RESUMO
BACKGROUND: There is a lack of randomized controlled trials of behavioral interventions and process-level research related to alcohol reduction among patients with chronic liver disease (e.g., hepatitis C viral (HCV) infection). We conducted a process-level, secondary analysis of the Hepatitis C-Alcohol Reduction Treatment (HepART) trial to investigate the association between change in psychological processes posited by the Integrated Behavioral Model (IBM) and change in World Health Organization (WHO) drinking risk levels. METHODS: Patients with HCV who consume alcohol were recruited from hepatology clinics and received provider-delivered SBIRT (Screening, Brief Intervention, Referral to Treatment) or SBIRT+ 6 months of co-located alcohol counseling. Treatment arms were combined for this analysis because no between-group differences were found. At baseline and 6 months, the timeline followback method was used to determine alcohol risk levels according to the 2000 WHO risk categories (based on average grams of alcohol per day). Changes in alcohol consumption and WHO risk levels were quantified and regressed on change in individual psychological processes (e.g., readiness, self-efficacy, motives, attitudes, and strategies) from baseline to 6 months. RESULTS: At the baseline assessment, 162 participants were classified as abstinent (5%), low (47%), moderate (16%), high (19%), or very high (13%) WHO risk levels. At 6 months, 38% remained at the same risk level and 48% decreased by at least one level. In univariate analyses, changes in 7 of 12 psychological processes were associated with change in risk levels. Adjusted multivariate analyses demonstrated that change in four processes were significantly associated with change in risk levels, including SOCRATES Taking Steps, Ambivalence, and Recognition scores and alcohol reduction strategies. CONCLUSIONS: These findings demonstrate significant reductions in quantitative indices of alcohol consumption following opportunistic alcohol interventions in patients with HCV. However, results provided mixed support for associations between change in IBM psychological processes and alcohol consumption.
RESUMO
Psychiatric disorders after liver transplantation (LT) are associated with worse patient and graft outcomes, which may be amplified by inadequate treatment. We aimed to characterize the burden of psychiatric disorders, treatment patterns, and associated financial burden among liver transplantation recipients (LTRs). IQVIA PharMetrics (R) Plus for Academics-a large health plan claims database representative of the commercially insured US population-was used to identify psychiatric diagnoses among adult LTRs and assess treatment. Multivariable logistic regression analysis identified factors associated with post-LT psychiatric diagnoses and receipt of pharmacotherapy. Patient financial liability was estimated using adjudicated medical/pharmacy claims for LTRs with and without psychiatric diagnoses. Post-LT psychiatric diagnoses were identified in 395 (29.5%) of 1338 LTRs, of which 106 (26.8%) were incident cases. Treatment varied, with 67.3% receiving pharmacotherapy, 32.1% psychotherapy, 21.0% combination therapy, and 21.5% no treatment. Among 340 LTRs on psychotropic medications before transplant, 24% did not continue them post-LT. Post-LT psychiatric diagnoses were independently associated with female sex, alcohol-associated liver disease (ALD), prolonged LT hospitalization (>2 wk), and pre-LT psychiatric diagnosis. Incident psychiatric diagnoses were associated with female sex, ALD, and prolonged LT hospitalization. Patients with a post-LT psychiatric diagnosis had higher rates of hospitalization (89.6% vs. 81.5%, p <0.001) and financial liability (median $5.5K vs. $4.6K USD, p =0.006). Having a psychiatric diagnosis post-LT was independently associated with experiencing high financial liability >$5K. Over 1 in 4 LTRs had a psychiatric diagnosis in a large national cohort, yet nearly a quarter received no treatment. LTRs with psychiatric diagnoses experienced increased health care utilization and higher financial liability. Sociodemographic and clinical risk factors could inform high-risk subgroups who may benefit from screening and mitigation strategies.
