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2.
J Prim Care Community Health ; 15: 21501319241231405, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38411101

RESUMEN

INTRODUCTION/OBJECTIVES: With growing vaccination misinformation and mistrust, strategies to improve vaccination communication across community-based settings are needed. METHODS: The Rural Adolescent Vaccine Enterprise (RAVE), a 5-year (2018-2022) stepped-wedge cluster randomized study, tested a clinic-based practice facilitation intervention designed to improve HPV vaccination. An exploratory aim sought to explore the use of partnerships between primary care clinics and a community partner of their choosing, to implement a social marketing campaign related to HPV immunization. We assessed perceptions about the value and success of the partnership, and barriers and facilitators to its implementation using a 29-item community partner survey, key informant interviews, and field notes from practice facilitators. RESULTS: Of the initial 45 clinics participating in RAVE, 9 were unable to either start or complete the study, and 36 participants (80.0%) were actively engaged. Of these, 16/36 clinics (44.4%) reported establishing successful partnerships, 10 reported attempting to develop partnerships (27.8%), and another 10 reported not developing a partnership (27.8%), which were often caused by the COVID-19 pandemic. The most common partnership was with public health departments at 27.3%. Other partnerships involved libraries, school districts, and local businesses. More than half (63.7%) reported that creating messages regarding getting HPV vaccination was moderately to very challenging. Just under half reported (45.5%) that messaging was hard because of a lack of understanding about the seriousness of diseases caused by HPV, parents being against vaccines because of safety concerns, and religious values that result in a lack of openness to HPV vaccines. Community partners' health priorities changed as a result of RAVE, with 80% prioritizing childhood immunizations as a result of the RAVE partnership. CONCLUSIONS: Community groups want to partner with primary care organizations to serve their patients and populations. More research is needed on how best to bring these groups together.


Asunto(s)
Infecciones por Papillomavirus , Vacunas contra Papillomavirus , Adolescente , Humanos , Conocimientos, Actitudes y Práctica en Salud , Pandemias , Infecciones por Papillomavirus/prevención & control , Aceptación de la Atención de Salud , Atención Primaria de Salud , Vacunación , Ensayos Clínicos Controlados Aleatorios como Asunto
3.
Sci Rep ; 14(1): 411, 2024 01 03.
Artículo en Inglés | MEDLINE | ID: mdl-38172325

RESUMEN

Rural children are more at risk for childhood obesity but may have difficulty participating in pediatric weight management clinical trials if in-person visits are required. Remote assessment of height and weight observed via videoconferencing may provide a solution by improving the accuracy of self-reported data. This study aims to validate a low-cost, scalable video-assisted protocol for remote height and weight measurements in children and caregivers. Families were provided with low-cost digital scales and tape measures and a standardized protocol for remote measurements. Thirty-three caregiver and child (6-11 years old) dyads completed remote (at home) height and weight measurements while being observed by research staff via videoconferencing, as well as in-person measurements with research staff. We compared the overall and absolute mean differences in child and caregiver weight, height, body mass index (BMI), and child BMI adjusted Z-score (BMIaz) between remote and in-person measurements using paired samples t-tests and one sample t-tests, respectively. Bland-Altman plots were used to estimate the limits of agreement (LOA) and assess systematic bias. Simple regression models were used to examine associations between measurement discrepancies and sociodemographic factors and number of days between measurements. Overall mean differences in child and caregiver weight, height, BMI, and child BMIaz were not significantly different between remote and in-person measurements. LOAs were - 2.1 and 1.7 kg for child weight, - 5.2 and 4.0 cm for child height, - 1.5 and 1.7 kg/m2 for child BMI, - 0.4 and 0.5 SD for child BMIaz, - 3.0 and 2.8 kg for caregiver weight, - 2.9 and 3.9 cm for caregiver height, and - 2.1 and 1.6 kg/m2 for caregiver BMI. Absolute mean differences were significantly different between the two approaches for all measurements. Child and caregiver age were each significantly associated with differences between remote and in-person caregiver height measurements; there were no significant associations with other measurement discrepancies. Remotely observed weight and height measurements using non-research grade equipment may be a feasible and valid approach for pediatric clinical trials in rural communities. However, researchers should carefully evaluate their measurement precision requirements and intervention effect size to determine whether remote height and weight measurements suit their studies.Trial registration: ClinicalTrials.gov NCT04142034 (29/10/2019).


