Introducing patient perspective in health technology assessment at the local level

Improving the quality of healthcare through the best scientific evidence available in a context of scarce resources is a challenge for health systems [1]. Health technology assessment (HTA) is a multidisciplinary field of applied research aimed at providing high-quality information about the clinical effectiveness, cost-effectiveness, and broader impact of drugs, medical technologies, and health interventions in order to support and inform those who make decisions about health policy and purchasing, health services organisation and management, and clinical practices [2, 3]. In Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH), and provincial agencies, such as the Agence d'évaluation des technologies et des modes d'intervention en santé (AETMIS) in Quebec, are responsible for conducting health technology assessments at a macroscopic level. However, HTA recommendations are seldom transferred into decisions and practices [4]. In order to favour knowledge transfer and to support evidence-based decision making at both mesoscopic and microscopic levels, local HTA units have been implemented in all five university hospitals in Quebec. The implementation of these local HTA units is viewed as a strategy to improve the relevance and timeliness of HTA recommendations and, ultimately, to facilitate their uptake [5]. This implementation could thus favour a culture of evaluation in university hospitals, which is coherent with the promotion and uptake of effective healthcare decisions.

Effective healthcare decisions are more and more conceptualised as the best course of action given the current scientific evidence, healthcare resources, clinical circumstances, and patient preferences [6]. With the increased emphasis on the engagement of patients as full partners in their care, there is a need to determine effective ways to involve them in the decision process [7, 8]. It is expected that the need for "patient guidance will only increase as clinical options multiply and the world of information continues its rapid growth" [9]. This is congruent with the fact that several HTA agencies and academics associated with HTA are now considering ways to incorporate the perspectives of patients in their methods, thus calling for patient-centred HTA [10, 11].

The literature proposes different terms to refer to the various groups of end-users of HTA, such as patients, consumers, citizens and public. There is a lack of terminological consensus with the term public involvement. The analysis by Gauvin [12] identified six publics that he grouped into two categories. Publics "whose role is to provide a societal or lay perspective about health technologies" constitute the first category that includes citizens, groups representing citizens, and other representatives such as elected officials. The second category consists of "those publics directly affected by a given health condition or health technology" and includes individual patients, services users, and the entities representing them [12]. According to Cayton [13], these two categories could be considered as the two sides of the same coin because they represent different roles individuals could take when they engage with health services. However, according to Gauvin [12], most experts in HTA believe that the broader perspective of citizen is more likely to be involved in the organizational and policy-making domains and the perspective of patients and service users in the research domain. In this last domain, patients and service users are better positioned to highlight matters relevant to service users such as social and ethical consideration, patient acceptance of the technology, and psychological implications. In this study, we are interested mainly by patients because they are the group most directly affected by HTA decisions, and their unique insight can most usefully contribute to the HTA process. They could provide 'experiential' evidence to the HTA process [14]. We include members of the public (i.e citizens) in our literature review because of their role in some HTA activities and given the lack of terminology consensus about these terms. However, the other stages of the project are focusing more precisely on the patients.

The value of an increased participation of patients in healthcare decisions is now recognised and leads decision makers to consider effective ways or strategies to incorporate patients' perspectives in decision making processes.

Two local HTA units participate in this study. One is located at the Quebec City University Medical Centre and the other one, at the Sherbrooke University Medical Centre. The implementation of these two local HTA units provides a unique opportunity to assess the feasibility of introducing patient perspectives in hospital HTA activities.

Globally, we adopt a pluralist action research strategy [34] that will allow constant adjustments between research objectives, methods, data collection, and analysis. This strategy seems the most appropriate, given the specific nature of the partnership between researchers and decision makers in this project. With regards to utility for decision making, this collaboration between researchers and decision makers is fundamental. The role of decision makers is to ensure the appropriateness of the research questions, objectives, methods, analysis, and outcomes to the context, and the relevance of the research for its potential beneficiaries. Researchers have a role of facilitators in order to translate decision makers' needs into a systematic and rigorous research process and to analyse factors influencing the decision-making behaviours.