RESUMO
BACKGROUND: The low prevalence of HDV infection in the United States could be attributed to insufficient testing rate, which can result in an underestimation of the true burden of HDV. The primary objective of this study is to quantify the prevalence of and factors associated with HDV antibody (anti-HDV) or RNA testing, among participants with positive HBsAg in the Veterans Health Administration (VHA). METHODS: We conducted a retrospective cohort study of participants who tested positive for HBsAg between January 2000 and December 2022 within the VHA. We identified those who were tested for HDV, and patient and provider-level factors associated with HDV testing. RESULTS: Of 41,658 participants with positive HBsAg who had follow-up, 4438 (10.7%) were tested at least once for HDV, of which 135 (3.0%) were positive. Participants in the Northeast (adjusted odds ratio [aOR]: 1.30, 95% CI: 1.17-1.44, p<0.001), and receiving hepatology care (aOR: 1.38, 95% CI: 1.24-1.54, p<0.001) were more likely, while those in the Midwest (aOR: 0.69, 95% CI: 0.60-0.79, p<0.001), under the care of a primary care provider (aOR: 0.61, 95% CI: 0.50-0.74, p<0.001), Blacks (aOR: 0.85, 95% CI: 0.77-0.94, p=0.001), participants who were HCV antibody-positive (aOR: 0.89, 95% CI: 0.81-0.99, p=0.03), and participants who were HIV-positive (aOR: 0.80, 95% CI: 0.71-0.90, p<0.001) were less likely to be tested for HDV. CONCLUSIONS: HDV screening rates in the VHA remain low overall. Participants who are Black, living in the Midwest, patients who are HIV-positive, and patients who are HCV-positive are less likely to be tested for HDV. These results suggest that risk-based screening strategies are ineffective in the VHA and highlight the need for refining testing strategies to increase HDV screening rates.
Assuntos
Infecções por HIV , Hepatite C , Hepatite D , Humanos , Vírus Delta da Hepatite/genética , Antígenos de Superfície da Hepatite B , Estudos Retrospectivos , Hepatite D/diagnóstico , Hepatite D/epidemiologia , Hepatite C/diagnóstico , Hepatite C/epidemiologiaRESUMO
BACKGROUND: Treatment choices in hepatocellular carcinoma (HCC) involve consideration of tradeoffs between the benefits, toxicities, inconvenience, and costs. Stated preference elicitation methods have been used in the medical field to help evaluate complex treatment decision-making. The aim of this study was to conduct a scoping review to assess the evidence base for the use of preference elicitation tools or willingness to pay/willingness to accept methods for HCC treatment decision-making from both the patient and provider perspective. METHODS: We performed a scoping review to identify abstracts or manuscripts focused on the role preference elicitation tools or willingness to pay/willingness to accept methods for HCC treatment options among patients, caregivers, and/or providers. Two researchers independently screened full-text references and resolved conflicts through discussion. We summarized key findings, including the type and setting of preference-elicitation tools used for HCC treatment decisions. RESULTS: Ten published abstracts or manuscripts evaluated the role of preference elicitation tools for HCC treatments. The studies revealed several attributes that are considered by patients and providers making HCC treatment decisions. Many of the studies reviewed suggested that while patients place the most value on extending their overall survival, they are willing to forgo overall survival to avoid risks of treatments and maintain quality of life. Studies of physicians and surgeons found that provider preferences are dependent on patient characteristics, provider specialty, and surgeon or hospital-related factors. CONCLUSION: This scoping review explored both patient and physician preferences towards treatment modalities in all stages of HCC. The studies revealed a large scope of potential attributes that may be important to patients and that many patients are willing to forgo survival to maintain quality of life. Further research should explore both preference elicitation of currently available and emerging therapies for HCC as well as the use of this data to develop patient-facing tools to assist in navigating treatment options.
