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Results for “Randomized controlled trials”

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PubMed2000

The methodology and operation of a pilot randomized control trial of the effectiveness of the Bug Busting method against a single application insecticide product for head louse treatment.

A Department of Health leaflet suggests two treatment methods for head lice: mechanical removal by wet combing; and insecticide lotion/rinses. However, there are no reports in the literature comparing the effectiveness of these two treatment methods and well controlled clinical trials of insecticide treatments are sparse. A pilot randomized control trial of the effectiveness of a specific method of wet combing, 'Bug Busting', against a single application of a proprietary insecticide product is reported. The difficulties of designing a trial are discussed and modifications that would allow a definitive trial to take place are suggested. The pilot study included enzyme analysis of lice for insecticide resistance status assessment.

Animals↗

PubMed2004

Treating drug using prison inmates with auricular acupuncture: a randomized controlled trial.

This study tested the viability of auricular acupuncture in prisons for alleviating inmates' symptoms of psychological and physical discomfort and reducing their drug use. The experimental NADA-Acudetox protocol was compared with a non-specific helix control protocol in a randomized trial. Over a period of 18 months, a 4-week, 14-session auricular acupuncture treatment program was offered in two prisons to 163 men and women with self-reported drug use. Among treatment completers, no differences by method were found in self-reported symptoms of discomfort. Drug use occurred in the NADA group but not in the helix group. In contrast, confidence in the NADA treatment increased over time while it decreased for the helix treatment. No significant negative side effects were observed for either method. Participants in both groups reported reduced symptoms of discomfort and improved nighttime sleep. Future research should compare auricular acupuncture to a non-invasive control in order to attempt to disentangle active effects from placebo.

Acupuncture, Ear↗

PubMed1993

A randomized, controlled trial of platelet transfusions in thrombocytopenic premature infants.

A multicenter prospective, randomized controlled trial was conducted to determine whether early use of platelet concentrates would reduce the incidence or extension of intracranial hemorrhage or both in sick preterm infants with thrombocytopenia. The effects on bleeding as reflected by the amount of blood product support administered and a shortened bleeding time were assessed as secondary outcomes. Premature infants with a platelet count < 150 x 10(9)/L within the first 72 hours of life were randomly assigned to receive either conventional therapy or conventional therapy plus platelet concentrates (10 ml/kg). The platelet count was maintained < 150 x 10(9)/L until day 7 of life by one to three platelet transfusions. In 22 (28%) of the 78 treated infants and 19 (26%) of the 74 control infants, either a new intracranial hemorrhage developed or an already-present one became more extensive (p = 0.73). Similar numbers of infants had each grade of intracranial hemorrhage on both initial and follow-up ultrasonography. Similar numbers of infants received fresh frozen plasma and packed red blood cells, but treated infants received less of both. The bleeding time was prolonged in the treated group before the infusion of platelet concentrates but subsequently shortened (mean difference, 79.0; 95% confidence interval, 73.1 to 84.9). Subanalysis of the control group showed that infants with platelet counts < 60 x 10(9)/L (n = 21) on at least one occasion received more fresh frozen plasma and packed red blood cells than did those with platelet counts > 60 x 10(9)/L.(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Component Transfusion↗

PubMed2026

Utility of Dynamic MRI in Surgical Outcome of Patients With Degenerative Cervical Myelopathy: A Single-Center, Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: The utility of dynamic MRI (dMRI) in surgical planning and outcomes for degenerative cervical myelopathy (DCM) has not been validated in any prospective randomized trials. METHODS: In this hospital-based randomized controlled trial conducted between February 2023 and December 2024, patients with DCM were randomized into 2 groups: the Static MRI Group, where surgery was guided by conventional static MRI alone, and the dMRI Group, in which dMRI was performed, with the potential to alter the surgical approach. The primary outcome was recovery rate (RR) at 3 months. Secondary outcomes included postoperative changes in modified Japanese Orthopaedic Association scores and Nurick grades, surgical plan alterations, comparison of surgical approaches, and complication rates. RESULTS: Seventy-four patients were analyzed at a 3-month follow-up. The dMRI group had a significantly higher mean RR (55.42% ± 29.05%) than the Static group (46.76% ± 29.51%) ( P = .044). A RR of ≥50% was observed in 91.9% of patients in the dMRI group, compared with 59.4% in the static MRI group ( P = .002). Modified Japanese Orthopaedic Association scores improved more in the dMRI group (15.47 ± 2.62 vs 13.77 ± 2.66, P = .007). While Nurick grades improved in both groups, the intergroup difference was not statistically significant ( P = .151). dMRI altered the surgical plan in 59.5% of cases. Anterior approaches yielded better RR but had more complications. By contrast, posterior approaches had fewer but more severe complications including mortality. CONCLUSION: dMRI enhances the detection of clinically significant cord compression and may aid in surgical decision-making, potentially contributing to superior functional outcomes in DCM. Further studies are required to determine its impact on long-term functional outcomes.

