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1.
JAMA Netw Open ; 4(5): e219211, 2021 05 03.
Artigo em Inglês | MEDLINE | ID: mdl-33944923

RESUMO

Importance: Financial incentives may improve health by rewarding patients for focusing on present actions-such as medication regimen adherence-that provide longer-term health benefits. Objective: To identify barriers to improving statin therapy adherence and control of cholesterol levels with financial incentives and insights for the design of future interventions. Design, Setting, and Participants: This qualitative study involved retrospective interviews with participants in a preplanned secondary analysis of a randomized clinical trial of financial incentives for statin therapy adherence. A total of 636 trial participants from several US insurer or employer populations and an academic health system were rank ordered by change in low-density lipoprotein cholesterol (LDLC) levels. Participants with the most LDLC level improvement (high-improvement group) and those with LDLC levels that did not improve (nonimprovement group) were purposively targeted, stratified across all trial groups, for semistructured telephone interviews that were performed from April 1 to June 30, 2018. Interviews were coded using a team-based, iterative approach. Data were analyzed from July 1, 2018, to October 31, 2020. Main Outcomes and Measures: The primary outcome was mean change in LDLC level from baseline to 12 months; the secondary outcome, statin therapy adherence during the first 6 months. Results: A total of 54 patients were interviewed, divided equally between high-improvement and nonimprovement groups, with a mean (SD) age of 43.5 (10.3) years; 36 (66.7%) were women, 28 (51.9%) had diabetes, and 18 (33.3%) had cardiovascular disease. Compared with the high-improvement group, the nonimprovement group had fewer interviewees with an annual income of greater than $50 000 (11 [40.7%] vs 22 [81.5%]), worse self-reported health (fair to poor, 13 [48.1%] vs 3 [11.1%]), more Black interviewees (16 [59.3%] vs 4 [14.8%]), and lower baseline LDLC levels (>160 mg/dL, 2 [7.4%] vs 25 [92.6%]). Participants in the nonimprovement group had a greater burden of chronic illness (≥2 chronic conditions, 13 [48.1%] vs 6 [22.2%]) and were less frequently employed (full-time, 6 [22.2%] vs 12 [44.4%]). In interviews, the nonimprovement group was less focused on risks of high LDLC levels, described less engagement in LDLC level management, articulated fewer specific nutritional choices for optimizing health, and recounted greater difficulty obtaining healthy food. Participants in both groups had difficulty describing the structure of the financial incentives but did recall features of the electronic pill containers used to track adherence and how those containers affected medication routines. Conclusions and Relevance: Participants in a statin adherence trial whose LDLC levels did not improve found it more difficult to create medication routines and respond to financial incentives in the context of complex living conditions and a high burden of chronic illness. These findings suggest that future studies should be more attentive to socioeconomic circumstances of trial participants. Trial Registration: ClinicalTrials.gov Identifier: NCT01798784.


Assuntos
Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Adesão à Medicação , Adulto , Idoso , LDL-Colesterol/sangue , Feminino , Humanos , Masculino , Adesão à Medicação/psicologia , Adesão à Medicação/estatística & dados numéricos , Pessoa de Meia-Idade , Motivação , Pesquisa Qualitativa
2.
Clin Transplant ; 35(6): e14316, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33844367

RESUMO

Deceased organ donor intervention research aims to increase organ quality and quantity for transplantation. We assessed the proportion of kidney transplant candidates who would accept "intervention organs," participate in organ intervention research, and factors influencing acceptance. Kidney transplant candidates were presented 12 hypothetical scenarios, which varied three attributes, donor age, predicted waiting time to receive another organ offer, and research risk to the organ. Candidates were also randomly assigned to one of two conditions varying recipient risk. For each scenario, candidates agreed to accept the intervention organ or remain waitlisted. We fit a multivariable logit model to determine the association between scenario attributes and the acceptance decision. Of 249 participants, most (96%) accepted intervention organs under some or all conditions. Factors independently associated with candidates' greater likelihood of accepting an intervention organ included: low risk to the kidney from the intervention (OR 20.53 [95% Confidence Interval (CI), 13.91-30.29]); younger donor age (OR 3.72 [95% CI, 2.83-4.89]), longer time until the next organ offer (OR 3.48 [95% CI, 2.65-4.57]), and greater trust in their transplant physician (OR 1.03 [95% CI, 1.00-1.06]). Candidates with a lower likelihood of acceptance had been waitlisted longer (OR 0.97 per month [95% CI, 0.96-0.99]) and were Black (OR 0.21 [95% CI, 0.08-0.55]). Most candidates would accept an intervention organ, which should encourage transplant leaders to conduct deceased donor organ intervention trials.


