TL;DR: Cytoreduction followed by HIPEC improves survival in patients with peritoneal carcinomatosis of colorectal origin, however, patients with involvement of six or more regions of the abdominal cavity, or grossly incomplete cytoreduction, had still a grave prognosis.
Abstract: Purpose: To confirm the findings from uncontrolled studies that aggressive cytoreduction in combination with hyperthermic intraperitoneal chemotherapy (HIPEC) is superior to standard treatment in patients with peritoneal carcinomatosis of colorectal cancer origin. Patients and Methods: Between February 1998 and August 2001, 105 patients were randomly assigned to receive either standard treatment consisting of systemic chemotherapy (fluorouracil-leucovorin) with or without palliative surgery, or experimental therapy consisting of aggressive cytoreduction with HIPEC, followed by the same systemic chemotherapy regime. The primary end point was survival. Results: After a median follow-up period of 21.6 months, the median survival was 12.6 months in the standard therapy arm and 22.3 months in the experimental therapy arm (log-rank test, P = .032). The treatment-related mortality in the aggressive therapy group was 8%. Most complications from HIPEC were related to bowel leakage. Subgroup analysis of the HIPEC g...
TL;DR: This classic gives you a solid grasp of the significance of etiologic agents, the pathogenic processes, epidemiology, and the basis of therapy for infectious diseases.
Abstract: Preface Acknowledgments Part I: The Nature of Infection Section 1. Key Issues in Hospital Medicine Section 2. Patient Safety Section 3. Quality Improvement Section 4. Leadership and Practice Management Skills Section 5. Professionalism and Medical Ethics Section 6. Medical Legal Issues and Risk Management Section 7. Teaching and Development Part II: Medical Consultation and Co-Management Section 1. Core Tenets of Medical Consultation Section 2. Key Issues Relating to Surgery Section 3. Anesthesia Section 4. Perioperative Assessment and Management Section 5. Perioperative Antithrombotic Management and Prevention Section 6. Medical Management of Neurosurgical Patients Section 7. Medical Management of Orthopedic Surgery Patients Section 8. Bariatric Surgery Part III: Clinical Problem-Solving in Hospital Medicine Part IV: Approach to the Patient at the Bedside Part V: Hospitalist Skills Section 1. Interpretation of Common Tests Section 2. Optimizing Utilization of Radiology Services Section 3. Procedures Part VI: Clinical Conditions Section 1. Emergency Medicine Section 2. Cardiovascular Medicine Section 3. Critical Care Section 4. Dermatology Section 5. Endocrinology Section 6. Gastroenterology Section 7. Geriatrics Section 8. Hematology Section 9. Oncology Section 10. Infectious Diseases Section 11. Neurology Section 12. Palliative Care Section 13. Pregnancy Section 14. Psychiatry Section 15. Addiction Section 16. Pulmonary and Allergy Immonology Section 17. Renal Section 18. Rheumatology Section 19. Vascular Medicine Section 20. Wartime Medicine Index
TL;DR: Several promising claims-based quality indicators were identified that, if found to be valid and reliable within data systems, could be useful in identifying health-care systems in need of improving end-of-life services.
Abstract: Purpose: To explore potential indicators of the quality of end-of-life services for cancer patients that could be monitored using existing administrative data. Methods: Quality indicators were identified and assessed by literature review for proposed indicators, focus groups with cancer patients and family members to assess candidate indicators and generate new ideas, and an expert panel ranking the meaningfulness and importance of each potential indicator using a modified Delphi approach. Results: There were three major concepts of poor quality of end-of-life cancer care that could be examined using currently-available administrative data (such as Medicare claims): institution of new anticancer therapies or continuation of ongoing treatments very near death; a high number of emergency room visits, inpatient hospital admissions, or intensive care unit days near the end of life; and a high proportion of patients never enrolled in hospice, only admitted in the last few days of life, or dying in an acute-car...
TL;DR: Spiritual well-being offers some protection against end-of-life despair in those for whom death is imminent, and these findings have important implications for palliative care practice.
TL;DR: Cannabinoids — the active components of Cannabis sativa and their derivatives — exert palliative effects in cancer patients by preventing nausea, vomiting and pain and by stimulating appetite.
