How Digital Solutions Might Provide a World of New Opportunities for Holistic and Empathic Support of Patients with Hidradenitis Suppurativa.

Hidradenitis suppurativa (HS) is a complex chronic relapsing inflammatory condition anchored in the hair follicle wherein painful abscesses, nodules, and tunnels form under the skin with the potential for intermittent pus drainage and tissue scarring. Current estimates of incidence are 1-4% globally with the disease three times more prevalent in women and higher rates among Black populations. Patients with HS are also more likely to suffer from depression, anxiety, and loneliness underscoring the need for carefully approached strategies on disease awareness and interventions. Delays in formal diagnosis, which have been estimated at 7-10 years on average, impede timely provision of optimal care. Despite best intent, when patients present at a physician's office, stigmas relating to physical appearance can be exacerbated by negative interactions experienced by patients. In addition to long wait times and the dearth of available HS expert dermatology professionals, patients perceive heightened physician focus on two of the HS flare risk factors (smoking and body mass index [BMI]) as negatively impacting their care. Given the need for continual, personal, and sensitive patient support, herein we advocate for re-examination of approach to care and the leveraging of highly personalized digital support solutions. New medications which can directly or indirectly control elements of the disease and its comorbidities are also entering the marketplace. Collectively, we posit that these new developments provide opportunity for a holistic approach for patients with HS, leading to long-term engagement and improved outcomes.

Impact of benralizumab on asthma exacerbation-related medical healthcare resource utilization and medical costs: results from the ZEPHYR 2 study.

BACKGROUND AND AIM: Benralizumab is a biologic add-on treatment for severe eosinophilic asthma that can reduce the rate of asthma exacerbations, but data on the associated medical utilization are scarce. This retrospective study evaluated the economic value of benralizumab by analyzing healthcare resource utilization (HRU) and medical costs in a large patient population in the US. METHODS: Insurance claims data (11/2016-6/2020) were analyzed. A pre-post design was used to compare asthma exacerbation rates, medical HRU and medical costs in the 12 months pre vs. post index (day after benralizumab initiation). Patients were aged ≥12 years, with ≥2 records of benralizumab and ≥2 asthma exacerbations pre index, and constituted non-mutually exclusive cohorts: biologic-naïve, biologic-experienced (switched from omalizumab or mepolizumab to benralizumab), or with extended follow-up (18 or 24 months). RESULTS: In all cohorts (mean age 51-53 years; 67-70% female; biologic-naïve, N = 1,292; biologic-experienced, N = 349; 18-month follow-up, N = 419; 24-month follow-up, N = 156), benralizumab treatment reduced the rate of asthma exacerbation by 53-68% (p < .001). In the biologic-naïve cohort, inpatient admissions decreased by 58%, emergency department visits by 54%, and outpatient visits by 58% post index (all p < .001), with similar reductions in exacerbation-related medical HRU in other cohorts. Exacerbation-related mean total medical costs decreased by 51% in the biologic-naïve cohort ($4691 pre-index, $2289 post-index), with cost differences ranging from 16% to 64% across other cohorts (prior omalizumab: $2686 to $1600; prior mepolizumab: $5990 to $5008; 18-month: $3636 to $1667; 24-month: $4014 to $1449; all p < .001). Medical HRU and cost reductions were durable, decreasing by 64% in year 1 and 66% in year 2 in the 24 month follow-up cohort. CONCLUSION: Patients treated with benralizumab with prior exacerbations experienced reductions in asthma exacerbations and exacerbation-related medical HRU and medical costs regardless of prior biologic use, with the benefits observed for up to 24 months after treatment initiation.

Benralizumab is a biologic approved as an add-on treatment for severe eosinophilic asthma. Previous real-world studies and clinical trials have shown that benralizumab can reduce the rate of asthma exacerbations and systemic corticosteroid use. However, there is little information on the economic value of benralizumab in real-world patient populations. This study showed that patients with severe asthma in the United States had lower rates of asthma exacerbations after starting treatment with benralizumab. The patients also had fewer asthma exacerbation-related hospitalizations, emergency department visits, and outpatient visits as well as lower medical costs related to asthma exacerbations compared with before the treatment. These benefits were observed in patients who had never taken and those who had been previously treated with biologic therapies, and for up to 24 months after starting benralizumab treatment. These results show that the clinical value of benralizumab translates into reduced medical utilization for patients with severe asthma.

