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

Abstract

Background

Open disclosure, or 'error disclosure,' is a policy requiring healthcare professionals to promptly offer an honest apology after an adverse event. While the fundamental principles of open disclosure have evolved into an important right for patients who experience adverse events, the process also plays an integral role in ensuring continuous improvements in the delivery of patient care. Healthcare providers often encounter challenges in fully adopting open disclosure processes, limiting their use in practice. This systematic review aims to explore patient experiences following open disclosure, focusing on how these experiences are being measured and evaluated. By examining patient experiences, this review seeks to enhance our understanding of the effectiveness of open disclosure and inform improvements in healthcare communication practices.

Methods

A detailed search strategy was developed to identify relevant literature published between 2008 and 2023. The review focused on original research in English, emphasising qualitative or quantitative studies that evaluate and measure patient experiences of disclosure. Four major databases (PubMed, CINAHL, PsycINFO, and EMBASE) were searched for studies reporting details of patients/clients/service users and their families/relevant others who have experienced the OD process/duty of candour. The Mixed Methods Appraisal Tool (MMAT) was used to appraise included studies. The review adopted a narrative approach to synthesise the findings.

Results

From the initial 8,940 studies identified, 26 met the inclusion criteria, comprising 17 qualitative studies, two quantitative studies, three mixed-methods studies, and four case studies. The study explored patients' and service users' perspectives on their experiences with OD following patient safety incidents. The synthesis highlights five key themes across the included studies: timeliness of disclosure, quality of communication, addressing patient and family support needs, organisational arrangements for the OD process, and viewing OD as a forward-looking conversation.

Conclusions

While explicit open disclosure policies are common in healthcare, routine assessments of patient and family experiences remain infrequent. Patients and families, as service users, perceive safety incidents differently from healthcare providers and hold specific expectations. They emphasise the importance of transparent, ongoing communication, emotional support, and active involvement in post-incident evaluations, considering OD vital for building trust and achieving resolution after adverse events.

Introduction

Open disclosure, also known as 'error disclosure’, is a policy directing healthcare professionals to promptly offer an open and honest apology following an adverse event during care to patients and their families through a series of discussions [1]. There is a growing trend towards adopting effective open disclosure (OD) processes, with most Western countries such as the USA, Australia, UK and many European countries now mandating policies in response to complaints and litigation [2, 3]. OD (sometimes referred to as duty of candour) entails healthcare professionals informing the patient about the occurrence of a patient safety incident that results in harm or the potential for harm, providing a factual account of the event, explaining the consequences of the incident for the patient under their care, and taking preventive measures to avoid recurrence. This allows patients to receive a meaningful explanation from healthcare providers and offers an opportunity for patients to express any concerns or distress they have experienced following the incident. For healthcare providers, this process can enhance their understanding of incidents, creating a learning opportunity to implement preventative measures and ultimately fostering a culture of openness and patient safety within clinical settings [1].

While the fundamental principles of OD have evolved into an important right for patients who experience adverse events, the process also plays an integral role in ensuring continuous improvements in the delivery of patient care. Although legislation and policy changes around OD have been welcomed, there are still many barriers which prevent healthcare providers from using OD in practice [4, 5]. In Australia, researchers found that despite state-wide OD training, formal OD processes only take place in 17% of all adverse events [6, 7]. Similarly, in the UK, only approximately 30% of patient safety incidents events are being disclosed in acute clinical settings [8]. A 2012 survey conducted in Ireland found that 55% of hospital staff reported that there were barriers to OD, with 24% of respondents citing fear of litigation as the main barrier [9]. Amidst these ongoing developments in policy, examining efforts to improve disclosure practices and processes is becoming increasingly important for enhancing patient care. It is key to explore the perceptions of the service provider-receiver perspectives on the OD process within current practice to understand what aspects of the process are effective and what is could be improved [10]. Patients' perspectives on adverse events were examined in two systematic reviews nearly 15 years ago, covering studies up to 2009 [11, 12].

