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Results for “Randomized controlled trials”

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PubMed2001

A cost-minimization analysis of the societal costs of realtime teledermatology compared with conventional care: results from a randomized controlled trial in New Zealand.

A randomized controlled trial was carried out to measure the societal costs of realtime teledermatology compared with those of conventional hospital care in New Zealand. Two rural health centres were linked to a specialist hospital via ISDN at 128 kbit/s. Over 10 months, 203 patients were referred for a specialist dermatological consultation and 26 were followed up, giving a total of 229 consultations. Fifty-four per cent were randomized to the teledermatology consultation and 46% to the conventional hospital consultation. A cost-minimization analysis was used to calculate the total costs of both types of dermatological consultation. The total cost of the 123 teledermatology consultations was NZ$34,346 and the total cost of the 106 conventional hospital consultations was NZ$30,081. The average societal cost of the teledermatology consultation was therefore NZ$279.23 compared with NZ$283.79 for the conventional hospital consultation. The marginal cost of seeing an additional patient was NZ$135 via teledermatology and NZ$284 via conventional hospital appointment. From a societal viewpoint, and assuming an equal outcome, teledermatology was a more cost-efficient use of resources than conventional hospital care.

Cost Savings↗

PubMed1998

Kangaroo mother care for low birthweight infants: a randomized controlled trial in different settings.

A randomized controlled trial was carried out for 1 y in three tertiary and teaching hospitals, in Addis Ababa (Ethiopia), Yogyakarta (Indonesia) and Merida (Mexico), to study the effectiveness, feasibility, acceptability and cost of kangaroo mother care (KMC) when compared to conventional methods of care (CMC). About 29% of 649 low birthweight infants (LBWI; 1000-1999 g) died before eligibility. Of the survivors, 38% were excluded for various reasons, 149 were randomly assigned to KMC (almost exclusive skin-to-skin care after stabilization), and 136 to CMC (warm room or incubator care). There were three deaths in each group and no difference in the incidence of severe disease. Hypothermia was significantly less common in KMC infants in Merida (13.5 vs 31.5 episodes/100 infants/d) and overall (10.8 vs 14.6). Exclusive breastfeeding at discharge was more common in KMC infants in Merida (80% vs 16%) and overall (88% vs 70%). KMC infants had a higher mean daily weight gain (21.3 g vs 17.7 g) and were discharged earlier (13.4 vs 16.3 d after enrolment). KMC was considered feasible and presented advantages over CMC in terms of maintenance of equipment. Mothers expressed a clear preference for KMC and health workers found it safe and convenient. KMC was cheaper than CMC in terms of salaries (US$ 11,788 vs US$ 29,888) and other running costs (US$ 7501 vs US$ 9876). This study confirms that hospital KMC for stabilized LBWI 1000-1999 g is at least as effective and safe as CMC, and shows that it is feasible in different settings, acceptable to mothers of different cultures, and less expensive. Where exclusive breastfeeding is uncommon among LBWI, KMC may bring about an increase in its prevalence and duration, with consequent benefits for health and growth. For hospitals in low-income countries KMC may represent an appropriate use of scarce resources.

Breast Feeding↗

PubMed2006

Growth hormone treatment improves growth and clinical status in prepubertal children with cystic fibrosis: results of a multicenter randomized controlled trial.

CONTEXT: This multicenter, randomized, controlled, crossover trial of prepubertal children with cystic fibrosis (CF) tests the hypotheses that recombinant human GH (rhGH) treatment 1) improves height, weight, lean mass, and bone content irrespective of baseline measures; 2) improves clinical status and quality of life; and 3) has continued effect after cessation after 1 yr of treatment. METHODS: Sixty-one prepubertal subjects (<or=25th percentile for height and weight) were randomized into two groups: daily rhGH treatment or no treatment groups for 1 yr. In yr 2, treatments were crossed over. Outcome measures included serial standardized height and weight, number of hospitalizations and antibiotic courses, random blood glucose levels, lean mass, bone mineral content, pulmonary function, nutritional intake, and CF quality of life questionnaires. RESULTS: Groups were similar at baseline and prepubertal during the entire study. After 1 yr, GH showed significantly greater gain in height, weight, lean mass, and bone mineral content. Gain in height was similar regardless of baseline. There were fewer hospitalizations in the rhGH-treated group and improvement in CF quality of life questionnaires measures of weight and body image. There was no difference in pulmonary function between groups. Results were similar in those treated with rhGH the second year. After cessation of rhGH treatment, there was sustained effect for increased height and weight velocity, as well as accrual of bone mineral. CONCLUSION: rhGH therapy improves height and weight, decreases the number of hospitalizations, and improves quality of life in prepubertal children with CF. These effects are sustained after rhGH is discontinued.

