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    Tassos Kyriakides

    Early postoperative hemorrhage is an infrequent complication of both laparoscopic and open Roux-en-Y gastric bypass (RYGBP). The objective of our study is to review the incidence and management of this complication and identify... more
    Early postoperative hemorrhage is an infrequent complication of both laparoscopic and open Roux-en-Y gastric bypass (RYGBP). The objective of our study is to review the incidence and management of this complication and identify contributing clinical and technical risk factors. Over a 3-year period, 1,025 patients underwent RYGBP at our institution. The medical records of patients who required postoperative blood transfusions were reviewed for clinical presentation, diagnostic evaluation and management. These patients were matched for surgical approach (open vs. laparoscopic) in a 1:3 ratio and compared to a random group of patients who underwent RYGBP during the same time period. Thirty-three patients (3.2%) were diagnosed with postoperative hemorrhage, 17 (51.5%) of which were intraluminal. The incidence of hemorrhage was higher in the laparoscopic group (5.1% vs. 2.4%, p = 0.02). Comparing bleeders to nonbleeders, the average BMI, gender distribution, gastro-jejunostomy anastomotic technique (stapled vs. hand sewn) and the postoperative administration of ketorolac were not significantly different. The bleeding group was older (47.5 vs. 42.8, p = 0.02), had a longer hospital stay (4.9 vs. 3 days, p = 0.0001) and was more likely to have received low molecular weight heparin (LMWH) preoperatively (p = 0.03). Hemorrhage occurred earlier (13.8 vs. 25.9 h, p = 0.039) and was more severe (4.1 vs. 2.3 transfused blood units, p = 0.007) in the patients who required surgical reexploration (n = 9). A laparoscopic approach and the preoperative administration of LMWH may increase the incidence of early hemorrhage after RYGBP. This complication frequently requires surgical reexploration and significantly prolongs the hospital stay.
    Background: Severe hypertension is an obstetric emergency. Timely identification and management can reduce risk of serious events. Aims of our study were to 1)assess whether severe hypertension is being recognized and managed within the... more
    Background: Severe hypertension is an obstetric emergency. Timely identification and management can reduce risk of serious events. Aims of our study were to 1)assess whether severe hypertension is being recognized and managed within the recommended time frame and 2)evaluate the factors that are associated with timely identification and treatment of severe maternal hypertension. Methods: A retrospective study of pregnant and postpartum women presenting with severe hypertension to tertiary care hospital between 1/1/19 to 12/1/19. Main outcome measures were ‘time to repeat blood pressure check(TTC)’ and ‘time interval between confirmation of severe hypertension and initiation of pharmacotherapy(TTT)’. We examined the association of the type of hospital unit, time of day of presentation and race/ethnicity with the outcome measures. Results: A total of 656 women were included in the study. Median time for repeat blood pressure check was 16 minutes. Only 46.2% of women had a repeat blood pressure check within 15 minutes. Median interval between confirmation of severe hypertension and initiation of therapy was 38.5 minutes. 63.3% of women were treated within the recommended time frame of 60 minutes. Both timely blood pressure re-check(15.6% vs 51.4%, p < 0.001) and initiation of treatment(38.5% vs 70.8%, p < 0.001) were significantly lower in the emergency department (ED). TTC(57.9% vs 31.4%, p < 0.001) and TTT(86.4% vs 42%, p < 0.001) were significantly better in the labor and delivery unit. Time of day(day 51.6% vs night 57.3%, p = 0.15) and race/ethnicity(black 57.1% vs non-black 51.6%, p = 0.16) were not associated with delay in repeat blood pressure check. However, black race(46.2% vs 28.6%, p = 0.018) was associated with delayed initiation of therapy compared to non-black patients. Conclusions: We found both the rates of timely identification and treatment of severe maternal hypertension in the ED were lower compared to other units. This points to need for continuous education of ED healthcare providers about timely recognition and management of severe maternal hypertension. We also found racial disparities in timely initiation of therapy, thus demonstrating the need for standardization of protocols.
    Introduction: Published reports suggest negative effect of exclusion of antegrade hypogastric artery flow on erectile function after endovascular aneurysm repair (EVR). This has stimulated new bran...
