A 4-year randomized trial comparing three outreach interventions to promote screening mammograms.

As population health has become a focus of health care payers and providers, interest has grown in mail, phone, and other forms of outreach for improving population rates of cancer screening. Translational research is needed to compare the effectiveness and cost of low- and high-intensity behavioral outreach interventions for promoting cancer screening. The purpose of the article is to compare the effectiveness in promoting biannual mammograms of three interventions delivered over 4 years to a primary care population with a high baseline mammography adherence of 83.3%. We randomized women aged 40-84 to reminder letter only (LO arm), letter + reminder call (RC arm), and two letters + counseling call (CC arm) involving tailored education and motivational interviewing. Mammography adherence (≥1 mammogram in the previous 24 months) at four time points was determined from insurance claims records. Over 4 years, 30,162 women were randomized. At the end of 4 years, adherence was highest in the RC arm (83.0%) compared with CC (80.8%) and LO (80.8%) arms (p = .03). Only 23.5% of women in the CC arm were reached and accepted full counseling. The incremental cost per additional mammogram for RC arm women was $30.45 over the LO arm cost. A simple reminder call can increase screening mammogram adherence even when baseline adherence is high. Some more complex behavioral interventions delivered by mail and phone as in this study may be less effective, due to limited participation of patients, a focus on ambivalence, lack of follow-up, and other factors.

Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial.

BACKGROUND: Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition. The National Institute for Health and Clinical Excellence (NICE) recommends Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because there is good evidence that it is effective. Despite this, most young people in the UK are unable to access local specialist CBT for CFS/ME. A randomised controlled trial (RCT) showed FITNET was effective in the Netherlands but we do not know if it is effective in the National Health Service (NHS) or if it is cost-effective. This trial will investigate whether FITNET-NHS is clinically effective and cost-effective in the NHS. METHODS: Seven hundred and thirty-four paediatric patients (aged 11-17 years) with CFS/ ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (delivered via video call). The internal pilot study will use integrated qualitative methods to examine the feasibility of recruitment and the acceptability of treatment. The full trial will assess whether FITNET-NHS is clinically effective and cost-effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS (Physical Function Scale) questionnaire. Cost-effectiveness is measured via cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders. DISCUSSION: If FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions. TRIAL REGISTRATION: ISRCTN registry, registration number: ISRCTN18020851 . Registered on 4 August 2016.

The Methodological Quality and Effectiveness of Technology-Based Smoking Cessation Interventions for Disadvantaged Groups: A Systematic Review and Meta-analysis.

Aims: To assess the methodological quality and effectiveness of technology-based smoking cessation interventions in disadvantaged groups. Method: Four databases (EMBASE, Cochrane, Medline, and PsycInfo) were searched for studies conducted from 1980 to May 2016. Randomized controlled trials that compared a behavioral smoking cessation intervention delivered primarily through a technology-based platform (eg, mobile phone) with a no-intervention comparison group among disadvantaged smokers were included. Three reviewers assessed all relevant studies for inclusion, and one reviewer extracted study, participant and intervention-level data, with a subset crosschecked by a second reviewer. Results: Thirteen studies targeting disadvantaged smokers (n =4820) were included. Only one study scored highly in terms of methodological rigor on EPOC criteria for judging risk of bias. Of the 13 studies using a technology-based platform, most utilized websites (n = 5) or computer programs (n = 5), and seven additionally offered nicotine replacement therapy. Technology-based interventions increased the odds of smoking cessation for disadvantaged groups at 1 month (odds ratio [OR] 1.70, 95% confidence interval [CI] 1.10, 2.63), 3 months (OR 1.30, 95% CI 1.07, 1.59), 6 months (OR 1.29, 95% CI 1.03, 1.62), and 18 months post-intervention (OR 1.83, 95% CI 1.11, 3.01). Conclusion: Few methodologically rigorous studies were identified. Mobile phone text-messaging, computer- and website-delivered quit support showed promise at increasing quit rates among Indigenous, psychiatric and inpatient substance use disorder patients. Further research is needed to address the role technology-based interventions have on overcoming health inequalities to meet the needs of disadvantaged groups. Implications: This review provides the first quantitative evidence of the effectiveness of a range of technology-based smoking cessation interventions among disadvantaged smokers, with separate estimates on the basis of intervention type, and cessation outcome measure. Providing cost-effective, easily accessible and real-time smoking cessation treatment is needed, and innovative technology-based platforms will help reach this endpoint. These interventions need to be tested in larger scale randomized controlled trial designs and target broader disadvantaged groups. Data collection beyond 6 months is also needed in order to establish the efficacy of these intervention approaches on long-term cessation rates among disadvantaged population groups.

APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial.

BACKGROUND: Despite evidence of successful weight loss for bariatric surgery patients, some patients experience considerable weight regain over the long term. Given the strong association between post-surgery health behaviors and outcomes, aftercare intervention to address key behaviors appears to be a reasonable relapse-prevention strategy. As the burden of obesity rates increases in healthcare centers, an internet-based program appears to be a reasonable strategy for supporting bariatric surgery patients in the long term. The primary purpose of the current project is to develop and test the efficacy and perceived utility of APOLO-Bari. METHODS/DESIGN: This study is a randomized control trial, which will be conducted in two hospital centers in the North of Portugal; it includes a control group receiving treatment as usual and an intervention group receiving the APOLO-Bari program for one year in addition to treatment as usual. A total of 180 male and female participants who underwent bariatric surgery (gastric sleeve or gastric bypass surgery) for 12 to 20 months will be recruited. Both groups will complete a similar set of questionnaires at baseline, every 4 months until the end of the intervention, and at 6 and 12 months follow-up. Assessment includes anthropometric variables and psychological self-report measures. The primary outcome measure will be weight regain measured at the end of treatment, and at 6 and 12 months follow-up. The secondary aims are to test the cost-effectiveness of the intervention and to investigate psychological predictors and trajectories of weight regain. APOLO-Bari was developed to address the weight regain problem in the bariatric population by offering additional guidance to bariatric patients during the postoperative period. The program includes: (a) a psychoeducational cognitive-behavioral-based self-help manual, (b) a weekly feedback messaging system that sends a feedback statement related to information reported by the participant, and (c) interactive chat sessions scheduled with a trained psychologist in the field. DISCUSSION: APOLO-Bari may play an important role in broadening therapeutic reach to bariatric patients who would not otherwise have continuous support, with important implications for public health treatment. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN37668662 .

Long-term health outcomes and cost-effectiveness of a computer-tailored physical activity intervention among people aged over fifty: modelling the results of a randomized controlled trial.

BACKGROUND: Physical inactivity is a significant predictor of several chronic diseases, becoming more prevalent as people age. Since the aging population increases demands on healthcare budgets, effectively stimulating physical activity (PA) against acceptable costs is of major relevance. This study provides insight into long-term health outcomes and cost-effectiveness of a tailored PA intervention among adults aged over fifty. METHODS: Intervention participants (N = 1729) received tailored advice three times within four months, targeting the psychosocial determinants of PA. The intervention was delivered in different conditions (i.e. print-delivered versus Web-based, and with or without additional information on local PA opportunities). In a clustered RCT, the effects of the different intervention conditions were compared to each other and to a control group. Effects on weekly Metabolic Equivalents (MET)-hours of PA obtained one year after the intervention started were extrapolated to long-term outcomes (5-year, 10-year and lifetime horizons) in terms of health effects and quality-adjusted life years (QALYs) and its effect on healthcare costs, using a computer simulation model. Combining the model outcomes with intervention cost estimates, this study provides insight into the long-term cost-effectiveness of the intervention. Incremental cost-effectiveness ratios (ICERs) were calculated. RESULTS: For all extrapolated time horizons, the printed and the Web-based intervention resulted in decreased incidence numbers for diabetes, colon cancer, breast cancer, acute myocardial infarctions, and stroke and increased QALYs as a result of increased PA. Considering a societal Willingness-to-Pay of €20,000/QALY, on a lifetime horizon the printed (ICER = €7,500/QALY) as well as the Web-based interventions (ICER = €10,100/QALY) were cost-effective. On a 5-year time horizon, the Web-based intervention was preferred over the printed intervention. On a 10-year and lifetime horizon, the printed intervention was the preferred intervention condition, since the monetary savings of the Web-based intervention did no longer outweigh its lower effects. Adding environmental information resulted in a lower cost-effectiveness. CONCLUSION: A tailored PA intervention in a printed delivery mode, without environmental information, has the most potential for being cost-effective in adults aged over 50. TRIAL REGISTRATION: The current study was registered at the Dutch Trial Register (NTR2297; April 26th 2010).

[Assessment of benefit and efficiency of innovative medical devices]. / Nutzen- und Wirtschaftlichkeitsbewertung der biomedizinischen Technik.

