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Results for “Randomized controlled trials”

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PubMed2005

Appraising the quality of randomized controlled trials: inter-rater reliability for the OTseeker evidence database.

RATIONALE AND AIMS: 'OTseeker' is an online database of randomized controlled trials (RCTs) and systematic reviews relevant to occupational therapy. RCTs are critically appraised and rated for quality using the 'PEDro' scale. We aimed to investigate the inter-rater reliability of the PEDro scale before and after revising rating guidelines. METHODS: In study 1, five raters scored 100 RCTs using the original PEDro scale guidelines. In study 2, two raters scored 40 different RCTs using revised guidelines. All RCTs were randomly selected from the OTseeker database. Reliability was calculated using Kappa and intraclass correlation coefficients [ICC (model 2,1)]. RESULTS: Inter-rater reliability was 'good to excellent' in the first study (Kappas >or= 0.53; ICCs >or= 0.71). After revising the rating guidelines, the reliability levels were equivalent or higher to those previously obtained (Kappas >or= 0.53; ICCs >or= 0.89), except for the item, 'groups similar at baseline', which still had moderate reliability (Kappa = 0.53). In study 2, two PEDro scale items, which had their definitions revised, 'less than 15% dropout' and 'point measures and variability', showed higher reliability. In both studies, the PEDro items with the lowest reliability were 'groups similar at baseline' (Kappas = 0.53), 'less than 15% dropout' (Kappas <or= 0.68) and 'point measures and variability data' (Kappas <or= 0.68). CONCLUSION: The PEDro scale is a reliable instrument for rating the quality of RCTs. Revised rating guidelines are provided for scale items that are difficult to rate, and helped to improve inter-rater reliability.

Australia↗

PubMed2000

A randomized controlled trial of rehabilitation at home after stroke in Southwest Stockholm: outcome at six months.

A 6-month follow-up of a single-blind, randomized, controlled trial in Southwest Stockholm was performed in order to evaluate the effect of early supported discharge and continued rehabilitation at home after stroke. Eighty-three stroke patients with moderate neurological impairments, continent, independent in feeding, and mental function within normal limits one week after onset were included in the study. The patients were allocated 1:1 to early supported discharge and continued rehabilitation at home by a specialized team, versus routine rehabilitation. Patient outcomes measured were motor capacity, dysphasia, activities of daily living, social activities, perceived dysfunction, mortality and reported falls. Data on length of stay in hospital; initial and recurrent during 6 months were compared. The 6-month follow-up of 78 patients showed no statistically significant differences in patient outcome. The results of multivariate logistic regression analysis suggest a positive effect of home rehabilitation on activities of daily living. At 3-6 months the frequency of significant improvements was higher in the intervention group. Death or dependency in activities of daily living was 24% in the intervention group compared with 44% in the control group. The mean initial hospitalization was 29 days in routine rehabilitation group versus 14 days in the home rehabilitation group. We conclude that for moderately disabled stroke patients with mental function within normal limits, early supported discharge and continued rehabilitation at home had no less a beneficial effect on patient outcome than routine rehabilitation, reduced initial hospitalization significantly and had no adverse effects on mortality and number of falls.

Activities of Daily Living↗

PubMed2004

Does primary care referral to an exercise programme increase physical activity one year later? A randomized controlled trial.

OBJECTIVE: To assess the effectiveness of a primary care referral scheme on increasing physical activity at 1 year from referral. Design Two-group randomized controlled trial recruiting primary care referrals to a borough-based exercise scheme. Setting A local authority borough in the north-west of England. Participants 545 patients defined as sedentary by a primary care practitioner. Intervention Referral to a local-authority exercise referral scheme and written information compared with written information only. Main outcome measures Meeting physical activity target at 12 months following referral, with a secondary outcome measured at 6 months from referral. RESULTS: At 12 months, a non-significant increase of 5 per cent was observed in the intervention compared with control group, for participation in at least 90 minutes of moderate/vigorous activity per week (25.8 versus 20.4 per cent, OR 1.45, 0.84 to 2.50, p = 0.18). At 6 months, a 10 per cent treatment effect was observed which was significant (22.6 versus 13.6 per cent, OR 1.67, 1.08 to 2.60, p = 0.05). The intervention increased satisfaction with information but this did not influence adherence with physical activity. CONCLUSION: Community-based physical activity referral schemes have some impact on reducing sedentary behaviour in the short-term, but which is unlikely to be sustained and lead to benefits in terms of health.

