Computerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia.

Using a qualitative approach, we interviewed 11 professionals involved in the implementation and evaluation of digital health technologies at national and regional levels. Data were thematically analyzed using both data-driven (inductive) and theory-based (deductive) approaches.

Our results suggest that current CDSS evaluations have an overly narrow perspective on the risks and benefits of CDSS due to an inability to capture the impact of the technology on the sociotechnical environment. By adopting a static view of the CDSS, these evaluation frameworks are unable to discern how rapidly evolving technologies and a dynamic clinical environment can impact CDSS performance. After software upgrades, CDSS can transition from providing information to specifying diagnoses and treatments. Therefore, it is not clear how CDSS can be monitored continuously when changes in the software can directly affect patient safety.

Our findings emphasize the importance of taking a living health technology assessment approach to the evaluation of digital health technologies that evolve rapidly. There is a role for observational (real-world) evidence to understand the impact of changes to the technology and the sociotechnical environment on CDSS performance.

Involving patients in defining the scope of health technology assessments is recognized as a valuable strategy that ensures that patient-relevant outcomes are considered.

The aim of this project was to pilot the focus group approach with cardiac patients in a European rapid assessment on the wearable cardioverter defibrillator, to improve involvement processes, to identify neglected outcomes, and to explore the potential of this methodology for eliciting the patients views on their disease and the wearable cardioverter defibrillator therapy.

An e-mail was sent to members of the nine regional associations of the Austrian Organization for Heart and Lung Transplant Patients to identify eligible participants. Guiding questions for the discussion were developed based upon a hand search of patient involvement initiatives and a review of appropriate literature. The 4-hour meeting was moderated by a patient support expert and recorded upon approval of participants. The anonymized transcript was analyzed using framework analysis.

Ten eligible patients responded, of which five men, aged between 55 and 73 years (mean 65 years) from Austria and Germany, were able to participate. All respondents experienced heart transplantation, and four had received an implantable cardioverter defibrillator before.

Participants reported that experiencing a sense of security was crucial to them and that they expected to do sports and live a life with few limitations, despite receiving a therapy. A wearable cardioverter defibrillator was hence not considered a long-term solution due to expected restrictions in living a ‘normal’ life.

Challenges included the identification of participants representative of this patient group and the complexity of patient histories.

The focus group approach proved useful in the wearable cardioverter defibrillator assessment. Gathered results informed the inclusion of outcomes relevant to the target group and revealed patients views on health-related quality of life. Lessons learned guide us in further improving patient involvement processes within the European Network for HTA (EUnetHTA) project.

In response to the Omicron surge in early 2022, the HTA Philippines evaluated the acceptability of Filipinos in using self-administered antigen tests (SAAgTs) as part of COVID-19 HTAs in the Philippines.

Scoping review from literature databases was initially conducted to identify preset codes in the use of SAAgT. Preset codes were used to establish the questions for focus group discussions (FGDs). Semi-structured questionnaires were created through Delphi technique. FGDs with four stakeholder groups (i.e., nine healthcare workers [HCWs], seven representatives of at-risk groups, six economic frontliners, and seven representatives of micro–small–medium-sized enterprises) were conducted.

Discomfort in being a target of stigma and being prescribed an “illness identity” when suspected or confirmed COVID-19-positive, along with lack of confidence to perform self-test, caused hesitancy in self-testing among participants. The need for subsidies for test kits from the government or employers was emphasized to increase its accessibility. Having a designated access point and reporting system for SAAgT was highlighted to avoid nepotism (padrino system attributed to debt of gratitude), inequitable distribution, and lapses in reporting. A participatory approach to education was perceived as crucial to reduce any misconceptions associated with the use of SAAgT.

All FGD groups expressed favorable reviews on the implementation of SAAgT because it can potentially reduce the burden of health facility-administered tests. These findings were considered by the HTA Council in the recommendation of SAAgT as part of the overarching national strategies for the diagnosis and screening of COVID-19.

Health technology assessment (HTA) agencies wish to ensure the impact of their HTAs. HTA impact assessment measures the influence of a HTA on decision-making and downstream to patient outcomes. Despite their potential to provide insights, the use of impact assessment frameworks by HTA agencies is limited. Understanding the underlying mechanisms of adopting HTA impact assessment frameworks is therefore important. Using a social cognitions lens, this study aims to provide insights into the enabling and hindering factors associated with the assessment of HTA impact by INAHTA members.

Using an interpretive description design, this cross-sectional study used semi-structured interviews of INAHTA members to gain insight into attitudes, social support, self-efficacy, barriers, and intentions towards HTA impact assessment. Transcriptions were analyzed using a social cognitions lens by two researchers using a constant comparative method to identify themes.

Twenty-six of forty-seven INAHTA members participated. Preliminary results showed that interviewees most often perceived support for assessing impact from their ministry of health or from agency staff. Most interviewees noted challenges to measuring impact at the right time and a lack of human resources, methods, and tools as internal barriers. A lack of transparency and a limited impact assessment culture were perceived as the main external barriers. Interviewees reported feeling fairly confident in overcoming internal barriers, but were less confident in overcoming external barriers. Providing feedback for improvement to HTA processes and making achievements visible were the most frequently reported advantages of assessing impact, whereas its time consuming nature was the biggest disadvantage.

This is the first study to use a social cognitions model to understand HTA impact assessment. Although the results of this convenience sample need to be interpreted with caution, they contribute knowledge on factors that facilitate and hinder agencies in the assessment of impact and illuminate opportunities for developing effective strategies to support HTA agencies in this area.

Trastuzumab is the most recent biological therapy incorporated by the Brazilian Health Ministry for HER-2 overexpressed metastatic breast cancer treatment (2012). The aim of this study was to investigate if access to this technology is appropriate.

We performed a web-based questionnaire, which received answers from October 2016 to April 2017. Oncologists that work in the care of patients with overexpressed HER-2 metastatic breast cancer were the focus of the survey. Forty-three professionals informed work location, sector (public, private or both) and trastuzumab access. This research was approved by Brazilian Ethics Committee (CAE 59076316300005260).

Among 43 valid answers, nine informed they work in the public sector, 10 in the private sector and 24 in both sectors. In total, 33 reported to work in public and 34 in private sector. We observed that 17 (51.5 percent) participants who work in the public sector do not have access to trastuzumab, while in private sector only one participant (2.9 percent) reported the lack of access to this technology for HER-2 overexpressed metastatic breast cancer treatment. Regarding the respondents who informed the lack of access, six (33.3 percent) work in Northeast Brazilian region, six (33.3 percent) in Southeast, two (11.1 percent) in South, one (5.6 percent) in Central-West and three (16.7 percent) did not give this information. Eleven respondents reported they do not have another treatment option for these patients, while seven informed access only to chemotherapy without biological therapy.

Trastuzumab is a biological therapy that can increase HER-2 overexpressed metastatic breast cancer patients overall survival by nine months on average. The questionnaire results indicate that its access in Brazil is still irregular, mainly in public sector, even five years after its incorporation by the Brazilian Health Ministry. Although universal access is one of Brazilian Public Health System main directives, there is evidence of a serious issue regarding its services equity.