Development and validation of novel simple prognostic model for predicting mortality in Korean intensive care units using national insurance claims data.

BACKGROUND/AIMS: Intensive care unit (ICU) quality is largely determined by the mortality rate. Therefore, we aimed to develop and validate a novel prognostic model for predicting mortality in Korean ICUs, using national insurance claims data. METHODS: Data were obtained from the health insurance claims database maintained by the Health Insurance Review and Assessment Service of South Korea. From patients who underwent the third ICU adequacy evaluation, 42,489 cases were enrolled and randomly divided into the derivation and validation cohorts. Using the models derived from the derivation cohort, we analyzed whether they accurately predicted death in the validation cohort. The models were verified using data from one general and two tertiary hospitals. RESULTS: Two severity correction models were created from the derivation cohort data, by applying variables selected through statistical analysis, through clinical consensus, and from performing multiple logistic regression analysis. Model 1 included six categorical variables (age, sex, Charlson comorbidity index, ventilator use, hemodialysis or continuous renal replacement therapy, and vasopressor use). Model 2 additionally included presence/absence of ICU specialists and nursing grades. In external validation, the performance of models 1 and 2 for predicting in-hospital and ICU mortality was not inferior to that of pre-existing scoring systems. CONCLUSION: The novel and simple models could predict in-hospital and ICU mortality and were not inferior compared to the pre-existing scoring systems.

Montelukast as a repurposable additive drug for standard-efficacy multiple sclerosis treatment: Emulating clinical trials with retrospective administrative health claims data.

BACKGROUND: Effective and safe treatment options for multiple sclerosis (MS) are still needed. Montelukast, a leukotriene receptor antagonist (LTRA) currently indicated for asthma or allergic rhinitis, may provide an additional therapeutic approach. OBJECTIVE: The study aimed to evaluate the effects of montelukast on the relapses of people with MS (pwMS). METHODS: In this retrospective case-control study, two independent longitudinal claims datasets were used to emulate randomized clinical trials (RCTs). We identified pwMS aged 18-65 years, on MS disease-modifying therapies concomitantly, in de-identified claims from Optum's Clinformatics® Data Mart (CDM) and IQVIA PharMetrics® Plus for Academics. Cases included 483 pwMS on montelukast and with medication adherence in CDM and 208 in PharMetrics Plus for Academics. We randomly sampled controls from 35,330 pwMS without montelukast prescriptions in CDM and 10,128 in PharMetrics Plus for Academics. Relapses were measured over a 2-year period through inpatient hospitalization and corticosteroid claims. A doubly robust causal inference model estimated the effects of montelukast, adjusting for confounders and censored patients. RESULTS: pwMS treated with montelukast demonstrated a statistically significant 23.6% reduction in relapses compared to non-users in 67.3% of emulated RCTs. CONCLUSION: Real-world evidence suggested that montelukast reduces MS relapses, warranting future clinical trials and further research on LTRAs' potential mechanism in MS.

Validating methods used to identify non-adherence adverse drug events in Canadian administrative health data.

AIMS: Medication non-adherence is a type of adverse drug event that can lead to untreated and exacerbated chronic illness, and that drives healthcare utilization. Research using medication claims data has attempted to identify instances of medication non-adherence using the proportion of days covered or by examining gaps between medication refills. We sought to validate these measures compared to a gold standard diagnosis of non-adherence made in hospital. METHODS: This was a retrospective analysis of adverse drug events diagnosed during three prospective cohorts in British Columbia between 2008 and 2015 (n = 976). We linked prospectively identified adverse drug events to medication claims data to examine the sensitivity and specificity of typical non-adherence measures. RESULTS: The sensitivity of the non-adherence measures ranged from 22.4% to 37.5%, with a proportion of days covered threshold of 95% performing the best; the non-persistence measures had sensitivities ranging from 10.4% to 58.3%. While a 7-day gap was most sensitive, it classified 61.2% of the sample as non-adherent, whereas only 19.6% were diagnosed as such in hospital. CONCLUSIONS: The methods used to identify non-adherence in administrative databases are not accurate when compared to a gold standard diagnosis by healthcare providers. Research that has relied on administrative data to identify non-adherent patients both underestimates the magnitude of the problem and may label patients as non-adherent who were in fact adherent.

