Treatment-limiting decisions in severe traumatic brain injured patients

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Treatment-limiting decisions in severe traumatic brain injured patients

Annette Robertsen ^1,2,3

1 Department of Research and Innovation, Division of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway

2 Department of Anesthesiology and Intensive Care, Divisions of Emergencies and Critical Care, Oslo University Hospital, Oslo, Norway

3 Institute of Clinical Medicine, University of Oslo, Oslo, Norway

Dissertation for the degree philosophiae doctor (PhD) 2022

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© Annette Robertsen, 2022

Series of dissertations submitted to the Faculty of Medicine, University of Oslo

ISBN 978-82-348-103-7

reproduced or transmitted, in any form or by any means, without permission.

Print production: Graphics Center, University of Oslo.

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Acknowledgement

In this PhD project, I have explored how clinicians deal with uncertainty and ethical

dilemmas in patients with severe traumatic brain injury (sTBI) in the context of the trauma hospital/neurointensive care unit (NICU). The challenges I describe and explore in my PhD project are issues I have encountered and grappled with as a physician myself.

The work in this thesis was carried out between 2015 and 2022. For 6 years, I have been privileged to be able to share my time between my clinical work as an intensivist and work specifically related to my PhD project. I am very grateful for having been given this

opportunity. Being a PhD candidate has been an enriching experience.

Thanks to neurosurgeon Hans-Kristian Nordby for piquing my interest in ethics and sTBI.

Many thanks to the sTBI patients and their families whom I have met throughout the years. I hope my research can be of value in the clinical setting for future patients and families.

I am deeply indebted to Reidun Førde and Eirik Helseth my PhD supervisors for their encouragement, patience and warm support throughout the PhD process.

I would like to extend my sincere thanks to Nils Oddvar Skaga and Jon Henrik Laake, my coauthors, for their valuable contributions.

Thanks to colleagues at the Center of Medical Ethics for serving as my research group, providing input on my work in progress and being an inspirational source helping me widen my perspectives in the field of ethics.

Thanks to all my clinical colleagues at Oslo University Hospital (OUH). Working with you brings me meaning and joy. A special thanks to all the interviewed physicians.

Thanks to the OUH trauma registry for providing data for my first study. Thanks to Thomas Dregni for helping me with the retrospective database. Thanks to the OUH librarians. Thanks to Leif Arne Rosseland, head of the department of research and innovation at OUH, who offered me the position as a PhD candidate. Special thanks to Anne Bøen for her support.

Thanks to UiO for the opportunity to be part of the university’s PhD program.

Last but not least thanks to my family and friends.

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Abbreviations

AD advance directives ACP advance care planning AIS Abbreviated Injury Scale E-o-L end of life

GCS Glasgow Coma Scale

CRS-r Coma Recovery Scale-Revised DBI devastating brain injury DOC disorder of consciousness ISS Injury Severity Score LST life-sustaining treatment NICU neurointensive care unit OUH Oslo University Hospital

PIT potentially inappropriate treatment SDM shared decision-making

sTBI severe traumatic brain injury TLD treatment-limiting decision TLT time-limited trial

WH withholding

WD withdrawing

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List of papers

I Robertsen A, Skaga NO, Førde R, Helseth E Treatment-limiting decisions in patients with severe traumatic brain injury in a Norwegian regional trauma center. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine 2017 April 26; 25 (1): 44 II Robertsen A, Helseth E, Laake JH, Førde R Neurocritical care physicians’ doubt about whether to withdraw life sustaining treatment the first days after a devastating brain injury: an interview study. Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine 2019 August 28; 27 (1): 81

III Robertsen A, Helseth E, Førde R Inter-physicians variability in strategies linked to treatment limitations after sever traumatic brain injury; proactivity or wait and see. BMC Medical Ethics 2021 April 13; 22 (1): 43

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Summary in Norwegian

Hvorvidt livsforlengende behandling bør startes, fortsettes, begrenses eller avsluttes etter en alvorlig hodeskade er både en medisinsk og en etisk utfordring som leger i

intensivavdelinger jevnlig konfronteres med. Pasientene er sårbare og kan ikke selv delta i beslutningsprosessen. Familien er i en emosjonelt krevende situasjon, og prognostiske vurderinger er usikre tidlig etter skade.

I denne avhandlingen har vi sett på praksis med å begrense og avslutte behandling av pasienter med alvorlig hodeskade ved Oslo Universitetssykehus i et retrospektivt materiale (artikkel 1). Vi fant at det er vanlig å begrense behandling i denne pasientgruppen og at beslutninger i mange tilfeller tas tidlig etter innleggelse.

Videre intervjuet vi beslutningstagere (nevrokirurger, intensivleger og rehabiliteringsleger) om hvordan de takler usikkerhet og tenker og handler i prosessen med å finne rett

behandlingsnivå for individuelle pasienter. Vi bad dem reflektere over situasjoner fra egen praksis der de hadde vært i tvil om valget.

Legene har fokus på å unngå for tidlige beslutninger og selvoppfyllende profetier.

Situasjoner spenner fra de åpenbar nytteløse tilfellene til situasjoner som krever mer

komplekse og verdiladede valg. Vi delte materialet i to og så separat på håndtering de første 72 timene etter skade (artikkel 2), og håndtering senere i forløpet (artikkel 3). Vi identifiserte tre hovedstrategier for å håndtere tvil tidlig etter skade; 1. tidsavgrensede

behandlingsforsøk, 2. bruke tiden det tar for å sikre et godt nok beslutningsgrunnlag og 3.

teamdiskusjoner og samarbeid. Familier inviteres ikke inn i selve beslutningen. Vi fant forskjeller i legers strategier med hensyn til håndtering av slike situasjoner senere i forløpet, med skille mellom «proaktivitet» versus «vent-og-se».

Selv om vi finner at praksis for en stor del følger etiske retningslinjer tror vi både etisk

bevissthet hos personalet på intensivavdelingen, triggere for etikk diskusjoner, involvering av pårørende og det palliative tilbudet for denne pasientgruppen kan styrkes.

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Summery in English

Whether to start, continue, limit or withdraw life-sustaining treatment in patients with severe traumatic brain injury is a medical and an ethical challenge neurointensive care physicians are faced with on a regular basis. The patients themselves are vulnerable and unable to participate in decision-making. Their families are in a demanding emotional situation. Prognostication early after injury is difficult and involves uncertainty.

In this thesis we seek insights into decision-making processes with regard whether to start, continue, limit or withdraw life-sustaining treatment in patients with severe traumatic brain injury.

We conducted a retrospective study at Oslo University Hospital. We found that treatment- limiting decisions in severe traumatic brain injured patients are common and most decisions occur early after admission (Paper 1).