Humans↗

PubMed2005

Impact of selective decontamination of the digestive tract on fungal carriage and infection: systematic review of randomized controlled trials.

OBJECTIVE: To determine the impact of the antifungal component of selective decontamination of the digestive tract on fungal carriage, infection and fungaemia. DESIGN: Meta-analysis of randomized controlled trials of selective decontamination of the digestive tract. STUDY SELECTION: Data sources included Medline, Embase, Cochrane Register of Controlled Trials, previous meta-analyses, personal communications and conference proceedings, without restriction of language or publication status. All randomized trials were selected that compared oropharyngeal and/or intestinal administration of antifungals amphotericin B or nystatin, as part of selective decontamination protocol, with no treatment in the controls. There were 42 randomized controlled trials with a total of 6,075 critically ill patients. METHODS: Three reviewers independently applied selection criteria, performed quality assessment and extracted the data. The main outcome measures were patients with fungal carriage, patients with fungal infections and patients with fungaemia. Odds ratios were pooled with the random effect model. MEASUREMENTS AND RESULTS: Enteral antifungals significantly reduced fungal carriage (odds ratio 0.32, 95% confidence interval 0.19-0.53) and overall fungal infections (0.30, 0.17-0.53). Fungaemia was not significantly reduced in the treatment group (0.89, 0.16-4.95). CONCLUSIONS: Antifungals, as part of selective decontamination of the digestive tract, reduce fungal carriage and infection but not fungaemia in critically ill patients and may justify the inclusion of an antifungal component in the decontamination protocol.

Anti-Bacterial Agents↗

PubMed2001

Randomized controlled trials in palliative care: overcoming the obstacles.

Problems associated with conducting randomized controlled trials (RCTs) in palliative care are well documented. Palliative care researchers commonly report difficulties with recruitment, attrition, and randomization. Despite these difficulties, there is a crucial need to enhance the evidence base of palliative care and RCTs are a recognized method for achieving this. Few publications to date have provided clear strategies for researchers considering RCTs in palliative care. This article presents an overview of the features of the RCT and reasons for using this research method. Problems with conducting RCTs are considered with discussion focusing on an approach for managing these hurdles. Examples are provided from an ongoing RCT investigating a support and information programme for lay caregivers of people receiving palliative care at home. The aim of the article is to provide a guide to conducting RCTs and to promote their use in palliative care when researchers are evaluating new interventions.

Humans↗

PubMed2004

Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design?

There is an increasing drive to make nursing care evidence-based. High quality evidence from systematic reviews relevant to postoperative pain relief exists, yet pain after surgery remains poorly controlled for many patients. This study aimed to assess whether implementing evidence-based pain management improved postoperative pain outcomes. Pain on a 0-10 scale was the primary outcome and analgesic consumption a secondary outcome. A baseline audit was undertaken on four surgical wards to establish whether there was a need for the study. A randomized-controlled trial was then designed to assess the effects of implementing an evidence-based approach to postoperative pain management. The four wards were randomized to receive the intervention or act as a control. Outcomes were assessed 3 months after the intervention on both intervention and control wards. The intervention (implementation of an oral analgesic algorithm derived from systematic reviews) was then implemented on the control wards and outcomes reassessed after 3 months on the control wards. The intervention was designed using an evidence-based approach to effective implementation. Four interactive sessions covered: (1) detailed feedback of baseline data and discussion (utilizing audit and feedback), (2) why systematic reviews, analgesic league tables and choice of drugs to develop an analgesic algorithm (see Figure 1), (3) principles of evidence based health care (EBHC), including critical appraisal and (4) facilitation and change workshop. The findings revealed no significant differences in pain level or drug use between the intervention and control wards. However, the control wards also changed during the control period. Possible explanations for this are discussed. When looking at changes compared with baseline, both intervention and control wards increased their use of algorithm drugs and reduced use of non-algorithm drugs during the study. No effects were found on pain in the intervention wards. Pain ratings at rest since surgery, on movement since surgery and worst pain on movement were significantly reduced compared with baseline in the control wards. Although there are many pressures to utilize a randomized-controlled trial study design in the culture of evidence-based health care, there will be times, especially when implementing complex changes in practice that other types of design should be considered.

