Cost-Effectiveness of Vioptix versus Clinical Examination for Flap Monitoring of Autologous Free Tissue Breast Reconstruction.

BACKGROUND: Vioptix is a near-infrared spectroscopy tissue oximetry technology that allows for noninvasive monitoring of flap perfusion. Despite the reported benefits of Vioptix, the cost-effectiveness of this flap monitoring technology has not been compared to clinical examination alone. METHODS: A cost-effectiveness model, from the patient perspective, was constructed with two treatment arms: clinical examination versus clinical examination combined with Vioptix for flap monitoring after autologous, free flap breast reconstruction. Costs, utilities, and other model inputs were identified from the literature. One-way and probabilistic sensitivity analyses were performed. Gamma distributions were created for cost variables, and beta distributions were created for probability variables. An incremental cost-effectiveness ratio under $50,000 per quality-adjusted life-year (QALY) was considered cost-effective. All analyses were performed using TreeAge Pro (Williamstown, Mass.). RESULTS: Mean cost of autologous free tissue transfer breast reconstruction with clinical examination-based flap monitoring was found to be $37,561 with an effectiveness of 0.79, whereas the mean cost of clinical examination with Vioptix for flap monitoring was $39,361 with effectiveness of 0.82. This yielded an incremental cost-effectiveness ratio of $60,507 for clinical examination combined with Vioptix for flap monitoring. One-way sensitivity analysis revealed that clinical examination with Vioptix became cost-effective when the cost of Vioptix was less than $1487. Probabilistic sensitivity analysis found that clinical examination was cost-effective in 86.5 percent of cases. CONCLUSION: Although clinical examination combined with Vioptix is minimally more effective for flap monitoring after autologous, free flap breast reconstruction, clinical examination alone is the more cost-effective flap monitoring option.

Cost-Effectiveness of Pain Management Strategies in Advanced Cancer.

OBJECTIVES: Uncontrolled pain in advanced cancer is a common problem and has significant impact on individuals' quality of life and use of healthcare resources. Interventions to help manage pain at the end of life are available, but there is limited economic evidence to support their wider implementation. We conducted a case study economic evaluation of two pain self-management interventions (PainCheck and Tackling Cancer Pain Toolkit [TCPT]) compared with usual care. METHODS: We generated a decision-analytic model to facilitate the evaluation. This modelled the survival of individuals at the end of life as they moved through pain severity categories. Intervention effectiveness was based on published meta-analyses results. The evaluation was conducted from the perspective of the U.K. health service provider and reported cost per quality-adjusted life-year (QALY). RESULTS: PainCheck and TCPT were cheaper (respective incremental costs -GBP148 [-EUR168.53] and -GBP474 [-EUR539.74]) and more effective (respective incremental QALYs of 0.010 and 0.013) than usual care. There was a 65 percent and 99.5 percent chance of cost-effectiveness for PainCheck and TCPT, respectively. Results were relatively robust to sensitivity analyses. The most important driver of cost-effectiveness was level of pain reduction (intervention effectiveness). Although cost savings were modest per patient, these were considerable when accounting for the number of potential intervention beneficiaries. CONCLUSIONS: Educational and monitoring/feedback interventions have the potential to be cost-effective. Economic evaluations based on estimates of effectiveness from published meta-analyses and using a decision modeling approach can support commissioning decisions and implementation of pain management strategies.

Cost-effectiveness of obstructive sleep apnea screening for patients with diabetes or chronic kidney disease.

