Looking for the "Little Things": A Multi-Disciplinary Approach to Medicines Monitoring for Older People Using the ADRe Resource.

Advances in medicines have increased the effectiveness of treatments and the social and cultural authority of doctors. However, as prescribing has become the dominant modality of treatment, the "pharmaceuticalization" of medical practice has often resulted in treatment "at a distance", with doctors having limited contact with patients. Older and poorer people, who are socially distanced from medical prescribers, suffer more adverse drug reactions (ADRs) than the general population. A team approach to checking patients systematically for ADRs, as detailed in manufacturers' literature, can minimise medication errors, but regular review is rare. This paper explains the benefits of medicines monitoring to protect older patients from iatrogenic harm, such as over-sedation, falls, or drug-induced Parkinsonism. We show how multidisciplinary initiatives to optimise prescribing can be supported by using a recognised resource-the adverse drug reaction profile (ADRe). The profile identifies and documents patients' signs and symptoms of putative ADRs. Better monitoring allows professionals to adjust prescribing and respond to identified problems with agility. Implementation of systematic monitoring will require changes to the regulatory regime and better inter-professional cooperation. Providing carers, nurses and pharmacists with a structured system to monitor patients would democratise relevant medical knowledge and help address ageism and the socio-economic health divide.

Long term extension of a randomised controlled trial of probiotics using electronic health records.

Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up. We completed a 5-year electronic follow up of a RCT investigating the impact of probiotics on asthma and eczema in children born 2005-2007, with traditional fieldwork follow up to two years. Participants and trial outcomes were identified and analysed after five years using secure, routine, anonymised, person-based electronic health service databanks. At two years, we identified 93% of participants and compared fieldwork with electronic health records, highlighting areas of agreement and disagreement. Retention of children from lower socio-economic groups was improved, reducing volunteer bias. At 5 years we identified a reduced 82% of participants. These data allowed the trial's first robust analysis of asthma endpoints. We found no indication that probiotic supplementation to pregnant mothers and infants protected against asthma or eczema at 5 years. Continued longer-term follow up is technically straightforward.

Probiotics in the prevention of eczema: a randomised controlled trial.

OBJECTIVE: To evaluate a multistrain, high-dose probiotic in the prevention of eczema. DESIGN: A randomised, double-blind, placebo-controlled, parallel group trial. SETTINGS: Antenatal clinics, research clinic, children at home. PATIENTS: Pregnant women and their infants. INTERVENTIONS: Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20; total of 10(10) organisms/day) or matching placebo. MAIN OUTCOME MEASURE: Diagnosed eczema at age 2 years. Infants were followed up by questionnaire. Clinical examination and skin prick tests to common allergens were done at 6 months and 2 years. RESULTS: The cumulative frequency of diagnosed eczema at 2 years was similar in the probiotic (73/214, 34.1%) and placebo arms (72/222, 32.4%; OR 1.07, 95% CI 0.72 to 1.6). Among the secondary outcomes, the cumulative frequency of skin prick sensitivity at 2 years was reduced in the probiotic (18/171; 10.5%) compared with the placebo arm (32/173; 18.5%; OR 0.52, 95% CI 0.28 to 0.98). The statistically significant differences between the arms were mainly in sensitisation to cow's milk and hen's egg proteins at 6 months. Atopic eczema occurred in 9/171 (5.3%) children in the probiotic arm and 21/173 (12.1%) in the placebo arm (OR 0.40, 95% CI 0.18 to 0.91). CONCLUSIONS: The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity. However, the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood. TRIAL REGISTRATION NUMBER: ISRCTN26287422.

Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy.

Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health. Although these organisms have a long record of safe use, it is important to identify any adverse effects in potentially vulnerable populations. In a randomized, double-blinded, placebo-controlled trial, we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants. Two strains of lactobacilli (Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08) and bifidobacteria (Bifidobacterium animalis subsp. lactis CUL34 and Bifidobacterium bifidum CUL20) with a total of 1 x 10(10) colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0-6 mo. Adverse events (AE) were classified according to WHO International Statistical Classification of Diseases criteria. Common symptoms were recorded by regular questionnaires. Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar. Compliance with the trial interventions, loss to follow-up, symptoms, drug usage, infant growth, method of feeding, visits to the doctor, and mothers' assessment of infant health were similar in the 2 groups. Fifteen (6.8%) mothers and 73 (33.2%) infants in the treatment group and 21 (9.0%) mothers and 75 (32.1%) infants in the placebo group reported AE (P = 0.49 and P = 0.84, respectively). Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group. None of the AE were attributed to the intervention. Our findings support the safe use of this consortium of organisms during pregnancy and early infancy.