Although direct observation during patient safety incidents is challenging, analysing patient perceptions based on real-world experiences with specific disclosure processes and styles provides valuable insights for learning and informing staff training [13]. It is important to assess how different OD practices used in varying healthcare settings are impacting patient care and patients' experiences following patient safety incidents. In line with the revised policy implementation in countries like Ireland [2, 14] and recent research highlighting the need for a renewed focus on OD [15, 16] this systematic review aims to address the gap in the literature by examining patient experiences following OD, with a focus on how these experiences are being measured and evaluated.

Methods

This systematic review protocol was designed to capture relevant studies that interpret how patient/service user experiences of OD processes in healthcare settings and was registered in PROSPERO (Ref: CRD42023450479). The full search strategy is presented in Supplementary file 1.

Data sources

We searched PubMed, CINAHL, PsycINFO, and EMBASE databases using combinations of search terms developed using MeSH and other key terms such as ‘OD’, ‘duty of candour’, ‘error disclosure’, etc. After piloting, a detailed search strategy was finalised to find relevant literature published over the last 15 years, only in English. The searches were conducted for four weeks starting from July 25, 2023, to capture studies from 2008–2023.

Inclusion and exclusion criteria

Participants/population: Studies reporting details of patients/clients/service users and their families/relevant others who have experienced the OD process/duty of candour were included. These studies involved healthcare staff disclosing harm that occurred during the course of healthcare. Original research published in journal papers, reports from the health sector, government, and related sectors were considered. All types of studies, including experimental, quasi-experimental, and observational studies from 2008–2023 were included in the screening. This review focused on understanding patient experiences, with an emphasis on any descriptive, qualitative or quantitative studies that evaluate and measure patient experiences of the OD process/disclosure.

Screening and data extraction

Covidence software was used to support data extraction, and all studies retrieved from the main search were uploaded and deduplicated by the software. Three reviewers (DR, AS, and AR) independently screened the abstracts for eligibility. Articles deemed potentially relevant were included in a second stage of full-text screening. DR and AS conducted the independent full-text screening, assessing the full texts against the inclusion/exclusion criteria to determine their eligibility. Disagreements over the inclusion or exclusion of articles were resolved by a third reviewer (ADB). The quality of the selected publications was evaluated using the Mixed Methods Appraisal Tool (MMAT) Version 2018 [17], given the considerable heterogeneity encountered in the eligible studies during preliminary searches. Relevant data were extracted into a Excel table by one reviewer (AS) to capture study characteristics, participant information, key outcomes and recommendations and 25% of the articles were randomly cross-checked by DR for accuracy. Given the anticipated heterogeneity of the studies, a narrative approach was used to synthesise the findings.

Results

The electronic search in the four databases yielded 8940 studies and 2048 were removed as duplicates as identified by the Covidence software and manual checking. 6892 studies were screened for relevance and 141 studies were selected as potentially eligible and retained for full-text screening. Following full-text screening, 26 studies met the eligibility criteria for inclusion in the systematic review. The study screening process is shown in PRISMA flowchart in Fig. 1 (PRISMA checklist – Supplementary file 2).

Fig. 1

PRISMA flow diagram for the study review process

Study characteristics

Twenty-six studies were included in the review in total (Table 1), with 10 of these from Australia, 10 from the United States, two from South Korea, and one from Japan, Sweden, New Zealand and Switzerland, respectively. The main objective of the review was to explore patient/family experiences of the OD process and how these experiences were measured and evaluated in each study. Seventeen of the 26 studies were qualitative in nature (65%), while 5 (19%) were quantitative/mixed methods. We considered the study settings of included articles and determined that 18 studies were conducted in acute care settings, with the remaining studies based on experience mixed in the acute and community health service settings.

Table 1 Summary of included studies

Given that all 26 studies aimed to explore specific patient experiences related to adverse events, all the results were based on evaluating post-event OD (OD) communication between patients, families, and healthcare providers. Most studies used interviews (n = 20) as their data collection method to explore the OD experience, with many guided by semi-structured or open-ended interview guides questionnaires [18,19,20,21,22,23,24]. Consequently, the results of the eligible studies covered various aspects of the OD processes, including the expected communication methods, the timing, and the quality of communication. A descriptive summary of the eligible studies for the review is shown in Table 2 to list and define all outcomes for which data were sought.

