Evaluation of a unique and innovative diabetes care model in primary care in Ontario, Canada: protocol for a multiple-methods study with a convergent parallel design.

INTRODUCTION: The growth and complexity of diabetes are exceeding the capacity of family physicians, resulting in the demand for community-based, interprofessional, primary care-led transition clinics. The Primary Care Diabetes Support Programme (PCDSP) in London, Ontario, is an innovative approach to diabetes care for high-risk populations, such as medically or socially complex and unattached patients. In this study, we will employ a quadruple-aim approach to evaluate the health system impacts of the PCDSP. METHODS AND ANALYSIS: We will use multiple methods through a convergent parallel design in this project across five unique studies: a case study, a patient study, a provider study, a complications study and a cost-effectiveness study. The project will be conducted in a dedicated stand-alone clinic specialising in chronic disease management, specifically focusing on diabetes care. Participants will include clinic staff, administrators, family physicians, specialists and patients with type 1 or type 2 diabetes who received care at the clinic between 2011 and 2023. The project design will define the intervention, support replication at other sites or for other chronic diseases and address each of the quadruple aims and equity. Following the execution of the five individual studies, we will build a business case by integrating the results. Data will be analysed using both qualitative (content analysis and thematic analysis) and quantitative techniques (descriptive statistics and multiple logistic regression). ETHICS AND DISSEMINATION: We received approval from the research ethics boards at Western University (reference ID: 2023-1 21 766; 2023-1 22 326) and Lawson Health Research Institute (reference ID: R-23-202). A privacy review was completed by St. Joseph's Healthcare Corporation. The findings will be shared among PCDSP staff and patients, stakeholders, academic researchers and the public through stakeholder sessions, conferences, peer-reviewed publications, infographics, posters, media interviews, social media and online discussions. For the patient and provider study, all participants will be asked to provide consent and are free to withdraw from the study, without penalty, until the data are combined. Participants will not be identified in any report or presentation except in the case study, for which, given the number of PCDSP providers, we will seek explicit consent to identify them.

The iterative implementation of a comprehensive enhanced recovery after surgery protocol in all spinal surgery in Korea: a comparative analysis of clinical outcomes and medical costs between primary spinal tumors and degenerative spinal diseases.

OBJECTIVE: Most studies on the enhanced recovery after surgery (ERAS) protocol in spine surgery have focused on patients with degenerative spinal diseases (DSDs), resulting in a lack of evidence for a comprehensive ERAS protocol applicable to patients with primary spine tumors (PSTs) and other spinal diseases. The authors had developed and gradually adopted components of the comprehensive ERAS protocol for all spine surgical procedures from 2003 to 2011, and then the current ERAS protocol was fully implemented in 2012. This study aimed to evaluate the impact and the applicability of the comprehensive ERAS protocol across all spine surgical procedures and to compare outcomes between the PST and DSD groups. METHODS: Adult spine surgical procedures were conducted from 2003 to 2021 at the Seoul National University Hospital Spine Center and data were retrospectively reviewed. The author divided the study periods into the developing ERAS (2003-2011) and post-current ERAS (2012-2021) periods, and outcomes were compared between the two periods. Surgical procedures for metastatic cancer, infection, and trauma were excluded. Interrupted time series analysis (ITSA) was used to assess the impact of the ERAS protocol on medical costs and clinical outcomes, including length of stay (LOS) and rates of 30-day readmission, reoperation, and surgical site infection (SSI). Subgroup analyses were conducted on the PST and DSD groups in terms of LOS and medical costs. RESULTS: The study included 7143 surgical procedures, comprising 1494 for PSTs, 5340 for DSDs, and 309 for other spinal diseases. After ERAS protocol implementation, spine surgical procedures showed significant reductions in LOS and medical costs by 22% (p = 0.008) and 22% (p < 0.001), respectively. The DSD group demonstrated a 16% (p < 0.001) reduction in LOS, whereas the PST group achieved a 28% (p < 0.001) reduction, noting a more pronounced LOS reduction in PST surgical procedures (p = 0.003). Medical costs decreased by 23% (p < 0.001) in the DSD group and 12% (p = 0.054) in the PST group, with a larger cost reduction for DSD surgical procedures (p = 0.021). No statistically significant differences were found in the rates of 30-day readmission, reoperation, and SSI between the developing and post-current ERAS implementation periods (p = 0.65, p = 0.59, and p = 0.52, respectively). CONCLUSIONS: Comprehensive ERAS protocol implementation significantly reduced LOS and medical costs in all spine surgical procedures, while maintaining comparable 30-day readmission, reoperation, and SSI rates. These findings suggest that the ERAS protocol is equally applicable to all spine surgical procedures, with a more pronounced effect on reducing LOS in the PST group and on reducing medical costs in the DSD group.