In an interview study conducted in the neurointensive care unit at Oslo University Hospital we asked decision makers (neurosurgeons, intensive care physicians and rehabilitation physicians) how they reason and act in the process of reaching the right decision for an individual patient and which strategies they use to deal with uncertainty. We asked them to talk about real-life cases they had been involved in, and where they at some point had been in doubt about whether to start, continue, limit or withdraw treatment. In Paper 2 we describe the first 72 hours after admission. In Paper 3 we describe how physicians deal with patients with long-term lack of neurological improvement.

The physicians were focused on avoiding premature decisions and avoiding self-fulfilling prophecies. There are obviously futile cases and more value-laden complex cases. We identified three main strategies the physicians used to deal with doubt during the first 72 hours after admission; 1. to provide time-limited treatment trials, 2. to use the time needed to strengthen decisional ground, 3. to collaborate within the multidisciplinary team. A shared decision-making model with family involvement was generally not used, at least not in the early phases after injury. In relation to patients with long-term lack of improvement we identified interphysician variability with a divide between proactive strategies and wait- and-see strategies.

Physicians’ strategies with regard to treatment-limitations are mostly in compliance with ethical guidelines. However, we believe ethical awareness among neurointensive care personnel, triggers for ethical discussions, involvement of families in decision-making and neuropalliative care all are areas that need more focus and future development.

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Introduction

The Polly case

I attended the European Society of Intensive Care Medicine (ESICM) congress in Paris in the autumn of 2014. There I heard about Polly and her sisters. Polly was a young woman who suffered a devastating brain injury in a car accident in March 2009. Prior to her accident, Polly was healthy, creative, and engaged in social work helping others get their voices heard;

see http:://www.welovepolly.org (1). Despite all efforts to optimize conditions for Polly’s best possible recovery, she remained in a state of disordered consciousness and was unable to interact with others (2). The situation lasted for weeks and months.

Multiple questions arose: Is “Polly” “still there” (3, 4)? Do nonresponsive sTBI patients experience suffering? Is it possible to make a long-term good recovery when there are no signs of neurological improvement months after sTBI (5, 6)? Is there reason to fear survival in “a life worse than death” after sTBI (7, 8)? How can a patient’s best interest be

determined in such a situation (9)? If a life or death-decision is to be made, when is the right time (not too early, not too late)? What does the term “life-sustaining treatment” actually mean and do different involved parts hold a similar understanding?

Polly had two sisters who were both devastated. In contrast to many other families in crisis who often have difficulties being confident about or finding words to articulate their loved one’s values, goals, or preferences in such a situation, Polly’s sisters were sure about what Polly would have wanted. They were convinced Polly would not want further life-sustaining treatment. However, what they discovered was as follows:

It was not possible for Polly to “have her voice heard”. Without an advance directive, a document that very few healthy young people make, Polly’s values and wishes (or what the sisters believed about Polly’s values and wishes) were not given decisive weight by Polly’s treatment team (10-12).

The sisters also discovered that as the closest relatives, they did not have any formal decisional authority in the United Kingdom (UK). Physicians decide. A similar legal status exists for the closest relatives when patients lack decision-making capacity in Norway (13).

Patients in vegetative states (VSs) or minimally conscious states (MCSs) are dependent on a feeding tube (nutrition and hydration by a feeding tube is seen by some as basic care and by others as medical treatment/life-sustaining treatment). Adding to the burden, in the UK at the time of Polly’s injury, life-sustaining treatment could not legally be removed if the patient remained in a long-term in a VS or MSC without taking the case to court for a judge to decide, even in cases where the family and the treatment team agreed (14). The sisters worried about missing “the window of opportunity” for withdrawal of life-sustaining

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treatment in the sense that if a decision was not made within the ICU context but rather postponed, there was a risk that the patient would not “be allowed” to die (15-17).

In the aftermath of their sister’s injury Polly’s sisters, both academics, wrote extensively about ethical dilemmas seen from a patient/family perspective (14). They were particularly focused on the vulnerability of sTBI patients and on how to protect patients’ interests and values in situations when patients’ capacity to make decisions for themselves is lost; see http://cdoc.org.uk (18-24).

I recognized these dilemmas, uncertainties, emotional tension and ambiguities from my own work as an intensivist in the largest trauma hospital in Norway. Is it true that it is more difficult or even impossible to withdraw life-sustaining treatment later than earlier (17)?

Does a “window of opportunity” for the withdrawal of life-sustaining treatment truly exist (16)? Discussions and decisions about life-sustaining treatment should be made in a timely manner, but what is “timely”? I knew from the medical literature that end-of life practices vary around the world (25-30). How would my colleagues have responded to a situation similar to Polly’s?

Figure 1 Trajectory for severe acute brain injury-patients present with a crisis that may result in early death or survival with a high degree of disability. From Creutzfeldt et al., Predicting decline and survival in severe acute brain injury: the fourth trajectory

BMJ 2015, vol 351, p 3904. Figure reused with permission.

Severe traumatic brain injury threatens both life and personhood (31, 32). The questions about whether to start, continue, withhold or withdraw life-sustaining treatment in a vulnerable patient unable to participate in decision-making go to the core of medical ethics:

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17 what is the best way to protect, promote, and honour the patient’s interests and values, do good and not do harm (33)? We lack knowledge about these decisions seen from

neurointensive care clinicians’ perspectives.

How do individual physicians and teams deal with uncertainty (34-37)? How do they reason and act? How do they weigh different considerations or conflicting values involved in these cases? How are decision-making processes, conversations, judgements and decisions related to treatment continuation or treatment limitations experienced by physicians? Are

treatment-limiting decisions (TLDs) common after sTBI? When, why and how are such decisions made?

The aim of this thesis is to explore life or death decision-making processes in sTBI patients in a Norwegian trauma hospital/neurointensive care unit (NICU) context.

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Severe traumatic brain injury- the medical perspective

Traumatic brain injury (TBI) is an alteration in brain function or evidence of brain pathology caused by an external force. Alteration in brain function refers to a period of loss of or decreased level of consciousness, loss of memory of events immediately before (retrograde amnesia) or after the injury, neurological deficits (weakness, loss of balance, change in vision, dyspraxia, paresis, paralysis, sensory loss, aphasia) or alterations in mental state (confusion, disorientation, slowed thinking) (38, 39).

Classification

There are several classification systems available for TBI. None of them work perfectly by themselves. Frequently used are the Glasgow Coma Scale (GCS) score, the head injury severity score (HISS), pathoanatomic injury descriptions, the Rotterdam CT-score and the Abbreviated Injury Scale (AIS) and Injury Severity Score (ISS) (40-45).

