| 1. |
- Conroy, Elizabeth J, et al.
(författare)
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A randomised controlled trial comparing palate surgery at 6months versus 12months of age (the TOPS trial): a statistical analysis plan.
- 2021
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Ingår i: Trials. - : Springer Science and Business Media LLC. - 1745-6215. ; 22:1
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Tidskriftsartikel (refereegranskat)abstract
- 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 12months (corrected for gestational age).The TOPS trial is an international, two-arm, parallel group, randomised controlled trial. The primary outcome is insufficient velopharyngeal function at 5years of age. Secondary outcomes, measured at 12months, 3years, and 5years of age, include measures ofspeech 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.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.ClinicalTrials.gov NCT00993551 . Registered on 9 October 2009.
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| 2. |
- Gamble, Carrol, et al.
(författare)
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Timing of Primary Surgery for Cleft Palate.
- 2023
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Ingår i: The New England journal of medicine. - : Massachusetts Medical Society. - 1533-4406 .- 0028-4793. ; 389:9, s. 795-807
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Tidskriftsartikel (refereegranskat)abstract
- Among infants with isolated cleft palate, whether primary surgery at 6 months of age is more beneficial than surgery at 12 months of age with respect to speech outcomes, hearing outcomes, dentofacial development, and safety is unknown.We randomly assigned infants with nonsyndromic isolated cleft palate, in a 1:1 ratio, to undergo standardized primary surgery at 6 months of age (6-month group) or at 12 months of age (12-month group) for closure of the cleft. Standardized assessments of quality-checked video and audio recordings at 1, 3, and 5 years of age were performed independently by speech and language therapists who were unaware of the trial-group assignments. The primary outcome was velopharyngeal insufficiency at 5 years of age, defined as a velopharyngeal composite summary score of at least 4 (scores range from 0 to 6, with higher scores indicating greater severity). Secondary outcomes included speech development, postoperative complications, hearing sensitivity, dentofacial development, and growth.We randomly assigned 558 infants at 23 centers across Europe and South America to undergo surgery at 6 months of age (281 infants) or at 12 months of age (277 infants). Speech recordings from 235 infants (83.6%) in the 6-month group and 226 (81.6%) in the 12-month group were analyzable. Insufficient velopharyngeal function at 5 years of age was observed in 21 of 235 infants (8.9%) in the 6-month group as compared with 34 of 226 (15.0%) in the 12-month group (risk ratio, 0.59; 95% confidence interval, 0.36 to 0.99; P=0.04). Postoperative complications were infrequent and similar in the 6-month and 12-month groups. Four serious adverse events were reported (three in the 6-month group and one in the 12-month group) and had resolved at follow-up.Medically fit infants who underwent primary surgery for isolated cleft palate in adequately resourced settings at 6 months of age were less likely to have velopharyngeal insufficiency at the age of 5 years than those who had surgery at 12 months of age. (Funded by the National Institute of Dental and Craniofacial Research; TOPS ClinicalTrials.gov number, NCT00993551.).
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| 3. |
- Hanstock, Helen, 1989-, et al.
(författare)
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Tear Fluid SIgA as a Noninvasive Biomarker of Mucosal Immunity and Common Cold Risk
- 2016
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Ingår i: Medicine & Science in Sports & Exercise. - 0195-9131 .- 1530-0315. ; 48:3, s. 569-577
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: Research has not convincingly demonstrated the utility of saliva secretory Immunoglobulin-A (SIgA) as a biomarker of upper-respiratory-tract-infection (URTI) risk and disagreement exists about the influence of heavy exercise ('open-window-theory') and dehydration on saliva SIgA. Prompted by the search for viable alternatives, we compared the utility of tear and saliva SIgA to predict URTI prospectively (study-one) and assessed the influence of exercise (study-two) and dehydration (study-three) using a repeated-measures-crossover design.Methods: In study-one, forty subjects were recruited during the common-cold season. Subjects provided tear and saliva samples weekly and recorded upper-respiratory-symptoms (URS) daily for 3-weeks. RT-PCR confirmed common-cold pathogens in 9 of 11 subjects reporting URS (82%). Predictive utility of tear and saliva SIgA was explored by comparing healthy samples with those collected the week pre-URS. In study-two, thirteen subjects performed a 2-hour run at 65% VO2peak. In study-three, thirteen subjects performed exercise-heat-stress to 3% body-mass-loss followed by overnight fluid restriction.Results: Tear SIgA concentration and secretion rate were 48% and 51% lower respectively during URTI and 34% and 46% lower the week pre-URS (P<0.05) but saliva SIgA remained unchanged. URS risk the following week increased 9-fold (95% CI: 1.7 to 48) when tear SIgA secretion rate <5.5 μg[BULLET OPERATOR]min and 6-fold (95% CI: 1.2 to 29) when tear SIgA secretion rate decreased >30%. Tear SIgA secretion rate >5.5 μg[BULLET OPERATOR]min or no decrease >30% predicted subjects free of URS in >80% of cases. Tear SIgA concentration decreased post-exercise (-57%: P<0.05) in line with the 'open-window-theory' but was unaffected by dehydration. Saliva flow rate decreased and saliva SIgA concentration increased post-exercise and during dehydration (P<0.05).Conclusion: Tear SIgA has utility as a non-invasive biomarker of mucosal immunity and common-cold risk.
