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Results for “Randomized controlled trials”

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At least 631 records · Page 35Linked to original sources
PubMed2000

Labeling smokers' charts with a "smoker" sticker: results of a randomized controlled trial among private practitioners.

We randomly assigned private practitioners (n = 393) to receiving, by mail, a box of "Smoker" stickers and a recommendation to label smokers' charts with these stickers, or to no intervention. Twenty percent of the physicians reported using the stickers and applying them on 43% of their smoking patients' charts. The intervention had no impact on physician reports of the proportion of smokers advised to quit smoking, but physicians who reported using the stickers stated that they advised more smokers to quit after the intervention (89%) than before (80%, P =.02). Thus, self-reports by physicians indicated that use of the stickers was associated with an increased proportion of smokers advised to quit. However, overall, the intervention did not modify physicians' behavior.

Counseling↗
PubMed2004

The use of intradiscal steroid therapy for lumbar spinal discogenic pain: a randomized controlled trial.

STUDY DESIGN: A prospective randomized study of the therapeutic effect of intradiscal steroid injection compared to a saline placebo. OBJECTIVES: To determine whether intradiscal steroid injection influences the clinical outcome at 1 year in patients with chronic low back pain of discogenic origin. SUMMARY OF BACKGROUND DATA: Steroids have been used empirically in the treatment of back pain. They have been used in the epidural space and around nerve roots and have been used as an alternative to chymopapain within the disc. Previous studies have, however, shown variable results. METHODS: A total of 120 patients with chronic low back pain of discogenic origin were enrolled in the study. At discography, if they had concordant pain, they were randomized to injection of normal saline or methylprednisolone into the disc space. These patients were prospectively followed up for 12 months, and they were asked to report pain according to a visual analogue score and their Oswestry Disability Index was recorded. The primary outcome measure was determined as a percentage change in disability, and the results were analyzed using independent samples t test. The secondary outcome measure was a change in the pain score, and this was analyzed using the Mann-Whitney U test. RESULTS: There was no significant difference in the primary outcome between the two groups (P = 0.71). The steroid group had a mean change of 2.28 (SE 2.49) in percentage disability, while the saline group had a mean change of 3.42 (SE 1.79). With respect to the change in pain score, there was no significant difference between the two groups (P = 0.72). Those patients who had saline injection had a median change in pain score of 0 (interquartile range -1 to 1), whereas those given steroid treatment had a median change in pain score of 0 (interquartile range -0.25 to 1). CONCLUSIONS: This study demonstrates that intradiscal steroid injections do not improve the clinical outcome in patients with discogenic back pain compared with placebo.

Chronic Disease↗
PubMedDate not supplied

Fixation of the greater omentum for prevention of delayed gastric emptying after left-sided hepatectomy: a randomized controlled trial.

BACKGROUND/AIMS: We performed a randomized trial to evaluate whether fixation of the greater omentum to the peritoneum prevents delayed gastric emptying and other complications after left-sided hepatectomy. METHODOLOGY: Patients undergoing left lateral segmentectomy or left hepatectomy were randomly assigned to a fixation group (n=24) and a non-fixation group (n=25). In the fixation group, the greater omentum was sutured to the peritoneum to prevent the stomach from contacting the cut surface of the liver. RESULTS: Delayed gastric emptying developed in 4 of the patients in the non-fixation group (16%) versus none of the patients in the fixation group. According to univariate analysis, fixation significantly lowered the risk of delayed gastric emptying (p<0.05). The overall morbidity was higher in the non-fixation group (20.0%) than in the fixation patients (8.3%) without significance. CONCLUSIONS: Fixation of the greater omentum to the peritoneum decreased the occurrence of delayed gastric emptying following left-sided hepatectomy.

Adult↗
PubMed1980

A randomized controlled trial of prenatal nutritional supplementation in New York City.

