Prospective comparison between a peristaltic pump and vacuum containers for paracentesis: Time, resources and safety.

RATIONALE AND OBJECTIVES: To meet the increasing demand for radiology departments to perform paracenteses, this study was done to compare the operational, financial and clinical impact of draining ascites with a peristaltic pump versus conventional vacuum containers. MATERIALS & METHODS: Prospective cohort study of 157 paracenteses (56 subjects) drained with ACCEL® evacuated drainage bottles (B. Braun Interventional Systems, Bethlehem, PA) and 159 paracenteses (53 subjects) drained with the RenovaRP® pump (Laborie Medical Technologies Corp., Portsmouth, NH). A short elective questionnaire was then distributed to the procedure staff and the subjects drained by both methods. RESULTS: Mean volume drained with the pump (5 L) was comparable to that drained by vacuum containers (4.9 L, p = 0.77). Mean time to drain subjects with the pump (18.6 min) was 9.1 min shorter and 3.8 min less variable than subjects drained with vacuum containers (27.7 min). This difference was statistically significant (p < 0.01) and clinically important (effect size = 0.73). Flow rate with the pump (4 min/L) was significantly faster (p < 0.05) than vacuum containers flow rate (6.6 min/L). No adverse events occurred in either group. Use of the pump increased the average cost by 21% and reduced earnings by 3%. All assistants (n = 6) and patients (n = 10) that responded to the questionnaire recommended the use of the pump over vacuum containers. CONCLUSION: The peristaltic pump safely drains ascites significantly faster and with less variability in time than vacuum containers. While use of the pump slightly increases cost per paracentesis, it was recommended by all paired subjects undergoing a paracentesis and all personnel assisting in the procedure.

Perceptions surrounding the possible interaction between physical activity, pollution and asthma in children and adolescents with and without asthma.

A cornerstone of asthma management is maintaining physical activity (PA), but this may lead to increased exposure to, and deeper inhalation of, pollutants. Furthermore, children and adolescents may be more susceptible to the deleterious impacts of such exposures. Despite the recent air quality campaigns and media coverage surrounding the dangers of air pollution to respiratory health, few target children and their understanding of such issues.Using semi structured interviews, understanding of PA, air pollution and their interaction was explored with 25 youth aged 7-17 years. Utilising NVIVO 12 software, an atheoretical, inductive thematic analysis was conducted to identify key themes which were subsequently presented as pen profiles with the number of common responses within a theme indicative of its strength.The majority (88%) of youth's indicated traffic-related air pollution and global manufacturing as key sources of air pollution. Whilst all youths were aware of outdoor pollution, only 52% were aware of indoor air pollutants, of which 62% had asthma. Despite some uncertainty, all youths described pollution in a negative fashion, with 52% linking air pollution to undesirable effects on health, specifically respiratory health. PA in a polluted area was thought to be more dangerous than beneficial by 44%, although 24% suggested the benefits of PA would outweigh any detriment from pollution.Youth are aware of, and potentially compensate for, the interaction between air pollution and PA. Strategies are needed to allow youth to make more informed decisions regarding how to promote PA whilst minimising exposure to air pollution.

Challenges, Barriers, and Successes of Standardized Report Templates: Results of a Society of Interventional Radiology Survey.

Registry data are being increasingly used to establish treatment guidelines, set benchmarks, allocate resources, and make payment decisions. Although many registries rely on manual data entry, the Society of Interventional Radiology (SIR) is using automated data extraction for its VIRTEX registry. This process relies on participants using consistent terminology with highly structured data in physician-developed standardized reports (SR). To better understand barriers to adoption, a survey was sent to 3,178 SIR members. Responses were obtained from 451 interventional radiology practitioners (14.2%) from 92 unique academic and 151 unique private practices. Of these, 75% used structured reports and 32% used the SIR SR. The most common barriers to the use of these reports include SR length (35% of respondents), lack of awareness about the SR (31%), and lack of agreement on adoption within practices (27%). The results demonstrated insights regarding barriers in the use and/or adoption of SR and potential solutions.

Bringing Opiates Off the Streets and Undertaking Excess Scripts: A novel opiate reclamation and prescription reduction program.

