The global impact of the COVID-19 pandemic on pediatric spinal care: A multi-centric study.

Background: The COVID-19 pandemic has affected healthcare worldwide since December 2019. We aimed to identify the effect of the COVID-19 pandemic on outpatient clinic and surgical volumes and peri-operative complications for pediatric spinal deformities patients. Methods: In this multi-center retrospective study, outpatient visits (in-person and virtual care) and pediatric spine surgeries volumes in four high-volume pediatric spine centers were compared between March and December 2019 and the same period in 2020. Peri-operative complications were collected and compared in the same periods. Descriptive statistics were calculated, and comparative analyses were performed. Results: During the 2020 study period, the outpatient visit (in-person and virtual care) volume decreased during local lockdown periods by 71% for new patients (p < 0.001) and 53% for returning patients (p = 0.03). Overall, for 2020, there was a 20% reduction in new patients (p = 0.001) and 21% decrease in returning patients (p < 0.001). During the pandemic, there was also 20% less overall surgical volume of adolescent idiopathic scoliosis (AIS) patients undergoing primary posterior spinal fusion, with a 70% reduction during lockdown times (p < 0.001). Complication rate and profile were similar between periods. Conclusion: There was a significant decrease in outpatient pediatric spine outpatient visits, particularly new patients, which may increase the proportion of pediatric patients with spinal deformities that present late, meeting surgical indication. This, in combination with the reduction in surgical volume of AIS over the first year of the pandemic, could result in an extended waitlist for surgeries during years to come. Complication rate was similar for both periods, suggesting it is safe to continue elective pediatric spine surgery even in a time of a pandemic. Level of evidence: level IV.

Building knowledge using a novel web-based intervention to promote HPV vaccination in a diverse, low-income population.

OBJECTIVES: HPV vaccination rates remain suboptimal despite proven efficacy. Data suggest misconceptions or lack of knowledge are leading barriers. Our study aimed to develop and pilot a novel interactive education resource designed to educate parents and patients about HPV vaccines. METHODS: This is a prospective pilot study conducted in an urban teaching hospital pediatric clinic. The Patient Activated Learning System (PALS) intervention included 3 web-based videos with HPV vaccine-related educational content. Participants were parents of adolescent patients, aged 11-17 years, and young adult patients, aged 18-26 years. Enrolled participants completed an HPV vaccine knowledge survey before and after watching PALS; paired scores were evaluated. Acceptability and participant-reported impact of PALS modules were measured via Likert-scale surveys. RESULTS: 132 individuals were approached; 101 (76%) enrolled and completed the study. Participants self-identified as Hispanic (50%), non-Hispanic Black (23%), non-Hispanic White (7%), Asian (6%), American/Alaskan/Hawaiian Native or Pacific Islander (5%). Half reported earning ≤$40,000 annually; 57% had only a high school education. Post-intervention knowledge scores were increased compared to baseline (9.87/27 points vs 17.53/27 points, p < 0.01). PALS modules were reported as enjoyable to use and understandable (89% and 93%, respectively), and improved participants' understanding of the importance of HPV vaccination (90%). Of the 18 patients unvaccinated at baseline, 39% received 1 shot of the HPV vaccine within one month. CONCLUSION: The PALS HPV vaccine educational intervention was feasible, acceptable, and improved knowledge among a diverse, underserved population. Our intervention may positively influence HPV vaccination rates, with potential to overcome HPV vaccine hesitancy.

Virtual Reality Distraction Is No Better Than Simple Distraction Techniques for Reducing Pain and Anxiety During Pediatric Orthopaedic Outpatient Procedures: A Randomized Controlled Trial.

