Plant-Based Diets and Disease Progression in Men With Prostate Cancer.

Importance: Plant-based diets are associated with many health and environmental benefits, including primary prevention of fatal prostate cancer, but less is known about postdiagnostic plant-based diet patterns in individuals with prostate cancer. Objective: To examine whether postdiagnostic plant-based dietary patterns are associated with risk of prostate cancer progression and prostate cancer-specific mortality. Design, Setting, and Participants: This longitudinal observational cohort study included men with biopsy-proven nonmetastatic prostate cancer (stage ≤T3a) from the diet and lifestyle substudy within the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) enrolled at 43 urology practices across the US from 1999 to 2018. Participants completed a comprehensive diet and lifestyle questionnaire (including a validated food frequency questionnaire [FFQ]) between 2004 and 2016. Data were analyzed from August 2022 to April 2023. Exposures: Overall plant-based diet index (PDI) and healthful plant-based diet index (hPDI) scores were calculated from the FFQ. Main Outcomes and Measures: The primary outcome was prostate cancer progression (recurrence, secondary treatment, bone metastases, or prostate cancer-specific mortality). The secondary outcome was prostate cancer-specific mortality. Results: Among 2062 participants (median [IQR] age, 65.0 [59.0-70.0] years), 61 (3%) identified as African American, 3 (<1%) identified as American Indian or Alaska Native, 9 (<1%) identified as Asian or Pacific Islander, 15 (1%) identified as Latino, and 1959 (95%) identified as White. Median (IQR) time from prostate cancer diagnosis to FFQ was 31.3 (15.9-62.0) months after diagnosis. During a median (IQR) follow-up of 6.5 (1.3-12.8) years after the FFQ, 190 progression events and 61 prostate cancer-specific mortality events were observed. Men scoring in the highest vs lowest quintile of PDI had a 47% lower risk of progression (HR, 0.53; 95% CI, 0.37-0.74; P for trend = .003). The hPDI was not associated with risk of progression overall. However, among 680 individuals with Gleason grade 7 or higher at diagnosis, the highest hPDI quintile was associated with a 55% lower risk of progression compared with the lowest hPDI quintile (HR 0.45; 95% CI, 0.25-0.81; P for trend = .01); no association was observed in individuals with Gleason grade less than 7. Conclusions and Relevance: In this cohort study of 2062 men with prostate cancer, higher intake of plant foods after prostate cancer diagnosis was associated with lower risk of cancer progression. These findings suggest nutritional assessment and counseling may be recommended to patients with prostate cancer to help establish healthy dietary practices and support well-being and overall health.

Post-diagnostic health behaviour scores and risk of prostate cancer progression and mortality.

BACKGROUND: Individual behaviours are associated with prostate cancer (PC) progression. Behavioural scores, comprised of multiple risk factors, allow assessment of the combined impact of multiple behaviours. METHODS: We examined the association between six a priori scores and risk of PC progression and mortality among 2156 men with PC in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) cohort: two scores developed based on the PC survivorship literature ('2021 Score [+ Diet]'); a score developed based on pre-diagnostic PC literature ('2015 Score'); and three scores based on US recommendations for cancer prevention ('WCRF/AICR Score') and survival ('ACS Score [+ Alcohol]'). Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated for progression and PC mortality via parametric survival models (interval censoring) and Cox models, respectively. RESULTS: Over a median (IQR) of 6.4 (1.3, 13.7) years, we observed 192 progression and 73 PC mortality events. Higher (i.e., healthier) 2021 Score + Diet and WCRF/AICR Scores were inversely associated with risk of PC progression (2021 + Diet: HRcontinuous = 0.76, 95% CI: 0.63-0.90. WCRF/AICR: HRcontinuous = 0.83, 95% CI: 0.67-1.02) and mortality (2021 + Diet: HRcontinuous = 0.65, 95% CI: 0.45-0.93. WCRF/AICR: HRcontinuous = 0.71; 95% CI: 0.57-0.89). The ACS Score + Alcohol was only associated with progression (HRcontinuous = 0.89, 95% CI: 0.81-0.98) while the 2021 Score was only associated with PC mortality (HRcontinuous = 0.62, 95% CI: 0.45-0.85). The 2015 was not associated with PC progression or mortality. CONCLUSION: Findings strengthen the evidence that behavioural modifications following a prostate cancer diagnosis may improve clinical outcomes.