BACKGROUND: Opioid diversion and misuse continue to present problems in modern medicine. The "opioid epidemic" has claimed more than 250,000 lives since 1999, with studies pointing to prescription opioids as the culprit for future opiate misuse. Currently, there are no well-described, data-driven processes to educate surgeons on reducing opiate prescribing, informed by personal practice patterns. We designed and implemented a novel opiate reclamation and prescription reduction program for surgeons to reclaim unused medications and decrease prescribing using individual provider data. METHODS: We performed a prospective collection of all unused opiate pain medications for general surgery postoperative patients from July 15, 2020 to January 15, 2021. Patients brought their unused opiates to their routine postoperative follow-up appointment, where they were counted and disposed of in a secure drug take-back bin. Reclaimed opiates were totaled, analyzed, and reported to the providers, who used their individual reclamation rates to refine prescribing habits. RESULTS: During the reclamation period, 168 operations were performed, with a total of 12,970 morphine milligram equivalents of opiate prescribed by 5 physicians. A total of 6,077.5 morphine milligram equivalents (46.9%) were reclaimed, which is the equivalent of 800 5-mg tablets of oxycodone. A review of these data led to a 30.9% decrease in opiate prescriptions by participating surgeons in addition to the reclamation of an additional 3,150 morphine milligram equivalents over the next 6 months. CONCLUSION: Continuous monitoring of the medications returned by patients now continues to inform our providers' prescribing practices, decreases the amount of opiates in the community, and improves patient safety.

A History and Modern Framework for Quality Improvement in Interventional Radiology.

Quality improvement (QI) initiatives have benefited patients as well as the broader practice of medicine. Large-scale QI has been facilitated by multi-institutional data registries, many of which were formed out of national or international medical society initiatives. With broad participation, QI registries have provided benefits that include but are not limited to establishing treatment guidelines, facilitating research related to uncommon procedures and conditions, and demonstrating the fiscal and clinical value of procedures for both medical providers and health systems. Because of the benefits offered by these databases, Society of Interventional Radiology (SIR) and SIR Foundation have committed to the development of an interventional radiology (IR) clinical data registry known as VIRTEX. A large IR database with participation from a multitude of practice environments has the potential to have a significant positive impact on the specialty through data-driven advances in patient safety and outcomes, clinical research, and reimbursement. This article reviews the current landscape of societal QI programs, presents a vision for a large-scale IR clinical data registry supported by SIR, and discusses the anticipated results that such a framework can produce.

Cardiac events following JYNNEOS vaccination for prevention of Mpox.

The incidence of cardiac adverse events following JYNNEOS vaccination for prevention of mpox is unknown, however the Advisory Committee on Immunization Practices states that people with underlying cardiac risk factors should be counseled about the theoretical risk for myopericarditis following vaccination. We conducted a retrospective cohort study of 2,126 patients who were vaccinated with at least 1 dose of JYNNEOS vaccine and searched the Kaiser Permanente Northwest databases, including the electronic health record, to evaluate for cardiac adverse events of special interest (AESI). After physician adjudication, there were 10 confirmed cardiac AESI for an incidence of 3.1 per 1000 doses (exact 95% CI, 1.5 to 5.7), however none of these events could be directly attributed to vaccination. This retrospective cohort study of JYNNEOS vaccination for prevention of mpox identified 10 cardiac events that all had alternative explanations; and no hospitalizations or serious adverse outcomes were attributed to vaccination.

LoRaD: Marginal likelihood estimation with haste (but no waste).

The Lowest Radial Distance (LoRaD) method is a modification of the recently introduced Partition-Weighted Kernel method for estimating the marginal likelihood of a model, a quantity important for Bayesian model selection. For analyses involving a fixed tree topology, LoRaD improves upon the Steppingstone or Thermodynamic Integration (Path Sampling) approaches now in common use in phylogenetics because it requires sampling only from the posterior distribution, avoiding the need to sample from a series of ad hoc power posterior distributions, and yet is more accurate than other fast methods such as the Generalized Harmonic Mean (GHM) method. We show that the method performs well in comparison to the Generalized Steppingstone method on an empirical fixed-topology example from molecular phylogenetics involving 180 parameters. The LoRaD method can also be used to obtain the marginal likelihood in the variable-topology case if at least one tree topology occurs with sufficient frequency in the posterior sample to allow accurate estimation of the marginal likelihood conditional on that topology. [Bayesian; marginal likelihood; phylogenetics.].

Inter- and Intra-Observer Agreement of PD-L1 SP142 Scoring in Breast Carcinoma-A Large Multi-Institutional International Study.

