Rural communities make up 19% of the US population, yet are underrepresented in clinical trials. Community engagement methods can facilitate collaboration and trust with local healthcare personnel to enhance enrollment. The purpose of this manuscript is to describe community engagement methods and their impact on enrollment in a pragmatic clinical trial.

We describe a variety of methods used in the Fibromyalgia TENS in Physical Therapy Study (FM-TIPS) to enhance enrollment in rural communities and low-enrolling clinics. Community engagement methods were implemented partway through the trial for selected groups: Targeted Rural (TR) (n = 10), Targeted Low Enrolling (TLE) (n = 6), and compared to Untargeted Groups (UT) (n = 13). The impact of these methods on inquiries, screening, and enrollment were evaluated by comparing actual enrollment to projected enrollment.

We trained and employed community engagement coordinators to implement strategies in TR and TLE physical therapy clinics. These included, posting flyers, community events, physician outreach, social media ads, and direct mailing. These methods increased study inquiries, screening and enrollment in the study. Specifically, when compared to projected values there were increases in enrollment for both the TR and the TLE groups, but not the UT group. Of those that passed screening 99% of rural and 32% of urban residents enrolled in the study.

A multi-pronged and individualized community engagement approach can increase enrollment of rural residents in clinical trials. Building strong relationships and partnering with community clinics and local communities is essential to success.

We assessed patient experience of care, comparing current and past smokers, and whether frequency of advice to quit smoking impacts patient rating of care.

Experience of care may be a concern for people who smoke and affect their partnership with healthcare providers.

We surveyed adults aged over 35 years who had visited a general practitioner (GP) for health care in the past year (n = 611 current and n = 275 ex-smokers). Questions assessed smoking history, experience of care, anticipation of stigma, and perceptions of smoking cessation advice received in general practice.

Fewer than half (48.8%) of current smokers reported ‘always’ or ‘usually’ being advised to quit smoking, or being advised in a way that motivated them to quit by a GP or other care provider at their GP practice. Current smokers tended to delay or avoid help seeking when needed and experienced more anticipation of stigma in healthcare settings. Conversely, respondents who reported being advised to quit more frequently rated overall quality of care more highly. These data show that asking about smoking and providing advice to quit smoking was acceptable to most respondents and associated with higher ratings of quality of care. However, advice should be provided in a way that motivates patients, without exacerbating the stigma associated with smoking, which may impact help seeking.

Having a relapse of schizophrenia or recurrent psychosis is feared by patients, can cause social and personal disruption and has been suggested to cause long-term deterioration, possibly because of a toxic biological process.

To assess whether relapse affected the social and clinical outcomes of people enrolled in a 24-month randomised controlled trial of antipsychotic medication dose reduction versus maintenance treatment.

The trial involved participants with a diagnosis of schizophrenia or recurrent, non-affective psychosis. Relapse was defined as admission to hospital or significant deterioration (assessed by a blinded end-point committee). We analysed the relationship between relapse during the trial and social functioning, quality of life, symptom scores (Positive and Negative Syndrome Scale) and rates of being in employment, education or training at 24-month follow-up. We also analysed changes in these measures during the trial among those who relapsed and those who did not. Sensitivity analyses were conducted examining the effects of ‘severe’ relapse (i.e. admission to hospital).

During the course of the trial, 82 out of 253 participants relapsed. There was no evidence for a difference between those who relapsed and those who did not on changes in social functioning, quality of life, symptom scores or overall employment rates between baseline and 24-month follow-up. Those who relapsed showed no change in their social functioning or quality of life, and a slight improvement in symptoms compared to baseline. They were more likely than those who did not relapse to have had a change in their employment status (mostly moving out of employment, education or training), although numbers changing status were small. Sensitivity analyses showed the same results for those who experienced a ‘severe’ relapse.

Our data provide little evidence that relapse has a detrimental effect in the long term in people with schizophrenia and recurrent psychosis.

To quantify the impact of patient- and unit-level risk adjustment on infant hospital-onset bacteremia (HOB) standardized infection ratio (SIR) ranking.

A retrospective, multicenter cohort study.

Infants admitted to 284 neonatal intensive care units (NICUs) in the United States between 2016 and 2021.

Expected HOB rates and SIRs were calculated using four adjustment strategies: birthweight (model 1), birthweight and postnatal age (model 2), birthweight and NICU complexity (model 3), and birthweight, postnatal age, and NICU complexity (model 4). Sites were ranked according to the unadjusted HOB rate, and these rankings were compared to rankings based on the four adjusted SIR models.

Compared to unadjusted HOB rate ranking (smallest to largest), the number and proportion of NICUs that left the fourth quartile (worst-performing) following adjustments were as follows: adjusted for birthweight (16, 22.5%), birthweight and postnatal age (19, 26.8%), birthweight and NICU complexity (22, 31.0%), birthweight, postnatal age and NICU complexity (23, 32.4%). Comparing NICUs that moved into the better-performing quartiles after birthweight adjustment to those that remained in the better-performing quartiles regardless of adjustment, the median percentage of low birthweight infants was 17.1% (Interquartile Range (IQR): 15.8, 19.2) vs 8.7% (IQR: 4.8, 12.6); and the median percentage of infants who died was 2.2% (IQR: 1.8, 3.1) vs 0.5% (IQR: 0.01, 12.0), respectively.

Adjusting for patient and unit-level complexity moved one-third of NICUs in the worst-performing quartile into a better-performing quartile. Risk adjustment may allow for a more accurate comparison across units with varying levels of patient acuity and complexity.

To evaluate the motor proficiency, identify risk factors for abnormal motor scores, and examine the relationship between motor proficiency and health-related quality of life in school-aged patients with CHD.

Patients ≥ 4 years old referred to the cardiac neurodevelopmental program between June 2017 and April 2020 were included. Motor skills were evaluated by therapist-administered Bruininks-Oseretsky Test of Motor Proficiency Second-Edition Short Form and parent-reported Adaptive Behavior Assessment System and Patient-Reported Outcomes Measurement Inventory System Physical Functioning questionnaires. Neuropsychological status and health-related quality of life were assessed using a battery of validated questionnaires. Demographic, clinical, and educational variables were collected from electronic medical records. General linear modelling was used for multivariable analysis.

The median motor proficiency score was the 10th percentile, and the cohort (n = 272; mean age: 9.1 years) scored well below normative values on all administered neuropsychological questionnaires. In the final multivariable model, worse motor proficiency score was associated with family income, presence of a genetic syndrome, developmental delay recognised in infancy, abnormal neuroimaging, history of heart transplant, and executive dysfunction, and presence of an individualised education plan (p < 0.03 for all predictors). Worse motor proficiency correlated with reduced health-related quality of life. Parent-reported adaptive behaviour (p < 0.001) and physical functioning (p < 0.001) had a strong association with motor proficiency scores.

This study highlights the need for continued motor screening for school-aged patients with CHD. Clinical factors, neuropsychological screening results, and health-related quality of life were associated with worse motor proficiency.