Assuntos
Carcinoma Hepatocelular , Neoplasias Hepáticas , Preferência do Paciente , Carcinoma Hepatocelular/terapia , Humanos , Neoplasias Hepáticas/terapia , Qualidade de Vida , Tomada de Decisão Clínica , Tomada de DecisõesRESUMO
BACKGROUND: Patient-reported outcomes (PRO) measures relevant to domains most important to patients with HCC who received locoregional therapies are needed to advance patient-centered research. Furthermore, electronic PRO monitoring in clinical care has been shown to reduce hospitalizations and deaths in patients with other cancers. We conducted a qualitative study among patients with HCC who recently received locoregional therapies to (1) identify common and distressing posttreatment symptoms to prioritize PRO domain selection and (2) gauge interest in an electronic PRO symptom monitoring system. METHODS: We performed semi-structured telephone interviews among adult patients who received locoregional therapies (median of 26 days after treatment) for treatment-naïve HCC at a single tertiary care center. Interviews were conducted until thematic saturation was reached. Qualitative content analysis was conducted to identify emerging themes and sub-themes. RESULTS: Ten of 26 patients (38%) reported at least 1 symptom before treatment. In contrast, all participants (n = 26) with recently treated HCC reported at least 1 posttreatment physical symptom, with the most common being appetite loss (73%), fatigue (58%), abdominal pain (46%), and nausea (35%). Most participants (77%) stated they saw potential benefits in posttreatment ePRO symptom monitoring. CONCLUSIONS: Posttreatment symptoms after HCC locoregional therapies are common and often severe. These data can inform and prioritize PRO domain selection. Patients are interested in ePRO monitoring to monitor and proactively address posttreatment symptoms. Given the clinical benefits in patients with metastatic cancers, ePRO monitoring warrants investigation in patients with HCC.
Assuntos
Carcinoma Hepatocelular , Neoplasias Hepáticas , Adulto , Humanos , Carcinoma Hepatocelular/terapia , Neoplasias Hepáticas/terapia , Pesquisa Qualitativa , Medidas de Resultados Relatados pelo PacienteRESUMO
AIMS: Evaluate patient-reported liver symptoms during treatment for chronic hepatitis B viral (HBV) infection and associations between changes in symptoms and levels of alanine aminotransferase (ALT) and viral markers. METHODS: Data from 200 participants in the Hepatitis B Research Network Immune Active Trial who completed symptom assessments were analyzed. Patients were treated with tenofovir, with or without peginterferon (TDF + PegIFN vs. TDF alone) for 192 weeks. Participants completed a Symptom Checklist at baseline and every 4-12 weeks. A total symptom score was created, ranging from 0 (none) to 40 (severe). The SF-36 was completed every 48 weeks. Associations of symptom scores with ALT and viral markers were evaluated at baseline and end of treatment. RESULTS: Participants were 65% male, 83% Asian, with a mean age of 42. Baseline symptoms were mild (median = 2, range 0-25) and associated with baseline ALT, HBV DNA levels and HBeAg + status. Patients on TDF alone experienced a more rapid and greater improvement in symptoms, but by week 192, symptom improvement was similar in both groups (54% vs 36%). Symptom improvements correlated with ALT and HBV DNA, most markedly among those with symptoms at baseline. Most patients (4 out of 6) who achieved HBsAg loss experienced symptom improvements. Overall, SF-36 scores did not change with treatment. CONCLUSIONS: Reduction in ALT and HBV DNA levels with therapy are associated with significant improvement in liver symptoms such as fatigue and pain over the liver, especially among those with higher ALT, HBV DNA, symptoms and HBeAg + status prior to treatment.
Assuntos
Antivirais , Hepatite B Crônica , Humanos , Masculino , Adulto , Feminino , Tenofovir/efeitos adversos , Antivirais/efeitos adversos , Antígenos E da Hepatite B , DNA Viral , Vírus da Hepatite B/genética , Resultado do Tratamento , Hepatite B Crônica/diagnóstico , BiomarcadoresRESUMO
Objective: To explore: a) whether videos that model naloxone communication skills improve student pharmacists' naloxone knowledge, self-efficacy and communication skills and b) whether outcomes differ between video versus written materials. Methods: Student pharmacists (N = 31) were randomized to either video or written materials training. Changes in naloxone dispensing barriers, self-efficacy, and naloxone knowledge were assessed via survey, while changes in naloxone communication were measured with a standardized patient assessment. Results: For the entire sample, knowledge and self-efficacy significantly increased and barriers to dispensing decreased. Communication improved significantly in both groups. In unadjusted analyses, students with video resources reported higher self-efficacy post-training. However, analyses that controlled for demographic characteristics and baseline measures found that training type did not significantly predict any outcome. Conclusion: Brief written or video-based naloxone training improved students' knowledge, self-efficacy, and communication. Given the small sample, results are inconclusive regarding impact of training material type on outcomes. Innovation: Teaching student pharmacists how to communicate about naloxone is important given increasing opioid overdose death rates. This study was innovative because it examined the impact of two training material types that can be delivered asynchronously and that pharmacy programs could incorporate into their curricula to improve students' naloxone communication skills.