The assessment of PD-L1 expression in TNBC is a prerequisite for selecting patients for immunotherapy. The accurate assessment of PD-L1 is pivotal, but the data suggest poor reproducibility. A total of 100 core biopsies were stained using the VENTANA Roche SP142 assay, scanned and scored by 12 pathologists. Absolute agreement, consensus scoring, Cohen's Kappa and intraclass correlation coefficient (ICC) were assessed. A second scoring round after a washout period to assess intra-observer agreement was carried out. Absolute agreement occurred in 52% and 60% of cases in the first and second round, respectively. Overall agreement was substantial (Kappa 0.654-0.655) and higher for expert pathologists, particularly on scoring TNBC (6.00 vs. 0.568 in the second round). The intra-observer agreement was substantial to almost perfect (Kappa: 0.667-0.956), regardless of PD-L1 scoring experience. The expert scorers were more concordant in evaluating staining percentage compared with the non-experienced scorers (R2 = 0.920 vs. 0.890). Discordance predominantly occurred in low-expressing cases around the 1% value. Some technical reasons contributed to the discordance. The study shows reassuringly strong inter- and intra-observer concordance among pathologists in PD-L1 scoring. A proportion of low-expressors remain challenging to assess, and these would benefit from addressing the technical issues, testing a different sample and/or referring for expert opinions.

Characterization of the Immune Microenvironment in Inflammatory Breast Cancer Using Multiplex Immunofluorescence.

INTRODUCTION: Inflammatory breast cancer (IBC) is an aggressive form of breast cancer with a poorly characterized immune microenvironment. METHODS: We used a five-colour multiplex immunofluorescence panel, including CD68, CD4, CD8, CD20, and FOXP3 for immune microenvironment profiling in 93 treatment-naïve IBC samples. RESULTS: Lower grade tumours were characterized by decreased CD4+ cells but increased accumulation of FOXP3+ cells. Increased CD20+ cells correlated with better response to neoadjuvant chemotherapy and increased CD4+ cells infiltration correlated with better overall survival. Pairwise analysis revealed that both ER+ and triple-negative breast cancer were characterized by co-infiltration of CD20 + cells with CD68+ and CD4+ cells, whereas co-infiltration of CD8+ and CD68+ cells was only observed in HER2+ IBC. Co-infiltration of CD20+, CD8+, CD4+, and FOXP3+ cells, and co-existence of CD68+ with FOXP3+ cells correlated with better therapeutic responses, while resistant tumours were characterized by co-accumulation of CD4+, CD8+, FOXP3+, and CD68+ cells and co-expression of CD68+ and CD20+ cells. In a Cox regression model, response to therapy was the most significant factor associated with improved patient survival. CONCLUSION: Those results reveal a complex unique pattern of distribution of immune cell subtypes in IBC and provide an important basis for detailed characterization of molecular pathways that govern the formation of IBC immune landscape and potential for immunotherapy.

A pilot study investigating the effects of a manuka honey sinus rinse compared to a standard sinus rinse on sino-nasal outcome test scores in cystic fibrosis patients.

BACKGROUND: People with cystic fibrosis (CF) are prone to bacterial respiratory infections; these are often antibiotic resistant, are difficult to treat, and impact on the quality of life and lung function. The upper respiratory tract can act as a reservoir for these pathogens, and as part of clinical care, sinus rinses are used to alleviate symptoms in the upper airway. We have developed a sinus rinse containing manuka honey, to identify whether it can help improve symptoms or reduce the bacterial load. METHODS: We will undertake a randomised controlled trial where 30 adults with CF will be recruited and randomised to either the control or intervention group. Both groups will follow a sinus rinse protocol for 30 days (± 7 days); the control group will use the standard of care rinse, and the intervention group will use a manuka honey rinse. Both groups will provide samples at day 0 and day 30. The primary outcome measure will be a change in the 22-item Sino-Nasal Outcome Test (SNOT-22) score. Secondary outcomes will include changes to quality of life (questionnaire), bacterial load/community composition, and sputum viscosity. DISCUSSION: This trial will look at the use of a manuka honey-infused sinus rinse solution on patients diagnosed with cystic fibrosis (CF) suffering with sinusitis; it will allow us to determine the efficacy of the manuka honey sinus rinse compared to standard rinse and will allow us to determine if molecular bacterial diversity analysis will provide in-depth information beyond the usual conventional microbiological. It will allow us to determine the feasibility of recruiting participants to this type of trial, allow us to check participant compliance with the protocol, and inform future studies. TRIAL REGISTRATION: Approval was obtained from the Research Ethics Committee Wales REC7 reference 18/WA/0319. Results of this study will be published at international conferences and in peer-reviewed journals; they will also be presented to the relevant stakeholders and research networks. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier NCT04589897 (retrospectively registered).