Measuring Costs of Cardiovascular Disease Prevention for Patients with Familial Hypercholesterolemia in Administrative Claims Data.

INTRODUCTION: Familial hypercholesterolemia is a common genetic condition that significantly increases an individual's risk of cardiovascular events such as heart attack, stroke, and cardiac death and is a candidate for population-wide screening programs. Economic analyses of strategies to identify and treat familial hypercholesterolemia are limited by a lack of real-world cost estimates for screening services and medications for reducing cardiovascular risk in this population. METHODS: We estimated the cost of lipid panel testing in patients with hyperlipidemia and the cost of statins, ezetimibe, and PCKS9 inhibitors in patients with familial hypercholesterolemia from a commercial claims database and report costs and charges per panel and prescription by days' supply. RESULTS: The mean cost for a 90-day supply for statins was $183.33, 2.3 times the mean cost for a 30-day supply at $79.35. PCSK9 inhibitors generated the highest mean costs among medications used by patients with familial hypercholesterolemia. CONCLUSIONS: Lipid testing and lipid-lowering medications for cardiovascular disease prevention generate substantial real-world costs which can be used to improve cost-effectiveness models of familial hypercholesterolemia screening and care management.

Improving Billing and Collections in a High-Volume Pediatric Surgery Practice: Denials-Based Approach.

BACKGROUND: Despite minimal coding and billing training, surgeons are frequently tasked with both in clinical practice. This often results in denials for reimbursement based on incorrect or insufficient documentation, and reduced collections for work performed. We sought to evaluate how to correct these deficits while improving reimbursement for the most frequently rejected procedures at a high-volume academic center. STUDY DESIGN: Hospital billing data were analyzed for a 4-year period (2018 to 2021) to determine the CPT code denials with the largest overall cost. The denials were then stratified according to payor, reason for denial, and preventability. Assigned ICD-10 codes were categorized based on specificity as related to the procedure. The distribution of denials according to ICD-10 specificity was evaluated using the chi-square test. RESULTS: A total of 8,833 denials representing $11,009,108 in billing were noted during the study period. The CPT code 44970 (laparoscopic appendectomy) was the code associated with the largest financial impact, representing 12.8% of the total denied amount ($1.41M). Of the 823 denials for CPT 44970, 93.3% were associated with nonspecific ICD-10 codes, whereas only 42.0% had been associated with procedure-specific ICD-10 codes. Of the patients with nonspecific codes, 80.7% of denials were due to criteria that could be remedied with supplemental information or timely filing, representing $1,059,968 in collections. CONCLUSIONS: This is the first study to systematically evaluate a pathway for using denial data to improve collections for work performed at a high-volume academic pediatric surgery practice. Using this methodology, targets for improvement in coding and/or documentation can be identified to improve the financial performance of a surgical department. This study also provides evidence that association with nonspecific diagnostic codes is correlated with initial denial of payment by insurance companies.

Improved Prediction of Body Mass Index in Real-World Administrative Healthcare Claims Databases.

INTRODUCTION: To continue closing the gap between the predictive modeling and its real-world application, we report a new data-to-prediction pipeline that advanced the state-of-the-art predictive performance of body mass index (BMI) classifications by integrating siloed claims databases via a common data model. METHODS: This study adapted the ensemble-based methodology of the baseline prediction model and focused on removing the silos in the claims databases. We applied the Super Learner machine learning algorithm (SLA) to learn a combined dataset consisting of 50% data from the Optum Date of Death database and 50% data from the IBM MarketScan Commercial Claims and Encounters (CCAE), and omitted the commonly used one-hot-encoding step and used multi-categorical variables directly in the feature engineering process. These developments were then optimized via a standard cross-validation scheme and the performance was evaluated on a holdout test set. RESULTS: Sociodemographic and clinical characteristics were used with (denoted as SLA1) and without (denoted as SLA2) baseline BMI values to predict BMI classifications (≥ 30, ≥ 35, and ≥ 40 kg/m2). Although the newly implemented SLA1 performed similarly to the previous model, with the area under the receiver operating characteristic curve (ROC AUC) being approximately 88% for all BMI classifications, specificity ranging from 90% to 96%, and accuracy ranging from 88% to 93%. The new SLA2 achieved consistently better performance on all metrics across all BMI classes. In particular, the new SLA2 achieved 77-79% in ROC AUC, increasing from the previously reported level (73%). Its specificity improved to the range of 76-90% from 71-86%. Its accuracy improved to the range of 77-86% from 73-80%. Its recall (i.e., sensitivity) improved to the range of 64-78% from 60-76%. CONCLUSIONS: This study demonstrates dramatic improvements in the prediction of BMI across classifications using integrated databases in a common data model for the generation of real-world evidence.

