Cytarabine dose intensification improves survival in older patients with secondary/high-risk acute myeloid leukemia in matched real-world versus clinical trial data.

Since 1980's, the established/standard treatment of acute myeloid leukemia (AML) is cytarabine infusion with anthracycline (7 + 3 regimen). We compared the 7 + 3 regimen in older secondary/high-risk AML patientsfrom a clinical trial with a matched population from the Swedish AML Registrytreated withan increased cytarabine dose in induction and consolidation as recommended in the Swedish National Guidelines since 2005. After successfulpropensity score matching, 104 patients per group were included. The primary outcome was overall survival (OS), and standard dosed patients had a median OS of 6.4 versus 10.7 months with increased dose intensity (hazard ratio:0.69, p = 0.012), with 5-year OS of 8.7% and 18.1%, andremission rates of 36% and 60%, respectively (p < 0.001). Median OS after allogeneic hematopoietic cell transplantation (in 27.9% per group) was 10.4 and 20.7 months, respectively. We conclude that the more intensive cytarabine schedule seems to provide improved outcomes inthe investigated AML patient group.

Prediction of outcome after spinal surgery-using The Dialogue Support based on the Swedish national quality register.

PURPOSE: To evaluate the predictive precision of the Dialogue Support, a tool for additional help in shared decision-making before surgery of the degenerative spine. METHODS: Data in Swespine (Swedish national quality registry) of patients operated between 2007 and 2019 found the development of prediction algorithms based on logistic regression analyses, where socio-demographic and baseline variables were included. The algorithms were tested in four diagnostic groups: lumbar disc herniation, lumbar spinal stenosis, degenerative disc disease and cervical radiculopathy. By random selection, 80% of the study population was used for the prediction of outcome and then tested against the actual outcome of the remaining 20%. Outcome measures were global assessment of pain (GA), and satisfaction with outcome. RESULTS: Calibration plots demonstrated a high degree of concordance on a group level. On an individual level, ROC curves showed moderate predictive capacity with AUC (area under the curve) values 0.67-0.68 for global assessment and 0.6-0.67 for satisfaction. CONCLUSION: The Dialogue Support can serve as an aid to both patient and surgeon when discussing and deciding on surgical treatment of degenerative conditions in the lumbar and cervical spine. LEVEL OF EVIDENCE: I.

How can technology support quality improvement? Lessons learned from the adoption of an analytics tool for advanced performance measurement in a hospital unit.

BACKGROUND: Technology for timely feedback of data has the potential to support quality improvement (QI) in health care. However, such technology may pose difficulties stemming from the complex interaction with the setting in which it is implemented. To enable professionals to use data in QI there is a need to better understand of how to handle this complexity. This study aims to explore factors that influence the adoption of a technology-supported QI programme in an obstetric unit through a complexity informed framework. METHODS: This qualitative study, based on focus group interviews, was conducted at a Swedish university hospital's obstetric unit, which used an analytics tool for advanced performance measurement that gave timely and case mix adjusted feedback of performance data to support QI. Data was collected through three focus group interviews conducted with 16 managers and staff. The Nonadoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework guided the data collection and analysis. RESULTS: Staff and managers deemed the technology to effectively support ongoing QI efforts by providing timely access to reliable data. The value of the technology was associated with a clear need to make better use of existing data in QI. The data and the methodology in the analytics tool reflected the complexity of the clinical conditions treated but was presented through an interface that was easy to access and user friendly. However, prior understanding of statistics was helpful to be able to fully grasp the presented data. The tool was adapted to the needs and the organizational conditions of the local setting through a collaborative approach between the technology supplier and the adopters. CONCLUSIONS: Technology has the potential to enable systematic QI through motivating professionals by providing timely and adequate feedback of performance. The adoption of such technology is complex and requires openness for gradual learning and improvement.

Comparison of individual and neighbourhood socioeconomic status in case mix adjustment of hospital performance in primary total hip replacement in Sweden: a register-based study.

