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Results for “Randomized trial”

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PubMed2000

Cognitive rehabilitation for traumatic brain injury: A randomized trial. Defense and Veterans Head Injury Program (DVHIP) Study Group.

CONTEXT: Traumatic brain injury (TBI) is a principal cause of death and disability in young adults. Rehabilitation for TBI has not received the same level of scientific scrutiny for efficacy and cost-efficiency that is expected in other medical fields. OBJECTIVE: To evaluate the efficacy of inpatient cognitive rehabilitation for patients with TBI. DESIGN AND SETTING: Single-center, parallel-group, randomized trial conducted from January 1992 through February 1997 at a US military medical referral center. PATIENTS: One hundred twenty active-duty military personnel who had sustained a moderate-to-severe closed head injury, manifested by a Glasgow Coma Scale score of 13 or less, or posttraumatic amnesia lasting at least 24 hours, or focal cerebral contusion or hemorrhage on computed tomography or magnetic resonance imaging. INTERVENTIONS: Patients were randomly assigned to an intensive, standardized, 8-week, in-hospital cognitive rehabilitation program (n=67) or a limited home rehabilitation program with weekly telephone support from a psychiatric nurse (n=53). MAIN OUTCOME MEASURES: Return to gainful employment and fitness for military duty at 1-year follow-up, compared by intervention group. RESULTS: At 1-year follow-up, there was no significant difference between patients who had received the intensive in-hospital cognitive rehabilitation program vs the limited home rehabilitation program in return to employment (90% vs 94%, respectively; P=.51; difference, 4% [95% confidence interval ¿CI¿, -5% to 14%]) or fitness for duty (73% vs 66%, respectively; P=. 43; difference, 7% [95% CI, -10% to 24%]). There also were no significant differences in cognitive, behavioral, or quality-of-life measures. In a post-hoc subset analysis of patients who were unconscious for more than 1 hour (n = 75) following TBI, the in-hospital group had a greater return-to-duty rate (80% vs 58%; P=. 05). CONCLUSIONS: In this study, the overall benefit of in-hospital cognitive rehabilitation for patients with moderate-to-severe TBI was similar to that of home rehabilitation. These findings emphasize the importance of conducting randomized trials to evaluate TBI rehabilitation interventions. JAMA. 2000;283:3075-3081

Absenteeism↗

PubMed1988

A randomized trial of progestogens in the primary treatment of endometrial carcinoma.

A randomized trial was arranged in Yorkshire to assess whether progestogens would improve survival as part of the primary treatment of endometrial carcinoma, in conjunction with surgery and radiotherapy. A total of 429 patients was randomized on diagnosis to the progestogen or control group and treated locally according to an agreed protocol. All the patients are now more than 1 year after operation and over half are more than 5 years after operation. The projected overall 5-year survival rate is 76% but contrary to expectation there is no statistically significant difference in survival between the patients treated with progestogens and the control group even after statistical adjustment for known prognostic factors.

Aged↗

PubMed1990

A randomized trial of two occlusive dressings in the treatment of leg ulcers.

Two occlusive dressings--one zinc oxide medicated (Mezinc) and one hydrocolloid (Duoderm)--were compared in a prospective, randomized trial over a period of 8 weeks to determine their healing ability and effect on pain for venous and arterial leg ulcers. All patients were patch-tested before the study and colophony allergy was an exclusion criterion. Of the 43 outpatients included, 31 completed the trial and 6 patients randomized to each treatment group were withdrawn. The initial ulcer areas decreased after 8 weeks of treatment with Mezinc by 64% and by 48% after treatment with Duoderm. Ulcer pain was relieved in 50% of the patients--with a similar analgesic effect for the two dressings. Mezinc treatment was discontinued in 2 cases due to sensitization to colophony (one ingredient of Mezinc) which indicated a risk of contact allergy to colophony due to Mezinc treatment. 1103 consecutive eczema patients were patch-tested on the back with Mezinc and colophony 20% in petrolatum simultaneously. It was found that 42 (4%) of the patients showed allergic skin reactions to colophony and 19 (2%) to Mezinc. Both dressings were well tolerated by leg ulcer patients and there appeared to be no major differences in the efficacy of the two occlusive dressings.

