The Glasgow Benefit Inventory: a systematic review of the use and value of an otorhinolaryngological generic patient-recorded outcome measure.

BACKGROUND: The Glasgow Benefit Inventory (GBI) is a validated, generic patient-recorded outcome measure widely used in otolaryngology to report change in quality of life post-intervention. OBJECTIVES OF REVIEW: To date, no systematic review has made (i) a quality assessment of reporting of Glasgow Benefit Inventory outcomes; (ii) a comparison between Glasgow Benefit Inventory outcomes for different interventions and objectives; (iii) an evaluation of subscales in describing the area of benefit; (iv) commented on its value in clinical practice and research. TYPE OF REVIEW: Systematic review. SEARCH STRATEGY: 'Glasgow Benefit Inventory' and 'GBI' were used as keywords to search for published, unpublished and ongoing trials in PubMed, EMBASE, CINAHL and Google in addition to an ISI citation search for the original validating Glasgow Benefit Inventory paper between 1996 and January 2015. EVALUATION METHOD: Papers were assessed for study type and quality graded by a predesigned scale, by two authors independently. Papers with sufficient quality Glasgow Benefit Inventory data were identified for statistical comparisons. Papers with <50% follow-up were excluded. RESULTS: A total of 118 eligible papers were identified for inclusion. A national audit paper (n = 4325) showed that the Glasgow Benefit Inventory gave a range of scores across the specialty, being greater for surgical intervention than medical intervention or 'reassurance'. Fourteen papers compared one form of surgery versus another form of surgery. In all but one study, there was no difference between the Glasgow Benefit Inventory scores (or of any other outcome). The most likely reason was lack of power. Two papers took an epidemiological approach and used the Glasgow Benefit Inventory scores to predict benefit. One was for tonsillectomy where duration of sore throat episodes and days with fever were identified on multivariate analysis to predict benefit albeit the precision was low. However, the traditional factor of number of episodes of sore throat was not predictive. The other was surgery for chronic rhinosinusitis where those with polyps on univariate analysis had greater benefit than those without. Forty-three papers had a response rate of >50% and gave sufficient Glasgow Benefit Inventory total and subscales for meta-analysis. For five of the 11 operation categories (vestibular schwannoma, tonsillectomy, cochlear implant, middle ear implant and stapes surgery) that were most likely to have a single clear clinical objective, score data had low-to-moderate heterogeneity. The value in the Glasgow Benefit Inventory having both positive and negative scores was shown by an overall negative score for the management of vestibular schwannoma. The other six operations gave considerable heterogeneity with rhinoplasty and septoplasty giving the greatest percentages (98% and 99%) most likely because of the considerable variations in patient selection. The data from these operations should not be used for comparative purposes. Five papers also reported the number of patients that had no or negative benefit, a potentially a more clinically useful outcome to report. Glasgow Benefit Inventory subscores for tonsillectomy were significantly different from ear surgery suggesting different areas of benefit CONCLUSIONS: The Glasgow Benefit Inventory has been shown to differentiate the benefit between surgical and medical otolaryngology interventions as well as 'reassurance'. Reporting benefit as percentages with negative, no and positive benefit would enable better comparisons between different interventions with varying objectives and pathology. This could also allow easier evaluation of factors that predict benefit. Meta-analysis data are now available for comparison purposes for vestibular schwannoma, tonsillectomy, cochlear implant, middle ear implant and stapes surgery. Fuller report of the Glasgow Benefit Inventory outcomes for non-surgical otolaryngology interventions is encouraged.

Health-related quality of life before and after management in adults referred to otolaryngology: a prospective national study.