BACKGROUND: Case mix adjustment is a pre-requisite for valid measurement of healthcare performance and socioeconomic status (SES) is important to account for. Lack of information on individual-level SES has led to investigations into using a proxy for SES based on patient area of residence. The objective of this study was to use neighbourhood SES for case mix adjustment of performance indicators in total hip replacement (THR) in Sweden, and to compare with use of individual SES. METHODS: Data from patient administrative systems and the Swedish Hip Arthroplasty Register were extracted for all patients undergoing THR in four Swedish regions. For each subject, individual data and neighbourhood data on country of birth, educational level, and income were provided by Statistics Sweden. Three variables were selected for analysis of performance; EQ-5D, hip pain and length of stay (LoS). In addition to socioeconomic information, several important clinical characteristics were used as case mix factors. Regression analysis was used to study each variable's impact on the three outcome variables and model fit was evaluated using mean squared error. RESULTS: A total of 27,121 patients operated between 2010 and 2016 were included in the study. Both educational level and income were higher when based on neighbourhood information than individual information, while proportion born in Sweden was similar. Higher SES was generally found to be associated with better outcomes and lower LoS, albeit with certain differences between the different measures of SES. The predictive ability of the models was increased when adding information on SES to the clinical characteristics. The increase in predictive ability was higher for individual SES compared to neighbourhood SES. When analysing performance for the two providers with most diverging case mix in terms of SES, the inclusion of SES altered the relative performance using individual as well as neighbourhood SES. CONCLUSIONS: Incorporating SES improves case mix adjustment marginally compared to using only clinical information. In this patient group, geographically derived SES was found to improve case mix adjustment compared to only clinical information but not to the same extent as actual individual-level SES.

Inter-hospital variations in health outcomes in childbirth care in Sweden: a register-based study.

OBJECTIVE: The objective of this study was to estimate case mix adjusted variations in central indicators of health outcomes in childbirth care and to assess whether hospitals who perform well on one indicator also perform well on others. DESIGN: Register-based study using regional administrative data, linked to clinical data and population data. SETTING: Twenty-one hospitals in seven Swedish regions covering 67% of deliveries in Sweden. PARTICIPANTS: The study included 139 756 women who gave birth in 2011 and 2012. INTERVENTION(S): N/A. MAIN OUTCOME MEASURE(S): Four indicators of health outcomes were studied: obstetric anal sphincter injuries (OASIS), haemorrhage >1000 ml, postpartum infection and Apgar <4 at 5 min. Variations between hospitals were estimated using fixed effects logistic regression, adjusted for numerous sociodemographic and clinical characteristics. RESULTS: Significant variations after case mix adjustment were observed for all four indicators. If all hospitals had performed as the average of the top five hospitals for each indicator, a total of 890 OASIS, 2700 haemorrhages, 1500 postpartum infections and 180 instances of low Apgar would have been avoided. A certain degree of correlation was observed between different indicators of outcomes. However, no hospital had a statistically significant higher or lower rate across all four indicators of health outcomes. CONCLUSIONS: The significant variations in all four indicators demonstrate a potential for improvement in performance at all studied hospitals. Hospital performance was not consistent across different indicators of outcomes and all hospitals have potential for improvement in certain aspects of labour management.

The effects of clinical and sociodemographic factors on survival, resource use and lead times in patients with high-grade gliomas: a population-based register study.

BACKGROUND: Previous studies indicate an effect of sociodemographic factors on risk for being diagnosed with, as well as on survival of cancer in general. Our primary aim was to analyse sociodemographic factors, resource use and lead times in health care after diagnosis with high grade malignant glioma (HGG) in a large population based cohort. METHODS: A register-based study using several unique high-coverage registries. All patients over the age of 18 diagnosed with HGG in the Swedish Stockholm-Gotland region between 2001 and 2013 (n = 1149) were included. RESULTS: In multivariable cox proportional hazard model of survival, older age, male sex and high tumour grade were associated with worse survival. No significant differences could be seen related to country of birth. A high disposable income was associated with better survival and fewer occasions of pre-diagnostic inpatient care. Older age and comorbidities were correlated with a significantly increased number of outpatient visits the year before HGG diagnosis. In addition, male sex, being born outside Sweden was associated to a higher number of outpatient visits the year after diagnosis in multivariable analysis. Leadtime from diagnosis (first suspicion on brain scan) to surgery showed that the oldest patients, patients with comorbidity and patients born outside Europe had to wait longer for surgery. CONCLUSIONS: Sociodemographic factors like education, income and country of birth have impact on care processes both before and after the diagnosis HGG. This needs to be acknowledged in addition to important clinical factors like age, comorbidity and tumour grade, in order to accomplish more equal cancer care.

