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Results for “Randomised Controlled Trial”

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At least 1,207 records · Page 67Linked to original sources

PubMed2002

Incidence of side effects during therapy with different types of alpha interferon: a randomised controlled trial comparing recombinant alpha 2b versus leukocyte interferon in the therapy of naive patients with chronic hepatitis C.

BACKGROUND: Alpha interferon (IFN) alone or in combination with Ribavirin (RBV) is the treatment of choice for HCV related chronic liver disease. There are many types of alpha IFN and to date only few reports are available comparing different types of alpha interferon. We run a randomised controlled trial with the aim to compare tolerability and efficacy of two different types of IFN: recombinant alpha 2b interferon (IFN-R) and leukocyte alpha n-3 interferon (IFN-L) at the same dosage of 3 MU subcutaneously thrice weekly for one year. METHODS: one hundred sixty eight consecutive anti-HCV positive naive patients, 34 mild chronic active hepatitis (MCH), 81 moderate-severe hepatitis (MSCR) and 53 active cirrhosis (CIRR) that met the inclusion criteria were enrolled into the study. The diagnosis of HCV chronic liver disease was established by liver biopsy performed on patients with abnormal serum alanine aminotransferase (ALT) value for at least one year. HCV serology: all patients were tested for confirmatory test RIBA II, HCV-RNA, and identification of viral genotype. Patients were randomised to receive either IFN-R or IFN-L. Follow-up continued for at least two years after stopping treatment. RESULTS: no significant differences were observed between the two groups of treatment as far as the incidence of side effects is concerned. Tolerability was good: only 11 in IFN-R and 8 patients IFN-L group respectively had to stop therapy due to side effects. The two types of IFN showed a comparable efficacy: an end of therapy response was observed in 34% of IFN-R and 30% of IFN-L patients; a sustained response was seen in 16% of IFN-R and in 19% of IFN-L patients. CONCLUSIONS: in the treatment of patients with chronic hepatitis C there was no statistically significant difference in tolerability and efficacy between the two IFNs tested.

Antiviral Agents↗

PubMed2001

Randomised controlled trial of an integrated versus an optometric low vision rehabilitation service for patients with age-related macular degeneration: study design and methodology.

A number of studies have measured the outcomes of low vision care but these have usually been longitudinal case series, thus constituting very low quality of evidence for effectiveness. To date, there have been no randomised controlled trials (RCTs) which have evaluated the effectiveness and cost effectiveness of different models of care in low vision. The size of the low vision population and the paucity of systematic evaluation have created a pressing need for evidence about cost-effectiveness in order to inform service developments for low vision rehabilitation. This paper describes the study design and methodology of a three-arm RCT currently under way in Manchester. The baseline population recruited is also described. A traditional hospital-based optometric service is being compared with an integrated service (comprising the addition of community-based rehabilitation officer input) and with more generic community input (which is non-integrated and is not vision specific). A wide range of outcome measures are being assessed at recruitment and 12 months post-intervention, including low vision specific and generic quality of life measures, patterns of low vision aid use, and task performance. The rationale for the trial is discussed and the main study outcomes are described.

Aged↗

PubMed2003

A randomised controlled trial to evaluate the clinical and cost-effectiveness of Hickman line insertions in adult cancer patients by nurses.

