Validity Assessment of an Automated Brain Morphometry Tool for Patients with De Novo Memory Symptoms.

BACKGROUND AND PURPOSE: Automated volumetric analysis of structural MR imaging allows quantitative assessment of brain atrophy in neurodegenerative disorders. We compared the brain segmentation performance of the AI-Rad Companion brain MR imaging software against an in-house FreeSurfer 7.1.1/Individual Longitudinal Participant pipeline. MATERIALS AND METHODS: T1-weighted images of 45 participants with de novo memory symptoms were selected from the OASIS-4 database and analyzed through the AI-Rad Companion brain MR imaging tool and the FreeSurfer 7.1.1/Individual Longitudinal Participant pipeline. Correlation, agreement, and consistency between the 2 tools were compared among the absolute, normalized, and standardized volumes. Final reports generated by each tool were used to compare the rates of detection of abnormality and the compatibility of radiologic impressions made using each tool, compared with the clinical diagnoses. RESULTS: We observed strong correlation, moderate consistency, and poor agreement between absolute volumes of the main cortical lobes and subcortical structures measured by the AI-Rad Companion brain MR imaging tool compared with FreeSurfer. The strength of the correlations increased after normalizing the measurements to the total intracranial volume. Standardized measurements differed significantly between the 2 tools, likely owing to differences in the normative data sets used to calibrate each tool. When considering the FreeSurfer 7.1.1/Individual Longitudinal Participant pipeline as a reference standard, the AI-Rad Companion brain MR imaging tool had a specificity of 90.6%-100% and a sensitivity of 64.3%-100% in detecting volumetric abnormalities. There was no difference between the rate of compatibility of radiologic and clinical impressions when using the 2 tools. CONCLUSIONS: The AI-Rad Companion brain MR imaging tool reliably detects atrophy in cortical and subcortical regions implicated in the differential diagnosis of dementia.

Validation of an algorithm to identify incident interstitial lung disease in patients with rheumatoid arthritis.

BACKGROUND/PURPOSE: Interstitial lung disease (ILD) is an important problem for patients with rheumatoid arthritis (RA). However, current approaches to ILD case finding in real-world data have been evaluated only in limited settings and identify only prevalent ILD and not new-onset disease. Our objective was to develop, refine, and validate a claims-based algorithm to identify both prevalent and incident ILD in RA patients compared to the gold standard of medical record review. METHODS: We used administrative claims data 2006-2015 from Medicare to derive a cohort of RA patients. We then identified suspected ILD using variations of ILD algorithms to classify both prevalent and incident ILD based on features of the data that included hospitalization vs. outpatient setting, physician specialty, pulmonary-related diagnosis codes, and exclusions for potentially mimicking pulmonary conditions. Positive predictive values (PPV) of several ILD algorithm variants for both prevalent and incident ILD were evaluated. RESULTS: We identified 234 linkable RA patients with sufficient data to evaluate for ILD. Overall, 108 (46.2%) of suspected cases were confirmed as ILD. Most cases (64%) were diagnosed in the outpatient setting. The best performing algorithm for prevalent ILD had a PPV of 77% (95% CI 67-84%) and for incident ILD was 96% (95% CI 85-100%). CONCLUSION: Case finding in administrative data for both prevalent and incident interstitial lung disease in RA patients is feasible and has reasonable accuracy to support population-based research and real-world evidence generation.

Time-Driven activity-based costing identifies opportunities for process efficiency and cost optimization for robot-assisted laparoscopic pyeloplasty.

