Availability, cost and affordability of essential medicines for chronic respiratory diseases in low-income and middle-income countries: a cross-sectional study.

Contemporary data on the availability, cost and affordability of essential medicines for chronic respiratory diseases (CRDs) across low-income and middle-income countries (LMICs) are missing, despite most people with CRDs living in LMICs. Cross-sectional data for seven CRD medicines in pharmacies, healthcare facilities and central medicine stores were collected from 60 LMICs in 2022-2023. Medicines for symptomatic relief were widely available and affordable, while preventative treatments varied widely in cost, were less available and largely unaffordable. There is an urgent need to address these issues if the Sustainable Development Goal 3 is to be achieved for people with asthma by 2030.

Association of Chronic Lower Respiratory Disease With County Health Disparities in New York State.

Importance: Chronic lower respiratory disease (CLRD) is the fourth leading cause of death in the United States, which imposes a considerable burden on individuals, families, and societies. The association between county-level health disparity and CLRD outcomes in New York state needs investigation. Objective: To evaluate the associations of CLRD outcomes with county-level health disparities in New York state. Design, Setting, and Participants: In this cross-sectional study, CLRD age-adjusted hospitalization for 2016 and mortality rates from 2014 to 2016 were obtained from the New York state Community Health Indicator Reports provided by the New York state Department of Health. County Health Rankings were used to evaluate various health factors to provide a summary z score for each county representing the county health status and how that county ranks in the state. Data analysis was performed from November 2020 to March 2021. Main Outcomes and Measures: The main outcomes were age-adjusted hospitalization and mortality rates for CLRD. The z score was calculated from the County Health Rankings, which includes subindicators of health behaviors, clinical care, social and economic factors, and physical environment. Pearson r and linear regression models were estimated. Results: During the study, 60 335 discharges were documented as CLRD hospitalizations in 2016 and 20 612 people died from CLRD from 2014 to 2016 in New York state. After adjusting for age, the CLRD hospitalization rate was 27.6 per 10 000 population, and the mortality rate was 28.9 per 100 000 population. Among 62 counties, Bronx had the highest hospitalization rate (64.7 per 10 000 population) whereas Hamilton had the lowest hospitalization rate (6.6 per 10 000 population). Mortality rates ranged from 17.4 per 100 000 population in Kings to 62.9 per 100 000 population in Allegany. County Health Rankings indicated Nassau had the lowest z score (the healthiest), at -1.17, but Bronx had the highest z score (the least healthy), at 1.43, for overall health factors in 2018. An increase of 1 point in social and economic factors z score was associated with an increase of 17.6 hospitalizations per 10 000 population (ß = 17.61 [95% CI, 10.36 to 24.87]; P < .001). A 1-point increase in health behaviors z score was associated with an increase of 41.4 deaths per 100 000 population (ß = 41.42 [95% CI, 29.88 to 52.97]; P < .001). Conclusions and Relevance: In this cross-sectional study, CLRD outcomes were significantly associated with county-level health disparities in New York state. These findings suggest that public health interventions and resources aimed at improving CLRD outcomes should be tailored and prioritized in health disadvantaged areas.

Prevalence and Economic Burden of Respiratory Diseases in Central Asia and Russia: A Systematic Review.

Prevalence data of respiratory diseases (RDs) in Central Asia (CA) and Russia are contrasting. To inform future research needs and assist government and clinical policy on RDs, an up-to-date overview is required. We aimed to review the prevalence and economic burden of RDs in CA and Russia. PubMed and EMBASE databases were searched for studies that reported prevalence and/or economic burden of RDs (asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, interstitial lung diseases (ILD), lung cancer, pulmonary hypertension, and tuberculosis (TB)) in CA (Kyrgyzstan, Uzbekistan, Tajikistan, Kazakhstan, and Turkmenistan) and Russia. A total of 25 articles (RD prevalence: 18; economics: 7) were included. The majority (n = 12), mostly from Russia, reported on TB. TB prevalence declined over the last 20 years, to less than 100 per 100,000 across Russia and CA, yet in those, multidrug-resistant tuberculosis (MDR-TB) was alarming high (newly treated: 19-26%, previously treated: 60-70%). COPD, asthma (2-15%) and ILD (0.006%) prevalence was only reported for Russia and Kazakhstan. No studies on cystic fibrosis, lung cancer and pulmonary hypertension were found. TB costs varied between US$400 (Tajikistan) and US$900 (Russia) for drug-susceptible TB to ≥US$10,000 for MDR-TB (Russia). Non-TB data were scarce and inconsistent. Especially in CA, more research into the prevalence and burden of RDs is needed.