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| 4. |
- Hayes, Mr Dexter Jl, et al.
(författare)
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Effect of encouraging awareness of reduced fetal movement and subsequent clinical management on pregnancy outcome : A systematic review and meta-analysis
- 2023
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Ingår i: American Journal of Obstetrics & Gynecology MFM. - : Elsevier BV. - 2589-9333. ; 5:3
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Forskningsöversikt (refereegranskat)abstract
- OBJECTIVE: Reduced fetal movement (RFM), defined as a decrease in maternal perception of frequency or strength of fetal movements, is a common reason for presentation to maternity care. Observational studies demonstrate an association between RFM, stillbirth, and fetal growth restriction related to placental insufficiency. However, individual intervention studies have described varying results. This systematic review and meta-analysis aimed to determine whether interventions aiming to encourage awareness of reduced fetal movement and/or improve its subsequent clinical management reduce the frequency of stillbirth or other important secondary outcomes.DATA SOURCES: Searches were conducted in MEDLINE, EMBASE, CINAHL, The Cochrane Library, Web of Science and Google Scholar. Guidelines, trial registries, and grey literature were also searched. Databases were searched from inception to the 20th January 2022.STUDY ELIGIBILITY CRITERIA: Randomised controlled trials (RCTs) and controlled non-randomised studies (NRS) were eligible if they assessed interventions aiming to encourage awareness of fetal movement or fetal movement counting and/or improve the subsequent clinical management of RFM. Eligible populations were singleton pregnancies after 24 completed weeks of gestation. The primary review outcome was stillbirth; a number of secondary maternal and neonatal outcomes were specified in the review.STUDY APPRAISAL AND SYNTHESIS METHODS: Risk of bias was assessed using Cochrane Risk of Bias 2 and ROBINS-I for RCTs and NRS respectively. Variation due to heterogeneity was assessed using I2. Data from studies employing similar interventions was combined using random effects meta-analysis.RESULTS: 1,609 citations were identified; 190 full text papers were evaluated against the inclusion criteria, 18 studies (16 RCTs and 2 NRS) were included. The evidence is uncertain about the effect of encouraging awareness of fetal movement on stillbirth compared with standard care (two studies, n=330,084); pooled aOR 1.19 (95% CI 0.96, 1.47). Interventions for encouraging awareness of fetal movement may be associated with a reduction in NICU admissions and Apgar scores <7 at five minutes of age and may not be associated with increases in caesarean section or induction of labour. The evidence is uncertain about the effect of encouraging fetal movement counting on stillbirth compared with standard care; pooled OR 0.69 (95% CI 0.18, 2.65), data from three RCTs (n=70,584). Counting fetal movements may increase maternal fetal attachment and decrease anxiety compared with standard care. When comparing combined interventions of fetal movement awareness and subsequent clinical management with standard care (one study, n=393,857) the evidence is uncertain about the effect on stillbirth (aOR 0.86, 95% CI 0.70, 1.05).CONCLUSIONS: The effect of interventions for encouraging awareness of RFM alone or in combination with subsequent clinical management on stillbirth is uncertain. Encouraging awareness of fetal movement may be associated with reduced adverse neonatal outcomes without an increase in interventions in labour. Meta-analysis is hampered by variation in interventions, outcome reporting and definitions. Individual studies are frequently underpowered to detect a reduction in severe, rare outcomes and no studies were included from high-burden settings. Studies from such settings are needed to determine whether interventions can reduce stillbirth.
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| 5. |
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- 2019
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Tidskriftsartikel (refereegranskat)
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