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PubMed2004

Safety and efficacy of analgesia-based sedation with remifentanil versus standard hypnotic-based regimens in intensive care unit patients with brain injuries: a randomised, controlled trial [ISRCTN50308308].

INTRODUCTION: This randomised, open-label, observational, multicentre, parallel group study assessed the safety and efficacy of analgesia-based sedation using remifentanil in the neuro-intensive care unit. METHODS: Patients aged 18-80 years admitted to the intensive care unit within the previous 24 hours, with acute brain injury or after neurosurgery, intubated, expected to require mechanical ventilation for 1-5 days and requiring daily downward titration of sedation for assessment of neurological function were studied. Patients received one of two treatment regimens. Regimen one consisted of analgesia-based sedation, in which remifentanil (initial rate 9 microg kg(-1) h(-1)) was titrated before the addition of a hypnotic agent (propofol [0.5 mg kg(-1) h(-1)] during days 1-3, midazolam [0.03 mg kg(-1) h(-1)] during days 4 and 5) (n = 84). Regimen two consisted of hypnotic-based sedation: hypnotic agent (propofol days 1-3; midazolam days 4 and 5) and fentanyl (n = 37) or morphine (n = 40) according to routine clinical practice. For each regimen, agents were titrated to achieve optimal sedation (Sedation-Agitation Scale score 1-3) and analgesia (Pain Intensity score 1-2). RESULTS: Overall, between-patient variability around the time of neurological assessment was statistically significantly smaller when using remifentanil (remifentanil 0.44 versus fentanyl 0.86 [P = 0.024] versus morphine 0.98 [P = 0.006]. Overall, mean neurological assessment times were significantly shorter when using remifentanil (remifentanil 0.41 hour versus fentanyl 0.71 hour [P = 0.001] versus morphine 0.82 hour [P < 0.001]). Patients receiving the remifentanil-based regimen were extubated significantly faster than those treated with morphine (1.0 hour versus 1.93 hour, P = 0.001) but there was no difference between remifentanil and fentanyl. Remifentanil was effective, well tolerated and provided comparable haemodynamic stability to that of the hypnotic-based regimen. Over three times as many users rated analgesia-based sedation with remifentanil as very good or excellent in facilitating assessment of neurological function compared with the hypnotic-based regimen. CONCLUSIONS: Analgesia-based sedation with remifentanil permitted significantly faster and more predictable awakening for neurological assessment. Analgesia-based sedation with remifentanil was very effective, well tolerated and had a similar adverse event and haemodynamic profile to those of hypnotic-based regimens when used in critically ill neuro-intensive care unit patients for up to 5 days.

Adjuvants, Anesthesia↗
PubMed2006

Popperian epidemiology and the logic of bi-conditional modus tollens arguments for refutational analysis of randomised controlled trials.

Popperian epidemiology is a biomedical science tool based on the hypothesis-deductive method and the falsifiability of scientific hypotheses. This article explores the applicability of the refutationist logic tools in the analysis of a randomised controlled trial (RCT), the randomised Aldactone evaluation study (RALES). This was carried out by using bi-conditional modus-tollens arguments of the type (i) P-then-Q(n) and (ii) Q(n)-If-X(P), X(P) being a set of potential falsifiers of Q(n) as part of the explicit falsity-content of P. In this model, P is the main hypothesis and Q(n) one or more logical predictions to be tested. The X(P) argument represents inclusion criteria, exclusion criteria and conditional criteria of the RCT so every P-then-X(P) argument should be fulfilled in canonical form to corroborate P-then-Q(n). Thus, falsifiability of a RCT would be determined by the empirical content of the conditional argument Q(n)-If-X(P) and its external validity would be determined by the empirical content of X(P). In this way it would be possible to mathematically assess the external validity of a RCT if the observational predicates of the X(P) argument in a given population are known. According to this popperian model, applicability of the RCT results to clinical practice implies transferring of all its empirical content, in other words, the totality of its truth and falsity contents. Thus, to ignore the explicit falsity-content of a RCT such as RALES may jeopardise its potential benefits in clinical practice as suggested by recent studies.

Clinical Trials as Topic↗
PubMed2003

Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: a double-blind placebo-controlled randomised trial.

