Measuring benefit from non-surgical interventions in otolaryngology for different conditions, using the revised 5-factor Glasgow Benefit Inventory.

OBJECTIVES: The Glasgow Benefit Inventory (GBI) has been extensively used to report the benefit from otolaryngological surgery. Benefit from non-surgical management has not been reported, despite this being the outcome of most otolaryngology and audiology consultations. DESIGN: GBI responses from 4543 adults from the Scottish ENT Outcome Study were categorised by diagnosis. Benefit scores for different interventions within diagnostic categories for which surgery was not a potential management are reported using the revised 5-factor Glasgow Benefit Inventory (GBI-5F; 15 questions and 5 factors). SETTING: Adult otolaryngology outpatient clinics in six university hospitals. PARTICIPANTS: Adults seen with conditions that had no surgical option and given non-surgical management. RESULTS: Overall, 80% of participants managed in Scottish Ear Nose and Throat Outcome Study (SENTOS) did not have surgery. A total of 1373 (30%) participants with various diagnoses were given reassurance and advice with no active intervention. There was no change in their GBI-5F total or factor scores, suggesting that they did not come to harm from their lack of active intervention. Hearing aids for bilateral sensorineural hearing loss gave greater benefit than reassurance in all factors, though individuals with a conductive impairment reported greater benefit in the Quality of life factor than those with a sensorineural impairment. Hearing aids and maskers produced benefit in the Support factor for patients with tinnitus. Epley's manoeuvre for benign paroxysmal positional vertigo gave benefit in the total score and the Quality of life factor compared with reassurance. Systemic medication for laryngo-pharyngeal reflux and topical medication for otitis externa gave no greater benefit in any factor or the total score compared with reassurance. CONCLUSION: The GBI-5F and its five factors give useful information for reporting the benefit of non-surgical interventions in adult otolaryngology and audiology clinics.

Revised 15-item Glasgow Benefit Inventory with five factors based on analysis of a large population study of medical and surgical otorhinolaryngological interventions.

OBJECTIVES: To review, using confirmatory factor analysis, the widely used 18-question Glasgow Benefit Inventory [GBI] that has three factors. Thereafter to develop, using exploratory factor analysis, a more coherent, revised version of the GBI. DESIGN: Confirmatory and exploratory factor analysis of a large national GBI data set of ORL interventions. SETTING: Adult otorhinolaryngology outpatient clinics in six University Hospital departments. PARTICIPANTS: One thousand nine hundred eighty adult patients who had complete GBI data and who underwent an active (medical or surgical) intervention, out of the total data set of 9005 patients from the original Scottish ENT Outcome Study [SENTOS]. RESULTS: One of the 18 questions was discarded from the data base because it was not answered by 8% of respondents. Two of the original factors remained (Physical Health, renamed General Health, and Social Support, renamed Support). The General factor was split into three new factors (Quality of Life, Self-Confidence and Social Involvement). The three new factors were found to give additional information regarding the area of benefit. This reduced number of questions does not make any material difference to the results of the >196 existing GBI papers in the literature. CONCLUSION: A 15-question GBI with five factors is provided that is more explanatory of the areas of benefit.

Hearing in Adults: A Digital Reprint of the Main Report From the MRC National Study of Hearing.

The 1011-page book, Hearing in Adults, published in 1995, contains the fullest report of the United Kingdom's Medical Research Council National Study of Hearing. It was designed to determine the prevalence and distribution in Great Britain of audiometrically measured hearing loss as a function of age, gender, occupation, and noise exposure. The study's size, quality, and breadth made it unique when it was done in the 1980s. These qualities remain, and its data are still the primary U.K. source for the prevalence of auditory problems. However, only 550 copies were printed, and the book is essentially unobtainable today. We describe here a fully searchable, open-access, digital (PDF) "reprinting" of Hearing in Adults, summarizing the study's design and the book's contents, together with a brief commentary in the light of subsequent developments.

Adenoidectomy with or without grommets for children with otitis media: an individual patient data meta-analysis.

