Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion

Minimize Implants Maximize Outcomes Study Group

doi:10.1007/s43390-020-00143-z

Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion

Minimize Implants Maximize Outcomes Study Group

Orthopaedic Surgery

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

STUDY DESIGN: Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves.

OBJECTIVE: We hypothesized that patients and families considering fusion surgery would be willing to enroll in a randomized controlled trial (RCT) evaluating the effect of number of implants on curve correction. Surgical RCTs are infrequently performed, particularly in a pediatric population. Parental willingness to enroll affects both study design and trial feasibility. The Minimize Implants Maximize Outcomes (MIMO) Clinical Trial proposes to randomize patients to more versus fewer screws (high or low density) for Lenke 1A curve patterns, but it is unclear whether families and patients are willing to enroll in such a trial.

METHODS: This study was undertaken at 4 of the 14 sites participating in the MIMO Clinical Trial. AIS patients with Cobb > 45° were included. Implant density is defined as screws per level fused. Patients and families reviewed the MIMO education module describing proposed advantages and disadvantages of high (> 1.8) vs. low (< 1.4) density screw constructs and completed a custom survey regarding their preferences about the trial.

RESULTS: 159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients. Of those surveyed, 95% mostly or completely understood the trial (range 47-78%), and 63% agreed to enroll. Parents and patients who completely understood the trial were significantly more likely to enroll.

CONCLUSION: Randomization in the MIMO Trial was acceptable to the majority (63%) of patients and parents. Clear patient and parent education materials and access to the surgeon may facilitate enrollment in the trial. Parents afforded the child much autonomy when considering enrollment, although most families agree both child and parent should be in agreement before entering the trial.

LEVEL OF EVIDENCE: II.

Original language	English (US)
Pages (from-to)	957-963
Number of pages	7
Journal	Spine Deformity
Volume	8
Issue number	5
DOIs	https://doi.org/10.1007/s43390-020-00143-z
State	Published - Oct 1 2020

Bibliographical note

Funding Information:
Funding was provided by Orthopedic Research and Education Foundation and Scoliosis Research Society.

Publisher Copyright:
© 2020, Scoliosis Research Society.

Keywords

Accrual
Education module
Pediatric spine
Screw density
Patient Participation/psychology
Parents/psychology
Prospective Studies
Bone Screws
Humans
Male
Patient Preference
Spinal Fusion/methods
Randomized Controlled Trials as Topic
Female
Patient Education as Topic
Scoliosis/surgery

PubMed: MeSH publication types

Research Support, Non-U.S. Gov't
Journal Article

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10.1007/s43390-020-00143-z

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@article{5190d4c836b749d6a17da23919bca04f,

title = "Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion",

abstract = "STUDY DESIGN: Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves.OBJECTIVE: We hypothesized that patients and families considering fusion surgery would be willing to enroll in a randomized controlled trial (RCT) evaluating the effect of number of implants on curve correction. Surgical RCTs are infrequently performed, particularly in a pediatric population. Parental willingness to enroll affects both study design and trial feasibility. The Minimize Implants Maximize Outcomes (MIMO) Clinical Trial proposes to randomize patients to more versus fewer screws (high or low density) for Lenke 1A curve patterns, but it is unclear whether families and patients are willing to enroll in such a trial.METHODS: This study was undertaken at 4 of the 14 sites participating in the MIMO Clinical Trial. AIS patients with Cobb > 45° were included. Implant density is defined as screws per level fused. Patients and families reviewed the MIMO education module describing proposed advantages and disadvantages of high (> 1.8) vs. low (< 1.4) density screw constructs and completed a custom survey regarding their preferences about the trial.RESULTS: 159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients. Of those surveyed, 95% mostly or completely understood the trial (range 47-78%), and 63% agreed to enroll. Parents and patients who completely understood the trial were significantly more likely to enroll.CONCLUSION: Randomization in the MIMO Trial was acceptable to the majority (63%) of patients and parents. Clear patient and parent education materials and access to the surgeon may facilitate enrollment in the trial. Parents afforded the child much autonomy when considering enrollment, although most families agree both child and parent should be in agreement before entering the trial.LEVEL OF EVIDENCE: II.",

keywords = "Accrual, Education module, Pediatric spine, Screw density, Patient Participation/psychology, Parents/psychology, Prospective Studies, Bone Screws, Humans, Male, Patient Preference, Spinal Fusion/methods, Randomized Controlled Trials as Topic, Female, Patient Education as Topic, Scoliosis/surgery",

author = "{Minimize Implants Maximize Outcomes Study Group} and Larson, {A. Noelle} and Floccari, {Lorena V.} and Sumeet Garg and Erickson, {Mark A.} and Sponseller, {Paul D.} and Brito, {Juan P.} and Aubin, {Carl Eric} and Polly, {David W.}",

note = "Funding Information: Funding was provided by Orthopedic Research and Education Foundation and Scoliosis Research Society. Publisher Copyright: {\textcopyright} 2020, Scoliosis Research Society.",

year = "2020",

month = oct,

day = "1",

doi = "10.1007/s43390-020-00143-z",

language = "English (US)",

volume = "8",

pages = "957--963",

journal = "Spine Deformity",

issn = "2212-134X",

publisher = "Elsevier BV",

number = "5",

}

TY - JOUR

T1 - Willingness to enroll in a surgical randomized controlled trial

T2 - patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion

AU - Minimize Implants Maximize Outcomes Study Group

AU - Larson, A. Noelle

AU - Floccari, Lorena V.