Identification of pregnancies and infants within a US commercial healthcare administrative claims database.

PURPOSE: Health care insurance claims databases are becoming a more common data source for studies of medication safety during pregnancy. While pregnancies have historically been identified in such databases by pregnancy outcomes, International Classification of Diseases, 10th revision Clinical Modification (ICD-10-CM) Z3A codes denoting weeks of gestation provide more granular information on pregnancies and pregnancy periods (i.e., start and end dates). The purpose of this study was to develop a process that uses Z3A codes to identify pregnancies, pregnancy periods, and links infants within a commercial health insurance claims database. METHODS: We identified pregnancies, gestation periods, pregnancy outcomes, and linked infants within the US-based Optum Research Database between 2015 and 2020 via a series of algorithms utilizing diagnosis and procedure codes on claims. The diagnosis and procedure codes included ICD-10-CM codes, Current Procedural Terminology (CPT) codes, and Healthcare Common Procedure Coding System (HCPCS) codes. RESULTS: We identified 1 030 874 pregnancies among 841 196 women of reproductive age. Of pregnancies with livebirth outcomes, 84% were successfully linked to infants. The prevalence of pregnancy outcomes (livebirth, stillbirth, ectopic, molar, and abortion) was similar to national estimates. CONCLUSIONS: This process provides an opportunity to study drug safety and care patterns during pregnancy and may be replicated in other claims databases containing ICD-10-CM, CPT, and HCPCS codes. Work is underway to validate and refine the various algorithms.

Healthcare utilization and costs among patients with chronic migraine, episodic migraine, and tension-type headache enrolled in commercial insurance plans.

OBJECTIVE: To quantify and compare healthcare utilization and costs for patients with chronic migraine (CM), episodic migraine (EM), and tension-type headache (TTH) enrolled in US commercial health plans. METHODS: This retrospective cohort study used the Optum Clinformatics® Data Mart database from January 2015 to December 2018. Adult patients with a diagnosis of EM, CM or TTH and at least 12 months of continuous enrollment before and after diagnosis were included. Inverse probability of treatment weighting was used to adjust for baseline differences among the three groups. Patient demographic and clinical characteristics at baseline, and healthcare utilization and costs during follow-up, were described and compared between the three groups. RESULTS: A total of 45,849 patients were included: 8955 with CM, 31,961 with EM, and 4933 with TTH. The total all-cause annual direct medical costs of patients with CM ($17,878) were 1.38 times higher (95% CI: 1.31-1.44) than those with EM ($12,986), and 2.26 times higher (95% CI: 2.08-2.47) than those with TTH ($7902). The annual migraine/TTH-related costs of patients with CM ($1869) were 4.19 times higher (95% CI: 3.92-4.48) than those with EM ($446), and 11.90 times (95% CI: 10.59-13.52) higher than those with TTH ($157). In the adjusted analyses, for all service categories (emergency department, inpatient, outpatient, and prescriptions), the expected costs in the migraine groups were higher than in the TTH group (all p < 0.001), while controlling for covariates. Main findings were consistent in both weighted and unweighted samples, and with both unadjusted and adjusted analyses. CONCLUSION: This study provides an updated assessment of healthcare utilization and expenditures for adult patients with primary headache disorders. Compared to TTH, migraine is associated with higher resource use and direct medical costs, especially for those with a chronic condition. Future studies are needed to understand the indirect medical costs (productivity loss) and humanistic burden (quality of life) between migraine and TTH.

