Governments in the United Kingdom, Australia, Canada, and other jurisdictions have increasingly incorporated public and patient involvement into health-related decision making over the past three decades (Reference Conklin, Morris and Nolte1). Initiatives to increase patient engagement have similarly been promoted in clinical care, in priority setting for health-related research, in conducting research, and in reviewing research output (Reference Mockford, Staniszewska, Griffiths and Herron-Marx2). The general aims of such public and patient involvement have been articulated from both an ethical perspective (to increase the openness and transparency of decision making, to incorporate social and ethical concerns into priority setting, and to directly involve communities for whom decisions will have the greatest impact) and to improve clinical and public health outcomes (to achieve better health outcomes, increase acceptance of decisions, ease implementation, and decrease conflict) (Reference Staley and Doherty3). Although such general aims are also often articulated in healthcare resource allocation decision making, few studies have explicitly defined evaluation criteria of such involvement.
Recent work has explored whether concerns expressed in submissions from patient advocacy groups are reflected in recommendations for drug-related health technology assessments and whether hospital-based assessments incorporate concerns raised in patient consultations (Reference Dipankui, Gagnon and Desmartis4;Reference Berglas, Jutai, MacKean and Weeks5). Additional evaluation challenges arise when considering how public input may be distinct from patient input and how to evaluate the success of having patient or public members of committees. Putting patient and public representatives at the same table as committee members with clinical or economic expertise invokes power differentials due to different types of “expert” knowledge (Reference Gibson, Martin and Singer6). Public and patient involvement can also be costly and time consuming. Therefore, it is also important to evaluate whether public and patient involvement results in meaningful participation in decision-making processes.
Our goal was to develop criteria to evaluate the success of patient and public involvement in healthcare decision making; our focus was on evaluating committees that make public drug formulary listing recommendations in Canada. Our specific aim was to define explicit evaluation criteria of patient and public involvement that would help to guide future development of evaluation criteria. We also identified processes and structures that both facilitate and impede implementing these evaluation criteria. We analyzed both direct involvement (such as committee membership) and indirect involvement (such as submissions to a committee) and sought multiple perspectives to explore the experiences and opinions of people who have been patient or public members of committees that make Canadian drug resource allocation recommendations or those who have interacted with such committees.
METHODS
Literature Review
We performed a literature review of studies that described the development or evaluation of an instrument to measure public or patient involvement in public decision making (not restricted to health-related fields). The review had two purposes (Figure 1). First, we used the results to structure the interview guide for stakeholder interviews. Second, we incorporated the literature review findings with the results of the key informant interviews to define the evaluation criteria of patient and public involvement.
Figure 1. Study overview.
We searched the following databases: Embase; Health & Psychosocial Instruments; MEDLINE; Cochrane Library; Social Science Citation; Geobase; and CINAHL. Our search strategy, developed with a medical research librarian, was as follows: (“public engagement” or “public involvement” or “public participation” or “citizen engagement” or “citizen participation” or “citizen involvement” or “citizen jury”) AND (”evaluation” or “framework” or “questionnaire” or “tool” or “assessment”). We limited our search to English language articles published between 1997 and January 2013 and did not include conference abstracts or theses. We identified additional articles through searching references of included articles and through searching Google Scholar. One author (Z.R.) reviewed all abstracts and flagged relevant articles for a full-text review. An author (Z.R.) and a research coordinator independently reviewed full-text articles and met to resolve discrepancies by consensus. When necessary, we contacted authors for additional information.
Interviews
We conducted twenty-seven key informant interviews with stakeholders knowledgeable about patient and public involvement in Canadian drug resource allocation decisions. We used purposive and theoretical sampling to recruit a maximum variation of participants who differed in terms of their role in healthcare decision making. Participants were eligible if they spoke English and were a member of one of the following groups: (i) drug formulary recommendation committee (past or present), including public, patient, and scientific or content expert representatives; (ii) government employees with current or previous experience with drug resource allocation decisions; (iii) patient advocacy group; and (iv) pharmaceutical manufacturer employees.
We identified participants from Web sites listing drug formulary recommendation committee members, from suggestions by staff in Ministries of Health, and by snowball sampling, in which we asked recruited participants to identify other potential participants (Reference Maxwell7). All interviews were conducted over the telephone with verbal informed consent. All interviews were digitally recorded and transcribed verbatim. The interviews followed a semi-structured format and used an interview guide, with probes as needed (Figure 2). The study was approved by the Research Ethics Board of St. Michael's Hospital in Toronto, Canada.
