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1.  Probiotics in the prevention of eczema: a randomised controlled trial 
Archives of Disease in Childhood  2014;99(11):1014-1019.
To evaluate a multistrain, high-dose probiotic in the prevention of eczema.
A randomised, double-blind, placebo-controlled, parallel group trial.
Antenatal clinics, research clinic, children at home.
Pregnant women and their infants.
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 1010 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.
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).
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
PMCID: PMC4215350  PMID: 24947281
Allergy; Microbiology; Dermatology
2.  Medication Monitoring for People with Dementia in Care Homes: The Feasibility and Clinical Impact of Nurse-Led Monitoring 
The Scientific World Journal  2014;2014:843621.
Objectives. People with dementia are susceptible to adverse effects of medicines. However, they are not always closely monitored. We explored (1) feasibility and (2) clinical impact of nurse-led medication monitoring. Design. Feasibility “before-and-after” intervention study. Setting. Three care homes in Wales. Participants. Eleven service users diagnosed with dementia, taking at least one antipsychotic, antidepressant, or antiepileptic medicine. Intervention. West Wales Adverse Drug Reaction (ADR) Profile for Mental Health Medicines. Outcome Measures. (1) Feasibility: recruitment, retention, and implementation. (2) Clinical impact: previously undocumented problems identified and ameliorated, as recorded in participants' records before and after introduction of the profile, and one month later. Results. Nurses recruited and retained 11 of 29 eligible service users. The profile took 20–25 minutes to implement, caused no harm, and supplemented usual care. Initially, the profile identified previously undocumented problems for all participants (mean 12.7 (SD 4.7)). One month later, some problems had been ameliorated (mean 4.9 (3.6)). Clinical gains included new prescriptions to manage pain (2 participants), psoriasis (1), Parkinsonian symptoms (1), rash (1), dose reduction of benzodiazepines (1), new care plans for oral hygiene, skin problems, and constipation. Conclusions. Participants benefited from structured nurse-led medication monitoring. Clinical trials of our ADR Profile are feasible and necessary.
PMCID: PMC3951004  PMID: 24707218
3.  Record Review to Explore the Adequacy of Post-Operative Vital Signs Monitoring Using a Local Modified Early Warning Score (Mews) Chart to Evaluate Outcomes 
PLoS ONE  2014;9(1):e87320.
1) To explore the adequacy of: vital signs’ recordings (respiratory and heart rate, oxygen saturation, systolic blood pressure (BP), temperature, level of consciousness and urine output) in the first 8 post-operative hours; responses to clinical deterioration. 2) To identify factors associated with death on the ward between transfer from the theatre recovery suite and the seventh day after operation.
Retrospective review of records of 11 patients who died plus four controls for each case.
We reviewed clinical records of 55 patients who met inclusion criteria (general anaesthetic, age >13, complete records) from six surgical wards in a teaching hospital between 1 May and 31 July 2009.
In the absence of guidelines for routine post-operative vital signs’ monitoring, nurses’ standard practice graphical plots of recordings were recoded into MEWS formats (0 = normal, 1–3 upper or lower limit) and their responses to clinical deterioration were interpreted using MEWS reporting algorithms.
No patients’ records contained recordings for all seven parameters displayed on the MEWS. There was no evidence of response to: 22/36 (61.1%) abnormal vital signs for patients who died that would have triggered an escalated MEWS reporting algorithm; 81/87 (93.1%) for controls. Death was associated with age, ≥61 years (OR 14.2, 3.0–68.0); ≥2 pre-existing co-morbidities (OR 75.3, 3.7–1527.4); high/low systolic BP on admission (OR 7.2, 1.5–34.2); tachycardia (≥111–129 bpm) (OR 6.6, 1.4–30.0) and low systolic BP (≤81–100 mmHg), as defined by the MEWS (OR 8.0, 1.9–33.1).
