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Here the aim was to assess experience in the new setting and compare it with a matched group of patients in Liverpool, cared for using the LCP in a free-standing hospice environment. The choice of contrasting settings hospital, non-hospital is not explained, but there were similar results across a number of important dimensions, with most care goals being met for the large majority of patients.
The setting was a specialist palliative care unit. During this period, a total of 36 patients died in the palliative care unit; the 12 who were not placed on the pathway all died suddenly. All members of the palliative care team were invited to participate in the focus group 10 nurses, three doctors, a caregiver, a social worker, a physiotherapist, an art therapist , but just seven nurses and the three doctors took part.
All the participants had experience of looking after patients the average was seven on the LCP. The results of the discussion are described at length in the paper. Overall, the participants were extremely positive about LCP. After this decision is made, and based on open exchange in the team, all further measures could then be coordinated together, for example: the discontinuation of investigations or therapies that are stressful and unnecessary for a dying person; the use of on-demand medication for common symptoms; or the support of relatives.
Participants reported unanimously that the LCP enhanced communication between nurses and physicians, which in turn encouraged patient interaction and family caregiving. The structure of the LCP provided reassurance especially around shift hand-over that everything was being thought through and essential questions clarified.
The flowcharts for drug-related symptom control attached to the LCP were found especially helpful for younger doctors with less experience in the field of dying. Likewise, the schematic structure of the LCP was a positive attribute, as the objectives to be achieved were well explained. Practical hints, such as informing the family doctor about the patient's situation were also described as helpful and as something that could often be forgotten in daily practice.
The authors of the Oldenburg study concluded that the LCP is a helpful and pragmatic tool for implementing palliative care in everyday clinical practice, but must always be supplemented and accompanied by qualitative guidance and palliative care training. There were however some limitations to the study, noted by the authors. First, only one focus group was conducted, with just 10 professionals, which could limit the scope of the results, albeit most of the team took part. Second, the LCP was implemented in a palliative care unit, though the target is the general ward of a hospital.
Third, the study provided only the impressions of the health professionals involved in the pilot and did not provide evidence of the measured effects of implementation. Their focus was on the meanings assigned by professionals to the care of the dying, and on communication, teamwork, documentation, and particular attitudes. The study had two components. The first comprised a focussed ethnography within a hospital based palliative care team that had started training in PAMPA.
The ethnography revealed favourable expectations about the of the value of LCP, doubts and fears concerning its applicability, and an acknowledgment of the role of intuition in end of life interventions. The survey respondents in both countries demonstrated high agreement on the choice of quality of care indicators In Argentina, a paper discovered after our analysis here was concluded reported on the use of PAMPA in five health centres, where between and a total of adult patients in the last days of life were included and cared for by palliative care teams trained in PAMPA.
The median range of follow up in the five centres from the beginning of the pathway until death varied from 16 to hours. It was concluded that PAMPA demonstrated its feasibility as a model of end of life care for patients and families, based on international quality standards But as early as , staff at Arohanui Hospice, the recognised lead collaborating centre for LCP, had begun to recognise some inconsistencies in how LCP was being implemented around the country. These included: a lack of consultation with specialist palliative care services, inappropriate and sometimes unsafe symptom management algorithms, the absence of general practice teams from LCP education and training, variability in LCP registrations, and the development and use in some places of modified, non-compliant LCP documents.
Thus informed, the Arohanui Hospice made a successful bid to the Ministry of Health to establish a national co-ordinating office to oversee LCP implementation in New Zealand, with support from the Liverpool team. The goal was to develop a robust support infrastructure that would minimise the risk of the kind of ad hoc implementation and dissemination of LCP that would dilute and compromise its effectiveness and sustainability over time.
The core approach to achieving this was the step continuous quality improvement programme, developed by LCP Central in Liverpool. New Zealand was thus the first country outside the UK to formally establish a National Office with responsibility for promoting the sustainable implementation of LCP within its own borders. A paper by Mackenzie et al. Data collection for the evaluation took place in , just six months after the New Zealand LCP office had been established.
Committed to principles of dependability, credibility and trustworthiness, the evaluation was designed to provide useful information to inform development. The results were positive. The goals of the LCP office were deemed important, the service quality was rated good or very good, its ongoing links with LCP Central were considered important, it was leading to better quality use of LCP by linking closely with local facilitators in ways that connected theory to practice, and it was serving as a voice for palliative care in New Zealand.
In Sweden there was a substantial engagement with the LCP initiative, albeit in a series of publications that did not begin appearing until after the withdrawal of the LCP in the UK. The study places a particular focus on the perceptions of family members relating to LCP, citing only a few examples of this from elsewhere in contrast to the large number of studies on the perceptions of staff.
Satisfaction with care was high in both settings pre-implementation, and family members were confident that staff had done everything possible to prevent suffering. Satisfaction on measures relating to existential issues and information on bereavement support was lower in the hospital ward, where relatives also considered that the patient had been more likely to experience breathlessness in the last three days of life.
But post-implementation family members were more likely to state that the patient was worried or anxious. The authors considered that more information may have made family members more observant of symptoms, hence the increase in reported anxiety. The study made use of the three phases initial assessment, continuous assessment, and after death follow up as a framework to sort the documentation. The study did not concern the implementation of LCP, but focussed on 50 sets of nursing records and 50 sets of medical records relating to deceased patients with dementia in two nursing homes.
Through the lens of the LCP, it revealed that the great extent of the documentation focussed on physical symptoms, with almost nothing recorded on existential issues or follow up with relatives after death. The work was conducted through five focus groups and two individual interviews, comprising a mixture of nurses and nursing assistants working in the care homes, as well as local GPs.
