Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C

Abstract Background Patients with chronic hepatitis C virus (HCV) experience reduced quality of life, HCV-associated symptoms, comorbid conditions, and treatment side effects. The Cognitive Behavioral Coping Skills group intervention for HCV (CBCS-HCV) was developed using the Stage Model of Behavioral Therapies Research. Intervention development and initial feasibility testing in wave 1 participants were previously reported. The primary objective of this subsequent pilot with wave 2–3 participants was to investigate the effect sizes and clinical improvements in patient-reported outcomes (PROs) and trial and intervention feasibility. Methods A pilot feasibility two-arm randomized controlled trial using block randomization to assign patients to CBCS-HCV or standard of care was conducted. Participants attended nine group sessions: four before HCV treatment and five during treatment. PRO data were collected at five time points: before the CBCS intervention (T1), immediately before HCV treatment (T2), during HCV treatment (T3, T4), and 1 month post-intervention/post-HCV treatment (T5). PROs included quality of life, perceived stress, HCV symptoms, and medication adherence. Cohen’s d was used to estimate within-group changes (WGCs) and between-group differences (BGDs), with d > 0.35 considered potentially clinically significant. Potential mechanisms of change were also evaluated. Results Several WGCs and BGDs (ES > .35) suggest that the CBCS-HCV may promote improvements in PROs: psychological stress, depression, anger, anxiety, sleep disturbance, and fatigue. The intervention did not appear to impact social functioning, pain, or medication adherence. Cognitive behavioral skills and group therapy dynamics, but not HCV treatment self-efficacy, may mediate improvements in PROs. Most aspects of the study trial, including intervention implementation, were feasible. Patient acceptance and retention were exceptional. The greatest feasibility challenge was due to patients needing to initiate treatment as soon as medications were obtained, but often before a full block could be created in wave 3. Challenges with PRO data collection were identified that will be resolved in future studies. Conclusions The CBCS-HCV intervention warrants future investigation in an efficacy trial to evaluate improvements in selected PROs. The next step is to pilot test the CBCS-HCV delivered via telehealth to an expanded pool of patients to reduce patient barriers, hone technical logistics, and improve intervention reach and effectiveness. Trial registration NCT03057236 Retrospectively registered

Impact of Public Health Education Program on the Novel Coronavirus Outbreak in the United States

The coronavirus outbreak in the United States continues to pose a serious threat to human lives. Public health measures to slow down the spread of the virus involve using a face mask, social-distancing, and frequent hand washing. Since the beginning of the pandemic, there has been a global campaign on the use of non-pharmaceutical interventions (NPIs) to curtail the spread of the virus. However, the number of cases, mortality, and hospitalization continue to rise globally, including in the United States. We developed a mathematical model to assess the impact of a public health education program on the coronavirus outbreak in the United States. Our simulation showed the prospect of an effective public health education program in reducing both the cumulative and daily mortality of the novel coronavirus. Finally, our result suggests the need to obey public health measures as loss of willingness would increase the cumulative and daily mortality in the United States

Emotional Expression and Depth Processing In Trauma Writing: Impact on HIV/AIDS-Targeted Quality of Life

Expressive writing has been linked to positive psychological and health outcomes in general and medical populations, but research examining this intervention in HIV is limited. Higher levels of emotional expression (EE) and depth processing (DP) during writing have been linked to better health status in HIV. Expressive writing has been shown to improve health-related quality of life (HRQoL) in other populations, but has not been examined in HIV. HRQoL is often compromised in HIV+ individuals and therefore improvements in this area are an appropriate goal of psychosocial interventions. This longitudinal study used HLM analyses to examine the relationship between levels of EE and DP during trauma writing and the rate of change in HRQoL over six months in an ethnically diverse sample of 106 HIV+ men and women. Three subscales of the HIV/AIDS-targeted Quality of Life measure were examined: Overall Healthy Functioing (HRQoL-Overall), Without Health Worries (HRQoL-Health), and Life Satisfaction (HRQoL-Life). All longitudinal analyses controlled for demographic (age, gender, race/ethnicity, education), medical (CD4 and VL) and psychological (stressful life events) factors. No significant effects were found for EE/DP to predict changes in HRQoL over time for the full sample. When men and women were examined separately, there was a non-significant tendency for men to decrease in HRQoL over time and for women to increase over time, and a number of EE/DP variables were significant predictors of rate of change in HRQoL. As hypothesized, for women (n = 44) higher level of Experiential Involvement DP predicted greater increase in HRQoL-Overall and HRQoL-Life, and higher negative EE also predicted greater increase in HRQoL-Life over time. Opposite of the direction hypothesized, higher Self Esteem DP predicted a lower level of increase in HRQoL-Life for women. For men (n = 62), findings appeared to be in the opposite direction of women, with greater Self Esteem DP working as a buffer to decreases in HRQoL-Life and HRQoL-Health over time. Furthermore, higher Experiential Involvement and negative EE appeared detrimental for men as both predicted greater decreases in HRQoL-Life over time and Experiential Involvement also predicted greater decreases in HRQoL-Health. Results should be interpreted with caution, as the overall slopes did not show significant change in HRQoL over time. The reasons for observed gender differences are not known. This is the first study to examine the impact of EE and DP in expressive trauma writing on HRQoL in HIV+ individuals. Implications and limitations are discussed

Novel patient-reported outcomes (PROs) used in a pilot and feasibility study of a Cognitive Behavioral Coping Skills (CBCS) group intervention for patients with chronic hepatitis C