Quality of life for men with metastatic castrate-resistant prostate cancer participating in an aerobic and resistance exercise pilot intervention.

BACKGROUND: Following a prostate cancer diagnosis, disease and treatment-related symptoms may result in diminished quality of life (QoL). Whether exercise improves QoL in men with metastatic castrate-resistant prostate cancer (mCRPC) is not fully understood. METHODS: We conducted a 3-arm pilot randomized controlled trial to assess the feasibility, acceptability, safety, and efficacy of a 12-week remotely monitored exercise program among men with mCRPC. Here we report qualitative changes in QoL, consistent with the guidelines for pilot trials. Men were randomized to control, aerobic exercise, or resistance exercise. Exercise prescriptions were based on baseline cardiorespiratory and strength assessments. QoL outcomes were evaluated using self-reported questionnaires (e.g., QLQ-C30, PROMIS Fatigue, Pittsburgh Sleep Quality Index (PSQI), EPIC-26) collected at baseline and 12 weeks. RESULTS: A total of 25 men were randomized (10 control, 8 aerobic, 7 resistance). Men were predominately white (76%) with a median age of 71 years (range: 51-84) and 10.5 years (range: 0.9-26.3) post prostate cancer diagnosis. The men reported poor sleep quality and high levels of fatigue at enrollment. Other baseline QoL metrics were relatively high. Compared to the controls at 12 weeks, the resistance arm reported some improvements in social function and urinary irritative/obstruction symptoms while the aerobic arm reported some improvements in social function and urinary incontinence, yet worsening nausea/vomiting. Compared to the resistance arm, the aerobic arm reported worse urinary irritative/obstruction symptoms and self-rated QoL, yet some improvements in emotional function, insomnia, and diarrhea. CONCLUSIONS: The 3-month exercise intervention pilot appeared to have modest effects on QoL among mCRPC survivors on ADT. Given the feasibility, acceptability, and safety demonstrated in prior analyses, evaluation of the effect of the intervention on QoL in a larger sample and for extended duration may still be warranted.

Post-diagnostic health behaviour scores in relation to fatal prostate cancer.

BACKGROUND: Individual health behaviours have been associated with fatal prostate cancer (PCa). Their combined association with fatal PCa after diagnosis is unknown. METHODS: This prospective cohort included 4518 men diagnosed with nonmetastatic PCa from the Health Professionals Follow-up Study. Exposures included a three-factor score integrating post-diagnostic fatal PCa risk factors ("2021 PCa Behaviour Score"), six-factor score integrating incident aggressive PCa risk factors ("2015 PCa Behaviour Score"), and two scores integrating recommendations for cancer prevention and survival, respectively. Multivariable Cox models estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for fatal PCa. RESULTS: Over a median 10.2 years, we observed 219 PCa deaths. Each additional point of one of the PCa-specific health behaviour scores (2015 PCa Behaviour Score) was associated with a 19% reduced fatal PCa risk (HR: 0.81, 95%CI: 0.68-0.97). The 2021 PCa Behaviour Score and scores integrating national recommendations were not associated with fatal PCa. CONCLUSIONS: While a PCa-specific health behaviour score was associated with a reduced risk of fatal PCa, we did not otherwise observe strong evidence of associations between post-diagnostic scores and fatal PCa. Avoiding tobacco, healthy body size, and physical activity may decrease PCa death risk, but further research is needed to inform cancer survivorship recommendations.

mHealth Interventions to Promote a Healthy Diet and Physical Activity among Cancer Survivors: A Systematic Review of Randomized Controlled Trials.

