Ambulatory Toxicity Management (AToM) Pilot: results of a pilot study of a pro-active, telephone-based intervention to improve toxicity management during chemotherapy for breast cancer.

BACKGROUND: Chemotherapy is associated with a significant risk of toxicity, which often peaks between ambulatory visits to the cancer centre. Remote symptom management support is a tool to optimize self-management and healthcare utilization, including emergency department visits and hospitalizations (ED+H) during chemotherapy. We performed a single-arm pilot study to evaluate the feasibility, acceptability, and potential impact of a telephone symptom management intervention on healthcare utilization during chemotherapy for early stage breast cancer (EBC). METHODS: Women starting adjuvant or neoadjuvant chemotherapy for EBC at two cancer centres in Ontario, Canada, received standardized, nurse-led calls to assess common toxicities at two time points following each chemotherapy administration. Feasibility outcomes included patient enrollment, retention, RN adherence to delivering calls per the study schedule, and resource use associated with calls; acceptability was evaluated based on patient and provider feedback. Impact on acute care utilization was evaluated post hoc by linking individual patient records to provincial data holdings to examine ED+H patterns among participating patients compared to contemporaneous controls. RESULTS: Between September 2013 and December 2014, 77 women were enrolled (mean age 55 years). Most commonly used regimens were AC-paclitaxel (58%) and FEC-docetaxel (16%); 78% of patients received primary granulocyte colony-stimulating factor prophylaxis. 83.8% of calls were delivered per schedule; mean call duration was 9 min. The intervention was well received by both patients and clinicians. Comparison of ED+H rates among study participants versus controls showed that there were fewer ED visits in intervention patients [incidence rate ratio (IRR) (95% CI) = 0.54 (0.36, 0.81)] but no difference in the rate of hospitalizations [IRR (95% CI) = 1.02 (0.59, 1.77)]. Main implementation challenges included identifying eligible patients, fitting the calls into existing clinical responsibilities, and effective communication to the patient's clinical team. CONCLUSIONS: Telephone-based pro-active toxicity management during chemotherapy is feasible, perceived as valuable by clinicians and patients, and may be associated with lower rates of acute care use. However, attention must be paid to workflow issues for scalability. Larger scale evaluation of this approach is in progress.

The Posttraumatic Stress Disorder Checklist as a screening measure for posttraumatic stress disorder in rehabilitation after burn injuries.

OBJECTIVES: To determine the profile of posttraumatic stress disorder (PTSD) among outpatients with burn injuries referred to psychology in a rehabilitation hospital, and the utility of the Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C) as a screening measure for PTSD. DESIGN: Retrospective psychological chart review. SETTING: Outpatient burn clinic of a rehabilitation hospital. PARTICIPANTS: Outpatients (N=132) with burns referred to psychology between December 1999 and January 2010. INTERVENTIONS: Psychological evaluation and self-report questionnaires measuring PTSD and depression. MAIN OUTCOME MEASURES: The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition to assess clinical diagnosis of disorders, PCL-C to measure PTSD, and the Beck Depression Inventory-II to measure depression. RESULTS: Of 132 outpatients, 127 (96%) had work-related injuries, 116 (88%) were men, and 16 (12%) were women. Mean age ± SD at injury was 39.0±11.1 years. Mean time from injury to assessment was 15.7±42.7 months. Burn etiology included: electrical (46.2%), scald (28.0%), flame (16.7%), chemical (5.3%), and contact (3.8%). Most patients (75%) were diagnosed with PTSD, either clinical (39.4%) or subclinical (35.6%). PTSD (clinical or subclinical) was frequently diagnosed in the following etiology groups: scald (85.7%), flame (77.3%), and electrical (74.6%). There were significant relationships between PTSD and depression (P<.001), and between subclinical PTSD and adjustment disorder (P<.03). PCL-C mean scores ± SD in the clinical and subclinical PTSD groups were 59.7±8.9 and 43.5±15.6, respectively. A PCL-C total score of 50 or higher had a sensitivity of 90% and specificity of 79% for PTSD diagnosis. CONCLUSIONS: There was a high prevalence of PTSD (clinical or subclinical) among outpatients with burns referred to psychology. Prospective screening of psychological symptoms, clinical assessment, and intervention is warranted, especially for patients with work-related burn injuries. Our results suggest that PCL-C is a useful screening measure for PTSD in patients with burns.

Neurocognitive development of children following in-utero exposure to labetalol for maternal hypertension: a cohort study using a prospectively collected database.

