Loss to follow-up in orthopaedic clinical trials: a systematic review
Purpose The rate of patients lost to follow-up may contribute to bias in randomized controlled trials (RCTs). Methods We systematically reviewed orthopaedic RCTs from 2008 to 2011, including 559 RCTs with 131,836 enrolled subjects. The loss to follow-up rates and minimum follow-up times were recorde...
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| Veröffentlicht in: | International orthopaedics 2016-11, Vol.40 (11), p.2213-2219 |
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| container_title | International orthopaedics |
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| creator | Somerson, Jeremy S. Bartush, Katherine C. Shroff, Jeffrey B. Bhandari, Mohit Zelle, Boris A. |
| description | Purpose
The rate of patients lost to follow-up may contribute to bias in randomized controlled trials (RCTs).
Methods
We systematically reviewed orthopaedic RCTs from 2008 to 2011, including 559 RCTs with 131,836 enrolled subjects. The loss to follow-up rates and minimum follow-up times were recorded for each trial. Orthopaedic subspecialty, country of origin, number of enrolled patients, patient age, follow-up strategy, and funding type were also recorded.
Results
Loss to follow-up was not reported in 111 of these studies (20 %). Mean loss to follow-up was 10.4 %. No orthopaedic subspecialty demonstrated significantly different follow-up rates. Remote follow-up strategies did not reduce the loss to follow-up rate. Studies with a minimum follow-up length of three years showed significantly higher loss to follow-up rates compared with studies with shorter minimum follow-up time (14.8 % versus 9.8 %,
p
= 0.01). Studies performed in the United States had a significantly higher rate of loss to follow-up compared with non-United States studies (13.8 % versus 9.4 %;
p
= 0.01).
Conclusions
Loss to follow-up rates in published orthopaedic randomized controlled trials is overall relatively low. A substantial portion of publications does not adequately report follow-up data. Studies performed in the United States and studies with longer follow-up periods seem to be at higher risk for loss to follow-up. |
| doi_str_mv | 10.1007/s00264-016-3212-5 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1868310771</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1868310771</sourcerecordid><originalsourceid>FETCH-LOGICAL-c377t-8b2b185ccaf91598d7dadb98ee946657c0117fd5b4029bb1c22578b1a6d0aea13</originalsourceid><addsrcrecordid>eNqNkD1PwzAQhi0EoqXwA1hQRhaDz4nthA1V5UOqxAKz5TgOuEriYCdU_fe4SmFE3HInvc-9w4PQJZAbIETcBkIozzABjlMKFLMjNIcsjQcU7BjNSZoBprxgM3QWwoYQEDyHUzSjAjKaUZij1dqFkAwuqV3TuC0e-8R2ifPDh-uVqaxOdGM7q1WTDN6qJtwlKgm7MJhWDTH15sua7Tk6qWNmLg57gd4eVq_LJ7x-eXxe3q-xToUYcF7SEnKmtaoLYEVeiUpVZZEbU2ScM6EJgKgrVmaEFmUJmlIm8hIUr4gyCtIFup56e-8-RxMG2dqgTdOozrgxSMh5ngIR4j8o5VzEIRGFCdU-yvCmlr23rfI7CUTuRctJtIyi5V60ZPHn6lA_lq2pfj9-zEaATkCIUfduvNy40XfRzh-t39hdh70</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1826677770</pqid></control><display><type>article</type><title>Loss to follow-up in orthopaedic clinical trials: a systematic review</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>SpringerNature Journals</source><creator>Somerson, Jeremy S. ; Bartush, Katherine C. ; Shroff, Jeffrey B. ; Bhandari, Mohit ; Zelle, Boris A.</creator><creatorcontrib>Somerson, Jeremy S. ; Bartush, Katherine C. ; Shroff, Jeffrey B. ; Bhandari, Mohit ; Zelle, Boris A.</creatorcontrib><description>Purpose
The rate of patients lost to follow-up may contribute to bias in randomized controlled trials (RCTs).
Methods
We systematically reviewed orthopaedic RCTs from 2008 to 2011, including 559 RCTs with 131,836 enrolled subjects. The loss to follow-up rates and minimum follow-up times were recorded for each trial. Orthopaedic subspecialty, country of origin, number of enrolled patients, patient age, follow-up strategy, and funding type were also recorded.