RESUMO
BACKGROUND: Many federal funding and regulatory agencies require patient engagement to conduct patient-centered research and drug development. We developed a liver transplantation patient-engagement program, which can serve as a model for bringing the patient perspective to digestive diseases research. METHODS: Six liver transplantation patient-engagement program advisors completed training in patient engagement; participated in several virtual sessions; and completed postsession surveys. RESULTS: Qualitative and quantitative results elucidated patient-centered liver transplantation study outcomes and barriers/facilitators to conducting clinical research. Group satisfaction was very high. CONCLUSIONS: The liver transplantation patient-engagement program model provides a paradigm for how to engage patients in the formative steps of patient-centered clinical research.
Assuntos
Hepatopatias , Transplante de Fígado , Humanos , Participação do Paciente/métodos , Avaliação de Resultados da Assistência ao Paciente , Hepatopatias/cirurgia , Assistência Centrada no Paciente/métodosRESUMO
Understanding survivorship experiences at different stages postliver transplantation (poat-LT) is essential to improving care. Patient-reported concepts including coping, resilience, post-traumatic growth (PTG), and anxiety/depression, have been implicated as important predictors of quality of life and health behaviors after LT. We aimed to descriptively characterize these concepts at different post-LT survivorship stages. This cross-sectional study featured self-reported surveys measuring sociodemographic, clinical characteristics, and patient-reported concepts including coping, resilience, PTG, anxiety, and depression. Survivorship periods were categorized as early (1 y or below), mid (1-5 y), late (5-10 y), and advanced (10 y or above). Univariable and multivariable logistic and linear regression modeling examined factors associated with patient-reported concepts. Among 191 adult LT survivors, the median survivorship stage was 7.7 years (interquartile range: 3.1-14.4) and median age was 63 years (range: 28-83); most were male (64.2%) and Caucasian (84.0%). High PTG was more prevalent in the early survivorship period (85.0%) than late survivorship (15.2%). High trait resilience was only reported by 33% of survivors and associated with higher income. Lower resilience was seen among patients with longer LT hospitalization stays and late survivorship stages. About 25% of survivors had clinically significant anxiety and depression, which was more frequent among early survivors and females with pre-LT mental health disorders. In multivariable analysis, factors associated with lower active coping included survivors ≥65 years, non-Caucasian race, lower levels of education, and nonviral liver disease. In a heterogeneous cohort including early and late LT survivors, there was variation in levels of PTG, resilience, anxiety, and depression at different survivorship stages. Factors associated with positive psychological traits were identified. Understanding determinants of LT survivorship has important implications for how we should monitor and support LT survivors.
Assuntos
Transplante de Fígado , Crescimento Psicológico Pós-Traumático , Transtornos de Estresse Pós-Traumáticos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida/psicologia , Estudos Transversais , Adaptação Psicológica , Sobreviventes , Transtornos de Estresse Pós-Traumáticos/psicologiaRESUMO
PURPOSE: To examine associations between perceived ease of syringe access, syringe sources, injection behaviors, and law enforcement (LE) interactions among people who inject drugs (PWID) in rural Appalachian North Carolina (NC). METHODS: Using respondent-driven sampling, a diverse sample of 309 self-reported PWID were recruited from rural Appalachian NC. Data were collected via audio computer-assisted self-interview technology from February 2019 through March 2020. Respondents reported demographics, sources of syringes, LE interactions, and injection behaviors. Univariate, bivariate, and linear regression analyses were performed. FINDINGS: Respondents most often obtained syringes from pharmacies and syringe service programs (SSPs). Twenty-one percent disagreed that it was easy to obtain sterile syringes, with 28% reporting low or no access to an SSP. PWID who reported longer physical distances to an SSP had greater difficulty accessing syringes (P<.001). PWID who reported greater ease of access to syringes reported engaging in receptive syringe sharing less often (P<.01). PWID who were stopped and searched by LE more often reported injecting drugs somebody else prepared with nonsterile supplies more often (P<.01). Participants shared used injection supplies more than twice as often than they shared used syringes. CONCLUSIONS: These results underscore the importance of SSPs to mitigate the spread of human immunodeficiency virus and viral hepatitis in rural areas. Supporting mobile SSP services in rural areas could increase access to sterile syringes and injection supplies. SSPs should educate PWID about the importance of not sharing injection supplies. Pharmacies could increase syringe access in areas where SSPs do not operate.
