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Physical, social, and psychological consequences of treatment for hepatitis C : a community-based evaluation of patient-reported outcomes.

ABSTRACT: Hepatitis C virus (HCV) antiviral therapy entails a long treatment course, as well as significant side effects that can lead to medication non-adherence and premature termination of treatment. Few large studies have comprehensively examined patient perspectives on the treatment experience, particularly the social and personal effects.We sought to understand how a diverse group of patients' lives were affected during HCV treatment, and to obtain suggestions about how to better support patients during treatment.On average, 13 months after therapy we interviewed by telephone a consecutive sample of 200 patients treated for hepatitis C with ribavirin and pegylated interferon in a comprehensive, integrated health plan in the years 2008-2010. Mixed (quantitative and qualitative) survey methods were used.The response rate was 68.9 %. Mean age at treatment was 51 years; 63.0 % were men; and Black, Hispanic, Asian, and White non-Hispanic racial/ethnic groups were similarly represented. Patients whose treatment was managed by nurses or clinical pharmacists (vs. physicians) were more likely to report their providers as being part of their support system (83.5 % vs. 58.9 %; p < 0.001). Most patients reported flu-like symptoms (93.5 %) and psychiatric problems (84.5 %), and 42.5 % reported side effects lasted up to 6 months after treatment. Black patients reported discontinuing treatment prematurely due to side effects more often than non-Blacks (29.4 % vs. 12.1 %; p < 0.001). Physical side effects (69.5 % of patients), psychiatric issues (43.5 %), and employment (27.4 %) were ranked among the three most difficult challenges. Patients desired help in anticipating and arranging work modifications during treatment. Most patients rated peer support, nutritional guidance, and weekly provider contact by telephone as potentially helpful resources for future patients undergoing HCV treatment.Patient perspectives can help formulate and refine HCV treatment support programs. Effective support programs for diverse populations are crucial as the complexities and costs of HCV treatment increase. The call for greater support from peers, providers, and employers demands new systems such as patient-centered care teams.

SUBMITTER: Manos MM

PROVIDER: S-EPMC3619379 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature

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Physical, social, and psychological consequences of treatment for hepatitis C : a community-based evaluation of patient-reported outcomes.

Manos M Michele MM Ho Chanda K CK Murphy Rosemary C RC Shvachko Valentina A VA

The patient 20130101 1

<h4>Background</h4>Hepatitis C virus (HCV) antiviral therapy entails a long treatment course, as well as significant side effects that can lead to medication non-adherence and premature termination of treatment. Few large studies have comprehensively examined patient perspectives on the treatment experience, particularly the social and personal effects.<h4>Objective</h4>We sought to understand how a diverse group of patients' lives were affected during HCV treatment, and to obtain suggestions ab ...[more]

PMID: 23420134

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Project description:Background & aimsHealth-related quality of life (HRQoL) determined by patient-reported outcomes (PROs) is impaired in chronic hepatitis B (CHB) and C patients, but there are no data regarding patients with chronic hepatitis D (CHD). The aim of this study was to assess PRO scores in untreated patients with CHD and compare them with those obtained for patients with CHB.MethodsPatients with CHD completed 3 PRO instruments (Chronic Liver Disease Questionnaire [CLDQ], Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F], and Work Productivity and Activity Impairment [WPAI]), and the results were compared with those of patients mono-infected with CHB.ResultsIn total, 125 patients were included: 43 with CHD and 82 with CHB. Overall, baseline PROs showed differences between both groups. Several assessments, such as the worry score from CLDQ (p = 0.0118), functional well-being from FACIT-F (p = 0.0281), and activity impairment from WPAI (p = 0.0029) showed a significant trend to worse scores in patients with CHD than with CHB. In addition, the linear regression model supports the finding that having CHD as opposed to having CHB was a predictor of a higher worry score (CLDQ) and a higher activity impairment (WPAI).ConclusionsIn this first assessment in CHD, PROs recorded in patients with CHD showed a significant impairment in some domains of HRQoL questionnaires in comparison with those with CHB. Studies in larger cohorts with lengthier follow-up are needed to fully assess patient-reported quality of life over the course of CHD.Lay summaryChronic hepatitis D (CHD) is a viral disease that causes rapid evolution to liver cirrhosis, amongst other severe complications, when compared to patients with chronic hepatitis B (CHB). Health-related quality of life in chronic hepatitis C and CHB has been reported widely, but no studies have been performed on patient-reported outcomes in patients with CHD. Results showed that CHD patients reported worse outcomes in psychological domains such as worry and emotional well-being, as well as in physical domains such as abdominal symptoms, physical well-being, and activity impairment in comparison with patients with CHB.

