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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for chronic hepatitis C viral (HCV) infection regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups. Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with HCV infection who are prescribed a regimen containing Sofosbuvir/Ledipasvir(SOF/LED), SOF/Velpatasvir(SOF/VEL), Grazoprevir/Elbasvir(GRZ/ELB), OBV/PTV/r + DSV (PRoD), or daclatasvir/SOF (DAC/SOF) will be recruited and approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will be evaluated before, during and after HCV treatment.
PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient engagement group and a patient advocacy organization.
Newer, more effective all-oral regimens for hepatitis C viral (HCV) infection are available. However the available data from industry-sponsored trials do not provide all the information that patients need, nor do these data represent the broad spectrum of patients treated in real-world practice. Trials also exclude disadvantaged subgroups, focus on short-term efficacy and clinician-rated adverse events, rarely obtain the patient's perspective, and do not investigate longer-term harms of treatment or benefits of viral cure. Given these informational gaps, patient-centered outcomes research on treatment harms and benefits that matter most to patients, is needed.
PROP UP is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate newly approved direct acting antiviral (DAA) treatment regimens for HCV regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups.
PROP UP is a collaborative effort between researchers, a patient engagement group, and a patient advocacy organization. Eleven U.S. liver centers will collaborate on PROP UP. Approximately 1920 patients with HCV infection who are prescribed a DAA regimen for chronic HCV will be consented and will complete baseline PRO surveys. Approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. Participants will complete several PRO surveys at 5 assessment periods during the study: baseline, treatment week 4, end of treatment, 3 months post-treatment, and 12 months post-treatment. PRO survey data will be collected via 3 options: patient home-based computers, tablet, smartphone; phone-administered surveys with a centralized call enter; or at regular clinic visits.
Analysis of PROs collected longitudinally before, during and after treatment for HCV will allow the investigators to answer a variety of questions important to patients and clinicians. Specifically, the investigators will evaluate: (a) prevalence of pre-existing baseline symptoms associated with HCV; (b) the development of new onset treatment side effects and exacerbation of pre-existing symptoms during HCV treatment; (c) medication adherence and out of pocket costs associated with treatment; (d) changes in HCV-associated symptoms and functional status in patients who are cured; (e) long-term patient-reported harms associated with treatments and long-term benefits associated with viral cure.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment | Change in "Overall Symptom Burden" was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score. Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful. | Baseline to up to 24 weeks of HCV Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment | Change in Treatment-Related Symptoms was measured using multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and the Headache Impact Test (HIT-6). Mean CHANGE Scores were calculated as baseline mean score minus T2 mean score or baseline mean score minus T3 mean score. Lower change scores (-) indicate symptoms improved.
To aid in interpretation of clinical significance, a 5% change from baseline is considered a "minimally important change (MIC)." The 5% MIC change in a PROMIS or HIT-6 score is +/- 2.5 points. |
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Inclusion Criteria:
Diagnosed with HCV genotype 1-6
English-speaking
Age 21 or older
Medically cleared and being prescribed one of the following DAA regimens:
Exclusion Criteria:
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Patients being evaluated for Hep C treatment in 9 large academic liver centers and two private gastroenterology practices in the US.
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| Name | Affiliation | Role |
|---|---|---|
| Donna M. Evon, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Davis | Davis | California | 95616 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33387381 | Derived | Serper M, Evon DM, Amador J, Stewart PW, Sarkar S, Lok AS, Sterling RK, Reeve BB, Golin CE, Rajender Reddy K, Lim JK, Reau N, Nelson DR, Di Bisceglie AM, Fried MW. Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study. Liver Int. 2021 Apr;41(4):692-704. doi: 10.1111/liv.14781. Epub 2021 Jan 22. | |
| 31096006 |
| Label | URL |
|---|---|
| PROP UP Patient Website | View source |
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None. Observational study included enrolled patients who completed PRO data at follow-up time periods.
11 liver or gastroenterology centers in the United States: 9 academic medical centers, 2 private gastroenterology centers.
