Early treatment with prednisolone or acyclovir in Bell's palsy.

BACKGROUND: Corticosteroids and antiviral agents are widely used to treat the early stages of idiopathic facial paralysis (i.e., Bell's palsy), but their effectiveness is uncertain. METHODS: We conducted a double-blind, placebo-controlled, randomized, factorial trial involving patients with Bell's palsy who were recruited within 72 hours after the onset of symptoms. Patients were randomly assigned to receive 10 days of treatment with prednisolone, acyclovir, both agents, or placebo. The primary outcome was recovery of facial function, as rated on the House-Brackmann scale. Secondary outcomes included quality of life, appearance, and pain. RESULTS: Final outcomes were assessed for 496 of 551 patients who underwent randomization. At 3 months, the proportions of patients who had recovered facial function were 83.0% in the prednisolone group as compared with 63.6% among patients who did not receive prednisolone (P<0.001) and 71.2% in the acyclovir group as compared with 75.7% among patients who did not receive acyclovir (adjusted P=0.50). After 9 months, these proportions were 94.4% for prednisolone and 81.6% for no prednisolone (P<0.001) and 85.4% for acyclovir and 90.8% for no acyclovir (adjusted P=0.10). For patients treated with both drugs, the proportions were 79.7% at 3 months (P<0.001) and 92.7% at 9 months (P<0.001). There were no clinically significant differences between the treatment groups in secondary outcomes. There were no serious adverse events in any group. CONCLUSIONS: In patients with Bell's palsy, early treatment with prednisolone significantly improves the chances of complete recovery at 3 and 9 months. There is no evidence of a benefit of acyclovir given alone or an additional benefit of acyclovir in combination with prednisolone. (Current Controlled Trials number, ISRCTN71548196 [controlled-trials.com].).

Does patient-perceived handicap correspond to the modified clinical test for the sensory interaction on balance?

OBJECTIVE: To determine whether patient self-reported handicap correlates with scores obtained from the modified Clinical Test for the Sensory Interaction on Balance as assessed by the Neurocom VSR Balance Master platform. STUDY DESIGN: Prospective observational. SETTING: Balance clinic in tertiary referral center. PATIENTS: Patients referred with dizziness or imbalance as their primary complaint. OUTCOME MEASURES: The modified Clinical Test for the Sensory Interaction on Balance scores as assessed by the Neurocom VSR Balance Master platform, the Dizziness Handicap Inventory, and the Health Utilities Index Marks 2 and 3. RESULTS: One hundred fifty-nine patients were entered into the study. The mean age of participants was 54.5 years, with a female-to-male ratio of 2.1:1. The scores for the Dizziness Handicap Inventory and Health Utilities Index are similar between sexes, and although the Dizziness Handicap Inventory score did not correlate with age, Health Utilities Index 2 and 3 scores did show a negative correlation with increasing age. There are weak, positive correlations between the Dizziness Handicap Inventory and the firm surface conditions of the modified Clinical Test for the Sensory Interaction on Balance but no useful correlation with the foam conditions. Similar weak negative correlations were found between the Health Utilities Index 2 and 3 and the modified Clinical Test for the Sensory Interaction on Balance scores. CONCLUSION: Patient-perceived handicap of imbalance appears to correlate poorly with assessment of postural stability using the modified Clinical Test for the Sensory Interaction on Balance.

Measuring quality of life in preschool children with sore throats and otitis media using the TAPQOL questionnaire.

OBJECTIVES: TNO-AZL Preschool Quality of Life Questionnaire (TAPQOL) is one of the few instruments designed to assess health-related quality of life in preschool children but its applicability to otolaryngology is unknown. STUDY DESIGN AND SETTING: We studied a consecutive series of children aged 1 to 5 years referred to hospital with recurrent sore throats, recurrent acute otitis media, or otitis media with effusion. RESULTS: TAPQOL domain scores were not influenced by age, sex, or socio-economic class, but correlated with markers of disease severity (frequency of sore throat or pyrexia, time off school), ear-related handicap (assessed with the OM6 questionnaire), and other measures of health-related quality of life (visual analogue scale, 5-point rating scale and the Health Utilities Index mark III). Comparison with published data from healthy children suggests that these common otolaryngologic problems have a large impact on a child's quality of life. CONCLUSIONS: TAPQOL seems to be appropriate for use in this context. Marked ceiling effects in some domains, however, may limit their sensitivity.

