Studying outcomes of intensive care unit survivors: measuring exposures and outcomes

Background Measurement of long-term outcomes and the patient and intensive care unit (ICU) factors predicting them present investigators with unique challenges. There is little systematic guidance for measuring these outcomes and exposures within the ICU setting. As a result measurement methods are often variable and noncomparable across studies.Methods We use examples from the critical care literature to describe measurement as it relates to three key elements of clinical studies: subjects, outcomes and exposures, and time. Using this framework we review the principles and challenges of measurement and make recommendations for long-term outcomes research in the field of critical care medicine.Discussion Relevant challenges discussed include: (a) selection bias and heterogeneity of ICU research subjects, (b) appropriate selection and measurement of outcome and exposure variables, and (c) accounting for the effect of time in the exposure-outcome relationship, including measurement of baseline data and time-varying variables.Conclusions Addressing these methodological challenges will advance research aimed at improving the long-term outcomes of ICU survivors.Electronic Supplementary Material Electronic supplementary material to this paper can be obtained by using the Springer Link server located at .This research was supported by National Institutes of Health (ALI SCCOR Grant # P050 HL 73994-01). D.M.N. is supported by Clinician-Scientist Awards from the Canadian Institutes of Health Research and the University of Toronto, and a Detweiler Fellowship from the Royal College of Physicians and Surgeons of Canada.     

Studying outcomes of intensive care unit survivors: the role of the cohort study

Background As research focuses on long-term patient outcomes and the real world effectiveness of intensive care unit (ICU) therapies, the cohort study is increasingly being used in critical care research.Methods Using examples of prior cohort studies in intensive care, we review the key elements of this research design and evaluate its advantages and limitations for critical care research. Furthermore, through a systematic search of the literature we summarize data from 70 prior published cohort studies of medium- and long-term outcomes in adult critical care medicine.Discussion This research demonstrates that the prospective cohort study is a powerful research design that has not been fully leveraged to assess relationships between exposures and long-term outcomes of ICU survivors.Conclusions We make recommendations for the design of future cohort studies to maximize the impact of this research in improving the long-term outcomes of critically ill patients.Electronic Supplementary Material Electronic supplementary material to this paper can be obtained by using the Springer Link server located at .An erratum to this article can be found at This research was supported by National Institutes of Health (ALI SCCOR Grant # P050 HL 73994-01). D.M.N. is supported by Clinician-Scientist Awards from the Canadian Institutes of Health Research and the University of Toronto, and a Detweiler Fellowship from the Royal College of Physicians and Surgeons of Canada.     

The impact of pharmaceutical services in community and ambulatory care settings: evidence and recommendations for future research

OBJECTIVE: To review and evaluate research on pharmaceutical services in community and ambulatory care pharmacy settings, specifically study designs and patient outcome measures, and to provide recommendations to improve future research on pharmaceutical services in community and ambulatory care pharmacy settings. DATA SOURCE: English-language articles were identified by searching MEDLINE (1966-December 1998) and International Pharmaceutical Abstracts (1970-December 1998), using a combination of search terms: pharmacist services, pharmacist interventions, community pharmacy, ambulatory care, primary care, and patient outcomes. Relevant studies were selected based on article abstracts. DATA EXTRACTION: From each relevant study, we extracted the study objectives, sample size, study period, study design, major tasks performed by pharmacists, and economic, clinical, and humanistic outcomes (ECHO). Results were tabulated separately for research on community pharmacy and ambulatory care pharmacy settings. RESULTS: We identified 95 relevant studies. Of these, 21 studies were conducted in community pharmacy settings and 74 in ambulatory care settings. Ten community pharmacy studies used prospective, single group, pretest/posttest, or posttest only designs; seven used prospective two or more group comparison designs; and four used randomized, controlled designs. Nine studies on community pharmacies measured clinical outcomes, two measured humanistic outcomes, and five measured economic outcomes. Four studies measured both clinical and humanistic outcomes and one measured humanistic and economic outcomes. No study measured all three ECHO variables. Twenty-three studies in ambulatory care settings used prospective or retrospective, single group, pretest/posttest or posttest only designs; 21 used prospective or retrospective two-or-more group comparison designs; and 30 used randomized, controlled designs. Thirty-six measured clinical outcomes, five measured humanistic outcomes, and 15 measured economic outcomes. Fifteen studies measured clinical and economic outcomes and three measured clinical and humanistic outcomes. CONCLUSIONS: Only 21 of 95 selected studies were conducted in community pharmacy settings and measured the impact of pharmaceutical services on patient outcomes. Few studies employed adequate research designs to control threats to internal and external validity. In order to obtain a comprehensive and accurate picture of the impact of pharmaceutical services on patient outcomes, an attempt must be made to measure all three ECHO variables while employing adequate research design.     