PURPOSE: Obstructive sleep apnea (OSA) is a common disorder with a high prevalence among patients with cardiovascular disease (CVD), diabetes, and chronic kidney disease (CKD). Routine evaluation of OSA for patients with CVD including hypertension has been performed according to the clinical guidelines for both OSA and CVD. However, most patients with diabetes and CKD who could benefit from treatment remain undiagnosed because routine screening of OSA is not recognized as part of standard practice. This study aims to evaluate the cost-effectiveness of OSA screening for patients with diabetes and CKD. METHODS: Cost-effectiveness analysis by a decision tree and Markov modeling from the societal perspective in Japan was carried out to provide evidence based on the economic evaluation of current clinical practice concerning diabetes and CKD. RESULTS: Incremental cost-effectiveness ratios of OSA screening compared with do-nothing were calculated as ¥3,516,976 to 4,514,813/quality-adjusted life year (QALY) (US$35,170 to 45,148/QALY) for diabetes patients and ¥3,666,946 to 4,006,866/QALY (US$36,669 to 40,069/QALY) for CKD patients. CONCLUSIONS: Taking the threshold to judge cost-effectiveness according to a suggested value of social willingness to pay for one QALY gain in Japan as ¥5 million/QALY (US$50,000QALY), OSA screening is cost-effective. Our results suggest that active case screening and treatment of OSA for untreated middle-aged male patients with diabetes or CKD could be justifiable as an efficient use of finite health-care resources in the world with high prevalence of these diseases.

The challenge of undiagnosed sleep apnea in low-risk populations: a decision analysis.

OBJECTIVES: Obstructive sleep apnea (OSA) may contribute to impaired performance among otherwise healthy active duty military personnel. We used decision analysis to evaluate three approaches to identifying and treating OSA in low-risk populations, which may differ from current standard practice for high-risk populations. METHODS: We developed a decision tree to compare two simple strategies for diagnosis and management of sleep apnea in a low-risk population. In one strategy, a simple screening inventory was followed by conventional laboratory polysomnography (split-night), whereas the alternative strategy involved performing home testing in all individuals. This allowed us to weigh the costs associated with large-scale diagnostic approaches against the costs of untreated OSA in a small fraction of the population. RESULTS: We found that the home testing approach was less expensive than the screen-then-test approach across a broad range of other important parameters, including the annual performance cost associated with untreated OSA, the prevalence of OSA, and the duration of active duty. CONCLUSIONS: Assuming even modest annual performance costs associated with untreated OSA, a population strategy involving large-scale home testing is less expensive than a screening inventory approach. These results may inform either targeted or large-scale investigation of undiagnosed OSA in low-risk populations such as active duty military.

The use of ambulatory strategies for the diagnosis and treatment of obstructive sleep apnea in adults.

Obstructive sleep apnea (OSA) is a highly prevalent disorder associated with complications such as arterial hypertension, coronary heart disease, cerebrovascular disease and traffic accidents. Patients with untreated OSA consume more financial and healthcare resources and have higher mortality than those treated properly. The resources allocated for OSA are insufficient in some countries for such a prevalent disorder. This has given rise to a significant public health problem and a search for alternative strategies based on the ambulatory management. In the diagnostic process, portable monitors have been evaluated. Continuous positive airway pressure is the most effective treatment in OSA, but other forms of treatments have also been used (weight loss, oral appliances, surgery and so on). Ambulatory monitoring of the therapeutic modalities has been evaluated to enhance the care process and reduce costs compared with the conventional approach, without sacrificing efficiency. This review aims to highlight the most important advances in this field, analyzing the results of the main works to date, in order to assess the current situation and future research needs.

Improving outcomes and lowering costs by applying advanced models of in-home care.

With advances in monitoring and telemedicine, the complexity of care administered in the home to properly selected patients can approach that delivered in the hospital. The challenges include making sure that qualified personnel regularly visit the patient at home, both individually and in teams; information is accurately communicated among the caregiver teams across venues and over time; and patients understand the information communicated to them by providers. Despite these challenges, the benefits of treating chronically or terminally ill patients at home are significant. Among the most important are improved patient satisfaction and reduced cost. Numerous studies have shown that most patients prefer to spend their convalescence or their last days at home. The financial benefits of enabling patients to recover or to die at home are significant.