This randomized controlled trial of nutritional supplementation in pregnancy, in a poor black urban population in the United States, aimed to increase the birth weight and influence the postnatal development of the offspring of mothers at high risk of having low birth weight infants. The execution of the research design and adherence to the treatment regimen among the experimental population appeared adequate for a reasonable test of the treatments. At birth, the only significant favorable effect of supplementation observed was the prevention of depressed birth weight among the offspring of mothers who smoked heavily. With balanced protein-calorie supplementation, length of gestation was increased, the proportion of low-birth-weight infants reduced, and mean birth weight raised by 41 gm (not statistically significant). With high protein supplementation, there was an excess of very early premature births and associated neonatal deaths, and there was significant growth retardation up to 37 weeks of gestation. At 1 year of age, significant effects of high protein supplement were found on three psychological measures: visual habituation, visual dishabituation, and mean length of free play episodes. These measures were unrelated to measures of growth at birth and at 1 year of age. There were no detectable residual adverse effects of high protein supplementation at 1 year of age.

Birth Weight↗
PubMed2005

Plasma exchange when myeloma presents as acute renal failure: a randomized, controlled trial.

BACKGROUND: Two small, randomized trials provide conflicting evidence about the benefits of plasma exchange for patients with acute renal failure at the onset of multiple myeloma. OBJECTIVE: To assess the effect of 5 to 7 plasma exchanges on a composite outcome in patients with acute renal failure at the onset of multiple myeloma. DESIGN: Randomized, open, controlled trial, stratified by chemotherapy and dialysis dependence, conducted from 1998 to 2004. SETTING: Hospital plasma exchange units in 14 Canadian medical centers. PARTICIPANTS: 104 patients between 18 and 81 years of age with acute renal failure at the onset of myeloma. INTERVENTION: Study participants were randomly assigned to conventional therapy plus 5 to 7 plasma exchanges of 50 mL per kg of body weight of 5% human serum albumin for 10 days or conventional therapy alone. Ninety-seven participants completed the 6-month follow-up. MEASUREMENTS: The primary outcome was a composite measure of death, dialysis dependence, or glomerular filtration rate less than 0.29 mL x s(-2) x m(-2) (<30 mL/min per 1.73 m2). RESULTS: At enrollment, the plasma exchange and control groups were similar for dialysis dependence, chemotherapy, sex, age, hypercalcemia, serum albumin level, 24-hour urine protein level, serum creatinine level, and Durie-Salmon staging. The primary composite end point occurred in 33 of 57 (57.9%) patients in the plasma exchange group and in 27 of 39 (69.2%) patients in the control group (difference between groups, 11.3% [95% CI, -8.3% to 29.1%]; P = 0.36). One third of patients in each group died. LIMITATIONS: The study was small, used a composite outcome, and did not use renal biopsy as an inclusion criterion. Recruiting physicians were blinded to treatment allocation but not to treatment thereafter. CONCLUSIONS: In patients with acute renal failure at the onset of multiple myeloma, there is no conclusive evidence that 5 to 7 plasma exchanges substantially reduce a composite outcome of death, dialysis dependence, or glomerular filtration rate less than 0.29 mL.s(-2).m(-2) (<30 mL/min per 1.73 m2) at 6 months.

Acute Kidney Injury↗
PubMed2002

Elective lymph node dissection in patients with melanoma: systematic review and meta-analysis of randomized controlled trials.

HYPOTHESIS: Elective lymph node dissection does not improve survival in patients with melanoma without clinically detectable lymph node metastases. OBJECTIVE: To determine whether elective lymph node dissection in patients with melanoma without clinically detectable regional metastases decreases overall mortality. DESIGN: Systematic review and meta-analysis of randomized controlled trials comparing elective lymph node dissection with delayed lymphadenectomy at the time of clinical recurrence. SETTING: Randomized controlled trials available by February 2001. SUBJECTS: The included trials comprised 1533 participants. INTERVENTION: Elective lymph node dissection compared with delayed lymphadenectomy or no lymphadenectomy in patients with melanoma without clinically detectable regional metastases. MAIN OUTCOME MEASURE: Overall mortality in treatment groups as compared with control groups at the end of a 5-year follow-up period. RESULTS: Three randomized controlled trials met the inclusion criteria. The pooled odds ratio for overall mortality for the 3 trials was 0.86 (95% confidence interval, 0.68-1.09). Results are statistically nonsignificant, but they have potential clinical significance. CONCLUSIONS: This systematic review of randomized controlled trials comparing elective lymph node dissection with surgery delayed until the time of clinical recurrence shows no significant overall survival benefit for patients undergoing elective lymph node dissection. Trials included in this review, however, contain significant bias. The question is not answered for all patients, and the results do not exclude the possibility that some subgroups may benefit from elective lymph node dissection. Further research is required.

