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Table 2 Descriptive summary of the included studies for the review

From: What can we learn from patient and family experiences of open disclosure and how they have been evaluated? A systematic review

Author and year

Country of origin of article

Setting (acute/ community)

Study method

Objectives of the study

Participant information

Outcomes, key findings (listed under major themes) and recommendations

Bryant et al., 2021 [25]

Australia

Acute—Haematological Oncology Treatment Centre

Mixed method research

To describe patients with confirmed haematological cancer who experienced an adverse event and how it was handled by the health-care organisation

Two consecutive self-administered questionnaires were distributed during patients' clinic visits, assessing demographics, disease and treatment characteristics, as well as patient safety-related questions, with a total of 166 patients participating

The results suggest there is significant scope for improvement in communication with parents about their rights and medical complaints

Major themes—OD as a future oriented conversation, Quality of communication

Claringbold, 2023 [26]

Australia

Acute and Community—target population is in the community however, patients recruited from clinic

Qualitative research

To understand women's responses to their interval cancer diagnosis and their feelings about the screening program

276 women

Feedback regarding the open disclosure process was largely positive as many expressed their appreciation of receiving the letter and opportunity to provide feedback via the questionnaire

Major themes—timeliness of disclosure, quality of communication

Elwy, 2014 [18]

United States

Acute—Veteran Affairs Hospitals

Qualitative research

 

27 veteran patients and family members

10 Themes included: better facility preparation (pre-crisis stage), creating rapid communication, modifying language as part of the disclosure, addressing perceptions of harm, reducing complexity in the disclosure process, and seeking assistance from others (initial event stage), managing communication with others (maintenance stage), decreasing effects on staff, improving trust (resolution stage) and addressing identified needs (evaluation stage)

Major themes—timeliness of disclosure, quality of communication, importance of accommodating patient/family support needs, organisational arrangements in place as part of OD process and OD as a future oriented conversation

Etchegaray, 2014 [27]

United States (Texas)

Acute—University of Texas

Qualitative research

To determine how patients and family members were already included in the event analysis and to obtain insights into how to improve their experiences

5 patients and 4 family members

Hospitals should give patients and families information about what changes will be implemented to prevent similar errors from happening in the future

Major themes—timeliness of disclosure, quality of communication, organisational arrangements in place as part of OD process and OD as a future oriented conversation

Formanek, 2008,

[28]

United States

Acute—Kaiser Permanente Facility

Case Report

To distinguish between the curing role and caring role, Expand the caring role as professionals as teams and as a healthcare system, especially following an adverse event

90-year-old female patient and her daughter who went through the adverse event

Appreciated the in-person apology and telling the truth of the events and expected to know what changes would be made so it wouldn't help to someone else and that the story will help physicians to think more about patients

Major themes—organisational arrangements in place as part of OD process

Gallagher, 2009,

[29]

United States

Acute—Beth Israel Deaconess Medical Centre

Case report

To highlight the challenges of communicating with patients after errors

62-year-old female patient

Patient received an immediate recognition and apology. Her only regret was they never had an opportunity to speak to the doctor who had mismarked the spot. However, it really established a sense of trust

Major themes—timeliness of disclosure, quality of communication, OD as a future oriented conversation

Hagensen,

2018, [30]

Norway

Acute

Qualitative research

To illuminate conditions surrounding adverse events from the patient perspective. Key aspects include how patients perceive the occurrence of events and the responses from health personnel and the health service

15 patients, 9 female, 6 male

Patients felt clinician's and health services' avoidance or lack of response, signs of denial of responsibility and use of loyalty systems to largely support and protect each other

Major themes—timeliness of disclosure, quality of communication, importance of accommodating patient/family support needs

Hannawa, 2019 [31]

Switzerland

Acute and Community

Mixed method research

To test the MEDC model and validate the extent to which physician's ability to adapt to their patients expressed needs and expectations during an OD. (grounded in a theoretically based Medical Error Disclosure Competence (MEDC) model)

A total of 193 patients participated in an online survey to assess their experiences with medical errors over the past five years and the subsequent disclosure of these errors to them

MEDC guideline adherent disclosure communication maintains the provider patient relationship, increases patient resilience, and decreases patient trauma after a medical error