Construction and validation of the area level deprivation index for health research: A methodological study based on Nepal Demographic and Health Survey.

Area-level factors may partly explain the heterogeneity in risk factors and disease distribution. Yet, there are a limited number of studies that focus on the development and validation of the area level construct and are primarily from high-income countries. The main objective of the study is to provide a methodological approach to construct and validate the area level construct, the Area Level Deprivation Index in low resource setting. A total of 14652 individuals from 11,203 households within 383 clusters (or areas) were selected from 2016-Nepal Demographic and Health survey. The index development involved sequential steps that included identification and screening of variables, variable reduction and extraction of the factors, and assessment of reliability and validity. Variables that could explain the underlying latent structure of area-level deprivation were selected from the dataset. These variables included: housing structure, household assets, and availability and accessibility of physical infrastructures such as roads, health care facilities, nearby towns, and geographic terrain. Initially, 26-variables were selected for the index development. A unifactorial model with 15-variables had the best fit to represent the underlying structure for area-level deprivation evidencing strong internal consistency (Cronbach's alpha = 0.93). Standardized scores for index ranged from 58.0 to 140.0, with higher scores signifying greater area-level deprivation. The newly constructed index showed relatively strong criterion validity with multi-dimensional poverty index (Pearson's correlation coefficient = 0.77) and relatively strong construct validity (Comparative Fit Index = 0.96; Tucker-Lewis Index = 0.94; standardized root mean square residual = 0.05; Root mean square error of approximation = 0.079). The factor structure was relatively consistent across different administrative regions. Area level deprivation index was constructed, and its validity and reliability was assessed. The index provides an opportunity to explore the area-level influence on disease outcome and health disparity.

Cost-utility analysis of endoscopic lumbar discectomy following a uniform clinical pathway in the Korean national health insurance system.

INTRODUCTION: Full-endoscopic lumbar discectomy (FELD) is a type of minimally invasive spinal surgery for lumbar disc herniation (LDH). Sufficient evidence exists to recommend FELD as an alternative to standard open microdiscectomy, and some patients prefer FELD due to its minimally invasive nature. However, in the Republic of Korea, the National Health Insurance System (NHIS) controls the reimbursement and use of supplies for FELD, but FELD is not currently reimbursed by the NHIS. Nonetheless, FELD has been performed upon patients' request, but providing FELD for patients' sake is inherently an unstable arrangement in the absence of a practical reimbursement system. The purpose of this study was to conduct a cost-utility analysis of FELD to suggest appropriate reimbursements. METHOD: This study was a subgroup analysis of prospectively collected data including 28 patients who underwent FELD. All patients were NHIS beneficiaries and followed a uniform clinical pathway. Quality-adjusted life years (QALYs) were assessed with a utility score using the EuroQol 5-Dimension (EQ-5D) instrument. The costs included direct medical costs incurred at the hospital for 2 years and the price of the electrode ($700), although it was not reimbursed. The costs and QALYs gained were used to calculate the cost per QALY gained. RESULT: Patients' mean age was 43 years and one-third (32%) were women. L4-5 was the most common surgical level (20/28, 71%) and extrusion was the most common type of LDH (14, 50%). Half of the patients (15, 54%) had jobs with an intermediate level of activity. The preoperative EQ-5D utility score was 0.48±0.19. Pain, disability, and the utility score significantly improved starting 1 month postoperatively. The average EQ-5D utility score during 2 years after FELD was estimated as 0.81 (95% CI: 0.78-0.85). For 2 years, the mean direct costs were $3,459 and the cost per QALY gained was $5,241. CONCLUSION: The cost-utility analysis showed a quite reasonable cost per QALY gained for FELD. A comprehensive range of surgical options should be provided to patients, for which a practical reimbursement system is a prerequisite.

