SEARCH · PubMed Health

Results for “Randomised Controlled Trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 1,333 records · Page 74Linked to original sources

PubMed2002

Randomised controlled trial of early detection and cognitive therapy for preventing transition to psychosis in high-risk individuals. Study design and interim analysis of transition rate and psychological risk factors.

BACKGROUND: There is interest in the possibility of indicated prevention of psychosis. There is a strong case for using psychological approaches to prevent transition to psychosis in high-risk patients. AIMS: To identify individuals at high risk of transition to psychosis, and psychological characteristics relevant to the development of psychosis in this group. METHOD: The design of a randomised controlled trial of cognitive therapy for the prevention of psychosis in people at high risk (meeting operational criteria of brief or attenuated psychotic symptoms, or first-degree family history with functional decline) is outlined. The first patients recruited are compared with non-patient samples on cognitive and personality factors; an interim analysis of transition rate is reported. RESULTS: Cases (n = 31) were recruited mainly from primary care. Of the 23 high-risk patients monitored for 6-12 months, 5 (22%) made the transition to psychosis. The high-risk group scored significantly higher than non-patients on measures of schizotypy, metacognitive beliefs and dysfunctional self-schemas (sociotropy). CONCLUSIONS: The findings validate the methods of identifying individuals at high risk of experiencing a psychotic episode. Compared with non-patient controls, the cases showed dysfunctional metacognitive beliefs and self-schemas.

Adult↗

PubMed2004

Examining within-country variation of maternity costs in the context of a multicountry, multicentre randomised controlled trial.

Understanding why healthcare costs vary between patients and between health facilities is important in guiding health policy decisions as well as in research. However, there is no comprehensive framework that analysts commonly use for expressing and examining causes of cost variation in the field of healthcare. The aim of this study is to better understand the size and causes of within-country healthcare cost variation, through presenting evidence for size and sources of such variations for two countries (Cuba and Thailand) in the context of a randomised controlled trial on antenatal care. The article separates total costs into their two components: unit costs and health service use. Unit costs are further separated into input quantity per patient visit or day, and the prices of these resources. The results show that the main determinant of average cost is the staffing pattern and productivity, whereas the main determinants of health service use include the model of antenatal care being practised and the risk status and illnesses suffered by patients. However, variations in inpatient health service use between facilities are largely related to unexplainable variations in practice between facilities, irrespective of the trial arm. In conclusion, cost variations have important implications for the design of clinical trials and for policy makers using evidence from trials in planning health services and budgets.

Ambulatory Care↗

PubMed2001

Randomised controlled trial of tailored strategies to implement guidelines for the management of patients with depression in general practice.

BACKGROUND: Various methods are available for implementing change in the clinical behaviour of general practitioners (GPs). Although passive dissemination of information is generally ineffective, other methods can be variably effective. Few studies have investigated the impact of tailored methods. AIM: To determine whether methods tailored to overcome obstacles to change using psychological theories are more effective than dissemination alone in the implementation of guidelines for depression among GPs. DESIGN OF STUDY: Randomised controlled trial. SETTING: Sixty general practices in England; 30 GPs in the control group, 34 in the intervention group. METHOD: Practitioners identified patients presenting with depression before and after the implementation of guidelines (control group n = 192 in the first data collection, n = 181 in the second; intervention group n = 210 in the first data collection and n = 197 in the second). The main outcome measures were: record of adherence to guideline recommendations in clinical records; proportion of patients with Beck Depression Inventory (BDI) score less than 11 at 16 weeks after diagnosis. RESULTS: In comparison with the control group, in the group of GPs receiving tailored implementation, there were increases in the proportions of patients assessed for suicide risk. In the intervention group, the proportion of patients with BDI scores of less than 11 at 16 weeks increased. CONCLUSION: Obstacles to implementation can be identified and strategies tailored to address them. The findings indicate a new approach for research to understand and develop methods of implementation.

Depressive Disorder↗

PubMed2002

Boosting uptake of influenza immunisation: a randomised controlled trial of telephone appointing in general practice.

