PubMed Health⌕ Search

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 1,765 records · Page 98Linked to original sources

Conceptual bases and methodology for the evaluation of women's and providers' perception of the quality of antenatal care in the WHO Antenatal Care Randomised Controlled Trial.

In this paper, we describe the conceptual bases and methodology used to assess women's and providers' perception of the quality of antenatal care, as part of a large randomised trial in four developing countries. Information has been obtained by applying both qualitative and quantitative methodologies. The focus group discussions and in-depth interviews have contributed useful insights into the cultural milieu in which care is provided, users' and providers' expectations, and their concept of quality. Based on these findings, we developed two standardised questionnaires, one being administered to a representative sample of pregnant women (n = 1600) and the other for all care providers. In this paper we present some of the findings of the focus group discussions and in-depth interviews with women in one country as an example of the kind of information we have obtained. Women expressed their point of view concerning a reduced number of visits, type of provider, information that they get during clinical encounters and interpersonal relations with health professionals. The qualitative information, together with the data we obtain from the surveys, will highlight the aspects that will have be to considered if the new model of care is to be introduced on a routine basis.

Argentina↗

Service variation in baseline variables and prediction of risk in a randomised controlled trial of psychological treatment in repeated parasuicide: the POPMACT Study.

The treatment protocol and baseline characteristics of 480 subjects with a history of repeated parasuicide recruited in five centres to a randomised therapeutic trial of manual assisted cognitive-behaviour therapy (MACT) and treatment as usual (TAU) are described. Most patients had significant anxiety and depressive disturbance with 42% having a personality disorder. Variation in service policies influenced recruitment, with earlier assessment centres seeing people with more frequent episodes of self-harm and greater parasuicide risk than later ones. Parasuicide risk was also significantly greater in those with their first parasuicide episode at an earlier age and in those with a more recent latest episode.

Adult↗

Effect of hyaluronidase on ocular motility and eyelid function in sub-Tenon's anaesthesia: randomised controlled trial.

PURPOSE: To assess the effect of hyaluronidase on eye and eyelid movements when used as an adjunct in sub-Tenon's anaesthesia. METHODS: A total of 60 patients who had sub-Tenon's anaesthesia prior to phacoemulsification surgery were divided into two equal groups in a double-masked randomised controlled fashion. Of these, Group A had 4 ml lignocaine 2%, while Group B had 4 ml lignocaine 2% with the addition of sodium hyaluronidase 75 IU/ml. Ocular motility, levator, and orbicularis oculi function were measured in all patients at 5 and 8 min. Levator function was scored from 0 (no function) to 3 (complete function) while orbicularis function was scored from 0 to 2. The score for ocular motility was the sum in four positions of gaze, each position scoring from 0 to 2. Results were compared using a nonparametric test. RESULTS: Group B achieved significantly better ocular and lid akinesia than Group A both at 5 and 8 min with P<0.01. The median scores for levator function at 5 and 8 min were 2 for Group A and 0 for Group B. For orbicularis function, the median scores at both time intervals were 2 for Group A and 1 for Group B. For ocular motility, the median score for Group A at 5 min was 3 and at 8 min was 2.5; for Group B at 5 min was 0.5 and at 8 min was 0. CONCLUSIONS: The addition of hyaluronidase in sub-Tenon's anaesthesia has a significant effect in improving ocular and lid (levator and orbicularis) akinesia.

Adjuvants, Anesthesia↗

Cost-effectiveness of referral for generic care or problem-solving treatment from community mental health nurses, compared with usual general practitioner care for common mental disorders: Randomised controlled trial.