Fantastic perspectives and where to find them: involving patients and citizens in digital health research.

BACKGROUND: Digital contact tracing and exposure notification apps have quickly emerged as a potential solution to achieve timely and effective contact tracing for the SARS-CoV-2 virus. Nonetheless, their actual uptake remains limited. Citizens, including patients, are rarely consulted and included in the design and implementation process. Their contribution supports the acceptability of such apps, by providing upstream evidence on incentives and potential barriers that are most relevant to users. The DIGICIT (DIGITal CITizenship) project relied on patient and citizen partnership in research to better integrate public perspectives on these apps. In this paper, we present the co-construction process that led to the survey instrument used in the DIGICIT project and the interpretation of its results. This approach promotes public participation in research on contact tracing and exposure notification apps, as well as related digital health applications. OBJECTIVES: This article has three objectives: (1) describe the methodological process to co-construct a questionnaire and interpret the survey results with patients and citizens, (2) assess their experiences regarding this methodology, and (3) propose best practices for their involvement in digital health research. METHODS: The DIGICIT project was developed in four steps: (1) creation of the advisory committee composed of patients and citizens, (2) co-construction of a questionnaire, (3) interpretation of survey results, and (4) assessment of the experience of committee participants. RESULTS: Of the 25 applications received for participation in the advisory committee, we selected 12 people based on pre-established diversity criteria. Participants initially generated 84 survey questions in the first co-construction meeting, and eventually selected 36 in the final version. Participants made more than 20 recommendations when interpreting survey results and suggested carrying out focus groups with marginalized populations to increase representativity. They appreciated their inclusion early in the research process, being listened to and respected, the collective intelligence, and the method used for integrating their suggestions. They suggested that the study objectives and roles be better defined, that more time in the brainstorming sessions be allowed, and that discussion outside of meetings be encouraged. CONCLUSION: Having patients and citizens actively participating in this research constitutes the main methodological strength. They enriched the study from start to finish, and recommended the addition of focus groups to seek the perspective of marginalized groups that are typically under-represented from digital health research. Clear communication of the project objectives, good organization in meetings, and continuous evaluation from participants allow best practices to be achieved for patients' and citizens' involvement in digital health research. Co-construction in research generates critical study design ideas through collective intelligence. This methodology can be used in various clinical contexts and different healthcare settings.

COVID Alert is a mobile application (app) that was developed created to help limit the spread of COVID-19 in Canada. Although promising, these apps have not been widely used by the population, in part due to limited citizen engagement in their design. The DIGICIT project (DIGITal CITizenship) was carried out in partnership with citizens, including patients, to gather public perspective in Quebec, Canada about the COVID Alert app. The purpose of this article is to describe our method of constructing a survey questionnaire with patients and citizens. We have created an advisory committee of 12 participants. Along with the research team, they created a 36-question survey. They also suggested doing focus groups to add data to the survey by reaching marginalized groups that are traditionally excluded from digital health research. We also wanted to know the experience of the participants being included in this study. We conducted interviews and did a small survey with them. They appreciated being included from the beginning of the research, being listened to, and being respected. They appreciated the creativity of the group and the brainstorming sessions. However, they would have liked the tasks to be clearer from the start. They also would have preferred to have more time in the brainstorming sessions to create the survey questions, and to have discussions outside of the meetings. The inclusion of patients and citizens is the main strength of this project. To improve their integration in health research, there needs to be good communication of project objectives. Also, meetings must be well organized, and participants must be able to evaluate their experience.

The WISDOM self-management intervention: A cost-effectiveness analysis to support the transformation of type 2 diabetes care in England.