Abstract: Cannabinoids - the active components of Cannabis sativa and their derivatives - exert palliative effects in cancer patients by preventing nausea, vomiting and pain and by stimulating appetite. In addition, these compounds have been shown to inhibit the growth of tumour cells in culture and animal models by modulating key cell-signalling pathways. Cannabinoids are usually well tolerated, and do not produce the generalized toxic effects of conventional chemotherapies. So, could cannabinoids be used to develop new anticancer therapies?
TL;DR: In the course of eliciting feedback on possible titles for this new journal the comments revealed a fascinating range of views on the terminology commonly used and abused in the literature, including 'Patient Reported Outcomes' which is becoming the new well-recognised phrase in this field.
Abstract: In the course of eliciting feedback on possible titles for this new journal the comments revealed a fascinating range of views on the terminology commonly used and abused in the literature. We describe here some highlights of the exploration on the meaning and the implication of the words that led to the title chosen after much deliberation.
The working title used by the Editor, Marcello Tamburini, during the early planing stages of this journal was 'Quality of Life Outcomes'. When he issued invitations to join the Editorial Board, Clare Bradley replied that there was indeed scope for the kind of journal described and welcomed the initiative but expressed concern about the title as follows:
"I think the use of the term 'quality of life' in the title of the journal Quality of Life Research' has contributed to the confusion about the measures described within the journal. Health status measures are often referred to as quality of life measures when they are actually measuring quality of health not quality of life. There are very important differences between the two and when those differences are not recognised it can lead to erroneous conclusions. I attach a commentary that was published last year in The Lancet where I discuss these issues [1].
"I hope you will understand why I would not want to have a journal called 'Quality of Life Outcomes' that then included papers on health status measures, patient satisfaction etc. Having said that, I think that health status and satisfaction measures are important too and I would like to see more outlets for publishing such material. Thus, rather than narrow down the content to fit the title of 'Quality of Life Outcomes', I would prefer to broaden the title to include all such measures. 'Patient Reported Outcomes' is becoming the new well-recognised phrase in this field and this might make a good title for a journal. What do you think?"
The Lancet commentary attached gave the example of the UK Prospective Diabetes Study [2] as one of many that has erroneously used a health status measure, in this case the EQ-5D (also known as the EuroQoL), as if it were a measure of quality of life. When no differences were found between EQ-5D scores of participants with Type 2 diabetes who were more intensively treated on insulin and scores of those treated less intensively with oral hypoglycaemic agents or diet alone, the UKPDS researchers concluded that the therapies were neutral in their effect on quality of life [3]. Clare Bradley pointed out that given the nature of the EQ-5D health status measure, in fact what had been shown was that the therapies had no differential effect on perceived health which is a very different matter. Perhaps surprisingly, more intensive treatment didn't make these patients feel any healthier. We don't know what it did to their quality of life because it wasn't measured. The problem of misinterpreting health status measures as if they were measuring quality of life continues and is not restricted to the EQ-5D. Speight has recently critiqued one of the many papers that wrongly describes the SF-36 as a measure of quality of life [4].
Marcello Tamburini circulated Clare Bradley's letter and attachment to 21 Editorial Board members when asking which of four possible titles they preferred and why. The four options offered were:
1. Quality of Life Outcomes
2. Health and Quality of Life Outcomes
3. Health-related Quality of Life Outcomes
4. Patient Reported Outcomes
The 16 immediate replies narrowed down the choice to options 2 and 4. A ballot was then taken among 63 experts in the field (most of them editorial board members of the new Journal). They were sent an extract from information presented as background to a symposium (May 19 2002) on Patient-Reported Outcomes to be held by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) (Table (Table1).1). The results of the ballot were as follows:
Table 1
Background – PATIENT-REPORTED OUTCOMES 'PRO' SYMPOSIUM CONCEPTUAL AND METHODOLOGICAL ISSUES – International Society for Pharmacoeconomics and Outcomes Research
Preferences and Number of Votes
• Missing 10
• No preference 2
• Preferred 'Health and Quality of Life Outcomes' 33
• Preferred 'Patient Reported Outcomes' 18
Reasons for preference were requested along with votes and those reasons are interesting (Table (Table2).2). It appeared to be accepted that 'patient reported outcomes' would cover the intended subject matter of the journal fairly well. However, there was one notable exception – we may not wish to restrict coverage to the reports of patients but may also wish to publish work that includes reports of family members and carers, and reports of people at risk of health problems who are not currently patients. However, as Deborah Lubeck pointed out 'Some quality of life studies still include instruments that are really physician completed symptom checklists that are not patient reported'. It would be an advantage to have a title that encouraged use of patient reports. Health and Quality of Life Outcomes had its own limitations concerning coverage. It would cover health status, symptoms, and, perhaps, well being under the 'health' label as well as quality of life measures under their own banner, and these could include reports by non-patients as well as by patients. However, it seemed that certain outcomes were excluded, in particular measures of satisfaction, and this was not intended. Patient Reported Outcomes was a broader term in this respect and could include patient satisfaction. Dorothy Keininger suggested that Patient Reported Outcomes might embrace articles on utilisation and economic data and asked if the journal intended to publish such articles (it does) and she was not alone in raising this question. Thus there was concern that Patient Reported Outcomes might be too narrow in excluding non-patient community surveys, carer's reports and chart audits.