An international otology database.

There are many reports in the literature on the outcome of ear surgery. However, it is difficult to make comparisons from these reports because of a lack of uniformity in the way in which outcomes are reported. At the same time, the general public expects doctors to provide them with information regarding the benefits and risks of surgery. Many ear surgeons will not be able to provide this information because few have an up-to-date database. A group of otologists in Europe has attempted to establish a common otology database. The aim is to create a framework whereby surgeons in Europe can contribute to a common ear database using a web-based system. The proposed methodology involves two levels of data entry. Level 1 is a minimal database where the main outcomes are included. Level 2 is a comprehensive database where detailed information on pathologies, risk factors, and surgical procedures is also recorded. As both databases share the same core data, clinicians using database 1 can still compare their outcomes with those using database 2. Clinicians will be able to input and retrieve ear data onto or from the web-based database. There has already been an international consensus on the content of the common ear database. The website address is www.ear-audit.net. The international project has now been in operation for more than 6 months, and Ear UK has already given its endorsement. The founder members include 27 otologists from 12 European countries. The cumulative outcome from this group of surgeons will be used as the benchmark for the purpose of comparative audit. These benchmark sites will be subjected to regular external validation. The web-based system is interactive and gives instant feedback to individual surgeons who wish to compare their results to the benchmark. Therefore, it can be a good learning tool for trainees or less experienced surgeons. The common data entry system also provides an opportunity for clinicians to collaborate in clinical research.

How appropriate is the OM6 as a discriminative instrument in children with otitis media?

BACKGROUND: The OM6 is a 6-item condition-specific handicap measure developed in the United States for children with recurrent acute otitis media and otitis media with effusion. Easy and quick to use, it has high test-retest repeatability and is sensitive to change after ventilation tube insertion. OBJECTIVES: To explore aspects of the validity of OM6 in a United Kingdom population and to specifically address the instrument's ability to discriminate between children with different burdens of disease. DESIGN: The parents of 179 consecutive newly referred children with otitis media with effusion or recurrent acute otitis media completed the OM6 on their first visit to the hospital. The parents of 72 children with sore throats completed the OM6 for comparison. Scores were compared with markers of disease severity, demographic variables, and generic quality-of-life measures. RESULTS: Poorer scores were found in those with ear complaints than in those with sore throats. The OM6 scores were not associated with age, sex, socioeconomic class, or respondent (mother vs father). The OM6 scores did not correlate with frequency of otalgia, frequency of otorrhea, or time off school in the recurrent acute otitis media group. In the otitis media with effusion group, poorer scores were associated with bilateral B or C2 tympanometric findings but not with a better ear threshold of more than 20 dB. Correlation with a global 10-cm visual analog scale for quality of life and with the Health Utilities Index Mark III was good. CONCLUSIONS: The OM6 scores correlate well with global quality-of-life measures and are free from many potential biases. However, OM6 does not adequately reflect disease severity, which may limit its usefulness as a discriminative measure.

The Yung percutaneous mastoid vent: results of a multicenter trial.

OBJECTIVE: The primary goal of the study was to find out whether the Yung vent would remain patent long-term. The secondary goal was to find out whether mastoid ventilation could overcome permanent ventilation disorder within the middle ear. STUDY DESIGN: The study was an open prospective investigation. SETTING: The study was a multicenter study involving three tertiary referral centers. PATIENTS: Twenty-three subjects older than 12 years were included. The inclusion criteria were complete atelectasis, failed tympanoplasty because of persistent eustachian tube dysfunction, and persistent otitis media with effusion in spite of repeated ventilation tube insertion. INTERVENTION: Tympanoplasty with insertion of the Yung percutaneous mastoid vent. MAIN OUTCOME MEASURES: Patency of the vent, adverse effects, patient acceptance, hearing results, and appearance of the tympanic membrane were assessed every 3 months up to 18 months postoperatively. RESULTS: : At 18 months, 20 of 23 vents were still patent. Overall, there had been no unacceptable adverse effect on any patient. Eighteen of 23 ears had improved hearing. The tympanic membrane had returned from a collapsed state to near normal in 13 of 17 completely atelectatic ears. There were five patients who had no benefit from the vent because of blockage within the epitympanum or middle ear effusion. CONCLUSION: The Yung percutaneous mastoid vent can maintain long-term patency. It is effective in the treatment of complete atelectasis as an adjunct to tympanoplasty.