OBJECTIVES: To assess the cost-effectiveness of the WISDOM self-management intervention for type 2 diabetes compared with care as usual. DESIGN: We performed a difference-in-differences analysis to estimate differences in risk factors for diabetes complications between people in the WISDOM group (n = 25, 276) and a control group (n = 15, 272) using GP records. A decision analytic model was then used to extrapolate differences in risk factors into costs and outcomes in the long term. SETTING: Participating GP practices in West Hampshire and Southampton, UK. PARTICIPANTS: All people diagnosed with type 2 diabetes between January 1990 and March 2020 (n = 40,548). OUTCOMES: Diabetes-related complications, quality-adjusted life years (QALYs) and costs to the English National Health Service at 5 years and lifetime. INTERVENTIONS: The WISDOM intervention included risk stratification, self-management education programme to professionals and people with type 2 diabetes, and monitoring of key treatment targets. RESULTS: WISDOM was associated with less atrial fibrillation [p = 0.001], albuminuria [p = 0.002] and blood pressure [p = 0.098]. Among all people in the intervention group, WISDOM led to 51 [95%CI: 25; 76] QALYs gained and saved £278,036 [95%CI: -631,900; 176,392] in the first 5 years after its implementation compared with care as usual. During those people' lifetime, WISDOM led to 253 [95%CI: 75; 404] QALYs gained and cost saving of £126,380 [95%CI: -1,466,008; 1,339,628]. The gains in QALYs were a result of reduced diabetes-related complications through improved management of the associated risk factors. CONCLUSIONS: The WISDOM risk-stratification and education intervention for type 2 diabetes appear to be cost-effective compared to usual care by reducing diabetes complications.

Public Perspectives on Exposure Notification Apps: A Patient and Citizen Co-Designed Study.

Canada deployed a digital exposure notification app (COVID Alert) as a strategy to support manual contact tracing. Our aims are to (1) assess the use, knowledge, and concerns of the COVID Alert app, (2) identify predictors of app downloads, and (3) develop strategies to promote social acceptability. A 36-item questionnaire was co-designed by 12 citizens and patients partnered with 16 academic researchers and was distributed in the province of Québec, Canada, from May 27 to 28 June 2021. Of 959 respondents, 43% had downloaded the app. Messaging from government sources constituted the largest influence on app download. Infrequent social contacts and perceived app inefficacy were the main reasons not to download the app. Cybersecurity, data confidentiality, loss of privacy, and geolocation were the most frequent concerns. Nearly half of the respondents inaccurately believed that the app used geolocation. Most respondents supported citizen involvement in app development. The identified predictors for app uptake included nine characteristics. In conclusion, this project highlights four key themes on how to promote the social acceptability of such tools: (1) improved communication and explanation of key app characteristics, (2) design features that incentivize adoption, (3) inclusive socio-technical features, and (4) upstream public partnership in development and deployment.

The Use of Pleural Adenosine Deaminase in the Early Diagnosis and Treatment of Spinal Tuberculosis.

Spinal tuberculosis (TB) is associated with serious neurologic morbidity. It commonly presents as back pain, with or without systemic symptoms. Magnetic resonance imaging (MRI) is the most sensitive and specific imaging modality for spinal TB. The diagnosis of spinal TB is made with tissue biopsy and acid-fast bacilli (AFB) culture; however, tissue AFB smear and tissue TB deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) can influence early clinical decision making. Ancillary tests such as the purified protein derivative (PPD) skin test, QuantiFERON®-TB Gold (QFT) or pleural adenosine deaminase (ADA) can be used in conjunction with radiology and clinical findings to initiate treatment while AFB tissue cultures are pending. Spinal TB responds well to early medical management and surgery is reserved for cases with neurologic complications.

An experimental test of Lanchester's models of combat in the neotropical termite Nasutitermes corniger (Blattodea: Termitidae).

Lanchester's models of combat have been invoked to explain the mechanics of group fighting in social animals. Specifically, Lanchester's square law posits that the fighting ability of the group is proportional to the square of the number of combatants. Although used to explain a variety of ecological phenomena, the models have not been thoroughly tested. We tested the Lanchester models using group battles between colonies of the termite Nasutitermes corniger. Our main goals were to determine if mortality rates fit the Lanchester models, and if so, whether the behavioural mechanisms underlying a group's success match those used in deriving the model. We initiated battles between pairs of colonies with different ratios of fighters and recorded deaths over time. We found that the numerically larger army has an advantage, but that the advantage is not as pronounced as predicted by Lanchester's square law. We also video-recorded battles to analyse individual behaviour, which did not support the mechanisms invoked by Lanchester. Instead, the killing power of an individual is increased by the presence of nest-mates, giving the larger group a disproportionate advantage. Although the behavioural mechanisms leading to the advantage may differ, our results still support some of the proposed ecological phenomena.

