bluuebunny/crossref_metadata_2025_split huggingface dataset:
Relationship Between Social Vulnerability Indicators and Trial Participant Attrition: Findings From the HYVALUE Trial
Authors: Henderson Kamal H. , Helmkamp Laura J. , Steiner John F. , Havranek Edward P. , Vupputuri Suma X. , Hanratty Rebecca , Blair Irene V. , Maertens Julie A. , Dickinson Miriam , Daugherty Stacie L. 
Published: April 2022

Background:
Social vulnerability indicators are associated with health care inequities and may similarly impede ongoing participation in research studies. We evaluated the association of social vulnerability indicators and research participant attrition in a trial focused on reducing health disparities.

Methods:
Self-identified White or Black adults enrolled in the HYVALUE trial (Hypertension and VALUEs), a randomized trial testing a values-affirmation intervention on medication adherence, from February 2017 to September 2019 were included. The self-reported measures of social vulnerability indicators included: (1) Black race; (2) female gender; (3) no health insurance; (4) unemployment; (5) a high school diploma or less; and (6) financial-resource strain. Full attrition was defined as not completing at least one 3- or 6-month follow-up study visit. Log-binomial regression models adjusted for age, gender, race, medical comorbidities, and the other social vulnerability indicators to estimate the relative risk of each social vulnerability indicator with study attrition.

Results:
Among 825 participants, the mean age was 63.3 years (±11.7 years), 60% were women, 54% were Black, and 97% reported at least one social vulnerability. Overall, 21% participants had full attrition after study enrollment. After adjustment for all other social vulnerabilities, only financial-resource strain remained consistently associated with full attrition (relative risk, 1.71 [95% CI, 1.28–2.29]). In a secondary analysis of partial attrition (completed only one follow-up visit), financial-resource strain (relative risk, 1.40 [95% CI, 1.09–1.81]) and being uninsured (relative risk, 1.54 [95% CI, 1.01–2.34]) were associated with partial attrition.

Conclusions:
In a trial aimed at reducing disparities in medication adherence, participants who reported financial-resource strain had a higher risk of participant attrition independent of race or gender. Our findings suggest that efforts to retain diverse populations in clinical trials should extend beyond race and gender to consider other social vulnerability indicators.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT03028597.
White Evangelicals, White Supremacy, and the ‘Born Again’ Identity in a Post-Trump America: A Latino Reading of John 3:1–8
Authors: Estrada Rodolfo Galvan 
Published: April 2022

Abstract
This essay seeks to provide a Latino rereading of the ‘born again’ identity in John 3:1–8. It argues that being ‘born again’ is not a religious identity as popularly understood in American evangelicalism but an anti-racist identity that rejects all notions of racial superiority through the negation of birthing privileges. To champion or support racist policies toward Latin American migrants (or any minoritized community) is contrary to the very identity of a ‘born again’ believer. This Latino reading explores the racial context of the historical milieu of the New Testament and reflects upon the contemporary challenges of white supremacy and white evangelicalism in a post-Trump America.
A Virtual Hybrid Care Hotel Model Supports the Recovery of Post-procedural Patients with Mild to Severe Systemic Diseases
Authors: Chadha Ryan M. , Paulson Margaret R. , Avila Francisco R. , Torres-Guzman Ricardo A. , Maita Karla C. , Garcia John P. , Forte Antonio J. , Matcha Gautam V. , Pagan Ricardo J. , Maniaci Michael J. 
Published: April 2022

