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Results for “Randomised Controlled Trial”

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PubMed2006

The PINE study of epidural steroids and local anaesthetics to prevent postherpetic neuralgia: a randomised controlled trial.

BACKGROUND: Postherpetic neuralgia is the most frequent complication of herpes zoster. Treatment of this neuropathic pain syndrome is difficult and often disappointing. We assessed the effectiveness of a single epidural injection of steroids and local anaesthetics for prevention of postherpetic neuralgia in older patients with herpes zoster. METHODS: We randomly assigned 598 patients older than 50 years, with acute herpes zoster (rash <7 days) below dermatome C6, to receive either standard therapy (oral antivirals and analgesics) or standard therapy with one additional epidural injection of 80 mg methylprednisolone acetate and 10 mg bupivacaine. The primary endpoint was the proportion of patients with zoster-associated pain 1 month after inclusion. Analyses were by intention-to-treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN32866390. FINDINGS: At 1 month, 137 (48%) patients in the epidural group reported pain compared with 164 (58%) in the control group (relative risk [RR] 0.83, 95% CI 0.71-0.97, p=0.02). After 3 months these values were 58 (21%) and 63 (24%) respectively (0.89, 0.65-1.21, p=0.47) and, at 6 months, 39 (15%) and 44 (17%; 0.85, 0.57-1.13, p=0.43). We detected no subgroups in which the relative risk for pain 1 month after inclusion substantially differed from the overall estimate. No patient had major adverse events related to epidural injection. INTERPRETATION: A single epidural injection of steroids and local anaesthetics in the acute phase of herpes zoster has a modest effect in reducing zoster-associated pain for 1 month. This treatment is not effective for prevention of long-term postherpetic neuralgia.

Aged↗

PubMed2003

ABFAB. Attachment to the breast and family attitudes to breastfeeding. The effect of breastfeeding education in the middle of pregnancy on the initiation and duration of breastfeeding: a randomised controlled trial [ISRCTN21556494].

BACKGROUND: It has proven difficult to reach World Health Organization (WHO) recommendations that infants be exclusively breastfed from birth to six months of age 12, yet there is limited knowledge about interventions that are effective in increasing breastfeeding initiation and duration. Particularly lacking is evidence about how to maintain breastfeeding rates in countries which already have a high initiation of breastfeeding. This study aims to determine whether mid-pregnancy breastfeeding education, with a focus on either attitudes to breastfeeding or on technical aspects of breastfeeding, has an effect on rates of breastfeeding initiation and duration. Secondary aims of the study are to: explore what factors might affect the duration of breastfeeding and evaluate the interventions from the participant and childbirth facilitator perspectives. METHODS/DESIGN: A randomised controlled trial (RCT) design will be used. Women having their first baby, and planning to give birth as public patients at the Royal Women's Hospital (RWH), Melbourne, will be approached at 18-20 weeks of pregnancy and invited to participate in the study. Participants will be randomly allocated to a control group or one of two group interventions: a previously designed and trialled tool to teach practical aspects of breastfeeding or an exploration of family attitudes to breastfeeding. The latter was developed and piloted by the investigators in conjunction with the group facilitators, prior to trial commencement. The interventions are planned to take place at 20-25 weeks. Data will be collected by questionnaire at recruitment, at interview in hospital after the birth and by telephone interview six months later. Medical/obstetric outcomes will be obtained from the medical record. The sample size (972) was calculated to identify an increase in breastfeeding initiation from 75 to 85% and an increase from 40 to 50% in breastfeeding at six months.

Journal Article↗

PubMed2003

Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: a community-based, multicentre, double-blind randomised controlled trial.