BACKGROUND: In-office procedures can be painful and anxiety-provoking for pediatric patients. Minimizing such pain and anxiety in children improves the patient experience and promotes a rewarding and productive patient-caregiver-provider relationship, which may for some young patients be their first memorable encounter with the healthcare system. Although virtual reality (VR) techniques have proven to be helpful in minimizing pain and anxiety during procedures in pediatric intensive care settings, it remains unclear how VR affects objective and subjective measures of pain and anxiety in children undergoing in-office orthopaedic procedures such as cast removal or percutaneous pin removal after fracture healing. QUESTIONS/PURPOSES: Is a VR gaming simulation more effective than either of two forms of noninteractive visual distraction (VR goggles or tablet computer displaying a noninteractive video) for reducing (1) objective measures of pain and anxiety and (2) subjective measures of pain and anxiety in children undergoing in-office cast removal or percutaneous pin removal? METHODS: This study was a randomized controlled trial with two parallel, separately analyzed cohorts: children undergoing in-office cast removal or in-office percutaneous pin removal at a single urban tertiary institution. We approached eligible patients who were scheduled to undergo outpatient cast or percutaneous pin removal and who met prespecified inclusion criteria. We enrolled until 105 patients were available for analysis in each of the cast removal and pin removal cohorts. Of note, the study institution was in an urban epicenter of the coronavirus-19 pandemic, and clinical research was paused sporadically, which resulted in a longer-than-expected enrollment period. In the cast removal cohort, all patients were eligible for inclusion and were enrolled and randomized into one of three groups: VR gaming simulation (n = 37), VR goggles with a noninteractive video (n = 36), or a tablet computer with the same noninteractive video (n = 40). Eleven percent (4), 8% (3), and 3% (1) withdrew from each of the three intervention groups, respectively. In the pin removal cohort, all patients were eligible for inclusion and were enrolled and randomized into the same three groups (37, 44, and 41 patients, respectively). In the pin removal group, 14% (5), 18% (8), and 10% (4) withdrew from each of the three intervention groups, respectively. In all, 235 patients were enrolled in the study and 210 patients (mean ± SD age 9 ± 3 years; 48% [100] girls) were included in the final analyses. There were no clinically important differences in age, gender, preprocedure pain, or anxiety among the intervention groups. Primary outcomes included preprocedure-to-maximum heart rate increase (objective measure) and preprocedure and postprocedure pain and anxiety using a VAS (subjective measures). One-way ANOVA and Bonferroni-adjusted pairwise comparisons were used to calculate between-group differences for the primary outcomes. RESULTS: There were no intervention-level groupwise differences between VR goggles with an interactive game, VR goggles with a noninteractive video, or the tablet computer with the same video in preprocedure-to-maximum heart rate increase in the cast removal cohort (18 ± 21 bpm versus 14 ± 11 bpm versus 20 ± 16 bpm, respectively; largest mean difference -6 bpm [95% CI -16 to 3]; p = 0.36) or pin removal cohort (27 ± 20 bpm versus 23 ± 12 bpm versus 24 ± 19 bpm, respectively; largest mean difference 4 bpm [95% CI -7 to 14]; p = 0.99). Similarly, there were no intervention-level groupwise differences in preprocedure to postprocedure VAS pain in the cast removal cohort (1 ± 1 versus 1 ± 2 versus 0 ± 2, respectively; largest mean difference 0 points [95% CI 0 to 1]; p = 0.89) or pin removal cohort (0 ± 3 versus 2 ± 3 versus 0 ± 3 points, respectively; largest mean difference 1 point [95% CI 0 to 3]; p = 0.13). Finally, there were no intervention-level groupwise differences between the same intervention groups in preprocedure to postprocedure VAS anxiety in the cast removal cohort (-2 ± 2 versus -1 ± 2 versus -1 ± 2 points, respectively; largest mean difference -1 point [95% CI -2 to 1]; p = 0.63) or pin removal cohort (-3 ± 3 versus -4 ± 4 versus -3 ± 3 points, respectively; largest mean difference -1 point [95% CI -2 to 1]; p = 0.99). CONCLUSION: During in-office cast and pin removal in pediatric patients, simple distraction techniques such as tablet video viewing are as effective as higher-fidelity VR headset video and interactive games in minimizing objective measures of procedural pain and subjective measures of pain and anxiety. Because of these findings and because of the associated costs, implementation logistics, and variable tolerance by young patients, widespread use of VR distraction techniques in the pediatric orthopaedic outpatient setting is unnecessary. LEVEL OF EVIDENCE: Level I, therapeutic study.

