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Journal of Critical Care Aug 2024Limitations of life sustaining therapies (LLST) are frequent in intensive care units (ICUs), but no previous studies have examined end-of-life (EOL) care and LLST in... (Observational Study)
Observational Study
PURPOSE
Limitations of life sustaining therapies (LLST) are frequent in intensive care units (ICUs), but no previous studies have examined end-of-life (EOL) care and LLST in South Africa (SA).
MATERIALS AND METHODS
This study evaluated LLST in SA from the data of a prospective, international, multicentre, observational study (Ethicus-2) and compared practices with countries in the rest of the world.
RESULTS
LLST was relatively common in SA, and withholding was more frequent than withdrawing therapy. However, withdrawing and withholding therapy were less common, while failed CPR was more common, than in many other countries. No patients had an advance directive. Primary reasons for LLST in SA were poor quality of life, multisystem organ failure and patients' unresponsiveness to maximal therapy. Primary considerations for EOL decision-making were good medical practice and patients' best-interest, with the need for an ICU bed only rarely considered.
CONCLUSIONS
Withholding was more common than withdrawing treatment both in SA and worldwide, although both were significantly less frequent in SA compared with the world average.
Topics: Humans; South Africa; Prospective Studies; Withholding Treatment; Male; Life Support Care; Female; Intensive Care Units; Terminal Care; Middle Aged; Quality of Life; Aged; Decision Making; Adult
PubMed: 38554544
DOI: 10.1016/j.jcrc.2024.154797 -
Viruses Mar 2024Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in...
Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in antibiotic resistance and the faltering development of new antibiotics. Bacteriophage therapy uses bacteriophages (phages), i.e., prokaryotic viruses, to specifically target and kill pathogenic bacteria. The legal handling of this type of therapy raises several questions. These include whether phage therapeutics belong to a specially regulated class of medicinal products, and which legal framework should be followed with regard to the various technical ways in which phage therapeutics can be manufactured and administered. The article shows to which class of medicinal products phage therapeutics from wild type phages and from genetically modified (designer) phages do or do not belong. Furthermore, the article explains which legal framework is relevant for the manufacture and administration of phage therapeutics, which are manufactured in advance in a uniform, patient-independent manner, and for tailor-made patient-specific phage therapeutics. For the systematically coherent, successful translation of phage therapy, the article considers pharmaceutical law and related legal areas, such as genetic engineering law. Finally, the article shows how the planned legislative revisions of Directive 2001/83/EC and Regulation (EC) No 726/2004 may affect the legal future of phage therapy.
Topics: Humans; Phage Therapy; Bacteriophages; Bacteria; Bacterial Infections; Anti-Bacterial Agents; Pharmaceutical Preparations
PubMed: 38543808
DOI: 10.3390/v16030443 -
Sao Paulo Medical Journal = Revista... 2024Advance Directive documents allow citizens to choose the treatments they want for end-of-life care without considering therapeutic futility.
BACKGROUND
Advance Directive documents allow citizens to choose the treatments they want for end-of-life care without considering therapeutic futility.
OBJECTIVES
To analyze patients' and caregivers' answers to Advance Directives and understand their expectations regarding their decisions.
DESIGN AND SETTING
This study analyzed participants' answers to a previously published trial, conceived to test the document's efficacy as a communication tool.
METHODS
Sixty palliative patients and 60 caregivers (n = 120) registered their preferences in the Advance Directive document and expressed their expectations regarding whether to receive the chosen treatments.
RESULTS
In the patient and caregiver groups, 30% and 23.3% wanted to receive cardiorespiratory resuscitation; 23.3% and 25% wanted to receive artificial organ support; and 40% and 35% chose to receive artificial feeding and hydration, respectively. The participants ignored the concept of therapeutic futility and expected to receive invasive treatments. The concept of therapeutic futility should be addressed and discussed with both the patients and caregivers. Legal Advanced Directive documents should be made clear to reduce misinterpretations and potential legal conflicts.
CONCLUSION
The authors suggest that all citizens should be clarified regarding the futility concept before filling out the Advance Directives and propose a grammatical change in the document, replacing the phrase "Health Care to Receive / Not to Receive" with the sentence "Health Care to Accept / Refuse" so that patients cannot demand treatments, but instead accept or refuse the proposed therapeutic plans.
TRIAL REGISTRATION
ClinicalTrials.gov ID NCT05090072.
URL
https://clinicaltrials.gov/ct2/show/NCT05090072.
Topics: Humans; Cross-Sectional Studies; Medical Futility; Portugal; Advance Directives; Delivery of Health Care
PubMed: 38536997
DOI: 10.1590/1516-3180.2022.0537.R2.201023 -
Resuscitation May 2024In case of out-of-hospital cardiac arrest (OHCA) personnel of the emergency medical services (EMS) are regularly confronted with advanced directives (AD) and...
