Invisible harm in patient safety: a framework and definition for preventable psychological harm in cancer care

Abstract

Background

While patient safety is receiving increasing attention in healthcare services research and policies, it is mainly centred around prevention of physical harm. Preventable psychological harm (PPH) remains invisible in reports and quality measurements. As patients with cancer are particularly vulnerable due to the severity of their condition and therapies, they are exposed to risks such as non-physical adverse events. Recently, incidents of psychological harm have gained more attention in patient safety research, but a common and accepted definition and classification are missing.

Aim

We aimed to develop a common definition of PPH and a corresponding framework to classify events, settled within patient safety concepts and terminology.

Methods

Through a literature review, expert interviews from various healthcare backgrounds and workshops with patient representatives, we gathered information on PPH, which was reviewed and structured by an interdisciplinary research team (patient safety, psycho-oncology, palliative care research, nursing, organisational psychology). The final definition and framework were iteratively developed taking into account existing patient safety concepts.

Results

The definition broadens the classification of PPH to include a wide range of commissions and omissions by individuals or organizational practices within the health care system. These actions and inactions result in consequences of varying severity for patients and their close ones. The framework complements the definition of PPH, including those impacted by PPH, types of PPH, potential causes and contributing factors, vulnerabilities influencing severity and occurrence, moderating factors for mitigation and negative consequences of PPH.

Conclusions

Defining and classifying PPH is the first step to make it accessible for measurement, analysis and prevention. Its integration within patient safety terminology is important to ensure uptake and integration in research and practice.

WHAT IS ALREADY KNOWN ON THIS TOPIC

• A common and accepted definition and classification of preventable psychological harm (PPH) events in health care does not yet exist in patient safety.

WHAT THIS STUDY ADDS

• This study provides a definition and framework of PPH and contributes to the understanding of these kinds of adverse events.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

• Having a common definition can contribute to the implementation of measurements and reporting of PPH events in patient safety, thus contributing to its visibility.

Background

Traditionally, patient safety research has concentrated on physical harm such as adverse drug events, infections, falls or surgical complications. In contrast, psychological harm resulting from healthcare has received comparatively little attention as a patient safety concern.^{1 2} However, the focus on physical harm does not align with global definitions of health, which encompass social and emotional well-being, and therefore, include psychological harm as well. Existing research indicates that patients’ understanding of harmful adverse events extends to psychological harm (PH), for example, when patients with cancer and relatives report errors, they often mention instances of psychological harm, such as missing/wrong communication, miscommunication between staff and transfer of care problems.^{3 4}

Patient safety has focused on PH mainly in the aftermath of an error (eg, not receiving an apology). Psychological effects following medical errors and communication of those events are already well-researched and calls for action and initiatives from patients and researchers emphasise the long-lasting psychological effects after physical harm incidents.^5–7 But events where PH is the primary source, independently from physical harm, have not been measured or included in patient safety indicators. The traditional emphasis on physical harm in patient safety research is reflected in the gold standard method for detecting adverse events: the medical record review.⁸ In this approach, patient records are initially screened for indicators of adverse events, such as unplanned transfers to intensive care units or the administration of antidotes. However, this method is inherently limited to detecting harmful events that result in documented changes in health status or healthcare utilisation. Since adverse events involving psychological harm are less likely to generate such documentation, record review studies are not suitable for investigating preventable psychological harm (PPH). Patients, their close ones (partners, family members, friends or anyone patients have a close relationship with) and healthcare professionals (HCP) all emphasise situations of non-physical harm as negative emotional experiences within the healthcare system, experiences that are not captured by common patient safety measures.^9–11 This is supported by a recent study which analysed critical incident reports and found incidents of PPH in the form of communication failures, privacy violations and disregard of patient preferences but argued that the system was not used to report PPH by hospital staff and that PPH might be underrepresented.¹² Compared with physical adverse events, psychological harm events are still in the phase of common acceptance of the occurrence of PPH in clinical practice and normalising these events as ‘this is just something that happens’. It can be concluded that there seems to be a harm measuring gap.¹³

