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OBJECTIVE To identify factors associated with referral and enrollment in early intervention (EI) for infants with neonatal abstinence syndrome (NAS). METHODS We conducted a retrospective cohort study of 256 infants born with NAS (2006-2013) at a tertiary care hospital in (Springfield), Massachusetts, linking maternal-infant birth hospitalization records with Department of Public Health EI records. We calculated the percent of infants retained at each step in the EI enrollment process over the first 3 years of life. We conducted separate multivariable logistic regression analyses to identify factors associated with EI referral and enrollment. RESULTS Among mothers, 82% received medication-assisted treatment at delivery, 36% endorsed illicit drug use during pregnancy, and 76% retained custody of their child at discharge. Among infants, 77% were referred to EI and 48% were enrolled in services. Of infants discharged to biological parents, 81% were referred to EI versus 66% of infants discharged to foster care (p ≤ 0.05); this difference persisted in multivariable analysis [adjusted odds ratio, 2.30; 95% confidence interval (CI), 1.09-4.86]. Infants in the highest tertile for length of stay had 2.70 times the odds of EI enrollment (95% CI, 1.37-5.31). CONCLUSION Fewer than half of the eligible infants with NAS were enrolled in EI services. Discharge to a biological parent and longer hospital stay had the strongest associations with EI referral and enrollment, respectively. Efforts to improve EI referral rates during the birth hospitalization, particularly among infants discharged into foster care, and close follow-up for infants with shorter hospital stays would enhance the developmental supports for this vulnerable population.

BACKGROUND: Increasing rates of maternal opioid use disorder has led to greater number of opioid exposed newborns (OENs). Maternal enrollment in medication for opioid use disorder (MOUD) program improves short term neonatal outcomes. This study aimed at assessing neurobehavioral outcomes for OENs. METHODS: Retrospective observational cohort study of OENs between Jul 2006 and Dec 2018. Two study groups were identified as initiation of medication for opioid use disorder (MOUD) prior to diagnoses of pregnancy or after. Primary outcome variables were enrollment in and duration of EI services. Secondary outcome variable was diagnoses of a behavioral and/or developmental disorder (BDD) during the study period. RESULTS: Of 242 infants, 113 were enrolled in EI and BDD diagnoses data was available for all infants [age range 6 to 12 years], 82% infants had exposure to maternal MOUD, while 18% were exposed to either maternal prescription non-MOUD opioids or illicit opioids. Maternal MOUD initiation prior to pregnancy was associated with improved short term outcomes for OENs. Almost a third of infants were diagnosed with a BDD with no differences between the two study groups. CONCLUSION: Early initiation of maternal MOUD improved short term outcomes and discharge disposition for OENs. Prolonged in-utero exposure to opioids presents a potential for negative impact on neurodevelopmental and behavioral outcomes. These risks must be considered to increase access and adherence to EI services, as well as to focus on non-opioid based maternal MOUD. Longitudinal studies assessing the safety of MOUD on short and long-term child health outcomes are needed.

Background Multiple births and first pregnancy are associated with higher preeclampsia risk. It is unknown if the transfer of multiple embryos or first embryo transfer with assisted reproductive technology (ART) is also associated with greater preeclampsia risk. Methods We performed a retrospective cohort study of IVF clinics and hospitals in Massachusetts. We used linked ART surveillance, birth certificate, and maternal hospitalization discharge data for 21,188 births, considering resident singleton (12,810) and twin (8378) live-births from autologous or donor eggs from 2005 to 2012. We used log binomial and Poisson regression to calculate adjusted relative risks (aRRs) and 95% confidence intervals (CI) for the association between preeclampsia and predictors of preeclampsia. Outcomes were stratified by singleton and twin birth, donor versus autologous cycles, and use of fresh versus cryopreserved embryos. Results Considering all singleton births, the transfer of multiple embryos increased the risk of preeclampsia [aRR = 1.10 (95% CI: 1.01–1.19)]. Relative risks were greatest for fresh non-donor cycles [aRR = 1.14 (95% CI: 1.03–1.26)]. Vanishing twin and number of prior ART cycles was not associated with preeclampsia among singleton births [aRR = 1.18 (95% CI: 0.91–1.53)], and aRR = 1.01 (95% CI: 0.96–1.05)], respectively. Considering all twin births, the transfer of > 2 embryos increased the risk of preeclampsia [aRR = 1.09 (95% CI: 1.001–1.19)]. Vanishing triplet and number of prior ART cycles were not associated with preeclampsia among twin births [aRR = 0.93 (95% CI: 0.69–1264), and aRR = 0.98 (CI: 0.95–1.02)], respectively. Conclusions Among ART births, the transfer of more than 1 embryo for singleton gestations and more than 2 embryos for twin gestations increased the risk for preeclampsia diagnosis.