This project aims at producing usable knowledge that could support decision makers responsible for HTA activities. According to a systematic review of factors determining knowledge application in decision making, interactions between researchers and healthcare policy makers and timing/timeliness are two factors that mostly appear to increase research use [51]. Our approach to knowledge translation is based on these two key-elements and is organised around three broad strategies.

The first strategy is the participation of stakeholders in each phase of the project. Notably, decision makers are involved in the elaboration of research objectives, the choice of the methodology, and the analysis and interpretation of results. To do so, workshops will be held with decision makers on the research team through a participatory approach [52]. These workshops will take place at key moments before and after each phase of the project. These transfer activities will allow the validation of research products according to decision makers' needs and comments. This strategy aims to ensure that the results are useful and usable to support decision making processes. The participation of decision makers in the formulation and implementation of research represents, according to Lomas [53], the best predictive element of the application of knowledge resulting from research.

The second strategy involves a representative of patients in HTA activities. This representative will participate in the meetings of the project team in order to validate the research processes. In addition, other representatives of patients will be solicited during the course of the project to take part in a focus group on their perceptions about patient participation in HTA activities. This direct participation of patient representatives will allow the consideration of their preferences in the proposed strategies. Moreover, the deliberative meeting will allow direct exchanges between hospital administrators, clinical managers, HTA producers and patients' representatives. This activity will allow the discussion of research findings in order to ensure that they are uniformly understood by all groups and are relevant to their decision-making needs. Following this deliberative meeting, consensual key messages will be elaborated for larger diffusion [54].

Finally, the third strategy is the transfer of research results to other HTA units in Quebec, and to other groups involved in HTA in Canada and elsewhere. This transfer will be done through participation of representatives from other HTA units of the province in the focus groups and the deliberative meeting. Collaborators from HTA agencies in other countries will also be informed about this initiative and their feedback will be sought through workshops organised at international HTA meetings.

At the end of the project, we will organise a provincial symposium targeting key decision makers (policy makers, managers and professionals) from the UETMIS, AETMIS and CADTH. This will be a unique occasion for all groups involved in HTA in the province of Quebec to present and share their research experiences with other teams. The symposium proceedings and presentations will be available on the Web through an open access. Decision makers from the Ministry of Health and regional health authorities will also be invited to this symposium.

All data collected for the document analysis in this study will be obtained from publicly available sources. Participants in the focus groups (phase 2) will be asked to complete a consent form presenting research objectives and information about research implications. Ethics approval for the project has been received from the Research Ethics Board of the Centre Hospitalier Universitaire de Québec (approved December 18 2008; ethics number 5-08-12-05).

This study will be the first, to the best of our knowledge, to systematically review international experiences on patient participation in HTA, and to propose a framework that will support the development of a guide to support local HTA units in their decisions regarding patient participation. It will also explore the perceptions of various HTA stakeholders regarding the implication of patients in healthcare decisions.

This study is being conducted in close collaboration with decision makers in order to allow constant linkages that are likely to favour the relevance and utilisation of research results. Based on results from the literature review, focus groups, and deliberative meeting, effective strategies for supporting patient participation in HTA will be identified. A subsequent phase of this project could be the implementation of such strategies in the local HTA unit of university hospitals of Quebec. Thus, this research is an essential first step to ensure the feasibility of introducing patient participation in HTA.

Also, members of our research team are involved in two other knowledge syntheses that share a similar focus. One deals with patient perspectives on an electronic health record [59]. The other deals with patients and public involvement in clinical practice guidelines [60].

Given the actual state of evidence, promoting patient participation in HTA could improve the quality and safety of healthcare. This project provides an opportunity to bridge the gap between the producers of HTA and its ultimate end-user: the patient. The knowledge that will be produced will be extremely useful for policy makers, healthcare managers, and academics interested in HTA nationally and internationally, as well as for the larger community of people interested in the active participation of citizens and patients in healthcare decision making. This project directly aligns with at least three of the Canadian Institutes of Health Research strategic priority research areas: 1) it will provide innovative insight on how to successfully involving the public in decision making and, in particular, strategies for engaging the public in priority-setting; 2) it will reinforce a patient-centred care approach in focusing on the participation and involvement of patients; and 3) it will serve as a strategy to increase quality of care and patient safety [61].