Comparative Safety of Dipeptidyl Peptidase-4 Inhibitors and Sudden Cardiac Arrest and Ventricular Arrhythmia: Population-Based Cohort Studies.

In vivo studies suggest that arrhythmia risk may be greater with less selective dipeptidyl peptidase-4 inhibitors, but evidence from population-based studies is missing. We aimed to compare saxagliptin, sitagliptin, and linagliptin with regard to risk of sudden cardiac arrest (SCA)/ventricular arrhythmia (VA). We conducted high-dimensional propensity score (hdPS) matched, new-user cohort studies. We analyzed Medicaid and Optum Clinformatics separately. We identified new users of saxagliptin, sitagliptin (both databases), and linagliptin (Optum only). We defined SCA/VA outcomes using emergency department and inpatient diagnoses. We identified and then controlled for confounders via a data-adaptive, hdPS approach. We generated marginal hazard ratios (HRs) via Cox proportional hazards regression using a robust variance estimator while adjusting for calendar year. We identified the following matched comparisons: saxagliptin vs. sitagliptin (23,895 vs. 96,972) in Medicaid, saxagliptin vs. sitagliptin (48,388 vs. 117,383) in Optum, and linagliptin vs. sitagliptin (36,820 vs. 78,701) in Optum. In Medicaid, use of saxagliptin (vs. sitagliptin) was associated with an increased rate of SCA/VA (adjusted HR (aHR), 2.01, 95% confidence interval (CI) 1.24-3.25). However, in Optum data, this finding was not present (aHR, 0.79, 95% CI 0.41-1.51). Further, we found no association between linagliptin (vs. sitagliptin) and SCA/VA (aHR, 0.65, 95% CI 0.36-1.17). We found discordant results regarding the association between SCA/VA with saxagliptin compared with sitagliptin in two independent datasets. It remains unclear whether these findings are due to heterogeneity of treatment effect in the different populations, chance, or unmeasured confounding.

Epidemiology, Etiology, and Treatment of Gastroparesis: Real-World Evidence From a Large US National Claims Database.

BACKGROUND & AIMS: Although gastroparesis carries a considerable health care and patient burden, associated epidemiological data are limited. To provide new real-world evidence for gastroparesis, we estimated disease prevalence, and investigated patient demographics and disease etiology in a large US claims database. METHODS: This retrospective, cross-sectional analysis used de-identified, longitudinal patient-level enrollment and billing data for adults from the Optum Clinformatics Data Mart database, a large US national administrative health insurance claims database. Prevalence was age-, sex-, and geographical region-standardized using the 2018 US census. Descriptive analyses of demographic and clinical variables and underlying disease etiologies were performed. RESULTS: The overall standardized prevalence of gastroparesis was 267.7 (95% confidence interval [CI] 264.8-270.7) per 100,000 US adults, whereas prevalence of "definite" gastroparesis (individuals diagnosed within 3 months of gastric emptying scintigraphy testing with persistent symptoms for more than 3 months) was 21.5 (95% CI 20.6-22.4) per 100,000 persons. Patients with gastroparesis had an overall Charlson Comorbidity Index score of 4.2, indicating substantial comorbidity burden. The most frequently documented comorbidities were chronic pulmonary disease (46.4%), diabetes with chronic complication (37.3%), and peripheral vascular disease (30.4%). Patients most commonly had a diabetic etiology (57.4%; type 1, 5.7% and type 2, 51.7%), followed by postsurgical (15.0%), drug-induced (11.8%), and idiopathic (11.3%) etiologies. CONCLUSIONS: New evidence is provided regarding the prevalence, patient demographics, and etiology of gastroparesis in the US general population. Wider availability of reliable objective gastric emptying measures and further education of medical professionals in recognizing and diagnosing gastroparesis would benefit future studies and improve understanding of disease epidemiology.

Real-World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men.