Results
Loss to follow-up was not reported in 111 of these studies (20 %). Mean loss to follow-up was 10.4 %. No orthopaedic subspecialty demonstrated significantly different follow-up rates. Remote follow-up strategies did not reduce the loss to follow-up rate. Studies with a minimum follow-up length of three years showed significantly higher loss to follow-up rates compared with studies with shorter minimum follow-up time (14.8 % versus 9.8 %,
p
= 0.01). Studies performed in the United States had a significantly higher rate of loss to follow-up compared with non-United States studies (13.8 % versus 9.4 %;
p
= 0.01).
Conclusions
Loss to follow-up rates in published orthopaedic randomized controlled trials is overall relatively low. A substantial portion of publications does not adequately report follow-up data. Studies performed in the United States and studies with longer follow-up periods seem to be at higher risk for loss to follow-up.</description><identifier>ISSN: 0341-2695</identifier><identifier>EISSN: 1432-5195</identifier><identifier>DOI: 10.1007/s00264-016-3212-5</identifier><identifier>PMID: 27142421</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Clinical Trials as Topic - statistics & numerical data ; Compliance ; Humans ; Lost to Follow-Up ; Medicine ; Medicine & Public Health ; Original Paper ; Orthopedics ; Orthopedics - statistics & numerical data</subject><ispartof>International orthopaedics, 2016-11, Vol.40 (11), p.2213-2219</ispartof><rights>SICOT aisbl 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c377t-8b2b185ccaf91598d7dadb98ee946657c0117fd5b4029bb1c22578b1a6d0aea13</citedby><cites>FETCH-LOGICAL-c377t-8b2b185ccaf91598d7dadb98ee946657c0117fd5b4029bb1c22578b1a6d0aea13</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00264-016-3212-5$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00264-016-3212-5$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,781,785,27929,27930,41493,42562,51324</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27142421$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Somerson, Jeremy S.</creatorcontrib><creatorcontrib>Bartush, Katherine C.</creatorcontrib><creatorcontrib>Shroff, Jeffrey B.</creatorcontrib><creatorcontrib>Bhandari, Mohit</creatorcontrib><creatorcontrib>Zelle, Boris A.</creatorcontrib><title>Loss to follow-up in orthopaedic clinical trials: a systematic review</title><title>International orthopaedics</title><addtitle>International Orthopaedics (SICOT)</addtitle><addtitle>Int Orthop</addtitle><description>Purpose
The rate of patients lost to follow-up may contribute to bias in randomized controlled trials (RCTs).
Methods
We systematically reviewed orthopaedic RCTs from 2008 to 2011, including 559 RCTs with 131,836 enrolled subjects. The loss to follow-up rates and minimum follow-up times were recorded for each trial. Orthopaedic subspecialty, country of origin, number of enrolled patients, patient age, follow-up strategy, and funding type were also recorded.
Results
Loss to follow-up was not reported in 111 of these studies (20 %). Mean loss to follow-up was 10.4 %. No orthopaedic subspecialty demonstrated significantly different follow-up rates. Remote follow-up strategies did not reduce the loss to follow-up rate. Studies with a minimum follow-up length of three years showed significantly higher loss to follow-up rates compared with studies with shorter minimum follow-up time (14.8 % versus 9.8 %,
p
= 0.01). Studies performed in the United States had a significantly higher rate of loss to follow-up compared with non-United States studies (13.8 % versus 9.4 %;
p
= 0.01).