BACKGROUND: Robot-assisted laparoscopic pyeloplasty (RALP) is a commonly performed procedure in children, but its actual cost implications on the healthcare ecosystem have not been adequately defined. Time-driven activity-based costing (TDABC) is a novel cost accounting method derived from value based healthcare systems that may offer one pathway to assess institutional costs. OBJECTIVE: To determine the true cost of a robot-assisted laparoscopic pyeloplasty (RALP) in the pediatric population using TDABC, and compare it to traditional cost accounting. And to utilize TDABC to minimize cost and improve time-flow efficiency. SUBJECTS/PATIENTS AND METHODS: The RALP care pathway was defined from patient arrival to the pre-operative suite to discharge from the post-anesthesia care unit (PACU). Process maps were created with an interdisciplinary team to survey RALP activities. Retrospective time stamps were obtained from the electronic medical record for fiscal year 2016 (FY16) RALP cases, and were validated by prospectively stopwatch timing additional RALP cases. Male and female pediatric patients undergoing a unilateral RALP during FY16 and during the prospective study period (June 2017-October 2017) were included. Procedure costs were calculated using TDABC after determining the capacity cost rate for all personnel and assets, and multiplying them with the time stamps. RESULTS: 25 RALP cases were analyzed for FY16. TDABC determined a total cost of $15 319/case, when direct, indirect and capital robot cost are included. Traditional cost accounting amounted to a total of $16 158/case. The current robot utilization rate is 22% of total capacity, effectively increasing the total RALP cost by 16%. Time stamps with the most variance were pre-operative services (115 ± 27.5 min), robotic console (142 min ±30.7 min) and PACU times (145 ± 101.1 min) (Figure) DISCUSSION: This study represents the first TDABC implementation in robot-assisted pediatric procedures. Previous TDABC in other areas of urology similarly revealed discrepancies between traditional cost accounting and TDABC. The present study demonstrates a higher total cost than previous cost accounting studies for the RALP, however, this is the first effort to include indirect costs in the final calculations. This study does convey the limitations of a retrospective analysis and those inherent to a single institution study. CONCLUSION: TDABC defined the magnitude of cost variation based on robot utilization of a RALP. Traditional cost accounting overestimates the actual costs of a RALP. TDABC also identified high-cost and high variability loci in the RALP process map that will be targeted for process and quality improvement while further reducing assessed costs.

Polyester-based biodegradable plastics: an approach towards sustainable development.

Non-degradability of conventional plastics, filling of landfill sites, raising water and land pollution and rapid depletion of fossil resources have raised the environmental issues and global concerns. The current demand and production of plastics is putting immense pressure on fossil resources, consuming about 6% of the global oil and is expected to grow up to 20%. The polyester-based biodegradable plastics (BPs) are considered as a remedy to the issue of plastics waste in the environment. BPs appear to manage the overflow of plastics by providing new means of waste management system and help in securing the non-renewable resources of nature. This review comprehensively presents the environmental burdens due to conventional plastics as well as production of polyester-based BPs as an alternative to conventional commodity plastics. The diversity of micro-organisms and their enzymes that degrade various polyester-based BPs (PLA, PCL, PHB/PHBV and PET) has also been described in detail. Moreover, the impact of plastics degradation products on soil ecology and ecosystem functions has critically been discussed. The report ends with special focus on future recommendations for the development of sustainable waste management strategies to control pollution due to plastics waste. SIGNIFICANCE AND IMPACT OF THE STUDY: Polyester-based BPs considered as a solution to current plastic waste problem as well as leading polymers in terms of biodegradability and sustainability has been critically discussed. The role of microorganisms and their enzymes involved in the biodegradation of these polymers and ecotoxicological impact of degradation products of BPs on soil microbial community and biogeochemical cycles has also been described. This report will provide an insight on the key research areas to bridge the gap for development of simulated systems as an effective and emerging strategy to divert the overflow of plastic in the environment as well as for the greener solution to the plastic waste management problems.

Negative pressure wound therapy in elective stoma reversal surgery: results of a UK district general hospital pilot.

The role of negative pressure wound therapy in stoma reversal surgery remains unknown. To evaluate this, a retrospective, non-randomized, single-institution, pilot study was conducted. Surgeon preference determined type of wound closure and application of the single-brand negative wound pressure device. No patient in the intervention group suffered wound complications, but five of the thirty-six patients in the control group suffered surgical site infection-related complications. Primary closure and negative pressure wound therapy use decreases wound complications in stoma reversal surgery, thereby alleviating the wound-management burden in hospitals and in the community. This has cost-saving implications, but further studies are needed.

Tuberculosis infection control measures at health care facilities offering HIV and tuberculosis services in India: A baseline assessment.

BACKGROUND: Tuberculosis (TB) is one of world's oldest infectious disease and ranks alongside HIV as leading infectious killer. Tuberculosis infection control especially in HIV and TB care facilities has warranted attention after the recent health care-associated outbreaks in South Africa. The aim of this study was to describe the tuberculosis infection control measures implemented by HIV and TB care facilities in five high HIV burden provinces in India. METHODS: Baseline assessment of 30 high burden Antiretroviral centers and TB facilities was conducted during Oct 2015-Dec 2015 by AIC trained staff using a structured format. RESULTS: Thirty HIV and TB care facilities in five high HIV burden provinces were enrolled. Facility infrastructure and airborne infection control practices were highly varied between facilities. TB screening and fast tracking at ART centers is happening at majority of centers however inadequate TB infection control training, poor compliance to administrative and personal protective measures and lack of mechanism for health care workers surveillance need attention. CONCLUSIONS: Local specific TB infection control interventions to be designed and implemented at HIV and TB care facilities including implementation of administrative, environmental and use of personal protective equipment's with the training of staff members. Health care workers surveillance needs to be prioritized considering the rising instances of tuberculosis among Health care workers.