Adolescents' and Parents' Attitudes Toward Adolescent Clinical Trial Participation: Changes Over One Year.

Little is known about how adolescents' and parents' thoughts about participation in clinical trials change over time. In this study, adolescent (14-17 years)-parent dyads were asked about willingness to participate in a hypothetical reproductive health study. A year later, they were asked how their thoughts about the study had changed. Qualitative responses were coded and analyzed using framework analysis. Thirty-two percent of adolescents and 18% of parents reported changes in thoughts; reasons included general changes in perception, clearer understanding, new knowledge or experiences, increased maturity/age of adolescents, and changes in participants independent of the study. Adolescents and parents may benefit from learning about studies multiple times, and investigators should account for development and new experiences to optimize adolescent research enrollment.

Adolescent-Parent Dyad Descriptions of the Decision to Start the HPV Vaccine Series.

STUDY OBJECTIVE: To examine how adolescent-parent dyads describe decision-making regarding initiation of the human papillomavirus (HPV) vaccine series, specifically who they viewed as making the final decision. DESIGN: Semistructured interviews with adolescent-parent dyads were audio-recorded and transcribed. Responses to the question: "How did you make a decision about whether or not to receive the HPV vaccine series?" were content-coded for each individual member of the dyad. SETTING: Adolescent medicine clinics of 2 large urban medical centers and through snowball sampling. PARTICIPANTS: Adolescents 14-17 years of age and a parent (N = 262). Qualitative analyses were conducted for those who agreed that they were offered and started the HPV vaccine series (n = 109). INTERVENTIONS: None. MAIN OUTCOME MEASURES: Descriptions of the decision-making included 1 person (adolescent or parent) making the decision or joint decision-making by the adolescent and parent together. RESULTS: More than half of the dyads did not agree on who made the decision to start the vaccine. Most adolescents and parents described a similar account about when they were offered the HPV vaccine, although the interpretation of the event in terms of the decision-maker might have differed. More than half of adolescents and parents individually mentioned the health care provider in their description of the HPV vaccine decision-making process even though they were not queried about the role of the provider. CONCLUSION: Understanding the range of descriptions of these dyads is helpful to guide interventions to promote vaccine uptake in a manner that balances provider expertise, adolescent autonomy, and parental involvement.

Adolescent and Parent Willingness to Participate in Microbicide Safety Studies.

STUDY OBJECTIVE: To understand adolescents' and parents' willingness to participate (WTP) in a hypothetical phase I prevention study of sexually transmitted infections, discordance within adolescent-parent dyads, and expectations of each other during decision-making. DESIGN AND SETTING: Adolescent-parent dyads were recruited to participate in a longitudinal study about research participation attitudes. PARTICIPANTS: Adolescents (14-17 years old) and their parents (n = 301 dyads) participated. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Individual interviews at baseline assessed WTP on a 6-level Likert scale. WTP was dichotomized (willing/unwilling) to assess discordance. RESULTS: WTP was reported by 60% (182 of 301) of adolescents and 52% (156 of 300) of parents. In bivariate analyses, older adolescent age, sexual experience, and less involvement of parents in research processes were associated with higher level of WTP for adolescents; only sexual experience remained in the multivariable analysis. For parents, older adolescent age, perceived adolescent sexual experience, and conversations about sexual health were significant; only conversations remained. Dyadic discordance (44%, 132 of 300) was more likely in dyads in which the parent reported previous research experience, and less likely when parents reported higher family expressiveness. Adolescents (83%, 248 of 299) and parents (88%, 263 of 300) thought that the other would have similar views, influence their decision (adolescents 66%, 199 of 300; parents 75%, 224 of 300), and listen (adolescents 90%, 270 of 300; parents 96%, 287 of 300). There were no relationships between these perceptions and discordance. CONCLUSION: Inclusion of adolescents in phase I clinical trials is necessary to ensure that new methods are safe, effective, and acceptable for them. Because these trials currently require parental consent, strategies that manage adolescent-parent discordance and support adolescent independence and parental guidance are critically needed.

