Dataset Information

Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial.

ABSTRACT:

Objective

To assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy.

Design

Open, randomised controlled trial.

Setting

21 general hospitals and three academic centres in the Netherlands.

Participants

300 children aged 2-8 years requiring adenotonsillectomy.

Intervention

Adenotonsillectomy compared with watchful waiting.

Main outcome measures

Episodes of fever, throat infections, upper respiratory tract infections, and health related quality of life.

Results

During the median follow up period of 22 months, children in the adenotonsillectomy group had 2.97 episodes of fever per person year compared with 3.18 in the watchful waiting group (difference -0.21, 95% confidence interval -0.54 to 0.12), 0.56 throat infections per person year compared with 0.77 (-0.21, -0.36 to -0.06), and 5.47 upper respiratory tract infections per person year compared with 6.00 (-0.53, -0.97 to -0.08). No clinically relevant differences were found for health related quality of life. Adenotonsillectomy was more effective in children with a history of three to six throat infections than in those with none to two. 12 children had complications related to surgery.

Conclusion

Adenotonsillectomy has no major clinical benefits over watchful waiting in children with mild symptoms of throat infections or adenotonsillar hypertrophy.

SUBMITTER: van Staaij BK

PROVIDER: S-EPMC517640 | biostudies-literature | 2004 Sep

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial.

van Staaij Birgit K BK van den Akker Emma H EH Rovers Maroeska M MM Hordijk Gerrit Jan GJ Hoes Arno W AW Schilder Anne G M AG

BMJ (Clinical research ed.) 20040910 7467

<h4>Objective</h4>To assess the effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy.<h4>Design</h4>Open, randomised controlled trial.<h4>Setting</h4>21 general hospitals and three academic centres in the Netherlands.<h4>Participants</h4>300 children aged 2-8 years requiring adenotonsillectomy.<h4>Intervention</h4>Adenotonsillectomy compared with watchful waiting.<h4>Main outcome measures</h4>Episodes of fever, throat infections, u ...[more]

PMID: 15361407

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Project description:BackgroundVitiligo is a common acquired skin depigmentation disorder and is associated with various other autoimmune diseases which include thyroid disease and rheumatoid arthritis. Similarly, adenotonsillar disease (ATD) may induce inflammatory or autoimmune diseases in other organs which include the skin. However, the influence of ATD on the development of vitiligo has not been studied.ObjectivesTo determine the association between ATD and adenotonsillectomy, and the development of vitiligo.Design and methodsUsing data from the National Health Insurance Service database, patients diagnosed with ATD between 2008 and 2010 were included in the study. We performed two rounds of 1:1 propensity score matching in the ATD and adenotonsillectomy groups. The ATD and non-ATD groups both included 206,514 individuals. Among the ATD group, the adenotonsillectomy and non-adenotonsillectomy groups both included 23,354 individuals. Each individual was monitored until 2019. The primary end point was the risk of vitiligo. Using the Cox Proportional Hazards model, the incidence of vitiligo and the hazard ratio (HR) were calculated.ResultsThe incidence of vitiligo was 1.16-fold higher in the ATD group than in the non-ATD group [adjusted HR (aHR), 1.16; 95% confidence interval (CI), 1.09-1.24] and 0.82-fold lower in the adenotonsillectomy group than in the non-adenotonsillectomy group (aHR, 0.82; 95% CI, 0.68-0.99). Additionally, the other risk factors for developing vitiligo included thyroid disease (aHR, 1.48; 95% CI, 1.11-1.98), age younger than 30 years (aHR, 1.18; 95% CI, 1.09-1.27), and age over 60 years (aHR, 1.22; 95% CI, 1.06-1.41), whereas factors including rural residency (aHR, 0.91; 95% CI, 0.85-0.98) and low economic status (aHR 0.87; 95% CI, 0.82-0.93) were associated with decreased incidence of vitiligo.ConclusionIn this study, ATD increases the risk of vitiligo and adenotonsillectomy attenuates its development. Clinicians should consider ATD as a pathogenic factor for vitiligo and the potential effect of adenotonsillectomy in its management.