OBJECTIVES: To examine the clinical and cost-effectiveness of image-guided Hickman line insertions versus blind Hickman line insertions undertaken by nurses in adult cancer patients. DESIGN: A cost-effectiveness analysis was carried out alongside a randomised controlled trial. SETTING: A large acute cancer centre in Manchester, UK. PARTICIPANTS: Cancer patients due to have a Hickman line insertion who were over 18 years of age and were clinically and physically compliant with specified protocols. INTERVENTIONS: In order to obtain central venous access for the patient, two interventions were investigated: (i) blind insertion of a Hickman line and (ii) image-guided insertion of a Hickman line. Both interventions involved blind venipuncture of the subclavian vein. In the blind arm, the Hickman line was routinely inserted without the use of image guidance at any point in the procedure. Transfer to the interventional X-ray suite and use of image guidance were options immediately available to the operator during the procedure if required. In the image-guided arm, the position of the guidewire was checked before the Hickman line was introduced and later the Hickman line was positioned with the use of X-ray fluoroscopy. MAIN OUTCOME MEASURES: The primary clinical outcome measure was catheter-tip misplacement and this was expected to be higher in the blind arm. When comparing the skill level of the trainer and the trainees, pneumothorax was the primary clinical outcome measure. Other outcomes measures included arterial puncture, haematoma, infection, failed insertion and assistance from other healthcare professionals. RESULTS: No statistically significant difference was found between the mean cost per patient in the two arms of the trial. The only statistically significant difference in clinical outcomes was the frequency of catheter-tip misplacement, which was higher in the blind arm of the trial. At very low costs, the image-guided approach dominates the blind approach as fewer costs and greater benefits are incurred. It is evident that nurses previously inexperienced in the procedure can be trained to insert Hickman lines successfully both at the bedside and under image guidance within a 3-month period. CONCLUSIONS: This report indicates that nurse insertion of Hickman lines in the majority of adult cancer patients is both safe and effective. However, there are a select group of patients for whom image-guided insertion may be preferred. The results reveal that skills and expertise can be transferred from trainer to trainee through a relatively short, but intensive, training course. It is also evident that patients support nurse insertion. Further research is suggested to compare the safety and efficacy of nurse versus doctor insertions in particular subgroups of patients and also to assess the quantity and quality of current service provision in order to inform NHS decision-making in this area.

Adult↗

PubMed2006

A cost effectiveness analysis within a randomised controlled trial of post-acute care of older people in a community hospital.

OBJECTIVE: To assess the cost effectiveness of post-acute care for older people in a locality based community hospital compared with a department for care of elderly people in a district general hospital, which admits patients aged over 76 years with acute medical conditions. DESIGN: Cost effectiveness analysis within a randomised controlled trial. SETTING: Community hospital and district general hospital in Yorkshire, England. PARTICIPANTS: 220 patients needing rehabilitation after an acute illness for which they required admission to hospital. INTERVENTIONS: Multidisciplinary care in the district general hospital or prompt transfer to the community hospital. MAIN OUTCOME MEASURES: EuroQol EQ-5D scores transformed into quality adjusted life years (QALYs), and health and social service costs over six months from randomisation. RESULTS: The mean QALY score for the community hospital group was marginally non-significantly higher than that for the district general hospital group (0.38 v 0.35) at six months after recruitment. The mean (standard deviation) costs per patient of the health and social services resources used were similar for both groups: community hospital group 7233 pounds sterling (euros 10,567; 13,341 dollars) (5031 pounds sterling), district general hospital group 7351 pounds sterling(6229 pounds sterling), and these findings were robust to several sensitivity analyses. The incremental cost effectiveness ratio for community hospital care dominated. A cost effectiveness acceptability curve, based on bootstrapped simulations, suggests that at a willingness to pay threshold of 10,000 pounds sterling per QALY, 51% of community hospital cases will be cost effective, which rises to 53% of cases when the threshold is 30,000 pounds sterling per QALY. CONCLUSION: Post-acute care for older people in a locality based community hospital is of similar cost effectiveness to that of an elderly care department in a district general hospital.

Acute Disease↗

PubMed2005

Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445].