Assuntos
Transplante de Rim , Obtenção de Tecidos e Órgãos , Transplantes , Humanos , Doadores de Tecidos , Transplantados , Listas de Espera
3.
J Am Soc Nephrol ; 31(11): 2678-2687, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32843477

RESUMO

BACKGROUND: Single-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. METHODS: We 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. RESULTS: We 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. CONCLUSIONS: Our 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.


Assuntos
Ácidos Aminoisobutíricos/uso terapêutico , Antivirais/uso terapêutico , Benzimidazóis/uso terapêutico , Ciclopropanos/uso terapêutico , Hepacivirus , Hepatite C/prevenção & controle , Transplante de Rim , Lactamas Macrocíclicas/uso terapêutico , Leucina/análogos & derivados , Prolina/análogos & derivados , Quinoxalinas/uso terapêutico , RNA Viral/sangue , Sulfonamidas/uso terapêutico , Adulto , Aloenxertos/fisiologia , Aloenxertos/virologia , Ácidos Aminoisobutíricos/efeitos adversos , Antivirais/efeitos adversos , Benzimidazóis/efeitos adversos , Ciclopropanos/efeitos adversos , Combinação de Medicamentos , Feminino , Taxa de Filtração Glomerular , Hepatite C/sangue , Humanos , Rim/fisiologia , Lactamas Macrocíclicas/efeitos adversos , Leucina/efeitos adversos , Leucina/uso terapêutico , Masculino , Prolina/efeitos adversos , Prolina/uso terapêutico , Estudos Prospectivos , Pirrolidinas , Quinoxalinas/efeitos adversos , Sulfonamidas/efeitos adversos , Resposta Viral Sustentada
4.
Am J Transplant ; 20(2): 474-492, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31550422

RESUMO

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.


Assuntos
Consentimento Livre e Esclarecido/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Obtenção de Tecidos e Órgãos/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Consentimento Livre e Esclarecido/ética , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Percepção , Pesquisa Qualitativa , Obtenção de Tecidos e Órgãos/ética , Listas de Espera , Adulto Jovem
5.
Musculoskeletal Care ; 17(2): 183-193, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30793827

RESUMO

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.


Assuntos
Instabilidade Articular/congênito , Adulto , Gerenciamento Clínico , Humanos , Instabilidade Articular/psicologia , Medidas de Resultados Relatados pelo Paciente , Inquéritos e Questionários
6.
In Vitro Cell Dev Biol Anim ; 54(4): 321-330, 2018 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-29442225

RESUMO

The adaptation to feeder-independent growth of a pig embryonic stem cell-derived pancreatic cell line is described. The parental PICM-31 cell line, previously characterized as an exocrine pancreas cell line, was colony-cloned two times in succession resulting in the derivative cell line, PICM-31A1. PICM-31A1 cells were adapted to growth on a polymerized collagen matrix using feeder cell-conditioned medium and were designated PICM-31FF. Like the parental cells, the PICM-31FF cells were small and grew relatively slowly in closely knit colonies that eventually coalesced into a continuous monolayer. The PICM-31FF cells were extensively cultured: 40 passages at 1:2, 1:3, and finally 1:5 split ratios over a 1-yr period. Ultrastructure analysis showed the cells' epithelial morphology and revealed that they retained their secretory granules typical of pancreas acinar cells. The cells maintained their expression of digestive enzymes, including carboxypeptidase A1 (CPA1), amylase 2A (AMY2A), and phospholipase A2 (PLA2G1B). Alpha-fetoprotein (AFP), a fetal cell marker, continued to be expressed by the cells as was the pancreas alpha cell-associated gene, transthyretin. Several pancreas-associated developmental genes were also expressed by the cells, including pancreatic and duodenal homeobox 1 (PDX1) and pancreas-specific transcription factor, 1a (PTF1A). Proteomic analysis of cellular proteins confirmed the cells' production of digestive enzymes and showed that the cells expressed cytokeratin-8 and cytokeratin-18. The PICM-31FF cell line provides an in vitro model of fetal pig pancreatic exocrine cells without the complicating presence of feeder cells.


