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.

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.

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.

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.

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.

Use of the emergency department for less-urgent care among type 2 diabetics under a disease management program.

BACKGROUND: This study analyzed the likelihood of less-urgent emergency department (ED) visits among type 2 diabetic patients receiving care under a diabetes disease management (DM) program offered by the Louisiana State University Health Care Services Division (LSU HCSD). METHODS: All ED and outpatient clinic visits made by 6,412 type 2 diabetic patients from 1999 to 2006 were extracted from the LSU HCSD Disease Management (DM) Evaluation Database. Patient ED visits were classified as either urgent or less-urgent, and the likelihood of a less-urgent ED visit was compared with outpatient clinic visits using the Generalized Estimating Equation methodology for binary response to time-dependent variables. RESULTS: Patients who adhered to regular clinic visit schedules dictated by the DM program were less likely to use the ED for less urgent care with odds ratio of 0.1585. Insured patients had 1.13 to 1.70 greater odds of a less-urgent ED visit than those who were uninsured. Patients with better-managed glycated hemoglobin (A1c or HbA1c) levels were 82 times less likely to use less-urgent ED visits. Furthermore, being older, Caucasian, or a longer participant in the DM program had a modestly lower likelihood of less-urgent ED visits. The patient's Charlson Comorbidity Index (CCI), gender, prior hospitalization, and the admitting facility showed no effect. CONCLUSION: Patients adhering to the DM visit guidelines were less likely to use the ED for less-urgent problems. Maintaining normal A1c levels for their diabetes also has the positive impact to reduce less-urgent ED usages. It suggests that successful DM programs may reduce inappropriate ED use. In contrast to expectations, uninsured patients were less likely to use the ED for less-urgent care. Patients in the DM program with Medicaid coverage were 1.3 times more likely to seek care in the ED for non-emergencies while commercially insured patients were nearly 1.7 times more likely to do so. Further research to understand inappropriate ED use among insured patients is needed. We suggest providing visit reminders, a call centre, or case managers to reduce the likelihood of less-urgent ED visit use among DM patients. By reducing the likelihood of unnecessary ED visits, successful DM programs can improve patient care.

A comparison of hospital adverse events identified by three widely used detection methods.

OBJECTIVE: Determine the degree of congruence between several measures of adverse events. DESIGN: Cross-sectional study to assess frequency and type of adverse events identified using a variety of methods. SETTING: Mayo Clinic Rochester hospitals. PARTICIPANTS: All inpatients discharged in 2005 (n = 60 599). INTERVENTIONS: Adverse events were identified through multiple methods: (i) Agency for Healthcare Research and Quality-defined patient safety indicators (PSIs) using ICD-9 diagnosis codes from administrative discharge abstracts, (ii) provider-reported events, and (iii) Institute for Healthcare Improvement Global Trigger Tool with physician confirmation. PSIs were adjusted to exclude patient conditions present at admission. MAIN OUTCOME MEASURE: Agreement of identification between methods. RESULTS: About 4% (2401) of hospital discharges had an adverse event identified by at least one method. Around 38% (922) of identified events were provider-reported events. Nearly 43% of provider-reported adverse events were skin integrity events, 23% medication events, 21% falls, 1.8% equipment events and 37% miscellaneous events. Patients with adverse events identified by one method were not usually identified using another method. Only 97 (6.2%) of hospitalizations with a PSI also had a provider-reported event and only 10.5% of provider-reported events had a PSI. CONCLUSIONS: Different detection methods identified different adverse events. Findings are consistent with studies that recommend combining approaches to measure patient safety for internal quality improvement. Potential reported adverse event inconsistencies, low association with documented harm and reporting differences across organizations, however, raise concerns about using these patient safety measures for public reporting and organizational performance comparison.

Health-related quality of life after total hip replacement: a Taiwan study.

This study applied the generalised estimating equations (GEE) in a large-scale prospective cohort study of predictors of health-related quality of life (HRQoL) in a Taiwan population. The study population included all patients who had undergone primary total hip replacement (THR) performed between March 1998 and December 2002 by either of two orthopaedic surgeons in two hospitals. The SF-36 was used in pre- and postoperative assessments of 335 patients. Young age, male gender, minimal comorbidity, use of epidural anaesthesia, lack of readmission within the previous 30 days, and higher preoperative functional status were positively associated with HRQoL (P < 0.05). Patients should be advised that their postoperative HRQoL may depend not only on their postoperative health care but also on their preoperative functional status. These analytical results should be applicable to other Taiwan hospitals and to other countries with similar social and cultural practices.

When should a multicampus hospital be considered a single entity for public reporting on patient safety issues?

OBJECTIVE: Attempts to provide information to consumers about patient safety on specific hospitals have conflicted with organization self-perceptions and led to confusion among the general public. This article presents organizational theory framework and criteria to classify organizations as single versus multiple reporting entities. PARTICIPANTS AND METHODS: Operational definitions are presented. A case study comparing institutions both within and across state boundaries in the Mayo Clinic Health System is used to demonstrate their utility. The study includes analysis of an employee survey on employee satisfaction and patient safety climate in 2004 among nurses and physicians at the 2 Mayo Clinic hospitals in Rochester, Minn. RESULTS AND CONCLUSIONS: The criteria for a single organization are more strongly supported for the Mayo Clinic hospitals located in the same city than for hospitals in the same system but separated geographically. Although there is debate about the measurement of organizational culture, employee surveys provide some evidence of a commonality across hospitals in the same city. The case study comparing institutions both within and across state boundaries in the Mayo Clinic Health System demonstrate the utility of the proposed criteria.

The Master of Medical Management (MMM) degree: an analysis of alumni perceptions.

Innovation in health administration education stimulates administrators and faculty to identify unmet educational needs within the health sector. In 1997, the inaugural class of the Master of Medical Management (MMM) at Tulane University graduated, signaling an individual achievement for all graduates and an accomplishment in innovation and collaboration in health administration education. Tulane University, in partnership with The American College of Physician Executives (ACPE), designed a unique health administration degree to meet the distinctive needs of physicians serving in executive and managerial roles or seeking to serve in such roles in the future. Since 1997, there are nearly 700 MMM graduates who hail from Carnegie Mellon, Tulane University, and the University of Southern California. ACPE administered a survey to 500 MMM alumni in the fall of 2005. The response rate was 47% (235 of 500). The findings from this survey describe the reasons why physicians decided to enroll in the MMM, their experiences as MMM students, and their perceptions of how the MMM had an impact on their careers. Moreover, in this article, recommendations are offered related to the design and delivery of innovative educational programs for emerging disciplines within the health sector.

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.

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.

On teaching governance.

Great governance is an effective and efficient process to develop policies that set the strategic directions for the healthcare enterprise, and then help assure that resources are assembled and allocated for the successful implementation of the plans, in compliance with the ethical and regulatory framework of the industry. Given the growing legal and political emphasis on governance, it is crucial that undergraduate and graduate health administration programs adequately prepare students in the fundamental aspects of governance. This paper will present the ten building blocks of effective governance as well as other theories and frameworks applicable to teaching governance in a healthcare management program.

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.