    The aim of this study was to determine whether glycemic control influences healing after tooth extractions. We enrolled 115 diabetic patients who required dental extractions in this prospective observer-blinded study. Epithelialization of... more
    The aim of this study was to determine whether glycemic control influences healing after tooth extractions. We enrolled 115 diabetic patients who required dental extractions in this prospective observer-blinded study. Epithelialization of extraction sites was assessed relative to the patient's history, non-fasting blood glucose levels, and glycosylated hemoglobin levels. Of 115 patients, 78 had 1- and 2-week follow-up data. There was no statistically significant difference in the rate of postextraction epithelialization between diabetic patients based on preoperative blood glucose levels, hemoglobin A1c levels, or patient history. Only the size of the extraction site at days 0 and 7 was predictive of future epithelialization. Glycemic control did not influence postextraction healing in diabetic patients. Recommendations for management of the diabetic patient requiring extractions are discussed.
    We aimed to characterize clinical and demographic factors affecting clinical outcomes of COVID‐19 and describe viral epidemiology among unvaccinated Veterans in New England. Veterans infected with COVID‐19 in Veterans Administration... more
    We aimed to characterize clinical and demographic factors affecting clinical outcomes of COVID‐19 and describe viral epidemiology among unvaccinated Veterans in New England. Veterans infected with COVID‐19 in Veterans Administration healthcare systems in six New England states from April 8, 2020, to September 2, 2021, were correlated with outcomes of 30‐day mortality, nonpsychiatric hospitalization, and intensive care unit admission (ICU‐care). We sequenced 827 viral genomes. Of 3950 Veterans with COVID‐19 before full vaccination, 81% were White, 8% were women, and the mean age was 60 years. Overall, 19% of Veterans required hospitalization, 2.8% required ICU care, and 4.9% died. In this largely male and older cohort, poor outcomes correlated with increasing age. Most New England Veterans (>97%) were infected with B.1 sublineages with the D614G mutation in 2020 and early 2021. B.1.617.2 lineage (68%) predominated after July 2021.
    Post-traumatic stress disorder (PTSD) leads to significant disability, unemployment, and substantial healthcare costs. The cost-effectiveness of vocational rehabilitation (VR) interventions is important to consider when determining which... more
    Post-traumatic stress disorder (PTSD) leads to significant disability, unemployment, and substantial healthcare costs. The cost-effectiveness of vocational rehabilitation (VR) interventions is important to consider when determining which services to offer. This study assesses the cost-effectiveness and return on investment of Individual Placement and Support (IPS) compared to transitional work (TW) programs. Employment outcomes from a multisite randomized trial comparing IPS to TW in military veterans with PTSD (n = 541) were linked to Veterans Health Administration (VHA) archival medical record databases to examine the comparative cost-effectiveness and return on investment. Effectiveness was defined as hours worked and income earned in competitive jobs. Costs for VR, mental health, and medical care and income earned from competitive sources were annualized and adjusted to 2019 US dollars. The annualized mean cost per person of outpatient (including vocational services) were $3970 higher for IPS compared to TW ($23,245 vs. $19,276, respectively; P = 0.004). When TW income was included in costs, mean grand total costs per person per year were similar between groups ($29,828 IPS vs. $26,772 TW; P = 0.17). The incremental cost-effectiveness analysis showed that while IPS is more costly, it is also more effective. The return on investment (excluding TW income) was 32.9% for IPS ($9762 mean income/$29,691 mean total costs) and 29.6% for TW ($7326 mean income/$24,781 mean total costs). IPS significantly improves employment outcomes for individuals with PTSD with negligible increase in healthcare costs and yields very good return on investment compared to non-IPS VR services.
    Background and Objectives:Transversus abdominis plane (TAP) block is a safe and effective type of regional anesthesia technique used in laparoscopic gynecologic surgery to minimize postoperative pain. Our study aimed to compare the... more
    Background and Objectives:Transversus abdominis plane (TAP) block is a safe and effective type of regional anesthesia technique used in laparoscopic gynecologic surgery to minimize postoperative pain. Our study aimed to compare the analgesic effects of the posterior versus lateral approaches to laparoscopic-assisted TAP block in minimally invasive gynecologic surgery.Methods:We performed a randomized controlled trial with 82 patients allocated to either posterior (n = 38) or lateral (n = 44) TAP block groups. Laparoscopic-assisted posterior or lateral TAP block was administered using liposomal bupivacaine mixture. All subjects were asked to fill out a questionnaire, which included postoperative pain scores at 6 h, 12 h, 24 h, 48 h, and 72 h, as well as narcotic utilization postoperatively. Both groups were compared for postoperative pain scores, opioid consumption, perioperative, and demographic characteristics.Results:A total of 67 patients were analyzed in our study (n = 33 in posterior arm, n = 34 in lateral arm). Demographic characteristics including race, body mass index, comorbidities, American Society of Anesthesiologists classification, pre-operative diagnosis, complication rates, length of stay, and estimated blood loss were comparable between the two groups. The distribution of different operative procedures was similar between the two groups. There was no statistically significant difference in pain scores at 6 h, 12 h, 24 h, 48 h, and 72 h postoperatively between the two groups. However, patients receiving posterior TAP had a significant reduction in narcotic intake (p = 0.0009).Conclusion:Laparoscopic-assisted TAP block is a safe and effective option for regional analgesia in laparoscopic gynecologic surgery. Posterior TAP block may help to reduce narcotic usage postoperatively.