BACKGROUND: Recombinant activated factor VII (factor VIIa) has prohaemostatic effects in bleeding patients with coagulation abnormalities. We aimed to test the hypothesis that recombinant factor VIIa could reduce perioperative blood loss in patients with normal coagulation systems. Therefore, we assessed safety and efficacy of this drug in patients undergoing retropubic prostatectomy, which is often associated with major blood loss and need for transfusion. METHODS: In a double-blind, randomised placebo-controlled trial, we recorded blood loss and transfusion requirements in 36 patients undergoing retropubic prostatectomy, who were randomised to receive an intravenous bolus of recombinant factor VIIa (20 microg/kg or 40 microg/kg) or placebo in the early operative phase. FINDINGS: Median perioperative blood loss was 1235 mL (IQR 1025-1407) and 1089 mL (928-1320) in groups given recombinant factor VIIa 20 microg/kg and 40 microg/kg, respectively, compared with 2688 mL (1707-3565) in the placebo group (p=0.001). Seven of twelve placebo-treated patients were transfused, whereas no patients who received 40 microg/kg recombinant factor VIIa needed transfusion. The odds ratio for receiving any blood product in patients treated with recombinant factor VIIa compared with control patients was 0 (95% CI 0.00-0.33) No adverse events arose. INTERPRETATION: An injection of recombinant factor VIIa can reduce perioperative blood loss and eliminate the need for transfusion in patients undergoing major surgery.

Aged↗
PubMed2026

Urate-lowering effects of losartan: a meta-analysis&#xa0;of randomised controlled trials and target trial emulation.

Common in hypertensive patients, hyperuricaemia is often exacerbated by guideline-recommended antihypertensive therapies such as thiazide diuretics. Losartan is known as an angiotensin II receptor type 1 antagonist with a uricosuric effect, but the magnitude of its efficacy in lowering urate has not been quantified versus a placebo-reference. We sought to quantify the urate-lowering effect of losartan versus placebo using two complementary approaches. We first conducted a meta-analysis of randomised controlled trials (RCTs) to quantify the effect of losartan on serum urate levels versus placebo. We then applied a target trial emulation framework in the UK Biobank as a secondary source of data and a replication experiment. The meta-analysis of six prospective randomised controlled trials (RCTs), including 1119 losartan-treated patients and 1093 controls, demonstrated that losartan reduced serum urate levels by approximately 0.29&#x2009;mg/dL relative to placebo (95% CI: -0.46 to -0.12, p&#x2009;=&#x2009;0.0009). In the target trial emulation, 23 losartan-treated individuals showed a reduction in serum urate of approximately 0.35&#x2009;mg/dL (95% CI: -0.66 to -0.03, p&#x2009;=&#x2009;0.03) when compared with 92 matched controls, and after accounting for 12 potential confounders including established urate-lowering therapies. Our results provide evidence for a modest yet consistent urate-lowering potential of losartan. This modest biochemical effect (~0.3&#x2009;mg/dL) may be an attractive option to mitigate the diuretic-induced urate elevation. Thus, losartan can be considered as a favourable antihypertensive choice for patients managed with diuretics or those who are at risk of hyperuricaemia/gout.

Losartan↗
PubMed2006

Randomised controlled trial of a collaborative care model with psychiatric consultation for persistent medically unexplained symptoms in general practice.

BACKGROUND: Patients with persistent medically unexplained symptoms often exhibit general dysfunction and psychiatric comorbidity and frequently resist psychiatric referral. The aim of this study was to evaluate the efficacy of a collaborative care model including training for general practitioners (GPs) and a psychiatric consultation model for patients with persistent medically unexplained symptoms in general practice. METHOD: Randomised controlled trial. Cluster randomisation at GP practices and multilevel analysis were performed. A total of 81 patients from 36 general practices completed the study. A collaborative care model of training and psychiatric consultation in general practice in the presence of the GP was compared with training plus care as usual by the GP. Outcome assessment on the patients' well-being, functioning and utilisation of health care services was performed 6 weeks and 6 months later. RESULTS: All the patients had somatoform disorders (Whitely Index 7.46), and 86% had comorbid psychiatric disorders. In the intervention group, the severity of the main medically unexplained symptoms decreased by 58%. The patients' social functioning improved. The utilization of health care was lower than in the care as usual group. CONCLUSIONS: A collaborative care model combining training with psychiatric consultation in the general practice setting is an effective intervention in the treatment of persistent medically unexplained symptoms. Anxiety and depressive disorders are highly comorbid in this group. The findings warrant a larger study.

Adult↗
PubMed2006

The acceptability and impact of a randomised controlled trial of welfare rights advice accessed via primary health care: qualitative study.

