المؤلفون: Conroy, Elizabeth J., Blazeby, Jane M., Burnside, Girvan, Cook, Jonathan A., Gamble, Carrol

المساهمون: Research Trainees Coordinating Centre

المصدر: Trials ; volume 23, issue 1 ; ISSN 1745-6215

مصطلحات موضوعية: Pharmacology (medical), Medicine (miscellaneous)

الوصف: Background The complexities associated with delivering randomised surgical trials, such as clustering effects, by centre or surgeon, and surgical learning, are well known. Despite this, approaches used to manage these complexities, and opinions on these, vary. Guidance documents have been developed to support clinical trial design and reporting. This work aimed to identify and examine existing guidance and consider its relevance to clustering effects and learning curves within surgical trials. Methods A review of existing guidelines, developed to inform the design and analysis of randomised controlled trials, is undertaken. Guidelines were identified using an electronic search, within the Equator Network, and by a targeted search of those endorsed by leading UK funding bodies, regulators, and medical journals. Eligible documents were compared against pre-specified key criteria to identify gaps or inconsistencies in recommendations. Results Twenty-eight documents were eligible (12 Equator Network; 16 targeted search). Twice the number of guidance documents targeted design ( n / N =20/28, 71%) than analysis ( n / N =10/28, 36%). Managing clustering by centre through design was well documented. Clustering by surgeon had less coverage and contained some inconsistencies. Managing the surgical learning curve, or changes in delivery over time, through design was contained within several documents ( n / N =8/28, 29%), of which one provided guidance on reporting this and restricted to early phase studies only. Methods to analyse clustering effects and learning were provided in five and four documents respectively ( N =28). Conclusions To our knowledge, this is the first review as to the extent to which existing guidance for designing and analysing randomised surgical trials covers the management of clustering, by centre or surgeon, and the surgical learning curve. Twice the number of identified documents targeted design aspects than analysis. Most notably, no single document exists for use when designing these ...

الإتاحة: https://doi.org/10.1186/s13063-022-06743-6Test

المؤلفون: Conroy, Elizabeth J., Cooper, Rachael, Shaw, William, Persson, Christina, Willadsen, Elisabeth, Munro, Kevin J., Williamson, Paula R., Semb, Gunvor, Walsh, Tanya, Gamble, Carrol

المصدر: Conroy , E J , Cooper , R , Shaw , W , Persson , C , Willadsen , E , Munro , K J , Williamson , P R , Semb , G , Walsh , T & Gamble , C 2021 , ' A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan ' , Trials , vol. 22 , no. 1 . https://doi.org/10.1186/s13063-020-04886-yTest

الوصف: Background Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, hearing, dental development, and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. The Timing Of Primary Surgery for cleft palate (TOPS) trial aims to determine whether, in infants with cleft palate, it is better to perform primary surgery at age 6 or 12 months (corrected for gestational age). Methods/design The TOPS trial is an international, two-arm, parallel group, randomised controlled trial. The primary outcome is insufficient velopharyngeal function at 5 years of age. Secondary outcomes, measured at 12 months, 3 years, and 5 years of age, include measures of speech development, safety of the procedure, hearing level, middle ear function, dentofacial development, and growth. The analysis approaches for primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The TOPS protocol has been published previously. Discussion This paper provides details of the planned statistical analyses for the TOPS trial and will reduce the risk of outcome reporting bias and data-driven results.

الإتاحة: https://doi.org/10.1186/s13063-020-04886-yTest
https://research.manchester.ac.uk/en/publications/08e85747-e527-4fb5-a158-ab295b9fe18dTest

المؤلفون: Persson , Christina, Conroy, Elizabeth J, Gamble, Carrol, Rosala-Hallas, Anna, Shaw, William, Willadsen, Elisabeth

المصدر: Persson , C , Conroy , E J , Gamble , C , Rosala-Hallas , A , Shaw , W & Willadsen , E 2021 , ' Adding a fourth rater to three had little impact in pre-linguistic outcome classification ' , Clinical Linguistics & Phonetics , vol. 35 , no. 2 , pp. 138-153 . https://doi.org/10.1080/02699206.2020.1758793Test