Abstract Background Patients with chronic hepatitis C virus (HCV) experience reduced quality of life, HCV-associated symptoms, comorbid conditions, and treatment side effects. The Cognitive Behavioral Coping Skills group intervention for HCV (CBCS-HCV) was developed using the Stage Model of Behavioral Therapies Research. Intervention development and initial feasibility testing in wave 1 participants were previously reported. The primary objective of this subsequent pilot with wave 2–3 participants was to investigate the effect sizes and clinical improvements in patient-reported outcomes (PROs) and trial and intervention feasibility. Methods A pilot feasibility two-arm randomized controlled trial using block randomization to assign patients to CBCS-HCV or standard of care was conducted. Participants attended nine group sessions: four before HCV treatment and five during treatment. PRO data were collected at five time points: before the CBCS intervention (T1), immediately before HCV treatment (T2), during HCV treatment (T3, T4), and 1 month post-intervention/post-HCV treatment (T5). PROs included quality of life, perceived stress, HCV symptoms, and medication adherence. Cohen’s d was used to estimate within-group changes (WGCs) and between-group differences (BGDs), with d > 0.35 considered potentially clinically significant. Potential mechanisms of change were also evaluated. Results Several WGCs and BGDs (ES > .35) suggest that the CBCS-HCV may promote improvements in PROs: psychological stress, depression, anger, anxiety, sleep disturbance, and fatigue. The intervention did not appear to impact social functioning, pain, or medication adherence. Cognitive behavioral skills and group therapy dynamics, but not HCV treatment self-efficacy, may mediate improvements in PROs. Most aspects of the study trial, including intervention implementation, were feasible. Patient acceptance and retention were exceptional. The greatest feasibility challenge was due to patients needing to initiate treatment as soon as medications were obtained, but often before a full block could be created in wave 3. Challenges with PRO data collection were identified that will be resolved in future studies. Conclusions The CBCS-HCV intervention warrants future investigation in an efficacy trial to evaluate improvements in selected PROs. The next step is to pilot test the CBCS-HCV delivered via telehealth to an expanded pool of patients to reduce patient barriers, hone technical logistics, and improve intervention reach and effectiveness. Trial registration NCT03057236 Retrospectively registered

Development and pilot-testing of a cognitive behavioral coping skills group intervention for patients with chronic hepatitis C

Psychosocial interventions for patients with chronic hepatitis C viral (HCV) infection are needed to attenuate the impact of extrahepatic symptoms, comorbid conditions, and treatment side effects on HCV health outcomes. We adapted empirically-supported interventions for similar patient populations to develop a Cognitive Behavioral Coping Skills group intervention for HCV patients (CBCS-HCV) undergoing treatment. The objectives of this paper are to describe the research activities associated with CBCS-HCV development and pilot testing, including: (1) formative work leading to intervention development; (2) preliminary study protocol; and (3) pilot feasibility testing of the intervention and study design. Formative work included a literature review, qualitative interviews, and adaption, development, and review of study materials. A preliminary study protocol is described. We evaluate the feasibility of conducting a randomized controlled trial (RCT) of the CBCS-HCV with 12 study participants in Wave 1 testing to examine: (a) feasibility of intervention delivery; (b) patient acceptability; (c) recruitment, enrollment, retention; (d) feasibility of conducting a RCT; (d) therapist protocol fidelity; and (e) feasibility of data collection. Numerous lessons were learned. We found very high rates of data collection, participant attendance, engagement, retention and acceptability, and therapist protocol fidelity. We conclude that many aspects of the CBCS-HCV intervention and study protocol were highly feasible. The greatest challenge during this Wave 1 pilot study was efficiency of participant enrollment due to changes in standard of care treatment. These findings informed two additional waves of pilot testing to examine effect sizes and potential improvements in clinical outcomes, with results forthcoming

Clinical presentation and antimicrobial resistance of invasive Escherichia coli disease in hospitalized older adults: a prospective multinational observational study

Background: Clinical data characterizing invasive Escherichia coli disease (IED) are limited. We assessed the clinical presentation of IED and antimicrobial resistance (AMR) patterns of causative E. coli isolates in older adults. Methods: EXPECT-2 (NCT04117113) was a prospective, observational, multinational, hospital-based study conducted in patients with IED aged ≥ 60 years. IED was determined by the microbiological confirmation of E. coli from blood; or by the microbiological confirmation of E. coli from urine or an otherwise sterile body site in the presence of requisite criteria of systemic inflammatory response syndrome (SIRS), Sequential Organ Failure Assessment (SOFA), or quick SOFA (qSOFA). The primary outcomes were the clinical presentation of IED and AMR rates of E. coli isolates to clinically relevant antibiotics. Complications and in-hospital mortality were assessed through 28 days following IED diagnosis. Results: Of 240 enrolled patients, 80.4% had bacteremic and 19.6% had non-bacteremic IED. One-half of infections (50.4%) were community-acquired. The most common source of infection was the urinary tract (62.9%). Of 240 patients, 65.8% fulfilled ≥ 2 SIRS criteria, and 60.4% had a total SOFA score of ≥ 2. Investigator-diagnosed sepsis and septic shock were reported in 72.1% and 10.0% of patients, respectively. The most common complication was kidney dysfunction (12.9%). The overall in-hospital mortality was 4.6%. Of 299 E. coli isolates tested, the resistance rates were: 30.4% for trimethoprim-sulfamethoxazole, 24.1% for ciprofloxacin, 22.1% for levofloxacin, 16.4% for ceftriaxone, 5.7% for cefepime, and 4.3% for ceftazidime. Conclusions: The clinical profile of identified IED cases was characterized by high rates of sepsis. IED was associated with high rates of AMR to clinically relevant antibiotics. The identification of IED can be optimized by using a combination of clinical criteria (SIRS, SOFA, or qSOFA) and culture results