Elective Surgical Procedures↗
PubMed1984

Fast neutrons in the treatment of head and neck cancers: the results of a multi-centre randomly controlled trial.

The results are presented of a multi-centre randomly controlled trial of fast neutron irradiation and mega-voltage X-rays in the treatment of patients with locally advanced squamous cell carcinoma of the head and neck region. No significant difference was observed in local tumour control rates. Salvage surgery was performed in a similar number of patients in the two groups. Late morbidity was also similar in the two treatment groups. Patients in a subgroup with cancer of the larynx treated by photons had a significantly better survival than those in the neutron treated group.

Aged↗
PubMed2004

Randomized controlled trial evaluating rapid pre-screen of cervical cytology specimens.

A randomized controlled trial of 75,355 cervical cytology specimens was performed comparing rapid pre-screen with no pre-screen. While the percentage of cases receiving a final report of definite high-grade abnormality was higher in the no pre-screen arm (no pre-screen = 0.70%, pre-screen = 0.65%), the percentage of cases receiving a final report of possible or definite high-grade abnormality was essentially identical in the two arms of the trial (no pre-screen = 1.22%, pre-screen = 1.21%). In the randomized trial, one extra cytology report of definite high-grade abnormality was made for every 12,568 slides pre-screened. This level of benefit was reduced by about half when rapid pre-screen was adopted as a routine laboratory practice.

Adult↗
PubMed2001

A prospective randomized controlled trial comparing nonstented versus stented ureteroscopic lithotripsy.

PURPOSE: A prospective randomized controlled trial was performed to determine whether stents may be eliminated after uncomplicated ureteroscopic lithotripsy for ureteral stones. MATERIALS AND METHODS: A total of 58 patients underwent uncomplicated ureteroscopic intracorporeal lithotripsy. After stone fragmentation patients were randomized to a nonstented (29) or a stented (29) treatment group. Intracorporeal lithotripsy was performed with the holmium laser in 57 cases and by electrohydraulic lithotripsy in 1 without balloon dilation or the extraction of stone fragments. Patients were followed 1, 6 and 12 weeks postoperatively. In stented cases the stent was removed at 1 week. Outcome measures included postoperative symptoms assessed with a visual analog scale, postoperative analgesic requirements, complications and the stone-free rate. RESULTS: At 1 week the symptoms of flank pain, abdominal pain, dysuria and frequency were significantly greater in the stented group (p <0.005). There were no differences in symptoms in the groups at subsequent followup visits. There was no difference in treatment groups in terms of the amount of analgesic required in the recovery room or during 1 week after ureteroscopy. Similarly there was no difference in the number of patients requiring antiemetics. One patient in the stented group required hospitalization for genitourinary sepsis and 1 patient in the nonstented group visited the emergency room for postoperative vomiting. The stone-free rate was 100% in each group. CONCLUSIONS: These results demonstrate that after ureteroscopic intracorporeal lithotripsy with the holmium laser patients with a stent have significantly greater irritative and painful symptoms than those without a stent in the early postoperative period. There was no difference in nonstented and stented ureteroscopy with respect to complications or stone-free status. Therefore, we believe that routine stenting after ureteroscopic intracorporeal lithotripsy with the holmium laser is not required as long as the procedure is uncomplicated and performed without balloon dilation of the ureteral orifice.

Adult↗
PubMed1999

Fallopian sperm perfusion versus intrauterine insemination: a randomized controlled trial and metaanalysis of the literature.