BACKGROUND: Immunisation against influenza is an effective intervention that reduces serologically confirmed cases by between 60% and 70%. Almost all influenza immunisation in the UK is done within general practice. Current evidence on the effectiveness of patient reminders for all types of immunisation programmes is largely based on North American studies. AIM: To determine whether telephone appointments offered bygeneral practice receptionists increase the uptake of irfluenza immunisation among the registered population aged over 65 years in east London practices. DESIGN OF STUDY: Randomised controlled trial. SETTING: Three research general practices within the East London and Essex network of researchers (ELENoR). METHOD: Participants were 1,820 low-risk patients aged 65 to 74 years who had not previously been in a recall system for influenza immunisation at their general practice. The intervention, during October 2000, was a telephone call from the practice receptionist to intervention group households, offering an appointment for influenza immunisation at a nurse-run. clinic Main outcome measures were the numbers of individuals in each group receiving immunisation, and practice costs of a telephone-appointing programme. RESULTS: intention to treat analysis showed an immunisation rate in the control group of 44%, compared with 50% in the intervention group (odds ratio = 1.29, 95% confidence interval = 1.03 to 1.63). Of the patients making a telephone appointment, 88% recieved immunisation, while 22% of those not wanting an appointment went on to be immunised. In the controlgroup, income generated was 11.35 pounds per immunisation, for each additional immunisation in the intervention group the income was 5.20 pounds. The 'number needed to telephone' was 17. CONCLUSION: Uptake of influenza immunisation among the low-risk older population in inner-city areas can be boosted by around 6% using a simple intervention by receptionists. Immunisation rates in this low-risk group fell well short of the 60% government target. Improving immunisation rates will require a sustained public health campaign. Retaining the item-of-service payments to practices should support costs of practice-based interventions.

Aged↗

PubMed2004

Is influenza vaccination cost effective for healthy people between ages 65 and 74 years? A randomised controlled trial.

The aim of this study was to determine the cost effectiveness of influenza vaccination for healthy people aged 65-74 years living in the UK. People without risk factors for influenza (chronic heart, lung or renal disease, diabetic, immunosuppressed or those living in an institution) were identified from 20 general practitioner (GP) practices in Liverpool in September 1999. 729/5875 (12.4%) eligible individuals were recruited and randomised to receive either influenza vaccine or placebo (ratio 3:1), with all participants receiving 23-valent-pneumococcal polysaccharide vaccine unless already administered. The primary analysis was the frequency of influenza as recorded by a GP diagnosis of pneumonia or influenza like illness. In 2000, the UK vaccination policy was changed with influenza vaccine becoming available for all people aged 65 years and over irrespective of risk. As a consequence of this policy change, the study had to be fundamentally restructured and only results obtained over a one rather than the originally planned two-year randomised controlled trial framework were used. Results from 1999/2000 demonstrated no significant difference between groups for the primary outcome (relative risk 0.8, 95% CI 0.16-4.1). In addition, there were no deaths or hospitalisations for influenza associated respiratory illness in either group. The subsequent analysis, using both national and local sources of evidence, estimated the following cost effectiveness indicators: (1) incremental NHS cost per GP consultation avoided = 2000 pound sterling; (2) incremental NHS cost per hospital admission avoided = 61,000 pound sterling; (3) incremental NHS cost per death avoided = 1,900,000 pound sterling and (4) incremental NHS cost per QALY gained = 304,000 pound sterling. The analysis suggested that influenza vaccination in this population would not be cost effective.

Aged↗

PubMed2026

The efficacy of modified psychodynamic psychotherapy for patients with schizophrenia-spectrum disorders in Germany: a prospective, single-centre, assessor-blinded, parallel-group, randomised controlled trial.