Guidelines for post-operative vital signs’ monitoring and reporting need to be established. The MEWS provides a useful scoring system for interpreting clinical deterioration and guiding intervention. Exploration of the ability of the Cape Town MEWS chart plus reporting algorithm to expedite recognition of signs of clinical and physiological deterioration and securing more skilled assistance is essential.
PMCID: PMC3909075  PMID: 24498075
4.  Monitoring Vital Signs: Development of a Modified Early Warning Scoring (Mews) System for General Wards in a Developing Country 
PLoS ONE  2014;9(1):e87073.
The aim of the study was to develop and validate, by consensus, the construct and content of an observations chart for nurses incorporating a modified early warning scoring (MEWS) system for physiological parameters to be used for bedside monitoring on general wards in a public hospital in South Africa.
Delphi and modified face-to-face nominal group consensus methods were used to develop and validate a prototype observations chart that incorporated an existing UK MEWS. This informed the development of the Cape Town ward MEWS chart.
One specialist anaesthesiologist, one emergency medicine specialist, two critical care nurses and eight senior ward nurses with expertise in bedside monitoring (N = 12) were purposively sampled for consensus development of the MEWS. One general surgeon declined and one neurosurgeon replaced the emergency medicine specialist in the final round.
Five consensus rounds achieved ≥70% agreement for cut points in five of seven physiological parameters respiratory and heart rates, systolic BP, temperature and urine output. For conscious level and oxygen saturation a relaxed rule of <70% agreement was applied. A reporting algorithm was established and incorporated in the MEWS chart representing decision rules determining the degree of urgency. Parameters and cut points differed from those in MEWS used in developed countries.
A MEWS for developing countries should record at least seven parameters. Experts from developing countries are best placed to stipulate cut points in physiological parameters. Further research is needed to explore the ability of the MEWS chart to identify physiological and clinical deterioration.
PMCID: PMC3901724  PMID: 24475226
5.  Volunteer Bias in Recruitment, Retention, and Blood Sample Donation in a Randomised Controlled Trial Involving Mothers and Their Children at Six Months and Two Years: A Longitudinal Analysis 
PLoS ONE  2013;8(7):e67912.
The vulnerability of clinical trials to volunteer bias is under-reported. Volunteer bias is systematic error due to differences between those who choose to participate in studies and those who do not.
Methods and Results
This paper extends the applications of the concept of volunteer bias by using data from a trial of probiotic supplementation for childhood atopy in healthy dyads to explore 1) differences between a) trial participants and aggregated data from publicly available databases b) participants and non-participants as the trial progressed 2) impact on trial findings of weighting data according to deprivation (Townsend) fifths in the sample and target populations. 1) a) Recruits (n = 454) were less deprived than the target population, matched for area of residence and delivery dates (n = 6,893) (mean [SD] deprivation scores 0.09[4.21] and 0.79[4.08], t = 3.44, df = 511, p<0.001). b) i)As the trial progressed, representation of the most deprived decreased. These participants and smokers were less likely to be retained at 6 months (n = 430[95%]) (OR 0.29,0.13–0.67 and 0.20,0.09–0.46), and 2 years (n = 380[84%]) (aOR 0.68,0.50–0.93 and 0.55,0.28–1.09), and consent to infant blood sample donation (n = 220[48%]) (aOR 0.72,0.57–0.92 and 0.43,0.22–0.83). ii)Mothers interested in probiotics or research or reporting infants’ adverse events or rashes were more likely to attend research clinics and consent to skin-prick testing. Mothers participating to help children were more likely to consent to infant blood sample donation. 2) In one trial outcome, atopic eczema, the intervention had a positive effect only in the over-represented, least deprived group. Here, data weighting attenuated risk reduction from 6.9%(0.9–13.1%) to 4.6%(−1.4–+10.5%), and OR from 0.40(0.18–0.91) to 0.56(0.26–1.21). Other findings were unchanged.