BACKGROUND: Otitis media (OM) is a leading cause of medical consultations, antibiotic prescription and surgery in children. The surgical procedures offered to children with recurrent or persistent OM are insertion of grommets, adenoidectomy or a combination of the two. There is clear National Institute for Health and Care Excellence guidance for the use of grommets in subgroups of children with persistent OM with effusion (OME), but similar guidance is not available for adenoidectomy, either in persistent OME or in recurrent acute OM (AOM). OBJECTIVES: (1) To develop a model to predict the risk of children referred for adenoidectomy having a prolonged duration of their OM. Then, (2a) to evaluate the overall effect of adenoidectomy, with or without grommets, on OM using individual patient data (IPD) and (2b) to identify those subgroups of children who are most likely to benefit from adenoidectomy with or without grommets. DATA SOURCES: A number of electronic databases were searched from their inception including the Cochrane Ear, Nose and Throat Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), metaRegister of Current Controlled Trials (mRCT), ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), ClinicalStudyResults.org and Google. REVIEW METHODS: Studies eligible for inclusion in this IPD meta-analysis were randomised controlled trials (RCTs) in children up to 12 years of age diagnosed with recurrent AOM and/or persistent OME in which adenoidectomy (with or without grommets) was compared with non-surgical treatment or grommets alone. The final selection of eligible studies and the quality assessment were carried out according to standard methods and disagreement was resolved by discussion. RESULTS: A total of 503 articles were identified of which 10 trials were included in the meta-analysis; eight of these were at a low risk of bias and two were at moderate risk. The primary outcome was failure at 12 months, defined by a set of persisting symptoms and signs. In the prognostic analysis 56% of those children referred for adenoidectomy (but randomised to the non-surgical group) failed to improve (38% of the children with recurrent AOM and 89% of the children with persistent OME). Children who had adenoidectomy had a greater chance of clinical improvement. The size of that effect is, in general, small but persists for at least 2 years. Two subgroups of children are most likely to benefit from adenoidectomy: first, children aged < 2 years with recurrent AOM - 16% of those who had adenoidectomy failed at 12 months whereas 27% of those who did not have adenoidectomy failed [rate difference (RD) 12%, 95% confidence interval (Cl) 6% to 18%; number needed to treat (NNT) = 9]; second, children aged ≥ 4 years with persistent OME - 51% of those who had adenoidectomy failed at 12 months whereas 70% of those who did not have adenoidectomy failed (RD 19%, 95% Cl 12% to 26%; NNT = 6). No significant benefit of adenoidectomy was found in children aged ≥ 2 years with recurrent AOM and children aged < 4 years with persistent OME. LIMITATIONS: The need to use a composite end point and the limited number of subgroup variables that could be studied are factors that reduce the robustness of these results; however, we do not believe that this reduces the validity of the conclusions. CONCLUSIONS: Adenoidectomy is most beneficial in children with persistent OME aged ≥ 4 years. A smaller beneficial effect was found in children with recurrent AOM aged < 2 years. Consideration must be given to the balance between benefits and harms. Future research is required in a number of key areas, including defining the best methods of selecting, developing and administering patient-reported outcome measures to assess the value of treatments for children with persistent OME and recurrent AOM and upper respiratory infections; investigating the clinical effectiveness and cost-effectiveness of hearing aids (air or bone conduction) and the use of interventions to improve classroom acoustics for children with different degrees of persistence and severity of hearing loss associated with OME; and investigating why professionals' and parents'/carers' treatment preferences vary so much both nationally and internationally. We do not understand why adenoidectomy works in different subgroups at different ages, nor its effects in special populations, such as children with Down syndrome. We also need further research on the impact and optimal management of otitis media in these special situations and others, such as in children with a cleft palate or developmental problems. STUDY REGISTRATION: The study is registered as PROSPERO CRD42011001549. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Interventions for the prevention of postoperative ear discharge after insertion of ventilation tubes (grommets) in children.

BACKGROUND: Grommets are frequently inserted in children's ears for acute otitis media and otitis media with effusion. A common complication is postoperative ear discharge (otorrhoea). A wide range of treatments are used to prevent the discharge, but there is no consensus on whether or not intervention is necessary nor which is the most effective intervention. OBJECTIVES: To assess the effectiveness of prophylactic interventions, both topical and systemic, in reducing the incidence of otorrhoea following the surgical insertion of grommets in children. SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 3 July 2012. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared the efficacy of prophylactic interventions against placebo/control and/or with other prophylactic interventions for postoperative otorrhoea in children. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility and risk of bias, and extracted data. The outcome data were dichotomous for all the included trials. We calculated individual and pooled risk ratios (RR) using the Mantel-Haenszel fixed-effect method. We also calculated the numbers needed to treat to benefit (NNTB). MAIN RESULTS: We found 15 eligible RCTs (2476 children, aged from four months to 17 years). We graded seven RCTs as being at a low risk of bias (n = 926 children) and for an eighth RCT we also graded two of the arms as being at a low risk of bias. We graded the other seven trials as being at a high risk of bias.For a single application at surgery, there was evidence from two low risk of bias trials that at two weeks postoperatively the risk of otorrhoea was reduced by multiple saline washouts (from 30% to 16%; RR 0.52, 95% confidence interval (CI) 0.27 to 1.00; NNTB 7; one RCT; 140 children) and antibiotic/steroid ear drops (from 9% to 1%; RR 0.13, 95% CI 0.03 to 0.57; NNTB 13; one RCT; 322 ears). A meta-analysis of two low risk of bias trials (222 ears) failed to find an effect of a single application of antibiotic/steroid ear drops at four to six weeks postoperatively.For a prolonged application of an intervention, there was evidence from four low risk of bias trials that the risk of otorrhoea was reduced two weeks postoperatively by antibiotic ear drops (from 15% to 8%; RR 0.54, 95% CI 0.30 to 0.97; NNTB 15; one RCT; 372 children), antibiotic/steroid ear drops (from 39% to 5%; RR 0.13, 95% CI 0.05 to 0.31; NNTB 3; one RCT; 200 children), aminoglycoside/steroid ear drops (from 15% to 5%; RR 0.37, 95% CI 0.18 to 0.74; NNTB 11; one RCT; 356 children) or oral antibacterial agents/steroids (from 39% to 5%; RR 0.13, 95% CI 0.03 to 0.51; NNTB 3; one RCT; 77 children).Only one trial assessed the secondary outcome of ototoxicity, but no effect was found. There were no trials that assessed quality of life. AUTHORS' CONCLUSIONS: Our review found that each of the following were effective at reducing the rate of otorrhoea up to two weeks following surgery: (1) multiple saline washouts at surgery, (2) a single application of topical antibiotic/steroid drops at surgery, (3) a prolonged application of topical drops (namely antibiotic ear drops, antibiotic/steroid eardrops or aminoglycoside/steroid ear drops) and (4) a prolonged application of oral antibacterial agents/steroids. However, the rate of otorrhoea between RCTs varied greatly and the higher the rates of otorrhoea within a RCT, the smaller the NNTB for therapy.We conclude that if a surgeon has a high rate of postoperative otorrhoea in children then either saline irrigation or antibiotic ear drops at the time of surgery would significantly reduce that rate. If topical drops are chosen, it is suggested that to reduce the cost and potential for ototoxic damage this be a single application at the time of surgery and not prolonged thereafter.

Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children.

BACKGROUND: Otitis media with effusion (OME; 'glue ear') is common in childhood and surgical treatment with grommets (ventilation tubes) is widespread but controversial. OBJECTIVES: To assess the effectiveness of grommet insertion compared with myringotomy or non-surgical treatment in children with OME. SEARCH STRATEGY: We searched the Cochrane ENT Disorders Group Trials Register, other electronic databases and additional sources for published and unpublished trials (most recent search: 22 March 2010). SELECTION CRITERIA: Randomised controlled trials evaluating the effect of grommets. Outcomes studied included hearing level, duration of middle ear effusion, language and speech development, cognitive development, behaviour and adverse effects. DATA COLLECTION AND ANALYSIS: Data from studies were extracted by two authors and checked by the other authors. MAIN RESULTS: We included 10 trials (1728 participants). Some trials randomised children (grommets versus no grommets), others ears (grommet one ear only). The severity of OME in children varied between trials. Only one 'by child' study (MRC: TARGET) had particularly stringent audiometric entry criteria. No trial was identified that used long-term grommets.Grommets were mainly beneficial in the first six months by which time natural resolution lead to improved hearing in the non-surgically treated children also. Only one high quality trial that randomised children (N = 211) reported results at three months; the mean hearing level was 12 dB better (95% CI 10 to 14 dB) in those treated with grommets as compared to the controls. Meta-analyses of three high quality trials (N = 523) showed a benefit of 4 dB (95% CI 2 to 6 dB) at six to nine months. At 12 and 18 months follow up no differences in mean hearing levels were found.Data from three trials that randomised ears (N = 230 ears) showed similar effects to the trials that randomised children. At four to six months mean hearing level was 10 dB better in the grommet ear (95% CI 5 to 16 dB), and at 7 to 12 months and 18 to 24 months was 6 dB (95% CI 2 to 10 dB) and 5 dB (95% CI 3 to 8 dB) dB better.No effect was found on language or speech development or for behaviour, cognitive or quality of life outcomes.Tympanosclerosis was seen in about a third of ears that received grommets. Otorrhoea was common in infants, but in older children (three to seven years) occurred in < 2% of grommet ears over two years of follow up. AUTHORS' CONCLUSIONS: In children with OME the effect of grommets on hearing, as measured by standard tests, appears small and diminishes after six to nine months by which time natural resolution also leads to improved hearing in the non-surgically treated children. No effect was found on other child outcomes but data on these were sparse. No study has been performed in children with established speech, language, learning or developmental problems so no conclusions can be made regarding treatment of such children.

Ear wax.

INTRODUCTION: Ear wax only becomes a problem if it causes a hearing impairment or other ear-related symptoms. Ear wax is more likely to accumulate and cause a hearing impairment when normal extrusion is prevented--for example, by the use of hearing aids, or by the use of cotton buds to clean the ears. Ear wax can visually obscure the ear drum, and may need to be removed for diagnostic purposes. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of methods to remove ear wax? We searched: Medline, Embase, The Cochrane Library and other important databases up to June 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found nine systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: ear syringing, manual removal (other than ear syringing), and wax softeners (alone or prior to syringing).