International Journal for Quality in Health Care Advance Access originally published online on September 17, 2008
International Journal for Quality in Health Care 2008 20(6):421-432; doi:10.1093/intqhc/mzn043
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Patients' and family members' experiences of open disclosure following adverse events
1 University of Technology Sydney, Australia
2 University of Melbourne, Australia
3 University of Queensland, Australia
4 The Australian Commission on Safety and Quality in Health Care
Address reprint requests to: Rick Iedema, University of Technology Sydney, Australia. Tel: +61 2 9514 2709; Fax: +61 2 9514 2711; E-mail: r.iedema{at}uts.edu.au
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Abstract |
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Objective. To explore patients' and family members' perceptions of Open Disclosure of adverse events that occurred during their health care.
Design. We interviewed 23 people involved in adverse events and incident disclosure using a semi-structured, open-ended guide. We analyzed transcripts using thematic discourse analysis.
Setting. Four States in Australia: New South Wales, Victoria, Queensland and South Australia.
Study participants. Twenty-three participants were recruited as part of an evaluation of the Australian Open Disclosure pilot commissioned by the Australian Commission on Safety and Quality in Health Care.
Results. All participants (except one) appreciated the opportunity to meet with staff and have the adverse event explained to them. Their accounts also reveal a number of concerns about how Open Disclosure is enacted: disclosure not occurring promptly or too informally; disclosure not being adequately followed up with tangible support or change in practice; staff not offering an apology, and disclosure not providing opportunities for consumers to meet with the staff originally involved in the adverse event. Analysis of participants' accounts suggests that a combination of formal Open Disclosure, a full apology, and an offer of tangible support has a higher chance of gaining consumer satisfaction than if one or more of these components is absent.
Conclusions. Staff need to become more attuned in their disclosure communication to the victim s perceptions and experience of adverse events, to offer an appropriate apology, to support victims long-term as well as short-term, and to consider using consumers' insights into adverse events for the purpose of service improvement.
Keywords: patient satisfaction, measurement of quality, qualitative methods, discourse analysis, Open Disclosure
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Introduction |
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Public awareness of adverse events is on the rise [1], and the pressure on health policy makers to address such events—particularly those that cause severe harm—is intensifying [2]. One policy response is ‘open disclosure’, mandating that clinicians apologize for adverse events and discuss what is known about them with those harmed. Disclosure of adverse events is now enshrined in several programs in the USA [3] and forms part of national policy in countries such as Canada [4], the UK [5] and Australia [6].
The fact that these developments are very recent may explain why the number of studies examining victims' experiences of clinical harm and incident disclosure is low [7]. Studies of adverse event responses that have been published focus on organizational rather than patients' personal consequences [e.g. 8–10], and studies that focus on the consumer experience do so mainly by eliciting hypothetical responses to adverse event scenarios [e.g. 11, 12]. Only a limited number of studies present accounts of consumers' actual experiences of adverse events and their disclosure by health facility staff [7, 13–15].
The present article reports on 23 interviews conducted with patients and family members about the disclosure process following adverse events. Undertaken as part of an evaluation of an Open Disclosure pilot conducted in 40 hospital sites across Australia in 2006 and 2007 [16], this study provides insight into the principal concerns on the part of consumers when it comes to disclosing and resolving adverse events.
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Background |
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In Australia, the need to negotiate the consequences of adverse events was put on the public agenda by the Australian Council for Safety and Quality in Health Care in 2002. This led to the publication of the Australian Open Disclosure Standard in 2003 [17]. In 2006, a successor national body, the Australian Commission on Safety and Quality in Health Care, contracted 40 hospital sites in five Australian States to participate in the Open Disclosure Pilot. This arrangement enabled these sites to develop Open Disclosure policies, initiate training and appoint Open Disclosure project officers (frequently patient safety officers working in clinical governance units and primarily from a nursing background) to liaise with patients and staff.
The model generally deployed now in Australia for disclosure involves a liaison person (usually the patient safety officer) contacting the victim of an adverse event, gathering data about the incident, convening a meeting for clinical staff to plan the disclosure meeting (and determine its level of formality), facilitating the primary disclosure meeting and maintaining contact with the patient (and/or family) following the initial meeting(s). The present article reports on consumers' experiences and views about these processes.