Project description:INTRODUCTION:Mild obstructive sleep-disordered breathing (oSDB), characterised by habitual snoring without frequent apnoeas and hypopnoeas on polysomnography, is prevalent in children and commonly treated with adenotonsillectomy (AT). However, the absence of high-level evidence addressing the role of AT in improving health and behavioural outcomes has contributed to significant geographical variations in care and potential for surgery to be both overused and underused. METHODS AND ANALYSIS:The Pediatric Adenotonsillectomy Trial for Snoring (PATS) is a single-blinded, multicentre randomised controlled trial designed to evaluate the effect of AT in treating mild oSDB. Four hundred sixty eligible children, aged 3.0-12.9 years old, will be randomised to either early adenotonsillectomy or to watchful waiting with supportive care (WWSC) with a 1:1 ratio. The study's coprimary endpoints are (1) change from baseline in executive behaviour relating to self-regulation and organisation skills as measured by the Behavioural Rating Inventory of Executive Function (BRIEF) Global Composite Score (GEC); and (2) change from baseline in vigilance as measured on the Go-No-Go (GNG) signal detection parameter (d-prime). A mixed effects model will be used to compare changes in the BRIEF GEC score and GNG score at 6 and 12 months from baseline between the AT arm and the WWSC arm. ETHICS AND DISSEMINATION:The study protocol was approved by the institutional review board (IRB) at Children's Hospital of Philadelphia (CHOP) on 3 October 2014 (14-0 11 214). The approval of CHOP as the central IRB of record was granted on 29 February 2016. The results will be published in peer-reviewed journals and presented at academic conferences. The data collected from the PATS study will be deposited in a repository (National Sleep Research Resource, sleepdata.org) after completion of the study to maximise use by the scientific community. TRIAL REGISTRATION NUMBER:NCT02562040; Pre-results.

Project description:ImportanceAdenotonsillectomy (ATE) is one of the most common surgical procedures to treat children with obstructive sleep apnea (OSA), but to our knowledge there are no randomized clinical trials confirming the benefit of surgery compared with watchful waiting in children between 2 and 4 years of age.ObjectiveTo determine whether ATE is more effective than watchful waiting for treating otherwise healthy children with mild to moderate OSA.Design, setting, and participantsThis randomized clinical trial was conducted from December 2014 to December 2017 at the Otorhinolaryngology Department of the Karolinska University Hospital, Stockholm, Sweden. A total of 60 children, 2 to 4 years of age, with an obstructive apnea-hypopnea index (OAHI) score of 2 or greater and less than 10, were randomized to ATE (n = 29) or watchful waiting (n = 31). A total of 53 participants (88%; ATE, n = 25; watchful waiting, n = 28) completed the study. Data were analyzed from August 2018 to December 2018.InterventionsAdenotonsillectomy.Main outcomes and measuresThe primary outcome was the difference between the groups in mean OAHI score change. Secondary outcomes were other polysomnography parameters, score on the Obstructive Sleep Apnea-18 (OSA-18) questionnaire, and subgroup analyses. Polysomnography and the OSA-18 questionnaire were completed at baseline and after 6 months.ResultsOf the 60 included children, 34 (57%) were boys and the mean (SD) age at first polysomnography was 38 (9) months. Both groups had a decrease in mean OAHI score, and the difference in mean OAHI score change between the groups was small (-1.0; 95% CI, -2.4 to 0.5), in favor of ATE. However, there were large differences between the groups in favor of ATE regarding the OSA-18 questionnaire (eg, total OSA-18 score: -17; 95% CI, -24 to -10). Also, a subgroup analysis of 24 children with moderate OSA (OAHI ≥5 and <10) showed a meaningful difference in mean OAHI score change between the groups in favor of ATE (-3.1; 95% CI, -5.7 to -0.5). Of 28 children, 10 (36%) in the watchful waiting group received ATE after the follow-up, and 7 of these had moderate OSA at baseline.Conclusions and relevanceThis randomized clinical trial found only small differences between the groups regarding changes in OAHI, but further studies are needed. However, there were large improvements in quality of life after ATE. These results suggest that otherwise healthy children with mild OSA and mild effect on quality of life may benefit from watchful waiting, while children with moderate OSA should be considered for ATE.Trial registrationClinicalTrials.gov Identifier: NCT02315911.

