The association between video-based assessment of intraoperative technical performance and patient outcomes: a systematic review.

BACKGROUND: Efforts to improve surgical safety and outcomes have traditionally placed little emphasis on intraoperative performance, partly due to difficulties in measurement. Video-based assessment (VBA) provides an opportunity for blinded and unbiased appraisal of surgeon performance. Therefore, we aimed to systematically review the existing literature on the association between intraoperative technical performance, measured using VBA, and patient outcomes. METHODS: Major databases (Medline, Embase, Cochrane Database, and Web of Science) were systematically searched for studies assessing the association of intraoperative technical performance measured by tools supported by validity evidence with short-term (≤ 30 days) and/or long-term postoperative outcomes. Study quality was assessed using the Newcastle-Ottawa Scale. Results were appraised descriptively as study heterogeneity precluded meta-analysis. RESULTS: A total of 11 observational studies were identified involving 8 different procedures in foregut/bariatric (n = 4), colorectal (n = 4), urologic (n = 2), and hepatobiliary surgery (n = 1). The number of surgeons assessed ranged from 1 to 34; patient sample size ranged from 47 to 10,242. High risk of bias was present in 5 of 8 studies assessing short-term outcomes and 2 of 6 studies assessing long-term outcomes. Short-term outcomes were reported in 8 studies (i.e., morbidity, mortality, and readmission), while 6 reported long-term outcomes (i.e., cancer outcomes, weight loss, and urinary continence). Better intraoperative performance was associated with fewer postoperative complications (6 of 7 studies), reoperations (3 of 4 studies), and readmissions (1 of 4 studies). Long-term outcomes were less commonly investigated, with mixed results. CONCLUSION: Current evidence supports an association between superior intraoperative technical performance measured using surgical videos and improved short-term postoperative outcomes. Intraoperative performance analysis using video-based assessment represents a promising approach to surgical quality-improvement.

Development and evaluation of a virtual knowledge assessment tool for transanal total mesorectal excision.

BACKGROUND: Transanal total mesorectal excision (TATME) is difficult to learn and can result in serious complications. Current paradigms for assessing performance and competency may be insufficient. This study aims to develop and provide preliminary validity evidence for a TATME virtual assessment tool (TATME-VAT) to assess the cognitive skills necessary to safely complete TATME dissection. METHODS: Participants from North America, Europe, Japan and China completed the test via an interactive online platform between 11/2019 and 05/2020. They were grouped into expert, experienced and novice surgeons depending on the number of independently performed TATMEs. TATME-VAT is a 24-item web-based assessment evaluating advanced cognitive skills, designed according to a blueprint from consensus guidelines. Eight items were multiple choice questions. Sixteen items required making annotations on still frames of TATME videos (VCT) and were scored using a validated algorithm derived from experts' responses. Annotation (range 0-100), multiple choice (range 0-100), and overall scores (sum of annotation and multiple-choice scores, normalized to µ = 50 and σ = 10) were reported. RESULTS: There were significant differences between the expert, experienced, and novice groups for the annotation (p < 0.001), multiple-choice (p < 0.001), and overall scores (p < 0.001). The annotation (p = 0.439) and overall (p = 0.152) scores were similar between the experienced and novice groups. Annotation scores were higher in participants with 51 or more vs. 30-50 vs. less than 30 cases. Scores were also lower in users with a self-reported recent complication vs. those without. CONCLUSIONS: This study describes the development of an interactive video-based virtual assessment tool for TATME dissection and provides initial validity evidence for its use.

The impact of the first wave of the COVID-19 pandemic on the exposure of general surgery trainees to operative procedures.

INTRODUCTION: During the COVID-19 pandemic, the redeployment of operating room (OR) staff resulted in a significant ramp-down of elective surgery. To mitigate the negative effects of the pandemic on surgical education, this study was planned to estimate the impact of the first wave of the pandemic on the participation of general surgery residency and fellowship trainees in operative procedures. METHODS: This study is a retrospective review of all adult general surgery procedures performed at 3 sites of an academic health care network. Cases performed during the first wave of the pandemic (March-June 2020) were compared to the same period of the previous year pre-pandemic (March-June 2019). Trainees were categorized as junior (Post-Graduate-Year [PGY] 1-2), senior (PGY3-5), or fellows (PGY6-7). Operating exposure was defined as (1) the total number of cases attended by at least one trainee and (2) total time spent in the OR by all trainees (hours). The impact of the pandemic was estimated as percentage of baseline (2019). RESULTS: During the first wave of the pandemic, a total of 914 cases were performed, compared to 1328 in the pre-pandemic period (69%). Junior trainees were more affected than senior trainees with reductions in both case volume (68% versus 78% of baseline attendance) and time (68% versus 77% of baseline operating time). Minimally invasive surgery fellows were most severely affected trainees and colorectal fellows were least affected (14% and 75% of baseline cases, respectively). Participation in emergency surgery cases and surgical oncology cases was relatively preserved (87% and 105% of baseline, respectively). CONCLUSIONS: The first wave of the COVID-19 pandemic reduced operative exposure for general surgery trainees by approximately 30%. Procedure-specific patterns reflected institutional policies for prioritizing cancer operations and emergency surgeries. These findings may inform the design of remediation activities to mitigate the impact of the pandemic on surgical training.

