Iain R. C. Swan

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 Childrens Benefit Inventory (GCBI) comprised 24 questions on the consequences of a specified intervention on various aspects of the childs 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.

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 Bells 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 Bells palsy as an effective treatment which may be considered cost-effective. Treatment with aciclovir, either alone or with steroids, had no effect on outcome.

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.

Stress proliferation in caregivers: The relationships between caregiving stressors and deterioration in family relationships

The aim of the present study is to examine the extent to which caregiving stressors could explain change in family relationships over time – a construct termed stress proliferation – in a secondary analysis of an existing database. The sample of caregivers and care recipients (N = 132) was drawn mainly from records held by general practitioners in Glasgow. Care recipients were aged 65 years and over, and the majority had impaired hearing. Caregivers were younger non-spouse relatives of care recipients. Using hierarchical multiple regression analysis, two stressors were found to be significantly related to deterioration in family relationships over a period of six months, irrespective of change in caregiver distress: the care recipients hearing disability (β = −0.21), and change in the caregivers negative reactions to caregiving (β = −0.23). It was concluded that the care recipients hearing disability and more negative reactions to caregiving were related to a deterioration in family relationships over time. The results highlight the need for further study in this area, with a view to informing intervention programmes.

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.

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

Clin. Otolaryngol. 2012, 37, 35–43

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.

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

OBJECTIVES Bells 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.

Optimum side for fitting a monaural hearing aid 1. Patients' preference

The criteria generally used to decide in which ear to fit a monaural hearing aid are based on theory or anecdote and have not been verified by experimental observation. In this study to determine optimum side of fitting, 58 new hearing aid users were fitted with a hearing aid in one ear for 10 weeks, and then fitted in the other ear for a further 10 weeks. Subsequently, the subjects were asked their preference for side of hearing aid use and their reasons for this preference. 30 (52%) subjects reported better hearing with their aid in one ear than in the other; 24 (80%) of these preferred the ear with the poorer half-peak level elevation on a speech audiogram. The remaining 28 (48%) reported no difference in their aided hearing ability between ears, though 20 preferred one ear for practical reasons, unrelated to audiometric parameters. A patients preference for side of fitting can be predicted from audiometric data but with only modest reliability. It is, therefore, recommended that bilateral ear moulds should be routinely provided for bilateral mild to moderate hearing impairment (speech frequency average less than 75 dB HL). If it is decided that only one ear mould should be provided, this should be made for the poorer hearing ear. The poorer hearing ear is best identified from the half-peak level elevation on a speech audiogram.

The social and psychological impact of an older relative's hearing difficulties

A newly developed self-report instrument, designed to assess variation in the social and psychological impact of a relatives hearing difficulties (‘hearing hassles’), was administered to younger relatives of people with hearing impairment. The first aim was to examine the properties (reliability, validity and sensitivity to change) of this instrument, and the second aim was to examine the contributions of a range of characteristics of the older person to the younger relatives appraisal. The analysis was informed by caregiving stress theory (Pearlin et al., 1990). This was a secondary analysis of an existing data set. The original study, which assessed the impact of hearing aid provision on stress-related measures, used a randomized controlled design. In the current analysis (N = 113), group (intervention or control) was controlled in all analyses. The measure of hearing hassles was found to be reliable, valid and sensitive to change. Those with higher hearing hassle scores had relatives with more hearing impairment and hearing disability, and a poorer relationship with the older person, with other characteristics of the older and younger participants controlled. A significant interaction was found between hearing disability and the older persons cognitive function. Implications for theory and intervention were discussed.