Aged↗

PubMed1987

Problems associated with comparisons of response-defined subsets of patients in randomized trials. Treatment-related bias and response migration.

Subset analysis may be justified between various arms of randomized trials as long as subsets are defined by variables which do not cause distortion of other prognostic factors. However, bias will occur when treatment response is used to define a subset of patients in which the results of the same treatment are analyzed. Thus, comparisons between groups of responders in randomized studies are just as inherently biased as comparisons between responders and non-responders. Using a constructed example the effects of treatment-related bias on the interpretation of trial results are demonstrated, and the concept of response migration is introduced. It is shown that in randomized trials the only unbiased measures of treatment efficacy are response rate, overall time to progression, and overall survival.

Clinical Trials as Topic↗

PubMed1996

A randomized trial of cisplatin, etoposide and bleomycin (PEB) versus carboplatin, etoposide and bleomycin (CEB) for patients with 'good-risk' metastatic non-seminomatous germ cell tumors.

BACKGROUND: Cisplatin-based combination chemotherapy will cure 70% to 80% of patients with metastatic non-seminomatous germ cell tumors but is associated with the possibility of severe neuro-, oto- and nephro-toxicities. Carboplatin, a cisplatin analogue, is an active drug in testicular cancer with a more favourable spectrum of side effects. In a randomized trial, the German Testicular Cancer Study Group compared a combination regimen of carboplatin, etoposide and bleomycin (CEB) to standard cisplatin, etoposide and bleomycin (PEB) chemotherapy for patients with 'minimal-' and moderate-disease' non-seminomatous germ cell tumors, according to the Indiana University classification. PATIENTS AND METHODS: PEB was given for three cycles at standard doses (given days 1-5), and the CEB regimen consisted of carboplatin (target AUC of 5 mg/ml x min) on day 1, etoposide 120 mg/m2 on days 1 to 3 and bleomycin 30 mg on days 1, 8 and 15. Four cycles of CEB were given, with the omission of bleomycin in the fourth cycle. Thus, the cumulative doses of etoposide and bleomycin applied in the two treatment arms were comparable. Fifty-four patients were entered on the trial, 29 were treated with PEB and 25 with CEB chemotherapy. Patients were stratified according to disease extent (minimal versus moderate) and the degree of tumor marker elevation. Thirty-two patients (59%) belonged to the group with minimal disease and low markers. RESULTS: No significant difference in response to chemotherapy was seen between the two arms, with CR rates of 81% for the PEB arm and 76% for CEB treatment. However, more patients treated with CEB (32% versus 13%) have relapsed after therapy, and 4 patients (16%) have died of disease progression after CEP in contrast to 1 (3%) after PEB therapy. The first interim analysis of negative events (relapse, vital tumor at secondary resection, death from disease and therapy-associated death) showed a significantly higher rate after CEB than after PEB therapy, and the trial was terminated early. After a median follow-up of 33 months for all patients, the calculation of negative events is still significantly in favour of PEB-treated patient, particularly since three late relapses > 2 years have been observed in the CEB arm (P = 0.03). CONCLUSION: This randomized trial demonstrates that even with the use of adequate doses of etoposide and full-dose bleomycin, carboplatin cannot altogether replace cisplatin in patients with testicular cancer. Treatment with the PEB regimen remains the standard approach in patients with 'good-risk' non-seminomatous germ cell tumors.

Adolescent↗

PubMedDate not supplied

A review of randomized trials of psychiatric consultation-liaison studies in primary care.

The field of consultation-liaison (C-L) psychiatry has developed a variety of research interventions to try to improve the recognition and treatment of mental disorders in primary care. The authors review the results of three generations of randomized trials of mental health interventions developed by C-L psychiatrists. In general, these trials have been more successful in improving detection of mental illness and increasing the application of mental health treatments by primary care physicians than in changing patient outcomes. The results of these randomized trials are interpreted by using models developed in the health services field.

