The use of three-dimensional (3D) printing in surgery is expanding and there is a focus on comprehensively evaluating the clinical impact of this technology. However, although additional costs are one of the main limitations to its use, little is known about its economic impact. The purpose of this systematic review is to identify the costs associated with its use and highlight the first quantitative data available.

A systematic literature review was conducted in the PubMed and Embase databases and in the National Health Service Economic Evaluation Database (NHS EED) at the University of York. Studies that reported an assessment of the costs associated with the use of 3D printing for surgical application and published between 2009 and 2019, in English or French, were included.

Nine studies were included in our review. Nine types of costs were identified, the three main ones being printing material costs (n = 6), staff costs (n = 3), and operating room costs (n = 3). The printing cost ranged from less than U.S. dollars (USD) 1 to USD 146 (in USD 2019 values) depending on the criteria used to calculate this cost. Three studies evaluated the potential savings generated by the use of 3D printing technology in surgery, based on operating time reduction.

This literature review highlights the lack of reliable economic data on 3D printing technology. Nevertheless, this review makes it possible to identify expenditures or items that should be considered in order to carry out more robust studies.

The National Health Insurance Law enacted in 1995 stipulates a minimum list of health services (benefits package) that the four health plans in Israel have to provide to their members. The recommendations on which new technologies or new indications for existing ones should be added every year to the benefits package, subject to a predetermined budget, are made by a public committee that evaluates and prioritizes candidate technologies according to their clinical merit, economic (mainly budget impact), social, ethical and other aspects. We assessed the legitimacy of this coverage decision process over the past 20 years.

The legitimacy of the process was assessed by adherence to the conditions outlined in the accountability for reasonableness (A4R) framework. A4R defines four conditions for legitimate and fair healthcare coverage decision processes: relevance, publicity, appeals/reversibility, and enforcement. We reviewed the changes made in the coverage decision process over the past 20 years and examined whether these changes have changed its legitimacy.

Our analysis suggests that despite several changes made over the years in the process for updating the benefits package, for example, increase in transparency, introducing a structured appeal process, it only partially fulfills the four A4R conditions. In order to accomplish these goals more fully, several widely used considerations such as cost-effectiveness analysis and incorporating views from patients should be included. Additionally, this decision-making process should become even more transparent than it currently is.

The annual process of updating the benefits package in Israel where hundreds of technologies are “competing” with each other for coverage under a pre-defined budget is unique and not without merit. This process has been operating in the same pattern with only minor changes made since 1999. The main barriers for fulfilling all A4R conditions may relate in part to the large number of technologies assessed each year within a short time frame. Several changes in the process including the assessment of societal values, involvement of diverse stakeholders including patient advocate groups should be made to improve its legitimacy.

When assessing the economic value of vaccines, decision makers should adopt a full societal perspective. One approach for estimation of the fiscal impact of a disease is to use the human capital method to determine productivity losses. The aim of this study was to test an analytical framework developed for the estimation of the fiscal impacts of vaccination programs for influenza (FLU), pneumococcus (PC), and herpes zoster (HZ), in Italy.

We tested the framework in a two-stage analysis. First, we estimated the fiscal impact of the disease, second we performed a cost–benefit analysis of the individual benefits of vaccination against the cost of the vaccine. To estimate the fiscal impact of the diseases, the human capital approach was used. Epidemiological data were extrapolated from the literature. A Monte Carlo simulation enabled exploration of the uncertainty in the model variables.

For FLU, assuming 2.1 million people infected, the total expected impact was EUR 999,371,520; the estimated fiscal impact was EUR 159,563,520. For PC, assuming 90,000 people infected, the total impact was EUR 148,055,040 and the estimated fiscal impact was EUR 23,639,040. For HZ, assuming 6,400 people infected, the total impact was EUR 4,777,200, with EUR 630,000 resulting from a decrease in fiscal taxation.

In conclusion, our work shows how traditional methods aimed at estimating the cost of illness from a social perspective can be improved by additionally considering the fiscal impact, which accounts for the decrease in fiscal revenues due to illness.