Patient-reported outcome measures and value-based medicine in paediatrics: a timely review.

Healthcare delivery is moving towards a more personalised and patient-centric approach. There is now an appropriate emphasis on providing value in our healthcare system. Patient-reported outcome measures (PROMs) assess our patients' perceptions of the status of their health and quality of life, measured over a period of time. PROM is an integral component of a value-driven and value-based healthcare system and is key if we want to practise value-based medicine. In paediatrics and child health, PROMs, if implemented well with appropriate measurement tools that are regularly updated and validated in a self-learning healthcare ecosystem, will help to enhance personalised healthcare delivery and collectively improve the health of the community at large. This review covers the role of PROMs in paediatrics, as well as their role in value-based medicine.

Patient-reported outcome measures and value-based medicine in paediatrics: a timely review

Healthcare delivery is moving towards a more personalised and patient-centric approach. There is now an appropriate emphasis on providing value in our healthcare system. Patient-reported outcome measures (PROMs) assess our patients' perceptions of the status of their health and quality of life, measured over a period of time. PROM is an integral component of a value-driven and value-based healthcare system and is key if we want to practise value-based medicine. In paediatrics and child health, PROMs, if implemented well with appropriate measurement tools that are regularly updated and validated in a self-learning healthcare ecosystem, will help to enhance personalised healthcare delivery and collectively improve the health of the community at large. This review covers the role of PROMs in paediatrics, as well as their role in value-based medicine.

The Inpatient Only Rule, Alternative Payment Models, and the Relative Value Update Committee Reimbursement and Coding Changes: What Do They Mean?

BACKGROUND: The unsustainable rising costs of healthcare, a greater portion of which is being borne by the federal government, has resulted in the government's development of programs aimed to control costs without adversely affecting outcomes. METHODS/RESULTS: Alternative Payment Models, the shift from inpatient to outpatient and ambulatory surgery centers' surgical venues, and Relative Value Update Committee coding and reimbursement strategies are all designed to achieve the aforementioned goal. These programs will continue to influence our practice patterns. CONCLUSION: It is clear that we must continue to advocate for access to high quality care reimbursed at a fair price. It is also clear that the successful adult reconstructive surgeon will understand these programs and adjust his/her practice to take full advantage of the opportunities that these programs present.

Cost and Value in Contemporary Heart Failure Clinical Guidance Documents.

OBJECTIVES: This study sought to evaluate the frequency and nature of cost/value statements in contemporary heart failure (HF) clinical guidance documents (CGDs). BACKGROUND: In an era of rising health care costs and expanding therapeutic options, there is an increasing need for formal consideration of cost and value in the development of HF CGDs. METHODS: HF CGDs published by major professional cardiovascular organizations between January 2010 and February 2021 were reviewed for the inclusion of cost/value statements. RESULTS: Overall, 33 documents were identified, including 5 (15%) appropriate use criteria, 7 (21%) clinical practice guidelines, and 21 (64%) expert consensus documents. Most CGDs (27 of 33; 82%) included at least 1 cost/value statement, and 20 (61%) CGDs included at least 1 cost/value-related citation. Most of these statements were found in expert consensus documents (77.7%). Three (9%) documents reported estimated costs of recommended interventions, but only 1 estimated out-of-pocket cost. Of 179 cost/value-related statements observed, 116 (64.8%) highlighted the economic impact of HF or HF-related care, 6 (3.4%) advocated for cost/value issues, 15 (8.4%) reported gaps in cost/value evidence, and 42 (23.5%) supported clinical guidance recommendations. Over time, patterns of inclusion of statements and citations of cost/value have been largely stable. CONCLUSIONS: Although most contemporary HF CGDs contain at least 1 cost/value statement, most CGDs focus on the high economic impact of HF and its related care; explicit inclusion of cost/value to support clinical guidance recommendations remains infrequent. These results highlight key opportunities for the integration of formalized cost/value considerations in future HF-focused CGDs.