Other recent studies have examined dignitary harms^14–17 as well as inequality, discrimination and dehumanisation in healthcare,^{18 19} with minorities and vulnerable groups being disproportionately affected.^{18 20} Traumatic healthcare experiences have been identified as indicators of harm but mostly following physical incidents and rarely systematically measured.²¹ Emotional harm, conceptualised as not being taken seriously or talked about, has also been reported in a study involving children and their caregivers in paediatric care.²² Especially palliative care research has examined different forms of PH such as insufficient end-of-life communication, non-patient-centred information and decision-making processes, disruption of the natural dying process and violations of patients’ preferences regarding life-sustaining measures.^{11 23–28}

Currently, various terms are used to describe PH, including disrespect, dehumanisation and lack of empathy. The code ‘psychological harm’ is used as an outcome in the Primary Care Patient Safety (PISA) Classification System,²⁹ while other authors distinguish between emotional and psychological harm in terms of severity but without detailed examples for application.³⁰ Recently, progress has been made to prioritise ‘emotional harm’ as a primary focus within patient safety.^{1 31} The most cited definition centred on dignity and respect was developed by Sokol-Hessner et al. in 2015: “Emotional harms can be conceptualized as harms to a patient’s ‘dignity’ which can be caused by a failure to demonstrate adequate ‘respect’ for the patient as a person”.¹ In their subsequent work, Sokol-Hessner et al. developed a framework which explains dignitary harms as the main component of emotional harm in healthcare consisting of the following categories: care processes, contributing factors, modifying factors and consequences.³¹ What this research has in common is that the main harmful interaction involves communication errors.³² Until now, common concepts and definitions fail to integrate other types and sources of emotional harm. To fully represent the patient’s reality of PH, it is essential to consider incidents that result from various levels within the healthcare system, including systemic and not just individual HCP factors. This highlights the need for a broader systemic definition, involving the role of the healthcare system itself.³³

PH events are relevant for all groups of patients but may be more frequent and significant in those with chronic or serious illnesses who require more frequent and long-term healthcare. Patients undergoing cancer treatment are especially vulnerable, necessitating safety measures to minimise further harm.³⁴ Protecting patients and especially those in vulnerable groups from avoidable harm is at the core of patient safety. While some physical harm—such as side effects like fatigue — cannot be entirely prevented, even with the best available care, early safety measures are needed to reduce additional PPH. One aspect of this vulnerability is the significant psychosocial distress, which up to 50% of patients with cancer experience, while a third develops mental disorders during the course of their cancer.^35–39 Being faced with a potential life-threatening diagnosis and undergoing extensive treatment leads to distress, which cannot be completely prevented, yet other causes of distress for these patients are likely to be entirely preventable.

Additionally, no common definition of these constructs to date has been accepted or tested with key stakeholders. Consequently, the frequency and impact of PH remain unknown, largely due to the lack of clear terminology and reporting mechanisms.

We aimed to identify core components of PPH and to develop a definition and framework of PPH from a patient safety perspective. We focus on primary PH as an event itself, which is not a consequence of physical harm (eg, harmful treatment error). While this research focuses on patients with cancer, we believe that our conceptual efforts are relevant for other patient groups, particularly those with life-threatening illnesses with intense and long healthcare utilisation.

Methods

To develop the definition and framework of PPH, we used a mixed-method approach based on the analysis of different data and information sources (see figure 1). The findings from these analyses were iteratively incorporated into both the definition and framework, with the sources complementing each other, as described in each step.

Figure 1.

Sources and process for developing the definition and framework of Preventable Psychological Harm (PPH).

As the first step, we conducted a comprehensive electronic literature search of relevant databases (eg, PubMed, Embase, Psyndex) and searched for publications that dealt with “emotional harm” or “psychological harm” or similar concepts, and which were published until June 2024 (see online supplemental file 1). Qualitative as well as quantitative studies, reviews and also statements, comments and editorials were included in the targeted narrative review.⁴⁰ The heterogeneous and rather limited number of studies (see online supplemental file 1) as well as the still-developing construct of PPH, and the lack of consistent terminology in the existing literature made a systematic review unfeasible and justified the use of a targeted narrative review. Proxies, concepts, examples and terminology were reviewed and used as a first base for further development of interview questions and ideas for the structure of the framework and definition.