Asunto(s)
Obesidad Infantil , Humanos , Niño , Peso Corporal , Obesidad Infantil/diagnóstico , Población Rural , Estatura , Índice de Masa Corporal , Atención Primaria de Salud
4.
Child Obes ; 20(3): 147-154, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37036783

RESUMEN

Objective: To describe satisfaction with the telehealth aspect of a pediatric obesity intervention among families from multiple rural communities and assess differences in satisfaction based on sociodemographic factors. Methods: This is a secondary analysis of data from a pilot randomized controlled trial of a 6-month intensive lifestyle intervention (iAmHealthy) delivered through telehealth to children 6-11 years old with BMI ≥85th%ile and their parents from rural communities. Parents completed a sociodemographic survey and a validated survey to assess satisfaction with the telehealth intervention across four domains (technical functioning, comfort of patient and provider with technology and perceived privacy, timely and geographic access to care, and global satisfaction) on a 5-point Likert scale. Kruskal-Wallis nonparametric rank test were used to compare mean satisfaction scores based on parent sociodemographics. Results: Forty-two out of 52 parents (67% White, 29% Black, 5% multiracial, and 50% with household income <$40,000) completed the survey. Mean satisfaction scores ranged from 4.16 to 4.54 (standard deviation 0.44-0.61). Parents without a college degree reported higher satisfaction across all domains compared with parents with a college degree, including global satisfaction (mean 4.64 vs. 4.31, p = 0.03). Parents reporting a household income <$40,000 (mean 4.70) reported higher scores in the comfort with technology and perceived privacy domain compared with parents with higher incomes (mean 4.30-4.45, p = 0.04). Discussion: Parents from rural communities, especially those from lower socioeconomic backgrounds, were highly satisfied with the iAmHealthy telehealth intervention. These findings can be used to inform future telehealth interventions among larger more diverse populations. ClinicalTrials.gov Identifier: NCT04142034.


Asunto(s)
Obesidad Infantil , Telemedicina , Niño , Humanos , Obesidad Infantil/epidemiología , Obesidad Infantil/prevención & control , Población Rural , Padres , Composición Familiar
5.
Pediatrics ; 152(5)2023 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-37867449

RESUMEN

OBJECTIVES: Addressing parental/caregivers' coronavirus disease 2019 (COVID-19) vaccine hesitancy is critical to improving vaccine uptake in children. Common concerns have been previously reported through online surveys, but qualitative data from KII and focus groups may add much-needed context. Our objective was to examine factors impacting pediatric COVID-19 vaccine decision-making in Black, Spanish-speaking, and rural white parents/caregivers to inform the content design of a mobile application to improve pediatric COVID-19 vaccine uptake. METHODS: Parents/caregivers of children aged 2 to 17 years from groups disproportionately affected by COVID-19-related vaccine hesitancy (rural-dwelling persons of any race/ethnicity, urban Black persons, and Spanish-speaking persons) were included on the basis of their self-reported vaccine hesitancy and stratified by race/ethnicity. Those expressing vaccine acceptance or refusal participated in KII, and those expressing hesitancy in focus groups. Deidentified transcripts underwent discourse analysis and thematic analysis, both individually and as a collection. Themes were revised until coders reached consensus. RESULTS: Overall, 36 participants completed the study: 4 vaccine acceptors and 4 refusers via KIIs, and the remaining 28 participated in focus groups. Participants from all focus groups expressed that they would listen to their doctor for information about COVID-19 vaccines. Infertility was a common concern, along with general concerns about vaccines. Vaccine decision-making was informed by the amount of information available to parents/caregivers, including scientific research; possible positive and negative long-term effects; and potential impacts of vaccination on preexisting medical conditions. CONCLUSIONS: Parents/caregivers report numerous addressable vaccine concerns. Our results will inform specific, targeted interventions for improving COVID-19 vaccine confidence.


Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Humanos , Niño , COVID-19/prevención & control , Investigación Cualitativa , Grupos Focales , Padres , Vacunación
6.
Vaccine ; 41(39): 5758-5762, 2023 09 07.
Artículo en Inglés | MEDLINE | ID: mdl-37573204

RESUMEN

INTRODUCTION: Immunization Information Systems (IIS) play an important information-sharing role at the point of care, and provide vital vaccination data for research studies and policy-makers. Previous validation studies comparing the accuracy of state registry data to health records have had mixed results. METHODS: We conducted a retrospective review of EHR vaccination data for 9-17 year-old patients from 10 Oregon primary care clinics who had at least one ambulatory care visit in the past 3 years from the date of validation data collection. Data on 100 age eligible youth were captured per clinic. We compared HPV and Tdap vaccinations captured in the EHR to the Oregon ALERT IIS. All clinics were located in rural areas with both family medicine (n = 7) and pediatric (n = 3) primary care clinics. RESULTS: Overall agreement for HPV vaccination between EHR and ALERT IIS was 89.4 % (k = 0.83; p < 0.05). For Tdap vaccination overall agreement was 80.8 % (k = 0.60; p < 0.05). Pediatric clinics showed a higher overall vaccine agreement for both HPV at 93.3 % (k = 0.89; p < 0.05) and Tdap at 95.3 % (k = 0.90; p < 0.05). Among clinics that used bidirectional data exchange (only family medicine clinics), HPV agreement was higher at 91 % (k = 0.85) versus 88 % (k = 0.81; p < 0.05) and was lower for Tdap 75 % with bidirectional data exchange (k = 0.50) versus 86 % without bidirectional data exchange (k = 0.70; p < 0.05). When the EHR and ALERT IIS disagreed, ALERT ISS usually had additional vaccines. CONCLUSIONS: ALERT IIS data provides more accurate data than EHRs can provide when measuring vaccine delivery among adolescents in rural Oregon.


Asunto(s)
Infecciones por Papillomavirus , Vacunas contra Papillomavirus , Adolescente , Humanos , Niño , Virus del Papiloma Humano , Registros Electrónicos de Salud , Oregon , Infecciones por Papillomavirus/prevención & control , Vacunación , Inmunización , Sistema de Registros , Vacunas Bacterianas
7.
J Rural Health ; 39(2): 499-507, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36396353

RESUMEN

PURPOSE: Human papillomavirus (HPV) infection contributes to vaccine-preventable malignancies. Rural populations experience lower HPV vaccination rates despite similar rates of other childhood vaccinations. Individual- and clinic-level characteristics likely contribute to this disparity, but little is known about the separate roles of each. We compared clinic-level HPV vaccination rates among rural versus urban primary care clinics, identified factors associated with HPV vaccination, and separately assessed the impact of individual- and clinic-level characteristics on rural disparities in HPV vaccination. METHODS: This cross-sectional study included 537 Oregon primary care clinics participating in the Vaccines for Children (VFC) program during 2019. Vaccination status was assessed using Oregon's ALERT Immunization Information System and included HPV vaccine ≥ 1 dose for ages 11 and 12; HPV vaccination up to date (UTD) for ages 13-17, and coadministration with tetanus, diphtheria, and acellular pertussis (Tdap). Rural versus urban clinic-level outcomes were assessed using negative binomial regression. FINDINGS: Participating clinics were 24.5% rural and 75.6% urban. Family medicine clinics comprised 71.1%; pediatrics, 16.9%; and mixed, 12.1%. Across clinics, the average proportion of patients qualifying for VFC was 43%, and non-White patients were 14.1%. The mean rate of HPV vaccine ≥1 dose was lower among rural clinics (46.9% vs 51.1%, P = .039), as was vaccination UTD (40.5% vs 49.9%, P < .001). Adjusting for differences in individual- and clinic-level characteristics, rural disparities were no longer statistically significant. CONCLUSIONS: Both individual- and clinic-level characteristics play a role in rural disparities in HPV vaccination, and modifiable clinic-level differences may be opportune targets to address these disparities.


Asunto(s)
Infecciones por Papillomavirus , Vacunas contra Papillomavirus , Humanos , Niño , Adolescente , Infecciones por Papillomavirus/prevención & control , Virus del Papiloma Humano , Oregon , Estudios Transversales , Población Rural , Vacunas contra Papillomavirus/uso terapéutico , Vacunación , Atención Primaria de Salud
8.
Clin Pediatr (Phila) ; 62(1): 24-32, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-35883261