A critical appraisal on the utility of long-term video-EEG monitoring in older adults.

BACKGROUND: World-over, the majority of patients undergoing video-EEG monitoring (VEM) are in their second or third decades. Although elderly represent the fastest growing segment of population with epilepsy, only few of them undergo VEM. We critically evaluated the utility of VEM in the diagnosis and long-term management of older adults with paroxysmal behavioral events. METHODS: 148 consecutive patients aged 45 and above, who underwent long-term (≥8 h) inpatient VEM from 1996 to 2009 formed the study cohort. Utilizing a structured proforma, we gathered their demographic, clinical, electrophysiological and long-term outcome data. VEM was considered as "useful" when it changed the diagnosis and/or management; it was "corroborative" when it helped the treating physician to confirm the diagnosis and "not useful" when it neither helped to improve the diagnosis nor the management. RESULTS: The mean age was 51.3 (SD 6.4) years; mean duration of VEM was 69.3 h. Out of 117 patients with a diagnosis of epileptic seizures referred for presurgical evaluation or classification, VEM was "useful" or "corroborative" in 111 patients (94.8%; p=0.0001). It was also "useful" or "corroborative" in 29 out of 31 patients (93.5%) referred with a suspicion of associated or pure psychogenic non-epileptic seizures (p=0.0001). None developed any complications during monitoring. At a mean follow-up of 37.7 months there was significant reduction in AED usage in patients with epilepsy (p=0.0001) and epilepsy with associated PNES (p=0.001). At a mean follow-up of 34.2 months, all patients with pure PNES were event-free and medication-free at last follow-up (p=0.002). Twenty-three patients (19.6%) underwent surgery, all except one remaining seizure-free at a mean follow-up of 39.2 months. CONCLUSIONS: VEM is a safe and cost-effective investigation strategy in older-adults. It aided in improving the diagnosis, offered better treatment including surgery and helped in excluding non-epileptic paroxysmal events in majority.

[Health economical aspects of telemedical glaucoma monitoring]. / Gesundheitsökonomische Aspekte des telematischen Glaukom-Monitorings.

BACKGROUND: Telemedical home monitoring of glaucoma patients is not covered by health insurance in Germany. Various clinical studies have indicated that 24 h monitoring of intraocular and blood pressure of glaucoma patients allows a better evaluation of the individual disease condition. If the necessary parameters can be collected with telemedical home monitoring it will be possible to reduce the number of 24 h intraocular pressure profiles which necessitate hospital admission. Therefore inpatient 24 h profiles have been chosen as a health economical allocation base with a presentable economical value for the comparative examination. Assuming an at least identical or even higher clinical outcome of the telemedical glaucoma home monitoring inpatient 24 h profiles were chosen as a health economical allocation base to compare and contrast these methods. METHODS: All procedures of the inpatient 24 h profiles at the ophthalmic clinic of Greifswald were measured using the stopwatch method. In a 1 day test run all activities of the medical staff were identified and documented in a list and afterwards measurements were carried out over 7 days with several stopwatches to allow the documentation of parallel activities. To determine the consumption of resources in telemedical home monitoring the self-documentation of all employees involved in the research project TT-MV were evaluated. Expert interviews helped to determine the economically relevant data about the applied medical technology, e.g. measuring devices, server and electronic health records. RESULTS: The number and complexity of the subprocesses of the inpatient 24 h intraocular pressure profiles were significantly higher compared to telemedical home monitoring. The total costs of the inpatient 24 h profiles were 571.21 € per patient including 291.21 € for medical care and 280 € for accommodation. In contrast the total costs of telemedical home monitoring were 288.72 € per patient. A direct cost comparison shows that telemedical home monitoring resulted in lower costs compared to hospital admission of glaucoma patients. CONCLUSION: Telemedical home monitoring of glaucoma patients is not only effective but also cost-efficient. As modern health care systems have to consider cost efficiency, a randomized, controlled longitudinal clinical study of both methods would be required.