OBJECTIVE: To identify the effect of prenatal labetalol exposure on children's long-term neurodevelopment. DESIGN: A cohort study with matched controls using a prospectively collected database. METHODS: Participants were women counseled for hypertension in pregnancy at the Motherisk Program at The Hospital for Sick Children, and The Sunnybrook Health Sciences Centre, Toronto, Canada and their children. Mother-child pairs were divided into groups based on in-utero exposure to labetalol (n = 32), non-teratogenic substances (n = 42), and methyldopa (n = 25). The main outcome measures were children's Full-Scale IQ, Performance IQ and Verbal IQ assessed with the Wechsler Preschool and Primary Scale of Intelligence. RESULTS: There were no statistically significant differences in scores on Full-Scale IQ, Performance IQ, or Verbal IQ between children exposed in utero to labetalol and to non-teratogenic substances (Full-Scale IQ: 109.60 +/- 8.20 vs. 111.90 +/- 11.39, p = 0.647; Performance IQ: 104.80 +/- 8.69 vs. 110.19 +/- 12.91, p = 0.186; Verbal IQ: 112.27 +/- 11.05 vs. 11.21 +/- 11.98, p = 0.922, respectively). Children in the methyldopa group achieved lower scores on measures of Full-Scale IQ and Performance IQ when compared to children exposed to non-teratogenic substances (Full-Scale IQ: 105.24 +/- 12.46 vs. 111.90 +/- 11.39, p = 0.043; Performance IQ: 98.80 +/- 16.16 vs. 110.19 +/- 12.91, p = 0.002, respectively). Linear regression analysis revealed that maternal Full Scale IQ was a significant predictor of children's Full-Scale IQ (p = 0.020, beta = 0.229). Maternal Performance IQ and duration of treatment with methyldopa were significant predictors of children's Performance IQ (p = 0.028, beta = 0.232; p = 0.16, beta = -0.255, respectively). CONCLUSION: In-utero exposure to labetalol does not appear to adversely affect the neurocognitive development of young children. These reassuring results may aid disease management for pregnant women with hypertension.

Long-term neurodevelopment of children exposed to maternal nausea and vomiting of pregnancy and diclectin.

OBJECTIVE: To determine the effects of nausea and vomiting of pregnancy (NVP) and its treatment with diclectin on child neurodevelopment. STUDY DESIGN: An observational cohort study of mother-child pairs ascertained via a pregnancy call-in center was conducted. Three groups of children were studied: 45 with NVP and diclectin, 47 with NVP no diclectin, and 29 with no NVP. Phone calls to mothers during pregnancy and 6 to 9 months after childbirth yielded information on pregnancy, birth, and early child development. Children aged 3 to 7 years received a comprehensive set of psychological tests. Mothers were assessed for IQ and socioeconomic status. RESULTS: All children scored in the normal range for IQ, with the NVP-exposed group scoring higher than the non-exposed group on Performance IQ (P < .02), NEPSY Verbal Fluency (P < .003) and Phonological Processing (P < .004), and McCarthy Numerical Memory (P < .004). Predictors of enhanced results were NVP severity and maternal IQ. CONCLUSIONS: NVP has an enhancing effect on later child outcome. Diclectin does not appear to adversely affect fetal brain development and can be used to control NVP when clinically indicated.

Child neurodevelopmental outcome and maternal occupational exposure to solvents.

BACKGROUND: Many women of reproductive age are employed in industries involving exposure to organic solvents. Animal toxicological studies and human case reports demonstrate that high exposure to solvents causes neurodevelopmental toxicity in exposed offspring. Data from occupationally exposed women and their children are few. OBJECTIVE: To compare the cognitive, language, and motor performance and the behavioral achievements of children whose mothers were exposed occupationally to organic solvents during pregnancy with those of a matched unexposed control group. PARTICIPANTS: Thirty-two pregnant women occupationally exposed to organic solvents were recruited during pregnancy and followed up. Their offspring (age range, 3-9 years) were tested for cognitive functioning (IQ), language, visual-motor functioning, and behavioral functioning and were compared with a matched unexposed control group that was recruited and tested in a similar manner. Examiners were blinded to the exposure status. RESULTS: Mothers occupationally exposed to organic solvents did not differ significantly from matched controls in demographic variables. After controlling for potential confounding because of maternal IQ and maternal education, children exposed in utero to organic solvents obtained lower scores on subtests of intellectual, language, motor, and neurobehavioral functioning. CONCLUSIONS: In utero exposure to organic solvents is associated with poorer performance on some specific subtle measures of neurocognitive function, language, and behavior. Reducing exposure in pregnancy is merited until more refined risk assessment is possible. Further studies that address exposure to specific solvents, dose, and gestational timing of exposure are needed.