OBJECTIVES: To compare the effectiveness of ototopical ciprofloxacin (0.3%; CIP) with framycetin (0.5%), gramicidin, dexamethasone (FGD) eardrops (5 drops twice daily for 9 days) together with povidone-iodine (0.5%) ear cleaning as treatments for chronic suppurative otitis media (CSOM) in Aboriginal children. DESIGN AND PARTICIPANTS: Aboriginal community-controlled, community-based, multicentre, double-blind, randomised controlled trial in eight Aboriginal Community Controlled Health Services across northern Australia, involving 147 Aboriginal children with CSOM. MAIN OUTCOME MEASURES: Resolution of otorrhoea (clinical cure), proportion of children with healed perforated tympanic membrane (TM) and improved hearing, 10-21 days after starting treatment. RESULTS: 111 children aged 1-14 years (CIP, 55; FGD, 56) completed treatment. CSOM cures occurred in 64% (CIP, 76.4%; FGD, 51.8%), with a significantly higher rate in the ciprofloxacin group (P = 0.009, absolute difference of 24.6% [95% CI, 15.8%-33.4%]). TM perforation size and the level of hearing impairment did not change. Pseudomonas aeruginosa was the most common bacterial pathogen (in 47.6%), while respiratory pathogens were rare (in 5.7%). CONCLUSIONS: Twice-daily ear cleaning and topical ciprofloxacin is effective at community-level in achieving cure for CSOM. Healthcare providers to Aboriginal children with CSOM should be given special access to provide ototopical ciprofloxacin as first-line treatment.

Administration, Topical↗

PubMed2004

Role of flies and provision of latrines in trachoma control: cluster-randomised controlled trial.

BACKGROUND: Eye-seeking flies have received much attention as possible trachoma vectors, but this remains unproved. We aimed to assess the role of eye-seeking flies as vectors of trachoma and to test provision of simple pit latrines, without additional health education, as a sustainable method of fly control. METHODS: In a community-based, cluster-randomised controlled trial, we recruited seven sets of three village clusters and randomly assigned them to either an intervention group that received regular insecticide spraying or provision of pit latrines (without additional health education) to each household, or to a control group with no intervention. Our primary outcomes were fly-eye contact and prevalence of active trachoma. Frequency of child fly-eye contact was monitored fortnightly. Whole communities were screened for clinical signs of trachoma at baseline and after 6 months. Analysis was per protocol. FINDINGS: Of 7080 people recruited, 6087 (86%) were screened at follow-up. Baseline community prevalence of active trachoma was 6%. The number of Musca sorbens flies caught from children's eyes was reduced by 88% (95% CI 64-100; p<0.0001) by insecticide spraying and by 30% (7-52; p=0.04) by latrine provision by comparison with controls. Analysis of age-standardised trachoma prevalence rates at the cluster level (n=14) showed that spraying was associated with a mean reduction in trachoma prevalence of 56% (19-93; p=0.01) and 30% with latrines (-81 to 22; p=0.210) by comparison with the mean rate change in the controls. INTERPRETATION: Fly control with insecticide is effective at reducing the number of flies caught from children's eyes and is associated with substantially lower trachoma prevalence compared with controls. Such a finding is consistent with flies being important vectors of trachoma. Since latrine provision without health education was associated with a significant reduction in fly-eye contact by M sorbens, studies of their effect when combined with other trachoma control measures are warranted.

Adolescent↗

PubMed2005

Randomised controlled trial of the cost-effectiveness of water-based therapy for lower limb osteoarthritis.