BACKGROUND: People with schizophrenia-spectrum disorders have difficulties in interpersonal functioning that remain insufficiently addressed by standard care. Despite long-standing clinical use, psychodynamic psychotherapy has little empirical support compared with other psychosocial treatments for people with schizophrenia-spectrum disorders. We evaluated the efficacy of Modified Psychodynamic Psychotherapy for Schizophrenia (MPP-S), a manualised treatment tailored to the interpersonal vulnerability characteristic of this population, plus treatment as usual (TAU), compared with TAU alone. METHODS: This prospective, single-centre, assessor-blinded, parallel-group, randomised controlled trial was conducted at the Psychiatric University Hospital of the Charité at St Hedwig Hospital in Berlin, Germany. Participants were outpatients aged 18-64 years who were diagnosed with schizophrenia or schizoaffective disorder and exclusion criteria included organic brain disorder, somatic illness affecting cerebral function, and current or past alcohol or illicit drug misuse requiring addiction-specific treatment. Participants were randomly assigned 1:1 in blocks of ten to MPP-S (minimum 30 sessions) plus TAU or TAU alone. Outcome assessors were masked, but participants and therapists were not. The primary outcome was psychosocial functioning, measured using the Mini International Classification of Functioning, Disability and Health Rating for Limitations of Activities and Participation in Psychological Disorders (Mini-ICF-APP) and evaluated at baseline and prespecified post-treatment (24 months) and follow-up (36 months) assessments. Analyses followed the intention-to-treat principle. Linear mixed models were used to analyse incomplete longitudinal data under a missing-at-random assumption. People with lived experience were not formally involved in the design, conduct, or reporting of this study. This trial was preregistered at ClinicalTrials.gov (NCT02576613) and is complete. FINDINGS: From Oct 12, 2015, to Dec 7, 2021, 130 participants (57 [44%] female and 73 [56%] male) were randomly assigned to either MPP-S plus TAU (n=65) or TAU alone (n=64). One participant withdrew consent to data analysis. Regarding the primary outcome of psychosocial functioning, linear mixed models showed significant group-by-time interactions favouring the intervention: estimated marginal means indicated adjusted between-group differences in Mini-ICF-APP scores of -3·45 (95% CI -5·51 to -1·40; p=0·0011) at 24 months and -4·07 (-6·19 to -1·94; p=0·0002) at 36 months. The frequency of adverse events was similar between groups. There were three serious adverse events: two participants died by suicide (one in the MPP-S plus TAU group who did not start psychotherapy and one in the TAU alone group) and one participant in the MPP-S plus TAU group was admitted to a forensic hospital. INTERPRETATION: MPP-S added to TAU could improve psychosocial functioning compared with TAU alone. Our findings suggest efficacy and possible long-term benefits of psychodynamic psychotherapy for schizophrenia-spectrum disorders and indicate its potential role alongside other psychotherapeutic and psychosocial treatments. FUNDING: Berlin Institute of Health, Deutsche Gesellschaft für Psychoanalyse, Psychotherapie, Psychosomatik und Tiefenpsychologie, International Psychoanalytic University Berlin, and Köhler-Stiftung.

Humans↗

PubMed2005

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 people aged 65 and over. The SAFE study.

OBJECTIVES: To determine the most cost-effective method of screening for atrial fibrillation (AF) in the population aged 65 years and over, as well as its prevalence and incidence in this age group. Also to evaluate the relative cost-effectiveness of different methods of recording and interpreting the electrocardiogram (ECG) within a screening programme. DESIGN: Multicentred randomised controlled trial. Purposefully selected general practices were randomly allocated to 25 intervention practices and 25 control practices. SETTING: Fifty primary care centres across the West Midlands, UK. PARTICIPANTS: Patients aged 65 years and over. INTERVENTIONS: GPs and practice nurses in 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 targeted screening of people at higher risk of AF and total population screening. MAIN OUTCOME MEASURES: AF detection rates in systematically screened and opportunistically screened populations in the intervention practices were compared with AF detection rate in 5000 patients in the control practices. The screening period was 12 months. RESULTS: Baseline prevalence of AF was 7.2%, with a higher prevalence in males (7.8%) and patients aged 75 years and over (10.3%). The control population demonstrated higher baseline prevalence (7.9%) than either the systematic (6.9%) or opportunistic (6.9%) intervention population. In the control population 47 new cases were detected (incidence 1.04% per year). In the opportunistic arm 243 patients without a baseline diagnosis of AF were found to have an irregular pulse, with 177 having an ECG, yielding 31 new cases (incidence 0.69% per year). A further 44 cases were detected outside the screening programme (overall incidence 1.64% per year). In the systematic arm 2357 patients had an ECG yielding 52 new cases (incidence 1.1% per year). Of these, 31 were detected by targeted screening and a further 21 by total population screening. A further 22 cases were detected outside the screening programme (overall incidence 1.62% per year). In terms of ECG interpretation, computerised decision support software (CDSS) gave a sensitivity of 87.3%, a specificity of 99.1% and a positive predictive value (PPV) of 89.5% compared with the gold standard (cardiologist reporting). GPs and practice nurses performed less well. The only difference in performance between intervention populations and controls was that practice nurses from the control arm performed less well than with intervention practice nurses on interpretation of limb-lead (PPV 38.8% versus 20.8%) and single-lead (PPV 37.7% versus 24.0%) ECGs. The within-trial economic evaluation results showed the lowest incremental cost to be for the opportunistic arm, with an incremental cost-effectiveness ratio of 337 pounds Sterling for each additional case detected compared to the control arm. Opportunistic screening dominated both more intensive screening strategies. Model-based analyses showed small differences in cost and quality-adjusted life-years for different methods and intensities of screening, but annual opportunistic screening resulted in the lowest number of ischaemic strokes and greatest proportion of cases of AF diagnosed. Probabilistic sensitivity results indicated that there was a probability of approximately 60% that screening from the age of 65 years was cost-effective in both men and women. CONCLUSIONS: The results of the study indicated that in terms of a screening programme for atrial fibrillation in patients 65 and over, the only strategy that improved on routine practice was opportunistic screening, model-based analyses indicated that there was a probability of approximately 60% of annual opportunistic screening being cost effective. It is suggested that the following topics are worthy of further investigation: the effect of the implementation of a screening programme for AF on the uptake and maintenance of anticoagulation in patients aged 65 years and over; an evaluation of the role of CDSS in the diagnosis of cardiac arrythmias; the best method for routinely detecting paroxysmal AF; ways of improving healthcare professionals' performance in ECG interpretation; development of a robust economic model to incorporate data on new therapeutic agents for use as thromboprophylactic agents for patients with AF, and an evaluation of the relative risk of stroke for patients with incident as opposed to prevalent AF.