Background: Technology-based interventions are increasingly used to improve physical activity (PA) and diet. Methods: We conducted a systematic review of randomized controlled trials (RCTs) published up to August 2021 that tested mobile health (mHealth) PA and/or dietary interventions among cancer survivors and reported on the feasibility, satisfaction, behavioral change, and/or quality of life (QOL) outcomes. Results: In total, 61 articles were identified on PubMed, and 23 of those met the inclusion criteria. The most common cancers were breast (n = 1000), prostate (n = 713), and colorectal (n = 650). Participants were predominantly White (median: 84%, interquartile range (IQR): 20%) and college-educated (58%). The interventions varied, but the most common combination of components (six studies) was a website/mobile app with an activity tracker and coaching. In terms of duration, 70% (n = 16) of the interventions lasted 12 weeks. The median total tracker wear was 87% of the study days (IQR: 6%) and the median text-message reply rate was 73% (IQR 4%). Most participants (median: 87%; IQR: 16%) were satisfied with at least one intervention component. Eleven out of 18 studies examining behavioral change reported significant between-group differences and six out of 11 studies examining QoL reported significant improvements. Conclusions: mHealth interventions are a promising approach to improving the PA and diets of cancer survivors. Research in racially/ethnically and socioeconomically diverse populations is needed.

Postdiagnostic Inflammatory, Hyperinsulinemic, and Insulin-Resistant Diets and Lifestyles and the Risk of Prostate Cancer Progression and Mortality.

BACKGROUND: Inflammatory and insulin pathways have been linked to prostate cancer; postdiagnostic behaviors activating these pathways may lead to poor outcomes. The empirical dietary inflammatory pattern (EDIP), empirical dietary index for hyperinsulinemia (EDIH), and empirical dietary index for insulin resistance (EDIR), and associated lifestyle indices (ELIH, ELIR) predict biomarkers of inflammation (EDIP: IL6, TNFaR2, CRP) and insulin secretion (EDIH/ELIH: c-peptide; EDIR/ELIR: TAG:HDL) from whole foods and behaviors. METHODS: Associations of these indices with time to prostate cancer progression (primary, n = 2,056) and prostate cancer-specific mortality (PCSM; secondary, n = 2,447) were estimated among men diagnosed with nonmetastatic prostate cancer in the Cancer of the Prostate Strategic Urologic Research Endeavor cohort diet and lifestyle sub-study. Because the true (versus clinically documented) date of progression is unobserved, we used parametric (Weibull) survival models to accommodate interval-censoringand estimated adjusted HR and 95% confidence intervals (CI) for prostate cancer progression per 1-SD increase in index. Cox proportional hazards models were used to estimate PCSM associations. RESULTS: During a median [interquartile range (IQR)] 6.4 years (IQR, 1.3-12.7), 192 progression and 73 PCSM events were observed. Inflammatory (EDIP: HR, 1.27; CI, 1.17-1.37), hyperinsulinemic (EDIH: HR, 1.24; CI, 1.05-1.46. ELIH: HR, 1.34; CI, 1.17-1.54), and insulin-resistant (EDIR: HR, 1.22; CI, 1.00-1.48. ELIR: HR, 1.36; CI, 1.12-1.64) indices were positively associated with risk of prostate cancer progression. There was no evidence of associations between the indices and PCSM. CONCLUSIONS: Both inflammatory and insulinemic dietary and lifestyle patterns are associated with risk of prostate cancer progression. IMPACT: For men with prostate cancer, consuming dietary patterns that limit chronic systemic inflammation and insulin hypersecretion may improve survivorship, especially when coupled with active lifestyle and healthy body weight. See related commentary by Kucuk, p. 1673.

Quality of Life of Prostate Cancer Survivors Participating in a Remotely Delivered Web-Based Behavioral Intervention Pilot Randomized Trial.