Assuntos
Infecções por HIV , Abuso de Substâncias por Via Intravenosa , Humanos , Abuso de Substâncias por Via Intravenosa/epidemiologia , Programas de Troca de Agulhas , Seringas , North Carolina/epidemiologia , Região dos ApalachesRESUMO
Background: Kidney transplantation (KT) is a life-saving therapy for kidney failure. However, KT recipients can suffer from debilitating depression, post-traumatic stress disorder (PTSD), and suicide. In contrast to PTSD, post-traumatic growth (PTG) is a positive psychologic change in response to a challenging situation. PTG has been studied in other chronic diseases, but less is known about its role in the setting of KT. We sought to elucidate the prevalence, predictors, and the effect of PTSD and PTG on post-KT outcomes. We also considered the roles of benefit finding and resilience. Methods: In a literature review, we identified publications that examined PTSD, PTG, benefit finding, and/or resilience in KT recipients. We excluded case reports and first-person narratives. Publications meeting the specified criteria after full text review underwent data abstraction and descriptive analysis. Results: Of the 1013 unique citations identified, 39 publications met our criteria. PTSD was the most common construct evaluated (16 publications). Resilience was studied in 11 publications, PTG in nine, and benefit finding in five. Up to 21% of adult and 42% of pediatric KT recipients may experience PTSD, which is associated with lower quality of life (QOL), impaired sleep, and other psychiatric comorbidity. PTG was associated with improved QOL, kidney function, and reduced risk of organ rejection. Although benefit finding tended to increase post KT, resilience remained stable post KT. Like PTG, resilience was associated with lower psychologic distress and increased treatment adherence and confidence in the health care team. Conclusions: PTG, resilience, and benefit finding appear to reduce the risk of PTSD, promote well-being, and reduce risk of graft failure in KT recipients. Future research to understand these relationships better will allow clinicians and researchers to develop interventions to promote PTG, resilience, and benefit finding, and potentially improve post-transplant outcomes such as adherence and reducing risk of organ rejection.
Assuntos
Transplante de Rim , Crescimento Psicológico Pós-Traumático , Transtornos de Estresse Pós-Traumáticos , Adaptação Psicológica , Adulto , Criança , Humanos , Transplante de Rim/efeitos adversos , Qualidade de Vida/psicologia , Transtornos de Estresse Pós-Traumáticos/epidemiologiaRESUMO
BACKGROUND: Despite the authority to dispense naloxone, pharmacists have been reluctant to offer and dispense it, often due to discomfort communicating about the sensitive topic of opioid overdose. Because existing online naloxone trainings do not sufficiently address how to communicate effectively with patients about naloxone, Nalox-Comm, a training module designed to improve pharmacists' self-efficacy to engage in naloxone discussions, was developed. OBJECTIVE: To describe the study protocol to evaluate the effectiveness of the Nalox-Comm training module on naloxone dispensing rates. METHODS: A randomized controlled trial, which began in July 2021, is used to evaluate the pre-post Nalox-Comm training intervention. Sixty pharmacists are being recruited from 62 pharmacies part of a single grocery store chain in rural counties of the southeastern United States. After completing a baseline survey, pharmacists are observed by simulated patients (SPs) who rate the quality of their pre-training naloxone communication. Pharmacists are then invited to complete either a basic online naloxone training module (control group) or a newly developed Nalox-Comm training (experimental group), after which they complete a post-training survey and are observed a second time by SPs. Three months post-training, study participants complete a final follow-up survey. Naloxone dispensing records are obtained from each participating pharmacy to assess change in naloxone dispensing rates. CONCLUSION: Informed by rural pharmacist stakeholders, the Nalox-Comm training module addresses communication barriers specific to rural communities. Compared to those in the control group, we hypothesize that pharmacies in the experimental group will dispense more naloxone in the three months post-training intervention.