BACKGROUND: UK general practitioners (GPs) refer patients with common mental disorders to community mental health nurses. AIMS: To determine the effectiveness and cost-effectiveness of this practice. METHOD: Randomised trial with three arms: usual GP care, generic mental health nurse care, and care from nurses trained in problem-solving treatment; 98 GPs in 62 practices referred 247 adult patients with new episodes of anxiety, depression and life difficulties, to 37 nurses. RESULTS: There were 212 (86%) and 190 (77%) patients followed up at 8 and 26 weeks respectively. No significant differences between groups were found in effectiveness at either point. Mean differences in Clinical Interview Schedule - Revised scores at 26 weeks compared with GP care were -1.4 (95% CI -5.5 to 2.8) for generic nurse care, and 1.1 (-2.9 to 5.1) for nurse problem-solving. Satisfaction was significantly higher in both nurse-treated groups. Mean extra costs per patient were 283 pound (95% CI154-411) for generic nurse care, and 315 pound (183-481) for nurse problem-solving treatment. CONCLUSIONS: GPs should not refer unselected patients with common mental disorders to specialist nurses. Problem-solving should be reserved for patients who have not responded to initial GP care.

Adolescent↗

Drug-resistance genotyping in HIV-1 therapy: the VIRADAPT randomised controlled trial.

BACKGROUND: Growing evidence has linked HIV-1 resistance mutations and drug failure. The use of genotypic-resistance analysis to assist therapeutic decision-making in patients failing therapy has not been investigated. We assessed the virological and immunological impact of genotypic-resistance testing. METHODS: We did a prospective, open, randomised, controlled study of HIV-1-infected patients in whom combination therapy was not successful. We randomly assigned patients standard care (control, n=43) or treatment according to the resistance mutations in protease and reverse-transcriptase genes (genotypic group, n=65). The major endpoint was the change in HIV-1 RNA viral load. Analysis was by intention to treat. FINDINGS: 108 patients were enrolled. All patients were similar for risk factors, age, sex, previous treatment, CD4-cell count (214/microL [SD14]) and log HIV-1 RNA viral load at baseline (4.7 copies/mL [0.1]). At month 3, the mean change in HIV-1 RNA was -1.04 log (0.14) in the study group compared with -0.46 log (0.17) in the control group (mean difference 0.58 log [95% CI 0.14-1.02], p=0.01). At month 6, changes were -1.15 (0.15) log copies/mL, and -0.67 (0.19) log copies/mL in the genotypic group and the control group, respectively (mean difference 0.48 log [0.01-0.97], p=0.05). Difference in the drop in viral load combined at 3 months and 6 months was significant (p=0.015). At month 3, HIV-1 RNA was lower than detection level (200 copies/mL) in 29% (19/65) of patients in the genotypic group versus 14% (6/43) in the control group (p=0.017). At month 6, the values were 32% (21/65) and 14% (6/43) (p=0.067) for the genotypic group and the control group, respectively. Therapy was generally well tolerated, with ten patients (six in the genotypic group, four in the control group) requiring toxic-effect-related drug modification. INTERPRETATION: We found genotypic-resistance testing to have a significant benefit on the virological response when choosing a therapeutic alternative. Further study of the use of genotypic-resistance testing in assisting clinical decision-making is warranted.

Acquired Immunodeficiency Syndrome↗

A randomised, controlled trial of cemented versus cementless press-fit condylar total knee replacement. Ten-year survival analysis.

We have carried out a long-term survival analysis of a prospective, randomised trial comparing cemented with cementless fixation of press-fit condylar primary total knee replacements. A consecutive series of 501 replacements received either cemented (219 patients, 277 implants) or cementless (177 patients, 224 implants) fixation. The patients were contacted at a mean follow-up of 7.4 years (2.7 to 13.0) to establish the rate of survival of the implant. The ten-year survival was compared using life-table and Cox's proportional hazard analysis. No patient was lost to follow-up. The survival at ten years was 95.3% (95% CI 90.3 to 97.8) and 95.6% (95% CI 89.5 to 98.2) in the cemented and cementless groups, respectively. The hazard ratio for failure in cemented compared with cementless prostheses was 0.97 (95% CI 0.36 to 2.6). A comparison of the clinical outcome at ten years in 80 knees showed no difference between the two groups. The survival of the press-fit condylar total knee replacement at ten years is good irrespective of the method of fixation and brings into question the use of more expensive cementless implants.

Arthritis, Rheumatoid↗

Randomised controlled trial of computer assisted management of hypertension in primary care.