    Background. The effect of antiretroviral therapy (ART) interruption or intensification on health-related quality of life (HRQoL) in advanced HIV patients is unknown. Objective. To assess the impact of temporary treatment interruption and... more
    Background. The effect of antiretroviral therapy (ART) interruption or intensification on health-related quality of life (HRQoL) in advanced HIV patients is unknown. Objective. To assess the impact of temporary treatment interruption and intensification of ART on HRQoL. Design. A 2 x 2 factorial open label randomized controlled trial. Setting. Hospitals in the United States, Canada, and the United Kingdom. Patients. Multidrug resistant (MDR) HIV patients. Intervention. Patients were randomized to receive a 12-wk interruption or not, and ART intensification or standard ART. Measurements. The Health Utilities Index (HUI3), EQ-5D, standard gamble (SG), time tradeoff (TTO), visual analog scale (VAS), and the Medical Outcomes Study HIV Health Survey (MOS-HIV). Results. There were no significant differences in HRQoL among the four groups during follow-up; however, there was a temporary significant decline in HRQoL on some measures within the interruption group during interruption (HUI3 −0.05, P = 0.03; VAS −5.9, P = 0.002; physical health summary −2.9, P = 0.001; mental health summary −1.9, P = 0.02). Scores declined slightly overall during follow-up. Multivariate analysis showed significantly lower HRQoL associated with some clinical events. Limitations. The results may not apply to HIV patients who have not experienced multiple treatment failures or who have not developed MDR HIV. Conclusions. Temporary ART interruption and ART intensification provided neither superior nor inferior HRQoL compared with no interruption and standard ART. Among surviving patients, HRQoL scores declined only slightly over years of follow-up in this advanced HIV cohort; however, approximately one-third of patients died during the trial follow up. Lower HRQoL was associated with adverse clinical events.
    ImportanceThe Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) randomized clinical trial sought to recruit 50 000 adults into a study comparing colorectal cancer (CRC) mortality outcomes... more
    ImportanceThe Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) randomized clinical trial sought to recruit 50 000 adults into a study comparing colorectal cancer (CRC) mortality outcomes after randomization to either an annual fecal immunochemical test (FIT) or colonoscopy.ObjectiveTo (1) describe study participant characteristics and (2) examine who declined participation because of a preference for colonoscopy or stool testing (ie, fecal occult blood test [FOBT]/FIT) and assess that preference’s association with geographic and temporal factors.Design, Setting, and ParticipantsThis cross-sectional study within CONFIRM, which completed enrollment through 46 Department of Veterans Affairs medical centers between May 22, 2012, and December 1, 2017, with follow-up planned through 2028, comprised veterans aged 50 to 75 years with an average CRC risk and due for screening. Data were analyzed between March 7 and December 5, 2022.ExposureC...
    Expansion of tuberculous preventive therapy (TPT) is essential to curb TB incidence and mortality among people with HIV (PWH), yet implementation has been slow. Innovative strategies to operationalize TPT are urgently needed. Here we... more
    Expansion of tuberculous preventive therapy (TPT) is essential to curb TB incidence and mortality among people with HIV (PWH), yet implementation has been slow. Innovative strategies to operationalize TPT are urgently needed. Here we present an evaluation of community-based identification and referral of PWH on completion of a six-month course of isoniazid in a highly prevalent region in rural South Africa. Using a community-based TB/HIV intensive case finding strategy, a team of nurses and lay workers identified community members with HIV who were without fever, night sweats, weight loss, or cough and referred them to the government primary care clinics for daily oral isoniazid, the only available TPT regimen. We measured monthly adherence and six-month treatment completion in the community-based identification and referral (CBR) group compared to those already engaged in HIV care. Adherence was measured by self-report and urine isoniazid metabolite testing. A multivariable analysi...
    Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These... more
    Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These overlapping epidemics have complex, multifactorial etiologies, and PCTs can be used to investigate the effectiveness of integrated therapies that are currently available but underused. Yet individual pragmatic studies can be limited in their reach because of existing structural and cultural barriers to dissemination and implementation. The National Institutes of Health, Department of Defense, and Department of Veterans Affairs formed an interagency research partnership, the Pain Management Collaboratory. The partnership combines pragmatic trial design with collaborative tools and relationship building within a large network to advance the science and impact of nonpharmacological approaches and integrated models of care for the management of pain and common c...
    PurposeThe net uptake rate constant (Ki) derived from dynamic imaging is considered the gold standard quantification index for FDG PET. In this study, we investigated the feasibility and assessed the clinical usefulness of generating Ki... more
    PurposeThe net uptake rate constant (Ki) derived from dynamic imaging is considered the gold standard quantification index for FDG PET. In this study, we investigated the feasibility and assessed the clinical usefulness of generating Ki images for FDG PET using only two 5‐min scans with population‐based input function (PBIF).MethodsUsing a Siemens Biograph mCT, 10 subjects with solid lung nodules underwent a single‐bed dynamic FDG PET scan and 13 subjects (five healthy and eight cancer patients) underwent a whole‐body dynamic FDG PET scan in continuous‐bed‐motion mode. For each subject, a standard Ki image was generated using the complete 0–90 min dynamic data with Patlak analysis (t* = 20 min) and individual patient's input function, while a dual‐time‐point Ki image was generated from two 5‐min scans based on the Patlak equations at early and late scans with the PBIF. Different start times for the early (ranging from 20 to 55 min with an increment of 5 min) and late (ranging fr...
    Background: Disclosing HIV status to HIV-positive children is a major challenge facing families and health care providers. Despite recommendations for disclosure, rates remain low. We tested whether a pediatric HIV disclosure intervention... more
    Background: Disclosing HIV status to HIV-positive children is a major challenge facing families and health care providers. Despite recommendations for disclosure, rates remain low. We tested whether a pediatric HIV disclosure intervention delivered as an integral component of routine HIV health care in Ghana would improve disclosure to children. Methods: Dyads of HIV-infected children aged 7–18 years and their caregivers were enrolled from 2 HIV clinics in Accra and Kumasi, Ghana. The sites were randomly assigned to one of the 2 intervention arms to avoid treatment contamination between intervention and control participants. Trained interventionist used theory-guided therapeutic communication and personalized interaction to promote disclosure. Disclosure outcomes were measured at 12-week intervals. All analyses were completed using a modified intention-to-treat approach. Results: We enrolled 446 child–caregiver dyads (N = 240 intervention group; N = 206 control group); 52% of the ch...
    Background/Aims: Electronic medical records are now frequently used for capturing patient-level data in clinical trials. Within the Veterans Affairs health care system, electronic medical record data have been widely used in clinical... more
    Background/Aims: Electronic medical records are now frequently used for capturing patient-level data in clinical trials. Within the Veterans Affairs health care system, electronic medical record data have been widely used in clinical trials to assess eligibility, facilitate referrals for recruitment, and conduct follow-up and safety monitoring. Despite the potential for increased efficiency in using electronic medical records to capture safety data via a centralized algorithm, it is important to evaluate the integrity and accuracy of electronic medical record–captured data. To this end, this investigation assesses data collection, both for general and study-specific safety endpoints, by comparing electronic medical record–based safety monitoring versus safety data collected during the course of the Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) clinical trial. Methods: The VA NEPHRON-D study was a multicenter, double-blind, randomized clinical trial designed to compare the ...
    Videogame interventions are becoming increasingly popular as a means to engage people in behavioral interventions; however, strategies for examining data from such interventions have not been developed. The objective of this study was to... more
    Videogame interventions are becoming increasingly popular as a means to engage people in behavioral interventions; however, strategies for examining data from such interventions have not been developed. The objective of this study was to describe how a technology-based intervention can yield meaningful, objective evidence of intervention exposure within a behavioral intervention. This study demonstrates the analysis of automatic log files, created by software from a videogame intervention, that catalog game play and, as proof of concept, the association of these data with changes in substance use knowledge as documented with standardized assessments. We analyzed 3- and 6-month follow-up data from 166 participants enrolled in a randomized controlled trial evaluating a videogame intervention, PlayForward: Elm City Stories (PlayForward). PlayForward is a videogame developed as a risk reduction and prevention program targeting HIV risk behaviors (substance use and sex) in young minority...