Clinical Trials as Topic↗

PubMed1985

To lay open or excise a fistula-in-ano: a randomized trial.

Two treatments for fistula-in-ano were compared in a randomized trial. Times of healing were significantly shorter when the fistula was laid open (median 34 days, n = 26) than after excision (41 days, n = 21) (P less than 0.02). Revisional surgery was necessary before healing could be obtained in 3 of 26 patients after lay open operations and 2 of 21 after excision. Recurrence rates within 1 year were similar (3/24 and 2/21).

Adult↗

PubMed1993

Evaluation of the dose for postoperative radiation therapy of head and neck cancer: first report of a prospective randomized trial.

PURPOSE: This study was designed to determine in a prospective randomized trial the optimal dose of conventionally fractionated postoperative radiotherapy for advanced head and neck cancer in relation to clinical and pathologic risk factors. METHODS AND MATERIALS: Between January 1983 and March 1991, 302 patients were enrolled on the study. This analysis is based on the first 240 patients entered through September 1989, of whom 221 (92%) had AJC Stage III or IV cancers of the oral cavity, oropharynx, hypopharynx, or larynx. The patients were stratified by postulated risk factors and randomized to one of three dose levels ranging between 52.2 Gy and 68.4 Gy, all given in daily doses of 1.8 Gy. Patients receiving > 57.6 Gy had a field reduction at this dose level such that boosts were only given to sites of increased risk. RESULTS: The overall crude and actuarial 2-year local-regional recurrence rates were 25.4% and 26%, respectively. Patients who received a dose of < or = 54 Gy had a significantly higher primary failure rate than those receiving > or = 57.6 Gy (p = 0.02). No significant dose response could be demonstrated above 57.6 Gy except for patients with extracapsular nodal disease in the neck in whom the recurrence rate was significantly higher at 57.6 Gy than at > or = 63 Gy. Analysis of prognostic factors predictive of local-regional recurrence showed that the only variable of independent significance was extracapsular nodal disease. However, clusters of two or more of the following risk factors were associated with a progressively increased risk of recurrence: oral cavity primary, mucosal margins close or positive, nerve invasion, > or = 2 positive lymph nodes, largest node > 3 cm, treatment delay greater than 6 weeks, and Zubrod performance status > or = 2. Moderate to severe complications of combined treatment occurred in 7.1% of patients; these were more frequent in patients who received > or = 63 Gy. CONCLUSION: With daily fractions of 1.7 Gy, a minimum tumor dose of 57.6 Gy to the whole operative bed should be delivered with a boost of 63 Gy being given to sites of increased risk, especially regions of the neck where extracapsular nodal disease is present. Treatment should be started as soon as possible after surgery. Dose escalation above 63 Gy at 1.8 Gy per day does not appear to improve the therapeutic ratio.

Adult↗

PubMed2001

Nasogastric tube versus gastrostomy tube for gastric decompression in abdominal surgery: a prospective, randomized trial comparing patients' tube-related inconvenience.

