Biomedical subjects

Sandra Eldridge

Publications and source records attributed to Sandra Eldridge.

9 recordsLinked to original sources

PubMed2006

The Diabetes Manual trial protocol - a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411].

BACKGROUND: The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. METHODS/DESIGN: In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. DISCUSSION: This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

Adult↗

PubMed2005

Why modelling a complex intervention is an important precursor to trial design: lessons from studying an intervention to reduce falls-related injuries in older people.

OBJECTIVES: To develop a cost-effectiveness model of a complex intervention from pilot study data in order to inform the viability and design of a subsequent falls prevention trial. METHODS: We used two models; the first estimated the probability of falling over a 12-month period based on a probability tree; the second used Markov simulation to assess the impact of the programme over time. RESULTS: The first model indicated that our intervention would reduce the proportion falling by only 2.8% over a 12-month period. The major reason for this small effect was that less than a quarter of older people at risk of falling were assessed using our screening tool. Even if policy-makers were willing to spend 30,000 pounds per quality-adjusted life-year gained, there is only a 40% chance that the intervention would be cost-effective. Sensitivity analyses showed that the only scenarios that produced a substantial increase in the effect of the intervention were those in which all older people are assessed. CONCLUSIONS: The model-building approach described in this paper is vital when designing complex trials and where a trial is not possible. Information from the modelling can be used to re-design the intervention. The effectiveness of our proposed intervention appears very small due to its inability to reach those at risk of falling. It is most likely not to be cost-effective. If inability to reach the target group is a weakness common to other similar interventions, this suggests an area for further research.

Accidental Falls↗

PubMed2005

Randomised controlled trial of a lay-led self-management programme for Bangladeshi patients with chronic disease.

BACKGROUND: Reducing the impact of chronic disease in minority ethnic groups is an important public health challenge. Lay-led education may overcome cultural and language barriers that limit the effectiveness of professionally-led programmes. We report the first randomised trial of a lay-led self-management programme - the Chronic Disease Self-Management Programme (CDSMP) (Expert Patient Programme) - in a south Asian group. AIM: To determine the effectiveness of a culturally-adapted lay-led self-management programme for Bangladeshi adults with chronic disease. DESIGN OF STUDY: Randomised controlled trial. SETTING: Tower Hamlets, east London. METHOD: We recruited Bangladeshi adults with diabetes, cardiovascular disease, respiratory disease or arthritis from general practices and randomised them to the CDSMP or waiting-list control. Self-efficacy (primary outcome), self-management behaviour, communication with clinician, depression scores, and healthcare use were assessed by blinded interviewer-administered questionnaires in Sylheti before randomisation and 4 months later. RESULTS: Of the 1363 people invited, 476 (34%) agreed to take part and 92% (439/476) of participants were followed up. The programme improved self-efficacy (difference: 0.67, 95% confidence interval [CI] = 0.08 to 1.25) and self-management behaviour (0.53; 95% CI = 0.01 to 1.06). In the 51% (121/238) of intervention participants attending three or more of the 6-weekly education sessions the programme led to greater improvements in self-efficacy (1.47; 95% CI = 0.50 to 1.82) and self-management behaviour (1.16; 95% CI = 0.50 to 1.82), and reduced HADS depression scores (0.64; 95% CI = 0.07 to 1.22). Communication and healthcare use were not significantly different between groups. The programme cost pound123 (181) per participant. CONCLUSION: A culturally-adapted CDSMP improves self-efficacy and self-care behaviour in Bangladeshi patients with chronic disease. Effects on health status were marginal. Benefits were limited by moderate uptake and attendance.

Adult↗

PubMed2004

Specialist nurse intervention to reduce unscheduled asthma care in a deprived multiethnic area: the east London randomised controlled trial for high risk asthma (ELECTRA).

