<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02975596</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201601894</org_study_id>
    <secondary_id>27449113</secondary_id>
    <secondary_id>IRB201703013</secondary_id>
    <nct_id>NCT02975596</nct_id>
  </id_info>
  <brief_title>MenB Vaccine: Implementation Via Information, Empowerment and Accessibility</brief_title>
  <acronym>MenBVaccine</acronym>
  <official_title>Establishing and Evaluating a School and University Campus-Based Approach to Implementing Serogroup B Meningococcal (MenB) Disease Recommendations in Older Adolescents and Young Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      As part of an effort to increase MenB vaccine uptake among adolescents and young adults,&#xD;
      study teams will conduct qualitative research to maximize the effectiveness of nationally&#xD;
      recommended MenB educational materials. In this study, Study Teams will assess local barriers&#xD;
      to MenB vaccination by conducting focus groups with parents, students, and health care&#xD;
      professionals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants (parents of 16-23 year old teens and young adults, high school and college&#xD;
      students 16-23 years old, and health care professionals for 16-23 year olds) will be asked to&#xD;
      share their thoughts on the completeness of nationally recommended and publicly available&#xD;
      MenB vaccine educational materials in addressing hesitations to receipt of the MenB vaccine.&#xD;
      There is no risk in discussing reactions to educational materials. The biggest risk is&#xD;
      disclosure of information provided in the study which will be reactions to health-promotion&#xD;
      material.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">October 8, 2019</completion_date>
  <primary_completion_date type="Actual">October 8, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaccine uptake in adolescents and young adults</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage receiving MenB vaccine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge about MenB vaccine efficacy, potential benefits, possible side effects</measure>
    <time_frame>12 months</time_frame>
    <description>Percent of parents and young adults with Men B knowledge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attitudes re: Meningococcal B vaccine</measure>
    <time_frame>12 months</time_frame>
    <description>Pre- and Post- intervention surveys to assess attitudes, perceptions and decision-making re vaccine acceptance</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">1326</enrollment>
  <condition>Meningococcal Vaccine</condition>
  <arm_group>
    <arm_group_label>Youth</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Youth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>College</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Age between 18-23 will be offered awareness, education, empowerment and accessibility intervention components.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>parents of adolescents and young adults will be offered awareness, education, and accessibility intervention components.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent focus group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Parents discussed barriers and reviewed MenB education materials.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Provider focus groups</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Providers discussed barriers and reviewed MenB education materials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Awareness</intervention_name>
    <description>Awareness: Conduct an awareness campaign throughout Alachua County to alert the community in general to the significance of Serogroup B meningococcal disease in the United States. To inform the material included in the awareness campaign and the education materials, semi-structured interviews with members for each of the key stakeholder groups: students, parents, and medical practitioners will be conducted.</description>
    <arm_group_label>Adult</arm_group_label>
    <arm_group_label>College</arm_group_label>
    <arm_group_label>Youth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Education: This component will be both web-based and in-person to meet the individual needs of the learners. There will be parent and a student (18-23 years old) version of the educational curriculum. National resources of patient -focused materials and guidelines will be adapted. There will be pre- and post-education surveys to assess knowledge and vaccine decision-making.</description>
    <arm_group_label>Adult</arm_group_label>
    <arm_group_label>College</arm_group_label>
    <arm_group_label>Youth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Empowerment</intervention_name>
    <description>Empowerment: A guided program for adolescents and young adults on &quot;Decision-Making for your Health&quot; will be offered on the vaccination days to assist youth in assessing and utilizing health information to guide their personal decision-making for vaccines.</description>
    <arm_group_label>College</arm_group_label>
    <arm_group_label>Youth</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Accessibility</intervention_name>
    <description>Accessibility: MenB vaccine will be offer on the high school and university campuses through a collaborative program between the local schools, university and department of health. We will offer students booster shots of Men ACWY and HPV at the same time. All vaccines will be offered free of charge. Each vaccine administered will be recorded in Florida SHOTS.</description>
    <arm_group_label>Adult</arm_group_label>
    <arm_group_label>College</arm_group_label>