BACKGROUND: Perioperative decompression of the stomach is still a common procedure and can be achieved using either nasogastric tubes (NTs) or gastrostomy tubes (GTs). While both procedures appear to be equally effective, some authors believe that NTs are less convenient for patients than GTs. However, to date, no reliable prospective data are available on this issue. METHODS: We conducted a prospective, randomized trial comparing NTs versus GTs with a total of 110 patients undergoing elective colon surgery. The primary outcome measure was the patient's tube-related inconvenience and pain, assessed in a standardized interview on day 2 after surgery and quantified by means of a visual-analog scale (VAS). A questionnaire including the EORTC QLQ-C30 and additional items regarding retrospective tube-related judgements was administered on the day of discharge and 4 weeks after discharge. Secondary endpoints were the therapy-related morbidity and general complications. RESULTS: When patients were asked which of their drainage tubes (all patients had three or four drainage tubes, such as decompression drains, urinary drains, central venous line) was most inconvenient, 43% (CI 33-53%) in the NT group reported that the NT was most inconvenient, while only 4% (CI 1-10%) of the GT patients judged the GT most inconvenient ( P<0.001, Chi(2) test). This effect was also found in VAS ratings of inconvenience and discomfort ( P<0.01). Also postoperatively (p.o.), NT patients evidenced less preference for their tube system (day 2 p.o.: 71%, CI 61-80%; 4 weeks p.o.: 66%, CI 56-75%) than did GT patients (day 2 p.o.: 94%, CI 88-98%; 4 weeks p.o.: 91% CI 84-96%); again, these differences were statistically significant ( P<0.02; Chi(2) test). No differences between groups emerged regarding global quality of life or conventional clinical outcomes. CONCLUSION: This prospective randomized trial supports the clinical observation that NT causes more subjective inconvenience than GT. In cases when a prolonged postoperative ileus is expected, decisions for a prophylactic decompressing tube system have to weigh up the possibilities of different averse clinical as well as subjective outcomes. It is then preferable to include patients' preferences in the individual decision making process (shared-decision making).

Aged↗

PubMed2006

When is measuring sensitivity and specificity sufficient to evaluate a diagnostic test, and when do we need randomized trials?

The clinical value of using a new diagnostic test depends on whether it improves patient outcomes beyond the outcomes achieved using an old diagnostic test. When can studies of diagnostic test accuracy provide sufficient information to infer clinical value, and when do clinicians need to wait for results from randomized trials? The authors argue that accuracy studies suffice if a new diagnostic test is safer or more specific than, but of similar sensitivity to, an old test. However, if a new test is more sensitive than an old test, it leads to the detection of extra cases of disease. Results from treatment trials that enrolled only patients detected by the old test may not apply to these extra cases. Clinicians need to wait for results from randomized trials assessing treatment efficacy in cases detected by the new diagnostic test, unless they can be satisfied that the new test detects the same spectrum and subtype of disease as the old test or that treatment response is similar across the spectrum of disease.

Diagnostic Techniques and Procedures↗

PubMedDate not supplied

Methodologic issues in randomized trials of liaison psychiatry in primary care.

Most anxiety, depressive, and substance abuse disorders are treated exclusively in the primary care health system. However, recognition and treatment of these disorders in primary care is deficient. Psychopharmacologic and psychotherapeutic interventions have been developed and proven effective in randomized trials in specialty care. However, the results of successful trials of mental health interventions in specialty settings may not generalize to primary care settings because of epidemiologic differences in patients, differences in skills of providers, as well as differences in the very structure of care. The importance of the development of innovative randomized trials to improve recognition and treatment of mental illness in primary care is emphasized, as well as the methodologic problems inherent in carrying out these trials.

Humans↗

PubMed2003

Delaying defibrillation to give basic cardiopulmonary resuscitation to patients with out-of-hospital ventricular fibrillation: a randomized trial.

