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Importance: Two mRNA-based vaccines against coronavirus disease 2019 (COVID-19) were found to be highly efficacious in phase 3 clinical trials in the US. However, patients with chronic illnesses, including cirrhosis, were excluded from clinical trials. Patients with cirrhosis have immune dysregulation that is associated with vaccine hyporesponsiveness., Objective: To study the association of receipt of the Pfizer BNT162b2 mRNA or the Moderna mRNA-1273 vaccines in patients with cirrhosis compared with a propensity-matched control group of patients at similar risk of infection and severe disease from COVID-19., Design, Setting, and Participants: We performed a retrospective cohort study of patients with cirrhosis who received at least 1 dose of a COVID-19 mRNA vaccine at the Veterans Health Administration. Patients who received at least 1 dose of the vaccine (n = 20 037) were propensity matched with 20 037 controls to assess the associations of vaccination with new COVID-19 infection and COVID-19 hospitalization and death., Exposures: Receipt of at least 1 dose of the BNT162b2 mRNA or the mRNA-1273 vaccines between December 18, 2020, and March 17, 2021., Main Outcomes and Measures: COVID-19 infection as documented by a positive result for COVID-19 by polymerase chain reaction, hospitalization, and death due to COVID-19 infection., Results: The median (interquartile range) age of the vaccinated individuals in the study cohort was 69.1 (8.4) years and 19 465 (97.2%) of the participants in each of the vaccinated and unvaccinated groups were male, consistent with a US veteran population. The mRNA-1273 vaccine was administered in 10 236 (51%) and the BNT162b2 mRNA in 9801 (49%) patients. Approximately 99.7% of patients who received the first dose of either vaccine with a follow-up of 42 days or more received a second dose. The number of COVID-19 infections in the vaccine recipients was similar to the control group in days 0 to 7, 7 to 14, 14 to 21, and 21 to 28 after the first dose. After 28 days, receipt of 1 dose of an mRNA vaccine was associated with a 64.8% reduction in COVID-19 infections and 100% protection against hospitalization or death due to COVID-19 infection. The association of reduced COVID-19 infections after the first dose was lower among patients with decompensated (50.3%) compared with compensated cirrhosis (66.8%). Receipt of a second dose was associated with a 78.6% reduction in COVID-19 infections and 100% reduction in COVID-19-related hospitalization or death after 7 days., Conclusions and Relevance: This cohort study of US veterans found that mRNA vaccine administration was associated with a delayed but modest reduction in COVID-19 infection but an excellent reduction in COVID-19-related hospitalization or death in patients with cirrhosis.

This article considers a particular aspect of palliative psychology that is inherent to the needs in the area of attitudes concerning Advance Healthcare Directives (AHDs) among Italian physicians and nurses after the promulgation of Law No. 219/2017 on AHDs and informed consent in 2018. The study utilized a mixed-method approach. The group of participants was composed of 102 healthcare professionals (63 females and 39 males). The quantitative part utilized the following scales: Attitudes toward Euthanasia, the Religious Orientation Scale, the Balanced Inventory of Desirable Responding, and the Testoni Death Representation Scale. The results were mostly in line with the current literature, especially concerning a positive correlation between religiosity and the participants' rejection of the idea of euthanasia. However, the qualitative results showed both positive and negative attitudes towards AHDs, with four main thematic areas: "Positive aspects of the new law and of AHDs", "Negative aspects of the new law and of AHDs", "Changes that occurred in the professional context and critical incidents", and "Attitudes towards euthanasia requests." It emerged that there is not any polarization between Catholics or religious people and secularists: Their positions are substantially similar with respect to all aspects, including with regard to euthanasia. The general result is that the law is not sufficiently understood, and so a quarter of the participants associate AHDs with euthanasia. Discussions on the opportunity for palliative psychologists to help health professionals to better manage these issues through death education courses are presented.

