Risk-Reducing Mastectomy and Reconstruction Following Prophylactic Breast Irradiation: Hope Sustained

Risk-reducing mastectomy (RRM) is often advocated for BRCA1/2 mutation carriers who face a heightened lifetime risk of breast cancer. However, many carrier patients seek alternative risk-reducing measures. In a phase II nonrandomized trial, we previously reported that prophylactic irradiation to the contralateral breast among BRCA carriers undergoing breast-conserving treatment significantly reduced subsequent contralateral breast cancer. Herein, we report the outcome of salvage mastectomy and reconstruction in 11 patients that suffered reoccurrences of breast cancer in either the ipsilateral or contralateral breast or elected to have the procedure for risk reduction during the eight-year follow-up period. Patients’ satisfaction with the procedure and physicians’ assessment of the cosmetic outcome were not inferior for previously irradiated compared to non-irradiated breasts. Although the numbers are small, the results are encouraging and sustain hope in a challenging population. Our findings support continuing research as well as a discussion of risk-reduction alternatives besides mastectomy, including prophylactic breast irradiation, in BRCA1/2 mutation carriers.

Early Insights From a Digitally Enhanced Diabetes Self-Management Education and Support Program: Single-Arm Nonrandomized Trial

Background Translation of diabetes self-management education and support (DSMES) into a digital format can improve access, but few digital programs have demonstrated outcomes using rigorous evaluation metrics. Objective The aim of this study was to evaluate the impact of a digital DSMES program on hemoglobin A1c (HbA1c) for people with type 2 diabetes. Methods A single-arm, nonrandomized trial was performed to evaluate a digital DSMES program that includes remote monitoring and lifestyle change, in addition to comprehensive diabetes education staffed by a diabetes specialist. A sample of 195 participants were recruited using an online research platform (Achievement Studies, Evidation Health Inc). The primary outcome was change in laboratory-tested HbA1c from baseline to 4 months, and secondary outcomes included change in lipids, diabetes distress, and medication adherence. Results At baseline, participants had a mean HbA1c of 8.9% (SD 1.9) and mean BMI of 37.5 kg/m2 (SD 8.3). The average age was 45.1 years (SD 8.9), 70% were women, and 67% were White. At 4-month follow up, the HbA1c decreased by 0.8% (P<.001, 95% CI –1.1 to –0.5) for the total population and decreased by 1.4% (P<.001, 95% CI –1.8 to –0.9) for those with an HbA1c of >9.0% at baseline. Diabetes distress and medication adherence were also significantly improved between baseline and follow up. Conclusions This study provides early evidence that a digitally enhanced DSMES program improves HbA1c and disease self-management outcomes.

A Nonrandomized Trial for Student Teachers of an In-Person and Telepractice Global Voice Prevention and Therapy Model With Estill Voice Training Assessed by the VoiceEvalU8 App

Purpose This study investigated the effects of the in-person and telepractice Global Voice Prevention and Therapy Model (GVPTM) treatment conditions and a control condition with vocally healthy student teachers. Method In this single-blinded, nonrandomized trial, 82 participants completed all aspects of the study. Estill Voice Training was used as the stimulability component of the GVPTM to train multiple new voices meeting all the vocal needs of the student teachers. Outcomes were assessed using acoustic, perceptual, and aerodynamic measures captured by the VoiceEvalU8 app at pre and post in fall and during student teaching in spring. Results Significant improvements were achieved for several acoustic and perceptual measures in the treatment conditions, but not in the control condition. The in-person and telepractice conditions produced similar results. The all-voiced phrase and connected speech were more successful in demonstrating voice change for some of the perturbation measures as compared to sustained /a/. Conclusions The treatment conditions were successful in improving the participants' voices for fundamental frequency and some acoustic perturbation measures while maintaining the improvements during student teaching. In addition, the treatment conditions were successful in decreasing the negative impact of voice-related quality of life and vocal fatigue during student teaching. Future research should address the effectiveness of the various components of the GVPTM, the application of the GVPTM with patients with voice disorders, the relevance of defining auditory–perceptual terms by the anatomy and physiology of the voice production system (i.e., Estill Voice Training), and the continued use of the VoiceEvalU8 app for clinical voice investigations. Supplemental Material https://doi.org/10.23641/asha.13626824

Understanding How Perfectionism Impacts Intensive Interdisciplinary Pain Treatment Outcomes: A Nonrandomized Trial

