Publications by authors named "Dipen Patel"

76 Publications

Skin-to-Skin Care by Mother vs. Father for Preterm Neonatal Pain: A Randomized Control Trial (ENVIRON Trial).

Int J Pediatr 2021 4;2021:8886887. Epub 2021 Jan 4.

Pramukhswami Medical College, Karamsad, Gujarat, India.

Objective: To compare skin-to-skin care (SSC) given by mother and father for preterm neonatal pain control by premature infant pain profile (PIPP) score.

Methods: 64 stable preterm (28-36 weeks gestational age) neonates born at a level-3 neonatal intensive care unit were included in the trial. Random allocation with the help of a computer-generated sequence was done. In group A, SSC was given by the mother 15 minutes before the first heel-stick, and subsequently, SSC was given by the father before the second heel-stick. In group B, the sequence of SSC provider was reversed. Blinded PIPP score assessment at 0, 1, and 5 minutes of heel-stick were done by two independent assessors using video recording.

Results: The mean (SD) birth weight was 1665.18 (339.35) grams, and mean (SD) gestational age was 34.28 (2.24) weeks. The PIPP score at 0, 1, and 5 minutes had no statistical or clinically significant differences between both groups (PIPP score mean (SD) at 0 minute = 3.20 (1.11) vs. 3.01 (1.29), value = 0.38; 1 minute = 8.59 (4.27) vs. 8.26 (4.08), value = 0.66; 5 minutes = 3.79 (1.40) vs. 3.93 (1.99), value = 0.65 in SSC by mother and father group, respectively). Furthermore, there was no statistical difference between the groups for any components of the PIPP score (all values > 0.05). The PIPP score at 5 minutes almost attained the 0-minute level in both the groups.

Conclusion: Father is as effective as the mother for providing skin-to-skin care for preterm neonatal pain control. This trial is registered with CTRI/2018/01/016783.
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http://dx.doi.org/10.1155/2021/8886887DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7803418PMC
January 2021

Efficacy and safety of anticoagulation in non-malignant portal vein thrombosis in patients with liver cirrhosis: a systematic review and meta-analysis.

Ann Gastroenterol 2021 2;34(1):104-110. Epub 2020 Oct 2.

Department of Gastroenterology and Hepatology, University of Toledo, Toledo, OH (Ali Nawras), USA.

Background: The role of anticoagulation in treating non-malignant portal vein (PV) thrombosis (PVT) in patients with liver cirrhosis remains unclear. In our meta-analysis, we aimed to evaluate the efficacy and safety of anticoagulation for the treatment of non-malignant PVT in these patients.

Methods: We conducted a meta-analysis to estimate the effects of anticoagulation on non-malignant PVT in patients with liver cirrhosis. We assessed the rates of PV recanalization, variceal bleeding, and any bleeding.

Results: We included 9 observational studies which involved 474 patients. The rate of PV recanalization was significantly higher in patients who received anticoagulation compared to those who did not: 65.2% vs. 25.2%; relative risk (RR) 2.31, 95% confidence interval (CI) 1.80-2.96; P<0.00001. Variceal bleeding was significantly lower in patients who received anticoagulation: 0.1% vs. 18.5%; RR 0.15, 95%CI 0.04-0.55; P=0.004. Any bleeding was similar between patients who received anticoagulation and those who did not: 10.3% vs. 22.7%; RR 0.43, 95%CI 0.09-1.99; P=0.28.

Conclusions: Anticoagulation use increased the rate of PV recanalization in cirrhotic patients with non-malignant PVT. Anticoagulation decreased the rate of variceal bleeding and did not increase the rate of any bleeding.
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http://dx.doi.org/10.20524/aog.2020.0544DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7774659PMC
October 2020

Comparability of European League Against Rheumatology-Recommended Pharmacological Treatments of Oral Ulcers Associated with Behçet's Disease: A Systematic Literature Review of Randomized Controlled Trials.

Open Access Rheumatol 2020 21;12:323-335. Epub 2020 Dec 21.

Division of Rheumatology and Systemic Inflammatory Diseases, University Hospital Hamburg Eppendorf and Clinic for Rheumatology and Immunology, Bad Bramstedt, Germany.

Objective: Oral ulcers are the cardinal manifestation in Behçet's disease (BD). The 2018 European League Against Rheumatism (EULAR) recommendations describe treatments for BD-associated oral ulcers with mucocutaneous involvement; however, little comparative effectiveness information for these agents is available. In the absence of head-to-head trials, an indirect treatment comparison (ITC) could provide useful evidence regarding comparative effectiveness of BD treatments. The purpose of this study was to conduct a comparative systematic literature review (SLR) and similarity assessment of randomized controlled trials (RCTs) investigating the oral ulcer-related efficacy outcomes of EULAR-recommended treatments for BD-associated oral ulcers to determine the feasibility of an ITC.

Methods: An SLR was performed to identify relevant RCTs indexed in MEDLINE/Embase before May 29, 2019. RCT similarities for the ITC were assessed based on a step-wise process recommended by the International Society for Pharmacoeconomics and Outcomes Research.

Results: In total, 317 articles were identified, of which 14 RCTs, reflecting 11 EULAR-recommended treatments, were evaluated in a similarity assessment. Number of oral ulcers, resolution of oral ulcers, and healing time for oral ulcers were identified as the possible oral ulcer-related outcomes. After completing the similarity assessment of these outcomes, it was determined that a robust ITC was infeasible for the three oral ulcer-related outcomes due to heterogeneity in outcomes reporting, study design, and/or patient characteristics. More broadly, the results underscore the need for and consistent use of standardized measures for oral ulcer outcomes to facilitate comparative research.

Conclusion: In the absence of head-to-head RCTs and infeasibility of quantitative ITC, comparative assessments for BD-associated oral ulcers are limited, including comparative effectiveness and cost-effectiveness evaluations. Healthcare decision-makers must continue to base treatment decisions on the extent and strength of available evidence (eg, robust RCTs), clinical guidelines, real-world experience, and patient considerations.
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http://dx.doi.org/10.2147/OARRR.S277036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7762439PMC
December 2020

Myocardial Infarction in a 28-Year-Old Male With Neurofibromatosis Type 1.

Cureus 2020 Oct 30;12(10):e11254. Epub 2020 Oct 30.

Internal Medicine, University of Toledo Medical Center, Toledo, USA.

