BACKGROUND: Practice-Based Research Network (PBRN) studies typically assess the effectiveness of clinical interventions in settings that match real-world conditions. Dental PBRNs have the capacity to amass, identify, and analyze vast amounts of data from patient populations that include diverse racial, ethnic, socio-economic, and geographic backgrounds. These dental studies encompass a broad spectrum of healthcare aspects, including prevention, diagnosis, symptom and disease treatment, quality enhancement, and care coordination.
METHODS: An extensive range of research methodologies can be employed within dental PBRNs to investigate these topics, including randomized controlled trials. Dental PBRNs have evolved from primarily focusing on case observations to leveraging advanced network infrastructure and collaborating across multiple regional and national sites. In addition to producing numerous high-impact peer-reviewed publications, study results have led to improved clinical care. However, PBRNs encounter challenges, such as the sustainability of research capacity (relying heavily on ongoing support from funding agencies), diverse research cultures, and an imperative to design studies that are both feasible and relevant to everyday clinical practice. Recognizing the pivotal role of real-world evidence, it is important to have sustained investment in dental PBRN infrastructure and feasible opportunities for practitioners to participate in network activities nationwide.
CONCLUSIONS: Practice-Based Research Network studies capitalize on an important research context within which to investigate a range of clinical topics that can employ multiple research methodologies. However, sustaining productive networks requires strategic effort, ongoing financial support, and customized organizational skills.

BACKGROUND: Phenylketonuria (PKU) is a rare inborn error of metabolism characterized by impaired catabolism of the amino acid phenylalanine (Phe) into tyrosine. Cross-sectional studies suggest slight alterations in cognitive performance and neural activation in adults with early-treated PKU. The influence of high Phe levels on brain function in adulthood, however, remains insufficiently studied. Therefore, we aimed to explore the effect of a four-week period of oral Phe administration - simulating a controlled discontinuation of Phe restriction and raising Phe to an off-diet scenario - on working memory-related neural activation and cerebral blood flow (CBF).
METHODS: We conducted a randomized, placebo-controlled, double-blind, crossover, non-inferiority trial to assess the effect of a high Phe load on working memory-related neural activation and CBF in early-treated adults with classical PKU. Twenty-seven patients with early-treated classical PKU were included and underwent functional magnetic resonance imaging (fMRI) of the working memory network and arterial spin labeling (ASL) MRI to assess CBF before and after a four-week intervention with Phe and placebo. At each of the four study visits, fMRI working memory task performance (reaction time and accuracy) and plasma Phe, tyrosine, and tryptophan levels were obtained. Additionally, cerebral Phe was determined by 1H-MR spectroscopy.
RESULTS: Plasma Phe and cerebral Phe were significantly increased after the Phe intervention. However, no significant effect of Phe compared to placebo was found on neural activation and CBF. Regarding fMRI task performance, a significant impact of the Phe intervention on 1-back reaction time was observed with slower reaction times following the Phe intervention, whereas 3-back reaction time and accuracy did not differ following the Phe intervention compared to the placebo intervention.
CONCLUSIONS: Results from this present trial simulating a four-week discontinuation of the Phe-restricted diet showed that a high Phe load did not uniformly affect neural markers and cognition in a statistically significant manner. These results further contribute to the discussion on safe Phe levels during adulthood and suggest that a four-week discontinuation of Phe-restricted diet does not demonstrate significant changes in brain function.

UNASSIGNED: The use of prophylactic drainage after laparoscopic cholecystectomy has been a routine practice for many years. However, the debate surrounding using it stems from conflicting evidence regarding its potential benefits and risks.
UNASSIGNED: Patients who underwent laparoscopic cholecystectomy from February 1, 2022, to November 30, 2022, at Aleppo University Hospital were enrolled according to our previously registered protocol (NCT05267860).
UNASSIGNED: This study included 232 patients (117 in the drainage group [DG], and 115 in the non-drainage group [NDG]). There was no statistical difference in the patients\' main characteristics, comorbidities, and laboratory findings. The duration of the surgical operation in NDG (mean = 44.92, SD = 1.85) was shorter than in DG (mean 55.14, SD = 2.14), with (p = 0.039) statistically significant, which indicates that the use of the drainage led to a prolongation of the surgical operation. The total number of complicated cases reached 22 (9.48%) cases (DG = 9 vs. NDG = 13, p = 0.348) as follows: bleeding (n = 1) (DG = 1 vs. NDG = 0; p = 0.320), bile leak with no established bile duct injury (n = 1) (DG = 1 vs. NDG = 0; p = 0.320), wound infection (n = 12) (DG = 4 vs. NDG = 8; p = 0.443), urinary tract infection (n = 3) (DG = 0 vs. NDG = 3; p = 0.079), prolonged shoulder pain (n = 2) (DG = 0 vs. NDG = 2; p = 0.152), and acute pancreatitis (n = 1) (DG = 1 vs. NDG = 0; p = 0.144).
UNASSIGNED: Based on the results of our study, the use of prophylactic drainage was safe, but ineffective, as it did not improve the outcomes statistically significantly or worsen them, which is consistent with previous studies highlighting the need for personalized patient care in this setting.

