A randomised controlled trial of a CBT intervention for anxiety in children with Asperger syndrome

Background: The aim of the study was to evaluate the effectiveness of a brief CBT intervention for anxiety with children diagnosed with Asperger syndrome (AS). A second interest was to evaluate whether more intensive parent involvement would increase the child's ability to manage anxiety outside of the clinic setting. Methods: Seventy-one children aged ten to twelve years were recruited to participate in the anxiety programme. All children were diagnosed with AS and the presence of anxiety symptoms was accepted on parent report via brief interview. Children were randomly assigned to one of three conditions: intervention for child only, intervention for child and parent, wait-list control. Results: The two intervention groups demonstrated significant decreases in parent-reported anxiety symptoms at follow-up and a significant increase in the child's ability to generate positive strategies in an anxiety-provoking situation. There were a number of significant differences between the two interventions to suggest parent involvement as beneficial. Conclusions: The sample of children with AS in this study presented with a profile of anxiety similar to a sample of clinically diagnosed anxious children. The intervention was endorsed by parents as a useful programme for children diagnosed with Asperger syndrome and exhibiting anxiety symptoms, and active parent involvement enhanced the usefulness of the programme. Limitations of the study and future research are discussed.

A programme of static positional stretches does not reduce hemiplegic shoulder pain or maintain shoulder range of motion - a randomized controlled trial

Objective: To evaluate the effectiveness of a programme of static positional stretches and positioning of the stroke-affected shoulder for maintaining shoulder external rotation and decreasing hemiplegic shoulder pain. Design: Randomized controlled trial with pretest and posttest design. Setting: Inpatient rehabilitation unit. Subjects: Thirty-two participants ( 17 treatment, 15 comparison) with a first time stroke who were admitted for rehabilitation. Interventions: Treatment participants completed a programme of static positional stretches of the stroke-affected shoulder twice daily and positioned the stroke-affected upper limb in an armrest support at all other times when seated. Main measures: The main outcome measures were pain-free range of motion into external rotation, pain in the stroke-affected shoulder at rest and with movement, motor recovery and functional independence. Results: All participants demonstrated a significant loss of external rotation ( P = 0.005) with no significant group differences. All participants demonstrated a significant improvement in motor recovery ( P < 0.01) and functional independence ( P < 0.01) with no significant group differences. There were no significant effects for pain. The comparison group recorded a decrease in mean pain reported with movement from admission to discharge, and the treatment group recorded an increase. Conclusions: Participation in the management programme did not result in improved outcomes. The results of this study do not support the application of the programme of static positional stretches to maintain range of motion in the shoulder. The effect of increasing pain for the treatment group requires further investigation.

Controlled trial of multidisciplinary care teams for acutely ill medical inpatients: enhanced multidisciplinary care

Background: Acute hospital general medicine services care for ageing complex patients, using the skills of a range of health-care providers. Evidence suggests that comprehensive early assessment and discharge planning may improve efficiency and outcomes of care in older medical patients. Aim: To enhance assessment, communication, care and discharge planning by restructuring consistent, patient-centred multidisciplinary teams in a general medicine service. Methods: Prospective controlled trial enrolling 1538 consecutive medical inpatients. Intervention units with additional allied health staff formed consistent multidisciplinary teams aligned with inpatient admitting units rather than wards; implemented improved communication processes for early information collection and sharing between disciplines; and specified shared explicit discharge goals. Control units continued traditional, referral-based multidisciplinary models with existing staffing levels. Results: Access to allied health services was significantly enhanced. There was a trend to reduced index length of stay in the intervention units (7.3 days vs 7.8 days in control units, P = 0.18), with no change in 6-month readmissions. in-hospital mortality was reduced from 6.4 to 3.9% (P = 0.03); less patients experienced functional decline in hospital (P = 0.04) and patients' ratings of health status improved (P = 0.02). Additional staffing costs were balanced by potential bed-day savings. Conclusion: This model of enhanced multidisciplinary inpatient care has provided sustainable efficiency gains for the hospital and improved patient outcomes.

A pragmatic 2 × 2 × 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care—methodology of the Palliative Care Trial [ISRCTN 81117481]

The demand for palliative care is increasing, yet there are few data on the best models of care nor well-validated interventions that translate current evidence into clinical practice. Supporting multidisciplinary patient-centered palliative care while successfully conducting a large clinical trial is a challenge. The Palliative Care Trial (PCT) is a pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial that tests the ability of educational outreach visiting and case conferencing to improve patient-based outcomes such as performance status and pain intensity. Four hundred sixty-one consenting patients and their general practitioners (GPs) were randomized to the following: (1) GP educational outreach visiting versus usual care, (2) Structured patient and caregiver educational outreach visiting versus usual care and (3) A coordinated palliative care model of case conferencing versus the standard model of palliative care in Adelaide, South Australia (3:1 randomization). Main outcome measures included patient functional status over time, pain intensity, and resource utilization. Participants were followed longitudinally until death or November 30, 2004. The interventions are aimed at translating current evidence into clinical practice and there was particular attention in the trial's design to addressing common pitfalls for clinical studies in palliative care. Given the need for evidence about optimal interventions and service delivery models that improve the care of people with life-limiting illness, the results of this rigorous, high quality clinical trial will inform practice. Initial results are expected in mid 2005. (c) 2005 Elsevier Inc. All rights reserved.