OBJECTIVE: An assessment of the effect of otolaryngological management on the health-related quality of life of patients. DESIGN: Application of the Health Utilities Index mark 3 (HUI-3) before and after treatment; application of the Glasgow Benefit Inventory (GBI) after treatment. SETTING: Six otolaryngological departments around Scotland. PARTICIPANTS: A 9005 adult patients referred to outpatient clinics. MAIN OUTCOME MEASURES: Complete HUI-3 data was collected from 4422 patients; complete GBI data from 4235; complete HUI-3 and GBI data from 3884. RESULTS: The overall change in health related quality of life from before to after management was just +0.02. In the majority of subgroups of data (classified by type of management) there was essentially no change in HUI-3 score. The major exceptions were those patients provided with a hearing aid (mean change 0.08) and those whose problem was managed surgically (mean change 0.04). The mean GBI score was 5.3 which is low. Those managed surgically reported a higher GBI score of 13.0. CONCLUSION: We found that patients treated surgically or given a hearing aid reported a significant improvement in their health related quality of life after treatment in otolaryngology departments. In general, patients treated in other ways reported no significant improvement. We argue that future research should look carefully at patient groups where there is unexpectedly little benefit from current treatment methods and consider more effective methods of management.

A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell's palsy: the BELLS study.

OBJECTIVE: To determine whether oral prednisolone or aciclovir, used separately or in combination, early in the course of Bell's palsy, improves the chances of recovery at 3 and 9 months. DESIGN: A 2 x 2 factorial randomised double-blind trial. Patients were randomly assigned to treatment by an automated telephone service using a permuted block randomisation technique with block sizes of four or eight, and no stratification. SETTING: Mainland Scotland, with referrals mainly from general practice to 17 hospital trial sites. PARTICIPANTS: Adults (aged 16 years or older) with unilateral facial nerve weakness of no identifiable cause presenting to primary care, the emergency department or NHS24 within 72 hours of symptom onset. INTERVENTIONS: Patients were randomised to receive active preparations or placebo for 10 days: (1) prednisolone (50 mg per day, 2 x 25-mg capsules) and aciclovir (2000 mg per day, 5 x 400-mg capsules); (2) prednisolone and placebo (lactose, indistinguishable); (3) aciclovir and placebo; and (4) placebo and placebo. OUTCOME MEASURES: The primary outcome was recovery of facial function assessed by the House-Brackmann scale. Secondary outcomes included health status, pain, self-perceived appearance and cost-effectiveness. RESULTS: Final outcomes were available for 496 patients, balanced for gender; mean age 44 years; initial facial paralysis moderate to severe. One half of patients initiated treatment within 24 hours of onset of symptoms, one-third within 24-48 hours and the remainder within 48-72 hours. Of the completed patients, 357 had recovered by 3 months and 80 at 9 months, leaving 59 with a residual deficit. There were significant differences in complete recovery at 3 months between the prednisolone comparison groups (83.0% for prednisolone, 63.6% for no prednisolone, a difference of + 19.4%; 95% confidence interval (CI): + 11.7% to + 27.1%, p < 0.001). The number needed to treat (NNT) in order to achieve one additional complete recovery was 6 (95% CI: 4 to 9). There was no significant difference between the aciclovir comparison groups (71.2% for aciclovir and 75.7% for no aciclovir). Nine-month assessments of patients recovered were 94.4% for prednisolone compared with 81.6% for no prednisolone, a difference of + 12.8% (95% CI: + 7.2% to + 18.4%, p < 0.001); the NNT was 8 (95% CI: 6 to 14). Proportions recovered at 9 months were 85.4% for aciclovir and 90.8% for no aciclovir, a difference of -5.3%. There was no significant prednisolone-aciclovir interaction at 3 months or at 9 months. Outcome differences by individual treatment (the four-arm model) showed significant differences. At 3 months the recovery rate was 86.3% in the prednisolone treatment group, 79.7% in the aciclovir-prednisolone group, 64.7% in the placebo group and 62.5% in the aciclovir group. At 9 months the recovery rates were respectively 96.1%, 92.7%, 85.3% and 78.1%. The increase in recovery rate conferred by the addition of prednisolone (both for prednisolone over placebo and for aciclovir-prednisolone over aciclovir) is highly statistically significant (p < 0.001). There were no significant differences in secondary measures apart from Health Utilities Index Mark 3 (HUI3) at 9 months in those treated with prednisolone. CONCLUSIONS: This study provided robust evidence to support the early use of oral prednisolone in Bell's palsy as an effective treatment which may be considered cost-effective. Treatment with aciclovir, either alone or with steroids, had no effect on outcome.