Neurofibromatosis type 1 (NF1) is an autosomal dominant genetic disorder that affects multiple systems throughout the body. Although there are multiple documented vasculopathies that can be seen in NF1, there are very few documented cases of coronary artery aneurysms with complete thrombosis of the ectatic vessel resulting in myocardial infarction. This case report describes a 28-year-old male with a past medical history of NF1 who presented with an anterolateral ST-segment elevation myocardial infarction. He underwent urgent cardiac catheterization, which was significant for severe thrombotic occlusion of the mid-left anterior descending artery (LAD) with thrombolysis in myocardial infarction (TIMI) flow 0. The LAD was noted to be severely ectatic. Percutaneous coronary intervention (PCI) with thrombectomy was attempted and was unsuccessful, with TIMI flow 0 after the intervention attempt. An echocardiogram was performed, which showed left ventricular ejection fraction (LVEF) of 30%-35%. This case report is presented to familiarize physicians with the rare vasculopathies that can occur in patients with NF1. Occlusive or aneurysmal disease can occur almost anywhere in the body in patients with NF1 due to the proliferation of fusiform endothelial cells in the blood vessels.
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http://dx.doi.org/10.7759/cureus.11254DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7707125PMC
October 2020

A Cost per Responder Model for Abatacept versus Adalimumab Among Rheumatoid Arthritis Patients with Seropositivity.

Clinicoecon Outcomes Res 2020 15;12:589-594. Epub 2020 Oct 15.

Modeling and Meta-Analysis, Pharmerit International, Bethesda, MD, USA.

Purpose: The primary objective of this study was to compare the cost per responder (CPR) between abatacept and adalimumab among seropositive rheumatoid arthritis (RA) patients.

Patients And Methods: CPR analysis was conducted from a US payer perspective over 24 weeks for early moderate-to-severe seropositive RA patients. Efficacy data (American College of Rheumatology [ACR] improvement criteria [ACR20/50/70] and DAS28-C reactive protein <2.6) for abatacept and adalimumab were sourced from the post hoc analysis of the Early AMPLE trial (NCT02557100). Medication costs were considered assuming complete adherence. A 30% rebate was applied for adalimumab in the base case.

Results: At week 24, the total per patient pharmacy cost was $26,273.34 and $21,731.18, whereas the CPR (using ACR70 as the responder definition) was $46,337.46 and $74,935.10 (difference of -$28,597.64) for abatacept and adalimumab, respectively. The CPR was consistently lower for abatacept compared to adalimumab across all clinical measures, with differences ranging from -$7099.32 to -$43,608.97.

Conclusion: While the pharmacy cost was higher for abatacept compared to adalimumab, due to its higher clinical efficacy, the CPR was consistently lower for seropositive RA patients treated with abatacept. The results may be useful for healthcare decision-makers in understanding how to optimize treatment for seropositive RA patients while minimizing costs in today's budget-constrained health environment.
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http://dx.doi.org/10.2147/CEOR.S263903DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571575PMC
October 2020

Prescribing in personality disorder: patients' perspectives on their encounters with GPs and psychiatrists.

Fam Med Community Health 2020 09;8(4)

Leicestershire Partnership NHS Trust, Leicester, UK.

Objective: The purpose of this study was to explore the views of patients with personality disorder on their experiences of prescribing practices by general practitioners (GPs) and psychiatrists, and their expectations of primary and secondary mental health services.

Design: This was a qualitative study involving two focus groups. Discussion in the focus groups was recorded, transcribed verbatim and then analysed by a thematic analysis process to generate the key themes.

Setting: The study took place at a specialist outpatient personality disorder service in the UK.

Participants: A total of seven participants took part in the study. They were purposively sampled from an NHS specialist outpatient personality disorder service. All participants had a primary diagnosis of emotionally unstable personality disorder and their age ranged from 20 to 52 years.

Results: Five key themes emerged. Participants felt that medication has a powerful impact on their mind and body but expressed confusion and uncertainty on how it is affecting them. Participants had a need for a good relationship with their doctors (GPs or psychiatrists). They described a feeling of being dismissed and not believed, expressing a desire to confront the 'powerful' position of their doctors by showing anger. The nature of the doctor-patient relationship was seen to moderate positively or negatively the experience of doctors' prescribing. Finally, there were key expectations of the primary-secondary care interface, including continuity of care, diagnostic clarity and a desire for different healthcare professionals to communicate with one another.

Conclusion: The doctor-patient relationship is an important medium for providing validation and seeking negotiation of therapeutic treatment strategies in patients with personality disorder. Given that personality disorder is associated with high rates of physical and mental health comorbidity, it is therefore vital for clinical guidelines and training packages to take more account of the relational aspects of prescribing in consultations for this patient group with a view to improve outcomes.
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http://dx.doi.org/10.1136/fmch-2020-000458DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7507887PMC
September 2020

Incidental Ascending Colon Ganglioneuroma in the Setting of Hematochezia.

Cureus 2020 Jul 28;12(7):e9447. Epub 2020 Jul 28.

Gastroenterology and Hepatology, University of Toledo Medical Center, Toledo, USA.

Ganglioneuromas are slow-growing hamartomatous tumors that are rarely found in the colon. There are three subtypes of ganglioneuromas: polypoid ganglioneuroma, ganglioneuromatous polyposis, and diffuse ganglioneuromatosis. They are differentiated depending on their endoscopic and histological characteristics. Patients with colonic ganglioneuroma may present with nonspecific symptoms; however, they are usually asymptomatic. We present a case of hematochezia, where an ascending colon ganglioneuroma was found incidentally on diagnostic colonoscopy. We will explain how to distinguish the three subtypes of ganglioneuroma on colonoscopy and will mention the genetic disorders associated with them. We will also discuss the treatment of ganglioneuromas.
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http://dx.doi.org/10.7759/cureus.9447DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7451080PMC
July 2020

Epidemiologic, humanistic and economic burden of hepatocellular carcinoma in the USA: a systematic literature review.

Hepat Oncol 2020 Jul 21;7(3):HEP27. Epub 2020 Jul 21.

AstraZeneca, Gaithersburg, MD 20878, USA.

Aim: To describe the epidemiologic, humanistic and economic burdens of hepatocellular carcinoma (HCC) in the USA.

Materials & Methods: Studies describing the epidemiology and economic burden from national cohorts, any economic models, or any humanistic burden studies published 2008-2018 were systematically searched.

Results: HCC incidence was 9.5 per 100,000 person-years in most recent data, but was ∼100-times higher among patients with hepatitis/cirrhosis. Approximately a third of patients were diagnosed with advanced disease. Patients with HCC experienced poor quality of life. Direct costs were substantial and varied based on underlying demographics, disease stage and treatment received. Between 25-77% of patients did not receive surgical, locoregional or systemic treatment.