Value-based approach to blood pressure telemonitoring and remote counseling in hypertensive patients.

PURPOSE: Blood pressure telemonitoring and remote counselling (BPTM) improves blood pressure (BP) control in patients with hypertension (HTN). Studies assessing the efficacy of BPTM from a value-based perspective are lacking. We investigated whether BPTM fits all principles of the value-based approach (clinical and economic effectiveness, improvement in patient-reported outcome/experience measures (PROM/PREM)). MATERIALS AND METHODS: Two hundred and forty ambulatory patients with uncontrolled HTN were randomised in a 2: 1 manner to BPTM (n = 160, mean age 47 y.o.) and usual care (UC, n = 80; 49 y.o.) with baseline and 3-month follow-up clinic visits. BPTM employed a mobile application (for patients) and a desktop version (for clinician), which allowed communication and exchange of medical data. The main outcomes were changes in office and ambulatory systolic (S) BPs, rate of BP control. The incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were evaluated in economic analysis. The MOS SF-36 score was taken as a PROM, and the PEQ score was used as a PREM. RESULTS: Larger decreases in office and ambulatory SBPs (-16.8 and -8.9 mm Hg, respectively; p < .05) was achieved in BPTM group while the treatment intensity was equal (2.4 drugs). The ICER 11.1 EUR/-1 mm Hg 24-hour SBP/1 year was 75% effective as per willingness-to-pay threshold. BPTM improved PROM (+2.1 in mean MOS SF-36; p = .04), reduced long-term mortality (+0.11 life years gained), leading to +0.49 quality-adjusted life years (QALYs) gained as compared with UC. The ICUR was 4 169.4 EUR/QALY gained. Patient-reported experience was higher in the BPTM (+10 PEQ, p = .01). The UC group showed minor changes in MOS SF-36 and PEQ (+1.3; +6, respectively; p n.s.). CONCLUSIONS: Being cost-effective, BPTM incorporates both clinical benefits and patient-perceived value. Larger randomised studies are needed to confirm our findings.

Progress and implications of value-based medical payment in the United States / 中华医院管理杂志

Value-based medicine is a healthcare delivery mode with the objective of obtaining better medical quality and health outcomes at a certain cost. The authors introduced the concept of value-based medicine, reviewed its background in the United States, described the transformation of payments from fee-for-service to value-based modes of the Centers for Medicare and Medicaid Services in the United States, and analyzed current challenges of value-based payment. Then the authors discussed the implications for China′s medical service providers to carry out value-based medical practice, in order to provide reference for China′s medical workers to participate in the construction of high-value medical system.

Value-based medicine, a compass to guide healthcare decisions in the COVID-19 aftermath.

The ongoing COVID-19 pandemics has claimed hundreds of thousands of lives among the elderly, the patients with chronic conditions and among underserved communities and people in social distress. In addition, the measures that succeeded in containing the epidemic created a profound economic crisis, which real dimension is still unclear. It is clear, however, that most healthcare systems were unprepared. Years of cost containments had eroded the ability of the healthcare sector to cope with the surge in cases. This editorial contends that rebuilding the healthcare systems will require forward thinking, a data-driven approach and avoidance of reactive decision making. The editorial proposes the Value Based Medicine approach as a way to avoid the errors of the past and to align decision making in healthcare with patient health and quality of life (Value). This is an approach that is gaining traction in several systems. It needs a built-in capability to collect and analyse outcome and costing data. Today the necessary informatic and computational capabilities are widely available.

Re-evaluating the utility of routine postoperative laboratory tests after primary total knee arthroplasty.