Telemedicine: what more is needed for its integration in everyday life?

The Health Authorities have huge expectations of telemedicine (TM): improved patient access to healthcare, a solution to the shortage of doctors in the face of an exponentially expanding disease, and reduced healthcare costs with improved quality. There are a host of applications for TM in the area of diabetes. TM has been validated and has been widely used to screen for diabetic retinopathy, and a number of studies are currently underway for the follow-up of diabetic foot ulcers. However, the main indication of TM remains the follow-up and control of blood glucose. In this area, many studies have been conducted to improve glycaemic control. While most of these studies have failed to show any benefits vs. conventional care, a small number have demonstrated great efficacy of this approach with regard to glycaemia. Using these studies, we attempt to define the key qualities of a successful TM system. How can we extend the results of these experiments beyond the framework of clinical studies and integrate them in daily practice so as to improve diabetes management? This is the key challenge for TM, implementation of which will require reorganization of healthcare, given the evolution of medical demographics. This reorganization will involve healthcare providers specialized in diabetes that may intervene in assigning physicians for especially distressed patients. However, such reorganization will require medico-economic evaluation before it can be implemented on a larger scale.

[Facing the challenges of ubiquitous computing in the health care sector]. / Herausforderungen durch ubiquitäres Computing im Gesundheitsbereich.

The steady progress of microelectronics, communications and information technology will enable the realisation of the vision for "ubiquitous computing" where the Internet extends into the real world embracing everyday objects. The necessary technical basis is already in place. Due to their diminishing size, constantly falling price and declining energy consumption, processors, communications modules and sensors are being increasingly integrated into everyday objects today. This development is opening up huge opportunities for both the economy and individuals. In the present paper we discuss possible applications, but also technical, social and economic barriers to a wide-spread use of ubiquitous computing in the health care sector.

Cost effectiveness analysis of using multiple neuromodalities in treating severe traumatic brain injury in a developing country like Malaysia.

OBJECTIVE: The aim of this study was to determine the cost-effectiveness of using baseline neuromonitoring (BNM) compared with multimodality monitoring (M3) for severe traumatic brain injury (TBI). METHODS: Sixty-two patients with severe TBI underwent a prospective observational study where they were divided into two groups of patients receiving treatment with M3 (32 patients) and BNM (30 patients). The macro and micro costings were performed on each patient. The Barthel Index score after 1 year was used as an outcome measurement tool for both groups. The cost-effectiveness (CE) ratio was calculated using the Poisson regression model. RESULTS: The costs of equipment and consumables between the groups was statistically significant (p < 0.001) after correcting for age and severity of injury. Other cost categories were not significantly different. The crude CE ratios were 168.66 (95% CI: 168.32, 169.03) and 144.16 (95% CI: 143.87, 144.45) for BNM and M3 respectively. The two crude CE ratios were significantly different (p < 0.001). It was calculated by controlling or adjusting age, gender, Glasgow Coma Score, Marshalls classification at admission and type of injury. The adjusted CE ratios were 171.32 (95% CI: 170.97, 171.68) and 141.50 (95% CI: 141.26, 141.79) for BNM and M3, respectively. The two adjusted CE ratios were significantly different ( p< 0.001). CONCLUSION: The application of M3 for severe TBI was more cost-effective than BNM. All calculations were made at 3.8 Malaysian Ringgit (MYR) to the United States dollar (USD).

Selective use of esophageal manometry and 24-Hour pH monitoring before laparoscopic fundoplication.