Conclusion: Better treatments are needed to extend survival and improve quality of life for patients with HCC.
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http://dx.doi.org/10.2217/hep-2020-0024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7399607PMC
July 2020

Embrace versus Cloth Wrap in preventing neonatal hypothermia during transport: a randomized trial.

J Perinatol 2021 Feb 20;41(2):330-338. Epub 2020 Jul 20.

Department of Pediatrics, Pramukhswami Medical College, Karamsad, India.

Background: We assessed the efficacy of Embrace Nest Infant Warmer versus Cloth Wrap in preventing hypothermia during short-term transport from the emergency department (ED) to the neonatal intensive care unit (NICU).

Methods: Neonates weighing ≥1500 g coming to the ED were randomized for transport to the NICU. Axillary temperature was measured.

Results: A total of 120 newborns (60 per group) were enrolled. From ED exit to NICU entry, the mean (SD) temperature increased in the Embrace group by 0.37 °C (0.54), whereas it reduced by 0.38 °C (0.80) in the Cloth group (p < 0.001). Hypothermia cases reduced in the Embrace group from 39 (65%) to 21 (35%), while it increased from 21 (35%) to 39 (65%) in the Cloth group (p = 0.001) from ED exit to NICU entry. The thermoregulation for 24 h after admission to the NICU was superior in the Embrace group.

Conclusions: Embrace showed significantly better thermoregulation in neonates. Further studies should be done to measure its effectiveness in different environments and distances.
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http://dx.doi.org/10.1038/s41372-020-0734-xDOI Listing
February 2021

Obstructing Pancreatic Ductal Calculus: A Case Report and Literature Review.

Cureus 2020 Apr 18;12(4):e7730. Epub 2020 Apr 18.

Internal Medicine, Promedical Toledo Hospital, Toledo, USA.

Pancreatic calculi are typically a sequela of chronic pancreatitis. Here, we present a patient who was found to have an obstructing one-centimeter pancreatic calculus secondary to recurrent gallstone pancreatitis. Recent retrospective studies have focused on the optimal treatment of large pancreatic calculi that were defined as greater than five millimeters. But most studies fail to comment on much larger stone as in this case report. Further guidelines and investigation need to be done aiming toward the optimal treatment of relatively large pancreatic stones.
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http://dx.doi.org/10.7759/cureus.7730DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7233929PMC
April 2020

Blinded randomized crossover trial: Skin-to-skin care vs. sucrose for preterm neonatal pain.

J Perinatol 2020 06 9;40(6):896-901. Epub 2020 Mar 9.

Pramukhswami Medical College, Anand, Gujarat, India.

Objective: To compare skin-to-skin care (SSC) and oral sucrose for preterm neonatal pain control.

Methods: Preterm neonates (28-36 weeks gestation) requiring heel-stick were eligible. In group-A, SSC was given 15-min before first heel-stick, and sucrose was given 2-min before second heel-stick. In group-B, the sequence was reversed. Blinded premature infant pain profile (PIPP) score assessment was done at 0, 1, and 5-min of heel-stick by two assessors.

Results: A hundred neonates were enrolled. The inter-rater agreement for the PIPP score was good. The behavior state component was significantly lower in the sucrose group at all assessment points. The mean (SD) difference between 1-min and 0 min was similar [SSC 3.58(3.16) vs. sucrose 4.09(3.82), p = 0.24] between groups. The PIPP score attained baseline values at 5-min in both groups.

Conclusion: Albeit sucrose indicated instantaneous action, SSC and sucrose have comparable clinical efficacy for preterm neonatal pain control. Multisensory stimulation with SSC may result in a higher behavioral state component of the PIPP score.
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http://dx.doi.org/10.1038/s41372-020-0638-9DOI Listing
June 2020

Phosphodiesterase Type-5 Inhibitor Prescription Patterns in the United States Among Men With Erectile Dysfunction: An Update.

J Sex Med 2020 05 3;17(5):941-948. Epub 2020 Mar 3.

Patient & Health Impact, Pfizer Inc, New York, NY, USA.

Background: While phosphodiesterase type-5 inhibitors (PDE5Is) are highly effective for the treatment of erectile dysfunction (ED) and well tolerated, updated data on prescription patterns have been limited in real-world settings.

Aim: To describe men in the United States who are prescribed PDE5Is for ED treatment and to evaluate patterns of initiation, switching, and treatment overlap.

Methods: This retrospective claims study used MarketScan Commercial and Medicare Supplement Databases from January 1, 2010, to December 31, 2015, to identify initial PDE5I claims (index date) for sildenafil, tadalafil, and/or vardenafil. Adults aged ≥18 years with ED were identified between July 1, 2010, and December 31, 2014, allowing for a 6-month preindex and 12-month follow-up period from the index date.

Outcomes: Outcomes included patient demographics and treatment-related patterns after treatment initiation.

Results: A total of 106,206 identified patients met all inclusion criteria. Of these, 51,694, 40,193, and 14,319 had initial claims for sildenafil, tadalafil, and vardenafil, respectively. Mean age was 50.35 years, and comorbidities included dyslipidemia (44.17%), hypertension (43.09%), diabetes (15.32%), and depression (10.61%). More patients (48.67%) initiated on sildenafil than tadalafil (37.85%) or vardenafil (13.48%). Rate of switching was lower in the 60 days after the end of day supply of the initial prescription in the sildenafil cohort (2.71%) compared with the tadalafil (2.81%) and vardenafil (3.88%) cohorts (P < .001 for sildenafil vs tadalafil or vardenafil). Treatment overlap was lower in the sildenafil cohort (0.35%) than in the tadalafil (0.75%) and vardenafil (0.62%) groups (P < .001 for sildenafil vs tadalafil or vardenafil).

Clinical Implications: These findings provide insight into updated patterns of PDE5I prescriptions in the United States and may aid in clinical decision-making.

Strengths & Limitations: Strengths include the large sample size, long data coverage period, and the real-world nature of the study. Limitations include the retrospective study design, use of data collected with a primary focus of claims, and lack of further details regarding reasons that drive switching. Actual rates of ED and impact on prescription patterns may be underestimated because the claims database only captured patients electing to visit a health-care provider.

Conclusion: Among men with ED in the United States, rates of switching and treatment overlap were low for all PDE5Is but were found to be the lowest for sildenafil compared with tadalafil and vardenafil. Mulhall JP, Chopra I, Patel D, et al. Phosphodiesterase Type-5 Inhibitor Prescription Patterns in the United States Among Men With Erectile Dysfunction: An Update. J Sex Med 2020;17:941-948.
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http://dx.doi.org/10.1016/j.jsxm.2020.01.027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546517PMC
May 2020

Intrathoracic kidney within bochdalek hernia: A diagnosis of high index suspicion.

