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 SEARCH STRATEGY: 'Glasgow Benefit Inventory' and 'GBI' were used as keywords to search for published, unpublished and ongoing trials in PubMed, EMBASE, CINAHL and Google in addition to an ISI citation search for the original validating Glasgow Benefit Inventory paper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.

Economic evaluation of early administration of prednisolone and/or aciclovir for the treatment of Bell's palsy.

OBJECTIVES: Bell's palsy (BP), which causes facial paralysis, affects 11-40 people per 100 000 per annum in the UK. Its cause is unknown but as many as 30% of patients have continuing facial disfigurement, psychological difficulties and occasionally facial pain. We present an randomised controlled trial (RCT)-based economic evaluation of the early administration of steroids (prednisolone) and/or antivirals (acyclovir) compared to placebo, for treatment of BP. METHODS: The RCT was not powered to detect differences in the cost-effectiveness; therefore, we adopted a decision analytic model approach as a way of gaining precision in our cost-effectiveness comparisons [e.g. prednisolone only (PO) versus acyclovir only versus prednisolone and acyclovir versus placebo, prednisolone versus no prednisolone (NP) and acyclovir versus no acyclovir]. We assumed that trial interventions affect the probability of being cured/not cured but their consequences are independent of the initial therapy. We used the percentage of individuals with a complete recovery (based on House-Brackmann grade = 1) at 9 months and Quality Adjusted Life Years (e.g. derived on responses to the Health Utilities Index III) as measures of effectiveness. Other parameter estimates were obtained from trial data. RESULTS: PO dominated-i.e. was less costly and more effective-all other therapy strategies in the four arms model [77% probability of cost-effective (CE)]. Moreover, Prednisolone dominated NP (77% probability of being CE at 30 000 UK pounds threshold) while no acyclovir dominated aciclovir (85% chance of CE), in the two arms models, respectively. CONCLUSIONS: Treatment of BP with prednisolone is likely to be considered CE while treatment with acyclovir is highly unlikely to be considered CE. Further data on costs and utilities would be useful to confirm findings.

Effect of adeno-associated virus on cancer expression by herpesvirus-transformed hamster cells.

Infection of herpes simplex virus type-2-transformed hamster tumor cells with adeno-associated virus type 1 before inoculation into hamsters specifically delayed the appearance of palpable tumors and increased the survival time of the animals. The data indicated that a defective virus of humans can influence cancer expression by a virus-transformed cell.

Sample convection in liquid-state NMR: why it is always with us, and what we can do about it.

Many NMR experiments on liquids suffer if the sample convects. This is particularly true for applications, such as the measurement of diffusion, that rely on spatial labelling of spins. It is widely assumed that, in most well-conducted experiments with stable temperature regulation, samples do not convect. Unfortunately this is not the case. It is shown here that typical NMR samples show measurable convective flow for all but a very narrow range of temperatures; convection is seen both above and below this range, which can be as small as a degree or so for a mobile solvent such as chloroform. This convection is driven by both vertical and horizontal temperature gradients. Measurements of convection velocity are presented for a range of samples, sample tubes, probes, and temperatures. Both decreasing sample tube inner diameter and changing sample tube material from glass to sapphire can slow convection markedly, with sapphire tubes being particularly effective. Such tubes are likely to be particularly helpful for accurate measurement of diffusion by NMR.

The Glasgow Benefit Plot: a new method for reporting benefits from middle ear surgery.

Conventionally, the results of middle ear surgery are reported in terms of postoperative closure of the air-bone gap or the improvement in air-conduction thresholds. While these are relevant in that they assess the technical success of the procedure and the lessening of monaural disability, they do not necessarily assess whether the patient has benefited. This is determined by many factors, not least of which is the hearing in the nonoperated ear. In this paper, we suggest that preoperative and postoperative plots of the air-conduction thresholds in both ears be used as an additional method of presenting the results. First, the proportion of patients that fall into each of three main preoperative impairment groups are identified. This is important, as the potential benefits from surgery are not the same in each group. Thereafter, the percentages of patients that achieve various postoperative hearing categories can be calculated, allowing surgeons to audit their results and make comparisons between series.

The crystal structure of an acid protease from Rhizopus chinensis at 2.5 A resolution.

This paper contains a preliminary report of the crystal structure of the acid protease from Rhizopus chinensis at 2.5 A resolution. The molecule is bilobal with a large cleft between the lobes. Pepstatin binds in the cleft near the catalytically active Asp-35. The overall folding of the molecule consists primarily of antiparallel beta-strands, there being only four small helices.