The hypothesis that general practitioners would obtain better outcomes for patients with hypertension using a computer than doctors not using a computer was tested. Sixty family physicians were randomised to two treatment strategies. "Test" physicians completed a data collection form after each visit from a patient with hypertension and mailed the forms to the test centre for processing. Computer feedback on management was mailed to the doctors. This encouraged doctors to apply the "stepped care" protocol, supplied charts of diastolic blood pressure v time, and ranked patients' diastolic blood pressures by percentile. Letters were mailed to patients to remind them of appointments. "Control" doctors filled out the same data collection forms as test physicians, but neither doctors nor patients received computer feedback. Physicians who used the computer saw more patients per practice than control doctors (test 50 patients, control 40). For all patients the length of follow up was significantly longer in test practices (test 199 days, control 167), and a smaller percentage dropped out of active treatment in test practices (test 37.5%, control 42.1%). For patients with "moderate" hypertension of a baseline diastolic pressure of greater than 104 mm Hg the mean score of the last recorded pressure was below the goal of 90 mm Hg in test practices (88.5 mm Hg), but it failed to reach this goal in control practices (93.3 mm Hg). A greater average reduction of diastolic pressure was achieved in test practices (test 21.7 mm Hg, control 16.7 mm Hg). Though patients with "moderate" hypertension were better controlled in test practices than in control practices, the patients in test practices visited their doctors less often (test 13.3 visits per patient-year, control 17.4 visits). Among patients with newly detected hypertension test practices achieved a greater reduction in diastolic pressure than control practices (test 15.1 mm Hg v control 11.3 mm Hg) and more sustained control of hypertension (test 323 days per patient-year with a diastolic pressure of 90 mm Hg or less v control 259 days).

Blood Pressure↗

Left thoracoabdominal approach versus abdominal-transhiatal approach for gastric cancer of the cardia or subcardia: a randomised controlled trial.

BACKGROUND: Because of the inaccessibility of mediastinal nodal metastases, the left thoracoabdominal approach (LTA) has often been used to treat gastric cancer of the cardia or subcardia. In a randomised phase III study, we aimed to compare LTA with the abdominal-transhiatal approach (TH) in the treatment of these tumours. METHODS: Between July, 1995, and December, 2003, 167 patients were enrolled from 27 Japanese hospitals and randomly assigned to TH (n=82) or LTA (n=85). The primary endpoint was overall survival, and secondary endpoints were disease-free survival, postoperative morbidity and hospital mortality, and postoperative symptoms and change of respiratory function. The projected sample size was 302. After the first interim analysis, the predicted probability of LTA having a significantly better overall survival than TH at the final analysis was only 3.65%, and the trial was closed immediately. Analysis was by intention to treat. This study is registered with , number NCT00149266. FINDINGS: 5-year overall survival was 52.3% (95% CI 40.4-64.1) in the TH group and 37.9% (26.1-49.6) in the LTA group. The hazard ratio of death for LTA compared with TH was 1.36 (0.89-2.08, p=0.92). Three patients died in hospital after LTA but none after TH. Morbidity was worse after LTA than after TH. INTERPRETATION: Because LTA does not improve survival after TH and leads to increased morbidity in patients with cancer of the cardia or subcardia, LTA cannot be justified to treat these tumours.

Adult↗

Early administration of Bifidobacterium breve to preterm infants: randomised controlled trial.

AIM: To investigate the colonisation with Bifidobacterium breve of the bowels of very low birthweight (VLBW) infants. METHODS: The adverse effects of B breve were examined in 66 VLBW infants (preliminary study). A prospective randomised clinical study of 91 VLBW infants was also completed and these infants were followed up for three years. Precise viable bacterial counts of serial stool specimens were examined for the first eight weeks after birth in 10 infants. The colonisation rates of administered bacteria were examined using immunohistochemical staining of stool specimens with a B breve specific monoclonal antibody. RESULTS: In the preliminary study there were no side effects attributable to the bacteria. Immunohistochemical staining of stool specimens showed that the colonisation rates of the administered bacteria were 73% at 2 weeks of age, but only 12% in the control group. Early administration of B breve significantly decreased aspirated air volume from the stomach and improved weight gain. CONCLUSIONS: B breve can colonise the immature bowel very effectively and is associated with fewer abnormal abdominal signs and better weight gain in VLBW infants, probably as a result of stabilisation of their intestinal flora and accelerated feeding schedules.