The Impact of Inflammatory Bowel Disease in Canada 2018: Indirect Costs of IBD Care.

The indirect cost of illness represents the portion of human capital that is foregone due to lost productivity of patients and their caregivers and out-of-pocket healthcare expenses borne directly by patients. Indirect costs among persons with inflammatory bowel diseases (IBD) may be substantial because disease onset occurs during the teens and 20s for most persons and is lifelong. Thus, most persons with IBD are affected during periods of study or employment. The literature on indirect health-related costs among persons with IBD is limited, particularly with regard to Canadian studies. The greatest burden of indirect costs in this population relates to absenteeism and presenteeism among working individuals and premature retirement. However, costs related to reduced professional development and personal achievement due to illness-as well as caregiver costs-are largely unknown. After being extrapolated from multiple sources, the total indirect health-related cost of IBD in Canada in 2018 is estimated to be $1.29 billion Canadian dollars. Notably, this may be a significant underestimate because costs relating to presenteeism, reduced achievement and caregiver burden could not be estimated and are excluded from this calculation. HIGHLIGHTS: Indirect costs account for a major portion of total healthcare costs among persons with inflammatory bowel disease (IBD) and are higher than indirect costs among persons without IBD.Persons with IBD are more likely to require time off work (absenteeism) and have reduced productivity at work (presenteeism) due to illness as compared with persons without IBD.Premature retirement and long-term disability are major factors contributing to indirect costs among IBD patients.A substantial proportion of individuals with IBD pay out-of-pocket for complementary and alternative medicines.After being extrapolated from multiple sources, the total annual indirect cost of IBD in Canada is estimated to be $1.29 billion CAD in 2018, or $4781 CAD per person with IBD. KEY SUMMARY POINTS: The total indirect economic burden of IBD in Canada is estimated to be $1.29 billion CAD in 2018, or roughly $4781 CAD per person with IBD. This estimate comprises lost wages related to sick days and disability, premature retirement and premature death, and out-of-pocket costs. Losses from presenteeism, reduced professional development and caregiver burden are not included due to insufficient data on the cost impact of these factors.In a meta-analysis of studies between 1994 and 2014, the annual indirect cost of absenteeism for IBD patients ranged from $515.67 USD (USA) to $14,727 USD (Germany) per patient per annum (pooled estimate $7189 USD), after adjusting for purchasing power disparity.A large US survey found that, on average, IBD patients incurred an extra 4.8 days off of work and $783 USD in excess lost wages annually compared with persons without IBD.A study based on US private insurance claims found that ulcerative colitis patients cost an additional $2164 per person per annum relating to disability days and medically related absenteeism.A prospective study from an IBD centre reported weekly indirect health-related costs of $1133 for IBD patients with active disease, $370.13 for IBD patients in remission, and $191.23 for persons without IBD relating to both presenteeism and absenteeism.In a survey of 744 IBD patients from Manitoba, reduced workplace productivity during the previous 14 days was reported in 37% of individuals, including a reduction of one to two days by 18% of patients, thre to nine days by 16% of patients, and on most days by 3% of patients.The estimated average lifetime lost wages due to premature retirement is $1,044,498 CAD per person with Crohn's disease and $994,760 CAD per person with ulcerative colitis. Aggregated over all IBD retirees, this equates to roughly $629 million CAD in permanent lost wages annually due to premature retirement.The lifetime indirect cost associated with premature death among IBD patients is estimated to be $746,070 CAD per decedent, or roughly $33.6 million aggregated across all IBD decedents of working age.In a US study of caregivers of children, the average unadjusted annual work loss was 214 hours for caregivers of Crohn's disease patients and 170 hours for caregivers of children without IBD, translating to an additional $1122 in lost productivity for caregivers of persons with Crohn's disease.Canadian studies have reported complementary and alternative medicines (CAMs) use in 56% to 74% of people with IBD. A US national survey study estimated annual per-person out of pocket costs of $1603 USD for Crohn's disease patients and $1263 USD for ulcerative colitis patients, which were substantially higher than in persons without IBD. GAPS IN KNOWLEDGE AND FUTURE DIRECTIONS: Canadian-specific data on indirect health-related costs of IBD is sparse across all domains of indirect costs.In particular, the rates of absenteeism, presenteeism and premature retirement among IBD patients living in Canada require further study to gauge more accurately the indirect health-related costs of IBD in Canada.Indirect costs relating to decreased professional development, caregiver burden and out-of-pocket purchases among IBD patients are largely unknown and require further study.Indirect costs incurred by Canadian children with IBD and their families or caregivers are largely unknown.

The Impact of Inflammatory Bowel Disease in Canada 2018: Direct Costs and Health Services Utilization.