In a second step, we generated a semistructured interview guide (see online supplemental file 2) for expert interviews on patient safety and/or cancer care with questions based on main aspects of PPH such as preventability, categories, causes, consequences, reporting culture and prevention and intervention strategies, as well as gaps in the literature. This methodological step is reported following the Consolidated Criteria for Reporting Qualitative Studies (COREQ).⁴¹ All interview questions were developed by the interprofessional study team and reviewed by a nurse and patient representative. Via stratified mixed purposive sampling,⁴² 21 experts, of different professions, work settings and regions within German speaking countries were recruited (see figure 1) and informed about the rationale of the study, the interviewer’s role in the study team and professional background. No drop-outs, declines or repetitions occurred. All interviews were held by a female postdoc/psycho-oncologist (LD), who had no prior (professional) relationship with the interviewees before, except in the cases of the psycho-oncologist and the case manager. With this approach, led by the principle of information power,⁴³ a variety of perspectives such as those from younger and older patients, inpatient and outpatient doctors, working in curative and palliative care settings, and representing various overarching systemic perspectives, such as quality management and clinical ethics, were obtained.⁴⁴ Individual interviews, lasting 40–80 min, were conducted face to face and alone in the participants’ work setting or via video call after obtaining participants’ consent. The audio files were transcribed using Aiko, a speech-to-text AI-powered transcription software,⁴⁵ anonymised and securely stored. Each file and all field notes were carefully reviewed by LD and compared with notes and the audio files. Afterwards, we performed a broad analysis of content, grouping and categorising answers to the interview questions and retrieved categories from the data.

The lists of definitions and examples of psychological harm as a singular event obtained from the literature search were complemented with the examples and definitions gathered from the interviews. Furthermore, potential causes and consequences of psychological harm events were extracted and listed. Subsequently, factors influencing the occurrence of PPH in the first place were compiled, as well as factors that might mitigate its consequences, if an event of PPH had already occurred.

As a complementary step, information from a separate analysis of PPH events reported to the voluntary critical incident reporting systems of three Swiss hospitals¹² was reviewed and included. Furthermore, based on the interview answers on how and where PPH events could be reported, we sought information from offices of ombudspersons, ethical committees and quality reports, in order to explore whether incidents of PPH were documented. There are no systematic databases for these reports available, which could be used to analyse single incidents, in order to summarise common causes or groups involved.

As a third step and to integrate the results of the literature review, expert interviews and additional data sources, three interprofessional workshops were held by the study team consisting of a patient safety expert (DS), a psychologist expert on palliative care communication (SZ), a postdoc/psycho-oncologist (LD) and an organisational psychologist (YP). During this phase, we identified core components essential for the definition, carefully selecting and refining all terms in alignment with patient safety terminology. Contents of the framework based on the preliminary interview categories were iteratively structured and revised by the study team. Early drafts of the definition were compared with existing definitions of physical harm, and the terminology was adapted and applied to PPH examples to ensure practical applicability in terms of comprehensiveness and potential design of corresponding measurements.

In a fourth step, the preliminary definition and framework were evaluated and discussed with patient representatives (different from all interview participants) regarding comprehensiveness, inclusiveness, representation and relevance to their reality. Patient representatives were approached via committees and local advisory boards to sign up for the workshop and received a short summary of the study procedure and goals. They were eligible if they had experience with patient engagement in research and/or led self-help groups in cancer (compensation for the 2-hour workshop was provided). For the workshop, 10 patient representatives participated, the majority with a past cancer diagnosis, while two of them also had experience as a close one of someone with a serious illness. Participants were between 31 and 72 years old and had between 1 and 7 years of experience as patient representatives, while some had been in treatment for over twenty years. The final results were translated and sent out to all workshop participants.