1601 patients officially enrolled who provided informed consent, completed baseline patient-reported outcome (PRO) surveys and were prescribed one of five direct acting antiviral treatment regimens for chronic hepatitis C.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chronic HCV Patients During and After HCV Treatment | 1601 patients with chronic hepatitis C were enrolled. Criteria for enrollment included: providing consent, completing baseline patient-reported outcome (PRO) measures, and initiating one of five direct acting antiviral (DAAs) therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Treatment (T1) |
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| Early On-Treatment (T2) |
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| Late On-Treatment (T3) |
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| 12 Weeks Post-Treatment (T4) |
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| 1-Yr Post-Treatment (T5) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chronic HCV Patients on Treatment | All 1,601 patients with chronic HCV enrolled at baseline |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment | Change in "Overall Symptom Burden" was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score. Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful. | Of 1533 patients with complete record at T2, 1517 provided sufficient TMSAS data to calculate change score. Of 1524 patients with complete record at T3, 1513 provided sufficient TMSAS data to calculate change score. Discrepancies due to missing TMSAS data at T2 or T3. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to up to 24 weeks of HCV Treatment |
Up to 1.5 years from time of patient enrollment.
This observational, non-interventional survey study did not systematically track NON-study related deaths, SAEs, or OAEs. Per protocol, only study-related deaths, SAEs, and OAEs were reportable and none occurred. All deaths observed were learned about inadvertently and via non-systematic methods during data collection processes. While possibly incomplete, the number reported represents all known observable deaths during the study. Other SAEs and OAEs were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chronic HCV Patients During and After HCV Treatment | 1601 patients with chronic HCV were enrolled. Criteria for enrollment included: providing consent, completing baseline patient-reported outcome (PRO) measures, and initiating one of five direct acting antiviral (DAAs) therapy. |
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The secondary outcome - cumulative out of pocket costs- may include less reliable data at the upper limit. Patient reporting of cumulative costs at 3 time points likely led to erroneous inflation affecting the upper limit.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna Evon, PhD | University of North Carolina at Chapel Hill | 919-260-4062 | donna_evon@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2016 | Dec 18, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D008107 | Liver Diseases |
| D006526 | Hepatitis C |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
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| Baseline to up to 24 weeks of HCV Treatment |
| Change in HCV-PRO Mean Scores From Baseline to On-Treatment | HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life. The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T2 HCV-PRO mean score or Baseline HCV-PRO mean score minus T3 HCV-PRO mean score. HCV-PRO mean change scores range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful. | Baseline to up to 24 weeks of HCV Treatment |
| Cumulative Out of Pocket Costs During HCV Treatment | Cumulative out of pocket (OOP) costs incurred by patients during HCV treatment was measured by a survey recording 5 direct and 5 indirect costs of treatment. OOP costs were collected early on-treatment (T2), late on-treatment (T3), and early post-treatment (T4) in case patients paid bills after treatment ended. The Mean is the average dollar ($$) amount for Total OOP Cost of HCV Treatment for the cohort, calculated by summing the OOP costs for each patient reported at T2+T3+T4.$$ | Up to 24 weeks of HCV Treatment |
| Percentage of Participants With Nonadherence During HCV Treatment | Medication adherence was measured using the Voils' Medication Adherence Survey (VMAS). The VMAS consists of 3 items that evaluated the extent of adherence using a 5-point Likert scale from 1=None of the time to 5=All of the time. The 3 items assess how often participants missed doses, skip doses, or do not take doses over the past 7 days and are averaged into a single score. A dichotomous variable was created to categorize patients as 100% (adherent) or <100% (nonadherent) during HCV treatment at early treatment (T2) and late treatment (T3). | Up to 24 weeks of HCV Treatment |
| Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment | Change in "Overall Symptom Burden" from Baseline to 3-months post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T4 TMSAS mean score. Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful. | Baseline to 3-months post-treatment |
| Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment | Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T4 mean. Lower change scores (-) indicate symptom improved
Change scores were calculated for two subgroups: Patients who did and did not achieve SVR | Baseline to 3-months post-treatment |
| Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment | HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T4 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. HCV-PRO Mean Change Scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful. | Baseline to 3-months post-treatment |
| Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment | Change in "Overall Symptom Burden" from Baseline to 1 year post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T5 TMSAS mean score. Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful | Baseline to 1 year post-treatment |
| Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment | Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T5 mean. Lower change scores (-) indicate symptom improved
Change scores were calculated for two subgroups: Patients who did and did not achieve SVR | Baseline to 1 year post-treatment |
| Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment | HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life. The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T5 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. HCV-PRO mean change scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful. | Baseline to 1 year post-treatment |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| St Louis University | St Louis | Missouri | 63104 | United States |
| Asheville Gastroenterology Associates | Asheville | North Carolina | 28801 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Wilmington Gastroenterology Associates | Wilmington | North Carolina | 28403 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Evon DM, Sarkar S, Amador J, Lok AS, Sterling RK, Stewart PW, Reeve BB, Serper M, Reau N, Rajender Reddy K, Di Bisceglie AM, Nelson DR, Golin CE, Lim JK, Fried MW. Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study. J Hepatol. 2019 Sep;71(3):486-497. doi: 10.1016/j.jhep.2019.04.016. Epub 2019 May 13. |
| 30067745 | Derived | Evon DM, Stewart PW, Amador J, Serper M, Lok AS, Sterling RK, Sarkar S, Golin CE, Reeve BB, Nelson DR, Reau N, Lim JK, Reddy KR, Di Bisceglie AM, Fried MW. A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study. PLoS One. 2018 Aug 1;13(8):e0196908. doi: 10.1371/journal.pone.0196908. eCollection 2018. |
| 28342989 | Derived | Evon DM, Golin CE, Stewart P, Fried MW, Alston S, Reeve B, Lok AS, Sterling RK, Lim JK, Reau N, Sarkar S, Nelson DR, Reddy KR, Di Bisceglie AM. Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment. Contemp Clin Trials. 2017 Jun;57:58-68. doi: 10.1016/j.cct.2017.03.013. Epub 2017 Mar 22. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| PROMIS Depression | Patients completed the PROMIS Depression-8 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Depression-8a range from 38.2 - 81.3. Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points.Higher scores indicate worse Depression. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| PROMIS Anger | Patients completed the PROMIS Anger-5 item short form at baseline (T1) prior to starting HCV Treatment. Higher scores indicate worse Anger/irritability. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Anger-5a range from 32.9 - 82.9. Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. | Mean | Standard Deviation | units on a scale |
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| PROMIS Anxiety | Patients completed the PROMIS Anxiety-4 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Anxiety-4a range from 40.3 - 81.6. Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Anxiety. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| PROMIS Cognitive Concerns | Patients completed the PROMIS Applied Cognitive-General Concerns 8 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Applied Cognitive-General Concerns-8a range from 22.41 - 63.48. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points.Higher scores indicate worse Cognitive Concerns. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| PROMIS Pain Interference | Patients completed the PROMIS Pain Interference 8 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Pain Interference-8a range from 40.7 - 77.0. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Pain Interference. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| PROMIS Fatigue | Patients completed the PROMIS Fatigue-7a item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Fatigue 7a short form range from 29.4 -83.2. Higher scores indicate worse symptoms. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points.Higher scores indicate worse Fatigue. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| PROMIS Sleep Disturbance | Patients completed the PROMIS Sleep Disturbance-8a short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Sleep Disturbance-8a short form scores range from 28.9 - 76.5. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Sleep Disturbance. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| PROMIS Abdominal Pain | Patients completed the PROMIS Belly Pain-5 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Belly Pain-5a range from 39.3 - 80. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Belly Pain. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| PROMIS Diarrhea | Patients completed the PROMIS Diarrhea-6 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Diarrhea-6a range from 45.9 - 75.2. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Diarrhea. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| PROMIS Nausea and Vomiting | Patients completed the PROMIS Nausea and Vomiting-4 item short form at baseline (T1) prior to starting HCV Treatment. PROMIS raw scores are converted to standardized T-scores, with a mean of 50 and standard deviation of 10. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Studies in other medical populations suggest that the minimally important difference generally ranges from 2-5 points. Higher scores indicate worse Nausea/Vomit. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| Headache Impact Test (HIT-6) | Patients completed the Headache Inventory Test-6 at baseline (T1) prior to starting HCV Treatment. The six items are scored on a 5-point likert scale ranging from never to always. The final score is summed and can range from 36-78, with higher scores indicate worse headaches. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| TMSAS Overall Symptom Burden | Overall symptom burden was measured using the Memorial Symptom Assessment Scale (MSAS). The MSAS is a reliable and validated 32-item instrument used to measure change in pre-existing HCV symptoms. The MSAS evaluates 32 symptoms common in medical populations. Patients indicate the presence or absence of a symptom. If present, rate the construct on severity, frequency and distress. An overall symptom burden score is created: TMSAS (total MSAS score). The TMSAS scores range from 0 (no symptom) to 4 (present, severe, frequent, distressing). Higher scores indicate worse overall symptom burden. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| HCV-PRO Functional Well-Being | Patients completed the HCV-PRO at baseline (T1) prior to starting HCV Treatment. The HCV-PRO is new disease specific measure. It has 16 items with responses ranging from 1-5 with the sum transformed to a 0-100 scale. Higher scores indicate better functional well-being. | 1601 patients were enrolled and have a PRO Completion Record. Lower numbers in each PRO row below due to missing data. | Mean | Standard Deviation | units on a scale |
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| ID | Title | Description |
|---|---|---|
| OG000 | Chronic HCV Patients on Therapy | All enrolled patients with MSAS data available at T2 or T3 during HCV treatment |
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| Secondary | Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment | Change in Treatment-Related Symptoms was measured using multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and the Headache Impact Test (HIT-6). Mean CHANGE Scores were calculated as baseline mean score minus T2 mean score or baseline mean score minus T3 mean score. Lower change scores (-) indicate symptoms improved.
To aid in interpretation of clinical significance, a 5% change from baseline is considered a "minimally important change (MIC)." The 5% MIC change in a PROMIS or HIT-6 score is +/- 2.5 points. | Sample size may differ for each mean change score due to missing survey data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to up to 24 weeks of HCV Treatment |
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| Secondary | Change in HCV-PRO Mean Scores From Baseline to On-Treatment | HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life. The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T2 HCV-PRO mean score or Baseline HCV-PRO mean score minus T3 HCV-PRO mean score. HCV-PRO mean change scores range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful. | Of 1533 patients with data records at T2, 1346 had analyzable HCV-PRO data at T2. Of 1524 patients with data records at T3, 1356 had analyzable HCV-PRO data at T3. Discrepancies due to missing HCV-PRO data. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to up to 24 weeks of HCV Treatment |
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| Secondary | Cumulative Out of Pocket Costs During HCV Treatment | Cumulative out of pocket (OOP) costs incurred by patients during HCV treatment was measured by a survey recording 5 direct and 5 indirect costs of treatment. OOP costs were collected early on-treatment (T2), late on-treatment (T3), and early post-treatment (T4) in case patients paid bills after treatment ended. The Mean is the average dollar ($$) amount for Total OOP Cost of HCV Treatment for the cohort, calculated by summing the OOP costs for each patient reported at T2+T3+T4.$$ | Of 1601 patients enrolled, OOP cost data was recorded by 1578 patients. Due to unreliable data, especially at the upper limit, 40 cases (2.53%) were eliminated from each tail (lower and upper limit), totaling 80 cases (5.06%) of the 1578 sample. OOP dollar amount below based on 1498 cases. | Posted | Mean | 95% Confidence Interval | units on a scale | Up to 24 weeks of HCV Treatment |
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| Secondary | Percentage of Participants With Nonadherence During HCV Treatment | Medication adherence was measured using the Voils' Medication Adherence Survey (VMAS). The VMAS consists of 3 items that evaluated the extent of adherence using a 5-point Likert scale from 1=None of the time to 5=All of the time. The 3 items assess how often participants missed doses, skip doses, or do not take doses over the past 7 days and are averaged into a single score. A dichotomous variable was created to categorize patients as 100% (adherent) or <100% (nonadherent) during HCV treatment at early treatment (T2) and late treatment (T3). | Of 1601 enrolled patients, 1562 had VMAS adherence data at either early treatment (T2) or late treatment (T3). 1513 patients had adherence data at T2. 1476 patients had adherence data at T3. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 weeks of HCV Treatment |
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| Secondary | Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment | Change in "Overall Symptom Burden" from Baseline to 3-months post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T4 TMSAS mean score. Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful. | Of 1601 patients enrolled, 1430 patients had post-treatment HCV RNA available to determine SVR status. Of these, 1362 achieved SVR, 68 did not achieve SVR. SVR data were missing on 171 patients. Additional missing numbers (from 1362 to 1313 and 68 to 58) were due to missing MSAS survey data at 3-months post-treatment. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 3-months post-treatment |
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| Secondary | Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment | Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T4 mean. Lower change scores (-) indicate symptom improved
Change scores were calculated for two subgroups: Patients who did and did not achieve SVR | Of 1601 patients enrolled, 1430 patients had post-treatment HCV RNA available to determine SVR status. Of these, 1362 achieved SVR, 68 did not achieve SVR. SVR data were missing on 171 patients. Missing numbers below are due to missing PRO survey data at T4. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 3-months post-treatment |