BACKGROUND: While advancements in surgery and reduced complication rates have made total knee arthroplasty (TKA) one of the most successful and cost-effective procedures in orthopaedic surgery, routine postoperative laboratory tests are still being ordered without evidence as to their necessity. With expansion of the bundled payment models, there may exist an opportunity to cut overall costs while maintaining quality of care by eliminating unnecessary interventions. The objective of this study was to examine the utility of routine postoperative laboratory tests in TKA. METHODS: A retrospective review of 319 TKAs performed at a single institution over a 2-year period was performed. The primary outcomes were the rates of acute blood loss anemia requiring transfusion, acute kidney injury (AKI), electrolyte abnormalities, and 90-day emergency department visits and readmissions. Multivariate logistic regression analysis was also performed to identify the risk factors associated with abnormal laboratory values. RESULTS: 89 patients (27.9%) had abnormal postoperative laboratory results, of which 78% were exclusively due to electrolyte (sodium or potassium) abnormalities. The rates of AKI and blood transfusion were 3.8% and 1% respectively. Factors associated with electrolyte abnormalities were abnormal baseline electrolyte levels (p = 0.002 and = 0.006 for sodium and potassium respectively) and anemia (p = 0.049). Factors associated with blood transfusion were ASA score ≥3, preoperative anemia, and no tranexamic acid use. Factors associated with AKI were chronic kidney disease or having at least two of the following: age >65 years, BMI> 35, ASA score ≥3, diabetes, heart disease, and/or anemia. Laboratory results did not change the course of care in 305 of 319 patients (95.6%). There was no increased risk for 90-days ED visits or readmissions with abnormal laboratory values (p = 0.356). CONCLUSION: With increasing pressure for cost containment in an era of bundled payment models, the very low rate of laboratory associated interventions suggest that routine postoperative laboratory tests is not justified. Obtaining laboratory after primary, unilateral TKA should be driven by patients' risk factors.

Fighting healthcare rocketing costs with value-based medicine: the case of stroke management.

Value-Based Medicine (VBM) is imposing itself as 'a new paradigm in healthcare management and medical practice.In this perspective paper, we discuss the role of VBM in dealing with the large productivity issue of the healthcare industry and examine some of the worldwide industrial and technological trends linked with VBM introduction. To clarify the points, we discuss examples of VBM management of stroke patients.In our conclusions, we support the idea of VBM as a strategic aid to manage rising costs in healthcare, and we explore the idea that VBM, by establishing value-generating networks among different healthcare stakeholders, can serve as the long sought-after redistributive mechanism that compensate patients for the industrial exploitation of their personal medical records.

Value-based care for the treatment and evaluation of benign prostatic hyperplasia: an analysis of a metropolitan service area claims database.

PURPOSE: With an aging population, cost containment and improved outcomes will be crucial for a sustainable healthcare ecosystem. Current data demonstrate great variation in payments for procedures and diagnostic workup of benign prostatic hyperplasia (BPH). To help determine the best financial value in BPH care, we sought to analyze the major drivers of total payments in BPH. MATERIALS AND METHODS: Commercial and Medicare claims from the Truven Health Analytics Markestscan® database for the Austin, Texas Metropolitan Service Area from 2012 to 2014 were queried for encounters with diagnosis and procedural codes related to BPH. Linear regression was utilized to assess factors related to BPH-related payments. Payments were then compared between surgical patients and patients managed with medication alone. RESULTS: Major drivers of total payments in BPH care were operative, namely transurethral resection of prostate (TURP) [$2778, 95% CI ($2385-$3171), p < 0.001) and photoselective vaporization (PVP) ($3315, 95% CI ($2781-$3849) p < 0.001). Most office procedures were also associated with significantly higher payments, including cystoscopy [$708, 95% CI ($417-$999), p < 0.001], uroflometry [$446, 95% CI ($225-668), p < 0.001], urinalysis [$167, 95% CI ($32-$302), p = 0.02], postvoid residual (PVR) [$245, 95% CI ($83-$407), p < 0.001], and urodynamics [$1251, 95% CI ($405-2097), p < 0.001]. Patients who had surgery had lower payments for their medications compared to patients who had no surgery [$120 (IQR: $0, $550) vs. $532 (IQR: $231, $1852), respectively, p < 0.001]. CONCLUSION: Surgery and office-based procedures are associated with increased payments for BPH treatment. Although payments for surgery were more in total, surgical patients paid significantly less for BPH medications.

Total Hip Arthroplasty for Femoral Neck Fracture: The Economic Implications of Orthopedic Subspecialty Training.