The Glasgow Children's Benefit Inventory: a new instrument for assessing health-related benefit after an intervention.

Most health-related quality-of-life measures make an assessment at a single point in time. Comparing results before and after an intervention is often difficult, because the difference measured is usually small compared with the variation between individuals. A retrospectively applied measure specifically worded to assess benefit would be very useful for clinical research. Such a measure exists for adults. We aimed to develop a similar measure for children. We chose potential items after reviewing existing health-related quality-of-life measures, published literature, and parental interviews. A draft questionnaire was given to a group of parents and modified. The resulting Glasgow Children's Benefit Inventory (GCBI) comprised 24 questions on the consequences of a specified intervention on various aspects of the child's day-to-day life, without reference to any specific symptoms, and was worded to apply to children of any age. The questionnaire was mailed to the parents of all 1,777 children who had undergone tonsillectomy or ventilation tube insertion at one hospital during the period January 1998 to December 2001. There were 670 questionnaires returned. The GCBI scores correlated well with parental satisfaction with surgery and with estimates of technical success (residual sore throats, reported hearing impairment, ear infections). The questionnaire had high internal consistency. Factor analysis showed 4 dimensions in the pattern of responses relating to emotion, physical health, learning, and vitality. The GCBI is a means to retrospectively assess benefit after an intervention in children, and we have shown initial evidence of reliability and validity. Although not restricted to any branch of pediatric medicine, it is eminently suitable for use in pediatric otolaryngology.

The effect of experience on the sensitivity and specificity of the whispered voice test: a diagnostic accuracy study.

OBJECTIVES: To determine the sensitivity and specificity of the whispered voice test (WVT) in detecting hearing loss when administered by practitioners with different levels of experience. DESIGN: Diagnostic accuracy study of WVT, through acoustic analysis of whispers of experienced and inexperienced practitioners (experiment 1) and behavioural validation of these recordings (experiment 2). SETTING: Research institute with a pool of patients sourced from local clinics in the Greater Glasgow area. PARTICIPANTS: 22 people had their whispers recorded and analysed in experiment 1; 4 older experienced (OE), 4 older inexperienced (OI) and 14 younger inexperienced (YI). In experiment 2, 73 people (112 individual ears) took part in a digit recognition task using 2 OE and 2 YI whisperers from experiment 1. MAIN OUTCOME MEASURES: Average level (dB sound pressure level) across frequency, average level across all utterances (dB A) and within/across-digit deviation (dB A) for experiment 1. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of WVT for experiment 2. RESULTS: In experiment 1, OE whisperers were 8-10 dB more intense than inexperienced whisperers across all whispered utterances. Variability was low and comparable regardless of age or experience. In experiment 2, at an optimum threshold of 40 dB HL, sensitivity and specificity were 63% (95% CI of 58% to 68%) and 93% (92% to 94%), respectively, for OE whisperers. PPV was 56% (51% to 61%), NPV was 95% (94% to 96%). For YI whisperers at an optimum threshold of 29 dB HL, sensitivity and specificity were 80% (78% to 82%) and 52% (50% to 55%), respectively. PPV was 65% (63% to 67%) and NPV was 70% (67% to 72%). CONCLUSIONS: WVT is an effective screening test, providing the level of the whisperer is considered when setting the test's hearing-loss criterion. Possible implications are voice measurement while training for inexperienced whisperers.

Family caregivers of older relatives: ways of coping and change in distress.

The aim of this secondary analysis was to examine the relationships between the ways in which caregivers coped with caregiving stressors and their experience of distress over time. Three coping subscales were derived from the Carers' Assessment of Management Index (CAMI) coping scale: "maintaining balance", "focusing on caregiving" and "avoidance". A proportional (relative) scoring technique was applied. The analysis was based on the responses of 115 pairs of caregivers and care recipients. Care recipients were aged 66-92 years, with no symptoms of dementia, and the majority had mild to moderate hearing impairment. Data were collected at baseline and 6 months later. Caregivers who increased the proportion of strategies endorsed in the "maintaining balance" subscale experienced a decrease in distress, irrespective of change in the proportion of strategies endorsed in the "avoidance" subscale. "Focusing on caregiving" was not significantly related to distress. The results highlight the potential benefits to these caregivers of maintaining a balance in their lives by taking breaks from caregiving.