BACKGROUND AND OBJECTIVES
In case of out-of-hospital cardiac arrest (OHCA) personnel of the emergency medical services (EMS) are regularly confronted with advanced directives (AD) and do-not-attempt-resuscitation (DNACPR) orders. The authors conducted a retrospective analysis of EMS operation protocols to examine the prevalence of DNACPR in case of OHCA and the influence of a presented DNACPR on CPR-duration, performed Advanced-Life-Support (ALS) measures and decision making.
MATERIALS AND METHODS
Retrospective analysis of prehospital medical documentation of all resuscitation incidents in a German county with 250,000 inhabitants from 1 January 2016 to 31 December 2022. Combined with data from the structured CPR team-feedback database patients characteristics, measures and course of the CPR were analysed. Statistic testing with significance level p < 0.05.
RESULTS
In total n = 1,474 CPR events were analysed. Patients with DNACPR vs. no DNACPR: n = 263 (17.8%) vs. n = 1,211 (82.2%). Age: 80.0 ± 10.3 years vs. 68.0 ± 13.9 years; p < 0.001. Patients with ASA-status III/IV: n = 214 (81.3%) vs. n = 616 (50.9%); p < 0.001. Initial layperson-CPR: n = 148 (56.3%) vs. n = 647 (55.7%); p = 0.40. Airway management: n = 185 (70.3%) vs. n = 1,069 (88.3%); p < 0.001. With DNACPR CPR-duration initiated layperson-CPR vs. no layperson-CPR: 19:14 min (10:43-25:55 min) vs. 12:40 min (06:35-20:03 min); p < 0.001.
CONCLUSION
In case of CPR EMS-personnel are often confronted with DNACPR-orders. Patients are older and have more previous diseases than patients without DNACPR. Initiated layperson-CPR might lead to misinterpretation of patients will with impact on CPR-duration and unwanted measures. Awareness of this issue should be created through measures such as training programs in particular to train staff in the interpretation and legal admissibility of ADs.
Topics: Humans; Retrospective Studies; Out-of-Hospital Cardiac Arrest; Male; Female; Aged; Aged, 80 and over; Cardiopulmonary Resuscitation; Emergency Medical Services; Germany; Resuscitation Orders; Middle Aged; Advance Directives
PubMed: 38522733
DOI: 10.1016/j.resuscitation.2024.110189 -
BMC Palliative Care Mar 2024Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated... (Randomized Controlled Trial)
Randomized Controlled Trial
Measuring patients' medical treatment preferences in advance care planning: development and validation of the Treat-Me-ACP instrument - a secondary analysis of a cluster-randomized controlled trial.
BACKGROUND
Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated early stage outcome instruments are lacking. Therefore, the Treatment-Preference-Measure-Advance Care Planning (Treat-Me-ACP) instrument was developed and validated as part of the cluster-randomized controlled trial STADPLAN (Study on Advance Care Planning in care-dependent community-dwelling older persons) to assess the effects of Advance Care Planning interventions on patients' medical treatment preferences.
METHODS
The design of Treat-Me-ACP is based on the Emanuel Medical Directive and the Life Support Preferences Questionnaires. Using a multi-stage team approach a preliminary version of the Treat-Me-ACP was developed and pre-tested. The pre-tested instrument consists of one global medical care goal-item, five hypothetical scenarios with five hypothetical treatments, and one how would you feel-item within each scenario. A total of five scenario preference scores and five treatment preference scores can be formed. This version was subsequently applied to a subsample of the STADPLAN project (n = 80) to assess patient's preferences at baseline (T0) and at 12-month follow-up (T2). The further validation steps were based on this subsample and included: (1) acceptance by using completion rate and frequencies of missing data, (2) internal consistency by using Cronbach's α to test whether it was possible to create preference scores by scenario and treatment, (3) concurrent validation examining the association between the global medical care goal-item and the preference scores and the association between the how would you feel-items and the scenario preference scores, and (4) responsiveness of the instrument to changes in preferences for life-sustaining treatments by comparing preference scores from T0 to T2 between study groups.
RESULTS
Acceptance of the instrument was high. Results of concurrent validation indicate that the five scenarios represent the global medical care goal well. The preference scores showed an average tendency for decreasing preferences for life-sustaining treatments across all scales for the intervention group during study follow-up.
CONCLUSIONS
The Treat-Me-ACP can be used to evaluate the dynamics of patients' medical treatment preferences in Advance Care Planning. It has been validated for care-dependent community-dwelling older persons and can be used as an additional outcome measure in evaluating the effectiveness of ACP interventions.