A multidisciplinary model of care for childhood cancer survivors with complex medical needs.

Long-term survival for children with cancer is often achieved at a considerable cost in terms of medical and psychological sequelae. Although many survivors are well and require only routine follow-up and surveillance, a cohort of survivors require comprehensive management of complex, chronic medical issues by multiple subspecialists. For these survivors, care delivered within the context of an annual visit to a traditional hospital-based late effects clinic or by a primary care physician in the community is often not adequate. A specialized clinic was implemented at The Children's Hospital of Philadelphia that crosses disciplines and provides same-day, same-clinic access to oncology/survivorship, endocrinology, pulmonology, cardiology, nutrition, and psychology. This multidisciplinary approach supports clinical efficiency and fosters seamless patient-centered care both for patients with identified late effects and for those with the highest risk for problems because of intense treatment exposures. The model is described with a focus on clinic structure/process, clinical outcomes, and benefits to survivor, health care provider, and institution. The diverse roles for nursing within this model are highlighted.     

American mistletoe exposures

American mistletoe is generally considered to be extremely toxic. Although there are no data to support this contention, both the lay public and medical professionals often respond very aggressively after ingestion of any portion of this plant. To determine if American mistletoe is deserving of this reputation, the outcomes of 1,754 exposures to this plant were examined. All mistletoe data extracted from the American Association of Poison Control Centers national data collection system for the period of 1985 to 1992 were analyzed according to patient age, gastrointestinal decontamination therapy, patient outcome, and geographic region of the exposure. Pediatric exposures accounted for 92.1% of the cases, and 94.7% of the reported cases were accidental exposures. Of all cases, 99.2% had an outcome associated with no morbidity, and there were no fatalities. Apparently, patient outcome was not influenced by the use of gastrointestinal decontamination techniques—96.2% of treated patients remained asymptomatic versus 96.3% of patients who received no therapy. The accidental ingestion of American mistletoe is not associated with profound toxicity.     

Comparison of pediatric atypical antipsychotic exposures reported to U.S. poison centers

Context: The rise in atypical antipsychotic prescribing increases the risk of pediatric exposures. Published studies in children are limited.

Objective: The objectives are to evaluate national poison center data on atypical antipsychotic exposures in young children and compare toxicity amongst selected agents.

Materials and methods: A retrospective study of U.S. National Poison Data System single substance exposures, from 2005 to 2013, of five atypical antipsychotics in children <6 years old, followed to known outcome was performed. Data were evaluated for reason, clinical effects, management site and outcome.

Results: There were 16,935 exposures included: 5018 aripiprazole, 1735 olanzapine, 3904 quetiapine, 4778 risperidone and 1500 ziprasidone. Median age was two years. Most common reason was unintentional-general (90.6%). Therapeutic error occurred more often with risperidone (19.9%). Clinical effects occurred in 59.4% of aripiprazole, 57.9% of olanzapine, 56.6% of ziprasidone, 40.1% of risperidone, and 29.3% of quetiapine. The most frequent were drowsiness/lethargy (35.6%), tachycardia (6.9%), agitation (4.0%), and ataxia (3.3%). Drowsiness/lethargy occurred most with aripiprazole (47.6%), ziprasidone (46.5%) and olanzapine (45.1%) and least with quetiapine (20.5%) and risperidone (28.6%). Tachycardia and agitation both occurred most often with olanzapine (11.4% and 12.7%, respectively). Management sites were non-health care facility (28.0%), treated/discharged from emergency department (48.9%), admitted – noncritical care (11.4%), critical care (9.5%), and other/unknown (2.2%). Admission was lowest for risperidone (13.9%) and quetiapine (11.9%) and highest for olanzapine (32.9%). Coded outcomes were no effect (53.3%), minor (33.7%), moderate (12.1%), major (0.9%) and no deaths. Moderate/major outcomes occurred most often with ziprasidone (20.5%) and olanzapine (19.0%) and least often with quetiapine (5.3%) and risperidone (10.9%).