OBJECTIVES: To determine the efficacy of community water-based therapy for the management of lower limb osteoarthritis (OA) in older patients. DESIGN: A pre-experimental matched-control study was used to estimate efficacy of water-based exercise treatment, to check design assumptions and delivery processes. The main study was a randomised controlled trial of the effectiveness of water-based exercise (treatment) compared with usual care (control) in older patients with hip and/or knee OA. The latter was accompanied by an economic evaluation comparing societal costs and consequences of the two treatments. SETTING: Water exercise was delivered in public swimming pools in the UK. Physical function assessments were carried out in established laboratory settings. PARTICIPANTS: 106 patients (93 women, 13 men) over the age of 60 years with confirmed hip and/or knee OA took part in the preliminary study. A similar, but larger, group of 312 patients (196 women, 116 men) took part in the main study, randomised into control (159) and water exercise (153) groups. INTERVENTIONS: Control group patients received usual care with quarterly semi-structured telephone interview follow-up only. The intervention in the main study lasted for 1 year, with a further follow-up period of 6 months. MAIN OUTCOME MEASURES: Pain score on the Western Ontario and McMaster Universities OA index (WOMAC). Additional outcome measures were included to evaluate effects on quality of life, cost-effectiveness and physical function measurements. RESULTS: Short-term efficacy of water exercise in the management of lower limb OA was confirmed, with effect sizes ranging from 0.44 [95% confidence interval (CI) 0.03 to 0.85] on WOMAC pain to 0.76 (95% CI 0.33 to 1.17) on WOMAC physical function. Of 153 patients randomised to treatment, 82 (53.5%) were estimated to have complied satisfactorily with their treatment at the 1-year point. This had declined to 28 (18%) by the end of the 6-month follow-up period, during which support for the intervention had been removed and those wishing to continue exercise had to pay their own costs for maintaining their exercise treatment. High levels of co-morbidity were recorded in both groups. Nearly two thirds of all patients had a significant other illness in addition to their OA. Fifty-four control and 53 exercise patients had hospital inpatient episodes during the study period. Water exercise remained effective in the main study but overall effect size was small, on WOMAC pain at 1 year, a reduction of about 10% in group mean pain score. This had declined, and was non-significant, at 18 months. Mean cost difference estimates showed a saving in the water exercise group of pound123--175 per patient per annum and incremental cost-effectiveness ratios ranged from pound3838 to pound5951 per quality-adjusted life-year (QALY). Net reduction in pain was achieved at a net saving of pound135--175 per patient per annum and the ceiling valuation of pound580--740 per unit of WOMAC pain reduction was favourably low. CONCLUSIONS: Group-based exercise in water over 1 year can produce significant reduction in pain and improvement in physical function in older adults with lower limb OA, and may be a useful adjunct in the management of hip and/or knee OA. The water-exercise programme produced a favourable cost--benefit outcome, using reduction in WOMAC pain as the measure of benefit. Further research is suggested into other similar public health interventions. Investigation is also needed into how general practice can best be supported to facilitate access to participants for research trials in healthcare, as well as an examination of the infrastructure and workforce capacities for physical activity delivery and the potential extent to which healthcare may be supported in this way. More detailed research is required to develop a better understanding of the types of exercise that will work for the different biomechanical subtypes of knee and hip OA and investigation is needed on access and environmental issues for physical activity programmes for older people, from both a provider and a participant perspective, the societal costs of the different approaches to the management of OA and longer term trends in outcome measures (costs and effects).

Aged↗

PubMed2006

Study protocol of a cluster randomised controlled trial investigating the effectiveness of a tailored energy balance programme for recent retirees.

BACKGROUND: People in transitional life stages, such as occupational retirement, are likely to gain weight and accumulate abdominal fat mass caused by changes in physical activity and diet. Hence, retirees are an important target group for weight gain prevention programmes, as described in the present paper. METHODS/DESIGN: A systematic and stepwise approach (Intervention Mapping) is used to develop a low-intensity energy balance intervention programme for recent retirees. This one-year, low-intensity multifaceted programme aims to prevent accumulation of abdominal fat mass and general weight gain by increasing awareness of energy balance and influencing related behaviours of participants' preference. These behaviours are physical activity, fibre intake, portion size and fat consumption. The effectiveness of the intervention programme is tested in a cluster randomised controlled trial. Measurements of anthropometry, physical activity, energy intake, and related psychosocial determinants are performed at baseline and repeated at 6 months for intermediate effect, at 12 months to evaluate short-term intervention effects and at 24 months to test the sustainability of the effects. DISCUSSION: This intervention programme is unique in its focus on retirees and energy balance. It aims at increasing awareness and takes into account personal preferences of the users by offering several options for behaviour change. Moreover, the intervention programme is evaluated at short-term and long-term and includes consecutive outcome measures (determinants, behaviour and body composition).

