Effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial spasm: a study protocol for a randomised controlled trial

Background Blepharospasm and hemifacial spasm are debilitating conditions that significantly impact on patient quality of life. Cyclical treatment with botulinum toxin injections offers temporary relief, but the duration of treatment efficacy is variable. The standard model of patient care defines routine fixed-time based scheduled treatment cycles which may lead to unnecessarily frequent treatment for some patients and experience of distressing symptoms in others, if symptoms return before the scheduled follow-up period. Methods/Design A randomised controlled trial will compare a patient-initiated model of care, where patients determine botulinum toxin treatment timing, to the standard model of care in which care is scheduled by the clinical team. A sample of 266 patients with blepharospasm or hemifacial spasm will be recruited from Moorfields Eye Hospital (MEH), London. The trial will be accompanied by a mixed methods evaluation of acceptability of the new service. Patients who meet eligibility criteria will be assessed at baseline and those in the intervention group will be provided instructions on how to book their own treatment appointments. Patients in both groups will be followed up 3 and 9 months into the trial and all patients will be returned to usual care after 9 months to meet safety protocols. Primary outcome measures include disease severity (questionnaire), functional disability (questionnaire) and patient satisfaction with care (questionnaire). Secondary outcomes include disease-specific quality of life (questionnaire), mood (questionnaire), illness and treatment perceptions (questionnaire and semi-structured interviews), economic impact (questionnaire) and acceptability (questionnaire and semi-structured interviews). Discussion This trial will assess the effectiveness and cost-effectiveness of a patient-led care model for botulinum toxin therapy. If the new model is shown to be effective in reducing distress and disability in these populations and is found to be acceptable to patients, whilst being cost-effective, this will have significant implications for service organisation across the NHS. Trial registration UK Clinical Research Network (UKCRN) Portfolio 18660. Clinicaltrials.gov ID NCT102577224 (registered 29th October 2015

Seasonality of hip fracture and vitamin D deficiency persists in a sub-tropical climate

Both hip fractures and vitamin D (25-hydroxyvitamin D (25-OHD)) deficiency are more common in winter in regions with temperate climates, but few data exist for a sub-tropical climate. In a South East Queensland tertiary hospital over a 7-year period, there were significantly more hip fractures in winter than the other three seasons (analysis of variance P = 0.003), with associated higher frequency of 25-OHD deficiency – 42.5% in winter compared to 28.5% in summer, odds ratio 1.86 (95% confidence interval 1.35–2.56), P = 0.0001. Seasonality of hip fracture and 25-OHD deficiency occurs even in a sub-tropical climate

A case series of trigeminal nerve injuries caused by periapical lesions of mandibular teeth

Aims Periapical lesions have been implicated in mandibular trigeminal sensory neuropathy. This study aimed to report on a case series of consecutive patients presenting with mandibular division trigeminal nerve injuries (TNI) caused by periapical lesions. Common presenting characteristics and possible strategies for management were also investigated.Materials and methods A retrospective study of 22 patients with TNI caused by periapical lesions. Data were extracted from patient records and analysed using Microsoft Excel and SPSS. Factors associated with TNI resolution were assessed using Student's t-Tests and one-way Analysis of Variance (ANOVA), where P <0.05 indicated statistical significance.Results Twenty-one patients had inferior alveolar nerve injuries (IANI) and one had a lingual nerve injury (LNI). The most commonly affected teeth were the first molars (11 patients; 50%). TNI symptoms included numbness, pain and/or paraesthesia. IANI resolved completely among five patients within a mean time of 4.7 months (range 1.5-12 months). Patients who showed complete resolution had the affected teeth extracted or primary endodontic treatment with antibiotics.Conclusions Patients with TNI caused by periapical lesions can suffer significantly from combined numbness, pain and paraesthesia. Resolution of these injuries may be maximised upon early diagnosis and treatment of the periapical lesion by tooth extraction or primary endodontic treatment