Objective Several factors are known to impact response to the intensive interdisciplinary pain treatment (IIPT) program described in this study, yet no research has explored the role of perfectionism. This secondary data analysis explored direct and indirect relations between perfectionism and functional disability (primary outcome) and pain severity (secondary outcome) after IIPT, with pain catastrophizing and fear of pain as mediators. Methods Youth (N = 253) aged 8–21 with chronic pain and associated disability completed pre- and post-IIPT measures of self-oriented perfectionism (SOP), socially prescribed perfectionism (SPP), pain catastrophizing, fear of pain, functional disability, and pain characteristics for routine clinical care and this nonrandomized trial. Eight mediated models were run for the two predictors, two mediators, and two outcomes. Results Pretreatment perfectionism (SOP and SPP) led to greater reductions in pain catastrophizing over the course of IIPT, which resulted in lower pain severity (β = −.02 [CI = −0.07, −0.01] for SOP and β = −.02 [CI = −0.06, −0.003] for SPP) and less functional disability (β = −.06 [CI = −0.13, −0.01] for SOP and β = −.06 [CI = −0.14, −0.01] for SPP). Independent of pain catastrophizing, pretreatment SPP was directly associated with more posttreatment functional disability (β = .16 [CI = 0.05, 0.27]). Fear of pain was not a mediator. Conclusions Findings suggest perfectionism has the potential to negatively impact IIPT outcomes. However, when perfectionistic youth with chronic pain learn to manage pain-related distress, they benefit. Results highlight the importance of assessing for and treating perfectionism and pain-related distress in youth with chronic pain.

Triple P for Parents of Children with Phenylketonuria: A Nonrandomized Trial

Objective Families of children with phenylketonuria (PKU) report child emotional and behavioral problems, parenting stress, and parenting difficulties, which are associated with worse health-related quality of life. This study aimed to examine acceptability and feasibility of a brief, group-based parenting program (Healthy Living Triple P) for families of children with PKU. Methods An uncontrolled nonrandomized trial design was used. Families of children aged 2–12 years (N = 17) completed questionnaire measures assessing child behavior and impact of PKU on quality of life (primary outcomes), and parenting behavior, self-efficacy and stress, and children’s behavioral and emotional adjustment (secondary outcomes). Routinely collected blood phenylalanine (Phe) levels were obtained from the treating team. Parents selected two child behaviors as targets for change. The intervention comprised two, 2-hr group sessions delivered face-to-face or online. Assessment was repeated at 4-week postintervention (T2) and 4-month follow-up (T3). Results Attrition was low and parent satisfaction with the intervention (face-to-face and online) was high. All families achieved success with one or both child behavior goals, and 75% of families achieved 100% success with both behavior goals by T3; however, there was no change in health-related quality of life. There were moderate improvements in parent-reported ineffective parenting (total score, d = 0.87, 95% CI −1.01 to 2.75) and laxness (d = 0.59, 95% CI −1.27 to 2.46), but no effects on parenting stress or children’s adjustment. Phe levels improved by 6month post-intervention for children with elevated preintervention levels. Conclusions Results support intervention acceptability and feasibility. A randomized controlled trial is warranted to establish intervention efficacy.

Early Insights From a Digitally Enhanced Diabetes Self-Management Education and Support Program: Single-Arm Nonrandomized Trial (Preprint)

BACKGROUND Translation of diabetes self-management education and support (DSMES) into a digital format can improve access, but few digital programs have demonstrated outcomes using rigorous evaluation metrics. OBJECTIVE The aim of this study was to evaluate the impact of a digital DSMES program on hemoglobin A_1c (HbA_1c) for people with type 2 diabetes. METHODS A single-arm, nonrandomized trial was performed to evaluate a digital DSMES program that includes remote monitoring and lifestyle change, in addition to comprehensive diabetes education staffed by a diabetes specialist. A sample of 195 participants were recruited using an online research platform (Achievement Studies, Evidation Health Inc). The primary outcome was change in laboratory-tested HbA_1c from baseline to 4 months, and secondary outcomes included change in lipids, diabetes distress, and medication adherence. RESULTS At baseline, participants had a mean HbA_1c of 8.9% (SD 1.9) and mean BMI of 37.5 kg/m² (SD 8.3). The average age was 45.1 years (SD 8.9), 70% were women, and 67% were White. At 4-month follow up, the HbA_1c decreased by 0.8% (<i>P</i>&lt;.001, 95% CI –1.1 to –0.5) for the total population and decreased by 1.4% (<i>P</i>&lt;.001, 95% CI –1.8 to –0.9) for those with an HbA_1c of &gt;9.0% at baseline. Diabetes distress and medication adherence were also significantly improved between baseline and follow up. CONCLUSIONS This study provides early evidence that a digitally enhanced DSMES program improves HbA_1c and disease self-management outcomes.