Table 2 Descriptive summary of the included studies for the review

Quality appraisal of the selected studies

The eligible studies utilised various research methods, and their quality was appraised using the Mixed Methods Appraisal Tool (MMAT), version 2018 [17]. Among the sixteen qualitative studies, thirteen had used all relevant methodological criteria tested in MMAT in their approach [18, 21, 22, 24, 26, 30, 33,34,35, 37, 38, 40, 41]. Both the quantitative and mixed-method studies included had methodological limitations which introduced some bias [6, 31, 39, 41], which introduced some bias. Additionally, the case studies demonstrated inherent limitations in generalisability [28, 29, 32, 42]. Details for the MMAT outcome for each study are provided in Table 3.

Table 3 Quality appraisal details of studies for Mixed Methods Appraisal Tool (MMAT)

Narrative synthesis of findings

Purpose and scope of measurement in included studies: All 26 studies were dependent on primary data originated from patient and family OD experiences within a selected timeframe. Significantly, authorities in Australia, such as the Australian Commission on Safety and Quality in Health Care, have attempted regular evaluation exercises to assess patient and family feedback on OD practices on a pilot basis [6, 20, 21, 32,33,34] to inform their OD policies and practices. Some studies utilised patient cohorts from databases maintained from routine hospital adverse event reporting systems [32] to capture OD experiences. In contrast, a study reported in Norway captured patient experiences from complaint registers maintained by the ombudsman, a formal complaint process in public services [30]. In the United States, frequent evaluations of the OD process from patient perspectives were reported, often through invited ongoing research partnerships [18, 38]. Otherwise, none of the studies showed health settings that recorded OD patient experience as part of routine data collection. Considering the purpose, the exploration of patient perspectives was mostly conducted to improve implementation of OD policies to enhance health care staff OD practices and performance at the operational level [22, 24, 35, 40].

The assessment of patient and family experiences with OD was conducted to explore their perspectives, aiming to improve OD policies and enhance healthcare staff practices at the operational level. In this section, we explore the lived experiences of patients and service users, capturing their perspectives on OD following patient safety incidents. The synthesis is structured on five major trends in findings across included studies: 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.

• 1. Timeliness of disclosure

OD involved engaging in communication and activities with patients after an adverse event. It emphasised patients' rights to be fully informed and promptly notified about any shortcomings in the care process, regardless of their timing or nature. As discussed in several studies, patients and their families strongly preferred immediate attention and support in the event of a patient safety incident [29, 30, 37, 41], along with the prompt initiation of an explicit OD process as soon as the issue was detected [18, 22, 26, 27, 29, 34, 38]. Without prompt OD communication, patients felt vulnerable and distrustful during healthcare encounters. People felt frustrated or angry due to delays in staff response. Additionally, some patients struggled to receive corrective or necessary treatment and ongoing monitoring in the aftermath of the incident, which resulted in additional harm.

• 2. Quality of communication

Effective communication in OD was considered pivotal in several studies for providing quality healthcare. It helped build successful therapeutic relationships between healthcare providers and patients, as well as their families, enabling effective decision-making and promoting good patient outcomes. During patient conversations, various aspects of communication in relation to OD were explored. In cases where a patient safety incident occurred, it was expected that the health service provider communicated in detail [7, 36, 38] and provided a sufficient explanation [25, 26, 30, 37] to the patient, family, or the guardian/carer. Additionally, the OD conversation used appropriate language that was simplified for non-experts to understand [18]. Medical jargon was avoided to reduce language complexity and make it easier for patients and their family members to understand the incident, its potential effects, and future implications [18].

When conducting a OD, it was essential that healthcare staff communicated in a manner that was honest, truthful, sincere, and empathetic towards all individuals involved in or affected by patient safety incidents [6, 20, 21, 24, 39, 40]. Service providers established reasonable grounds to convey to the patient the risk of unintended or unanticipated injury or harm during OD discussions. Maintaining a calm demeanour, minimising anger, and reducing reactive responses towards service users were described as essential for achieving a satisfactory outcome in these OD conversations [42].