INTRODUCTION: Goal-directed therapy (GDT) has been shown to improve outcome when commenced before surgery. This requires pre-operative admission to the intensive care unit (ICU). In cardiac surgery, GDT has proved effective when commenced after surgery. The aim of this study was to evaluate the effect of post-operative GDT on the incidence of complications and duration of hospital stay in patients undergoing general surgery. METHODS: This was a randomised controlled trial with concealed allocation. High-risk general surgical patients were allocated to post-operative GDT to attain an oxygen delivery index of 600 ml min(-1) m(-2) or to conventional management. Cardiac output was measured by lithium indicator dilution and pulse power analysis. Patients were followed up for 60 days. RESULTS: Sixty-two patients were randomised to GDT and 60 patients to control treatment. The GDT group received more intravenous colloid (1,907 SD +/- 878 ml versus 1,204 SD +/- 898 ml; p < 0.0001) and dopexamine (55 patients (89%) versus 1 patient (2%); p < 0.0001). Fewer GDT patients developed complications (27 patients (44%) versus 41 patients (68%); p = 0.003, relative risk 0.63; 95% confidence intervals 0.46 to 0.87). The number of complications per patient was also reduced (0.7 SD +/- 0.9 per patient versus 1.5 SD +/- 1.5 per patient; p = 0.002). The median duration of hospital stay in the GDT group was significantly reduced (11 days (IQR 7 to 15) versus 14 days (IQR 11 to 27); p = 0.001). There was no significant difference in mortality (seven patients (11.3%) versus nine patients (15%); p = 0.59). CONCLUSION: Post-operative GDT is associated with reductions in post-operative complications and duration of hospital stay. The beneficial effects of GDT may be achieved while avoiding the difficulties of pre-operative ICU admission.

Aged↗

PubMedDate not supplied

Assessment of the clinical effectiveness of pulmonary artery catheters in management of patients in intensive care (PAC-Man): a randomised controlled trial.

BACKGROUND: Over the past 30 years the pulmonary artery catheter (PAC) has become a widely used haemodynamic monitoring device in the management of critically ill patients, though doubts exist about its safety. Our aim was, therefore, to ascertain whether hospital mortality is reduced in critically ill patients when they are managed with a PAC. METHODS: We did a randomised controlled trial to which we enrolled 1041 patients from 65 UK intensive care units. We assigned individuals to management with (n=519) or without (n=522) a PAC. The timing of insertion and subsequent clinical management were at the discretion of the treating clinician. Intensive care units decided a priori to have the option of using an alternative cardiac output-monitoring device in control patients. FINDINGS: 1014 patients were eligible for analysis. We noted no difference in hospital mortality between patients managed with or without a PAC (68% [346 of 506] vs 66% [333 of 507], p=0.39; adjusted hazard ratio 1.09, 95% CI 0.94-1.27). We noted complications associated with insertion of a PAC in 46 of 486 individuals in whom the device was placed, none of which was fatal. INTERPRETATION: Our findings indicate no clear evidence of benefit or harm by managing critically ill patients with a PAC. Efficacy studies are needed to ascertain whether management protocols involving PAC use can result in improved outcomes in specific groups if these devices are not to become a redundant technology.

Adolescent↗

PubMed2026

Impact of a thermal care bundle on peri-operative hypothermia, surgical site infection, and readmissions in osteosynthesis patients: A randomised controlled trial.

