<?xml version="1.0"?>
<doi_batch xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://www.crossref.org/schema/4.4.0" xmlns:fr="http://www.crossref.org/fundref.xsd" xmlns:ct="http://www.crossref.org/clinicaltrials.xsd" xmlns:ai="http://www.crossref.org/AccessIndicators.xsd" xmlns:rel="http://www.crossref.org/relations.xsd" xmlns:jats="http://www.ncbi.nlm.nih.gov/JATS1" version="4.4.0" xsi:schemaLocation="http://www.crossref.org/schema/4.4.0 crossref4.4.0.xsd">
  <head>
    <doi_batch_id>TODENTJ-25-03-2019_TODENTJ-4-55</doi_batch_id>
    <timestamp>1553505149</timestamp>
    <depositor>
      <depositor_name>Bentham Open</depositor_name>
      <email_address>doi@benthamopen.net</email_address>
    </depositor>
    <registrant>Bentham Open</registrant>
  </head>
  <body>
    <journal>
      <journal_metadata language="en">
        <full_title>The Open Dentistry Journal</full_title>
        <abbrev_title>TODENTJ</abbrev_title>
        <issn media_type="print">1874-2106</issn>
      </journal_metadata>
      <journal_issue>
        <publication_date media_type="print">
          <month>7</month>
          <day>16</day>
          <year>2010</year>
        </publication_date>
        <journal_volume>
          <volume>4</volume>
        </journal_volume>
        <issue>1</issue>
      </journal_issue>
      <journal_article publication_type="full_text">
        <titles>
          <title>Dealing with Missing Outcomes: Lessons from a Randomized Trial of a Prenatal Intervention to Prevent Early Childhood Caries </title>
        </titles>
        <contributors>
          <person_name contributor_role="author" sequence="first">
            <given_name>Kamila </given_name>
            <surname>Plutzer</surname>
          </person_name>
          <person_name contributor_role="author" sequence="additional">
            <given_name>Gloria C</given_name>
            <surname>Mejia</surname>
          </person_name>
          <person_name contributor_role="author" sequence="additional">
            <given_name>A. John</given_name>
            <surname>Spencer</surname>
          </person_name>
          <person_name contributor_role="author" sequence="additional">
            <given_name>Marc J.N.C</given_name>
            <surname>Keirse</surname>
          </person_name>
        </contributors>
        <jats:abstract>
                <jats:p>Severe early childhood caries (S-ECC) affects 17% of 2-3 year old children in South Australia impacting on their general health and well-being. S-ECC is largely preventable by providing mothers with anticipatory guidance. Randomised controlled trials (RCTs) are the most decisive way to test this, but that approach suffers from near inevitable loss to follow-up that occurs with preventative strategies and distant outcome assessment.</jats:p>
                <jats:p>We re-examined the results of an RCT to prevent S-ECC using sensitivity analyses and multiple imputation to test different assumptions about violation of random allocation (1%) and major loss to follow-up (32%). Irrespective of any assumptions about missing outcomes, providing expectant mothers with anticipatory guidance during pregnancy and in the child’s first year of life, significantly reduced the incidence of S-ECC at 20 months of age. However, the relative risk of S-ECC varied from 0.18 (95% confidence interval (CI): 0.06 – 0.52) to 0.70 (95% CI: 0.56 – 0.88). Also the ‘number needed to treat’ (NNT) to prevent one case of S-ECC varied 2.5-fold: from 8 to 20 women given anticipatory guidance. Multiple imputation provided a best estimate of 0.25 (95% CI: 0.11 – 0.56) for the relative risk and of 14 (95% CI: 10 – 33) for the number needed to treat.</jats:p>
                <jats:p>Avoiding loss to follow-up is crucial in any RCT, but is difficult with preventative health care strategies. Instead of abandoning randomisation in such circumstances, sensitivity analyses and multiple imputation can consolidate the findings of an RCT and add extra value to the conclusions derived from it.</jats:p>
            </jats:abstract>
        <publication_date>
          <month>7</month>
          <day>16</day>
          <year>2010</year>
        </publication_date>
        <pages>
          <first_page>55</first_page>
          <last_page>60</last_page>
        </pages>
        <publisher_item>
          <identifier id_type="sici">TODENTJ-4-55</identifier>
        </publisher_item>
        <crossmark>
          <crossmark_version>1</crossmark_version>
          <crossmark_policy>10.2174/crossmark_policy</crossmark_policy>
          <crossmark_domains>
            <crossmark_domain>
              <domain>opendentistryjournal.com</domain>
            </crossmark_domain>
            <crossmark_domain>
              <domain>benthamopen.com</domain>
            </crossmark_domain>