Diagnostic vetting of individuals with asymmetric sensorineural hearing impairments.

Audiological and vestibular tests were administered conjointly in a neurological or general ORL clinic to exclude cerebellopontine angle (CPA) tumours. This study aimed to assess the efficiency of various tests in achieving that exclusion with the minimum of unnecessary investigations. All patients received the full battery of auditory brainstem responses, acoustic reflex thresholds and decay, alternate binaural loudness balance and ENG and caloric testing. All patients who did not have normal auditory brainstem responses proceeded to high resolution CT scanning. One hundred and fifteen patients were investigated and four acoustic neuromas were diagnosed. The efficiency of these tests in a general ORL clinic is very much poorer than often suggested, due largely to the number of occasions on which the tests cannot be done, and to the very small proportion of the test population who have CPA tumours.

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.

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 doubtful value of tympanometry in the diagnosis of otosclerosis.

Many consider that the compliance of the middle ear as measured from the tympanogram can be helpful in diagnosing otosclerosis. To test this assertion, the compliance in 34 individuals with surgically proven otosclerosis was compared with the compliance in 34 age and sex matched, normal controls, randomly selected from the population. Though the mean compliance was different in the two groups, there was considerable overlap in the range of values which severely limits the practical usefulness of tympanometry. If the level of compliance is taken at which a false negative diagnosis would be made in 10 per cent of otosclerotic ears, a false positive diagnosis of otosclerosis would be made in 88 per cent of normal ears. If the level of compliance is taken at which a false positive diagnosis of otosclerosis would be made in 10 per cent of normal ears, 72 per cent of ears with otosclerosis would be considered normal. It is concluded that tympanometry will not help to arrive at a diagnosis of otosclerosis.

Clinical role of informal tests of hearing.

Clinical tests of hearing are regularly used in adults but their role, now that pure-tone audiometry is almost universally available, has not been evaluated by modern methods of analysis including sensitivity and specificity. Free-field voice testing was carried out in 101 patients and the Rinne tuning-fork test in a different group of 127 patients prior to clinical or audiometric evaluation. The results were subsequently compared to air and bone conduction pure-tone thresholds assessed using rigorous standards. Depending on the audiometric definition as to what constitutes a hearing impairment, the sensitivity of free-field voice testing to identify such an impairment because of an inability to hear a whispered voice at two feet (60 cm.) was 86 per cent or better with the specificity being in the region of 90 per cent. In the Rinne test the 256 Hz fork was superior to the 512 Hz fork (p less than 0.05) and the loudness comparison method superior to the threshold decay method (p less than 0.01) in detecting an air-bone gap. Combining the responses to the two forks did not improve the results. The Rinne test with the 256 Hz fork will identify correctly 48 per cent of individuals with a 15 dB, 69 per cent with a 20 dB, 87 per cent with a 25 dB, and 95 per cent with a 30 dB conductive impairment. In all instances the specificity is greater than 90 per cent.

Clinical and financial audit of diagnostic protocols for lesions of the cerebellopontine angle.

OBJECTIVE: To assess the diagnostic efficiency and costs of protocols used for investigating patients with suspected lesions of the cerebellopontine angle. DESIGN: Prospective evaluation of tests of auditory brain stem responses and acoustic reflex thresholds, electronystagmography, and calorics. Positive test results were confirmed or refuted by high resolution computed tomography with intravenous enhancement. SETTING: Single general otolaryngology clinic in a teaching hospital. PATIENTS: 270 consecutive patients with sensorineural hearing loss requiring investigation to exclude a lesion of the cerebellopontine angle. MAIN OUTCOME MEASURES: Estimated costs of various diagnostic protocols and performance in detecting tumours of the cerebellopontine angle. RESULTS: Protocols including tests of auditory brain stem responses and acoustic reflex thresholds as sifting tests before computed tomography were clinically acceptable and presented considerable savings over the use of computed tomography in all patients (74,000 pounds or 84,000 pounds v 122,000 pounds). The use of electronystagmography and calorics could not be justified on clinical or financial grounds. CONCLUSIONS: Audiological tests of auditory brain stem responses and acoustic reflex thresholds followed by computed tomography constitute the most cost effective protocol for determining suspected lesions of the cerebellopontine angle. IMPLICATIONS: The cost effectiveness of diagnostic protocols should be evaluated throughout the health service.