BACKGROUND: Maintaining normothermia throughout the peri-operative period prevents the occurrence of complications related to hypothermia. OBJECTIVE: To determine the effect of a thermal care bundle with a short prewarming period on inadvertent peri-operative hypothermia (IPH), surgical site infection (SSI), and unplanned readmission among osteosynthesis patients, and to identify associated variables. DESIGN: Open-label, randomised controlled trial. SETTING: University hospital. PATIENTS: One hundred and forty-eight patients who underwent osteosynthesis surgery. INTERVENTION: The intervention group received the thermal care bundle, which consisted in prewarming patients 10 min before anaesthesia delivery and maintaining body temperature with a forced air device during surgery and the immediate postoperative period; in addition, the operating room environmental temperature was kept at 21 °C, and fluids were warmed to 38 °C. MAIN OUTCOME MEASURES: For the primary objective, hypothermia was defined as core body temperature below 36 °C and measured using the 3M Spot On zero heat flux sensor. Core temperature was recorded upon admission to the pre-operative holding area and subsequently every 30 min until postanaesthesia care unit (PACU) discharge. Secondary objectives were SSI and readmissions: a follow-up at 30 to 60 and 90 days was performed by the principal investigator. RESULTS: All 148 patients completed the study, and there were no significant differences between the groups at baseline. At the start of surgery, the incidence of hypothermia was significantly lower in the bundle group (1.3 vs. 9.9% among controls; odds ratio = 7.59, P  = 0.021). A significantly lower incidence of hypothermia was also observed at admission to the PACU (14.3% in the bundle group vs. 29.6% among controls; odds ratio = 2.07; P  = 0.024). Application of the bundle increased patients' core body temperature by 0.13 °C (95% confidence interval (CI), 0.003 to 0.254; P  = 0.045). Patients in the bundle group had a slightly lower observed incidence of wound infections requiring readmission (odds ratio = 0.35; 95% CI, 0.04 to 2.92), although this difference was not statistically significant ( P  = 0.332). CONCLUSIONS: The bundle reduces peri-operative hypothermia by up to 59%, but does not affect on SSI; factors like presurgery hospital stay, operating room and PACU occupancy were identified as risk factors for SSI. REGISTRATION: 21 July 2022: NCT05469958 (Clinical Trials.gov), first recruitment 15 August 2022.

Adult↗

PubMed2026

Efficacy and Safety of Anti-Obesity Medications for Weight Loss Maintenance in Adults With Overweight or Obesity: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

AIMS: This systematic review and meta-analysis aimed to evaluate the efficacy and safety of anti-obesity medications (AOMs) for long-term weight maintenance following initial weight loss in adults with overweight or obesity. METHODS: We searched PubMed, Embase, Web of Science and the Cochrane Library from inception to 31 October 2025. Eligible studies were randomised controlled trials (RCTs) comparing AOMs with placebo during the weight-maintenance phase in adults with overweight or obesity after initial weight loss achieved through lifestyle, dietary, surgical or pharmacological interventions. Outcomes included anthropometric indices, cardiometabolic measures, safety endpoints, quality of life and neuropsychiatric adverse events. Weighted mean differences (WMDs) and odds ratios (ORs), each with 95% confidence intervals (CIs), were pooled for continuous and categorical outcomes, respectively, using fixed-effect or random-effects models as appropriate. Risk of bias was assessed using the Cochrane RoB 2 tool, and certainty of evidence was evaluated using the GRADE framework. The protocol was registered with PROSPERO (CRD420261293040). RESULTS: A total of 12 RCTs comprising 4915 participants met the inclusion criteria. Compared with placebo, AOM therapy during the weight-maintenance phase was associated with prevention of weight regain and additional improvements in anthropometric and cardiometabolic outcomes. AOMs led to further reductions in body weight (BW, WMD: -8.68 kg, 95% CI: -13.25 to -4.11), waist circumference (WC, WMD: -7.16 cm, 95% CI: -10.34 to -3.98) and body mass index (BMI, WMD: -3.58 kg/m2, 95% CI: -5.69 to -1.46). Additional benefits were observed for triglycerides, total cholesterol, low-density lipoprotein cholesterol, systolic blood pressure and diastolic blood pressure. Gastrointestinal adverse events were more common with AOMs, whereas serious adverse events were not significantly increased. Neuropsychiatric adverse events were generally comparable between groups, and available quality-of-life measures favoured AOM treatment. CONCLUSIONS: AOM therapy during the weight-maintenance phase can help prevent weight regain, provide further reductions in body weight and improve cardiometabolic risk factors in adults with overweight or obesity. Gastrointestinal adverse events were more common with AOMs, whereas serious adverse events were not significantly increased. Further long-term trials are needed to clarify optimal treatment strategies and safety.

Humans↗

PubMed2002

[Acupuncture for back pain: meta-analysis of randomised controlled trials and an update with data from the most recent studies].