CONTEXT: Defibrillation as soon as possible is standard treatment for patients with ventricular fibrillation. A nonrandomized study indicates that after a few minutes of ventricular fibrillation, delaying defibrillation to give cardiopulmonary resuscitation (CPR) first might improve the outcome. OBJECTIVE: To determine the effects of CPR before defibrillation on outcome in patients with ventricular fibrillation and with response times either up to or longer than 5 minutes. DESIGN, SETTING, AND PATIENTS: Randomized trial of 200 patients with out-of-hospital ventricular fibrillation in Oslo, Norway, between June 1998 and May 2001. Patients received either standard care with immediate defibrillation (n = 96) or CPR first with 3 minutes of basic CPR by ambulance personnel prior to defibrillation (n = 104). If initial defibrillation was unsuccessful, the standard group received 1 minute of CPR before additional defibrillation attempts compared with 3 minutes in the CPR first group. MAIN OUTCOME MEASURE: Primary end point was survival to hospital discharge. Secondary end points were hospital admission with return of spontaneous circulation (ROSC), 1-year survival, and neurological outcome. A prespecified analysis examined subgroups with response times either up to or longer than 5 minutes. RESULTS: In the standard group, 14 (15%) of 96 patients survived to hospital discharge vs 23 (22%) of 104 in the CPR first group (P =.17). There were no differences in ROSC rates between the standard group (56% [58/104]) and the CPR first group (46% [44/96]; P =.16); or in 1-year survival (20% [21/104] and 15% [14/96], respectively; P =.30). In subgroup analysis for patients with ambulance response times of either up to 5 minutes or shorter, there were no differences in any outcome variables between the CPR first group (n = 40) and the standard group (n = 41). For patients with response intervals of longer than 5 minutes, more patients achieved ROSC in the CPR first group (58% [37/64]) compared with the standard group (38% [21/55]; odds ratio [OR], 2.22; 95% confidence interval [CI], 1.06-4.63; P =.04); survival to hospital discharge (22% [14/64] vs 4% [2/55]; OR, 7.42; 95% CI, 1.61-34.3; P =.006); and 1-year survival (20% [13/64] vs 4% [2/55]; OR, 6.76; 95% CI, 1.42-31.4; P =.01). Thirty-three (89%) of 37 patients who survived to hospital discharge had no or minor reductions in neurological status with no difference between the groups. CONCLUSIONS: Compared with standard care for ventricular fibrillation, CPR first prior to defibrillation offered no advantage in improving outcomes for this entire study population or for patients with ambulance response times shorter than 5 minutes. However, the patients with ventricular fibrillation and ambulance response intervals longer than 5 minutes had better outcomes with CPR first before defibrillation was attempted. These results require confirmation in additional randomized trials.

Adult↗

PubMed1993

Comparison of prophylaxis and rescue treatment with Curosurf in neonates less than 30 weeks' gestation: a randomized trial.

OBJECTIVE: The aim of this randomized clinical trial was to evaluate the immediate effects of prophylactic administration of Curosurf and to compare outcomes after prophylactic or expectant management. STUDY DESIGN: Porcine surfactant (Curosurf, 200 mg/kg body weight) was administered intratracheally within 10 minutes of birth to preterm neonates with a gestational age of 26 to 29 weeks (n = 75); rescue-eligible neonates (n = 72) were initially subjected to a sham maneuver. The primary end points of the trial, evaluated at the age of 6 hours, were to obtain (1) a 40% decrease in the ratio between transcutaneous oxygen tension (tcPO2) (kPa) and fraction of inspired oxygen (FIO2), and (2) a 50% decrease in the incidence of radiologically verified respiratory distress syndrome (RDS). After 6 to 24 hours, a similar dose of surfactant was given to the neonates of both the prophylaxis and the rescue-eligible group, if they needed mechanical ventilation with an FIO2 > or = 0.6. RESULTS: At 6 hours the prophylaxis group had, in comparison with the rescue-eligible group, significantly higher tcPO2/FIO2 ratios (mean +/- SD: 39.7 +/- 15.3 vs 28.1 +/- 18.1; P < .001) and less severe RDS by radiological scoring (chi 2 = 14.9; P = .005). Severe RDS was present in 19% of the prophylactically treated neonates versus 32% in the rescue-eligible group (P < .05). The prophylaxis group needed shorter periods of FIO2 > 0.40 than the rescue-eligible neonates (P < .01), and eight neonates of the prophylaxis group (11%) versus 23 of the rescue-eligible group (32%) qualified for rescue treatment with surfactant in the interval 6 to 24 hours (P < .01). There were no differences in the incidence or severity of pneumothorax, pulmonary interstitial emphysema, cerebral hemorrhage, periventricular leukomalacia, patent ductus arteriosus, in the duration of mechanical ventilation or time in supplemental oxygen, or in mortality. CONCLUSIONS: Subgroup analysis revealed (1) that administration of corticosteroids reduced the risk of developing neonatal RDS as effectively as did surfactant prophylaxis at birth, and (2) that prophylaxis was effective especially in neonates with gestational age < 28 weeks or birth weight < 1000 g, in male neonates, and in neonates who had received no antenatal treatment with corticosteroids. Our data indicate that prophylactic treatment with surfactant should be considered in high-risk neonates fulfilling these latter criteria.