الوصف: The consequence of differing levels of agreement across raters is rarely studied. Subsequently, knowledge is limited on how number of raters affects the outcome. The present study aimed to examine the impact on pre-linguistic outcome classifications of 12-month-old infants when using four raters compared to three. Thirty experienced Speech and Language Therapists (SLTs) from five countries assessed 20 minute video recordings of four 12-month-old infants during a play session with a parent. One recording was assessed twice. A naturalistic listening method in real time was used. This involved: (1) assessing, each syllable as canonical or non-canonical, and (2) following the recording, assessing if the infant was babbling canonically and listing the syllables the infant produced with command. The impact that four raters had on outcome, compared to three, was explored by classifying the outcome based on all possible combinations of three raters and determining the frequency that the outcome assessment changed when a fourth assessor was added. Results revealed that adding a fourth rater had a minimal impact on canonical babbling ratio assessment. Presence/absence of canonical babbling and size of consonant inventory showed a negligible impact on three out of four recordings, whereas the size of syllable inventory and presence/absence of canonical babbling was minimally affected in one recording by adding a fourth rater. In conclusion, adding a forth rater in assessment of pre-linguistic utterances in 12-month-old infants with naturalistic assessment in real time does not affect outcome classifications considerably. Thus, using three raters, as opposed to four, is recommended.

وصف الملف: application/pdf

الإتاحة: https://doi.org/10.1080/02699206.2020.1758793Test
https://curis.ku.dk/portal/da/publications/adding-a-fourth-rater-to-three-had-little-impact-in-prelinguistic-outcome-classificationTest(1a1e2b1e-03fd-4892-8a4f-10211081daac).html
https://curis.ku.dk/ws/files/240739888/Adding_a_fourth_rater_to_three_had_little_impact_in_pre_linguistic_outcome_classification.pdfTest

المؤلفون: Hall, Benjamin J., Gillespie, Conor S., Sunderland, Geraint J., Conroy, Elizabeth J., Hennigan, Dawn, Jenkinson, Michael D., Pettorini, Benedetta, Mallucci, Conor

المصدر: Child's Nervous System ; volume 37, issue 11, page 3485-3495 ; ISSN 0256-7040 1433-0350

مصطلحات موضوعية: Neurology (clinical), General Medicine, Pediatrics, Perinatology and Child Health

الوصف: Purpose To review the use of different valve types in infants with hydrocephalus, in doing so, determining whether an optimal valve choice exists for this patient cohort. Methods We conducted (1) a literature review for all studies describing valve types used (programmable vs. non-programmable, valve size, pressure) in infants (≤ 2 years) with hydrocephalus, (2) a review of data from the pivotal BASICS trial for infant patients and (3) a separate, institutional cohort study from Alder Hey Children’s Hospital NHS Foundation Trust. The primary outcome was any revision not due to infection. Results The search identified 19 studies that were included in the review. Most did not identify a superior valve choice between programmable and non-programmable, small compared to ultra-small, and differential pressure compared to flow-regulating valves. Five studies investigated a single-valve type without a comparator group. The BASICS data identified 391 infants, with no statistically significant difference between gravitational and programmable subgroups. The institutional data from our tertiary referral centre did not reveal any significant difference in failure rate between valve subtypes. Conclusion Our review highlights the challenges of valve selection in infant hydrocephalus, reiterating that the concept of an optimal valve choice in this group remains a controversial one. While the infant-hydrocephalic population is at high risk of valve failure, heterogeneity and a lack of direct comparison between valves in the literature limit our ability to draw meaningful conclusions. Data that does exist suggests at present that there is no difference in non-infective failure rate are increasing in number, with the British valve subtypes in infant hydrocephalus, supported by both the randomised trial and institutional data in this study.

الإتاحة: https://doi.org/10.1007/s00381-021-05326-1Test

المؤلفون: Mallucci, C.L., Jenkinson, Michael, Conroy, Elizabeth J., Hartley, John C., Brown, Michaela, Moitt, Tracey, Dalton, Joanne, Kearns, Tom, Griffiths, Michael J., Culeddu, Giovanna, Solomon, Tom, Hughes, Dyfrig, Gamble, Carrol