BACKGROUND: Hip fractures have significant economic implications as a result of their associated direct and indirect medical costs. Under alternative payment models, it has become increasingly important for institutions to find avenues by which costs could be reduced while maintaining outcomes in these cases. METHODS: A multi-institutional retrospective analysis of Medicare patients who underwent total hip arthroplasty (THA) for femoral neck fracture was conducted to assess the impact of fellowship training in adult reconstruction (AR) on the total costs of the 90-day episode of care. Patients were divided into 2 cohorts according to fellowship training status of the operating surgeon: (1) AR-trained and (2) other fellowship training (non-AR). The primary outcome was the total cost of the 90-day episode of care converted to a percentage of the bundled payment target price. RESULTS: A total of 291 patients who underwent THA for the treatment of a femoral neck fracture were included. The average total cost percentage of the 90-day episode of care was significantly lower for the AR cohort 70.9% (±36.6%) than the non-AR cohort 82.6% (±36.1%) (P < .01). After controlling for baseline demographics in the multivariable logistic regression, the care episodes in which the operating surgeons were AR fellowship-trained were still found to be significantly lower, at a rate of 0.87 times the costs of the non-AR surgeons (95% confidence interval 0.78-0.97, P = .011). In addition, the non-AR cohort exceeded the bundle target price more frequently than the AR cohort, 49 (28.7%) vs 16 (13.3%) (P = .02). CONCLUSION: In an era of bundled payments, ascertaining factors that may increase the value of care while decreasing the cost is paramount for institutions and policymakers alike. The results presented in this study suggest that in the femoral neck fracture population, surgeons trained in AR achieve lower total costs for the THA episode of care. Furthermore, non-AR fellowship-trained surgeons exceeded the bundled payment target more frequently than the AR surgeons.

Clinical outcome indicators in chronic hepatitis B and C: A primer for value-based medicine in hepatology.

BACKGROUND & AIMS: Chronic liver diseases (CLDs) are major health problems that require complex and costly treatments. Liver-specific clinical outcome indicators (COIs) able to assist both clinicians and administrators in improving the value of care are presently lacking. The Value-Based Medicine in Hepatology (VBMH) study aims to fill this gap, devising and testing a set of COIs for CLD, that could be easily collected during clinical practice. Here we report the COIs generated and recorded for patients with HBV or HCV infection at different stages of the disease. METHODS/RESULTS: In the first phase of VBMH study, COIs were identified, based on current international guidelines and literature, using a modified Delphi method and a RAND 9-point appropriateness scale. In the second phase, COIs were tested in an observational, longitudinal, prospective, multicentre study based in Lombardy, Italy. Eighteen COIs were identified for HBV and HCV patients. Patients with CLD secondary to HBV (547) or HCV (1391) were enrolled over an 18-month period and followed for a median of 4 years. The estimation of the proposed COIs was feasible in the real-word clinical practice and COI values compared well with literature data. Further, the COIs were able to capture the impact of new effective treatments like direct-acting antivirals (DAAs) in the clinical practice. CONCLUSIONS: The COIs efficiently measured clinical outcomes at different stages of CLDs. While specific clinical practice settings and related healthcare systems may modify their implementation, these indicators will represent an important component of the tools for a value-based approach in hepatology and will positively affect care delivery.

Optimizing mandibular sagittal split of large maxillomandibular advancements for obstructive sleep apnea: patient and surgical factors.

OBJECTIVES: Maxillomandibular advancement (MMA) confers consistent and high rates of surgical success for obstructive sleep apnea (OSA). In the era of value-based medicine, identifying factors that affect the stability of rigid fixation and allow rapid return to function are important targets for improvement. The aim of this study was to identify patient and surgical factors associated with mandibular sagittal split outcomes associated with optimal postoperatively skeletal stability. STUDY DESIGN: Retrospective cohort study. MATERIALS AND METHODS: Forty-six subjects (43 males and 3 females) with postoperative CT scans including three-dimensional reconstruction from which mandibular split patterns could be analyzed were enrolled. Patient factors (age and polysomnographic measures) and surgical factors (extent of osteotomy prior to controlled fracture) were assessed. Outcome measures include (1) bone thickness for rigid fixation and (2) area of passive bony overlap after advancement. RESULTS: Age and severity of disease did not contribute significantly to optimal mandibular split patterns. For optimal area for passive bony overlap and thickness of buccal and lingual plates for rigid fixation, the most important factors are related to surgical technique. CONCLUSIONS: Anterior osteotomy just to the midline of inferior border and horizontal osteotomy to the mandibular foramen are associated with split patterns that result in optimal rigid fixation and passive bony overlap for OSA patients undergoing MMA. CLINICAL RELEVANCE: Optimal surgical technique has the most significant influence in allowing rapid return to function after MMA in patients with OSA.