BACKGROUND: Qualitative research is increasingly used alongside randomised controlled trials (RCTs) to study a range of factors including participants' experiences of a trial. The need for a sound evidence base within public health will increase the need for RCTs of non-clinical interventions. Welfare rights advice has been proposed as an intervention with potential to reduce health inequalities. This qualitative study, nested within an RCT of the impact of welfare rights advice, examined the acceptability of the intervention, the acceptability of the research process and the perceived impact of the intervention. METHODS: 25 men and women aged 60 years or over were recruited from four general practices in Newcastle upon Tyne (UK), a sub-sample of those who consented to be contacted (n = 96) during the RCT baseline interview. Semi-structured interviews were undertaken and analysed using the Framework Method. RESULTS: Participants viewed the trial positively although, despite agreeing that the information leaflet was clear, some had agreed to participate without being fully aware of what was involved. Some participants were unaware of the implications of randomisation. Most thought it fair, but a few concerns were raised about the control condition. The intervention was acceptable and made participants feel confident about applying for benefit entitlements. 14 out of 25 participants received some financial award; median weekly income gain was pounds 57 (Euro 84, dollar 101). The perceived impact of additional finances was considerable and included: increased affordability of necessities and occasional expenses; increased capacity to deal with emergencies; and a reduction in stress related to financial worries. Overall, perceived independence and ability to participate in society increased. Most participants perceived benefits to their mental well-being, but no-one reported an improvement in physical health. The RCT showed little or no effect on a wide range of outcome measures. CONCLUSION: Participation in the trial and the intervention was acceptable to participants. Welfare rights advice targeted at people aged 60 years or over and accessed via primary care had a positive impact on quality of life and resulted in increased social participation. The divergence of qualitative and quantitative findings suggests that both methods make important contributions to the evaluation of complex social interventions.

Aged↗
PubMed2002

[Randomised controlled trials in mental health services research: practical problems of implementation].

This article outlines problems of implementation and clinical practice of randomised controlled trials in mental health services. Furthermore, it offers practical solutions taking into account the experiences with a randomisation process in a multi-site EC-funded (EDEN-) study on the evaluation of acute treatment in psychiatric day hospitals. Identification of the problems follows the time-course of a research project: 1. Problems to be solved prior to the study's commencement: Definition of the eligibility criteria, information of clinically working colleagues. 2. Problems referring to the process of randomisation: Influence of clinical experience of the research fellows, precise time-point of implementing the randomisation into the process of admission, assessment of the patient's ability to give informed consent, patient's refusal of randomisation but agreement to study participation, availability of treatment places. 3. Problems which might occur after randomisation: Early break-off of treatment, transfer from one treatment setting to another. General conclusion: Detailed definitions of the randomisation procedure do not guarantee high performance quality and randomisation rates. Continuous precise assessment of the implementation into the clinical routines of every study centre, adaptation according to specific conditions and personal discussions with all participants are obligatory to establish and maintain a high quality of this important research procedure.

Humans↗
PubMed2006

What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies.

BACKGROUND: A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme. METHODS: The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. RESULTS: Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. CONCLUSION: Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.

Journal Article↗
PubMed1993

Home-based care and standard hospital care for patients with severe mental illness: a randomised controlled trial.

"OBJECTIVE--To compare the efficacy of home based care with standard hospital care in treating serious mental illness. DESIGN--Randomised controlled trial. SETTING--South Southwark, London. PATIENTS--189 patients aged 18-64 living in catchment area. 92 were randomised to home based care (daily living programme) and 97 to standard hospital care. At three months' follow up 68 home care and 60 hospital patients were evaluated. MAIN OUTCOME MEASURES--Use of hospital beds, psychiatric diagnosis, social functioning, patients' and relatives' satisfaction, and activity of daily living programme staff. RESULTS--Home care reduced hospital stay by 80% (median stay 6 days in home care group, 53 days in hospital group) and did not increase the number of admissions compared with hospital care. On clinical and social outcome there was a non-significant trend in favour of home care, but both groups showed big improvements. On the global adjustment scale home care patients improved by 26.8 points and the hospital group by 21.6 points (difference 5.2; 95% confidence interval--1.5 to 12). Other rating scales showed similar trends. Home care patients required a wide range of support in areas such as housing, finance, and work. Only three patients dropped out from the programme. CONCLUSIONS--Home based care may offer some slight advantages over hospital based care for patients with serious mental illness and their relatives. The care is intensive, but the low drop out rate suggests appreciation. Changes to traditional training for mental health workers are required."

Activities of Daily Living↗
PubMed1992

Home based care and standard hospital care for patients with severe mental illness: a randomised controlled trial.