RESUMEN

Vaccine refusal is increasing. Objectives were to assess frequency of declining or dismissing patients who refuse vaccines, which vaccine(s) prompt pediatricians to decline/dismiss patients, and demographics of pediatricians who decline/dismiss patients. Active members of the Oklahoma American Academy of Pediatricians (AAP) were surveyed. Chi-square tests with non-overlapping 95% confidence intervals compared proportions of providers across various metrics. In all, 47% (48/103) versus 35% (34/98) reported declining versus dismissing patients for refusing vaccines, respectively. Pediatricians were unlikely to decline/dismiss patients if they refused influenza, human papilloma virus (HPV), or MenB vaccines. Pediatricians with more years in practice were less likely to decline 15% (9/62) versus 44% (16/36), P = 0.002 and dismiss 8% (5/62) versus 33% (12/36), P = 0.002 patients. Rural pediatricians were less likely than urban to decline 12% (2/17) versus 29% (26/89), P = NS and dismiss patients 0% (0/17) versus 21% (19/89), P = 0.04. Dismissing/declining patients for vaccine refusal is more common among Oklahoma pediatricians than nationally reported. Patterns differ by practice setting, years in practice, and specific vaccine refused.


Asunto(s)
Pediatras , Vacunas , Humanos , Estados Unidos , Oklahoma , Negativa a la Vacunación , Encuestas y Cuestionarios , Vacunación , Conocimientos, Actitudes y Práctica en Salud
9.
JAMA Netw Open ; 5(11): e2244040, 2022 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-36445709

RESUMEN

Importance: To our knowledge, there are no published randomized clinical trials of recruitment strategies. Rigorously evaluated successful recruitment strategies for children are needed. Objective: To evaluate the feasibility of 2 recruitment methods for enrolling rural children through primary care clinics to assess whether either or both methods are sufficiently effective for enrolling participants into a clinical trial of a behavioral telehealth intervention for children with overweight or obesity. Design, Setting, and Participants: This cluster-randomized clinical trial of 2 recruitment methods was conducted at 4 primary care clinics in 4 separate states. Each clinic used both recruitment methods in random order. Clinic eligibility criteria included at least 40% pediatric patients with Medicaid coverage and at least 100 potential participants. Eligibility criteria for children included a rural home address, age 6 to 11 years, and body mass index at or above the 85th percentile. Recruitment began February 3, 2020, and randomization of participants occurred on August 17, 2020. Data were analyzed from October 3, 2021, to April 21, 2022. Interventions: Two recruitment methods were assessed: the active method, for which a list of potential participants seen within the past year at each clinic was generated through the electronic health record and consecutively approached by research staff based on visit date to the clinic, and the traditional method, for which recruitment included posters, flyers, social media, and press release. Clinics were randomized to the order in which the 2 methods were implemented in 4-week periods, followed by a 4-week catch-up period using the method found most effective in previous periods. Main Outcomes and Measures: For each recruitment method, the number and proportion of randomized children among those who were approached was calculated. Results: A total of 104 participants were randomized (58 girls [55.8%]; mean age, 9.3 [95% CI, 9.0-9.6] years). Using the active method, 535 child-parent dyads were approached and 99 (18.5% [95% CI, 15.3%-22.1%]) were randomized. Using the traditional method, 23 caregivers expressed interest, and 5 (21.7% [95% CI, 7.5%-43.7%]) were randomized. All sites reached full enrollment using the active method and no sites achieved full enrollment using the traditional method. Mean time to full enrollment was 26.3 (range, 21.0-31.0) days. Conclusions and Relevance: This study supports the use of the active approach with local primary care clinics to recruit children with overweight and obesity from rural communities into clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT04142034.


Asunto(s)
Sobrepeso , Población Rural , Femenino , Estados Unidos , Humanos , Niño , Índice de Masa Corporal , Obesidad , Atención Primaria de Salud
10.
Res Sq ; 2022 Oct 10.
Artículo en Inglés | MEDLINE | ID: mdl-36238712

RESUMEN

Background: Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19. Methods: Custodial parents/caregivers with ≥1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child's age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine. Discussion: The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine-uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts. Clinical Trials Registration: Name of the registry: clinicaltrials.gov Trial registration number: NCT05386355 Date of registration: May 23, 2022 URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT05386355.