المصدر: Mallucci , C L , Jenkinson , M , Conroy , E J , Hartley , J C , Brown , M , Moitt , T , Dalton , J , Kearns , T , Griffiths , M J , Culeddu , G , Solomon , T , Hughes , D & Gamble , C 2020 , ' Silver-impregnated, antibiotic-impregnated or non-impregnated ventriculoperitoneal shunts to prevent shunt infection: the BASICS three-arm RCT ' , Health Technology Assessment , vol. 24 , no. 17 . https://doi.org/10.3310/hta24170Test

الوصف: BACKGROUND: Insertion of a ventriculoperitoneal shunt to treat hydrocephalus is one of the most common neurosurgical procedures worldwide. Shunt infection affects up to 15% of patients, resulting in long hospital stays, multiple surgeries and reduced cognition and quality of life. OBJECTIVES: The aim of this trial was to determine whether or not antibiotic-impregnated ventriculoperitoneal shunts (hereafter referred to as antibiotic shunts) (e.g. impregnated with rifampicin and clindamycin) or silver-impregnated ventriculoperitoneal shunts (hereafter referred to as silver shunts) reduce infection compared with standard ventriculoperitoneal shunts (hereafter referred to as standard shunts). DESIGN: This was a three-arm, superiority, multicentre, parallel-group randomised controlled trial. Patients and a central primary outcome review panel, but not surgeons or operating staff, were blinded to the type of ventriculoperitoneal shunt inserted. SETTING: The trial was set in 21 neurosurgical wards across the UK and the Republic of Ireland. PARTICIPANTS: Participants were patients with hydrocephalus of any aetiology who were undergoing insertion of their first ventriculoperitoneal shunt. INTERVENTIONS: Participants were allocated 1 : 1 : 1 by pressure-sealed envelope to receive a standard non-impregnated, silver-impregnated or antibiotic-impregnated ventriculoperitoneal shunt at the time of insertion. Ventriculoperitoneal shunts are medical devices, and were used in accordance with the manufacturer's instructions for their intended purpose. MAIN OUTCOME MEASURES: The primary outcome was time to ventriculoperitoneal shunt failure due to infection. Secondary outcomes were time to failure for any cause, reason for failure (infection, mechanical), types of ventriculoperitoneal shunt infection, rate of infection after first clean (non-infected) revision and health economics. Outcomes were analysed by intention to treat. RESULTS: Between 26 June 2013 and 9 October 2017, 1605 patients from neonate to 91 years of age were randomised to the trial: n = 36 to the standard shunt, n = 538 to the antibiotic shunt and n = 531 to the silver shunt. Patients who did not receive a ventriculoperitoneal shunt ( n = 4) or who had an infection at the time of insertion ( n = 7) were not assessed for the primary outcome. Infection occurred in 6.0% ( n = 32/533) of those who received the standard shunt, in 2.2% ( n = 12/535) of those who received the antibiotic shunt and in 5.9% ( n = 31/526) of those who received the silver shunt. Compared with the standard shunt, antibiotic shunts were associated with a lower rate of infection (cause-specific hazard ratio 0.38, 97.5% confidence interval 0.18 to 0.80) and a decreased probability of infection (subdistribution hazard ratio 0.38, 97.5% confidence interval 0.18 to 0.80). Silver shunts were not associated with a lower rate of infection than standard shunts (cause-specific hazard ratio 0.99, 97.5% confidence interval 0.56 to 1.74). The ventriculoperitoneal shunt failure rate attributable to any cause was 25.0% overall and did not differ between arms. Antibiotic shunts save £135,753 per infection avoided. There were no serious adverse events. LIMITATIONS: It was not possible to blind treating neurosurgeons to the ventriculoperitoneal shunt type. The return rate for patient-reported outcomes was low. Limitations to the economic evaluation included failure to obtain Hospital Episode Statistics data from NHS Digital, as per protocol. Reliance on patient-level information and costing systems data mitigated these limitations. CONCLUSIONS: Antibiotic shunts have a reduced infection rate compared with standard shunts, whereas silver shunts do not. Antibiotic shunts are cost-saving. FUTURE WORK: A sample collection has been established that will enable the study of surrogate markers of ventriculoperitoneal shunt infection in cerebrospinal fluid or blood using molecular techniques. A post hoc analysis to study factors related to shunt failure will be performed as part of a future study. An impact analysis to assess change in practice is planned. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49474281. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 17. See the NIHR Journals Library website for further project information.

