Cost-effectiveness of soluble beta-glucan gel in hard-to-heal wounds: an evaluation.

OBJECTIVE: To evaluate the cost-effectiveness of a soluble beta-glucan-containing gel as short-term adjunct therapy in the treatment of hard-to-heal wounds in a UK community health-care setting. METHODS: A comparative clinical evaluation involving consecutive patients treated for up to eight weeks with a beta-glucan-containing gel as adjunct to standard care. This was compared with consecutive patients as retrospective controls, and using the same standard care protocol from a year previously. The inclusion criteria was wounds that were slow-healing or stalled (<40% healing in four weeks). RESULTS: A total of 300 patients took part. Complete follow-up at 24 weeks was available for 144 patients in the beta-glucan group, and 136 patients in the standard care group. At 24 weeks, the beta-glucan group had a 96% healing rate compared with 75% in the standard care group (p<0.001). The improvement in healing was associated with a reduction in the mean number of weeks of treatment per patient (7.2 and 10.7 for beta-glucan and standard care, respectively), and a reduction in the mean cost of treatment (£576 versus £685 for beta-glucan and standard care, respectively). Treatment costs included nursing time, prescription medications and dressings. In a subset of ulcer wounds (50% of the full sample), at 24 weeks the beta-glucan group had a 92% healing rate compared with 46% in the standard care group (p<0.001). Mean weeks of treatment were 10.4 versus 17.6, leading to a reduction in treatment cost of £388 per patient (£1227 versus £839) over 24 weeks. CONCLUSION: The results of this evaluation suggest that short-term use of the beta-glucan gel as an adjunct to standard care on slow-healing wounds can shorten healing times and reduce NHS costs.

Assessment of clinical effectiveness of haemoglobin spray as adjunctive therapy in the treatment of sloughy wounds.

OBJECTIVE: To assess use of an adjunctive topical haemoglobin spray in the treatment of sloughy wounds. METHOD: In addition to a standard wound care regimen, consecutive patients with sloughy wounds self-administered haemoglobin spray treatment twice a week until the wound was healed. All patients were followed-up for 26 weeks. Results were compared with a retrospective cohort of 100 consecutive patients, treated during the same period the previous year with standard wound care alone. Data were collected on wound characteristics including percentage of slough, exudate levels, wound pain, and wound size. RESULTS: After 26 weeks, 94/100 patients (94%) treated with haemoglobin spray were completely healed compared with 63/100 control patients (63%). Positive results were evident as early as week one with 52% mean wound size reduction using the heamoglobin spray versus 11% in the retrospective control (p<0.001). At baseline, mean slough coverage was higher in the haemoglobin group, 58% versus 44% in the control group (p<0.001). By week four, mean slough coverage was 1% in the haemoglobin versus 29% in the control group (p<0.001). Reductions in exudate and pain levels (p<0.001) were also observed. CONCLUSION: Overall, results of this evaluation showed the addition of adjunctive haemoglobin spray to standard wound care treatment achieved positive clinical outcomes for patients self-managing complicated sloughy wounds, by supporting reduction of wound exudate and slough within the complex multifaceted process of wound healing.

In an era of highly effective treatment, hepatitis C screening of the United States general population should be considered.

BACKGROUND & AIMS: Hepatitis C virus (HCV) treatment with all oral direct acting antiviral agents (DAA's) achieve sustained virologic response (SVR) rates of 98%. Re-assessment of general US population screening for HCV is imperative. This study compared the cost-effectiveness (CE) of three HCV screening strategies: screen all (SA), screen Birth Cohort (BCS), and screen high risks (HRS). METHODS: Using a previous designed decision-analytic Markov model, estimations of the natural history of HCV and CE evaluation of the three HCV screening strategies over a lifetime horizon in the US population was undertaken. Based on age and risk status, 16 cohorts were modelled. Health states included: Fibrosis stages 0 to 4, decompensated cirrhosis, hepatocellular carcinoma, LT, post-LT, and death. The probability of liver disease progression was based on the presence or absence of virus. Treatment was with approved all-oral DAAs; 86% were assumed to be seen annually by a primary care provider; SVR rates, transition probabilities, utilities, and costs were from the literature. One-way sensitivity analyses tested the impact of key model drivers. RESULTS: SA cost $272.0 billion [$135 279 per patient] and led to 12.19 QALYs per patient. BCS and HRS cost $274.5 billion ($136 568 per patient) and $284.5 billion ($141 502 per patient) with 11.65 and 11.25 QALYs per patient respectively. Compared to BCS, SA led to an additional 0.54 QALYs per patient and saved $2.59 billion; compared to HRS, SA led to 0.95 additional QALYs per patient and saved $12.5 billion. CONCLUSIONS: Screening the entire US population and treating active viraemia was projected as cost-saving.