Assuntos
Células-Tronco Embrionárias/metabolismo , Suínos , Animais , Biomarcadores/metabolismo , Técnicas de Cultura de Células/veterinária , Linhagem Celular , Meios de Cultivo Condicionados , Células-Tronco Embrionárias/citologia , Células-Tronco Embrionárias/fisiologia , Expressão Gênica , Pâncreas/citologia
7.
Pancreas ; 46(6): 789-800, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28609368

RESUMO

OBJECTIVES: The aim of this study was to identify an epithelial cell line isolated from the spontaneous differentiation of totipotent pig epiblast cells. METHODS: PICM-31 and its colony-cloned derivative cell line, PICM-31A, were established from the culture and differentiation of an epiblast mass isolated from an 8-day-old pig blastocyst. The cell lines were analyzed by transmission electron microscopy, marker gene expression, and mass spectroscopy-based proteomics. RESULTS: The PICM-31 cell lines were continuously cultured and could be successively colony cloned. They spontaneously self-organized into acinarlike structures. Transmission electron microscopy indicated that the cell lines' cells were epithelial and filled with secretory granules. Candidate gene expression analysis of the cells showed an exocrine pancreatic profile that included digestive enzyme expression, for example, carboxypeptidase A1, and expression of the fetal marker, α-fetoprotein. Pancreatic progenitor marker expression included pancreatic and duodenal homeobox 1, NK6 homeobox 1, and pancreas-specific transcription factor 1a, but not neurogenin 3. Proteomic analysis of cellular proteins confirmed the cells' production of digestive enzymes and showed that the cells expressed cytokeratins 8 and 18. CONCLUSIONS: The PICM-31 cell lines provide in vitro models of fetal pig pancreatic exocrine cells. They are the first demonstration of continuous cultures, that is, cell lines, of nontransformed pig pancreas cells.


Assuntos
Blastocisto/citologia , Diferenciação Celular , Separação Celular/métodos , Células-Tronco Embrionárias/fisiologia , Pâncreas Exócrino/citologia , Células-Tronco Totipotentes/fisiologia , Animais , Linhagem Celular , Linhagem da Célula , Proliferação de Células , Técnicas de Cocultura , Células-Tronco Embrionárias/metabolismo , Células-Tronco Embrionárias/ultraestrutura , Células Alimentadoras , Regulação da Expressão Gênica no Desenvolvimento , Regulação Enzimológica da Expressão Gênica , Fenótipo , Sus scrofa , Fatores de Tempo , Células-Tronco Totipotentes/metabolismo , Células-Tronco Totipotentes/ultraestrutura
8.
Mol Reprod Dev ; 84(6): 468-485, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28332752

RESUMO

Thirteen independent induced bovine trophectroderm (iBT) cell lines were established by reprogramming bovine fetal liver-derived fibroblasts after viral-vector transduction with either six or eight factors, including POU5F1 (OCT4), KLF4, SOX2, MYC, NANOG, LIN28, SV40 large T antigen, and hTERT. Light- and electron-microscopy analysis showed that the iBT cells had epithelial cell morphology typical of bovine trophectoderm cells. Reverse-transcription-PCR assays indicated that all of the cell lines expressed interferon-tau (IFNT) at passages 1 or 2. At later passages (≥ passage 8), however, immunoblot and antiviral activity assays revealed that more than half of the iBT cell lines had stopped expressing IFNT. Messenger RNAs specific to trophectoderm differentiation and function were found in the iBT cell lines, and 2-dimensional-gel analysis for cellular proteins showed an expression pattern similar to that of trophectoderm cell lines derived from bovine blastocysts. Integration of some of the human reprogramming factors, including POU5F1, KLF4, SOX2, MYC, NANOG, and LIN28, were detected by PCR, but their transcription was mostly absent in the iBT cell lines. Gene expression assessment of endogenous bovine reprogramming factor orthologs revealed endogenous bLIN28 and bMYC transcripts in all; bSOX2 and bNANOG in none; and bKLF4 and bPOU5F1 in less than half of the iBT cell lines. These results demonstrate that bovine trophectoderm can be induced via reprogramming factor expression from bovine liver-derived fibroblasts, although other fibroblast populations-e.g., derived from fetal thigh tissue-may produce similar results, albeit at lower frequencies.


Assuntos
Técnicas de Reprogramação Celular , Reprogramação Celular , Fibroblastos/metabolismo , Células-Tronco Pluripotentes Induzidas/metabolismo , Fatores de Transcrição , Animais , Bovinos , Fibroblastos/citologia , Células-Tronco Pluripotentes Induzidas/citologia , Fatores de Transcrição/biossíntese , Fatores de Transcrição/genética
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