The Glasgow Coma Scale (GCS) is a widely used tool for systematic assessments of level of consciousness developed by pioneers in the neurosurgical field (40, 46, 47). With a GCS score <9, the patient is considered comatose by convention. With a GCS score =3, the patient is totally unresponsive. The GCS score does not distinguish between various causes of reduced consciousness, such as drug or alcohol use, intoxication, hypotension,

hypothermia, hypoglycaemia or TBI. The observed response to stimulation is categorized by whatever reason consciousness is reduced.

According to the head injury severity score (HISS), TBI is classified as minimal, mild, moderate or severe (41).

Pathoanatomic injury descriptions are mostly based on head computed tomography (CT):

fractures of the skull, diffuse swelling of the brain, epidural haematoma (EDH), subdural haematoma (SDH), traumatic subarachnoid haemorrhage (tSAH), intraventricular

haematoma (IVH), brain contusions, and/or diffuse axonal injury (DAI) (48). Head magnetic resonance imaging (MRI) is the preferred imaging technique for diagnosing cerebral

ischaemia and DAI lesions (also called traumatic axonal injury, TAI) (49, 50). DAI/TAI is subclassified into Type 1 with lesions in the brain hemispheres, Type 2 with lesions in the corpus callosum, and Type 3 with lesions in the brain stem.

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19 Table 1 The Glasgow Coma Scale

The Glasgow Coma Scale (GCS) Eye opening

response

Spontaneously 4

To speech 3

To pain 2

No response 1

Best verbal response

Oriented to time, place and person 5

Confused 4

Words, incomprehensible 3

Sounds, inappropriate 2

No response 1

Best motor response

Obey commands 6

Move to localized pain 5

Withdrawal from pain 4

Abnormal flexion 3

Abnormal extension 2

No response 1

Sum GCS score 3-15

Table 2 The head injury severity score (HISS)

Minimal GCS score 15, no loss of consciousness (LOS)

Mild GCS score 14-15 and either LOS < 5 minutes or amnesia, loss of memory and impaired reactivity

Moderate GCS score 9-13 or LOC > 5 minutes or focal neurological deficits Severe GCS score 3-8

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Figure 2 CT scans showing the heterogeneity of TBI, the yellow arrows in CT scan number 1 show a fracture of the skull and EDH, in number 2 SDH, number 3 tSAH and number 4 brain contusion. Figure used with permission from the OUH Department of Neuroradiology.

Figure 3 Young male injured in a high-energy trauma that included head rotation.

Traumatic axonal injury (TAI; yellow arrows) can be seen in the cerebral hemisphere (TAI grade I), corpus callosum (TAI grade II), and brainstem (TAI grade III). Figure used with permission from the OUH Department of Neuroradiology.

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21 Several scoring systems for evaluating TBI severity and predicting mortality based on initial head CT scans are in clinical use, e.g., the Rotterdam CT score (44, 45).

Table 3 The Rotterdam CT classification system

Predictor value Score

Basal cisterns Normal 0

Compressed 1

Absent 2

Midline shift No shift or <= 5 mm 0

Shift > 5 mm 1

Epidural mass lesion Present 0

Absent 1

Interventricular or

subarachnoid haemorrhage

Absent 0

Present 1

Sum score + 1

Each of the four elements is given a score, and these are tallied, with an addition of 1 to the sum to make the score comparable with the Marshall classification (51).

The term primary brain injury refers to the brain pathology present immediately after the accident. Secondary brain injury refers to pathology that may develop in the aftermath.

Mass lesions and brain swelling may, if untreated, result in secondary brain injury and in some cases progress to brain death, a situation with a total irreversible cessation of blood flow to the brain (52-54).

Appropriate classification of injuries by type and severity is fundamental for quality assessment analyses. The internationally recognized tool for anatomic injury scoring following trauma is the Abbreviated Injury Scale (AIS). The most common edition in use is the 1990 Revision, Update 98 (AIS 98) (42). The coding dictionary containing 1339 injury descriptions is divided into nine anatomic body regions; in each region, every anatomic injury is given a seven-digit injury description indicating body region, type and specification of anatomic structure, level and severity. AIS classifies individual injuries by body region on a six-point ordinal severity scale ranging from AIS 1 (minor) to AIS 6 (lethal) and is the

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foundation for the Injury Severity Score (ISS), a recognized tool for the assessment of overall injury severity (43). For the calculation of ISS, the 9 AIS-regions are merged into 6 ISS-

regions. The ISS is the sum of the squares of the highest AIS severity code in each of the three most severely injured ISS body regions. AIS 98 is the classification system we used to select the study cohort for Paper I (55). The coding system head AIS based on a combination of clinical presentation and extent/type of anatomic pathology on imaging includes injuries to the cranium and the brain.

Table 4 Examples of injury descriptions for head AIS scores of 4, 5 and 6 AIS

score

Severity Injuries

4 Severe Cerebral contusion, large, 30-50 ml, midline shift > 5 mm Cerebral SDH or EDH, small, ≤ 50 ml, ≤1 cm

Complex skull base fracture Complex skull vault fracture Transverse sinus thrombosis

Internal carotid artery cerebral thrombosis (occlusion) 5 Critical Cerebral contusion, extensive, > 50 ml

Cerebral SDH or EDH, large, > 50 ml, > 1 cm Penetration injury > 2 cm

Diffuse axonal injury / traumatic axonal injury Absent ventricles or brain stem cisterns

Unconsciousness (GCS score 3) lasting for > 24 hours

Unconsciousness lasting 6-24 hours with neurological deficit 6 Maximum Massive destruction of both cranium (skull) and brain

Massive destruction of brain stem

Comment: AIS 6 is only used for injuries specifically categorized as lethal according to AIS 98. AIS 6 is not an arbitrary choice used just because the patient died.

Epidemiology of TBI

The incidence TBI cases admitted to the hospital in high-income countries is 83–262/100 000 (39, 56-58). Narrowing down to hospital-admitted patients with abnormal traumatic

intracranial findings on computed tomography (CT), the incidence rate in Scandinavian countries drops to 26–42/100 000 (59-61). For sTBI (GCS score 3-8), the age-adjusted incidence is 4-5 per 100000 in Norway (62).

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23 Figure 4 Incidences of TBI, used with permission from Cathrine Tverdal

TBI occurs in all ages, but in high-income countries, TBI is most common in elderly individuals and in men. The most common injury mechanism in high-income countries is low energy falls (39). The typical TBI patient in Norway has during the last decades shifted from a healthy young male suffering a high-energy injury (motor vehicle accidents or fall >3 m) to a frail elderly individual suffering a low-energy fall (63). Comorbidity and frailty influence the consequences of TBI more than age per se due to the lack of physiological reserves (64).

Management of patients with severe traumatic brain injury (sTBI)

The optimal outcome after sTBI depends on a chain of treatment starting at the scene of the accident, as illustrated in the figure below (65).