The line of questioning focussed on how the participants had experienced using LCP, its influence on their practice, as well as their perceptions of its strengths and weaknesses and their views on using it in the future. The participants considered that using LCP had fostered a team approach that increased individual confidence, and this had been generated through the supporting educational programme and the new way of documenting care.
Agreement about whether the resident was dying could prove difficult to establish, and this was exacerbated by the short amount of time spent in the homes each week by the GPs who took the decision in each individual case about LCP use. But there was also an enhanced sense of individualised care when using LCP. LCP was seen to have fostered earlier and greater involvement of family members in end of life discussions with relatives.
Care staff were also more attentive to the care environment and gave more attention to creating a sense of comfort and welcome for family members when a resident was dying. They concluded cautiously that the LCP might be a useful tool for use in residential care homes and could increase attention to the goals of care, the individual needs of residents, and the involvement of relatives.
Another Swedish study by Andersson et al. A total of 15 family members of deceased residents took part, drawn from 10 different residential care homes. The results showed that family members most of whom were daughters of the deceased had an overall positive experience of the care provided, felt involved in the caring process and found that LCP clarified the decision about moving to end of life care, and gave structure to what was happening.
Also in Sweden, Olsson et al. A total of registered nurses and assistant nurses working in a single Municipality in mid-Sweden, where the LCP had been introduced in the period October — December and completed a structured study-specific questionnaire containing 50 items. Both groups considered that communication with patients and families and the information exchange between team members was facilitated.
We identified just one item a conference poster on the use of the LCP in Denmark, presented in June , in Australia xviii. The primary endpoints of the study were relief of symptoms, and correlation between symptoms and use of medication.
Time on the mLCP was on average 48 hours. There was no correlation between presented symptoms and time spent on mLCP, nor was there a correlation between presented symptoms during the first four hours and during the last four hours before death. There was a significant relief of pain using syringe drivers, and a significant correlation between the use of analgesics and symptom relief.
The authors concluded that integrated care pathways for best care of the dying person could be a valuable tool for providing good symptom relief. Kaori Ichihara, a doctoral researcher at the Medical School of Osaka University, reported evidence of the use of what had come to be known as LCP-J see below in the Commentaries and other publications section in two Japanese palliative care units xix. Forty nurses were involved in the experiment and more than half considered the LCP-J useful, believing that it could contribute to providing standardised criteria for multi-disciplinary healthcare teams, as well as developing consistent and continuing care and support for patients and their families.
Educational outcomes for healthcare professionals were also highly praised. Kanno et al. At the same time LCP-J was felt to increase the burden on professionals in relation to the task of diagnosing the dying phase and the need for associated training.
The authors concluded that the requisite support and training should come from the hospital palliative care team. In Italy, the LCP studies were mainly conducted by a team of researchers and clinicians associated with a regional palliative care network of the National Cancer Research Institute and located in Genoa, Italy. The team was led by Dr Massimo Costantini in a three-year programme of research funded by the Italian Minister of Health from to determine whether the implementation of LCP in a hospital setting could be effective in improving end of life care for cancer patients.
To this end, LCP version 11 was first translated into Italian for hospital use in and for hospice use in An initial paper by Costantini, Beccaro and di Leo xxi draws attention to the issue of improving end of life care for patients dying in hospital, and their families.
Noting its use in over 20 countries, the authors also acknowledge that evidence for its effectiveness remains weak. Crucially, and in contrast to all previous efforts in this regard, they adopt the MRC Framework for the Evaluation of Complex Interventions 39 as the organising principle for their endeavours, in a focus on cancer patients dying in the hospital. The researchers recognised that the LCP is a typical complex intervention, involving multiple components interacting with each other as well as with the local implementation setting.
They named their intervention LCP-I Program, and it contained 10 constituent steps that followed the continuous quality improvement programme recommended by the LCP Central team in Liverpool. Leo et al. LCP-I was led by an experienced palliative care team comprising two physicians, three nurses and two psychologists. The Italian group placed a very strong emphasis on training, with a mandatory programme of 12 hours for ward staff prior to implementation.
The setting was three medical wards 72 beds and one respiratory disease ward 24 beds of the Villa Scassi Hospital, in Genoa during In total over deaths occurred on the four wards each year, about half from cancer. The implementation was assessed using a mixed methods approach. Pre- and post-implementation focus groups conducted with doctors and nurses showed perceived benefits, particularly in pain management and in communication with families.
Process and outcome measures were tested using more quantitative approaches. The results were encouraging and began to demonstrate the possibility of undertaking studies aimed at assessing complex interventions in end of life care. Di Leo and colleagues describe the carefully designed staff focus groups held at the Villa Scassi Hospital.
Two focus groups with nurses and physicians were conducted both at step 4 and at step 8 and were moderated by a psychologist. A researcher took field notes at each session and audio recordings were made. Nurses perceived some resistance to change on the part of medical staff as a barrier to the introduction of LCP-I. All participants became more aware of their own limitations in communicating with patients and families, in ways that heightened their own uncertainties — an outcome seen by the authors as potentially positive and as a first step towards improvement.
Overall, there was significant agreement that the implementation of LCP-I had improved and intensified communication between the medical and nursing staff on the ward. The researchers were reassured that, although undertaken in a different culture to the one in which LCP was first developed, LCP-I appeared to be acceptable and valid in the Italian context.