Major themes—importance of accommodating patient/family support needs, and OD as a future oriented conversation

Iedema, 2012 [32]

Australia

Acute

Case Study

To understand the possibilities from a disclosure communication and to understand from a patient's perspective what went wrong and what went right

120 patients and family members

The disclosure process was more of a dialogue which allowed the patient to feel like she could develop her judgements and turn it into specific issues in the service that needs to be addressed. Major themes—importance of accommodating patient/family support needs and OD as a future oriented conversation

Iedema et al., 2011 [33]

Australia

Acute and Community

Qualitative research

To understand what patients and family members know about problems and failures in healthcare

119 patients and families

Patients and family members need access to structured processes to ensure the dialogue with health service personnel about perceived risks, problems and incidents. Major themes—quality of communication, importance of accommodating patient/family support needs, organisational arrangements in place as part of OD process

Iedema et al., 2011 [33]

Australia

Acute and Community

Qualitative research

To investigate the patients' and family members' perceptions and experiences of open disclosure of healthcare incidents and to derive principles of effective disclosure

39 patients and 80 family members

All patient and family member interviews except one expressed concern about process of incident disclosure. Concerns included: inadequate preparation, inappropriate disclosure for unexpected outcomes, lack of follow up support, lack of appropriate closure, insufficient integration of open disclosure with improvement of patient safety Major themes- quality of communication, importance of accommodating patient/family support needs, organisational arrangements in place as part of OD process

Iedema et al., 2008, [34]

Australia

Acute—across 21 hospital sites

Qualitative research

To explore patients' and family members' perceptions of Open Disclosure of adverse events that occurred during their healthcare

23 patients and family members

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. Major themes—quality of communication, importance of accommodating patient/family support needs, organisational arrangements in place as part of OD process

Iedema et al., 2008 [20]

Australia

Acute—across 21 hospital sites

Qualitative research

To determine which aspects of OD work for patients and healthcare based on an evaluation of the National OD pilot

23 patients and family members

Open disclosure works when patients and family members are shows respect by offering immediate and sincere apology. It is conducted as much as possible, and consumers can appoint a support person. Major themes—timeliness of disclosure, quality of communication, importance of accommodating patient/family support needs, organisational arrangements in place as part of OD process

Kim 2021, [35]

South Korea

Acute—hospital

Qualitative research

To identify patients' and families' experiences regarding disclosure of patient safety incidents

15 patients and their families

Concrete protocols and policies must be developed to protect patients and their families from physical/psychological injury and the stress experienced due to patient safety incidents. Major themes—importance of accommodating patient/family support needs, organisational arrangements in place as part of OD process

Kooienga 2011 [23]

US

Acute

Qualitative research

To explore the community members perceptions of error

30 participants

Medical error was perceived overall as a lack of communication, missed communication or poor interpersonal communication styles by physicians or other healthcare providers. Negative attitudes directed towards themselves and family members with huge form of lack of respect, blame and stigma. Major themes—quality of communication

Lyu 2017 [36]

US

Acute and Community

Qualitative research

To describe patient's perceptions regarding disclosure and their actions after harm

236 respondents

Perception of an inadequate apology—patients think that hospitals and clinicians do not disclosure completely information regarding their incident and there needs to be increased transparency and improved communications. Major themes—quality of communication, importance of accommodating patient/family support needs, organisational arrangements in place as part of OD process

Moore 2017 [37]

New

Zealand

Acute

Qualitative Research

To explore factors that facilitate and impede reconciliation following patient safety incidents and to identify factors to facilitate reconciliation following patient safety incidents for strengthening institution-led alternatives to malpractice litigation

62 patients

Policymakers favour non-litigation approaches, stressing that apologies shouldn't replace necessary remedial actions. Flexible, best-practice guidelines should ensure all steps are followed without a 'one size fits all' approach

Major themes—timeliness of disclosure, quality of communication and OD as a future oriented conversation

Maguire, 2016 [38]

US

Acute—Veterans Health

Qualitative research

To evaluate VA's national large scale disclosure policy and identify gaps and successes in its implementation

97 patients

e greatest costs of disclosure of these events: trust in the healthcare organisation. delays in discovering issues and then in notifying patients, caught the mistake and improved, learning more about the event and how the detail helped them to feel more confident. Major themes—timeliness of disclosure, quality of communication, importance of accommodating patient/family support needs, organisational arrangements in place as part of OD process