BACKGROUND: Following a prostate cancer (PC) diagnosis, treatment-related symptoms may result in diminished quality of life (QoL). Improved diet and increased exercise may improve QoL in men with PC. METHODS: We conducted a 4-arm pilot randomized trial to assess feasibility and acceptability of a 3-month web-based diet and exercise intervention, among men (>18 years of age) with PC (reported elsewhere). The purpose of this study is to describe the change in QoL measured by surveys (eg, QLQ-C30, PROMIS Fatigue) at enrollment and following the intervention. Men were randomized 1:1:1:1 to increasing levels of web-based behavioral support: Level 1: website; Level 2: Level 1 plus personalized diet and exercise prescription; Level 3: Levels 1-2 plus Fitbit and text messages; Level 4: Levels 1-3 plus 2 30-minute coaching calls. T-tests were used to compare pre-post change in mean QoL scores between each Level and Level 1. RESULTS: Two hundred and two men consented and were randomized (n = 49, 51, 50, 52 for Levels 1-4, respectively). Men were predominantly white (93%), with a median age of 70 years (Intra-quartile Range [IQR]: 65,75) and 3 years (IQR: 1,9) post primary treatment for mostly localized disease (74% with T1-2). There were no meaningful changes in QoL, but there were notable trends. Level 3 participants had small improvements in QLQ-C30 Global Health (5.46; 95% CI: -0.02, 10.95) compared to Level 1. In contrast, Level 2 participants trended toward decreasing Global QoL (-2.31, 95% CI: -8.05, 3.42), which may reflect declines in function (eg, Cognitive: -6.94, 95% CI: -13.76, -0.13) and higher symptom burden (eg, Diarrhea: 4.63, 95% CI: -1.48, 10.74). CONCLUSIONS: This short, web-based intervention did not appear to have an impact on PC survivors' QoL. Most men were several years past treatment for localized disease; the potential for this approach to reduce symptoms and improve QoL in men who have worse health may still be warranted.

Post-diagnostic coffee and tea consumption and risk of prostate cancer progression by smoking history.

PURPOSE: Post-diagnostic coffee and tea consumption and prostate cancer progression is understudied. METHODS: We examined 1,557 men from the Cancer of the Prostate Strategic Urologic Research Endeavor who completed a food frequency questionnaire a median of 28 months post-diagnosis. We estimated associations between post-diagnostic coffee (total, caffeinated, decaffeinated) and tea (total, non-herbal, herbal) and risk of prostate cancer progression (recurrence, secondary treatment, bone metastases, or prostate cancer death) using Cox proportional hazards regression. We also examined whether smoking (current, former, never) modified these associations. RESULTS: We observed 167 progression events (median follow-up 9 years). Higher coffee intake was associated with higher risk of progression among current smokers (n = 95). The hazard ratio (HR) [95% confidence interval (CI)] for 5 vs 0 cups/day of coffee was 0.5 (CI 0.2, 1.7) among never smokers, but 4.5 (CI 1.1, 19.4) among current smokers (p-interaction: 0.001). There was no association between total coffee intake and prostate cancer progression among never and former smokers. However, we observed an inverse association between decaffeinated coffee (cups/days) and risk of prostate cancer progression in these men (HR > 0 to < 1 vs 0: 1.1 (CI 0.7, 1.8); HR1 to <2 vs 0: 0.7 (CI 0.3, 1.4); HR≥2 vs 0: 0.6 (CI 0.3, 1.1); p-trend = 0.03). There was no association between tea and prostate cancer progression, overall or by smoking status. CONCLUSION: Among non-smoking men diagnosed with localized prostate cancer, moderate coffee and tea consumption was not associated with risk of cancer progression. However, post-diagnostic coffee intake was associated with increased risk of progression among current smokers.

Post-Diagnostic Dietary and Lifestyle Factors and Prostate Cancer Recurrence, Progression, and Mortality.

PURPOSE OF REVIEW: This study aimed to summarize evidence published between 1999 and June 2020 examining diet and lifestyle after prostate cancer (PC) diagnosis in relation to risk of biochemical recurrence, PC progression, and PC-specific mortality. RECENT FINDINGS: Secondary prevention is an important research area in cancer survivorship. A growing number of studies have reported associations between post-diagnostic modifiable behaviors and risk of PC outcomes. Evidence on modifiable lifestyle factors and PC remains limited. Where multiple studies exist, findings are often mixed. However, studies consistently suggest that smoking and consumption of whole milk/high-fat dairy are associated with higher risk of PC recurrence and mortality. In addition, physical activity and ½ to 1 glass of red wine/day have been associated with lower risk of recurrence and PC-specific mortality. Greater inclusion of racially/ethnically diverse groups in future research is necessary to understand these relationships in populations most impacted by adverse PC outcomes.

Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial.

