The Hip Impact Protection Project: Design and Methods
Identifieur interne : 000136 ( Pmc/Curation ); précédent : 000135; suivant : 000137The Hip Impact Protection Project: Design and Methods
Auteurs : Bruce A. Barton [États-Unis] ; Stanley J. Birge [États-Unis] ; Jay Magaziner [États-Unis] ; Sheryl Zimmerman [États-Unis] ; Linda Ball [États-Unis] ; Kathleen M. Brown [États-Unis] ; Douglas P. Kiel [États-Unis]Source :
- Clinical trials (London, England) [ 1740-7745 ] ; 2008.
Abstract
Nearly 340,000 hip fractures occur each year in the U.S. With current demographic trends, the number of hip fractures is expected to double at least in the next 40 years.
The Hip Impact Protection Project (HIP PRO) was designed to investigate the efficacy and safety of hip protectors in an elderly nursing home population. This paper describes the innovative clustered matched-pair research design used in HIP PRO to overcome the inherent limitations of clustered randomization.
Three clinical centers recruited 37 nursing homes to participate in HIP PRO. They were randomized so that the participating residents in that home received hip protectors for either the right or left hip. Informed consent was obtained from either the resident or the resident's responsible party. The target sample size was 580 residents with replacement if they dropped out, had a hip fracture, or died. One of the advantages of the HIP PRO study design was that each resident was his/her own case and control, eliminating imbalances, and there was no confusion over which residents wore pads (or on which hip).
Generalizability of the findings may be limited. Adherence was higher in this study than in other studies because of: (1) the use of a run-in period, (2) staff incentives, and (3) the frequency of adherence assessments. The use of a single pad is not analogous to pad use in the real world and may have caused unanticipated changes in behavior. Fall assessment was not feasible, limiting the ability to analyze fractures as a function of falls. Finally, hip protector designs continue to evolve so that the results generated using this pad may not be applicable to other pad designs. However, information about factors related to adherence will be useful for future studies.
The clustered matched-pair study design avoided the major problem with previous cluster-randomized investigations of this question – unbalanced risk factors between the experimental group and the control group. Because each resident served as his/her own control, the effects of unbalanced risk factors on treatment effect were virtually eliminated. In addition, the use of frequent adherence assessments allowed us to study the effect of various demographic and environmental factors on adherence, which was vital for the assessment of efficacy.
Url:
DOI: 10.1177/1740774508095120
PubMed: 18697849
PubMed Central: 3725461
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<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title>
<p id="P1">Nearly 340,000 hip fractures occur each year in the U.S. With current demographic trends, the number of hip fractures is expected to double at least in the next 40 years.</p>
</sec>
<sec id="S2"><title>Purpose</title>
<p id="P2">The Hip Impact Protection Project (HIP PRO) was designed to investigate the efficacy and safety of hip protectors in an elderly nursing home population. This paper describes the innovative clustered matched-pair research design used in HIP PRO to overcome the inherent limitations of clustered randomization.</p>
</sec>
<sec id="S3"><title>Methods</title>
<p id="P3">Three clinical centers recruited 37 nursing homes to participate in HIP PRO. They were randomized so that the participating residents in that home received hip protectors for either the right or left hip. Informed consent was obtained from either the resident or the resident's responsible party. The target sample size was 580 residents with replacement if they dropped out, had a hip fracture, or died. One of the advantages of the HIP PRO study design was that each resident was his/her own case and control, eliminating imbalances, and there was no confusion over which residents wore pads (or on which hip).</p>
</sec>
<sec id="S4"><title>Limitations</title>
<p id="P4">Generalizability of the findings may be limited. Adherence was higher in this study than in other studies because of: (1) the use of a run-in period, (2) staff incentives, and (3) the frequency of adherence assessments. The use of a single pad is not analogous to pad use in the real world and may have caused unanticipated changes in behavior. Fall assessment was not feasible, limiting the ability to analyze fractures as a function of falls. Finally, hip protector designs continue to evolve so that the results generated using this pad may not be applicable to other pad designs. However, information about factors related to adherence will be useful for future studies.</p>
</sec>
<sec id="S5"><title>Conclusions</title>
<p id="P5">The clustered matched-pair study design avoided the major problem with previous cluster-randomized investigations of this question – unbalanced risk factors between the experimental group and the control group. Because each resident served as his/her own control, the effects of unbalanced risk factors on treatment effect were virtually eliminated. In addition, the use of frequent adherence assessments allowed us to study the effect of various demographic and environmental factors on adherence, which was vital for the assessment of efficacy.</p>
</sec>
</div>
</front>
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<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">101197451</journal-id>
<journal-id journal-id-type="pubmed-jr-id">32521</journal-id>
<journal-id journal-id-type="nlm-ta">Clin Trials</journal-id>
<journal-id journal-id-type="iso-abbrev">Clin Trials</journal-id>