Evidence review and ENT-UK consensus report for the use of aminoglycoside-containing ear drops in the presence of an open middle ear.

UNLABELLED: BACKGROUND AND OBJECTIVES OF REVIEW: The use of aminoglycoside drops in the presence of a perforation/grommet is still a common practice amongst the UK ENT community, in spite of theoretical risk of ototoxicity. Mindful of the need to produce clinical guidelines based on the best available evidence, it was the intention of the Clinical Audit and Practice Advisory Group of the British Association of Otolaryngologists - Head and Neck Surgeons (ENT-UK) to produce evidence-based guidelines. In the absence of good evidence, intentions were shifted towards producing consensus guidelines using validated methodology. TYPE OF REVIEW: Literature review, review of international guidelines and consensus guidelines. SEARCH STRATEGY: A MEDLINE literature search (1966 to August 2006) was conducted, using the following strategies: 'ototoxicity and drops', 'ototoxic and drops', 'vestibulotoxicity and drops', 'vestibulotoxic and drops', 'cochleotoxicity and drops', 'cochleotoxic and drops'. Foreign language articles were not excluded. RESULTS OF THE LITERATURE REVIEW: The inclusion of foreign language articles and manually searching the reference sections of identified articles revealed further evidence not considered in previous reviews on this subject. However, the available 'evidence' that does exist remains to be of poor quality, consisting of data from a number of case reports and small case series. Prospective studies into the ototoxic effects of aminoglycoside ear drops either support their use but lack power to statistically confirm this, or are performed in conditions that are not representative of normal clinical conditions. EVALUATION METHOD: In the light of issues raised from the literature review, a questionnaire was produced. The questionnaire was initially completed by council members of the British Society of Otology, then revised and presented at a meeting of the British Society of Otology, where a consensus panel was formed. CONCLUSIONS: ENT-UK recommends that when treating a patient with a discharging ear, in whom there is a perforation or patent grommet: if a topical aminoglycoside is used, this should only be in the presence of obvious infection. Topical aminoglycosides should be used for no longer than 2 weeks. The justification for using topical aminoglycosides should be explained to the patient. Baseline audiometry should be performed, if possible or practical, before treatment with topical aminoglycosides.

Outcomes of septal surgery.

OBJECTIVE: To assess the change in health-related quality of life following septal surgery. STUDY DESIGN: Post-intervention, health-related quality of life questionnaire. PARTICIPANTS: Adult patients undergoing septal surgery, recruited from two sources (the Scottish ENT outcomes study and the North Glasgow National Health Service Trust) over an 18-month period. MAIN OUTCOME MEASURE: Glasgow benefit inventory score. RESULTS: A total of 149 Glasgow benefit inventories were returned. Of these, 13 were incomplete and were thus excluded, leaving 136 to be analysed. The response rate from the Scottish ENT outcomes study patients was 55 per cent and the response rate from the North Glasgow National Health Service Trust patients was 41 per cent, giving an overall response rate of 49 per cent. The mean Glasgow benefit inventory score was 11.3 (standard deviation 20, 95 per cent confidence interval 7.8 to 14.7). This result was similar to those of other studies using the Glasgow benefit inventory to assess septal surgery outcomes. CONCLUSION: Patients reported minimal improvement in their health-related quality of life following septal surgery.

Interobserver reliability in evaluating postural stability between clinicians and posturography.