Altruistic reasoning in adolescent-parent dyads considering participation in a hypothetical sexual health clinical trial for adolescents.

Altruism is a well-established reason underlying research participation. Less is known about altruism in adolescent-parent decision-making about clinical trials enrolling healthy adolescents. This qualitative investigation focused on identifying spontaneous statements of altruism within adolescent-parent (dyadic) discussions of participation in a hypothetical phase I clinical trial related to adolescent sexual health. Content analysis revealed several response patterns to each other's altruistic reasoning. Across 70 adolescent-parent dyads in which adolescents were 14-17 years of age and 91% of their parents were mothers, a majority (61%) of dyadic discussions included a statement reflecting altruism. Parents responded to adolescents' statements of altruism more frequently than adolescents responded to parents' statements. Responses included: expresses concern, reiterates altruistic reasoning, agrees with altruistic reasoning, and adds to/expands altruistic reasoning. Since an altruistic perspective was often balanced with concerns about risk or study procedures, researchers cannot assume that altruism will directly lead to study participation. Optimizing the informed consent process for early phase clinical trials involving healthy adolescents may include supporting parents to have conversations with their adolescents which will enhance their capacity to consider all aspects of trial participation.

Parents' and Adolescents' Attitudes about Parental Involvement in Clinical Research.

STUDY OBJECTIVE: To understand parent and adolescent attitudes toward parental involvement during clinical trials and factors related to those attitudes. DESIGN: As part of a study on willingness to participate in a hypothetical microbicide study, adolescents and their parents were interviewed separately. SETTING: Adolescent medicine clinics in New York City. PARTICIPANTS: There were 301 dyads of adolescents (ages 14-17 years; 62% female; 72% Hispanic) and their parents. INTERVENTIONS: None. MAIN OUTCOME MEASURES: The interview included questions on demographic characteristics, sexual history, and family environment (subscales of the Family Environment Scale) that were associated with attitudes about parental involvement. RESULTS: Factor analysis of the parental involvement scale yielded 2 factors: LEARN, reflecting gaining knowledge about study test results and behaviors (4 items) and PROCEDURE, reflecting enrollment and permissions (4 items). Adolescents endorsed significantly fewer items on the LEARN scale and the PROCEDURE scale indicating that adolescents believed in less parental involvement. There was no significant concordance between adolescents and their own parents on the LEARN scale and the PROCEDURE scale. In final multivariate models predicting attitudes, adolescents who were female and had sexual contact beyond kissing, and non-Hispanic parents had lower LEARN scores. Adolescents who were older, had previous research experience, and reported less moral or religious emphasis in their family had lower PROCEDURE scores; there were no significant predictors for parents in the multivariate analyses. CONCLUSION: Parents wanted greater involvement in the research process than adolescents. Recruitment and retention might be enhanced by managing these differing expectations.

A Practitioner's Guide to Electronic Cigarettes in the Adolescent Population.

We present guidance on electronic nicotine delivery systems (ENDS) for health care professionals who care for adolescents. ENDS provide users with inhaled nicotine in an aerosolized mist. Popular forms of ENDS include e-cigarettes and vape-pens. ENDS range in disposability, customization, and price. Growth of ENDS usage has been particularly rapid in the adolescent population, surpassing that of conventional cigarettes in 2014. Despite surging use throughout the United States, little is known about the health risks posed by ENDS, especially in the vulnerable adolescent population. These products may potentiate nicotine addiction in adolescents and have been found to contain potentially harmful chemicals. The growth in these products may be driven by relaxed purchasing restrictions for minors, lack of advertising regulations, and youth friendly flavors. Taken together, ENDS represent a new and growing health risk to the adolescent population, one that health care professionals should address with their patients. We suggest a patient centered strategy to incorporate ENDS use into routine substance counseling.

Low Vitamin D Levels in Children with Fractures: a Comparative Cohort Study.