Value-based medicine and palliative care: how do they converge?

Introduction: Sick persons need doctors who understand their pathology, know how to treat their problem, and accompany them through their illness. This study aimed to synthesize the state of knowledge regarding the concept of value-based medicine (VBM) through an integrative literature review, and establish how VBM can be applied in palliative care. Areas covered: An integrative review was conducted with the keywords 'value-based medicine,' 'patient-centered care,' and 'medicina baseada em valor' (Portuguese for VBM) in PubMed and Virtual Health Library, identifying 17,189 articles in total. Of these, 10 articles met the eligibility criteria. VBM combines the highest level of technical-scientific data with patients' values. It is defined as the combination of evidence-based medicine, patient-centered care, and cost-effectiveness. Patients' values are a set of preferences, concerns, and expectations that contribute toward accommodating their needs in the treatment clinic. Expert opinion: Like VBM, palliative care focuses on patients' values and quality of life, respecting natural limits. The early development of a care plan with active participation of the patient in the face of life-threatening diseases should be encouraged and can bring peace and comfort in a person's final moments.

Routine Postoperative Laboratory Tests Are Not Necessary After Primary Total Hip Arthroplasty.

BACKGROUND: Postoperative laboratory testing has been used routinely for patients undergoing total hip arthroplasty (THA). However, with modern-day improvements in perioperative care pathways, it is unclear whether this practice remains justified. The purpose of this study was to assess the utility of routine postoperative laboratory tests in primary THA. METHODS: The electronic medical records of 351 patients who underwent primary, unilateral THA between 2015 and 2017 were retrospectively reviewed. The primary outcomes were the rates of acute blood loss anemia requiring transfusion, acute kidney injury (AKI), electrolyte abnormalities, and 90-day emergency department visits or readmissions. Multivariate logistic regression analysis was also performed to identify the risk factors associated with abnormal laboratory values. RESULTS: Seventy-four patients (21%) had abnormal postoperative laboratory results, of which 82.4% were exclusively due to electrolyte (sodium or potassium) abnormalities. Factors associated with electrolyte abnormalities were abnormal baseline electrolyte levels (P < .001 and P = .013 for sodium and potassium, respectively), diabetes (P = .007), and lack of tranexamic acid use (P < .01). The rates of AKI and blood transfusion were 2.0% and 2.3%, respectively. Factors associated with blood transfusion were higher American Society of Anesthesiologists class and intraoperative blood loss ≥250 mL combined with either preoperative anemia or lack of tranexamic acid use. Factors associated with AKI were higher American Society of Anesthesiologists class and diabetes. Laboratory results did not change the standard course of care in 338 of 351 patients (96%). Abnormal laboratory values were not associated with increased length of stay (P = .228) or emergency department visits/readmissions (P = .21). CONCLUSION: This study provides evidence that routine postoperative laboratory testing is not necessary in modern-day primary, unilateral THA. Instead, the decision to obtain laboratory tests after surgery should be driven by patients' risk factors.

Value and Payment in Sleep Medicine.

ABSTRACT: Value, like beauty, exists in the eye of the beholder. This article places the value of clinical sleep medicine services in historical context and presents a vision for the value-based sleep of the future. First, the history of value and payment in sleep medicine is reviewed from the early days of the field, to innovative disruption, to the widespread adoption of home sleep apnea testing. Next, the importance of economic perspective is discussed, with emphasis on cost containment and cost-shifting between payers, employers, providers, and patients. Specific recommendations are made for sleep medicine providers and the field at large to maximize the perceived value of sleep. Finally, alternate payment models and value-based care are presented, with an eye toward the future for clinical service providers as well as integrated health delivery networks.