The Genoa team then engaged in careful methodological testing of how the intervention could be evaluated xxiii. They acknowledged that this design has the potential to exaggerate the effects of the intervention. The researchers contacted the informal care giver most closely involved with the patient, two months after the death, and invited them to take part in an interview. A total of patients was identified, 65 before and 50 after LCP-I implementation; four of these were excluded as they were related to staff members on the wards, leaving There were also differences in carer compliance at assessment interviews in the pre-intervention group took place longer after the death and in the characteristics of the interviews post-implementation interviews were significantly more likely to be by telephone , suggesting a selection bias and interviewer variability.
In addition, the researchers identified a cluster effect associated with patterns of scores on the toolkit scale that correlated strongly with particular wards in the four that were included in the study. They concluded that the design they adopted had substantial limitations, and noted how this was reflected in the Cochrane Review of end of life pathways, which indicated potential benefits, but could not ascertain measureable effects from the available studies At the same time, they were encouraged that it had proved possible to implement LCP-I, that staff had responded positively to the programme, and that insights had been gained for a future, and more robust evaluation.
Nevertheless, the question remained whether this intensive method of LCP implementation, focussed on a single hospital and just four inter-related wards, could be replicated at scale across multiple settings. The second group showed higher scores on four out of seven dimensions of the Toolkit, relating to: respect, kindness and dignity; family emotional support; family self-efficacy; and co-ordination of care. There was no improvement in scores relating to symptom control. The group also explored the potential for LCP-I outside the hospital, in the context of the Italian in-patient hospice xxv.
The interpretation by staff of its value varied widely across the seven settings: two hospices reported a positive impact, two took the opposite view; in three others, opinions were mixed. There was an overall concern about the lack of knowledge to underpin the use of LCP in the hospice and also about the methods of implementation that had been used.
There was also a comparative assessment of the feasibility of the pre- and post-implementation research design in the two settings of hospice and hospital, reported in a methodological article xxvi. Here the primary aim was to evaluate the feasibility of using a combination of assessment methods, directed at different respondents, to create a measure of the quality of end of life care.
The two cluster trials took place in eight hospitals and five hospices. Only cancer patients were included in the analysis. Overall, the method seemed to work effectively in both settings, with high levels of compliance and adherence to the study instruments. Another study examined the views of staff involved in the hospital implementation of the LCP-I, and who had shown reservations about it xxvii.
It was claimed as the first of its type. Six nurses and five physicians from six out of eight hospital wards that had used the LCP-I were interviewed. The authors themselves confirmed that the eligibility criteria for inclusion in the study were subjective and not insufficiently detailed. Conducted before the Neuberger review had been reported, the authors took the view that their results were nevertheless similar to concerns raised by Neuberger.
Verhofstede and colleagues xxviii broke new ground by addressing the effects of the LCP in older patients and at the same time sought to develop a new programme of care for those dying in acute geriatric wards in the Belgian context. Their work began before the publication of the Neuberger review of the LCP, but in some ways foreshadowed its outcomes.
This led to the identification of three common elements: the LCP document and here the authors identify the substantive changes made in the translation process from the relevant English language version into Dutch ; the supporting documentation; and the implementation guide. Then a literature review of successful LCP implementation strategies revealed five key factors: the importance of a dedicated training facilitator; the provision of initial and ongoing training; the organization of an audit and feedback opportunities; a central co-ordinating office to support local LCP facilitators; funding and available staff time.
The understanding developed from these actions was then used to model a care programme for the last days of life among older hospital patients. This comprised a care guide, supporting documentation, and an implementation guide. Adaptations were made to the care goals, with older hospital patients as the focus. Colour highlights were also introduced to improve readability of the care goals. The authors located these elements of activity in stages of the MRC Framework for the design and implementation of a complex intervention The paper concluded with the intention to proceed to phase 2 — to evaluate the feasibility of the implementation.
As described, it was a process strikingly different to those which shaped the original development of the LCP in the UK. We identified just seven studies of this type, from just three countries: three each from Italy and Belgium, and one from Sweden. The earlier work in Italy had provided enough evidence to justify the use of a randomised trial to evaluate LCP-I effectiveness.
The team had then published a protocol for their new design xxix. The chosen patient group would remain those with a diagnosis of cancer. Inclusion criteria were carefully defined, the primary end points and sample size were described, and a detailed account was given of the administrative and implementation arrangements.
The results showed no differences between the intervention and control groups in relation to the overall quality of care the primary endpoint. But two of nine secondary outcomes reported by family members showed better results in the intervention group — improvements in respect, dignity and kindness and in the control of breathlessness. There were no differences in the medicines prescribed to the two groups, in the survival time after admission to hospital, or in the management of symptoms like pain, nausea and vomiting.
In general, the beneficial effects were lower than in the phase 2 trials in the Netherlands and in Italy. But the die was cast. Neuberger had reported the previous summer and the verdict was that LCP should be discontinued xxxi. As in Italy, the work in Belgium included the development and publication of a protocol for an intervention study xxxii. The design was again that of a cluster randomised control trial, to be conducted in 10 hospitals in the Flanders region, each with one or more acute geriatric units.
In year one a baseline assessment would take place of usual care, based on completion of a questionnaire by relevant physicians, nurses and family members concerning each patient who died on the unit. Thereafter the hospitals would be randomised to receive the intervention, or not. This cluster randomisation, operationalised at the ward level, was thought likely to reduce the potential for contamination, since the comparisons would be between hospitals with and without the intervention.
Subsequently in the intervention hospitals, the new Care Programme for the Last Days of Life would be implemented over a period of six months. A post-intervention assessment would be performed immediately after the baseline assessment in the control hospitals and after the implementation period in the intervention hospitals. The primary outcomes to be measured were symptom burden and frequency among patients in the last 48 hours of life.
