Reporting of Randomized Controlled Trials in Cleft Lip and Palate: A 10-Year Review

Hardwicke, Joseph; Nassimizadeh, Mohammad; Richard, Bruce

doi:10.1597/14-267

Cited by 15 publications

(16 citation statements)

References 44 publications

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“…The RCT is the gold standard for clinical investigations (Schutz et al 2011;Hardwicke et al 2017). Any treatment protocol should be fully assessed in a prospective well-controlled randomized study, with full control of all the other variables affecting the treatment outcomes.…”

Section: Discussion Trial Objective and Designmentioning

confidence: 99%

Early Progressive Maxillary Changes with Nasoalveolar Molding: Randomized Controlled Clinical Trial

Saad

Fata

Farouk

et al. 2019

JDR Clinical & Translational Research

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Objectives: Quantitative assessment of 3-dimensional progressive changes of the maxillary geometry in unilateral cleft lip palate (UCLP) with and without nasoalveolar molding (NAM). Methods: The study was designed as a prospective 2-arm randomized controlled clinical trial conducted in parallel. Forty infants with nonsyndromic UCLP were randomly assigned into a NAM-treated group (n = 20) and non–NAM treated group (n = 20). A total of 120 laser-scanned maxillary casts were collected and blindly analyzed via a modified algorithm at T0 (initial visit; baseline), T1 (after 3 wk; first interval), and T2 (after 6 wk; second interval). The main outcome measures were the amount and rate of cleft gap changes, the midline position, and the transverse, sagittal, and vertical growth through intervals. Results: More than 50% of the cleft gap (56.42%; P < 0.001) was reduced in the first 3 wk of alveolar molding (AM). The end point of the AM was obtained in 6 wk (86.25%; P < 0.001); then, the kinks of the greater segment were noticed. The AM effect decreased as far as posterior; the anterior arch width reduced slightly (1.23%; P < 0.001), while the middle and posterior arches increased slightly (P > 0.999 and P = 0.288, respectively). The posterior arch width was the least changing and was considered a baseline, while the anterior was the pivot of the segment rotation. Both groups showed different patterns of segment rotation and sagittal growth. The non–NAM treated group showed a slight increase in cleft gap length, arch width, and midline position. Conclusion: Based on this study, it was concluded that the NAM treatment is effective in minimizing cleft severity and realigning maxillary segments without the deterioration of the transverse and vertical arch growth. Near follow-up visits are recommended to monitor the rapid gap reduction within the first 3 wk. Further trials are recommended to compare the outcomes regarding the sagittal growth to reference values ( ClinicalTrials.gov NCT03029195). Knowledge Transfer Statement: The results of this study will help clinicians understand nasoalveolar molding biomechanics that may improve the treatment outcomes for patients with unilateral cleft lip and palate. The trial data can be a valuable guide to the qualitative and quantitative predictive virtual molding in computer aided design–simulated nasoalveolar molding therapy. The modified algorithm can be used by researchers to quantify the rate, the sequence, and the direction of the maxillary segments movement in unilateral cleft lip and palate.

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Section: Discussion Trial Objective and Designmentioning

confidence: 99%

Early Progressive Maxillary Changes with Nasoalveolar Molding: Randomized Controlled Clinical Trial

Saad

Fata

Farouk

et al. 2019

JDR Clinical & Translational Research

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“…The evidence for an association of surgical technique is limited. There is a paucity of randomized controlled trials on cleft lip repair technique, likely due to the challenges in executing such a trial (Hardwicke et al, 2017; Bekisz et al, 2018). There have been numerous prospective and retrospective studies comparing techniques for primary cleft lip repair, but they have all had substantial methodologic limitations such as comparing surgical techniques applied over 2 distinct time periods (Reddy et al, 2010; Zaleckas et al, 2011), techniques applied by different surgeons (Adetayo et al, 2018), and changes in technique concomitant with changes in use of presurgical nasolabial orthopedics.…”

Section: Discussionmentioning

confidence: 99%

Marked Variation Exists Among Surgeons and Hospitals in the Use of Secondary Cleft Lip Surgery