Figure 2. Interview guide.
Analysis
We used a qualitative thematic approach to analyze the interviews. The process was inductive and involved line-by-line coding, with codes and categories developed directly from individuals’ interview transcripts. Coding was performed by both co-authors who discussed discrepancies and established consensus for the preliminary coding scheme from the first five transcripts. The coding scheme was revised as the interviews progressed using an iterative process. We used constant comparison to examine relationships within and across codes and categories and developed core themes using focused and theoretical coding. Interviews continued until no new codes or categories were developed. We integrated our qualitative analysis results with the findings from our literature review to define the evaluation criteria for patient and public involvement. All data were managed using QSR NVivo 8 (8).
RESULTS
Literature Review
Our literature review identified 2,629 articles, of which 100 were selected for full-text review (Figure 3). Five studies developed or evaluated an instrument assessing patient or public involvement in public decision making; topic areas included smoking policy, environmental management, participation in Open Space technology for community development, genetically modified crops, and food policy (Reference Carnes, Schweitzer and Peelle9–Reference Rowe, Horlick-Jones, Walls, Poortinga and Pidgeon13). We contacted two authors and received additional information from one.
Figure 3. PRISMA flow diagram.
Domains that were consistently assessed across studies included ensuring that: the role and representativeness of patient and public members are clearly defined; the decision-making processes are inclusive, transparent, and adequately resourced; patient and public members had sufficient support to fulfill their roles and could freely express their values and opinions; and that patient and public involvement had a meaningful impact on decisions. These themes informed the development of our interview guide (Figure 2). These articles, as well as selected others identified in the review and cited with each evaluation criterion below, informed our final list of evaluation criteria. The full list is available in the Supplementary References.
Interviews
We interviewed twenty-seven key informants including four industry representatives, six patient advocacy group representatives, one past government employee who was also a past drug formulary recommendation committee (hereafter referred to as “committee”) member, five current government employees, and eleven current committee members. The average age of participants was 55 years (range, 39 to 68 years), eighteen participants (67 percent) were women, and twenty (74 percent) had a professional or graduate degree. The twelve participants who were past or current committee members represented nine committees at the provincial or territorial level (Yukon, British Columbia, Alberta, Saskatchewan, Ontario, Quebec), a federal committee for First Nations and Inuit peoples (the Non-Insured Health Benefits Drugs and Therapeutics Advisory Committee), and two national committees that make recommendations to sub-national committees (the Canadian Drug Expert Committee and pan-Canadian Oncology Drug Review Expert Review Committee). The patient advocacy group participants each represented a group that had received industry funding, as disclosed on their websites.
Evaluation Criteria
We used key informants’ interview responses and the results of our literature review to identify nine evaluation criteria of patient and the public involvement in healthcare resource allocation decision making: clarity regarding rationale and roles of patient and public members, sufficient support, adequate representation of relevant views, fair decision-making processes, legitimacy of committee processes, adequate opportunity for participation, meaningful degree of participation, noticeable effect on decisions, and considerations of the efficiency of patient and public involvement. We list each criterion with examples of items that conceptualize the utility of evaluating public and patient involvement within the context of drug resource allocation. Supporting quotations from respondents have been included with each criterion below.
Criterion 1. Clarity Regarding Rationale and Roles of Patient and Public Members
The purposes of patient and public involvement should be clearly defined (Reference Asthana, Richardson and Halliday14–Reference Thurston, MacKean and Vollman19). This criterion may define whether a member's role is to represent the broader public view, the patient view, or both. Furthermore, rationale may define whether the objective of involvement is to consult with external patient advocacy groups or to actively partner with them in making decisions.