Direct health care costs of illness reflect the costs of medically necessary services and treatments paid for by public and private payers, including hospital-based care, outpatient physician consultations, prescription medications, diagnostic testing, complex continuing care, and home care. The costs of caring for persons with inflammatory bowel disease (IBD) have been rising well above inflation over the past fifteen years in Canada, largely due to the introduction and penetration of expensive biologic therapies. Changing paradigms of care toward frequent patient monitoring and achievement of stricter endpoints for disease control have also increased health services utilization and costs among IBD patients. While the frequency and costs of surgeries and hospitalizations have declined slightly in parallel with increased biologic use (due to better overall disease control), the direct medical costs of care for IBD patients are largely dominated by prescription drug costs. Introduction and penetration of biosimilar agents (at a markedly lower price point than the originator drugs) and increasing gastroenterologist involvement in the care of IBD patients may help to balance rising health care costs while improving health outcomes and quality of life for IBD patients. Ultimately, however, the predicted rise in the prevalence of IBD over the next decade, combined with increasing use of expensive biologic therapies, will likely dictate a continued rise in the direct costs of IBD patient care in Canada for years to come. In 2018, direct health care costs of IBD are estimated to be at least $1 billion Canadian dollars (CAD) and possibly higher than $2 billion CAD. HIGHLIGHTS: 1. In Canada, the direct cost of caring for people living with IBD is estimated in 2018 to be close to $1.28 billion (roughly $4731 per person with IBD).2. The costs of caring for people living with IBD are dominated by prescription drugs, followed by hospitalization costs. There has been a shift away from hospitalizations and toward pharmaceuticals as the predominant driver of direct health care costs in IBD patients, due to the introduction and widespread use of expensive biologic therapies.3. The rates of hospitalizations and major abdominal surgeries have been declining in IBD patients in Canada over the past two decades, possibly due to penetration of biologic therapies and advances in patient management paradigms.4. Inflammatory bowel disease patients cared for by gastroenterologists have better outcomes, including lower risks of surgery and hospitalization. Canadians who live in rural and underserviced areas are less likely to receive gastroenterologist care, potentially due to care preferences or poorer access, which may result in poorer long-term outcomes.5. Introduction of biosimilar agents at a lower price point than originator biologic therapies, increased gastroenterologist care of IBD patients, and improvements in IBD care paradigms may balance overall treatment costs while improving health outcomes and quality of life for IBD patients. However, in the long-term, direct costs of care may continue to increase, dictated by a rising IBD prevalence and increasing use of biologic therapies. KEY SUMMARY POINTS: 1. The costs of health care for patients with IBD are more than double those without IBD.2. Prescription drug use accounts for 42% of total direct costs in IBD patients, and costs to treat IBD continue to rise due to increased use of existing biologic therapies and the introduction of several new biologic therapies in recent years.3. In Manitoba, the mean health care utilization and medication costs for persons with IBD in the year before beginning anti-TNF therapy was $10,206 and increased to $44,786 in the first year of therapy.4. Biosimilar agents to anti-TNF drugs are now entering the Canadian marketplace and may result in cost savings in patients using biologic agents to treat their IBD.5. Timely gastroenterologist care has been associated with reduced risks of requiring surgery and emergency care among ambulatory IBD patients and a reduced risk of death among hospitalized patients with ulcerative colitis.6. Inflammatory bowel disease care provided by gastroenterologists has increased over the past two decades. Even then, the average time from symptom onset to IBD diagnosis exceeds six months, and only one-third of IBD patients receive continuing care with a gastroenterologist during the first five years following diagnosis.7. Senior (age ≥65), rural-dwelling, and non-immigrant IBD patients have less frequent gastroenterologist care than other groups.8. About one in five adults with Crohn's disease and one in eight adults with ulcerative colitis are hospitalized in Ontario every year. Hospitalizations are most common during the first year following IBD diagnosis. Children with IBD (age <18) have the highest rates of hospitalizations and hospital re-admissions.9. In Canada, 16% of patients hospitalized for Crohn's disease undergo an intestinal resection, and 11% of patients hospitalized for ulcerative colitis undergo a colectomy during their initial hospitalization. Rates of intestinal resection and colectomy are declining in Canada in persons with Crohn's disease and ulcerative colitis, respectively.10. In Ontario, one-third of adult-onset Crohn's disease patients undergo intestinal resection within ten years of diagnosis. Among Canadian children with Crohn's disease, approximately one in fifteen children will require intestinal surgery within the first year of diagnosis, and up to one-third will require surgery within ten years of diagnosis.11. In Ontario, the ten-year colectomy risk following ulcerative colitis diagnosis is 13.3% among young persons and adults and 18.5% among individuals with senior-onset ulcerative colitis. In children with ulcerative colitis, the risk of colectomy is 4.8% to 6% in the first year following diagnosis and increases to 15% to 17% by ten years. GAPS IN KNOWLEDGE AND FUTURE DIRECTIONS: 1. Forecasting models are necessary to predict the rising costs attributable to biologics associated with increasing prevalence of IBD, more frequent use of these medications, and the introduction of newer agents.2. Research into ways to minimize the escalating costs associated with increasing use of biologic therapies to treat IBD (and other chronic diseases) is necessary to ensure sustainability of our publicly funded health care system. Biosimilars offer an opportunity to drive down the cost of biologic therapies, and future research should assess the uptake of biosimilars as new biosimilars are introduced into the marketplace.3. Cost-utility models and budget impact analyses that integrate changes in direct costs (i.e., reduced hospitalizations and increased pharmaceutical costs) with indirect cost savings from improved quality of life are necessary to inform policy decisions.4. Research into ways to reduce IBD hospitalizations further through targeted outpatient interventions is equally important for health system sustainability and to improve patient quality of life.5. Research into reasons for reduced gastroenterologist care among rural and underserviced IBD residents would allow targeted interventions to improve specialist care and thereby improve patient health outcomes and quality of life.