Table 2
Comments on the title of the new journal
It was widely recognised that 'patient reported outcomes' was a new term and would be unfamiliar to many potential readers of this new journal. The novelty was greeted with caution by some and enthusiasm by others. There was concern that the term was 'somewhat obscure' although 'becoming better recognised' and that it was 'too cryptic' while Health and Quality of Life Outcomes was more 'self-explanatory and descriptive'. Dorothy Keininger suggested that patient reported outcomes may not be understood 'outside of the circle of researchers who follow ISPOR and the FDA' (Federal Drugs Administration). In contrast there was some suggestion that 'Maybe Patient Reported Outcomes will become the new buzz word that quality of life was...' (Anne Coscarelli), and that 'Here is a chance to be on the cutting edge of a new way of thinking about outcomes that puts the patient's view first' (Carol Buckhardt). Franco Toscani expressed a clear preference for Patient Reported Outcomes, commenting 'do you remember the term "palliative care"? When we started using it, it looked a strange, unusual, peculiar term, and many colleagues suggested rather "continuing care". History always prizes the new and difficult, not the old and comfortable. If you need work and application for making Patient Reported Outcomes understandable, clear and accepted, well, this is part of the fun!' Catherine Acquadro was equally confident of her preference for Patient Reported Outcomes (PRO) Journal. 'As Clare tells so aptly, PRO has a broader scope, and will include HRQL (Health Related Quality of Life) as well as satisfaction with treatment, health status measures, global impression, well-being etc. Moreover the term PRO is widely accepted by regulators especially by the FDA'.
Marcello Tamburini declared himself to be 'lacerate' between the two titles, welcoming the familiarity of Health and Quality of Life and the word 'patient' in Patient Reported Outcomes. He observed that 'patient' occurs in the titles of only 17 of 4,600 biomedical journals included in Medline. A downside of Patient Reported Outcomes is that the term 'patient' has unfortunate and inappropriate connotations of passivity that Clare Bradley would rather avoid although others have restricted their concern to the fact that a focus on patients excludes other groups of interest. The term does, however, have advantages over the old chestnut 'subjective outcomes', the reverse of which was the much-prized 'objective outcomes' (also known as 'hard outcomes') against which 'subjective outcomes' (or 'soft outcomes') came a poor second in the typical medical mind if not the psychological one.
Finally, as pointed out by John Ware in his response to the ballot, 'A noteworthy strength of 'Health and Quality of Life Outcomes' is that it recognises the crucial distinction between health and quality of life'. The majority of the Editorial Board members expressed a preference for Health and Quality of Life Outcomes. The outcomes referred to here are more specific than those encompassed by 'patient reported outcomes' and the title does not specify some outcomes that we may go on to include in the journal, such as patient satisfaction. This title has the advantage of familiarity but also makes the crucial distinction between two of the most important goals attainable – health and quality of life.
Abstract: Although many patients with cancer report positively on their experience of care, others claim they are not receiving the information and support they need at different stages of their care pathway. The national cancer patient survey (Department of Health, 2002), for example, showed wide variations in the quality of care delivered across the country.
TL;DR: An Index Medicus--generated review of clinical and scientific reports of xerostomia in the dental and medical literature during the past 20 years found it to be an uncomfortable condition and a common oral complaint for which patients may seek relief from dental practitioners.