A cost-utility analysis between decompression only and fusion surgery for elderly patients with lumbar spinal stenosis and sagittal imbalance.

Lumbar spinal stenosis (LSS) and sagittal imbalance are relatively common in elderly patients. Although the goals of surgery include both functional and radiological improvements, the criteria of correction may be too strict for elderly patients. If the main symptom of patients is not forward-stooping but neurogenic claudication or pain, lumbar decompression without adding fusion procedure may be a surgical option. We performed cost-utility analysis between lumbar decompression and lumbar fusion surgery for those patients. Elderly patients (age > 60 years) who underwent 1-2 levels lumbar fusion surgery (F-group, n = 31) or decompression surgery (D-group, n = 40) for LSS with sagittal imbalance (C7 sagittal vertical axis, C7-SVA > 40 mm) with follow-up ≥ 2 years were included. Clinical outcomes (Euro-Quality of Life-5 Dimensions, EQ-5D; Oswestry Disability Index, ODI; numerical rating score of pain on the back and leg, NRS-B and NRS-L) and radiological parameters (C7-SVA; lumbar lordosis, LL; the difference between pelvic incidence and lumbar lordosis, PI-LL; pelvic tilt, PT) were assessed. The quality-adjusted life year (QALY) and incremental cost-effective ratio (ICER) were calculated from a utility score of EQ-5D. Postoperatively, both groups attained clinical and radiological improvement in all parameters, but NRS-L was more improved in the F-group (p = 0.048). ICER of F-group over D-group was 49,833 US dollars/QALY. Cost-effective lumbar decompression may be a recommendable surgical option for certain elderly patients, despite less improvement of leg pain than with fusion surgery.

Direct medical costs after surgical or nonsurgical treatment for degenerative lumbar spinal disease: A nationwide matched cohort study with a 10-year follow-up.

OBJECTIVE: The demand for treating degenerative lumbar spinal disease has been increasing, leading to increased utilization of medical resources. Thus, we need to understand how the budget of insurance is currently used. The objective of the present study is to overview the utilization of the National Health Insurance Service (NHIS) by providing the direct insured cost between patients receiving surgery and patients receiving nonsurgical treatment for degenerative lumbar disease. METHODS: The NHIS-National Sample Cohort was utilized to select patients with lumbar disc herniation, spinal stenosis, spondylolisthesis or spondylolysis. A matched cohort study design was used to show direct medical costs of surgery (n = 2,698) and nonsurgical (n = 2,698) cohorts. Non-surgical treatment included medication, physiotherapy, injection, and chiropractic. The monthly costs of the surgery cohort and nonsurgical cohort were presented at initial treatment, posttreatment 1, 3, 6, 9, and 12 months and yearly thereafter for 10 years. RESULTS: The characteristics and matching factors were well-balanced between the matched cohorts. Overall, surgery cohort spent $50.84/patient/month, while the nonsurgical cohort spent $29.34/patient/month (p<0.01). Initially, surgery treatment led to more charge to NHIS ($2,762) than nonsurgical treatment ($180.4) (p<0.01). Compared with the non-surgical cohort, the surgery cohort charged $33/month more for the first 3 months, charged less at 12 months, and charged approximately the same over the course of 10 years. CONCLUSION: Surgical treatment initially led to more government reimbursement than nonsurgical treatment, but the charges during follow-up period were not different. The results of the present study should be interpreted in light of the costs of medical services, indirect costs, societal cost, quality of life and societal willingness to pay in each country. The monetary figures are implied to be actual economic costs but those in the reimbursement system instead reflect reimbursement charges from the government.