Figure 5 The chain of treatment after sTBI. Figure by Annette Robertsen

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Emergency room (ER)

From the moment a multitrauma/high-energy/sTBI patient is admitted to the hospital, the trauma surgeons, neurosurgeons, orthopaedic surgeons, anaesthesiologists and specialized nurses work together to achieve physiological stabilization according to ABCDE principles (airway, breathing, circulation, disability/neurology, exposure), diagnose and treat injuries, protect the injured brain and identify and treat related/other critical medical issues (66, 67).

“Trauma team activation” (who are needed in the ER) is based upon specific triage criteria.

Health care organization, roles and manner of collaboration may vary across hospitals and countries (65, 68). International and local recommendations on medical, surgical and ethical management after trauma/sTBI are available and guide clinicians’ treatment choices (69-73).

The standard approach for sTBI is that all patients with a GCS score < 9 are intubated and sedated (69). A tube is necessary for protecting the patient’s airway and connecting the patient to respiratory support (life-sustaining treatment) in the first vulnerable phase after the injury.

In some cases, physicians may recognize futility and consider treatment-limiting decisions (TLDs) already in the ER.

Emergency neurosurgery

Neurosurgeons assess whether mass lesions or severe brain swelling requires surgery (70, 73-75).

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25 Table 5 Treatment protocol OUH. Indications for emergency neurosurgical procedures.

Procedure Indication

ICP-monitoring GCS score < 9 and abnormal CT

GCS score < 9 and normal CT and with ≥ 2 of the following features:

age > 40 years

systolic blood pressure < 90 mmHg GCS motor score < 4 (best side) GCS score < 13 and

prolonged surgery in other organ systems

expected prolonged ventilator therapy due to other injuries Evacuation of

EDH (epidural haematoma)

GCS score < 14 and

haematoma volume > 30 ml or midline shift > 5 mm or

haematoma width > 15 mm Evacuation of

cerebral contusion

GCS score < 12 and

contusion volume > 20 ml or midline shift > 5 mm

CSF diversion Is considered when

ICP > 22 mmHg for 10 minutes or ICP > 22 mmHg for 5 minutes Decompressive

craniectomy

Persisting ICP > 22 mmHg despite all neuroprotective efforts or if an evacuation of mass lesion alone does not provide ICP control When CT and clinical presentation are compatible with a

meaningful life Age < 60 years

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Neurointensive care unit (NICU)

Neurosurgeons, intensivists and, to a certain extent, rehabilitation physicians are responsible for treatment decisions for neurologically injured and sick patients within the NICU.

Intracranial pressure monitors are routinely inserted, enabling intracranial pressure (ICP) monitoring and cerebral perfusion pressure (CPP)-directed treatment (69, 76). A repertoire of interventions are used in a stepwise manner to protect the injured brain by keeping the ICP below a certain threshold thereby preventing the development of secondary brain injuries (intubation, controlled ventilation, sedation, cerebrospinal fluid drainage, hypertonic saline to reduce swelling, temperature controlling measures, metabolic suppression using barbiturates, decompressive craniectomy) (77, 78). The sequence of interventions may vary among different institutions, but most institutions follow Brain Trauma Foundation

guidelines (69, 79). Individual tailoring and ongoing adjustments of different strategies are necessary to balance benefit and potential harm (see figure below).

Figure 6 Stepwise approach to the treatment of intracranial pressure. From Stocchetti N and Maas A. Traumatic intracranial hypertension NEJM 2014 vol 370, issue 22, p 2121-30.

Reproduced with permission, copyright Massachusetts Medical Society.

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27 Figure 7 Illustration of components in neuroprotective treatment/sTBI treatment guided by ICP and CPP. ©Rønning. Used with permission.

The evidence base is weak for most of the interventions applied in the NICU (69). Sometimes an intervention, e.g., a decompressive craniectomy (surgical removal of part of the skull to give room for a swollen brain), is assessed as life-saving but nonrestorative, meaning that without the intervention, the patient will die; secondary injuries can be prevented, but the already established irreversible components of the brain damage will not be healed by the intervention (75).

Figure 8 A CT scan after decompressive craniectomy on the right side, used with permission from the OUH Department of Neuroradiology.

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There are ongoing controversies about how and when to select individual patients for decompressive craniectomy (80). Recent studies have shown that more patients survive when craniectomy is performed compared to conventional medical management of

intracranial hypertension, but also that more survivors will have poor outcomes (74, 75, 81).

There are important milestones to be reached along the trajectory of treatment in the NICU.

In the first phase, when patients are in a coma/sedated, ventilated and provided targeted treatment for ICP/CPP, the short-term medical treatment goals are to prevent intracranial hypertension, prevent secondary brain injuries and enable survival.

If/when ICP is stabilized (may require days or several weeks with more or less aggressive treatment efforts), sedation is stopped, the weaning process from the ventilator is started, the ICP monitor is removed, and the short-term goals of treatment shift to follow the awakening process and overall clinical neurological development.

Before patients are ready for discharge and transfer to a specialized rehabilitation facility, they need to be able to breathe on their own and have a solution in place for hydration and nutrition. If they lack the ability to drink and eat on their own, percutaneous endoscopic gastrostomy (PEG) can be used, enabling long-term artificial nutrition and hydration. At this point, some patients can cooperate and communicate, some are in a posttraumatic

confusional state, while others have not regained awareness and/or consciousness.

Proper access to rehabilitation to optimize recovery after brain injury is crucial in all age groups (39, 82, 83). Ideally, there is an unbroken chain from the NICU (OUH in our study) to the specialized rehabilitation facilities (in our setting Sunnaas Hospital, Kongsgaard Hospital or other specialized facilities) and access for all eligible patients. To be eligible for

rehabilitation, a “recovery potential” is needed. Some of the most injured patients will not gain access to specialized rehabilitation or will only be offered a short evaluation stay (common practice at the Norwegian rehabilitation hospital Sunnaas). An ambulant team (neuropsychologists and rehabilitation physicians from Sunnaas) can provide support in evaluating disorders of consciousness (DOCs) and patients’ rehabilitation potential

(regardless of whether the patients are treated in the NICU/trauma hospital, local hospitals or nursing homes) (84). Initial rejections regarding access to rehabilitation are in some cases open for reconsideration (delayed recoveries do occur).

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29 Table 6 Definition of categories of disorder of consciousness (DOC)

DOC Definition

Coma Coma indicate a nonresponsive patient with eyes closed.

Vegetative state A vegetative state (VS), also called

unresponsive wakefulness syndrome, indicate an unconscious patient with sleep-wake cycles.

Minimally conscious state

The term minimally conscious state (MCS) refers to a patient who is awake with transient signs of consciousness either without the ability to follow any commands (MCS-) or with the intermittent ability to respond (MCS+).