Saudi J Kidney Dis Transpl 2020 Jan-Feb;31(1):263-265

Department of Urology, Ruby Hall Clinic, Pune, Maharashtra, India.

Intrathoracic kidney is a rare developmental anomaly representing <5% of all ectopic kidneys. Here, we present a case of a 60-year-old woman who presented with nonspecific abdominal pain for two years, on and off in nature. She was investigated and found to have intrathoracic kidney within Bochdalek hernia. The idea of presenting the case is to have familiarity with this rare condition and keep a high index of suspicion to diagnose the same.
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http://dx.doi.org/10.4103/1319-2442.279950DOI Listing
January 2021

A budget impact analysis for making treatment decisions based on anti-cyclic citrullinated peptide (anti-CCP) testing in rheumatoid arthritis.

J Med Econ 2020 Jun 19;23(6):624-630. Epub 2020 May 19.

Pharmerit North America LLC - Modeling and Meta-Analysis, Bethesda, MD, USA.

Given that rheumatoid arthritis (RA) patients with high anti-citrullinated protein antibodies (ACPA) titer values respond well to abatacept, the aim of this study was to estimate the annual budget impact of anti-cyclic citrullinated peptide (anti-CCP) testing and treatment selection based on anti-CCP test results. Budget impact analysis was conducted for patients with moderate-to-severe RA on biologic or Janus kinase inhibitor (JAKi) treatment from a hypothetical US commercial payer perspective. The following market scenarios were compared: (1) 90% of target patients receive anti-CCP testing and the results of anti-CCP testing do not impact the treatment selection; (2) 100% of target patients receive anti-CCP testing and the results of anti-CCP testing have an impact on treatment selection such that an increased proportion of patients with high titer of ACPA receive abatacept. A hypothetical assumption was made that the use of abatacept would be increased by 2% in Scenario 2 versus 1. Scenario analyses were conducted by varying the target population and rebate rates. In a hypothetical health plan with one million insured adults, 2,181 patients would be on a biologic or JAKi treatment for moderate-to-severe RA. In Scenario 1, the anti-CCP test cost was $186,155 and annual treatment cost was $101,854,295, totaling to $102,040,450. In Scenario 2, the anti-CCP test cost increased by $20,684 and treatment cost increased by $160,467, totaling an overall budget increase of $181,151. This was equivalent to a per member per month (PMPM) increase of $0.015. The budget impact results were consistently negligible across the scenario analyses. The analysis only considered testing and medication costs. Some parameters used in the analysis, such as the rebate rates, are not generalizable and health plan-specific. Testing RA patients to learn their ACPA status and increasing use of abatacept among high-titer ACPA patients result in a small increase in the total budget (<2 cents PMPM).
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http://dx.doi.org/10.1080/13696998.2020.1732991DOI Listing
June 2020

The Level and Sources of Stress in Mothers of Infants Admitted in Neonatal Intensive Care Unit.

Indian J Psychol Med 2019 Jul-Aug;41(4):338-342

Central Research Services, HM Patel Center for Medical Care and Education, Karamsad, Gujarat, India.

Background: Hospitalization of a new-born child is stressful for parents. This study was done to determine the level and sources of stress in mothers of infants admitted in Neonatal Intensive Care Unit (NICU) and variance in stress by infant and maternal characteristics.

Materials And Methods: Parental Stressor Scale for NICU was used as the primary outcome measure. Maternal socio-demography, maternal and infant characteristics such as gravidity, number of prenatal visits, perceived support from family members, perceived level of discomfort that the baby underwent, pregnancy and delivery complications, gestational age, sex, birth weight, length of NICU stay and ventilator support, and neonatal morbidity were also collected from maternal and infant hospital records.

Results: Amongst these rural and poorly educated mothers, the appearance of the baby, sights and sounds of NICU environment were major sources of stress. Higher maternal stress was found to be associated with poor family support during pregnancy, mothers' perception of the baby's discomfort, lower birth weight of the baby, baby on ventilator, post-partum depression, and moderate to severe anxiety symptoms. Mothers who had higher levels of education and those with pregnancy complications were more stressed.

Conclusions: Before designing remediation programs for parents, local demography and the predominant NICU stressors need to be kept in mind. Possibility of screening at-risk mothers by questioning them about perception of baby's discomfort needs to be evaluated further.
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http://dx.doi.org/10.4103/IJPSYM.IJPSYM_415_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6657484PMC
August 2019

Cost-Effectiveness of Early Treatment with Originator Biologics or Their Biosimilars After Methotrexate Failure in Patients with Established Rheumatoid Arthritis.

Adv Ther 2019 08 30;36(8):2086-2095. Epub 2019 May 30.

Pfizer Inc, New York, NY, USA.

Introduction: Evidence supports the clinical benefits of early aggressive biologic treatment in patients with rheumatoid arthritis (RA) who have an inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but the cost-effectiveness of early intervention with originator biologics such as tumor necrosis factor inhibitors (TNFis) or their biosimilars has not been well studied.

Methods: We developed a Markov model to estimate lifetime costs and utilities for patients with established RA who do not respond to methotrexate (MTX) therapy. A cost-effectiveness analysis was conducted comparing a standard intervention pathway (addition of originator biologic TNFis to MTX monotherapy at 12 months) and two early intervention pathways (either addition of originator biologic TNFis or addition of biosimilar TNFis to MTX monotherapy at 6 months).

Results: Early intervention with an originator biologic TNFi at 6 months was associated with increases in total lifetime costs of £1692 and utilities of 0.10 quality-adjusted life-years (QALYs) per patient compared with standard intervention at 12 months, resulting in an incremental cost-effectiveness ratio (ICER) of £17,335/QALY. Early intervention with a biosimilar TNFi increased costs by £70 and utilities by 0.10 QALYs per patient and was associated with an ICER of £713/QALY.

Conclusion: Switching from MTX monotherapy to combination therapy with either an originator biologic or biosimilar TNFis at 6 months after csDMARD failure in patients with RA was cost-effective at a threshold of £30,000/QALY.

Funding: Pfizer Inc.
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http://dx.doi.org/10.1007/s12325-019-00986-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6822985PMC
August 2019

A time-motion analysis of the mothers staying in the neonatal care unit.

J Family Med Prim Care 2019 Mar;8(3):1129-1133

Department of Pediatrics, Shree Krishna Hospital, Pramukhswami Medical College, Anand, Gujarat, India.