Results

From the literature search, we reviewed the existing definitions of similar concepts, for example, emotional harm or psychological harm, identified overlaps such as communication and disrespect as main aspects, as well as gaps such as organisational structures as a source of harm or factors influencing the occurrence of harm (see table 1).

Table 1.

Aspects of concepts related to PPH

Main aspect	Quote	Source
Harm to dignity of a patient Failure to demonstrate respect	“Emotional harms can be conceptualized as harms to a patient’s ‘dignity’ which can be caused by a failure to demonstrate adequate ‘respect’ for the patient as a person.” (1)	Sokol-Hessner et al., 2015 1
Severity and endurance of harm	“We considered “emotional harm” to be the most appropriate terminology for mild, and generally transient, harm but used “psychological harm” to describe moderate or severe and, usually, more enduring harm.” (29)	Cooper et al., 2018 30
Lack of compassion, empathy, respect Caused to patient/ family Negative impact on family	“Emotional harm is subjective in nature—characterized as a failure to demonstrate adequate compassion, empathy, and/or respect for the patient or family member as a human being, and it may negatively impact the patient’s and/or family member’s dignity.” (13)	Press Ganey, 202313
Feeling unsafe Consequences of feeling unsafe	“Both the antecedents and the consequences of feeling unsafe are forms of emotional harm.” (46)	Lyndon et al., 2023 59

Regarding the definition, experts discussed the differentiation between PPH as a primary or secondary event and its distinction from psychological distress as an important aspect to define. The experts agreed that a definition of PPH was needed, while emphasising that it should include an external event, its impact on the quality of life or change in behaviour after the event, and a focus on the severity of its consequences rather than a feeling of dissatisfaction. They also highlighted the need to focus on how the event happened rather than the event itself, and the potential for multiple events to have a compound effect. For the framework, we structured the experts’ answers based on the interview guide, resulting in a set of categories and subcategories (see some examples in table 2). Further analysis led to a preliminary draft of the framework which we refined with additional subcategories (such as further subcategories for types, vulnerabilities and consequences) and examples during the subsequent methodological steps.

Table 2.

Quotes from expert interviews along examples of framework categories

Category	Subcategory	Quote
Impacted Individuals	Patients and close ones	“So not just patients, yes. Sure, patients, relatives too, family members and close ones.” (P04, patient)
	HCP	“I think it’s important to consider that this produces second victims, so to speak.” (P01, nurse)
Types	Poor communication/disrespect to autonomy	“They [patients] don't feel taken seriously or brashly brushed off when they have questions. So it’s almost the opposite of patients' rights.” (P02, ombuds person)
	Poor care coordination	“We sometimes have patients where so many, how do you say? Specialties are involved and no one knows what the others are doing and the patient hangs somewhere in the air in between.” (P02, ombuds person)
	Violation of privacy	“Privacy is also somehow permanently disregarded.” (P16, case manager)
Causes	HCP	"Then it is a lack of training, lack of communication skills, lack of time. Perhaps also fear on the part of the treatment team or avoidance in the sense of not wanting to put the patient through this(…).” (P12, pastoral care)
	Organisational	“The financing of services in general, then in the structure of the healthcare system, that is, the focus on the purely biological level (…).” (P08, social worker)
	System-based and societal	“The greater the pressure on the healthcare system, the greater the pressure on the patient.” (P06, psychiatrist)
Consequences	Patient: Emotional impact	“The patient doesn't feel like they are being taken seriously, they are probably disappointed maybe they are also afraid(…)whether they are in really good hands here.” (P16, case manager)
	Patient: Healthcare behaviour	“So the worst case scenario can be that a person refuses cancer treatment because they don't feel understood, because they've been hurt. Yes, there are people who then shut down, aren't there? So if they feel hurt, they don't want to know anything more.” (P18, nurse)
	HCP	“And that [cost pressure] also puts the practitioner under stress(…). And that can also lead to burnout rates and cause some people to give up their jobs. Which is not good for the system as a whole, simply because we suffer from a shortage of skilled workers.” (P10, psycho-oncologist)
	Organisational	“Yes, it is certainly damaging to the institution’s reputation. I think there are a lot of stories that circulate where people tell us what they experienced and that it was difficult.” (P12, pastoral care)
Vulnerabilities	Personal characteristics	“That’s not my area, but I could imagine that older people might be a bit vulnerable. They also belong to a generation that is not so quick to communicate and manifest themselves. And then, of course, perhaps also migrants to some extent, who are of course getting off less well in treatment anyway.” (P06, psychiatrist)
Moderating/ mitigation factors	Validation	“That you prove through the act that you will do better in the future, how you can restore that trust. (…) If it’s a system error that you only discuss the CT findings with the patient after 14 days, for example, then an apology is not enough. Then you should probably change your practice management.” (P05, oncologist)
	Provision of support	“That the conversation is certainly sought once again, that is, the professional group concerned, and if they don't go any further, at best, with a superior of theirs. That psychological support or the ombuds office also offered as a further opportunity to process the situation. So further support.” (P09, social worker)