          </crossmark_domains>
          <crossmark_domain_exclusive>true</crossmark_domain_exclusive>
          <custom_metadata>
            <assertion name="review_status" label="Review Status" group_name="peer_review_details" group_label="Peer Review Details" order="0">Peer Reviewed</assertion>
            <assertion name="review_process" label="Review Process" group_name="peer_review_details" group_label="Peer Review Details" order="1">Single blind</assertion>
            <assertion name="screening_status" label="Screening Status" group_name="plagiarism_screening" group_label="Plagiarism Screening" order="0">Checked with iThenticate</assertion>
            <assertion name="received" label="Received" group_name="publication_history" group_label="Publication History" order="0">2009-10-2</assertion>
            <assertion name="revised" label="Revised" group_name="publication_history" group_label="Publication History" order="1">2009-10-14</assertion>
            <assertion name="accepted" label="Accepted" group_name="publication_history" group_label="Publication History" order="2">2009-10-15</assertion>
            <assertion name="published" label="Published" group_name="publication_history" group_label="Publication History" order="3">2010-7-16</assertion>
            <ai:program name="AccessIndicators">
              <ai:license_ref>http://creativecommons.org/licenses/by-nc/3.0/</ai:license_ref>
            </ai:program>
          </custom_metadata>
        </crossmark>
        <doi_data>
          <doi>10.2174/1874210601004010055</doi>
          <timestamp>1553505149</timestamp>
          <resource>https://opendentistryjournal.com/VOLUME/4/PAGE/55/</resource>
          <collection property="crawler-based">
            <item crawler="google">
              <resource>https://opendentistryjournal.com/contents/volumes/V4/TODENTJ-4-55/TODENTJ-4-55.pdf</resource>
            </item>
            <item crawler="msn">
              <resource>https://opendentistryjournal.com/contents/volumes/V4/TODENTJ-4-55/TODENTJ-4-55.pdf</resource>
            </item>
            <item crawler="altavista">
              <resource>https://opendentistryjournal.com/contents/volumes/V4/TODENTJ-4-55/TODENTJ-4-55.pdf</resource>
            </item>
            <item crawler="yahoo">
              <resource>https://opendentistryjournal.com/contents/volumes/V4/TODENTJ-4-55/TODENTJ-4-55.pdf</resource>
            </item>
            <item crawler="scirus">
              <resource>https://opendentistryjournal.com/contents/volumes/V4/TODENTJ-4-55/TODENTJ-4-55.pdf</resource>
            </item>
            <item crawler="iParadigms">
              <resource>https://opendentistryjournal.com/contents/volumes/V4/TODENTJ-4-55/TODENTJ-4-55.pdf</resource>
            </item>
          </collection>
          <collection property="text-mining">
            <item>
              <resource mime_type="application/pdf">https://opendentistryjournal.com/contents/volumes/V4/TODENTJ-4-55/TODENTJ-4-55.pdf</resource>
            </item>
            <item>
              <resource mime_type="application/xml">https://opendentistryjournal.com/contents/volumes/V4/TODENTJ-4-55/TODENTJ-4-55.xml</resource>
            </item>
          </collection>
        </doi_data>
        <citation_list>
          <citation key="refR1">
            <journal_title>J Public Health Dent</journal_title>
            <author>Drury TF</author>
            <volume>59</volume>
            <first_page>192</first_page>
            <cYear>1999</cYear>
            <unstructured_citation>
                    Drury TF, Horowitz AM, Ismail AI, Maertens MP, Rozier RG, Selwitz RH. 
                    Diagnosis and reporting early childhood caries for research purposes: a report of a workshop by the NCDR 
                    J Public Health Dent  
                    1999; 
                    59
                    : 192-7.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR2">
            <journal_title>Commu Dent Oral Epidemiol</journal_title>
            <author>Horowitz HS</author>
            <volume>26</volume>
            <first_page>67</first_page>
            <cYear>1998</cYear>
            <unstructured_citation>
                    Horowitz HS. 
                    Research issues in early childhood caries 
                    Commu Dent Oral Epidemiol  
                    1998; 
                    26
                    (Suppl 1)
                    : 67-81.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR3">
            <journal_title>Pediatr Dent</journal_title>
            <author>Peretz B</author>
            <volume>25</volume>
            <first_page>114</first_page>
            <cYear>2003</cYear>
            <unstructured_citation>
                    Peretz B, Ram D, Azo E, Efrat Y. 