Objective: This paper presents a two-phase cross-sectional study aimed at examining the possible mitigating role of perceived meaning of life and representation of death on psychological distress, anxiety, and depression., Method: The first phase involved 219 healthy participants, while the second encompassed 30 cancer patients. Each participant completed the Personal Meaning Profile (PMP), the Testoni Death Representation Scale (TDRS), the Hospital Anxiety and Depression Scale (HADS), and the Distress Thermometer (DT). The primary analyses comprised (1) correlation analyses between the overall scores of each of the instruments and (2) path analysis to assess the indirect effect of the PMP on DT score through anxiety and depression as determined by the HADS., Results: The path analysis showed that the PMP was inversely correlated with depression and anxiety, which, in turn, mediated the effect on distress. Inverse correlations were found between several dimensions of the PMP, the DT, and the HADS-Anxiety and HADS-Depression subscales, in both healthy participants and cancer patients. Religious orientation (faith in God) was related to a stronger sense of meaning in life and the ontological representation of death as a passage, rather than annihilation., Significance of Results: Our findings support the hypothesis that participants who represent death as a passage and have a strong perception of the meaning of life tend to report lower levels of distress, anxiety, and depression. We recommend that perceived meaning of life and representation of death be more specifically examined in the cancer and palliative care settings.

OBJECTIVETo directly observe healthcare workers in a nursing home setting to measure frequency and duration of resident contact and infection prevention behavior as a factor of isolation practiceDESIGNObservational studySETTING AND PARTICIPANTSHealthcare workers in 8 VA nursing homes in Florida, Maryland, Massachusetts, Michigan, Washington, and TexasMETHODSOver a 15-month period, trained research staff without clinical responsibilities on the units observed nursing home resident room activity for 15-30-minute intervals. Observers recorded time of entry and exit, isolation status, visitor type (staff, visitor, etc), hand hygiene, use of gloves and gowns, and activities performed in the room when visible.RESULTSA total of 999 hours of observation were conducted across 8 VA nursing homes during which 4,325 visits were observed. Residents in isolation received an average of 4.73 visits per hour of observation compared with 4.21 for nonisolation residents (P<.01), a 12.4% increase in visits for residents in isolation. Residents in isolation received an average of 3.53 resident care activities per hour of observation, compared with 2.46 for residents not in isolation (P<.01). For residents in isolation, compliance was 34% for gowns and 58% for gloves. Healthcare worker hand hygiene compliance was 45% versus 44% (P=.79) on entry and 66% versus 55% (P<.01) on exit for isolation and nonisolation rooms, respectively.CONCLUSIONSHealthcare workers visited residents in isolation more frequently, likely because they required greater assistance. Compliance with gowns and gloves for isolation was limited in the nursing home setting. Adherence to hand hygiene also was less than optimal, regardless of isolation status of residents.Infect Control Hosp Epidemiol 2018;39:683-687.

We estimated the number of isolation beds needed to care for a surge in patients during an airborne-transmissible influenza pandemic. Based on US health system data, the amount of available airborne isolation beds needed for ill patients will be exceeded early in the course of a moderate or severe influenza pandemic, requiring medical facilities to find ways to further expand isolation bed capacity. Rather than building large numbers of permanent airborne infection isolation rooms to increase surge capacity, an investment that would come at great financial cost, it may be more prudent to prepare for wide-scale creation of just-in-time temporary negative-pressure wards.

Background: Exposure to patients with varicella or herpes zoster causes considerable disruption to a health care facility's operations and has a significant health and economic impact. However, practices related to screening for immunity and immunization of health care personnel (HCP) for varicella vary widely., Methods: A decision tree model was built to evaluate the cost-effectiveness of 8 different strategies of screening and vaccinating HCP for varicella. The outcomes are presented as probability of acquiring varicella, economic impact of varicella per employee per year, and cost to prevent additional cases of varicella. Monte Carlo simulations and 1-way sensitivity analyses were performed to address the uncertainties inherent to the model. Alternative epidemiologic and technologic scenarios were also analyzed., Results: Performing a clinical screening followed by serologic testing of HCP with negative history diminished the cost impact of varicella by >99% compared with not having a program. Vaccinating HCP with negative screen cost approximately $50,000 per case of varicella prevented at the current level of U.S. population immunity, but was projected to be cost-saving at 92% or lower immunity prevalence. Improving vaccine acceptance rates and using highly sensitive assays also optimize cost-effectiveness., Conclusion: Strategies relying on screening and vaccinating HCP for varicella on employment were shown to be cost-effective for health care facilities and are consistent with current national guidelines for varicella prevention., (Published by Elsevier Inc.)