Discussion and conclusion: Overall outcomes were favorable, with major toxicity in <1% of exposures. Risperidone and quetiapine exposures resulted in less toxicity. This finding may be attributed to higher frequency of therapeutic errors for risperidone but the reason for less toxicity with quetiapine is unclear.     

Clinical usefulness and feasibility of using Reality Orientation with patients who have dementia in acute care settings

Reality Orientation (RO) was developed as a strategy to assist people with dementia to improve their orientation and everyday function. Although its efficacy has been extensively studied in long-term care facilities, its effectiveness has rarely been examined in acute care settings. The aim of this review was to examine the studies cited in systematic reviews of RO to determine the potential clinical usefulness and the feasibility of using RO in acute care settings. Based on this information, the authors make recommendations for future research in this area. The feasibility of implementing RO in acute care poses challenges because of the short time a patient is in hospital and their ability to participate given their acute medical condition. Although the efficacy and feasibility of using RO in acute care settings have not been sufficiently examined, its potential to improve care should not be ignored. A comprehensive and rigorous study is necessary to investigate the usefulness of RO in the acute care setting and to help establish clinical guidelines for dementia care in the context of acute care nursing.     

Analysis of the relationship between the utilization of physical therapy services and outcomes for patients with acute stroke.

BACKGROUND AND PURPOSE: Little research has been conducted on the outcomes of care for people who have had a stroke. In this study, the relationship between physical therapy utilization and outcomes of care for patients with acute stroke was examined. SUBJECTS: The sample consisted of 6,342 patients treated in US academic health center hospitals in 1996 who survived their inpatient stay and received physical therapy. METHODS: The primary data source was the University HealthSystem Consortium Clinical Data Base. Physical therapy use was assessed by examining physical therapy charges. Outcomes of care were assessed in terms of the total cost of care (ie, whether the cost of care was more costly or less costly than expected, taking into account patient characteristics) and in terms of discharge destination (ie, whether the patient was discharged home or elsewhere). Regression analyses were conducted to examine the relationship between physical therapy use and outcomes. RESULTS: Physical therapy use was directly related to a total cost of care that was less than expected and to an increased probability of discharge home. CONCLUSION AND DISCUSSION: The results of this study provide preliminary evidence to support the use of physical therapy in the acute care of patients with strokes and indicate the need for further study of this topic.     

Asenapine,iloperidone and lurasidone exposures in young children reported to U.S. poison centers

Context: Asenapine, iloperidone and lurasidone are relatively new atypical antipsychotics. There is limited information on toxicity on pediatric exposures to these drugs. The objective of this study was to compare toxicity associated with asenapine, iloperidone and lurasidone exposures in young children.

Methods: A retrospective study of U.S. National Poison Data System from 2010 to 2015 of single substance exposures to asenapine, iloperidone or lurasidone in children <6 years of age that were followed to known outcome was performed.

Results: There were 95 asenapine, 64 iloperidone and 124 lurasidone cases that met inclusion criteria. Reason was exploratory for 96% of cases. Drowsiness/lethargy occurred most frequently with iloperidone (45%) and least often with lurasidone (8%). Two iloperidone cases had respiratory depression. For asenapine, iloperidone and lurasidone, respectively, management sites were on-site non-health care facility (non-HCF) (32%, 16%, 26%), treated/discharged from emergency department (ED) (46%, 47%, 63%), admitted to noncritical care (9%, 14%, 10%) and admitted to critical care (10%, 22%, 2%). Clinical effect duration was 8?h or less for the majority of non-HCF cases (80%) and for children treated/discharged from the ED (72%). For asenapine, iloperidone and lurasidone, coded outcomes were no effect (50%, 41%, 81%), minor effect (43%, 39%, 17%), moderate (6%, 19%, 2%) and major (0, 2%, 0).

