Ruth Pickering

Effects of a clinical-practice guideline and practice-based education on detection and outcome of depression in primary care: Hampshire Depression Project randomised controlled trial.

BACKGROUND Depression is a major individual and public-health burden throughout the world and is managed mainly in primary care. The most effective strategy to reduce this burden has been believed to be education of primary-care practitioners. We tested this assumption by assessing the effectiveness of an educational programme based on a clinical-practice guideline in improving the recognition and outcome of primary-care depression. METHODS We carried out a randomised controlled trial in a representative sample of 60 primary-care practices (26% of the total) in an English health district. Education was delivered to practice teams and quality tested by feedback from participants and expert raters. The primary endpoints were recognition of depression, defined by the hospital anxiety and depression (HAD) scale, and clinical improvement. Analysis was by intention to treat. FINDINGS The education was well received by participants, 80% of whom thought it would change their management of patients with depression. 21409 patients were screened, of whom 4192 were classified as depressed by the HAD scale. The sensitivity of physicians to depressive symptoms was 39% in the intervention group and 36% in the control group after education (odds ratio 1.2 [95% CI 0.88-1.61]). The outcome of depressed patients as a whole at 6 weeks or 6 months after the assessment did not significantly improve. INTERPRETATION Although well received, this in-practice programme, which was designed to convey the current consensus on best practice for the care of depression, did not deliver improvements in recognition of or recovery from depression.

A meta-analysis of six prospective studies of falling in Parkinson's disease

Recurrent falls are a disabling feature of Parkinsons disease (PD). We have estimated the incidence of falling over a prospective 3 month follow‐up from a large sample size, identified predictors for falling for PD patients repeated this analysis for patients without prior falls, and examined the risk of falling with increasing disease severity. We pooled six prospective studies of falling in PD (n = 473), and examined the predictive power of variables that were common to most studies. The 3‐month fall rate was 46% (95% confidence interval: 38–54%). Interestingly, even among subjects without prior falls, this fall rate was 21% (12–35%). The best predictor of falling was two or more falls in the previous year (sensitivity 68%; specificity 81%). The risk of falling rose as UPDRS increased, to about a 60% chance of falling for UPDRS values 25 to 35, but remained at this level thereafter with a tendency to taper off towards later disease stages. These results confirm the high frequency of falling in PD, as almost 50% of patients fell during a short period of only 3 months. The strongest predictor of falling was prior falls in the preceding year, but even subjects without any prior falls had a considerable risk of sustaining future falls. Disease severity was not a good predictor of falls, possibly due to the complex U‐shaped relation with falls. Early identification of the very first fall therefore remains difficult, and new prediction methods must be developed.

A randomised controlled trial of a home based exercise programme to reduce the risk of falling among people with Parkinson’s disease

Objective: To evaluate the effectiveness of a personalised home programme of exercises and strategies for repeat fallers with Parkinson’s disease (PD). Method: Patients with a confirmed diagnosis of idiopathic PD, independently mobile, living at home in the community, experiencing more than one fall in the previous 12 months and with intact gross cognitive function were invited to participate in this randomised controlled trial. Usual care was compared with a personalised 6 week, home based exercise and strategy programme. The primary outcomes were rates of falling at 8 weeks and 6 months. Whether participants had repeat fallen, nearly fallen or experienced injurious falls were also examined. Functional Reach, the Berg Balance Test, PD Self-assessment Scale and the Euro Quol were rated by a blinded assessor. Results: Participants were randomised to the exercise (n = 70) and control (n = 72) groups. There was a consistent trend towards lower fall rates in the exercise group at both 8 weeks and 6 months and lower rates of injurious falls needing medical attention at 6 months. Lower rates of repeat near falling were evident for the exercise group at 8 weeks (p = 0.004) and 6 months (p = 0.007). There was a positive effect of exercises at 6 months on Functional Reach (p = 0.009) and quality of life (p = 0.033). No significant differences were found on other secondary outcomes measures. Conclusion: There was a trend towards a reduction in fall events and injurious falls with a positive effect of exercises on near falls and quality of life.

