Low-value care practice in headache: a Spanish mixed methods research study.

BACKGROUND: Headache is one of the most prevalent diseases. The Global Burden of Disease Study ranks it as the seventh most common disease overall and the second largest neurological cause of disability in the world. The "Do Not Do" recommendations are a strategy for increasing the quality of care and reducing the cost of care for headache. This study aimed to identify specific low-value practices in headache care, determine their frequency, and estimate the cost overrun that they represent, in order to establish "Do not Do" recommendations specifically for headache by consensus and according to scientific evidence. METHODS: This was a mixed methods research study that combined qualitative consensus-building techniques, involving a multidisciplinary panel of experts to define the "Do Not Do" recommendations in headache care, and a retrospective observational study with review of a randomized set of patient records from the past 6 months in four hospitals, to quantify the frequency of these "Do Not Do" practices. We calculated the sum of direct costs of medical consultations, medicines, and unnecessary diagnostic tests. RESULTS: Seven "Do Not Do" recommendations were established for headache. In total, 3507 medical records were randomly reviewed. Low-value practices had a highly variable occurrence, depending on the hospital and type of headache. Overall, 34.1% of low-value practices were related to treatment, 21% were related to overuse of imaging in consultation, and 19% were related to emergency care. The estimated cost of low-value practices in the four hospitals was 203,520.47 euros per 1000 patients. CONCLUSIONS: This study identified low-value headache practices that need to be eradicated and provided data on their frequency and cost overruns.

Intraluminal mesh erosion after prosthetic hiatoplasty: incidence, management, and outcomes.

The purpose of the present study was to analyze the incidence, presentation, and treatment of mesh erosion into the esophagus or stomach after mesh hiatoplasty for primary or recurrent hiatal hernia. The study is a single-institution, retrospective cohort study. From November 2005 to December 2016, 122 patients consecutively underwent mesh hiatoplasty in our department, 91 during a primary surgery and 31 for a surgical revision. Follow-up was complete for 74%. Six patients of this series were evaluated for mesh erosion. In all cases, the mesh employed was a dual-type circular one. The mean time from surgery to erosion diagnosis was 42 months (median time 46 months, interquartile range 64 months). Three patients were asymptomatic, 1 had dysphagia, 1 had reflux recurrence, and 1 presented with mediastinal perforation. The absolute erosion rate was 4.9%. For patients under surveillance, the erosion rate was 6.6%, or 1 case every 48 patient-years of follow-up. The erosion rate after primary surgery was 3% or 1/86 patient-years of follow-up, and after surgery for recurrent hernia recurrence was 16% or 1/29 patient-years of follow-up. The mesh was left in place in 2 asymptomatic cases and endoscopically removed in 2 cases. Two patients submitted to surgical removal of the mesh, and only one needed a limited gastroesophageal junction resection for a conversion to a Roux-en-Y gastric bypass. The patient with esophageal perforation submitted to mesh removal, drainage, and an anterior partial fundoplication. There was no mortality. Mesh erosion after hiatoplasty presents with a high rate, especially when hiatoplasty is performed during revisional antireflux surgery. Most patients can be managed conservatively, and endoscopic removal should be considered a first-line therapy.

Registration-based methods applied to serial high-resolution T1-weighted magnetic resonance imaging for the assessment of brain volume changes in anorexia nervosa of the restricting type.

We aimed to determine whether variation in the body mass index (BMI)­a marker of anorexia nervosa (AN) severity­is associated with brain volume changes longitudinally estimated using registration-based methods on serial high-resolution T1-weighted magnetic resonance images (MRI). Fifteen female patients (mean age = 21 years; standard deviation [SD] = 5.7; range: 15­33 years) with the diagnosis of AN of the restricting type (AN-r)­according to the Diagnostic and Statistic Manual of Mental Disorders, 5th edition criteria­underwent T1-weighted MRI at baseline and after a mean follow-up period of 11 months (SD = 6.4). We used the brain boundary shift integral (BSI) and the ventricular BSI (VBSI) to estimate volume changes after registering voxels of follow-up onto baseline MRI. Very significant and strong correlations were found between BMI variation and the brain BSI, as well as between BMI variation and the VBSI. After adjustment for age at onset, duration of illness, and the BMI rate of change before baseline MRI, the statistical significance of both associations persisted. Registration-based methods on serial MRI represent an additional tool to estimate AN severity, because they provide measures of brain volume change strongly associated with BMI variation.

The Impact of Severe Obesity on Healthcare Resource Utilisation in Spain.