Aged↗

PubMed1995

When a randomised controlled trial is needed to assess drug safety. The case of paediatric ibuprofen.

Drugs are frequently made available for use before risks of rare but serious reactions have been identified and quantified. While this situation may be acceptable for drugs used to treat serious conditions, greater information on safety is needed for drugs used to treat less serious conditions, and particularly those medications available without prescription. Spontaneous reports and observational studies can provide useful data in most instances, but nonrandomised studies are inadequate in the presence of confounding by indication (i.e. when patients treated with a drug differ in their underlying risk of adverse outcome from patients given alternate treatments, independent of the effect of the drug). Such is the case in the US with regard to the use of paediatric ibuprofen as an antipyretic. In this setting, a rigorous and large randomised controlled trial is needed to provide valid and statistically stable risk estimates. A trial of this kind is a feasible way to develop clinically meaningful data on safety with respect to rare but serious adverse reactions.

Drug-Related Side Effects and Adverse Reactions↗

PubMed1996

Body dysmorphic disorder: a cognitive behavioural model and pilot randomised controlled trial.

A cognitive behavioural model of body image is presented with specific reference to body dysmorphic disorder (BDD). We make specific hypotheses from the model for testing BDD patients in comparison with: (i) patients with "real" disfigurements who seek cosmetic surgery; (ii) subjects with "real" disfigurements who are emotionally well adjusted; and (iii) healthy controls without any defect. There have been no randomised controlled trials of treatment for BDD and therefore the model has clear implications for the development of cognitive behavioural therapy. This was evaluated in a pilot controlled trial. Nineteen patients were randomly allocated to either cognitive behaviour therapy or a waiting list control group over 12 weeks. There were no significant pre-post differences on any of the measures in the waiting list group. There were significant changes in the treated group on specific measures of BDD and depressed mood. Cognitive behaviour therapy should be further evaluated in a larger controlled trial in comparison with another psychological treatment such as interpersonal therapy and pharmacotherapy.

Adult↗

PubMed2004

A randomised controlled trial and cost effectiveness study of systematic screening (targeted and total population screening) versus routine practice for the detection of atrial fibrillation in the over 65s: (SAFE) [ISRCTN19633732].

BACKGROUND: Atrial fibrillation (AF) has been recognised as an important independent risk factor for thromboembolic disease, particularly stroke for which it provides a five-fold increase in risk. This study aimed to determine the baseline prevalence and the incidence of AF based on a variety of screening strategies and in doing so to evaluate the incremental cost-effectiveness of different screening strategies, including targeted or whole population screening, compared with routine clinical practice, for detection of AF in people aged 65 and over. The value of clinical assessment and echocardiography as additional methods of risk stratification for thromboembolic disease in patients with AF were also evaluated. METHODS: The study design was a multi-centre randomised controlled trial with a study population of patients aged 65 and over from 50 General Practices in the West Midlands. These purposefully selected general practices were randomly allocated to 25 intervention practices and 25 control practices. GPs and practice nurses within the intervention practices received education on the importance of AF detection and ECG interpretation. Patients in the intervention practices were randomly allocated to systematic (n = 5000) or opportunistic screening (n = 5000). Prospective identification of pre-existing risk factors for AF within the screened population enabled comparison between high risk targeted screening and total population screening. AF detection rates in systematically screened and opportunistically screened populations in the intervention practices were compared to AF detection rate in 5,000 patients in the control practices.

Aged↗

PubMed2002

A randomised controlled trial of a patient based Diabetes Recall and Management System: the DREAM trial: a study protocol [ISRCTN32042030].