HCP, Healthcare professionals; P, participant.

During the interprofessional workshops, the content of the framework was clustered, structured and repetitions eliminated. For the definition, the following core aspects were identified:

• Non-subjectivity.

• No limitation to individual failures but inclusion of organisational practices.

• Recognition of an omission as a form of harm.

• Distinction between preventable and non-preventable (stemming from the disease) events.

• Conceptualisation within patient safety models and terminology to ensure uptake and integration.

• Inclusion of close ones and healthcare professionals as those also impacted by PPH.

• Applicability across various settings.

These core components were transformed to align to definition standards, arranged in sequence and further specified.

Feedback from patient representatives on the preliminary framework resulted in additional categories and examples for PPH types (eg, lack of inclusion of close ones, not listening) and consequences (eg, anger, social withdrawal). Regarding the definition, appropriate terminology was discussed and adapted for a lay version for patients.

Finally, the following definition of PPH was developed:

Psychological harm is the result of any act of commission or omission in the interaction between the patient/close one and the health care system which has the potential to impact the patient’s and/or their close one’s well-being or health care behavior in a significant and negative way. The act of commission or omission can be classified as a deviation from appropriate patient-centered care. The deviation manifests itself in individual behavior or an organizational practice. This deviation makes the psychological harm potentially preventable. The psychological harm is not an outcome of the underlying disease or distress itself but results from medical care. The potential harmfulness of an event exists beyond the evaluation of the interaction by the involved individual(s). The potential effects range from mild to severe, have short or long-term consequences, and originate from a single event or the accumulation of multiple events.

The proposed definition further describes the involved parties, type of action, potential impact and consequences, with the different elements building on one another (see table 3).

Table 3.