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Methods |
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Subjects and setting
Only 21 of the 40 pilot sites participated in the evaluation. Indicating the challenging nature of this kind of research and the trepidation experienced by both health facilities and ethics bodies when confronted with project applications targeting Open Disclosure, five Ethics Committees chose not to approve our evaluation; four sites (all in one State) considered legal (qualified privilege) provisions to prohibit discussion about disclosure-related information with the evaluation team, and a further ten sites failed to translate ethics approval that was granted into hospital-level support for the evaluation.
Between March and November 2007, consumers who had been offered Open Disclosure of adverse events were identified by these 21 sites' Open Disclosure project officers. The evaluation team did not have access to Open Disclosure (or clinical) records, nor to the criteria applied for selection and rejection of patients and family members for the invitation to participate in the evaluation. Hospital staff contacted participants to obtain permission for the evaluation team to engage them in the study. In total, 24 participants' contact details were provided to the evaluation team. All but one agreed to be interviewed: fifteen interviews were conducted with patients and eight with family members.
Procedures
Members of the evaluation team conducted the interviews either face-to-face or over the telephone. Lasting from 15 to 90 min, the interviews were semi-structured and in-depth, guided by an interview schedule (included in the Appendix), containing questions approved by all relevant ethics committees. They also allowed interviewees to expand on matters they considered important.
Analysis
Interviews were transcribed verbatim from sound files by project team members. Potentially identifying information was removed to ensure confidentiality. The accuracy of transcriptions was checked against the original audio-recordings. Data familiarization was achieved by up to four team members reading and checking the transcripts and independently tabulating issues into salient ‘themes’. These themes were collated and then verified in two ways: first, by team members comparing their theme choices against those of others at set intervals, and second, by reconnecting chosen themes to relevant interview data to maintain their representativeness. This process of iterative data anchoring and constant comparison [18] ensured that our analysis remained reliable and retrievable [19]. The five most prevalent themes that were identified in this way are covered here.
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Results |
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Table 1 contains summaries of the 22 cases as revealed in interviews with consumers (among the 23 interviewees, interviewee #13 was the wife of interviewee #12 who was the person harmed, and both discussed the same case, giving 22 cases in total).
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Overall, Open Disclosure was seen as positive and interviewees judged Open Disclosure to have been crucial to resolving their adverse event. Thus, interviewees reported that ‘I's [sic] just sorry it ever happened, naturally, but ... as far as I'm concerned, the outcome, everything come alright in the end’ (interviewee #6); ‘it was very good’ (#8) and ‘It was very useful’ (#12). One interviewee elaborated on the positive emotional impact of Open Disclosure: ‘I know there wasn't a dry eye in the whole entire room when I was telling them about the guilt that I had felt and then [name doctor] said that it had nothing to do with me and it wasn't my fault [so] I think since the Open Disclosure I've got some answers, I've been able to talk to the hospital, to the people involved’ (#1).
The remainder of this section addresses the five most prevalent themes identified in the interview analysis. These themes are recast as questions for the purpose of our discussion: was the adverse event promptly disclosed to the victim (or family) by staff at the facility where the adverse event occurred?; how formal was the disclosure meeting and did this match the victim's expectations?; what kind of apology was offered?; was there an offer of tangible support?; was the consumer's concern about practice improvement heard? and was there an opportunity to meet with the clinicians involved in the adverse event? We have included two tables that provide more comprehensive interview quotes.
Was the incident promptly disclosed to the patient and/or family?
Interviewees felt that staff should have been more forthcoming about an adverse event having occurred. Indeed, seven interviewees had to explicitly request or insist on Open Disclosure. Wanting to find out why the birthing process had been so problematic, one interviewee (#1) approached different staff for explanations. Eventually, she was granted Open Disclosure: ‘I've talked and talked and talked and talked. I've talked to counsellors and I've talked to midwives, I've talked to doctors and I've talked to a lot of people. I've talked to the Health Rights Commission ... and then finally, yeah, eighteen months later, no fifteen months later, we finally had the Open Disclosure.’
Another (#2) reported how their adverse event was noticed by their GP: ‘I went for a six-weekly, oh, sorry, two-weekly check up and in that check up I told the doctor then what had happened and he said, "Oh, my goodness me, I've not heard anything about this." And from then that's what started the ball rolling so that I had the [disclosure] interview with the other people [clinicians who originally treated this person].’ Yet another (#18) said, ‘it was probably more weeks, over a month I would say before they got round to ... ask us to a meeting.’