Predicting Fallers in a Community-Based Sample of People with Parkinson’s Disease

Background: The risk of people with Parkinson’s disease (PD) falling is greater than that of the general population but to date, disease-specific predictors of falling have not been identified. Objectives: To identify one or more features, which would predict individuals at risk of falling during a 3-month prospective follow-up study. Method: A battery of standardised tests administered in the home and the laboratory with a 3-month follow-up telephone interview. Results: Sixty-three people with PD were recruited from GP practices. Eleven interview variables and six gait laboratory variables were used with subsamples (55 and 44 subjects, respectively) to fit predictive models for identifying future fallers. The number of falls in the previous year was the most important variable, without exception, to be selected as a predictor in various logistic regression models. A history of two or more falls had a sensitivity of 86.4% (95% CI 67.3–96.2%) and a specificity of 85.7% (95% CI 71.2–94.2%) in predicting falling in the next 3 months. Conclusion: Healthcare workers should be asking their patients with PD regularly and carefully about falling, and should consider instigating programmes of fall management for patients with PD who have fallen two or more times in the previous 12 months.

Predicting people with stroke at risk of falls

BACKGROUND falls are common following a stroke, but knowledge about predicting future fallers is lacking. OBJECTIVE to identify, at discharge from hospital, those who are most at risk of repeated falls. METHODS consecutively hospitalised people with stroke (independently mobile prior to stroke and with intact gross cognitive function) were recruited. Subjects completed a battery of tests (balance, function, mood and attention) within 2 weeks of leaving hospital and at 12 months post hospital discharge. RESULTS 122 participants (mean age 70.2 years) were recruited. Fall status at 12 months was available for 115 participants and of those, 63 [55%; 95% confidence interval (CI) 46-64] experienced one or more falls, 48 (42%; 95% CI 33-51) experienced repeated falls, and 62 (54%) experienced near-falls. All variables available at discharge were screened as potential predictors of falling. Six variables emerged [near-falling in hospital, Rivermead leg and trunk score, Rivermead upper limb score, Berg Balance score, mean functional reach, and the Nottingham extended activities of daily living (NEADL) score]. A score of near-falls in hospital and upper limb function was the best predictor with 70% specificity and 60% sensitivity. CONCLUSION participants who were unstable (near-falls) in hospital with poor upper limb function (unable to save themselves) were most at risk of falls.

Randomised controlled trial of labouring in water compared with standard of augmentation for management of dystocia in first stage of labour

Abstract Objectives To evaluate the impact of labouring in water during first stage of labour on rates of epidural analgesia and operative delivery in nulliparous women with dystocia. Design Randomised controlled trial. Setting University teaching hospital in southern England. Participants 99 nulliparous women with dystocia (cervical dilation rate < 1 cm/hour in active labour) at low risk of complications. Interventions Immersion in water in birth pool or standard augmentation for dystocia (amniotomy and intravenous oxytocin). Main outcome measures Primary: epidural analgesia and operative delivery rates. Secondary: augmentation rates with amniotomy and oxytocin, length of labour, maternal and neonatal morbidity including infections, maternal pain score, and maternal satisfaction with care. Results Women randomised to immersion in water had a lower rate of epidural analgesia than women allocated to augmentation (47% v 66%, relative risk 0.71 (95% confidence interval 0.49 to 1.01), number needed to treat for benefit (NNT) 5). They showed no difference in rates of operative delivery (49% v 50%, 0.98 (0.65 to 1.47), NNT 98), but significantly fewer received augmentation (71% v 96%, 0.74 (0.59 to 0.88), NNT 4) or any form of obstetric intervention (amniotomy, oxytocin, epidural, or operative delivery) (80% v 98%, 0.81 (0.67 to 0.92), NNT 5). More neonates of women in the water group were admitted to the neonatal unit (6 v 0, P = 0.013), but there was no difference in Apgar score, infection rates, or umbilical cord pH. Conclusions Labouring in water under midwifery care may be an option for slow progress in labour, reducing the need for obstetric intervention, and offering an alternative pain management strategy.