Purpose: Patent ductus arteriosus (PDA) continues to be one of the most common complications associated with preterm birth. Up to 70% of infants born before 28 weeks gestational age may require som...

Peroral endoscopic myotomy (POEM) has become an acceptable incisionless treatment for achalasia based on encouraging outcomes in multiple series worldwide. This report reflects our early experience.Data were collected prospectively on all patients undergoing POEM between June 2011 and April 2016 under IRB approval. Diagnosis of achalasia was confirmed by standard preoperative work-up. Primary outcome was symptom relief, measured by Eckardt score. Secondary outcomes were operative time, length of stay (LOS), adverse events, failure, and recurrence.Fifty patients were included; 30 were female. Mean age was 55.7 ± 17.7 years. Mean BMI was 29.5 ± 9.2. Median OR time was 133.5 minutes (range 70-462); average myotomy was 13.1 ± 2.3 cm. One early case was converted to a laparoscopic Heller myotomy due to extensive submucosal fibrosis from a recent Botox injection. Two cases were aborted; one due to extensive submucosal fibrosis and the other to intraoperative capnopericardium. Median LOS was 1 day (range 0.8-8). Two major complications occurred: intraoperative cardiac arrest due to capnopericardium and postoperative submucosal hemorrhage. There were no deaths. Mean postoperative Eckardt score was 1.0 ± 1.9 (range 0-8) at 2-6 weeks (vs. preoperative score 7.7 ± 2.8; P .0001); mean dysphagia component 0.35 ± 0.28 (vs. preoperative score 2.6 ± 0.7; P .0001). Two recurrences were identified, both at 6 months.POEM is a safe and durable treatment for achalasia in the short term. We demonstrated marked improvement of symptoms in all completed cases. There was an acceptable serious adverse event rate of 4%, failure of 6% due to patient selection, and recurrences occurring in only 4% of cases.

Opioid use disorder is often treated with short term hospitalization and medically supervised withdrawal from opioids followed by counseling alone without medication assisted treatment (MAT). More evidence is needed to confirm the expectation that the rate of relapse would be high after short term inpatient treatment and withdrawal from opioids without follow-up MAT.To examine relapse to opioid use disorder in a randomized, multi-site effectiveness trial of extended-release injection naltrexone (XR-NTX) vs community-based treatment as usual (TAU) without medication, as a function of the type of clinical service where treatment was initiated-short-term inpatient (N=59), long-term inpatient (N=48), or outpatient (N=201). Inpatients typically were admitted to treatment actively using opioids and had completed withdrawal from opioids before study entry. Outpatients typically presented already abstinent for varying periods of time.One month after randomization, relapse rates on TAU by setting were: short-term inpatient: 63%; long term inpatient: 14%; outpatient: 28%. On XR-NTX relapse rates after one month were low (12%) across all three settings. At the end of the 6 month trial, relapse rates on TAU were high across all treatment-initiation settings (short term inpatient 77%; long term inpatient 59%; outpatient 61%), while XR-NTX exerted a modest protective effect against relapse across settings (short term inpatient: 59%; long term inpatient 46%; outpatient 38%).Short term inpatient treatment is associated with a high rate of relapse among patients with opioid use disorder. These findings support the recommendation that medically supervised withdrawal from opioids should be followed by medication assisted treatment.