11.
Trials ; 23(1): 911, 2022 Oct 28.
Artículo en Inglés | MEDLINE | ID: mdl-36307830

RESUMEN

BACKGROUND: Coronavirus disease 2019 (COVID-19) vaccines demonstrate excellent effectiveness against infection, severe disease, and death. However, pediatric COVID-19 vaccination rates lag among individuals from rural and other medically underserved communities. The research objective of the current protocol is to determine the effectiveness of a vaccine communication mobile health (mHealth) application (app) on parental decisions to vaccinate their children against COVID-19. METHODS: Custodial parents/caregivers with ≥ 1 child eligible for COVID-19 vaccination who have not yet received the vaccine will be randomized to download one of two mHealth apps. The intervention app will address logistical and motivational barriers to pediatric COVID-19 vaccination. Participants will receive eight weekly push notifications followed by two monthly push notifications (cues to action) regarding vaccinating their child. Through branching logic, users will access customized content based on their locality, degree of rurality-urbanicity, primary language (English/Spanish), race/ethnicity, and child's age to address COVID-19 vaccine knowledge and confidence gaps. The control app will provide push notifications and information on general pediatric health and infection prevention and mitigation strategies based on recommendations from the American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC). The primary outcome is the proportion of children who complete COVID-19 vaccination series. Secondary outcomes include the proportion of children who receive ≥ 1 dose of COVID-19 vaccine and changes in parent/caregiver scores from baseline to immediately post-intervention on the modified WHO SAGE Vaccine Hesitancy Scale adapted for the COVID-19 vaccine. DISCUSSION: The COVID-19 pandemic inflicts disproportionate harm on individuals from underserved communities, including those in rural settings. Maximizing vaccine uptake in these communities will decrease infection rates, severe illness, and death. Given that most US families from these communities use smart phones, mHealth interventions hold the promise of broad uptake. Bundling multiple mHealth vaccine uptake interventions into a single app may maximize the impact of deploying such a tool to increase COVID-19 vaccination. The new knowledge to be gained from this study will directly inform future efforts to increase COVID-19 vaccination rates across diverse settings and provide an evidentiary base for app-based vaccine communication tools that can be adapted to future vaccine-deployment efforts. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT05386355 . Registered on May 23, 2022.


Asunto(s)
COVID-19 , Telemedicina , Vacunas , Niño , Humanos , Vacunas contra la COVID-19 , Pandemias/prevención & control , COVID-19/prevención & control , Vacunación , Ensayos Clínicos Controlados Aleatorios como Asunto
12.
J Clin Transl Sci ; 6(1): e115, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36285019

RESUMEN

Background/Objective: Prior to the COVID-19 pandemic, our research group initiated a pediatric practice-based randomized trial for the treatment of childhood obesity in rural communities. Approximately 6 weeks into the originally planned 10-week enrollment period, the trial was forced to pause all study activity due to the COVID-19 pandemic. This pause necessitated a substantial revision in recruitment, enrollment, and other study methods in order to complete the trial using virtual procedures. This descriptive paper outlines methods used to recruit, enroll, and manage clinical trial participants with technology to obtain informed consent, obtain height and weight measurements by video, and maintain participant engagement throughout the duration of the trial. Methods: The study team reviewed the IRB records, protocol team meeting minutes and records, and surveyed the site teams to document the impact of the COVID-19 shift to virtual procedures on the study. The IRB approved study changes allowed for flexibility between clinical sites given variations in site resources, which was key to success of the implementation. Results: All study sites faced a variety of logistical challenges unique to their location yet successfully recruited the required number of patients for the trial. Ultimately, virtual procedures enhanced our ability to establish relationships with participants who were previously beyond our reach, but presented several challenges and required additional resources. Conclusion: Lessons learned from this study can assist other study groups in navigating challenges, especially when recruiting and implementing studies with rural and underserved populations or during challenging events like the pandemic.

13.
Prev Med Rep ; 28: 101893, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35855918

RESUMEN

Completion of the Human Papilloma Virus (HPV) vaccine series remains low. Partnerships between primary care (PC) clinics and local pharmacies could boost vaccination rates. We conducted a scoping literature review to address what is known and what gaps exist on the interface between U.S. primary care clinics and pharmacies for HPV vaccination. We searched Ovid MEDLINE ALL file and Cumulative Index to Allied Health Literature for articles published between 1/1/2010 and 12/31/2020. Search subjects included: 1) Pharmacy HPV Vaccination, 2) Pharmacy/PC Collaboration, and 3) Pharmacy/PC Collaboration vaccination. We developed an abstraction form to collect information on research methods, settings, strengths, weaknesses and findings. We screened 407 articles for inclusion; 17 met inclusion criteria: 13 (76.5%) reported on observational/descriptive studies; 4 articles (23.5%) reported on intervention studies, none of which were conducted in rural areas. Observational studies focused on willingness to be vaccinated for HPV and facilitators and barriers for vaccination, especially at pharmacies. Many studies concluded that knowledge about and comfort with HPV vaccine administration were needed for all vaccination stakeholders (clinicians, pharmacists, parents, and patients). Intervention studies were small with weak study designs, many of which revealed that pharmacists were not successful in integrating services into broader primary care systems. Challenges included getting physicians to sign standing order protocols, poor service delivery due to engagement barriers, and low parental demand for pharmacists to administer the vaccine. In conclusion, larger more discerning studies are needed to fully understand the potential of primary care and pharmacy interactions for HPV vaccination.