Adolescent↗

PubMed2004

Matching patients and practitioners based on beliefs about care: results of a randomized controlled trial.

OBJECTIVE: To determine whether an intervention designed to inform and guide patients in choosing a primary care provider (PCP) could increase satisfaction and trust. DESIGN: A randomized controlled trial conducted at the Santa Clara Medical Center of the Kaiser Permanente Medical Care Program in Northern California. PATIENTS AND METHODS: Patients needing a PCP were randomly assigned to Informed Choice (provider-level information offered), Guided Choice (PCP names provided based on the similarity of patients' and practitioners' patient-centered beliefs, and patients then chose), or Usual Care. One year later, mailed questionnaires asked about patients' trust and satisfaction, perceptions of the choice process, and trust and satisfaction with Kaiser Permanente. More than 5000 adult patients were linked with a PCP as part of the project, and completed surveys were returned by 2437 patients. RESULTS: Neither intervention arm generated better matches on patient-practitioner beliefs than Usual Care; however, trust and satisfaction were higher among Guided Choice patients. Across study arms, patient-practitioner belief discrepancy showed a consistent positive association with trust, satisfaction, and attitudes toward Kaiser Permanente. CONCLUSIONS: The discrepancy between patient and practitioner beliefs about care is an important determinant of trust and satisfaction, and involving patients in the selection of their PCP can have an independent positive effect. It should be possible to build on the experience of this project to develop programs that better match patients and practitioners within managed care plans.

Adult↗

PubMed1988

Randomized, controlled trial of recombinant human alpha-interferon in patients with chronic hepatitis B.

Forty-five patients with chronic hepatitis B were entered into a randomized controlled trial of recombinant human alpha-interferon therapy. All patients had hepatitis B surface antigen in serum for at least 1 yr and had stable serum levels of both hepatitis B virus deoxyribonucleic acid and hepatitis B e antigen. During the 4-mo period of therapy, 10 of 31 (32%) treated patients and only 1 of 14 (7%) control patients became negative for serum hepatitis B virus deoxyribonucleic acid and deoxyribonucleic acid polymerase. All 10 patients who became negative for serum hepatitis B virus deoxyribonucleic acid subsequently had a marked improvement in serum aminotransferase activities and lost hepatitis B e antigen from serum, and 9 of them had improvement in liver histology. Comparison of responders to nonresponders indicated that female sex and a high initial level of serum aspartate aminotransferase correlated best with response to interferon therapy. These findings indicate that a 4-mo course of recombinant alpha-interferon can induce a remission in disease in approximately one-third of patients with chronic hepatitis B.

Adolescent↗

PubMed1993

Randomized controlled trial of recombinant alpha-2a-interferon for chronic hepatitis C. Comparison of alanine aminotransferase normalization versus loss of HCV RNA and anti-HCV IgM.

We enrolled 32 patients with chronic hepatitis C into a randomized, controlled trial to evaluate the efficacy of recombinant alpha-2a-interferon treatment. Sixteen patients were randomized to receive 1.5 million units of recombinant alpha-2a-interferon subcutaneously, thrice weekly, for six months while the remaining 16 patients were randomized to a control group that received no treatment. The mean serum alanine aminotransferase (ALT) level during the six-month study period, expressed as a percentage of the prestudy baseline value, was 82% for the control group compared to 56% for the treatment group (P = 0.014). One fourth of the treatment group normalized their serum ALT level compared to only 6% of the controls (P = 0.05). During posttherapy follow-up, 86% of responders clinically relapsed. Loss of anti-HCV IgM and HCV RNA occurred exclusively in interferon-treated responders. Anti-interferon antibodies developed in 32% of all treated patients. Forty percent of nonresponders developed anti-interferon antibodies compared to only 14% of responders (P = NS). We conclude that recombinant alpha-2a-interferon is clinically effective in patients with chronic hepatitis C. However, most responders in this trial of low-dose interferon relapsed upon cessation of treatment.

Adult↗

PubMed1991

Randomized controlled trial of antenatal social support to prevent preterm birth.