Laparoscopic versus open hemihepatectomy: comprehensive comparison of complications and costs at 90 days using a propensity method.

Laparoscopic hemihepatectomy (LHH) may offer advantages over open hemihepatectomy (OHH) in blood loss, recovery, and hospital stay. The aim of this study is to evaluate our recent experience performing hemihepatectomy and compare complications and costs up to 90 days following laparoscopic versus open procedures. Retrospective evaluation of patients undergoing hemihepatectomy at our center 01/2010-12/2018 was performed. Patient, tumor, and surgical characteristics; 90-day complications; and costs were analyzed. Inverse probability of treatment weighting (IPTW) was used to balance covariates. A total of 141 hemihepatectomies were included: 96 OHH and 45 LHH. While operative times were longer for LHH, blood loss and transfusions were less. At 90 days, there were similar rates of liver-specific and surgical complications but fewer medical complications following LHH. Medical complications that arose with greater frequency following OHH were primarily pulmonary complications and urinary and central venous catheter infections. Complications at 90 days were lower following LHH (Clavien-Dindo grade ≥ III OHH 23%, LHH 11%, p = 0.130; Comprehensive Complication Index OHH 20.0 ± 16.1, LHH 10.9 ± 14.2, p = 0.001). While operating costs were higher, costs for hospital stay and readmissions were lower with LHH. Patients undergoing LHH experience a significant reduction in postoperative medical complications and costs, resulting in 90-day cost equity compared with OHH.

Vaccination Status and Adherence to Quality Measures for Acute Respiratory Tract Illnesses.

OBJECTIVES: To assess the relationship between vaccination status and clinician adherence to quality measures for children with acute respiratory tract illnesses. METHODS: We conducted a multicenter prospective cohort study of children aged 0 to 16 years who presented with 1 of 4 acute respiratory tract illness diagnoses (community-acquired pneumonia, croup, asthma, and bronchiolitis) between July 2014 and June 2016. The predictor variable was provider-documented up-to-date (UTD) vaccination status. Our primary outcome was clinician adherence to quality measures by using the validated Pediatric Respiratory Illness Measurement System (PRIMES). Across all conditions, we examined overall PRIMES composite scores and overuse (including indicators for care that should not be provided, eg, C-reactive protein testing in community-acquired pneumonia) and underuse (including indicators for care that should be provided, eg, dexamethasone in croup) composite subscores. We examined differences in length of stay, costs, and readmissions by vaccination status using adjusted linear and logistic regression models. RESULTS: Of the 2302 participants included in the analysis, 92% were documented as UTD. The adjusted mean difference in overall PRIMES scores by UTD status was not significant (adjusted mean difference -0.3; 95% confidence interval: -1.9 to 1.3), whereas the adjusted mean difference was significant for both overuse (-4.6; 95% confidence interval: -7.5 to -1.6) and underuse (2.8; 95% confidence interval: 0.9 to 4.8) composite subscores. There were no significant adjusted differences in mean length of stay, cost, and readmissions by vaccination status. CONCLUSIONS: We identified lower adherence to overuse quality indicators and higher adherence to underuse quality indicators for children not UTD, which suggests that clinicians "do more" for hospitalized children who are not UTD.

Perioperative inhaled corticosteroids treatment is associated with decreased length-of-stay and direct medical costs in high-respiratory-risk surgeries.