OBJECTIVE: The aim of the study was to determine the effect of WhatsApp-based BETTER sex counselling on sexual function and sexual quality of life in breast cancer survivors in a randomized control trial.
METHODS: This is a randomized controlled trial in which a total of 90 breast cancer survivors were recruited using convenience sampling and then randomly assigned to two groups of WhatsApp-based BETTER model counselling and routine care. Data collection tools consisted of a demographic questionnaire, the Sexual Quality of Life-Female (SQOL-F) and the Sexual Function Index (FSFI-BC). Participants in the intervention group were given access to the 6-week program. The program consisted of six consultation and assignment packages covering all six steps of the BETTER model. Data were analyzed using SPSS software version 20. Chi-square test, independent samples t-test and repeated measures analysis of variance were used. The significance level (p-value) was considered to be less than 0.05.
RESULTS: In the control group, the mean score of SQL scale changed from 35.16 ± 10.71 to 35.16 ± 12.97 (P > 0.05) and in the intervention group, it significantly increased from 34.76 ± 10.13 to 68.20 ± 20.48 (P < 0.001). Similarly, the comparison of mean of FSF in the control group showed a none-significant change from 58.13 ± 7.11 to 58.35 ± 6.11 (P > 0.05), and in the intervention group, it significantly improved from 59.49 ± 6.10 to 120.73 ± 25.54 (P < 0.001). The results of rANOVA indicated that there was a significant difference in the mean scores of the SQL and SFS between the two groups from pre- to post-intervention, and then over the 1-month follow-up period in the intervention group (p < 0.001). Considering partial eta squared, the effect of the intervention had the highest interaction effect on both variables of the sexual function index (η2 = 0.73) and sexual quality of life (η2 = 0.41).
CONCLUSIONS: The intervention program was a successful model for improving female sexual quality of life and female sexual function in breast cancer survivors.
BACKGROUND: IRCT20210926052601N1, 7-11-2021.

Understanding alignment and gap balancing in Total Knee Arthroplasty (TKA) can be challenging for trainee and experienced orthopedic surgeons. Traditional learning methods may not effectively translate to real-life scenarios. The advent of advanced technologies like robotic surgery and navigation systems has revolutionized intraoperative understanding of gap balancing techniques. This trial aims to investigate the effectiveness of robotic TKA planning software in educating trainees about alignment and ligament balancing. We hypothesize that a single session with the software will significantly enhance trainees\' understanding of these techniques. This UK-based single-center, two-arm, group parallel randomized controlled trial was conducted during a national robotic arthroplasty symposium. It aims to evaluate the effect of robotic knee arthroplasty software training on understanding TKA alignment and gap balancing principles using Multiple Choice Questions (MCQs). The MCQ test was crafted based on established guidelines from a different institution with expert consensus in the field. Our study revealed that baseline knowledge of gap balancing and alignment principles was generally low among all participants. However, the intervention group, which received comprehensive robotic software training, demonstrated a significant improvement in their MCQ scores compared to the control group, which did not undergo the training. In conclusion, our study demonstrates that robotic arthroplasty software training significantly improves the understanding of TKA alignment and balancing principles among orthopedic trainees. Level of Evidence II.

BACKGROUND: Implementing evidence that changes practice in emergency departments (EDs) is notoriously difficult due to well-established barriers including high levels of uncertainty arising from undifferentiated nature of ED patients, resource shortages, workload unpredictability, high staff turnover, and a constantly changing environment. We developed and implemented a behaviour-change informed strategy to mitigate these barriers for a clinical trial to implement the evidence-based emergency nursing framework HIRAID® (History including Infection risk, Red flags, Assessment, Interventions, Diagnostics, communication, and reassessment) to reduce clinical variation, and increase safety and quality of emergency nursing care.
OBJECTIVE: To evaluate the behaviour-change-informed HIRAID® implementation strategy on reach, effectiveness, adoption, quality (dose, fidelity) and maintenance (sustainability).
METHODS: An effectiveness-implementation hybrid design including a step-wedge cluster randomised control trial (SW-cRCT) was used to implement HIRAID® with 1300 + emergency nurses across 29 Australian rural, regional, and metropolitan EDs. Evaluation of our behaviour-change informed strategy was informed by the RE-AIM Scoring Instrument and measured using data from (i) a post HIRAID® implementation emergency nurse survey, (ii) HIRAID® Instructor surveys, and (iii) twelve-week and 6-month documentation audits. Quantitative data were analysed using descriptive statistics to determine the level of each component of RE-AIM achieved. Qualitative data were analysed using content analysis and used to understand the \'how\' and \'why\' of quantitative results.
RESULTS: HIRAID® was implemented in all 29 EDs, with 145 nurses undertaking instructor training and 1123 (82%) completing all four components of provider training at 12 weeks post-implementation. Modifications to the behaviour-change informed strategy were minimal. The strategy was largely used as intended with 100% dose and very high fidelity. We achieved extremely high individual sustainability (95% use of HIRAID® documentation templates) at 6 months and 100% setting sustainability at 3 years.
CONCLUSIONS: The behaviour-change informed strategy for the emergency nursing framework HIRAID® in rural, regional, and metropolitan Australia was highly successful with extremely high reach and adoption, dose, fidelity, individual and setting sustainability across substantially variable clinical contexts.
BACKGROUND: ANZCTR, ACTRN12621001456842 . Registered 25 October 2021.