A process evaluation was also proposed to assess the quality of the implementation of the new programme, to which the Belgian researchers then turned their attention xxxiii. They undertook a phase 2 mixed methods study, according with the MRC framework, in the acute geriatric ward of Ghent University Hospital between 1 April and 30 September The approach included observation, interviews and the use of a quantitative tool, which measured the success of implementation using several indicators, such as whether a steering group was formed, whether and how many of the health care staff were informed and trained, and how many patients were cared for according to the Care Guide for the Last Days of Life.
Barriers to successful implementation of the Care Programme included difficulties with the content of the documents used within the Programme and the low participation rate of physicians in the training sessions and audits. The results were encouraging and suggested feasibility and favourable effects. Based on the identified barriers during the implementation process, the authors were able to make recommendations for future implementation and to further refine the Programme before its deployment in a phase 3 cluster randomized controlled trial for the evaluation of its effectiveness.
Again echoing the Italian study and with Costantini as a co-author, the results of the trial were published in The Lancet in xxxiv. The authors included online a page supplementary appendix to the published paper. The Belgian authors noted that in a Cochrane review of end of life pathways, updated in , the Italian study had been judged to be statistically under-powered and at high risk of bias, mainly because patients were not masked to treatment allocation and there were high levels of attrition.
The Belgian study avoided some of these weaknesses, though again the nurses knew about and took part in the CAREFUl intervention with the patients for whom they gave ratings. Nevertheless, the results still seemed equivocal. There were patients in the control group and in the CAREFul group who were eligible for assessment.
In an accompanying editorial, Aslakson and Lorenz 44 praise the ambition of the study, but home in on the involvement of nurses as both the unmasked study interventionists and the study assessors, creating a high risk of unconscious bias leading to more favourable reported outcomes. A randomised study of an end of life pathway had therefore been conducted in both Italy and Belgium, and published in a world class medical journal, but in both instances the results were equivocal.
Researchers in Sweden recognised the lack of controlled studies of LCP outside of cancer settings and focussed on its use in care homes and in residential care homes xxxv. The design was an exploratory, controlled before and after study. During a 15 month baseline period June — August , usual care was assessed in two areas of the municipality, containing 10 and 9 care homes, respectively.
In the following 14 months, staff introduced LCP in one area and usual care continued in the other. A translation of LCP Version 11 was used, in collaboration with the Swedish LCP co-ordination centre based at Stockholm Sjukhem, and the process included a structured education programme to support the implementation. In both areas in the pre- and post-intervention periods, care was assessed through the completion by relatives after the resident had died of two structured instruments Edmonton Symptom Assessment System and Views of Informal Carers — Evaluation of Services, known as VOICES , sent by post.
A total of patients died during the whole study period. Cardiovascular disease and dementia were the main causes of death. The total response rate for completion of the questionnaire was The main result was a reduction in two symptoms among residents in the intervention group — shortness of breath and nausea. Reductions in both of these symptoms were reported by the symptom assessment measure and for shortness for breath only by the carer evaluation tool.
On such a basis, and following a detailed reflection on the practical and technical limitations and potential biases of the study, the authors felt able to conclude that the LCP may be a useful tool for providing end of life care for elderly people in non-cancer settings. Interestingly they note that, based on the positive experience of conducting the study as much as its outcome , the municipality involved made a policy decision to implement the use of LCP in all its residential care homes. Commentaries and other publications.
Beyond these audit, implementation and controlled studies we identified 20 commentaries of various kinds and also nine miscellaneous pieces that could not easily be classified — almost a third of the total number of publications on the use of the LCP outside the UK.
The early Dutch papers set the scene for the introduction of LCP into the Netherlands, the link with Ellershaw and the processes being adopted, including the translation-back translation approach xxxvi — xxxviii.
By , Geijteman, Dekkers and Zuylen xxxix could observe that institutions, including 35 nursing homes were working with the LCP in the Netherlands and that a digital version of the LCP was under construction, which would make it possible to integrate it in electronic patient files, as well as serving the purposes of quality assurance and scientific research. A paper by Raijmakers et al. This was built on the perceived positive research results in the pre and post implementation Dutch studies.
Raijmakers et al. These people were asked to nominate organisational examples of successful implementation, 10 of these led to follow on interviews with project leaders from 25 examples given. Perspectives from one palliative care network from each of the CCCN regions were also obtained and all interviewees in the study were invited to take part in a summative focus group by way of conclusion. No studies of LCP or similar pathway implementation were identified for Ireland, but one case note review, given ethics approval by the Beaumont Hospital, Dublin, focussed on dementia patients during acute hospital admission, and used LCP as a standards benchmark for quality palliative care in a comparison with patients who did not have dementia xli.
Data were collected between January and June on a total of 50 patients, a condensed version of the LCP was used to focus on nine aspects of good quality care — rationalization of medicine, discontinuation of unnecessary invasive interventions, prescription of palliative drugs, referral to specialist palliative care, documentation of resuscitation decisions, communication with primary care, supporting caregivers in bereavement, and assessment of religious and spiritual needs.
The researchers found that whilst both groups of patients had similar levels of invasive treatment, those with dementia were less likely to be referred to palliative care, were prescribed fewer palliative medications, and had less involvement of relatives in dialogue about treatment. The authors drew no conclusion about the value of LCP implementation, in a study where it was used simply as part of the research design.
As late as , a reflective piece by a Swiss internist on experiences of palliative care concluded that, among a list of shortcomings, there was still a lack of standardization across settings of care in the final phase of terminal care, and used comparison with the guidelines contained in the LCP as an indication of this xlii.