Abstract: Background Clinicians may encounter symptoms of xerostomia, commonly called “dry mouth,” among patients who take medications, have certain connective tissue or immunological disorders or have been treated with radiation therapy. When xerostomia is the result of a reduction in salivary flow, significant oral complications can occur. Types of Studies Reviewed The authors conducted an Index Medicus–generated review of clinical and scientific reports of xerostomia in the dental and medical literature during the past 20 years. The literature pertaining to xerostomia represented the disciplines of oral medicine, pathology, pharmacology, epidemiology, gerodontology, dental oncology, immunology and rheumatology. Additional topics included the physiology of salivary function and the management of xerostomia and its complications. Results Xerostomia often develops when the amount of saliva that bathes the oral mucous membranes is reduced. However, symptoms may occur without a measurable reduction in salivary gland output. The most frequently reported cause of xerostomia is the use of xerostomic medications. A number of commonly prescribed drugs with a variety of pharmacological activities have been found to produce xerostomia as a side effect. Additionally, xerostomia often is associated with Sjogren's syndrome, a condition that involves dry mouth and dry eyes and that may be accompanied by rheumatoid arthritis or a related connective tissue disease. Xerostomia also is a frequent complication of radiation therapy. Conclusions and Clinical Implications Xerostomia is an uncomfortable condition and a common oral complaint for which patients may seek relief from dental practitioners. Complications of xerostomia include dental caries, candidiasis or difficulty with the use of dentures. The clinician needs to identify the possible cause(s) and provide the patient with appropriate treatment. Remedies for xerostomia usually are palliative but may offer some protection from the condition's more significant complications.
TL;DR: This article found that low-SES children are less able to respond to a given health shock, and that low SES children experience more shocks than high SES and that the relationship between socio-economic status (SES) and health grows stronger over time.
Abstract: Case, Lubotsky, and Paxson (2001) show that the well-known relationship between socio- economic status (SES) and health exists in childhood and grows more pronounced with age. However, in cross-sectional data it is difficult to distinguish between two possible explanations. The first is that low-SES children are less able to respond to a given health shock. The second is that low SES children experience more shocks. We show, using panel data on Canadian children that: 1) the gradient we estimate in the cross section is very similar to that estimated previously using U.S. children; 2) both high and low-SES children recover from past health shocks to about the same degree; and 3) that the relationship between SES and health grows stronger over time mainly because low-SES children receive more negative health shocks. In addition, we examine the effect of health shocks on math and reading scores. We find that health shocks affect test scores and future health in very similar ways. Our results suggest that public policy aimed at reducing SES-related health differentials in children should focus on reducing the incidence of health shocks as well as on reducing disparities in access to palliative care.
TL;DR: Although many patients with cancer report positively on their experience of care, others claim they are not receiving the information and support they need at different stages of their care pathway.
Abstract: Although many patients with cancer report positively on their experience of care, others claim they are not receiving the information and support they need at different stages of their care pathway. The national cancer patient survey (Department of Health, 2002), for example, showed wide variations in the quality of care delivered across the country.
TL;DR: Improved survival following S1P can be achieved with strategies that allow for early identification of decreased systemic output and the use of afterload reduction to stabilize systemic vascular resistance and therefore the pulmonary to systemic flow ratio.
Abstract: Background Outcome of stage 1 palliation (S1P) for hypoplastic left heart syndrome (HLHS) has improved coincident with application of treatment strategies including continuous superior vena cava oximetry (SvO 2 ), phenoxybenzamine (POB), strategies to minimize the duration of deep hypothermic circulatory arrest (DHCA) and efforts to ameliorate the inflammatory response to cardiopulmonary bypass (CPB) using aprotinin and modified ultrafiltration. Methods and Results Analysis of a consecutive series of 115 patients undergoing S1P was done to identify the risk factors for mortality and the impact of new treatment strategies. For the current era, July 1996 to October 2001, hospital survival was 93% (75/81) compared with 53% (18/34) for the time period, January 1992 to June 1996, P P P 2 monitoring as a factor favoring S1P survival ( P =0.02) and use of POB as a factor favoring survival to S2P ( P =0.003). In the current era shorter duration of DHCA was associated with improved survival to S2P ( P =0.02). Conclusions–Improved survival following S1P can be achieved with strategies that allow for early identification of decreased systemic output and the use of afterload reduction to stabilize systemic vascular resistance and therefore the pulmonary to systemic flow ratio. Strategies to ameliorate the inflammatory response to CPB may decrease the degree and duration of postoperative support. Strategies to minimize duration of DHCA may improve intermediate survival and merit additional studies.