Adult↗

PubMed1998

A randomized controlled trial of pelvic floor muscle exercises to treat postnatal urinary incontinence.

A randomized controlled trial was carried out to evaluate the extent to which a program of reinforced pelvic floor muscle exercises (PFME) reduces urinary incontinence 1 year after delivery. Two hundred and thirty women who were incontinent 3 months postpartum were randomized to either a control group doing standard postnatal pelvic floor muscle exercises (n = 117) or to an intervention group (n = 113) who saw a physiotherapist for instruction at approximately 3, 4, 6 and 9 months postpartum. Results collected 12 months after delivery included prevalence and frequency of incontinence and PFME, sexual satisfaction, perineometry measurements and pad tests. Twenty-six (22%) of the control group and 59 (52%) of the intervention group withdrew before the final assessment. The prevalence of incontinence was significantly less in the intervention group than in the control group (50% versus 76%, P=0.0003), and this group also did significantly more PFME. There were no significant differences between the groups as regards sexual satisfaction, perineometry measurements or pad test results.

Exercise Therapy↗

PubMed1999

Isoniazid prophylaxis for tuberculosis in HIV infection: a meta-analysis of randomized controlled trials.

OBJECTIVES: To evaluate the efficacy of isoniazid for the prevention of tuberculosis in tuberculin skin test-positive and negative individuals with HIV infection. DESIGN: Meta-analysis of randomized controlled trials. SETTING: Seven trials from Mexico, Haiti, the United States, Zambia, Uganda and Kenya. PATIENTS: Individuals free from tuberculosis, 2367 persons in the intervention and 2162 in the control groups. INTERVENTION: Comparison of isoniazid with placebo or no prophylaxis. METHODS: A systematic search of the literature was carried out from 1985 to October 1997 for randomized controlled trials of isoniazid prophylaxis in HIV-infected persons. Two reviewers evaluated the relevance of each candidate study and the validity of eligible trials. Studies were pooled using a random effect model, conducting secondary analyses for tuberculin skin test-positive and negative persons. RESULTS: Mean follow-up in trials varied between 0.4 and 3.2 years. Pooling all seven trials, a risk ratio was found for persons treated with isoniazid for developing tuberculosis of 0.58 [95% confidence interval (CI), 0.43-0.80] and 0.94 (95% CI, 0.83-1.07) for death. In groups of tuberculin skin test-positive and negative persons, the risk ratio of tuberculosis was 0.40 (95% CI, 0.24-0.65) and 0.84 (95% CI, 0.54-1.30), respectively, and the difference in the effectiveness of isoniazid versus placebo between these groups was statistically significant (P = 0.03, for the difference of summary estimates). Consistency of results was found across trials (P > 0.10, heterogeneity value) for all comparisons. CONCLUSIONS: Prophylaxis with isoniazid reduces the risk of tuberculosis in persons with HIV infection. The effect is restricted to tuberculin skin test-positive persons.

AIDS-Related Opportunistic Infections↗

PubMed2003

Parents' attitudes to children's participation in randomized controlled trials.