Discussion and conclusions: These findings suggest that in children under 6 years of age, lurasidone exposures were least serious and iloperidone exposures were most serious based on clinical effects, management sites and coded outcomes. Observation of symptomatic children in the ED for 8?h should be sufficient to make triage decisions based on persistence or resolution of clinical effects.     

Toxicity and clinical outcomes of paliperidone exposures reported to U.S. Poison Centers

Context. Paliperidone is an atypical antipsychotic that was approved in the U.S. in 2006, and is also available in Canada, Australia, New Zealand, Europe, and Asia. Information regarding paliperidone overdoses is limited to case reports. Serious toxicity has yet to be reported. Objective. To evaluate the toxicity of paliperidone exposures using a national poison center database. Methods. A retrospective, observational case series of single-substance paliperidone cases reported to the National Poison Data System from 2007 to 2012 was conducted. Cases were evaluated for demographics, reason for exposure, clinical effects, treatments, disposition, and coded medical outcomes. For cases with major effects the text fields in poison center charts were evaluated to verify accuracy of coded outcome. The relationship between dose and severity of medical outcome was analyzed for acute exposure cases. Results. There were 801 paliperidone cases that met inclusion criteria that included 592 persons of 13 years or greater, 67 children of 6–12 years, 140 children of less than 6 years, and 2 unknown ages. Most common reasons for exposure included: suicide attempt (39.6%), unintentional general (21.1%), therapeutic error (15.7%), and adverse drug reaction (11.9%). The most commonly observed clinical effects were drowsiness/lethargy (28.7%), tachycardia (23.3%), and dystonia (14.2%). Most patients were managed in the emergency department (40.3%) or were admitted to a health care facility (HCF) (42.7%). In 564 cases treated in a HCF, treatments included activated charcoal (25.7%), antihistamines (21.1%), and benzodiazepines (9.4%). Medical outcomes were no effect (35.0%), minor (30.8%), moderate (33.7%), and major effect (0.5%). There were no deaths. Of 491 acute exposures, dose was coded for 74.3% of exposures. There was a significant difference in the reported median dose between those with no effect (6 mg) and either minor effect (12 mg; p = 0.047) or moderate effect cases (12 mg; p = 0.020) in 91 children less than 6 years. Conclusions. The majority of patients experienced no or minor toxicity and were not admitted for medical care. Although a higher dose was associated with a more serious outcome in children less than 6 years, the data do not provide clear-cut triage guidelines.     

Nurses' experiences of practice and political reform in long-term aged care in Australia: implications for the retention of nursing personnel

AIM: The aim of the study was to explore registered nurses' experiences in long-term aged care in light of the political reform of aged care services in Australia. BACKGROUND: In Australia, the aged care industry has undergone a lengthy period of political and structural reform. Despite reviews into various aspects of these reforms, there has been little consideration of the effect these are having on the practice experiences and retention of nursing staff in long-term care. METHODS: In this critical hermeneutic study, 14 nurses from long-term care facilities in Australia were interviewed about their experiences during the reform period. RESULTS: The data revealed a sense of tension and conflict between nurses' traditional values, roles and responsibilities and those supported by the reforms. Nurses struggled to re-negotiate both their practice roles and values as the reforms were implemented and the system evolved. Nursing management support was an important aspect in mediating the effect of reforms on nursing staff. CONCLUSION: This research highlights both the tensions experienced by nurses in long-term aged care in Australia and the need to re-negotiate nursing roles, responsibilities and values within an evolving care system. This research supports a role for sensitive and proactive nursing management during periods of industry reform as a retention strategy for qualified nursing personnel.     