OBJECTIVE: To test the effect of a programme of additional antenatal social support on the occurrence of preterm birth (a birth from 20 to 36 weeks gestation) in women at risk of preterm birth. DESIGN: A prospective randomized controlled trial. The design was one of randomization before consent for a new treatment. SETTING: Three public hospital antenatal clinics in Perth and the offices of 87 obstetricians and general practitioners in Western Australia. SUBJECTS: 1970 pregnant women with poor obstetric histories entered the trial; 983 of these were randomly allocated to the programme group and 987 to the control group. INTERVENTIONS: Normal antenatal care was provided for both groups. In addition, members of the programme group were offered an intervention aimed at providing expressive (emotional) social support, consisting of antenatal home visits and telephone calls by midwives. Of the women allocated to the programme group, 24 refused consent and 69 were not traced before completion of their pregnancies, the remaining 890 women (90.5%) agreed to enter the programme, and each received at least one intervention. MAIN OUTCOME MEASURES: Gestational age at completion of the pregnancy. A pregnancy ending before 20 weeks was labelled a miscarriage. RESULTS: There were 126/981 (12.8%) preterm births in the programme group and 147/986 (14.9%) in the control group. The outcome data for two women in the programme group and one in the control group could not be found. The unadjusted odds ratio for preterm birth in the programme was 0.84 (95% CI 0.65-1.09). The observed relative reduction in preterm births associated with the programme was 13.8% (95% CI -8.2% to +31.5%) and the trial had a 60% power to exclude a true relative reduction of 25%. CONCLUSIONS: The results of this trial and those of other controlled clinical trials provide little evidence for the effectiveness of social support interventions in the prevention of preterm birth in women with poor obstetric histories.

Female↗

PubMed2006

Does reduction mammaplasty improve lung function test in women with macromastia? Results of a randomized controlled trial.

BACKGROUND: To determine the effects of reduction mammaplasty on lung function in women with mammary hypertrophy (macromastia), a prospective, randomized, controlled trial was conducted at the Academic Surgery and Plastic Surgery Units, Castle Hill Hospital, Cottingham, United Kingdom. METHODS: Seventy-three women who were referred for consideration of bilateral breast reduction surgery were randomized into either an early intervention group (surgery within 6 weeks) or a control group (surgery 6 months after recruitment). Each group had two sets of lung function tests: the intervention group had one before and one 3 months after surgery and the control arm had one test initially and a second test 4 months after randomization and before surgery. The main outcome measure was the lung function test. RESULTS: Sixty-five patients completed the study. The mean age was 39 years (SD, 12 years); both groups were equally matched for age, smoking status, social class, and educational status. By independent t test, there was no significant difference in lung function in the two groups. Subgroup analysis of the intervention group demonstrated a positive correlation between specimen weight and forced expiratory volume/vital capacity, forced expiratory volume/forced vital capacity, peak expiratory flow rate, and forced vital capacity. A paired sample t test revealed a significant improvement in the percentage of forced vital capacity performed/forced vital capacity predicted. CONCLUSION: The improvement in pulmonary function following reduction mammaplasty correlates with specimen weight resected.

Adolescent↗

PubMed2001

Evaluation of a hospital diabetes specialist nursing service: a randomized controlled trial.

AIMS: To evaluate the effectiveness and cost implications of a hospital diabetes specialist nursing service. METHODS: We conducted a prospective, open, randomized, controlled trial of standard in-patient care for adults with diabetes, with and without the intervention of a diabetes specialist nursing (DSN) service. The setting was a single UK university hospital. SUBJECTS: were unselected patients referred to the hospital DSN service. Primary outcome measures were length of hospital stay and patterns of readmission (frequency and time to first readmission). Secondary outcome measures were subjects' diabetes-related quality of life, diabetes knowledge score, satisfaction with treatment, and GP and community care contacts following discharge. Costs were estimated from the hospital and published sources. RESULTS: Median length of stay was lower in the intervention group (11.0 vs. 8.0 days, P < 0.01). Readmission rates were the same in the two groups (25%), and mean time to readmission was similar in the two groups, although slightly less in the control group (278 vs. 283 days, P = 0.80). The cost per patient for nursing input was 38.94 pounds sterling. However, when the reduced length of stay was accounted for, the intervention produced a mean cost per admission of 436 ponds sterling lower than that of the control group (P = 0.19). Patients in the intervention group were more knowledgeable regarding their diabetes and more satisfied with their care. CONCLUSIONS: Diabetes specialist nurses are potentially cost saving by reducing hospital length of stay (LOS). There was no evidence of an adverse effect of reduced LOS on re-admissions, use of community resources, or patient perception of quality of care.