The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe.

Nonalcoholic fatty liver disease (NAFLD) is a major cause of chronic liver disease. There is uncertainty around the economic burden of NAFLD. We constructed a steady-state prevalence model to quantify this burden in the United States and Europe. Five models were constructed to estimate the burden of NAFLD in the United States and four European countries. Models were built using a series of interlinked Markov chains, each representing age increments of the NAFLD and the general populations. Incidence and remission rates were calculated by calibrating against real-world prevalence rates. The data were validated using a computerized disease model called DisMod II. NAFLD patients transitioned between nine health states (nonalcoholic fatty liver, nonalcoholic steatohepatitis [NASH], NASH-fibrosis, NASH-compensated cirrhosis, NASH-decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, post-liver transplant, and death). Transition probabilities were sourced from the literature and calibrated against real-world data. Utilities were obtained from NAFLD patients using the Short Form-6D. Costs were sourced from the literature and local fee schedules. In the United States, over 64 million people are projected to have NAFLD, with annual direct medical costs of about $103 billion ($1,613 per patient). In the Europe-4 countries (Germany, France, Italy, and United Kingdom), there are ∼52 million people with NAFLD with an annual cost of about €35 billion (from €354 to €1,163 per patient). Costs are highest in patients aged 45-65. The burden is significantly higher when societal costs are included. CONCLUSION: The analysis quantifies the enormity of the clinical and economic burdens of NAFLD, which will likely increase as the incidence of NAFLD continues to rise. (Hepatology 2016;64:1577-1586).

Self-care and postoperative dressing management.

As the increasing burden on healthcare costs continues to rise, posing clinical and financial challenges for all healthcare providers attempting to provide optimal, evidence-based wound care, the situation appears to be reaching the tipping point with regard to reduced resources, increasing patient groups with complex wounds and financial restraints. It is clearly time for action and new ways of working that include empowering patients and carers to take appropriate ownership within their personal wound-care journey. This observational evaluation explores 10 community-based patients presenting with postoperative acute surgical wounds; it examines and evaluates the patients' experience with regard to self-care satisfaction, Leukomed Control product satisfaction and actual traditional/personal costs incurred up to a 4-week period. The evaluation highlights not only an overall positive improvement within patient satisfaction and experience, alongside optimised wound progression and related cost savings, but also offers a valuable insight into the promotion and success of patients taking ownership of their wound-care journey.

Resource utilization and survival among Medicare patients with advanced liver disease.

BACKGROUND: The prevalence of advanced liver disease and its complications may be on the rise within the Medicare population. The study aim was trend assessment for prevalence, mortality and resource utilization of patients with advanced liver disease. METHODS: A retrospective, cross-sectional design was used to analyze a national sample of non-institutionalized Medicare in/outpatients from 2005 to 2009. Cases were ascertained by International Classification of Diseases, 9th Edition. Outcomes were overall mortality (within 1 year) and resource utilization [hospital length of stay (LOS/days) and institutional costs to Medicare]. Multivariate analyses were used to estimate the odds ratios for mortality predictors; linear regression was used for resource utilization predictors. RESULTS: A total of 21,913 beneficiaries with advanced liver disease were identified in the Medicare inpatient and outpatient administrative data sets from 2005 to 2009. Over 70 % of the beneficiaries with advanced liver disease died during study time period with 17 % dying while hospitalized. Predictors of mortality were: admission to the intensive care unit (ICU) and increasing Charlson Comorbidity Index. Predictors for increased LOS and cost were: ICU admission and having a thoracentesis procedure (both indicators of the levels of illness). CONCLUSIONS: Advanced liver disease and its related complication are increasing in the Medicare population and are associated with very high mortality. Further study is warranted to understand the drivers of the increased prevalence of advanced liver disease for earlier identification and treatment.

Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: the VALENCE study.