How formal was the disclosure meeting and did it match victims' expectations?
Interviewees saw the level of formality of the disclosure meeting(s) as an indicator of respect. Formal disclosure is described in the Australian Open Disclosure Standard as ‘High-Level Open Disclosure’, which is to be provided in cases of serious harm and death [17: 37]. Formality should not necessarily be associated with the number of managerial staff present, however: ‘I probably didn't like the fact that they were in suits and you know like it was "We're going to fix this because we're the hierarchy’ that sort of thing".' (#13).
Interviewees made it clear that for them formality referred to whether the situation was taken seriously by staff, and whether their communication was constant and supportive. As one of the one-third of interviewees who experienced their disclosure meetings as formal, interviewee #15, commented: ‘They both [the patient liaison person and the surgeon] sat with us. They were both there when they sat us down and told us about it. And they answered questions we wanted to know. ... It was really good’. Only one interviewee who had been offered such formal Open Disclosure remained dissatisfied: ‘They explained to us what had happened. They ... admitted that they made a mistake, that they don't [sic] get a chance to read the patient's booklets, and folders on their conditions. They have something written up above their bed and that's all they basically go by. Now the problem is that these ... nurses [involved with the incident] are, I feel, getting away with it ... They did apologize ... but it wasn't enough at the time’ (#16).
Nearly half of all interviewees regarded their disclosure as too informal, denying them the chance to formulate questions and probe clinicians about the adverse event: ‘she [clinician] just popped up to see me ... it wasn't planned so I didn't have any questions planned or anything’ (#9). Another said, ‘I didn't receive the opportunity to follow up and try to understand the whole’ (#17).
Was an apology offered and of what kind?
Almost half of all interviewees stated they had received a full apology, with staff acknowledging responsibility for the adverse event. The remainder included those who were not offered an apology when they felt they should have been: ‘All the doctor said was the [clinician involved in the incident] was very upset’ (#3). Other interviewees reported not being satisfied with staff giving partial apologies (expressions of regret eschewing responsibility): ‘ ... but it would have been nice if someone had have just acknowledged and said "This is our fault"‘. One interviewee reported receiving an apology which was subsequently undermined: ‘ ... the first meeting she apologized ... Then when I handed her the birth certificate that said staphylococcal chorioamionitis she backtracked and said, "No, no, no ... ". And that to me seemed like she just completely and utterly was not sorry anymore’ (#1).
In cases where staff resisted acknowledging responsibility, interviewees expressed disappointment: ‘I definitely didn't like the defensive nature of the people involved’ (#5), and ‘They were blaming the cancer’ (#16). Important to note here is that the Australian Open Disclosure requires staff to ‘express regret’; that is, offer partial apologies. In practice, as our interview data show, staff may assume responsibility in the interest of strengthening their apology [20]: ‘That person that did own up was very upset that it happened, which ... would have taken a lot of guts’ (#23) (Table 2).
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Was there an offer of tangible support?
A majority of interviewees (15) reported having been offered tangible support, including counselling, additional clinical treatment and ex gratia payments. One interviewee (#12) comments on how he received ‘the royal treatment’ when staff realized he had been given the wrong plasma. He was placed in intensive care and received home care when sent back.
Offers of support were not guaranteed to satisfy, however: [the patient liaison officer] said, ‘You know, anything we can do for you, anything the hospital can do ... ' and [name husband] said, ‘Are you going to pay for our IVF?’ and [staff member] said, ‘Oh I don't think we can do that but certainly if you need any flights ... ’ (#1). Interviewees comment on being disappointed about having ‘to pay your own meals and everything. They don't [provide for that]’ (#7).
Was the consumer's concern about system improvement heard?
Besides offers of support for the patients harmed, staff responses to adverse events also included taking seriously the service implications of patients' concerns: ‘What I liked about the meeting was that they said they would make sure that they would review the procedures [...] and the hospital to identify how this could have happened’ (#13). Interviewee #6 commented that: ‘the outcome was that they just have to tighten up on procedure ... a couple of months after ... oh yes [laughs] it was a changed situation.’ Similarly, interviewee #1 reported that ‘he said to me that they'd actually had some more cases of infection in the Department but thanks to case studies and observation logs and things like that, and he said, "[name], you put that in place." "It happened because of you so that's a pat on your back".’