Body Height↗

PubMed1998

The clinical utility of randomized controlled trials.

OBJECTIVE: Efficacy studies using randomized controlled trials (RCTs), on which empirically supported treatments are based, are often rejected as having little if any relevance to clinical practice. RCTs are faulted for allegedly excluding poor prognosis patients and therapists and treatments that are unrepresentative of clinical practice. METHODS: Evidence on the generalizability of findings from RCTs to diverse patient populations, different therapists, and varied clinical settings is critically evaluated. RESULTS: Existing research indicates that RCTs commonly include patients with multiple problems and levels of disturbance as severe as patients in clinical settings. DISCUSSION: The applicability of the findings of RCTs to clinical practice will be a changing function of the nature of the particular study and clinical setting to which the results are to be generalized. Future research should address the clinical utility of the findings of efficacy studies across different patient populations, therapists, and treatment methods.

Bulimia↗

PubMed2002

Effectiveness and cost-effectiveness analysis of neuroreflexotherapy for subacute and chronic low back pain in routine general practice: a cluster randomized, controlled trial.

STUDY DESIGN: A cluster randomized, controlled trial was performed. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of adding patients' referral to neuroreflexotherapy intervention to the usual management of subacute and chronic low back pain in routine general practice. SUMMARY OF BACKGROUND DATA: Neuroreflexotherapy consists of the temporary implantation of epidermal devices in trigger points in the back and referred tender points in the ear. The efficacy of this procedure for treating subacute and chronic low back pain has been demonstrated in previous randomized, double-blind, controlled clinical trials. METHODS: Twenty-one primary care physicians working in seven primary care centers of the Spanish National Health Service in Palma de Mallorca, Spain, were randomly assigned to the intervention group (n = 11) or the control group (n = 10). The physicians recruited patients who had low back pain that had lasted for 14 or more days despite drug treatment and who did not meet criteria for surgery. The 45 patients recruited by physicians from the control group were treated according to the standard protocol, whereas the 59 patients recruited by physicians from the intervention group were, in addition, referred to neuroreflexotherapy intervention. The analysis of variables was performed taking into account that physicians, not patients, were randomly assigned. RESULTS: Patients underwent clinical evaluations at baseline and 15, 60, and 365 days later. At baseline, median intensity of pain was higher in patients undergoing neuroreflexotherapy than in control patients (visual analogue scale, 6.07; range, 4.67-8.80 vs. 5.15, range 4.11-8.00) and median duration of pain was also higher (48.1, range 28.4-211.1 vs. 17.5, range 15.0-91.5 days). At the last follow-up visit, patients treated with neuroreflexotherapy showed greater improvement than did control patients in low back pain (visual analogue scale, 5.5; range, 3.7-8.8 vs. 1.9; range, -1.2-3.0; P < 0.001); referred pain (visual analogue scale, 3.6; range, 2.7-7.3 vs. 0.6; range, -1.5-2.0; P = 0.001); and disability (Roland-Morris scale, 8.7; range, 2.0-13.3 vs. 2.0; range, -1.5-6.7; P = 0.007). Moreover, neuroreflexotherapy intervention was associated with a significantly (P < 0.035) lower number of consultations to private or public specialists, fewer indications of radiographs by primary care physicians, lower cost of drug treatment, and less duration of sick leave throughout the follow-up period. There were also differences in favor of neuroreflexotherapy intervention in the cost-effectiveness ratio for pain, disability, and quality of life that persisted in the most optimistic, the most conservative, and the average (break-even case) assumptions. CONCLUSIONS: Referral to neuroreflexotherapy intervention improves the effectiveness and cost-effectiveness of the management of nonspecific low back pain.