Exploring methods for comparing the real-world effectiveness of treatments for osteoporosis: adjusted direct comparisons versus using patients as their own control.

Using Swedish and Dutch registry data for women initiating bisphosphonates, we evaluated two methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for differences in patient baseline characteristics. Each method has advantages and disadvantages; both are potential complements to clinical trial analyses. PURPOSE: We evaluated methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for both observed and unobserved confounding. METHODS: Swedish and Dutch registry data for women initiating zoledronate or oral bisphosphonates (OBPs; alendronate/risedronate) were used; the primary outcome was fracture. In adjusted direct comparisons (ADCs), regression and matching techniques were used to account for baseline differences in known risk factors for fracture (e.g., age, previous fracture, comorbidities). In an own-control analysis (OCA), for each treatment, fracture incidence in the first 90 days following treatment initiation (the baseline risk period) was compared with fracture incidence in the 1-year period starting 91 days after treatment initiation (the treatment exposure period). RESULTS: In total, 1196 and 149 women initiating zoledronate and 14,764 and 25,058 initiating OBPs were eligible in the Swedish and Dutch registries, respectively. Owing to the small Dutch zoledronate sample, only the Swedish data were used to compare fracture incidences between treatment groups. ADCs showed a numerically higher fracture incidence in the zoledronate than in the OBPs group (hazard ratio 1.09-1.21; not statistically significant, p > 0.05). For both treatment groups, OCA showed a higher fracture incidence in the baseline risk period than in the treatment exposure period, indicating a treatment effect. OCA showed a similar or greater effect in the zoledronate group compared with the OBPs group. CONCLUSIONS: ADC and OCA each possesses advantages and disadvantages. Combining both methods may provide an estimate of real-world treatment efficacy that could potentially complement clinical trial findings.

Case mix adjusted variation in cesarean section rate in Sweden.

INTRODUCTION: Cesarean section (CS) rate is a well-established indicator of performance in maternity care and is also related to resource use. Case mix adjustment of CS rates when performing comparisons between hospitals is important. The objective of this study was to estimate case mix adjusted variation in CS rate between hospitals in Sweden. MATERIAL AND METHODS: In total, 139 756 deliveries in 2011 and 2012 were identified in administrative systems in seven regions covering 67% of all deliveries in Sweden. Data were linked to the Medical birth register and population data. Twenty-three different sociodemographic and clinical characteristics were used for adjustment. Analyses were performed for the entire study population as well as for two subgroups. Logistic regression was used to analyze differences between hospitals. RESULTS: The overall CS rate was 16.9% (hospital minimum-maximum 12.1-22.6%). Significant variations in CS rate between hospitals were observed after case mix adjustment: hospital odds ratios for CS varied from 0.62 (95% CI 0.53-0.73) to 1.45 (95% CI 1.37-1.52). In nulliparous, cephalic, full-term, singletons the overall CS rate was 14.3% (hospital minimum-maximum: 9.0-19.0%), whereas it was 4.7% for multiparous, cephalic, full-term, singletons with no previous CS (hospital minimum-maximum: 3.2-6.7%). In both subgroups significant variations were observed in case mix adjusted CS rates. CONCLUSIONS: Significant differences in CS rate between Swedish hospitals were found after adjusting for differences in case mix. This indicates a potential for fewer interventions and lower resource use in Swedish childbirth care. Best practice sharing and continuous monitoring are important tools for improving childbirth care.

Healthcare resource use, comorbidity, treatment and clinical outcomes for patients with primary intracranial tumors: a Swedish population-based register study.