BACKGROUND: Diet and exercise may be associated with quality of life and survival in men with prostate cancer. OBJECTIVE: This study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer. METHODS: We conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ≥18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls-one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes. RESULTS: In total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1. CONCLUSIONS: A web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013.

Web-Based Lifestyle Interventions for Prostate Cancer Survivors: Qualitative Study.

BACKGROUND: Exercise and a healthy diet can improve the quality of life and prognosis of prostate cancer survivors, but there have been limited studies on the feasibility of web-based lifestyle interventions in this population. OBJECTIVE: This study aims to develop a data-driven grounded theory of web-based engagement by prostate cancer survivors based on their experience in the Community of Wellness, a 12-week randomized clinical trial designed to support healthy diet and exercise habits. METHODS: TrueNTH's Community of Wellness was a four-arm pilot study of men with prostate cancer (N=202) who received progressive levels of behavioral support (level 1: website; level 2: website with individualized diet and exercise recommendations; level 3: website with individualized diet and exercise recommendations, Fitbit, and text messages; and level 4: website with individualized diet and exercise recommendations, Fitbit and text messages, and separate phone calls with an exercise trainer and a registered dietitian). The primary aim of the study is to determine the feasibility and estimate the effects on behaviors (results reported in a separate paper). Following the 12-week intervention, we invited participants to participate in 4 focus groups, one for each intervention level. In this report, we used grounded theory analyses including open, axial, and selective coding to generate codes and themes from the focus group transcripts. Categories were refined across levels using embodied categorization and constant comparative methods. RESULTS: In total, 20 men with prostate cancer participated in the focus groups: 5, 4, 5, and 6 men in levels 1, 2, 3, and 4, respectively. Participants converged on 5 common factors influencing engagement with the intervention: environment (home environment, competing priorities, and other lifestyle programs), motivation (accountability and discordance experienced within the health care system), preparedness (technology literacy, health literacy, trust, and readiness to change), program design (communication, materials, and customization), and program support (education, ally, and community). Each of these factors influenced the survivors' long-term impressions and habits. We proposed a grounded theory associating these constructs to describe the components contributing to the intuitiveness of a web-based lifestyle intervention. CONCLUSIONS: These analyses suggest that web-based lifestyle interventions are more intuitive when we optimize participants' technology and health literacy; tailor interface design, content, and feedback; and leverage key motivators (ie, health care providers, family members, web-based coach) and environmental factors (ie, familiarity with other lifestyle programs). Together, these grounded theory-based efforts may improve engagement with web-based interventions designed to support prostate cancer survivorship.

Obesity at Diagnosis and Prostate Cancer Prognosis and Recurrence Risk Following Primary Treatment by Radical Prostatectomy.

BACKGROUND: The association of obesity at diagnosis with prostate cancer progression is uncertain. This study aimed to examine the relationship between body mass index (BMI; 18.5-<25, 25-<30, 30-<35, ≥35 kg/m2) and prognostic risk at diagnosis, compare the concordance between prognostic risk assessed at diagnostic biopsy versus pathologic risk assessed at surgery across BMI categories, and investigate the association between obesity and prostate cancer recurrence and all-cause death. METHODS: We examined men enrolled in CaPSURE who underwent radical prostatectomy between 1995 and 2017. Multiple imputation methods were used to handle missing data and reported along with complete case findings. RESULTS: Participants (n = 5,200) were followed for a median of 4.5 years; 685 experienced recurrence. Obesity was associated with higher prognostic risk at time of diagnosis (ORobese = 1.5; ORvery obese = 1.7) and upward reclassification of disease between biopsy and surgery, driven by change in tumor stage (ORobese = 1.3; ORvery obese = 1.6). We observed an association between BMI and recurrence with adjustment for disease severity using diagnostic factors (HRvery obese = 1.7); this association disappeared when adjusting for disease severity factors obtained at surgery. CONCLUSIONS: Our findings suggest that residual confounding may partially explain the conflicting evidence regarding obesity's influence on prostate cancer progression. Assessing T-stage via digital rectal exam may be complicated in larger men, potentially affecting clinical treatment decisions. A strong association with all-cause mortality demonstrates healthier BMI at diagnosis may still improve overall survival. IMPACT: Patients with greater BMI are prone to more advanced disease at diagnosis and may be more likely to have their tumor stage underestimated at diagnosis.