Interview respondents noted a need for clarity regarding the distinction between the rationales for patient involvement versus public involvement. One committee respondent explained:
“We have to distinguish citizen involvement from patient involvement because we are not looking for the same kind of input . . . We expect from our citizens . . . to be sensitive of the patient perspective . . . but they're also there for other . . . broader issues to be taken into account, [such] as the social . . . and ethical values . . . [and] equitable and reasonable access to treatment.” (INT9)
Patient and public committee members also identified ambiguity about their role on committees:
“It depends on what we consider our ultimate goal to be. If we consider our ultimate goal to have decisions that are reflective of the values of the general public, then it is fine to have the public inform those decisions. But if we consider our objective to be . . . decisions that are fair and equitable [and as], ethical as possible, then it's not necessarily going to be the case, that the public is going to give us the best answers.” (INT4)
Criterion 2. Adequate Representation of Relevant Views
A full range of perspectives should be represented (Reference Grant and Curtis16;Reference Jabbar and Abelson17;Reference Thurston, MacKean and Vollman19–Reference Sykes and Goodwin29). This criterion may assess whether patient and public members are sufficiently representative of their constituencies and whether patient advocacy group submissions that are received from several groups adequately represent diversity. Several respondents discussed the need for a process that ensures appropriate representation. One respondent recognized the challenge of representing both patient and public perspectives:
“You know there are the tax-payers and there are the patients and . . . various groups that are part of the public. So it is a challenge for the public member to represent all those views.” (INT3)
A few respondents discussed the challenge of public involvement as getting the “breadth of perspective that you would need for a jurisdiction . . . for example, there's urban/rural . . . it's male/female. It's rich/poor . . . And it's even worse at a national level.” (INT 17) Similarly, another patient advocacy group representative suggested the creation of a
“Patient advisory committee that's made up geographically, you know, disease, and gender, and age, and have that well rounded committee that can actually, you know, they can take their issues to and get feedback too.” (INT18)
Criterion 3. Fair Decision-Making Processes
The processes and procedures used by the committee should ensure fairness in decision making from the perspective of patient and public representatives (Reference Martineau-Delisle and Nadeau26–Reference Rowe and Frewer28;Reference Chafe, Neville, Rathwell and Deber30;Reference Stanghellini31). This criterion may assess whether committee decisions recognize outcomes that are valued by patients and which patient advocacy groups, if any, the public would prioritize for funding decisions. Respondents thought that patient and public involvement was an important component in facilitating a fair and democratic process. As one respondent noted, “Those who will be affected by our decisions must be consulted, it's not our decisions.” (INT9)
Some patient representatives thought that not all types of evidence were considered by committees when making recommendations, including patients’ experiences and values. One patient / public member discussed the challenge of integrating patients’ narratives:
“[W]e have to come up with a way . . . of considering patient experience given in contradistinction to something like safety, which is obviously critical, we don't want to market unsafe drugs, but also cost-effectiveness.”(INT19)
Criterion 4. Sufficient Support
Patient and public representatives should have sufficient support to fulfill their responsibilities (Reference Asthana, Richardson and Halliday14;Reference Brinkerhoff20;Reference Laverack21;Reference Rowe and Frewer28;Reference Smiley, de Loë and Kreutzwiser32;Reference Webler33). This criterion may address whether public and patient committee members have access to education and training and whether patient advocacy groups have sufficient guidance and support in preparing submissions.
Many respondents describe a steep learning curve for patient and public committee members; some respondents suggested that the terms for committee members should be longer than their committee's usual three years because of this:
“In the beginning, the intimidation level was very high . . . My comfort level has improved. I can ask better questions from a more informed point of view. I think the term is three years, and I am now at the point where I am comfortable . . . It probably should be a longer term, only because if I am just getting really comfortable and have no qualms about asking questions.” (INT12)
While all committee members had an orientation session and ongoing access to phone support for questions arising during their review of reports, some committee members discussed ways to improve their training, including webinars and the creation of a reference handbook.
Education was also discussed as a method of supporting both patient advocacy groups and the public in the recommendation process. Some patient and public committee members thought that their role should be expanded:
“[To] be a good liaison with the patient advocacy groups and . . . tell them what that committee is looking for . . . how to make the submissions better . . . . because it might sound better coming from them [the committee] as opposed to the ministry.” (INT5)
Several respondents noted that the majority of patient education regarding the submission process is being done by industry; industry representatives believe that they are supporting patients by filling a gap that is not being addressed by the committees or government. As one industry respondent explained:
“In my opinion, none of the entities have done a good job in education . . . We're [industry] really just facilitating that process. . .So helping them to think about what their options were, whether it was surveys . . . these patient advocacy groups are just thirsting for knowledge and an understanding and someone to talk to, and ask questions of.” (INT11)
Criterion 5. Legitimacy of Committee Processes
Committees’ processes should be accountable and transparent (Reference Asthana, Richardson and Halliday14;Reference Grant and Curtis16;Reference Brinkerhoff20;Reference Abelson, Forest, Eyles, Smith, Martin and Gauvin22;Reference Rowe and Frewer28;Reference Branch and Bradbury34–Reference Davies and Burgess37). This criterion may assess whether participants understand how decisions are made and whether stakeholders are able to appeal decisions (Reference Rosenberg-Yunger and Bayoumi38).