    <arm_group_label>Youth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must be able to provide informed consent or assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent or assent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Ryan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health Family Medicine and Pediatrics - Magnolia Parke</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Pediatric After Hours</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Pediatrics - Gerold L. Schiebler CMS Center</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Pediatrics - Tower Square</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Family Medicine - Eastside</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32641</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Soeters HM, McNamara LA, Whaley M, Wang X, Alexander-Scott N, Kanadanian KV, Kelleher CM, MacNeil J, Martin SW, Raines N, Sears S, Vanner C, Vuong J, Bandy U, Sicard K, Patel M; Centers for Disease Control (CDC). Serogroup B Meningococcal Disease Outbreak and Carriage Evaluation at a College - Rhode Island, 2015. MMWR Morb Mortal Wkly Rep. 2015 Jun 12;64(22):606-7.</citation>
    <PMID>26068563</PMID>
  </reference>
  <reference>
    <citation>MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel M, Martin SW. Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR Morb Mortal Wkly Rep. 2015 Oct 23;64(41):1171-6. doi: 10.15585/mmwr.mm6441a3.</citation>
    <PMID>26492381</PMID>
  </reference>
  <reference>
    <citation>Reagan-Steiner S, Yankey D, Jeyarajah J, Elam-Evans LD, Singleton JA, Curtis CR, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 Years - United States, 2014. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6429a3.htm. Accessed 24 June 2016.</citation>
  </reference>
  <reference>
    <citation>Hamborsky J, Kroger A, Wolfe CS. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 13th ed. Washington D.C. Public Health Foundation; 2015.</citation>
  </reference>
  <reference>
    <citation>McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988 Winter;15(4):351-77. doi: 10.1177/109019818801500401.</citation>
    <PMID>3068205</PMID>
  </reference>
  <reference>
    <citation>DiClemente RJ, Salazar LF, Crosby RA. A review of STD/HIV preventive interventions for adolescents: sustaining effects using an ecological approach. J Pediatr Psychol. 2007 Sep;32(8):888-906. doi: 10.1093/jpepsy/jsm056. Epub 2007 Aug 27.</citation>
    <PMID>17726032</PMID>
  </reference>
  <reference>
    <citation>Burrus B, Leeks KD, Sipe TA, Dolina S, Soler R, Elder R, Barrios L, Greenspan A, Fishbein D, Lindegren ML, Achrekar A, Dittus P; Community Preventive Services Task Force. Person-to-person interventions targeted to parents and other caregivers to improve adolescent health: a community guide systematic review. Am J Prev Med. 2012 Mar;42(3):316-26. doi: 10.1016/j.amepre.2011.12.001.</citation>
    <PMID>22341170</PMID>
  </reference>
  <reference>
    <citation>Albert D, Chein J, Steinberg L. Peer Influences on Adolescent Decision Making. Curr Dir Psychol Sci. 2013 Apr;22(2):114-120. doi: 10.1177/0963721412471347.</citation>
    <PMID>25544805</PMID>
  </reference>
  <reference>
    <citation>Corbin J, Strauss A. Basics of qualitative research: Techniques and procedures for developing grounded theory. Sage publications; 2014.</citation>
  </reference>
  <reference>
    <citation>Centers for Disease Control and Prevention. Adolescent and adult vaccine quiz. http://www2.cdc.gov/nip/adultimmsched/. Accessed 24 June 2016.</citation>
  </reference>
  <reference>
    <citation>Tsai Y, Zhou F, Wortley P, Shefer A, Stokley S. Trends and characteristics of preventive care visits among commercially insured adolescents, 2003-2010. J Pediatr. 2014 Mar;164(3):625-30. doi: 10.1016/j.jpeds.2013.10.042. Epub 2013 Nov 25.</citation>
    <PMID>24286572</PMID>
  </reference>
  <reference>
    <citation>Tran CH, Sugimoto JD, Pulliam JR, Ryan KA, Myers PD, Castleman JB, Doty R, Johnson J, Stringfellow J, Kovacevich N, Brew J, Cheung LL, Caron B, Lipori G, Harle CA, Alexander C, Yang Y, Longini IM Jr, Halloran ME, Morris JG Jr, Small PA Jr. School-located influenza vaccination reduces community risk for influenza and influenza-like illness emergency care visits. PLoS One. 2014 Dec 9;9(12):e114479. doi: 10.1371/journal.pone.0114479. eCollection 2014.</citation>
    <PMID>25489850</PMID>
  </reference>
  <reference>
    <citation>Livingston MD, Komro KA, Wagenaar AC. The effects of survey modality on adolescents' responses to alcohol use items. Alcohol Clin Exp Res. 2015 Apr;39(4):710-5. doi: 10.1111/acer.12659. Epub 2015 Mar 9.</citation>
    <PMID>25752744</PMID>
  </reference>
  <reference>
    <citation>Edwards PJ, Roberts I, Clarke MJ, Diguiseppi C, Wentz R, Kwan I, Cooper R, Felix LM, Pratap S. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):MR000008. doi: 10.1002/14651858.MR000008.pub4.</citation>
    <PMID>19588449</PMID>
  </reference>
  <reference>
    <citation>Faes C, Molenberghs G, Aerts M, Verbeke G, Kenward MG. The effective sample size and an alternative small-sample degrees-of-freedom method. Am Stat. 2009 Nov 1;63(4):389-99.</citation>
  </reference>
  <reference>
    <citation>Yuan CT, Nembhard IM, Stern AF, Brush JE Jr, Krumholz HM, Bradley EH. Blueprint for the dissemination of evidence-based practices in health care. Issue Brief (Commonw Fund). 2010 May;86:1-16.</citation>
    <PMID>20469542</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>educational intervention</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02975596
org study id: IRB201601894
secondary id: 27449113
secondary id: IRB201703013
nct id: NCT02975596
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As part of an effort to increase MenB vaccine uptake among adolescents and young adults,
      study teams will conduct qualitative research to maximize the effectiveness of nationally
      recommended MenB educational materials. In this study, Study Teams will assess local barriers
      to MenB vaccination by conducting focus groups with parents, students, and health care
      professionals.