Specific guidance on the size and composition of respiratory protective device (RPD) stockpiles for use during a pandemic is lacking. We explore the economic aspects of stockpiling various types and combinations of RPDs by adapting a pandemic model that estimates the impact of a severe pandemic on a defined population, the number of potential interactions between patients and health care personnel, and the potential number of health care personnel needed to fulfill those needs. Our model calculates the number of the different types of RPDs that should be stockpiled and the consequent cost of purchase and storage, prorating this cost over the shelf life of the inventory. Compared with disposable N95 or powered air-purifying respirators, we show that stockpiling reusable elastomeric half-face respirators is the least costly approach. Disposable N95 respirators take up significantly more storage space, which increases relative costs. Reusing or extending the usable period of disposable devices may diminish some of these costs. We conclude that stockpiling a combination of disposable N95 and reusable half-face RPDs is the best approach to preparedness for most health care organizations. We recommend against stockpiling powered air-purifying respirators as they are much more costly than alternative approaches.

Streptococcus pneumoniae-related infections have a major global impact on healthcare, especially in the developing world, and are considered the number one vaccine-preventable cause of death in children. There are more than 90 pneumococcal serotypes and 46 serogroups. The first capsular polysaccharide pneumococcal vaccine was licensed in the USA in 1977 for individuals older than 2 years of age at high risk for pneumococcal disease. Two decades later, the first 7-valent pneumococcal polysaccharide-protein conjugate vaccine completed the required clinical trials and was introduced as part of the national immunization program of various countries. New-generation vaccines that include emerging serotypes, while maintaining protection against the 7-valent pneumococcal serotypes, have recently been approved. With the addition of these serotypes, the majority of potential pneumococcal serotypes causing invasive disease in most parts of the world could be covered.

Faced with increasing concerns about the likelihood of an influenza pandemic, healthcare systems have been challenged to determine what specific medical supplies that should be procured and stockpiled as a component of preparedness. Despite publication of numerous pandemic planning recommendations, little or no specific guidance about the types of items and quantities of supplies needed has been available. The primary purpose of this report is to detail the approach of 1 healthcare system in building a cache of supplies to be used for patient care during the next influenza pandemic. These concepts may help guide the actions of other healthcare systems.

Objective: To evaluate the efficacy and safety of inhaled tobramycin (TOBI) in the treatment of ventilator-associated pneumonia (VAP) in a randomized, double-blind pilot study., Patients and Methods: Ten patients from a cohort of 108 mechanically ventilated patients with documented clinical and bacteriological evidence of VAP caused by Pseudomonas aeruginosa or Acinetobacter spp. in the surgical and trauma intensive care units of a university teaching hospital were randomized to receive either TOBI (n = 5) or intravenous tobramycin (TOBRA; n = 5). The two groups were similar in their Acute Physiology and Chronic Health Evaluation (APACHE) score, Clinical Pulmonary Infection Score (CPIS), and Multiple Organ Dysfunction Score (MODS) prior to randomization. The primary outcome measure was resolution of pneumonia. The CPIS and MODS were used as objective indicators of clinical progress., Results: All TOBI patients had clinical resolution of VAP. Two TOBRA patients were considered failures. One had deterioration in MODS, and the other had doubling of his serum creatinine concentration. The patients treated with TOBI may have had more ventilator-free days than those receiving TOBRA, but the difference was not statistically significant owing to the small sample size (24 +/- 3 vs. 14 +/- 13 days; p = 0.12)., Conclusion: Aerosolized tobramycin for the treatment of VAP appeared safe and effective in this pilot study. A larger study is warranted to determine if aerosolized tobramycin will lead to better outcomes than intravenous tobramycin when used for the treatment of VAP.