BACKGROUND & AIM: Interferon (IFN) negatively impacts patients' well-being and patient-reported outcomes (PROs). Our aim was to assess PROs during treatment with an IFN-free regimen [sofosbuvir (SOF)+ribavirin (RBV)]. METHODS: Four PRO questionnaires [Short Form-36 (SF-36), Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Index: Specific Health Problem (WPAI:SHP)] were administered at baseline, end-of-treatment and post-treatment to 334 HCV genotype 2 and 3 patients (naïve or treatment-experienced) enrolled in the VALENCE study. Of these, 250 genotype 3 patients were treated for 24 weeks while 73 genotype 2 and 11 genotype 3 patients received 12 weeks of treatment. RESULTS: Baseline PRO scores were similar between the two arms of the study. Throughout and after treatment, patients receiving 12 or 24 weeks had similar FACIT-F, CLDQ-HCV, SF-36 and WPAI:SHP scores (all p>0.05). Compared to their own baseline scores, patients receiving SOF+RBV experienced modest declines in some aspects of SF-36, CLDQ-HCV, fatigue and WPAI:SHP scores (p = 0.04 to <0.0001). By follow-up week 12, all PRO scores returned to the pre-treatment levels (p>0.05). In patients achieving SVR-12 (regardless of the regimen), significant improvements were noted in general health (p = 0.0004), CLDQ-HCV (p<0.0001), fatigue (p = 0.005), emotional well-being (p<0.0001) and physical component summary score of SF-36 (p = 0.0022). In multivariate analysis, baseline depression, fatigue, insomnia, cirrhosis, and treatment-related adverse events were the most consistent predictors of PRO impairment (all p<0.05). CONCLUSIONS: PROs are minimally impacted by SOF+RBV regimens. An additional 12 weeks of treatment does not substantially add to the PRO burden.

Impact of interferon free regimens on clinical and cost outcomes for chronic hepatitis C genotype 1 patients.

BACKGROUND & AIMS: Hepatitis C (HCV) is a common cause of chronic liver disease worldwide. Current standard treatment for genotype-1 patients uses a triple combination of pegylated-interferon alpha (IFN), ribavirin (RBV) and a direct-acting antiviral agent (DAA) with 75-80% sustained virologic response (SVR) rates. The aim is to determine cost-effectiveness of staging-guided vs. treat all HCV genotype-1 patients with interferon-based vs. interferon-free regimens. METHODS: A decision analytic Markov model simulating patients until death compared four strategies for treating HCV genotype-1: Triple therapy (IFN, RBV, DAA) with staging-guidance or treat all, and oral IFN-free regimen with staging-guidance or treat all. Strategies with staging initiated treatment at fibrosis stages F2-F4, with staging repeated every 5 years until age 70. The reference case was a treatment-naïve 50-year-old. Analysis was repeated for 50% increase in cost of oral therapy. Effectiveness was measured in quality-adjusted life years (QALYs). RESULTS: Treatment of all patients with oral IFN-free regimen was the most cost-effective strategy, with an ICER of $15,709/QALY at baseline cost of oral therapy. The ICER remained below $50,000/QALY in sensitivity analyses for baseline and +50% cost of oral therapy scenarios. The treat all strategy was also the most effective strategy; associated with the lowest risk of developing advanced liver disease. CONCLUSIONS: Treating all HCV patients with oral IFN-free regimen reduced the number of patients developing advanced liver disease and increased life expectancy. Additionally, IFN-free regimen without staging may be the most cost-effective approach for treating HCV genotype-1 patients. The efficacy and safety of these regimens must be confirmed using randomized clinical trials.

Patient disposition and long-term outcomes after valve surgery in octogenarians.

BACKGROUND: Valve surgery is performed routinely in octogenarians. This study explored variables affecting patient discharge disposition (home versus other facility) and whether patient disposition was related to long-term survival. METHODS: Patients 80 years or older who presented for aortic valve or mitral valve surgery from 2002 to 2010 were included. Baseline demographic, perioperative, and long-term outcomes were captured. Disposition was categorized into 2 groups; home (n=184) or other facility (n=123). The National Death Index and Social Security Death Index verified deaths. RESULTS: Mean age was 82.9±2.5; 46% (140 of 307) were female. Discharge location logistic regression, adjusted for gender (odds ratio [OR]=1.45, p=0.17) and European System for Cardiac Operative Risk Evaluation score (OR=1.09, p=0.10), predicted that older (OR=1.18, p<0.001), unmarried (OR=2.07, p=0.006) patients with at least 1 major complication (OR=3.86, p<0.001) were more likely to be not discharged home. Kaplan-Meier analysis found significantly lower 1- and 2-year (85.8% vs 94.6%, p=0.009; 80.1% vs 90.3%, respectively, p=0.01) cumulative survival in patients not discharged home. A multivariate Cox proportional hazards model demonstrated poorer 1- and 2-year survival (hazard ratio [HR]=2.56, p=0.04; HR=2.06, p=0.05, respectively). Predictors of follow-up mortality for patients not discharged home were length of stay (OR=1.06, p=0.03) and any major complication (OR=6.90, p=0.002); lower body mass index was marginally significant (OR=1.12, p=0.06). The significant predictor for patients discharged home was length of stay (OR=1.17, p=0.002). CONCLUSIONS: Octogenarians can expect excellent survival after valve surgery. Those not discharged home had poorer long-term survival. Therefore, adequate resources should be secured so sicker patients receive the appropriate level of care.