BACKGROUND: Preoperative esophageal manometry and 24-hour pH monitoring commonly are used in preoperative evaluation of patients undergoing fundoplication. Here we review our experience with the selective preoperative workup of patients undergoing fundoplication to treat gastroesophageal reflux disease. STUDY DESIGN: A series of 628 consecutive antireflux procedures was reviewed. History and physical examination, upper endoscopy, and upper gastrointestinal videofluoroscopy were obtained preoperatively on all patients; the first 30 patients also underwent esophageal manometry and pH monitoring (routine evaluation group). Thereafter, pH monitoring only was performed for atypical reflux symptoms, and manometry only was performed for a history of dysphagia, odynophagia, or for abnormal motility on videofluoroscopy (selective evaluation group). All patients underwent a laparoscopic floppy Nissen fundoplication, and then endoscopy and fluoroscopy at 3 months and 12 months postoperatively. RESULTS: Eighty-five of the patients in the selective evaluation group (14%) required manometry, and 88 (15%) underwent pH monitoring. Eighteen of the 115 patients who underwent manometry (16%) had evidence of dysmotility. None of these 18 patients had increased dysphagia postoperatively; 8 of 18 reported improvement with swallowing. Five patients in the selective group (0.8%) had persistent postoperative dysphagia caused by technical error (four patients) or with no identifiable cause (one patient). The estimated charge or collection reduction with use of the selective evaluation was 1,253,100 US dollars or 395,000 US dollars, respectively. CONCLUSIONS: Selective use of manometry and pH monitoring was cost effective and safe in this series. Although esophageal manometry and 24-hour pH monitoring might be necessary with abnormal findings on videofluoroscopy or atypical symptoms, in our experience, their routine use is not essential in preoperative evaluation of patients undergoing fundoplication for gastroesophageal reflux disease.

Assessment of a low-cost home monitoring spirometer for children.

Electronic devices are now available to measure and store lung function parameters in the home. Before adopting a device for clinical or research use, it is important to validate it in the target patient group. The aim of this study was to assess a low-cost, portable, logging spirometer, the VM Plus (VM), against a standard laboratory Jaeger spirometer (JS) for use in children with respiratory disease. Seventy children with stable asthma or cystic fibrosis performed spirometry on the two devices, and results for peak expiratory flow (PEF) and forced expiratory volume in 1 sec (FEV(1)) were compared. Comparison was made both using the two devices separately (separate method) and with the devices connected in series (series method). Reproducibility of the VM measurements was also assessed. Correlation between measurements was close (R values: separate, PEF, 0.91; FEV(1), 0.94; series, PEF, 0.97, FEV(1), 0.99), but PEF readings on the VM Plus were substantially higher than with the JS (mean difference: separate, 54.8 L/min; series, 28.2 L/min). This reflects well-reported differences in PEF measurements between the Mini-Wright PEF meter, on which the VM Plus spirometer is based, and conventional spirometers. Limits of agreement (series method) were: PEF, -13.2 to +69.6 L/min; FEV(1), -0.03 to +0.19 L. Reproducibility of VM Plus measurements was acceptable: coefficient of variation for PEF was 4%; for FEV(1), 4.3%; coefficient of reproducibility for PEF, 39 L/min; for FEV(1), 0.26 L. The VM Plus provides reasonably accurate, reproducible measurements of PEF and FEV(1), but intrinsic bias, particularly in PEF measurement, needs to be taken into account. Its potential to document longitudinal changes in lung function in children with respiratory disease at home merits further study.

Outcomes of laparoscopic antireflux procedures.