Assuntos
Overdose de Drogas , Farmácias , Analgésicos Opioides/uso terapêutico , Humanos , Naloxona/uso terapêutico , Antagonistas de Entorpecentes/uso terapêutico , Epidemia de Opioides , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Poor access to care has made western North Carolina vulnerable to an outbreak of hepatitis C viral infection (HCV), particularly among persons who inject drugs (PWID). As substance use disorder (SUD) treatment providers could potentially improve linkage to HCV testing and treatment, we sought to understand SUD providers, clinic and client characteristics; referral patterns; HCV knowledge; willingness to participate in additional trainings; and local linkage-to-care pathways for treatment of substance use and HCV. Online survey data were collected from 78 SUD providers serving PWID in eight western rural North Carolina counties. Providers' attitudes toward working with HCV+ clients were very positive. One-third of providers reported a low fund of knowledge regarding HCV, HCV treatment, and financial assistance opportunities. Non-prescribing providers rarely initiated discussions about HCV testing/treatment, but were receptive to training. Respondents indicated that HCV testing and treatment were best delivered at local health departments or primary care clinics but were open to other venues where PWID access care. The vast majority of prescribing and non-prescribing providers expressed interest in obtaining training in HCV treatments, how to obtain HCV medications and topics on advanced liver disease. Data from prescribing and non-prescribing SUD providers suggest opportunities to develop or expand integrated care models for HCV testing/treatment in PWID in rural Appalachian North Carolina.
RESUMO
The PRIORITIZE trial (clinicaltrials.gov: NCT02786537) was the first comparative effectiveness study to directly compare ledipasvir/sofosbuvir (LDV/SOF) and elbasvir/grazoprevir (EBR/GZR) for the treatment of chronic hepatitis C virus (HCV). A secondary aim of this study was to compare LDV/SOF and EBR/GZR on sustainable changes in several HCV-associated symptoms and functional well-being in patients who achieved sustained virological response (SVR). PRIORITIZE, a randomized controlled trial conducted between 2016 and 2020, evaluated change in six PROMIS® symptom scores (fatigue, sleep disturbance, cognitive disturbance, nausea, diarrhoea, abdominal pain) and functional well-being using the disease-specific HCV-PRO instrument. Survey assessments were administered at baseline, early post-treatment (median = 6 months) and late post-treatment (median = 21 months). Constrained longitudinal linear mixed-effects models were used to evaluate within-treatment change and between-treatment differences. Data from 793 participants (average 55 years old, 57% male, 44% black, 17% with cirrhosis) were analysed. From baseline to early post-treatment, 5 out of 6 symptoms and functional well-being significantly improved (all p's < .05). In the LDV/SOF arm, mean changes ranged from -3.73 for nausea to -6.41 for fatigue and in the EBR/GZR, mean changes ranged from -2.19 for cognitive impairment to -4.67 for fatigue. Change of >3 points was consider clinically meaningful. Improvements in most symptoms slightly favoured LDV/SOF, although the magnitude of differences between the regimens were small. Both regimens demonstrated significant improvements in symptoms and functional well-being that were sustained during the late post-treatment phase. EBR/GZR and LDV/SOF regimens had clinically equivalent and durable improvements in HCV symptoms and functional well-being up to two years after SVR.