Participants (parents of 16-23 year old teens and young adults, high school and college
      students 16-23 years old, and health care professionals for 16-23 year olds) will be asked to
      share their thoughts on the completeness of nationally recommended and publicly available
      MenB vaccine educational materials in addressing hesitations to receipt of the MenB vaccine.
      There is no risk in discussing reactions to educational materials. The biggest risk is
      disclosure of information provided in the study which will be reactions to health-promotion
      material.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Vaccine uptake in adolescents and young adults
time frame: 12 months
description: Percentage receiving MenB vaccine
measure: Knowledge about MenB vaccine efficacy, potential benefits, possible side effects
time frame: 12 months
description: Percent of parents and young adults with Men B knowledge
measure: Attitudes re: Meningococcal B vaccine
time frame: 12 months
description: Pre- and Post- intervention surveys to assess attitudes, perceptions and decision-making re vaccine acceptance
arm group label: Youth
arm group type: Other
description: Youth between the ages beteen ages 13-18 will be offered awareness, education, empowerment and accessibility intervention components.
arm group label: College
arm group type: Other
description: Age between 18-23 will be offered awareness, education, empowerment and accessibility intervention components.
arm group label: Adult
arm group type: Other
description: parents of adolescents and young adults will be offered awareness, education, and accessibility intervention components.
arm group label: Parent focus group
arm group type: No Intervention
description: Parents discussed barriers and reviewed MenB education materials.
arm group label: Provider focus groups
arm group type: No Intervention
description: Providers discussed barriers and reviewed MenB education materials.
intervention type: Other
intervention name: Awareness
description: Awareness: Conduct an awareness campaign throughout Alachua County to alert the community in general to the significance of Serogroup B meningococcal disease in the United States. To inform the material included in the awareness campaign and the education materials, semi-structured interviews with members for each of the key stakeholder groups: students, parents, and medical practitioners will be conducted.
arm group label: Adult
arm group label: College
arm group label: Youth
intervention type: Other
intervention name: Education
description: Education: This component will be both web-based and in-person to meet the individual needs of the learners. There will be parent and a student (18-23 years old) version of the educational curriculum. National resources of patient -focused materials and guidelines will be adapted. There will be pre- and post-education surveys to assess knowledge and vaccine decision-making.
arm group label: Adult
arm group label: College
arm group label: Youth
intervention type: Other
intervention name: Empowerment
description: Empowerment: A guided program for adolescents and young adults on "Decision-Making for your Health" will be offered on the vaccination days to assist youth in assessing and utilizing health information to guide their personal decision-making for vaccines.
arm group label: College
arm group label: Youth
intervention type: Other
intervention name: Accessibility
description: Accessibility: MenB vaccine will be offer on the high school and university campuses through a collaborative program between the local schools, university and department of health. We will offer students booster shots of Men ACWY and HPV at the same time. All vaccines will be offered free of charge. Each vaccine administered will be recorded in Florida SHOTS.
arm group label: Adult
arm group label: College
arm group label: Youth
criteria: 
gender: All
minimum age: 16 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen Ryan, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Soeters HM, McNamara LA, Whaley M, Wang X, Alexander-Scott N, Kanadanian KV, Kelleher CM, MacNeil J, Martin SW, Raines N, Sears S, Vanner C, Vuong J, Bandy U, Sicard K, Patel M; Centers for Disease Control (CDC). Serogroup B Meningococcal Disease Outbreak and Carriage Evaluation at a College - Rhode Island, 2015. MMWR Morb Mortal Wkly Rep. 2015 Jun 12;64(22):606-7.