Definition and rationale for PPH

Definition	Rationale	Example
Psychological harm is the result of any act of commission or omission	PPH can constitute an active action.	Commission: A patient in room 2 overhears a nurse talking to another nurse in the hallway about them: “The patient in room 2 is too fat. It is their fault that they got so sick.”
	PPH can also be the lack of an action or empathy/care etc.	A HCP promises to call a patient on Friday to discuss the pathology results since the patient is scared that the cancer might have progressed but the HCP does not call and the patient cannot reach them.
In the interaction between the patient/close one and the healthcare system	PPH constitutes not only communication or verbal interaction but any interaction occurring at any point from the first encounter with the healthcare system.	A patient tries to get an appointment for a head CT scan after being referred by their general practitioner due to the suspicion of a tumor. When trying to book the appointment online, the system crashes several times over consecutive days and the hotline is constantly busy.
Which has the potential to impact the patient’s and/or their close one’s	PPH can affect not only patients but also their close ones (family, friends, proxies, etc), who may be directly impacted by PPH and become primary subjects themselves.	A daughter with her young child is denied access to see her father, who is an inpatient at the hospital. The staff argues that the child is too small to see their grandfather so ill.
Well-being or healthcare behaviour	PPH can have a negative impact on physical and mental health and safety.	The patient from room 2 continues to hear the insulting comment from the nurses in their head for years, feeling that the illness is their fault too. The patient becomes depressive and withdraws from interactions with friends and family.
	PPH can impact the uptake of support and use of healthcare services, potentially resulting in a greater need for care in the future.	The patient who should have been called about their pathology results and cannot reach their doctor, loses trust and feels like there is no hope for them. They do not try to reach the doctor again and do not consult any other health services, despite the symptoms worsening.
In a significant and negative way.	A PPH event is characterised by its potential or risk for serious negative impact and is to be differentiated from mere discomfort or dissatisfaction.	A patient who received parenteral nutrition while in a coma, despite their stated preferences otherwise, discharges themselves against medical advice. Feeling their autonomy had been violated, a few days later they seek emergency treatment at a different hospital.
The act of commission or omission can be classified as a deviation from appropriate patient-centred care.	PPH is a deviation from current standards of care, which evolve over time.	In the 1940s, a patient not being asked about their treatment preferences had no other choice then but to undergo the surgery offered to them. This would not have been considered inadequate at the time, but perceptions and standards have changed over time.
	The deviation from the principles of patient-centred care, which emphasise tailoring care to patients’ needs, should be examined as a factor for PPH.	A patient who does not speak the language of the country where they are being treated is not provided with a translator, leaving them extremely anxious and unable to know which procedure is being performed or why.
The deviation manifests itself in individual behaviour	PPH can be caused by an individual but it is not limited to a specific group of HCP. It can involve anyone interacting with patients.	A patient calls the outpatient clinic they were previously treated at since they have questions regarding the duration between follow-up appointments. The assistant on the phone tells them they will not give them an appointment with the doctor, since this is a minor concern, and it is something they can find on the internet.
Or an organisational practice.	PPH can result from practices, standards, policies, and cultural norms within an organisation, healthcare system or society.	A patient is treated at a university hospital where student involvement is part of the treatment agreement. In the hospital, patients are visited without prior notice or opportunity to decline the presence of students on certain days or for certain procedures. A doctor and 10 students enter the patient’s room and the patient is asked to undress in front of them.
This deviation makes the psychological harm potentially preventable.	PPH constitutes a deviation from the standard of care when measures to prevent it exist and alternative approaches could be used to avoid it.	A patient with a history of trauma expresses discomfort about being examined by multiple doctors. In a routine check-up, despite the patient’s concerns, the doctors proceed with the examination in a crowded room without offering alternatives. In contrast, an example of non-preventable psychological harm could be denying face-to-face access to the daughter and granddaughter of a patient due to an infection risk to the patient or the family members.
The psychological harm is not an outcome of the underlying disease	PPH results directly from the deviation itself and not from the disease, its treatment or any side effects of the physical aspects of care.	A patient experiencing fatigue after being treated with radiation is a secondary consequence of the disease/treatment itself, and therefore, not classified as a primary PPH event.
Or distress itself but results from medical care.	PPH does not include the psychological consequences (anxiety, trauma, etc) that arise from the disease or its treatment and which are not preventable.	A patient experiencing fear of progression after being in remission without any contributing interaction is also a secondary consequence due to the inherent distress associated with the disease.
The potential harmfulness of an event exists beyond the evaluation of the interaction by the involved individual(s).	Even though individuals might evaluate an incident as not harmful, it still carries the risk to cause potential harm. Patients might evaluate PPH differently due to varying vulnerabilities and resilience, which influence their perception of harm. Regardless of its evaluation, a PPH event still carries the risk of harm to any patient. The deviation itself is not dependent on its consequences.	A patient overhearing the nurses making an insulting comment might perceive it as less harmful, knowing that weight is not a factor associated with their disease. In contrast, another patient with lower health literacy might feel deeply hurt by the comment.
The potential effects range from mild to severe, have short-term or long-term consequences, and originate from a single event or accumulation of multiple events.	PPH can lead to a variety of consequences for different individuals, with impact of differing duration. It may result from a single major event or from many less severe events that accumulate over time.	A patient is not greeted by their doctor in the hallway and thinks of it as a minor incident of disrespectful behavior. However, after the same interaction is repeated over consecutive days, the patient begins to doubt whether they are receiving the best care. Feeling disrespected, they prepare their switch to another institution.