BACKGROUND: Acupuncture is commonly used to treat back pain. A meta-analysis of clinical trials of acupuncture for this condition came to a positive conclusion whilst a qualitative review was negative. AIM: To compare our meta-analysis of trials of acupuncture for the treatment of back pain with a qualitative review and the most recent studies on the subject. METHODS: A systematic literature search was conducted to retrieve all randomised controlled trials of any form of acupuncture for any type of back pain in humans. The adequacy of the acupuncture was assessed by consulting six experienced acupuncturists. The main outcome measure for the meta-analysis was numbers of subjects who where improved at the end of treatment. These data are discussed in relation to the qualitative review and the most recent studies. RESULTS: Twelve studies were included of which nine presented data suitable for meta-analysis. The odds ratio of improvement with acupuncture compared with control intervention was 2.30 (95% confidence interval 1.28 to 4.13). For sham-controlled, evaluator-blinded studies, the odds ratio was 1.37 (95% confidence interval, 0.84-2.25). The results from the majority of the most recent studies also support the effectiveness of acupuncture in the treatment of back pain. CONCLUSIONS: Collectively, these data imply that acupuncture is superior to various control interventions, although there is insufficient evidence to state whether it is superior to placebo.

Acupuncture Analgesia↗

PubMed2002

Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial.

BACKGROUND: Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals, their efficacy and safety in elderly people is not fully established. Our aim was to test the benefits of pravastatin treatment in an elderly cohort of men and women with, or at high risk of developing, cardiovascular disease and stroke. METHODS: We did a randomised controlled trial in which we assigned 5804 men (n=2804) and women (n=3000) aged 70-82 years with a history of, or risk factors for, vascular disease to pravastatin (40 mg per day; n=2891) or placebo (n=2913). Baseline cholesterol concentrations ranged from 4.0 mmol/L to 9.0 mmol/L. Follow-up was 3.2 years on average and our primary endpoint was a composite of coronary death, non-fatal myocardial infarction, and fatal or non-fatal stroke. Analysis was by intention-to-treat. FINDINGS: Pravastatin lowered LDL cholesterol concentrations by 34% and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo (hazard ratio 0.85, 95% CI 0.74-0.97, p=0.014). Coronary heart disease death and non-fatal myocardial infarction risk was also reduced (0.81, 0.69-0.94, p=0.006). Stroke risk was unaffected (1.03, 0.81-1.31, p=0.8), but the hazard ratio for transient ischaemic attack was 0.75 (0.55-1.00, p=0.051). New cancer diagnoses were more frequent on pravastatin than on placebo (1.25, 1.04-1.51, p=0.020). However, incorporation of this finding in a meta-analysis of all pravastatin and all statin trials showed no overall increase in risk. Mortality from coronary disease fell by 24% (p=0.043) in the pravastatin group. Pravastatin had no significant effect on cognitive function or disability. INTERPRETATION: Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals. PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle aged people.

Aged↗

PubMed1997

Analgesic efficacy of peripheral opioids (all except intra-articular): a qualitative systematic review of randomised controlled trials.

Anaesthetists, using basic scientific concepts of peripheral opioid activity, try to improve regional anaesthesia and postoperative analgesia by injecting opioids, with or without local anaesthetic, close to nerve trunks or nerve endings. To test the evidence that peripherally applied opioids (all except intra-articular) have an analgesic effect outside the knee joint. Systematic search for published reports of randomised controlled trials in the period 1966-1996 (MEDLINE, EMBASE, Oxford Data Base, reference lists) which compared efficacy of peripheral opioids with placebo, local anaesthetic, or systemic opioids in acute pain. Reports of pethidine or intra-articular opioids were not included. Data on intraoperative efficacy (onset, quality, duration of sensory block), and postoperative efficacy (pain intensity, analgesic consumption) were extracted. Statistical significance as indicated in the original reports and clinical relevance of differences between opioids and controls were taken into account to estimate qualitatively overall efficacy. Twenty-six trials with data from 952 patients were analysed. Opioids used were morphine (16 trials), fentanyl (8), alfentanil (1), buprenorphine (1), and butorphanol (1). Of four experimental pain trials, two reported a statistically significant difference in favour of the opioid. In 22 clinical trials efficacy of opioid injections into the brachial plexus (10), Bier's block (4), perineural (3), or other sites (5) was tested. Five of 10 clinical trials measuring intraoperative efficacy reported statistically significant efficacy with opioids compared with control; none of them were judged to be clinically relevant. Five of 17 clinical trials measuring postoperative efficacy reported a significant difference in favour of the opioid; none was judged to be clinical relevant. Trials of lower quality were more likely to report increased efficacy with opioids. Adverse events related to the route of administration were not reported. These trials provide no evidence for a clinically relevant peripheral analgesic efficacy of opioids in acute pain.

