Randomised, double-blind, placebo-controlled trial of glycopyrronium in children and adolescents with severe sialorrhoea and neurodisabilities: protocol of the SALIVA trial.

INTRODUCTION: Severe sialorrhoea is a common, distressing problem in children/adolescents with neurodisabilities, which has adverse health and social consequences. The SALIVA trial is designed to evaluate the efficacy and safety of a paediatric-specific oral solution of glycopyrronium along with its impact on quality-of-life (QoL), which has been lacking from previous trials of sialorrhoea treatments. METHODS AND ANALYSIS: A double-blind, placebo-controlled, randomised phase IV trial is ongoing in several centres across France. Eighty children aged 3-17 years with severe sialorrhoea (≥6 on the modified Teachers Drooling Scale) related to chronic neurological disorders in whom non-pharmacological standard of care has already been implemented or has failed, will be recruited. Patients will be randomised 1:1 to receive a 2 mg/5 mL solution of glycopyrronium bromide (Sialanar 320 µg/mL glycopyrronium) or placebo three times daily during a 3-month blinded period. After Day 84, participants will be invited into a 6-month, open-label study extension period, where they will all receive glycopyrronium. The primary endpoint of the double-blind period will be the change from baseline to Day 84 in the Drooling Impact Scale (DIS), a validated measure to assess sialorrhoea. A series of secondary efficacy endpoints involving change in total DIS, specific DIS items and response (DIS improvement ≥13.6 points) will be analysed in a prespecified hierarchy. QoL data will be collected from parents, caregivers and patients where possible using specific DIS questions and DISABKIDS questionnaires. Safety endpoints, including adverse events, will be assessed throughout the trial periods. ETHICS AND DISSEMINATION: In total, 87 children have been recruited and recruitment is now complete. Final results are expected by the end of 2023. Findings will be presented at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: EudraCT 2020-005534-15.

Surgery for fractured neck of femur - are patients adequately consented?

INTRODUCTION: Obtaining valid consent is a legal and ethical obligation when performing any procedure in clinical practice. This study was performed to identify the validity and effectiveness of the new consent form and any potential improvement that could be made when taking consent. PATIENTS AND METHODS: Case notes of 173 patients undergoing surgery for fractured neck of femur were retrospectively reviewed. Risks and complications of the surgery as listed on the consent form were noted. Sixty-five cases were excluded from the study as they had either old consent forms with no risks recorded or a consent form signed by a consultant due to patient inability to consent. Six of the consent forms could not be located in the notes. This left 102 consent forms to be analysed. RESULTS: The number of risks documented on each form ranged from 0-8 (mean, 3.92). No risks were recorded in 2 of these 102 forms. Most commonly recorded risks were infection (95.1%), DVT/PE (81.4%) and failure of procedure (59.8%). It was shown that many of the consent forms analysed did not have all the serious or frequently occurring risks recorded on them and that a large proportion of the forms had acronyms or phrases that may mean nothing to the patient. Comparison of documented risks for different hip surgery were made using Fisher's exact test showing no significant difference between the risks recorded on the forms for each type of procedure. CONCLUSIONS: Although documentation of risks has been improved compared to old consent forms, patients are not necessarily given the most appropriate information to ensure consent is valid. Further refining of consent forms may be necessary to ensure that all major risks are explained and understood by patients and that there is satisfactory recording of this information.