HCP, Healthcare professional.

Incorporating all elements identified from the different sources of information, the definition was further contextualised within a broader framework.

Framework

The resulting framework (see figure 2) identifies impacted individuals, differentiates types of PPH, systematises causal factors and consequences of PPH, specifies vulnerabilities for occurrence and/or severity of harm, and accounts for moderating factors that may mitigate harm. Each factor has a set of categories, and some contain subcategories, which are followed by a list of short examples. The relationships between different factors are illustrated using arrows.

Figure 2.

Framework of PPH. HCP, Healthcare professionals

Even though the framework includes most common events, categories and examples are not exhaustive. PPH events can differ in characteristics, including overlaps between categories and differences across settings. Both the definition and the framework can be applied to examples of PPH from clinical practice.

Discussion

Three important results can be taken from the study. First, the focus on the system-level factors rather than solely on personal interactions is essential when it comes to PPH. Previous research overwhelmingly links PH to communication failures during one-to-one communication, such as disrespect. Our results confirm this as a common type of PPH; however, this narrow focus overlooks systemic factors contributing to psychological harm and the role of healthcare organisational policies and behaviours. The proposed definition and framework specifically broaden the perspective by providing a description of where, why and how PPH can occur across all levels of healthcare. This is supported by recent research on administrative harm⁴⁶ which emphasises the role of harmful behaviour at an organisational and system level, as well as for its recognition and prevention. Another new aspect is that our framework of PPH includes HCP as affected individuals since being complicit in a harmful environment can cause moral distress.⁴⁷

The second key result of this study is the significant need for a common definition of PPH emphasised by clinicians, patient safety experts and patient representative groups to enable the consistent recording and analysis of incidents. The definition of PPH can foster measurement, visibility and approachability, which in turn can help assess intervention effectiveness. The standards of how safety is defined change over time, so that earlier acceptance of physical harm during treatments, for example, is now considered unacceptable. A similar shift would apply to psychological harm, which has been long considered tolerable but is increasingly recognised as unacceptable and unethical, as also highlighted in our interviews. In addition, research on how patient satisfaction with positive relational behaviours, such as active listening, has been associated with health outcomes such as pain reduction, shorter hospital stays, treatment adherence and quality of life,⁴⁸ which further supports our findings. On the other hand, psychological harm can negatively impact decision-making, influencing where patients receive care, their willingness to seek appointments and their overall healthcare behaviour. Having the ability to define and measure PPH might help to further understand patients that drop out of the healthcare system or refuse treatment. This is supported by findings on reasons for discharge against medical advice, which include experience of disrespect, discrimination and poor quality of care.⁴⁹ However, since a definition and framework alone are not sufficient to make PPH measurable, appropriate methods are needed. One approach could be to adapt trigger tools and review medical records for PPH. Triggers could be events that are not part of routine treatment, such as psychological/psychiatric or ethical consultations, which were requested after an incident.⁵⁰ Patient reports such as complaints or seeking help after a PPH event are an essential source, but multisystem reports, for example, building new categories for reporting in CIRS or routine checklists for prevention of PPH, are important to capture PPH events regardless of the patients’ evaluation.