Negative Focused Abdominal Sonography for Trauma examination predicts successful nonoperative management in pediatric solid organ injury: A prospective Arizona-Texas-Oklahoma-Memphis-Arkansas + Consortium study.

BACKGROUND: Focused Abdominal Sonography for Trauma (FAST) examination has long been proven useful in the management of adult trauma patients, however, its utility in pediatric trauma patients is not as proven. Our goal was to evaluate the utility of a FAST examination in predicting the success or failure of nonoperative management (NOM) of blunt liver and/or spleen (BLSI) in the pediatric trauma population. METHODS: A retrospective analysis of a prospective observational study of patients younger than 18 years presenting with BLSI to one of ten Level I pediatric trauma centers between April 2013 and January 2016. 1,008 patients were enrolled and 292 had a FAST examination recorded. We analyzed failure of NOM of BLSI in the pediatric trauma population. We then compared FAST examination alone or in combination with the pediatric age adjusted shock index (SIPA) as it relates to success of NOM of BLSI. RESULTS: Focused Abdominal Sonography for Trauma examination had a negative predictive value (NPV) of 97% and positive predictive value (PPV) of 13%. The odds ratio of failing with a positive FAST examination was 4.9 and with a negative FAST was 0.20. When combined with SIPA, a positive FAST examination and SIPA had a PPV of 17%, and an odds ratio for failure of 4.9. The combination of negative FAST and SIPA had an NPV of 96%, and the odds ratio for failure was 0.20. CONCLUSION: Negative FAST is predictive of successful NOM of BLSI. The addition of a positive or negative SIPA score did not affect the PPV or NPV significantly. Focused Abdominal Sonography for Trauma examination may be useful clinically in determining which patients are not at risk for failure of NOM of BLSI and do not require monitoring in an intensive care setting. LEVEL OF EVIDENCE: Prognostic study, level IV; therapeutic/care management, level IV.

Car seat education: A randomized controlled trial of teaching methods.

OBJECTIVE: To determine if a less labor-intensive video-based program for teaching car seat installation can be as effective as the traditional didactic lecture component. METHODS: This is a randomized controlled trial of caregivers seeking car seat education. Caregivers were assigned to didactic or video-based social learning classes. The didactic class involved live lecture; the social learning class included a brief lecture and the video, Simple Steps to Child Passenger Safety, utilizing social learning principles. Proficiency in child passenger safety was evaluated pre- and post-class via: (1) 5-question confidence assessment; (2) 15-question knowledge test; and (3) 5-part car seat installation demonstration. Data were analyzed to compare post-class assessment scores between teaching modalities using pre-test scores as covariates, and correlation of participant confidence and knowledge with installation ability. RESULTS: 526 individuals registered and were randomized. A total of 213 arrived for class with 103 randomized to didactic teaching and 111 to social learning. Didactics and social learning groups showed similar increases in post-class confidence, knowledge, and installation ability. In the pre-class assessment, 16% of participants in each group installed the car seat correctly. After controlling for baseline installation ability, correct post-class car seat installation did not vary between groups (mean difference = 0.001; p = 0.964). Among participants with high scores on the knowledge assessment, only 57% could demonstrate correct car seat installation (rs = 0.160, p = 0.023). CONCLUSION: Video-based social learning methodology, which requires less time and resources, was as effective in teaching child passenger safety as didactic lecture. Both teaching methods significantly improved proficiency in child passenger restraint. Car seat installation knowledge is only weakly correlated with proper installation ability and proper installation remains a challenge, even after education.

Hypotension and the need for transfusion in pediatric blunt spleen and liver injury: An ATOMAC+ prospective study.

