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Biomedical subjects

Michelle White

Publications and source records attributed to Michelle White.

8 recordsLinked to original sources

Cognitive Behavior vs Bright Light Therapy for Insomnia in Women Undergoing Chemotherapy for Breast Cancer: A Randomized Clinical Trial.

IMPORTANCE: Women receiving chemotherapy for breast cancer experience insomnia and fatigue, which impair quality of life. To date, no randomized clinical trial (RCT) has evaluated the use of cognitive behavior therapy for insomnia (CBT-I) and bright light therapy (BLT) both alone and in combination, and few have evaluated the use of either during chemotherapy. OBJECTIVE: To determine the main effects of CBT-I and BLT on insomnia and fatigue symptoms in women undergoing chemotherapy for breast cancer. DESIGN, SETTING, AND PARTICIPANTS: Sleep, Cancer, Rest (SleepCARE) was a 6-week, 2 × 2 factorial, superiority, parallel RCT conducted at 5 metropolitan and regional hospitals in Australia from January 22, 2021, to August 21, 2024. Participants were women (aged ≥18 years) receiving chemotherapy for early or metastatic breast cancer. INTERVENTIONS: Two brief interventions were administered: CBT-I and BLT alone (using light glasses at 1500 lux) and in combination, creating 4 groups (CBT-I alone, BLT alone, CBT-I plus BLT, and sleep hygiene education [SHE]). All interventions included SHE. The interventions lasted 6 weeks and included a 1:1 consultation session, emails sent once or twice per week, and a midpoint call for all groups, as well as light glasses for the BLT groups. MAIN OUTCOMES AND MEASURES: Dual primary outcomes were Insomnia Severity Index (ISI) scores and Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue T scores. Both are patient-reported outcome measures and measure insomnia and fatigue symptoms, respectively. Assessments occurred via surveys administered at baseline and at the midpoint (3 weeks), postintervention (6 weeks), and follow-up (3 months and 6 months) periods. Modified intention-to-treat analyses used latent growth models. RESULTS: Of the 219 women enrolled (mean [SD] age, 50.7 [10.8] years; 54 [26.9%] with metastatic cancer), 55 were randomized to CBT-I, 55 to BLT, 52 to CBT-I plus BLT, and 57 to SHE. A total of 208 women (95.0%) with any data at any time point were analyzed. Insomnia symptoms (ISI score mean difference [MD], -2.19 [95% CI, -3.33 to -1.05] points; P = .002) but not fatigue symptoms (PROMIS-Fatigue score MD, -0.90 [95% CI, -3.08 to 1.28] points; P = .52) improved more in the CBT-I groups compared with the non-CBT-I groups. The BLT groups (compared with the non-BLT groups) did not differ in insomnia symptoms (ISI score MD, -0.88 [95% CI, -2.02 to 0.26] points; P = .26) or fatigue symptoms (PROMIS-Fatigue score MD, -0.71 [95% CI, -2.89 to 1.47] points; P = .52). Comparable results emerged in the high-adherence subgroup and in the subgroups with high initial insomnia and fatigue symptoms. However, exploratory subgroup analyses in women with metastatic breast cancer showed that BLT (vs non-BLT) improved insomnia symptoms (ISI score MD, -2.87 [95% CI, -5.06 to -0.67] points; P = .01) and fatigue symptoms (PROMIS-Fatigue score MD, -5.16 [95% CI, -9.57 to -0.76] points; P = .02). CONCLUSIONS AND RELEVANCE: In the SleepCARE RCT of CBT-I and BLT administered for 6 weeks to women receiving chemotherapy for breast cancer, CBT-I improved insomnia but not fatigue compared with SHE or BLT. BLT did not produce greater improvements in fatigue or insomnia symptoms compared with non-BLT treatment. The study findings indicate that brief CBT-I, but not BLT, may reduce insomnia symptoms among women receiving chemotherapy for breast cancer. TRIAL REGISTRATION: ANZCTR Identifier: ACTRN12620001133921.

Humans↗

Neoadjuvant palbociclib in women with operable, hormone receptor-positive breast cancer.

The addition of a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor to endocrine therapy augments biological response in breast cancer. This phase III randomized, double-blind study evaluated the efficacy of adding palbociclib to neoadjuvant endocrine therapy (NET) for operable, hormone receptor-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Patients randomly received 16 weeks of endocrine therapy (letrozole for postmenopausal and tamoxifen plus ovarian function suppression for pre-/perimenopausal patients) plus palbociclib or placebo. The co-primary endpoints included preoperative endocrine prognostic index (PEPI) score and EndoPredict (EPclin) risk score according to the gatekeeping procedure. Of 141 randomized patients, 130 completed the treatment with surgical samples evaluable for endpoints in 126 patients. The proportion of patients with a low, moderate, and high PEPI score was 15.2, 50.0, and 34.8% in the palbociclib arm and 13.3, 55.0, and 31.7% in the placebo arm, respectively, with no statistical difference (one-sided P = 0.563). Statistical analysis was not performed on EPclin risk score. No new safety signals were reported. Permanent treatment discontinuation by adverse events was reported for seven (9.7%) and zero patients in the palbociclib and placebo arms, respectively. In conclusion, the addition of palbociclib to NET did not improve the efficacy. ClinicalTrials.gov NCT03969121.