    ObjectivesThe aim of the study was to determine the prognostic value of HIV replication capacity (RC) for subsequent antiretroviral (ARV) treatment response in ARV‐experienced patients.MethodsRC and phenotypic resistance testing were... more
    ObjectivesThe aim of the study was to determine the prognostic value of HIV replication capacity (RC) for subsequent antiretroviral (ARV) treatment response in ARV‐experienced patients.MethodsRC and phenotypic resistance testing were performed at baseline and week 12 on plasma samples from patients randomized to undergo a 12‐week ARV drug‐free period (ARDFP) or initiate immediate salvage therapy (no‐ARDFP group) in the Options in Management with Antiretrovirals (OPTIMA) trial. Dichotomous and incremental phenotypic susceptibility scores (dPSSs and iPSSs, respectively) were calculated. The predictive value of RC and PSS for ARV therapy response and/or ARDFP was evaluated using multivariate regression analysis and Pearson correlations.ResultsIn 146 no‐ARDFP subjects, baseline RC (50.8%) did not change at week 12 and was not correlated with CD4 cell count or viral load changes at week 12 (P = 0.33 and P = 0.79, respectively) or at week 24 (P = 0.96 and P = 0.14, respectively). dPSS pre...
    The OPTions In Management with Antiretrovirals (OPTIMA) Trial, a collaboration between three governmental agencies in the USA, UK and Canada is a large-scale, multicenter, randomized controlled trial designed to compare the relative... more
    The OPTions In Management with Antiretrovirals (OPTIMA) Trial, a collaboration between three governmental agencies in the USA, UK and Canada is a large-scale, multicenter, randomized controlled trial designed to compare the relative efficacy of different therapeutic strategies in HIV disease. The collaboration of three coordinating centers introduced unique data management issues including: a) use of different data systems for managing “country” trial data; b) two-way data transfer between the coordinating centers and the center where OPTIMA data is merged and analysis files are generated; and c) translation of certain data forms (mainly patient completed questionnaires) into French and Spanish. The involvement of three data centers provided a challenge in planning, designing and executing data management procedures in OPTIMA. Processes were implemented to ensure the trial's successful execution at the trinational level, without disregarding countryspecific requirements and regu...
    Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD) is caused by mutations in the CYP21A2 gene. The study refers to CAH patients of Greek-Cypriot ancestry between years 2007 and 2018. One hundred and twenty... more
    Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD) is caused by mutations in the CYP21A2 gene. The study refers to CAH patients of Greek-Cypriot ancestry between years 2007 and 2018. One hundred and twenty patients with various degrees of CAH were categorized and genotyped. The patients were categorized in 4 mutation groups based on their clinical and biochemical findings. The majority of patients (85.0%) belonged to the non-classic (NC)-CAH form and the disorder was more often diagnosed in females (71.7%). The most severe classic salt-wasting (SW) form was identified in 11 neonates (9.2%). Seven (5.8%) children were also identified with the simple virilizing (SV) form and a median presentation age of 5 years [interquartile range (IQR) 3.2–6.5]. In the 240 nonrelated alleles, the most frequent mutation was p.Val281Leu (60.0%) followed by c.655 A/C>G (IVS2–13A/C>G) (8.8%), p.Pro453Ser (5.8%), DelEx1–3 (4.6%), p.Val304Met (4.6%), and p.Gln318stop (4.2...
    Background: Severe hypertension is an obstetric emergency. Timely identification and management can reduce risk of serious events. Aims of our study were to 1)assess whether severe hypertension is being recognized and managed within the... more
    Background: Severe hypertension is an obstetric emergency. Timely identification and management can reduce risk of serious events. Aims of our study were to 1)assess whether severe hypertension is being recognized and managed within the recommended time frame and 2)evaluate the factors that are associated with timely identification and treatment of severe maternal hypertension. Methods: A retrospective study of pregnant and postpartum women presenting with severe hypertension to tertiary care hospital between 1/1/19 to 12/1/19. Main outcome measures were ‘time to repeat blood pressure check(TTC)’ and ‘time interval between confirmation of severe hypertension and initiation of pharmacotherapy(TTT)’. We examined the association of the type of hospital unit, time of day of presentation and race/ethnicity with the outcome measures. Results: A total of 656 women were included in the study. Median time for repeat blood pressure check was 16 minutes. Only 46.2% of women had a repeat blood ...

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