Aged↗

PubMed2005

Reducing blood loss at open myomectomy using triple tourniquets: a randomised controlled trial.

OBJECTIVES: To evaluate triple tourniquets in controlled conditions and for the first time to investigate the hypothesis that leaving a semi-permanent tourniquet around the uterine artery reduces post-operative bleeding from the uterine incisions. DESIGN: A randomised controlled trial. SETTING: Two University teaching hospitals. POPULATION: Twenty-eight patients with symptomatic fibroids and uterine sizes ranging from 14 to 24 weeks of gestation undergoing open myomectomy. METHODS: A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels. At the end of the procedure, the ovarian ties were released but the uterine artery suture remained in situ. MAIN OUTCOME MEASURES: Intra-operative blood loss, post-operative blood loss, blood transfusion rates, operative morbidity, uterine blood flow and ovarian function. RESULTS: There was significantly less blood lost in the tourniquet group than in the control group (difference between means 1870 mL, 95% CI 1159-2580 mL, P < 0.0001; transfusion rates of 7% and 79%, P= 0.0003). The volume in the pelvic drain 20 min post-operatively and after 48 hours failed to reach statistical significance between the two groups (P= 0.10 and P= 0.165). There were no differences in uterine artery Doppler resistance indices at five days (P= 0.54), six weeks (P= 0.47), three months (P= 0.49) and at six months (P= 0.18). Day two serum FSH concentrations after surgery were unchanged (P= 0.45), compared with baseline values. CONCLUSIONS: Triple tourniquets are effective in reducing bleeding and transfusion rates. There appears no obvious adverse effect on uterine perfusion or ovarian function.

Adult↗

PubMed2001

Randomised controlled trial of training health visitors to identify and help couples with relationship problems following a birth.