OBJECTIVE: To determine whether fallopian sperm perfusion significantly improves pregnancy rates over intrauterine insemination (IUI) in infertile patients. DESIGN: Prospective, randomized, controlled trial and metaanalysis of the literature. SETTING: University-based infertility practice. PATIENT(S): Patients undergoing controlled ovarian stimulation were included in the prospective trial. They were <40 years of age and had no tubal obstructions, and their partners had no history of severe oligospermia. The metaanalysis was done using the patients with unexplained infertility from this study and from other randomized controlled trials found through a MEDLINE data base search. INTERVENTION(S): After undergoing controlled ovarian stimulation, the patients were randomly assigned to receive either IUI or fallopian sperm perfusion. MAIN OUTCOME MEASURE(S): Clinical pregnancy rates. RESULT(S): Only the patients with unexplained infertility had a statistically higher pregnancy rate with fallopian sperm perfusion (odds ratio, 4.1; confidence interval, 1.1-16.4). A metaanalysis of the prospective randomized trials that provided data on patients with unexplained infertility showed a significant improvement in pregnancy rates with fallopian sperm perfusion (odds ratio, 1.9; confidence interval, 1.2-3). CONCLUSION(S): Fallopian sperm perfusion does not improve the chances of pregnancy in patients with infertility other than those with unexplained infertility. Fallopian sperm perfusion does significantly improve the pregnancy rates of patients with unexplained infertility who undergo controlled ovarian stimulation with gonadotropin/insemination protocols.

Adult↗
PubMed1977

Randomized controlled trial of early discharge for inguinal hernia and varicose veins.

A randomized controlled trial has been conducted into the effects of discharging patients from hospital either at 48 h or 6-7 days after operation for inguinal hernia or varicose veins. There was no statistically significant difference in the frequency of major postoperative complications between the two lengths of stay for either of the conditions studied. Similarly there was no difference between the two groups of hernia patients in relation to eventual recurrences.

Clinical Trials as Topic↗
PubMed1987

Successful management of daytime enuresis using alarm procedures: a randomly controlled trial.

Forty four children with daytime wetting were included in a randomly controlled trial of two alarm devices, a contingent one that sounded when wetting occurred and a non-contingent one that went off from time to time unrelated to wetting events. A quota allocation system ensured comparability between treatment groups. Two thirds responded to an alarm by becoming dry. The non-contingent alarm produced as good a response as the contingent one and is recommended for routine use in children with diurnal enuresis. Twenty three per cent of those who responded to treatment relapsed up to two years after completion of the trial.

Adolescent↗
PubMed1990

How best to teach women breast self-examination. A randomized controlled trial.

OBJECTIVE: To compare three methods for teaching breast self-examination. DESIGN: Randomized controlled trial with factorial design. SETTING: A general medicine group practice in a university hospital. PATIENTS: Continuing-care patients from 40 to 68 years of age. Of 456 eligible women, 156 refused participation, 300 were randomly assigned, 269 completed assigned interventions, and 260 completed the post-test 1 year later. INTERVENTIONS: One third of patients received nurse instruction stressing tactile skills (Mammacare group) (Mammatech Corporation, Gainesville, Florida); one third, traditional nurse instruction emphasizing technique (traditional group); and one third, no nurse instruction (control group). Half of each group received physician encouragement. MEASUREMENTS AND MAIN RESULTS: One year later, women in the Mammacare group found more lumps (mean, 57%; 95% CI, 54% to 60%) in manufactured breast models than did those in the traditional (mean, 47%; CI, 44% to 51%) and control (mean, 45%; CI, 42% to 48%) groups. Lump detection specificity was unaffected. Self-reported examination frequency rose in all groups, to 5.1 times per 6 months in the traditional group, 4.2 in the Mammacare group, and 3.9 in the control group. Physician encouragement did not improve sensitivity, specificity, or overall frequency. Women in the Mammacare group used more of seven examination techniques (4.9) than did those in the traditional (3.9) or control (3.2) groups (P less than 0.001). No group increased health care use or reported more overall worry about breast cancer. CONCLUSIONS: Mammacare instruction resulted in more long-term improved lump detection and examination technique use than did traditional instruction or physician encouragement. Breast self-examination instruction should emphasize lump detection skills.