OBJECTIVE: To compare the efficacy of home based care with standard hospital care in treating serious mental illness. DESIGN: Randomised controlled trial. SETTING: South Southwark, London. PATIENTS: 189 patients aged 18-64 living in catchment area. 92 were randomised to home based care (daily living programme) and 97 to standard hospital care. At three months' follow up 68 home care and 60 hospital patients were evaluated. MAIN OUTCOME MEASURES: Use of hospital beds, psychiatric diagnosis, social functioning, patients' and relatives' satisfaction, and activity of daily living programme staff. RESULTS: Home care reduced hospital stay by 80% (median stay six days in home care group, 53 days in hospital group) and did not increase the number of admissions compared with hospital care. On clinical and social outcome there was a non-significant trend in favour of home care, but both groups showed big improvements. On the global adjustment scale home care patients improved by 26.8 points and the hospital group by 21.6 points (difference 5.2; 95% confidence interval -1.5 to 12). Other rating scales showed similar trends. Home care patients required a wide range of support in areas such as housing, finance, and work. Only three patients dropped out from the programme. CONCLUSIONS: Home based care may offer some slight advantages over hospital based care for patients with serious mental illness and their relatives. The care is intensive, but the low drop out rate suggests appreciation. Changes to traditional training for mental health workers are required.

Adult↗
PubMed2004

A randomised controlled trial comparing Drawtex with standard dressings for exuding wounds.

OBJECTIVE: This randomised controlled clinical trial compared a capillary dressing (Drawtex, now rebranded as Vibriant RCD [Vibriant Technology Services]) with routine practice for exuding wounds greater than 2.5 x 2.5 cm. METHOD: The target population was 300 control and 300 test subjects across three sites in the UK, but recruitment difficulties resulted in only 125 patients being evaluable. Wound progress was recorded by nurses' perception of the progress of wound healing and by objective digital imaging. In the final analysis digital images were randomised (in time order) and a panel of nurses who were not otherwise involved in the research project graded the wound's progress. RESULTS: After deconvolution of the data, the subjective (nurse perception) method of evaluation determined that the new dressing resulted in wound improvement in 12.7% more patients than did routine practice, but the blinded assessment method (based on the digital images) showed that routine practice was better by 6.6%. CONCLUSION: Evaluation of wound progress is clearly difficult. Human nature makes us favour novelty if we believe it is going to be better. Making interpretation more objective removed that bias and did not demonstrate a significant advantage for the test dressing. The findings suggest that unblinded assessment by trial nurses is unacceptable on its own. Blinded assessments may miss finer nuances of wound progression, but are likely to be more accurate. The authors suggest that the true result lies somewhere in the middle, with the trial dressing likely to be as effective as, but not more effective than, a standard dressing.

Aged↗
PubMed2004

Promoting urinary continence in postpartum women: 12-month follow-up data from a randomised controlled trial.

A physiotherapist-delivered continence promotion program was recently implemented with postpartum women in Australia. A previous randomised controlled trial demonstrated that the program was effective in promoting pelvic floor exercises and continence at 3 months postpartum. The present study compares pelvic floor exercise frequency and continence status for women in the intervention and 'usual care' control groups at 12 months postpartum. While there was no significant difference in continence status, women in the intervention group were more likely than those in the control group to be practising pelvic floor exercises at adequate frequencies. In turn, continued adherence to pelvic floor exercises at 12 months was predictive of continence at that time. Potential strategies for enhancing women's adherence to pelvic floor exercise regimes during and beyond the postpartum year are discussed.

Adolescent↗
PubMed1997

Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics: verification from independent data.

A previously established relationship for deriving dichotomous from continuous information in randomised controlled trials (RCTs) of analgesics has been tested using an independent data set. Individual patient information from 18 RCTs of parallel-group design in acute postoperative pain (after abdominal, gynaecological and oral surgery) was used to calculate the percentage of the maximum possible pain relief score (%maxTOTPAR) and the proportion of patients with > 50%maxTOTPAR for the different treatments. The relationship between the measures was investigated in 85 treatments with over 3400 patients. In 80 of 85 treatments (94%) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 (85%) was within three (average of 40 patients per treatment, range 21-58 patients). Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm. Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices, rather than using discontinuous events, such as number or proportion of patients with 50% pain relief. Because mean data inadequately describe information with a non-normal distribution, combining mean data in systematic reviews may compromise the results. Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic reviews which require data in dichotomous form.