PURPOSE: Children with blunt liver or spleen injury (BLSI) requiring early transfusion may present without hypotension despite significant hypovolemia. This study sought to determine the relationship between early transfusion in pediatric BLSI and hypotension. METHODS: Secondary analysis of a 10-institution prospective observational study was performed of patients 18years and younger presenting with BLSI. Patients with central nervous system (CNS) injury were excluded. Children receiving blood transfusion within 4h of injury were evaluated. Time to first transfusion, vital signs, and physical exams were analyzed. Patients with hypotension were compared to those without hypotension. RESULTS: Of 1008 patients with BLSI, 47 patients met inclusion criteria. 22 (47%) had documented hypotension. There was no statistical difference in median time to first transfusion for those with or without hypotension (2h vs. 2.5h, p=0.107). The hypotensive group was older (median 15.0 versus 9.5years; p=0.007). Median transfusion volume in the first 24h was 18.2mL/kg (IQR: 9.6, 25.7) for those with hypotension and 13.9mL/kg (IQR: 8.3, 21.0) for those without (p=0.220). Mortality was 14% (3/22) in children with hypotension and 0% (0/25) in children without hypotension. CONCLUSION: Hypotension occurred in less than half of patients requiring early transfusion following pediatric BLSI suggesting that hypotension does not consistently predict the need for early transfusion. TYPE OF STUDY: Secondary analysis of a prospective observational study. LEVEL OF EVIDENCE: Level IV cohort study.

Failure of nonoperative management of pediatric blunt liver and spleen injuries: A prospective Arizona-Texas-Oklahoma-Memphis-Arkansas Consortium study.

BACKGROUND: Nonoperative management (NOM) is standard of care for most pediatric blunt liver and spleen injuries (BLSI); only 5% of patients fail NOM in retrospective reports. No prospective studies examine failure of NOM of BLSI in children. The aim of this study was to determine the frequency and clinical characteristics of failure of NOM in pediatric BLSI patients. METHODS: A prospective observational study was conducted on patients 18 years or younger presenting to any of 10 Level I pediatric trauma centers April 2013 and January 2016 with BLSI on computed tomography. Management of BLSI was based on the Arizona-Texas-Oklahoma-Memphis-Arkansas Consortium pediatric guideline. Failure of NOM was defined as needing laparoscopy or laparotomy. RESULTS: A total of 1008 patients met inclusion; 499 (50%) had liver injury, 410 (41%) spleen injury, and 99 (10%) had both. Most patients were male (n = 624; 62%) with a median age of 10.3 years (interquartile range, 5.9, 14.2). A total of 69 (7%) underwent laparotomy or laparoscopy, but only 34 (3%) underwent surgery for spleen or liver bleeding. Other (nonexclusive) operations were for 21 intestinal injuries; 15 hematoma evacuations, washouts, or drain placements; 9 pancreatic injuries; 5 mesenteric injuries; 3 diaphragm injuries; and 2 bladder injuries. Patients who failed were more likely to receive blood (52 of 69 vs. 162 of 939; p < 0.001) and median time from injury to first blood transfusion was 2.3 hours for those who failed versus 5.9 hours for those who did not (p = 0.002). Overall mortality rate was 24% (8 of 34) in those who failed NOM due to bleeding. CONCLUSION: NOM fails in 7% of children with BLSI, but only 3% of patients failed for bleeding due to liver or spleen injury. For children failing NOM due to bleeding, the mortality was 24%. LEVEL OF EVIDENCE: Therapeutic study, level II.

Prospective validation of the shock index pediatric-adjusted (SIPA) in blunt liver and spleen trauma: An ATOMAC+ study.

BACKGROUND: Age-adjusted pediatric shock index (SIPA) does not require knowledge of age-adjusted blood pressure norms, yet correlates with mortality, serious injury, and need for transfusion in trauma. No prospective studies support its validity. METHODS: A multicenter prospective observational study of patients 4-16years presenting April 2013-January 2016 with blunt liver and/or spleen injury (BLSI). SIPA (maximum heart rate/minimum systolic blood pressure) thresholds of >1.22, >1.0, and >0.9 in the emergency department were used for 4-6, 7-12 and 13-16year-olds, respectively. Patients with ISS ≤15 were excluded to conform to the original paper. Discrimination outcomes were compared between SIPA and shock index (SI). RESULTS: Of 1008 patients, 386 met inclusion. SI was elevated in 321, and SIPA elevated in 282. The percentage of patients with elevated index (SI or SIPA) and blood transfusion within 24 hours (30% vs 34%), BLSI grade ≥3 requiring transfusion (28% vs 32%), operative intervention (14% vs 16%) and ICU admission (64% vs 67%) was higher in the SIPA group. CONCLUSION: SIPA was validated in this multi-institutional prospective study and identified a higher percentage of children requiring additional resources than SI in BLSI patients. SIPA may be useful for determining necessary resources for injured patients with BLSI. LEVEL OF EVIDENCE: Level II prognosis.

