found to be reliable and valid indicators of symptoms in patients with HCV. About 30-59% of patients reported not having some of the symptoms, especially for diarrhea, nausea/vomiting, and abdominal pain. Between 41% to 63% of patients reported mild to severe symptoms. Higher symptom scores were associated with more advanced cirrhosis and having a greater number of other health conditions. Almost all patients indicated some level of fatigue or sleep disturbance, that is, very few patients reported having no fatigue or sleep problems.
The PROMIS and HIT-6 performed well when taken by many patients living with HCV in this large prospective study. The outcomes of the study reveal how symptom experiences can vary from person to person. The authors noted that there is room for refinement in the PROMIS and HIT-6 measures and inclusion of other subgroups of patients in future studies. This study sets the stage to now evaluate how patients' symptoms change over time, during HCV treatment and up to one year after treatment ends, to see if these symptoms stay the same, get better, or get worse over time.
I was cured of hepatitis C infection more than a decade ago. For me, it was very frustrating that many of the symptoms I experienced before being cured were never validated. The validation of the PROMIS and HIT-6 in this study will help to bring more understanding and compassion to patients living with HCV who experience these symptoms. There will be more information published from the PROP UP study on patient-reported outcomes in 2018-2019 that will be reported here.
Alan Franciscus is the executive director of the Hepatitis C Support Project and the editor-in-chief of the HCV Advocate website.
[Note from TheBodyPRO: This article was originally published by HCV Advocate in July 2018. We have cross-posted it with their permission.]
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