Conclusions
Loss to follow-up rates in published orthopaedic randomized controlled trials is overall relatively low. A substantial portion of publications does not adequately report follow-up data. Studies performed in the United States and studies with longer follow-up periods seem to be at higher risk for loss to follow-up.</description><subject>Clinical Trials as Topic - statistics & numerical data</subject><subject>Compliance</subject><subject>Humans</subject><subject>Lost to Follow-Up</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Paper</subject><subject>Orthopedics</subject><subject>Orthopedics - statistics & numerical data</subject><issn>0341-2695</issn><issn>1432-5195</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkD1PwzAQhi0EoqXwA1hQRhaDz4nthA1V5UOqxAKz5TgOuEriYCdU_fe4SmFE3HInvc-9w4PQJZAbIETcBkIozzABjlMKFLMjNIcsjQcU7BjNSZoBprxgM3QWwoYQEDyHUzSjAjKaUZij1dqFkAwuqV3TuC0e-8R2ifPDh-uVqaxOdGM7q1WTDN6qJtwlKgm7MJhWDTH15sua7Tk6qWNmLg57gd4eVq_LJ7x-eXxe3q-xToUYcF7SEnKmtaoLYEVeiUpVZZEbU2ScM6EJgKgrVmaEFmUJmlIm8hIUr4gyCtIFup56e-8-RxMG2dqgTdOozrgxSMh5ngIR4j8o5VzEIRGFCdU-yvCmlr23rfI7CUTuRctJtIyi5V60ZPHn6lA_lq2pfj9-zEaATkCIUfduvNy40XfRzh-t39hdh70</recordid><startdate>20161101</startdate><enddate>20161101</enddate><creator>Somerson, Jeremy S.</creator><creator>Bartush, Katherine C.</creator><creator>Shroff, Jeffrey B.</creator><creator>Bhandari, Mohit</creator><creator>Zelle, Boris A.</creator><general>Springer Berlin Heidelberg</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7QP</scope></search><sort><creationdate>20161101</creationdate><title>Loss to follow-up in orthopaedic clinical trials: a systematic review</title><author>Somerson, Jeremy S. ; Bartush, Katherine C. ; Shroff, Jeffrey B. ; Bhandari, Mohit ; Zelle, Boris A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c377t-8b2b185ccaf91598d7dadb98ee946657c0117fd5b4029bb1c22578b1a6d0aea13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Clinical Trials as Topic - statistics & numerical data</topic><topic>Compliance</topic><topic>Humans</topic><topic>Lost to Follow-Up</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Paper</topic><topic>Orthopedics</topic><topic>Orthopedics - statistics & numerical data</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Somerson, Jeremy S.</creatorcontrib><creatorcontrib>Bartush, Katherine C.</creatorcontrib><creatorcontrib>Shroff, Jeffrey B.</creatorcontrib><creatorcontrib>Bhandari, Mohit</creatorcontrib><creatorcontrib>Zelle, Boris A.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Calcium & Calcified Tissue Abstracts</collection><jtitle>International orthopaedics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Somerson, Jeremy S.</au><au>Bartush, Katherine C.</au><au>Shroff, Jeffrey B.</au><au>Bhandari, Mohit</au><au>Zelle, Boris A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Loss to follow-up in orthopaedic clinical trials: a systematic review</atitle><jtitle>International orthopaedics</jtitle><stitle>International Orthopaedics (SICOT)</stitle><addtitle>Int Orthop</addtitle><date>2016-11-01</date><risdate>2016</risdate><volume>40</volume><issue>11</issue><spage>2213</spage><epage>2219</epage><pages>2213-2219</pages><issn>0341-2695</issn><eissn>1432-5195</eissn><abstract>Purpose
The rate of patients lost to follow-up may contribute to bias in randomized controlled trials (RCTs).
Methods
We systematically reviewed orthopaedic RCTs from 2008 to 2011, including 559 RCTs with 131,836 enrolled subjects. The loss to follow-up rates and minimum follow-up times were recorded for each trial. Orthopaedic subspecialty, country of origin, number of enrolled patients, patient age, follow-up strategy, and funding type were also recorded.
Results
Loss to follow-up was not reported in 111 of these studies (20 %). Mean loss to follow-up was 10.4 %. No orthopaedic subspecialty demonstrated significantly different follow-up rates. Remote follow-up strategies did not reduce the loss to follow-up rate. Studies with a minimum follow-up length of three years showed significantly higher loss to follow-up rates compared with studies with shorter minimum follow-up time (14.8 % versus 9.8 %,
p
= 0.01). Studies performed in the United States had a significantly higher rate of loss to follow-up compared with non-United States studies (13.8 % versus 9.4 %;
p
= 0.01).
Conclusions
Loss to follow-up rates in published orthopaedic randomized controlled trials is overall relatively low. A substantial portion of publications does not adequately report follow-up data. Studies performed in the United States and studies with longer follow-up periods seem to be at higher risk for loss to follow-up.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>27142421</pmid><doi>10.1007/s00264-016-3212-5</doi><tpages>7</tpages></addata></record> |
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| language | eng |
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| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; SpringerNature Journals |
| subjects | Clinical Trials as Topic - statistics & numerical data Compliance Humans Lost to Follow-Up Medicine Medicine & Public Health Original Paper Orthopedics Orthopedics - statistics & numerical data |
| title | Loss to follow-up in orthopaedic clinical trials: a systematic review |
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