Regardless of the level of harm caused by the error, offering a sincere apology and expressing regret to the patient helped demonstrate the openness of the clinical staff involved in their care, providing comfort to both the patient and their family or guardians [19, 20, 25, 28, 31, 32, 34, 39, 40]. It was strongly emphasised to involve the patient, their family, and guardians/carers in OD conversations [27, 33]. Arranging a face-to-face meeting for OD discussions was typically preferred by patients over other modes of communication such as phone calls, emails, or post [21, 28]. Patients expected the OD conversation to be a two-way dialogue, with service providers actively listening to their perspectives on the experience [23]. They also preferred direct communication with the staff involved in the incident, such as medical doctors, nurses, or laboratory technicians, depending on the nature of the safety incident [24, 29, 40]. Healthcare staff involved in OD communication demonstrated a human-centred approach [6], drawing upon their previous learning and training to engage in ethical and mature interactions with patients. This patient-centred approach helped support the patient in recovering from the upsetting situation [22, 23] and enhanced their resilience in facing such challenges [31].

• 3. Importance of accommodating patient/family support needs

Included studies reflected that, in the aftermath of patient safety incidents, patients often required additional treatment, rehabilitation, or psychological support, leading to extended hospital stays or readmission to address associated risks and harm. In such situations, priority was given to resolving patients' physical and clinical injuries [34, 35] along with providing emotional and psychological support [22, 35] to both patients and their families. There were added financial burdens due to unintended treatments and care, such as additional hospital bills and extended support to mobilise the patient. In some contexts, this prompted discussions about compensation [6, 7, 24, 34]. Regardless of the extent of harm, it was important to openly acknowledge responsibility [18, 19, 30, 40] and provide ongoing support, such as follow-up reviews, until patients or their families had fully recovered or come to terms with the consequences [33, 36].

• 4. Organisational arrangements in place as part of OD process, including post-incident investigation

Included studies reflected that, in addition to the actions undertaken by involved staff members, several organisational arrangements were incorporated into the OD process. Specifically, regarding patient safety incident events, healthcare organisations had established formal and structured protocols integrated into their organisational policies [19, 21, 34,35,36]. All staff members were thoroughly briefed on the OD plan and adequately prepared [18, 33] to initiate it promptly upon incident reporting.

Conducting a post-incident evaluation was identified as a key action [27], and patients and families preferred to be directly involved in the event analysis process [33]. This involvement included clinicians and other relevant staff involved in the care pathway [21], facilitated by a senior medical professional from the hospital [41], ensuring a transparent fact-finding exercise [36] aligned with an explicit OD process. Moreover, it was suggested to designate a specific support person or a named designated individual as a focal point of communication for patients to contact [20] to avoid miscommunications and help patients navigate healthcare organisations. Patients expected healthcare organisations, as service providers, to have formal arrangements in place to promptly address needs arising from adverse events [18, 33]. These organisational arrangements complemented the actions taken by staff members and contributed to a comprehensive approach to managing adverse events and fostering a culture of accountability and patient-centred care within healthcare institutions.

• 5. OD as a future oriented conversation

Included studies reflected that patients and families had not considered Open Disclosure (OD) as a one-off conversation but rather as an ongoing dialogue that continued from its initiation. Each interaction between the service provider and user prioritised building trust [22, 29, 37, 38] and maintaining the relationship [29, 31] until the issue was resolved. Patients and families expected organisations to take prompt corrective actions to prevent future incidents [18, 19, 22, 27, 32, 40] and to keep them informed with updates [27]. Beyond addressing the incident itself, hospitals played a vital role as community service organisations, and maintaining open communication with patients helped preserve social relationships [21, 24]. Some patients highlighted the importance of keeping patients and families well-informed about their future rights regarding medical complaints associated with the safety incident [25]. This emphasised the necessity of transparent and ongoing communication between healthcare providers and patients throughout the entire process.