Background: Despite the large body of evidence suggesting a beneficial role of fever in the host response, antipyretic therapy is commonly employed for febrile critically ill patients. Our objective was to evaluate the impact of antipyretic therapy strategies on the outcomes of critically ill patients., Methods: Patients admitted to the Trauma Intensive Care Unit over a nine-month period were eligible for inclusion, except those with traumatic brain injury. Patients were randomized on day three of the ICU stay into aggressive or permissive groups. The aggressive group received acetaminophen 650 mg every 6 h for temperature of >38.5 degrees C and a cooling blanket was added for temperature of >39.5 degrees C. The permissive group received no treatment for temperature of >38.5 degrees C, but instead had treatment initiated at temperature of >40 degrees C, at which time acetaminophen and cooling blankets were used until temperature was <40 degrees C. Patient demographics, daily temperatures, systemic inflammatory response syndrome (SIRS) scores, multiple organ dysfunction syndrome (MODS) scores, and infections and complications were recorded., Results: Between December, 2002 and September, 2003, 572 patients were screened, of whom 82 met criteria for enrollment. Forty-four patients were randomized to the aggressive group and 38 patients were randomized to the permissive group for a total of 961 and 751 ICU days, respectively. There were 131 infections in the aggressive group and 85 infections in the permissive group (4 +/- 6 vs. 3 +/- 2 infections per patient, p = 0.26). There were seven deaths in the aggressive group and only one death in the permissive group (p = 0.06, Fisher Exact Test). The study was stopped after the first interim analysis due to the mortality difference, related to the issues of waiver of consent and the mandate for minimal risk., Conclusions: Aggressively treating fever in critically ill patients may lead to a higher mortality rate.

Although the subjective nature of quality of life perception is generally accepted, less attention has been paid to the procedure of selecting domains to be explored with questionnaires. In most cases domains are selected by panel of experts. It is not known whether these domains are relevant for the patients. Moreover, questionnaires developed in 'foreign' countries may not be culturally sound or relevant for patients living in different cultural background. In order to explore what really contributes to quality of life of Italian patients, a survey was conducted with the aim of identifying any dimension of quality of life, positively or negatively impacted on from the illness and therapies. A sample of two hundred and eighty eight cancer patients with previously specified characteristics (primary tumor, stage of disease and place of residence) were identified. After consenting to partecipate to the study, a staff member (a physician, a nurse or a psychologist) asked the patient to complete an open-ended questionnaire in the out-patient clinic or at home. This questionnaire, partially derived from a study by Padilla et al. made up of 5 questions: 'What does the term quality of life mean to you?', 'What contributes to a good quality of life?', 'What contributes to a poor or bad quality of life?', 'Which either physical or psychological symptom interferes with your quality of life?', 'State any positive or negative change in your quality of life, due to illness or treatments'. The first question was asked to explore the meaning of quality of life for the patient; the second and third question were asked to determine the contents of quality of life not health related; the fourth question and the diary provided information about quality of life contents related to his own experience of disease. Two hundred and forty eight questionnaires (86.1%) were obtained from 7 Cancer Centres participating to the study (Genova, Milano, Roma, Perugia, Napoli, Cagliari, Palermo). All the questionnaires were transcribed and subsequently broken down in phrases on a form that allowed coding. Three raters (a research nurse, an oncologist and a clinical psychologist) made the content analysis using as conceptual framework the list of domains identified by the Italian Society of Psycho-Oncology. The present study shows the possibility to define the content domain of quality of life attributes for cancer patients, using patients as experts.