Were consumers able to meet with the clinicians involved in the adverse event?
Interviewees saw the opportunity to meet with staff closely involved in the incident as important, and regarded being denied this opportunity as a negative. One interviewee (#3) felt that she was denied crucial information by not being told who had been involved: ‘And they wouldn't even tell me who the nurse was.’ Others expressed their disappointment as follows: ‘The nurses didn't come and see me ... it was just the two doctors that kept coming to the bedside’ (interviewee #7); ‘no, no doctor actually spoke to me’ (#20) and ‘All the doctor said was the [clinician involved in the incident] was very upset’ (#3). Out of the 13 instances where contact with one or more staff who were close to the incident was possible, seven reported a positive experience: ‘I think since the Open Disclosure I've got some answers’ (#1); ‘They were very good at explaining exactly what was happening and they were very honest’ (#8) and ‘It was very useful’ (#12) (Table 3).
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Discussion |
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This study confirms earlier reports regarding the importance of recognizing the consumer's perspective on the incident [12], of the need for constant and supportive communication [7], of offering tangible support [13] and of improvements to clinical practice to rule out re-occurrence of the adverse event [21]. The present article contributes two additional findings.
First, disclosures are complex social events: some aspects can be experienced as positive and others as negative. Particularly in the cases of interviewees #1, #2 and #17, disclosure was judged to be satisfactory in some ways but not in others. Interviewee #17 comments, for example, that ‘I think you know we were treated quite well [but] we did not get the opportunity to follow up’ (#17). Positive comments were made about support staff (the Open Disclosure project officers) who were generally perceived as caring and attentive, but not always about clinical staff who were seen to distance themselves at times (‘The nurses didn't come and see me’; #7). The positive impact of the disclosure in these cases was counter-balanced by staff not making themselves freely available or by providing what appeared to be defensive or irreconcilable explanations. This finding points to the importance of not just constant communication, but also of consistent disclosure communication.
Second, analysis of the data reveals that interviewees regarded staff as comfortable with disclosing non-serious adverse events, and as less comfortable with having to disclose serious adverse events. Echoing findings that the response to the adverse event needs to be proportional to its severity [3], interviewees who expressed satisfaction about the disclosure process were typically those whose expectations of a full apology, formal disclosure and an offer of tangible support were met. Consumers commented that clinicians drew back from showing the kind of openness and honesty that consumers regard as naturally complementary to the trust invested in the clinical service provided, and that they therefore expect to have contact with their clinicians following serious adverse events. This finding points to the need to educate (junior) clinical staff not just in the technicalities of their profession, but also about the full set of responsibilities that professional expertise incurs, such as communicating with their patients when things go wrong. The finding also suggests that health facilities should deploy Open Disclosure officers for adverse event communication coaching, instead of relying on them to relieve clinical staff of adverse events disclosure. To lay claim to professional expertise but then be excluded (or for clinicians to exclude themselves) from discussions about unexpected outcomes (while no doubt challenging and even threatening) inappropriately de-emphasizes the moral-ethical responsibilities of the clinical role.
This article's findings should be read in the context of the sampling limitations described in the methods section: 28 ethics committee approvals yielded only 23 consumer interviewees. These interviewees were identified and vetted by participating healthcare organizations that retained discretion over whether to pass on consumers' details. The interviewees in this study may therefore not be representative of the full contingent of patients who experienced disclosure of adverse events. Further, as was evident from their correspondence in response to the request to participate in the evaluation of the Open Disclosure pilot, some organizations (and ethics committees) judged our project as potentially destabilizing the delicate equilibrium achieved with consumers in the time following incidents and rekindling undesirable emotions. Despite considerable effort by the research team, then, research access for this project remained limited, thus depriving consumers of a legitimate voice in the debate about the disclosure of incidents. More consumer-experience research is needed where recruitment techniques are not constrained by health facilities' judgment about whom to interview.
That said, the consumers who were referred to us may have been judged by health facilities to represent instances of relatively successful disclosure, rendering our findings all the more significant. If the organizations that referred these interviewees did indeed see these consumers as having been provided with adequate disclosure and as satisfied with the procedure, it is noteworthy to learn that over half of those interviewed judged the experience to be unsatisfactory, and that seven had to pursue the health facility for an appropriate disclosure of the adverse event.