BACKGROUND: Stresses imposed by parenthood can provoke or intensify relationship problems between parents. These problems, which are often associated with postnatal depression, can have serious consequences for family well-being but are often not revealed to primary health care personnel. AIM: To evaluate a means of extending the primary health care team's ability to identify and respond to relationship problems of mothers and their partners in the postnatal period. DESIGN OF STUDY: Cluster randomised controlled trial. SETTING: Specially trained health visitors in nine 'intervention' clinics--each matched with a 'control' clinic' in an outer London borough. METHOD: Health visitors in intervention clinics invited mothers attending for the six-to-eight-week developmental check to complete a screening scale for relationship problems, and offered help (supportive listening, advice, or referral) if needed. When visiting the clinic for the 12-week immunizations, mothers from all clinics were asked to complete a follow-up self-report questionnaire. After the completion of the trial, 25 women who had attended the intervention clinics and had been offered support with a relationship problem were interviewed to elicit their views on the acceptability and value of the intervention. All 25 of the health visitors engaged in the intervention were asked to complete a questionnaire on their experience. RESULTS: Screening led to striking differences between intervention and control clinics in the percentage of women identified at the six-to-eight-week check as potentially in need of help with a relationship problem (21% versus 5%, P = 0.007) and in the percentage actually offered help (18% versus 3%, P = 0.014). About one-half of the mothers so identified were also identified as having postnatal depression. At the 12-week visit for immunizations, the intervention group was twice as likely (P = 0.006) as the control group to report having discussed relationship problems with the health visitor and 75% more likely (P = 0.046) to report having received help with a problem. CONCLUSION: The intervention offers a useful way of extending the primary health care team's ability to respond to problems that often have serious consequences for family well-being.

Adolescent↗

PubMed2003

Psychological treatment for insomnia in the management of long-term hypnotic drug use: a pragmatic randomised controlled trial.

OBJECTIVE: To evaluate the clinical and cost impact of providing cognitive behaviour therapy (CBT) for insomnia (comprising sleep hygiene, stimulus control, relaxation and cognitive therapy components) to long-term hypnotic drug users in general practice. DESIGN: A pragmatic randomised controlled trial with two treatment arms (a CBT treated 'sleep clinic' group, and a 'no additional treatment' control group), with post-treatment assessments commencing at 3 and 6 months. SETTING: Twenty-three general practices in Sheffield, UK. PARTICIPANTS: Two hundred and nine serially referred patients aged 31-92 years with chronic sleep problems who had been using hypnotic drugs for at least 1 month (mean duration = 13.4 years). RESULTS: At 3- and 6-month follow-ups patients treated with CBT reported significant reductions in sleep latency, significant improvements in sleep efficiency, and significant reductions in the frequency of hypnotic drug use (all P<0.01). Among CBT treated patients SF-36 scores showed significant improvements in vitality at 3 months (P<0.01). Older age presented no barrier to successful treatment outcomes. The total cost of service provision was 154.40 per patient, with a mean incremental cost per quality-adjusted life-year of 3416 (at 6 months). However, there was evidence of longer term cost offsets owing to reductions in sleeping tablet use and reduced utilisation of primary care services. CONCLUSIONS: In routine general practice settings, psychological treatments for insomnia can improve sleep quality and reduce hypnotic consumption at a favourable cost among long-term hypnotic users with chronic sleep difficulties.

Adult↗

PubMed2002

Health related quality of life assessment methodology and reported outcomes in randomised controlled trials of primary brain cancer patients.

Over the last 20 years, the assessment of quality of life (QOL) has become an important endpoint in cancer clinical trials, helping us to understand patient survival and QOL experiences and aiding clinicians in providing the best possible treatment and care, with the least toxicity and ill-effects. In primary brain cancer, these are critical issues. Survival is often limited and treatment difficult to tolerate. In recent years, some authors have questioned the methodological quality of the investigations and the reporting of QOL assessments from randomised controlled trials (RCTs), of cancer patients yet this assessment has never specifically focused on brain cancer. This paper therefore reports a systematic review of the research methodology and QOL assessment reporting in brain cancer patients in RCTs. The search was mainly performed on the following databases: Medline, Cancerlit and the Cochrane Controlled Trials Register. We identified only five RCTs, enrolling a total of 1026 patients. In many of these studies, we had identified methodological limitations which would hinder the interpretation of the results. These included a lack of detailed reporting regarding missing data, use of poorly validated tools, and general limitations regarding the presentation and interpretation of the results. Based on the results of our review, we make recommendations for future investigations to avoid these shortcomings.

Brain Neoplasms↗

PubMed2007

Protocol for the THREAD (THREshold for AntiDepressants) study: a randomised controlled trial to determine the clinical and cost-effectiveness of antidepressants plus supportive care, versus supportive care alone, for mild to moderate depression in UK general practice.

