Best practice considerations on the assessment of robotic assisted surgical systems: results from an international consensus expert panel.

BACKGROUND: Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. METHODS: A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. RESULTS: A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. CONCLUSIONS: Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.

Exploring Successful Implementation of Organizational Supports at the Worksite Environment: A Mixed Methods Approach.

While there is evidence that organizational supports may lead to better employee health, research on implementing such organizational supports is lacking. This research sought to understand organizational supports and implementation of those supports using an Explanatory Sequential Mixed Methods design approach. Employee survey responses (n = 202) were used to classify organizations into "high" and "low" categories for employee-reported health behavior improvement, agreement, and readiness for implementing change. For the qualitative phase of research (organization-level), semi-structured interviews were conducted with organization leads, and data were analyzed through constant comparative analysis procedure. Analyses sought to identify differences between "high" versus "low" organizations. In addition, the researcher used the "high" and "low" classifications to further review themes that emerged, to determine where there may be differences in organizations classified as "high" versus "low." Study results found the following nine themes to explain how organizations can improve implementing organizational supports: provide a contracted wellness program, formalized programming, and wellness incentives; create a culture of wellness in the organization; provide consistency in the supports offered; provide clear communication to employees; utilize leadership role modeling to show support; focus on leadership support that ensures organizational supports are implemented and sustained; and work to combat employee hesitation of organizational supports. The results of this study show that organizations have the opportunity to improve implementation of their organizational supports by applying the nine themes found.

Grateful Patient Philanthropy: A Challenge to Organizational Ethics.

An examination of organization development in health care reveals a pattern of increasing reliance of academic medical centers toward new sources of revenue in support of operations. This trend is partly in response to the reduction of traditional funding sources such as public appropriations and tuition. Clinical income from faculty earnings and hospital transfer payments have supplanted heritage funding sources and are now predominantly institutional transactions rather than physician-patient interactions. Grateful patient philanthropy can be viewed as moving toward transactional status, with challenging ethical questions for the involved physician and patient as institutional control increases.

Costs of Biopsy and Complications in Patients with Lung Cancer.

PURPOSE: To describe the distribution of diagnostic procedures, rates of complications, and total cost of biopsies for patients with lung cancer. PATIENTS AND METHODS: Observational study using data from IBM Marketscan® Databases for continuously insured adult patients with a primary lung cancer diagnosis and treatment between July 2013 and June 2017. Costs of lung cancer diagnosis covered 6 months prior to index biopsy through treatment. Costs of chest CT scans, biopsy, and post-procedural complications were estimated from total payments. Costs of biopsies incidental to inpatient admissions were estimated by comparable outpatient biopsies. RESULTS: The database included 22,870 patients who had a total of 37,160 biopsies, of which 16,009 (43.1%) were percutaneous, 14,997 (40.4%) bronchoscopic, 4072 (11.0%) surgical and 2082 (5.6%) mediastinoscopic. Multiple biopsies were performed on 41.9% of patients. The most common complications among patients receiving only one type of biopsy were pneumothorax (1304 patients, 8.4%), bleeding (744 patients, 4.8%) and intubation (400 patients, 2.6%). However, most complications did not require interventions that would add to costs. Median total costs were highest for inpatient surgical biopsies ($29,988) and lowest for outpatient percutaneous biopsies ($1028). Repeat biopsies of the same type increased costs by 40-80%. Complications account for 13% of total costs. CONCLUSION: Costs of biopsies to confirm lung cancer diagnosis vary substantially by type of biopsy and setting. Multiple biopsies, inpatient procedures and complications result in higher costs.

Supporting Health System Transformation: The development of an integrated interprofessional curriculum inclusive of public health students.

Under pressures to support health system transformation, many health professional accreditation organizations have incorporated standards requiring interprofessional education. However, the inclusion of population health topics and public health or health administration students into IPE experiences is limited. With the belief that understanding and cooperation among the health professions will be important to support health system transformation, The Louisiana State University Health Sciences Center-New Orleans has created several IPE experiences focused on population health, programs that are examined in this article along with insights that could prove useful for other programs seeking to build IPE into their regular curricula.

The Use of Topical Hemostatic Agents in Cardiothoracic Surgery.