BAY 94-9027, a PEGylated recombinant factor VIII, exhibits a prolonged half-life and higher area under the curve in patients with severe haemophilia A: Comprehensive pharmacokinetic assessment from clinical studies.

INTRODUCTION: Recombinant factor VIII (rFVIII) products with extended half-lives, such as BAY 94-9027, can potentially maintain higher FVIII levels for longer periods of time, thus providing improved bleeding protection vs standard-acting FVIII products. AIM: To characterize the pharmacokinetic (PK) profile of BAY 94-9027 from phase 1, phase 2/3 (PROTECT VIII) and phase 3 (PROTECT VIII Kids) clinical trials in adults, adolescents and children with severe haemophilia A METHODS: Patients with severe haemophilia A (FVIII <1%) with >50 FVIII exposure days (EDs) and no history of inhibitors were included in the phase 1 (18-65 years, ≥150 EDs), PROTECT VIII (12-65 years, ≥150 EDs) and PROTECT VIII Kids (<12 years, >50 EDs) trials. PK parameters were assessed following a 25-IU/kg or 60-IU/kg BAY 94-9027 dose in the phase 1 study after the first and repeated infusion, in PROTECT VIII after the first and repeated 60-IU/kg infusion and in PROTECT VIII Kids after a single 60-IU/kg infusion. The chromogenic assay was used to assess FVIII activity. RESULTS: Compared with sucrose-formulated rFVIII, BAY 94-9027 had reduced clearance that resulted in a ~1.4-fold increase in half-life and dose-normalized area under the curve (AUC). The BAY 94-9027 PK profile was comparable after single- and repeated-dose administrations. Dose-proportional increases were observed between 25- and 60-IU/kg administrations. BAY 94-9027 PK characteristics were age dependent, consistent with other FVIII products. CONCLUSIONS: BAY 94-9027 shows an extended half-life and increased AUC vs standard-acting FVIII products. These PK characteristics will result in higher FVIII levels for longer duration.

Evaluation of microtitre plate-based Haemoglobin estimation.

INTRODUCTION: Haemoglobin estimation is one of the most important clinical investigations. Many techniques are available to measure haemoglobin; still there is a need for a haemoglobin assay technique which is cheap, robust and simple and can be used in field conditions very quickly using figure prick sample. We evaluated a cyanmethaemoglobin-based haemoglobin estimation using a microtitre plates for the purpose. METHODS: Microtitre plate-based haemoglobin estimation was developed using cyanmethaemoglobin-based assay and was compared with standard haematology analyser-based haemoglobin estimation in a large number of samples from a population of voluntary blood donors. Various tests were performed to evaluate the stability of colour, variation of the results during duplicate assay on the same days and on different days as well as linearity of the test was performed against broad range of haemoglobin values for the new microtitre plate-based technique. Standard statistical test of significance was applied to validate the assay. RESULTS: Total 200 samples from in-house and field conditions were evaluated. 10 µL blood sample in 300 µL Drabkin's solution provided optimum and comparable results after 10 minutes of incubation. The colour was stable up to 6 hours, the coefficient of variation was less than 3%, and the cost per test including everything was less than 3 cent/2P. Turnaround time for 90 samples was only 30 minutes. CONCLUSION: Cyanmethaemoglobin-based assay in microtitre plate is feasible, robust, rapid, cheap and cost-effective method for haemoglobin estimation in field conditions.

The Validity of a New Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS) for Evaluating Symptoms in the Clinical Setting.

