Victoria S Hammersley

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.

Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

BackgroundIt is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window.Bells palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bells palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community.MethodsWhere possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centresResultsAlthough the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale.ConclusionWhile difficult, recruitment to and retention within multi-centre trials from primary care can be successfully achieved through the application of the best available evidence, establishing good relationships with practices, minimising the workload of those involved in recruitment and offering enhanced care to all participants. Primary care trialists should describe their experiences of the methods used to persuade patients to participate in their trials when publishing their results.

Patient-reported outcome measures for asthma: a systematic review

Background:Patient-reported outcome measures (PROMs) are measures of the outcome of treatment(s) reported directly by the patient or carer. There is increasing international policy interest in using these to assess the impact of clinical care.Aims:To identify suitably validated PROMs for asthma and examine their potential for use in clinical settings.Methods:We systematically searched MEDLINE, EMBASE and Web of Science databases from 1990 onwards to identify PROMs for asthma. These were critically appraised, then narratively synthesised. We also identified the generic PROMs commonly used alongside asthma-specific PROMs.Results:We identified 68 PROMs for asthma, 13 of which were selected through screening as being adequately developed to warrant full-quality appraisal: 8 for adults, 4 for children and 1 for a child’s caregiver. The PROMs found to be sufficiently well validated to offer promise for use in clinical settings were the Asthma Quality of Life Questionnaire (AQLQ) and mini-AQLQ for adults, and Pediatric Asthma Quality of Life Questionnaire for children. Rhinasthma was considered promising in simultaneously assessing the impact of asthma and rhinitis in those with coexistent disease. We identified 28 generic PROMs commonly used in conjunction with asthma-specific instruments.Conclusions:We identified asthma PROMs that offer the greatest potential for use in clinical settings. Further work is needed to assess whether these are fit-for-purpose for use in clinical practice with individual patients. In particular, there is a need to ensure these are validated for use in clinical settings, acceptable to patients, caregivers and clinicians, and yield meaningful outcomes.

Investigating the effectiveness of the Mediterranean diet in pregnant women for the primary prevention of asthma and allergy in high-risk infants: protocol for a pilot randomised controlled trial

BackgroundOver recent decades there has been a substantial increase in asthma and allergic disease especially in children. Given the high prevalence, and the associated high disease burden and costs, there is a need to identify effective strategies for the primary prevention of asthma and allergy. A recent systematic review of the literature found strong supportive epidemiological evidence for a protective role of the Mediterranean diet, which now needs to be confirmed through formal experimental studies. This pilot trial in pregnant women aims to establish recruitment, retention and acceptability of a dietary intervention, and to assess the likely impact of the intervention on adherence to a Mediterranean diet during pregnancy.Methods/DesignThis study was a pilot, two-arm, randomised controlled trial in a sample population of pregnant women at high risk of having a child who will develop asthma or allergic disease.DiscussionThe work ultimately aims to contribute to improving health outcomes through seeking to reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable in informing the subsequent planned large-scale, parallel group, randomised controlled trial.Trial registrationClinicalTrials.gov: NCT01634516

Systematic literature review and evaluation of patient reported outcome measures (PROMs) for asthma and related allergic diseases

Systematic literature review and evaluation of patient reported outcome measures (PROMs) for asthma and related allergic diseases

Continuing cancer screening later in life: attitudes and intentions among older adults in England.

Background: the rise in life expectancy, together with age-related increase in the incidence of most cancers, has led to mounting interest in cancer screening in older people. In England, routine invitations stop and an ‘opt-in’ (individual request) process is available from ages 71 to 76 years for breast and colorectal screening respectively. Little is known about public attitudes towards age-stoppage policy. Objective: this study examined public attitudes to current stoppage policy, information preferences and intentions to request screening beyond the age of routine invitations. Sample: participants (n = 927; age 60–74 years) were recruited as part of a TNS Research International survey and took part in home-based, computer-assisted interviews. Methods: measures included: (i) attitudes towards current stoppage policy, (ii) preference for communications about screening after the end of the routine invitation period and (iii) intention to opt-in. Results: the majority of respondents (78%) did not agree with age-based stoppage policies. Most (83%) wanted a strong recommendation to opt-in after this age, although the number who thought they would follow such a recommendation was much lower (27%). A majority of participants (54%) thought information on screening at older ages should come from their general practitioner (GP). Conclusion: this survey indicates that older people in England wish to continue to be actively invited for cancer screening, although only a minority think that they would ultimately take up the offer. Primary care may play a role in negotiating a shared decision that is based on individual circumstances.