Assuntos
Hepatite C Crônica , Hepatite C , Amidas , Antivirais/uso terapêutico , Benzimidazóis , Benzofuranos , Carbamatos , Ciclopropanos , Quimioterapia Combinada , Fadiga , Feminino , Fluorenos/uso terapêutico , Genótipo , Hepacivirus , Hepatite C/tratamento farmacológico , Hepatite C Crônica/complicações , Hepatite C Crônica/tratamento farmacológico , Humanos , Imidazóis , Masculino , Pessoa de Meia-Idade , Náusea/tratamento farmacológico , Quinoxalinas , Sofosbuvir/uso terapêutico , SulfonamidasRESUMO
Survivorship after liver transplantation (LT) is a novel concept providing a holistic view of the arduous recovery experienced after transplantation. We explored components of early survivorship including physical, emotional, and psychological challenges to identify intervention targets for improving the recovery process of LT recipients and caregivers. A total of 20 in-person interviews were conducted among adults 3 to 6 months after LT. Trained qualitative research experts conducted interviews, coded, and analyzed transcripts to identify relevant themes and representative quotes. Early survivorship comprises overcoming (1) physical challenges, with the most challenging experiences involving mobility, driving, dietary modifications, and medication adherence, and (2) emotional and psychological challenges, including new health concerns, financial worries, body image/identity struggles, social isolation, dependency issues, and concerns about never returning to normal. Etiology of liver disease informed survivorship experiences including some patients with hepatocellular carcinoma expressing decisional regret or uncertainty in light of their post-LT experiences. Important topics were identified that framed LT recovery including setting expectations about waitlist experiences, hospital recovery, and ongoing medication requirements. Early survivorship after LT within the first 6 months involves a wide array of physical, emotional, and psychological challenges. Patients and caregivers identified what they wish they had known prior to LT and strategies for recovery, which can inform targeted LT survivorship interventions.
Assuntos
Transplante de Fígado , Sobrevivência , Adulto , Cuidadores/psicologia , Humanos , Transplante de Fígado/efeitos adversos , Transplante de Fígado/psicologia , Pesquisa Qualitativa , Qualidade de Vida/psicologiaRESUMO
BACKGROUND: Patients' motivations for undergoing direct-acting antiviral (DAA) therapy for chronic hepatitis C may include anticipation of treatment benefits not well described in the literature. AIMS: Evaluate patients' anticipated and actualized improvements in several domains of functioning before and after viral cure. METHODS: Pre-post-study utilizing in-depth interviews with 28 patients prior to, and several months after, DAA therapy. Interviews were audio-recorded, transcribed, coded, and analyzed by two qualitative experts. RESULTS: Patients had a median age of 54 years, 43% were male, 57% white, 25% had cirrhosis, and 71% were treated with sofosbuvir/ledipasvir. Pre-treatment, patients hoped for improvements in several domains including psychological, emotional, physical, social, and occupational functioning. After viral cure, increased energy and less fear of transmission were pathways to better quality of life. Psychological and emotional improvements positively affected physical, social, and occupational functioning. Social improvements were due to better mood and motivation, fewer symptoms, and reduced fear of stigma and transmission. Occupational benefits were linked to increased stamina, self-confidence, and less pain, anxiety, and stigma. Reduced fear of stigma had a pervasive impact on all life improvements after cure. Patient characteristics such as the presence of cirrhosis or psychiatric issues influence treatment motivations. Qualitative data correspond with change in pre-post-survey scores. CONCLUSIONS: Tremendous hope is placed on the ability of DAA therapy to bring about substantial improvements in life functioning after viral cure. Highly interconnected effects on quality of life worked synergistically through improved physical and psychological well-being. Stakeholders should appreciate the multi-dimensional benefits that viral eradication bestows upon individuals and society.
Assuntos
Benzimidazóis/uso terapêutico , Fluorenos/uso terapêutico , Hepatite C Crônica , Saúde Mental , Qualidade de Vida , Interação Social , Sofosbuvir/uso terapêutico , Antecipação Psicológica , Antivirais/uso terapêutico , Erradicação de Doenças , Transmissão de Doença Infecciosa/prevenção & controle , Feminino , Hepatite C Crônica/tratamento farmacológico , Hepatite C Crônica/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Motivação , Resultado do TratamentoRESUMO
Few studies exist on the change over time in positive and negative emotions during treatment for alcoholism disorders. We aimed to evaluate relationship between alcohol reduction and change in positive and negative emotions. Chronic HCV patients (n=174) with alcohol use received brief alcohol counseling. Participants completed the PANAS-Short Form, MHC-Short Form, and the Alcohol Timeline Follow back at baseline and 3, 6, and 12 months. Decreases in alcohol use were related to decreased negative emotions from baseline to 3 months, baseline to 6 months and baseline to 12 months. Decreases in alcohol use were associated with increased positive emotions from baseline to 12 months but not sooner.
