The experiences and acceptability of a novel multimodal programme for the management of fibromyalgia: A qualitative service evaluation.

INTRODUCTION: Fibromyalgia guidelines recommend multi-modal, non-pharmacological interventions but there is limited evidence on the optimal programme. The Fibromyalgia Active Management and Exercise programme (FAME) aimed to improve function and quality of life. It consisted of 12 sessions delivered by a multidisciplinary team and incorporated education, exercise, Cognitive Behavioural Therapy and mindfulness approaches. This qualitative service evaluation explored the experience and acceptability of FAME from the perspective of the patients' and healthcare practitioners' (HCP). METHODS: All patients and HCP involved in the first FAME programme were invited to attend either one audio-recorded focus group or an individual semi-structured interview. Topic guides were developed a priori. Data were transcribed verbatim and analysed thematically. RESULTS: Thirteen participants (six HCP (three physiotherapists, two nurses, one psychologist)) and seven patients (mean age 46 (7.5) years, all female,) were enroled. FAME was acceptable to HCP participants but not to all patient participants. Where patient participants understood and anticipated the aims of FAME, the programme was found to be acceptable. Whereas, patient participants who did not fully understand the aims of the programme reported lower acceptability. Three themes were generated: expectations and preparation for FAME, the value of social support, and FAME as a learning opportunity. The themes could be explained by five constructs of the Theoretical Framework of Acceptability. CONCLUSION: FAME was acceptable to HCPs but not to all patient participants. Patient and HCP participants valued social support and regarded this as central to their learning. Further adaptation of FAME is required to optimise acceptability.

Phase II Study of Avelumab in Patients With Mismatch Repair Deficient and Mismatch Repair Proficient Recurrent/Persistent Endometrial Cancer.

PURPOSE: Despite the tissue-agnostic approval of pembrolizumab in mismatch repair deficient (MMRD) solid tumors, important unanswered questions remain about the role of immune checkpoint blockade in mismatch repair-proficient (MMRP) and -deficient endometrial cancer (EC). METHODS: This phase II study evaluated the PD-L1 inhibitor avelumab in two cohorts of patients with EC: (1) MMRD/POLE (polymerase ε) cohort, as defined by immunohistochemical (IHC) loss of expression of one or more mismatch repair (MMR) proteins and/or documented mutation in the exonuclease domain of POLE; and (2) MMRP cohort with normal IHC expression of all MMR proteins. Coprimary end points were objective response (OR) and progression-free survival at 6 months (PFS6). Avelumab 10 mg/kg intravenously was administered every 2 weeks until progression or unacceptable toxicity. RESULTS: Thirty-three patients were enrolled. No patient with POLE-mutated tumor was enrolled in the MMRD cohort, and all MMRP tumors were not POLE-mutated. The MMRP cohort was closed at the first stage because of futility: Only one of 16 patients exhibited both OR and PFS6 responses. The MMRD cohort met the predefined primary end point of four ORs after accrual of only 17 patients; of 15 patients who initiated avelumab, four exhibited OR (one complete response, three partial responses; OR rate, 26.7%; 95% CI, 7.8% to 55.1%) and six (including all four ORs) PFS6 responses (PFS6, 40.0%; 95% CI, 16.3% to 66.7%), four of which are ongoing as of data cutoff date. Responses were observed in the absence of PD-L1 expression. IHC captured all cases of MMRD subsequently determined by polymerase chain reaction or genomically via targeted sequencing. CONCLUSION: Avelumab exhibited promising activity in MMRD EC regardless of PD-L1 status. IHC for MMR assessment is a useful tool for patient selection. The activity of avelumab in MMRP/non-POLE-mutated ECs was low.

Gender differences in fundamental motor skill development in disadvantaged preschoolers from two geographical regions.

This study examined the influence of gender and region on object control (OC) and locomotor skill development. Participants were 275 midwestern African American and 194 southwestern Hispanic preschool children who were disadvantaged. All were evaluated on the Test of Gross MotorDevelopment-2 (Ulrich, 2000). Two, 2 Gender (girls, boys) x 2 Region (midwest, southwest) analyses of variance were conducted on OC and locomotor percentile rank. Both midwestern and southwestern preschoolers were developmentally delayed in locomotor and OC skills (< 30th percentile). There was a significant difference for gender (p < .0001) and Gender x Region interaction (p = .02) for OC skills. Boys outperformed girls in the midwestern and southwestern regions. For locomotor skills, there was a significant difference for region (p < .001), with midwestern preschoolers having better locomotor skills.