Potential for volunteer bias intensified during the trial, due to non-participation of the most deprived and smokers. However, these were not the only predictors of non-participation. Data weighting quantified volunteer bias and modified one important trial outcome.
Trial Registration
This randomised, double blind, parallel group, placebo controlled trial is registered with the International Standard Randomised Controlled Trials Register, Number (ISRCTN) 26287422. Registered title: Probiotics in the prevention of atopy in infants and children.
PMCID: PMC3706448  PMID: 23874465
6.  The Implementation of Crisis Resolution Home Treatment Teams in Wales: Results of the National Survey 2007-2008 
In mental health nursing, Crisis Resolution and Home Treatment (CRHT) services are key components of the shift from in-patient to community care. CRHT has been developed mainly in urban settings, and deployment in more rural areas has not been examined.
We aimed to evaluate CRHT services’ progress towards policy targets.
Participants and Setting:
All 18 CRHT teams in Wales were surveyed.
A service profile questionnaire was distributed to team leaders.
Fourteen of 18 teams responded in full. All but one were led by nurses, who formed the main professional group. All teams reported providing an alternative to hospital admission and assisting early discharge. With one exception, teams were ‘gatekeeping’ hospital beds. There was some divergence in clients seen, perceived impact of the service, operational hours, distances travelled, team structure, input of consultant psychiatrists and caseloads. We found some differences between the 8 urban teams and the 6 teams serving rural or mixed areas: rural teams travelled more, had fewer inpatient beds, and less medical input (0.067 compared to 0.688 whole time equivalents).. Most respondents felt that resource constraints were limiting further developments.
Teams met standards for CHRT services in Wales; however, these are less onerous than those in England, particularly in relation to operational hours and staffing complement. As services develop, it will be important to ensure that rural and mixed areas receive the same level of input as urban areas.
PMCID: PMC2874216  PMID: 20502646
Mental health nursing; crisis resolution; home treatment; rurality.
7.  Antibiotics and Allergic Disorders in Childhood 
The Open Nursing Journal  2008;2:48-57.
This paper explores the possible association between antibiotics prescribed in infancy and allergic disorders, mainly eczema and asthma, in childhood.
No-one fully understands why childhood asthma and eczema have become so common. Some authorities suggest that there may be an association between eczema and asthma and antibiotics prescribed in childhood; however, others disagree.
The available literature was reviewed to examine the links between prescribed antibiotics and childhood eczema and asthma.
Findings/Key Issue:
Some, but not all, research indicates that antibiotic administration in pregnancy, childbirth or infancy may be linked to childhood asthma and eczema, but much uncertainty remains. None of the papers identified stated the doses of antibiotics prescribed. In addition, we were unable to locate studies reporting the interactions between antibiotics and the developing immune system.
Health care professionals should be selective when prescribing antibiotics. Further prospective work is needed to guide the prescribing of antibiotics in childbirth and infancy.
PMCID: PMC2582823  PMID: 19319220
Allergic disorders; antibiotics; prescribing; adverse drug reactions; evidence based practice.
8.  Infant feeding and analgesia in labour: the evidence is accumulating 
The interesting and important paper by Torvaldsen and colleagues provides further circumstantial evidence of a positive association between intrapartum analgesia and feeding infant formula. Not all research supports this association. Before 'failure to breastfeed' can be adjudged an adverse effect of intrapartum analgesia, the research evidence needs to be considered in detail. Examination of the existing evidence against the Bradford-Hill criteria indicates that the evidence is not yet conclusive. However, the difficulties of obtaining funding and undertaking large trials to explore putative adverse drug reactions in pregnant women may mean that we shall never have conclusive evidence of harm. Therefore, reports of large cohort studies with regression models, as in the paper published today, assume a greater importance than in other areas of investigation. Meanwhile, women and their clinicians may feel that sufficient evidence has accumulated to justify offering extra support to establish breastfeeding if women have received high doses of analgesics in labour.
PMCID: PMC1712219  PMID: 17331266

Results 1-8 (8)