BACKGROUND: Laparoscopy has increased the number of patients undergoing operative correction of gastroesophageal reflux disease (GERD). Symptom improvement has been most commonly reported as the means to assess operative outcome. We compared symptomatic outcome to postoperative pH testing at short-term follow-up to determine the accuracy of clinical assessment at predicting whether acid exposure would be normal or abnormal. METHODS: Of 640 patients who had antireflux surgery between 1993 and 1999, 228 (36%) agreed to repeat manometry and 24-hour pH monitoring 8 to 12 weeks postoperatively and are the subject of this study. Symptom resolution was assumed if the frequency was less than once per week. Normal acid exposure consisted of a distal esophageal pH below 4 less than 4% of the time and a DeMeester composite score less than 14.7. Accuracy of symptom scoring was calculated using acid exposure as the standard. RESULTS: The primary symptom was improved in 93% of the 228 patients. Acid exposure was reduced from a preoperative DeMeester score of 71 to 16 (P <0.05). Eighty percent of patients had normalization of acid exposure postoperatively. Heartburn was the only symptom to have a significant correlation with acid exposure in the postoperative period (P <0.05). Heartburn resolved in 181 patients, 168 of whom had normal acid exposure (true negative). Thirty-eight patients without symptoms had abnormal acid exposure (false negative). Nine patients had persistent heartburn with abnormal acid exposure (true positive) whereas 13 patients had persistent heartburn with normal acid exposure (false positive). Thus, the positive predictive value of heartburn was 43%, the negative predictive value was 82%, and the overall accuracy was 78%. CONCLUSIONS: Operative treatment improves both the symptoms of GERD and the degree of acid exposure as measured by pH monitoring. The most accurate symptom for predicting acid exposure in the postoperative period is heartburn. Although the absence of heartburn postopertively is fairly reliable at predicting normal acid exposure on pH testing, the presence of heartburn warrants postoperative pH monitoring, as more than half of these patients will have normal acid exposure.

Five-year audit of ambulatory 24-hour esophageal pH-manometry in clinical practice.

BACKGROUND: Esophageal function testing was developed to aid diagnosis in patients with negative endoscopy. Although combined 24-h esophageal pH-manometry is now commercially available, its routine clinical effectiveness has not yet been studied. METHODS: From 1992 to 1996 we evaluated 303 consecutive patients who were first-time referrals to our unit for 24-h esophageal pH-manometry. The referral indications were gastroesophageal reflux disease, 47.2%; dysphagia, 18.5%; non-cardiac chest pain, 14.9%; connective tissue disease, 13.2%; and symptomatic patients after antireflux surgery, 6.3%. RESULTS: Overall, esophageal function testing altered the diagnosis of 44% of the patients, confirmed it in 38%, and specifically changed the management of 66%. The final clinical 'diagnosis' was reflux disease, 54% (32% with non-specific esophageal motility disorder); connective tissue disease, 9.9%; achalasia, 9.6%; other specific esophageal motility disorders, 3.3%; non-specific esophageal motility disorders, 6.9%; and normal, 16.2%. The cost per testing was estimated to be US$305 and per change in management US$465. CONCLUSION: Combined 24-h pH-manometry has been shown to be a useful and cost-effective test for the management of selected patients in whom the primary investigation was insufficient.

Identification of obstructive sleep apnea in patients who snore.

As the field of sleep medicine has evolved, the clinical implications of obstructive sleep apnea (OSA) in snoring patients have become well accepted. Recent advances in surgical therapy for snoring allow otolaryngologists to offer simple outpatient treatment to patients with this problem. However, because the incidence of OSA in snorers seeking medical attention is unknown, the appropriate pretreatment evaluation of these patients is a subject of continued debate. Ninety-four snoring patients were recruited for a study to determine the incidence of OSA in this highly selected population. Subjects answered an extensive sleep questionnaire to determine factors that might suggest a diagnosis of OSA. Level III ambulatory sleep studies were performed on each participant. The incidence of OSA in this group was 72% (42% severe and 30% mild to moderate). Twenty of the subjects with OSA also underwent formal level I sleep studies, and the diagnosis of OSA was confirmed in each instance. Although there was a relationship between body mass index and OSA and certain questions correlated with OSA, the sensitivity and specificity of these data alone or in combination were too low to recommend their use in lieu of a formal sleep study. Given the remarkably high incidence of OSA in this group, which may reflect that seen by otolaryngologists who treat snoring, a sleep study should be performed to diagnose OSA and institute therapy for this condition. Level III ambulatory monitoring devices may be the most cost-effective alternative for evaluating this high-risk population.