                    Preschool caries as an indicator of future caries: a longitudinal study 
                    Pediatr Dent  
                    2003; 
                    25
                    : 114-8.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR4">
            <journal_title>Pediatr Dent J</journal_title>
            <author>Wyne AH</author>
            <volume>9</volume>
            <first_page>31</first_page>
            <cYear>1999</cYear>
            <unstructured_citation>
                    Wyne AH. 
                    Prevalence and risk factors of nursing caries in Adelaide South Australia 
                    Pediatr Dent J  
                    1999; 
                    9
                    : 31-6.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR5">
            <journal_title>J Paediatr Child Health</journal_title>
            <author>Gussy MG</author>
            <volume>42</volume>
            <first_page>37</first_page>
            <cYear>2006</cYear>
            <unstructured_citation>
                    Gussy MG, Waters EG, Walsh O, Kilpatrick NM. 
                    Early childhood caries: current evidence for aetiology and prevention 
                    J Paediatr Child Health  
                    2006; 
                    42
                    : 37-43.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR6">
            <journal_title>J Am Dent Assoc</journal_title>
            <author>Nowak AJ</author>
            <volume>126</volume>
            <first_page>1156</first_page>
            <cYear>1995</cYear>
            <unstructured_citation>
                    Nowak AJ, Casamassimimo PS. 
                    Using anticipatory guidance to provide early dental intervention 
                    J Am Dent Assoc  
                    1995; 
                    126
                    : 1156-63.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR7">
            <journal_title>Commun Dent Oral Epidemiol</journal_title>
            <author>Plutzer K</author>
            <volume>6</volume>
            <first_page>335</first_page>
            <cYear>2008</cYear>
            <unstructured_citation>
                    Plutzer K, Spencer AJ. 
                    Efficacy of an oral health promotion intervention in the prevention of early childhood caries 
                    Commun Dent Oral Epidemiol  
                    2008; 
                    6
                    : 335-46.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR8">
            <journal_title>BMJ</journal_title>
            <author>Kotaska A</author>
            <volume>329</volume>
            <first_page>1039</first_page>
            <cYear>2004</cYear>
            <unstructured_citation>
                    Kotaska A. 
                    Inappropriate use of randomized trials to evaluate complex phenomena: case study of vaginal breech delivery 
                    BMJ  
                    2004; 
                    329
                    : 1039-42.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR9">
            <journal_title>Commun Dent Oral Epidemiol</journal_title>
            <author>Watt R</author>
            <volume>29</volume>
            <first_page>161</first_page>
            <cYear>2001</cYear>
            <unstructured_citation>
                    Watt R, Fuler S, Harnett R, Treasure E, Stillman-Lowe C. 
                    Oral health promotion evaluation – time for development 
                    Commun Dent Oral Epidemiol  
                    2001; 
                    29
                    : 161-6.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR10">
            <journal_title>Commun Dent Health</journal_title>
            <author>Petersen PE</author>
            <volume>21</volume>
            <first_page>319</first_page>
            <cYear>2004</cYear>
            <unstructured_citation>
                    Petersen PE, Kwan S. 
                    Evaluation of community-based oral health promotion and oral disease prevention – WHO recommendations for improved evidence in public health practice 
                    Commun Dent Health  
                    2004; 
                    21
                    (Supp1)
                    : 319-29.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR11">
            <journal_title>BMC Oral Health</journal_title>
            <author>Freeman R</author>
            <volume>9</volume>
            <first_page>1</first_page>
            <cYear>2009</cYear>
            <unstructured_citation>
                    Freeman R. 
                    Health promotion and the randomised controlled trial: a square peg in a round hole? 
                    BMC Oral Health  
                    2009; 
                    9
                    : 1.
                </unstructured_citation>
          </citation>
          <citation key="refR12">
            <journal_title>BMJ</journal_title>
            <author>Hollis S</author>
            <volume>319</volume>
            <first_page>670</first_page>
            <cYear>1999</cYear>
            <unstructured_citation>
                    Hollis S, Campbell F. 