A randomized, controlled trial of massage therapy as a treatment for migraine

Background: Migraine is a distressing disorder that is often triggered by stress and poor sleep. Only one randomized controlled trial (RCT) has assessed the effects of massage therapy on migraine experiences, which yielded some promising findings. Purpose: An RCT was designed to replicate and extend the earlier findings using a larger sample, additional stress-related indicators, and assessments past the final session to identify longer-term effects of massage therapy on stress and migraine, experiences. Methods: Migraine sufferers (N = 47) who were randomly assigned to massage or control conditions completed daily assessments of migraine experiences and sleep patterns for 13 weeks. Massage participants attended weekly massage sessions during Weeks 5 to 10. State anxiety, heart rates, and salivary cortisol were assessed before and after the sessions. Perceived stress and coping efficacy were assessed at Weeks 4, 10, and 13. Results: Compared to control participants, massage participants exhibited greater improvements in migraine frequency and sleep quality during the intervention weeks and the 3 follow-up weeks. Trends for beneficial effects of massage therapy on perceived stress and coping efficacy were observed. During sessions, massage induced decreases in state anxiety, heart rate, and cortisol. Conclusions: The findings provide preliminary support for the utility of massage therapy as a nonpharmacologic treatment for individuals suffering from migraines.

CDP571, a humanized monoclonal antibody to tumour necrosis factor-alpha, for steroid-dependent Crohn's disease: a randomized, double-blind, placebo-controlled trial

Background More than 50% of patients with Crohn's disease become either steroid resistant or dependent. Accordingly, development of new treatments for steroid-dependent Crohn's disease is a research priority. Aim To evaluate CDP571, a humanized antibody to tumour necrosis factor-α, for the treatment of steroid-dependent Crohn's disease. Methods Patients with steroid-dependent Crohn's disease (n = 271) were enrolled in a 36-week, double-blind, placebo-controlled trial. Steroid dependence was defined as use of prednisolone or prednisone (15–40 mg/day) or budesonide (9 mg/day) for ≥8 weeks, a previous failed attempt to decrease or discontinue steroids within 8 weeks of screening, and a Crohn's Disease Activity Index score of ≤150 points. Patients were randomized to receive intravenous CDP571 10 mg/kg or placebo 8-weekly through to week 32. Steroids were then tapered using a defined schedule. The primary efficacy endpoint was the percentage of patients with steroid sparing, defined as discontinuation of steroid therapy without a disease flare (Crohn's Disease Activity Index score ≥220 points) at week 36. Results Steroid sparing occurred in 53 of 181 (29.3%) CDP571 patients and 33 of 90 (36.7%) placebo patients (P = 0.24). Adverse events occurred at similar frequencies in both treatment groups. Conclusions CDP571 was ineffective for sparing steroids in patients with steroid-dependent Crohn's disease. CDP571 was well tolerated.

Zinc and vitamin A supplementation in Indigenous Australian children hospitalised with lower respiratory tract infection: a randomised controlled trial

Objective: To evaluate the efficacy of supplementation with zinc and vitamin A in Indigenous children hospitalised with acute lower respiratory infection (ALRI). Design: Randomised controlled, 2-by-2 factorial trial of supplementation with zinc and vitamin A. Setting and participants: 187 Indigenous children aged < 11 years hospitalised with 215 ALRI episodes at Alice Springs Hospital (April 2001 to July 2002). Interventions: Vitamin A was administered on Days 1 and 5 of admission at a dose of 50 000 IU (infants under 12 months), or 100 000 IU; and zinc sulfate was administered daily for 5 days at a daily dose of 20 mg (infants under 12 months) or 40 mg. Main outcome measure: Time to clinical recovery from fever and tachypnoea, duration of hospitalisation, and readmission for ALRI within 120 days. Results: There was no clinical benefit of supplementation with vitamin A, zinc or the two combined, with no significant difference between zinc and no-zinc, vitamin A and no-vitamin A or zinc + vitamin A and placebo groups in time to resolution of fever or tachypnoea, or duration of hospitalisation. Instead, we found increased morbidity; children given zinc had increased risk of readmission for ALRI within 120 days (relative risk, 2.4; 95% CI, 1.003–6.1). Conclusion: This study does not support the use of vitamin A or zinc supplementation in the management of ALRI requiring hospitalisation in Indigenous children living in remote areas. Even in populations with high rates of ALRI and poor living conditions, vitamin A and zinc therapy may not be useful. The effect of supplementation may depend on the prevalence of deficiency of these micronutrients in the population.

Efficacy of speech pathology management for chronic cough: a randomised placebo controlled trial of treatment efficacy

Background: Chronic cough that persists despite medical treatment may respond to speech pathology intervention, but the efficacy of such treatment has not been investigated in prospective randomised trials. The aim of this study was to determine the efficacy of a speech pathology intervention programme for chronic cough. Methods: A single blind, randomised, placebo controlled trial was conducted in 87 patients with chronic cough that persisted despite medical treatment. Patients were randomly allocated to receive either a specifically designed speech pathology intervention or a placebo intervention. Participants in both groups attended four intervention sessions with a qualified speech pathologist. Results: Participants in the treatment group had a significant reduction in cough (8.9 to 4.6, p, 0.001), breathing (7.9 to 4.7, p < 0.001), voice (7.3 to 4.6, p < 0.001) upper airway (8.9 to 5.9, p < 0.001) symptom scores and limitation (2.3 to 1.6, p < 0.001) ratings following intervention. There was also a significant reduction in breathing (6.8 to 5.6, p=0.047), cough (7.6 to 6.3, p=0.014), and limitation ( 2.3 to 2.0, p=0.038) scores in the placebo group, but the degree of improvement was significantly less than in the treatment group (p < 0.01). Clinical judgement of outcome indicated successful ratings in 88% of participants in the treatment group compared with 14% in the placebo group ( p, 0.001). Conclusion: Speech pathology is an effective management intervention for chronic cough which may be a viable alternative for patients who do not respond to medical treatment.