Adult↗
PubMed1992

A randomized controlled trial of early surgery in Duchenne muscular dystrophy.

We performed a randomized controlled trial of early surgical treatment of contractures in 20 boys with Duchenne muscular dystrophy, age 4-6 yr. Surgery consisted of release of hip flexors, removal of iliotibial bands, and lengthening of tendo Achilles bilaterally. All patients were monitored for at least 12 months post-randomization, and assessed quantitatively for muscle strength and function. Surgery corrected the deformities, but had no beneficial effect on strength or function. Indeed, data in the second year showed more rapid deterioration of function in some of the operated boys. There appeared to be continued evolution of pathology following surgery, as assessed by sequential muscle ultrasound and muscle biopsy. We cannot recommend this type of surgery as a routine treatment.

Biopsy↗
PubMed2004

Does it matter which exercise? A randomized control trial of exercise for low back pain.

STUDY DESIGN: Multicentered randomized controlled trial. OBJECTIVES: To determine if previously validated low back pain (LBP) subgroups respond differently to contrasting exercise prescriptions. SUMMARY OF BACKGROUND DATA: The role of "patient-specific" exercises in managing LBP is controversial. METHODS: A total of 312 acute, subacute, and chronic patients, including LBP-only and sciatica, underwent a standardized mechanical assessment classifying them by their pain response, specifically eliciting either a "directional preference" (DP) (i.e., an immediate, lasting improvement in pain from performing either repeated lumbar flexion, extension, or sideglide/rotation tests), or no DP. Only DP subjects were randomized to: 1) directional exercises "matching" their preferred direction (DP), 2) exercises directionally "opposite" their DP, or 3) "nondirectional" exercises. Outcome measures included pain intensity, location, disability, medication use, degree of recovery, depression, and work interference. RESULTS: A DP was elicited in 74% (230) of subjects. One third of both the opposite and non-directionally treated subjects withdrew within 2 weeks because of no improvement or worsening (no matched subject withdrew). Significantly greater improvements occurred in matched subjects compared with both other treatment groups in every outcome (P values <0.001), including a threefold decrease in medication use. CONCLUSIONS: Consistent with prior evidence, a standardized mechanical assessment identified a large subgroup of LBP patients with a DP. Regardless of subjects' direction of preference, the response to contrasting exercise prescriptions was significantly different: exercises matching subjects' DP significantly and rapidly decreased pain and medication use and improved in all other outcomes. If repeatable, such subgroup validation has important implications for LBP management.

Exercise Therapy↗
PubMed2003

Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up.

STUDY DESIGN: A multicenter, randomized, controlled trial with 1-year follow-up. OBJECTIVES: To compare the effect of manual therapy to exercise therapy in sick-listed patients with chronic low back pain (>8 wks). SUMMARY AND BACKGROUND DATA: The effect of exercise therapy and manual therapy on chronic low back pain with respect to pain, function, and sick leave have been investigated in a number of studies. The results are, however, conflicting. METHODS: Patients with chronic low back pain or radicular pain sick-listed for more than 8 weeks and less than 6 months were included. A total of 49 patients were randomized to either manual therapy (n = 27) or to exercise therapy (n = 22). Sixteen treatments were given over the course of 2 months. Pain intensity, functional disability (Oswestry disability index), general health (Dartmouth COOP function charts), and return to work were recorded before, immediately after, at 4 weeks, 6 months, and 12 months after the treatment period. Spinal range of motion (Schober test) was measured before and immediately after the treatment period only. RESULTS: Although significant improvements were observed in both groups, the manual therapy group showed significantly larger improvements than the exercise therapy group on all outcome variables throughout the entire experimental period. Immediately after the 2-month treatment period, 67% in the manual therapy and 27% in the exercise therapy group had returned to work (P < 0.01), a relative difference that was maintained throughout the follow-up period. CONCLUSIONS: Improvements were found in both intervention groups, but manual therapy showed significantly greater improvement than exercise therapy in patients with chronic low back pain. The effects were reflected on all outcome measures, both on short and long-term follow-up.

Adult↗