Acute Disease↗

PubMed2006

Therapeutic and prophylactic utility of the memory-enhancing drug donepezil hydrochloride on cognition of patients undergoing electroconvulsive therapy: a randomized controlled trial.

OBJECTIVES: Substantial progress has been made in identifying how the treatment parameters used in electroconvulsive therapy (ECT) impact its cognitive side effects. However, there is limited information regarding the role of memory enhancers in post-ECT cognitive disturbances. We evaluated the therapeutic and prophylactic efficacy of the memory-enhancing drug donepezil hydrochloride on cognition of patients undergoing ECT. METHODS: A triple blind (the study subjects, clinician assessing the cognition, and the data analyst were unaware of subject allocation for trial assessment) randomized controlled trial was carried out in a General Hospital Psychiatry Unit. Subjects were randomized into 2 groups. One group received ECT with placebo, whereas the other group received ECT and donepezil (a memory-enhancing drug). Study participants were assessed in post-ECT period to analyze cognitive deficits and to compare the differences in 2 groups, as regards recovery of various aspects of cognition. RESULTS: The post-ECT recovery of various components of cognition was more rapid in patients using donepezil as compared to those not given donepezil (P < 0.05). CONCLUSIONS: This significant improvement in recovery time among patients receiving donepezil bears therapeutic implication in immediate post-ECT cognitive deficits.

Adult↗

PubMed1992

The effect of 17 alpha-hydroxyprogesterone caproate/oestradiol valerate on the development and outcome of early pregnancies following in vitro fertilization and embryo transfer: a prospective and randomized controlled trial.

A prospective and randomized study was performed to investigate the effect of supportive hormones on the development and outcome of early pregnancies following in vitro fertilization and embryo transfer. Immediately after pregnancies were confirmed endocrinologically on day 15 after oocyte collection, 17 alpha-hydroxyprogesterone caproate and oestradiol valerate (PC/EV) was administered to half of the patients in a randomly controlled trial. One group received supportive treatment until the twelfth week of gestation, whereas the other group received no treatment at all. Both groups were followed up by measurements of serum levels of human chorionic gonadotrophin (HCG), oestradiol and progesterone every three days until day 35, when a first ultrasound examination was carried out to confirm fetal vitality. Subsequently, pregnancies were monitored sonographically at regular intervals. In cases of miscarriage, dilatation and curettage was performed and histology analysed. A total of 120 pregnant patients entered the study: 55 of them received hormone treatment and 65 patients were controls. Within the treatment group 48 (89%) clinically ongoing pregnancies were observed, five (9%) miscarriages occurred after the seventh week of gestation and one preclinical pregnancy was noted. In the control group, 38 (59%) ongoing pregnancies were observed, nine (14%) miscarriages occurred and 17 (27%) preclinical pregnancies were recorded. Two ectopic pregnancies, one in each group, were excluded from evaluation. A significantly higher percentage of pregnancies were intact at 7 weeks of gestation after treatment with PC/EV (p less than or equal to 0.01).

17 alpha-Hydroxyprogesterone Caproate↗

PubMed1995

Primary care management of acute herpes zoster: systematic review of evidence from randomized controlled trials.

Although a number of randomized controlled trials of treatment for herpes zoster have been performed, there is no consensus on how it should be managed in general practice. A systematic review of existing trials, including meta-analysis, was performed to determine the efficacy of available therapies in reducing the incidence of postherpetic neuralgia. The treatments studied included antiviral agents, corticosteroids and other drugs which had been studied in randomized trials. Trials were included if the subjects were immunocompetent adults and the intervention was feasible in general practice. The main outcome measure was prevalence of pain at one, three and six months after onset of the acute herpetic rash. Data for each time point were not available for all trials. The quality of studies was also assessed. Pooled analyses of trials with acyclovir failed to detect a significant reduction of pain in the treatment group at one or six months, but found a 35% reduction at three months. Confidence limits were wide, and a modest benefit of treatment cannot be ruled out at one and six months. Pooled analyses were not possible for other treatments, either because too few trials had been performed, or because completed trials demonstrated significant heterogeneity. Many clinical trials in this area have been too small to give reliable results. Variations in the definition and reporting of postherpetic neuralgia create difficulties in combining data from different studies. Firm recommendations for clinical practice are not possible because existing evidence neither confirms nor refutes the hypothesis that treatment during the acute phase of herpes zoster reduces pain later.