Sitzman

Carle

Lundberg

et al. 2019

The Cleft Palate Craniofacial Journal

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Objective: To identify child-, surgeon-, and hospital-specific factors at the time of primary cleft lip repair that are associated with the use of secondary cleft lip surgery. Design: Retrospective cohort study. Setting: Forty-nine pediatric hospitals. Participants: Children who underwent cleft lip repair between 1999 and 2015. Main outcome measure: Time from primary cleft lip repair to secondary lip surgery. Results: By 5 years after primary lip repair, 24.0% of children had undergone a secondary lip surgery. In multivariable analysis, primary lip repair before 3 months had a 1.22-fold increased hazard of secondary surgery (95% confidence interval [CI]: 1.02-1.46) compared to repair at 7 to 12 months of age, and children with multiple congenital anomalies had a 0.77-fold decreased hazard of secondary surgery (95% CI: 0.68-0.87). After adjusting for cleft type, age at repair, presence of multiple congenital anomalies, and procedure volume, there remained substantial variation in secondary surgery use among surgeons and hospitals ( P < .01). For children with unilateral cleft lip repaired at 3 to 6 months of age, the predicted proportion of children undergoing secondary surgery within 5 years of primary repair ranged from 4.9% to 21.8% across surgeons and from 4.5% to 24.7% across hospitals. Conclusions: There are substantial differences among surgeons and hospitals in the rates of secondary lip surgery. Further work is needed to identify causes for this variation among providers.

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“…A protocol aims to standardise care and has the potential to streamline multidisciplinary clinical practice by detailing steps of management. CL/P is associated with a striking diversity of management protocols in common use and furthermore there is a paucity of a scientific evidence to support any of them (de Ladeira and Alonso, 2012; Hardwicke et al, 2017). The reason for this may be the complex, heterogeneous nature of the condition, with multidisciplinary care administered by a range of specialists at different stages of child development (Allori et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

Adapting cleft care protocols in low- and middle-income countries during and after COVID-19: a process-driven review with recommendations

Fell

Goldwasser

Jayanth³

et al. 2021

Preprint

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Objective: A consortium of global cleft professionals, predominantly from low- and middle-income countries, identified adaptions to cleft care protocols during and after COVID as a priority learning area of need. Design: A multidisciplinary international working group met on a videoconferencing platform in a multi-staged process to make consensus recommendations for adaptions to cleft protocols within resource-constrained settings. Feedback was sought from a roundtable discussion forum and global organisations involved in comprehensive cleft care. Results: Foundational principles were agreed to enable recommendations to be globally relevant and two areas of focus within the specified topic were identified. First the safety aspects of cleft surgery protocols were scrutinised and COVID adaptions, specifically in the pre and peri-operative periods, were highlighted. Second, surgical operations and access to services were prioritized according to their relationship to functional outcomes and time-sensitivity. The operations assigned the highest priority were emergent interventions for breathing and nutritional requirements and primary palatoplasty. The cleft services assigned the highest priority were new-born assessments, paediatric support for children with syndromes, management of acute dental or auditory infections and speech pathology intervention. Conclusions: A collaborative, interdisciplinary and international working group delivered consensus recommendations to assist with the provision of cleft care in low- and middle-income countries. At a time of global cleft care delays due to COVID-19, a united approach amongst global cleft care providers will be advantageous to advocate for children born with cleft lip and palate in resource-constrained settings.

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Reporting of Randomized Controlled Trials in Cleft Lip and Palate: A 10-Year Review

Cited by 15 publications

References 44 publications

Early Progressive Maxillary Changes with Nasoalveolar Molding: Randomized Controlled Clinical Trial

Early Progressive Maxillary Changes with Nasoalveolar Molding: Randomized Controlled Clinical Trial

Marked Variation Exists Among Surgeons and Hospitals in the Use of Secondary Cleft Lip Surgery

Adapting cleft care protocols in low- and middle-income countries during and after COVID-19: a process-driven review with recommendations

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