BACKGROUND: Obesity is not only a health problem but also a source of increased monetary expenditures. The objectives of this study were to analyse the use of healthcare resources in the Spanish adult population with class II obesity and above (BMI ≥35 kg/m2) and to compare it with other BMI groups. METHOD: We used the Spanish National Health Survey, a longitudinal population-based survey (n = 18,682), to analyse healthcare resource utilisation by BMI groups. Adjusted and unadjusted logistic regression models were used to calculate odds ratios (OR) for healthcare use among class II and over obese subjects versus normal BMI. RESULTS: Persons with BMI ≥35 are more likely to attend general practitioner (GP)'s consultations (17%), to visit the emergency department (26%), to consume medications (36%), to be hospitalised (49%), to require nursing consultations (61%) and to require psychology consultations (83%). The proportion of obese people receiving home visits is 2.6 times higher than among normal BMI. After controlling for sex and age groups, people with severe obesity (BMI ≥35 kg/m2) were more prone to requiring home care visits (OR 2.3; CI [1.3; 4.2]), GP visits (OR 2.1; CI [1.5; 3.0]), psychologist visits (OR 1.96; CI [1.3; 2.99]), emergency service visits (OR 1.5; CI [1.2; 1.8]), nurse visits (OR 1.46; CI [1.2; 1.9]) and hospitalisations (OR 1.43; CI [1.1; 1.9]) and after also adjusting for relevant comorbidities like hypertension, diabetes and cardiovascular diseases: GP visits (OR 1.85; CI [1.3; 2.7]), psychologist visits (OR 1.8; CI [1.2; 2.7]), specialised care visits (OR 0.92; CI [0.7; 1.2]) and physiotherapist visits (OR 0.7; CI [0.5; 1.0]). CONCLUSIONS: Severe obesity significantly increases healthcare resource utilisation in Spain. The results shed light on the real magnitude of the burden of obesity in Spain.

Pharmacokinetics and Dosing of Ceftobiprole Medocaril for the Treatment of Hospital- and Community-Acquired Pneumonia in Different Patient Populations.

Hospital-acquired pneumonia (HAP) and community-acquired pneumonia (CAP) are among the most common infections treated in the hospital setting, and together they place a significant burden on healthcare systems. Successful management of HAP and CAP depends on rapid initiation of empirical antibiotic therapy with broad-spectrum antibiotics. Ceftobiprole is a new-generation, broad-spectrum cephalosporin antibiotic for the treatment of HAP (excluding ventilator-associated pneumonia) and CAP. It displays potent in vitro activity against a broad range of pathogens important in pneumonia. This review summarizes the pharmacokinetic profile of ceftobiprole, and considers the pharmacokinetic parameters and pharmacodynamics underlying the choice of dosing regimen. Ceftobiprole shows linear pharmacokinetics after single and multiple doses and is eliminated predominantly through the kidneys. Ceftobiprole is administered as a 500 mg intravenous infusion over 2 h every 8 h, and steady-state concentrations are reached on the first day of dosing. Dose adjustment is recommended for patients with moderate or severe renal impairment and for those with end-stage renal disease. Extending the infusion time of ceftobiprole to 4 h is recommended to optimize drug exposure in critically ill patients with augmented renal clearance. However, there is no need for dose adjustments based on age, sex or ethnicity, or for patients with severe obesity. Population pharmacokinetic modelling and Monte Carlo simulations were used to determine the optimal dosing regimen for ceftobiprole in special patient populations, including paediatric patients. Future studies of ceftobiprole in patients with HAP and CAP would be of interest.

Listening to immigrant latino men in rural Oregon: exploring connections between culture and sexual and reproductive health services.

This study explored factors that affect access to and use of sexual and reproductive health services including family planning among immigrant Latino men residing in rural Oregon communities that have experienced a high growth in their Latino population. In-depth interviews were conducted with 49 sexually active men aged 18 to 30 years who recently immigrated to the United States. Findings from content analysis identified multiple overlapping individual-level barriers, including lack of knowledge, perception of personal risk for unintended pregnancy and STIs, and fear of disease. On a service delivery level, structural factors and the importance of confianza when interacting with providers and clinic staff were dominant themes. The majority of these themes were grounded in a cultural context and linked to men's cultural background, beliefs, and experiences. Examining the needs of immigrant Latino men through this cultural lens may be critically important for improving access and use of sexual and reproductive health services.

Cost-effectiveness and budget impact of obesity surgery in patients with type 2 diabetes in three European countries(II).

BACKGROUND: This study aimed to establish a payer-perspective cost-effectiveness and budget impact model of adjustable gastric banding (AGB) and gastric bypass (GBP) vs. conventional treatment (CT) in patients with a body mass index (BMI) > or = 35 kg x m(-2) and type 2 diabetes mellitus (T2DM) in Austria, Italy, and Spain. METHODS: A health economics model described in a previous publication was applied to resource utilization and cost data in AGB, GBP, and CT from Austria, Italy, and Spain in 2009. RESULTS: The base case time scope is 5 years; the annual discount rate for utilities and costs is 3.5%. In Austria and Italy, both AGB and GBP are cost-saving and are thus dominant in terms of incremental cost-effectiveness ratio compared to CT. In Spain, AGB and GBP yield a moderate cost increase but are cost-effective, assuming a willingness-to-pay threshold of 30,000 euro per quality adjusted life-year. Under worst-case analysis, AGB and GBP remain cost-saving or around breakeven in Austria and Italy and remain cost-effective in Spain. CONCLUSION: In patients with T2DM and BMI > or = 35 kg x m(-2) at 5-year follow-up vs. CT, AGB and GBP are not only clinically effective and safe but represent satisfactory value for money from a payer perspective in Austria, Italy, and Spain.