Aims: To examine the impact of perioperative inhaled corticosteroids (ICS) on length-of-stay (LOS) and costs among patients receiving high-respiratory-risk surgeries.Methods: Adult patients who underwent high-respiratory-risk surgeries in 2015 were identified in the Tianjin Urban Employee Basic Medical Insurance database. Patients were grouped into ICS or non-ICS cohorts according to whether they received ICS during the perioperative period of the index hospitalization. Propensity Score Matching was performed to create matched pairs between two cohorts. The impact of perioperative ICS on LOS and direct medical costs was estimated by negative binomial model and generalized liner model.Results: Eight hundred and twenty-one hospital stays with high-respiratory-risk were selected in the ICS cohort and another 821 stays in the non-ICS cohort were matched. The mean LOS was 13.0 (±0.3) days in the ICS cohort, which was significantly lower than the matched non-ICS cohort. Patients with thorax and ear-nose-throat surgeries had a significant decrease in LOS in the ICS cohort compared to the non-ICS cohort, with a mean decrease of 5.5 and 1.1 days, respectively. In adjusted analyses, perioperative ICS treatment was associated with shorter LOS, lower total, and respiratory-related costs (reductions of 10.1%, 7%, and 5.3%, respectively) after controlling for demographic, clinical, and hospital characteristics.Limitations: Some respiratory risk factors such as living behavior and environment were unable to be captured and respiratory-related costs might be underestimated, limited by claim data. Lastly, caution should be taken when generalizing the results to other populations, as only patients with moderate-to-severe surgeries on the thorax and above were selected in this study.Conclusions: Perioperative ICS treatment was associated with decreased LOS and lower costs for patients undergoing high-respiratory-risk surgeries in China.

Preweaning cost of bovine respiratory disease (BRD) and cost-benefit of implementation of preventative measures in calves on California dairies: The BRD 10K study.

Bovine respiratory disease (BRD) is a multifactorial disease that is estimated to affect 22% of preweaned dairy calves in the United States and is a leading cause of preweaning mortality in dairy calves. Overall cost of calfhood BRD is reflected in both the immediate cost of treating the disease as well as lifetime decrease in production and increased likelihood of affected cattle leaving the herd before their second calving. The goal of this paper was to develop an estimate of the cost of BRD based on longitudinal treatment data from a study of BRD with a cohort of 11,470 preweaned dairy calves in California. Additionally, a cost-benefit analysis was performed for 2 different preventative measures for BRD, an increase of 0.47 L of milk per day for all calves or vaccination of all dams with a modified live BRD vaccine, using differing assumptions about birth rate and number of calves raised per year. Average short-term cost of BRD per affected calf was $42.15, including the use of anti-inflammatory medications in the treatment protocols across all management conditions. The cost of treating BRD in calves appears to have increased in recent years and is greater than costs presented in previous studies. A cost-benefit analysis examined different herd scenarios for a range of cumulative incidences of BRD from 3 to 25%. Increasing milk fed was financially beneficial in all scenarios above a 3% cumulative incidence of BRD. Use of a modified live vaccine in dams during pregnancy, examining only its value as a form of BRD prevention in the calves raised on the farm, was financially beneficial only if the cumulative incidence of BRD exceeded 10 to 15% depending on the herd size and whether the dairy farm was raising any bull calves. The cost-benefit analysis, under the conditions studied, suggests that producers with high rates of BRD may benefit financially from implementing preventative measures, whereas these preventative measures may not be cost effective to implement on dairy farms with very low cumulative incidences of BRD. The long-term costs of calfhood BRD on lifetime productivity were not factored into these calculations, and the reduction in disease may be associated with additional cost savings and an improvement in calf welfare and herd life.

Living conditions and respiratory health in Walmer Township and Wells Estate, Port Elizabeth, South Africa.