Cost-Effectiveness of Extended Thromboprophylaxis in Patients Undergoing Colorectal Surgery from a Canadian Health Care System Perspective.

BACKGROUND: There is increasing evidence to support extended thromboprophylaxis after colorectal surgery to minimize the incidence of postdischarge venous thromboembolic events. However, the absolute number of events is small, and extended thromboprophylaxis requires significant resources from the health care system. OBJECTIVE: This study aimed to determine the cost-effectiveness of extended thromboprophylaxis in patients undergoing colorectal surgery for malignancy or IBD. DESIGN: An individualized patient microsimulation model (1,000,000 patients; 1-month cycle length) comparing extended thromboprophylaxis (28-day course of enoxaparin) to standard management (inpatient administration only) after colorectal surgery was constructed. SETTINGS: The sources for this study were The American College of Surgeons National Surgical Quality Improvement Project Participant User File and literature searches. OUTCOMES: Costs (Canadian dollars), quality-adjusted life-years, and venous thromboembolism-related deaths prevented over a 1-year time horizon starting with hospital discharge were determined. The results were stratified by malignancy or IBD. RESULTS: In patients with malignancy, extended prophylaxis was associated with higher costs (+113$; 95% CI, 102-123), but increased quality-adjusted life-years (+0.05; 95% CI, 0.04-0.06), resulting in an incremental cost-effectiveness ratio of 2473$/quality-adjusted life-year. For IBD, extended prophylaxis also had higher costs (+116$; 95% CI, 109-123), more quality-adjusted life-years (+0.05; 95% CI, 0.04-0.06), and an incremental cost-effectiveness ratio of 2475$/quality-adjusted life-year. Extended prophylaxis prevented 16 (95% CI, 4-27) venous thromboembolism-related deaths per 100,000 patients and 22 (95% CI, 6-38) for malignancy and IBD. There was a 99.7% probability of cost-effectiveness at a willingness-to-pay threshold of 50,000$/quality-adjusted life-year. To account for statistical uncertainty around variables, sensitivity analysis was performed and found that extended prophylaxis is associated with lower overall costs when the incidence of postdischarge venous thromboembolic events reaches 1.8%. LIMITATIONS: Significant differences in health care systems may affect the generalizability of our results. CONCLUSIONS: Despite the rarity of venous thromboembolic events, extended thromboprophylaxis is a cost-effective strategy. See Video Abstract at http://links.lww.com/DCR/A976. COSTO-EFECTIVIDAD DE LA TROMBOPROFILAXIS EXTENDIDA EN PACIENTES SOMETIDOS A CIRUGÍA COLORRECTAL DESDE UNA PERSPECTIVA DEL SISTEMA DE SALUD CANADIENSE:: Cada vez hay más pruebas que apoyen la tromboprofilaxis extendida después de la cirugía colorrectal para minimizar la incidencia de eventos tromboembólicos venosos después del alta hospitalaria. Sin embargo, el número absoluto de eventos es pequeño y la tromboprofilaxis extendida requiere recursos significativos del sistema médico.Determinar la rentabilidad (relación costo-efectividad) de la tromboprofilaxis extendida en pacientes sometidos a cirugía colorrectal por neoplasia maligna o enfermedad inflamatoria intestinal.Un modelo de microsimulación de paciente individualizado (1,000,000 de pacientes; ciclo de 1 mes) que compara la tromboprofilaxis extendida (curso de enoxaparina de 28 días) con el tratamiento estándar (solo para pacientes hospitalizados) después de la cirugía colorrectal.Archivo de usuario participante del Proyecto de Mejoramiento de la Calidad Quirúrgica del Colegio Nacional de Cirujanos Americanos (ACS-NSQIP) y búsquedas bibliográficas.Costos (en dólares Canadienses), años de vida ajustados por la calidad y muertes relacionadas con el tromboembolismo venoso prevenidas en un horizonte temporal de 1 año a partir del alta hospitalaria. Los resultados fueron estratificados por malignidad o enfermedad inflamatoria intestinal.En pacientes con neoplasias malignas, la profilaxis extendida se asoció con costos más altos (+113 $; IC del 95%, 102-123), pero con un aumento de la calidad de vida ajustada por años de vida (+0.05; IC del 95%, 0.04-0.06), lo que resultó en un incremento de relación costo-efectividad de 2473 $/año de vida ajustado por calidad. Para la enfermedad inflamatoria intestinal, la profilaxis extendida también tuvo costos más altos (+116 $; 95% IC, 109-123), más años de vida ajustados por calidad (+0.05; 95% IC, 0.04-0.06) y una relación costo-efectividad incremental de 2475 $/año de vida ajustado por calidad. La profilaxis prolongada evitó 16 (95% IC, 4-27) muertes relacionadas con tromboembolismo venoso por cada 100,000 pacientes y 22 (95% IC, 6-38) por malignidad y enfermedad inflamatoria intestinal, respectivamente. Hubo un 99.7% de probabilidad de costo-efectividad en un límite de disposición a pagar de 50,000 $/año de vida ajustado por calidad. Para tener en cuenta la incertidumbre estadística en torno a los variables, se realizó un análisis de sensibilidad y se encontró que la profilaxis extendida se asocia con menores costos generales cuando la incidencia de eventos tromboembólicos venosos después del alta hospitalaria alcanza 1.8%.Las diferencias significativas en los sistemas de salud pueden afectar la generalización de nuestros resultados.A pesar de la escasez de eventos tromboembólicos venosos, la tromboprofilaxis extendida es una estrategia rentable. Vea el video del resumen en http://links.lww.com/DCR/A976.