RESUMO
BACKGROUND: Symptoms of chronic hepatitis B (CHB) are not well characterized. AIMS: To evaluate CHB symptoms and associations with disease activity and clinical outcomes. METHODS: Longitudinal data from 1,576 participants in the Hepatitis B Research Network Cohort Study who completed symptom assessments were analyzed. A composite symptom score was calculated using a Symptom Checklist (0=none to 40=extreme). Multivariable mixed models assessed variables associated with symptom change over time. Latent class symptom trajectories were evaluated. The cumulative probability of long-term clinical outcomes (new onset cirrhosis, hepatic decompensation, hepatocellular carcinoma, liver transplantation, death) was examined by baseline symptom groups. RESULTS: Participants median age was 42 (range:18-80), 51% were male, 75% Asian, (68% of whom were born outside North America) with a median follow-up of 4.2 years. On average, symptoms did not significantly change over time. The multivariable model identified several variables associated with higher symptoms during follow-up: being female, non-Asian, born in the US/Canada, lower education, higher AST, lower platelets, and more comorbidities. Two patient subgroups were identified based on longitudinal symptom trajectories: a low symptom group (92%, n=1,451) with symptom scores averaging 2.4 over time and a moderate symptom group (8%, n=125) with symptom scores averaging 11.5. During follow-up, 7.3% in the moderate symptom group, but only 3.2% of the low symptom group, developed adverse outcomes (p=0.02). CONCLUSIONS: In this large cohort of CHB patients, symptoms were generally mild and stable over time. However, in some patients with moderate symptoms at baseline, deleterious clinical outcomes were more frequent in follow-up.
RESUMO
BACKGROUND AND AIMS: Multiple direct-acting antiviral (DAA) regimens are available to treat HCV genotype 1 infection. However, comparative effectiveness from randomized controlled trials of DAA regimens is unavailable. APPROACH AND RESULTS: We conducted a pragmatic randomized controlled trial (NCT02786537) to compare the effectiveness of DAAs for HCV genotype 1a or 1b on viral response, safety, tolerability, and medication nonadherence. Adults with compensated liver disease, HCV genotype 1, not pregnant or breastfeeding, and with health insurance likely to cover ledipasvir/sofosbuvir (LDV/SOF) were recruited from 34 US viral hepatitis clinics. Participants were randomized (± ribavirin) to LDV/SOF, elbasvir/grazoprevir (EBR/GZR), and paritaprevir/ritonavir/ombitasvir+dasabuvir (PrOD; treatment arm stopped early). Primary outcomes included sustained viral response at 12 weeks (SVR12), clinician-recorded adverse events, patient-reported symptoms, and medication nonadherence. Between June 2016 and March 2018, 1,609 participants were randomized. Among 1,128 participants who received ≥1 dose of EBR/GZR or LDV/SOF (± ribavirin), SVR12 was 95.2% (95% CI, 92.8%-97.6%) and 97.4% (95% CI, 95.5%-99.2%), respectively, with a difference estimate of 2.2% (-0.5% to 4.7%), falling within the "equivalence" interval (-5% to 5%). While most (56%) participants experienced adverse events, few were serious (4.2%) or severe (1.8%). In the absence of ribavirin, discontinuations due to adverse events were rare. Patient-reported symptoms and medication nonadherence were similar. Study limitations were dropout due to insurance denial and loss to follow-up after treatment, limiting the ability to measure SVR12. CONCLUSIONS: This pragmatic trial demonstrated high SVR12 for participants treated with EBR/GZR and LDV/SOF with few adverse effects. Overall, the two regimens were equivalent in effectiveness. The results support current HCV guidelines that do not distinguish between ribavirin-free EBR/GZR and LDV/SOF.