What is a Digital Health Technology? The PICOTS-ComTeC Framework Could Set the Standard

Whilst a lot of focus at ISPOR Europe 2023 was on effective value assessment frameworks for digital health technologies (DHTs), another major barrier to their uptake was also discussed. Namely, what is a digital health technology? The ISPOR Digital Health Special Interest Group (SIG) set out to determine a value assessment framework, but instead found themselves stuck at this initial question, and for good reason. Currently, digital health technologies are often poorly and variably described in the literature, leading to challenges in conducting effective literature reviews; for example, it was highlighted that ~10 new “digital health” terms are emerging each year. This is something we’ve encountered at Costello Medical too, and means that it is exceptionally challenging to devise a search strategy for a literature review that is able to identify all relevant papers, without resulting in a huge swathe of noise. Not only could this lead to a time-consuming literature review, but it highlights wider issues with the field that likely impact market access. How do you judge if a paper is reporting data on a relevant comparator to your own intervention? How can you synthesise evidence for relevant comparators? How can you truly assess the value of your intervention within these limitations?

One of the standout contributions came from ZsomborZrubka, Associate Professor at Óbuda University, who introduced the PICOTS-ComTeC framework on behalf of the Digital Health SIG (Figure 1).¹ This innovative framework evolves from the traditional PICOTS structure, and is specifically adapted to the intricacies of patient-facing digital health technologies. Developed via a Delphi panel of Digital Health SIG members to ensure relevance, the framework determines a detailed, adaptable set of criteria to enable accurate reporting of technologies and limit variability in terminology.

Figure 1. The PICOTS-ComTeC framework

Quite clearly, this framework could address the issues highlighted above. The ComTeC domains (Communication, Technology, Context) enable developers to specific key facets of the technology that should ensure reproducibility between studies and allow for clearer definition of comparators for future evidence syntheses or decision problems. However, for maximum impact, widespread adoption and promotion of this framework are essential. Adaptation of the PICOTS framework, rather than developing something completely de novo, does mitigate the risk somewhat; building on such a well-established framework ensures immediate familiarity with many of the domains and should boost early adoption. However, its success hinges on uniform application; otherwise, it risks only marginally improving the clarity and relevance of research in this field. An assessment on its usability once introduced will be important in driving any further updates.

One additional aspect to consider is that previously published research not conforming to this framework could end up left behind. If literature search strategies are designed based on PICOTS-ComTeC, publications that have previously failed to detail all domains will likely not be identified. The question is, does that matter? Yes, publications on relevant interventions will not be captured, but are these publications of most relevance to your question anyway? Are they rigorous enough to warrant inclusion in your literature review? Do they provide enough context on the DHT to enable meaningful and reliable comparisons? None of the domains in this framework recommend inconsequential information. Perhaps, instead, this simply highlights the role PICOTS-ComTeC could have in raising evidence standards, and ensuring only the most robust historical papers are considered in future evidence syntheses. However, judicial implementation of the framework, where domains may be deprioritised to ensure that a literature review strategy can adequately identify the studies necessary, may be sensible initially, until use of the PICOTS-ComTeC is more universal. It will also be necessary to consider how uptake of the framework sits alongside other definitions of digital health technologies, such as ISO/TR 11147:2023.²

Professor Zrubka noted that that the manuscript outlining the PICOTS-ComTeC framework was submitted for publication during the conference itself; we look forward to seeing this in print and hope the impact matches its promise. We certainly plan to put this framework to use in relevant digital health projects at Costello Medical, and expect it to become an increasingly important part of our work going forward. By encouraging a standardised approach, reviews employing the PICOTS-ComTeC framework could significantly enhance the assessment and comparison of digital health solutions, thereby streamlining future evaluations and facilitating more rapid integration of impactful digital health technologies. It should also serve as an effective checklist for those publishing manuscripts on patient-facing DHTs, with these two benefits coming together in harmony to improve evidence standards for the digital health field.