BACKGROUND: Many impoverished communities in South Africa (SA) simultaneously face multiple preventable socioenvironmental hazards associated with elevated burdens of ill health. One such hazard is failure to institute effective buffer zones between human settlements and point sources of pollution such as airports and industrial zones. OBJECTIVES: To gather information on living conditions, housing quality and health status in two poor communities in the SA coastal industrial city of Port Elizabeth. METHODS: The study was undertaken in Walmer Township, situated in close proximity to Port Elizabeth International Airport, and Wells Estate, which borders two industrial sites. Approximately 120 households were randomly selected from each study site. Following written informed consent, information on the neighbourhood environment and housing conditions was collected through administration of a structured questionnaire. RESULTS: The two study sites were similar in respect of household language, income, education, high levels of debt servicing and high reliance on social grants. Relative to Walmer Township, higher levels of indoor dust and bad odours in the neighbourhood were reported in Wells Estate, as were higher rates of selected respiratory ill-health symptoms. Upper respiratory tract symptoms were significantly associated with reports of high levels of indoor dust, while lower respiratory tract symptoms were significantly associated with low income, overcrowding, and having a young child in the household. CONCLUSIONS: The study highlights a scenario of a triple environmental hazard to health in the study communities: (i) poverty; (ii) poor-quality housing; and (iii) lack of an effective buffer zone between the study communities and local point sources of pollution. Respiratory ill-health conditions were significantly associated with poverty, household composition and living conditions.

Economic assessment of a high-dose versus a standard-dose influenza vaccine in the US Veteran population: Estimating the impact on hospitalization cost for cardio-respiratory disease.

OBJECTIVE: To compare the economic impact of high-dose trivalent (HD) versus standard-dose trivalent (SD) influenza vaccination on direct medical costs for cardio-respiratory hospitalizations in adults aged 65 years or older enrolled in the United States (US) Veteran's Health Administration (VHA). METHODS: Leveraging a relative vaccine effectiveness study of HD versus SD over five respiratory seasons (2010/11 through 2014/15), we collected cost data for healthcare provided to the same study population both at VHA and through Medicare services. Our economic assessment compared the costs of vaccination and hospital care for patients experiencing acute cardio-vascular or respiratory illness. RESULTS: We analyzed 3.5 million SD and 158,636 HD person-seasons. The average cost of HD and SD vaccination was $23.48 (95% CI: $21.29 - $25.85) and $12.21 (95% CI: $11.49 - $13.00) per recipient, respectively, while the hospitalization rates for cardio-respiratory disease in HD and SD recipients were 0.114 (95% CI: 0.108-0.121) and 0.132 (95% CI: 0.132-0.133) per person-season, respectively. Attributing the average cost per hospitalization of $11,796 (95% CI: $11,685 - $11,907) to the difference in hospitalization rates, we estimated savings attributable to HD to be $202 (95% CI: $115 - $280) per vaccinated recipient. CONCLUSIONS: For the five-season period of 2010/11 through 2014/15, HD influenza vaccination was associated with net cost savings due to fewer hospitalizations, and therefore lower direct medical costs, for cardio-respiratory disease as compared to SD influenza vaccination in the senior US VHA population.

Patterns of health care use related to respiratory conditions in early life: A birth cohort study with linked administrative data.

OBJECTIVES: To identify distinctive patterns of respiratory-related health services use (HSU) between birth and 3 years of age, and to examine associated symptom and risk profiles. METHODS: This study included 729 mother and child pairs enrolled in the Toronto site of the Canadian Healthy Infant Longitudinal Development study in 2009-2012; they were linked to Ontario health administrative databases (2009-2016). A model-based cluster analysis was performed to identify distinct groups of children who followed a similar pattern of respiratory-related HSU between birth and 3 years of age, regarding hospitalization, emergency department (ED) and physician office visits for respiratory conditions and total health care costs (2016 Canadian dollars). RESULTS: The majority (estimated cluster weight = 0.905) showed a pattern of low and stable respiratory care use (low HSU) while the remainder (weight = 0.095) showed a pattern of high use (high HSU). From 0 to 3 years of age, the low- and high-HSU groups differed in mean trajectories of total health care costs ($783 per 6 months decreased to $114, vs $1796 to $177, respectively). Compared to low-HSU, the high-HSU group was associated with a constant risk of hospitalizations, early high ED utilization and physician visits for respiratory problems. The two groups differed significantly in the timing of wheezing (late onset in low-HSU vs early in high-HSU) and future total costs (stable vs increased). CONCLUSIONS: One in ten children had high respiratory care use in early life. Such information can help identify high-risk young children in a large population, monitor their long-term health, and inform resource allocation.