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| Secondary | Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment | HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T4 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. HCV-PRO Mean Change Scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful. | Of 1601 patients enrolled, 1430 patients had post-treatment HCV RNA available to determine SVR status. Of these, 1362 achieved SVR, 68 did not achieve SVR. SVR data were missing on 171 patients. Additional missing numbers due to missing HCV-PRO survey data at 3-months post-treatment. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 3-months post-treatment |
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| Secondary | Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment | Change in "Overall Symptom Burden" from Baseline to 1 year post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T5 TMSAS mean score. Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful | 1430 of 1601 patients had post-treatment HCV RNA available to determine SVR status: 1362 achieved SVR, 68 did not. SVR data were missing on 171 patients. Of 1430, T5 records were missing for 93 cases (1337 remaining). Of the remaining 1337 records, TMSAS data were missing for 17 patients (1320 remaining: 1269 with SVR, 51 with no SVR) | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 1 year post-treatment |
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| Secondary | Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment | Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T5 mean. Lower change scores (-) indicate symptom improved
Change scores were calculated for two subgroups: Patients who did and did not achieve SVR | 1430 patients had post-treatment HCV RNA available to determine SVR status: 1362 achieved SVR, 68 did not. SVR data were missing on 171 patients. T5 records were missing for 93 cases. Discrepancies from 1362 and 68 due to missing survey data at T5 for specific measure. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 1 year post-treatment |
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| Secondary | Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment | HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life. The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T5 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR. HCV-PRO mean change scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful. | 1430 of 1601 patients had post-treatment HCV RNA available to determine SVR status: 1362 achieved SVR, 68 did not. SVR data were missing on 171 patients. Of 1430, T5 records were missing for 93 cases (1337 remaining). Of the remaining 1337 records, HCV-PRO data were missing for 156 patients (1181 remaining: 1132 with SVR, 49 with no SVR) | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline to 1 year post-treatment |
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| 34 |
| 1,601 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
Not provided
| D018178 |
| Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Change in Nausea/Vomiting mean score from T1 to T2 |
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| Change in Diarrhea mean score from T1 to T2 |
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| Change in Irritability mean score from T1 to T2 |
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| Change in Anxiety mean score from T1 to T2 |
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| Change in headache HIT-6 mean score from T1 to T2 |
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| Change in Fatigue mean score from T1 to T3 |
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| Change in sleep disturbance score from T1 to T3 |
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| Change in nausea/vomiting mean score from T1 to T3 |
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| Change in Diarrhea mean score from T1 to T3 |
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| Change in anger mean score from T1 to T3 |
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| Change in anxiety mean score from T1 to T3 |
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| Change in headache HIT-6 mean score from T1 to T3 |
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| Nonadherence rate (%) late on-treatment (T3) |
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| Anger change score |
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| Anxiety change score |
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| Cognitive Concerns change score |
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| Pain Interference change score |
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| Fatigue change score |
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| Sleep change score |
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| Belly Pain change score |
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| Diarrhea change score |
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| Nausea change score |
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| Headache change score |
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| Anger change score |
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| Anxiety change score |
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| Cognitive Concern change score |
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| Pain Interference change score |
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| Fatigue change score |
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| Sleep Disturbance change score |
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| Belly Pain change score |
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| Diarrhea change score |
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| Nausea change score |
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| Headache HIT-6 Change score |
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