Enhanced Recovery After Surgery: Economic Impact and Value.

Value in health care is defined as the best outcome that matters to the patient at the lowest cost. Therefore, a valuable intervention is one that either results in better outcomes at the same cost, the same outcomes at lower cost, or in the best-case scenario, better outcomes at lower cost. Enhanced recovery pathways (ERPs) increase value by improving clinical outcomes without increasing costs. ERPs do not increase overall costs, even when implementation and maintenance costs are considered. More research on patient-reported outcomes and other downstream effects of ERPs is required to fully characterize their true value.

Clinical and Economic Impact of an Enhanced Recovery Pathway for Open and Laparoscopic Rectal Surgery.

BACKGROUND: The short-term benefits of laparoscopy for rectal surgery are equivocal. The objective of this study was to determine the clinical and economic impact of an enhanced recovery pathway (ERP) for laparoscopic and open rectal surgery. MATERIALS AND METHODS: All patients who underwent elective rectal resection with primary anastomosis between January 2009 and March 2012 at two tertiary-care, university-affiliated institutions were identified. Patients who met inclusion criteria were divided into four groups, according to surgical approach (laparoscopic [lap] or open) and perioperative management (ERP or conventional care [CC]). Length of stay (LOS), postoperative complications, and hospital costs were compared. RESULTS: A total of 381 patients were included in the analysis (201 open-CC, 34 lap-CC, 38 open-ERP, and 108 lap-ERP). Patients were mostly similar at baseline. ERPs significantly reduced median LOS after both open cases (open-CC 10 days versus open-ERP 7.5 days, P = .003) and laparoscopic cases (lap-CC 5 days versus lap-ERP 4.5 days, P = .046). ERPs also reduced variability in LOS compared with CC. There was no difference in postoperative complications with the use of ERPs (open-CC 51% versus open-ERP 50%, P = .419; lap-CC 32% versus lap-ERP 36%, P = .689). On multivariate analysis, both ERP (-3.6 days [95% confidence interval, CI -6.0 to -1.3]) and laparoscopy (-3.6 days [95% CI -5.9 to -1.0]) were independently associated with decreased LOS. Overall costs were only lower when lap-ERP was compared with open-CC (mean difference -2420 CAN$ [95% CI -5628 to -786]). CONCLUSIONS: ERPs reduced LOS after rectal resections, and the combination of laparoscopy and ERPs significantly reduced overall costs compared to when neither strategy was used.

Economic Impact of an Enhanced Recovery Pathway for Lung Resection.

BACKGROUND: Multimodal enhanced recovery pathways (ERP) improve clinical outcomes and hospital length of stay for patients undergoing lung resection. However, data supporting their economic impact is lacking. This study evaluated the effect of an ERP on costs of lung resection. METHODS: Adult patients undergoing elective lung resection from August 2011 to August 2013 at a single university-affiliated institution were prospectively recruited. Pneumonectomies and extended resections were excluded. Beginning in September 2012, patients were enrolled in a multimodal ERP. Outcomes were recorded until 90 days after discharge. Total costs from institutional, health care system, and societal perspectives are reported in 2016 Canadian dollars, with uncertainty expressed as 95% confidence intervals derived using bootstrapped estimates (10,000 repetitions). RESULTS: The study included 133 patients (conventional care: n = 58; ERP: n = 75). Patient and operative characteristics were similar between the groups. The ERP group had shorter median (interquartile range) length of stay (4 [3 to 6] days vs 6 [4 to 9] days, p < 0.01), decreased total complications (32% vs 52%, p = 0.02), and decreased pulmonary complications (16% vs 34%, p = 0.01), with no difference in readmissions. After discharge, there was a trend towards less caregiver burden for the ERP group (53 ± 90 hours vs 101 ± 252 hours, p = 0.17). Overall societal costs were lower in the ERP group (mean difference per patient: -$4,396 Canadian; 95% confidence interval -$8,674 to $618 Canadian). CONCLUSIONS: A multidisciplinary ERP is associated with improved clinical outcomes and societal cost savings compared with conventional perioperative management for elective lung resection.

Systematic review of the influence of enhanced recovery pathways in elective lung resection.