Lock in state Locked-in state (LIS) refers to a situation with an awake and aware patient who totally lacks the ability to communicate. This can, for example, be the result of severe brainstem damage. In a partial locked-in state the patient is able to communicate with their eyes. Comment: LIS is not a DOC, but may be misdiagnosed as one.

Some sTBI patients will not be able to survive or do not want life-sustaining treatment (based on preinjury statements). Therefore, in the NICU, it is important to recognize imminent death, futility or potentially inappropriate treatment in a timely manner and act accordingly (85-88).

However, whether and when it is right to use treatment-limiting decisions (TLDs) will depend on the level of certainty in physicians’ prognostication, goals set and perceptions of what constitutes a meaningful survival/an unacceptable outcome (8, 34, 89-92).

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Outcome

The long-term consequences for sTBI survivors may be negative changes in physical functioning, cognitive status, emotions, personality and mood. As a result the sTBI survivor may be left living with impairments of different degrees related to activities of daily living (ADLs), capacity for social

interactions, work and education.

It is difficult to dichotomize outcomes into bad/unfavourable (dead, vegetative, severe disability) versus good/favourable (moderate disability, good recovery) (39, 93).

There are different perspectives on what is important for a good/acceptable life. Proper access to care, symptom management and the possibility for proximity to close ones are important for most people. However, there are different opinions about the importance of the ability to speak, to socially interact, to move or to live independently. Some place a very high importance on the value of life itself.

Attitudes, perceptions and preferences might change throughout life.

All individuals think, react and adapt differently. The response shift and the disability

paradox are two phenomena that deserve particular attention (94, 95). Many will eventually accept a life with disability. Preinjury assumptions often do not correspond with how quality of life (QOL) is reported when a person is actually in the situation they feared. People living with severe disabilities (those who are able to communicate how they are feeling), and even patients in partially locked-in states (totally paralyzed, only able to communicate through their eyes or through communication aids), report good QOL (accept they will not recover, focus on what is good despite the challenging situation) (96). On the other hand, mild TBI may lead to long-term problems and may significantly reduce perceived QoL (people expect to recover but do not).

Prognostication

Prognostication of the risk of dying and expected long-term functional outcomes after sTBI is difficult and involves uncertainty, especially in the early phases after the injury (6, 71, 97, 98).

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31 Figure 9 A model of the prognostic cycle/process that takes place prior to treatment decisions, from Steinberg et al. Physicians’ cognitive approach to prognostication after cardiac arrest (sTBI is even more difficult) published in Resuscitation 2022. Figure reused with permission.

The process relies on clinical judgement with interpretations and integration of information from CT, MRI, EEG, SEP, VEP, BAEP and Coma Recovery Scale-Revised (CRS-r). Old age, frailty, comorbidities, prolonged hypotension or severe hypoxia all may have a negative impact on prognosis. The clinical examination, clinical development and responses to therapeutic intervention carry much weight. Dilated nonreactive pupils or intractable ICP are usually certain signs of a grim prognosis or a dying/nonrescuable patient.

Two prognostic tools have been developed for sTBI but are not reliable for individual patients (99, 100).

In regards to prognostication for patients lacking neurological improvement, it is important to be aware that the CRS-r, used to systematically detect subtle signs of improvement in patients with disorders of consciousness, relies on behavioural responses, meaning that sensory and/or motor impairments (paralysis) in these patients may contribute to a patient’s lack of response (5, 101, 102).

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Several studies have revealed discordance between families’ and physicians’ prognostic beliefs for sTBI patients, a challenge to be aware of (103-106).

Recovery after sTBI may improve over time, and it is therefore important to let the recovery process unfold over time before concluding about what are reversible and irreversible components of the injury pattern (83, 107, 108). The long path to potential recovery after sTBI truly complicates the decisions of whether to continue, limit or withdraw treatment and results in ongoing controversies about what is considered ethical and sound timing for such decisions.

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Whether to start, continue, limit or withdraw life-sustaining treatment

“Treatment decisions near the end of life are not simple, consistent, logical or predictable, but are complex, uncertain, emotionally laden and fluid.”

Quote from Morrison el al., JAMA 2021 What is wrong with Advance Care Planning? (109)

Futility and potentially inappropriate treatment

TLDs need justifications, reasons and to make sense:

There is no consensus about the definition of futility (110-112). In the literature this concept is widely debated (113-123). The lack of a common understanding of this key concept may be a source of confusion and conflict in the clinical practice setting. In 2015 Bosslet et al issued a multisociety statement (an official ATS/AACN/ESICM/SCCM policy statement/

nurse- and physician- intensive care societies in the US and in Europe) that suggested using the concept of futility narrowly, only when physiological goals cannot be achieved (87). They also introduced the concept of potentially inappropriate treatment (PIT) for more value- laden situations when there is doubt about whether goals are achievable or in the patient’s best interest. Last, they talk about prescribed or prohibited treatments, meaning that laws and regulations dictate what can and cannot be done in certain circumstances.

When I heard about the Bosslet terminology, it made a lot of sense to me as a clinician (124).

The term futility is currently in the Norwegian clinical setting often used broadly and vaguely. Using the word broadly might be an ethical problem because it may contribute to simplifying complex decisions and hiding inherent value-dimensions.

To acknowledge and talk openly about the uncertainty and doubt that exist in the clinical setting is important; therefore, the term “potentially inappropriate treatment“ is helpful in the sense that it acknowledges the complexity of decision-making and the existence of doubt (125). Specifically, the word “potentially” indicates the preliminary nature of the judgement or the question. Resolutions require openness to determine whether treatment is truly inappropriate. The concept serves as an invitation to seek more or different

perspectives, resolution through shared deliberation, and a shared understanding of what the best decision tailored for this person in this situation is. The futility and appropriateness of treatment cannot be assessed without a clarification of treatment goals. Some talk about the aim of goal-concordant care (126-128). Is this achieved by current practice?

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The Society of Critical Care Medicine Ethics Committee has suggested that “ICU interventions should generally be considered inappropriate when there is no reasonable expectation that the patient will improve sufficiently to survive outside the acute care setting, or when there is no reasonable expectation that the patient’s neurologic function will improve sufficiently to allow the patient to perceive the benefit of treatment” (129).

Guidelines are available to support clinicians

There are helpful guidelines, frameworks, tools and concepts, national and international, sTBI specific or more generally applicable for the intensive care setting to support clinicians in their work when confronted with ethical dilemmas/hard choices/the process of deciding whether to start, continue, limit or withdraw life-sustaining treatment (13, 71, 72, 130-134).

Oslo University Hospital has its own guidelines on sTBI with sections on prognostication, communication and treatment limitations for sTBI (see Table 1 in Paper II).