OBJECTIVES: To assess the interobserver reliability in assessing postural stability and to compare with results obtained by computerized posturography. DESIGN: Cross-sectional study. SETTING: Balance clinic, teaching hospital. PARTICIPANTS: 81 patients attending with a primary complaint of imbalance. MAIN OUTCOME MEASURES: Inter-rater reliability between two clinicians and the modified Clinical Test for the Sensory Interaction on Balance (mCTSIB) as assessed by the Neurocom VSR Balance Master platform. RESULTS: Inter-rater reliability scores were high (0.53-0.81) for all conditions of the mCTSIB except for the easiest, i.e. firm surface eyes open, where concordance levels were poor to fair. CONCLUSIONS: Overall there was good agreement between observers and the computerized mCTSIB.

Hearing impairment in 18q deletion syndrome.

The 18q-syndrome is associated with hearing impairment in 50-80 per cent of cases. The hearing loss may be sensorineural or conductive. A high proportion of cases are associated with narrow or stenosed external auditory canals. This may be a useful clinical pointer to the syndrome. Two cases with impaired hearing are presented in this paper including one case with complex external ear and middle ear malformations. The clinical and audiological features in each case are described.

The value of routine in-the-ear measurement of hearing aid gain.

When selecting the frequency response of a hearing aid, a target is usually selected using a predictive formula from the international literature. Nowadays real ear measurements can readily be carried out to ensure that the real ear gain closely matches the prescribed target. Such measurements are usually only carried out on a subset of patients fitted in the UK, though it has been suggested that they should be carried out on all hearing aid prescriptions. Real ear insertion gains were measured on 319 first-time National Health Service (NHS) hearing aid issues. A total of 181 (57%) failed to come within 10 dB of the target gain at one or more frequencies between 0.25 and 3 kHz. Though there were audiometric differences between those who achieved satisfactory gain and those who did not, there was too much overlap between groups to make any audiometric index or combination of indices of value in predicting the likelihood of failure to achieve target gain. Sixty-eight patients with inadequate real ear gain were invited to attend for alterations to their hearing aid prescription. Twelve (18%) were fitted with a high frequency aid, while the rest were managed by alterations to their NHS aid or to the earmould and tubing. After appropriate changes, 58 (85%) achieved a satisfactory gain. The routine use of real ear insertion gains in all hearing aid fittings would result in many patients having a more accurately fitted hearing aid. As the majority of prescriptions could be adequately improved using NHS hearing aids, the effects on the hearing aid budget would be relatively small.

Auditory rehabilitation: needs and realities on long-stay wards for elderly people.

A survey was made of the problem of age-related hearing impairment within a sample of National Health Service long-stay wards for elderly people. Detailed assessment of hearing was completed for 188 residents derived from 15 long-stay wards, located within nine Scottish hospitals. The sample residents were more than four times as likely to need a hearing aid as their contemporaries in the general population. Of the 131 people considered to be potential hearing aid candidates, 103 (78%) demonstrated a positive attitude towards hearing aids ownership. Medical policies on the study wards were not considered sensitive to the needs of the hearing-impaired; screening was haphazard and specialist referral problematic.

A prospective evaluation of direct referral to audiology departments for hearing aids.

It has been suggested that a proportion of individuals with a hearing impairment can be fitted with a hearing aid without being otolaryngologically assessed. Such assessments are deemed advisable: (a) to identify otological pathology that might require management and (b) because surgery can be a viable alternative in those with a conductive impairment. The aim of this study was to prospectively study individuals referred to an Otolaryngology Department in a teaching hospital to assess how technicians, at a direct referral clinic for the provision of a hearing aid, could screen to identify those meriting an otolaryngological opinion. Two hundred and forty-eight patients were evaluated by technicians using strict audiometric and tympanometric criteria. One hundred and twenty-five patients (50 per cent) failed these criteria and were referred to an otologist. The remaining 123 (50 per cent) were managed by technicians but were subsequently reviewed for the purpose of this study by an otologist and their management assessed. In only two patients (one per cent) was it thought that the initial management would have been different if seen by an otologist. Alternative criteria for deciding suitability for management by technicians were applied. The inclusion of tympanometry was essential to avoid missing middle ear pathology.