BACKGROUND: Depression guidelines in the UK recommended a policy of watchful waiting for mild depression due to a lack of evidence for the effectiveness of antidepressant treatment for mild cases. However there has been relatively little research carried out in primary care to help establish the severity threshold at which antidepressant treatment is effective and cost-effective. METHODS/DESIGN: The THREAD (THREshold for AntiDepressants) study is a multi-centre randomised controlled trial designed to determine the clinical and cost effectiveness of a selective serotonin reuptake inhibitor (SSRI) plus general practitioner (GP) supportive care, versus supportive care alone, for mild to moderate depression in primary care. The aim is to recruit 300 patients from three centres (Southampton, London and Liverpool). Depressive symptoms will be assessed at baseline, 12 weeks and 26 weeks, using the 17-item Hamilton Depression Rating Scale (HDRS). Two severity sub-groups of patients will be recruited, with HDRS scores of 12-15, and 16-19. Possible predictors of response will be explored including life events and difficulties and alcohol consumption. Analysis of covariance, controlling for baseline value, severity group and centre will be used to estimate the overall treatment effectiveness (difference in HDRS score) at final follow up. The primary analysis will be by 'intention to treat' using double sided tests. The interaction between severity sub-group and treatment will be tested, and if appropriate, effects within separate severity sub-groups estimated. The economic analysis will compare the two treatment groups in terms of mean costs and cost-effectiveness. DISCUSSION: The results of this study will give GPs important information to help them determine the severity of depression at which antidepressant treatment is likely to be cost-effective.

Antidepressive Agents↗

PubMedDate not supplied

Blood-pressure control for renoprotection in patients with non-diabetic chronic renal disease (REIN-2): multicentre, randomised controlled trial.

BACKGROUND: In chronic nephropathies, inhibition of angiotensin-converting enzyme (ACE) is renoprotective, but can further renoprotection be achieved by reduction of blood pressure to lower than usual targets? We aimed to assess the effect of intensified versus conventional blood-pressure control on progression to end-stage renal disease. METHODS: We undertook a multicentre, randomised controlled trial of patients with non-diabetic proteinuric nephropathies receiving background treatment with the ACE inhibitor ramipril (2.5-5 mg/day). We randomly assigned participants either conventional (diastolic <90 mm Hg; n=169) or intensified (systolic/diastolic <130/80 mm Hg; n=169) blood-pressure control. To achieve the intensified blood-pressure level, patients received add-on therapy with the dihydropyridine calcium-channel blocker felodipine (5-10 mg/day). The primary outcome measure was time to end-stage renal disease over 36 months' follow-up, and analysis was by intention to treat. FINDINGS: Of 338 patients who were randomised, three (two assigned intensified and one allocated conventional blood-pressure control) never took study drugs and they were excluded. Over a median follow-up of 19 months (IQR 12-35), 38/167 (23%) patients assigned to intensified blood-pressure control and 34/168 (20%) allocated conventional control progressed to end-stage renal disease (hazard ratio 1.00 [95% CI 0.61-1.64]; p=0.99). INTERPRETATION: In patients with non-diabetic proteinuric nephropathies receiving background ACE-inhibitor therapy, no additional benefit from further blood-pressure reduction by felodipine could be shown.

Adolescent↗

PubMed2003

A randomised controlled trial comparing the use of manual versus mechanical compression to obtain haemostasis following coronary angiography.

Cardiac interventions have become a commonly accepted treatment option for patients with coronary heart disease. Managing the arterial puncture site and femoral sheath removal is an important aspect of cardiac nursing practice for patients who have had cardiac diagnostic and interventional procedures. The purpose of this study was to compare the use of manual compression with a mechanical compression device in achieving haemostasis after femoral sheath removal in coronary angiography patients and to determine the ability of these two techniques to reduce groin complications. A randomised controlled trial comparing two compression protocols (manual and QuicKlamp) was undertaken on a sample of 100 patients scheduled to have coronary angiography. Descriptive statistics were used to analyse and describe the data. Inter-group comparisons were analysed using either Chi-squared analysis for nominal data, or the Mann-Whitney U-test for continuous variables. The results indicated that the QuicKlamp device took longer to effect haemostasis after femoral sheath removal (P=0.000) and subjects took longer to mobilise than after manual compression (P=0.001). More haematomas occurred following manual compression after pressure dressing removal (P=0.027). At 5-day follow-up, more bruising was identified in those subjects in the QuicKlamp compression group (P=0.046), as was swelling in female subjects (P=0.044). More episodes of chest pain at 5-day follow-up were identified in the manual compression group (P=0.014). The findings demonstrate that QuicKlamp mechanical compression is a safe alternative to manual compression for attaining haemostasis after femoral sheath removal.