Adult↗

PubMed2002

The cost-effectiveness of population Helicobacter pylori screening and treatment: a Markov model using economic data from a randomized controlled trial.

BACKGROUND: Economic models have suggested that population Helicobacter pylori screening and treatment may be a cost-effective method of reducing mortality from gastric cancer. These models are conservative as they do not consider that the programme may reduce health service peptic ulcer and other dyspepsia costs. We have evaluated the economic impact of population H. pylori screening and treatment over 2 years in a randomized controlled trial and have incorporated the results into an economic model exploring the impact of H. pylori eradication on peptic ulcer disease and gastric cancer. METHODS: Subjects between the ages of 40 and 49 years were randomly invited to attend their local primary care centre. H. pylori status was evaluated by (13)C-urea breath test and infected individuals were randomized to receive omeprazole, 20 mg b.d., clarithromycin, 250 mg b.d., and tinidazole, 500 mg b.d., for 7 days or identical placebos. Economic data on health service costs for dyspepsia were obtained from a primary care note review for the 2 years following randomization. These data were incorporated into a Markov model comparing population H. pylori screening and treatment with no intervention. RESULTS: A total of 2329 of 8407 subjects were H. pylori positive: 1161 were randomized to receive eradication therapy and 1163 to receive placebo. The cost difference favoured the intervention group 2 years after randomization, but this did not reach statistical significance (11.42 ponds sterling per subject cost saving; 95% confidence interval, 30.04 ponds sterling to -7.19 pounds sterling; P=0.23). Analysis by gender suggested a statistically significant dyspepsia cost saving in men (27.17 ponds sterling per subject; 95% confidence interval, 50.01 pounds sterling to 4.32 pounds sterling; P=0.02), with no benefit in women (-4.46 per subject; 95% confidence interval, -33.85 pounds sterling to 24.93 pounds sterling). Modelling of these data suggested that population H. pylori screening and treatment for 1,000,000 45-year-olds would save over 6,000,000 pounds sterling and 1300 years of life. The programme would cost 14, 200 pounds sterling per life year saved if the health service dyspepsia cost savings were the lower limit of the 95% confidence intervals and H. pylori eradication had only a 10% efficacy in reducing mortality from distal gastric cancer and peptic ulcer disease. CONCLUSIONS: Modelling suggests that population H. pylori screening and treatment are likely to be cost-effective and could be the first cost-neutral screening programme. This provides a further mandate for clinical trials to evaluate the efficacy of population H. pylori screening and treatment in preventing mortality from gastric cancer and peptic ulcer disease.

Adult↗

PubMed2026

Efficacy and safety of JAK inhibitors for vitiligo: an updated systematic review and meta-analysis of randomized controlled trials.

Purpose: Janus kinase (JAK) inhibitors are a promising therapeutic option for vitiligo, but previous meta-analyses have focused mainly on topical ruxolitinib versus placebo. Newer randomized controlled trials (RCTs) evaluating oral agents and head-to-head comparisons with active treatments have not been comprehensively synthesized. Materials and methods: We searched PubMed, Embase, the Cochrane Library, and Web of Science to 11 March 2026. Eligible RCTs evaluated JAK inhibitor monotherapy versus placebo or active comparators. Two reviewers screened records, extracted data, and assessed risk of bias using RoB 2.0. The primary outcome was F-VASI75. Meta-analyses used fixed-effect or random-effects models. GRADE assessed certainty of evidence. Results: Nine RCTs (1826 patients) were included. JAK inhibitors increased F-VASI75 versus placebo (RR 4.59, 95% CI 3.20-6.59; p < 0.001). For F-VASI50, they were superior to tacrolimus (RR 1.88, 95% CI 1.02-3.45) but not significantly different from dexamethasone (RR 2.17, 95% CI 0.95-4.94). Serious adverse events were comparable between groups (RR 1.15, 95% CI 0.57-2.33). Evidence certainty was moderate. Conclusions: JAK inhibitors are effective and well tolerated for vitiligo. Topical ruxolitinib is supported as a first-line option for limited facial disease; oral agents show promise but require longer-term safety data.