Topical hemostatic agents are used in conjunction with conventional procedures to reduce blood loss. They are often used in cardiothoracic surgery, which is particularly prone to bleeding risks. Variation in their use exists because detailed policy and practice guidelines reflecting the current medical evidence have not been developed to promote best surgical practice in this setting. To address this need, the Society for the Advancement of Blood Management convened an International Hemostatic Expert Panel. This article reviews the available literature and sets out evidence-based recommendations for the use of topical hemostatic agents in cardiothoracic surgery.

The Evolution of the Medical School Deanship: From Patriarch to CEO to System Dean.

Medical school deanship in the US has evolved during the past 200 years as the complexity of the US health care system has evolved. With the introduction of Medicare and Medicaid and the growth of the National Institutes of Health, the 19th-century and first half of the 20th-century role of the medical school dean as guild master transformed into that of resource allocator as faculty practice plans grew in scope and grew as an important source of medical school and university revenue. By 2000, the role of the medical school dean had transformed into that of CEO, with the dean having control over school mission and strategy, faculty practice plans, education, research dollars, and philanthropy. An alternative path to the Dean/CEO model has developed-the System Dean, who functions as a team player within a broader health system that determines the mission for the medical school and the related clinical enterprise. In this paper, the authors discuss the evolution of the medical school dean with respect to scope of authority and role within the health care system.

Data monitoring committees for pragmatic clinical trials.

In any clinical trial, it is essential to monitor the accumulating data to be sure that the trial continues to be safe for participants and that the trial is being conducted properly. Data monitoring committees, independent expert panels who undertake regular reviews of the data as the trial progresses, serve an important role in safeguarding the interests of research participants and ensuring trial integrity in many trials. Many pragmatic clinical trials, which aim to inform healthcare decisions by comparing alternate interventions in heterogeneous healthcare delivery settings, will warrant review by an independent data monitoring committee due to their potential impact on clinical practice. However, the very features that make a trial "pragmatic" may pose challenges in terms of which aspects of a trial to monitor and when it is appropriate for a data monitoring committee to intervene. Using the Pragmatic-Explanatory Continuum Indicator Summary tool that draws distinctions between pragmatic and explanatory clinical trials, we review characteristics of pragmatic clinical trials that may have implications for data monitoring committees and interim monitoring plans. These include broad eligibility criteria, a focus on subjective patient-centered outcomes, and in some cases a lack of standardized follow-up procedures across study sites. Additionally, protocol adherence is often purposefully not addressed in pragmatic trials in order to accurately represent the clinical practice setting and maintain practicability of implementation; there are differing viewpoints as to whether adherence should be assessed and acted upon by data monitoring committees in these trials. Some other issues not specifically related to the Pragmatic-Explanatory Continuum Indicator Summary criteria may also merit special consideration in pragmatic trials. Thresholds for early termination of a pragmatic clinical trial might be controversial. The distinguishing features of pragmatic clinical trials require careful consideration when developing interim data monitoring plans, and trial sponsors, investigators, and data monitoring committees should agree on a plan before trial inception. Finally, special expertise, such as an informatics, may be helpful on data monitoring committees for some pragmatic clinical trials. Patient representatives may provide particularly valuable insights in the monitoring process.

Patient-centered medical homes in Louisiana had minimal impact on Medicaid population's use of acute care and costs.

The patient-centered medical home model of primary care has received considerable attention for its potential to improve outcomes and reduce health care costs. Yet little information exists about the model's ability to achieve these goals for Medicaid patients. We sought to evaluate the effect of patient-centered medical home certification of Louisiana primary care clinics on the quality and cost of care over time for a Medicaid population. We used a quasi-experimental pre-post design with a matched control group to assess the effect of medical home certification on outcomes. We found no impact on acute care use and modest support for reduced costs and primary care use among medical homes serving higher proportions of chronically ill patients. These findings provide preliminary results related to the ability of the patient-centered medical home model to improve outcomes for Medicaid beneficiaries. The findings support a case-mix-adjusted payment policy for medical homes going forward.

Androgen-deprivation therapy versus radical prostatectomy as monotherapy among clinically localized prostate cancer patients.