The PRISMA Symposium 3: lessons from beyond Europe. why invest in research and service development in palliative care? An Australian perspective

Hospice and palliative care services need to be able to compete with finite health care resources. To compete for such funding, the sector needs to continuously improve the evidence base that demonstrates improved outcomes, or else funding will continue to be at the level of a "social good" rather than as services that deliver improved health outcomes. Three questions need to be answered for policy makers and health funders: 1) Why invest health care spending in hospice and palliative care?, 2) Why invest research monies in hospice and palliative care clinical research and health service development?, and 3) How can emerging evidence be more effectively implemented to improve patient outcomes? No single measure captures the net benefit of hospice and palliative care services. By patient-defined parameters, hospice and palliative care services have demonstrated benefits, including physical symptom control. To meet patients' concerns, greater emphasis needs to be placed on maintaining physical independence for a longer period of time. Targeted investment of research funding can deliver further improvements in patient outcomes and models of service delivery. Rigorous studies are feasible and necessary if each patient is going to receive the best possible support. Benchmarking and service development strategies can deliver improved patient outcomes. With routine point-of-care data collection and feedback loops to individual services, patient-valued outcomes and resourcing can be improved in hospice and palliative care. Public-good investments in hospice and palliative care research are vital to building the evidence base for improving the quality of care offered.     

Dollars and sense: the economics and outcomes of patients undergoing carotid endarterectomy at Royal Adelaide Hospital.

This study examined the costs and outcomes of patients undergoing carotid endarterectomy who returned directly to the vascular unit after surgery rather than to the intensive care unit (ICU)/high dependency unit (HDU). The ICU/HDU is for critically ill patients. HDU is the step-down area from the ICU. The nurse-to-patient ratio for these patients is 1:2 and senior medical staff are available 24 hours a day. To prepare staff for the change in practice, an intense educational program was provided and protocols for patient management were developed and implemented. Outcomes were then monitored for the group of patients who returned directly to the vascular unit. Case notes audits, informal patient interviews, daily monitoring of patient outcomes, and an analysis of costing data from Australian Diagnostic Related Groups demonstrated that 50% of patients required transfer to the ICU/HDU after surgery for respiratory, hemodynamic, or neurologic management. The remaining 50% of patients returned directly to the vascular unit with no major complications and had better outcomes with less intensive nursing care overall. The length of hospital stay and the management costs were reduced significantly.     

The Johnson Behavioral Systems Model as a framework for patient outcome evaluation

Background: Although there is a great deal of interest in the outcome of the nursing care of psychiatric patients, there is little empirical research about the effectiveness of nursing care.Methods: This study evaluated the medical record documentation by nurses as an important database (N = 380 patients). The predicted patient outcome instrument developed by the authors was used to collect the data related to patient demographics, acuity, nursing diagnosis, short-and long-term goals, and nursing interventions. The Johnson Behavioral System Model was the nursing conceptual framework used.Findings: Overall, 80% of the predicted patient outcomes were achieved by the time of discharge, with increased length of stay being a factor in increasing the likelihood of achievement of goals. A positive link was found between achievement of outcomes at time of discharge and nursing interventions. A nursing theoretical framework made it possible to prescribe nursing care as a distinction from medical care.Conclusion: This study showed the importance of the nursing database in the medical records and the effectiveness of nursing interventions on predicted patient outcomes achieved by the time of discharge.     

Towards a nursing minimum data set for Ireland: making Irish nursing visible

AIM: The aim of this study was to identify patient problems, nursing interventions and nursing outcomes to be included in a nursing minimum data set for Ireland. BACKGROUND: In 2002, a research programme funded by the Irish Health Research Board, was established to develop and test a nursing minimum data set to capture the nursing contribution to patient care in Ireland. A nursing minimum data set is comprised of the smallest number of information items required to capture the range of patient problems, nursing interventions and nursing outcomes recorded by nurses on a regular basis. Nursing minimum data sets have been developed in several countries for a range of applications such as workforce planning, financing nursing care, examining patient profiles and forecasting trends in nursing diagnoses. METHOD: Eleven focus groups were conducted with 59 registered general nurses to explore their conceptualizations of patient problems, nursing interventions and nursing outcomes. In addition, data relating to nurses' recordings of patient problems, nursing interventions and nursing outcomes were collected from a sample of 45 sets nursing records. The research took place between January 2003 and April 2004. FINDINGS: A range of patient problems, nursing interventions and outcomes were identified that were similar to those found in existing nursing minimum data sets. However, several new items and categories of items were also identified, justifying the empirical approach taken to generate the initial list of items. Data from nursing records supported several points raised in focus groups and also highlighted some inconsistencies between nurses' perceptions and recordings of what they do. CONCLUSION: Our research identified several new types of indirect interventions and managing/organizing activities in addition to items found in existing nursing minimum data sets. The importance of these aspects of the nursing contribution to patient care will be tested further in the development of the Irish nursing minimum data set.     