OBJECTIVE: Enhanced-recovery pathways aim to accelerate postoperative recovery and facilitate early hospital discharge. The aim of this systematic review was to summarize the evidence regarding the influence of this intervention in patients undergoing lung resection. METHODS: The review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement. Eight bibliographic databases (Medline, Embase, BIOSIS, CINAHL, Web of Science, Scopus, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials) were searched for studies comparing postoperative outcomes in adult patients treated within an enhanced-recovery pathway or traditional care. Risk of bias was assessed using the Cochrane Collaboration risk of bias tool. RESULTS: Six studies fulfilled our selection criteria (1 randomized and 5 nonrandomized studies). All the nonrandomized studies reported shorter length of stay in the intervention group (difference, 1.2-9.1 days), but the randomized study reported no differences. There were no differences between groups in readmissions, overall complications, and mortality rates. Two nonrandomized studies reported reduction in hospital costs in the intervention group. Risk of bias favoring enhanced recovery pathways was high. CONCLUSIONS: A small number of low-quality comparative studies have evaluated the influence of enhanced-recovery pathways in patients undergoing lung resection. Some studies suggest that this intervention may reduce length of stay and hospital costs, but they should be interpreted in light of several methodologic limitations. This review highlights the need for well-designed trials to provide conclusive evidence about the role of enhanced-recovery pathways in this patient population.

Cost-Effectiveness of Diagnostic Lobectomy Versus Observation for Thyroid Nodules >4 cm.

BACKGROUND: The management of thyroid nodules >4 cm with benign cytology after fine-needle aspiration biopsy (FNAB) is controversial. FNAB is associated with a high false-negative rate in this setting, and may result in a delayed diagnosis and management of thyroid cancer. However, the majority of these nodules are benign. Therefore, the objective of this study was to determine the cost-utility of observation versus surgical management for thyroid nodules >4 cm with benign cytology after FNAB. METHODS: A microsimulation model comparing routine thyroid lobectomy with observation for low-risk patients with >4 cm thyroid nodules with benign FNAB cytology was constructed. Costs, quality-adjusted life-years (QALYs), and life-years gained were calculated over a lifetime time horizon from a U.S. Medicare perspective. RESULTS: The proportion of patients undergoing thyroid lobectomy for benign final pathology was 40% in the observation strategy versus 66% in the surgical strategy (p < 0.001). Overall, the surgical strategy was associated with higher lifetime costs compared with the observation strategy (incremental difference: + US$12,992 [confidence interval (CI) 13,042-13,524]), but also more QALYs (+0.12 QALYs [CI 0.02-0.24]) and longer life expectancy (+1.67 years [CI 1.00-2.41]). Incremental lifetime costs were lower for patients <55 years compared with those ≥55 years (+11,181 vs. +14,811, p < 0.001). The probability of cost-effectiveness of the surgical strategy was 49% at a $100k/QALY threshold or 65% at a $100k/life-year gained threshold. CONCLUSIONS: Routine thyroid lobectomy is associated with improved outcomes at an acceptable cost compared with observation for thyroid nodules >4 cm with benign cytology after FNAB. Surgical resection may be a cost-effective strategy to rule out malignancy in these nodules.

What outcomes are important in the assessment of Enhanced Recovery After Surgery (ERAS) pathways?

PURPOSE: The purpose of this narrative review is to provide a framework from which to measure the outcomes of Enhanced Recovery After Surgery (ERAS) programs. PRINCIPLE FINDINGS: We define the outcomes of recovery from the perspective of different stakeholders and time frames. There is no single definition of recovery. There are overlapping phases of recovery which are of particular interest to different stakeholders (surgeons, anesthesiologists, nurses, patients and their caregivers), and the primary outcome of interest may vary depending on the phase and the perspective. In the earliest phase (from the end of the surgery to discharge from the postanesthesia care unit [PACU]), biologic and physiologic outcomes are emphasized. In the intermediate phase (from PACU to discharge from the hospital), symptoms related to pain and gastrointestinal function as well as basic activities are important. Studies of ERAS pathways have reported clinical outcomes and symptoms, including complications, hospital stay, mobilization, and gastrointestinal function, largely during hospitalization. Nevertheless, patients define recovery as return to normal functioning, a process that occurs over weeks to months (late phase). Outcomes reflecting functional status (e.g., physical activity, activities of daily living) and overall health (e.g., quality of life) are important in this phase. To date, few studies reporting the effectiveness of ERAS pathways compared with conventional care have included functional status or quality-of-life outcomes, and there is little information about recovery after discharge from hospital. CONCLUSION: Recovery after surgery is a complex construct. Different outcomes are important at different phases along the recovery trajectory. Measures for quantifying recovery in hospital and after discharge are available. A consensus-based core set of outcomes with input from multiple stakeholders would facilitate research reporting.

Cost-effectiveness of Enhanced Recovery Versus Conventional Perioperative Management for Colorectal Surgery.