Adult↗

PubMed2006

Effectiveness of prolonged use of continuous passive motion (CPM) as an adjunct to physiotherapy following total knee arthroplasty: design of a randomised controlled trial [ISRCTN85759656].

BACKGROUND: Adequate and intensive rehabilitation is an important requirement for successful Total Knee Arthroplasty. The primary focus of early rehabilitation is ambulation of patients and regaining range of motion in the knee. Although research suggests that Continuous Passive Motion should be implemented in the first rehabilitation phase following surgery, there is substantial debate about the duration of each session and the total period of CPM application and. A Cochrane review on this topic concluded that short-term use of CPM leads to greater short-term range of motion. It also suggested, however, that future research should concentrate on the treatment period during which CPM should be administered. METHODS: In a randomised controlled trial we intend to investigate the efficacy of prolonged use of a continuous passive motion (CPM) device in the home situation as an adjunct to standardised physical therapy. The experimental treatment is compared to standardised physical therapy, in patients with osteoarthritis of the knee undergoing Total Knee Arthroplasty (TKA). Efficacy will be assessed in terms of faster improvements in range of motion and functional recovery. Seventy patients with knee osteoarthritis undergoing TKA and experiencing early postoperative flexion impairment (less than 80 degrees of knee flexion at the time of discharge) will be randomised over two treatment groups, a usual care group and an experimental group. The experimental group will receive CPM + physiotherapy for 17 consecutive days after surgery, whereas the usual care group will receive the same treatment during the in-hospital phase (i.e. about four days), followed by physical therapy alone (usual care) in the first two weeks after hospital discharge. From 18 days to three months after discharge, both groups will receive standardised PT. The primary focus of rehabilitation will be functional recovery (e.g. ambulation) and regaining range of motion (ROM) in the knee. DISCUSSION: Because restricted knee ROM affects functional activities, knee ROM and knee function are regarded as the primary indicators of successful TKA. Potential effects of the intervention under study include rapid return of knee flexion accompanied by earlier return to functional activities of daily life. If patients benefit significantly from prolonged CPM use, this treatment should be added to the standard PT treatment at home. We expect the additional home CPM programme to be more effective than the usual physiotherapy programme, resulting in a difference in ROM of at least 5 degrees , 17 days after surgery. This clinically important difference, with a possible flexion ROM of about 100 degrees , is expected to lead to better functioning in activities of daily life, like walking, and earlier ability to cycle. These advantages should result in earlier and increasing independence.

Arthroplasty, Replacement, Knee↗

PubMed2003

Randomised controlled trial of the impact of guidelines, prioritized review criteria and feedback on implementation of recommendations for angina and asthma.

BACKGROUND: Guidelines are frequently used in an attempt to influence the performance of health professionals, and a national agency has been established in England and Wales to develop and disseminate guidelines. Professionals prefer short guidelines that highlight key recommendations, but whether such guidelines are more likely to be implemented is unknown. AIM: To determine the relative impact of the dissemination of full guidelines, reduced guidelines in the form of prioritized review criteria, and review criteria supplemented by feedback. DESIGN OF STUDY: Cluster randomised controlled trial, with an incomplete block design. SETTING: Eighty-one general practices in Leicestershire, Lincolnshire, Northamptonshire, North Derbyshire, and Nottinghamshire. METHOD: The practices received one of the study interventions, either for care of adults with asthma or for care of people with angina. Data were collected before and after the interventions, the process measures being adherence to ten recommendations about asthma and 14 about angina, and outcome measures being scores in response to an asthma symptom questionnaire or the Seattle Angina Questionnaire, and levels of patient satisfaction. RESULTS: There were no consistent differences between the interventions in stimulating improvements in performance as indicated by adherence to the recommendations for asthma or angina. Patients with angina in practices that had received criteria or criteria plus feedback reported better symptom control. CONCLUSION: The dissemination of guidelines in the format of prioritized review criteria does not increase adherence to recommendations in comparison with the traditional guideline format, and the further provision of feedback has minimal additional effect.

Aged↗

PubMed2003

How to improve the quality of kidneys from non-heart-beating donors: a randomised controlled trial of thrombolysis in non-heart-beating donors.