Background: Screening for psychological distress in cancer patients is important, considering the high prevalence of psychiatric disorders responsive to treatment. The aim of this study is to test the psychometric properties of the Psychological Distress Inventory (PDI), a 13-item self-administered questionnaire developed to measure psychological distress in cancer patients., Patients and Methods: The PDI was tested in three samples of 434 cancer patients. In the first sample (n = 102) it was administered with the State Trait Anxiety Inventory (STAI) and with the Eysenck Personality Questionnaire (EPQ). Its validity as a screening method for psychiatric disorders was evaluated through a clinical interview in the second sample (n = 107). The third sample (n = 225) provided information on the ability of the PDI to discriminate among patients in different clinical phases of disease and allowed an estimate of the prevalence of psychiatric disorders in these groups of patients., Results: A 0.88 alpha coefficient was obtained in the whole study sample. The correlations with the STAI scales were > 0.70. A positive correlation with neuroticism (r = 0.59) and a negative correlation with extroversion (r = -0.34) was observed. In the second sample, 67 patients (62.6%) received a psychiatric diagnosis according to the ICD-X criteria. The mean PDI scores were significantly lower for the 40 patients with no psychiatric diagnosis (mean 24.5) as compared with the 49 patients with adjustment disorders (mean 36.4) and with the 12 patients with depressive disorders (mean 40.8). The area under curve, estimated through a Receiver-Operating Characteristics analysis, was 0.88. A cut-off of 29 was associated with a 75% sensitivity and a 85% specificity. In the third sample, the lowest PDI scores were in patients with no evidence of disease (mean 24.7, 95% CL 23.0-26.4) as compared to patients undergoing antineoplastic treatment (mean 30.9, 95% CL 28.9-32.9) and to patients under palliative therapy (mean 36.0, 95% CL 34.0-37.9). The estimated prevalence of patients with psychiatric disorders in these three groups were respectively 5.0, 56.6 and 98.8%., Conclusions: Our results suggest that the PDI is a reliable and valid tool for measuring psychological distress in cancer patients and to detect psychiatric disorders through a screening procedure.

Breast reconstruction has become an available option for most patients undergoing mastectomy. In fact, many authors agree that breast reconstruction does not interfere with possible therapies and improves the women's quality of life. The aim of this study was to evaluate the psychological adjustment of patients who had immediate or delayed reconstruction using two different methods: implants and autologous tissues. Specifically, it was explored whether the different methods of breast reconstruction have caused significant changes in psychological functioning. The study population (102 patients) was derived from patients who underwent breast reconstruction in the period January 1988 to December 1991 at the Department of Plastic and Reconstructive Surgery of the National Institute for Cancer Research in Genoa, Italy. Fifty-two patients underwent breast reconstruction using implants and 50 using the transverse rectus abdominis myocutaneous (TRAM) flap. Demographic information was gathered from each patient. The psychological instruments consisted of three standardized self-administered questionnaires: Psychological Distress Inventory, State Trait Anxiety Inventory, Form Y, and the Eysenck Personality Inventory. To better assess the changes in body image after breast reconstruction, three more specific questions about sexual desire, physical image, and social relationships were added. The 102 patients assessed in this study indicated a low incidence of psychological distress. Impairment was reported regarding body image by patients who underwent delayed reconstruction; these patients also showed higher distress scores. The type of breast reconstruction also seems to influence body image, showing in the patients with TRAM flap reconstruction more relevant psychological discomfort.(ABSTRACT TRUNCATED AT 250 WORDS)

Breast reconstruction has become an available option for most patients undergoing mastectomy: in fact many authors agree that breast reconstruction does not interfere with possible therapies and improves the quality of life of women. The aim of the study was to evaluate the psychological adjustment of patients who had immediate or delayed reconstruction using 2 different methods: implants and autologous tissues. The study population (115 patients) was derived from patients who underwent breast reconstruction in the period January 1988-December 1991, in follow-up at the Department of Plastic and Reconstructive Surgery; no patient was undergoing psychological therapy. 58 patients underwent breast reconstruction using implants and 57 using Transverse Rectus Abdominis Myocutaneous Flap (TRAMF). Informations were gathered, including the patient's age, the number of offspring, the marital status, the scholastic education, the job and the relapse between mastectomy and reconstruction. The psychological instruments consisted in three standardized self-administered questionnaires: Psychological Distress Inventory (PDI), State Trait Anxiety Inventory form Y (STAI), Eysenk Personality Inventory (EPQ-R). These tests were chosen to gauge the psychological distress, such anxiety, anger, depression and psychosocial maladjustment. To better perform the changes of body image after breast reconstruction, women were requested to answer three more specific questions about the sexual desire, physical image and social relationships. The 102 patients assessed in this study indicate low incidence of psychological distress and adaptive coping strategies. Impairment was reported, regarding body image, by patients undergoing delayed reconstruction; in these patients higher scores in distress tests were observed.