TRIAL REGISTRATION
German Clinical Trials Register: DRKS00016886 on 04/06/2019.
Topics: Humans; Aged; Aged, 80 and over; Advance Directives; Advance Care Planning; Terminal Care; Patient Preference; Independent Living
PubMed: 38509501
DOI: 10.1186/s12904-024-01404-8 -
Alzheimer's & Dementia (Amsterdam,... 2024Many people dread prolonged dying with suffering in the terminal illness, advanced dementia. To successfully facilitate a timely dying, advance directives must be...
Many people dread prolonged dying with suffering in the terminal illness, advanced dementia. To successfully facilitate a timely dying, advance directives must be effective and acceptable. This article considers whether authorities, including treating physicians, can accept as moral, the effective intervention that ceases caregivers' assistance with oral feeding and hydrating. The article presents eight criticisms and "alternate views" regarding ceasing assisted feeding/hydrating. It draws on perspectives from clinical medicine, law, ethics, and religion. The conflict is between (A) people's core beliefs that reflect cultural norms and religious teachings regarding what is moral versus (B) patients' autonomous right of self-determination and claim right to avoid suffering. The article presents each side as strongly as possible. Accepting the intervention as moral could allow patients a peaceful and timely dying from patients' underlying disease. Confidence in future success can deter patients and their surrogates from considering a hastened dying in earlier stages of dementia.
PubMed: 38496720
DOI: 10.1002/dad2.12528 -
Alzheimer's & Dementia (Amsterdam,... 2024Many healthcare providers think withholding food and fluids from advance dementia patients, even if those patients requested that when competent, is immoral. This means...
Many healthcare providers think withholding food and fluids from advance dementia patients, even if those patients requested that when competent, is immoral. This means such patients suffer unnecessarily long. Patients have the ethical right when capacitated to specify that they want assistance with food and drink stopped when they have advanced dementia. Physicians should implement these patient choices when advance dementia patients can no longer feed themselves. In some states there may be legal barriers to this practice. The perpetual placement of food and drink within reach of patients who are unable to feed themselves is futile, so there is no need for it. The best way for persons concerned about suffering in advanced dementia is to add a supplement to one's advance directive specifying under what circumstances one wants food and fluids assistance stopped.
PubMed: 38496718
DOI: 10.1002/dad2.12532 -
Alzheimer's & Dementia (Amsterdam,... 2024Patients living with advanced dementia (PLADs) face several challenges to attain the goal of avoiding prolonged dying with severe suffering. One is how to determine when...
Patients living with advanced dementia (PLADs) face several challenges to attain the goal of avoiding prolonged dying with severe suffering. One is how to determine when PLADs' current suffering becomes severe enough to cease all life-sustaining treatments, including withdrawing assistance with oral feeding and hydrating, a controversial order. This article broadens the concept of suffering by including suffering that cannot be observed contemporaneously and the suffering of loved ones. Four paradigm shifts operationalize these concepts. During advance care planning, patients can judge which future clinical conditions would cause severe suffering. To decide when to allow patients to die, treating physicians/providers only need to assess if patients have reached patients' previously judged, qualifying conditions. Questions: Will this protocol prevent PLADs' prolonged dying with suffering? Deter early-stage dementia patients from committing preemptive suicide? Sway decision-making surrogates from withholding life-sustaining treatments from patients with middle-stage dementia? Provoke providers' resistance to relinquish their traditional, unilateral authority to determine patients' suffering?
PubMed: 38496716
DOI: 10.1002/dad2.12527 -
Alzheimer's & Dementia (Amsterdam,... 2024We comment on Dr. Terman's considerations on the moral justification of ceasing assisted feeding and hydration for people with advanced dementia. The core idea of his...
We comment on Dr. Terman's considerations on the moral justification of ceasing assisted feeding and hydration for people with advanced dementia. The core idea of his paper is that an advance directive can solve future dilemmas regarding assisted feeding. We submit that this static instrument is unfit for the complex and dynamic nature of assessing how to deal with refusals to eat, in particular for people with dementia. It overvalues the past in relation to the present situation and leaves no room for the possibility of changing wishes. Moreover, the perspectives of professional caregivers and families are not addressed because the focus is entirely on individual autonomy in early dementia. Multiple perspectives should be considered in interpreting directives and the actual situation in light of the patient's view of life in order to realistically account for what is morally justifiable in care in advanced dementia.
PubMed: 38496715
DOI: 10.1002/dad2.12531 -
Alzheimer's & Dementia (Amsterdam,... 2024
PubMed: 38496713
DOI: 10.1002/dad2.12533