One anastomosis gastric bypass (OAGB) has become a widespread technique over the last few years in France, without any prior assessment and despite existing controversies among bariatric surgeons. An older bypass technique for treating obesity, the Roux-en-Y gastric bypass (RYGB), is available and reimbursed, having been assessed and approved for use in 2005. In 2019, the French Haute Autorité de Santé (HAS) assessed OAGB for the treatment of severe and massive obesity. This assessment, the first in the world, was undertaken for OAGBs carried out with a 200- or 150-centimeter biliopancreatic-limb (BP-limb) length.

A systematic review (SR) of the literature and consultation of a working group consisting of both healthcare professionals (clinician and surgeons) and patients were carried out. The primary aim of our assessment was to determine whether the OAGB technique can replace RYGB. The efficacy and safety profile of OAGB was compared with RYGB in adult patients with massive, severe obesity. Complications and postoperative follow up specific to OAGB were identified.

The three selected randomized controlled trials (RCTs) could not confirm the superiority or the non-inferiority of OAGB, compared with RYGB, on the selected efficacy endpoints of weight loss, resolution of comorbidities, and quality of life. Adverse events reported for OAGB included severe nutritional complications and bile reflux that could potentially lead to lower esophageal cancer. In one RCT, the frequency of serious adverse events in the OAGB group was almost two times higher than in the RYGB group.

HAS considered that OAGB carried out with a longer (200 centimeter) BP-limb is not a validated technique for the surgical treatment of massive, severe obesity. Thus, it cannot be considered an alternative to RYGB. There were insufficient data available on OAGB performed with a 150-centimeter BP-limb. Thus, HAS recommended undertaking a multicenter RCT to assess the efficacy and safety of OAGB. Patients who have already undergone OAGB should receive the same follow up as patients who have received RYGB, including close monitoring for nutritional complications and lower esophageal cancer and an endoscopic examination five years after surgery.

Mobile health (mHealth) due to its popularity and accessibility can be widely applied in different health areas such as the management of chronic diseases. However, its success depends on the acceptance of their users. Therefore, the aim of this study was to survey the attitudes of patients with chronic disease toward mHealth technology and their willingness to use it.

This study was conducted within a 2-year period (2016–2018) to determine and compare the attitude and willingness of patients with asthma, diabetes, and multiple sclerosis (MS) toward using mHealth technology in a province in Iran.

In total, 222 patients participated in this study. More than 93 percent of the patients with diabetes and MS, and 65 percent of the asthmatic patients preferred using mHealth services rather than consulting a physician (p < .0001). About 98, 94, and 49 percent of the MS, diabetic, and asthmatic patients, respectively felt comfortable if their health conditions checked by physicians through mHealth technology (p < .0001).

Our results showed that the majority of the patients felt comfortable and preferred using mHealth technology rather than consulting the physicians. The attitudes of diabetic and MS patients toward mHealth technology were rather more positive compared to asthmatic patient attitude. These results may be helpful for the developers of mHealth technology, and researchers who design mHelath interventions for patients with chronic disease.

We designed, developed, and implemented a new hospital-based health technology assessment (HB-HTA) program called Smart Innovation. Smart Innovation is a decision framework that reviews and makes technology adoption decisions. Smart Innovation was meant to replace the fragmented and complex process of procurement and adoption decisions at our institution. Because use of new medical technologies accounts for approximately 50 percent of the growth in healthcare spending, hospitals and integrated delivery systems are working to develop better processes and methods to sharpen their approach to adoption and management of high cost medical innovations.

The program has streamlined the decision-making process and added a robust evidence review for new medical technologies, aiming to balance efficiency with rigorous evidence standards. To promote system-wide adoption, the program engaged a broad representation of leaders, physicians, and administrators to gain support.

To date, Smart Innovation has conducted eleven HB-HTAs and made clinician-led adoption decisions that have resulted in over $5 million dollars in cost avoidance. These are comprised of five laboratory tests, three software-assisted systems, two surgical devices, and one capital purchase.