The impact of morbid obesity on solid organ injury in children using the ATOMAC protocol at a pediatric level I trauma center.

INTRODUCTION: Obesity is an epidemic in the pediatric population. Childhood obesity in trauma has been associated with increased incidence of long-bone fractures, longer ICU stays, and decreased closed head injuries. We investigated for differences in the likelihood of failure of non-operative management (NOM), and injury grade using a subset of a multi-institutional, prospective database of pediatric patients with solid organ injury (SOI). METHODS: We prospectively collected data on all pediatric patients (<18years) admitted for liver or splenic injury from September 2013 to January 2016. SOI was managed based upon the ATOMAC protocol. Obesity status was derived using CDC definitions; patients were categorized as non-obese (BMI <95th percentile) or obese (BMI ≥95th percentile). The ISS, injury grade, and NOM failure rate were calculated among other data points. RESULTS: Of 1012 patients enrolled, 117 were identified as having data regarding BMI. Eighty-four percent of patients were non-obese; 16% were obese. The groups did not differ by age, sex, mechanism of injury, or associated injuries. There was no significant difference in the rate of failure of non-operative management (8.2% versus 5.3%). Obesity was associated with higher likelihood of severe (grade 4 or 5) hepatic injury (36.8% versus 15.3%, P=0.048) but not a significant difference in likelihood of severe (grade 4 or 5) splenic injury (15.3% versus 10.5%, P=0.736). Obese patients had a higher mean ISS (22.5 versus 16.1, P=0.021) and mean abdominal AIS (3.5 versus 2.9, P=0.024). CONCLUSION: Obesity is a risk factor for more severe abdominal injury, specifically liver injury, but without an associated increase in failure of NOM. This may be explained by the presence of hepatic steatosis making the liver more vulnerable to injury. A protocol based upon physiologic parameters was associated with a low rate of failure regardless of the pediatric obesity status. LEVEL OF EVIDENCE: Level II prognosis.

Outcomes of arterial vascular extremity trauma in pediatric patients.

BACKGROUND: Vascular trauma in children, although rare, carries significant risk for repair. Here we report outcomes from a single trauma center for children with extremity vascular trauma, proximal to the digits. METHODS: Retrospective chart review of patients less than age 18years with an acute, non-iatrogenic traumatic arterial vascular injury of the upper and/or lower extremity between January 2008 and December 2013. Abstracted patient demographics, injury characteristics, surgical management, and disposition were summarized and compared with nonparametric methods. RESULTS: 23 children comprised the study cohort: median age of 8years (IQR: 4.6-12), 61% (n=14) males, 100% survival. Penetrating injuries were the predominate mechanism (n=17, 74%). The median time to presentation was 154min (IQR: 65-330). Acute operations for revascularization included a primary repair (n=15, 65%) or reversed vein graft (n=7, 30%). Fasciotomies were done for 3 (13%) patients. Three amputations were done for failed revascularization. Upper extremity vascular injury (n=15, 65%) was more common. The rate of associated extremity fracture was similar between upper (21%) and lower (33%) extremities (p=0.643). Eight (35%) patients required additional surgery most commonly for debridement, washouts and dressing changes. Three patients' hospital stays were complicated by infection. Impaired function was the most common short- and long-term complication (60%, 75%). CONCLUSION: Pediatric vascular injuries are commonly associated with penetrating injuries and male gender and occurred more frequently in the upper extremities. Overall patency rates after repair were 87%. Fasciotomies were done in 13% of patients, and the overall surgical amputation rate was 13%. There was no mortality in this cohort; however, multiple operations are commonly required, including the return to OR for washouts, debridements and dressing changes. The most common short- and long-term complication was impaired function. Overall good results are achievable in pediatric vascular trauma treated with revascularization.