Acute Disease↗

PubMed2002

Is the randomized, controlled trial in children an endangered species?

OBJECTIVE: To discuss the potential effects of current Food and Drug Administration (FDA) policy in the United States facilitating the approval of novel therapies for use in children (based on safety trials) on pediatric randomized, controlled trials in the pediatric intensive care unit setting. Method: The history of randomized, controlled trials, the FDA, and the events that led to this ruling are discussed. RESULTS: A recent FDA ruling ensures increased drug testing in children; however, it also opens the possibility for drug approval for use in children without any requirement for randomized, controlled trial testing of the efficacy of the drug on disease-specific outcomes. CONCLUSIONS: In light of the high degree of instability of pediatric intensive care unit patients, the frequent use of multiple drugs in a given patient with resultant drug-drug interactions, the risk of toxicity in critically ill infants and children with impaired drug metabolism, and age-dependent differences in physiology, clinicians must strive to be informed of the meaning of FDA approval or disapproval of the drugs they use for children.

Journal Article↗

PubMedDate not supplied

Methodological issues of randomized controlled trials for the evaluation of reproductive health interventions.

Randomized controlled trials proved the most valid basis for comparing alternative treatment modalities. Unfortunately, the quality of many such trials has not been as high as our patients deserve. We offer here methodological and practical insights to key issues related to the design, implementation, and analysis of randomized controlled trials in obstetrics and gynecology, based on our experience in exploring research hypotheses in this field. Specifically, we present randomization as a method for the prevention of confounding; we discuss the process of randomization and the bias that can be introduced to randomized controlled trials by some popular methods of randomization. The strategies for presenting baseline comparisons and evaluating the impact of a treatment or intervention are also reviewed. We hope to contribute to a more rigorous selection of treatments for our clinical and public health armamentarium.

Bias↗

PubMed2006

Analysis of randomized controlled trials on hepatopancreatic surgery.

The randomized controlled trial (RCT) is an important research method, providing the highest evidence and playing a pivotal role in the performance of evidence-based medicine. However, RCTs on hepatopancreatic surgery have been performed less frequently than RCTs in other fields. Therefore, this review analyzes the characteristics of RCTs on hepatic and pancreatic surgery to propose a breakthrough. We retrieved studies performed via a MEDLINE search to identify prospective RCTs on hepatopancreatic surgery in the last decade. Eligible RCTs were analyzed using the following items: study design, publication year, geographical area, sample size, multicenter study, and impact factor. Studies comparing surgical technique or methods have composed the majority of the RCTs involving hepatectomy and pancreatectomy. About half of the RCTs on hepatectomy have been performed in East Asia, whereas most of the RCTs on pancreatectomy were undertaken in Western countries. The average sample number of RCT on hepatectomy is significantly smaller than those in other fields. Moreover, multicenter studies are less frequently performed on hepatectomy compared with pancreatectomy. Promoting the organization of multicenter studies would be the best way to increase the number and sample size of RCTs on hepatectomy. Adequate RCTs observing the Consolidated Standards of Reporting Trials statements are necessary to obtain reliable evidence.

Bibliometrics↗

PubMed2002

[Randomized controlled trials in Japan--lung cancer].

Randomized controlled trials conducted in Japan were reviewed. Using PubMed, 12 papers published after 1990 were selected. Six papers presented at the annual meeting of the American Society of Clinical Oncology from 1999 to 2002 were also added for use in this review. According to the results of those trials, cisplatin plus either irinotecan or docetaxel for advanced non-small cell lung cancer, cisplatin plus irinotecan for small cell lung cancer and concurrent chemoradiotherapy for a localized disease of both small and non-small cell lung cancers have been established as standard treatments. No adjuvant treatment method for resected patients has been proved to be sufficiently effective.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2003

A qualitative evaluation of implementing a randomized controlled trial in general practice.