Population pharmacokinetics of high-dose methotrexate in children with acute lymphoblastic leukaemia.

OBJECTIVE: To develop and a priori validate a methotrexate population pharmacokinetic model in children with acute lymphoblastic leukaemia (ALL), receiving high-dose methotrexate followed by folinic acid rescue, identifying the covariates that could explain part of the pharmacokinetic variability of methotrexate. METHODS: The study was carried out in 49 children (aged 6 months to 17 years) who received high-dose methotrexate (3 g/m(2) per course) in long-term treatment. In an index group (37 individuals; 1236 methotrexate plasma concentrations), a population pharmacokinetic model was developed using a nonlinear mixed-effects model. The remaining patients' data (12 individuals; 278 methotrexate plasma concentrations) were used for model validation. Age, sex, total bodyweight (TBW), height, body surface area, lowest urine pH during infusion, serum creatinine, ALT, AST, folinic acid dose and length of rescue were analysed as possible covariates. The final predictive performance of the pharmacokinetic model was tested using standardised mean prediction errors. RESULTS: The final population pharmacokinetic model (two-compartmental) included only age and total bodyweight as influencing clearance (CL) and volume of distribution of central compartment (V(1)). For children aged < or =10 years: CL (L/h) = 0.287 . TBW(0.876); V(1) (L) = 0.465 . TBW, and for children aged >10 years: CL (L/h) = 0.149 . TBW; V(1) (L) = 0.437 . TBW. From the base to the final model, the inter-individual variabilities for CL and V(1) were significantly reduced in both age groups (30-50%). The coefficients of variation of the pharmacokinetic parameters were <30%, while residual and inter-occasional coefficients maintained values close to 40%. Validation of the proposed model revealed the suitability of the model. CONCLUSION: A methotrexate population pharmacokinetic model has been developed for ALL children. The proposed model could be used in Bayesian algorithms with a limited sampling strategy to estimate the systemic exposure of individual patients to methotrexate and adapt both folinic acid rescue and methotrexate dosing accordingly.

Assessment of the usefulness of sputum culture for diagnosis of community-acquired pneumonia using the PORT predictive scoring system.

BACKGROUND: The usefulness of sputum culture in guiding microbiological diagnosis of community-acquired pneumonia is controversial. We evaluate and assess it using the Patients Outcome Research Team (PORT) predictive scoring system. METHODS: A cohort of 1669 patients with community-acquired pneumonia was studied. Before administering antibiotic therapy, sputum was collected and its quality evaluated. Samples were gram stained and those of good quality were assessed for a predominant morphotype (PM). Sputum cultures were processed according to standard protocols. RESULTS: A sputum sample was obtained from 983 (59%) of the 1669 patients and 532 (54%) of the samples were of good quality. There was a PM in 240 (45%) of the latter samples (ie, for 14.4% of the 1669 patients) and there was no PM in 292 (55%). Culture yielded a microorganism in 207 (86%) of the 240 samples with PM and 57 (19.5%) of the 292 samples without PM (P<.05). Rates of sputum obtained, good-quality sputum specimens, PM identification, and positive culture were not significantly different among the PORT-score groups of patients (P>.05). The sensitivity and specificity of the gram-positive diplococci identification in the sputum culture of Streptococcus pneumoniae were 60% and 97.6%, and the positive and negative predictive values were 91% and 85.3%, respectively. CONCLUSIONS: Good-quality sputum with PM could be obtained in only 14.4% of all patients. A PORT-score group in which sputum could be of greater usefulness in identifying the causative organism could not be identified. The presence of gram-positive diplococci in gram-stained sputum culture was highly specific for S pneumoniae.

Surgical site infection - a European perspective of incidence and economic burden.

This retrospective review of reported surgical site infection (SSI) rates in Europe was undertaken to obtain an estimated scale of the problem and the associated economic burden. Preliminary literature searches revealed incomplete datasets when applying the National Nosocomial Infection Surveillance System criteria. Following an expanded literature search, studies were selected according to the number of parameters reported, from those identified as critical for accurate determination of SSI rates. Forty-eight studies were analysed. None of the reviewed studies recorded all the data necessary to enable a comparative assessment of the SSI rate to be undertaken. The estimated range from selected studies analysed varied widely from 1.5-20% - a consequence of inconsistencies in data collection methods, surveillance criteria and wide variations in the surgical procedures investigated - often unspecified. SSIs contribute greatly to the economic costs of surgical procedures - estimated range: 1.47-19.1 billion Euro dollars. The analysis suggests that the true rate of SSIs, currently unknown, is likely to have been previously under-reported. Consequently, the associated economic burden is also likely to be underestimated. A significant improvement in study design, data collection, analysis and reporting will be necessary to ensure that SSI baseline rates are more accurately assessed to enable the evaluation of future cost-effective measures.