Background Patients with mild to severe chronic systemic disease undergoing low-risk procedures are often hospitalized for observation. The Care Hotel is a novel virtual medicine hybrid model of care that offers patients a comfortable, out of hospital environment where they can receive both in-person and virtual care after a surgery or procedure. This study aimed to analyze if virtual hybrid post-procedure care in a hotel could be both conducted on and accepted by patients, even those with moderate to severe chronic diseases. Methods This retrospective cohort study was conducted between July 23, 2020 and June 4, 2021 at Mayo Clinic in Florida, a 306-bed community academic hospital. We collected the sex, age, race, ethnicity, acceptance rate, ASA score, and primary procedure of patients using the Care Hotel. Results Out of 392 patients, 272 (69.4%) opted for care in the program. Median patient age was 61.5 years, 59.56% were males, and 86.40% were white. We found that 50.37% had an ASA score of 2 and 43.4% had an ASA score of 3. Ten different surgical specialties were able to utilize the Care Hotel for care in 47 different procedure types. Urology had the most patients (n=70, 25.7%). Post-electrophysiologic procedures were the most common procedures (n=39, 14.3%). Conclusion Our virtual hybrid Care Hotel program was widely accepted by patients and could care for a multitude of post-operative procedures. Additionally, this novel program can care for patients with both mild and severe systemic diseases.
An Evaluation of Pediatric Gastrocutaneous Fistula Closure Through the Punch Excision of Epithelized Tract Procedure
Authors: Stephenson Krista J. , Bonasso Patrick C. , Vasquez Isabel L. , Burford Jeffrey M. , Wyrick Deidre L. , Bhavaraju Avi , Dassinger Melvin S. 
Published: April 2022

Background Persistent gastrocutaneous fistulae frequently complicate gastrostomy tube placement. A minimally invasive technique for tract closure employing balloon catheter retraction and punch excision of the epithelized tract (PEET) was recently reported. We hypothesized the PEET technique of closure would lead to decreased complications without an increased incidence of recurrence. Methods We conducted a single-center retrospective cohort study evaluating children who underwent gastrocutaneous fistula (GCF) closure 1/1/2018–12/31/2021, comparing patients who underwent the PEET procedure to those repaired with layered closure. Procedure duration and outcomes were additionally compared to the 2018-2019 National Surgical Quality Improvement Program (NSQIP) Participant Use File (PUF) database. Results Sixty-two children underwent operative GCF closure, including 25 with PEET and 37 traditional layered closure. Procedural time was significantly decreased employing PEET (14 vs 26 minutes, P < .0001), less than half the national median by the NSQIP PUF database of 292 GCF closures (14 vs 34.5 minutes, P < .0001). Those repaired with the PEET method experienced no episodes of recurrence, surgical site infection, readmission, reoperation, or mortality within 30 days of the procedure. Conversely, in traditional closure, there was a 24.3% complication rate, including 7 surgical site infections, 1 readmission, and 2 unplanned reoperations. National procedural complication rate by NSQIP PUF was 5.5%, with a 4.8% rate of surgical site infection, .3% reoperation incidence, and .3% mortality. Discussion Our study suggests GCF closure employing the PEET procedure is a safe, more efficient method of tract closure than the traditional layered closure technique.
Forecasting of Future Medical Care Expenditure in Japan Using a System Dynamics Model
Authors: Inoue Sachie , Xu Hua , Maswana Jean-Claude , Kobayashi Makoto 
Published: April 2022

Background The aim of this study was to construct a system dynamics (SD) model to estimate the future medical care expenditure and to address the dynamic issues of health care that should be resolved. In particular, the measures for promoting the spread of generic drug (GE drug) usage in Japan and reducing cancer-related medical expenses were investigated regarding their future impact on medical finances. Methods The SD model was constructed from FY 2018 to FY 2050. The change in the future GE drug quantity share was analyzed by using a regression equation. The impact of the increase in medical expense for cancer and the change in the future national medical care expenditure were also estimated. Results The annual total medical care expenditure in FY 2050 would arrive at 58.9–64.2 trillion JPY (US$ 535.1–584.0 billion) (1.3–1.5 times higher than that in FY 2018) with different trends in age groups. The cumulative total medical care expenditure was expected to decrease by about 787.0–989.4 billion JPY (US$ 7.2–9.0 billion) if the impact of the spread of GE drug usage was considered. On the other hand, due to the continuous increase in the cancer-related medical expense, the cumulative total medical care expenditure was estimated to increase about 7554.3–11715.0 billion JPY (US$ 68.7–106.5 billion). Conclusions If the cancer-related medical expense continues to increase in the future, an increase of 686.4–1104.2 billion JPY (US$ 6.2–10.0 billion) in FY 2050 is expected which suggests that this disease field should be prioritized regarding the measures to maintain medical finances.
Adherence over 48 Weeks in An Antiretroviral Clinical Trial: Variable within Patients, Affected by Toxicities and Independently Predictive of Virological Response
Authors: Nieuwkerk Pythia , Gisolf Elisabeth , Sprangers Mirjam , Danner Sven ,   Prometheus Study Group, Gisolf EH , Reiss P , Weverling GJ , Duurvoort M , Krijger E , Brouwer E , Visser GR , Klotz A , Benschop C , Wulfert F , Danner SA , de Wolf F , Jurriaans S , Portegies P , Colebunders R , Pelgrom J , Wijnants H , de Roo A , Keersmaekers K , Vandenbruane M , van den Brande D , James T , van Wanzeele F , van der Gucht B , van der Ende ME , Nouwen J , Deenenkamp R , van der Meyden D , Koopmans PP , Brinkman K , ter Hofstede H , Zomer B , Blok WL , Ruissen C , Sprenger H , Law G , van der Meulen P , ten Veen C , Juttmann JR , van der Heul C , Santegoets R , van der Ven B , Gasthuis Kennemer , haarlem  , ten Kate RW , Schoemaker M , Kauffmann RH , Henrichs JM , Maat A , Prins E , ten Napel CH , Pogany K , Duyts T , Lansink T , Simons P , Lacor P , de Waele A , van Wijngaarden E , Lejeune M , Scholte R , Dijkman J 
Published: April 2022