This report examined the benefits and risks of palbociclib plus endocrine therapy (ET) in men with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). Palbociclib was evaluated using three independent data sources: real-world data from pharmacy and medical claims, a de-identified real-world data source derived from electronic health records (EHRs), and a global safety database. From medical and pharmacy records, 1,139 men with MBC were identified; in the first-line setting, median duration of treatment was longer with palbociclib plus ET (n = 37, 8.5 months, 95% confidence interval (CI), 4.4-13.0) than ET alone (n = 214, 4.3 months, 95% CI, 3.0-5.7) and specifically, was longer with palbociclib plus letrozole (n = 26, 9.4 months, 95% CI, 4.4-14.0) than letrozole alone (n = 63, 3.0 months, 95% CI, 1.8-4.8). In the EHR-derived database, 59 men received treatment for MBC; real-world response across all lines of therapy in the metastatic setting was reported in 4 of 12 patients (33.3%) in the palbociclib plus ET group vs. 1 of 8 (12.5%) patients in the ET group. Review of the global safety database did not identify any new safety signals in palbociclib-treated men. Real-world data indicated that men with MBC benefit from palbociclib plus ET, with a safety profile consistent with previous observations in women with MBC. Collective data on palbociclib in women and men in this report, including clinical trial data, real-world data, and a well-established risk/benefit profile, led to US approval of an expansion of the palbociclib indication to include men with MBC.

Angiotensin-Converting Enzyme Inhibitors Used Concomitantly with Insulin Secretagogues and the Risk of Serious Hypoglycemia.

Serious hypoglycemia is a major adverse event associated with insulin secretagogues. Previous studies have suggested a potential relationship between angiotensin-converting enzyme inhibitors (ACEIs) used with sulfonylureas and serious hypoglycemia, and widely used drug compendia warn of this potential drug-drug interaction. We investigated the association between serious hypoglycemia and concomitant use of ACEIs in patients receiving insulin secretagogues, using the self-controlled case series design and Medicaid claims data from 5 US states linked to Medicare claims from 1999-2011. The exposure of interest was active prescription for ACEIs during insulin secretagogue or metformin (negative control object drug) episodes. The outcome was hospital presentation for serious hypoglycemia, identified by discharge diagnosis codes in inpatient and emergency department claims (positive predictive value ~ 78-89%). We calculated confounder-adjusted rate ratios (RRs) and 95% confidence internals (CIs) of outcome occurrence during ACEI-exposed vs. ACEI-unexposed time using conditional Poisson regression. The RRs for ACEIs were not statistically elevated during observation time of glipizide (RR, 1.06; CI, 0.98-1.15), glyburide (RR, 1.05; CI, 0.96-1.15), repaglinide (RR, 1.15; CI, 0.94-1.41), or metformin (RR, 1.02; CI, 0.97-1.06); but was modestly elevated with glimepiride (RR, 1.23; CI, 1.11-1.37) and modestly reduced with nateglinide (RR, 0.73; CI, 0.56-0.96). The overall pattern of results do not suggest that ACEIs used with insulin secretagogues were associated with increased rates of serious hypoglycemia, with the possible exception of glimepiride.

Longitudinal Data Discontinuity in Electronic Health Records and Consequences for Medication Effectiveness Studies.

Electronic health record (EHR) discontinuity (i.e., receiving care outside of the study EHR system), can lead to information bias in EHR-based real-world evidence (RWE) studies. An algorithm has been previously developed to identify patients with high EHR-continuity. We sought to assess whether applying this algorithm to patient selection for inclusion can reduce bias caused by data-discontinuity in four RWE examples. Among Medicare beneficiaries aged >=65 years from 2007 to 2014, we established 4 cohorts assessing drug effects on short-term or long-term outcomes, respectively. We linked claims data with two US EHR systems and calculated %bias of the multivariable-adjusted effect estimates based on only EHR vs. linked EHR-claims data because the linked data capture medical information recorded outside of the study EHR. Our study cohort included 77,288 patients in system 1 and 60,309 in system 2. We found the subcohort in the lowest quartile of EHR-continuity captured 72-81% of the short-term and only 21-31% of the long-term outcome events, leading to %bias of 6-99% for the short-term and 62-112% for the long-term outcome examples. This trend appeared to be more pronounced in the example using a nonuser comparison rather than an active comparison. We did not find significant treatment effect heterogeneity by EHR-continuity for most subgroups across empirical examples. In EHR-based RWE studies, investigators may consider excluding patients with low algorithm-predicted EHR-continuity as the EHR data capture relatively few of their actual outcomes, and treatment effect estimates in these patients may be unreliable.