وصف الملف: application/pdf

الإتاحة: https://doi.org/10.3310/hta24170Test
https://research.bangor.ac.uk/portal/en/researchoutputs/silverimpregnated-antibioticimpregnated-or-nonimpregnated-ventriculoperitoneal-shunts-to-prevent-shunt-infection-the-basics-threearm-rctTest(89716c95-dea5-4bcd-bee0-651f72c84126).html
https://research.bangor.ac.uk/ws/files/28648389/2020_Silver_impregnated.pdfTest

المؤلفون: Persson, Christina, Conroy, Elizabeth J., Gamble, Carrol, Rosala-Hallas, Anna, Shaw, William, Willadsen, Elisabeth

المصدر: Persson , C , Conroy , E J , Gamble , C , Rosala-Hallas , A , Shaw , W & Willadsen , E 2020 , ' Adding a fourth rater to three had little impact in pre-linguistic outcome classification ' , Clinical LInguistics and Phonetics . https://doi.org/10.1080/02699206.2020.1758793Test

مصطلحات موضوعية: Inter-rater-reliability, pre-linguistic syllables, real-time listening

الوصف: The consequence of differing levels of agreement across raters is rarely studied. Subsequently, knowledge is limited on how number of raters affects the outcome. The present study aimed to examine the impact on pre-linguistic outcome classifications of 12-month-old infants when using four raters compared to three. Thirty experienced Speech and Language Therapists (SLTs) from five countries assessed 20 minute video recordings of four 12-month-old infants during a play session with a parent. One recording was assessed twice. A naturalistic listening method in real time was used. This involved: (1) assessing, each syllable as canonical or non-canonical, and (2) following the recording, assessing if the infant was babbling canonically and listing the syllables the infant produced with command. The impact that four raters had on outcome, compared to three, was explored by classifying the outcome based on all possible combinations of three raters and determining the frequency that the outcome assessment changed when a fourth assessor was added. Results revealed that adding a fourth rater had a minimal impact on canonical babbling ratio assessment. Presence/absence of canonical babbling and size of consonant inventory showed a negligible impact on three out of four recordings, whereas the size of syllable inventory and presence/absence of canonical babbling was minimally affected in one recording by adding a fourth rater. In conclusion, adding a forth rater in assessment of pre-linguistic utterances in 12-month-old infants with naturalistic assessment in real time does not affect outcome classifications considerably. Thus, using three raters, as opposed to four, is recommended.

الإتاحة: https://doi.org/10.1080/02699206.2020.1758793Test
https://research.manchester.ac.uk/en/publications/2eacb87c-5f1a-433c-829e-807d898299e6Test
http://www.scopus.com/inward/record.url?scp=85084480885&partnerID=8YFLogxKTest

المؤلفون: Conroy, Elizabeth J, Blazeby, Jane M, Burnside, Girvan, Cook, Jonathan A, Gamble, Carrol

المصدر: Conroy , E J , Blazeby , J M , Burnside , G , Cook , J A & Gamble , C 2020 , ' Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials : A survey to establish current practice ' , Trials . https://doi.org/10.1186/s13063-020-04318-xTest

مصطلحات موضوعية: trials, clinical trials unit, clinical trial, randomised controlled trial, complex intervention, surgical intervention, trial design, trial analysis, survey, clustering, learning

الوصف: Background Patient outcomes can depend on the treating centre, or health professional, delivering the intervention. Health professional’s skill in delivery improves with experience, meaning that outcomes may be associated with learning. Considering differences in intervention delivery at trial design will ensure that any appropriate adjustments can be made during analysis. This work aimed to establish practice for the allowance of clustering and learning effects in the design and analysis of randomised multicentre trials. Methods A survey that drew upon quotes from existing guidelines, references to relevant publications, and example trial scenarios was delivered. Registered UK Clinical Research Collaborative registered Clinical Trials Units were invited to participate. Results Forty-four Units participated (N=50). Clustering was managed through design by stratification, more commonly by centre than treatment provider. Managing learning by design through defining a minimum expertise level for treatment provider was common (89%). One-third reported experience of expertise-based designs. The majority of Units had adjusted for clustering during analysis, although approaches varied. Analysis of learning was rarely performed for the main analysis (n=1), although was explored by other means. Insight behind the approaches used within and reasons for, or against, alternative approaches were provided. Conclusions Widespread awareness of challenges in designing and analysing multicentre trials is identified. Approaches used, and opinions on these, vary both across Units and within, indicating that approaches are dependent on the type of trial. Agreeing principles to guide trial design and analysis across a range of realistic clinical scenarios should be considered.