Risk of myopericarditis following COVID-19 mRNA vaccination in a large integrated health system: A comparison of completeness and timeliness of two methods.

PURPOSE: How completely do hospital discharge diagnoses identify cases of myopericarditis after an mRNA vaccine? METHODS: We assembled a cohort 12-39 year-old patients, insured by Kaiser Permanente Northwest, who received at least one dose of an mRNA vaccine (Pfizer-BioNTech or Moderna) between December 2020 and October 2021. We followed them for up to 30 days after their second dose of an mRNA vaccine to identify encounters for myocarditis, pericarditis or myopericarditis. We compared two identification methods: A method that searched all encounter diagnoses using a brief text description (e.g., ICD-10-CM code I40.9 is defined as 'acute myocarditis, unspecified'). We searched the text description of all inpatient or outpatient encounter diagnoses (in any position) for "myocarditis" or "pericarditis." The other method was developed by the Centers for Disease Control and Prevention's Vaccine Safety Datalink (VSD), which searched for emergency department visits or hospitalizations with a select set of discharge ICD-10-CM diagnosis codes. For both methods, two physicians independently reviewed the identified patient records and classified them as confirmed, probable or not cases using the CDC's case definition. RESULTS: The encounter methodology identified 14 distinct patients who met the confirmed or probable CDC case definition for acute myocarditis or pericarditis with an onset within 21 days of receipt of COVID-19 vaccination. When we extended the search for relevant diagnoses to 30 days since vaccination, we identified two additional patients (for a total of 16 patients) who met the case definition for acute myocarditis or pericarditis, but those patients had been misdiagnosed at the time of their original presentation. Three of these patients had an ICD-10-CM code of I51.4 "Myocarditis, Unspecified;" that code was omitted by the VSD algorithm (in the late fall of 2021). The VSD methodology identified 11 patients who met the CDC case definition for acute myocarditis or pericarditis. Seven (64%) of the 11 patients had initial care for myopericarditis outside of a KPNW facility and their diagnosis could not be ascertained by the VSD methodology until claims were submitted (median delay of 33 days; range of 12-195 days). Among those who received a second dose of vaccine (n = 146 785), we estimated a risk as 95.4 cases of myopericarditis per million second doses administered (95% CI, 52.1-160.0). CONCLUSION: We identified additional valid cases of myopericarditis following an mRNA vaccination that would be missed by the VSD's search algorithm, which depends on select hospital discharge diagnosis codes. The true incidence of myopericarditis is markedly higher than the incidence reported to US advisory committees in the fall of 2021. The VSD should validate its search algorithm to improve its sensitivity for myopericarditis.

Does Early Secondary Alveolar Bone Grafting Influence Need for Additional Maxillary Advancement Procedures in Cleft Lip and Palate?

OBJECTIVE: To determine if secondary alveolar bone grafting (SABG) timing in patients with cleft lip and palate (CLP) influences the future need for additional maxillary advancement procedures, particularly Le Fort I osteotomy with rigid external distraction (RED). DESIGN: Retrospective cohort study. Groups were separated by SABG timing: early mixed dentition (ages 68 years) or late mixed dentition (ages 9-11 years). The criterion for RED was negative overjet ≥8 mm, and sufficient dental development for RED. SETTING: Single tertiary care institution. PATIENTS: Patients with CLP that underwent SABG from 2010 to 2015. Exclusion criteria included syndromic conditions, SABG surgery at age >12 years, current age <12 years, and <2 years follow-up. 104 patients were included. MAIN OUTCOME MEASURES: The number of RED candidates and treated patients. RESULTS: There was no statistical difference in the number of RED candidates (P = .0718) nor treated patients (P = .2716) based on SABG timing; stratification by laterality was also insignificant. Early SABG is associated with higher odds of being a RED candidate (pooled, unilateral, bilateral) and treated patient (pooled and unilateral); however, there were no statistically significant associations between SABG timing and the number of RED candidates and treated patients as determined by logistic regression models. CONCLUSION: There is no statistically significant association between SABG timing and the odds of being a RED candidate or treated patient. Future prospective studies are recommended to assess the relationship between SABG timing and maxillary growth in patients with CLP.