These would avoid acting arbitrarily or criminally , provide security to medical staff and advice on what to look for while helping the dying to leave life in a dignified and pain-free way. But taking his cue from controversies emerging in the UK, he argued that the LCP also has the potential to be dangerous in a context where the matter of diagnosing dying can be imprecise.
The remarks neatly anticipated the subsequent events and discussions in England. Meanwhile, commentary on LCP emerged from Austria in in the form of a published undergraduate dissertation in advanced nursing practice, by Zinner xlv. Her focus was on how the LCP could be implemented in hospitals in the German-speaking area and how the quality of life of the dying can be preserved or improved by using the LCP. After the withdrawal of the LCP in England, senior clinicians from Australia commented on the implications for the continuing use of end of life pathways in their country Chan et al.
They acknowledged that, across Australia, several end of life care pathways had been adapted from the LCP, though with no precise numbers of the institutions involved. In particular, they highlighted the recommendation for a national roll out of an integrated end of life care pathway through primary, acute and aged care sectors, that had been included in the Australian National Palliative Care Strategy of Despite the widespread experimentation with and policy endorsement of the end of life pathway in Australia however, the authors took the view that as elsewhere there had been insufficient evaluation of its net effect.
The authors made a plea for more rigorous, randomised, studies of end of life pathway outcomes and implementation, but acknowledged that this would take time. The authors explained the goals and background to the LCP and noted its ongoing use in Norway since , though with no details of extent or setting. The aim of the review was to assess the effectiveness of the LCP and also its relevance to patients with dementia.
Only two studies met the inclusion criteria from Sweden, in and Italy, in The results as we have seen above showed small or no differences between LCP and standard palliative care at the end of life. At the same time the authors had very low confidence in the evidence they reviewed, mainly due to a high risk of bias in the studies, which also enrolled few participants and contained shortcomings with regard to the implementation of the intervention.
The authors therefore noted that the various weaknesses of the available studies limit confidence in the then current evidence and restricted the potential to draw firm conclusions. The following year a systematic review of the use of LCP in nursing homes was produced by a team in Norway xlix. Describing the media and public concerns that had arisen about LCP and which led to the Neuberger review, the authors observed that in contrast to the UK, no open and critical debate had taken place about LCP in Norway or other Scandinavian countries.
The aim of the review was therefore to assess the evidence for the use of LCP, but specifically in the nursing home context and in relation to people with dementia. It focussed on how LCP had been validated and tested in these contexts, with which study designs and methods, the implementation strategies in use, and how they had been described, along with the main outcomes.
Twelve papers, one purely methodological, were selected for inclusion in the Norwegian review, based on nine clinical studies; seven studies were from outside the UK and are discussed elsewhere in the present paper. None of the selected studies used randomized, blinded or prospective designs.
Only one was controlled. The reviewers concluded that evidence for the use of LCP in nursing homes was virtually absent and when present was weak and the results not definitive. Acknowledging the problems of randomised designs in these populations, the authors were nevertheless critical of the absence of alternatively designed studies that document the development and testing of the instrument by including elderly, multi-morbid patients and those with dementia. They concluded that the LCP had not been adapted to the individual needs of people in nursing homes and those with dementia.
The one paper we located on LCP in China l took the form of a professional commentary and looked at the potential of LCP in relation to the development of hospice nursing in mainland China. The article explains how LCP was developed, reviews the research on its implementation and benefits, but also acknowledges the critical commentary on LCP that had occurred in the British press and from some clinical commentators. In a paper on the status of palliative care in Japan, a group of authors li commented that standardised frameworks, guidelines and clinical pathways for end of life care, available in the English-speaking world, had not been developed or were inadequately disseminated in the Japanese context.
They indicated that a validation study of several such interventions was underway to modify the originals and make them suitable for Japanese culture. The list included the Liverpool Care Pathway. Two years later, in , a special issue of the Japanese Journal of Clinical Nursing was published that focussed entirely on the use of LCP in Japan lii.
Edited by Mitsunori Miyashita, a professor in palliative nursing at Tohoku University, the special issue aimed to provide a comprehensive picture of the introduction and implementation of the LCP in Japan, at that time. The editor introduced the issue with some background on end of life care in Japan, addressing the importance of promoting and adapting the LCP to the Japanese context, and pre-viewing the main articles in the special issue liii.
This one special issue contributed eight of the 17 articles on LCP in Japan within our review, though most were commentaries of one sort or another. The implementation is recorded in great detail by showing how the patient and her family were supported at different stages of the dying process. The author concludes that the LCP-J improved the quality of palliative care for the patient and her family.
The last article in the special issue pays attention to an evidence-based booklet produced for family members of dying patients lv. Hiroyuki Otani, from the Kyushu Cancer Centre, argues that the booklet can help family members to better understand end of life care, reducing anxiety and empowering them to give improved support to their dying family member. The author also points out the benefits of using the booklet with the LCP.
A short paper by Yoshikazu lvi gives an overview of the rise and fall of the LCP in the UK, in relation to end of life care in Japan. It acknowledges the usefulness of the LCP as a guideline for end of life care practices and for the education of medical professionals. While highlighting the increasing influence of the LCP in Japan, the paper also documents the wider debates in the UK on the effectiveness and appropriateness of the LCP.
Given the criticisms and the withdrawal of the LCP in the UK, the author suggests that the promotion of the LCP in Japan should stop and an alternative pathway that fits Japanese contexts needs to be developed. In a further paper from , Chinone lvii , a palliative care doctor in charge of developing the Japanese version of LCP-J, also sets out the wider historical background of the LCP, its contents and some examples of its implementation elsewhere, before describing the reasons for introducing the LCP to Japan, why it should be adapted to the Japanese context, and the continuing possibilities for its implementation.