Including intangible costs into the cost-of-illness approach: a method refinement illustrated based on the PM2.5 economic burden in China.

The concentrations of particulate matter with aerodynamic diameters less than 2.5 µm (PM2.5) and 10 µm (PM10) is a widespread concern and has been demonstrated for 103 countries. During the past few years, the exposure-response function (ERf) has been widely used to estimate the health effects of air pollution. However, past studies are either based on the cost-of-illness or the willingness-to-pay approach, and therefore, either do not cover intangible costs or costs due to the absence of work. To address this limitation, a hybrid health effect and economic loss model is developed in this study. This novel approach is applied to a sample of environmental and cost data in China. First, the ERf is used to link PM2.5 concentrations to health endpoints of chronic mortality, acute mortality, respiratory hospital admission, cardiovascular hospital admission, outpatient visits-internal medicine, outpatient visits-pediatrics, asthma attack, acute bronchitis, and chronic bronchitis. Second, the health effect of PM2.5 is monetized into the economic loss. The mean economic loss due to PM2.5 was much heavier in the North than the South of China. Furthermore, the empirical results from 76 cities in China show that the health effects and economic losses were over 4.98 million cases and 382.30 billion-yuan in 2014 and decreased dramatically compared with those in 2013.

Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial.

BACKGROUND: Transcutaneous electric acupoint stimulation (TEAS) has shown benefits when used peri-operatively. However, the role of numbers of areas with acupoint stimulation is still unclear. Therefore, we report the protocol of a randomized controlled trial of using TEAS in elderly patients subjected to gastrointestinal surgery, and comparing dual-acupoint and single-acupoint stimulation. METHODS/DESIGN: A multicenter, randomized, controlled, three-arm design, large-scale trial is currently undergoing in four hospitals in China. Three hundred and forty-five participants are randomly assigned to three groups in a 1:1:1 ratio, receiving dual-acupoint TEAS, single-acupoint TEAS, and no stimulation, respectively. The primary outcome is incidence of pulmonary complications at 30 days after surgery. The secondary outcomes include the incidence of pulmonary complications at 3 days after surgery; the all-cause mortality within 30 days and 1 year after surgery; admission to the intensive care unit (ICU) and length of ICU stay within 30 days after surgery; the length of postoperative hospital stay; and medical costs during hospitalization after surgery. DISCUSSION: The result of this trial (which will be available in September 2019) will confirm whether TEAS before and during anesthesia could alleviate the postoperative pulmonary complications after gastrointestinal surgery in elderly patients, and whether dual-acupoint stimulation is more effective than single-acupoint stimulation. TRIALS REGISTRATIONS: ClinicalTrials.gov, ID: NCT03230045 . Registered on 10 July 2017.

Interdisciplinary aerodigestive care model improves risk, cost, and efficiency.

OBJECTIVE: This study sought to evaluate the impact of an interdisciplinary care model for pediatric aerodigestive patients in terms of efficiency, risk exposure, and cost. METHODS: Patients meeting a standard clinical inclusion definition were studied before and after implementation of the aerodigestive program. RESULTS: Aerodigestive patients seen in the interdisciplinary clinic structure achieved a reduction in time to diagnosis (6 vs 150 days) with fewer required specialist consultations (5 vs 11) as compared to those seen in the same institution prior. Post-implementation patients also experienced a significant reduction in risk, with fewer radiation exposures (2 vs 4) and fewer anesthetic episodes (1 vs 2). Total cost associated with the diagnostic evaluation was significantly reduced from a median of $10,374 to $6055. CONCLUSION: This is the first study to utilize a pre-post cohort to evaluate the reduction in diagnostic time, risk exposure, and cost attributable to the reorganization of existing resources into an interdisciplinary care model. This suggests that such a model yields improvements in care quality and value for aerodigestive patients, and likely for other pediatric patients with chronic complex conditions.

The Dust Bowl in the US: An Analysis Based on Current Environmental and Clinical Studies.