OBJECTIVE: To explore parents' attitudes to children's participation in randomized controlled trials. STUDY DESIGN: Qualitative analysis of focus group discussions involving 33 parents from a pediatric teaching hospital and local school in Australia. Parents varied in age, gender, ethnicity, level of education, research experience, and child's health status. The transcribed discussions were analyzed by theme linkage using the constant comparative method. RESULTS: Parents balance risks and benefits when deciding about trial participation for their child. Perceived benefits include the offer of hope, better care of their child, the opportunity to access new treatments, healthcare professionals and health information, meeting others in similar circumstances, and helping others. Perceived risks include potential side effects, being randomized to ineffective treatments, and the inconvenience of participation. The decision for trial participation is also influenced by parental factors (parents' knowledge, beliefs, and emotional responses), child factors (the child's health status and preference about participation), trial factors (the use of placebos and uncertainties of participation), and doctor factors (doctor's recommendations and communication of trial information). CONCLUSIONS: Educating parents about trials, improving communication between trialists, pediatricians, and parents, increasing incentives while decreasing inconveniences, and providing decision aids for parents may increase parents' willingness to participate in trials.

Adult↗

PubMed1976

Selective and total shunts in the treatment of bleeding varices. A randomized controlled trial.

Two types of surgical therapy of bleeding esophageal varices were evaluated in 48 patients by a randomized controlled trial: 24 were randomized for a total shunt and 24 for the selective shunt. In two of the latter, a total shunt had to be performed for technical reasons. The fatality rates (six in the 24 total, and six in 22 selective [performed], and seven in 24 selective [randomized]), the frequency of shunt occlusion (two in each group), and of recurrent gastronintestinal bleeding (three in each group) were similar. Encephalopathy developed more often after a total shunt -- 10 of 24, or one per 58 patient-months -- than after selective (performed) -- one of 22, or one per 593 patient-months (P less than 0.005). Total shunts consistently diverted the hepatopetal mesenteric-portal flow from the liver. Deterioration of hepatic function (maximum rate of urea synthesis) was greater after total than selective shunt (P less than 0.05).

Adult↗

PubMedDate not supplied

A systematic review and meta-analysis of the incidence of cancer in randomized, controlled trials of verapamil.

We conducted a systematic review of all published randomized, controlled trials to assess the risk of cancer or death in patients receiving verapamil for hypertension, angina pectoris, or cardiac arrhythmias. Meta-analysis comparing the risk of new cancers, cancer deaths, and all deaths was performed. Thirty-nine trials comprising 11,201 patients were eligible. Study durations ranged from 8 days-6 years (mean 29.5 wks). Nine trials (6507 patients) were 24 weeks in duration or longer. For cancer and cancer death, OR was 1.20 (95% CI = 0.60-2.42) for verapamil versus active controls and 0.73 (95% CI = 0.39-1.39) for verapamil versus placebo. For all deaths, OR was 1.13 (95% CI = 0.70-1.82) for verapamil versus active controls and 0.85 (95% CI = 0.71-1.00) for verapamil versus placebo. Sensitivity analysis for the 9 trials 24 weeks' duration or longer gave similar results. There is no statistically significant increased risk of cancer or deaths with verapamil compared with active controls or placebo.

Calcium Channel Blockers↗

PubMed2006

Improving the quality of randomized controlled trials in Chinese herbal medicine, part I: clinical trial design and methodology.

OBJECTIVE: To discuss the quality of randomized controlled trials (RCTs) in Chinese herbal medicine (CHM) with respect to design and methodology, and provide suggestions for further improvement in future clinical trials. METHODS: A search of the Cochrane Library was conducted to identify RCTs of CHM on line in July 2005. Quality of the RCTs was assessed using a 11-item checklist modified from the revised CONSORT statement, with 2 items specific to CHM (i.e. herb preparation form and quality control of herbs). RESULTS: The search yielded 167 RCTs that were selected for assessment. All trials included statements about the interventions, objectives, primary outcome design, statistical methods, and herb preparation form. Although 163 (97.6%) trials reported inclusion criteria, exclusion criteria were only reported in 26 (15.6%) trials. Fewer than 10% of trials clearly stated the random allocation sequence generation methods, and only 2.4% mentioned allocation concealment. The vast majority (86.8%) of trials were open-label, while only 13.2% used blinding. Almost half (45.5%) administered the CHM intervention as a tea or decoction. Only one trial (0.6%) reported a sample size calculation, and a single trial (0.6%) discussed quality control of the CHM intervention. CONCLUSION: The overall methodologic quality of RCTs in CHM was poor. It is essential to improve the design of future RCTs in this clinical area. RECOMMENDATIONS: (1) Investigator conducting RCTs should have formal training about clinical trial design; (2) A flow chart is recommended to ensure that all essential steps of clinical trial design are included. (3) Conducting pilot studies prior to RCTs may help improve their design; (4) Registration of clinical trials and publishing their protocols prior to enrollment may reduce publication bias and solicit peer reviews of the proposed design; (5) Collaboration between CHM investigators and traditional medicine academic research centers interested in integrative medicine may lead to quality improvement of RCTs of CHM.