14.
Am J Public Health ; 111(9): 1645-1653, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34436921

RESUMEN

We provide guidance for conducting clinical trials with Indigenous children in the United States. We drew on extant literature and our experience to describe 3 best practices for the ethical and effective conduct of clinical trials with Indigenous children. Case examples of pediatric research conducted with American Indian, Alaska Native, and Native Hawaiian communities are provided to illustrate these practices. Ethical and effective clinical trials with Indigenous children require early and sustained community engagement, building capacity for Indigenous research, and supporting community oversight and ownership of research. Effective engagement requires equity, trust, shared interests, and mutual benefit among partners over time. Capacity building should prioritize developing Indigenous researchers. Supporting community oversight and ownership of research means that investigators should plan for data-sharing agreements, return or destruction of data, and multiple regulatory approvals. Indigenous children must be included in clinical trials to reduce health disparities and improve health outcomes in these pediatric populations. Establishment of the Environmental Influences on Child Health Outcomes Institutional Development Award States Pediatric Clinical Trials Network (ECHO ISPCTN) in 2016 creates a unique and timely opportunity to increase Indigenous children's participation in state-of-the-art clinical trials.


Asunto(s)
/estadística & datos numéricos , Creación de Capacidad/organización & administración , Protección a la Infancia/estadística & datos numéricos , Ensayos Clínicos como Asunto/normas , Indígenas Norteamericanos/estadística & datos numéricos , Niño , Humanos , Proyectos de Investigación , Seguridad , Estados Unidos
15.
Contemp Clin Trials ; 107: 106476, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-34118426

RESUMEN

A significant percentage of clinical trials fail due to poor recruitment. Despite this, few studies exist to evaluate clinical trial recruitment strategies using a randomized approach in any population, and none exist to test recruitment strategies for trials involving children or rural populations. For clinical trials focused on weight control, evaluating retention and dose are extremely important, as poor retention can lead to biased samples and existing research shows that dose (i.e. contact hours) is directly related to patient outcome. Finally, adequacy of blinding of assessment teams is rarely reported in pediatric trials, and unblinded staff may be more likely to inadvertently bias findings. Therefore, in this feasibility trial we aim to use rigorous clinical trial methodology to assess the effectiveness of two different recruitment strategies, as well as test retention, dose, and blinding. Specifically, we describe the rationale, design, and planned implementation of a feasibility study of a rural pediatric obesity treatment trial that will be implemented in four medical clinics in four states affiliated with the Environmental influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO ISPCTN). The primary objective is to assess recruitment rate for consecutive recruitment (approaching recently seen eligible patients in consecutive order by date seen) compared to traditional recruitment (such as posters, flyers, tear-offs), as well as to assess retention, dose, and blinding. If successful, this trial will support the implementation of a large multi-state trial directed at addressing obesity in rural children and their families recruited from their primary care clinics. Registered with ClinicalTrials.gov NCT ID NCT04142034.


Asunto(s)
Obesidad Infantil , Población Rural , Niño , Estudios Cruzados , Estudios de Factibilidad , Humanos , Obesidad Infantil/prevención & control , Atención Primaria de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto
16.
Hum Vaccin Immunother ; 17(4): 1059-1067, 2021 04 03.
Artículo en Inglés | MEDLINE | ID: mdl-33074774