BACKGROUND: The currently accepted ranges for "normal" serum vitamin D have recently been challenged in adults on the basis that healthy bone metabolism requires higher levels of vitamin D than previously thought. PURPOSE: The purpose of this study was to evaluate whether a new "biologically based" classification based on 25(OH)vitamin D levels that invoke an endocrine biomarker response (<20 ng/mL for deficiency and <32 ng/mL for insufficiency) is more appropriate for children with fractures than historical criteria. METHODS: Serum 25(OH)vitamin D levels were collected from 58 children with acute low-energy fractures from an outpatient orthopedic clinic from 2009 to 2012. These vitamin D levels were compared with a cohort of 103 children with chronic kidney disease (CKD) from an adjacent clinic, a condition with acknowledged low levels of vitamin D. Then, the prevalence of vitamin D sufficiency in the fracture cohort was evaluated and compared using both historical guidelines and newer biologically based criteria. RESULTS: 25(OH)vitamin D levels in the fracture cohort did not differ from levels in the CKD cohort (27.5 vs. 24.6 ng/mL) indicating a similar distribution of vitamin D levels. This finding was consistent when controlling for significant covariables using linear regression analyses. In the fracture cohort, there was a discrepancy between historical and biologically based criteria in 64% of children. CONCLUSIONS: The results of the current study suggest that fracture patients are more frequently vitamin D deficient than previously thought. This finding is more readily apparent when newer biologically based criteria for vitamin D sufficiency are used.

Return to athletic activity after posterior spinal fusion for adolescent idiopathic scoliosis: analysis of independent predictors.

BACKGROUND: The cause of adolescent idiopathic scoliosis (AIS) is unknown and is currently believed to be multifactorial. AIS is a largely asymptomatic condition and many adolescents with AIS are involved with organized athletics and physical activity. To date, no data exist indicating predictors of return to physical activity after posterior spinal fusion for AIS. In this cohort study, adolescents who underwent posterior spinal fusion for AIS were evaluated to determine what clinical, surgical, and demographic variables predicted rate of return play in organized athletics. METHODS: Forty-two athletically active adolescents who underwent posterior spinal fusion for AIS at a single tertiary care academic orthopaedic institution by a single surgeon were analyzed for clinical, surgical, and demographic predictors of return to presurgical activity levels. Data were collected by chart review, patient interview, and completion of postoperative SRS-22 outcomes score. RESULTS: At an average of 5.5 years follow-up, 25 patients (59.5%) had returned to sports at an equal or higher level of physical activity. Three variables were independently associated with return to athletic activity postoperatively. The relationship between distal level of fusion and rate of return to play demonstrated a statistically significant stepwise decline from T11 to L4. Lenke classification and final SRS-22 score were also predictive of return to activity. No complications related to return to play were reported. CONCLUSIONS: In this retrospective cohort study, distal level of fusion, Lenke classification, and postoperative SRS-22 score were each independent predictors of rate of return to preoperative level of athletic activity after posterior spinal fusion for AIS. LEVEL OF EVIDENCE: Prognostic Level II: retrospective Study.

The findings of preoperative cardiac screening studies in adolescent idiopathic scoliosis.