TL;DR: In NSCLC, reduction of metabolic activity after one cycle of chemotherapy is closely correlated with final outcome of therapy and using metabolic response as an end point may shorten the duration of phase II studies evaluating new cytotoxic drugs and may decrease the morbidity and costs of therapy in nonresponding patients.
Abstract: Purpose: To prospectively evaluate the use of positron emission tomography with the glucose analog fluorodeoxyglucose (FDG-PET) to predict response to chemotherapy in patients with advanced non–small-cell lung cancer (NSCLC). Patients and Methods: Patients with stage IIIB or IV NSCLC scheduled to undergo platinum-based chemotherapy were eligible for this study. Patients were studied by FDG-PET before and after the first cycle of therapy. Based on previous studies, a reduction of tumor FDG uptake by more than 20% as assessed by standardized uptake values (SUV) was used as a criterion for a metabolic response. Furthermore, changes in tumor SUVs were compared with changes in FDG net-influx constants (Ki) and tumor/muscle ratios (t/m). Results: Fifty-seven patients were included in the study. There was a close correlation between metabolic response and best response to therapy according to Response Evaluation Criteria in Solid Tumors (P < .0001; sensitivity and specificity for prediction of best response, 95%...
TL;DR: This is the first study to quantitatively demonstrate benefit from palliative and hospice care teams PCHCTs, and wide variations in the type of service delivered by each team were found.
TL;DR: The meaning to patients of declines in pain intensity and percent pain reduction are established and are applicable in the clinical setting and research arena to assess treatment efficacy.
Abstract: Despite widespread use of the 0-10 numeric rating scale (NRS) of pain intensity, relatively little is known about the meaning of decreases in pain intensity assessed by means of this scale to patients. We aimed to establish the meaning to patients of declines in pain intensity and percent pain reduction. Upon arrival to the postanesthesia care unit, postsurgical patients rated their baseline pain intensity on both a 0-10 NRS and on a 4-point verbal scale. Patients whose NRS was higher than 4/10 received intravenous opioids until their pain intensity declined to 4/10 or lower. During opioid titration, patients were asked every 10 min to rate pain intensity on a NRS and to indicate the degree of pain improvement on a 5-point Likert scale from 'no improvement' to 'complete pain relief'. Seven hundred adult patients were enrolled. For patients with moderate pain, a decrease of 1.3 units (20% reduction) corresponded to 'minimal' improvement, a decrease of 2.4 (35% reduction) to 'much' improvement, a decrease of 3.5 units (45% reduction) corresponded to 'very much' improvement. For patients with severe pain, the decrease in NRS pain score and the percentage of pain relief had to be larger to obtain similar degrees of pain relief. The change in pain intensity that is meaningful to patients increases as the severity of their baseline pain increases. The present findings are applicable in the clinical setting and research arena to assess treatment efficacy.
TL;DR: In this paper, the authors evaluated the impact of multidisciplinary management on ALS patients' survival and found that active and aggressive management enhances survival, particularly among ALS patients with bulbar dysfunction.
Abstract: Background: In recent years, there has been a paradigm shift in the method of healthcare delivery to amyotrophic lateral sclerosis (ALS) patients with the emergence of multidisciplinary ALS clinics that cater exclusively for patients with this condition. The impact of multidisciplinary management has not been previously evaluated.
Methods: Using data from the Irish ALS Register, we conducted a prospective, population based study of all ALS cases diagnosed in Ireland over a five year period to evaluate the effectiveness of a multidisciplinary clinic on ALS survival.
Results: Eighty two (24%) patients attended the multidisciplinary ALS clinic, with the remaining 262 (76%) cases followed in a general neurology clinic. The ALS clinic cohort was an average of five years younger (60.1 v 65.6 years) and were more likely to receive riluzole than the general neurology cohort (99% v 61%). The median survival of the ALS clinic cohort was 7.5 months longer than for patients in the general neurology cohort (logrank = 15.4, p < 0.0001). Overall, one year mortality was decreased by 29.7%. Prognosis of bulbar onset patients was extended by 9.6 months if they attended the ALS clinic. Using multivariate analysis, attendance at the ALS clinic was an independent covariate of survival (HR = 1.47, p = 0.02).
Conclusions: ALS patients who received their care at a multidisciplinary clinic had a better prognosis than patients attending a general neurology clinic. The data suggest that active and aggressive management enhances survival, particularly among ALS patients with bulbar dysfunction. The effect of clinic type must be considered in future clinical trials design.
