The multimorbidity collaborative medication review and decision making (MyComrade) study: a pilot cluster randomised trial in two healthcare systems.

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. AIM: The pilot study aimed to assess the feasibility of a definitive trial of the MyComrade intervention across two healthcare systems (Republic of Ireland (ROI) and Northern Ireland (NI)). DESIGN: A pilot cluster-randomised controlled trial was conducted (clustered at general practice level), using specific progression criteria and a process evaluation framework. SETTING: General practices in the ROI and NI. PARTICIPANTS: Eligible practices were those in defined geographical areas who had GP's and Practice Based Pharmacists (PBP's) (in NI) willing to conduct medication reviews. Eligible patients were those aged 18 years and over, with multi morbidity and on ten or more medications. INTERVENTION: The MyComrade intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care, using a planned collaborative approach guided by an agreed checklist, within a specified timeframe. OUTCOME MEASURES: Feasibility outcomes, using pre-determined progression criteria, assessed practice and patient recruitment and retention and intervention acceptability and fidelity. Anonymised patient-related quantitative data, from practice medical records and patient questionnaires were collected at baseline, 4 and 8 months, to inform potential outcome measures for a definitive trial. These included (i) practice outcomes-completion of medication reviews; (ii) patient outcomes-treatment burden and quality of life; (iii) prescribing outcomes-number and changes of prescribed medications and incidents of potentially inappropriate prescribing; and (iv) economic cost analysis. The framework Decision-making after Pilot and feasibility Trials (ADePT) in conjunction with a priori progression criteria and process evaluation was used to guide the collection and analysis of quantitative and qualitative data. RESULTS: The recruitment of practices (n = 15) and patients (n = 121, mean age 73 years and 51% female), representing 94% and 38% of a priori targets respectively, was more complex and took longer than anticipated; impacted by the global COVID-19 pandemic. Retention rates of 100% of practices and 85% of patients were achieved. Both practice staff and patients found the intervention acceptable and reported strong fidelity to the My Comrade intervention components. Some practice staff highlighted concerns such as poor communication of the reviews to patients, dissatisfaction regarding incentivisation and in ROI the sustainability of two GPs collaboratively conducting the medication reviews. Assessing outcomes from the collected data was found feasible and appropriate for a definitive trial. Two progression criteria met the 'Go' criterion (practice and patient retention), two met the 'Amend' criterion (practice recruitment and intervention implementation) and one indicated a 'Stop - unless changes possible' (patient recruitment). CONCLUSION: The MyComrade intervention was found to be feasible to conduct within two different healthcare systems. Recruitment of participants requires significant time and effort given the nature of this population and the pairing of GP and pharmacist may be more sustainable to implement in routine practice. TRIAL REGISTRATION: Registry: ISRCTN, ISRCTN80017020 ; date of confirmation 4/11/2019; retrospectively registered.

The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial.

BACKGROUND: While international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) intervention is an evidence-based, theoretically informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)). METHODS: A pilot cluster randomised controlled trial will be conducted, using a mixed-methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention based on pre-defined progression criteria. A total of 16 practices will be recruited (eight in ROI; eight in NI), and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥ 10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of general practitioners (GPs) in ROI, and a GP and practice-based pharmacist (PBP) in NI. The GPs/GP and PBP will schedule the time to review the medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment and 4 and 8 months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed. DISCUSSION: The findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN80017020 . Date of confirmation is 4/11/2019.

Ultrasound investigation of sacral dimples and other stigmata of spinal dysraphism.

OBJECTIVE: To assess whether there was any relationship between the number of clinical markers for spinal dysraphism and its presence on ultrasound and whether there was any relationship between the presence of an isolated sacral dimple and the presence of spinal dysraphism. Outcomes and further imaging were also examined. METHODS: All patients who underwent spinal ultrasound (SUS) in University Hospital Galway (UHG) over a 5-year period (2006-2011) were identified. Patients were excluded based on age (>14 years old excluded) and indication for imaging (only patients being investigated for suspected spinal dysraphism were included). Indications for imaging, ultrasound results and information on further imaging were accessed from the computerised radiology software in UHG. Statistical analysis was performed using SPSS-18. RESULTS: Data were analysed for 216 patients. A single clinical indication was recorded for 174 ultrasound requests, ≥2 indications for 42 requests. Nineteen of 216 (8.8%) ultrasound images were abnormal, 7 having spinal dysraphism. Multiple clinical indications were 6 times more likely to have dysraphism than those imaged on the basis of a single marker (OR 6.0, 95% CI 1.289 to 27.922, p=0.022), and there was no significant correlation between the presence of a sacral dimple and the presence of dysraphism (95% CI 0.71 to 6.622, p=0.722). CONCLUSIONS: SUS performed on the basis of multiple clinical indications is six times more likely to detect spinal dysraphism than imaging performed for isolated abnormalities or risk factors. Sacral dimple is a poor marker for occult spinal pathology.

Diagnosis of pyridoxine-dependent seizures in a nineteen-year-old patient.

Although a diagnosis of pyridoxine-dependent seizures may commonly be delayed, this case involves an extremely late diagnosis with associated morbidity. Our patient received pyridoxine during the neonatal period, in conjunction with other antiepileptic drugs that masked its effect. This patient also underwent ventriculoperitoneal shunting, which complicated the diagnosis. Pyridoxine was continued with other antiepileptic drugs, without definite recognition of its therapeutic relationship. Pyridoxine-dependent seizures were finally recognized at age 19 years when the patient manifested refractory status epilepticus, several days after wisdom tooth removal (and discontinuing oral medications including pyridoxine and phenobarbital before surgery). The diagnosis was only established via genetic testing. Our patient highlights the difficulty in diagnosing this rare seizure type and its potential importance in refractory epilepsy.