Performance of four risk algorithms in predicting intermediate survival in patients undergoing aortic valve replacement.

OBJECTIVE: : Several risk models exist to predict operative outcomes after cardiac surgery and are used in selecting patients for alternative procedures such as transcatheter valve implantation. We sought to evaluate the performance of the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) model in accurately identifying patients at high risk for aortic valve replacement (AVR). METHODS: : Three hundred and ninety four consecutive patients who underwent isolated AVR from January 1, 2001, to July 1, 2007, at a tertiary care center were analyzed using the STS database. Patients were stratified into tertiles according to operative surgical risk calculated by the four models [STS-PROM, European system for cardiac operative risk evaluation (EuroSCORE), Ambler, and Providence]. Vital status at 1 year was determined using the National Death Index and Social Security Death Index. RESULTS: : There were 310 low-risk patients, 56 intermediate-risk patients, and 28 high-risk patients with respect to the STS-PROM. The predicted risk of death for the low-risk, intermediate-risk, and high-risk groups were 2.4% ± 1.1%, 6.9% ± 1.4%, 15.8% ± 7.6% (P < 0.001) with respect to the STS-PROM model. Actual operative mortality for each respective group was 1.94%, 5.36%, 14.29% (P < 0.001) and 1-year mortality was 3.23%, 12.50%, 21.43% (P < 0.001), respectively. CONCLUSIONS: : High-risk patients have significantly high mortality after AVR. The STS-PROM accurately predicts operative mortality and can be used to predict 1-year survival as well. This risk model may be preferentially used instead of the EuroSCORE.

The effect of previous coronary artery stenting on short- and intermediate-term outcome after surgical revascularization in patients with diabetes mellitus.

OBJECTIVES: Percutaneous intervention for coronary revascularization is associated with an increased risk of repeat revascularization, especially in patients with diabetes mellitus. In this study we sought to examine the effect of previous percutaneous intervention on the rate of adverse perioperative outcome and intermediate-term survival in patients undergoing coronary artery bypass surgery. METHODS: Between January 1, 2001, and December 31, 2006, 1758 consecutive patients with diabetes mellitus who underwent first-time isolated coronary artery bypass surgery were identified. Survival and major perioperative complications for 1537 patients who did not have prior percutaneous intervention (group 1) were compared with those in 221 patients with prior percutaneous intervention (group 2) after adjusting for baseline risk factors. Vital status was determined by using the National Death Index and Social Security Death Index. Age-adjusted survival at 2 years' follow-up was calculated with the Cox singular proportional hazards model. RESULTS: At baseline, group 2 patients had higher incidences of hypercholesterolemia and myocardial infarction. Compared with group 1 patient, group 2 patients had significantly higher operative mortality (adjusted odds ratio, 4.05; 95% confidence interval, 1.41-11.63), perioperative major adverse cardiac events (adjusted odds ratio, 2.72; 95% confidence interval, 1.08-6.85), and atrial fibrillation (adjusted odds ratio, 1.97; 95% confidence interval, 1.29-3.01). Group 2 patients had worse age-adjusted survival at 2 years' follow-up (93.4% vs 87.4%, P < .017). CONCLUSIONS: Patients with diabetes mellitus and a history of percutaneous coronary stenting before coronary artery bypass surgery were found to have an increased risk of operative death, increased perioperative complications, and decreased age-adjusted survival at 2 years' follow-up.

Comparison of outcomes and cost for endometrial cancer staging via traditional laparotomy, standard laparoscopy and robotic techniques.