BACKGROUND: For findings of randomized controlled trials in primary care to be applicable, both the sample of clinicians implementing the trial and the recruited patients should be as representative as possible. The processes of conducting trials should be made "user-friendly" to clinician investigators in order to maximize their participation in research. Formal evaluations of trial implementation are unusual. This study reports clinicians' perspectives on acting as a clinician investigator in a randomized controlled trial (the SAVIT study) in general practice. OBJECTIVE: Our purpose was to explore clinicians' accounts of taking part in a randomized controlled trial in which subjects were recruited opportunistically during general practice consultations. METHOD: Individual semi-structured interviews were conducted with nine GPs and one practice nurse practising in the Bro Taf area of South Wales who recruited children into the SAVIT study. A structured interview guide was used and data were analysed using the qualitative method of pattern coding. RESULTS: Major emerging themes included recruitment difficulties and concerns about the safety of the study medication. Participants also outlined positive aspects of the study (clarity and simplicity of the study, potential benefits to clinicians and patients and study team follow-up of recruited patients). Recommendations for possible improvements in study implementation included the simplification and reduction of patient reading materials and improved presentation of study materials. CONCLUSIONS: Difficulty in recruiting patients was the most frequently mentioned problem by clinician investigators. Insufficient time in the consultation was perceived as the main barrier. Ingredients of successful trial implementation include good organization, simple documentation and study procedures, and the ability to allay concerns about patient safety. Findings from this evaluation may assist researchers in the design and implementation of future community-based randomized controlled trials.

Attitude of Health Personnel↗

PubMed2005

Inflammatory response in children after laparoscopic vs open Nissen fundoplication: randomized controlled trial.

UNLABELLED: We performed a randomized controlled trial to compare the inflammatory and immune responses to Nissen fundoplication in infants and children undergoing either open or laparoscopic surgery. METHODS: Forty children undergoing Nissen fundoplication were randomized to laparoscopy or open surgery using minimization with respect to age, neurologic status, and operating surgeon. Intraoperative and postoperative analgesias were standardized. Inflammatory markers (plasma malondialdehyde, nitrate plus nitrite level, and cytokines) and monocyte class II major histocompatibility complex expression were measured preoperatively, at end of surgery, 4, 24, and 48 hours postoperatively. Postoperative changes were compared between open and laparoscopic groups. RESULTS: There were no significant changes in circulating malondialdehyde, nitrates plus/ nitrite, interleukin-10, or tumor necrosis factor alpha in the postoperative period in either group. Interleukin-1 receptor antagonist (IL-1rA) and IL-6 were significantly increased in both groups, with a tendency for greater elevation of IL-1rA in the open group. Monocyte major histocompatibility complex expression fell significantly in both groups; however, this fall appeared to be slightly more marked in the open group. CONCLUSIONS: The postoperative cytokine response is similar in children undergoing open and laparoscopic Nissen fundoplication. This trial indicates that laparoscopy may partly reduce postoperative immune suppression.

Child↗

PubMed2005

Methotrexate/misoprostol vs. a more standard approach for termination of pregnancies of undetermined location: a randomized, controlled trial.

OBJECTIVE: To conduct a randomized, controlled trial to compare a group of patients receiving methotrexate intramuscularly on day 1 and vaginal misoprostol on day 5 to terminate a pregnancy of undetermined location with a group in which the diagnosis was established prior to treatment. STUDY DESIGN: We randomized 43 women with a pregnancy of undetermined location to 2 study groups: (1) 1 group received methotrexate/misoprostol, and (2) the other group had a diagnosis established first and then were treated appropriately. The outcomes that were measured for the 2 groups were: (1) hospital admission rate, (2) laparoscopy rate, (3) uterine aspiration rate, (4) patient visits, and (5) interval to end point. RESULTS: The uterine aspiration rate was lower in the methotrexate/misoprostol group (0.0% vs. 77.3%, p<0.0001). The mean number of patient visits in the methotrexate/misoprostol group was higher (3.8 vs. 2.5 visits, p<0.0001), and the mean interval to the end point in the methotrexate/misoprostol group was higher (26.4 days vs. 4.5 days, p<0.0001). CONCLUSION: To terminate pregnancies of undetermined location, empirical methotrexate/misoprostol is associated with a lower uterine aspiration rate but more patient encounters and longer follow-up.