وصف الملف: application/pdf

الإتاحة: https://doi.org/10.1186/s13063-020-04318-xTest
https://hdl.handle.net/1983/55fb6070-8a7b-4d55-a541-58e6dc097bf3Test
https://research-information.bris.ac.uk/en/publications/55fb6070-8a7b-4d55-a541-58e6dc097bf3Test
https://research-information.bris.ac.uk/ws/files/239534401/s13063_020_04318_x.pdfTest

المؤلفون: Sunderland, Geraint J, Conroy, Elizabeth J, Nelson, Alexandra, Gamble, Carrol, Jenkinson, Michael D, Griffiths, Michael J, Mallucci, Conor L

الوصف: Objective The British Antibiotic and Silver Impregnated Catheter Shunt (BASICS) trial established level I evidence of the superiority of antibiotic-impregnated catheters in the prevention of infection of newly implanted ventriculoperitoneal shunts (VPSs). A wealth of patient, shunt, and surgery-specific data were collected from trial participants beyond that of the prespecified trial objectives. Methods This post hoc analysis of the BASICS survival data explores the impact of patient age, hydrocephalus etiology, catheter type, valve type, and previous external ventricular drain on the risk of infection or mechanical failure. Time to failure was analyzed using Fine and Gray survival regression models for competing risk. Results Among 1594 participants, 75 patients underwent revision for infection and 323 for mechanical failure. Multivariable analysis demonstrated an increased risk of shunt infection associated with patient ages < 1 month (subdistribution hazard ratio [sHR] 4.48, 95% CI 2.06-9.72; p < 0.001) and 1 month to < 1 year (sHR 2.67, 95% CI 1.27-5.59; p = 0.009), as well as for adults with posthemorrhagic hydrocephalus (sHR 2.75, 95% CI 1.21-6.26; p = 0.016). Age ≥ 65 years was found to be independently associated with reduced infection risk (sHR 0.26, 95% CI 0.10-0.69; p = 0.007). Antibiotic-impregnated catheter use was also associated with reduced infection risk (sHR 0.43, 95% CI 0.22-0.84; p = 0.014). Independent risk factors predisposing to mechanical failure were age < 1 month (sHR 1.51, 95% CI 1.03-2.21; p = 0.032) and 1 month to < 1 year (sHR 1.31, 95% CI 0.95-1.81; p = 0.046). Age ≥ 65 years was demonstrated to be the only independent protective factor against mechanical failure risk (sHR 0.64, 95% CI 0.40-0.94; p = 0.024). Conclusions Age is the predominant risk for VPS revision for infection and/or mechanical failure, with neonates and infants being the most vulnerable.

وصف الملف: application/vnd.openxmlformats-officedocument.wordprocessingml.document

العلاقة: http://livrepository.liverpool.ac.uk/3166171/1/2022_BASICS%20post%20hoc%20analysis.docxTest; Sunderland, Geraint J orcid:0000-0001-9040-5949 , Conroy, Elizabeth J, Nelson, Alexandra, Gamble, Carrol orcid:0000-0002-3021-1955 , Jenkinson, Michael D orcid:0000-0003-4587-2139 , Griffiths, Michael J and Mallucci, Conor L orcid:0000-0002-5509-0547 (2023) Factors affecting ventriculoperitoneal shunt revision: a post hoc analysis of the British Antibiotic and Silver Impregnated Catheter Shunt multicenter randomized controlled trial. JOURNAL OF NEUROSURGERY, 138 (2). pp. 483-493.