Tanaka and Satoshi lviii in also provide an overview of end of life care in Japan, with a particular focus on developments in the UK, including the LCP, and their relevance in the Japanese context. Reviewing the debates surrounding LCP in the UK and its eventual withdrawal, the authors suggest that end of life care in Japan needs to 1 pay more attention to individualised care and communications, 2 develop education programmes as well as institutional and home-based services, and also 3 enhance the involvement of local authorities and communities for the benefit of patients and carers.
The Italian researchers Costantini and di Leo lix went on to describe the debate that took place in Italy, following the recommendations of the Neuberger report. Early results in Genoa had been positive and supported the design of a cluster randomized Phase III study, to assess the effectiveness of the programme in improving the quality of care of end of life care for patients dying of cancer in Italian hospitals.
Despite the standardized implementation process and carefully planned support from the palliative care teams, the findings of this study were less encouraging than the Phase II studies and did not reach significance for the primary outcome, but did demonstrate some secondary benefits.
In light of all these factors, over 50 clinicians from six Italian regions came together to share opinions and experiences about LCP-I. A list of 12 strengths and 13 weaknesses of the LCP programme in Italy was generated. There was a strong emphasis on coping with the risks associated with the intrinsic limitations of LCP and its inappropriate dissemination. The LCP studies had demonstrated the feasibility of conducting high quality research in this field and this strategy would continue.
In the same year, , Costantini, Alquati and di Leo published a review on the evidence for pathways in end of life care lx. They acknowledged that two separate Cochrane reviews, last updated at June , did not find any studies of end of life care pathways that met the inclusion criteria, though their unique Italian study, albeit with its negative results, post-dated this.
Two major drawbacks could be seen in the analysis of the quantitative studies on end of life pathways. First, poor internal validity of design: uncontrolled before and after studies have intrinsic weaknesses and are vulnerable to changes in the external environment that might lead to improvement, they are at risk of the Hawthorne effect, regression to the mean and are likely to overestimate the effects of interventions.
Second: the piecemeal character of the studies meant they lacked a comprehensive strategy for research, in line with the MRC framework for the evaluation of complex interventions. The pool of studies undertaken in Italy, and proceeding through the three phases of the MRC framework, seems to be the only example of such a comprehensive strategy, though the authors note developments in Belgium and Sweden at the time unpublished, but described above here that might merit inclusion in a future Cochrane review of end of life pathways.
In noting the outcome of the Neuberger review, the Italian authors also observe that none of the published studies report any adverse effects, relating to patients, family members or involved professionals. Conclusions to literature review. We identified 95 publications covering the period —09 and referring to 20 countries in which LCP interest and implementation had been considered or tried.
It is difficult to see how most of these countries reveal a high-level commitment to LCP transfer, with the exception of Switzerland, which was part of a three country German language group and Norway, where there was significant in-country take up of LCP. Beyond those, publications from these countries arose mainly from small scale developments, only occasionally based on wider collaborations and which had little impact on wider transfer or diffusion for example colleagues in Spain working with others in Argentina.
However, this is not to undermine the value of this work to the actors involved, who gained local experience of the translation of an intervention into a new context, who sometimes adapted it with imagination and flair to local cultures and healthcare systems, and who used it to audit and benchmark their own end of life services.
The remaining nine countries, just under a half of those identified in the review, produced publications each: Japan, Netherlands, Italy, New Zealand, Australia, Sweden, Belgium, Austria, Germany. These were countries where, in some cases, LCP transfer gained significant momentum, sometimes operating at scale and in some instances being subjected to rigorous testing in robust research studies.
This in turn produced impactful publications in international journals, greater visibility in professional conferences, and in the case of Japan, a journal special edition devoted to LCP. The authors of the papers reviewed were overwhelmingly clinicians, some with a strong research orientation and holding senior academic positions. The leading authors were mainly medical, and several of them took part in our interviews see below. There were few papers that involved nurses or other health professionals, and almost none that included social scientists or implementation experts.
This is reflected in the character of the published outputs. The largest single group of outputs, making one third of the total and completed in 15 countries, comprised descriptive audit studies, drawn from clinical records. Some were baseline, pre-implementation assessments, others compared outcomes pre- and post- implementation.
The remaining one fifth of the outputs comprised commentaries or descriptive pieces of some kind, all without a research design. The nine countries with the most outputs, were also those that produced the most robust research results, albeit with only three of these conducting the sort of controlled studies that would stand up to critical review and be published in leading journals. The 95 outputs we reviewed were therefore long on commentary and the sharing of experience, or focussed mainly on descriptive audit methodologies, sometimes with added process measures to shed light on acceptability and feasibility.
Only a tiny minority used rigorous designs, albeit with some flaws, and equivocal results. In Sweden the key study had modest results — a reduction in two symptoms in the intervention group — shortness of breath and nausea. In Italy, in an under-powered RCT, there were no overall differences in quality of care between the intervention and control group, though the latter, as described by family members, showed better results in the intervention group on two counts: improvements in respect, dignity and kindness and in the control of breathlessness.
Table 2 lists the 19 interviews we conducted with 20 people from 14 countries. One interviewee subsequently withdrew from the study and is not included in the analysis. Six countries with some measure of LCP activity identified in the literature review were not included in the interviews. In Spain, Ireland and Hong Kong those we approached declined to participate. In Slovenia our desired interviewee was unavailable for interview.