Background Extended release naltrexone (XR-NTX) injected intramuscularly monthly has been shown to reduce relapse in persons with opioid use disorder. Baseline factors, including patients' demographics, comorbidities and lifestyle, may help identify patients who will benefit most or least from XR-NTX treatment. Methods Potential moderators of XR-NTX's effect were examined in the largest North American randomized open-label effectiveness trial of XR-NTX. Relapse status (Yes/No) at 6-month follow-up was regressed on treatment group (XR-NTX, N=153; or Treatment-as-Usual [TAU], N=155), baseline covariates, and their two-way interaction to identify moderator effects. Baseline covariates included age, gender, summary scores for depression, suicidal thoughts, drug abuse risk, substance use, medical, psychiatric and employment status, socialization, legal and family/social issues, history of abuse and quality of life measures. Results Alcohol use to intoxication in the 30days before randomization was a significant moderator: during the treatment phase, those who reported being recently intoxicated before randomization to XR-NTX relapsed to opioids at a rate (56%) similar to TAU (58%), while those without alcohol intoxication in the prior 30days had a lower rate of opioid relapse (41% vs. 65%, respectively, P Conclusions XR-NTX appeared to work equally well across subgroups with diverse demographic, addiction, mental health and environmental characteristics, with the possible exception of working better among those without recent alcohol intoxication. These findings should be reassuring to practitioners increasingly using XR-NTX as medical addiction therapy in diverse and often vulnerable populations.

Background Opioid use disorders have reached epidemic proportions, with overdose now the leading cause of accidental death in the United States. Extended release naltrexone (XR-NTX) has emerged as a medication treatment that reduces opioid use and craving. However, the effect of XR-NTX therapy on acute healthcare utilization, including emergency department visits and inpatient hospitalizations, remains uncertain. The objective of the current study is to evaluate hospital-based healthcare resource utilization in adults involved in the criminal justice system with a history of opioid use disorder randomized to XR-NTX therapy compared with treatment as usual (TAU) during a 6-month treatment phase and 12months post-treatment follow up. Methods This retrospective exploratory analysis uses data collected in a published randomized trial. Comparisons of the number of emergency department visits and hospital admissions (for drug detox, psychiatric care and other medical reasons) were performed using chi square tests for any admission and negative binomial models for number of admissions. Results Of the 308 participants randomized, 96% had utilization data (76% complete 6months, 67% complete follow up). No significant differences were seen in overall healthcare utilization (IRR=0.88, 95%CI 0.63–1.23, p =0.45), or substance use-related drug detox hospitalizations (IRR=0.83, 95%CI 0.32–2.16, p =0.71). Despite having more participants report chronic medical problems at baseline (43% vs. 32%, p =0.05), those receiving XR-NTX generally experienced equivalent or lower rates of healthcare utilization compared to TAU. The XR-NTX group had significantly lower medical/surgical related hospital admissions (IRR=0.55, 95%CI 0.30–1.00, p =0.05) during the course of the entire study. Conclusions XR-NTX did not significantly increase rates of healthcare utilization compared to TAU. Provider concerns regarding healthcare utilization should not preclude the consideration of XR-NTX as therapy for opioid use disorders.

Peritoneal closure during laparoscopic trans-abdominal preperitoneal (TAPP) inguinal hernia repair has been the standard of care to prevent bowel obstruction due to adhesions generated by contact with mesh. However, with newer coated meshes, leaving the peritoneal layer open may be safe. While many studies compare methods of peritoneal flap closure, there is a deficit of literature reporting the outcomes of non-closure. A retrospective comparison of peritoneal flap closure versus non-closure during primary laparoscopic TAPP inguinal hernia repair with coated mesh was performed for all patients at Baystate Medical Center meeting inclusion criteria between January 2005 and August 2016. Primary outcome was any procedure-related adverse outcome following repair. Secondary outcomes included operative time, resolution of pre-operative pain and/or gastrointestinal symptoms, and hernia recurrence. Of 231 patients, 55 (24%) underwent peritoneal flap closure and 176 (76%) underwent non-closure. Demographic, comorbidity, and hernia characteristics were comparable between groups with the exception of obesity (p = 0.01), current smoking status (p = 0.05) and hernia side [p = 0.04 (left), 0.0003 (right)]. Mean operative time was higher in the closure group than non-closure (98.1 ± 37.1 min vs. 76.8 ± 32.9, p