Humans↗

Pain management in fulminating ulcerative colitis.

BACKGROUND: Toxic megacolon is a life-threatening complication of ulcerative colitis (UC) characterized by systemic toxicity, loss of blood per rectum and severe pain. Pain management is challenging in these patients because nonsteroidal anti-inflammatory drugs may exacerbate bleeding and opioids are contraindicated because they adversely affect bowel peristalsis causing an increased risk of colonic perforation. METHODS: We describe three episodes of fulminating UC in two children in whom ketamine analgesia was used. Our protocol for a low-dose continuous ketamine infusion with either nurse-controlled analgesia (NCA) or patient-controlled analgesia (PCA) bolus administration is presented and a review of the literature regarding the use of ketamine analgesia in children is discussed. RESULTS: Low-dose ketamine N/PCA with a continuous background infusion provided satisfactory analgesia and none of our children reported adverse effects. CONCLUSIONS: We have demonstrated the safe and effective use of ketamine analgesia in children with toxic megacolon, a condition in which the child is in severe pain and morphine is contraindicated.

Analgesia, Patient-Controlled↗

Outcome of critically ill children before and after the establishment of a pediatric retrieval service as a component of a national strategy for pediatric intensive care.

OBJECTIVE: To compare outcomes of critically ill children transferred for intensive care by specialist and nonspecialist retrieval before and after the establishment of a dedicated pediatric intensive care transfer service. DESIGN: Prospective, observational study. SETTING: All hospitals that admitted children in a defined geographic region of the United Kingdom. PATIENTS: There were a total of 284 critically ill children (<16 yrs old) transferred from a district general hospital to a tertiary pediatric intensive care unit. MEASUREMENTS AND MAIN RESULTS: Age, diagnosis, Pediatric Risk of Mortality score, Therapeutic Intervention Scoring System, details of interhospital transfer, and survival to hospital discharge were analyzed for two periods, before and after the establishment of a regional transfer service. Patients were categorized as low or high risk (predicted mortality, </=15% or >15%, respectively). Standardized mortality was calculated as the ratio of observed to predicted deaths in each category. After the transfer service was established, a significantly higher proportion of high-risk children were transferred by a specialist team, and there was a decreased standardized mortality rate of transferred patients (1.09 to 0.74). The greatest decrease in standardized mortality rate occurred in low-risk children transferred by nonspecialist teams (2.27 to 0.52). During the equivalent period in the same geographic region, standardized mortality rate of nontransferred children also fell in pediatric intensive care (1.59 to 0.60) and general intensive care units (1.11 to 0.81). CONCLUSIONS: We conclude that the establishment of a regional transfer service coincided with a fall in standardized mortality that reflected more general changes in intensive care performance rather than a specific benefit of a specialist transfer team.

Journal Article↗

Talk and task mastery: the importance of socially shared talk during computer-based problem solving.

In order to examine more closely the ways that children use socially constructed dialogue to mediate task mastery a hierarchical set of computer tasks were presented in an animated game format (ToonTalk) to three adult/child (US Kindergarten) dyads over five sessions. Transcriptions of the adult-child talk were used to determine (1) the types of discourses utilized by the children (i.e., procedural, conversation, narrative) during problem solving and (2) the relationship of this talk to task mastery. It was found that (1) shared talk was associated with more successful problem solving; (2) socially shared talk did not have to be on task to be beneficial; and (3) procedural discourse was more successfully and frequently used for independent problem solving if first requested by the child. These results highlight the importance of socially shared talk in the development of problem solving strategies even when using computer technology.

Adult↗

Issues in assessing satisfaction: findings of the arkansas medicaid family planning demonstration waiver evaluation.

Arkansas was one of the first states to expand family planning services under its state Medicaid plan through a Section 1115 Demonstration Waiver. In addition to an assessment of other outcome measures, evaluators used exit interviews, which had been designed to reduce courtesy bias, to assess client satisfaction with family planning services available under the waiver in public health units. Client satisfaction with family planning services can serve as a simple measure of one dimension of perceived quality of care. Findings indicate overall client satisfaction with family planning services. However, noted methodological issues may limit the generalizability of these findings. Potential corrective measures are suggested for improving client satisfaction with family planning services and for increasing the utility of survey instrument utilized in this effort.

Adolescent↗