In Norway, the national ethics guideline on TLDs was first published in 2009 as a response to the Christina case in Bergen. Christina was a girl with a devastating brain injury. After initial treatment efforts to save her life, the treatment team perceived further treatment to be futile and advised the withdrawal of life-sustaining treatment. A conflict arose with the father who did not want his daughter to die and denied withdrawal of treatment. The case received a great deal of media attention and revealed a need for structural support for doctors responsible for TLD processes. The guideline was last updated in 2013 (13). For the key recommended steps in this Norwegian national ethical guideline considering limitations of life-sustaining treatment, see the appendix.

Modern ethics focus more on what constitutes a sound ethical process rather than on the labelling of a decision as “right” or “wrong” per se (13). Ethically sound decision-making processes explore, clarify, take into account and are based upon the available medical facts, knowledge about the natural course after injury, possible recovery trajectories, outcome data, and individualized medical assessments and are also guided by ethical considerations linked to beneficence, nonmaleficence, patient autonomy and justice (33).

Norwegian laws determine how physicians should make decisions when patients lack the capacity to do so, which is the case for sTBI patients (135). Physicians have decision-making authority if a patient lacks capacity, but the law oblige doctors to communicate and involve the family in the decision-making process, whenever possible seek to elicit what the patient would have wanted (a shared decision-making model is promoted as opposed to physician- driven/paternalistic decisions), not make decisions without team deliberations and make decisions “in the patient’s best interest” (136). The concept “best interest” refers to person- centeredness and taking into account a person’s preferences, priorities and values (in value- sensitive decisions). For patients with TBI, “best interest” can be difficult to interpret.

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35 Patient wishes and values

One available instrument for exercising autonomy or at least influencing decisions in the case of a future loss of capacity is to write an advance directive (AD) (10). However, one may question what is preferable in the moment: relying on involved parties and clinicians’ ability to find good solutions when a situation arises, or being prepared by making plans ahead of time?

The value of having an AD is debated (109, 137, 138). In Norway, ADs are not legally binding, and they are seldom used. Nevertheless, if an AD does exist and is considered by the

physician, it may contribute to informing physicians about the values and preferences of the patient. Physicians should therefore clarify whether such a document exists and if it does, evaluate its applicability and validity. Applicability means that the content matches the situation at hand. Quite often, the actual situation during courses of critical illness or

trajectories after injuries does not match the scenarios described in an AD. Validity refers to whether the formal requirements of ADs as stipulated in the countries’ jurisdiction are fulfilled. Whether ADs are legally binding varies between countries.

A tool to structure discussions on ethical issues

A helpful tool when discussing ethical questions is the 6-step model developed by the Center of Medical Ethics (CME) at the University of Oslo (139). All Norwegian hospitals have a clinical ethics committee (CEC). The Norwegian CECs use this model in case deliberations.

Some clinicians see ethics as vague. The model is applicable both by individual clinicians and for multidisciplinary discussions. With this structured tool, important considerations and solutions can be clarified and assessed from multiple angles.

1. What is the ethical problem? Are there ethical problems in this case (or is it perhaps rather a communication problem/misunderstanding between involved parties)? It can be helpful to try to articulate the dilemma as an “ought-question”.

2. What are the facts of the case? What is not known?

3. Who are the involved parties and what are their viewpoints and interests?

4. What are the relevant values, principles, virtues, experiences from similar situations and judicial constraints?

5. What are the possible courses of action?

6. Discuss the above and formulate one or more acceptable actions and a conclusion/summary.

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To make explicit what is not known is very relevant for sTBI. Another important point in the model is the need for clarification of options. Multiple studies have shown that palliative care options may not be presented in a timely manner by the physicians in charge despite an obviously poor prognosis.

Choosing Wisely

The Choosing Wisely campaign (in Norwegian “Kloke valg”) therefore decided that in the field of intensive care, one of five key prioritized recommendations should be ”Do not continue life-sustaining treatment (LST) for patients at high risk of death or severely impaired functional recovery without offering patients and their families the alternative of care focused entirely on comfort” (140-142). On the other hand, experienced clinicians may see opportunities and suggest treatment options that family members in shock and despair with limited medical insight had never thought about or did not believe possible.

Variability in EoL practice and TLDs

Despite fine-grained guidelines, it is well-established that great variability exists with regard to TLDs both related to sTBI in particular and for ICU patients in general. The reason behind the variability is complex and linked to geography, culture, societal laws and norms,

economy, patient factors and physician factors (specialty, experience, personal bias and emotions) (27, 29, 143-150). End-of-life practices may change over time as societies and norms are changing. The issue of variability and the lack of data from our own institution were both drivers for this research project.

We lack knowledge about the prevalence, timing and reasons behind TLDs in our own institution and lack insight into how physicians deal with real-life cases.

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Research questions

How often, when and how are decisions made about withholding or withdrawing life- sustaining treatment in sTBI patients in OUH?

How do physicians address questions about whether to continue, limit or withdraw life - sustaining treatment in sTBI patients in the neurointensive care context?

How do physicians deal with inherent uncertainty (not when treatment can most likely benefit the patient or when treatment will most like be futile, but in situations with potentially inappropriate treatment)?

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Methods

Study setting: The three studies in this thesis were all performed in Oslo University Hospital (OUH) in Norway, a hospital serving as the regional trauma care facility for approximately 3.0 million people, which is more than half of the Norwegian population of 5.3 million.

Geographically, the catchment area for the trauma facility of OUH is 110000 km2, and it is located in the south-eastern region of the country.

Paper 1: Quantitative methods

Study name: Treatment-limiting decisions in patients with severe traumatic brain injury in a Norwegian regional trauma center.

Study type: Retrospective cohort study.

Study population: We defined our study population as consisting of all adult patients (>17 years) with head AIS (AIS version 98) severity scores of 4, 5 or 6 (severe, critical or

unsalvageable TBI), with or without noncranial injuries, fulfilling the criteria for registration in the Oslo University Hospital trauma registry (TR-OUH), and admitted to OUH between January 1st 2011 and December 31st 2012, comprising a cohort of 579 patients.

Study variables: Demographic data and basic injury data were extracted from the TR-OUH, while information regarding TLDs made during their stay at OUH was based on chart review.

To strengthen data validity, a definition guide for our study variables was developed.

Table 7 From the variable guide we developed

Variable Definition guide

Prognostic statements in the medical record

Explicit physician prognostication identified (estimated and or communicated what to expect) in the medical record at any time during OUH stay.

Decision to withhold or withdraw therapy during OUH stay

Any of the WH/WD decisions described below identified (no access to ICU, out of reach for surgery, DNR, no organ support, no escalation of treatment, withdrawing neurointensive care, withdrawing organ support such as ventilator, vasopressors, dialysis or late withdrawal by stopping nutrition via PEG or

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nasogastric tube and any decisions about explicit change of goal to only palliative measures).