Abortifacient Agents, Nonsteroidal↗

PubMedDate not supplied

Efficacy of intravaginal misoprostol in second-trimester pregnancy termination: a randomized controlled trial.

A prospective randomized, double-blind, controlled clinical trial to compare the clinical efficacy and side effects of intravaginal misoprostol with the traditional prostaglandin, gemeprost, in second-trimester pregnancy interruption was conducted. A sample size of 100 women was calculated to demonstrate that misoprostol was as effective as gemeprost in achieving delivery within 24 hours (alpha = 0.1, 80% power). Women were recruited with fetal death in utero, severe fetal anomaly, or psychosocial pregnancy termination between 14 and 28 weeks gestation and randomized to receive either 1 mg gemeprost 3 hourly for 5 doses, or 200 mcg misoprostol 6 hourly for 4 doses, intravaginally. The therapeutic regimens were repeated if undelivered by 24 hours. Those undelivered after 48 hours received an extra-amniotic PGF2 alpha infusion. The median gestation at recruitment was identical: gemeprost 19 weeks (IQ 17-22 weeks) vs. misoprostol 19 weeks (IQ 17-21 weeks), P = 0.887. Delivery within 24 hours occurred in 75.1% of women receiving gemeprost and 74.9% receiving misoprostol (P = 1.0). The median time from prostaglandin commencement to delivery was similar: gemeprost 13.7 hours (IQ 9.0-23.5 hours) vs. misoprostol 16.9 hours (IQ 10.3-23.5 hours), P = 0.769. A significant reduction in the incidence of vomiting in women randomized to misoprostol occurred (34% vs. 13.2%, P = 0.017). There was no significant difference in the incidence of maternal fever > 37.5 degrees C, nausea, diarrhea, or placental retention. A 200-fold pharmaceutical cost advantage was observed with the use of misoprostol compared with gemeprost. Intravaginal misoprostol performs as effectively as gemeprost in achieving delivery in the second trimester without increase in adverse effects and displaying a significant cost advantage.

Abortifacient Agents, Nonsteroidal↗

PubMed1992

Economic analysis in randomized control trials.

In medical technology assessment, randomized control trials (RCTs) play an important role in determining the relative efficacy of compared treatments. As scarce resources necessitate choosing among options for care, comparing costs of alternative tests, treatments, or programs also becomes important. This study assessed the prevalence and completeness of economic analyses in RCTs published from January 1966 through June 1988. It was found that only 121 of over 50,000 published randomized trials (0.2%) included economic analyses. For a random sample of 51 of these 121 studies, results revealed a mean quality of research score of 0.32 (SD of measurement = 0.14) and a mean economic analysis completeness score of 0.52 (SD = 0.13) on scales of 0 to 1. It was also found that higher economic completeness scores were positively correlated with later dates of publication (r = 0.28, P = 0.046) and with the presence of a statement of study perspective (r = 0.38, P = 0.006). A near-zero correlation between the economic completeness and the quality of research scores was revealed. Also noted were several deficiencies among the economic analyses, including improper allocation of overhead costs, absence of sensitivity analyses, and the fact that only 28% of the 51 studies included some form of aggregation of treatment costs and consequences. Progress in health care depends on accurate assessments of both relative efficacy and costs. The quality of both needs improvement.

Cost-Benefit Analysis↗

PubMed1995

A model of regular geriatric follow-up by home visits to selected patients discharged from a geriatric ward: a randomized controlled trial.

The aim of this randomized controlled trial was to describe and evaluate a model of regular follow-up by home visits to selected elderly patients discharged from a geriatric ward. Ninety-seven patients were randomized to receive regular follow-up visits by a geriatric team at 1, 3, 8 and 16 weeks after discharge, and 96 patients to receive standard care. Based on the geriatric evaluation, medical and social adjustment was carried out, if indicated. Six months after discharge, significantly more patients in the intervention group were allocated to home help (p < 0.05), but only 42 (44%) were readmitted to a hospital, vs 62 (64%) in the control group (p < 0.005). Differences between the groups in mortality and nursing-home placement were not statistically significant. Regular follow-up home visits by a geriatric team after in-patient geriatric evaluation and management reduce the risk of hospital readmissions among highly selected frail geriatric patients.

Aged↗