                    What is meant by intention to treat analysis? survey of published randomised controlled trials 
                    BMJ  
                    1999; 
                    319
                    : 670-4.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR13">
            <journal_title>Eur J Obstet Gynecol Reprod Biol</journal_title>
            <author>Keirse MJNC</author>
            <volume>92</volume>
            <first_page>67</first_page>
            <cYear>2000</cYear>
            <unstructured_citation>
                    Keirse MJNC, Hanssens M. 
                    Control of error in randomised clinical trials 
                    Eur J Obstet Gynecol Reprod Biol  
                    2000; 
                    92
                    : 67-74.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR14">
            <journal_title>Lancet</journal_title>
            <author>Schultz KF</author>
            <volume>359</volume>
            <first_page>781</first_page>
            <cYear>2002</cYear>
            <unstructured_citation>
                    Schultz KF, Grimes DA. 
                    Sample size slippages in randomised controlled trials: exclusions and the lost and wayward 
                    Lancet  
                    2002; 
                    359
                    : 781-5.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR15">
            <journal_title>New Engl J Med</journal_title>
            <author>Zelen M</author>
            <volume>300</volume>
            <first_page>1242</first_page>
            <cYear>1979</cYear>
            <unstructured_citation>
                    Zelen M. 
                    A new design for randomized controlled trials 
                    New Engl J Med  
                    1979; 
                    300
                    : 1242-5.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR16">
            <journal_title>New Engl J Med</journal_title>
            <author>Ellenberg SS</author>
            <volume>310</volume>
            <first_page>1404</first_page>
            <cYear>1984</cYear>
            <unstructured_citation>
                    Ellenberg SS. 
                    Randomisation designs in comparative clinical trials 
                    New Engl J Med  
                    1984; 
                    310
                    : 1404-8.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR17">
            <journal_title>Eur J Cancer</journal_title>
            <author>Altman DG</author>
            <volume>31A</volume>
            <first_page>1934</first_page>
            <cYear>1995</cYear>
            <unstructured_citation>
                    Altman DG, Whitehead J, Parmar MKB, Stenning SP, Fayers PM, Machin D. 
                    Randomised consent designs in cancer clinical trials 
                    Eur J Cancer  
                    1995; 
                    31A
                    : 1934-44.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR18">
            <journal_title>J Adv Nurs</journal_title>
            <author>Homer CS</author>
            <volume>38</volume>
            <first_page>200</first_page>
            <cYear>2002</cYear>
            <unstructured_citation>
                    Homer CS. 
                    Using the Zelen design in randomized controlled trials: debates and controversies 
                    J Adv Nurs  
                    2002; 
                    38
                    : 200-7.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR19">
            <journal_title>Stat Med</journal_title>
            <author>Zelen M</author>
            <volume>9</volume>
            <first_page>645</first_page>
            <cYear>1990</cYear>
            <unstructured_citation>
                    Zelen M. 
                    Randomized consent design for clinical trials: an update 
                    Stat Med  
                    1990; 
                    9
                    : 645-56.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR20">
            <journal_title>Ann Intern Med</journal_title>
            <author>Altman DG</author>
            <volume>134</volume>
            <first_page>663</first_page>
            <cYear>2001</cYear>
            <unstructured_citation>
                    Altman DG, Schultz KF, Moher D, et al. 
                    For the CONSORT group. 
                    the revised CONSORT statement for reporting randomised controlled trials: explanation and elaboration 
                    Ann Intern Med  
                    2001; 
                    134
                    : 663-94.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR21">
            <journal_title>J Clin Epidemiol</journal_title>
            <author>Donders ART</author>
            <volume>59</volume>
            <first_page>1087</first_page>
            <cYear>2006</cYear>
            <unstructured_citation>
                    Donders ART, van der Heijden GJMG, Stijnen T, Moons KGM. 
                    Review: a gentle introduction to imputation of missing values 
                    J Clin Epidemiol  
                    2006; 
                    59
                    : 1087-91.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR22">
            <journal_title>Stat Med</journal_title>
            <author>Harel O</author>
            <volume>26</volume>
            <first_page>3057</first_page>
            <cYear>2007</cYear>
            <unstructured_citation>
                    Harel O, Zhou XH. 
                    Multiple imputation: review of theory implementation and soft ware 
                    Stat Med  
                    2007; 
                    26
                    : 3057-77.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR23">
            <journal_title>Surv Methodol</journal_title>
            <author>Raghunathan TE</author>
            <volume>27</volume>
            <first_page>85</first_page>
            <cYear>2001</cYear>
            <unstructured_citation>
                    Raghunathan TE, Lepkowski JM, Van Hoewyk J, Solenberger P. 