BACKGROUND: Whilst there is broad agreement on what constitutes high quality health care for people with diabetes, there is little consensus on the most efficient way of delivering it. Structured recall systems can improve the quality of care but the systems evaluated to date have been of limited sophistication and the evaluations have been carried out in small numbers of relatively unrepresentative settings. Hartlepool, Easington and Stockton currently operate a computerised diabetes register which has to date produced improvements in the quality of care but performance has now plateaued leaving substantial scope for further improvement. This study will evaluate the effectiveness and efficiency of an area wide 'extended' system incorporating a full structured recall and management system, actively involving patients and including clinical management prompts to primary care clinicians based on locally-adapted evidence based guidelines. METHODS: The study design is a two-armed cluster randomised controlled trial of 61 practices incorporating evaluations of the effectiveness of the system, its economic impact and its impact on patient wellbeing and functioning.

Database Management Systems↗

PubMed2001

Monitoring response during a randomised controlled trial of escalating interferon dose for chronic hepatitis C infection: predictive value of quantitative and qualitative HCV RNA assays.

BACKGROUND: In chronic hepatitis C infection, raising the interferon dose in initial non-responders may increase the generally poor sustained response rates. Monitoring virological response is essential in this kind of individual patient based approach. Quantitative HCV RNA assays are increasingly used for this purpose. However, their additional value as compared to strictly qualitative HCV RNA assays should be evaluated before they are implemented as a routine measurement, since these assays are more expensive and time consuming than qualitative assays. OBJECTIVES: Goals of this study were (1) to test the hypothesis that increasing interferon dose in initial non-responders results in permanent viral clearance in more patients and (2) evaluation of the predictive value of quantitative versus qualitative HCV RNA assays before and during treatment. STUDY DESIGN: 63 patients were treated in a randomised controlled trial of escalating interferon dose. In the standard treatment group patients received 6 MU alpha-2a thrice weekly for 3 months followed by 3 MU thrice weekly for 3 months. In the experimental group interferon dose was escalated at 6 weeks to 9 MU if HCV RNA was still detectable at 4 weeks. Predictors of response were analyzed at various time points before and during treatment and the predictive value of quantitative HCV RNA measurements was compared to that of qualitative HCV RNA assays. RESULTS: No significant difference in sustained response rate was found between the treatment groups at the end of follow-up. At baseline, the strongest independent predictor for a sustained response was a viral load level below 10(6) copies/ml and age younger than 40 years. During treatment a negative HCV RNA status at week 4 was the strongest predictor of a sustained response. Viral load levels during treatment did not independently predict a sustained response. CONCLUSIONS: While on treatment, qualitative HCV RNA assays should be used to monitor response.

Adult↗

PubMed2005

Randomised controlled trial of animal facilitated therapy with dolphins in the treatment of depression.

OBJECTIVE: To evaluate the effectiveness of animal facilitated therapy with dolphins, controlling for the influence of the natural setting, in the treatment of mild to moderate depression and in the context of the biophilia hypothesis. SETTING: The study was carried out in Honduras, and recruitment took place in the United States and Honduras. DESIGN: Single blind, randomised, controlled trial. PARTICIPANTS: Outpatients, recruited through announcements on the internet, radio, newspapers, and hospitals. RESULTS: Of the 30 patients randomly assigned to the two groups of treatment, two dropped out of the treatment group after the first week and three withdrew their consent in the control group after they had been randomly allocated. For the participants who completed the study, the mean severity of the depressive symptoms was more reduced in the treatment group than in the control group (Hamilton rating scale for depression, P = 0.002; Beck depression inventory, P = 0.006). For the sample analysed by modified intention to treat and last observation carried forward, the mean differences for the Hamilton and Beck scores between the two groups was highly significant (P = 0.007 and P = 0.012, respectively). CONCLUSIONS: The therapy was effective in alleviating symptoms of depression after two weeks of treatment. Animal facilitated therapy with dolphins is an effective treatment for mild to moderate depression, which is based on a holistic approach, through interaction with animals in nature.

Adolescent↗

PubMed2006

Neonatal respiratory distress syndrome after repeat exposure to antenatal corticosteroids: a randomised controlled trial.