The Dust Bowl occurred in the Central Plains states in the United States between 1930 and 1940. Prolonged drought, intense recurrent dust storms and economic depression had profound effects on human welfare. The causes included increased farming on marginal land, poor land management, and prolonged drought. There was a significant increase in the number of cases of measles, increased hospitalization for respiratory disorders and increased infant and overall mortality in Kansas during the Dust Bowl. Recent scientific studies have demonstrated that dust transmits measles virus, influenza virus and Coccidioides immitis, and that mortality in the United States increases following dust storms with 2-3-day lag periods. Advances in technology have provided information about the composition of dust and the transfer of microbial pathogens in dust and provided the framework for reducing the economic and health consequences of the next prolonged drought in the United States.

Acceptance, satisfaction and cost of an integrative anthroposophic program for pediatric respiratory diseases in a Swiss teaching hospital: An implementation report.

BACKGROUND: For the pilot phase of an integrative pediatric program, we defined inpatient treatment algorithms for bronchiolitis, asthma and pneumonia, using medications and nursing techniques from anthroposophic medicine (AM). Parents could choose AM treatment as add-on to conventional care. MATERIAL AND METHODS: To evaluate the 18-month pilot phase, parents of AM users were asked to complete the Client Satisfaction Questionnaire (CSQ-8) and a questionnaire on the AM treatment. Staff feedback was obtained through an open-ended questionnaire. Economic data for project set-up, medications and insurance reimbursements were collected. RESULTS: A total of 351 children with bronchiolitis, asthma and pneumonia were hospitalized. Of these, 137 children (39%) received AM treatment, with use increasing over time. 52 parents completed the questionnaire. Mean CSQ-8 score was 29.77 (95% CI 29.04-30.5) which is high in literature comparison. 96% of parents were mostly or very satisfied with AM; 96% considered AM as somewhat or very helpful for their child; 94% considered they learnt skills to better care for their child. The staff questionnaire revealed positive points about enlarged care offer, closer contact with the child, more relaxed children and greater role for parents; weak points included insufficient knowledge of AM and additional nursing time needed. Cost for staff training and medications were nearly compensated by AM related insurance reimbursements. CONCLUSIONS: Introduction of anthroposophic treatments were well-accepted and led to high parent satisfaction. Additional insurance reimbursements outweighed costs. The program has now been expanded into a center for integrative pediatrics.

PM2.5-related health and economic loss assessment for 338 Chinese cities.

China is in a critical stage of ambient air quality management after global attention on pollution in its cities. Industrial development and urbanization have led to alarming levels of air pollution with serious health hazards in densely populated cities. The quantification of cause-specific PM2.5-related health impacts and corresponding economic loss estimation is crucial for control policies on ambient PM2.5 levels. Based on ground-level direct measurements of PM2.5 concentrations in 338 Chinese cities for the year 2016, this study estimates cause-specific mortality using integrated exposure-response (IER) model, non-linear power law (NLP) model and log-linear (LL) model followed by morbidity assessment using log-linear model. The willingness to pay (WTP) and cost of illness (COI) methods have been used for PM2.5-attributed economic loss assessment. In 2016 in China, the annual PM2.5 concentration ranged between 10 and 157 µg/m3 and 78.79% of the total population was exposed to >35 µg/m3 PM2.5 concentration. Subsequently, the national PM2.5-attributable mortality was 0.964 (95% CI: 0.447, 1.355) million (LL: 1.258 million and NPL: 0.770 million), about 9.98% of total reported deaths in China. Additionally, the total respiratory disease and cardiovascular disease-specific hospital admission morbidity were 0.605 million and 0.364 million. Estimated chronic bronchitis, asthma and emergency hospital admission morbidity were 0.986, 1.0 and 0.117 million respectively. Simultaneously, the PM2.5 exposure caused the economic loss of 101.39 billion US$, which is 0.91% of the national GDP in 2016. This study, for the first time, highlights the discrepancies associated with the three commonly used methodologies applied for cause-specific mortality assessment. Mortality and morbidity results of this study would provide a measurable assessment of 338 cities to the provincial and national policymakers of China for intensifying their efforts on air quality improvement.