                    A multivariate technique for multiply imputing missing values using a sequence of regression models 
                    Surv Methodol  
                    2001; 
                    27
                    : 85-95.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR24">
            <unstructured_citation>
                    Raghunathan TE, Solenberger PW, Van Hoewyk J. 
                    IVEware: Imputation and Variance Estimation Software 
                    [http://www.isr.umich.edu.src/smp/ive/] 
                    2002.
                </unstructured_citation>
          </citation>
          <citation key="refR25">
            <journal_title>BMJ</journal_title>
            <author>Eldridge S</author>
            <volume>336</volume>
            <first_page>876</first_page>
            <cYear>2008</cYear>
            <unstructured_citation>
                    Eldridge S, Ashby D, Bennett C, Wakelin M, Feder G. 
                    Internal and external validity of cluster randomised trials: systematic review of recent trials 
                    BMJ  
                    2008; 
                    336
                    : 876-0.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR26">
            <unstructured_citation>
                    Chan A, Scott J, Nguyen AM, Sage L. 
                    Pregnancy outcome in South Australia 2007 Adelaide: Pregnancy outcome unit, SA Health, Government of South Australia 2008 
                </unstructured_citation>
          </citation>
          <citation key="refR27">
            <journal_title>Contemp Clin Trials</journal_title>
            <author>Adamson J</author>
            <volume>27</volume>
            <first_page>305</first_page>
            <cYear>2006</cYear>
            <unstructured_citation>
                    Adamson J, Cockayne S, Puffer S, Torgerson DJ. 
                    Review of randomised trials using the post-randomised consent (Zelen's) design 
                    Contemp Clin Trials  
                    2006; 
                    27
                    : 305-19.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR28">
            <journal_title>J Clin Epidemiol</journal_title>
            <author>Wright CC</author>
            <volume>56</volume>
            <first_page>833</first_page>
            <cYear>2003</cYear>
            <unstructured_citation>
                    Wright CC, Sim J. 
                    Intention-to-treat approach to data from randomized controlled trials: a sensitivity analysis 
                    J Clin Epidemiol  
                    2003; 
                    56
                    : 833-42.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR29">
            <journal_title>J Clin Periodontol</journal_title>
            <author>Hujoel PP</author>
            <volume>22</volume>
            <first_page>397</first_page>
            <cYear>1995</cYear>
            <unstructured_citation>
                    Hujoel PP, DeRouen TA. 
                    A survey of endpoint characteristics in periodontal clinical trials published 1988-1992 and implications for future studies 
                    J Clin Periodontol  
                    1995; 
                    22
                    : 397-407.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR30">
            <journal_title>Obstet Gynecol</journal_title>
            <author>Grimes DA</author>
            <volume>105</volume>
            <first_page>1114</first_page>
            <cYear>2005</cYear>
            <unstructured_citation>
                    Grimes DA, Schultz KF. 
                    Surrogate outcomes in clinical research: hazardous to your health 
                    Obstet Gynecol  
                    2005; 
                    105
                    : 1114-8.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR31">
            <journal_title>Am J Obstet Gynecol</journal_title>
            <author>Glezerman M</author>
            <volume>194</volume>
            <first_page>20</first_page>
            <cYear>2006</cYear>
            <unstructured_citation>
                    Glezerman M. 
                    Five years to the term breech trial: the rise and fall of a randomized controlled trial 
                    Am J Obstet Gynecol  
                    2006; 
                    194
                    : 20-5.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR32">
            <journal_title>Clin Trials</journal_title>
            <author>Gravel J</author>
            <volume>4</volume>
            <first_page>350</first_page>
            <cYear>2007</cYear>
            <unstructured_citation>
                    Gravel J, Opatrny L, Shapiro S. 
                    The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say? 
                    Clin Trials  
                    2007; 
                    4
                    : 350-6.
                    
                </unstructured_citation>
          </citation>
          <citation key="refR33">
            <journal_title>BMJ</journal_title>
            <author>Sterne JA</author>
            <volume>338</volume>
            <first_page>157</first_page>
            <cYear>2009</cYear>
            <unstructured_citation>
                    Sterne JA, White IR, Carlin JB, et al. 
                    Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls 
                    BMJ  
                    2009; 
                    338
                    : 157-60.
                    
                </unstructured_citation>
          </citation>
        </citation_list>
      </journal_article>
    </journal>
  </body>
</doi_batch>