Context: In addition to various barriers studied for kangaroo mother care (KMC), time opportunities for better implementation of KMC need to be studied.

Aim: Time-motion analysis of the mother's daily activities was carried out to identify scope to improve KMC.

Settings And Design: This is a 24-h recall-based questionnaire study. Mothers were interviewed whose newborns were admitted at a tertiary and secondary care neonatal care unit of western India over a period of 9 months from November 2015 to July 2016.

Materials And Methods: Mothers were approached when the preterm neonate and mother dyad was eligible for KMC, that is, when mothers were physically healthy and newborns were physiologically stable. A total of 60 mothers were enrolled in the study. Mothers' daily activities were noted, and time spent in each activity was charted for 3 consecutive days. Missed time opportunities which could be used to increase daily KMC hours were studied.

Statistical Analysis Used: To compare quantitative variables, two-sample unpaired -test and one-way analysis of variance were used.

Results: The average time of activities which consumed most was 8.24 h for sleep/rest, 3.46 h for meals/snacks, 4.89 h for breastfeeding, and a daily average of only 1.4 h was used for KMC. A quite a significant proportion, that is, 3.89 h, was spent for meeting relatives which could be used for KMC as well without affecting social meetings.

Conclusion: Time-motion analysis was helpful to find out weak links in KMC implementation. Providing family-centered environment in terms of implementing KMC during meeting hours with family may augment KMC hours.
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http://dx.doi.org/10.4103/jfmpc.jfmpc_348_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6482785PMC
March 2019

Cost-Effectiveness of Alemtuzumab in the Treatment of Relapsing Forms of Multiple Sclerosis in the United States.

Value Health 2019 02 6;22(2):168-176. Epub 2018 Dec 6.

Sanofi, Cambridge, MA, USA. Electronic address:

Objective: To evaluate the cost-effectiveness of alemtuzumab compared with fingolimod, natalizumab, ocrelizumab, and generic glatiramer acetate 20 mg among patients with relapsing multiple sclerosis (RMS) in the United States.

Study Design: Markov model with annual periods from payer perspective.

Methods: The modeled population represented pooled patients from the CARE-MS I and II trials. Therapies' comparative efficacy at reducing relapses and slowing disability worsening was obtained from network meta-analyses. Safety information was extracted from package inserts. Withdrawal rates, treatment waning, resource use, cost, and utility inputs were derived from published studies and clinical expert opinion. To project the natural history of disease worsening, data from the British Columbia cohort was used.

Results: Alemtuzumab dominated comparators by accumulating higher total quality-adjusted life-years (QALYs) (8.977) and lower total costs ($421 996) compared with fingolimod (7.955; $1 085 814), natalizumab (8.456; $1 048 599), ocrelizumab (8.478; $908 365), and generic glatiramer acetate (7.845; $895 661) over a 20-year time horizon. Alemtuzumab's dominance was primarily driven by savings in treatment costs because alemtuzumab has long-term duration of response and is initially administered as 2 annual courses, with 36.1% of patients requiring retreatment over 5 years, whereas comparators are used chronically. In model scenarios where alemtuzumab's long-term duration of response was assumed not to hold and therapy had to be administered annually, probabilistic sensitivity analyses showed that alemtuzumab remained cost-effective versus ocrelizumab at a willingness-to-pay threshold of $100 000/QALY in 74% to 100% of model runs.

Conclusions: Alemtuzumab was a cost-effective therapy. Model results should be used to optimize clinical and managed care decisions for effective RMS treatment.
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http://dx.doi.org/10.1016/j.jval.2018.08.011DOI Listing
February 2019

Treatment patterns and healthcare resource utilization among patients with hereditary angioedema in the United States.

Orphanet J Rare Dis 2018 10 12;13(1):180. Epub 2018 Oct 12.

CSL Behring, King of Prussia, PA, USA.

Background: Real-world data on usage and associated outcomes with hereditary angioedema (HAE)-specific medications introduced to the United States (US) market since 2009 are very limited. The purpose of this retrospective study was to evaluate real-world treatment patterns of HAE-specific medications in the US and to assess their impact on healthcare resource utilization (HCRU). This analysis used IMS PharMetrics PlusTM database records (2006-2014) of patients with HAE, ≥1 insurance claim for an HAE-specific medication, and continuous insurance enrollment for ≥3 months following the first HAE prescription claim.

Results: Of 631 total patients, 434 (68.8%) reported C1-INH(IV) use; 396 (62.8%) reported using ecallantide and/or icatibant. There were 306 episodes of prophylactic use of C1-INH(IV) (defined by continuous refills averaging ≥1500 IU/week for ≥13 weeks) in 155 patients; use of ≥1 on-demand rescue medication was implicated during 53% (163/306) of those episodes. Sixty-eight (20.2%) of 336 C1-INH(IV) users eligible for the HCRU analysis were hospitalized at least once, and 191 (56.8%) visited the emergency department (ED). Eighteen patients (5.4%) had a central venous access device (CVAD); of these, 5 (27.7%) required hospitalization and 14 (77.7%) had an ED visit. The adjusted relative risk of hospitalization and/or ED visits for patients with a CVAD was 2.6 (95% CI: 0.17, 39.23) compared to C1-INH(IV) users without a CVAD.

Conclusions: Despite widespread availability of modern HAE medications in the US, we identified a subset of patients requiring long-term prophylaxis who continue to be burdened by frequent rescue medication usage and/or complications related to the use of CVADs for intravenous HAE medication.
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http://dx.doi.org/10.1186/s13023-018-0922-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6186115PMC
October 2018

Adaptation of Subtests of Kaufman Assessment Battery for Children, Second Edition for Gujarati Pre-school Children.

Indian J Psychol Med 2018 Sep-Oct;40(5):420-425

Department of Pediatrics, Pramukhswami Medical College, Shree Krishna Hospital, Karamsad, Anand, Gujarat, India.

Context: Cognition testing is frequently used in children to assess their intelligence for various needs. Abundant tests to assess cognition are available in the western world. The paucity of such tests for use in Gujarati population necessitates their adaptation for Gujarati culture.

Aims: To adapt three subtests (Number Recall, Word Order, and Triangles) of Kaufman Assessment Battery for Children, Second Edition for Gujarati-speaking preschool age children using priori (judgemental) procedures of test adaptation process.

Settings And Design: This was a prospective study of test adaptation process carried out in three kindergarten schools of Gujarat.