Preclinical efficacy studies in investigator brochures: Do they enable risk-benefit assessment?

Human protection policies require favorable risk-benefit judgments prior to launch of clinical trials. For phase I and II trials, evidence for such judgment often stems from preclinical efficacy studies (PCESs). We undertook a systematic investigation of application materials (investigator brochures [IBs]) presented for ethics review for phase I and II trials to assess the content and properties of PCESs contained in them. Using a sample of 109 IBs most recently approved at 3 institutional review boards based at German Medical Faculties between the years 2010-2016, we identified 708 unique PCESs. We then rated all identified PCESs for their reporting on study elements that help to address validity threats, whether they referenced published reports, and the direction of their results. Altogether, the 109 IBs reported on 708 PCESs. Less than 5% of all PCESs described elements essential for reducing validity threats such as randomization, sample size calculation, and blinded outcome assessment. For most PCESs (89%), no reference to a published report was provided. Only 6% of all PCESs reported an outcome demonstrating no effect. For the majority of IBs (82%), all PCESs were described as reporting positive findings. Our results show that most IBs for phase I/II studies did not allow evaluators to systematically appraise the strength of the supporting preclinical findings. The very rare reporting of PCESs that demonstrated no effect raises concerns about potential design or reporting biases. Poor PCES design and reporting thwart risk-benefit evaluation during ethical review of phase I/II studies.

Disease and Economic Burden of Hospitalizations Attributable to Diabetes Mellitus and Its Complications: A Nationwide Study in Brazil.

Diabetes is associated with a significant burden globally. The costs of diabetes-related hospitalizations are unknown in most developing countries. The aim of this study was to estimate the total number and economic burden of hospitalizations attributable to diabetes mellitus (DM) and its complications in adults from the perspective of the Brazilian Public Health System in 2014. Data sources included the National Health Survey (NHS) and National database of Hospitalizations (SIH). We considered diabetes, its microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular complications (coronary heart disease, cerebrovascular disease, and peripheral arterial disease), respiratory and urinary tract infections, as well as selected cancers. Assuming that DM patients are hospitalized for these conditions more frequently that non-DM individuals, we estimated the etiological fraction of each condition related to DM, using the attributable risk methodology. We present number, average cost per case, and overall costs of hospitalizations attributable to DM in Brazil in 2014, stratified by condition, state of the country, gender and age group. In 2014, a total of 313,273 hospitalizations due to diabetes in adults were reported in Brazil (4.6% of total adult hospitalization), totaling (international dollar) Int$264.9 million. The average cost of an adult hospitalization due to diabetes was Int$845, 19% higher than hospitalization without DM. Hospitalizations due to cardiovascular diseases related to diabetes accounted for the higher proportion of costs (47.9%), followed by microvascular complications (25.4%) and DM per se (18.1%). Understanding the costs of diabetes and its major complications is crucial to raise awareness and to support the decision-making process on policy implementation, also allowing the assessment of prevention and control strategies.

The Financial Impact of a Hospital-Based Care Coordination Program for Children With Special Health Care Needs.

Care coordination programs are important in caring for medically complex pediatric patients, particularly for children with special health care needs. This study is a retrospective financial analysis of a hospital-based care coordination program involving one procedural subgroup of children with special health care needs: those receiving pediatric tracheostomy. Hospital records were reviewed for patients who received a tracheostomy at a large Midwestern U.S. hospital from 1999 through 2015. The population was divided into two subgroups: patients who received a tracheostomy before the development of a care coordination program and patients who received a tracheostomy after enrollment in the care coordination program. Patient records were reviewed for length of stay, readmissions related to respiratory and tracheostomy management, and total hospital charges. Enrollment in a care coordination program for the pediatric tracheostomy patient resulted in a decrease in mean length of stay and reduced hospital charges and a slight increase in readmissions. Further analysis using larger sample sizes and multiple centers is necessary to determine whether such outcomes are the direct result of enrollment in a care coordination program.