The absence of Harvey ras mutations during development and progression of squamous cell carcinomas of the head and neck.

We have examined the incidence of Harvey ras mutations in human squamous cell carcinomas (SCC) of the upper aerodigestive tract using the polymerase chain reaction (PCR) followed by direct sequencing. No mutations were detected at codons 12, 13, 59 or 61 of this gene in any of six papillomas, five erythroplakias, 56 squamous cell carcinomas, and 16 SCC cell lines. Some of the SCC were lymph node metastases (three) or tumours which had recurred following radiotherapy (seven). We conclude that Harvey ras mutations are not a common event in the pathogenesis or recurrence of SCCs from Caucasian subjects, in contrast to the situation with Indian populations (Saranath et al., 1991).

Endoscopic photographic comparison of drug delivery by ear-drops and by aerosol spray.

The Otomize (Stafford-Miller Ltd) aerosol spray is a new device for delivering topical ear medication in otitis externa. Both the manufacturers and a recent study have claimed that the spray produces better coverage of the external ear canal than do traditional ear-drops. We performed an endoscopic photographic comparison study to investigate this claim. The are of tympanic membrane and ear canal covered with medication was greater in those ears treated with the aerosol (P less than 0.001, paired t-test). The ability of the aerosol to deliver drug to the level of the tympanic membrane suggests a possible role for this device in the treatment of chronic otitis media. The technique of endoscopic photography provides an objective and reproducible means of investigating drug delivery systems for otological conditions.

Chronic otitis media: a new extra-articular manifestation in ankylosing spondylitis?

Following a study reporting a fourfold increase in the occurrence of chronic otitis media in patients with ankylosing spondylitis, this prospective study examines this association with respect to severity, duration of disease, and acute phase in ankylosing spondylitis. Forty two consecutive patients with classical ankylosing spondylitis seen at the rheumatology clinic of a teaching hospital where the features of ankylosing spondylitis were recorded had an otological examination by an otolaryngologist. The occurrence of chronic otitis media (all categories) was 12/42 (29%). The acute phase serum markers (C reactive protein and IgG) were increased in patients with active or inactive chronic otitis media. Extra-articular manifestations were significantly more common in the chronic otitis media group than in those with no history of chronic otitis media. The results of this study suggest that chronic otitis media may be another extra-articular manifestation of ankylosing spondylitis. Alternative explanations, however, include similar aetiological factors for the two conditions or a previously unrecognised increased occurrence of HLA-B27 in patients with chronic otitis media.

Costs of investigative protocols for cerebellopontine angle lesions in Scotland.

Efficient use of resources demands evaluation of current practices. This paper presents a prospective evaluation of investigative protocols for cerebellopontine angle lesions. Commonly used protocols vary greatly in their clinical effectiveness and in their costs. The use of appropriate protocols would increase the number of tumours correctly diagnosed each year while also limiting the costs of investigation.

Chronic otitis media and ankylosing spondylitis: an HLA association?

A prospective study was undertaken to investigate an apparent correlation between ankylosing spondylitis (AS) and the incidence of otological conditions. 42 consecutive patients attending the ankylosing spondylitis clinic were examined otoscopically and had audiometric assessment. 19% of the patients (8/42) had active or inactive chronic otitis media. The prevalence of chronic otitis media in this group was significantly greater (P less than 0.01) than a stratified sample of the general population from the Medical Research Council Institute of Hearing Research National Study of Hearing, controlled for age, sex and socio-economic group, where the expected incidence was 5%. A hypothetical explanation for the association is given and the need for HLA studies into chronic otitis media is discussed.