In China and Singapore, we failed to track down potential interviewees who could be approached. Only three interview participants Boughey, Douglas, Medicus were not among the authorship of papers we identified for the literature review. We set out six dimensions that resulted from our analysis of the interviews: 1 context and motivation for engaging with the LCP; 2 translating and adapting the LCP for a new context; 3 deployment and diffusion of the LCP within countries; 4 perceived benefits of the LCP; 5 challenges and drawbacks associated with the LCP; and 6 perspectives on the withdrawal of LCP in the UK and its consequences.
Context and motivation for engaging with the LCP. LCP adoption varied in its organisational focus, from specialist palliative care settings, to general hospital wards or care homes, but those involved shared a common enthusiasm for what they saw in the LCP as a structured approach to improve care of the dying, and they came to it through a variety of networks.
But it structured what we already did or wanted to do in a very good way. We saw it as a good checklist and a framework securing a certain quality of care … no aspect was forgotten. So we thought that providing this framework for clinical decision making provided a standard for good care. So it would be more uniform everywhere, not so much dependent on the individual professional. Interviewees from 10 countries recalled how they were drawn to the pathway because of pre-existing networks with the LCP team in the UK or the worth of its reputation, and especially the relevant publications that were emerging.
Dr Svend Ottesen, an oncologist who had led a palliative care unit in Denmark between and , recalled that his introduction to the LCP came through a specialist course in palliative care for the Nordic countries and then the opportunity in to attend a course on the LCP, in Liverpool.
You know the international research group? Argentina was one of the countries participating in the project with another eight countries, and we met the group on this occasion. So, since we start working on the best care of the dying, in this research group. Dr Vilma Tripodoro, Interview 3, Argentina. She was subsequently approached by a senior clinical colleague who had worked in London to collaborate on a study mapping the last 24—48 hours of life of patients and leading to an adaptation of the LCP:.
I was successful in getting some Commonwealth funding in about , to try and develop a pathway for dying. Associate Professor Carol Douglas, Interview 8. In some cases, notably Italy, Belgium, Switzerland, the Netherlands and Japan, interviewees reported a research-oriented rationale to the introduction and assessment of the LCP. He decided to join the LCP international reference group with the intention to immediately embark on a research study of the pathway:. I had to decide what to do, so my decision to join the international group was a consequence of my decision to start with a research trajectory in Italy because it was really clear to me that LCP had to be assessed before implemented.
The evidence in my opinion was not strong enough to justify implementation without research. In the meantime, I joined the international group and I started the process of research in Italy. Dr Massimo Costantini, Interview 19, Italy. Interviewees from Belgium, whose main roles were as University based palliative care researchers rather than clinicians, also reported a primarily research-oriented rationale to the introduction of the LCP, and the experience of linking with other researchers elsewhere.
In , opportunities for palliative care research funding via the Flemish Government Agency for Innovation by Science and Technology resulted in resources for six palliative care studies. It focused on whether the adapted version of the LCP improved levels of comfort at the end of life among patients in geriatric wards in ten hospitals in Flanders:. I remember very well my first talk with John about this LCP. In the UK there was already a big rush around implementation.
But there was no scientific evidence of benefit. So the Head said, if you want to introduce this it will take time and energy. You have to know if it gives benefits for the patients. So that was the moment that I said, okay, now I have to do something else, I have to go into research and I was thinking about it because I was not familiar with this kind of research. Dr Lia van Zuylen, Interview In Japan, Professor of Palliative Care Nursing, Mitsunori Miyashita described how his initial introduction to the LCP was related to his knowledge of an early attempt at implementation by a medical doctor, which had started in The attempt failed for two reasons: scale of the task and the difficulty associated with translation into the Japanese clinical context.
This highlighted the importance of preliminary research testing. At first, Dr name was principal investigator. But this project [did] not work well. He was so busy. The second reason is … it was difficult to agree with the translation especially on this algorithm … [and]…the usage of medicine … the progression was very slow. Then I entered the team. And I became principal investigator … in or Then I completed the translation and pilot… [and] did pilot tests at two inpatient palliative care units.
Professor Mitsunori Miyashita, Interview Translating and adapting the LCP for a new context. In 11 countries the LCP required linguistic translation and a variable degree of cultural or contextual adaptation. In the other three countries New Zealand, Australia and India , there was no need for translation, but other adaptations were necessary.
Interviewees gave variable accounts of their recollection of the translation and adaptation process. Their emphasis varied from a focus on precise and exact translation of the UK documents often referring to the use of translation guidelines published by the European Organisation for Research and Treatment of Cancer to the use of the LCP as a framework or set of principles for care of the dying.
The book garnered attention at the time the LCP was introduced in Austria, creating some sensitivities around use of the term. Interviewees from Argentina, Denmark and the Netherlands described how they engaged in a process of both linguistic translation and cultural adaptation. So, we used the terminology for a kind of making it easier for us - talking about the dying-dying patient.
One of those organs was the one from which the evil of epilepsy was known to stem — the brain. Castration could well have been one of their relaxing measures. In the case of epilepsy this was the status strictus , in which the patient suffers from tenseness; curing that status meant to achieve the opposite, relaxation.
Epileptics were seen as carriers of a contagious, magic-religious impurity, and were known to have been literally spat upon in public. This has been identified with what we now call lepromatous leprosy, a disease of the skin and nerves, in which widespread inflamed skin bumps and rashes, as well as muscle weakness make their appearance; the nose, the kidneys, and the male reproductive organs may also be affected.
In castrated persons, you should know, the evil will not get any worse. So we can be sure that, in this case, castration was indicated not because the genitals were impaired, but to stop the disease from spreading further. In extant Greco-Roman literature the disease was first mentioned by the Roman poet Lucretius in the first century BCE, and in the first century CE it is still spoken of as a relatively new disease for Europe; it would have first appeared, though, around BCE.