Medical devices cover a wide spectrum of products with very different diagnostic and therapeutic applications. However, for market licensing, uniform rules apply. Uniform rules are also valid for coverage decisions in German health care. In this article, the criteria for the assessment of benefit and efficiency of innovative biomedical technologies are described from the perspective of the statutory health insurance system. The key concepts relevant in the mandatory health insurance' "innovation"' "benefit", and "economic efficiency" are characterized. Only measurable effects of an intervention which lead to a more than marginal improvement in prognosis, symptoms, or quality of life as compared to a standard treatment are considered as beneficial. An innovative device is, therefore, subject to a benefit assessment if it is not yet reimbursed (or not yet part of the benefit package), when it is relevant to the health care system and a high public interest exists. In addition, it is important to consider a positive benefit assessment as a part of the value added chain to avoid conflicts of interest. Within the scope of early technology assessment, some conclusions can already be drawn in the early developmental stage of a device.

Providing comprehensive smoking cessation care to surgical patients: the case for computers.

INTRODUCTION AND AIMS: The provision of smoking cessation care to surgical patients before admission can reduce post-operative complications and encourage long-term smoking cessation. Our aim was to show how a comprehensive computer-based smoking cessation intervention, developed to enhance smoking cessation care to surgical patients, addresses barriers to care provision. DESIGN AND METHODS: Consultations with preoperative clinic staff and reviews of the scientific literature were conducted and identified the following barriers to the provision of effective smoking cessation care: a lack of organisational support, perceived patient objection, a lack of systems to identify smokers, a lack of staff time and skill, perceived inability to change care practices, a perceived lack of efficacy of cessation care and the cost of providing care. Based on positive findings of a pilot trial, a comprehensive computer-based smoking cessation intervention was implemented in a preoperative clinic. Data from previous evaluations of the intervention were used to assess the extent to which the intervention addressed clinician barriers to care. RESULTS: The computer-based intervention was found to provide a means to accurately and systematically identify smokers; it required little clinical staff time or skill; it was considered an acceptable form of care by staff and patients; it was effective in encouraging patient cessation and it was inexpensive to deliver relative to other surgical costs. Furthermore, the computer-based intervention continues to operate in the preoperative clinic in the absence of ongoing research support. DISCUSSION AND CONCLUSIONS: The implementation of such a model of care should be considered by clinical services interested in reducing the smoking related morbidity and mortality of patients.

Patterns of use of an automated interactive personalized coaching program for smoking cessation.

BACKGROUND: The QuitCoach, an "expert system" program of tailored advice for smoking cessation developed in Australia, has been publicly available since July 2003, albeit with limited promotion. The program is designed to be used on multiple occasions, guiding the user through the process of smoking cessation in the manner of a "life coach". Email reminders are sent at scheduled intervals to prompt optimal and repeated use. OBJECTIVES: The aims of this study were to characterize QuitCoach users and to determine what characteristics of smokers affect their participation over time. Of particular interest was whether users tend to return following a relapse and, thus, use the program as a tool for relapse prevention or recovery. We also explored patterns of change associated with returns to the site, whether prompted by reminder emails or not prompted at all. METHODS: Between July 2003 and June 2007, 28,247 individuals completed an initial assessment on the QuitCoach, of whom 83.7% (n = 23,656) registered. Data were collected during a 10-minute online questionnaire that all users completed in order to obtain tailored cessation advice. This included questions concerning basic demographic information, quitting history, current smoking status and cigarette consumption, stage of change, and use of pharmacotherapy. RESULTS: The median age of users was 34 years, and 62% were female. Most (96%) were current smokers. Overall, 91% were planning to quit in the next 30 days, and half (49.9%) had set a quit date. Those who had recently relapsed to smoking following a quit attempt made up 37%. Among registered users, 27% returned for a second visit, a median 9 days after their first. Overall, a third visit was completed by 11% and 2% returned within 2 days. Women, older smokers, those who had recently quit, and those using pharmacotherapy were more likely to return. From the second visit on, most people who completed an assessment had quit. Likelihood of responding to a prompt to return was largely unrelated to user characteristics or cessation outcome. CONCLUSIONS: Internet-based programs have considerable potential to reach large numbers of smokers at low cost. The QuitCoach is attracting considerable use, with most using it to make a quit attempt and, for those who continue to use the QuitCoach, to help them stay quit. Nonetheless, most users only visited the site once, suggesting improved strategies are needed for encouraging repeated use.

Online advertising as a public health and recruitment tool: comparison of different media campaigns to increase demand for smoking cessation interventions.