TL;DR: Students and residents in the United States feel unprepared to provide, and faculty and residents unprepared to teach, many key components of good care for the dying.
Abstract: OBJECTIVE: To assess the status of medical education in end-of-life care and identify opportunities for improvement.
TL;DR: These EOLC domains and the associated quality indicators, developed through a consensus process, provide clinicians and researchers with a framework for understanding quality of E OLC in the intensive care unit.
Abstract: ObjectiveThe primary goal of this study was to address the documented deficiencies in end-of-life care (EOLC) in intensive care unit settings by identifying key EOLC domains and related quality indicators for use in the intensive care unit through a consensus process. A second goal was to propose sp
TL;DR: Proactive interventions from a palliative care consultant within this subset of patients decreased the use of nonbeneficial resources and avoided protracted dying.
TL;DR: It is concluded that patients are more likely to receive higher doses of both opioids and sedatives as they get closer to death, and the doctrine of double effect is not essential for justification of the use of these drugs, and may act as a deterrent to the provision of good symptom control.
Abstract: Summary Opioids and sedative drugs are commonly used to control symptoms in patients with advanced cancer. However, it is often assumed that the use of these drugs inevitably results in shortening of life. Ethically, this outcome is excused by reference to the doctrine of double effect. In this review, we assess the evidence for patterns of use of opioids and sedatives in palliative care and examine whether the doctrine of double effect is needed to justify their use. We conclude that patients are more likely to receive higher doses of both opioids and sedatives as they get closer to death. However, there is no evidence that initiation of treatment, or increases in dose of opioids or sedatives, is associated with precipitation of death. Thus, we conclude that the doctrine of double effect is not essential for justification of the use of these drugs, and may act as a deterrent to the provision of good symptom control.
TL;DR: It is demonstrated that the cannabinoid system is neuroprotective during EAE, an animal model of multiple sclerosis, and exogenous CB1 agonists can provide significant neuroprotection from the consequences of inflammatory CNS disease in an experimental allergic uveitis model.
Abstract: Multiple sclerosis is increasingly being recognized as a neurodegenerative disease that is triggered by inflammatory attack of the CNS. As yet there is no satisfactory treatment. Using experimental allergic encephalo myelitis (EAE), an animal model of multiple sclerosis, we demonstrate that the cannabinoid system is neuroprotective during EAE. Mice deficient in the cannabinoid receptor CB1 tolerate inflammatory and excitotoxic insults poorly and develop substantial neurodegeneration following immune attack in EAE. In addition, exogenous CB1 agonists can provide significant neuroprotection from the consequences of inflammatory CNS disease in an experimental allergic uveitis model. Therefore, in addition to symptom management, cannabis may also slow the neurodegenerative processes that ultimately lead to chronic disability in multiple sclerosis and probably other diseases.
TL;DR: This strategy of simultaneously hoping for the best and preparing for the worst is a useful strategy for approaching patients with potentially life-limiting illness and embraces the divided thinking many patients, families, and even health care providers have.
Abstract: Physicians often deal with hope as something to embrace or negate completely. But this exclusive focus on hope constricts options for discussing how a patient, family, and physician can work togeth...
TL;DR: Unconjugated sibrotuzumab (BIBH 1), which is a humanised version of the murine anti-FAP mAb F19, was investigated for its anti-tumour activity, safety and pharmacokinetics and was well tolerated and safe.
Abstract: Background: A novel immunological approach to colon cancer therapy is the antibody targeting of the fibroblast activation protein (FAP), which is highly expressed by stroma cells of this tumour. Unconjugated sibrotuzumab (BIBH 1), which is a humanised version of the murine anti-FAP mAb F19, was investigated for its anti-tumour activity, safety and pharmacokinetics. Patients and Methods: Patients with metastatic colorectal cancer received weekly intravenous infusions of unconjugated sibrotuzumab at a dose of 100 mg over 12 scheduled weeks. The study was implemented as an open-label, uncontrolled, multicentre trial. Results: 25 patients were enrolled. Patients had one or more measurable lesions, predominantly liver lesions, at baseline. At least 8 repeated weekly infusions of sibrotuzumab in 17 evaluable patients did not result in complete or partial remission. Rather, ongoing tumour progression was noted in all patients except for 2 patients with stable disease. However, progressive disease was also observed post-study in these 2 patients who received 1 and 6 additional infusions, respectively, of sibrotuzumab. Sibrotuzumab exhibited 2-compartment pharmacokinetics with a dominant terminal phase and t1/2 ? = 5.3 ± 2.3 days. Adverse drug reactions (rigors/chills, nausea, flushing and one incidence of bronchospasm) were observed in 5 patients. Of the 24 patients given 2 or more infusions of sibrotuzumab, antibodies against sibrotuzumab were found in 3 patients (12.5%) after 4–12 infusions. Conclusions: Sibrotuzumab was well tolerated and safe. The minimal requirement for the continuation of this exploratory trial, of at least one complete or partial remission, or equivalently, of 4 patients with stable disease, was not met.