Bifidobacterium↗

A randomised controlled trial of specialist health visitor intervention for failure to thrive.

AIMS: To determine whether home intervention by a specialist health visitor affects the outcome of children with failure to thrive. METHODS: Children referred for failure to thrive were randomised to receive conventional care, or conventional care and additional specialist home visiting for 12 months. Outcomes measured were growth, diet, use of health care resources, and Bayley, HAD (hospital anxiety and depression), and behavioural scales. RESULTS: Eighty three children, aged 4-30 months, were enrolled, 42 received specialist health visitor intervention. Children in both groups showed good weight gain (mean (SD) increase in weight SD score for the specialist health visitor intervention group 0.59 (0.63) v 0.42 (0.62) for the control group). Children < 12 months in the intervention group showed a higher mean (SD) increase in weight SD score than the control group (0.82 (0.86) v 0.42 (0.79)). Both groups improved in developmental score and energy intake. No significant differences were found for the primary outcome measures, but controls had significantly more dietary referrals, social service involvement, and hospital admissions, and were less compliant with appointments. CONCLUSIONS: The study failed to show that specialist health visitor intervention conferred additional benefits for the child. However, the specialist health visitor did provide a more coordinated approach, with significant savings in terms of health service use. Problems inherent to health service research are discussed.

Child Behavior↗

A prospective randomised controlled trial of VNUS closure versus surgery for the treatment of recurrent long saphenous varicose veins.

OBJECTIVE: This study aimed to assess the outcome of endoluminal thermal ablation (VNUS) and traditional redo groin surgery (RGS) and long saphenous vein (LSV) stripping in patients with bilateral recurrent long saphenous varicose veins. METHODS: This was a randomised patient controlled double blind study. Sample size calculations required 16 patients. Their median age was 54 and 11 were women. The median CEAP class was 3. At operation one leg, chosen at random, was treated with VNUS and avulsions using intra-operative duplex control. The other leg was treated with traditional RGS, exposure of the femoral vein, stripping of the LSV and multiple avulsions. Post-operatively patients completed 10 cm visual analogue scales for pain and bruising. Digital Image analysis was used to objectively assess bruising. Statistical analysis was done using Wilcoxon signed rank test for paired data. Results are expressed as median values (inter-quartile ranges). RESULTS: Time to perform VNUS was 25.5 (20.5-31.3) min compared with 40 (34.5-45.5) min it took for RGS (p=0.02). Pain score for VNUS was 1.7 (0.2-4), significantly lower than that for RGS 3.8 (0.6-6.3) (p=0.02). Bruise score for VNUS was 1.7 (0.4-4.4), and that for RGS was 5.2 (2.6-7) (p=0.03). All LSVs were sealed by VNUS at duplex follow up. Three legs in the RGS group and two in the VNUS group had a minor complication. CONCLUSIONS: VNUS caused less pain and bruising and was performed more quickly than RGS. VNUS should be considered the treatment of choice for recurrent long saphenous varicose veins.

Adult↗

Effects of exercise on depressive symptoms in older adults with poorly responsive depressive disorder: randomised controlled trial.

BACKGROUND: Depression is common in later life. AIMS: To determine whether exercise is effective as an adjunct to antidepressant therapy in reducing depressive symptoms in older people. METHOD: Patients were randomised to attend either exercise classes or health education talks for 10 weeks. Assessments were made "blind" at baseline, and at 10 and 34 weeks. The primary outcome was seen with the 17-item Hamilton Rating Scale for Depression (HRSD). Secondary outcomes were seen with the Geriatric Depression Scale, Clinical Global Impression and Patient Global Impression. RESULTS: At 10 weeks a significantly higher proportion of the exercise group (55% v. 33%) experienced a greater than 30% decline in depression according to HRSD (OR=2.51, P=0.05, 95% CI 1.00-6.38). CONCLUSIONS: Because exercise was associated with a modest improvement in depressive symptoms at 10 weeks, older people with poorly responsive depressive disorder should be encouraged to attend group exercise activities.