BACKGROUND: The most recent randomized controlled trial in a predominantly prostate-specific antigen-detected prostate cancer (PC) population found a nonsignificant reduction in mortality from radical prostatectomy (RP) compared to conservative management. The optimal treatment for clinically localized prostate cancer is anything but clear. The PC-specific mortality and all-cause mortality were compared between primary androgen-deprivation treatment (PADT) and RP, both as monotherapy, among clinically localized PC patients. METHODS: A retrospective cohort study among PC patients in Surveillance, Epidemiology and End Results-Medicare data with a median follow up of 2.87 years in the PADT cohort and 2.95 years in the RP cohort. Propensity score-matching was employed to adjust for the observed selection bias. PC-specific mortality and all-cause mortality were modeled using the Fine and Gray competing risk model and Cox proportional hazards model, respectively. The independent variables in these models included age, race, Gleason score risk groups, T-score, prostate-specific antigen, Charlson comorbidity, and index year of treatment initiation. RESULTS: After propensity score-matching, there were 1624 in the PADT cohort and 1624 in the RP cohort. All baseline values were comparable (all P-values >0.35). There were a total of 266 deaths (16.38%) and 60 (3.69%) PC-specific deaths among PADT recipients, while there were 56 (3.45%) deaths and four (0.25%) PC-specific deaths among RP recipients. According to the Kaplan-Meier estimation, the 8-year survival rate was 43.39% in the PADT cohort and 79.62% in the RP cohort. PADT was associated with increased risk of overall mortality (hazard ratio = 2.98, 95% confidence interval 2.35-3.79; P < 0.001) and increased risk of PC-specific mortality (hazard ratio = 12.47, 95% confidence interval 4.48-34.70; P < 0.001). CONCLUSION: With adjustment for the observed selection bias, PADT was associated with increased all-cause mortality and PC-specific mortality when compared to RP.

Breast cancer surgery volume-cost associations: hierarchical linear regression and propensity score matching analysis in a nationwide Taiwan population.

BACKGROUND: No outcome studies have longitudinally and systematically compared the effects of hospital and surgeon volume on breast cancer surgery costs in an Asian population. This study purposed to evaluate the use of hospital and surgeon volume for predicting breast cancer surgery costs. METHODS: This cohort study retrospectively analyzed 97,215 breast cancer surgeries performed from 1996 to 2010. Relationships between volumes and costs were analyzed by propensity score matching and by hierarchical linear regression. RESULTS: The mean breast cancer surgery costs for all breast cancer surgeries performed during the study period was $1485.3 dollars. The average breast cancer surgery costs for high-volume hospitals and surgeons were 12% and 26% lower, respectively, than those for low-volume hospitals and surgeons. Propensity score matching analysis showed that the average breast cancer surgery costs for breast cancer surgery procedures performed by high-volume hospitals ($1428.6 dollars) significantly differed from the average breast cancer surgery costs of those performed by low-/medium-volume hospitals ($1514.0 dollars) and that the average breast cancer surgery costs of procedures performed by high-volume surgeons ($1359.0 dollars) significantly differed from the average breast cancer surgery costs of those performed by low-/medium-volume surgeons ($1550.3 dollars) (P < 0.001). CONCLUSIONS: The factors significantly associated with hospital resource utilization for this procedure included age, surgical type, Charlson co-morbidity index score, hospital type, hospital volume, and surgeon volume. The data indicate that analyzing and emulating the treatment strategies used by high-volume hospitals and by high-volume surgeons may reduce overall breast cancer surgery costs.

Predicting two-year quality of life after breast cancer surgery using artificial neural network and linear regression models.

The purpose of this study was to validate the use of artificial neural network (ANN) models for predicting quality of life (QOL) after breast cancer surgery and to compare the predictive capability of ANNs with that of linear regression (LR) models. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and its supplementary breast cancer measure were completed by 402 breast cancer patients at baseline and at 2 years postoperatively. The accuracy of the system models were evaluated in terms of mean square error (MSE) and mean absolute percentage error (MAPE). A global sensitivity analysis was also performed to assess the relative significance of input parameters in the system model and to rank the variables in order of importance. Compared to the LR model, the ANN model generally had smaller MSE and MAPE values in both the training and testing datasets. Most ANN models had MAPE values ranging from 4.70 to 19.96 %, and most had high prediction accuracy. The ANN model also outperformed the LR model in terms of prediction accuracy. According to global sensitivity analysis, pre-operative functional status was the best predictor of QOL after surgery. Compared with the conventional LR model, the ANN model in the study was more accurate for predicting patient-reported QOL and had higher overall performance indices. Further refinements are expected to obtain sufficient performance improvements for its routine use in clinical practice as an adjunctive decision-making tool.