TL;DR: In 1991, a debate at the European Parliament on euthanasia stimulated discussion at all levels in Europe and the Board of Directors of the EAPC organised a working session together with two experts to help them clarify the position the organisation should adopt towards euthanasia.
Abstract: In 1991, a debate at the European Parliament on euthanasia stimulated discussion at all levels in Europe. Subsequently, the Board of Directors of the EAPC organised a working session together with two experts to help them clarify the position the organisation should adopt towards euthanasia. The experts collaborated with the Board of Directors on a document and in 1994 the EAPC produced a first statement, Regarding euthanasia, published in the official journal of the EAPC – the European Journal of Palliative Care . In February 2001, the EAPC Board asked an expert group to form an Ethics Task Force to review the subject and advise the organisation accordingly.
TL;DR: This work provides a set of guidelines to help nurses identify methodologically sound qualitative research studies that can inform their practice and proposes criteria for appraising qualitative research.
Abstract: You work on a palliative care unit where you have many opportunities to discuss end of life decisions with patients and family members. In a recent team meeting of your unit’s providers, the topic of “appropriate” treatment choices for patients at end of life comes up. Some providers believe that they should counsel patients and family members to “help them make better end of life decisions so that they will have a good death.” There is, however, no consensus about how this should be done.
You volunteer to see if any studies have been done on decision making at the end of life. You remember that your institution has an online subscription to Evidence-Based Nursing . You sign in and go to the search screen. In the field “word(s) anywhere in article” you type in “end of life” (in quotations because you are looking for articles that include all 3 words together) and “decision”. 4 matches are found. The first is an abstract entitled “Providers tried to help patients and families make end of life decisions”.1 You review the full text of the abstract, which describes a qualitative study by Norton and Bowers2 that seems to address the issues of interest. You get a copy of the full article from the library so that you can more fully assess the usefulness of this study for your team.
Many authors have proposed criteria for appraising qualitative research.3–,10 Some question the appraisal process because of a lack of consensus among qualitative researchers on quality criteria.6–8,10 Despite this controversy, and while recognising that criteria will continue to evolve, we provide a set of guidelines to help nurses identify methodologically sound qualitative research studies that can inform their practice. Our standard approach to appraising an article …
TL;DR: Through integrating palliative care into curative care practices earlier in the disease trajectory, chronically ill patients nearing the end of life report improved satisfaction with care and demonstrate less acute care use resulting in lower costs of care.
Abstract: Context: Despite the widespread recognition of the need for new models of care to better serve patients at the end-of-life, little evidence exists documenting the effectiveness of these models. Objective: To evaluate the effectiveness of a palliative program for end-of-life care. Design: A comparison group study was conducted between March 1999 and August 2000 comparing subjects enrolled in a palliative care intervention to those receiving usual care. Setting: Home Health Department at Kaiser Permanente, TriCentral Service Area. Subjects: During the course of the 2-year study, 558 subjects were enrolled. A subgroup of 300 patients who had died during the course of the study was selected for analysis; 161 were enrolled in the Palliative Care Program and 139 in the comparison group. Intervention: The Kaiser Permanente Palliative Care Project is a multidisciplinary care management approach for home-based end of life care and treatment. The program is designed to facilitate the transition from acute to pallia...
TL;DR: None of the treatment schedules was proven to prolong overall survival and patients with disseminated melanoma should be treated with well-tolerated drug regimens, such as single-agent treatments or in combination with interferon alfa.