BACKGROUND: The clinical assessments of patients with gastrointestinal symptoms can be time-consuming, and the symptoms captured during the consultation may be influenced by a variety of patient and non-patient factors. To facilitate standardized symptom assessment in the routine clinical setting, we developed the Structured Assessment of Gastrointestinal Symptom (SAGIS) instrument to precisely characterize symptoms in a routine clinical setting. AIMS: We aimed to validate SAGIS including its reliability, construct and discriminant validity, and utility in the clinical setting. METHODS: Development of the SAGIS consisted of initial interviews with patients referred for the diagnostic work-up of digestive symptoms and relevant complaints identified. The final instrument consisted of 22 items as well as questions on extra intestinal symptoms and was given to 1120 consecutive patients attending a gastroenterology clinic randomly split into derivation (n = 596) and validation datasets (n = 551). Discriminant validity along with test-retest reliability was assessed. The time taken to perform a clinical assessment with and without the SAGIS was recorded along with doctor satisfaction with this tool. RESULTS: Exploratory factor analysis conducted on the derivation sample suggested five symptom constructs labeled as abdominal pain/discomfort (seven items), gastroesophageal reflux disease/regurgitation symptoms (four items), nausea/vomiting (three items), diarrhea/incontinence (five items), and difficult defecation and constipation (2 items). Confirmatory factor analysis conducted on the validation sample supported the initially developed five-factor measurement model ([Formula: see text], p < 0.0001, χ 2/df = 4.6, CFI = 0.90, TLI = 0.88, RMSEA = 0.08). All symptom groups demonstrated differentiation between disease groups. The SAGIS was shown to be reliable over time and resulted in a 38% reduction of the time required for clinical assessment. CONCLUSIONS: The SAGIS instrument has excellent psychometric properties and supports the clinical assessment of and symptom-based categorization of patients with a wide spectrum of gastrointestinal symptoms.

Star excursion balance test for assessment of dynamic instability of the ankle in patients after harvest of a fibular free flap: a two-centre study.

We aimed to show that the star excursion balance test can identify instability in the ankle of patients who have had harvest of a fibular free flap. We compared the reach distance of the operated leg against that of the non-operated leg in 26 patients who had had harvest of the flap over a period of three years from August 2009 at two different centres. The goal of the test is to reach as far as possible with one leg in eight directions while balancing on the other. We also assessed the overall function of the operated leg using the Foot and Ankle Disability Index (FADI) and the American Orthopaedic Foot and Ankle Score (AOFAS). The star excursion balance test is simple and cheap, and is quick and easy to do in the outpatient department.

Accuracy and cost-effectiveness of dynamic contrast-enhanced CT in the characterisation of solitary pulmonary nodules-the SPUtNIk study.

INTRODUCTION: Solitary pulmonary nodules (SPNs) are common on CT. The most cost-effective investigation algorithm is still to be determined. Dynamic contrast-enhanced CT (DCE-CT) is an established diagnostic test not widely available in the UK currently. METHODS AND ANALYSIS: The SPUtNIk study will assess the diagnostic accuracy, clinical utility and cost-effectiveness of DCE-CT, alongside the current CT and 18-flurodeoxyglucose-positron emission tomography) (18FDG-PET)-CT nodule characterisation strategies in the National Health Service (NHS). Image acquisition and data analysis for 18FDG-PET-CT and DCE-CT will follow a standardised protocol with central review of 10% to ensure quality assurance. Decision analytic modelling will assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with SPNs. ETHICS AND DISSEMINATION: Approval has been granted by the South West Research Ethics Committee. Ethics reference number 12/SW/0206. The results of the trial will be presented at national and international meetings and published in an Health Technology Assessment (HTA) Monograph and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN30784948; Pre-results.

A Novel early pregnancy assessment unit/Gynaecology assessment unit dashboard: An experience from a UK district general hospital.

The establishment of early pregnancy assessment units (EPAUs)/Gynaecology assessment units (GAUs) started more than 20 years ago in the UK to decrease hospital admissions of patients with early pregnancy problems. However, there are still wide variations in the quality of services provided by these units. The objective of this study was to create a method that can be used for continuous assessment of these units on a regular basis. We designed a dashboard covering all aspects of EPAU/GAU activities depending upon the early pregnancy unit association guidelines, and the department of health data and statistics. The EPAU/GAU dashboard has been used successfully in the early assessment pregnancy unit of Yeovil District hospital for few years and is still implemented until now. It is an excellent tool for continuous audit. It is a simple method that should be adopted by different EPAUs/GAUs for their objective assessment in order to improve the services provided by these units.

Predictors of maternal mortality in institutional deliveries in Nigeria.