Smart Innovation has achieved cost savings, avoided uncertain or low-value technologies, and assisted in the implementation of new technologies that have strong evidence. The keys to its success have been the program's collaborative and efficient decision-making systems, partnerships with clinicians, executive support, and proactive role with vendors.

Video consultation (VC) is considered promising in delivering healthcare closer to the patient and improving patient satisfaction. Indeed, providing care-at-distance via VC is believed to be promising for some situations and patients, serving their needs without associated concomitant costs. In order to assess implementation and perceived benefits, patient satisfaction is frequently measured. Measuring patient satisfaction with VC in healthcare is often performed using quantitative and qualitative outcome analysis. As studies employ different surveys, pooling of data on the topic is troublesome. This systematic review critically appraises, summarizes, and compares available questionnaires in order to identify the most suitable questionnaire for qualitative outcome research using VC in clinical outpatient care.

PubMed, Embase, and Cochrane were searched for relevant articles using predefined inclusion criteria. Methodological quality appraisal of yielded questionnaires to assess VC was performed using the validated COSMIN guideline.

This systematic search identified twelve studies that used ten different patient satisfaction questionnaires. The overall quality of nine questionnaires was rated as “inadequate” to “doubtful” according to the COSMIN criteria. None of the questionnaires retrieved completed a robust validation process for the purpose of use.

Although high-quality studies on measurement properties of these questionnaires are scarce, the questionnaire developed by Mekhjian has the highest methodological quality achieving validity on internal consistency and the use of a large sample size. Moreover, this questionnaire can be used across healthcare settings. This finding may be instrumental in further studies measuring patient satisfaction with VC.

The aim of the study was to measure the economic impact of informal care (IC) on caregivers assisting myocardial infarction (MI) survivors in France. Health and social impacts were also described.

Data from the prospective 2008 Health and Disabilities Households Survey (Enquête Handicap-Santé), carried out among the French general population, were used to obtain information about patients with MI and their informal caregivers. To estimate the approximate monetary value of IC, three methods were used: the proxy good method, opportunity cost method (OCM), and contingent valuation method (CVM). A multivariate analysis was performed to determine the associations of the IC duration and the existence of professional care with the health indicators stated by caregivers.

The analysis included data from 147 caregivers. The mean value of IC ranged from €9,679 per year using the CVM to €11,288 per year using the OCM (p > .05). The mean willingness to pay for an additional hour of IC was €10.9 (SD = 8.3). A total of 46.2 percent of caregivers reported that IC negatively affected theirs physical condition, and 46.3 percent reported that it negatively affected their psychological health. In addition, 40.1 percent declared that caregiving activity made them anxious and 38.8 percent stated they felt alone. Associations were identified between the duration of IC and feeling the need to be replaced, feeling alone and making sacrifices (p < .05).

Informal caregiver burden may be recognized in health technology assessment in order not to underestimate the cost of strategies and to facilitate the comparability of cost-effectiveness outcomes between studies.

Worldwide, governments employ health technology assessment (HTA) in healthcare funding decision making. Requests to include public perspectives in this are increasing, with the idea being that the public can identify social values to guide policy development, increasing the transparency and accountability of government decision making.

To understand the perspectives of the Canadian public on the rationale and design of public involvement in HTA.

A demographically representative sample of residents of a Canadian province was selected to take part in two sets of two focus groups (sixteen people for the first set and twenty for the second set).

Participants were suspicious of the interests driving various stakeholders involved in HTA. They saw the public as uniquely impartial though also lacking knowledge about health technologies. Participants were also suspicious of personal biases and commended mechanisms to reduce their impact. Participants suggested various involvement methods, such as focus groups, citizens' juries and surveys, noting advantages and disadvantages belonging to each and commending a combination.

We identified a lack of public understanding of how decisions are made and distrust concerning whose interests and values are being considered. Public involvement was seen as a way of providing information to the public and ascertaining their views and values. Participants suggested that public involvement should employ a mixed-methods strategy to support informed debate and participation of a large number of people.