Homebound status among older adult home care recipients in Ontario, Canada.

BACKGROUND: Homebound status is associated with an increased risk of morbidity and mortality in older adults, yet little is known about homebound older adults in Canada. Our objectives were to describe time trends in the prevalence of homebound status among community-dwelling long-term home care recipients and the characteristics associated with homebound status. METHODS: This was a retrospective cross-sectional and cohort study using linked health administrative data in Canada's most populous province, Ontario. We included adults aged 65 years and older who received at least one long-term home care assessment from 2006 to 2017 (N = 666,514). Homebound individuals were those who exited the home an average of 0-1 days/week over the previous 30 days; not homebound comparators exited the home 2-7 days per week. We compared baseline characteristics between groups and estimated the association between these characteristics and homebound status at baseline and over time. RESULTS: From 2006 to 2017, the annual proportion of long-term home care recipients who were homebound increased from 48% to 65%. At first assessment, 50% of the cohort (331,836 of 666,514) were homebound. Among those with a 4-12 month repeat assessment, homebound status persisted over time for 80%, and developed anew in 24%. Dependency on others for locomotion, use of an assistive device, poor access to dwelling, older age, and female sex were most strongly associated with homebound status at baseline, as well as its development and persistence over time. CONCLUSIONS: We found that half of Ontario older adult long-stay home care clients were homebound at the time of their first assessment, and that the prevalence of homebound status among home care recipients rose steadily from 2006 to 2017. This informs further research and policy development to ensure the adequacy of supports for older homebound persons.

Racial disparities in the utilization of parathyroidectomy among patients with primary hyperparathyroidism: Evidence from a nationwide analysis of Medicare claims.

BACKGROUND: Among patients with primary hyperparathyroidism, parathyroidectomy offers a chance of cure and mitigation of disease-related complications. The impact of race/ethnicity on referral and utilization of parathyroidectomy has not been fully explored. METHODS: Population-based, retrospective cohort study using 100% Medicare claims from beneficiaries with primary hyperparathyroidism from 2006 to 2016. Associations of race/ethnicity with disease severity, surgeon evaluation, and subsequent parathyroidectomy were analyzed using adjusted multivariable logistic regression models. RESULTS: Among 210,206 beneficiaries with primary hyperparathyroidism, 63,136 (30.0%) underwent parathyroidectomy within 1 year of diagnosis. Black patients were more likely than other races/ethnicities to have stage 3 chronic kidney disease (10.8%) but had lower prevalence of osteoporosis and nephrolithiasis compared to White patients, Black and Hispanic patients were more likely to have been hospitalized for primary hyperparathyroidism-associated conditions (White 4.8%, Black 8.1%, Hispanic 5.8%; P < .001). Patients who were White and met operative criteria were more likely to undergo parathyroidectomy than Black, Hispanic, or Asian patients (White 30.5%, Black 23.0%, Hispanic 21.4%, Asian 18.7%; P < .001). Black and Hispanic patients had lower adjusted odds of being evaluated by a surgeon (odds ratios 0.71 [95% confidence interval 0.69-0.74], 0.68 [95% confidence interval 0.61-0.74], respectively) and undergoing parathyroidectomy if evaluated by a surgeon (odds ratios 0.72 [95% confidence interval 0.68-0.77], 0.82 [95% confidence interval 0.67-0.99]). Asian race was associated with lower adjusted odds of being evaluated by a surgeon (odds ratio 0.64 [95% confidence interval 0.57-0.71]), but no difference in odds of parathyroidectomy. CONCLUSION: Racial/ethnic disparities exist in the management of primary hyperparathyroidism among older adults. Determining the factors that account for this disparity require urgent attention to achieve parity in the management of primary hyperparathyroidism.