PHASE II TRIAL TO EVALUATE THE ACTIGAIT IMPLANTED DROP-FOOT STIMULATOR IN ESTABLISHED HEMIPLEGIA

OBJECTIVE To evaluate a selective implantable drop foot stimulator (ActiGait) in terms of effect on walking and safety. DESIGN A phase II trial in which a consecutive sample of participants acted as their own controls. SUBJECTS People who had suffered a stroke at least 6 months prior to recruitment and had a drop-foot that affected walking were recruited from 3 rehabilitation centres in Denmark. METHODS Stimulators were implanted into all participants. Outcome measures were range of ankle dorsiflexion with stimulation and maximum walking speed and distance walked in 4 minutes. Measurements were applied before implantation, at 90 days and at a long-term follow-up assessment. Changes over time and with and without stimulation are reported. Safety was evaluated by nerve conduction velocity and adverse events. RESULTS Fifteen participants were implanted and 13 completed the trial. Long-term improvements were detected in walking speed and distance walked in 4 minutes when stimulated, and the orthotic effect of stimulation showed statistically significant improvement. The device did not compromise nerve conduction velocity and no serious device-related adverse events were reported. Technical problems were resolved by the long-term follow-up assessment at which further improvement in walking was observed. CONCLUSION This trial has evaluated the safety and performance of the device, which was well accepted by patients and did not compromise safety.

Mechanical methods of reducing blood transfusion in cardiac surgery: randomised controlled trial

Abstract Objective: To assess the effectiveness of two mechanical methods of blood conservation in reducing the need for allogeneic red blood cells or coagulation products during cardiac surgery. Design: Randomised controlled trial. Setting: Regional cardiac centre in a teaching hospital in Southampton. Participants: 263 adults aged 18-80 years undergoing elective coronary artery bypass surgery entered the study, of whom 252 completed the trial. All patients received routine perioperative care. Patients were allocated to one of three treatment groups: intraoperative cell salvage, intraoperative cell salvage with acute perioperative normovolaemic haemodilution, or no mechanical blood conservation. There were 84 patients in each group. Main outcome measures: Numbers of patients who received allogeneic blood or coagulation products, and the mean number of units of blood transfused per patient. Results: Of the patients in the intraoperative cell salvage group, 26 were given a transfusion of allogeneic blood, compared with 43 in the control group (odds ratio 0.43 (95% confidence interval 0.23 to 0.80)). The mean number of units of allogeneic blood transfused per patient in the intraoperative cell salvage group was 0.68 units (SD=1.55), compared with 1.07 (1.56) units in the control group. 32 of the patients in the intraoperative cell salvage group were given any blood product, compared with 47 in the control group (odds ratio 0.47 (0.25 to 0.89); P=0.019). Combining acute perioperative normovolaemic haemodilution with intraoperative cell salvage conferred no additional benefits. Conclusions: An intraoperative cell salvage device should be used in elective coronary artery bypass grafting. Pharmacological strategies may achieve further reductions in blood transfusions. Yet further reductions in blood transfusions could be achieved if the lower safe limit of haemoglobin concentration in patients undergoing cardiac surgery were known.

Questions asked and answered in pilot and feasibility randomized controlled trials

BackgroundIn the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials.MethodsA search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that met our search criteria. A random sample of 50 was selected for detailed review.ResultsMost of the papers focused on efficacy: those reporting drug trials additionally addressed safety/toxicity; while those reporting non-drug trials additionally addressed methodological issues. In only 56% (95% confidence intervals 41% to 70%) were methodological issues discussed in substantial depth, 18% (95% confidence interval 9% to 30%) discussed future trials and only 12% (95% confidence interval 5% to 24%) of authors were actually conducting one.ConclusionsDespite recent advice on topics that can appropriately be described as pilot or feasibility studies the large majority of recently published papers where authors have described their trial as a pilot or addressing feasibility do not primarily address methodological issues preparatory to planning a subsequent study, and this is particularly so for papers reporting drug trials. Many journals remain willing to accept the pilot/feasibility designation for a trial, possibly as an indication of inconclusive results or lack of adequate sample size.

Mobility and dementia: is physiotherapy treatment during respite care effective?

Mobility problems experienced by elderly people with a dementia are associated with falls, fractures and admission to long‐term care. A hospital respite care admission is therefore often seen as an opportunity to provide physiotherapy treatment.