AU - Garg, Sumeet

AU - Erickson, Mark A.

AU - Sponseller, Paul D.

AU - Brito, Juan P.

AU - Aubin, Carl Eric

AU - Polly, David W.

PY - 2020/10/1

Y1 - 2020/10/1

N2 - STUDY DESIGN: Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves.OBJECTIVE: We hypothesized that patients and families considering fusion surgery would be willing to enroll in a randomized controlled trial (RCT) evaluating the effect of number of implants on curve correction. Surgical RCTs are infrequently performed, particularly in a pediatric population. Parental willingness to enroll affects both study design and trial feasibility. The Minimize Implants Maximize Outcomes (MIMO) Clinical Trial proposes to randomize patients to more versus fewer screws (high or low density) for Lenke 1A curve patterns, but it is unclear whether families and patients are willing to enroll in such a trial.METHODS: This study was undertaken at 4 of the 14 sites participating in the MIMO Clinical Trial. AIS patients with Cobb > 45° were included. Implant density is defined as screws per level fused. Patients and families reviewed the MIMO education module describing proposed advantages and disadvantages of high (> 1.8) vs. low (< 1.4) density screw constructs and completed a custom survey regarding their preferences about the trial.RESULTS: 159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients. Of those surveyed, 95% mostly or completely understood the trial (range 47-78%), and 63% agreed to enroll. Parents and patients who completely understood the trial were significantly more likely to enroll.CONCLUSION: Randomization in the MIMO Trial was acceptable to the majority (63%) of patients and parents. Clear patient and parent education materials and access to the surgeon may facilitate enrollment in the trial. Parents afforded the child much autonomy when considering enrollment, although most families agree both child and parent should be in agreement before entering the trial.LEVEL OF EVIDENCE: II.

AB - STUDY DESIGN: Prospective survey of adolescent idiopathic scoliosis (AIS) patients/parents with surgical magnitude curves.OBJECTIVE: We hypothesized that patients and families considering fusion surgery would be willing to enroll in a randomized controlled trial (RCT) evaluating the effect of number of implants on curve correction. Surgical RCTs are infrequently performed, particularly in a pediatric population. Parental willingness to enroll affects both study design and trial feasibility. The Minimize Implants Maximize Outcomes (MIMO) Clinical Trial proposes to randomize patients to more versus fewer screws (high or low density) for Lenke 1A curve patterns, but it is unclear whether families and patients are willing to enroll in such a trial.METHODS: This study was undertaken at 4 of the 14 sites participating in the MIMO Clinical Trial. AIS patients with Cobb > 45° were included. Implant density is defined as screws per level fused. Patients and families reviewed the MIMO education module describing proposed advantages and disadvantages of high (> 1.8) vs. low (< 1.4) density screw constructs and completed a custom survey regarding their preferences about the trial.RESULTS: 159 individuals were surveyed (78 families), including 82 parents/guardians, and 77 patients. Of those surveyed, 95% mostly or completely understood the trial (range 47-78%), and 63% agreed to enroll. Parents and patients who completely understood the trial were significantly more likely to enroll.CONCLUSION: Randomization in the MIMO Trial was acceptable to the majority (63%) of patients and parents. Clear patient and parent education materials and access to the surgeon may facilitate enrollment in the trial. Parents afforded the child much autonomy when considering enrollment, although most families agree both child and parent should be in agreement before entering the trial.LEVEL OF EVIDENCE: II.

KW - Accrual

KW - Education module

KW - Pediatric spine

KW - Screw density

KW - Patient Participation/psychology

KW - Parents/psychology

KW - Prospective Studies

KW - Bone Screws

KW - Humans

KW - Male

KW - Patient Preference

KW - Spinal Fusion/methods

KW - Randomized Controlled Trials as Topic

KW - Female

KW - Patient Education as Topic

KW - Scoliosis/surgery

UR - http://www.scopus.com/inward/record.url?scp=85086014494&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85086014494&partnerID=8YFLogxK

U2 - 10.1007/s43390-020-00143-z

DO - 10.1007/s43390-020-00143-z

M3 - Article

C2 - 32495208

AN - SCOPUS:85086014494

SN - 2212-134X

VL - 8

SP - 957

EP - 963

JO - Spine Deformity

JF - Spine Deformity

IS - 5

ER -

Willingness to enroll in a surgical randomized controlled trial: patient and parent preferences regarding implant density for adolescent idiopathic scoliosis fusion

Abstract

Bibliographical note

Keywords

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