Project description:ObjectiveTo assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms.DesignPragmatic, double blind, placebo controlled, randomised trial.SettingEight ear, nose, and throat outpatient clinics, United Kingdom.Participants346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to lansoprazole and 174 to placebo.InterventionRandom blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks.Main outcome measuresPrimary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score. Secondary outcomes included symptom response at 12 months, quality of life, and throat appearances.ResultsOf 1427 patients initially screened for eligibility, 346 were recruited. The mean age of the study sample was 52.2 (SD 13.7) years, 196 (57%) were women, and 162 (47%) had severe symptoms at presentation; these characteristics were balanced across treatment arms. The primary analysis was performed on 220 patients who completed the primary outcome measure within a window of 14-20 weeks. Mean RSI scores were similar between treatment arms at baseline: lansoprazole 22.0 (95% confidence interval 20.4 to 23.6) and placebo 21.7 (20.5 to 23.0). Improvements (reduction in RSI score) were observed in both groups-score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms: estimated difference 1.9 points (95% confidence interval -0.3 to 4.2 points; P=0.096) adjusted for site and baseline symptom severity. Lansoprazole showed no benefits over placebo for any secondary outcome measure, including RSI scores at 12 months: lansoprazole 16.0 (13.6 to 18.4) and placebo 13.6 (11.7 to 15.5): estimated difference 2.4 points (-0.6 to 5.4 points).ConclusionsNo evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up.Trial registrationISRCTN Registry ISRCTN38578686 and EudraCT 2013-004249-17.

Project description:BackgroundSymptoms from throat (sensation of globus; frequent throat clearing; irritated throat) are common in patients referred to voice clinics and to ENT specialists. The relation to symptoms of voice discomfort is unclear and in some cases patients do not have voice problems at all. Instruments for patients' self-reporting of symptoms, and assessment of handicap, such as the Voice Handicap Index (VHI), are in common use in voice clinics. Symptoms from throat are however only marginally covered.PurposeTo develop and evaluate an instrument that could make the patients' estimation of symptoms from the throat possible. Further to facilitate the consideration of the relation between throat- and voice problems with the Throat subscale together with a Swedish translation of the Voice Handicap Index. Finally to try the VHI with the Throat subscale: the VHI-T, for test-retest reliability and validity.MethodsA subscale with 10 throat related items was developed for appliance with the VHI. The VHI was translated to Swedish and retranslated to English. The questionnaire was tried in two phases on a total of 23+144 patients and 12+58 voice healthy controls. The reliability was calculated with Cronbach's alpha, ICC and Pearson's correlation coefficient. The validity was estimated by independent T-test.ResultsThe difference in VHI-T scores between the patients and the voice-healthy controls was significant (p = < 0,01) and there was a good correlation of the test- retest occasions. The reliability testing of the entire questionnaire showed an alpha value of r = 0,90 and that for the Throat subscale separately a value of r = 0,87 which shows a high degree of reliability.ConclusionsFor the estimation of self-perceived throat and voice problems the scale on throat related problems together with the present Swedish translation of the Voice Handicap Index, (VHI) the VHI-Throat, proves to be a valid and reliable instrument. The throat subscale seems to help revealing a category of symptoms that are common in our patients. These are symptoms that have not earlier been possible to cover with the questionnaires designed for use in the voice clinic.

Dataset Information

Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial.

Objective

Design

Setting

Participants

Intervention

Main outcome measures

Results

Conclusion

Publications

Effectiveness of adenotonsillectomy in children with mild symptoms of throat infections or adenotonsillar hypertrophy: open, randomised controlled trial.

Similar Datasets

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