Humans↗

PubMed1986

A randomized controlled trial of low carbohydrate and low fat/high fiber diets for weight loss.

Among 135 overweight subjects, we conducted a three-month randomized controlled trial of two sets of dietary advice, each providing approximately 1,000 calories per day but differing in fiber, carbohydrate, and fat content. Information on weight and eating habits, as well as measures of lipoprotein and glucose metabolism were obtained at entry and one and three months later. We found that dieters given low carbohydrate/low fiber dietary advice tended to lose more weight than those given a higher carbohydrate/higher fiber regimen (5.0 vs 3.7 kg on average at three months). This pattern was particularly marked among women, and among participants who were under age 40 or of lower social class. There were no differences between the diet groups in the proportion complaining of hunger but, in general, members of the low carbohydrate group complained of more problems in dieting. There were only minor differences in the serum lipoprotein patterns during the diet period. In view of these results, we believe previous claims of the benefits of fiber for weight loss may have been overstated.

Adult↗

PubMed1999

SAFE PACE 2: Syncope and Falls in the Elderly--Pacing and Carotid Sinus Evaluation: a randomized controlled trial of cardiac pacing in older patients with falls and carotid sinus hypersensitivity.

SAFE PACE is a multicentre randomized controlled trial to assess the efficacy of dual-chamber pacing in older patients with carotid sinus hypersensitivity and recurrent unexplained falls. Patients are eligible if they have had two or more unexplained falls (+/- up to one syncope) and if they have a cardio-inhibitory response (>3 s asystole) to carotid sinus massage. Patients will be randomized to receive either a Medtronic Kappa 700(Europe)/Kappa 400(North America) pacemaker or an implantable loop recorder (ILR)(control group). Patients will be required to complete weekly fall diaries. The primary outcome measure is the number of patients who fall in the 24-month follow-up period. Recruitment began in October 1998 and continues for 12 months; the follow-up is for 24 months.

Accidental Falls↗

PubMed1996

Randomized controlled trial of a drug regimen that includes ciprofloxacin for the treatment of pulmonary tuberculosis.

The fluoroquinolones are promising new antituberculous agents. A randomized controlled trial of 200 adult patients with sputum smear-positive pulmonary tuberculosis was conducted in Tanzania. Patients received either a trial regimen (HRC) consisting of isoniazid (300 mg), rifampin (600 mg), and ciprofloxacin (750 mg) or a control regimen (HRZE) consisting of isoniazid (300 mg), rifampin (600 mg), pyrazinamide (25 mg/kg), and ethambutol (15 mg/kg). The 168 evaluable patients all had negative smears and cultures by month 6, but the time to conversion to negativity was longer for the HRC group than for the HRZE group because of the poor response of patients infected with human immunodeficiency virus (HIV) to the HRC regimen. Relapse was more frequent in the HRC group. The sterilizing activity of ciprofloxacin does not appear to be equal to that of the combination of pyrazinamide and ethambutol, but the difference in outcome was significant only among HIV-infected patients.

AIDS-Related Opportunistic Infections↗

PubMed1996

Searching for signals: mortality and cardiovascular events in published randomized control trials of nifedipine in ischemic heart disease and hypertension.

UNLABELLED: META-ANALYSIS: A meta-analysis of published randomized control trials of nifedipine in hypertension and stable angina pectoris was performed. RESULTS: The results suggest a formulation-dependent increased risk of mortality and adverse cardiovascular outcomes for monotherapy use in patients with stable angina pectoris. No increased risk was seen in the hypertension studies.

Humans↗

PubMed1997

Does vitamin C cause hemolysis in premature newborn infants? Results of a multicenter double-blind, randomized, controlled trial.