Objectives To investigate adherence to antiretroviral therapy over 48 weeks, to investigate the association between adherence and treatment-related symptoms and to investigate the impact of adherence on virological response over 48 weeks among established predictors of treatment success. Methods One-hundred-and-sixty HIV-1 infected protease inhibitor- and stavudine-naive patients participating in a trial of ritonavir/saquinavir versus ritonavir/saquinavir/ stavudine completed an adherence questionnaire and a symptom checklist at weeks 12, 24, 36 and 48. We calculated odds ratios between experienced symptoms and non-adherence. Regression models were used to determine predictors of HIV-1 RNA below 400 copies/ml at week 48, and of the area about the change from baseline over 48 weeks (ACFB) in serum HIV-1 RNA. Results The percentage of patients reporting missing medication, deviation from time schedule, and dietary prescriptions at separate time-points ranged from 12 to 15%, 32 to 35% and 17 to 22%, respectively. The percentage that changed their level of adherence during 48 weeks ranged from 29% for skipping medication to 48% for deviation from time-schedule. Experienced side-effects were associated with an increased likelihood of non-adherence. Not skipping medication was an independent predictor of both having a serum HIV-1 RNA below 400 copies/ml at week 48 and the ACFB over 48 weeks in serum HIV-1 RNA. Conclusions Adherence was an independent predictor of virological response over 48 weeks. The level of adherence is variable within patients over time. This suggests the need for continued adherence monitoring in all patients as part of standard medical practice.
Hyperlactataemia in HIV-Infected Patients: The Role of NRTI-Treatment
Authors: Vrouenraets Saskia ME , Treskes Marco , Regez Rosa M , Troost Nancy , Smulders Yvo M , Weigel Hugo M , Frissen PH Jos , Brinkman Kees 
Published: April 2022