OBJECTIVE: To determine the cost-effectiveness of enhanced recovery pathways (ERPs) versus conventional care for patients undergoing elective colorectal surgery. BACKGROUND: ERPs for colorectal surgery are clinically effective, but their cost-effectiveness is unknown. METHODS: A multi-institutional prospective cohort cost-effectiveness analysis was performed. Adult patients undergoing elective colorectal resection at 2 university-affiliated institutions from October 2012 to October 2013 were enrolled. One center used an ERP, whereas the other did not. Postoperative outcomes were recorded up to 60 days. Total costs were reported in 2013 Canadian dollars. Effectiveness was measured using the SF-6D, a health utility measure validated for postoperative recovery. Uncertainty was expressed using bootstrapped estimates (10,000 repetitions). RESULTS: A total of 180 patients were included (conventional care: n = 95; ERP: n = 95). There were no differences in patient characteristics except for a higher proportion of laparoscopy in the ERP group. Mean length of stay was shorter in the ERP group (6.5 vs 9.8 days; P = 0.017), but there were no differences in complications or readmissions. Patients in the ERP group returned to work quicker and had less caregiver burden. There was no difference in quality of life between the 2 groups. The cost of the ERP program was $153 per patient. Overall societal costs were lower in the ERP group (mean difference = -2985; 95% confidence interval, -5753 to -373). The ERP had a greater than 99% probability of cost-effectiveness. The results were insensitive to a range of assumptions and subgroups. CONCLUSIONS: Enhanced recovery is cost-effective compared with conventional perioperative management for elective colorectal resection.

Validity of the EuroQol-5 dimensions as a measure of recovery after pulmonary resection.

BACKGROUND: Surgical innovations advocated to improve patient recovery are often costly. Economic evaluation requires preference-based measures that reflect the construct of patient recovery. We investigated the responsiveness and construct validity of the EuroQol-5 dimensions (EQ-5D) as a measure of postoperative recovery after planned pulmonary resection for suspected malignant tumors. METHODS: Patients undergoing pulmonary resection completed the EQ-5D questionnaire and visual analog scales (VAS) for pain and fatigue at baseline (preoperatively) and at 1 and 3 mo postoperatively. Responsiveness and construct validity (discriminant and convergent) were investigated by testing a priori hypotheses. RESULTS: Fifty-five patients were analyzed (45% male, 62 ± 12 y, 29% video-assisted). There was no significant difference between median EQ-5D scores obtained at baseline (0.83 [interquartile range {IQR 0.80-1}]) compared to scores at 1 mo (0.83 [0.80-1], P = 0.86) and 3 mo after surgery (1 [0.83-1]; P = 0.09). At 1 mo after surgery, EQ-5D scores were significantly lower in patients undergoing thoracotomy versus video-assisted surgery (0.82 [IQR 0.77-0.89] versus 1 [0.83-1], P = 0.003), but there were no significant differences between patients ≥ 70-y old versus younger (0.95 [IQR 0.82-1] versus 0.83 [0.77-1], P = 0.09) or between patients with versus without complications (0.82 [IQR 0.79-0.95] versus 0.83 [0.80-1], P = 0.10). There was a low but significant correlation between EQ-5D and VAS scores of pain and fatigue (Rho -0.30 to -0.47, P ≤ 0.01). CONCLUSIONS: Despite evidence of convergent validity, the EQ-5D was not sensitive to the hypothesized trajectory of postoperative recovery and showed limited discriminant validity. This study suggests that the EQ-5D may not be appropriate to value recovery after lung resection.

A simple and powerful method for the estimation of intervention effects on serological endpoints using paired interval-censored data.

Clinical trials often use a binary "fold increase" endpoint defined according to the ratio of interval-censored measurement at end-of-study to that at baseline. We propose a simple yet principled analytic approach based on the linear mixed-effects model for interval-censored data for the analysis of such paired measurements. Having estimated the model parameters, the risk ratio can be estimated by explicit composite estimand and the variance is estimated using the delta method. The estimation can be implemented using the existing procedures in popular statistical software. We use antibody data from the Chloroquine for Influenza Prevention Trial for illustration.

Cost-effectiveness of molecular testing for thyroid nodules with atypia of undetermined significance cytology.

CONTEXT: Novel molecular diagnostics, such as the gene expression classifier (GEC) and gene mutation panel (GMP) testing, may improve the management for thyroid nodules with atypia of undetermined significance (AUS) cytology. The cost-effectiveness of an approach combining both tests in different practice settings in North America is unknown. OBJECTIVE: The aim of the study was to determine the cost-effectiveness of two diagnostic molecular tests, singly or in combination, for AUS thyroid nodules. DESIGN AND SETTING: We constructed a microsimulation model to investigate cost-effectiveness from US (Medicare) and Canadian healthcare system perspectives. PATIENTS: Low-risk patients with AUS thyroid nodules were simulated. INTERVENTIONS: We examined five management strategies: 1) routine GEC; 2) routine GEC + selective GMP; 3) routine GMP; 4) routine GMP + selective GEC; and 5) standard management. MAIN OUTCOME MEASURES: Lifetime costs and quality-adjusted life-years were measured. RESULTS: From the US perspective, the routine GEC + selective GMP strategy was the dominant strategy. From the Canadian perspective, routine GEC + selective GMP cost and additional CAN$24 030 per quality-adjusted life-year gained over standard management, and was dominant over the other strategies. Sensitivity analyses reported that the decisions from both perspectives were sensitive to variations in the probability of malignancy in the nodule and the costs of the GEC and GMP. The probability of cost-effectiveness for routine GEC + selective GMP was low. CONCLUSIONS: In the US setting, the most cost-effective strategy was routine GEC + selective GMP. In the Canadian setting, standard management was most likely to be cost effective. The cost of these molecular diagnostics will need to be reduced to increase their cost-effectiveness for practice settings outside the United States.