Respondents discussed improving transparency by enabling dialogue between the committee and patient advocacy groups before a submission is finalized:
“Feedback to the groups making the public submissions would be beneficial because . . . they're providing information without having a good sense of what it is that we're looking for.” (INT17)
A few respondents reported the need to establish better structures to ensure appropriate information flow between committees and governmental staff and between committees and stakeholders. Methods currently being used by committees to communicate with patient advocacy groups and the public include email, online surveys and forums, presentations to patient advocacy groups, and direct conversations.
Criterion 6. Adequate Opportunity for Participation
Committees should have processes that allow public and patient representatives the opportunity to participate fully in discussions and to address power differentials (Reference Grant and Curtis16,Reference Brinkerhoff20–Reference Abelson, Forest, Eyles, Smith, Martin and Gauvin22;Reference Chafe, Neville, Rathwell and Deber30;Reference Stanghellini31;Reference Blackstock, Kelly and Horsey35). This criterion may assess whether there is dedicated time during discussions for patient and public input and whether there is sufficient time for external stakeholders to prepare submissions.
Many patient and public committee members were satisfied with their level of involvement on the committees. One patient/public member described their interaction on the committee as, “we have an opportunity to speak at any time . . . I feel that our opinions are valued.” (INT12).
Criterion 7. Meaningful Degree of Participation
Committee deliberations should include meaningful patient and public participation (Reference Grant and Curtis16;Reference Brinkerhoff20;Reference Abelson, Forest, Eyles, Smith, Martin and Gauvin22;Reference Rowe and Frewer28;Reference Webler and Tuler39). This criterion may assess the level of participation of public and patient members in decisions and the number and quality of patient advocacy group submissions. As one respondent noted,
“Have the patient members been fully integrated into the committee and are viewed by other committee members . . . as equal members?” (INT10)
Criterion 8. Noticeable Effect on Decisions
Public and patient involvement should materially influence committees’ recommendations (Reference Nadeem and Fischer27;Reference Rowe and Frewer28;Reference Pohjola and Tuomisto40). This criterion may assess how many decisions would have led to different conclusions had patient or public involvement not been present. As a respondent explained: “What difference did it [patient input] make, how did it impact the final recommendation that came out of the process?” (INT11)
Many patient advocacy groups wondered about the effect of their involvement on the process and whether the endeavor to include patients was “just window dressing” (INT 11). Some believed involvement was just “optics” while others believed it was genuine. One patient representative described frustration with how patient submissions were used in decision-making processes:
“Every health ministry across the country has given an awful lot of lip service to listening to patients, and we are going to have patient representatives and we are going to have patient submissions . . . . but when the rubber hits the road, they are not really serious about it because . . . if it doesn't come to them in their science mode, they don't want it . . . the emphasis is always going to be on the science, and the science is always going to use language like averages, and means, and progressions, the mean progression free survival. And there is a lot of artifice about how the science is spoken about and described. So it is very frustrating.” (INT1)
In general, respondents believed patient and public involvement could lead to better decisions by broadening the committees’ understanding of relevant issues, providing information on important trade-offs, and “bring[ing] humanity to the science of evaluating new drugs” (INT1). However, respondents did not articulate specific thoughts about how to ascertain whether patient and public involvement led to notably different decisions.
Criterion 9. Considerations of Efficiency
Committees should have sufficient resources to ensure effective participation, which should be used efficiently (Reference Thurston, MacKean and Vollman19;Reference Nadeem and Fischer27;Reference Charnley and Engelbert41). This criterion may assess the time and money needed to make recommendations and the value obtained relative to the resources expended.
