1.2.1

Population

We performed a cross-sectional, descriptive study. All physical medicine and rehabilitation (PMR) departments, nursing homes, geriatric units and local hospitals were approached via a mail contact with either the administrative director or the medical staff. All over, 18 PVS/MCS patients housed in institutions in Maine-et-Loire were included in the study.

1.2.2

Evaluation

All patients and their medical records were examined by the same investigator. Individual data were collected on the following parameters: gender, age, PVS or MCS, the date of the brain injury, the aetiology, the care protocol and the patient’s personal, professional and legal status. Medical difficulties were listed. Medical records were screened for written advance directives or instructions on the care to be provided in the event of worsened health status. An interview with a member of the care team served to evaluate the existence of non-written advance directives.

The Wessex Head Injury Matrix (WHIM) was used to evaluate wakefulness and the patient’s neurological and orthopaedic statuses were analysed.

A questionnaire for carers aimed at estimating the daily nursing load and routine for each patient (nursing, physiotherapy, participation in activities and the state of involvement of the patients’ relatives).

A second questionnaire for head nurses was used to gather data on the staffing ratio, problems encountered by the carers, the care team’s wishes, staff meetings, dialogue with the patients’ families and the presence or absence of dedicated accommodation for the latter.

1.3.1

Population

Thirteen patients were identified (eight men and five women). The mean age at the time of the survey was 48 [range: 29 to 77]. Nine of the patients were married and 11 had children. Eight patients were in work at the time of brain injury. There were four PVS patients and nine MCS patients.

Seven patients had sustained traumatic brain injury, five patients had experienced anoxic brain injury and one patient had undergone a stroke.

The mean time since brain injury was 7 years [6 months–15 years].

Ten patients were housed in geriatric units (in six different institutions), one in a PMR unit and two in local hospitals.

All patients had been initially admitted to an intensive care unit (ICU), for an average of 1.4 months [0.5–4 months]. Six patients had then been admitted to a PMR department (for an average period of 7.2 months [0.5–19 months]) and two had been readmitted to a PRM department for further assessment.

1.3.2

Clinical findings

The highest-ranked WHIM behaviours ranged from 3 to 43. The PVS patients scored 3 or 4. The MCS patients scored between 7 and 43: three had a score of 26 (frowns, grimaces, etc. to show dislike) and two others scored 43 (smiles). There was clear inter-observer disagreement on the behaviour of four patients.

All patients displayed spastic hypertonia in flexion and adduction. Two patients had an intrathecal baclofen pump and botulinum toxin injections were performed in two others. The orthopaedic deformities caused by spasticity impacted on hygiene and nursing care in all cases. In half of the patients, the medical staff considered that care was extremely difficult. Orthopaedic surgery had not been performed. None of the patients had pressure sores.

On average, two carers were required for personal care and dressing, which lasted 30 minutes. All but one of the patients had required gastrostomy for feeding. None of the patients had an indwelling bladder catheter. Two carers were required for transfer to a wheelchair. Three patients were permanently confined to bed. Others patients were transferred to the sitting position three to seven times per week, for 2 to 6 hours at a time.

Seven patients received respiratory physiotherapy and/or range of motion exercises (one to three times a week). Occupational therapy was also performed from time to time in certain institutions.

Apart from spasticity and orthopaedic deformities, the most frequent medical problems were pulmonary and digestive disorders. Nine patients had tracheostomy problems and/or bronchial obstruction, with superinfection in some cases. Three patients had received antibiotics for these infections in the month preceding the survey. Eight patients have digestive disorders.

During the previous 12 months, eight patients had been referred to acute care facilities for either consultations or hospitalisation. This was due to epidermal necrosis in one case and for the treatment of spasticity or complications of tracheostomy/gastrostomy in the other cases.

1.3.3

Advance directives in the event of worsened health status

The actions to be taken in the event of worsened health status varied significantly from one patient to another. Written advance directives were present in four sets of medical records, consisting in instructions not to treat the patient with antibiotics in two cases (although one patient had nevertheless been treated with antibiotics) and not to admit the patient to the ICU in the other two cases. In four other sets of medical records, verbal advance directives were mentioned: instructions not to admit the patient to the ICU in three cases and not to treat the patient with antibiotics or admit him patient to the ICU in one case.

1.3.4

Description of the facilities

There were one or two PVS/MCS patients per unit (each of which had a total of about 30 nursing beds). The nursing staff/patient ratio ranged from 0.45 to 0.70. The physiotherapist/patient ratio varied from 0.04/10 to 1/10 and was below 0.10/10 in five geriatric units.

There were no specific meetings about PVS/MCS patients but discussions did take place during the usual staff meetings. Head nurses expressed the need for a support group, better initial and continuing professional education, meetings with staff from other units and meetings with the patient’s family circle. Three units had dedicated accommodation for the patients’ families. In half of the units, there was significant interaction with families (activities, meetings with the family or a special family room).

All the head nurses reported practical difficulties and, above all, ethical issues. Carers were seen to have difficulties in creating a “life plan” for the patient and not merely a “care plan”. Many staff members raised questions about the sense of the care and were concerned about decision-making, interdisciplinarity, their relationship with the patients’ families, the distress experienced by the families and, indeed, their own emotional trauma as carers.

1.4.1

Epidemiological data

In the present work, the PVS/MCS prevalence was found to be 2.8 per 100,000 inhabitants – a value in agreement with the available literature . Epidemiological studies are scarce and often dated, and prevalence figures range widely. The prevalence of a PVS ranges from 56 to 140 per million inhabitants or as few as two to 20 per million inhabitants in other reports. Epidemiological studies of MCS patients are even less common . This variability in prevalence probably testifies to the difficulty in establishing and applying diagnostic criteria . Prevalence may also vary from one country to another because of differences in physicians’ attitudes to end-of-life decisions and actions.