BACKGROUND: Primary intracranial tumors are relatively uncommon and heterogeneous, which make them challenging to study. We coupled data from unique Swedish population-based registries in order to deeper analyze the most common intracranical tumor types. Patient characteristics (e.g. comorbidities), care process measures like adherence to national guidelines, healthcare resource use and clinical outcome was evaluated. MATERIALS AND METHODS: A register-based study including several population-based registries for all patients living in Stockholm-Gotland, diagnosed with primary intracranial tumor between 2001 and 2013 was performed. Patient characteristics were captured and investigated in relation to survival, healthcare resource use (inpatient-, outpatient- and primary care) and treatment process. RESULTS: High-grade glioma and meningioma were the most common tumor types and most patients (76%) were above the age of 40 in the patient population (n = 3664). Older age, comorbidity (Elixhauser comorbidity index) and type of tumor (high-grade glioma) were associated with lower survival rate and increased use of healthcare resources, analyzed for patients living in Stockholm (n = 3031). The analyses of healthcare use and survival showed no differences between males and females, when stratifying by tumor types. Healthcare processes were not always consistent with existing national treatment recommendations for patients with high-grade gliomas (n = 474) with regard to specified lead times, analyzed in the Swedish Brain Tumor Registry, as also observed at the national level. CONCLUSIONS: Age, comorbidity and high-grade gliomas, but not sex, were associated with decreased survival and increased use of healthcare resources. Fewer patients than aimed for in national guidelines received care according to specified lead times. The analysis of comprehensive population-based register data can be used to improve future care processes and outcomes.

Case mix adjustment of health outcomes, resource use and process indicators in childbirth care: a register-based study.

BACKGROUND: Unwarranted variation in care practice and outcomes has gained attention and inter-hospital comparisons are increasingly being used to highlight and understand differences between hospitals. Adjustment for case mix is a prerequisite for meaningful comparisons between hospitals with different patient populations. The objective of this study was to identify and quantify maternal characteristics that impact a set of important indicators of health outcomes, resource use and care process and which could be used for case mix adjustment of comparisons between hospitals. METHODS: In this register-based study, 139 756 deliveries in 2011 and 2012 were identified in regional administrative systems from seven Swedish regions, which together cover 67 % of all deliveries in Sweden. Data were linked to the Medical birth register and Statistics Sweden's population data. A number of important indicators in childbirth care were studied: Caesarean section (CS), induction of labour, length of stay, perineal tears, haemorrhage > 1000 ml and post-partum infections. Sociodemographic and clinical characteristics deemed relevant for case mix adjustment of outcomes and resource use were identified based on previous literature and based on clinical expertise. Adjustment using logistic and ordinary least squares regression analysis was performed to quantify the impact of these characteristics on the studied indicators. RESULTS: Almost all case mix factors analysed had an impact on CS rate, induction rate and length of stay and the effect was highly statistically significant for most factors. Maternal age, parity, fetal presentation and multiple birth were strong predictors of all these indicators but a number of additional factors such as born outside the EU, body mass index (BMI) and several complications during pregnancy were also important risk factors. A number of maternal characteristics had a noticeable impact on risk of perineal tears, while the impact of case mix factors was less pronounced for risk of haemorrhage > 1000 ml and post-partum infections. CONCLUSIONS: Maternal characteristics have a large impact on care process, resource use and outcomes in childbirth care. For meaningful comparisons between hospitals and benchmarking, a broad spectrum of sociodemographic and clinical maternal characteristics should be accounted for.

Economic evaluation of rFVIIa high initial dose compared to rFVIIa standard initial dose in patients with haemophilia with inhibitors using the Czech HemoRec registry.

INTRODUCTION: In the treatment of bleeds in haemophilia patients with inhibitors, a high initial dose of recombinant Factor VIIa (rFVIIa) provides at least equal efficacy and a similar safety profile to a standard initial dose. However, no pharmacoeconomic comparison between these dosing regimens has previously been performed. Here, we assess the pharmacoeconomics of high (>120 µg/kg) versus standard (≤120 µg/kg) initial rFVIIa dose in inhibitor patients and the impact of time to treatment initiation on costs and outcomes. METHODS: In a retrospective analysis, observational data on bleed characteristics, rFVIIa treatment, hospitalizations and outcomes were extracted from the Czech Republic HemoRec registry. Crude comparisons and generalized linear regression modelling (GLM; correcting for patient differences) were performed to compare costs and outcomes between the high and standard initial dosing groups. RESULTS: Of 314 rFVIIa-treated bleeding episodes (12 inhibitor patients), most were spontaneous joint bleeds and 67.5% were treated with a high initial dose. In the crude comparison, high initial rFVIIa dosing was associated with a lower mean number of doses needed to achieve haemostasis compared with standard dosing (p<0.001), but higher total dose and costs (p ≤ 0.008). However, regression analyses revealed that high initial dose was associated with similar costs (p=0.891) and a shorter time to bleeding resolution (p=0.014). Increasing time to treatment initiation increased both time to bleeding resolution and total costs. CONCLUSION: Compared with a standard dose, a high initial rFVIIa dose may improve treatment outcomes without increasing costs. Early treatment initiation may reduce treatment costs.