Background Criminal justice involved (CJS) populations with opioid use disorder (OUD) have high rates of relapse, future arrests, and death upon release. While medication for OUD (MOUD) reduces opioid relapse, concerns regarding diversion and stigma limit treatment in CJS populations. Extended release naltrexone (XR-NTX), as an opioid antagonist, may be more acceptable to CJS administrators. However, the impact of XR-NTX on criminal recidivism remains unknown. Methods Arrest data from a published randomized trial comparing XR-NTX to treatment as usual (TAU) was captured by self-report and official state arrest records. Comparisons of future arrests, time to first arrest and total number of arrests were performed using chi square tests and multivariable generalized regression models. Secondary outcomes explored differences in arrests by type and severity of crime, use of opioid and other drugs, and study phase. Results Of 308 participants randomized, 300 had arrest data. The incidence of arrests did not differ between XR-NTX (47.6%) and TAU (42.5%) participants. (ChiSq p = 0.37). Additionally, there was no significant difference in time to first arrest (adjusted HR 1.35, CI 0.96–1.89) and number of arrests per participant (adjusted IR 1.33, CI 0.78–2.27). Controlling for gender, age, previous criminal activity, and use of non-opioid drugs, logistic regression demonstrated no significant difference in incidence of arrests between groups (adjusted OR 1.38, 95% CI 0.85–2.22). Conclusions We detected no significant difference in arrests between CJS participants with OUD randomized to XR-NTX or TAU. Despite its efficacy in reducing opioid use, XR-NTX alone may be insufficient to reduce criminal recidivism.

Medication-assisted treatment (MAT) is effective for alcohol and opioid use disorders but it is stigmatized and underutilized in criminal justice settings.This study cluster-randomized 20 community corrections sites to determine whether an experimental implementation strategy of training and an organizational linkage intervention improved staff perceptions of MAT and referral intentions more than training alone. The 3-hour training was designed to address deficits in knowledge, perceptions and referral information, and the organizational linkage intervention brought together community corrections and addiction treatment agencies in an interagency strategic planning and implementation process over 12 months.Although training alone was associated with increases in familiarity with pharmacotherapy and knowledge of where to refer clients, the experimental intervention produced significantly greater improvements in functional attitudes (e.g. that MAT is helpful to clients) and referral intentions. Corrections staff demonstrated greater improvements in functional perceptions and intent to refer opioid dependent clients for MAT than did treatment staff.Knowledge, perceptions and information training plus interorganizational strategic planning intervention is an effective means to change attitudes and intent to refer clients for medication assisted treatment in community corrections settings, especially among corrections staff.

Objective To determine whether assisted reproductive technology (ART) cycles involving cryopreserved-warmed embryos are associated with the development of preeclampsia. Design Retrospective cohort study. Setting IVF clinics and hospitals. Patient(s) A total of 15,937 births from ART: 9,417 singleton and 6,520 twin. Intervention(s) We used linked ART surveillance, birth certificate, and maternal hospitalization discharge data, considering resident singleton and twin births from autologous or donor eggs from 2005–2010. Main Outcome Measure(s) We compared the frequency of preeclampsia diagnosis for cryopreserved-warmed versus fresh ET and used multivariable logistic regression to adjust for confounders. Result(s) Among pregnancies conceived with autologous eggs resulting in singletons, preeclampsia was greater after cryopreserved-warmed versus fresh ET (7.51% vs. 4.29%, adjusted odds ratio=2.17 [95% CI 1.67–2.82]). Preeclampsia without and with severe features, preeclampsia with preterm delivery, and chronic hypertension with superimposed preeclampsia were more frequent after cryopreserved-warmed versus fresh ET (3.99% vs. 2.55%; 2.95% vs. 1.41%; 2.76 vs. 1.48%; and 0.95% vs. 0.43%, respectively). Among pregnancies from autologous eggs resulting in twins, the frequency of preeclampsia with severe features (9.26% vs. 5.70%) and preeclampsia with preterm delivery (14.81% vs. 11.74%) was higher after cryopreserved versus fresh transfers. Among donor egg pregnancies, rates of preeclampsia did not differ significantly between cryopreserved-warmed and fresh ET (10.78% vs. 12.13% for singletons and 28.0% vs. 25.15% for twins). Conclusion(s) Among ART pregnancies conceived using autologous eggs resulting in live births, those involving transfer of cryopreserved-warmed embryos, as compared with fresh ETs, had increased risk for preeclampsia with severe features and preeclampsia with preterm delivery.

Extended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited.In this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78.A total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P=0.91). The rates of other prespecified secondary outcome measures--self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration--were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P=0.02).In this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.).