Discussion

While health and social care organisations primarily aim to offer safe services and positive outcomes, patient safety incident can occur, leading to patient harm due to the dynamic and complex nature of the healthcare environment. This review found that while it is common to have explicit OD process in many health care settings, routine assessment and evaluation of patient and family experiences is infrequent. The routine data collection of OD experiences was lacking and the assessment from patients experiences mainly focused on evaluating OD policy implementation and practice. Patients and families, as service users, perceive safety incidents differently from healthcare providers and hold specific expectations. They seek open, timely, supportive, and informative conversations about their concerns. Often unsure of the full extent of harm, they highlighted their rights to know the complete information and prompt attention within a OD policy formally embedded in organisational practice. Patients expect OD to involve open, honest, and transparent communication, including expressions of regret and apology for staff actions. They view OD as an ongoing dialogue, not a one-time event, valuing face-to-face conversations and direct involvement in post-incident evaluations with clinicians and senior healthcare professionals with a mind to prevent future incidents.

Patient-reported experience data can significantly enhance our understanding of potential medical errors and patient safety incidents. Patient complaints also offer unique insights into healthcare issues [43], but challenges persist in effectively utilising this data compared to other quality and safety metrics. Most findings into OD have emerged from the included studies, highlighting the significant role of qualitative exploration in understanding the OD experience; however, it remains to be determined which approach works best common surveys that fit all or tailored interviews. Despite efforts to normalise OD in practice, many studies report the conduct of OD processes as unsatisfactory. The 2009 systematic review highlighted patients' perspectives on disclosing adverse events and its role in improving patient safety culture [11]. Another comprehensive review a decade earlier explored both patient and practitioner perspectives on OD [12]. In this review, we focused exclusively on firsthand patient experiences of the OD process, focusing deeper insight into patient evaluations and assessments to support its formalisation into standard protocols. Interestingly, despite the earlier reviews being published over an extended period to support the persistent gap in evolving OD practice to meet patient needs.

From this work, it is clear that compounded harm is still happening through poor implementation of OD, and this is avoidable. Sincere apology is paramount to patients and its absence serves to compound the harm. According to Wailling et al., “compounded harm can feel worse than the original injury, especially when people feel unheard or invalidated” [44]. It is imperative that when patient safety incidents occur, healthcare professionals must act within the ‘Golden Moment’ to communicate with patients openly before trust is breached [45]. Supporting healthcare staff to do this, creating a culture of openness and psychological safety are keys steps to embedding a culture of OD. Openness, transparency and honesty are critical to building trusting relationships between patients and service providers.

Limitations of the study

Our review specifically focused on examining patient experiences following OD to better understand these experiences and the methods used to measure and evaluate them. We did not include studies that explored healthcare staff experiences or perspectives, which could also provide valuable insights into OD processes. We limited our review to articles published in the last 15 years and included studies only in English language. This means we may have excluded earlier studies that could offer useful evidence. However, by focusing on recent studies, we aim to ensure greater relevance to contemporary practice and to explore if/how patients experiences may have changed since previous reviews. The lack of experimental research or quantitative analyses, such as meta-analyses, to evaluate the effects of interventions or assess potential publication bias may be a limitation of the review.

Study implications to policy and practice

Consideration of patient experience plays a key role in improving healthcare and, it is directly linked to the quality of care that patients receive. A positive patient experience can indicate higher-quality care, promoting trust, communication, and collaboration between patients and healthcare providers. The articles reviewed have brought to light that while explicit OD policies are present in all healthcare settings, routine assessments of patient and family experiences in OD are lacking. This highlights the need for more consistent and systematic data collection on OD experiences to inform policy and practice. By consistently capturing patient and family feedback, in addition to other patient experience surveys, healthcare providers can better evaluate the effectiveness of OD policies and identify specific areas for service performance improvement. Enhancing OD practices based on comprehensive data can lead to improved patient satisfaction, trust, and overall quality of care. Therefore, incorporating regular assessments into healthcare protocols is essential for the continuous improvement of OD practices and staff performance.