Racial, ethnic and socioeconomic disparities in patients undergoing transcatheter mitral edge-to-edge repair.

BACKGROUND: Transcatheter mitral edge-to-edge repair (TEER) is an increasingly common procedure performed on patients with severe mitral regurgitation. This study assessed the impact of race/ethnicity and socioeconomic status on in-hospital complications after TEER. METHODS: Cohort-based observational study using the National Inpatient Sample between October 2013 and December 2018. The population was stratified into 4 groups based on race/ethnicity and quartiles of neighborhood income levels. The primary outcome was in-hospital complications, defined as the composite of death, bleeding, cardiac and vascular complications, acute kidney injury, and ischemic stroke. RESULTS: 3795 hospitalizations for TEER were identified. Patients of Black and Hispanic race/ethnicity comprised 7.4% and 6.4%, respectively. We estimated that White patients received TEER with a frequency of 38.0/100,000, compared to 29.7/100,000 for Blacks and 30.5/100,000 for Hispanics. In-hospital complications occurred in 20.2% of patients and no differences were found between racial/ethnic groups (P = 0.06). After multilevel modelling, Black and Hispanic patients had similar rate of overall in-hospital complications (OR: 0.84, CI:0.67-1.05 and OR: 0.84, CI:0.66-1.07, respectively) as compared to White patients, however, higher rates of death were observed in Black patients. Individuals living in income quartile-1 had worse in-hospital outcomes as compared to quartile-4 (OR: 1.19, CI:0.99-1.42). CONCLUSION: In this study assessing racial/ethnic disparities in TEER outcomes, aged-adjusted race/ethnicity minorities were less underrepresented as compared to other structural heart interventions. Black patients experienced a higher rate of in-hospital death, but similar overall rate of post-procedural adverse events as compared to White patients. Lower income levels appear to negatively impact on in-hospital outcomes. BRIEF SUMMARY: This study appraises race/ethnic and socioeconomical disparities in access and outcomes following transcatheter mitral edge-to-edge repair. Racial minority groups were less underrepresented as compared to other structural heart interventions. While Black patients experienced a higher rate of in-hospital death, they experienced similar overall rate of post-procedural complications compared to White patients. Lower income levels also appeared to negatively impact on outcomes.

Racial, ethnic and socioeconomic disparities in patients undergoing left atrial appendage closure.

OBJECTIVE: This manuscript aims to explore the impact of race/ethnicity and socioeconomic status on in-hospital complication rates after left atrial appendage closure (LAAC). METHODS: The US National Inpatient Sample was used to identify hospitalisations for LAAC between 1 October 2015 to 31 December 2018. These patients were stratified by race/ethnicity and quartiles of median neighbourhood income. The primary outcome was the occurrence of in-hospital major adverse events, defined as a composite of postprocedural bleeding, cardiac and vascular complications, acute kidney injury and ischaemic stroke. RESULTS: Of 6478 unweighted hospitalisations for LAAC, 58% were male and patients of black, Hispanic and 'other' race/ethnicity each comprised approximately 5% of the cohort. Adjusted by the older Americans population, the estimated number of LAAC procedures was 69.2/100 000 for white individuals, as compared with 29.5/100 000 for blacks, 47.2/100 000 for Hispanics and 40.7/100 000 for individuals of 'other' race/ethnicity. Black patients were ~5 years younger but had a higher comorbidity burden. The primary outcome occurred in 5% of patients and differed significantly between racial/ethnic groups (p<0.001) but not across neighbourhood income quartiles (p=0.88). After multilevel modelling, the overall rate of in-hospital major adverse events was higher in black patients as compared with whites (OR: 1.60, 95% CI 1.22 to 2.10, p<0.001); however, the incidence of acute kidney injury was higher in Hispanics (OR: 2.19, 95% CI 1.52 to 3.17, p<0.001). No significant differences were found in adjusted overall in-hospital complication rates between income quartiles. CONCLUSION: In this study assessing racial/ethnic disparities in patients undergoing LAAC, minorities are under-represented, specifically patients of black race/ethnicity. Compared with whites, black patients had higher comorbidity burden and higher rates of in-hospital complications. Lower socioeconomic status was not associated with complication rates.