Respondents understood that there may be constraints to fully including patient and public members but it was still valuable. As one patient/public member commented:
“It takes more time, more deliberation, sometimes more money. But then you have to weigh that against what we're getting out of it, as a system. So their contribution to the discussion, possibly better decisions, possibly more accountability and more transparency.” (INT12)
DISCUSSION
Through key informant interviews and a literature review, we identified nine evaluation criteria that characterize optimal patient and public involvement in decision making for publicly funded drug resource allocation. We believe these criteria will apply broadly to other resource allocation decisions that integrate stakeholder input in health and other sectors. Although public and patient involvement is often accepted as advantageous, the literature review indicates that ours is one of the first studies to delineate the objectives of such engagement in healthcare decision making. Clearly articulating these objectives provides a framework for developing evaluation criteria to better define, design, implement, and evaluate patient and public involvement. Three of our criteria relate to the purpose and organization and of committees (rationale and roles, representation, and fair decision making), three to the structures and processes by which committees operate (support, legitimacy, and opportunity for participation), and three to evaluating the outcomes of public and patient involvement (degree of participation, effect on decisions, and efficiency of incorporating patient and public involvement).
Although patient and public involvement are often conflated and the perspectives may frequently overlap, they may also occasionally be in opposition. For example, drug formulary committees may encounter such conflicts when considering very high cost drugs for rare conditions. In such circumstances, the perspective of a public representative as a steward of scarce resources might differ from that of a patient representative advocating for a neglected group. Similarly, committees would benefit from clearly distinguishing between patient and public input in terms of representation and agency. That is, do patient and public members or submitting groups provide input as individuals with particular backgrounds, do they speak as representatives of their constituencies, or do they seek to reflect the diversity of patient and public views when decisions are being made? Patient and public members may also have different roles when presenting patient experiences and when voting on recommendations. Ensuring authentic patient voices raises concerns relating to the independence of patient advocacy groups from industry funding.
Finally, defining fairness as, in part, including the patient perspectives raises questions regarding how patient narratives are considered as evidence alongside clinical and economic data (Reference Staley and Doherty3;Reference Abelson, Li, Wilson, Shields, Schneider and Boesveld42). Some of these conflicts may not be resolvable and the tension between these roles may indeed be instructive for the committees. Nevertheless, providing guidance to patient and public representatives regarding how to consider such issues and identifying committee members’ specific roles in a committee's terms of reference may increase the effectiveness of their participation.
While the importance of support and legitimacy may be self-evident, our participants’ responses and our previous work indicate that, at least in Canada, there is considerable variation across committees in committee structure, transparency, and how much backing public and patient representatives receive (Reference Rosenberg-Yunger and Bayoumi38). Issues that are likely relevant across jurisdictions include the need to create formal appeal mechanisms and to establish consistent rules about the use of, and public access to, proprietary evidence.
Abelson et al. have emphasized the importance of having a culture of participation (Reference Abelson, Li, Wilson, Shields, Schneider and Boesveld42). Ensuring adequate opportunities for participation can be addressed by such processes as allowing patient advocacy groups sufficient time to prepare submissions, putting patient input submissions first on the agenda, ensuring that public and patient representatives have protected time to speak, and perhaps by having deliberations that are open to the public, as in Scotland (43). Measuring the degree of participation will be more challenging; a tally of the number of submissions or the proportion of time in meetings dedicated to patient/public representatives will not evaluate the quality of such participation, which will require sufficient time and resources to conduct a full qualitative assessment.
Berglas and colleagues have explored methods to evaluate whether drug recommendations reflect concerns in patient advocacy group submissions but recognize that this is only an aspect of measuring whether participation is meaningful (Reference Berglas, Jutai, MacKean and Weeks5). Assessing the level of participation of members in decisions may require an observational study of committee deliberations. Careful attention to how to measure such metrics will be important for any evaluation instrument.
Similarly challenging will be how to measure the effect of patient and public input on decisions. Some might argue that patient and public involvement is justifiable solely on the basis of democratic principles and that such involvement will, therefore, result in necessarily better decisions, even if it does not result in different decisions. We suspect that such an argument will not persuade many advocates who participate to influence committees’ recommendations in substantive ways. This evaluation criterion might be assessed by comparing decisions for similar drugs across jurisdictions that vary in the composition of public and patient members. In particular, it may be instructive to explore whether funding recommendations for drugs that offer clinical benefit but are not cost-effective at conventional thresholds, are regarded differently by patient and by public representatives. Similarly, future research should explore how decision making frameworks evolve as patient input increases, particularly for issues related to rare diseases.
