Sonya de Laat

When research seems like clinical care: a qualitative study of the communication of individual cancer genetic research results

BackgroundResearch ethicists have recently declared a new ethical imperative: that researchers should communicate the results of research to participants. For some analysts, the obligation is restricted to the communication of the general findings or conclusions of the study. However, other analysts extend the obligation to the disclosure of individual research results, especially where these results are perceived to have clinical relevance. Several scholars have advanced cogent critiques of the putative obligation to disclose individual research results. They question whether ethical goals are served by disclosure or violated by non-disclosure, and whether the communication of research results respects ethically salient differences between research practices and clinical care. Empirical data on these questions are limited. Available evidence suggests, on the one hand, growing support for disclosure, and on the other, the potential for significant harm.MethodsThis paper explores the implications of the disclosure of individual research results for the relationship between research and clinical care through analysis of research-based cancer genetic testing in Ontario, Canada in the late 1990s. We analyze a set of 30 interviews with key informants involved with research-based cancer genetic testing before the publicly funded clinical service became available in 2000.ResultsWe advance three insights: First, the communication of individual research results makes research practices seem like clinical services for our respondents. Second, while valuing the way in which research enables a form of clinical access, our respondents experience these quasi-clinical services as inadequate. Finally, our respondents recognize the ways in which their experience with these quasi-clinical services is influenced by research imperatives, but understand and interpret the significance and appropriateness of these influences in different ways.ConclusionOur findings suggest that the hybrid state created through the disclosure of research results about individuals that are perceived to be clinically relevant may produce neither sufficiently adequate clinical care nor sufficiently ethical research practices. These findings raise questions about the extent to which research can, and should, be made to serve clinical purposes, and suggest the need for further deliberation regarding any ethical obligation to communicate individual research results.

The primary care physician role in cancer genetics: a qualitative study of patient experience

BACKGROUND Increased availability of genetic testing is changing the primary care role in cancer genetics. The perspective of primary care physicians (PCPs) regarding their role in support of genetic testing has been explored, but little is known about the expectations of patients or the PCP role once genetic test results are received. METHODS Two sets of open-ended semi-structured interviews were completed with patients (N=25) in a cancer genetic programme in Ontario, Canada, within 4 months of receiving genetic test results and 1 year later; written reports of test results were collected. RESULTS Patients expected PCPs to play a role in referral for genetic testing; they hoped that PCPs would have sufficient knowledge to appreciate familial risk and supportive attitudes towards genetic testing. Patients had more difficulty in identifying a PCP role following receipt of genetic test results; cancer patients in particular emphasized this as a role for cancer specialists. Still, some patients anticipated an ongoing PCP role comprising risk-appropriate surveillance or reassurance, especially as specialist care diminished. These expectations were complicated by occasional confusion regarding the ongoing care appropriate to genetic test results. CONCLUSIONS The potential PCP role in cancer genetics is quite broad. Patients expect PCPs to play a role in risk identification and genetics referral. In addition, some patients anticipated an ongoing role for their PCPs after receiving genetic test results. Sustained efforts will be needed to support PCPs in this expansive role if best use is to be made of investments in cancer genetic services.

Patients’ decision making to accept or decline an implantable cardioverter defibrillator for primary prevention of sudden cardiac death

Background  Patients are offered implantable defibrillators (ICDs) for the prevention of sudden cardiac death (SCD). However, patients’ decision‐making process (DMP) of whether or not to accept an ICD has not been explored. We asked patients about their decision making when offered an ICD.

Readability and content of patient education material related to implantable cardioverter defibrillators.

Background:Implantable cardioverter defibrillators (ICDs) are increasingly offered to patients for primary prevention of sudden cardiac death. Candidates for ICD receive ICD-related patient education material when they make decisions to consent or decline a primary prevention ICD. Printed patient education material directed at ICD candidates has not been the focus of direct appraisal. Objective:We evaluated the readability and content of ICD-related print education materials made available to patients who were enrolled in a study involving patient decision making for ICD from 3 ICD sites in southern Ontario, Canada. Methods:All ICD print materials referred to during interviews and/or that were available in ICD site waiting rooms were collected for analysis. Readability testing was conducted using the “simple measurement of gobbledygook” and Fry methods. The material was evaluated according to selected plain-language criteria, thematic content analysis, and rhetoric analysis. Results:Twenty-one print materials were identified and analyzed. Documents were authored by device manufacturers, tertiary care hospitals, and cardiac support organizations. Although many documents adhered to plain-language recommendations, text-reading levels were higher than recommended. Twelve major content themes were identified. Content focused heavily on the positive aspects of living with the device to the exclusion of other possible information that could be relevant to the decisions that patients made. Conclusions:Print-based patient education materials for ICD candidates are geared to a highly literate population. The focus on positive information to the exclusion of potentially negative aspects of the ICD, or alternatives to accepting 1, could influence and/or confuse patients about the purpose and implications of this medical device. Development of print materials is indicated that includes information about possible problems and that would be relevant for the multicultural and debilitated population who may require ICDs. The findings are highly relevant for nurses who care for primary prevention ICD candidates.