In loco nursing practice inspection costs in a Brazilian setting / Costes de la inspección in loco de la supervisión de la práctica profesional de enfermería en una realidad brasileña / Custos da inspeção in loco da fiscalização do exercício profissional de Enfermagem em uma realidade brasileira

Abstract Objective: To identify the average direct cost related to the direct labor of the inspectors involved in the "in loco inspection" step of the inspection process carried out at the Headquarters of the Regional Nursing Council of São Paulo. Method: Quantitative, exploratory-descriptive research, in the form of a single case study. The non-probabilistic convenience sample consisted of records of initial and return "in loco inspections", carried out by inspectors working at the Headquarters of The Regional Nursing Council of São Paulo, from January 13, 2020 to March 13, 2020. Results: The average direct cost of initial in loco inspection (N = 182) corresponded to BRL 331.67 (SD = 140.32), ranging from BRL 115.80 to BRL 1071.15, and that of return in loco inspection (N = 98) to BRL 256.16 (SD = 130.90), ranging from BRL 77.20 to BRL 694.80. Time and cost variables analysis of initial and return in loco inspections showed an alpha significance level of 0.05, and it was possible to statistically state that the time (p ≤ 0.001) and the cost of initial in loco inspection (p ≤ 0.001) are higher than those for return in loco inspection. Conclusion: the cost of the step of "in loco inspection" will support the Nursing Council in the decision-making process aiming at allocating efficiency of human resources required in the inspection process.

RESUMEN Objetivo: Identificar el coste medio directo relacionado con la labor directa de los inspectores involucrados en la etapa de "inspección in loco" del proceso de inspección realizado en la Unidad Sede del Consejo Regional de Enfermería de São Paulo. Método: Investigación cuantitativa, exploratoria-descriptiva, en forma de estudio de caso único. La muestra de conveniencia no probabilística consistió en registros de "inspecciones in loco", iniciales y de retorno, realizadas por inspectores que trabajan en la Sede, desde el 13/01/2020 al 13/03/2020. Resultados: El coste medio directo de la inspección inicial (N = 182) correspondió a R$ 331,67 (DP = 140,32), con un rango de R$ 115,80 a R$ 1071,15, y el de la inspección de retorno (N = 98) a R$ 256,16 (DP = 130,90), oscilando entre R$ 77,20 y R$ 694,80. El análisis de las variables tiempo y coste de las inspecciones inicial y de retorno indicó un nivel de significancia alfa de 0.05, y fue posible afirmar estadísticamente que el tiempo (p ≤ 0.001) y el costo de la inspección inicial (p ≤ 0,001) son mayores que los de la inspección de retorno. Conclusión: el costo de la etapa de "inspección in loco" subsidiará el Consejo en el proceso de toma de decisiones buscando la eficiencia en la asignación de los recursos humanos requeridos en el proceso de inspección.

RESUMO Objetivo: Identificar o custo direto médio relativo à mão de obra direta dos fiscais envolvidos na etapa "inspeção in loco" do processo de fiscalização realizado na Unidade Sede do Conselho Regional de Enfermagem de São Paulo. Método: Pesquisa quantitativa, exploratório-descritiva, na modalidade de estudo de caso único. A amostra de conveniência, não probabilística, foi constituída por registros de "inspeções in loco", iniciais e de retorno, realizadas por fiscais atuantes na Unidade Sede, no período de 13/01/2020 a 13/03/2020. Resultados: O custo direto médio da inspeção in loco inicial (N = 182) correspondeu a R$ 331,67 (DP = 140,32), variando de R$ 115,80 a R$ 1071,15, e da inspeção in loco de retorno (N = 98) a R$ 256,16 (DP = 130,90), variando entre R$77,20 e R$ 694,80. A análise das variáveis tempo e custo das inspeções in loco iniciais e de retorno evidenciou nível de significância alfa de 0,05, sendo possível afirmar estatisticamente que o tempo (p ≤ 0,001) e o custo da inspeção in loco inicial (p ≤ 0,001) são maiores do que os da inspeção in loco de retorno. Conclusão: o custeio da etapa "inspeção in loco" subsidiará o Conselho no processo decisório visando à eficiência alocativa dos recursos humanos requeridos no processo de fiscalização.