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Conference Paper: An alternative to a randomized control design for assessing the efficacy and effectiveness of bracing in AIS

TitleAn alternative to a randomized control design for assessing the efficacy and effectiveness of bracing in AIS
Authors
KeywordsMedical sciences medical sciences
Computer applications
Issue Date2012
PublisherIOS Press. The Journal's web site is located at http://www.iospress.nl
Citation
The 9th Biennial Scientific Meeting of the International Research Society of Spinal Deformities (IRSSD), Poznan, Poland, 1-4 July 2012. In Studies in Health Technology and Informatics, 2012, v. 176, p. 493-493 How to Cite?
AbstractCurrent randomized controlled trials (RCTs) for assessing the efficacy of bracing in patients with adolescent idiopathic scoliosis (AIS) suffer from poor recruitment. Additionally, patients who consent for randomization may be a highly selected group of individuals who have no preference on treatment; thus may limit the assessment of effectiveness. Therefore, we aimed to determine the feasibility of an alternative study design, “the comprehensive cohort study” that can overcome the concerns of conventional RCTs. AIS patients aged ≥10 years, had Risser sign between 0-II, and had a Cobb angle of 25° to <30° or 20° to <25° with 5° deterioration over the past 4 months were invited to join a RCT. Those who declined were given an option to stay in the study, but choose whether they wish to be braced or observed. A randomization schedule was generated for all patients whether or not they joined the RCT; thus patients who made their own choice may also fit with the randomized choices. For those without brace but had ≥6° curve progression or reached 30° were considered failures, and braces were offered. Patients were followed every 4 months. Over 1 year, there were 87 eligible patients, 68 (78%) patients with mean age of 12.5 years consented to participate with a median follow-up of 57 weeks. Of which, 19 (28%) patients accepted randomization with respectively 13 and 6 patients allotted to brace and observation. For others who declined randomization, 18 (37%) chose brace and 28 (57%) patients had their choice of treatment the same as that on the randomization schedule. This Comprehensive Cohort Study design has the potential to improve the rate of recruitment such that both efficacy and effectiveness of bracing in AIS can be assessed. Our preliminary study showed that it can be feasibly conducted with less recruitment burden.
DescriptionSession 13 - Conservative Treatment: no. 75
Studies in Health Technology and Informatics, v. 176 entitled: Research into Spinal Deformities 8
Persistent Identifierhttp://hdl.handle.net/10722/160368
ISBN
ISSN
2023 SCImago Journal Rankings: 0.289

 

DC FieldValueLanguage
dc.contributor.authorFong, Den_US
dc.contributor.authorCheung, Ken_US
dc.contributor.authorWong, YWen_US
dc.contributor.authorCheung, WYen_US
dc.contributor.authorFu, Ien_US
dc.contributor.authorKuong, EEYLen_US
dc.contributor.authorMak, KCen_US
dc.contributor.authorTo, Men_US
dc.contributor.authorLuk, Ken_US
dc.date.accessioned2012-08-16T06:09:07Z-
dc.date.available2012-08-16T06:09:07Z-
dc.date.issued2012en_US
dc.identifier.citationThe 9th Biennial Scientific Meeting of the International Research Society of Spinal Deformities (IRSSD), Poznan, Poland, 1-4 July 2012. In Studies in Health Technology and Informatics, 2012, v. 176, p. 493-493en_US
dc.identifier.isbn978-1-61499-066-6-
dc.identifier.issn0926-9630-
dc.identifier.urihttp://hdl.handle.net/10722/160368-
dc.descriptionSession 13 - Conservative Treatment: no. 75-
dc.descriptionStudies in Health Technology and Informatics, v. 176 entitled: Research into Spinal Deformities 8-
dc.description.abstractCurrent randomized controlled trials (RCTs) for assessing the efficacy of bracing in patients with adolescent idiopathic scoliosis (AIS) suffer from poor recruitment. Additionally, patients who consent for randomization may be a highly selected group of individuals who have no preference on treatment; thus may limit the assessment of effectiveness. Therefore, we aimed to determine the feasibility of an alternative study design, “the comprehensive cohort study” that can overcome the concerns of conventional RCTs. AIS patients aged ≥10 years, had Risser sign between 0-II, and had a Cobb angle of 25° to <30° or 20° to <25° with 5° deterioration over the past 4 months were invited to join a RCT. Those who declined were given an option to stay in the study, but choose whether they wish to be braced or observed. A randomization schedule was generated for all patients whether or not they joined the RCT; thus patients who made their own choice may also fit with the randomized choices. For those without brace but had ≥6° curve progression or reached 30° were considered failures, and braces were offered. Patients were followed every 4 months. Over 1 year, there were 87 eligible patients, 68 (78%) patients with mean age of 12.5 years consented to participate with a median follow-up of 57 weeks. Of which, 19 (28%) patients accepted randomization with respectively 13 and 6 patients allotted to brace and observation. For others who declined randomization, 18 (37%) chose brace and 28 (57%) patients had their choice of treatment the same as that on the randomization schedule. This Comprehensive Cohort Study design has the potential to improve the rate of recruitment such that both efficacy and effectiveness of bracing in AIS can be assessed. Our preliminary study showed that it can be feasibly conducted with less recruitment burden.-
dc.languageengen_US
dc.publisherIOS Press. The Journal's web site is located at http://www.iospress.nl-
dc.relation.ispartofStudies in Health Technology and Informaticsen_US
dc.subjectMedical sciences medical sciences-
dc.subjectComputer applications-
dc.titleAn alternative to a randomized control design for assessing the efficacy and effectiveness of bracing in AISen_US
dc.typeConference_Paperen_US
dc.identifier.emailFong, D: dytfong@hku.hken_US
dc.identifier.emailCheung, K: cheungmc@hku.hken_US
dc.identifier.emailWong, YW: yatwa@hkucc.hku.hken_US
dc.identifier.emailCheung, WY: lcheung@hkucc.hku.hken_US
dc.identifier.emailFu, I: cyfu@hku.hken_US
dc.identifier.emailKuong, EEYL: eylkuong@hku.hken_US
dc.identifier.emailMak, KC: kincmak@hku.hken_US
dc.identifier.emailTo, M: mikektto@hku.hken_US
dc.identifier.emailLuk, K: hcm21000@hku.hk-
dc.identifier.authorityFong, D=rp00253en_US
dc.identifier.authorityCheung, K=rp00387en_US
dc.identifier.authorityFu, I=rp00254en_US
dc.identifier.authorityTo, M=rp00302en_US
dc.identifier.authorityLuk, K=rp00333en_US
dc.description.naturelink_to_OA_fulltext-
dc.identifier.hkuros203672en_US
dc.identifier.volume176-
dc.identifier.spage493-
dc.identifier.epage493-
dc.publisher.placeNetherlands-
dc.customcontrol.immutablesml 140113-
dc.identifier.issnl0926-9630-

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