The mean age and gender ratio were similar to the literature data. In the present work, a non-traumatic cause was less frequent (46%) than in other studies (over 70% in many cases ). However, it was similar to the value reported by Beis et al. .

The mean time since brain injury was 7 years and we identified four patients who had been in a PCS/MCS for more than 10 years. This is higher than the typical literature values for PVS patients . Data on MCS patients in France are scarce. However, according to a preliminary study , the mortality rate in dedicated units in the Île-de-France region was 28% over 4.5 years – lower than the values reported in literature . Hence, our data is consistent with recent French studies. According to Kiefer et al. , the incidence of a PVS/MCS and the life expectancy of affected patients are growing (probably as a result of better healthcare and changing care strategies), which would lead to a higher prevalence.

1.4.2

Clinical findings

In the present work, we observed fairly high WHIM scores in some MCS patients. Few studies on this topic have been published . The frequency of scores of 26 and 43 was similar to that suggested in the literature . Scores between 30 and 46 are thought to correspond to cognitive abilities . However, a score of 43 does not necessarily mean that the patient has significant cognitive ability; this score can be found in MCS patients but also in severely handicapped individuals having emerged from MCS . There is no clear WHIM score threshold for the upper boundary of MCS . Even though WHIM analysis is useful, it is not sufficient for the assessment of PVS/MCS patients .

The frequency of gastrostomy in our study population (100%) was higher than the literature values . This probably reveals why artificial nutrition and hydration (ANH) status is so important. In France, debate on this subject has intensified since the introduction of the 2005 Parliamentary Act on Patients’ Rights and End-of-Life Care, which authorizes the limitation or withdrawal of “futile or disproportionate treatments or those which only seek to artificially extend life” . Indeed, ANH can be considered to be a form of active treatment and certain demands to withdraw ANH have been given media exposure . Conversely, other authors consider life to be sacred and regard ANH as a basic form of care, the withdrawal of which cannot be justified .

We observed severe orthopaedic deformities resulting from spasticity; this means that the nursing load is high, care is very difficult and patients are totally dependent. Despite the fact that orthopaedic deformity is the most important cause of difficulty in care, physiotherapy was very rare administered. Furthermore, none of the patients had undergone orthopaedic surgery. In contrast, there were two intrathecal baclofen pumps. Unpublished data from Île-de-France patients shows that 44 out of 46 patients had orthopaedic deformities and 40 had heterotopic bone formation; 28 patients (61%) underwent orthopaedic surgery (22 of them for orthopaedic deformities and six for heterotopic bone formation). Beis et al. reported nine cases of orthopaedic surgery (for a total of 47 patients) . It is highly probable that therapeutic strategies and decisions to operate depend on the medical staff’s habits. Nevertheless, orthopaedic surgery appears to be the most important unresolved issues, especially since these interventions are known to improve comfort and facilitate nursing in severely brain-injured patients .

1.4.3

Organizational findings

On the organizational level, the patient management procedures comply in part with the provisions of the recent government circular . The patient management pathway appears to be fairly fluid, since patients do not spend too long in ICU and the PMR unit. However, our survey was not able to assess patients who died in the ICU. Furthermore, daily care was appropriate. As recommended in the government circular, patients were located in institutions close to their families. Staff in geriatric units was able to implement both a “life plan” and a “care plan”. Furthermore, staff “burn out” appears to have been avoided by the small number of PVS/MCS patients in each unit. However, part of the cost of hospitalisation in these units is paid for by the patients’ families, which goes against the provisions of the recent regulations under which “extended care” is fully eligible for payment by the social insurance system. The organisational system in which PCS/MCS patients are mixed with other patients raises questions as to whether dedicated units should to be created; these would probably have both advantages and disadvantages. This management system means that care is local but not yet “specialized”, as requested by the new regulations. It is likely that dedicated units would help uncover and address ethical issues and their practical consequences. For example, the development of palliative care units has enabled research into end-of-life issues and helped disseminate this knowledge into routine practice.

1.4.4

The decision-making process

Head nurses report practical difficulties and, above all, ethical issues. The decision-making process is thus one of the most acute difficulties. For instance, there is no consensus on the advantages and disadvantages of orthopaedic surgery or the definition of futility of care. Different environments generated different strategies. In the initial resuscitation phase, there is general agreement that if survival in a persistent vegetative state is highly likely, it is legitimate to refrain from disproportionately intense, life-prolonging treatment . In contrast, in the chronic phase, opinions diverge strongly . It is important to emphasize that these questions concern PVS patients much more than MCS patients.

In the present work, advance directives were available for eight patients and were written in four cases. Hence, decisions could be made (specifically in the event of a medical emergency) by a physician who did not know the patient. It is essential to establish procedures for addressing ethical issues within these units. This could include anticipated discussions on futility of care for each patient. These discussions must take account of living wills and the healthcare proxy’s opinion .

The recent government circular seeks to impose dedicated, long-term care facilities for PVS/MCS patients and flexible patient management pathways. The main issue relates to the management of severely disabled patients, for which the government circular gives a number of practical specifications. Nevertheless, issues concerning decision-making, staff management and relations with the patients’ families – all very important points, according to our survey – are not really dealt with. The circular merely advises dedicated units to forge link with medical ethics departments. Although the circular admits that ethical issues exist, it does not provide practical solutions. The sometimes-heated debates concerning these patients encompass concepts such as dignity, the sacred nature of life, respect for personal independence and the status of ANH . Given that some opinions are diametrically opposed , these issues and procedures for dealing with them should be considered before creating dedicated units.