OBJECTIVE: To determine whether asthma specialist nurses, using a liaison model of care, reduce unscheduled care in a deprived multiethnic area. DESIGN: Cluster randomised controlled trial. SETTING: 44 general practices in two boroughs in east London. PARTICIPANTS: 324 people aged 4-60 years admitted to or attending hospital or the general practitioner out of hours service with acute asthma; 164 (50%) were South Asian patients, 108 (34%) were white patients, and 52 (16%) were from other, largely African and Afro-Caribbean, ethnicities. INTERVENTION: Patient review in a nurse led clinic and liaison with general practitioners and practice nurses comprising educational outreach, promotion of guidelines for high risk asthma, and ongoing clinical support. Control practices received a visit promoting standard asthma guidelines; control patients were checked for inhaler technique. MAIN OUTCOME MEASURES: Percentage of participants receiving unscheduled care for acute asthma over one year and time to first unscheduled attendance. RESULTS: Primary outcome data were available for 319 of 324 (98%) participants. Intervention delayed time to first attendance with acute asthma (hazard ratio 0.73, 95% confidence interval 0.54 to 1.00; median 194 days for intervention and 126 days for control) and reduced the percentage of participants attending with acute asthma (58% (101/174) v 68% (99/145); odds ratio 0.62, 0.38 to 1.01). In analyses of prespecified subgroups the difference in effect on ethnic groups was not significant, but results were consistent with greater benefit for white patients than for South Asian patients or those from other ethnic groups. CONCLUSION: Asthma specialist nurses using a liaison model of care reduced unscheduled care for asthma in a deprived multiethnic health district. Ethnic groups may not benefit equally from specialist nurse intervention.

Adolescent↗

PubMed2004

Randomised controlled trial of support from volunteer counsellors for mothers considering breast feeding.

OBJECTIVE: To investigate whether offering volunteer support from counsellors in breast feeding would result in more women breast feeding. DESIGN: Randomised controlled trial. SETTING: 32 general practices in London and south Essex. PARTICIPANTS: 720 women considering breast feeding. MAIN OUTCOME MEASURES: Primary outcome was prevalence of any breast feeding at six weeks. Secondary outcomes were the proportion of women giving any breast feeds, or bottle feeds at four months, duration of any breast feeding, time to introduction of bottle feeds, and satisfaction with breast feeding. RESULTS: Offering support in breast feeding did not significantly increase the prevalence of any breast feeding to six weeks (65% (218/336) in the intervention group and 63% (213/336) in the control group; relative risk 1.02, 95% confidence interval 0.84 to 1.24). Survival analysis up to four months confirmed that neither duration of breast feeding nor time to introduction of formula feeds differed significantly between control and intervention groups. Not all women in the intervention group contacted counsellors postnatally, but 73% (123/179) of those who did rated them as very helpful. More women in the intervention group than in the control group said that their most helpful advice came from counsellors rather than from other sources. CONCLUSIONS: Women valued the support of a counsellor in breast feeding, but the intervention did not significantly increase breastfeeding rates, perhaps because some women did not ask for help.

Adolescent↗

PubMed2004

Patterns of intra-cluster correlation from primary care research to inform study design and analysis.

OBJECTIVE: To provide information concerning the magnitude of the intraclass correlation coefficient (ICC) for cluster-based studies set in primary care. STUDY DESIGN AND SETTING: Reanalysis of data from 31 cluster-based studies in primary care to estimate intraclass correlation coefficients from random effects models using maximum likelihood estimation. RESULTS: ICCs were estimated for 1,039 variables. The median ICC was 0.010 (interquartile range [IQR] 0 to 0.032, range 0 to 0.840). After adjusting for individual- and cluster-level characteristics, the median ICC was 0.005 (IQR 0 to 0.021). A given measure showed widely varying ICC estimates in different datasets. In six datasets, the ICCs for SF-36 physical functioning scale ranged from 0.001 to 0.055 and for SF-36 general health from 0 to 0.072. In four datasets, the ICC for systolic blood pressure ranged from 0 to 0.052 and for diastolic blood pressure from 0 to 0.108. CONCLUSION: The precise magnitude of between-cluster variation for a given measure can rarely be estimated in advance. Studies should be designed with reference to the overall distribution of ICCs and with attention to features that increase efficiency.

Cluster Analysis↗

PubMed2004

Development and preliminary examination of the predictive validity of the Falls Risk Assessment Tool (FRAT) for use in primary care.