RESUMEN

This study explored the association between provider recommendation and adolescent vaccine coverage. We analyzed data from the 2008 to 2018 National Immunization Survey-Teen including coverage with one dose of quadrivalent meningococcal conjugate vaccine (MenACWY), Tetanus-diphtheria-acellular pertussis vaccine (Tdap), and one and three doses of Human papillomavirus (HPV) vaccine. We compared vaccine coverage between those who recalled a provider recommendation and those who did not. Among those who received a provider recommendation for MenACWY, coverage trended from 67.8% (2008) to 88.1% (2013), contrasted to those who did not, trending from 30.9% to 73.1%. Among those with a provider recommendation for Tdap, coverage trended from 47.6% to 89.7%, contrasted to those who did not, trending from 35.6% to 82.2%. Among females with a provider recommendation for HPV vaccine, receipt of initial dose of HPV vaccine trended from 57.5% (2008) to 74.3% (2018), contrasted to those who did not, trending from 18.1% to 49.8%, and among males, trended from 17.2% (2010) to 75.1% (2018) for those with a provider recommendation, compared to 0.5% to 44.7% for those without. In 2013, coverage difference by provider recommendation was 26.0% among females for one dose of HPV vaccine and 21.9% for three doses, and among males was 44.8% and 20.8%, respectively, while it was lower at 15% for MenACWY and 7.6% for Tdap. For each vaccine, coverage was higher with a provider recommendation; the largest difference was noted for HPV vaccine. This finding verifies for providers the importance of their recommendation, especially for the HPV vaccine.


Asunto(s)
Vacunas contra Difteria, Tétanos y Tos Ferina Acelular , Vacunas Meningococicas , Vacunas contra Papillomavirus , Adolescente , Femenino , Humanos , Esquemas de Inmunización , Masculino , Vacunación
17.
Vaccine ; 38(52): 8326-8333, 2020 12 14.
Artículo en Inglés | MEDLINE | ID: mdl-33208239

RESUMEN

BACKGROUND: Previous work suggests provider recommendation improves vaccine delivery. Less examined is the role of practice's front office staff and nurses in vaccine communication. Messaging and communication about vaccines should be consistent across all levels of the pediatric practice. METHODS: We distributed surveys to clinicians, nurses, front office staff, and parents of adolescents 11-17 years in pediatric and family medicine office practices. We inquired about perceived importance of adolescent vaccines and the use of recommendations to families about receiving vaccines. We also asked front office staff about concerns from families about vaccines as well as vaccine refusal for themselves and their child. RESULTS: Nurses perceived that the HPV vaccine was less important than the MenACWY and Tdap vaccines (% very important 84% v. 95% and 94%; P < .01). Parents also perceived HPV vaccine as being less important than MenACWY and Tdap vaccines (59% v 68% and 79%; P < .01. Between groups, parents perceived all vaccines as being less important than front office staff. Nurses and clinicians reported using a strong recommendation less often for HPV vaccine compared to the MenACWY and Tdap (70% v 84% and 84%; P < .01 for nurses, and 77% v. 88% and 86%; P < .05 for clinicians). Front office staff were more likely to report concerns from parents about HPV vaccine than from MenACWY and Tdap after the visit is complete. CONCLUSION: Parents, front office staff and nurses differ on the importance of vaccines. Interventions to improve vaccine communication and delivery must include all who work in the practice.


Asunto(s)
Vacunas contra Papillomavirus , Adolescente , Niño , Comunicación , Humanos , Padres , Encuestas y Cuestionarios , Vacunación
18.
Implement Sci ; 14(1): 30, 2019 03 14.
Artículo en Inglés | MEDLINE | ID: mdl-30866981

RESUMEN

OBJECTIVES: To test the effectiveness of a comprehensive team-based intervention to improve human papillomavirus (HPV) vaccination completion rates and reduce missed opportunities to vaccinate in rural Oregon. DESIGN: Stepped-wedge cluster randomized trial. PARTICIPANTS: Forty family physicians and pediatricians who are members of the Oregon Rural Practice-based Research Network. INTERVENTION: Tailored to individual practice needs, components will include (1) practice facilitation with clinicians, nurses, front office staff, and others who have patient contact to redesign patient care and communication strategies to optimize HPV vaccine series completion; (2) workflow mapping adapted to practice context to support HPV vaccine delivery; (3) a practice improvement model designed to firmly establish reminder and recall systems and then standing orders; (4) education for patients and parents that underscores HPV vaccination is safe, effective, and an important approach for reducing cancer risk; and (5) partnering with community organizations to plan and implement a social marketing campaign on HPV vaccination. MAIN OUTCOME MEASURES: Initiation and completion of the HPV vaccine series as well as reduction in rates of missed opportunities to vaccinate derived from Oregon Immunization Program data. TRIAL REGISTRATION: ClinicalTrials.govPRS, NCT03604393 : .Trial was registered on July 11, 2018. The first participant was enrolled on September 11, 2018.