Background Long-term treatment with nucleoside reverse transcriptase inhibitors (NRTIs) can induce mitochondrial dysfunction, most severely represented by lactic acidosis. Diagnostic tests for mitochondrial dysfunction are lacking, although persistently elevated serum lactate might be a surrogate marker. Objectives To determine the occurrence of hyperlactataemia in HIV-infected patients on NRTI-treatment and to evaluate the possible risk factors. Methods Cross-sectional analysis of lactic-acid levels in asymptomatic HIV-infected patients. Hyperlactactaemia was considered mild if between 2.0–5 mmol/l, serious if >5 mmol/l and lactic acidosis was defined as lactic acid levels >5 mmol/l with bicarbonate <20 mmol/l. Possible risk factors, such as current and preceding NRTI-treatment as well as treatment with non-nucleoside reverse transcriptase inhibitors or protease inhibitors and concurrent liver disease, were analysed. Results Two hundred and twenty three asymptomatic HIV-infected patients were studied, including 174 patients (78%) on NRTI treatment, 12 patients (5%) treated without NRTIs and 37 patients (17%) not treated. Mild hyperlactataemia was found in 42 patients (19%), from whom 38/42 (90%) were NRTI-treated and the remaining patients (4/42, 10%) received no treatment (χ2, P<0.05). The significant risk factors for hyperlactataemia in the univariate analysis were NRTI-treatment as a group ( P=0.03) and elevated ALT ( P=0.008). In multivariate analysis NRTI use ( P=0.05) and ALT level ( P=0.03) remained a significant determinant of hyperlactataemia. Among the different individual NRTIs, a stavudine-containing ( P=0.004) and a zalcitabine-containing ( P=0.07) regimen were most notably associated with the development of hyperlactataemia, whereas for the combinations of NRTIs, such association was only found for stavudine/lamivudine ( P=0.05). Conclusions A correlation between hyperlactataemia and NRTI treatment was found, but the value of routine lactate measurement for individual treatment monitoring remains uncertain.
Divergent Distribution of HIV-1 Drug-Resistant Variants on and off Antiretroviral Therapy
Authors: Venturi Giulietta , Romano Laura , Carli Tiziana , Corsi Paola , Pippi Luigi , Valensin Pier E , Zazzi Maurizio 
Published: April 2022

Objective To investigate the distribution of drug-resistant HIV-1 variants in plasma RNA and peripheral blood monuclear cell (PBMC) DNA at treatment failure while on therapy and after stopping therapy. Design Fifty-eight patients failing their first highly active antiretroviral treatment while on therapy and 50 patients after a median of 18.6 weeks after treatment interruption following multiple treatment failures were analysed. Methods Paired plasma HIV-1 RNA and PBMC HIV-1 DNA were used for genotypic antiretroviral resistance testing. Drug resistance was computed by using the Stanford on-line genotype interpretation system. Results The extent of drug resistance was larger in plasma RNA than in PBMC DNA in the on-therapy group ( P=0.004) and in PBMC DNA than in plasma RNA in the off-therapy group ( P=0.04). Interpretation of genotype based on PBMC DNA and plasma RNA in the on-therapy and in the off-therapy group would have missed detection of resistance to one or more drugs in 21 and 22% of the patients, respectively, compared to interpretation based on the other blood compartment. In a subset of 27 patients for whom a sample before stopping therapy was available, there was a significant decrease in the number of RNA (mean 8.1 to 5.3, P=0.004), but not DNA (mean 6.8 to 5.7, P=0.143), resistance mutations following treatment interruption. Conclusion While plasma RNA is the material of choice for early detection of drug resistance while on therapy, analysis of PBMC DNA may additionally support and possibly improve sensitivity of resistance testing in the absence of therapy.
Persistent Brain Abnormalities in Antiretroviral-Naive HIV Patients 3 Months after Haart
Authors: Chang Linda , Ernst Thomas , Witt Mallory D , Ames Nina , Walot Irwin , Jovicich Jorge , DeSilva Menaka , Trivedi Neha , Speck Oliver , Miller Eric N 
Published: April 2022

Background Proton magnetic resonance spectroscopy (1H-MRS) and neuropsychological tests may be useful for monitoring the effectiveness of highly active antiretroviral therapy (HAART) in HIV-associated brain injury. We aimed to evaluate whether brain abnormalities will improve 3 months after HAART. Method Thirty-three HIV patients naive to antiretroviral medications were evaluated before and 3 months after HAART using 1H-MRS and neuropsychological tests; results were compared with those of 26 seronegative control subjects. Results Despite significant improvement in CD4 counts, and suppression of plasma and cerebrospinal fluid (CSF) viral loads, elevated brain metabolites (choline compounds and myoinositol in the frontal lobes) and neuropsychological tests abnormalities (including the computerized tests [CalCAP®]) persisted after 3 months of HAART. In the basal ganglia, choline and myoinositol became elevated only after treatment. No interaction effect was observed between the number of CSF-penetrating drugs (one vs two) and changes (baseline vs 3 months) in any of the brain metabolites, cognitive performance or CSF viral load. Conclusions The persistent brain abnormalities suggest ongoing repair or reactive inflammatory processes in the brain after 3 months of HAART. Regimens with two CSF-penetrating antiretroviral medications do not appear to be more effective than those with one CSF-penetrating drug in treating HIV brain injury at 3 months.
Simplification of Protease Inhibitor-Containing Regimens with Efavirenz, Nevirapine or Abacavir: Safety and Efficacy Outcomes
Authors: Chiesa Elisabetta , Bini Teresa , Adorni Fulvio , Capetti Amedeo , Rizzardini Giuliano , Faggion Ivano , Mussini Cristina , Sollima Salvatore , Melzi Sara , Bongiovanni Marco , Tordato Federica , Cicconi Paola , Castelnuovo Barbara , Rusconi Stefano , Monforte Antonella d'Arminio 
Published: April 2022