Ultrafast Dynamic Contrast-Enhanced Breast MRI: Lesion Conspicuity and Size Assessment according to Background Parenchymal Enhancement.

OBJECTIVE: To evaluate the clinical utility of ultrafast dynamic contrast-enhanced (DCE)-MRI compared to conventional DCE-MRI by studying lesion conspicuity and size according to the level of background parenchymal enhancement (BPE). MATERIALS AND METHODS: This study included 360 women (median age, 54 years; range, 26-82 years) with 361 who had undergone breast MRI, including both ultrafast and conventional DCE-MRI before surgery, between January and December 2017. Conspicuity was evaluated using a five-point score. Size was measured as the single maximal diameter. The Wilcoxon signed-rank test was used to compare median conspicuity score. To identify factors associated with conspicuity, multivariable logistic regression was performed. Absolute agreement between size at MRI and histopathologic examination was assessed using the intraclass correlation coefficient (ICC). RESULTS: The median conspicuity scores were 5 at both scans, but the interquartile ranges were significantly different (5-5 at ultrafast vs. 4-5 at conventional, p < 0.001). Premenopausal status (odds ratio [OR] = 2.2, p = 0.048), non-mass enhancement (OR = 4.1, p = 0.001), moderate to marked BPE (OR = 7.5, p < 0.001), and shorter time to enhancement (OR = 0.9, p = 0.043) were independently associated with better conspicuity at ultrafast scans. Tumor size agreement between MRI and histopathologic examination was similar for both scans (ICC = 0.66 for ultrafast vs. 0.63 for conventional). CONCLUSION: Ultrafast DCE-MRI could improve lesion conspicuity compared to conventional DCE-MRI, especially in women with premenopausal status, non-mass enhancement, moderate to marked BPE or short time to enhancement.

Rationale, design, and characteristics of the multimedia family planning campaign for a small, happy, and prosperous family in Ethiopia (SHaPE).

BACKGROUND: Ethiopia, the second most populous country in Africa, has a total fertility rate of 4.6, a decrease from 5.5 in 2000. However, only 35.3% of women in the reproductive age group use modern family planning (FP) methods, and the 22.3% of them who have an unmet need for family planning is among the highest rates in sub-Saharan African countries. The Small, Happy, and Prosperous family in Ethiopia (SHaPE) is one of the country's first comprehensive multimedia family planning campaigns. Its purpose is to increase FP-related knowledge, attitude, and practice of Ethiopians, particularly women of reproductive age. METHODS/DESIGN: The SHaPE campaign has multiple components: (1) a nationwide representative survey, which serves as formative research to identify region-specific and culture-appropriate media, messages, and barriers and determinants of family planning; (2) a multimedia communication campaign intervention, including radio dramas and other interpersonal, community-level, and mass media channels; and (3) campaign evaluation, including pre-, process-, and post-evaluation research using both quantitative and qualitative methodologies. The main target population for SHaPE is reproductive age women and men in three regions: Amhara, Oromia, and Somali. These regions take up about 66.6% of the entire country and have distinct ethnicities, cultures, and languages. DISCUSSION: SHaPE contributes to existing family planning research and intervention because it is theory- and evidence-based, and it employs integrated marketing communications and entertainment-education approaches with key messages that are tailored to audiences within unique cultures. But even within a country, a nationwide campaign with uniform messages is neither possible nor desirable due to different cultures, norms, and languages across regions. Last, media campaigns in developing and underdeveloped countries require constant monitoring of political situations.