Date of first decision to withhold or withdraw

If there is a sequence of withholding and/or withdrawing decisions, the variable is defined as the date of the first

withhold/withdraw decision. The date of later revised, refined, or removed decisions are not registered.

Decision to withhold surgery/ "surgery out of reach"

Answer YES if: Neurosurgeons decide to not offer surgery to a patient with a brain pathology assessable for surgery, e.g.,

intracranial bleeding, that may have been appropriate to operate in other circumstances but in this case is judged not to be right for surgery. Answer NO if: The lesion is not surgically assessable under any circumstance.

Decision to withhold organ support

Decision to withhold ventilator support, vasopressors, or dialysis if a patient is developing organ failure at the time of decision or related to future deterioration.

Decision to remove WH/WD

The clinical situation is often dynamic and treatment courses may last for a long period of time with sometimes unexpected

improvement in patient condition, necessitating the need to reevaluate and sometimes remove previously made decisions about WH/WD. If previous WH/WD decisions (access to ICU, surgery, organ support, no escalation, DNR) are removed answer YES.

Futility is obvious very early

Futility is defined narrowly as recommended in the current ethical literature (ref Bosslet) as not possible to accomplish physiological goals.

Very early is defined as occurring during the period of primary, secondary and tertiary survey by trauma physician and the first multidisciplinary team evaluation when the clinical situation, first CT, and initial treatment response can be included in the

evaluation.

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41 The main reason behind each TLD was categorized as either futile or potentially

inappropriate based on the researcher’s (AR) interpretation (87). A predefined guide was used for to support the researcher’s categorization; see paper 1.

We included decisions immediately acted upon after decisions were made (e.g., withdrawing the ventilator support in a dying patient) and decisions regarding what seemed right in the future (e.g., “do-not-resuscitate orders”), decisions to withhold (including decisions not to escalate treatment) and to withdraw, not only related to organ supportive interventions (e.g. ventilator, vasopressors, dialysis, cardio-pulmonary resuscitation, feeding tube) but also related to neurocritical interventions and surgery. Categories of TLDs included: 1.

withholding surgery, 2. withholding access to ICU, 3. withholding organ support, 4. do-not- resuscitate (DNR) orders, 5. no escalation of treatment (151-153), 6. withdrawing

intracranial pressure-targeted treatment, 7. withdrawing organ support and 8. withdrawing nutrition (after being weaned off the ventilator).

For one patient, several TLDs could be applied. In the analytic phase, we dichotomized cases based on dominant decision type (mutually exclusive categories) into: 1. only withholding life-sustaining interventions, and 2. withdrawing life-sustaining interventions (may include withholding). The times of decision-making were related to the time of injury and the time of death. If a sequence of TLDs existed for one patient, only the time of the first decision was noted (154).

We predefined decision-making items in line with the recommended steps described in the Norwegian national ethical guidelines as prognostic statements, family meetings, presence of an AD, patient’s wishes expressed by the family, presence of multidisciplinary discussions, request from families to withhold or withdraw, request from families to continue if team advocated to withhold or withdraw, rationale behind decision, major conflicts, involvement of CEC, and involvement of palliative care consultants (13, 139, 155, 156).

Regarding mortality, in-hospital mortality, 30-day mortality (30 days after injury) and 2-year mortality were registered. The 30-day mortality data are part of the data we received from the OUS trauma registry. We added the 2-year mortality data because long-term outcomes are of interest because of potentially long recovery trajectories, delayed recoveries and potentially late mortality.

Statistics

We used simple descriptive statistics with the intention of providing a broad picture of TLD practice. We compared patient characteristics and mortality for patients with and without TLDs.

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Paper 2 and 3: Qualitative methods

To explore neurocritical care physicians’ experiences and reflections linked to TLDs in real- life cases we used qualitative methods, including interviews and thematic content analysis.

Interviews with a focus on value-laden, ethically challenging cases

In our interviews, we narrowed down the type of cases in focus from the broad definition of severe traumatic brain injury we used in the first study, to focus on the hard, value-laden, ethically challenging cases.

We interviewed senior consultants from OUH with extensive trauma care experience who were actively engaged in patient care, including: neurosurgeons, intensive care physicians and rehabilitation physicians. We included all the groups of involved specialties to maximize sample diversity.

Prior to the interviews, the participants were provided with background information and illustrations to prepare them for the interviews, including the Bosslet definitions of futility and potentially inappropriate treatment, a figure describing decision-making processes as circular not linear, and a list of types of decisions we included in this study as TLDs (see appendix) (87).

The opening question used in the interview was: “Please share your experiences and reflections regarding encounters with patients with sTBI and their families, in a situation when you were in doubt about whether to start, continue, withhold or withdraw life- sustaining treatment. Please use real-life cases you have been involved in. How did you perceive the situation at hand, and how did you reason and act?”

We asked the physicians to talk in a manner understandable to an outsider. We used open- ended questions to access descriptions in the physician’s own words, and we used probing to explore the meaning of what the physicians said (157).

Interview guide

The interview guide consisted of a list of items to be covered. A list of items instead of fixed questions enabled the researcher to use the guide in a flexible manner during the

interviews. To make more space for the physicians’ free comments, we reduced the number of questions and the level of detail in our questions compared to our initial version of the interview guide; see appendix for the initial interview guide of the Norwegian version. The

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43 adjustments were based on AR’s sense of what worked and did not work so well in the first interviews and on discussions between AR and RF.

Table 8 Items to be covered Items to be covered

Strategies you use to deal with uncertainty and doubt Crucial steps in the decision-making process

Roles /collaboration within the teams Estimation and communication of prognosis Weight you give different considerations Patient’s values, wishes and will

Impact of family input

Timing issues; early vs. late withdrawals Flipping roles: If you were the patient Concerns about current practice Additional comments: Please share

The interviewed physicians were free to select cases they felt were suitable, irrespective of whether they described decisions around cases in the very early phase after admittance or in patients with a long-term slow recovery or who were not recovering who sometimes stayed in our NICU for weeks and months.

The timeframe for each interview was 1 hour, which was rarely exceeded. The number of interviews was not preset. Saturation was judged as obtained after 18 interviews. The concept “saturation” means that further data collection ceased to add understanding in regard to what had already been gained.

The interviews were audio-recorded and transcribed verbatim by AR immediately after they took place. The main supervisor read all the transcribed interviews consecutively.