Financial implications of increasing medical school class size: does tuition cover cost?

INTRODUCTION: In 2006, the Association of American Medical Colleges (AAMC) issued a recommendation that medical schools increase the supply of physicians by 30% to meet the patient needs of the new millennium. OBJECTIVE: To provide financial analysis of the cost of increasing class size. METHODS: To determine the financial consequences of increasing medical student enrollment and in the absence of nationally published cost data for medical schools, adjusted secondary revenue data was analyzed using AAMC and Liaison Committee on Medical Education (LCME) financial data from 2009. Linear regression analysis was used to determine average fixed costs and variable cost per student in USD. RESULTS: In USD, $62,877 represents the best point estimate of the annual variable cost of educating a medical student. CONCLUSION: Comparing this cost to current tuitions and fees of LCME-accredited medical schools suggests that revenues other than tuition are needed to cover increases in class size. Tuition and fees revenue from increasing enrollment will not increase overall revenue to medical schools.

Effect of illness severity and comorbidity on patient safety and adverse events.

The objective was to investigate the effect of admission health status on hospital adverse events and added costs. Secondary data were from merged administrative and clinical sources for Mayo Clinic Rochester, Minnesota hospital discharges in 2005 (N = 60,599). This was a retrospective cross-sectional study of the effect of demographics, diagnosis group, comorbidity, and admission illness severity on adverse events, incremental costs, and length of stay (LOS) using the Agency for Healthcare Research and Quality Patient Safety Indicators and provider-reported events with harm. Estimates are derived from generalized linear models. Admission severity increased the likelihood of all types of adverse events (7.2% per unit acute physiology score for any event); 7 specific comorbidities were associated with increased events and 2 with decreased events. High admission severity increased incremental costs and LOS. Selected comorbidities increased incremental LOS but had no significant effect on incremental costs. Adverse event reporting should incorporate comorbidity and admission severity. Reimbursement incentives to improve patient safety should consider adjustment for admission health status.

Board quality scorecards: measuring improvement.

Board accountability for quality and patient safety is widely accepted but the science for how to measure it is immature, and differences between measuring performance, identifying hazards, and monitoring progress are often misunderstood. Hospital leaders often provide scorecards to assist boards with their oversight role yet, in the absence of national standards, little evidence exists regarding which measures are valid and useful to boards to assess quality improvement. The authors describe results of a cross-sectional board study, identifying the measures used to monitor quality. The measures varied widely and many were of uncertain validity, generally identifying hazards rather than measuring rates. This article identifies some important policy implications regarding boards' oversight of quality and acknowledges existing limits to how we can measure quality and safety progress on the national or hospital level. If boards and their hospitals are to monitor progress in improving quality, they need more valid outcome measures.

Factors influencing inappropriate use of ED visits among type 2 diabetics in an evidence-based management programme.

OBJECT: This study analyses inappropriate use of emergency department (ED) services among type 2 diabetics under an evidence-based management programme. METHODS: Using 1999-2006 databases of Louisiana Health Care Services Division (HCSD) eight public hospitals ED visits among the uninsured and other patients in Louisiana, we termed urgent ED visits appropriate and less-urgent visits inappropriate. Eliminating weekend ED visits, 17,458 urgent and 22,395 less-urgent visits by 8596 patients were analysed, using generalized estimating equation methods. RESULTS: Caucasians were 0.82 times (95% CI: 0.751-0.889) less likely to use the ED inappropriately compared with African Americans. Patients with commercial insurance, Medicaid and Medicare used the ED more inappropriately than uninsured, with odds ratios of 1.28, 1.32 and 1.28, respectively. Patients hospitalized the prior year were 0.84 times (95% CI: 1.08-1.31) less likely for inappropriate. Patients in larger hospitals used the ED more inappropriately, with an odds ratio of 1.44 (95% CI: 1.32-1.56). CONCLUSIONS: The study suggests that inappropriate use of the ED among diabetic patients in an evidence-based management programme is more likely to occur among African American, patients with insurance coverage and those seeking care in larger hospitals. Reinforcing the regular use of clinic services for diabetes management, providing clinic access in off-hours, and engaging the health plans in providing incentives for more appropriate use of the ED might reduce inappropriate ED visits. Notably, uninsured patients with diabetes from HCSD were more efficient users of the ED.