BACKGROUND: The efficacy and safety of repeat doses of prenatal corticosteroids remains uncertain. Our aim was to establish whether repeat prenatal corticosteroids given to women at risk of preterm birth can reduce neonatal morbidity without harm. METHODS: In this hospital-based study, 982 women who remained at risk of preterm birth at less than 32 weeks' gestation, 7 or more days after receiving a first course of prenatal corticosteroids, were randomly assigned to receive a repeat intramuscular dose of either 11.4 mg betamethasone (as Celestone Chronodose), or saline placebo. This was repeated every week the woman remained undelivered, at less than 32 weeks' gestation, and at risk of preterm birth. Primary outcomes were occurrence and severity of neonatal respiratory distress syndrome, use and duration of oxygen and mechanical ventilation, and weight, length, and head circumference at birth and hospital discharge. Statistical analyses were on an intention to treat basis. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN48656428. FINDINGS: Fewer babies exposed to repeat corticosteroids had respiratory distress syndrome (33%vs 41%; relative risk 0.82, 95% CI 0.71-0.95, p=0.01) and fewer had severe lung disease (12%vs 20%; relative risk 0.60, 95% CI 0.46-0.79, p=0.0003) than those in the placebo group. In keeping with these benefits, babies exposed to repeat corticosteroids needed less oxygen therapy (p=0.03), and shorter duration of mechanical ventilation (p=0.01). Mean weight, length, and head circumference at birth and hospital discharge did not differ between treatment groups. Z-scores for weight (p=0.04) and head circumference (p=0.03) at birth were lower in the babies who received repeat corticosteroids although at the time of hospital discharge Z-scores did not differ between treatment groups (p=0.29 for weight, p=0.48 for head circumference). INTERPRETATION: Exposure to repeat doses of antenatal corticosteroids reduces neonatal morbidity. Pending long-term outcome results, the short-term benefits for the babies in our study support the use of repeat doses of corticosteroids in women who remain at risk of very preterm birth 7 or more days after an initial course.

Betamethasone↗

PubMed2006

Effectiveness and cost-effectiveness of a minimal psychological intervention to reduce non-severe depression in chronically ill elderly patients: the design of a randomised controlled trial [ISRCTN92331982].

BACKGROUND: Depression is a prevalent disorder in chronically ill elderly persons. It may decrease quality of life, and increase functional disability, medical costs, and healthcare utilisation. Because patients may slip into a downward spiral, early recognition and treatment of depression is important. Depression can be treated with antidepressants or psychological interventions; the latter can also be applied by trained paraprofessionals. In this paper, we describe the design of the DELTA study (Depression in Elderly with Long-Term Afflictions). The first objective of the DELTA study is to evaluate the effectiveness and cost-effectiveness of a minimal psychological intervention (MPI) to reduce depression in chronically ill elderly patients. The second objective is to evaluate whether a potential effect of the MPI may differ between types of chronic illnesses. The tailor-made intervention is administered by nurses, who are trained in the principles of cognitive behavioural therapy and self-management. METHODS/DESIGN: DELTA is a two-armed randomised controlled trial, comparing MPI to usual care. A total number of 180 patients with diabetes mellitus type II (DM) and 180 patients with chronic obstructive pulmonary disease (COPD), who in addition suffer from non-severe depression, will be included in the study. In our study, non-severe depression is defined as having minor depression, mild major depression or moderate major depression. The primary outcome measure is depression using the Beck Depression Inventory. Secondary outcome measures include quality of life, daily functioning, self-efficacy, autonomy, and participation. In the economic evaluation, cost-effectiveness and cost-utility ratios will be calculated. Furthermore, a process evaluation will be carried out. Analyses will include both univariate and multivariate techniques and according to the intention to treat principle. The economic evaluation will be done from a societal perspective and data of the process evaluation will be analysed using descriptive techniques. DISCUSSION: A total number of 361 patients has been included in the study. All interventions have been administered and follow-up data will be complete in September 2006. Preliminary results from the process evaluation indicate that patients' satisfaction with the intervention is high. If this intervention proves to be effective, implementation of the DELTA intervention is considered and anticipated.

Aged↗

PubMed2005

Improving management of hypertension in general practice: a randomised controlled trial of feedback derived from electronic patient data.