Asunto(s)
Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus , Atención Primaria de Salud/estadística & datos numéricos , Vacunación/estadística & datos numéricos , Adolescente , Niño , Servicios de Salud del Niño/estadística & datos numéricos , Análisis por Conglomerados , Recolección de Datos , Utilización de Instalaciones y Servicios , Medicina Familiar y Comunitaria/estadística & datos numéricos , Femenino , Humanos , Masculino , Estudios Multicéntricos como Asunto , Oregon , Aceptación de la Atención de Salud/estadística & datos numéricos , Práctica Profesional/estadística & datos numéricos , Ensayos Clínicos Controlados Aleatorios como Asunto , Salud Rural/estadística & datos numéricos , Neoplasias Urogenitales/prevención & control , Neoplasias Urogenitales/virología
19.
Glob Pediatr Health ; 6: 2333794X18821948, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30671498

RESUMEN

Objective. To evaluate the association between characteristics known to be associated with under-immunization and participation in immunization campaigns among Peruvian children. Methods. This is an analysis of data collected as part of the Peru 2012 Demographic and Health Survey. Analyses were conducted among children in 2 groups: children aged 18 to 29 months among whom core vaccine coverage is typically determined by the Peruvian authorities and children aged 30 to 59 months who may have received the core vaccines at older ages. The associations between relative wealth, location, maternal education, primary maternal language and the outcome, participation in an immunization campaign within the past 2 years were estimated using logistic regression models adjusted for survey design in each age group. Results. For children aged 18 to 29 months, campaign participation was higher if the mother had completed secondary school compared with those not having completed secondary school (27.4% vs 20.1% [prevalence odds ratio (POR) = 1.51 (1.08, 2.13)]). For children aged 30 to 59 months, campaign participation was higher if the mother had completed secondary school (40.4% vs 35.1% [POR = 1.23 (1.02, 1.49)], adjusted for residence) and if the child resided in Lima versus in other urban areas (46% vs 35.4% [POR = 1.52 (1.16, 2.01)], adjusted for maternal education). Relative wealth and mothers' primary language were not associated with campaign participation. Conclusions. This study suggests that children of mothers with higher education and those residing in Lima had higher prevalence odds of reporting that their children had participated in a vaccination campaign. This contrasts with the populations vaccination campaigns typically target (poor, rural, or indigenous) to improve vaccination coverage.

20.
Vaccine ; 36(20): 2788-2793, 2018 05 11.
Artículo en Inglés | MEDLINE | ID: mdl-29653849

RESUMEN

BACKGROUND: Direct-to-adolescent text messaging may be a consideration for vaccine reminders, including human papilloma virus (HPV), but no studies have explored the minimum age at which parents would allow adolescents to receive a text message. METHODS: We distributed a survey to parents of 10-17 year olds during any office visit in two practice based research networks in South Carolina and Oklahoma. We asked about parental preference for receiving vaccine reminders for their adolescent, whether they would allow the healthcare provider to directly message their adolescent, and if so, what would be the acceptable minimum age. RESULTS: In 546 surveys from 11 practices, parents of females were more supportive of direct-to-teen text message reminders than were parents of males, (75% v. 60%, p < .001). The median age at which parents would allow direct text messages from physicians' offices was 14 in females compared to 15 in males, p = .049. We found a correlation between the child's age and the youngest age at which parents would allow a direct text message. Of the parents who permitted a text message directly to their adolescent, most reported an allowable age higher than their adolescent's current age until the age of 15. CONCLUSION: Our study suggests that direct-to-adolescent text messaging would be allowed by parents for older adolescents. This supports an intervention aimed at older adolescents, such as for receipt of MCV4 dose #2, delayed HPV vaccine series completion and annual influenza vaccination.


Asunto(s)
Citas y Horarios , Padres/psicología , Psicología del Adolescente , Sistemas Recordatorios/estadística & datos numéricos , Envío de Mensajes de Texto/estadística & datos numéricos , Vacunación/psicología , Adolescente , Adulto , Factores de Edad , Estudios Transversales , Femenino , Humanos , Vacunas contra la Influenza , Masculino , Vacunas Meningococicas , Oklahoma , Vacunas contra Papillomavirus , Factores Sexuales , South Carolina , Encuestas y Cuestionarios
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