INTRODUCTION: We sought to evaluate findings of screening cardiac studies in adolescent idiopathic scoliosis (AIS) patients by reviewing the echocardiograms and electrocardiograms (EKGs) performed at their preoperative evaluation for spinal fusion. METHODS: Retrospective chart review of all surgical AIS patients from 2000 to 2007 was completed (n=212). Patients with neuromuscular scoliosis, known connective tissue disease, or known/suspected cardiac disease were excluded. In presurgical screening, 12 lead EKG, 2dimensional-Doppler, and M-mode echocardiograms were analyzed. RESULTS: A total of 154 (73%) female and 58 (27%) male patients (aged 12 to 18 y, avg: 14.8 y) were analyzed. EKG findings, 180/212 (85%), were within normal limits. Twenty-eight of 212 (13%) patients were found to have normal variant readings. Four of 212 (2%) patients met criteria for left ventricular hypertrophy on EKG, but were subsequently found to have normal echocardiograms. Significant echocardiogram findings revealed 2 (0.94%) subjects with atrial septal defects (ASDs) (that delayed surgery) and 7 (3.3%) subjects with aortic root/valve abnormalities. CONCLUSIONS: In our cohort of preoperative AIS patients, cardiac abnormalities ranged from mild to severe, and in 2 cases, affected the surgical timing. Novel findings of aortic abnormalities were identified in 3.3% of patients. In a study which examined the prevalence of heart disease in randomly selected healthy adolescents with previously unknown cardiac disease (Steinberger), there was a rate of 3.6% (13/357) of cardiac anomalies. Of note, only 0.6% had aortic root/valve findings. The results of our retrospective review indicate that EKG does not provide significant information compared with echocardiogram as part of the preoperative evaluation of asymptomatic and otherwise healthy patients with AIS who are undergoing spinal deformity surgery. However, use of the echocardiogram may be appropriate for the diagnosis of previously unknown cardiac abnormalities in this population, as aortic root/valve abnormalities seem to be unique findings in these patients. LEVEL OF EVIDENCE: Level IV, Retrospective, descriptive case series.

The role of human papillomavirus vaccination in promoting delivery of other preventive and medical services.

OBJECTIVE: Adolescents infrequently present for preventive health visits. The 3-dose human papillomavirus (HPV) vaccine may result in increased health care visits and thus indirectly improve health services for teens. We examined whether other health services were delivered in conjunction with the second (HPV2) or third (HPV3) dose of the HPV vaccine. METHODS: We conducted a chart review for girls 9 to 20 years of age (n = 571) who received HPV2 or HPV3 within 4 months of its due date at any of 9 clinical sites. Analyses were limited to the 422 visits (72%) where HPV vaccine was specified as a reason for the visit. A generalized linear model was used to evaluate the impact of site of care on delivery of other health services. RESULTS: Nearly half (43%) of adolescents received another medical or preventive health service at the time of HPV2 or HPV3 vaccine administration. Most common services were 1 or more other vaccines (30%) or medical services (35%). Older teens were more likely than younger teens to receive reproductive health services and sexually transmitted infection screening. After controlling for age and adjusting for clustering within sites, receiving care at an academic health center versus a private practice was strongly associated with increased odds of receiving other medical or preventive health services at follow-up (odds ratio 2.07; 95% confidence interval 1.44-2.97). CONCLUSIONS: Adolescents, especially those receiving care at an academic health center, often received other health services at the time of HPV2 or HPV3 vaccination. Because visits occurred within 6 to 8 months of the prior vaccine dose, our findings suggest vaccine visits may lead to improved delivery of adolescent health services.

At what price? The current state of subject payment in adolescent research.

PURPOSE: To examine how subject payment was associated with study features, such as investigator characteristics and project specifics, among randomly selected studies using adolescent subjects. METHODS: Using Psychinfo we gathered a list of original research studies published in 1999 that used adolescent subjects. We randomly selected corresponding authors and mailed confidential questionnaires on subject payment. We gathered complete data from 127 authors of adolescent research. While our main outcome was subject payment, we also examined the monetary value and form of the payment. Predictor variables included the principal investigator's demographics and professional information and the project's design and sample. Data were analyzed using Student's t-tests, Pearson correlations, and logistic regression. RESULTS: Of the studies using adolescent subjects, 55% (n=61) involved payment. Total payment varied (range $1 to $600, mean=$82.35) and the mean value per session was $26.61. Investigator characteristics associated with payment were a principal investigator's current discipline area and the decade, level and area of highest educational degree obtained. Funding and protocol complexity were related to payment, as was the sample's size, gender composition, ethnic makeup, SES distribution, and at-risk status. Logistic regression analyses found that researchers using payment were 7.2 times more likely to have funding, 2.8 times more likely to work with at-risk youth, and for every unit increase in positive attitude toward compensation, there was a 1.1-fold increase in the likelihood of using payment. CONCLUSIONS: Of those who responded to our questionnaire, slightly more than one-half the 1999 published studies done with adolescents used payment; however, the amount paid varied tremendously.