PMID: 26068563
citation: MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel M, Martin SW. Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR Morb Mortal Wkly Rep. 2015 Oct 23;64(41):1171-6. doi: 10.15585/mmwr.mm6441a3.
PMID: 26492381
citation: Reagan-Steiner S, Yankey D, Jeyarajah J, Elam-Evans LD, Singleton JA, Curtis CR, et al. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 Years - United States, 2014. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6429a3.htm. Accessed 24 June 2016.
citation: Hamborsky J, Kroger A, Wolfe CS. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 13th ed. Washington D.C. Public Health Foundation; 2015.
citation: McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988 Winter;15(4):351-77. doi: 10.1177/109019818801500401.
PMID: 3068205
citation: DiClemente RJ, Salazar LF, Crosby RA. A review of STD/HIV preventive interventions for adolescents: sustaining effects using an ecological approach. J Pediatr Psychol. 2007 Sep;32(8):888-906. doi: 10.1093/jpepsy/jsm056. Epub 2007 Aug 27.
PMID: 17726032
citation: Burrus B, Leeks KD, Sipe TA, Dolina S, Soler R, Elder R, Barrios L, Greenspan A, Fishbein D, Lindegren ML, Achrekar A, Dittus P; Community Preventive Services Task Force. Person-to-person interventions targeted to parents and other caregivers to improve adolescent health: a community guide systematic review. Am J Prev Med. 2012 Mar;42(3):316-26. doi: 10.1016/j.amepre.2011.12.001.
PMID: 22341170
citation: Albert D, Chein J, Steinberg L. Peer Influences on Adolescent Decision Making. Curr Dir Psychol Sci. 2013 Apr;22(2):114-120. doi: 10.1177/0963721412471347.
PMID: 25544805
citation: Corbin J, Strauss A. Basics of qualitative research: Techniques and procedures for developing grounded theory. Sage publications; 2014.
citation: Centers for Disease Control and Prevention. Adolescent and adult vaccine quiz. http://www2.cdc.gov/nip/adultimmsched/. Accessed 24 June 2016.
citation: Tsai Y, Zhou F, Wortley P, Shefer A, Stokley S. Trends and characteristics of preventive care visits among commercially insured adolescents, 2003-2010. J Pediatr. 2014 Mar;164(3):625-30. doi: 10.1016/j.jpeds.2013.10.042. Epub 2013 Nov 25.
PMID: 24286572
citation: Tran CH, Sugimoto JD, Pulliam JR, Ryan KA, Myers PD, Castleman JB, Doty R, Johnson J, Stringfellow J, Kovacevich N, Brew J, Cheung LL, Caron B, Lipori G, Harle CA, Alexander C, Yang Y, Longini IM Jr, Halloran ME, Morris JG Jr, Small PA Jr. School-located influenza vaccination reduces community risk for influenza and influenza-like illness emergency care visits. PLoS One. 2014 Dec 9;9(12):e114479. doi: 10.1371/journal.pone.0114479. eCollection 2014.
PMID: 25489850
citation: Livingston MD, Komro KA, Wagenaar AC. The effects of survey modality on adolescents' responses to alcohol use items. Alcohol Clin Exp Res. 2015 Apr;39(4):710-5. doi: 10.1111/acer.12659. Epub 2015 Mar 9.
PMID: 25752744
citation: Edwards PJ, Roberts I, Clarke MJ, Diguiseppi C, Wentz R, Kwan I, Cooper R, Felix LM, Pratap S. Methods to increase response to postal and electronic questionnaires. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):MR000008. doi: 10.1002/14651858.MR000008.pub4.
PMID: 19588449
citation: Faes C, Molenberghs G, Aerts M, Verbeke G, Kenward MG. The effective sample size and an alternative small-sample degrees-of-freedom method. Am Stat. 2009 Nov 1;63(4):389-99.
citation: Yuan CT, Nembhard IM, Stern AF, Brush JE Jr, Krumholz HM, Bradley EH. Blueprint for the dissemination of evidence-based practices in health care. Issue Brief (Commonw Fund). 2010 May;86:1-16.
PMID: 20469542
responsible party type: Sponsor
sharing ipd: No