BACKGROUND: Although absolute risk of death associated with raised blood pressure increases with age, the benefits of treatment are greater in older patients. However, fewer patients in this group are identified, treated, and controlled. AIM: To evaluate the impact of the provision of different levels of feedback on identification, treatment, and control of older patients with hypertension. DESIGN OF STUDY: Randomised controlled trial. SETTING: Fifty-two Scottish general practices. METHOD: Practices were randomly allocated to either control (n = 19), audit only feedback (n = 16), or audit plus risk feedback, prioritising patients by absolute risk (n = 17). Electronic data were extracted from practice computer systems annually from 1999 to 2001 and used to develop feedback. Data were collected for 30 345 patients aged 65-79 years. RESULTS: The majority of known patients with hypertension in each group had an initial blood pressure recorded (control = 89.6%; audit = 80.4%; risk = 96.1%) and this increased over the study period (control = 92.3%; audit = 86.0%; risk = 96.6%). Initially, more than 80% of patients in each group were treated but many were uncontrolled (blood pressure >/=160/ >/=90 mmHg) (control = 41.5%; audit = 41.3%; risk = 36.1%). The numbers of untreated and uncontrolled patients in each group reduced (control = 32.3%; audit = 38.3%; risk = 32.6%). There was some evidence of a significant difference in mean systolic pressure between the audit plus risk and audit only groups: (149.6 versus 152.7 mmHg; P = 0.019) and of significantly greater control in the audit plus risk group compared with the other groups 49.4% (versus audit only = 35.4%; versus control = 46.5%; odds ratio = 1.72 [95% confidence interval = 1.09 to 2.70]; P = 0.019). CONCLUSIONS: Levels of identification, treatment, and control improved in each group. Although there were still significant numbers of patients with uncontrolled hypertension, there is some evidence to suggest that providing patient-specific feedback may have a positive impact on identification and management of hypertension in older people and produce an increase in control.

Aged↗

PubMed2006

Azathioprine dosed by thiopurine methyltransferase activity for moderate-to-severe atopic eczema: a double-blind, randomised controlled trial.

BACKGROUND: Atopic eczema affects 1-2% of adults, and can cause considerable morbidity. We aimed to assess the safety and efficacy of azathioprine as systemic monotherapy for moderate-to-severe atopic eczema, and the therapeutic importance of the thiopurine methyltransferase (TPMT) polymorphism (a key determinant of azathioprine-induced myelotoxicity) by using TPMT enzyme activity to establish azathioprine dose. METHODS: We did a parallel-group, double-blind, placebo-controlled trial in an outpatient setting. Minimisation was used to assign 63 patients with active disease despite optimum topical therapy to treatment with azathioprine (n=42) or placebo (n=21) for 12 weeks. As maintenance treatment, patients with heterozygous range TPMT activity received azathioprine 1.0 mg/kg daily, compared with 2.5 mg/kg daily in patients with normal TPMT activity. For the first 4 weeks, all participants received lower azathioprine doses (0.5 and 1.0 mg/kg daily, respectively) to reduce gastrointestinal side-effects. The primary measure of clinical response was disease activity assessed by the SASSAD (six area six sign atopic dermatitis) score. Analysis was by intention-to-treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN58943280. FINDINGS: 54 (86%) participants completed the study; two (3%) withdrew from the placebo group and seven (11%) from the azathioprine group. At week 12, there was a 37% (12.0 unit) improvement in mean disease activity with azathioprine compared with a 20% (6.6 unit) improvement with placebo (17% [5.4 unit] difference, 95% CI 4.3-29%). This finding was accompanied by significant improvements in patient-reported itch, area of involvement, global assessment, and quality of life. Between participants there was a wide variation in response to the drug. Generally, azathioprine was well tolerated, although two individuals developed drug hypersensitivity. Participants with heterozygous range TPMT activity responded to azathioprine in similar proportions to other participants, but none developed bone-marrow toxicity. TPMT-based dosing seemed to reduce predicted toxicity, and drug efficacy was maintained. INTERPRETATION: Treatment with azathioprine as systemic monotherapy produces clinically relevant improvement in moderate-to-severe atopic eczema that remains active despite optimum therapy with topical corticosteriods. We believe the study of azathioprine as systemic monotherapy for atopic eczema has major advantages, which should allow clarification of the relation between azathioprine effectiveness and metabolite profiles in other inflammatory diseases.