Subjects And Methods: Three subtests were translated and adapted into Gujarati. A pilot study evaluating the applicability and appropriateness of the adapted version of the three tests was done, and the results of these raw scores were compared with English tests' scores. Of 68 children (age 3-6 years) who completed the pilot study, 15 boys and 15 girls 4-6 years of age were randomly selected to perform English tests for agreement between English and the adapted versions.

Statistical Analysis Used: Agreement between the adapted and English versions of the tests was measured.

Results: During adaptation, modifications were required only in the items of the Word order subtest. All children were able to understand and perform the test. Triangles did not require adaptation or modifications in test items. The agreement between raw scores of the two versions was good for both "Number Recall" (mean difference = 0.8, 95% confidence limits: -2.6, 4.1) and "Word Order" (mean difference = 0.6, 95% confidence limits: -3.2, 4.4).

Conclusion: Adaptation of three subtests of KABC-II using , that is, judgemental, procedure was suitable for Gujarati-speaking preschool children.
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http://dx.doi.org/10.4103/IJPSYM.IJPSYM_104_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6149313PMC
October 2018

Cost-effectiveness analysis of voriconazole, fluconazole, and amphotericin B for invasive fungal infections following allogeneic hematopoietic stem cell transplantation in Mexico.

Clinicoecon Outcomes Res 2018 6;10:511-520. Epub 2018 Sep 6.

Pfizer International Operations, Paris, Île-de-France, France,

Background: Patients receiving allogeneic hematopoietic stem cell transplantation (alloHSCT) are at high risk of invasive fungal infections (IFIs), which are associated with high mortality and economic burden. The cost-effectiveness of prophylaxis for the prevention of IFIs in alloHSCT recipients in Mexico has not yet been assessed.

Methods: This analysis modeled a hypothetical cohort of 1,000 patients to estimate costs and outcomes for patients receiving prophylaxis for IFIs following alloHSCT, from the perspective of institutional payers in Mexico. The main prophylaxis agents currently used in Mexican clinical practice are voriconazole, fluconazole, and amphotericin B (AmB). The model accounted for event rates of IFIs during each treatment, assuming IFI causality due to invasive aspergillosis, invasive candidiasis, or other IFIs, and that the outcome for patients during follow-up was IFI-related death, death from other causes, or survival. Clinical efficacies were obtained from published literature; costs were based on local sources. Cost-effectiveness was assessed using incremental cost-effectiveness ratios (ICERs). Univariate (assessing the impact of varying each model parameter) and probabilistic sensitivity analyses were performed.

Results: Voriconazole was associated with the lowest number of breakthrough IFIs, IFI-related deaths, and total number of deaths. Total costs were lower for fluconazole (Mexican pesos [MXN] 72,944; US $4,079) than voriconazole (MXN 101,413; US $5,671) or AmB (MXN 110,529; US $6,180). Voriconazole had better clinical outcomes and lower costs than AmB and could be considered cost-effective compared with fluconazole in line with the local ICER threshold. Drug costs, monitoring costs, and duration of prophylaxis were most sensitive to variation from univariate sensitivity analysis. Findings from the probabilistic sensitivity analysis were consistent with the base-case results.

Conclusion: Voriconazole had the most favorable clinical outcomes, but overall prophylaxis costs were higher than with fluconazole. Overall, based on local ICER thresholds (MXN 184,665; US $10,326), voriconazole was considered a cost-effective option for prophylaxis of IFI in Mexico.
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http://dx.doi.org/10.2147/CEOR.S157642DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6130275PMC
September 2018

Oral corticosteroid exposure and increased risk of related complications in patients with noninfectious intermediate, posterior, or panuveitis: Real-world data analysis.

Ophthalmic Epidemiol 2019 02 10;26(1):27-46. Epub 2018 Sep 10.

a Real-World Evidence , Pharmerit International , Bethesda , MD , USA.

Purpose: This study causally examined the dose-response relationship between oral corticosteroids (OCS) exposure and long-term complications among noninfectious uveitis adult patients in the United States.

Methods: The study design was longitudinal, retrospective cohort using Truven Health MarketScan claims database years 2000-2015. The index date was the first day after diagnosis on which OCS≥ 5 mg prednisone equivalent was administered. The period following the index date was parsed into quarters for tracking OCS-related complications; follow-up time was censored when patients switched off of OCS monotherapy. Each quarter of follow-up was divided into 4 groups based on the mean cumulative daily OCS dose (< 7.5 mg; 7.5 to < 30 mg; 30 to < 60 mg; and ≥ 60 mg) and covariate balancing propensity scoring was used to balance groups on baseline characteristics in the first quarter post-index. Marginal structural models (MSMs) were employed to account for time-varying endogeneity between temporal changes in mean cumulative OCS dose and the risk of complications. Patients with systemic autoimmune conditions at baseline were excluded.

Results: The study sample included 3966 patients with a median follow-up of 2 years. Compared to those receiving < 7.5 mg, patients with higher mean cumulative OCS dose had 10%, 16%, and 28% higher risk, respectively, of any OCS-related complication in any given quarter.

Conclusions: A moderate dose-response relationship was found between the long-term use of OCS monotherapy and the risk of developing complications in noninfectious intermediate, posterior, or panuveitis patients. Future research should examine optimal approaches to achieve inflammation control while minimizing OCS exposure.
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http://dx.doi.org/10.1080/09286586.2018.1513042DOI Listing
February 2019

Efficacy of Polyethylene Skin Wrapping in Preventing Hypothermia in Preterm Neonates (<34 Weeks): A Parallel Group Non-blinded Randomized Control Trial.

J Trop Pediatr 2019 Apr;65(2):122-129

Central Research Services, Charutar Arogya Mandal, Karamsad, Gujarat, India.

Objective: The objective of this study was to determine the efficacy of polyethylene skin wrapping on thermoregulation in preterm neonates.

Methods: Total 151 neonates were enrolled in this randomized control trial. In the control group, neonates were transferred to the radiant warmer and covered with warm cloth after initial care. In the study group, neonates were transferred to the radiant warmer and placed in a food-grade polyethylene bag for 1 h. Axillary temperature of all neonates was recorded for first 24 h at frequent time intervals.

Results: Mean temperature reached to normal range earlier and remained significantly higher in the study group for most time intervals, and this difference persisted even at 24 h. Significantly less number of preterm newborns suffered from hypothermia in the study group as compared with the control group [50 (67.6%) vs. 67 (87%), p = 0.004].

Conclusions: Polyethylene wraps achieved rapid, sustained thermal control and were effective in preventing hypothermia in preterm newborns.
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http://dx.doi.org/10.1093/tropej/fmy025DOI Listing
April 2019

Prevalence of vitamin D deficiency in adult patients admitted to a psychiatric hospital.