To assess the effectiveness, efficacy, and safety of a wearable cardioverter-defibrillator (WCD) in adult persons with high risk for sudden cardiac arrest and for which an implantable cardioverter is currently not applicable.

We performed a systematic literature search in Medline, Embase, Cochrane Library, and CRD-databases. Study selection was performed by two reviewers independently. Data were presented quantitatively; due to heterogeneity of studies no meta-analysis was performed.

One randomized-controlled trial (RCT), one non-randomized comparative trial, and forty-four non-comparative trials were included. The RCT reported an overall mortality of 3.1 percent in the WCD group versus 4.9 percent in controls (relative risk [RR]: .64; 95 percent confidence interval [CI], .43–.98, p = .04), but no significant effect on arrhythmia-related mortality. The RR for arrhythmia-related mortality amounted to .67 (95 percent CI, .37–1.21, p = .18) as assessed in the RCT. Appropriate shocks were observed in 1.3 percent of patients in both comparative studies, and inappropriate shocks in .6 percent of patients in the RCT. Termination of ventricular tachycardia (VT) or ventricular fibrillation (VF) was successful in 75 to 100 percent of appropriate shocks in all studies. Adverse events assessed in the RCT showed a lower incidence of shortness of breath (38.8 percent vs. 45.3 percent; p = .004), higher incidence of rash at any location (15.3 percent vs. 7.1 percent; p < .001), and higher incidence of itching at any location (17.2 percent vs. 6.4 percent; p < .001) for WCD.

Available evidence demonstrates that the WCD detects and terminates VT/VF events reliably and shows a high rate of appropriate shocks in mixed patient populations. Data of large registries confirm that the WCD is a safe intervention.

The aim of this study was to develop a module which could be used to facilitate the assessment of mobile medical applications (MMA) for regulatory and reimbursement purposes.

In-depth interviews were conducted with policymakers, healthcare practitioners, and application developers to determine possible pathways and impediments to MMA reimbursement. These findings were integrated with our previous research on MMA reimbursement and regulation to create a module that could be used with existing health technology assessment (HTA) methodological frameworks to guide the evaluation of MMAs.

Stakeholders indicated that they trust how traditional medical devices are currently appraised for reimbursement. They were concerned that there was a lack of clarity regarding which entity in the health system was responsible for determining app quality. They were also concerned about the digital health literacy of medical practitioners and patients. Concepts emerging from our previous research were reinforced by the interview findings, including that the connectivity and cybersecurity of apps need to be considered, along with an assessment of software reliability. It is also critical that the credibility of the information presented in apps is assessed as it could potentially mislead patients and clinicians.

An MMA evaluation module was created that would enable an existing HTA process to be adapted for the assessment of MMA technology. These adaptations include making provisions for an assessment of app cybersecurity, the impact on MMA clinical utility of software updates, and compatibility issues. Items to address concerns around practitioner responsibility and app misinformation were also incorporated into the module.

Type 2 diabetes results mainly from weight gain in adult life and affects one in twelve people worldwide. In the Diabetes REmission Clinical Trial (DiRECT), the primary care-led Counterweight-Plus weight management program achieved remission of type 2 diabetes (for up to six years) for forty-six percent of patients after one year and thirty-six percent after two years. The objective of this study was to estimate the implementation costs of the program, as well as its two-year within-trial cost effectiveness and lifetime cost effectiveness.

Within-trial cost effectiveness included the Counterweight-Plus costs (including training, practitioner appointments, and low-energy diet), medications, and all routine healthcare contacts, combined with achieved remission rates. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year two of DiRECT and the consequent life expectancy, quality of life and healthcare costs.

The two-year intervention cost was EUR 1,580 per participant, with over eighty percent of the costs incurred in year one. Compared with the control group, medication savings were EUR 259 (95% confidence interval [CI]: 166–352) for anti-diabetes drugs and EUR 29 (95% CI: 12–47) for anti-hypertensive medications. The intervention was modeled with a lifetime horizon to achieve a mean 0.06 (95% CI: 0.04–0.09) gain in QALYs for the DiRECT population and a mean total lifetime cost saving per participant of EUR 1,497 (95% CI: 755–2,331), with the intervention becoming cost-saving within six years.