Abstract: We undertook a systematic review of 41 randomised studies in disseminated melanoma, identified by a comprehensive search. We aimed to investigate rates of response to various treatment modalities and the outcome for the patients. We analysed seven studies that compared polychemotherapy with single-agent dacarbazine, six that compared different chemotherapeutic schedules with each other, five on the addition of tamoxifen to a reference therapy, and six that included non-specific immunostimulators. In 17 studies, the addition of interferon alfa, interleukin 2, or both, to a reference therapy was investigated, including trials with biochemotherapy. Many trials had small sample sizes and did not report a power analysis; not all were analysed by intention to treat. Although some treatment regimens, especially polychemotherapeutic schedules, seem to increase response rates, none of the treatment schedules was proven to prolong overall survival. Patients with disseminated melanoma should be treated with well-tolerated drug regimens, such as single-agent treatments or in combination with interferon alfa. Systemic treatments should preferably be investigated in randomised trials so that the potential benefits of new treatment concepts can be thoroughly examined.
TL;DR: It is suggested that different patient subgroups may have different needs in terms of symptoms, which will be relevant for the planning and rationalization of palliative care services.
Abstract: The demographics and prevalence of symptoms in patients at first referral to the different components of palliative care services were identified by a retrospective case note study of 400 patients referred to three palliative care centres in London, UK: Michael Sobell House, Mount Vernon Hospital; The North London Hospice; St Bartholomew's and the Royal London Hospitals. One hundred consecutive referrals to each of the following service components were analysed: a hospice inpatient service; a community team; an NHS hospital support team and an outpatient service. A standardized proforma was used to collect the data. Ninety five per cent (380/400) of patients referred had a cancer diagnosis. The five most prevalent symptoms overall were pain (64%), anorexia (34%), constipation (32%), weakness (32%) and dyspnoea (31%), which is similar to other published reports. However, the commonest symptoms and their prevalence varied depending on the service component to which the patient was referred. Patients referre...
TL;DR: Noninvasive ventilation use was associated with improved QoL and survival, and subjects with orthopnea and preserved bulbar function showed the largest benefit.
Abstract: Background: Noninvasive ventilation (NIV) probably improves survival in ALS, but the magnitude and duration of any improvement in quality of life (QoL) and the optimal criteria for initiating treatment are unclear. Methods: QoL (Short Form-36 [SF-36], Chronic Respiratory Disease Questionnaire, Sleep Apnea Quality of Life Index) and respiratory function were assessed every 2 months and polysomnography every 4 months in 22 subjects with ALS. A trial of NIV was offered when subjects met one or more predefined criteria: orthopnea, daytime sleepiness, unrefreshing sleep, daytime hypercapnia, nocturnal desaturation, or an apnea–hypopnea index (AHI) of >10. Seventeen subjects were offered a trial of NIV; 15 accepted, and 10 continued treatment subsequently. Outcome was assessed by changes in QoL and NIV compliance (h/day). Subjects were followed to death or for at least 26 months. Results: QoL domains assessing sleep-related problems and mental health improved (effect sizes 0.88 to 1.77, p 10 was unhelpful. Moderate or severe bulbar weakness was associated with lower compliance and less improvement in QoL. Conclusions: NIV use was associated with improved QoL and survival. Subjects with orthopnea and preserved bulbar function showed the largest benefit.
TL;DR: Appropriate standardized care of medically complex terminally ill patients in a high-volume, specialized unit may significantly lower cost.
Abstract: Background: Current end-of-life hospital care can be of poor quality and high cost. High volume and/or specialist care, and standardized care with clinical practice guidelines, has improved outcomes and costs in other areas of cancer care. Methods: The objective of this study was to measure the impact of the palliative care unit (PCU) on the cost of care. The PCU is a dedicated 11-bed inpatient (PCU) staffed by a high-volume specialist team using standardized care. We compared daily charges and costs of the days prior to PCU transfer to the stay in the PCU, for patients who died in the first 6 months after the PCU opened May 2000. We performed a case-control study by matching 38 PCU patients by diagnosis and age to contemporary patients who died outside the PCU cared for by other medical or surgical teams, to adjust for potential differences in the patients or goals of care. Results: The unit admitted 237 patients from May to December 2000. Fifty-two percent had cancer followed by vascular events, immunod...
TL;DR: It was confirmed that pain, anxiety and depression were associated with impaired quality of life and longitudinal studies are required to examine the direction of the causal association between pain and depression in patients receiving palliative care.
Abstract: Backgroung: The aim of palliative care services is to ensure the best quality of life for patients and their carers. Depression is common amongst palliative care patients and has been shown to adve...