A comparison of the validity of two indirect utility instruments as measures of postoperative recovery.

BACKGROUND: Cost-effectiveness analyses of surgical interventions require valid measures of postoperative recovery. The objective of this study was to compare the validity of two indirect utility instruments, the Short Form 6D (SF-6D) and EuroQol 5D (EQ-5D), as measures of postoperative recovery. MATERIALS AND METHODS: A prospective cohort of patients undergoing elective colorectal resection at two university-affiliated institutions from October 2012-October 2013 completed the SF-6D and EQ-5D (including the EQ-visual analog scale [EQ-VAS]) at baseline (before surgery), and at 4 and 8 wk after surgery. Responsiveness and construct validity were assessed through a priori hypotheses. RESULTS: A total of 165 patients were included. The SF-6D was the most responsive to the expected postoperative changes at 4 and 8 wk compared with the EQ-5D and the EQ-VAS. The 4-wk SF-6D, EQ-5D, and EQ-VAS discriminated between patients with and without complications after controlling for confounders with adjusted mean differences of -0.070 (95% confidence interval [CI] -0.126 to -0.015), -0.133 (95% CI -0.231, -0.030), and -7.91 (95% CI -14.77, -1.04), respectively. Mean SF-6D and EQ-5D values were significantly different from the US population norms at all time points, but the magnitude of change was highest for the SF-6D. The strength of correlation between all three instruments was moderate at all time points (r=0.550-0.684, all P<0.05). CONCLUSIONS: The SF-6D preference-based health index appears to be a more valid measure of postoperative recovery than the EQ-5D and EQ-VAS in surgical cost-effectiveness analyses.

A systematic review of economic evaluations of enhanced recovery pathways for colorectal surgery.

OBJECTIVE: To perform a systematic review of economic evaluations of enhanced recovery pathways (ERP) for colorectal surgery. BACKGROUND: Although there is extensive literature investigating the clinical effectiveness of ERP, little is known regarding its cost-effectiveness. METHODS: A systematic literature search identified all relevant articles published between 1997 and 2012 that performed an economic evaluation of ERP for colorectal surgery. Studies were included only if their ERP included all 5 of the key components (patient information, preservation of GI function, minimization of organ dysfunction, active pain control, and promotion of patient autonomy). Quality assessment was performed using the Consensus on Health Economic Criteria instrument (scored 0-19; high quality ≥ 12). Incremental cost-effectiveness ratios were calculated if sufficient data were provided, using difference in length of stay and overall complication rates as effectiveness measures. RESULTS: Of a total of 263 unique records identified (253 from databases and 10 from other sources), 10 studies met our inclusion criteria and were included for full qualitative synthesis. Overall quality was poor (mean quality 7.8). Eight reported lower costs for ERP. The majority (8 of 10) of studies were performed from an institutional perspective and therefore did not include costs related to changes in productivity and other indirect costs (eg, caregiver burden). Five studies provided enough information to calculate ICERs, of which ERP was dominant (less costly and more effective) in all cases for reduction in length of stay and was dominant or potentially cost-effective in 4 and questionable (no difference in costs nor effectiveness) in 1 for reduction in overall complications. CONCLUSIONS: The quality of the current evidence is limited but tends to support the cost-effectiveness of ERP. There is need for well-designed trials to determine the cost-effectiveness of ERP from both the institutional and societal perspectives.

Cost effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing permanent colostomy for rectal cancer.

BACKGROUND: Parastomal hernia (PSH) is common after stoma formation. Studies have reported that mesh prophylaxis reduces PSH, but there are no cost-effectiveness data. Our objective was to determine the cost effectiveness of mesh prophylaxis vs no prophylaxis to prevent PSH in patients undergoing abdominoperineal resection with permanent colostomy for rectal cancer. STUDY DESIGN: Using a cohort Markov model, we modeled the costs and effectiveness of mesh prophylaxis vs no prophylaxis at the index operation in a cohort of 60-year-old patients undergoing abdominoperineal resection for rectal cancer during a time horizon of 5 years. Costs were expressed in 2012 Canadian dollars (CAD$) and effectiveness in quality-adjusted life years. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: In patients with stage I to III rectal cancer, prophylactic mesh was dominant (less costly and more effective) compared with no mesh. In patients with stage IV disease, mesh prophylaxis was associated with higher cost (CAD$495 more) and minimally increased effectiveness (0.05 additional quality-adjusted life years), resulting in an incremental cost-effectiveness ratio of CAD$10,818 per quality-adjusted life year. On sensitivity analyses, the decision was sensitive to the probability of mesh infection and the cost of the mesh, and method of diagnosing PSH. CONCLUSIONS: In patients undergoing abdominoperineal resection with permanent colostomy for rectal cancer, mesh prophylaxis might be the less costly and more effective strategy compared with no mesh to prevent PSH in patients with stage I to III disease, and might be cost effective in patients with stage IV disease.