BACKGROUND: Maternal mortality in poor countries reflects the under-development in these societies. Global recognition of the burden of maternal mortality and the urgency for a reversal of the trend underpin the Millenium Development Goals (MDGs). OBJECTIVE: To determine risk factors for maternal mortality in institutional births in Nigeria. METHOD: Twenty one health facilities in three states were selected using stratified multi-stage cluster sampling strategy. Information on all delivered mothers and their newborn infants within a three-month period was culled from medical records. RESULTS: A total of 9 208 deliveries were recorded. About one-fifth (20.5%) of women had no antenatal care while 79.5% had at least one antenatal visit during pregnancy. Four-fifths (80.5%) of all deliveries were normal deliveries. Elective and emergency caesarean section rates were 3.1% and 11.5% respectively. There were 79 maternal deaths and 8 526 live births, giving a maternal mortality ratio of 927 maternal deaths per 100 000 live births. No antenatal care, parity, level of education, and mode of delivery were significantly associated with maternal mortality. Low maternal education, high parity, emergency caesarean delivery, and high risk patients risk independently predicted maternal mortality. CONCLUSION: Meeting goal five of the MDGs remains a major challenge in Nigeria. Multi-sectoral approaches and focused political will are needed to revert the high maternal mortality.

Solid-organ transplantation in older adults: current status and future research.

An increasing number of patients older than 65 years are referred for and have access to organ transplantation, and an increasing number of older adults are donating organs. Although short-term outcomes are similar in older versus younger transplant recipients, older donor or recipient age is associated with inferior long-term outcomes. However, age is often a proxy for other factors that might predict poor outcomes more strongly and better identify patients at risk for adverse events. Approaches to transplantation in older adults vary across programs, but despite recent gains in access and the increased use of marginal organs, older patients remain less likely than other groups to receive a transplant, and those who do are highly selected. Moreover, few studies have addressed geriatric issues in transplant patient selection or management, or the implications on health span and disability when patients age to late life with a transplanted organ. This paper summarizes a recent trans-disciplinary workshop held by ASP, in collaboration with NHLBI, NIA, NIAID, NIDDK and AGS, to address issues related to kidney, liver, lung, or heart transplantation in older adults and to propose a research agenda in these areas.

Socioeconomic inequalities in cancer survival in England after the NHS cancer plan.

BACKGROUND: Socioeconomic inequalities in survival were observed for many cancers in England during 1981-1999. The NHS Cancer Plan (2000) aimed to improve survival and reduce these inequalities. This study examines trends in the deprivation gap in cancer survival after implementation of the Plan. MATERIALS AND METHOD: We examined relative survival among adults diagnosed with 1 of 21 common cancers in England during 1996-2006, followed up to 31 December 2007. Three periods were defined: 1996-2000 (before the Cancer Plan), 2001-2003 (initialisation) and 2004-2006 (implementation). We estimated the difference in survival between the most deprived and most affluent groups (deprivation gap) at 1 and 3 years after diagnosis, and the change in the deprivation gap both within and between these periods. RESULTS: Survival improved for most cancers, but inequalities in survival were still wide for many cancers in 2006. Only the deprivation gap in 1-year survival narrowed slightly over time. A majority of the socioeconomic disparities in survival occurred soon after a cancer diagnosis, regardless of the cancer prognosis. CONCLUSION: The recently observed reduction in the deprivation gap was minor and limited to 1-year survival, suggesting that, so far, the Cancer Plan has little effect on those inequalities. Our findings highlight that earlier diagnosis and rapid access to optimal treatment should be ensured for all socioeconomic groups.

The possible evidence for an epidemiological transition hypothesis for elderly suicides.

BACKGROUND: An epidemiological transition hypothesis has been developed to explain simultaneously wide cross-national variations in elderly suicide rates, trends over time for elderly suicide rates and age-associated trends in suicides rates. This speculative hypothesis suggests that there is a curvilinear (inverted U-shaped curve) relationship between elderly suicide rates and socioeconomic status fitting the quadratic equation y = a + bx - cx2 (where y is the suicide rate, x is the socioeconomic status, and a, b and c are constants). METHODS: The predicted curvilinear relationship between elderly suicide rates and gross national domestic product (GDP), a measure of socioeconomic status, fitting the above quadratic equation was examined with a curve estimation regression model using data from the World Health Organization. RESULTS: The relationship between suicide rates in both sexes in the age-bands 65-74 and 75+ years and the GDP was curvilinear (inverted U-shaped curve) and fitted the above quadratic equation, and was statistically significant (at least p<0.05) in all four groups. CONCLUSIONS: Caution should be exercised in accepting this model of the epidemiological transition hypothesis for elderly suicide rates because it is generated from cross-sectional data using an ecological design. Ideally, this model requires rigorous testing by following selected countries of low socioeconomic status over time as they develop socioeconomically.