Thematic content analysis

In the thematic content analysis we used the following steps (158):

1. Reading of interviews for overall impression and search for preliminary themes (AR, RF);

2. Rereading, searching for meaning-units and coding interviews word by word using inductive coding (AR). Inductive means “from the data”;

3. Looking for similarities and differences across interviews and nuances within interviews (AR, RF);

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4. To understand the content in more depth, the researchers developed the analysis further with a focus on two overarching questions: why/in what kind of circumstances were

physicians in doubt, and how did they cope in situations when doubt was prevailing (AR, RF, EH)?

In the analytic phase, the research team vacillated between a position of critical thinking and interpretation of details such as single words or expressions to a more comprehensive view of searching for the essence of what was found in the text in relation to the research questions.

The analytic team

To increase the quality of the analytic process, participants with different professional backgrounds were recruited. Two of the authors (AR and EH) were involved in clinical tasks related to some of the cases that were referred to; RF is a physician and an ethicist without clinical obligations, and JHL (involved only in Paper II) is an intensivist without links to trauma care.

The NVivo Pro tool

NVivo Pro 11 (QSR International, Melbourne, Australia) was used as a tool to organize the data and support our analysis (159). NVivo is a data-program specifically developed to handle qualitative data that is helpful in the process of moving between decontextualized and recontextualized data fragments and in searching for patterns across interviews. The sense-making part of the analysis, however, fell on the researcher, not on a data-program.

Dividing the interview material into the early phase (the first 72 h) and the later phases

Since the physicians could select the cases in the interviews, our material consisted of a mixture of early cases in situations of time constrains immediately after admission when there was a lack of information, a lack of a relationship with families and a lack of availability of broad collegial support and cases when patients had been in the NICU for weeks or months with the availability of all sorts of diagnostic and prognostic tools and plenty of time and space for interaction within the treatment team and the involvement of families. Due to this mixture of cases involving different types of ethical challenges, we made the decision to split the material into two groups, separating what happened in the first 72 hours from what happened later on.

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Ethical considerations in research

We obtained permission from the data protection officer at OUH to perform the studies.

Informed consent was given by all participating physicians. The consent form is available in the appendix.

We were careful about protecting confidentiality for the physicians interviewed throughout the research process.

Confidentiality considerations also limited the use of patient narratives shared in the interviews.

We were cognizant and careful about the use of patient stories. Patient stories could not reveal details that could directly or indirectly serve as patient-identifiers or physician- identifiers.

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Main results and summaries of the papers

Paper 1

We found TLDs in 17% (101) of hospital admitted sTBI patients (579) in our 2-year cohort from OUH. We found 46 cases of withholding and 55 cases of withdrawing (mutually exclusive categorization, see Methods section).

All predefined types of TLDs were identified except withdrawal by removing the feeding tube in isolation. The three most frequent types of TLDs (one patient could have more than one TLD at different time points) were not offering neurosurgery, do-not-resuscitate orders and withdrawing organ support.

We found that the decision-making processes involved physicians’ prognostic statements (91%), deliberations within the treatment team (92%), family meetings (89%) and physicians’

reason-giving (100%). The role of the patient’s wishes, however, was unclear. Notification of patient preferences based on communication with family existed in a minority of cases (7 %).

No patients had advance directives. Palliative care consultants or the CEC were not involved.

No major conflicts were reported.

The main reason behind TLDs was categorized as “potentially inappropriate” in 42 cases and

“futile” in 59 cases.

The mean time between a TLD and death was 2 days (not all patients with TLDs died). In 70%

of cases the first TLD (there could be more than one, see the Methods section) was made within 2 days after admittance. Twenty percent of these were later adjusted or amended as the patient’s situation evolved over time. In 14% of the cases, the first TLD was made later than Day 7.

TLDs were found in 93% of in-hospital death cases. In-hospital mortality was 73% in the TLD group (which means 27% of patients were alive at discharge despite TLDs), 1% in the non- TLD group. Eight percent of the patients with TLDs made within the trauma hospital phase later died, as evaluated by our 2-year follow-up.

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Paper II

In the second study, we explored neurocritical care physicians’ reasoning regarding whether to offer, limit or withdraw LST in sTBI/DBI patients in the first 72 hours after admission and strategies for dealing with doubt.

We found that the degree of doubt regarding decisions to limit LST varied among the physicians. Fallibility in early prognostic judgements and the risk of self-fulfilling prophecies humbled physicians.

Common strategies used to mitigate doubt were as follows:

Taking time before making definitive decisions by seeing how a patient was responding to treatment and letting a situation unfold first.

Using treatment trials, meaning that treatment was started, not open-ended, but followed by reevaluations of appropriateness of continued treatment at a later stage when things were clearer. The time needed to reach a conclusion about withdrawal of life-sustaining treatment was determined on a case-by-case basis. Physicians were open to changing their minds in either de-escalating or re-escalating treatment. For example, if an assessed patient with a poor prognosis was initially not offered treatment, but then surprisingly showed good neurological signs, decisions and plans were adjusted accordingly.

Shared interprofessional deliberations and consensus seeking.

Emphasis was placed on medical facts, not on patient’s values or wishes. The process did not follow a “shared decision-making model” but was rather found to be “physician-directed”.

Nevertheless, making decisions understandable and providing emotional support to families were seen by the NICU physicians as crucial.

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Paper III

In the third study, we sought insights into clinicians’ strategies regarding treatment limitations in patients with minimal or no signs of neurological improvement in the later trauma hospital phase.

The study was based on the same interviews as Paper II, but here, we looked at the parts of the interviews where our interviewed physicians addressed the challenges of the later trauma hospital phase.

We found interphysician variability with regard to ethical reasoning around the issue of TLDs, preferred ways to interact with families and preferred strategies for dealing with uncertainty.

We created a typology and named the two different strategies proactive and wait-and-see.

The proactive physicians were open to considering limitations of life-sustaining treatment when the prognosis was grim. They emphasized their duty to ensure that treatment did not lead to a life unacceptable for the patient. At the same time, they acknowledged that this commitment was challenging, given residual prognostic uncertainty, the existence of different opinions about what constitutes a good, bad, and unacceptable outcome and the fact that patients’ and families’ values may change as they adapt to a new situation. The proactive physicians described how they initiated ethical discussions, took leadership in clarification and deliberation processes regarding goals and options, saw themselves as guides for families, believed in the necessity to prepare for both best-case and worst-case scenarios and believed in their ability to resolve complicated matters.

The “wait-and-see” physicians preferred open-ended treatment (no limitations).

Neurologically injured patients need time to uncover their true recovery potential, they argued. They often avoided talking to the family about dying or other worst-case scenarios.

It seemed that their way of reasoning was anchored in a deep sense of humility, duty to provide treatment, the belief that continued treatment was actually in the patient’s best interest and their nonjudgmental attitudes towards quality of life after severe brain injury.

Treatment-limiting decisions in severe traumatic brain injured patients