Humans↗

PubMed2004

Macrolide therapy for Chlamydia pneumoniae in the secondary prevention of coronary artery disease: a meta-analysis of randomized controlled trials.

STUDY OBJECTIVE: As recent studies have shown that antibiotic therapy to eradicate Chlamydia pneumoniae may be beneficial in the secondary prevention of coronary artery disease, and studies to date may have lacked statistical power, we conducted a meta-analysis of randomized controlled trials to determine the role of antibiotic therapy in this patient population. DESIGN: Systematic review and meta-analysis of randomized controlled trials. PATIENTS: A total of 12,032 patients from nine studies. MEASUREMENTS AND MAIN RESULTS: We searched MEDLINE, EMBASE, the Cochrane Controlled Trials Register, and abstracts of conference proceedings to identify pertinent studies. The random effects model was used to estimate a pooled relative risk. Heterogeneity was assessed using the bootstrap version of the Q statistic with 1000 replications. In total, we reviewed nine randomized controlled trials enrolling 12,032 patients; six enrolled patients with acute coronary syndrome, two enrolled patients with stable coronary artery disease, and one enrolled a mixed population. Compared with placebo, macrolide therapy was not associated with a significant reduction in any coronary event (relative risk [RR] 0.98, 95% confidence interval [CI] 0.88-1.08), myocardial infarction or angina (RR 0.89, 95% CI 0.68-1.16), or overall mortality (RR 0.95, 95% CI 0.81-1.12). CONCLUSION: Our results do not support routine use of antichlamydial therapy for secondary prevention of coronary events.

Antibiotic Prophylaxis↗

PubMed2001

Evaluation and appraisal of randomized controlled trials in myeloma.

PURPOSE: To critically appraise therapeutic innovations tested in randomized controlled trials (RCTs) in multiple myeloma from 1966-1998. DESIGN: We performed a comprehensive search to identify published RCTs in multiple myeloma. Quality dimensions of the design, conduct, analysis and reporting of each trial were assessed. RESULTS: We identified 136 RCTs reported in 114 papers. Overall, therapeutic efforts in multiple myeloma resulted in a 5% absolute gain in five-year survival at a cost of a 0.35% increase in treatment related deaths. Hence on average a patient enrolled in a RCT in myeloma is 14 (5/35) times more likely to be helped than harmed. However, when the RCTs were critically appraised for key quality dimensions of trials' conduct, we found that only 7%) of the trials (10 of 136) were analyzed according to intention-to-treat (ITT), 9% (12 of 136) reported a power analysis (beta error), 32% (35 of 111) adequately concealed treatment allocation, 78% (106 of 136) provided a detailed description of patient withdrawals, and 83%) (19 of 22) of the double blind RCTs had appropriately described methodology. CONCLUSIONS: Therapeutic innovations tested through RCTs have improved the outcomes of patients with multiple myeloma. However, the quality of RCT reporting and methodology in multiple myeloma could be substantially improved. Most therapeutic strategies in multiple myeloma are based on modest quality, low power evidence. Despite these shortcomings our findings suggest patients may often clinically benefit from enrollment in clinical trials when available. Patients on average received modest benefit from innovative therapies tested in RCTs at little additional risk of side effects.

Humans↗

PubMed2003

Elicitation of prior distributions for a phase III randomized controlled trial of adjuvant therapy with surgery for hepatocellular carcinoma.

