Development of an evidence-based regimen of prednisolone to treat giant cell arteritis - the Norwich regimen.

We have reviewed the literature to form a bespoke regimen for daily oral prednisolone (DP) in GCA. Initial DP in clinical trials is 40-60 mg daily, but relapse rates are 67-92%. Cumulative prednisolone (CP) of 3.2 and 3.9 g (at 6 months) resulted in a relapse rate of 83 and 67%, respectively; and 3 and 3.9 g (at 12 months) resulted in 92 and 82% relapse, respectively. CP was 6.2-7.1 g in the first year. Mean DP was 18.8 mg at 3 months and 6.6-7.4 mg at 12 months. The duration of treatment with prednisolone for GCA was 22-26 months. The CP to achieve discontinuation was 6.5-12.1 g. Using these data, the Norwich regimen starts DP at 1 mg/kg/day of lean body mass, discontinuing over 100 weeks. For the average UK woman, initial DP is 45 mg daily, reaching 21 mg daily by 12 weeks and 6 mg daily by 52 weeks. The CP for the average UK woman would be 6.5 g at 52 weeks and 7.4 g to discontinuation.

Microinvasive Glaucoma Stent (MIGS) Surgery With Concomitant Phakoemulsification Cataract Extraction: Outcomes and the Learning Curve.

PURPOSE: To evaluate learning effects with respect to outcomes of a microinvasive glaucoma stent (MIGS) inserted during cataract surgery in glaucoma patients. PATIENTS AND METHODS: Single surgeon, observational cohort study of 25 consecutive Ivantis Hydrus microstent insertions, with a minimum follow-up of 12 months. A learning curve analysis was performed by assessing hypotensive effect, adverse effects, and surgical procedure duration, with respect to consecutive case number. Success was defined with respect to various intraocular pressure (IOP) targets (21, 18, 15 mm Hg) and reduction in required antiglaucoma medications. Complete success was defined as achieving target IOP without antiglaucoma therapy. RESULTS: No clinically significant adverse events or learning effects were identified, although surgical time reduced with consecutive case number. Mean follow-up was 16.8 months. At final follow-up the mean IOP for all eyes was reduced from 18.1 (±3.6) mm Hg [and a simulated untreated value of 25.9 (±5.2) mm Hg] to 15.3 (±2.2) mm Hg (P=0.007; <0.0001) and the mean number of topical antiglaucoma medications was reduced from 1.96 (±0.96) to 0.04 (±0.20) (P<0.0001). Complete success (IOP<21 mm Hg, no medications) was 96% at final follow-up. Complete success (IOP<18 mm Hg, no medications) was 80% at final follow-up, but only 32% with a target IOP of <15 mm Hg (no medications). CONCLUSIONS: No significant learning curve effects were observed for a trained surgeon with respect to MIGS microstent insertion performed at the time of cataract surgery. Adjunctive MIGS surgery was successful in lowering IOP to <18 mm Hg and reducing/abolishing the requirement for antiglaucoma medication in eyes with open-angle glaucoma, but less successful at achieving low IOP levels (<15 mm Hg).

Pharmacotherapy and Adherence Issues in Treating Elderly Patients with Glaucoma.

Glaucoma is a leading cause of visual morbidity throughout the world and is an age-related condition, the prevalence of which rises significantly with increasing age. Glaucoma, a condition affecting the optic nerve, has a variety of subtypes with multiple aetiological factors, the most important of which are intraocular pressure (IOP) and increasing age. Treatment by lowering of IOP is the only current method, for which there is evidence, by which the rate of progressive visual deterioration can be slowed or halted. Although there are surgical and laser treatments that are efficacious in lowering IOP, the most common manner in which patients with glaucoma control their IOP is with administration of daily topical ocular hypotensive drugs (eye drops). The variety of topical drugs utilised in the management of glaucoma all have the potential to have adverse effects and/or interactions with concomitant medications, many of which may be used for other age-related conditions. Adherence with appropriate medicines has a major effect on the outcome of medical conditions and this aspect applies to the management of glaucoma. There are certain specific issues that relate to the administration of topical agents, with respect to both adverse effects and adherence. Although many suspect poor adherence in elderly patients with glaucoma, relative to younger patients, adequate evidence for this is lacking. Furthermore, the manner by which adherence issues could be improved remains inadequately understood and poorly addressed. The aims of this article were to review, from a clinical perspective, the medical therapies currently used for glaucoma and discuss adherence issues with respect to the population of patients with glaucoma, who tend to be relatively elderly.

A comparison of measures used to describe adherence to glaucoma medication in a randomised controlled trial.