<journal-title-group><journal-title>Clinical trials (London, England)</journal-title>
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<issn pub-type="ppub">1740-7745</issn>
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<article-id pub-id-type="doi">10.1177/1740774508095120</article-id>
<article-id pub-id-type="manuscript">NIHMS495185</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Article</subject>
</subj-group>
</article-categories>
<title-group><article-title>The Hip Impact Protection Project: Design and Methods</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Barton</surname>
<given-names>Bruce A</given-names>
</name>
<xref ref-type="aff" rid="A1">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Birge</surname>
<given-names>Stanley J</given-names>
</name>
<xref ref-type="aff" rid="A2">b</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Magaziner</surname>
<given-names>Jay</given-names>
</name>
<xref ref-type="aff" rid="A3">c</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Zimmerman</surname>
<given-names>Sheryl</given-names>
</name>
<xref ref-type="aff" rid="A4">d</xref>
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<contrib contrib-type="author"><name><surname>Ball</surname>
<given-names>Linda</given-names>
</name>
<xref ref-type="aff" rid="A2">b</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Brown</surname>
<given-names>Kathleen M</given-names>
</name>
<xref ref-type="aff" rid="A1">a</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Kiel</surname>
<given-names>Douglas P</given-names>
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<xref ref-type="aff" rid="A5">e</xref>
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</contrib-group>
<aff id="A1"><label>a</label>
Maryland Medical Research Institute, Baltimore, MD, USA</aff>
<aff id="A2"><label>b</label>
Division of Geriatrics and Nutritional Science, Washington University School of Medicine, St. Louis, MO, USA</aff>
<aff id="A3"><label>c</label>
Division of Gerontology, Department of Epidemiology and Preventive Medicine, University of Maryland Baltimore, Baltimore, MD, USA</aff>
<aff id="A4"><label>d</label>
Program on Aging, Disability and Long-Term Care, Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA</aff>
<aff id="A5"><label>e</label>
Institute for Aging Research, Hebrew SeniorLife, and Harvard Medical School, Boston, MA, USA</aff>
<author-notes><corresp id="CR1">Author for correspondence: Bruce A Barton, Maryland Medical Research Institute, 600 Wyndhurst Ave., Baltimore, MD 21210, USA. <email>bbarton@mmri.org</email>
</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted"><day>24</day>
<month>7</month>
<year>2013</year>
</pub-date>
<pub-date pub-type="ppub"><year>2008</year>
</pub-date>
<pub-date pub-type="pmc-release"><day>29</day>
<month>7</month>
<year>2013</year>
</pub-date>
<volume>5</volume>
<issue>4</issue>
<fpage>347</fpage>
<lpage>355</lpage>
<abstract><sec id="S1"><title>Background</title>
<p id="P1">Nearly 340,000 hip fractures occur each year in the U.S. With current demographic trends, the number of hip fractures is expected to double at least in the next 40 years.</p>
</sec>
<sec id="S2"><title>Purpose</title>
<p id="P2">The Hip Impact Protection Project (HIP PRO) was designed to investigate the efficacy and safety of hip protectors in an elderly nursing home population. This paper describes the innovative clustered matched-pair research design used in HIP PRO to overcome the inherent limitations of clustered randomization.</p>
</sec>
<sec id="S3"><title>Methods</title>
<p id="P3">Three clinical centers recruited 37 nursing homes to participate in HIP PRO. They were randomized so that the participating residents in that home received hip protectors for either the right or left hip. Informed consent was obtained from either the resident or the resident's responsible party. The target sample size was 580 residents with replacement if they dropped out, had a hip fracture, or died. One of the advantages of the HIP PRO study design was that each resident was his/her own case and control, eliminating imbalances, and there was no confusion over which residents wore pads (or on which hip).</p>
</sec>
<sec id="S4"><title>Limitations</title>
<p id="P4">Generalizability of the findings may be limited. Adherence was higher in this study than in other studies because of: (1) the use of a run-in period, (2) staff incentives, and (3) the frequency of adherence assessments. The use of a single pad is not analogous to pad use in the real world and may have caused unanticipated changes in behavior. Fall assessment was not feasible, limiting the ability to analyze fractures as a function of falls. Finally, hip protector designs continue to evolve so that the results generated using this pad may not be applicable to other pad designs. However, information about factors related to adherence will be useful for future studies.</p>
</sec>
<sec id="S5"><title>Conclusions</title>
<p id="P5">The clustered matched-pair study design avoided the major problem with previous cluster-randomized investigations of this question – unbalanced risk factors between the experimental group and the control group. Because each resident served as his/her own control, the effects of unbalanced risk factors on treatment effect were virtually eliminated. In addition, the use of frequent adherence assessments allowed us to study the effect of various demographic and environmental factors on adherence, which was vital for the assessment of efficacy.</p>
</sec>
</abstract>
<funding-group><award-group><funding-source country="United States">National Institute on Aging : NIA</funding-source>
<award-id>R01 AG018461 || AG</award-id>
</award-group>
</funding-group>
</article-meta>
</front>
</pmc>
</record>
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