Objective To describe the immunological and virological outcome, and the factors associated to discontinuation in patients switching to a regimen containing efavirenz (EFV), nevirapine (NVP) or abacavir (ABC) after long-term viral suppression under protease inhibitor-including HAART. Design Observational study at three outpatient clinics for HIV care in Italy. Methods Patients with HIV RNA <80 copies/ml and CD4 >200 cells/ml for at least 6 months on a protease inhibitor-containing treatment who switched to NVP, EFV or ABC were included in the study. End-points were immunological failure, virological failure and discontinuation due to toxicity. Survival analyses were performed to find out any independent variables predictive of reaching the end-points. Results 177 patients were enrolled; 85 started EFV, 54 NVP and 38 ABC as part of the simplification regimen. 16/159 patients experienced immunological failure: the variables associated to CD4 count decrease were HIV RNA set point value (HR 2.32 for each log10 copies more, P=0.040) and intolerance/toxicity as reason for simplification (HR 3.96, P=0.05). 13/151 subjects showed virological failure; an AIDS diagnosis (HR 6.04, P=0.021) and the use of NVP (HR 7.98, P=0.027) were associated to a worse virological outcome, while patients naive before HAART showed a lower risk of failure (HR 0.008, P=0.007). 16/177 patients discontinued simplification regimen due to toxicity; longer HAART duration before switch was associated to risk reduction (HR 0.92, P=0.004). Conclusions Simplification is safe and effective, but it should be offered to patients with shorter treatment duration, and in good clinical and immunovirological conditions.
Low versus High CD4 Cell Count as Starting Point for Introduction of Antiretroviral Treatment in Resource-Poor Settings: A Scenario-Based Analysis
Authors: Bogaards Johannes A , Weverling Gerrit Jan , Geskus Ronald B , Miedema Frank , Lange Joep MA , Bossuyt Patrick MM , Goudsmit Jaap 
Published: April 2022

Objective To evaluate CD4 cell count-driven strategies for the initiation of highly active antiretroviral therapy (HAART) in terms of the reduction of the incidence of AIDS-defining events in resource-poor settings. Methods Data from the Amsterdam Cohort Study on HIV infection and AIDS were used to estimate the hazard of AIDS in untreated HIV-1 infection and after initiation of HAART, respectively, conditional on CD4 cell count. Different strategies for initiating therapy were compared by calculating the expected HAART administration rate and 1-year cumulative AIDS incidence in three different population settings, varying in the stage of HIV-1 infection at the time of presentation. Results Among 695 HIV-1-infected cohort participants, the 1-year AIDS incidence density (ID) ranged from 3.2 per 100 person-years for CD4 cell counts 600–700 cells/mm3, to 31.9 per 100 person-years for CD4 cell counts 100–200 cells/mm3 and 77.9 per 100 person-years for CD4 cell counts below 100 cells/mm3. Upon initiation of HAART, the ID in the lowest CD4 strata declined to 13.3 and 16.3 per 100 person-years, respectively. Extrapolated to developing countries, supply of HAART to patients presenting with HIV-1 infection below 200 CD4 cells/mm3 is expected to give an administration rate of 67%, while the AIDS incidence will drop from over 30% to almost 10%. Conclusions Introduction of HAART in populations with advanced HIV-1 infection can accomplish a threefold reduction of the AIDS incidence when HAART is administered to patients with CD4 cell counts below 200 cells/mm3. In a hospital-based setting in resource-poor environments this ensures an efficient treatment allocation.