Acute Disease↗
PubMed1995

An overview of randomised controlled trials of adjuvant chemotherapy in head and neck cancer.

Meta-analysis of the published results from 54 randomised controlled trials of adjuvant chemotherapy in head and neck cancer suggests that chemotherapy might increase absolute survival by 6.5% (95% confidence interval 3.1-9.9%). The odds ratio in favour of chemotherapy is 1.37 (95% confidence interval 1.24-1.5). Single-agent chemotherapy given synchronously with radiotherapy increased survival by 12.1% (95% confidence interval 5-19%). The benefit from neoadjuvant chemotherapy was less: a rate difference of 3.7% (95% confidence interval 0.9-6.5%). The results suggest that the investigation of optimal agents and scheduling for synchronous radiotherapy and chemotherapy might still be important in clinical trials in head and neck cancer.

Chemotherapy, Adjuvant↗
PubMed2001

Are specialist outreach clinics for orthodontic consultation effective? A randomised controlled trial.

OBJECTIVE: To develop outreach clinics for orthodontic consultation and evaluate their costs and effectiveness. DESIGN: Single centre randomised controlled trial with random allocation of referred patients to outreach or main base consultation appointments. SETTING: One hospital orthodontic department and three community health centre clinics in Greater Manchester. Subjects 324 patients who were referred for orthodontic treatment. MAIN OUTCOME MEASURES: The outcome of consultation, the cost and duration of the visit and the consumer's perceptions of the visit. RESULTS: There were no differences in outcome of the consultation. While consumer travel costs and the duration of appointments were significantly higher for the main base clinics, these differences were not great. However, consumers preferred to attend an appointment in an outreach clinic. CONCLUSIONS: There do not appear to be marked advantages or disadvantages in providing consultation appointments for orthodontics in outreach clinics

Analysis of Variance↗
PubMed1997

Cost effectiveness of day and inpatient psychiatric treatment: results of a randomised controlled trial.

OBJECTIVE: To compare direct and indirect costs of day and inpatient treatment of acute psychiatric illness. DESIGN: Randomised controlled trial with outcome and costs assessed over 12 months after the date of admission. SETTING: Teaching hospital in an inner city area. SUBJECTS: 179 patients with acute psychiatric illness referred for admission who were suitable for random allocation to day hospital or inpatient treatment. 77 (43%) patients had schizophrenia. INTERVENTIONS: Routine inpatient or day hospital treatment. MAIN OUTCOME MEASURES: Direct and indirect costs over 12 months, clinical symptoms, social functioning, and burden on relatives over the follow up period. RESULTS: Clinical and social outcomes were similar at 12 months, except that inpatients improved significantly faster than day patients and burden on relatives was significantly less in the day hospital group at one year. Median direct costs to the hospital were 1923 pounds (95% confidence interval 750 pounds to 3174 pounds) per patient less for day hospital treatment than inpatient treatment. Indirect costs were greater for day patients; when these were included, overall day hospital treatment was 2165 pounds cheaper than inpatient treatment (95% confidence interval of median difference 737 pounds to 3593 pounds). Including costs to informants when appropriate meant that day hospital treatment was 1994 pounds per patient cheaper (95% confidence interval 600 pounds to 3543 pounds). CONCLUSIONS: Day patient treatment is cheaper for the 30-40% of potential admissions that can be treated in this way. Carers of day hospital patients may bear additional costs. Carers of all patients with acute psychiatric illness are often themselves severely distressed at the time of admission, but day hospital treatment leads to less burden on carers in the long term.

Adolescent↗
PubMed2003

Effectiveness of dynamic muscle training, relaxation training, or ordinary activity for chronic neck pain: randomised controlled trial.

OBJECTIVE: To determine the effectiveness of dynamic muscle training and relaxation training for chronic neck pain. DESIGN: Randomised controlled trial. SETTING: Five occupational healthcare centres, Tampere, Finland. PARTICIPANTS: 393 female office workers (mean age 45 years) with chronic non-specific neck pain randomly assigned to 12 weeks of dynamic muscle training (n = 135) or relaxation training (n = 128), plus one week of reinforcement training six months after baseline; or ordinary activity (control group; n = 130). MAIN OUTCOME MEASURE: Change in intensity of neck pain at three, six, and 12 months. RESULTS: No significant difference was found in neck pain between the groups at follow up. However, the range of motion for cervical rotation and lateral flexion increased more in the training groups than in the control group. CONCLUSIONS: Dynamic muscle training and relaxation training do not lead to better improvements in neck pain compared with ordinary activity.

Algorithms↗