One hundred twelve pregnant women who were diagnosed depressed were randomly assigned to a group who received group Interpersonal Psychotherapy or to a group who received both group Interpersonal Psychotherapy and massage therapy. The group Interpersonal Psychotherapy (one hour sessions) and massage therapy (30 minute sessions) were held once per week for six weeks. The data suggested that the group who received psychotherapy plus massage attended more sessions on average, and a greater percentage of that group completed the six-week program. The group who received both therapies also showed a greater decrease in depression, depressed affect and somatic-vegetative symptom scores on the Center for Epidemiological Studies Depression Scale (CES-D), a greater decrease in anxiety scale (STAI) scores and a greater decrease in cortisol levels. The group therapy process appeared to be effective for both groups as suggested by the increased expression of both positive and negative affect and relatedness during the group therapy sessions. Thus, the data highlight the effectiveness of group Interpersonal Psychotherapy and particularly when combined with massage therapy for reducing prenatal depression.

The risk of thrombosis related to peripherally inserted central catheters (PICCs) is a well-known complication. A study was conducted to compare thrombosis rates associated with the old technique of inserting PICCs by visualizing veins in the antecubital fossa, using anatomical landmarks and palpation versus using ultrasound guidance to locate veins in the upper arm. The findings from data collected on 538 patients included a significant decline in the thrombosis rates, as thrombosis decreased from 9.3% with the palpation method to 1.9% with the ultrasound method, and successful PICC placements by registered nurses increased from 76.9% when using the old method to 98.9% when using ultrasound guidance.

Intensive care unit (ICU) core measures that target the prevention of catheter-related bloodstream infections (CRBSIs) and ventilator-associated pneumonia (VAP) in ventilated ICU patients are underway across the United States. Implementation often requires additional personnel to educate providers and collect the data. We hypothesized that use of our current computerized ICU flowsheet could provide timely, accurate data on ICU core measures without additional personnel dedicated to data capture.In a 10-bed, closed surgical ICU with existing protocols for deep vein thrombosis (DVT) prophylaxis, stress ulcer bleeding prophylaxis (SUP), ventilator weaning parameters, and glucose control, we created a reporting tool that would document daily weaning parameters, head of bed (HOB) at 30 degrees , glucose levels, DVT prophylaxis, and SUP. Our glucose protocol targeted150 mg/dL, with all daily glucose values reported rather than just the morning value. The results from the previous 12 am to 11:59 pm were available to the rounding team at 7 am. We examined compliance at the start and after education of medical staff (March/April for HOB up, DVT, and SUP; May/June for glucose control).During 2005, compliance with all protocols improved. Percent compliance for DVT prophylaxis, SUP, and HOB up rose from as low as 32% at the start of the documentation process to consistently higher than the target level of 95%. Compliance for glucose control increased after intensive education of nursing and physicians with the mean glucose falling from 144 to 122 mg/dL. There was increased nursing workload for checking glucose levels in which the mean number of glucose checks rose from a low of 1.5 per patient to as high as 8.2 per patient per day. CRBSI and VAP rates did not decrease during this period compared with the prior year. Length of stay and mortality were unchanged.Reporting of ICU core measures to treating staff can be done accurately and promptly with a computerized system. Education was effective in improving compliance levels. No additional personnel were required to create reports, capture data, or improve compliance after initial development and testing. Although compliance with core measures met target levels at the end of the year, we did not observe improved outcomes in terms of CRBSI, VAP, mortality, or length of stay.

Individuals who are involved with the death of a person with a terminal illness will often classify the death as either ‘good’ or ‘bad’. Families and health-care practitioners assess many factors when determining their ‘success’ or ‘failure’ in assisting someone in the terminal phase. Palliative care nurses are particularly vulnerable to self-assessments about care of the dying, because death is a daily occurrence. Feelings of failure, unmet expectations and feelings of regret about not being able to prevent a traumatic death may be a source of stress for palliative care nurses and may affect their abilities to function effectively. This article reports the findings of a study involving interviews with 20 palliative care nurses to determine their perceptions of a good and bad death. The study also examined the expectations they hold of themselves and that they believe others hold of them in helping patients to attain a good death. Clinical implications are discussed based on these findings.

In 1992, 82.2% of deaths in Alberta occurred in acute care hospitals or continuing care facilities. This paper outlines the end-of-life care of adult in patients who died that year in four such facilities (n=137). CPR was an infrequent end-of-life treatment modality (2.9%), in stark contrast to the extensive use of other medical technologies. Almost every inpatient (94.2%) died with one or more technologies in continuous operation. Although reasons were infrequently given, the desire to promote patient comfort was the most frequent influence on end-of-life technology use. The findings of this study raise issues for debate and further investigation. Chief among these issues is whether or not medical technologies promote comfort during the dying process.