الإتاحة: https://doi.org/10.3171/2022.4.jns22572Test
http://livrepository.liverpool.ac.uk/3166171Test/
http://livrepository.liverpool.ac.uk/3166171/1/2022_BASICS%20post%20hoc%20analysis.docxTest

المؤلفون: Potter, Shelley, Conroy, Elizabeth J., Cutress, Ramsey, Williamson, Paula R., Whisker, Lisa J., Thrush, Steven, Skillman, Joanna M., Barnes, Nicola, Mylvaganam, Senthurun, Teasdale, Elisabeth, Jain, Abhilash, Gardiner, Matthew D., Blazeby, Jane M., Holcombe, Christopher

الوصف: Background Use of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction—breast reconstruction with implants or expanders at the time of mastectomy—but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques. Methods In this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281. Findings Between Feb 1, 2014, and June 30, 2016, 2108 patients had 2655 mastectomies with immediate implant-based breast reconstruction at 81 units across the UK. 1650 (78%) patients had planned single-stage reconstructions (including 12 patients who had a different technique per breast). 1376 (65%) patients had reconstruction with biological (1133 [54%]) or synthetic (243 [12%]) mesh, 181 (9%) had non-mesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had pre-pectoral implants, and 79 (4%) had other or a combination of implants. 3-month outcome data were available for 2081 ...

وصف الملف: text

العلاقة: https://eprints.soton.ac.uk/425848/1/3rd_revision_iBRA_CLEAN.docxTest; https://eprints.soton.ac.uk/425848/2/1_s2.0_S1470204518307812_main.pdfTest; Potter, Shelley, Conroy, Elizabeth J., Cutress, Ramsey, Williamson, Paula R., Whisker, Lisa J., Thrush, Steven, Skillman, Joanna M., Barnes, Nicola, Mylvaganam, Senthurun, Teasdale, Elisabeth, Jain, Abhilash, Gardiner, Matthew D., Blazeby, Jane M. and Holcombe, Christopher , Breast Reconstruction Research Collaborative (2019) Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study. The Lancet Oncology, 20 (2), 254-266. (doi:10.1016/S1470-2045(18)30781-2 ).

الإتاحة: https://doi.org/10.1016/S1470-2045Test(18)30781-2
https://eprints.soton.ac.uk/425848Test/
https://eprints.soton.ac.uk/425848/1/3rd_revision_iBRA_CLEAN.docxTest
https://eprints.soton.ac.uk/425848/2/1_s2.0_S1470204518307812_main.pdfTest

المؤلفون: Shaw, William, Semb, Gunvor, Lohmander, Anette, Persson, Christina, Willadsen, Elisabeth, Clayton-smith, Jill, Trindade, Inge Kiemle, Munro, Kevin J, Gamble, Carrol, Harman, Nicola, Conroy, Elizabeth J, Weichart, Dieter, Williamson, Paula

المصدر: Shaw , W , Semb , G , Lohmander , A , Persson , C , Willadsen , E , Clayton-smith , J , Trindade , I K , Munro , K J , Gamble , C , Harman , N , Conroy , E J , Weichart , D & Williamson , P 2019 , ' Timing Of Primary Surgery for cleft palate (TOPS): protocol for a randomised trial of palate surgery at 6 months versus 12 months of age ' , BMJ Open , vol. 9 , no. 7 , pp. e029780 . https://doi.org/10.1136/bmjopen-2019-029780Test

الوصف: Introduction Cleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, speech, hearing, dental development and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. This has led to palatal closure in one-stage procedures being carried out around the age of 12 months, but in some cases as early as 6 months. The primary objective of the Timing Of Primary Surgery for Cleft Palate (TOPS)trial is to determine whether surgery for cleft palate performed at 6 or 12 months of age is most beneficial for speech outcomes. Methods and analysis Infants with a diagnosis of non-syndromic isolated cleft palate will be randomised to receive standardised primary surgery (Sommerlad technique) for closure of the cleft at either 6 months or 12 months, corrected for gestational age. The primary outcome will be perceived insufficient velopharyngeal function at 5 years of age. Secondary outcomes measured across 12 months, 3 years and 5 years will include growth, safety of the procedure, dentofacial development, speech, hearing level and middle ear function. Video and audio recordings of speech will be collected in a standardised age-appropriate manner and analysed independently by multiple speech and language therapists. The trial aims to recruit and follow-up 300 participants per arm. Data will be analysed according to the intention-to-treat principle using a 5% significance level. All analyses will be prespecified within a full and detailed statistical analysis plan.

الإتاحة: https://doi.org/10.1136/bmjopen-2019-029780Test
https://research.manchester.ac.uk/en/publications/594749ae-d849-4c5d-840b-4113703a6adbTest