OBJECTIVES: The study purpose was to compare hysterectomy and lymphadenectomy completed via robotic assistance, laparotomy, and laparoscopy for endometrial cancer staging with respect to operative and peri-operative outcomes, complications, adequacy of staging, and cost. METHODS: One hundred and ten patients underwent hysterectomy with bilateral salpingo-oophorectomy, pelvic and para-aortic lymphadenectomy for endometrial cancer staging. All cases were performed by a single surgeon, at a single institution (40 robotic, 40 laparotomy, and 30 laparoscopic) and were retrospectively reviewed to compare demographics and peri-operative variables including, operative time, estimated blood loss, lymph node count, hospital stay, complications, and return to normal activity. Additionally, a cost comparison between all three modalities was performed. RESULTS: Patients undergoing robotic assisted hysterectomy and staging experienced longer operative time than the laparotomy cohort with no difference in comparison to the laparoscopic cohort (184 min, 108.6 min, 171 min, p<0.0001, p=0.14). Estimated blood loss was significantly reduced for the robotic cohort in comparison to the laparotomy cohort and comparable to laparoscopic cohort (166 cc, 316 cc, 253 cc, p=0.01, p=0.25). The complication rate was lowest in the robotic cohort (7.5%) relative to the laparotomy (27.5%) and laparoscopic cohorts (20%) (p=0.015, p=0.03). Average return to normal activity for the robotic patients was significantly shorter than those undergoing laparotomy (24.1 days versus 52 days, p<0.0001) and those undergoing laparoscopy (31.6 days, p=0.005). Lymph node retrieval did not differ between the 3 groups (robotic 17 nodes, laparotomy 14 nodes, laparoscopic 17 nodes). The total average cost for hysterectomy with staging completed via laparotomy was $12,943.60, for standard laparoscopy $7569.80, and for robotic assistance $8212.00. The difference in cost between laparotomy and robotic cohorts was significant p=0.0001 while there was no statistically significant difference in cost between laparoscopy and robotic cohorts p=0.06. CONCLUSIONS: Robotic hysterectomy provides comparable node retrieval to laparotomy and laparoscopic procedures in the case of the experienced laparoscopic surgeon. While robotic hysterectomy takes longer to perform than hysterectomy completed via laparotomy, it is equivalent to laparoscopic hysterectomy and provides the patient with a more expeditious return to normal activity with reduced post-operative morbidity. Additionally, the average cost for hysterectomy and staging was highest for laparotomy, followed by robotic, and least for standard laparoscopy.

Survival and quality of life following elective open-heart surgery.

Eight hundred thirty-six patients who had open-heart surgery were available for analysis of health-related quality of life (HRQL) data and survival at the 1-year follow-up. Elective open-heart surgery patients with decreasing HRQL at 1 year following surgery may experience a survival disadvantage in comparison with those patients experiencing positive gains. Clinical care should extend beyond the immediate postoperative period.

Mobilizing communities for teen pregnancy prevention: associations between coalition characteristics and perceived accomplishments.

PURPOSE: To describe coalition membership, examine associations between coalition processes and short-term coalition outcomes, and assess the relative contribution of key coalition processes to perceived accomplishments in teen pregnancy prevention coalitions. METHODS: A self-administered survey was distributed to active members of 21 teen pregnancy prevention coalitions in 13 communities. The overall response rate was 67%, with 471 surveys returned. Process measures included staff competence, member influence in decision making, and coalition functioning. Short-term outcome measures included perceived accomplishments, member satisfaction, member participation, and coalition viability. RESULTS: About 50% of coalition members represented health or teen pregnancy prevention or youth development service organizations, with 13% participating primarily as residents or youth. None of the process measures were associated with coalition viability (defined as active 2 years post-survey). Many bivariate associations between coalition processes and other short-term outcomes were significant at the individual and coalition levels of analysis. In a multivariate random coefficients model, coalition functioning (p <.001) and member influence in decision making (p = .019) were significantly associated with perceived coalition accomplishments. CONCLUSION: Consistent with research on coalitions that have addressed other health issues, good coalition processes were associated with short-term indicators of effectiveness in these teen pregnancy prevention coalitions. Coalition processes were not associated with coalition viability 2 years post-survey, however, suggesting that other factors influence coalition survival.

The economic implications of noninvasive molecular testing for cardiac allograft rejection.

Endomyocardial biopsy is the mainstay for monitoring cardiac allograft rejection. A noninvasive strategy--peripheral blood gene expression profiling of circulating leukocytes--is an alternative with proven benefits, but unclear economic implications. Financial data were obtained from five cardiac transplant centers. An economic evaluation was conducted to compare the costs of outpatient biopsy with those of a noninvasive approach to monitoring cardiac allograft rejection. Hospital outpatient biopsy costs averaged 3297 US dollars, excluding reimbursement for professional fees. Costs to Medicare and private payers averaged 3581 US dollars and 4140 US dollars, respectively. A noninvasive monitoring test can reduce biopsy utilization. The savings to health care payers in the United States can be conservatively estimated at approximately 12.0 million US dollars annually. Molecular testing using gene expression profiling of peripheral circulating leukocytes is a new technology that offers physicians a noninvasive, less expensive alternative to endomyocardial biopsy for monitoring allograft rejection in cardiac transplant patients.