BACKGROUND: The growth in the prevalence of end-stage renal failure has been accompanied with a rise in the waiting list for renal transplantation, which has not been matched by an increase in the kidney donor pool. Non-heart-beating donors (NHBD) offer a potential source of kidneys that are not currently being significantly used. Cardiac arrest for a protracted period of time leads to in situ thrombosis, and, as a consequence, the discard rates for harvested kidneys is higher than brain-stem-dead donors. METHODS: A double-blinded, randomised, controlled trial of streptokinase preflush or placebo for NHBD was performed. An initial 30 donors were entered into the study. After routine nephrectomy, NHBD kidneys were machine perfused as part of viability screening before transplantation. Kidneys were then transplanted within 24 hours of cardiac arrest. The primary objectives were the improvements of viability parameters (perfusion, enzyme levels, and histopathology) of the kidneys. The secondary objective was to increase the number of kidneys passing the viability tests and thus transplanted. RESULTS: The two groups of NHBD donors and their kidneys were similar in their descriptive epidemiologic characteristics. The NHBD kidneys from the streptokinase-treated donors had a better appearance at procurement (P<0.001) and performed better during machine preservation (P<0.001). Enzyme biomarkers present in the kidney perfusate were all significantly reduced by the use of streptokinase. These included glutathione S-transferase (P<0.001), fatty acid binding protein (P<0.001), and alanine aminopeptidase (P<0.001). However, although there was a higher proportion of kidneys transplanted through the use of streptokinase (63.6% with streptokinase vs. 42.6% with placebo), this did not achieve significance. There was no difference with respect to postoperative bleeding and transfusion requirements in the recipient whether streptokinase preflush or placebo was used. CONCLUSION: This study using streptokinase preflush in the NHBD was found to improve the condition of the kidneys retrieved. The improvement in the quality of the donor kidneys was not associated with an increased morbidity in the recipient.

Alanine Transaminase↗

PubMed2004

Management of osteoarthritis (OA) with an unsupervised home based exercise programme and/or patient administered assessment tools. A cluster randomised controlled trial with a 2x2 factorial design.

BACKGROUND: Diary recording of pain and disabling activities in osteoarthritis (OA) is widely recommended, but, to our knowledge, its impact on symptoms has not been investigated. Exercise programmes have been shown to be effective when patients are closely supervised by nurses or physiotherapists; however, data are lacking on the efficacy of an unsupervised home based exercise regimen in patients with OA. OBJECTIVES: To evaluate the clinical efficacy of patient administered assessment tools and an unsupervised home based exercise programme alone or in combination in patients with OA. METHODS: The study was a 24 week, open cluster randomised controlled trial with a factorial design. Rheumatologists (n = 867) were assigned to four groups according to the treatment given: standardised tools (ST; n = 220), exercises (EX; n = 213), both tools and exercises (ST+EX; n = 213), or usual care (n = 221). Each rheumatologist was to enroll four patients who met the American College of Rheumatology criteria for OA (three with knee OA, one with hip OA). "Tools" consisted of weekly recording of pain and disabling activities in a diary. A home based exercise programme was performed daily at least four times per week with the aid of videotape and booklet. In addition to exercise and assessment, all patients received 12.5 mg or 25 mg of the non-steroidal anti-inflammatory drug rofecoxib once daily. Outcome variables were: pain (measured on a visual analogue scale, 0-100); Western Ontario and McMaster Universities Osteoarthritis Index, function subscale (0-100); and patient assessment of the quality of care (0-100). RESULTS: Overall, 2957 patients with OA (2216 knee, 741 hip) were included. After 24 weeks, both pain and function improved in the ST, EX, ST+EX, and usual care groups (mean (SD) -17 (27), -20 (29), -15 (27), -19 (29); and -11 (19), -12 (19), -10 (19), -11 (20), respectively), without significant differences between groups. However, patients in the EX and ST+EX groups were more likely to agree that their rheumatologist had done his best to preserve their functional and physical activities. CONCLUSION: Although patients' assessments favoured the exercise programme, results from this study failed to demonstrate a short term symptomatic effect of the two non-pharmacological treatments (weekly recording of condition and exercise) in patients with OA concurrently receiving nonsteroidal anti-inflammatory drugs.

Aged↗