Analgesics, Opioid↗

PubMed1996

Randomised controlled trial of general practitioner versus usual medical care in an urban accident and emergency department: process, outcome, and comparative cost.

OBJECTIVE: To see whether care provided by general practitioners to non-emergency patients in an accident and emergency department differs significantly from care by usual accident and emergency staff in terms of process, outcome, and comparative cost. DESIGN: A randomised controlled trial. SETTING: A busy inner city hospital's accident and emergency department which employed three local general practitioners on a sessional basis. PATIENTS: All new attenders categorised by the triage system as "semiurgent" or "delay acceptable." 66% of all attenders were eligible for inclusion. MAIN OUTCOME MEASURES: Numbers of patients undergoing investigation, referral, or prescription; types of disposal; consultation satisfaction scores; reattendance to accident and emergency department within 30 days of index visit; health status at one month; comparative cost differences. RESULTS: 4684 patients participated. For semiurgent patients, by comparison with usual accident and emergency staff, general practitioners investigated fewer patients (relative difference 20%; 95% confidence interval 16% to 25%), referred to other hospital services less often (39%; 28% to 47%), admitted fewer patients (45%; 32% to 56%), and prescribed more often (41%; 30% to 54%). A similar trend was found for patients categorised as delay acceptable and (in a separate analysis) by presenting complaint category. 393 (17%) patients who had been seen by general practitioner staff reattended the department within 30 days of the index visit; 418 patients (18%) seen by accident and emergency staff similarly reattended, 435 patients (72% of those eligible) completed the consultation satisfaction questionnaire and 258 (59% of those eligible) provided health status information one month after consultation. There were no differences between patients managed by general practitioners and those managed by usual staff regarding consultation satisfaction questionnaire scores or health status. For all patients seen by general practitioners during the study, estimated marginal and total savings were Ir1427 pounds and Ir117,005 pounds respectively. CONCLUSION: General practitioners working as an integral part of an accident and emergency department manage non-emergency accident and emergency attenders safely and use fewer resources than do usual accident and emergency staff.

Adult↗

PubMed1998

A multidisciplinary approach for improving services in primary care: randomised controlled trial of screening for haemoglobin disorders.

OBJECTIVE: To investigate the feasibility of improving screening for carriers of haemoglobin disorders in general practice by using a nurse facilitator to work with primary care teams and the relevant haematology laboratories; to identify problems in communication between all those involved in delivering the service, and to implement solutions. DESIGN: Two year, practice based randomised controlled trial. SETTING: North London area where 29% of residents and 43% of births are in ethnic groups at risk for haemoglobin disorders. SUBJECTS: 26 of the 93 practices using the services of the area's haematology laboratory agreed to take part and were randomly divided into control and intervention practices. MAIN OUTCOME MEASURE: Change in number of requests for screening tests for haemoglobin disorders made by control and intervention practices in baseline and intervention years. RESULTS: The number of screening tests requested varied from 0-150 in the 93 practices in the baseline year. Study practices tended to have made a moderate number of requests (10-50) during this period. During the intervention year intervention practices made 292 more requests (99% increase) and control practices made 74 fewer requests (23% decrease; P=0.001 for difference in median change). Four practices, three of which were singlehanded, accounted for 75% of the increase. The number of requests from intervention practices, adjusted for baseline requests, was 3.2 times higher than control practices (P<0.0001). CONCLUSION: General practitioners and practice nurses are willing to undertake a new genetic screening service (or expand an existing one) if they are persuaded that it benefits the health of a significant proportion of their practice population. They need appropriate tools (for example, information materials for carriers and groups at risk), and the laboratory must be sensitive to their needs. Preconceptional carrier screening and counselling need to be coupled with antenatal screening.