BACKGROUND: To improve the overall impact (reach x efficacy) of cessation treatments and to reduce the population prevalence of smoking, innovative strategies are needed that increase consumer demand for and use of cessation treatments. Given that 12 million people search for smoking cessation information each year, online advertising may represent a cost-efficient approach to reach and recruit online smokers to treatment. Online ads can be implemented in many forms, and surveys consistently show that consumers are receptive. Few studies have examined the potential of online advertising to recruit smokers to cessation treatments. OBJECTIVE: The aims of the study were to (1) demonstrate the feasibility of online advertising as a strategy to increase consumer demand for cessation treatments, (2) illustrate the tools that can be used to track and evaluate the impact of online advertising on treatment utilization, and (3) highlight some of the methodological challenges and future directions for researchers. METHODS: An observational design was used to examine the impact of online advertising compared to traditional recruitment approaches (billboards, television and radio ads, outdoor advertising, direct mail, and physician detailing) on several dependent variables: (1) number of individuals who enrolled in Web- or telephone-based cessation treatment, (2) the demographic, smoking, and treatment utilization characteristics of smokers recruited to treatment, and (3) the cost to enroll smokers. Several creative approaches to online ads (banner ads, paid search) were tested on national and local websites and search engines. The comparison group was comprised of individuals who registered for Web-based cessation treatment in response to traditional advertising during the same time period. RESULTS: A total of 130,214 individuals responded to advertising during the study period: 23,923 (18.4%) responded to traditional recruitment approaches and 106,291 (81.6%) to online ads. Of those who clicked on an online ad, 9655 (9.1%) registered for cessation treatment: 6.8% (n = 7268) for Web only, 1.1% (n = 1119) for phone only, and 1.2% (n = 1268) for Web and phone. Compared to traditional recruitment approaches, online ads recruited a higher percentage of males, young adults, racial/ethnic minorities, those with a high school education or less, and dependent smokers. Cost-effectiveness analyses compare favorably to traditional recruitment strategies, with costs as low as US $5-$8 per enrolled smoker. CONCLUSIONS: Developing and evaluating new ways to increase consumer demand for evidence-based cessation services is critical to cost-efficiently reduce population smoking prevalence. Results suggest that online advertising is a promising approach to recruit smokers to Web- and telephone-based cessation interventions. The enrollment rate of 9.1% exceeds most studies of traditional recruitment approaches. The powerful targeting capabilities of online advertising present new opportunities to reach subgroups of smokers who may not respond to other forms of advertising. Online advertising also provides unique evaluation opportunities and challenges to determine rigorously its impact and value.

A deposit contract method to deliver abstinence reinforcement for cigarette smoking.

Eight smokers were randomly assigned to a deposit contract ($50.00) or to a no-deposit group. Using a reversal design, participants could recoup their deposit (deposit group) or earn vouchers (no-deposit group) for smoking reductions and abstinence (breath carbon monoxide [CO] < or =4 parts per million) during treatment phases. Treatment was delivered via a novel Internet-based method to monitor smoking status. Although equivalent decreases in breath CO and abstinence were observed during treatment in both groups, $178.50 in vouchers were distributed to participants in the no-deposit group, whereas a small surplus remained in the deposit group. A deposit contract method may represent a cost-effective model to deliver abstinence reinforcement for cigarette smoking.

Patient dose optimization in plain radiography based on standard exposure factors.

A computational technique for assessing patient dose in plain radiography is described allowing a large number of examinations to be assessed and enabling dose optimization to be promoted. Entrance surface dose (ESD) was calculated for more than 1500 standard exposure settings in an initial dose assessment. Validation of the technique showed good agreement with thermoluminescent dosimetry and showed broad agreement between the standard exposures and the exposure settings used in practice. The dose assessment was repeated 18 months later using the same techniques for almost 2000 standard exposure settings. In both cases, calculated doses showed good compliance with national diagnostic reference levels where available. Suggested investigation levels were established and set at twice the mean dose for each of 47 examinations. Radiology departments were encouraged to review and optimize doses exceeding these levels. The computed mean ESD in the review study was less than the corresponding value in the initial study in 37 of the 47 examinations. The dose reduction was attributable partly to equipment replacement, but primarily to optimization of exposure settings. The technique employed here provides a valid and cost effective method of complying with statutory requirements for the assessment of representative patient dose and is useful in assisting the ongoing process of dose optimization.

Developing a trust-wide centralised approach to the use of TNP.