BJPsych Bull 2018 Jun 2;42(3):123-126. Epub 2018 May 2.

Leicestershire Partnership NHS Trust,Leicester,UK.

Aims and methodVitamin D deficiency is increasing in the general population, and is linked with physical and mental illness. However, evidence on its prevalence in people with mental illness is limited. This study investigated vitamin D deficiency in 104 adult patients admitted to a psychiatric hospital in the UK.

Results: Forty-nine per cent were vitamin D deficient (serum 25(OH)D 50 nmol/L). There were no statistically significant differences in mean serum vitamin D between different subgroups of mental illness.Clinical implicationsVitamin D deficiency is highly prevalent among individuals with severe mental illness admitted to hospital. Assessment and treatment of vitamin D deficiency should be considered in in-patients to protect musculoskeletal health. Further epidemiological and intervention studies are needed to investigate the role of vitamin D in the pathophysiology of mental disorders.Declaration of interestNone.
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http://dx.doi.org/10.1192/bjb.2017.34DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6048729PMC
June 2018

Educational intervention to improve intravenous cannulation skills in paediatric nurses using low-fidelity simulation: Indian experience.

BMJ Paediatr Open 2017 22;1(1):e000148. Epub 2017 Dec 22.

Department of Physiology, Pramukhswami Medical College, Karamsad, Gujarat, India.

Introduction: Inserting, monitoring and maintaining intravenous access are essential components of nursing. We evaluated simulation training on a manikin to improve cannulation skills.

Methods: Nursing staff managing paediatric patients were asked to cannulate NITA Newborn-1800 manikin before and after appropriate training. Skills were assessed by a single assessor using an objective structured clinical examination (OSCE) checklist. Four steps were identified as critical. A score of 8/10 (80%) was considered satisfactory. Knowledge was assessed by 10 questions. A training module consisting of theoretical aspects, PowerPoint presentations, videos and hands on training over a manikin was conducted. Post-training assessment was done 1 week later.

Results: Seventy-five (80.6%) nurses who completed preassessments and postassessments were assessed for paired comparisons of knowledge and skill. The majority of the nurses were females, had contractual appointment, were in their early career phase and from the paediatric wards. The mean (SD) post-training knowledge score was greater vis-a-vis pretraining score (7.52 (1.58) vs 5.32 (1.57), P<0.001). A similar result was observed for total OSCE scores (9.22 (0.66) vs 7.91 (1.11), P<0.001). Significantly higher proportion of participants exhibited intravenous cannulation satisfactorily after the training vis-a-vis pretraining assessment (69 (92%) vs 36 (48%), P<0.001).

Conclusion: Training using manikin showed improvement in post-training score of intravenous cannulation skill of paediatric nurses; however, this finding needs further confirmation by a randomised control trial, as our study does not have a control group.
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http://dx.doi.org/10.1136/bmjpo-2017-000148DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5862185PMC
December 2017

Poverty, population density, and the epidemiology of burns in young children from Mexico treated at a U.S. pediatric burn facility.

Burns 2018 08 7;44(5):1269-1278. Epub 2018 Mar 7.

Shriners Hospitals for Children in Galveston Texas, 77550, USA; Department of Surgery at the University of Texas Medical Branch, Galveston, TX 77555, USA.

Introduction: Children 5 and younger are at risk for sustaining serious burn injuries. The causes of burns vary depending on demographic, cultural and socioeconomic variables. At this pediatric burn center we provided medical care to children from Mexico with severe injuries. The purpose of this study was to understand the impact of demographic distribution and modifiable risk factors of burns in young children to help guide prevention.

Methods: A retrospective chart review was performed with children 5 and younger from Mexico who were injured from 2000-2013. The medical records of 447 acute patients were reviewed. Frequency counts and percentages were used to identify geographic distribution and calculate incidence of burns. Microsoft Powermap software was used to create a geographical map of Mexico based on types of burns. A binomial logistic regression was used to model the incidence of flame burns as opposed to scald burns in each state with relation to population density and poverty percentage. In all statistical tests, alpha=0.05 for a 95% level of confidence.

Results: Burns were primarily caused by flame and scald injuries. Admissions from flame injuries were mainly from explosions of propane tanks and gas lines and house fires. Flame injuries were predominantly from the states of Jalisco, Chihuahua, and Distrito Federal. Scalds were attributed to falling in large containers of hot water or food on the ground, and spills of hot liquids. Scald injuries were largely from the states of Oaxaca, Distrito Federal, and Hidalgo. The odds of a patient having flame burns were significantly associated with poverty percentage (p<0.0001) and population density (p=0.0085). Increasing levels of poverty led to decrease in odds of a flame burn, but an increase in the odds of scald burns. Similarly, we found that increasing population density led to a decrease in the odds of a flame burn, but an increase in the odds of a scald burn.

Conclusions: Burns in young children from Mexico who received medical care at this pediatric burn center were attributed to flame and scalds. Potential demographic associations have been identified. Different states in Mexico have diverse cultural and socioeconomic variables that may influence the etiology of burns in young children and this information may help efficiently tailor burn prevention campaigns for burn prevention efforts in each region.

Applicability Of Research To Practice: This information will be used to develop and help modify existing prevention campaigns.
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http://dx.doi.org/10.1016/j.burns.2018.02.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6453533PMC
August 2018

Effective Antimicrobial Stewardship Strategies for Cost-effective Utilization of Telavancin for the Treatment of Patients With Hospital-acquired Bacterial Pneumonia Caused by Staphylococcus aureus.

Clin Ther 2018 03 15;40(3):406-414.e2. Epub 2018 Feb 15.

Albany College of Pharmacy and Health Sciences, Albany, Maryland.

Purpose: Clinicians and stewardship programs are challenged with positioning of novel, higher priced antibiotic agents for the treatment of clinical infections. We developed a decision-analytic model to describe costs, including drug, total treatment costs, and health care outcomes, associated with telavancin (TLV) compared with vancomycin (VAN) for patients with Staphylococcus aureus (SA) hospital-acquired bacterial pneumonia (HABP).

Methods: This decision-analytic model assessed the treatment of SA-HABP with TLV versus VAN. Data were obtained from the ATTAIN (Assessment of Telavancin for Treatment of Hospital-Acquired Pneumonia) clinical trials on the following: the probability of clinical cure; probability of nephrotoxicity; and prevalence of polymicrobial infection (30%), methicillin-resistant Staphylococcus aureus (MRSA) (68%), and SA with VAN MIC ≥1 µg/mL (85%). Data on length of stay for cure (10 days), failure (10 additional days), and nephrotoxicity (3.5 days) were based on literature. Cost per treated patient and incremental cost-effectiveness ratio (ICER) per additional cure were calculated for SA-HABP and for monomicrobial SA-HABP. One-way sensitivity analyses were performed.