Communication↗

PubMed2004

Once a week is not enough: effects of a widely implemented group based exercise programme for older adults; a randomised controlled trial.

OBJECTIVES: To determine the effects of gymnastics on the health related quality of life (HRQoL) and functional status of independently living people, aged 65 to 80 years. Gymnastics formed part of the More Exercise for Seniors (MBvO in Dutch) programme, a group based exercise programme for older adults in the Netherlands. It has been widely implemented since 1980. DESIGN: Randomised controlled trial with pretest and post-test measurements. INTERVENTION: The exercise programme given by experienced instructors lasted 10 weeks and was given weekly (MBvO1; n = 125, six groups) or twice weekly (MBvO2; n = 68, six groups). The control group (n = 193) was offered a health education programme. SETTING: Community dwelling of older people, with a comparatively low level of fitness as assessed with the Groningen Fitness test for the Elderly. RESULTS: No significant effects were found on the HRQoL (Vitality Plus Scale, TAAQoL, and RAND-36) and the functional status (Physical Performance Test and the Groningen Activity Restriction Scale). The MBvO2 group, with a low level of physical activity at baseline, showed the only improvement found on the Vitality Plus Scale (F = 4.53; p = 0.01). CONCLUSIONS: MBvO gymnastics once a week did not provide benefits in HRQoL and functional status after 10 weeks. However, participants with a low level of physical activity may benefit from MBvO gymnastics if they participate twice a week. To improve the health of the general public, sedentary older adults should be recruited and encouraged to combine MBvO with the health enhancing physical activity guidelines.

Activities of Daily Living↗

PubMed1999

Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Medical Research Council Renal Cancer Collaborators.

BACKGROUND: Metastatic renal carcinoma has a 2-year survival of around 20% and is largely resistant to chemotherapy. The use of interferons in the treatment of metastatic renal carcinoma remains controversial. Although non-randomised studies suggest that biological therapy with interferons produces a small number of tumour responses, most clinicians judge such treatment to be ineffective. We have investigated the effect of treatment with interferon-alpha on survival in patients with metastatic renal carcinoma. METHODS: In a multicentre, randomised trial, patients with metastatic renal carcinoma were randomly assigned subcutaneous interferon-alpha (three doses--5 MU, 5 MU, 10 MU--for the first week, then 10 MU three times per week for a further 11 weeks; n=174) or oral medroxyprogesterone acetate (MPA; 300 mg once daily for 12 weeks; n=176). The primary endpoint was overall survival. Analysis was by intention to treat. The trial used a triangular sequential design for early termination as soon as results were conclusive. The trial was stopped in November, 1997, when data were available for 335 patients (167 interferon-alpha, 168 MPA). FINDINGS: A total of 111 patients have died in the interferon-alpha group, and 125 patients have died in the MPA group. There was a 28% reduction in the risk of death in the interferon-alpha group (hazard ratio 0.72 [95% CI 0.55-0.94], p=0.017). Interferon-alpha gave an improvement in 1-year survival of 12% (MPA 31% survival, interferon-alpha 43%), and an improvement in median survival of 2.5 months (MPA 6 months, interferon-alpha 8.5 months). INTERPRETATION: The benefit of treatment with interferon-alpha should be weighed against the drug's toxic effects. Combination regimens of biological therapy and chemotherapy should now be compared with interferon-alpha monotherapy in randomised controlled trials.

