Simple Interventions for Pediatric Residents' Moral Distress: A Randomized, Controlled Experiment.

BACKGROUND AND OBJECTIVES: Pediatric residents are at high risk for moral distress, knowing the moral or ethically right thing to do but feeling unable to do it, which is associated with poor patient care and burnout. Researchers have proposed numerous interventions to reduce distress, but few (if any) have been supported by experimental evidence. In this study, we used an experimental method to provide proof-of-concept evidence regarding the effect of various simple supports on pediatric residents' reported degree of moral distress. METHODS: We conducted a study of pediatric residents using a split sample experimental design. The questionnaire contained 6 clinical vignettes describing scenarios expected to cause moral distress. For each case, participants were randomly assigned to see 1 of 2 versions that varied only regarding whether they included a supportive statement. After reading each of the 6 cases, participants reported their level of associated moral distress. RESULTS: Two hundred and twenty respondents from 5 residency programs completed the experiment. Cases were perceived to represent common scenarios that cause distress for pediatric residents. The addition of a supportive statement reduced moral distress in 4 of the 6 cases. CONCLUSIONS: In this proof-of-concept study, simple yet effective interventions provided support by offering the resident empathy and shared perspective or responsibility. Interventions that were purely informational were not effective in reducing moral distress.

Validity of self-reported migraine in adolescents and children.

OBJECTIVE: To assess agreement for migraine day between self-report and diagnostic guidelines for children and adolescents using a headache diary. BACKGROUND: Trial guidelines recommend prospective collection of headache features and adoption of migraine day as an outcome measure, but there is no clear consensus on the definition of migraine day. METHODS: This is a secondary analysis of data from two projects-a prospective cohort study validating a pediatric scale of treatment expectancy and a clinical trial of occipital nerve blocks to treat status migrainosus. Participants completed a text message-based diary for 4 or 12 weeks (depending on treatment), and a detailed headache assessment on a random 20% of headache days. Using this assessment, we determined whether a headache day qualified for migraine or probable migraine, based on the International Classification of Headache Disorders, 3rd edition (ICHD-3). RESULTS: Of 122 enrolled children and adolescents, 106 (86.9%) completed ≥1 detailed headache assessment (438 entries). We found moderate agreement between self-reported and ICHD-derived migraine day, with a Cohen's Kappa of 0.50 (positive predictive value [PPV]: 0.66; negative predictive value [NPV]: 0.85; correlation: 0.51). Allowing for ICHD-derived probable migraine significantly increased PPV (0.66 vs. 0.94; 95% CI: 0.57-0.74 vs. 0.90-0.97), but decreased NPV (0.85 vs. 0.293; CI: 0.77-0.90 vs. 0.199-0.40), Cohen's Kappa (0.50 vs. 0.237; CI: 0. 389-0.60 vs. 0.139-0.352), and correlation (r = 0.51 vs. 0.302; CI: 0.41-0.61 vs. 0.192-0.41). Pain severity (OR: 5.7; CI: 2.39-13.8), photophobia (OR: 4.1; CI: 1.02-16.6), and phonophobia (OR: 7.5; CI: 1.95-29.3) were significantly associated with participants' perception of migraine. CONCLUSION: We found only moderate agreement between self-reported and ICHD-derived migraine day, suggesting both measures are not equal but may represent overlapping aspects of migraine as a disease. This highlights the difficulty of applying ICHD criteria to individual attacks. We recommend greater methodological transparency in future research to avoid readers conflating both measures.

Development of a text message-based headache diary in adolescents and children.

BACKGROUND: International guidelines recommend diaries in migraine trials for prospective collection of headache symptoms. Studies in other patient populations suggest higher adherence with electronic diaries instead of pen-and-paper. This study examines the feasibility of a text message-based (texting) diary for children and adolescents with headache. METHODS: This is a secondary analysis of data from a study validating a pediatric scale of treatment expectancy. We developed a Health Insurance Portability and Accountability Act-compliant texting diary collecting headache characteristics, medication use, and disability with 3-5 core daily questions for 4 or 12 weeks depending on headache treatment. Adherence was incentivized. RESULTS: 93 participants consented to the expectancy study. Five participants opted for a paper diary for follow-up. 88 participants chose the texting diary with 28 4-week and 60 12-week participants. Five participants did not complete the enrollment visit. Of those remaining 83, 89% of 4-week and 93% of 12-week participants responded on at least 80% of days. On average, participants fully completed 88% (4-week cohort) and 90% (12-week) of diary entries. CONCLUSIONS: Text messages are a promising method for collecting patient-reported data. Adherence was similar to that reported for paper diaries in other pediatric migraine trials, but time-stamped entries ensure real-time data collection.

Female cancer survivors exposed to alkylating-agent chemotherapy have unique reproductive hormone profiles.