Findings: Patients with SA-HABP were sub-grouped by methicillin susceptibility (n = 140, 32%) or resistance (n = 293, 68%), and occurrence of polymicrobial (n = 128, 30%) vs monomicrobial (n = 305, 70%) infections. Under the base case, hospital cost for patients with HABP treated with TLV was $42,564 and with VAN, it was $42,296. Telavancin was associated with higher drug ($2082) and nephrotoxicity ($467) costs and lower intensive care unit (-$1738) and ventilator (-$114) costs. ICER was $4156 per additional cure. ICER was sensitive to probabilities of cure, length of treatment in cures, intensive care unit cost, TLV cost, and additional length of stay due to failure. For monomicrobial SA-HABP, TLV was associated with a net cost savings of $907 per patient and yielded economic dominance.

Implications: Our decision-analytic model suggests that TLV for monomicrobial SA-HABP is associated with higher drug acquisition costs but a favorable ICER relative to VAN, provided that effective antimicrobial stewardship limits therapy to 7 days. Sensitivity analyses suggest a potential economic benefit of TLV treatment with appropriate patient selection. Antimicrobial stewardship programs may be able to reduce total costs through judicious use of novel antimicrobial agents. ClinicalTrials.gov identifiers: NCT00107952 and NCT00124020.
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http://dx.doi.org/10.1016/j.clinthera.2018.01.010DOI Listing
March 2018

Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.

Indian Pediatr 2018 Apr 9;55(4):292-296. Epub 2018 Feb 9.

Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat, India.

Objective: To compare individual efficacy and additive effects of pain control interventions in preterm neonates.

Design: Randomized controlled trial.

Setting: Level-3 University affiliated neonatal intensive care unit.

Participants: 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions.

Intervention: Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention.

Main Outcome Measures: Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos.

Results: The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group.

Conclusions: Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.
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April 2018

Direct medical costs of treatment in newly-diagnosed high-grade glioma among commercially insured US patients.

J Med Econ 2017 Dec 16;20(12):1237-1243. Epub 2017 Aug 16.

c Dana-Farber/Brigham and Women's Cancer Center , Boston , MA , USA.

Aim: This analysis assessed the direct medical costs of newly-diagnosed, temozolomide (TMZ)-treated glioblastoma (GBM) from the perspective of a US commercial setting.

Materials And Methods: The analysis included subjects identified from the IMS PharMetrics LifeLink Plus™ claims database from January 1, 2008 to August 31, 2014 who were ≥18 years of age, had ≥1 malignant brain cancer diagnosis, had brain surgery ≤90 days prior to TMZ initiation, had TMZ treatment, and were continuously enrolled for ≥12 months pre-diagnosis and ≥1 month post-diagnosis. Per-patient per-month (PPPM) and cumulative costs from 3 months pre-diagnosis to various post-diagnosis follow-up time points were calculated. Multivariable analyses were used to estimate adjusted mean cost and identify contributors of cost.

Results: The study included 2,921 subjects (median age = 56 years; 60% male). After diagnosis, the median (interquartile range, IQR) number of inpatient, emergency department, and outpatient visits were 2 (1-4), 1 (1-3), and 19 (13-27); median (IQR) length of stay per hospitalization was 5 (3-9) days. Mean total cumulative costs per patient from 3 months pre-diagnosis to 12 months and to 5 years post-diagnosis were $201,749 (197,490-206,024) and $268,031 (262,877-274,416). Mean (SD) PPPM costs were $818 (1,128) and $7,394 (8,676) pre- and post-GBM diagnosis, respectively. The variables most predictive of cumulative costs included radiation therapy (+$81,732), ≥2 weeks of hospitalization (+$49,629), and ≥7 MRI scans (+$40,105).

Conclusions: The direct medical costs of newly-diagnosed, TMZ-treated GBM in commercially insured patients are substantial, with estimated total cumulative costs of $268,031.
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http://dx.doi.org/10.1080/13696998.2017.1364258DOI Listing
December 2017

Clinical Profile and Outcome of Newborns with Acute Kidney Injury in a Level 3 Neonatal Unit in Western India.

J Clin Diagn Res 2017 Mar 1;11(3):SC01-SC04. Epub 2017 Mar 1.

Professor, Department of Paediatrics, Pramukhswami Medical College, Karamsad, Gujarat, India.

Introduction: Acute Kidney Injury (AKI) is a serious condition in neonatal care. It complicates the management necessitating the restrictive use of medications.

Aim: To evaluate clinical profile, identify associated and prog-nostic factors in newborns with AKI.

Materials And Methods: This was a case control study done between January 2008 to January 2010. Total 1745 newborns were admitted, of which 74 babies had AKI. It was defined as serum creatinine >1.5mg/dl. Control group was selected randomly from the hospital numbers of the newborns derived from the electronic registry with serum creatinine below 1.5 mg/dl. Demographic variables like birth weight, gender, gestational age, admission age, growth restriction, Apgar scores, electrolyte levels; and common clinical conditions like asphyxia, sepsis, meningitis, persistent pulmonary hypertension, Necrotizing Enterocolitis (NEC), mechanical ventilation, congenital heart disease; were compared amongst the two groups. Information was obtained from the admission register, admission files, labor register of obstetrics and gynaecology department and electronic registry. Chi square/independent sample t-test as applicable and logistic regression were used to establish an association of various factors and outcome with AKI.

Results: The incidence of AKI in our study was 4.24%. Demographic variables more common in AKI group were inborn (p=0.011), male gender (p=0.032), term gestation (p=0.001), Appropriate for gestational age (0.001), higher birth weight (p<0.001), full term (p<0.001), sepsis (p<0.001), NEC (p=0.042), low ApGAR scores at one minute (p=0.011) and five minute (p=0.003). However, on multivariate logistic regression only male gender [Odds Radio (OR)=2.84, Confidence Interval (CI)=1.12-7.21] and Sepsis (OR=14.46, CI=4.5-46.46) were associated with AKI. Respiratory distress syndrome was more prevalent in the control group (p<0.003). No need of mechanical ventilation and absence of shock, improved the survival.

Conclusions: AKI continues to be of clinical significance in neonatal intensive care. Further studies are needed to evaluate newer associations (like male gender and low APGAR scores).
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http://dx.doi.org/10.7860/JCDR/2017/23398.9327DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5427395PMC
March 2017