Aged↗

Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial.

BACKGROUND: Diabetic foot wounds, particularly those secondary to amputation, are very complex and difficult to treat. We investigated whether negative pressure wound therapy (NPWT) improves the proportion and rate of wound healing after partial foot amputation in patients with diabetes. METHODS: We enrolled 162 patients into a 16-week, 18-centre, randomised clinical trial in the USA. Inclusion criteria consisted of partial foot amputation wounds up to the transmetatarsal level and evidence of adequate perfusion. Patients who were randomly assigned to NPWT (n=77) received treatment with dressing changes every 48 h. Control patients (n=85) received standard moist wound care according to consensus guidelines. NPWT was delivered through the Vacuum Assisted Closure (VAC) Therapy System. Wounds were treated until healing or completion of the 112-day period of active treatment. Analysis was by intention to treat. This study has been registered with , number NCT00224796. FINDINGS: More patients healed in the NPWT group than in the control group (43 [56%] vs 33 [39%], p=0.040). The rate of wound healing, based on the time to complete closure, was faster in the NPWT group than in controls (p=0.005). The rate of granulation tissue formation, based on the time to 76-100% formation in the wound bed, was faster in the NPWT group than in controls (p=0.002). The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups. INTERPRETATION: NPWT delivered by the VAC Therapy System seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care.

Air Pressure↗

Improving hypertension control among excessive alcohol drinkers: a randomised controlled trial in France. The WALPA Group.

OBJECTIVES: To improve blood pressure control among hypertensive ( > 140/90 mmHg) excessive alcohol drinkers. DESIGN: Fourteen worksite physicians were randomised onto an intervention group and a control group. The intervention was based on training the worksite physicians and follow up of those hypertensive subjects defined as excessive drinkers. Follow up was based on self monitoring of alcohol consumption by the subject, in view of the results of their gamma glutamyl transferase (GGT) activity determination. SETTING: Fourteen workplaces in France - mainly in the industrial sector. SUBJECTS: Altogether 15 301 subjects were screened by the 14 physicians: 129 of these were included in the study. MAIN OUTCOME MEASURES: This was the difference between the initial systolic blood pressure (SBP) and the SBP one year later (delta BP). Secondary criteria were the difference between the initial and final diastolic blood pressure (delta DBP) and delta BP at two years; antihypertensive treatment; state alcohol consumption (delta AC); delta GGT; and body mass index (delta BMI). RESULTS: The decrease in SBP levels was significantly larger in the intervention group than in the control group: at one year, delta SBP values were -11.9 (15.6) mmHg and -4.6 (13.8) respectively (p < 0.05). This benefit was still observed after two years of follow up (-13.8 (17.4) mmHg v -7.5 (14.2) mmHg (p < 0.05)). No difference was observed in DBP. The percentage of treated subjects did not differ between groups. At one year, delta AC was larger in the intervention group (-2.8 (5.2) U/d) than in the control group (-1.6 (3.4) (p < 0.1)). delta GGT and delta BMI did not differ between the two groups. A weak positive correlation was observed between delta AC and delta SBP (r = 0.16). CONCLUSION: An intervention aimed at the hypertensive excessive drinkers in a working population was found to be effective in reducing SBP on a long term basis (two years). The mechanisms of reduction in alcohol consumption and improved drug compliance cannot be ascertained in this pragmatic study. From a public health point of view, reducing the excess cardiovascular risk among a "hard to reach" population seems feasible with a strategy specifically designed for this high risk group.

Absenteeism↗

Short-term effectiveness of ceftriaxone single dose in the initial treatment of acute uncomplicated pyelonephritis in women. A randomised controlled trial.