BACKGROUND: There is no validated assessment of an older person's risk of falling that is easily applied in primary care. We aimed to develop a two-part tool for use in primary care or the community. Part 1 includes a rapid assessment of the individual's risk of falling for administration by clinical or non-clinical staff. Part 2 (for clinical staff) includes guidance on further assessment, referral and interventions. We assessed the predictive validity of part 1. METHODS: The tool was developed by an expert panel following the updating of an existing systematic review of community-based prospective studies identifying risk factors for falling and modified in accordance with the feedback from extensive piloting. We assessed predictive validity by a questionnaire survey sent at baseline and 6 months to a random sample of 1000 people aged over 65 in one Primary Care Group area. RESULTS: Five items were included in part 1: history of any fall in the previous year, four or more prescribed medications, diagnosis of stroke or Parkinson's disease, reported problems with balance, inability to rise from a chair without using arms. The presence of three or more risk factors had a positive predictive value for a fall in the next 6 months of 0.57 (95 per cent confidence interval 0.43-0.69). Less than three risk factors had a negative predictive value of 0.86 (0.82-0.89), and a specificity of 0.92 (0.88-0.94). CONCLUSION: The tool may be useful for identifying people who would benefit from further assessment of their risk of falling and appropriate intervention.

Accident Prevention↗

PubMed2004

Beliefs and behavior of deceivers in a randomized, controlled trial of anti-smoking advice at a primary care clinic in Kelantan, Malaysia.

Smoking deception is often ignored, but is important in health care. In this trial it was assessed at both study entry and outcome. At study entry, 1,044 males at a primary care clinic were asked smoking status and tested for breath carbon monoxide (CO). Of self-reported non-smokers, 57/402 (14%) were actually smokers, as were 59/251 (24%) of self-reported ex-smokers. The self-reported smokers (n=387) entered a randomized, controlled trial where the intervention comprised four questions on knowledge and beliefs about smoking, standardized verbal advice against smoking, and a leaflet. At follow-up, subjects were also questioned about beliefs. Follow-up was difficult, but 191/387 (49%) attended at three or six months. Of 27 who claimed to have quit, 6 (22%) were deceivers and 21 were confirmed quitters. Cessation did not differ between intervention and control groups. Overall confirmed cessation at six months was 16/387 (4.1 %). Confirmed quitters were significantly lighter smokers than deceivers and still smokers. There were non-significant trends between the outcome groups whereby deceivers had least knowledge and most lay beliefs, and quitters had most knowledge and fewest lay beliefs. The lay beliefs may prevent some smokers from quitting.

Adolescent↗

PubMed2002

'Inappropriate' attendance at an accident and emergency department by adults registered in local general practices: how is it related to their use of primary care?

OBJECTIVES: To identify the relationship between 'inappropriate' attendance at an accident and emergency department (AED) by adults registered with local general practices and their use of primary care. METHODS: A case-control study matched for age, sex, distance from the AED, social class and registered general practice and set in a single AED and two health centres in South Essex. The participants were a total of 452 patients over 15 years old from the two health centres classified as having attended the AED 'inappropriately' in 1997 as identified by a modified Sheffield process method, and 452 controls. The predictive variables were measures of utilisation in the year 1997, including number of contacts in primary care, referral and investigation costs. Measures of morbidity were collected as potential confounders. These included a recorded history of anxiety or depression in the year 1997, or being in receipt of repeat prescriptions in that year. RESULTS: The rate of 'inappropriate' attendance was 16.8% [95% confidence interval (CI): 15.7-18.0]. All measures of utilisation and markers of anxiety and depression were significantly positively associated with 'inappropriate' attendance, but there was no association with markers of chronic morbidity. Only the number of general practitioner (GP) appointments (P < 0.0001) and out-of-hours advice calls (P < 0.0001) were independently correlated with 'inappropriate' attendance in a conditional logistic regression. 'Inappropriate' attendees had approximately twice as many GP appointments and 10 times as many out-of-hours telephone contacts with the GP. CONCLUSIONS: GP-registered, 'inappropriate' attendees at AEDs utilise primary care services more than matched controls; this pattern of service utilisation appears to be unrelated to chronic physical illness. Thus, simply providing new, directly accessible primary health care services may not significantly reduce AED use.

Adolescent↗