The intensive weight loss and maintenance program reduced the cost of anti-diabetes drugs through improved metabolic control, achieved diabetes remission in over one-third of participants, and reduced total healthcare contacts and costs over two years. A substantial lifetime healthcare cost saving is anticipated from periods of diabetes remission and delaying complications. Healthcare resources could be shifted cost effectively to establish diabetes remission services, using the existing DiRECT intervention, even if remissions are only maintained for limited durations. However, more research investment is needed to further improve weight-loss maintenance and extend remissions.

User experience (UX) plays a key role in uptake and usage of mental health smartphone interventions, yet remains underinvestigated. This review aimed to characterize and compare UX evaluation approaches that have been applied in this specific context, and to identify implications for research and practice.

A narrative review was conducted of UX-themed studies published in PubMed, PsycINFO, and Scopus up to February 2019. Eligible studies reported on data reflecting users' interactions with a smartphone intervention for any mental health condition. Studies were categorized into “situated” versus “construct-based” methods according to whether or not an established UX construct was used to acquire and analyze data.

Situated approaches used bespoke UX metrics, including quantitative measures of usage and performance, as well as grounded interview data. Construct-based approaches such as assessments of usability and acceptability were based on conceptual frameworks, with methodologically stronger versions featuring construct definitions, validated measurement tools, and an ability to compare data across studies. Constructs and measures were sometimes combined to form bespoke construct-based approaches.

Both situated and construct-based UX data may provide benefits during design and implementation of a mental health smartphone intervention by helping to clarify the needs of users and the impact of new features. Notable however was the omission of UX methods, such as split testing. Future research should consider these unaddressed methods, aim to improve the rigor of UX assessment, integrate their use alongside clinical outcomes, and explore UX assessment of more complex, adaptive interventions.

Patients with distributive shock who are unresponsive to traditional vasopressors are commonly considered to have severe distributive shock and are at high mortality risk. Here, we assess the cost-effectiveness of adding angiotensin II to the standard of care (SOC) for severe distributive shock in the US critical care setting from a US payer perspective.

Short-term mortality outcomes were based on 28-day survival rates from the ATHOS-3 study. Long-term outcomes were extrapolated to lifetime survival using individually estimated life expectancies for survivors. Resource use and adverse event costs were drawn from the published literature. Health outcomes evaluated were lives saved, life-years gained, and quality-adjusted life-years (QALYs) gained using utility estimates for the US adult population weighted for sepsis mortality. Deterministic and probabilistic sensitivity analyses assessed uncertainty around results. We analyzed patients with severe distributive shock from the ATHOS-3 clinical trial.

The addition of angiotensin II to the SOC saved .08 lives at Day 28 compared to SOC alone. The cost per life saved was estimated to be $108,884. The addition of angiotensin II to the SOC was projected to result in a gain of .96 life-years and .66 QALYs. This resulted in an incremental cost-effectiveness ratio of $12,843 per QALY. The probability of angiotensin II being cost-effective at a threshold of $50,000 per QALY was 86 percent.

For treatment of severe distributive shock, angiotensin II is cost-effective at acceptable thresholds.

Transcatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve.

A systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database. Prospective studies regarding TAVI were included. The quality of information reported about the learning curve was evaluated using the following criteria: mention of the learning curve, the description of a roll-in phase, the involvement of a proctor, and the number of patients suggested to maintain skills.

A total of sixty-eight studies met the selection criteria and were suitable for analysis. The learning curve was addressed in approximately half of the articles (n = 37, 54 percent). However, the roll-in period was mentioned by only eight studies (12 percent) and with very few details. Furthermore, a proctorship was disclosed in three articles (4 percent) whereas twenty-five studies (37 percent) included authors that were proctors for manufacturers of TAVI.

Many prospective studies on TAVI over the past 10 years mention learning curves as a core component of successful TAVI procedures. However, the quality of information reported about the learning curve is relatively poor, and uniform guidance on how to properly assess the learning curve is still missing.