Developing a How-to-Guide for Health Technology Reassessment: "The HTR Playbook"

Background: To develop a knowledge translation (KT) tool that will provide guidance to stakeholders actively planning or considering implementation of a health technology reassessment (HTR) initiative. Methods: The KT tool is an international and collaborative endeavour between HTR researchers in Canada, Australia, and the United Kingdom. Evidence from a meta-review of documented international HTR experiences and approaches provided the conceptual framing for the KT tool. The purpose, audience, format, and overall scope and content of the tool were established through iterative discussions and consensus. An initial version of the KT tool was beta-tested with an international community of relevant stakeholders (i.e., potential users) at the Health Technology Assessment International 2018 annual meeting. Results: An open access workbook, referred to as the HTR playbook, was developed. As a KT tool, the HTR playbook is intended to simplify the complex HTR planning process by navigating users step-by-step through 6 strategic domains: characteristics of the candidate health technology (The Stats and Projections), stakeholders to engage (The Team), potential facilitators and/or barriers within the policy context (The Playing Field), strategic use of different levers and tools (The Offensive Plays), unintended consequences (The Defensive Plays), and metrics and methods for monitoring and evaluation (Winning the Game). Conclusion: The HTR playbook is intended to enhance a user’s ability to successfully complete a HTR by helping them systematically consider the different elements and approaches to achieve the right care for the patient population in question.


II. CHALK TALK Key Words
Definitions (derived and adapted from Elshaug et al., 2017 and the Right Care series published in the Lancet) Low Value Care A health service, treatment or procedure in which evidence suggests it confers no or very little benefit for patients, or risk of harm exceeds probable benefit, or, more broadly, the added costs of the intervention do not provide proportional added benefits 1 High Value Care A health service, treatment or procedure in which evidence suggests it confers benefit on patients, or probability of benefit exceeds probable harm, or, more broadly, the added costs of the intervention provide proportional added benefits relative to alternatives Right Care Care that is tailored for optimising health and well-being by delivering what is needed, wanted, clinically effective, affordable, equitable, and responsible in its use of resources Overuse Provision of a service, treatment or procedure above its intended scope of use; unlikely to increase the quality or quantity of life, that poses more harm than benefit, or that patients who were fully informed of its potential benefits and harms would not have wanted Underuse Failure to deliver a service, treatment, or procedure that is highly likely to improve the quality or quantity of life, that represents good value for money, and that patients who were fully informed of its potential benefits and harms would have wanted Misuse Provision of a service, treatment or procedure outside of its intended or funded scope of use; unlikely to increase the quality or quantity of life, that poses more harm than benefit, or that patients who were fully informed of its potential benefits and harms would not have wanted

III. LEAGUE RULES
We outline a set of eight overarching principles to guide the development of your HTR process. These are informed by a review of the literature, an environmental scan, and expert input and also serve as backdrop for the recommendations and policy levers discussed in this playbook.

#1. THE STATS & PROJECTIONS
Understanding characteristics of the health technology itself, including the way in which it is currently being used and the surrounding issues, will help you understand your next steps and the objective or goal of the HTR. Complete the following sections concerning the characteristics, value, and utilization gap of the technology and outcomes of its reassessment. Use this information to then specify your goal for the HTR.
What is the health technology being reassessed?

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Which patients are being treated with it?

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Where is this health technology being used (e.g., in-hospital, primary care physician offices)?

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How is this care being delivered and how is it being paid for (e.g., fee-for-service, bundled payment)?

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What HEALTH TECHNOLOGY is a term used to describe an intervention that may be used to promote health, to prevent, diagnose or treat acute or chronic disease, or for rehabilitation. Health technologies include pharmaceuticals, devices, procedures and/or organizational systems used in healthcare.

Where
How 5 VALUE of a health technology is the impact and outcomes it achieves in relation to its cost. Value can be considered from the patient, healthcare system or societal perspectives. The spectrum of technology value spans from high value (highly beneficial, acceptable costs); low value (minimal benefit, cost irrespective); no demonstrable value (ineffective); or harmful.
What is the value of the technology? Indicate whether it is low, high, of no demonstrable value, or harmful.

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UTILIZATION GAP is the difference between the optimal and observed use of the health technology. This includes overuse of a technology that is ineffective or harmful, overuse or misuse of an effective technology outside of its intended scope of use (i.e., appropriate technology, but wrong patient, indication, or time), or underuse of a technology of proven clinical-and/or costeffectiveness. The gap may be identified through temporal, provider, and/or geographic variations in practice.

What is the utilization gap? Indicate whether it is overused, misused, or underused.
____________________________________________________________________________________________________________ OUTCOME refers to the anticipated impacts of reassessing the technology. Think broadly in terms of outcomes, including clinical endpoints (e.g., patient safety, quality of life, satisfaction), health system or process-related outcomes (e.g., reduced length of stay), and cost savings to the health care system.

What is the anticipated outcome(s)?
___________________________________________________________________________________________________________ Your goal is to _____________________________ of ________________________________ for _______________________________.
(insert optimal use) (insert health technology) (insert patient group)

#2. DRAFTING YOUR TEAM
Meaningful and broad stakeholder engagement is fundamental to the HTR process. The specific individuals that need to be engaged will depend on your healthcare context and technology in question; not all stakeholders are required at all times. Examples of five key stakeholder groups are provided below. Based on these groups, identify your role, the key players and their roles and interests in the HTR initiative.

Patients, community, civil society organisations
•Present and past patients and the wider public; represented as individuals or groups (e.g., patient advocay groups with experience with technology)

Clinical professionals
•Individuals involved in the care of patients and use of the technology; represented as individuals or in groups by clinical professional associations

Industry representatives
•Includes technology manufacturers, pharmaceutical industry, and industry union

System leaders
•Administrators and executives in arm's-length (e.g., safety and health quality commissions) or non-government organisations, and thir party payers or insurers

Government policy-makers
•Elected officials (e..g., Ministers of Health) at the regional (e.g., municipal, provincial, state) or federal levels

#3. THE PLAYING FIELD
Describe the key features of the healthcare system context, including the organization and governance, the financing mechanisms, the political forces or issues, and the resources and analytic assets at your disposal to conduct the HTR.

Who is covered and how is insurance financed, including any rules/limits?
How is the delivery system organized and financed?

#4. THE OFFENSIVE PLAYS
With the stats and projections, the team, and the playing field in mind, it is now time to plan out the offensive plays for your HTR initiative. Here are 3 categories of approaches and policy levers for you to consider. In order to reach your goal, you may require a variety of levers to target different stakeholder groups in your context. Therefore, we also provide recommendations for the ideal players and assets that need to be in place to employ each lever type.

#5. THE DEFENSIVE PLAYS
It is important to acknowledge that despite your best efforts, there may be some unanticipated consequences (either positive or negative) to your offensive play. For example, one potential negative unanticipated consequence that can arise from the removal of an existing technology is the increased use of another technology that is potentially less effective and/or more expensive. Consider potential unintended consequences and the actions you would take to monitor and mitigate them.

#6. WINNING THE GAME
Evaluating the outcome(s) of your HTR initiative, against your intended goal, will help you determine if you achieved success. Evaluation can incorporate formative, process, and outcome evaluation using both quantitative (e.g., analysis of technology utilization and costs) and qualitative (e.g., observation, interviews, focus groups) methods. We offer you some key questions to reflect upon to plan your evaluation.

REMEMBER TO PIVOT IF NECESSARY!
You can always shake up the plays if something is not working.