If there are lessons arising from this research, they are that not just the technical-practical dimensions of harm but also the personal ones should play a central role in how adverse events are responded to, and that besides understanding consumers' general disclosure expectations we need to clarify their experiences of in situ processes and procedures [22]. Internationally, such a practice of making consumers' experiences part of patient safety considerations and service improvements appears to be gaining momentum [23]. Open Disclosure offers an important opportunity to acknowledge consumers' role in healthcare reform by enabling clinicians and consumers to discuss adverse events and address how such events can be prevented from occurring again.
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Conclusion |
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Hospital-initiated harm brings with it an onus on clinicians and health services to redeem themselves through Open Disclosure. Our limited data suggests however that the Open Disclosure process is not yet reliably meeting consumer needs. Casually informing consumers about an adverse event was not sufficient for the interviewees who participated in our study. Full apology and adequate recognition of what the adverse event means to them is needed, as well as a clear plan of how the patient will be supported after the adverse event, physically, emotionally, clinically and financially.
In Australia, the positive findings of the present study notwithstanding, the policy of Open Disclosure may still remain somewhat aspirational. Lest Open Disclosure policy fail its health reform objectives, more insight into what works for consumers involved in adverse events is essential, requiring institutional support for practice-based research into consumers' experiences of existing approaches to adverse event management.
Action has been proposed on a number of fronts to bolster the Open Disclosure initiative. Legal reform may promote collaborative principles to govern lawyers' roles in negotiating adverse events [24], make tangible support a standard component [3, 25] and strengthen clinicians' accountability for (appropriate) disclosure [26]. Education of clinicians and managers should encompass response procedures to adverse events, emphasize disclosure communication that includes apologizing and listening to consumers and give prominence to the need to take account of the consumer experience to improve the disclosure process. Most important is that health facilities accord consumers a voice in how adverse event responses are to be structured. For this to occur, scenario-based surveys confirming consumers' in-principle preference for disclosure [27] need to be complemented with practice-based research such as that described here, in order to determine best practice in error response processes and to make sure this is delivered to every patient.
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Funding |
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TopAbstractIntroductionBackgroundMethodsResultsDiscussionConclusionFundingAppendixAcknowledgementsReferences |
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This evaluation project was funded by the Australian Commission on Safety and Quality in Health Care, Rick Iedema, Principal Investigator.
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Appendix |
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Appendix: Interview guide for patients and family members
OPEN DISCLOSURE—INTERVIEW GUIDE
FOR PATIENTS AND THEIR FAMILY MEMBERS
- What is your age?
- What is your gender?
- Are you the patient, a family member or close friend?
- What was the main reason why you were admitted to hospital?
- What were the unexpected harms that occurred to you that led to the OD meetings?
- When were you first made aware the unexpected harm was done to you?
- How did you feel when you were told that unexpected harm was done to you?
- Did you feel that health professionals had been open and honest with you?
- Did you feel listened to and all your questions answered. Were the answers explained to you in simple English?
- What supports were you offered and received? What did you need?
- What notification did you get about the meeting? When, where, duration, attendees, how much notice
- Were you involved in an RCA and notified of the findings?
- How serious was the unexpected harm that occurred to you or your relative or friend (very serious, serious, somewhat serious, not serious, not very serious)?
- How many Open Disclosure meetings have you attended where a doctor or another health worker spoke to you about the unexpected harm that occurred in hospital?
- What type of health professionals were present at these meetings? (doctor, nurse, pharmacist, other)?
- How useful did you find the meetings in dealing with harms that occurred to you or your relative or friend?
- How involved have you felt in relation to health professionals' interactions with you since your unexpected harms were found?
- Do you see Open Disclosure as a useful approach to acknowledging errors in care to patients and their families? In what ways?
- Have you found the outcomes of these sessions satisfactory? In what ways?
- What did you like about these meetings?
- What did you not like about these meetings?
- Is there anything you would like to change about the way the meetings were carried out in the hospital for you or for your relative or for your friend?
- Are there any other comments you would like to make about Open Disclosure?
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Acknowledgements |
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We are grateful to the patients and family members who shared their accounts with us. We also acknowledge that the constructive and probing comments from the anonymous reviewers made an important contribution to the article. Any remaining shortcomings are our own.
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References |
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