OBJECTIVE: To compare the short-term effectiveness of ceftriaxone single dose followed by cefixime with a standard treatment of acute uncomplicated pyelonephritis in women. METHODS: An open, prospective, and randomised trial of women with acute uncomplicated pyelonephritis was performed. Group A were given a daily intravenous dose of 1 g ceftriaxone; group B: ceftriaxone 1 g intravenous single dose followed by oral cefixime. When urine culture was received, both groups completed a 10 day treatment based in sensitivity studies. Only women with positive initial urine culture were included. After three days of treatment, clinical and bacteriological efficacy was assessed. Clinical response was classified as "cured" if acute symptoms (fever, urinary syndrome and flank pain) were settled. Bacteriological response was classified as: eradication, or no eradication. RESULTS: Of 144 eligible patients, urine culture was positive in 54 of 72 (75%) women in group A and 51 of 72 (71%) in group B. There were no significant differences between groups in resolution of acute symptoms. Clinical cure was observed in 49 of 54 (91%) patients in the group A and in 47 of 51 (92%) patients in the group B (p = 0.68). After three days of treatment urine culture was negative for all patients. No adverse effects were observed in either of the groups. CONCLUSION: These data suggest that a intravenous single dose of ceftriaxone followed by oral cefixime is both effective and safe for the initial treatment of acute uncomplicated pyelonephritis in women. This regimen could be useful in managing selected patients with pyelonephritis as outpatients.

Acute Disease↗

Long-term follow-up in a randomised controlled trial of recombinant alpha 2-interferon in Chinese patients with chronic hepatitis B infection.

72 Chinese patients who had been positive for hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) for more than six months with stable serum hepatitis B virus DNA were randomised to receive recombinant alpha 2-interferon at doses of 2.5, 5, or 10 X 10(6) U/m2 intramuscularly thrice weekly for 12-24 weeks, or no treatment. 6 (11%) of 54 treated and 1 (6%) of 18 control patients became HBeAg-negative at the end of therapy or after 24 weeks of follow-up. 9 (17%) of treated but none of the control patients became HBeAg-negative between completion of therapy and 12 months. Reactivation of HBV replication subsequently occurred in 7 (13%) of the treated patients and in 1 control. Thus, sustained clearance of HBeAg was achieved only in 8 (15%) of treated patients at 12 months. Between 12 and 24 months 3 (9%) of treated patients and 1 control became negative for HBeAg. None of the patients became HBsAg-negative. alpha 2-interferon in the dose regimen used has little long-term effect in the suppression of HBV replication in Chinese patients with chronic HBV infection.

Adolescent↗

Treatment of superficial venous incompetence with the SAVAS technique--(Section Ambulatoire des Varices avec Sclérothérapie). A 4 year randomised, controlled trial comparing venous hemodynamic and costing after SAVAS, sclerotherapy and the dentist's technique.

Three techniques for treatment of chronic venous incompetence on an out patients basis were compared in a randomised study. One hundred thirty eight limbs (107 patients) with superficial venous incompetence were randomly treated with the dentist's technique (DT) [Group A, 44 limbs], compression sclerotherapy (CS) [Group B, 45 limbs] or the SAVAS (section en Ambulatoire des Varices avec Sclérothérapie) technique [Group C, 49 limbs]. Patients were evaluated and followed up (every year for 4 years) with ambulatory venous pressure (AVP) measurements and Quantum angiodynography (colour duplex scanning). DT consisted in the section under local anesthesia of incompetent veins. CS was done injecting polidocanol 3% with compression applied for 4 weeks. The SAVAS was done with a combination of DT and CS with section of the incompetent veins under local anesthesia and retrograde injection in the distal vein of polidocanol 3%. With this type of injection only incompetent veins were perfused. After 4 years there was a significantly lower refilling time (RT) with AVP in the SAVAS group (21 sec). RT was 13 sec in group B and 16 in A. The number of significantly incompetent residual veins was in average 0.5 in the SAVAS group, significantly lower than in the other two groups. Also the average cost per treated limb was significantly lower in the SAVAS group (917 francs in comparison with 1100 in group A and 1211 in group B). In conclusion considering the four year follow up, the SAVAS technique is a more effective treatment of superficial venous incompetence, its hemodynamic value is superior to sclerotherapy alone and its costs are lower.

Adult↗