Developing and testing of a screening tool to predict people without IgE-mediated allergy: a quantitative analysis of the predictive value of a screening tool

BACKGROUND Consultations in primary care for allergies are common. It can be difficult to differentiate between IgE-mediated (atopic) symptoms - which respond to allergen-specific interventions - and those that are non-atopic, without performing objective tests that are largely unavailable in UK general practice. AIM To develop and test a screening tool that can accurately discriminate between atopic and non-atopic individuals. DESIGN AND SETTING A validation study that took place in 2012 in adult volunteers aged >16 years in Scotland. METHOD A questionnaire screening tool was developed using questions from a large cohort study and through consultation with experts. Participants answered the questions and had skin prick tests for four aeroallergens (house dust mite, cat, dog, and mixed grasses). Participants were classified as atopic if any average wheal diameter was ≥3 mm bigger than the negative control. Sensitivity, specificity, and positive and negative predictive values of individual and combinations of questions were calculated. RESULTS In all, 143 participants completed the questionnaire and underwent skin prick testing. Of these, 81 (56.6%) were atopic. Negative predictive values for the individual questions ranged from 48.2% (55 not atopic out of 114 negative answers) to 72.0% (18/25). An optimum combination of four questions was identified, in which a negative answer to all four questions was reported by 24 participants, 21 (87.5%) of whom were not atopic. CONCLUSION The authors have identified a set of questions that correctly predict negative skin prick tests to common aeroallergens 88% of the time. These may be useful to exclude patients who do not warrant further investigation and who can reliably be advised that allergen avoidance is neither necessary nor helpful.

Adolescent seasonal allergic rhinitis and the impact of health-care professional training: cluster randomised controlled trial of a complex intervention in primary care

Background:Seasonal allergic rhinitis is typically poorly managed, particularly in adolescents, in whom it is responsible for considerable morbidity. Our previous work has demonstrated that if poorly controlled this can impair educational performance.Aim:The primary aim of this trial was to assess the impact of a primary care–based professional training intervention on clinical outcomes in adolescents with seasonal allergic rhinitis. Methods:Cluster trial in which UK general practice staff were randomised to a short, intensive workshop on the evidence-based management of seasonal allergic rhinitis. The primary outcome measure was the change in the validated Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQ(S)) score between baseline and 6 weeks post intervention (minimal clinically important difference=0.5). Secondary outcome measures of interest included health-care professionals’ knowledge and confidence in managing seasonal allergic rhinitis, number of seasonal allergic rhinitis-related consultations, relevant treatments prescribed and symptom scores.Results:Thirty-eight general practices were randomised (20 in the intervention arm) and 246 patients (50.2% males, mean age 15 years) were included in the primary outcome analysis. Health-care professionals’ knowledge and confidence of the clinical management of seasonal allergic rhinitis improved. This did not, however, result in clinically or statistically significant improvements in RQLQ(S): −0.15, (95% confidence interval, −0.5 to +0.2). There were no differences in consultation frequency, treatments issued for seasonal allergic rhinitis or symptom scores.Conclusions:Although associated with increases in professionals’ self-assessed confidence and understanding of seasonal allergic rhinitis management, this intensive training workshop did not translate into improvements in adolescents’ disease-specific quality of life or a reduction in rhinitis symptoms.

Is it unfair to hayfever sufferers to have to sit examinations during periods of high pollen counts

Crucial examinations take place during adolescence in most societies, which can have a major impact on an individual’s career trajectory. Examination boards have recognized that some health problems can impact on a student’s ability to perform in examinations and in response have introduced measures to take account of this – for example, offering extra examination time for students with dyslexia. However, this is not yet generally the case in relation to students with hayfever (also known as seasonal or intermittent allergic rhinitis). This is concerning since, in the UK, critical examinations for children 15–18 years of age take place over a 6-week period during May and June when grass pollen counts are typically at their highest (see Figure 1) [1]. Also of relevance is that tree pollens tend to peak from late February to the middle of May when students are likely to be revising for their examinations. Hayfever thus has the potential to disrupt students both when revising for and sitting examinations, which has led some quarters to call for the timing of examinations to be changed. In this article, we review the evidence of the disease burden associated with hayfever and summarize recent evidence that suggests that poorly controlled hayfever can adversely impact on examination performance, drawing on these data to reflect on the question of whether students with hayfever are indeed unfairly disadvantaged by being forced to prepare for and sit examinations during the peak of the pollen season.