Regrettably, also, any explanation on the part of Archigenes as to why eunuchs and women hardly suffered from the disease is lacking in the cited passage. For him, the immunity was related to the fact that sexual intercourse the active kind of sex — as is implicitly assumed — not being exercised by a castrated male or a woman was most inimical to elephantiasis. It is certainly true that earlier authors reported an extraordinary craving for sex in one of the phases of the disease.
Oribasius provides a further answer by citing Philumenus, an Alexandrian physician active c. Apparently, this is why he thinks that women and castrated men are immune to the lepromatous form of leprosy. It was felt that the loss of semen following orgasm could be injurious, as well as the physical exertion involved.
At the same time, sexual activity was thought to have an impact on the principal qualities of the body hot and cold, moist and dry and on its humours, especially bile and phlegm; many ancient physicians thought that a disturbance in the balance of qualities and humours due, for instance, to sexual activity was harmful.
Most ancient theories of seed-formation posited that the semen was not produced by the testicles, but wholly or mostly elsewhere in the body. Reasoning along the usual Greco-Roman line of thought, castration would not have stopped the production, but — like sexual abstinence — merely prevented the flowing out of semen, thus keeping the vital, healthy semen in. However, as I have said, it remains unclear in which period doctors started actually castrating for these reasons. As to the patients themselves, they too will have felt a great need to get rid of the affliction.
We know for sure that, along with all the disgusting physical inconveniences, it could bring about serious social isolation because of its believed severe contagiousness. Then again, if he had lived through the bitter stream of foul blood, all the same the disease passed into his sinews and his limbs and even into the genital parts of the body.
Some men feared the threshold of death so severely that they carried on living after having their manly organ removed with a blade The historian Thucydides who lived during this pestilence himself, mentions only the deprivation of the genitals without explaining how that happened. Homosexual behaviour in itself was not considered sick or wrong. It was only the inclination to passive non-penetrating sexual behaviour which was considered unworthy of free men.
Our sources indicate that physicians in the Greco-Roman world did more than cooperate in castrations in the interest of their patients. Medicine, after all, was not just an ideal to strive for, it was a handicraft to earn money by. If this is not some sort of historical slander, it indicates perhaps that the ancient healers did see some deontological limits, even if they were dependent. It is clear that physicians were also involved in castration practices for the perceived benefit of the sick.
This may have been the case from the earliest days onwards. We have first-hand evidence of a certain reluctance on the part of the Hippocratic physicians to perform such surgery. Second-hand evidence suggests that in the later centuries before the Christian era, doctors were a lot quicker to draw their scalpels, although in the testimonials about Herophilus, or in the compilation made by Celsus, this is not so evident. Explicitly recorded castration practices on medical grounds have come down to us from the first century CE onwards; in sources from later antiquity we encounter them regularly.
The apparent increase may be due to the developing skills and changing insights of physicians regarding anatomy and surgery. Apart from that, we need to remember that in the earliest times, the effects of castration must have been known mostly from stock-breeding of animals rather than on human males.
The increasing experience with castrated humans when eunuch slaves were introduced into the Greek and Roman households will have made a difference. As to the specific motives for medical castration, there were some which today may be thought of as fairly obvious. For us, it is not hard to accept that testicular disorders were a recurring reason. Accidents causing damage to the testicle s , various kinds of ruptures, fistulae, putrefaction and cancerous growths could lead to the decision to perform a castration; we read about castration of female hermaphrodites, as well.
Extant sources also show, however, that in certain cases the immediate cause was not necessarily a matter of impairment of the gonads. Here, the motives stated are rather unexpected and at first sight mysterious to our modern views. In the case of epilepsy, castration seems to have been a measure contrary to sexual activity, which was thought to be detrimental to various organs, including the one from which the evil was known to stem — the brain.
Any remaining mistakes are to be attributed to me. Brisson, L. Le Sexe Incertain. Second edition. Paris: Les Belles Lettres, Search in Google Scholar. Browe, P. Zur Geschichte der Entmannung. Bullough, V. Coles, A. Congourdeau, M. Cornarius, J. Foucault, M. The Use of Pleasure. Volume 2. New York: Pantheon, Godwin, J.
Grmek, M. Diseases in the Ancient Greek World. Muellner and L. Baltimore: Johns Hopkins U. Guyot, P. Stuttgart: Klett-Cotta, Hefele, C. Heriot, A. The Castrati in Opera. Hopfner, T. Jahrhundert nach Christus auf Grund der Literarischen Quellen Prague: J. Calve R. Lerche , Hopkins, M. Horstmanshoff, H. Deroux, 85— Brussels: Latomus, Horstmanshoff, M.
Medical and religious ideas about eunuchs and castration in the works of Clement of Alexandria. Kottek, et al. Rotterdam: Erasmus, King, H. Greek and Roman Medicine. London: Bristol Classical, Kudlien, F. Claudii Galeni Opera Omnia. Leipzig: Officina Libraria Car. Cnoblochii, — Lesky, E. Leven, K. Antike Medizin. Munich: C. Beck, Paris: J.
Mazzini, I. Sabbah and P. Mudry, — Moulinier-Brogi, L. Bodiou, V. Mehl and M. Soria Audebert, — Turnhout: Brepols, Mudry, P. Flashar and J. Geneva: Fondation Hardt, , — Nutton, V. Ancient Medicine. London: Routledge, Rowlands, R. Eunuchs and Sex. University of Missouri, Scholz, P. Eunuchs and Castrati. Broadwin and S. Princeton: Markus Wiener, Schrijvers, P. Amsterdam: B.
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