Optimising the clinical strategy for autoimmune liver diseases: Principles of value-based medicine.

BACKGROUND: Autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis represent the three major autoimmune liver diseases (AILDs). Their management is highly specialized, requires a multidisciplinary approach and often relies on expensive, orphan drugs. Unfortunately, their treatment is often unsatisfactory, and the care pathway heterogeneous across different centers. Disease-specific clinical outcome indicators (COIs) able to evaluate the whole cycle of care are needed to assist both clinicians and administrators in improving quality and value of care. Aim of our study was to generate a set of COIs for the three AILDs. We then prospectively validated these indicators based on a series of consecutive patients recruited at three tertiary clinical centers in Lombardy, Italy. METHODS: In phase I using a Delphi method and a RAND 9-point appropriateness scale a set of COIs was generated. In phase II the indicators were applied in a real-life dataset. RESULTS: Two-hundred fourteen patients were enrolled and followed-up for a median time of 54months and the above COIs were recorded using a web-based electronic medical record program. The COIs were easy to collect in the clinical practice environment and their values compared well with the available natural history studies. CONCLUSIONS: We have generated a comprehensive set of COIs which sequentially capture different clinical outcome of the three AILDs explored. These indicators represent a critical tool to implement a value-based approach to patients with these conditions, to monitor, compare and improve quality through benchmarking of clinical performance and to assess the significance of novel drugs and technologies. This article is part of a Special Issue entitled: Cholangiocytes in Health and Diseaseedited by Jesus Banales, Marco Marzioni, Nicholas LaRusso and Peter Jansen.

Budget Impact of a Comprehensive Nutrition-Focused Quality Improvement Program for Malnourished Hospitalized Patients.

BACKGROUND: Nutrition interventions can alleviate the burden of malnutrition by improving patient outcomes; however, evidence on the economic impact of medical nutrition intervention remains limited. A previously published nutrition-focused quality improvement program targeting malnourished hospitalized patients showed that screening patients with a validated screening tool at admission, rapidly administering oral nutritional supplements, and educating patients on supplement adherence result in significant reductions in 30-day unplanned readmissions and hospital length of stay. OBJECTIVES: To assess the potential cost-savings associated with decreased 30-day readmissions and hospital length of stay in malnourished inpatients through a nutrition-focused quality improvement program using a web-based budget impact model, and to demonstrate the clinical and fiscal value of the intervention. METHODS: The reduction in readmission rate and length of stay for 1269 patients enrolled in the quality improvement program (between October 13, 2014, and April 2, 2015) were compared with the pre-quality improvement program baseline and validation cohorts (4611 patients vs 1319 patients, respectively) to calculate potential cost-savings as well as to inform the design of the budget impact model. Readmission rate and length-of-stay reductions were calculated by determining the change from baseline to post-quality improvement program as well as the difference between the validation cohort and the post-quality improvement program, respectively. RESULTS: As a result of improved health outcomes for the treated patients, the nutrition-focused quality improvement program led to a reduction in 30-day hospital readmissions and length of stay. The avoided hospital readmissions and reduced number of days in the hospital for the patients in the quality improvement program resulted in cost-savings of $1,902,933 versus the pre-quality improvement program baseline cohort, and $4,896,758 versus the pre-quality improvement program in the validation cohort. When these costs were assessed across the entire patient population enrolled in the quality improvement program, per-patient net savings of $1499 when using the baseline cohort as the comparator and savings per patient treated of $3858 when using the validated cohort as the comparator were achieved. CONCLUSION: The nutrition-focused quality improvement program reduced the per-patient healthcare costs by avoiding 30-day readmissions and through reduced length of hospital stay. These clinical and economic outcomes provide a rationale for merging patient care and financial modeling to advance the delivery of value-based medicine in a malnourished hospitalized population. The use of a novel web-based budget impact model supports the integration of comparative effectiveness analytics and healthcare resource management in the hospital setting to provide optimal quality of care at a reduced overall cost.