OBJECTIVE: We tested the hypothesis that vitamin C supplementation of premature neonates is associated with hemolysis. STUDY DESIGN: A double-blind, randomized, controlled trial of vitamin C supplementation (50 mg/day) was undertaken in premature neonates (birth weight, 1000 to 1500 gm). Infants were randomly assigned to receive vitamin C (Ce-Vi-Sol) (n = 32) or placebo (n = 24) for 14 days. Twenty-three subjects per group were required to detect a difference of 1 SD in corrected carboxyhemoglobin values (alpha = 0.05, beta = 0.10). RESULTS: Day 14 vitamin C levels were lower in control subjects than in supplemented neonates (62 +/- 24 vs 125 +/- 62 micromol/L, p = 0.005). There was no difference in corrected blood carboxyhemoglogin concentrations (0.72 +/- 0.44 vs 0.72 +/- 0.23%; p = 0.95), other parameters of hemolysis, weight gain, blood sampled, presumed septic episodes, necrotizing enterocolitis, feeding intolerance, or transfusion. On day 14, bilirubin values were higher in control subjects than in the supplemented group (77 +/- 37 vs 55 +/- 33 micromol/L; p = 0.04). When a distant outlier in the nonsupplemented group was excluded (163 micromol/L), statistical significance was lost (73 +/- 32 vs 55 +/- 33 micromol/L; p = 0.09). CONCLUSION: Oral supplementation of premature infants with vitamin C is not associated with evidence of increased erythrocyte destruction, hyperbilirubinemia, or other morbidity.

Anemia, Hemolytic↗

PubMed2003

Randomized controlled trials in psychiatry. Part 1: methodology and critical evaluation.

OBJECTIVE: To introduce clinicians to the methodology and critical appraisal of randomized controlled trials (RCTs) in psychiatry. METHOD: The methodology of RCTs in psychiatry is discussed. Using a systematic approach to critical appraisal, a published RCT of treatments for severe depression is examined and evaluated. RESULTS AND CONCLUSIONS: The RCT appraised illustrates certain problematic areas in the methodology of trials in psychiatry. A detailed knowledge of methodology and critique of RCTs is essential in determining whether reported results will influence clinicians' practice.

Cyclohexanols↗

PubMed2001

Only pathologic complete response to neoadjuvant chemotherapy improves significantly the long term survival of patients with resectable esophageal squamous cell carcinoma: final report of a randomized, controlled trial of preoperative chemotherapy versus surgery alone.

BACKGROUND: Surgery is the standard treatment for patients with resectable esophageal carcinoma, but the long term prognosis of these patients is unsatisfactory. Some randomized trials of preoperative chemotherapy suggest that the prognosis of patients who respond may be improved. METHODS: This randomized, controlled trial compared patients with clinically resectable esophageal epidermoid carcinoma who underwent surgery alone (Arm A) with those who received preoperative chemotherapy (Arm B). Overall survival and the prognostic impact of major response to chemotherapy were analyzed. Forty-eight patients were enrolled in each arm. Chemotherapy consisted of two or three cycles of cisplatin (100 mg/m2 on Day 1) and 5- fluorouracil (1000 mg/m2 per day continuous infusion on Days 1-5). In both study arms, transthoracic esophagectomy plus two-field lymphadenectomy was performed. The two groups were comparable in terms of patient characteristics. RESULTS: Forty-seven patients were evaluable in each arm. The curative resection rate was 74.4% (35 of 47 patients) in Arm A and 78.7% (37 of 47 patients) in Arm B. Treatment-related mortality was 4.2% in both arms. The response rate to preoperative chemotherapy was 40% (19 of 47 patients), including 6 patients (12.8%) who achieved a pathologic complete responses. Overall survival was not improved significantly. The 19 patients in Arm B who responded to chemotherapy and underwent curative resection had significantly better 3-year and 5-year survival rates (74% and 60%, respectively) compared with both nonresponders (24% and 12%, respectively; P = 0.0002) and patients in Arm A who underwent complete resection (46% and 26%, respectively; P = 0.01): Patients who achieved a pathologic complete response (P = 0.01), but not those who achieved a partial response (P = 0.2), had significantly improved survival. CONCLUSIONS: Patients with resectable esophageal carcinoma who underwent preoperative chemotherapy and obtained a pathologic complete response had a significantly improved long term survival. Major efforts should be undertaken to identify patients before neoadjuvant treatments who are likely to respond.

Adolescent↗