OBJECTIVE: To evaluate reproductive hormone patterns in women exposed to alkylating-agent chemotherapy. DESIGN: Prospective cohort. SETTING: University hospital. PATIENT(S): Normally menstruating mid-reproductive-age women (20-35 years old) who had previously been exposed to alkylating-agent chemotherapy for cancer treatment were compared with two healthy control populations: similarly-aged women and late-reproductive-age women (43-50 years old). INTERVENTION(S): Subjects collected daily urine samples for one cycle. MAIN OUTCOME MEASURE(S): Integrated urinary pregnanediol glucuronide (PDG) and estrone conjugate (E1c) and urinary excretion of gonadotropins (FSH and LH). RESULT(S): Thirty-eight women (13 survivors, 11 same-age control subjects, 14 late-reproductive-age control subjects) provided 1,082 urine samples. Cycle length, luteal phase length, and evidence of luteal activity were similar among the groups. As expected, ovarian reserve was impaired in cancer survivors compared with same-age control subjects but similar between survivors and late-reproductive-age control subjects. In contrast, survivors had total and peak PDG levels that were similar to same-age control subjects and higher than those observed in late-reproductive-age control subjects. Survivors had higher E1c levels than both same-age and late-reproductive-age control subjects. There was no difference in urinary gonadotropins among the groups. CONCLUSION(S): Women exposed to alkylating agents have a unique reproductive hormone milieu that is not solely explained by age or ovarian reserve. The urinary hormone profile observed in survivors appears more similar to same-age control subjects than to late-reproductive-age women with similar ovarian reserve, which may suggest that age plays a more important role than ovarian reserve in the follicular dynamics of survivors.

Antimüllerian hormone and antral follicle count are lower in female cancer survivors and healthy women taking hormonal contraception.

OBJECTIVE: To determine the impact of hormonal contraception (HC) on markers of ovarian reserve, including antimüllerian hormone (AMH) and antral follicle count (AFC). DESIGN: Longitudinal prospective cohort. SETTING: University hospital. PATIENT(S): Young adult female cancer survivors and healthy similar-age women. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Participants were followed annually to determine hormone levels and for transvaginal ultrasound. Subjects who used HC within the preceding 3 months were considered to be exposed. Linear mixed effects models were used to incorporate repeated measures and adjust for potential confounders. RESULT(S): A total of 249 women (126 survivors, 123 control subjects; average age 25.5 years) were followed for an average of 2.1 visits and 2.15 years. After adjusting for confounders, AMH was found to be 21% lower among survivors using HC and 55% lower among control subjects using HC (relative risk [RR] 0.79, 95% confidence interval [CI] 0.68-0.93; and RR 0.45, 95% CI 0.30-0.68; respectively). AFC was 20% lower among survivors and control subjects using HC (RR 0.80, 95% CI 0.69-0.93). When considering an individual subject, AMH was 17%-35% lower when a subject had recently used HC than when she had not (survivors: RR 0.83, 95% CI 0.75-0.93; control subjects: RR 0.65, 95% CI 0.55-0.78), and AFC was 11% lower (RR 0.89, 95% CI 0.82-0.96). Additive HC exposure across multiple visits was not associated with differences in AMH or AFC. CONCLUSION(S): AMH and AFC are significantly lower among women with recent exposure to HC. AMH and AFC should be interpreted with caution when measured in the setting of recent hormone use.

Pregnancy after cancer: results from a prospective cohort study of cancer survivors.

BACKGROUND: Future fertility is an important concern for many cancer survivors. Cancer therapies have been shown to adversely impact reproductive function. However, it is difficult to predict the extent to which reproductive dysfunction will occur. The purpose of this study was to compare measures of ovarian reserve (MOR) and pregnancy rates in young female cancer survivors and similar-aged controls. PROCEDURES: A prospective cohort study was conducted in a university-hospital setting. Participants were followed annually for a mean 25 months to assess reproductive history, the incidence of pregnancy, and MOR (serum follicle-stimulating hormone, luteinizing hormone, estradiol, inhibin B, anti-mullerian hormone (AMH), antral follicle counts and mean ovarian volume). RESULTS: Eighty-four female survivors (average age 26, and 14 years post-treatment) and 98 similar-aged controls that were sexually active with men were included. At baseline, 27/84 survivors and 42/98 controls reported a prior pregnancy. Adjusted models showed that anti-mullerian hormone (AMH) and antral follicle count (AFC) were impaired in survivors with a prior pregnancy compared to controls with a prior pregnancy (P < 0.01, P = 0.03). During follow-up in 56 survivors and 74 controls, 19 pregnancies occurred in survivors and 18 in controls. Comparison of MOR between survivors who became pregnant and controls who became pregnant revealed that AMH and AFC were impaired in survivors (P < 0.05). Compared to survivors who did not become pregnant, survivors who did were older (P < 0.01) and more likely to be cohabitating (P < 0.01), but had similar MOR and exposure to alkylators (P = 0.34). CONCLUSIONS: Survivors achieved pregnancy at a rate similar to controls despite impaired MOR.