Mahmudah, 2022 [39]

South Korea

Acute and Community

Qualitative research

Explore the various types and frequency of patient safety incidents during a cancer screening health examination for the public

11 patients

There was a significant association between the judgment of medical error occurrence (P = .038) and level of patient harm (P = .032) both in experience by family members and total experience of patient safety incidents. Major themes—quality of communication

Mazor, 2013 [40]

US

Acute—Cancer Care

Qualitative research

To examine whether patients consider recommended responses to be appropriate and desirable and whether clinicians’ actions after adverse events are consistent with recommendations

78 patients

Patients valued apology, expression of remorse, empathy and caring, explanation acknowledgement of responsibility and efforts to prevent recurrences—but these were often missing. Clinicians' responses continue to fall short of expectations. Major themes—quality of communication, importance of accommodating patient/family support needs, and OD as a future oriented conversation

Moore, 2017 [24]

US

Acute—3 Hospitals

Qualitative research

To explore the experiences of patients and family members with medical injuries and communication and resolution programmes (CRP) to understand the different aspects of institutional responses to injury that promoted and impeded reconciliation

27 patients, 3 family members

Satisfaction with OD was highest when communications were empathetic and no adversarial, including compensation negotiations. Patients and families expressed a strong need to be heard and expected the attending physician to listen without interrupting during conversations about the event. Major themes—quality of communication, importance of accommodating patient/family support needs and OD as a future oriented conversation

Okamoto, 2011 [41]

Japan

Acute and Community

Quantitative research

To examine the perceptions of persons who experienced a medical error and elements that may serve to open communication with those who experience a medical error in Japan

A detailed questionnaire was administered to 80 patients who had experienced adverse events

Following an immediate disclosure of medical error by a senior medical personnel and medical provider should create an environment to continue communication in order to accommodate shifting perspectives of those who experienced the error. Major themes—timeliness of disclosure, organisational arrangements in place as part of OD process

Piper, 2014 [21]

Australia

Acute and Community (from the 100 patient stories study)

Retrospective qualitative study

To analyse rural patients' and their families' experiences of open disclosure and offer recommendations to improve disclosure in rural areas

Subset of 13 /100 patient participants from rural or regional area

OD processes were generally initiated via letter and conducted over phone 0 which patients did not like. Patients and family members were often uncertain who was attending it on telephone and why they were there. Staff involved should be there if they wanted to patients to feel it was sincere. OD often had to be initiated by the patient of family themselves. Major themes—quality of communication, organisational arrangements in place as part of OD process and OD as a future oriented conversation

Sheridan, 2008

US

Acute—4 hospital cases

Case Series

To understand how lives of family members would have been different if new disclosure practices had been in place when they experience the preventable loss of their loved ones

4 patient stories

Most of the patients 3/4 did not receive any disclosure at all. They said that had they been told what had happened, how their care could have been different and what they would do so that it would never happen again—they would have greatly appreciated and reduced their anger and grief. Major themes quality of communication

Sorensen, 2010 [22]

Australia

Acute—21 hospitals and health services in 4 Australian sites

Qualitative

research

To understand patient's and health professionals' experience of OD and how practice can inform policy

15 patients and 8 family members

Patients and family members highlighted the biggest problem is that no one had asked what the patient or family wanted, and the absence of feedback or remedy made patients feel not reassured that the adverse event would not happen again making their suffering even more meaningless. Major themes—timeliness of disclosure, quality of communication, importance of accommodating patient/family support needs, and OD as a future oriented conversation

Walton, 2019 [6]

Australia

Acute

Mix method research

To determine the frequency with which patients who report an adverse event had information disclosed to them about the incident

A cross-sectional survey on patient experiences of disclosure (not a validated survey) related to adverse events was conducted among a random sample of hospitalized patients in NSW, Australia, with responses from 7661 people, including 474 who reported an adverse event

Positive aspects of open disclosure were found to be the human approach, openness and honesty and reciprocal resolution. Negative experiences were when there was a lack of open disclosure process, inadequate implementation of open disclosure and non-responsive staff. Major themes—quality of communication, importance of accommodating patient/family support needs