Third, adopting a patient safety perspective in developing the definition and framework proved helpful and valuable. Understanding PPH as events within the existing patient safety approach guided the process. Simulating the application of the definition within patient safety practices was useful and led to further optimisation. This also contributed to a clear terminology and differentiation, which might support the practical use of the definition. One example is the focus on preventability, which refers to the potential to detect risks, intervene early or take action to avert harm before it occurs, provided that effective interventions are available.⁵¹ This concept of preventability is also applicable to psychological harm, as seen in situations such as hurtful comments or poor care coordination, both of which can be prevented.⁵² In addition, existing concepts and training could be expanded to focus on PPH as well.^{53 54}

Finally, it is worth discussing why psychological harm needs its own framework and definition and why it is not considered to be included in patient safety measures already. One could argue that it fits the general definition of patient safety and therefore is already covered. As shown, this might be true in theory, but in practice, psychological harm incidents are clearly not covered, measured or improved. Alongside others,^{1 13} we argue that psychological harm should be part of patient safety theory and practice in line with the purpose of patient safety activities. However, in order to accomplish this, a dedicated framework is required in order to make psychological harm incidents visible in patient safety activities and work on ways to reduce it. As long as we do not acknowledge and systematically assess PPH events, they will continue to happen to patients, close ones and even HCP.⁵⁵ While our work focused mainly on incidents in cancer care, most of the content within the definition and framework is broadly applicable to other medical fields, diseases and treatments.

Strengths and limitations

Since this definition aimed to capture the risks of psychological harm, individual perception of harmfulness of different situations might differ and cannot be displayed in its entirety. While no systematic literature review or in-depth content analysis of interviews was conducted, and only European experts were involved, the results align with existing discourse and definitions of similar concepts worldwide. This underlines the universality of the concept, which should, however, be investigated in further multimethod studies in the future.

Notably, the involvement of patient representatives as experts in the interviews and the workshop was particularly valuable to the process. Patients and their close ones often have a broader view of what safe and unsafe means, observe care processes closely and are experts in experience.^{56 57} This multilevel perspective is an important characteristic of our definition, since it does not only describe PPH through the providers’ eye but through various points of view.

Another important strength of this work is the integration of definition within core aspects of patient safety and using similar terminology. This makes the definition concrete but also flexible enough to be applicable to various settings and events. New concepts such as ‘never words’ which list words and expressions that should never be said to patients, are a reference to ‘never events’ in patient safety.⁵⁸ The same should apply to PPH events as never events.⁵⁹ Efforts that are rooted within patient safety frameworks will promote the acceptance through integration of new disciplines.

Outlook

For future research, the results should be underpinned with quantitative data on severity and frequency from patients, close ones and HCP, which is planned in a further study. This will be the basis to develop a severity rating of PPH along the framework and incorporating different perspectives, and in line with current classifications such as ‘low’, ‘moderate’ and ‘severe’.⁶⁰ In addition, international experts from oncology and patient safety and patient advocates will evaluate further risk factors, probabilities and case studies of PPH. In another consecutive study, HCP will also be asked to assess their awareness of the situations and how they are affected. As the concept of PPH and the framework gain broader empirical and clinical relevance, a full systematic review may finally represent the application to different research areas and questions. In the future, it would also be important to find out what financial costs PPH could also entail for the healthcare system, for example, in the form of avoiding further consultations or additional necessary psychotherapy. Another major focus could be the evaluation of implementation of strategies on PPH and transferability as well as acceptance in different fields and healthcare systems.

Conclusions

The present work contributes to overcoming the invisibility of PPH by providing a common definition and framework to apply to adverse events. This could potentially support the reporting of PPH events and therefore be the basis for strategies to prevent psychological harm in cancer care. In practice, it is necessary for HCP and hospital management, as well as healthcare administrators, to ask themselves: Did this interaction cause psychological harm to the patient or their close ones that could have been prevented? The same question should be applied on a system level evaluating structures and new plans, such as when designing facilities, software and care processes to avoid psychological harm for patients, their close ones and HCP in healthcare.

Data availability statement

Data are available on reasonable request.

Ethics statements

Patient consent for publication

Not applicable.

Ethics approval

This study involves human participants but the Cantonal Ethics Committee for Research Bern (Switzerland) exempted this study according to the local law (Req-2024-00368, reason: The project does not fall under the Human Research Act, Art. 2, para. 1). Participants gave informed consent to participate in the study before taking part.