Project description:Repeated exposure to social stress can precipitate the development of psychosocial disorders including depression and comorbid cardiovascular disease. While a major component of social stress often encompasses physical interactions, purely psychological stressors (i.e. witnessing a traumatic event) also fall under the scope of social stress. The current study determined whether the acute stress response and susceptibility to stress-related consequences differed based on whether the stressor consisted of physical versus purely psychological social stress. Using a modified resident-intruder paradigm, male rats were either directly exposed to repeated social defeat stress (intruder) or witnessed a male rat being defeated. Cardiovascular parameters, behavioral anhedonia, and inflammatory cytokines in plasma and the stress-sensitive locus coeruleus were compared between intruder, witness, and control rats. Surprisingly intruders and witnesses exhibited nearly identical increases in mean arterial pressure and heart rate during acute and repeated stress exposures, yet only intruders exhibited stress-induced arrhythmias. Furthermore, re-exposure to the stress environment in the absence of the resident produced robust pressor and tachycardic responses in both stress conditions indicating the robust and enduring nature of social stress. In contrast, the long-term consequences of these stressors were distinct. Intruders were characterized by enhanced inflammatory sensitivity in plasma, while witnesses were characterized by the emergence of depressive-like anhedonia, transient increases in systolic blood pressure and plasma levels of tissue inhibitor of metalloproteinase. The current study highlights that while the acute cardiovascular responses to stress were identical between intruders and witnesses, these stressors produced distinct differences in the enduring consequences to stress, suggesting that witness stress may be more likely to produce long-term cardiovascular dysfunction and comorbid behavioral anhedonia while exposure to physical stressors may bias the system towards sensitivity to inflammatory disorders.

Project description:BackgroundTransplantoux's MVT exercise intervention prepares organ transplant recipients to cycle or hike up France's Mont Ventoux. We aimed to assess (i) MVT's effects on patient-reported outcomes (PROs) and (ii) perceived barriers and facilitators to physical activity.MethodsUsing a hybrid design, a convenience sample of transplant recipients participating in MVT (n = 47 cycling (TxCYC); n = 18 hiking (TxHIK)), matched control transplant recipients (TxCON, n = 213), and healthy MVT participants (HCON, n = 91) completed surveys to assess physical activity (IPAQ), health-related quality of life (HRQOL; SF-36 and EuroQol VAS), mental health (GHQ-12), and depressive symptomatology, anxiety, and stress (DASS-21) at baseline, then after 3, 6 (Mont Ventoux climb), 9, and 12 months. TxCYC and TxHIK participated in a 6-month intervention of individualized home-based cycling/hiking exercise and a series of supervised group training sessions. Barriers and facilitators to physical activity (Barriers and Motivators Questionnaire) were measured at 12 months.ResultsRegarding PROs, except for reducing TxHIK stress levels, MVT induced no substantial intervention effects. For both TxCYC and TxHIK, between-group comparisons at baseline showed that physical activity, HRQOL, mental health, depressive symptomatology and stress were similar to those of HCON. In contrast, compared to TxCYC, TxHIK, and HCON, physical activity, HRQOL and mental health were lower in TxCON. TxCON also reported greater barriers, lower facilitators, and different priority rankings concerning physical activity barriers and facilitators.ConclusionBarely any of the PROs assessed in the present study responded to Transplantoux's MVT exercise intervention. TxCON reported distinct and unfavorable profiles regarding PROs and barriers and facilitators to physical activity. These findings can assist tailored physical activity intervention development.Trial registrationClinical trial notation: The study was approved by the University Hospitals Leuven's Institutional Review Board (B322201523602).

Project description:BackgroundA better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients' physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care.MethodsAdults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes.ResultsParticipants' (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p<0.01). Most validity analyses demonstrated medium-to-large effect sizes (≥0.5) and clinically important differences in mean PROMIS scores (up to 14.8 points). Ranges of minimally important differences for 4 PROMIS measures were as follows: fatigue (3-5 points), physical function (2-3), ability to participate in social roles and activities (3), and satisfaction with social roles and activities (3-5).ConclusionsThe findings provide convincing evidence for the relevance and validity of PROMIS physical, mental, and social health measures in patients from early-to-late post-LVAD implantation. Findings may inform shared decision-making when patients consider treatment options. Patients with an LVAD, their caregivers, and their clinicians should find it useful to interpret the meaning of their PROMIS scores in relation to the general population, that is, PROMIS may help to monitor a return to normalcy in everyday life.

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Physical, social, and psychological consequences of treatment for hepatitis C : a community-based evaluation of patient-reported outcomes.

Publications

Physical, social, and psychological consequences of treatment for hepatitis C : a community-based evaluation of patient-reported outcomes.

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