Adolescent↗

PubMed2006

Twenty-four hours or 10 days? A prospective randomised controlled trial in children comparing head bandages following pinnaplasty.

The perceived benefits of bandaging for 10 days following pinnaplasty have been questioned by previous studies. The problems arising from these dressings are many [Powell BWEM. The value of head dressings in the postoperative management of the prominent ear. Br J Plast Surg 1989;42:692-4. Bartley J. How long should ears be bandaged after otoplasty? J Laryngol Otol 1998;112:531-2. Wong MC, Sylaidis P. Head dressings for pinnaplasty: a tradition not supported by evidence. Br J Plast Surg 2001;54:81-2], including their slippage [Powell BWEM. The value of head dressings in the postoperative management of the prominent ear. Br J Plast Surg 1989;42:692-4. Bradbury ET, Hewison J, Timmons MJ. Psychological and social outcome of prominent ear correction in children. Br J Plast Surg 1992;45:97-100. Jeffery SLA. Complications following correction of prominent ears: an audit review of 122 cases. Br J Plast Surg 1999;52:588-90]. Eighty children were recruited into a prospective randomised controlled trial comparing the use of a head bandage for only 24 h with a standard practise of a 10-day head bandage. A preoperative measurement of the lateral ear projection (LEP) was made. The outcome measures recorded during the two planned postoperative visits at 10 days (visit 1) and 2 months (visit 2) were: patient satisfaction score, LEP, complications and any unscheduled hospital visits associated with the surgery. There was no significant difference in LEP and patient satisfaction between the two groups at both the scheduled postoperative visits. Differences between the groups in the number of unscheduled visits (p=0.21) did not reach statistical significance. The findings indicate that it is safe and effective to use head bandage for only 24 h following surgical correction of prominent ears. This study shows no benefit from the application of a formal head bandage for any longer than 1 day.

Adolescent↗

PubMed2003

Suicide prevention in first episode psychosis: the development of a randomised controlled trial of cognitive therapy for acutely suicidal patients with early psychosis.

BACKGROUND: Young people with early psychosis are at particularly high risk of suicide. However, there is evidence that early intervention can reduce this risk. Despite these advances, first episode psychosis patients attending these new services still remain at risk. To address this concern, a program called LifeSPAN was established within the Early Psychosis Prevention and Intervention Centre (EPPIC). The program developed and evaluated a number of suicide prevention strategies within EPPIC and included a cognitively oriented therapy (LifeSPAN therapy) for acutely suicidal patients with psychosis. We describe the development of these interventions in this paper. METHOD: Clinical audit and surveys provided an indication of the prevalence of suicidality among first episode psychosis patients attending EPPIC. Second, staff focus groups and surveys identified gaps in service provision for suicidal young people attending the service. Third, a suicide risk monitoring system was introduced to identify those at highest risk. Finally, patients so identified were referred to and offered LifeSPAN therapy whose effectiveness was evaluated in a randomised controlled trial. RESULTS: Fifty-six suicidal patients with first episode psychosis were randomly assigned to standard clinical care or standard care plus LifeSPAN therapy. Forty-two patients completed the intervention. Clinical ratings and measures of suicidality and risk were assessed before, immediately after the intervention, and 6 months later. Benefits were noted in the treatment group on indirect measures of suicidality, e.g., hopelessness. The treatment group showed a greater average improvement (though not significant) on a measure of suicide ideation. CONCLUSIONS: Early intervention in psychosis for young people reduces the risk of suicide. Augmenting early intervention with a suicide preventative therapy may further reduce this risk.

Acute Disease↗