BACKGROUND: Understanding the magnitude of non-adherence in pre-marketing clinical trials and clinical practice is essential. However, accurately measuring non-adherence to medication is problematic, and the variety of adherence measures and/or calculation methods has led to highly variable results. PURPOSE: To compare commonly used methods for measuring adherence to eye drop therapy in order to assess which methods achieve the most complete datasets over an 8-month monitoring period, to quantify the magnitude of variance in adherence estimations and to review the different methods used to calculate or interpret adherence data. METHODS: Adherence was measured electronically for 8 months by participants administering eye drops using a Travalert® dosing aid. The mean number of Travalert dosing aid recorded doses administered over the monitoring period was used to calculate a percentage adherence score. In addition, the value of graphically presenting Travalert dosing aid data to classify patterns of adherence behaviour was explored. The validated Morisky Measure of Adherence Scale and questions requesting participants to report the Frequency of Missed Doses were two measures of self-reported adherence calculated for each participant. Finally, medication possession ratio was calculated from expected repeat prescription orders compared with actual repeat prescription orders. RESULTS: For the 208 recruited participants, self-reported adherence was the most reliable method of collecting complete datasets over the 8-month period; 16% of self-reported adherence data were missing compared with 45% of Travalert dosing aid data missing at 8 months. The mean adherence measured over the monitoring period by the Travalert dosing aid was 77%. When adherence measures were dichotomised into adherent and non-adherent groups, the Travalert dosing aid found 54% of participants were adherent, compared to 60% Morisky Measure of Adherence Scale and 57% Frequency of Missed Dose self-report measures. However, there was poor agreement between the Travalert dosing aid measured adherence and self-report measures. Medication possession ratio was not a reliable measure of persistence with medication. Graphical Travalert dosing aid data presentation provided additional information about participant behaviour by indicating that most non-adherence was due to participants taking drug holidays rather than missing occasional doses. CONCLUSION: The analysis provided evidence about the inconsistencies between different monitoring strategies and adherence measures. Furthermore, the analysis highlighted the difficulties in collecting complete data for studies investigating chronic, slowly progressive conditions that require long-term follow-up. Future adherence studies could use multiple methods for quantifying and classifying adherence in parallel, both to maximise precision of adherence estimates and to facilitate comparison between studies. However, the authors are cautious of the effect of using multiple adherence measures on participant behaviour and their potential reactivity effects is an area for future research.

Improving adherence to glaucoma medication: a randomised controlled trial of a patient-centred intervention (The Norwich Adherence Glaucoma Study).

BACKGROUND: Improving adherence to ocular hypertension (OH)/glaucoma therapy is highly likely to prevent or reduce progression of optic nerve damage. The present study used a behaviour change counselling intervention to determine whether education and support was beneficial and cost-effective in improving adherence with glaucoma therapy. METHODS: A randomised controlled trial with a 13-month recruitment and 8-month follow-up period was conducted. Patients with OH/glaucoma attending a glaucoma clinic and starting treatment with travoprost were approached. Participants were randomised into two groups and adherence was measured over 8 months, using an electronic monitoring device (Travalert® dosing aid, TDA). The control group received standard clinical care, and the intervention group received a novel glaucoma education and motivational support package using behaviour change counselling. Cost-effectiveness framework analysis was used to estimate any potential cost benefit of improving adherence. RESULTS: Two hundred and eight patients were recruited (102 intervention, 106 control). No significant difference in mean adherence over the monitoring period was identified with 77.2% (CI, 73.0, 81.4) for the control group and 74.8% (CI, 69.7, 79.9) for the intervention group (p = 0.47). Similarly, there was no significant difference in percentage intraocular pressure reduction; 27.6% (CI, 23.5, 31.7) for the control group and 25.3% (CI, 21.06, 29.54) for the intervention group (p = 0.45). Participants in the intervention group were more satisfied with information about glaucoma medication with a mean score of 14.47/17 (CI, 13.85, 15.0) compared with control group which was 8.51 (CI, 7.72, 9.30). The mean intervention cost per patient was GB£10.35 (

Protocol for a randomised controlled trial to estimate the effects and costs of a patient centred educational intervention in glaucoma management.

BACKGROUND: Poor glaucoma education is thought to be a causative factor of non-adherence to glaucoma therapy. However, the multi-factorial nature of non-adherent behaviour may explain the failure of purely educational interventions to achieve significant improvement in adherence. Behaviour Change Counselling (BCC) allows both the imparting of information and assessment of patient ambivalence to medication use and may elicit behaviour change in order to achieve better adherence. The chronic and complex nature of glaucoma means that patient non-adherence to glaucoma therapy does not easily correlate with measureable objective clinical endpoints. However, electronic medication monitoring offers an objective method of measuring adherence without reliance on clinical endpoints. METHODS/DESIGN: The study is a randomised controlled trial (RCT) with glaucoma (open angle) or ocular hypertension patients attending a glaucoma clinic and prescribed travoprost. The study will determine whether additional glaucoma education using BCC is beneficial and cost effective in improving adherence with glaucoma therapy. An 8-month follow-up period, using an electronic adherence monitoring device (Travalert dosing aid, TDA), will indicate if the intervention is likely to be sustained in the longer term. Additionally, a cost-effectiveness framework will be used to estimate the cost benefit of improving adherence. The development of a novel intervention to deliver glaucoma education using BCC required practitioner training and fidelity testing. Five practitioners were successfully trained to become Glaucoma Support Assistants able to deliver the BCC intervention. The research group had prior clinical and investigative experience in this setting, and used multiple strategies to design a method to address the study objectives. DISCUSSION: This RCT, using BCC to improve adherence to ocular hypotensive therapy, to our knowledge is the first within this disease area. Using a variety of adherence measures allows examination of the known inaccuracies of patient self-report with respect to glaucoma medication. The novel BCC component has undergone fidelity testing using BECCI and the BCC template will ensure conformity to a standardised intervention. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN89683704.