Ethics and Emergency Disaster Response. Normative Approaches and Training Needs for Humanitarian Health Care Providers

Health care professionals who travel outside their familiar contexts to provide humanitarian health aid after disasters encounter ethical challenges that are both familiar and distinct from those they experience in their home settings. Few however, are given ethics training, preparation or resources for managing these situations in ways which can help them cope with moral distress and support ethical action as they attend to the needs of those they aim to assist. In a qualitative study we collected and analysed the stories of ethical challenges and moral experience of humanitarian health care professionals who travelled to settings around the globe where needs are widespread and elevated due to extreme poverty, large scale violence, or in the aftermath of natural disaster. Their stories illustrated how health care decision-making in disaster contexts is often beset by complicating factors such as resource scarcity, security conflicts and disparate cultural expectations.

Opportunities, limits and challenges of perceptions studies for humanitarian contexts

ABSTRACT This article aims to advance understanding and discussion of perceptions studies as a method for strengthening humanitarian performance. Perceptions studies are qualitative studies produced for and often by humanitarian organisations, based on analysis of local perceptions of humanitarian efforts. While these studies are normatively asserted as valuable within the humanitarian sector, there has been no synthesis to date of their potential and limitations. This critical review of 59 perceptions-related documents responds to that gap, outlining key assertions of the value added and challenges of using perceptions studies in humanitarian work. While the objective is to inform and strengthen future use of this method, the perceptions literature also points to significant tension between this qualitative method and dominant expectations in humanitarian monitoring and evaluation.

Exploring the experiences of substitute decision-makers with an exception to consent in a paediatric resuscitation randomised controlled trial: study protocol for a qualitative research study

Introduction Prospective informed consent is required for most research involving human participants; however, this is impracticable under some circumstances. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) outlines the requirements for research involving human participants in Canada. The need for an exception to consent (deferred consent) is recognised and endorsed in the TCPS for research in individual medical emergencies; however, little is known about substitute decision-maker (SDM) experiences. A paediatric resuscitation trial (SQUEEZE) (NCT01973907) using an exception to consent process began enrolling at McMaster Childrens Hospital in January 2014. This qualitative research study aims to generate new knowledge on SDM experiences with the exception to consent process as implemented in a randomised controlled trial. Methods and analysis The SDMs of children enrolled into the SQUEEZE pilot trial will be the sampling frame from which ethics study participants will be derived. Design: Qualitative research study involving individual interviews and grounded theory methodology. Participants: SDMs for children enrolled into the SQUEEZE pilot trial. Sample size: Up to 25 SDMs. Qualitative methodology: SDMs will be invited to participate in the qualitative ethics study. Interviews with consenting SDMs will be conducted in person or by telephone, taped and professionally transcribed. Participants will be encouraged to elaborate on their experience of being asked to consent after the fact and how this process occurred. Analysis: Data gathering and analysis will be undertaken simultaneously. The investigators will collaborate in developing the coding scheme, and data will be coded using NVivo. Emerging themes will be identified. Ethics and dissemination This research represents a rare opportunity to interview parents/guardians of critically ill children enrolled into a resuscitation trial without their knowledge or prior consent. Findings will inform implementation of the exception to consent process in the planned definitive SQUEEZE trial and support development of evidence-based ethics guidelines.

The development of a humanitarian health ethics analysis tool

UNLABELLED Introduction Health care workers (HCWs) who participate in humanitarian aid work experience a range of ethical challenges in providing care and assistance to communities affected by war, disaster, or extreme poverty. Although there is increasing discussion of ethics in humanitarian health care practice and policy, there are very few resources available for humanitarian workers seeking ethical guidance in the field. To address this knowledge gap, a Humanitarian Health Ethics Analysis Tool (HHEAT) was developed and tested as an action-oriented resource to support humanitarian workers in ethical decision making. While ethical analysis tools increasingly have become prevalent in a variety of practice contexts over the past two decades, very few of these tools have undergone a process of empirical validation to assess their usefulness for practitioners. METHODS A qualitative study consisting of a series of six case-analysis sessions with 16 humanitarian HCWs was conducted to evaluate and refine the HHEAT. RESULTS Participant feedback inspired the creation of a simplified and shortened version of the tool and prompted the development of an accompanying handbook. CONCLUSION The study generated preliminary insight into the ethical deliberation processes of humanitarian health workers and highlighted different types of ethics support that humanitarian workers might find helpful in supporting the decision-making process.

Combat Hospital’s deployment of ethics and entertainment

After a quick glance at the promotional photographs of the new military medical drama Combat Hospital it’s easy to peg this show as formulaic, thin and propagandist. Being a made-for-prime-time series with high production value and well-known actors gives an air of entertainment rather than