A randomized, controlled clinical trial of radioactive iodine tagged with lipiodol in patients with resected hepatocellular carcinoma was criticized for its early stopping and resulting small sample size. To clarify its results, a new, larger multicenter trial was therefore proposed. This paper describes the elicitation of the pretrial opinions of the investigators involved in the new trial and the construction of appropriate clinical and skeptical prior distributions based on their responses. The prior distributions provide a useful tool in assessing the state of equipoise before the start of the trial. They can also be used in Bayesian analyses, both at the interim stage(s) as well as at the end of the trial. We illustrate these analyses, assuming that the data resulting from the new trial was the same as that obtained in the earlier trial when it was stopped.

Bayes Theorem↗

PubMed2003

A prospective randomized controlled trial on ureteral stenting after ureteroscopic holmium laser lithotripsy.

PURPOSE: A prospective randomized controlled trial was conducted to evaluate whether postoperative ureteral stenting is necessary after ureteroscopic laser lithotripsy. MATERIALS AND METHODS: A total of 58 patients with unilateral ureteral stones were randomized into either stented or unstented groups. Ureteroscopic laser lithotripsy was performed using a semirigid ureteroscope (6.5/7Fr) and holmium laser without ureteral orifice dilation. There were no selection criteria regarding stone size, location, preoperative ureteral obstruction and hydronephrosis. Endoscopic evidence of stone impaction or mucosal edema/damage did not exclude a patient from the study. Ureteral perforation on completion retrograde pyelogram was the only intraoperative criterion for study exclusion. Postoperative pain scores and symptoms were recorded. Excretory urography was performed to document stone-free status and stricture formation. Radionuclide scan was performed selectively to exclude functional obstruction when ureteral narrowing was found on excretory urogram. RESULTS: Mean stone size +/- SD was 9.7 +/- 4.0 mm. (range 4 to 27). Proximal ureteral stones accounted for 43% of all stones. Stented and unstented groups were comparable with respect to demographic data, stone parameters, preoperative obstruction and hydronephrosis. There was no significant difference in operating time, laser energy used, stone impaction and mucosal edema/damage between the 2 groups. Postoperative pain and symptoms were more severe and frequent (p <0.05) in the stented group. However, there was no difference in the incidence of postoperative sepsis and unplanned medical visits. The stone-free and stricture formation rates showed no statistical difference between the 2 groups. CONCLUSIONS: Ureteral stenting is not necessary after uncomplicated ureteroscopic laser lithotripsy for ureteral stones. Ureteral stent increases the incidence of pain and urinary symptoms but does not prevent postoperative urinary sepsis and unplanned medical visits. Severity of preoperative obstruction and intraoperative ureteral trauma were not shown to be determining factors for stenting.

Adult↗

PubMed1997

Kangaroo mother versus traditional care for newborn infants </=2000 grams: a randomized, controlled trial.

BACKGROUND: In 1978, kangaroo mother care (KMC) was proposed as a caring alternative for low birth weight (LBW) infants. We are reporting here early outcomes of a randomized, controlled trial comparing KMC to traditional care. METHOD: An open randomized, controlled trial was conducted in a large tertiary care hospital. All newborn infants </=2000 g, surviving the neonatal period and being eligible for a minimal care unit, were included. A total of 1084 newborns </=2000 g were followed, and 746 were randomized-382 to KMC and 364 to traditional care. KMC infants were discharged after randomization, regardless of weight or gestational age. Infants spent 24 hours per day in an upright position, in skin-to-skin contact, and attached to the mother's chest. After randomization, control infants remained at the minimal care unit until meeting usual discharge criteria. Both groups are being followed up to 12 months of corrected age; 679 (90%) were available for evaluation when they reached term (40 to 41 weeks of postconceptional age). The present paper reports early outcomes (when reaching term) including mortality, infectious episodes, hospital stay after eligibility, and growth and feeding patterns. RESULTS: Both study groups were similar regarding all baseline variables but weight at eligibility. The risk of dying was similar in both groups (relative risk = 0.59, 95% confidence interval 0.22-1. 6). There were no differences in growth indices. Nosocomial infections were more frequent in control infants. Hospital stay after eligibility was shorter in KMC, primarily for infants </=1800 g. CONCLUSIONS: These results show that KMC is a safe approach to the care of clinically stable LBW infants. Our findings provide the necessary scientific support to a method that is already incorporated in the care of LBW infants at many hospitals around the world and at different levels of care.

Birth Weight↗