Introduction. XR-NTX is increasingly considered as a therapeutic option for opioid use disorders in criminal justice settings despite limited evidence for its effectiveness in this population. Methods. A 5-site open-label 24-week randomized effectiveness trial examined whether XR-NTX (6 monthly 380mg IM injections and Medical Management visits) reduced relapse compared with treatment-as-usual (TAU) among criminal justice-involved, opioid dependent participants. Assessments occurred every 2 weeks. The primary outcome of relapse was defined as 5 or more days of self-reported opioid use, or 2 or more self-reported days of opioid use plus a positive urine for opioids in a two week period (i.e. fortnight); missing urines were counted as positive. Results. 308 subjects randomized to XR-NTX (n = 153) and TAU (n = 155) did not differ at baseline; 87% reported lifetime heroin use. 282 of 308 have completed the 24-week treatment phase to date. XR-NTX subjects vs. TAU were less likely to relapse at any point (13% vs. 32%, p < 0.0001), have a lower rate of relapse fortnights (5% vs. 16%, p < 0.0001), and a longer median time-to-relapse (6 vs. 3 fortnights, Hazard Ratio 0.36, p < 0.0002). Conclusion. XR-NTX reduced opioid misuse among criminal justice-involved opioid dependent participants.

Approximately one-third of all home care patients have wound care needs. Home care patients tend to be older and have multiple chronic diseases rendering them at risk for developing wounds and impairing their ability to heal wounds. Enterostomal therapy (ET) nurses have expertise in wound, ostomy, and continence care, and were recently recognized by the Canadian Nurses Association as a specialty practice. We completed a systematic review in order to identify and synthesize evidence about the value of ET nurses in the Canadian home care sector, focusing on wound care. A literature search was conducted, using 9 computerized library databases. Eight articles were identified for review; each was analyzed using qualitative content analysis. Two themes emerged from our analysis: (1) assessing the outcomes of ET nurse involvement in client care and (2) methods for using ET nurses' expertise. Within these themes, the benefits of ET nurses working in home care were identified: (1) a decreased number of visits, (2) reduced wound-healing times, (3) successful healing, (4) reduced cost of wound care, (5) greater support for nurses and families, (6) fewer emergency department visits, (7) fewer hospital readmissions, (8) increased interest in education in wound care among other nurses, and (9) standardized protocols for wound care. Although only 8 studies were located for this review, their findings provide evidence that ET nurses' contributions to wound care are not only positive but also necessary in the home care sector.

Emphasis on hospital mortality as a monitoring tool has raised concerns about the validity of mortality rates as a measure of quality of care. An indepth review of all mortalities at Beth Israel Medical Center was conducted from 1988 through 1993. Clinical issues identified from chart review were referred for departmental physician peer review, and quarterly reports of trends and issues were disseminated to all levels of the institution. Mortality rates declined 21% over the 6 years, from 3.3% to 2.6% of all discharges. Clinical quality issues were identified in less than 3% of all mortalities. The majority of problems were related to delays and appropriateness of treatment (57% of quality issues). The review program identified specific hospital processes for improvement, and, more importantly, created a "watchful concern" about quality-of-care issues throughout the hospital.

23 Background: The informed consent process is used to provide research participants information that includes the purpose and procedures of the research study, risks, benefits, potential alternatives and that participation is voluntary. The goal of informed consent to is to provide this information in language that is understandable to the research participant. The aim of this study is to evaluate whether research participants in adult hematology/oncology clinical trials understand the information presented during the informed consent process. Methods: Patients receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy were eligible to participate in this study. After informed consent was obtained, research participants are given a 14-question test. The questions evaluate whether patients understand the following elements on the informed consent related to their oncology treatment study: The purpose and procedures of the research study, risks, benefits, potential alternatives, research related injury compensation, study contact information, measures used to protect confidentiality, and that participation is voluntary. The possible answers to each question are disagree, unsure, and agree. Results: This study was initiated in June 2012. Eleven patients enrolled on this study within the first month. Participants include those on cooperative group studies, pharmaceutical industry trials and investigator initiated trials. The average length of the informed consent document exceeded 20 pages. An initial analysis of data is planned after the study has been open for six months. Conclusions: Informed consents are becoming increasingly lengthy and complex. Much of the language added is regulatory and legal in nature and used to protect the institutions conducting the research. This study will assess the readability of the informed consent and whether patients participating in oncology research trials understand the essential elements of the informed consent document. The first data analysis will be December 2012.