Economic analysis of recombinant activated factor VII versus plasma-derived activated prothrombin complex concentrate in mild to moderate bleeds: haemophilia registry data from the Czech Republic.

INTRODUCTION: Several studies suggest that recombinant activated factor VII (rFVIIa) is more cost-effective than plasma-derived activated prothrombin complex concentrate (pd-aPCC) in haemophilia with inhibitors. However, most do not consider differences between treated patients. This study compared the pharmacoeconomics of rFVIIa versus pd-aPCC treatment of mild to moderate bleeds in inhibitor patients, taking co-variables into account. METHODS: The HemoRec and HemIS registries capture exhaustive bleeding data in inhibitor patients in the Czech Republic. For each bleed, patient and bleed characteristics, treatment outcomes and bypassing agent use were retrospectively analysed, and direct costs of care per bleed calculated. Generalised Linear Model regression methods with cluster effect were employed to account for the possibility of several bleedings from the same patient. RESULTS: There were 108 and 53 mild to moderate bleeds in the rFVIIa and pd-aPCC groups, respectively. Although re-bleeding rates were similar in both groups, deeper analyses revealed significant differences in time to bleed resolution: 93.8% of bleeds treated with rFVIIa were resolved within ≤ 12 h, versus 60.4% with pd-aPCC (P < 0.001). Mean total cost/bleed was lower with rFVIIa (336,852 [median, 290,696] CZK; €12,760 [11,011]) than pd-aPCC (522,768 [341,310] CZK; €19,802 [12,928]) (P = 0.002). Results were maintained after controlling for potential co-variables (bleed nature, time to treatment, target joints). CONCLUSIONS: The lower total treatment costs per bleed with rFVIIa than pd-aPCC suggest that first-line rFVIIa is more cost-effective than pd-aPCC in mild to moderate bleeds. Time to bleed resolution was also significantly shorter with rFVIIa. These results were maintained when controlled for potential confounders.

Resource use and societal costs for Crohn's disease in Sweden.

BACKGROUND: The usual onset of Crohn's disease (CD) is between 15 and 30 years of age, thus affecting people during their most economically productive period in life. METHODS: This study intended to estimate societal costs and health-related quality of life (HRQoL) in Swedish patients in different stages of CD. Cross-sectional data on disease activity (measured with the Harvey-Bradshaw Index [HBI]), direct medical resource use, work productivity, and HRQoL (assessed using the 15D instrument) were collected for 420 patients by questionnaires to patients, to the treating physician, and from medical records. Based on HBI, current treatment, and response to treatment, patients were classified into the following disease states: Remission, Response, Active, Refractory, and Surgery. RESULTS: The average 4-week cost per patient in 2007 was estimated at €721 (USD 988), of which 64% was due to lost productivity. The total 4-week cost of care was €255 (USD 349) in Remission, €831 (USD 1138) in Response, €891 (USD 1220) in Active, €1360 (USD 1864) in Refractory, and €16984 (USD 23269) in Surgery. HBI was the most important predictor of costs of care--a 1-point increase in HBI increased total costs by 25% (P < 0.001). HRQoL differed between the disease states: 0.92 in Remission, 0.90 in Response, 0.82 in Active, 0.81 in Refractory, and 0.77 in Surgery. CONCLUSIONS: Patients in remission have the lowest costs and the highest HRQoL. Patients responding to treatment have lower costs of care than patients with high disease activity who are not treated or do not respond to treatment. Thus, total costs of care might be reduced by efficient treatment.