Human exposures to stinging caterpillar: Lophocampa caryae exposures

The purpose of this project was to characterize the presentation and treatment associated with Lophocampa caryae caterpillar exposures. Three hundred sixty-five exposures to Lophocampa caryae managed by a certified regional poison information center over a 2-year period were analyzed. Pediatric exposures were responsible for 80% of the reports and 92.1% were dermal exposures, 7.5% oral, and 0.4% ocular. Dermal exposures with minimal symptoms were treated at home with the supportive measures of hair and spine removal, irrigation, antihistamine, and/or topical steroid administration. Symptom resolution occurred within 24 hours. Symptomatic patients with oral exposures and positive visualization of hairs or spines, were referred to an emergency department for medical evaluation and removal of the caterpillar hairs. Adult exposure and treatment patterns were similar to the pediatric exposures. Removal of the defensive guard hairs or spines is the primary treatment. Supportive care with irrigation, antihistamines, and/or corticosteroids can decrease the intensity of symptoms.     

The business case for nursing in long-term care

Lower nurse staffing in hospitals has been associated with adverse patient outcomes; results in nursing homes (NHs) are less clear. We examined the association between nurses' direct care time and outcomes in long-stay NH residents and potential cost savings from decreased adverse outcomes versus additional wages for adequate nurse staffing. Data were from the National Pressure Ulcer Long-Term Care Study of 1,376 at-risk residents from 82 NHs. Primary data came from medical records. Hospital, pressure ulcer (PrU) treatment, and urinary tract infection (UTI) costs were from national statistics or cost-identification studies. Time horizon was 1 year. More registered nurse (RN) direct care time/resident/day was associated with fewer PrUs, hospitalizations, and UTIs. Annual net societal benefit was $3,191/resident/year in high-risk NH units with 30-40 min of RN time/resident/day versus units with <10 min. Thus, after controlling for important variables, more RN time/day was strongly associated with better outcomes and lower societal cost.     

The ventilator care bundle and its impact on ventilator-associated pneumonia: a review of the evidence

Aims and objectives: The aim of this review was to critically analyse recent research that has investigated ventilator care bundle (VCB) use, with the objective of analysing its impact on ventilator‐associated pneumonia (VAP) outcomes. Background: The VCB is a group of four evidence‐based procedures, which when clustered together and implemented as an ‘all or nothing’ strategy, may result in substantial clinical outcome improvement. VAP is a nosocomial lung infection associated with endotracheal tube use in ventilated patients. Since the VCB was introduced there have been several studies that have reported significant VAP rate reductions. Search strategy: A comprehensive search for research, published between 2004 and 2009, was conducted using Medline and PubMed. Key words were used to identify English language studies reporting VCB implementation within adult intensive care units (ICU) and associated clinical outcomes. Studies that implemented bundle variations that did not include all four elements were excluded. Conclusions: Because of the limitations of the observational designs used in the studies retrieved, a definitive causal relationship between VCB use and VAP reduction cannot be stated. However, the evidence to date is strongly indicative of a positive association. Several studies reported the use of additional VCB elements. In these cases it is difficult to establish which elements are related to the measured outcomes. Further research is recommended to establish baseline outcome measures using the four‐element VCB, before adding further processes singly, as well as research investigating the effect of audit and feedback on VCB compliance and its effect on clinical outcomes. Relevance to clinical practice: A reduction in VAP is associated with VCB use. The evidence to date, whilst not at the highest experimental level, is at the highest ethically permissible level. In the absence of contradictory research, the current evidence suggests that use of the VCB represents best practice for all eligible adult ventilated patients in ICU.