Use of topical negative pressure, also known as VAC, gradually increased throughout a trust following its success in a burns and plastic surgery unit. A trust-wide centralised approach set out to standardise its use and to reduce costs.

Desktop and mobile software development for surgical practice.

PURPOSE: The aim of this study was to develop a mobile software solution that will merge patient data with a centralized patient database, aid surgical decision making, and document clinical services. METHODS: iIncise is a computerized, menu-driven database that was developed for real-time entry of historical, clinical, and laboratory data. Within the process, examination data, testing rationale, and test results are captured. AAST staging criteria are presented during data entry to describe and classify organ injuries accurately. A legible, time-stamped, conclusive report can be generated for printed or electronic entry into the medical record. The handheld version of the database runs on a Compaq iPAQ Pocket PC in either stand-alone mode or via LAN or WAN through the Internet. Microsoft Information Internet Server 5.0 provides data transaction services to Microsoft SQL Server 2000 to merge multiuser replicate data between the back ends stored on the desktop and handheld devices. RESULTS: The printed report provides superior documentation for comprehensive evaluation and management services, including history and physical examination, documentation of medical decision making, appropriateness of diagnostic/or therapeutic services, and coordination of care in accordance with Health Care Financing Administration (HCFA) regulations. CONCLUSIONS: Rapid data entry, ease of use, and appropriate documentation of detailed and legible patient visits and procedural notes are early benefits. Wireless data transmission between handheld devices and the desktop database provides the required speed, flexibility, and multitasking environment necessary for the mobile surgeon.

Moore's Law, disruptive technologies, and the clinician.

The advancement of technical power described by Moore's Law offers great potential for enabling more cost-effective medical devices and systems. However, progress has been slow. Many factors for this failure have been cited, including the anti-rational economic structure of healthcare and the complexity and long time scale of medical development. Christensen et al. suggest that "disruptive technologies" may circumvent some of these difficulties. "Disruptive Technologies" are defined as those that are established in one market, but then penetrate and overwhelm another market. These incursions are accelerated by economic factors, and capitalize on functionality, reliability, and advancements supported by the original market. Christensen has cited many examples from industrial and service businesses, but few examples can be found yet in healthcare. We argue that positive technology impacts in medicine occur most readily when innovators augment the skills of and collaborate with caregivers, rather than seeking to displace them. In the short term, a new approach may improve efficiency or quality. In the longer term, such approaches may obviate human tasks at lower-skill levels, and even permit task automation. One successful example has been the introduction of flexible monitoring for physiologic information. Systems for computer-aided diagnosis, which have failed to impact complex decision making, have succeeded in simpler specialty areas such as the interpretation of EKG's and mammograms, and may do the same with analysis of some pathology images. The next frontier may the operating room, and the adoption of such systemic technologies by caregivers in emergency medicine and general care may then have an even wider "disruptive" effect. Responding to time and cost pressures, and the desire to move care to the patient, other workers, such as radiologists, will drive the trend away from isolated, complex, large-scale devices, and toward integrated, modular, and simpler networked technologies. In summary, technological "push" will continue in the demanding cutting-edge application areas as always, but the "disruption" will occur through wider application of lower-cost technologies, pulled by the users. The capabilities described by Moore's Law will allow the advancements necessary to facilitate this dissemination of capability and its ultimate benefit, so long sought.

Computer-aided frontal sinus surgery.

Computer-aided surgery technology supports computer-enabled review of CT images and intraoperative surgical anatomy. Many rhinologic surgeons have embraced computer-aided surgery for complicated frontal sinus procedures because computer-aided surgery may simplify these complex procedures. This article discusses the fundamental principles of computer-aided surgery, its limitations, and its application to frontal sinus surgery.

Cost analysis of computer-aided endoscopic sinus surgery.

Functional endoscopic sinus surgery' (FESS) is a common otolaryngologic procedure, with over 250,000 operations performed annually. Computerized surgical navigation systems are available to assist the rhinologic surgeon in the complex dissection required for FESS. Our objective was to determine whether this system provided quantifiable benefits in FESS. We retrospectively reviewed 203 patients with chronic sinusitis who underwent endoscopic sinus surgery, and divided them into two groups based on whether or not computerized surgical navigation was used. There was no statistically significant difference between the two groups in terms of surgery duration, extent of surgery, percent of complementary procedures, percent of supplementary procedures, complexity of surgery, and percent revision surgery. Computer-assisted surgery (CAS) was 6.7% more expensive than sinus surgery without computerized surgical navigation (p = 0.01). However, the intangible benefits of CAS may outweigh the added expense. (American