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BACKGROUND: Chronic neck pain (CNP) is prevalent, and it reduces functional status and quality of life and is associated with deleterious psychological outcomes in affected individuals. Despite the desirability of massage and its demonstrated effectiveness in CNP treatment, multiple accessibility barriers exist. Caregiver-applied massage has demonstrated feasibility in various populations but has not been examined in Veterans with CNP or compared in parallel to therapist-delivered massage.OBJECTIVE: This manuscript described the original study design, lessons learned, and resultant design modifications for the Trial Outcomes for Massage: Care Ally-Assisted Versus Therapist-Treated (TOMCATT) study.METHODS: TOMCATT began as a 3-arm, randomized controlled trial of 2 massage delivery approaches for Veterans with CNP with measures collected at baseline, 1 and 3 months after intervention, and 6 months (follow-up). Arm I, care ally-assisted massage, consisted of an in-person, 3.5-hour training workshop, an instructional DVD, a printed treatment manual, and three 30-minute at-home care ally-assisted massage sessions weekly for 3 months. Arm II, therapist-treated massage, consisted of two 60-minute sessions tailored to individual pain experiences and treatments per week for 3 months. The treatments followed a standardized Swedish massage approach. Arm III consisted of wait-list control.RESULTS: Retention and engagement challenges in the first 30 months were significant in the care ally-assisted massage study arm (63% attrition between randomization and treatment initiation) and prompted modification to a 2-arm trial, that is, removing arm I.CONCLUSIONS: The modified TOMCATT study successfully launched and exceeded recruitment goals 2.5 months before the necessary COVID-19 pause and is expected to be completed by early 2023.TRIAL REGISTRATION: ClinicalTrials.gov NCT03100539; https://clinicaltrials.gov/ct2/show/NCT03100539.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DE

BACKGROUND: Chronic neck pain (CNP) is prevalent, and it reduces functional status and quality of life and is associated with deleterious psychological outcomes in affected individuals. Despite the desirability of massage and its demonstrated effectiveness in CNP treatment, multiple accessibility barriers exist. Caregiver-applied massage has demonstrated feasibility in various populations but has not been examined in Veterans with CNP or compared in parallel to therapist-delivered massage.OBJECTIVE: This manuscript described the original study design, lessons learned, and resultant design modifications for the Trial Outcomes for Massage: Care Ally-Assisted Versus Therapist-Treated (TOMCATT) study.METHODS: TOMCATT began as a 3-arm, randomized controlled trial of 2 massage delivery approaches for Veterans with CNP with measures collected at baseline, 1 and 3 months after intervention, and 6 months (follow-up). Arm I, care ally-assisted massage, consisted of an in-person, 3.5-hour training workshop, an instructional DVD, a printed treatment manual, and three 30-minute at-home care ally-assisted massage sessions weekly for 3 months. Arm II, therapist-treated massage, consisted of two 60-minute sessions tailored to individual pain experiences and treatments per week for 3 months. The treatments followed a standardized Swedish massage approach. Arm III consisted of wait-list control.RESULTS: Retention and engagement challenges in the first 30 months were significant in the care ally-assisted massage study arm (63% attrition between randomization and treatment initiation) and prompted modification to a 2-arm trial, that is, removing arm I.CONCLUSIONS: The modified TOMCATT study successfully launched and exceeded recruitment goals 2.5 months before the necessary COVID-19 pause and is expected to be completed by early 2023.TRIAL REGISTRATION: ClinicalTrials.gov NCT03100539; https://clinicaltrials.gov/ct2/show/NCT03100539.INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DE

BACKGROUND: The goal of this study was to identify clinical features associated with abnormal infant pulmonary function tests (iPFTs), specifically functional residual capacity (FRC), in infants with cystic fibrosis (CF) diagnosed via newborn screen (NBS). We hypothesized that poor nutritional status in the first 6-12 months would be associated with increased FRC at 12-24 months. METHODS: This study utilized a combination of retrospectively and prospectively collected data from ongoing research studies and iPFTs performed for clinical indications. Demographic and clinical features were obtained from the electronic medical record. Forced expiratory flows and volumes were obtained using the raised volume rapid thoracoabdominal technique (RVRTC) and FRC was measured via plethysmography. RESULTS: A total of 45 CF NBS infants had iPFTs performed between 12 and 24 months. Mean forced vital capacity, forced expiratory volume in 0.5 s, and forced expiratory flows were all within normal limits. In contrast, the mean FRC z-score was 2.18 (95% confidence interval [CI] = 1.48, 2.88) and the mean respiratory rate (RR) z-score was 1.42 (95% CI = 0.95, 1.89). There was no significant association between poor nutritional status and abnormal lung function. However, there was a significant association between higher RR and increased FRC, and a RR cutoff of 36 breaths/min resulted in 92% sensitivity to detect hyperinflation with 32% specificity. CONCLUSION: These results suggest that FRC is a more sensitive measure of early CF lung disease than RVRTC measurements and that RR may be a simple, noninvasive clinical marker to identify CF NBS infants with hyperinflation.

BACKGROUND: Viral infections contribute to morbidity in cystic fibrosis (CF), but the impact of respiratory viruses on the development of airway disease is poorly understood. METHODS: Infants with CF identified by newborn screening were enrolled prior to 4 months of age to participate in a prospective observational study at 4 centers. Clinical data were collected at clinic visits and weekly phone calls. Multiplex PCR assays were performed on nasopharyngeal swabs to detect respiratory viruses during routine visits and when symptomatic. Participants underwent bronchoscopy with bronchoalveolar lavage (BAL) and a subset underwent pulmonary function testing. We present findings through 8.5 months of life. RESULTS: Seventy infants were enrolled, mean age 3.1 ± 0.8 months. Rhinovirus was the most prevalent virus (66%), followed by parainfluenza (19%), and coronavirus (16%). Participants had a median of 1.5 viral positive swabs (range 0-10). Past viral infection was associated with elevated neutrophil concentrations and bacterial isolates in BAL fluid, including recovery of classic CF bacterial pathogens. When antibiotics were prescribed for respiratory-related indications, viruses were identified in 52% of those instances. CONCLUSIONS: Early viral infections were associated with greater neutrophilic inflammation and bacterial pathogens. Early viral infections appear to contribute to initiation of lower airway inflammation in infants with CF. Antibiotics were commonly prescribed in the setting of a viral infection. Future investigations examining longitudinal relationships between viral infections, airway microbiome, and antibiotic use will allow us to elucidate the interplay between these factors in young children with CF.