Aged↗

PubMed2005

Lack of effect of shorter turnaround time of microbiological procedures on clinical outcomes: a randomised controlled trial among hospitalised patients in the Netherlands.

Shortening the turnaround time of microbiological procedures was associated with an improved clinical outcome in two studies performed in the USA. To study the clinical impact of a shortened turnaround time in a northwest European setting in which an automated system was used for bacterial identification and susceptibility testing, a single-blind, prospective, randomised controlled trial was conducted in a hospital in the Netherlands. All hospitalised patients with a bacterial infection confirmed by culture were randomly assigned to a control (conventional) group or an intervention (rapid) group. Overnight methods were used for identification and susceptibility testing in the control group, while the Vitek 2 system (bioMerieux, Marcy l'Etoile, France) was used in the rapid group. In each of three consecutive study periods, accelerating factors were added progressively to the laboratory workflow of the rapid group to increase same-day reporting, whereas methods remained identical in the conventional group. The turnaround time of the microbiological cycle using the Vitek 2 system as compared to conventional methods was studied and the clinical impact of a shortened turnaround time assessed in terms of mortality, morbidity, and cost. For the rapid groups, the turnaround time was significantly shorter for oral reporting of final susceptibility results in all three study periods and for reporting on paper in the third study period. There was no significant difference between groups in any of the clinical impact variables. Vitek 2 results were available for reporting significantly earlier as compared to conventional testing. For the overall patient group in our hospital setting, however, this had no clinical impact.

Aged↗

PubMed1994

Randomised controlled trial of routine cervical examinations in pregnancy. European Community Collaborative Study Group on Prenatal Screening.

Preterm delivery is strongly associated with neonatal mortality and morbidity. In some European countries, cervical examinations are used routinely during pregnancy to identify women at risk of preterm delivery. We sought to evaluate the efficacy and secondary effects of these routine cervical examinations. We did a randomised controlled trial in seven European countries, comparing two policies--namely, an attempt to do a cervical examination at every prenatal visit (2803 women) and avoidance of cervical examination if possible (2799). The median number of cervical examinations was 6 in the experimental group and 1 in the controls. There were 6.7% preterm (< 37 weeks) deliveries in the experimental group and 6.4% in the control group (risk ratio 1.05 [95% confidence interval 0.85-1.29]; non-significant). The low birthweight rate was 6.6% in the experimental group and 7.7% in the controls (non-significant). Premature rupture of membranes was not significantly more frequent in the experimental group (27.1% vs 26.5%). Our findings do not support the routine use of cervical examinations during pregnancy.

Adult↗

PubMed2005

Peri-operative physiotherapy improves outcomes for women undergoing incontinence and or prolapse surgery: results of a randomised controlled trial.

BACKGROUND: Urinary incontinence and pelvic organ prolapse are common complaints in women. Physiotherapy and surgery to correct these conditions are often seen as mutually exclusive. No study has yet investigated their synergistic potential. AIM: This study aimed to investigate the role of peri-operative physiotherapy in women undergoing corrective surgery for pelvic organ prolapse and/or incontinence. METHODS: In this randomised controlled trial, 30 women underwent preoperative physiotherapy and 30 others had no physiotherapy prior to their incontinence and or prolapse surgeries. Comparison was performed on the basis of the following tests: paper towel test, urinary symptom specific health and quality of life questionnaire, frequency/volume chart and pelvic floor muscle manometry. Women were followed up for 3 months. RESULTS: Both groups showed improvement in urinary continence. Significant group differences were noted in the quality of life questionnaire (P= 0.004), urinary symptoms (P= 0.017) and maximum pelvic floor muscle squeeze on manometry (P= 0.022). Diurnal frequency analysis indicates that there is a significant difference in favour of the treatment group (P= 0.024). CONCLUSION: Routine pre and post operative physiotherapy interventions improve physical outcomes and quality of life in women undergoing corrective surgery for urinary incontinence and or pelvic organ prolapse.

Adult↗