Although there was strong support for the principle of patient and public involvement, many participants indicated that an evaluation framework should also measure the efficiency of such a process and whether resources expended on such participation represent good value for money, perhaps because our participants were primed to think of evaluation from the perspective of opportunity cost given their experience with resource allocation decisions.
Our analysis focused specifically on drug-related resource allocation decisions that may have characteristics that make the nature of patient and public involvement different than health technology assessments at the local level, such as in hospitals (Reference Dipankui, Gagnon and Desmartis4;Reference Berglas, Jutai, MacKean and Weeks5). For example, drug-related decisions often have shorter timelines and, in the Canadian setting, may have less opportunity for input by experts in ethics or social values. Indeed, our results indicate that social and ethical considerations may default to public representatives, although they may not have formal training in these areas. Furthermore, drug-related recommendations in the Canadian setting are frequently phrased using relatively strong wording. Thus, while patient concerns may be communicated in the reasons for a decision, they may not be strongly reflected in the summary recommendation. This structure introduces further challenges to evaluating the effect of patient and public input on decision making.
Abelson and colleagues recently published the results of the development and usability testing of a Public and Patient Engagement Evaluation Tool (Reference Abelson, Li, Wilson, Shields, Schneider and Boesveld42). Abelson defined four domains of quality engagement (integrity of design and process, influence and impact, participatory culture, and collaboration and common purpose) and developed three unique questionnaires to assess engagement from the perspectives of participants in public and patient engagement activities, those who “plan, execute, or sponsor” such activities, and leaders within organizations.
In contrast to Abelson, we engaged a wider diversity of stakeholders, included a broader range of public engagement literature (such as environmental studies), and had a narrower focus on resource allocation. Nevertheless, we similarly found a lack of evaluation instruments specific to health care. While Abelson's domains of quality engagement overlap somewhat with our identified evaluation criteria, particularly in issues of process, our list probes deeper into issues of rationale for involvement, roles, representation, measuring the effects on decisions, and evaluating whether patient and public input is an efficient use of resources.
Our study has significant strengths, including a comprehensive literature review, the inclusion of a wide spectrum of stakeholders including the public, industry, and academic experts, and inclusion of a range of evaluation criteria addressing divergent issues. Our study also has some limitations. While our search was wide-ranging, we did not perform a full systematic review of the literature on patient, public, and stakeholder engagement across all sectors. Such a review would require search terms that are highly sensitive, but not necessarily specific, and searching across many social science and humanities databases, which was beyond the scope of our project.
We also do not address operational issues; such issues are complex and the optimal approaches will frequently be context-specific (for example, smaller provinces with large rural communities may need to use telecommunication for meetings). We restricted our study to stakeholders with interests in drug resource allocation; committees that evaluate nondrug technologies or that are focused on other aspects of health care besides funding might have additional concerns. Several of the issues we raise, such as how “patients” are defined, are specific to the health context. Similarly, we have not addressed societal issues outside of health, such as whether and how to include representatives of marginalized communities. Finally, we included only Canadian settings but recognize that similar issues are being addressed internationally. The applicability of these evaluation criteria to other countries is a topic for future research.
CONCLUSIONS
Although more patient and public participation in public decision making has been adopted globally, there is considerable uncertainty about how the specific objectives of such involvement are both articulated and evaluated. We have presented an approach to conceptualizing patient and public involvement in drug resource allocation decisions which draws from the evaluation literature broadly, including both health and nonhealth domains, and integrates these findings with stakeholder perspectives to identify nine evaluation criteria that define optimal involvement. These evaluation criteria can help to develop, refine, and test additional evaluative instruments that assess public and patient involvement in healthcare resource allocation decision making.
SUPPLEMENTARY MATERIAL
Supplementary Reference List: https://doi.org/10.1017/S0266462317000307
CONFLICTS OF INTEREST
Dr. Bayoumi was supported by a Canadian Institutes of Health Research / Ontario Ministry of Health and Long-Term Care Applied Chair in Health Services and Policy Research and is currently supported by the Fondation Baxter & Alma Ricard Chair in Inner City Health at St. Michael's Hospital and the University of Toronto. Dr. Rosenberg-Yunger has nothing to disclose.