Increased Volume of Surgery for Lumbar Spinal Stenosis and Changes in Surgical Methods and Outcomes: A Nationwide Cohort Study with a 5-Year Follow-Up.

OBJECTIVE: Examining spine surgery patterns over time is crucial to provide insights into variations and changes in clinical decision making. Changes in the number of surgeries, surgical methods, reoperation rates, and cost-effectiveness were analyzed for all patients who underwent surgery for lumbar spinal stenosis without spondylolisthesis in 2003 (2003 cohort) and 2008 (2008 cohort). METHODS: The national health insurance database was used to create the 2003 cohort (n = 10,990) and 2008 cohort (n = 27,942). The surgical methods were classified into decompression and fusion surgery. The cumulative reoperation probability between those surgeries was calculated using the Kaplan-Meier method in the 2003 cohort and 2008 cohort. Comparison of the incremental cost-effectiveness ratios showed the additional direct cost of a 1% change in the reoperation probability. RESULTS: The surgical volume increased 2.54-fold in the 2008 cohort. The age-adjusted number of surgeries per 1 million people increased 2.6-fold (from 154 in the 2003 cohort to 399 in the 2008 cohort) in aged patients and 1.9-fold (from 154 in the 2003 cohort to 291 in the 2008 cohort) in patients 20-59 years old in the 2008 cohort. The proportion of fusion surgeries increased from 20.3% in the 2003 cohort to 37.0% in the 2008 cohort. In total, the 5-year reoperation probabilities increased from 8.1% in the 2003 cohort to 11.2% in the 2008 cohort. Fusion decreased the reoperation probability by 1% at the cost of 1,711 U.S. dollars. CONCLUSIONS: The increased numbers of spinal surgeries, fusion surgeries, and surgeries in older patients in a recent cohort were noteworthy. However, the increased surgical volume and fusion surgeries did not reduce the reoperation rate.

Increased Volume of Lumbar Surgeries for Herniated Intervertebral Disc Disease and Cost-Effectiveness Analysis: A Nationwide Cohort Study.

STUDY DESIGN: Retrospective cohort study of a nationwide database. OBJECTIVE: The primary objective was to summarize the use of surgical methods for lumbar herniated intervertebral disc disease (HIVD) at two different time periods under the national health insurance system. The secondary objective was to perform a cost-effectiveness analysis by utilizing incremental cost-effectiveness ratio (ICER). SUMMARY OF BACKGROUND DATA: The selection of surgical method for HIVD may or may not be consistent with cost effectiveness under national health insurance system, but this issue has rarely been analyzed. METHODS: The data of all patients who underwent surgeries for HIVD in 2003 (n = 17,997) and 2008 (n = 38,264) were retrieved. The surgical methods included open discectomy (OD), fusion surgery, laminectomy, and percutaneous endoscopic lumbar discectomy (PELD). The hospitals were classified as tertiary-referral hospitals (≥300 beds), medium-sized hospitals (30-300 beds), or clinics (<30 beds). ICER showed the difference in the mean total cost per 1% decrease in the reoperation probability among surgical methods. The total cost included the costs of the index surgery and the reoperation. RESULTS: In 2008, the number of surgeries increased by 2.13-fold. The number of hospitals increased by 34.75% (731 in 2003 and 985 in 2008). The proportion of medium-sized hospitals increased from 62.79% to 70.86%, but the proportion of surgeries performed at those hospitals increased from 61.31% to 85.08%. The probability of reoperation was highest after laminectomy (10.77%), followed by OD (10.50%), PELD (9.20%), and fusion surgery (7.56%). The ICERs indicated that PELD was a cost-effective surgical method. The proportion of OD increased from 71.21% to 84.12%, but that of PELD decreased from 16.68% to 4.57%. CONCLUSION: The choice of surgical method might not always be consistent with cost-effectiveness strategies, and a high proportion of medium-sized hospitals may be responsible for this change. LEVEL OF EVIDENCE: 4.