This study assesses the impact of financial incentives on hygienic latrine ownership by poor/near-poor households in Vietnam. Rural communes were randomly assigned to a control group and three treatment arm groups: (T1) a rebate for households that installed a hygienic latrine; (T2) a financial reward for commune governments if the proportion of hygienic latrines in their commune increased by 30 percentage points; (T3) both a household rebate and a commune reward. We find a strong and positive effect from the household rebate (treatment arms 1 and 3) but an insignificant effect from the commune reward (treatment arm 2) on household ownership of a septic tank latrine. Our analysis provides suggestive evidence that microcredit is a channel through which a rebate encourages the installation of septic tank latrines. We also find that treatment arm 3 increases people\'s knowledge regarding sanitation and the availability of water and soap for handwashing within households.

Acceptance and commitment therapy (ACT) for obsessive-compulsive disorder (OCD) has been found efficacious in randomized clinical trials (RCTs), but the two widely known RCTs were conducted within the United States with predominantly White samples. Research that evaluates treatments like ACT for OCD outside the typical Western cultures is needed. The current scoping review summarizes the key characteristics and findings from 18 RCTs that evaluated ACT for OCD in Iran. These RCTs are largely unknown in the broader scientific literature despite representing the vast majority of ACT for OCD trials, in part because the majority are published in Persian. The preponderance of RCTs treated participants in groups, and most protocols did not include exposure exercises. Of 18 trials, 5 were single sex. Use of selective serotonin reuptake inhibitors (SSRIs) was common with all participants on stable doses at pretreatment in many of the trials. Methodological quality was low to medium. ACT was inconsistent against nontraditional comparison conditions, slightly favorable to empirically validated treatments, and favorable compared with the waitlist and SSRIs. The process of change data indicated that ACT increased the psychological flexibility more than cognitive behavior therapy or SSRIs. These results highlight that findings on ACT for OCD from Western populations replicate and generalize to individuals in Iran. These findings also offer insights gained from studying ACT in Iran and significantly expand the literature based on ACT for OCD that can be integrated into scholarship by all researchers.

OBJECTIVE: Randomized controlled trials (RCTs) are the gold standard for evaluating the comparative efficacy and safety of new cancer therapies. However, enrolling patients in control arms of clinical trials can be challenging for rare cancers, particularly in the context of precision oncology and targeted therapies. External Control Arms (ECAs) are a potential solution to address these challenges in clinical research design. We conducted a scoping review to explore the use of ECAs in oncology.
METHODS: We systematically searched four databases, namely MEDLINE, EMBASE, Web of Science, and Scopus. We screened titles, abstracts, and full texts for eligible articles focusing on patients undergoing therapy for cancer, employing ECAs, and reporting clinical outcomes.
RESULTS: Of the 629 articles screened, 23 were included in this review. The earliest included studies were published in 1996, while most studies were published in the past 5 years. 44% (10/23) of ECAs were employed in blood-related cancer studies. Geographically, 30% (7/23) of studies were conducted in the United States, 22% (5/23) in Japan, and 9% (2/23) in South Korea. The primary data sources used to construct the ECAs involved pooled data from previous trials (35%, 8/23), administrative health databases (17%, 4/23) and electronic medical records (17%, 4/23). While 52% (12/23) of the studies employed methods to align treatment and ECAs characteristics, 48% (11/23) lacked explicit strategies.
CONCLUSIONS: ECAs offer a valuable approach in oncology research, particularly when alternative designs are not feasible. However, careful methodological planning and detailed reporting are essential for meaningful and reliable results.

Mindfulness is a promising health promotion strategy for African Americans, and it is imperative that culturally responsive mindfulness approaches be accessible to this population. One way to address this need is to develop and test if culturally responsive mobile health (mhealth) applications are efficacious in reducing stress-related outcomes in this population. With this goal in mind, we employed a repeated-measures randomized control trial (RCT) across a 12-week intervention period to evaluate if participants in the intervention group outperformed a wait-list control group in reductions in stress, depressive symptoms, anxiety, emotional regulation difficulties as well as in increases in self-compassion, resilience, and mindfulness attitudes and behaviors. Our sample included 170 Black/African American participants who were randomly assigned to either the intervention condition (n = 84) or the wait-list control group (n = 86). Participants in the intervention condition reported more self-compassion, used more mindfulness, and had greater self-efficacy using mindfulness; yet, no other differences were evident. Participants expressed high levels of satisfaction with the app and gave it a positive rating for its relevance to their lives. These findings support the efficacy of a culturally responsive mindfulness mHealth app to enhance self-compassion and increase the use of health-promoting behaviors, like mindfulness, among African Americans. Implications for future research are discussed.