BackgroundSingle-center trials and retrospective case series have reported promising outcomes using kidneys from donors with hepatitis C virus (HCV) infection. However, multicenter trials are needed to determine if those findings are generalizable.MethodsWe conducted a prospective trial at seven centers to transplant 30 kidneys from deceased donors with HCV viremia into HCV-uninfected recipients, followed by 8 weeks of once-daily coformulated glecaprevir and pibrentasvir, targeted to start 3 days posttransplant. Key outcomes included sustained virologic response (undetectable HCV RNA 12 weeks after completing treatment with glecaprevir and pibrentasvir), adverse events, and allograft function.ResultsWe screened 76 patients and enrolled 63 patients, of whom 30 underwent kidney transplantation from an HCV-viremic deceased donor (median kidney donor profile index, 53%) in May 2019 through October 2019. The median time between consent and transplantation of a kidney from an HCV-viremic donor was 6.3 weeks. All 30 recipients achieved a sustained virologic response. One recipient died of complications of sepsis 4 months after achieving a sustained virologic response. No severe adverse events in any patient were deemed likely related to HCV infection or treatment with glecaprevir and pibrentasvir. Three recipients developed acute cellular rejection, which was borderline in one case. Three recipients developed polyomavirus (BK) viremia near or >10,000 copies/ml that resolved after reduction of immunosuppression. All recipients had good allograft function, with a median creatinine of 1.2 mg/dl and median eGFR of 57 ml/min per 1.73 m2 at 6 months.ConclusionsOur multicenter trial demonstrated safety and efficacy of transplantation of 30 HCV-viremic kidneys into HCV-negative recipients, followed by early initiation of an 8-week regimen of glecaprevir and pibrentasvir.
Deceased donor organ intervention research holds promise for increasing the quantity and quality of organs for transplantation by minimizing organ injury and optimizing function. Such research will not progress until ethical, regulatory, and legal issues are resolved regarding whether and how to obtain informed consent from transplant candidates offered intervention organs given time constraints intrinsic to distribution. This multi‐center, mixed‐methods study involved semi‐structured interviews using open‐ and closed‐ended questions to assess waitlisted candidates’ preferences for informed consent processes if offered an organ after undergoing intervention. Data were analyzed thematically. Sixty‐one candidates participated (47% participation rate). Most were male (57%), white (61%), with a mean age of 56 years. Most candidates (79%) desired being informed that the organ offered was an intervention organ before accepting it, and were likely to accept an intervention organ if organ quality was good (defined as donor age 30) (81%), but fewer candidates would accept an intervention organ if quality was moderate (ie, donor age 50) (26%). Most perceived informed consent important for decision‐making, while others considered it unnecessary given medical necessity to accept an organ and trust in their physician. Our findings suggest that most candidates desire an informed consent process before accepting an intervention organ and posttransplant data collection.
Introduction Joint hypermobility syndrome (JHS) has been reported to have widespread impacts on people with the condition. However, our understanding of those impacts is still developing and we do not know if they can be captured effectively using patient‐reported outcome measures. The aim of the present study was to explore written qualitative comments from previously administered questionnaires, to identify the impacts of JHS and any issues related to using patient‐reported outcome measures to assess those impacts. Methods Previous research administered a draft condition‐specific questionnaire and Short Form‐36 questionnaire to adult members of a patient organization in the UK, incorporating an open text box for further comments. Those comments were transcribed, anonymized and analysed using thematic analysis. A coding list, themes and subthemes were developed through double coding, parallel independent analysis and consensus. Results A total of 393 of 614 eligible questionnaires (64%) contained qualitative comments and were analysed (mean respondent age 41 years, mean Bristol Impact of Hypermobility questionnaire score 228/360, 95% women). Three main themes were identified: (a) “Impacts of living with JHS”; (b) “Management strategies for JHS”; and (c) “Measurement and research into JHS”. Participants highlighted a range of impacts of JHS, incorporating physical, social and psychological domains. Respondents described difficult journeys to diagnosis, and feeling unsupported and misunderstood by their peers and healthcare professionals. They detailed helpful strategies for managing their condition and provided useful comments on using questionnaires to assess JHS. Conclusions The study yielded valuable findings that can be used to directly inform the assessment and management of JHS.
Thought Field Therapy (TFT) is a promising treatment for posttraumatic stress in a resource poor environment. This study further explores the benefits of this treatment in a rural population in Uganda, which had suffered from the psychological consequences of previous violent conflict. Thirty-six local community workers received a two-day training in TFT trauma intervention and treated 256 volunteers with symptoms suggestive of Posttraumatic Stress Disorder (PTSD) who had been randomly allocated to a treatment or waitlist (control) group. Assessment was by the Posttraumatic Checklist for Civilians (PCL-C). One week after treatment, the treated group scores had improved significantly from 58 to 26.1. The waitlist group scores did improve without treatment, from 61.2 to 47, although significantly less than the treatment group, but improved markedly to 26.4 following treatment. There was some evidence of persisting benefit 19 months later. This study supports the value of TFT as a rapid, efficient and effective therapy, empowering traumatized communities to treat themselves, although repeated treatment may still be needed.
Key Points Question What barriers to statin therapy adherence and control of cholesterol levels are revealed through qualitative interviews with participants in a randomized trial of financial incentives for adherence? Findings In this qualitative study of 54 participants, individuals whose cholesterol levels did not improve described a greater burden of chronic illness, were less frequently employed, were less focused on the risks of high cholesterol levels, appeared to have lower health literacy, were less engaged in their cholesterol level management, made fewer specific nutritional choices for optimizing health, and had greater difficulty obtaining healthy food compared with participants with marked improvement of cholesterol levels. Meaning These findings suggest that future interventions should consider addressing socioeconomic circumstances in combination with adherence interventions among patients needing to reduce cholesterol levels.
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