Biological Products↗

PubMed1978

Adjuvant chemotherapy in large-bowel cancer: demonstration of effectiveness of single agent chemotherapy in a prospectively controlled,, randomized trial.

In a prospectively randomized study, the effect of adjuvant chemotherapy with 5-FU on survival and recurrence rates was analyzed in 299 evaluable patients with colorectal carcinoma who either underwent a curative or a palliative resection. In the treatment group, chemotherapy consisted of the intravenous administration of 12 mg/kg daily of 5-FU for 4 consecutive days, then 6 mg/kg on alternate days, to the point of toxicity, or to a maximum of five doses, followed by 12mg/kg weekly for 1 year. Some degree of drug toxicity was seen in the majority of patients, was rarely severe, and there have been no drug-related deaths. Analysis of the survival curves and disease-free interval curves reveal definite evidence of drug benefit in two unfavorable subgroups, namely patients with Dukes C tumors and in patients whose tumor was located in the rectum. In the chemotherapy groups, patients who were treated to toxicity (WBC less than 4000 mm3), the disease-free interval was significantly longer than the nonleukopenic patients. We conclude that the addition of 5-FU to the surgical treatment of colorectal carcinoma provides a small, but significant benefit in patients with colorectal cancer in certain unfavorable subgroups, namely patients with Dukes C lesions and patients with rectal carcinoma.

Clinical Trials as Topic↗

PubMed1998

A prospective, randomized trial comparing laparoscopic versus conventional techniques in colorectal cancer surgery: a preliminary report.

BACKGROUND: Uncontrolled studies using laparoscopic techniques in colorectal surgery have not demonstrated clear advantages to these procedures compared with conventional ones, and surgeons are concerned about unusual early recurrences reported after laparoscopic colorectal cancer surgery. STUDY DESIGN: We conducted a prospective, randomized trial in one surgical department comparing laparoscopic (LAP) and conventional (CON) techniques in 109 patients undergoing bowel resection for colorectal cancers or polyps. Postoperatively, all patients underwent measurement of pulmonary function tests every 12 hours, and were treated identically on a highly controlled protocol with regard to analgesic administration, feeding, and postoperative care. RESULTS: Of the 55 patients assigned to LAP and 54 to the CON group, there were 42 and 38 with cancer, respectively (the other patients had large adenomas). Overall recovery of 80% of forced expiratory volume in 1 second and forced vital capacity was a median of 3 days for LAP and 6.0 days for CON (p = 0.01). LAP patients used significantly less morphine than CON patients up to the second day after surgery (0.78 +/- 0.32 versus 0.92 +/- 0.34 mg/kg per day, p = 0.02). Flatus returned a median of 3.0 days after LAP versus 4.0 days after CON surgery (p = 0.006). Tumor margins were clear in all patients. After a median followup of 1.5 years (LAP) and 1.7 years (CON), there were no port site recurrences in the LAP group. Seven cancer-related deaths have occurred (three in the LAP group, four in the CON group). CONCLUSIONS: Within this prospective, randomized trial, laparoscopic techniques were as safe as conventional surgical techniques and offered a faster recovery of pulmonary and gastrointestinal function compared with conventional surgery for selected patients undergoing large bowel resection for cancer or polyps. There were no apparent shortterm oncologic disadvantages. Longer followup is needed to fully assess oncologic outcomes.

Adenocarcinoma↗

PubMed2006

An evaluation of emergency sclerotherapy of varices in randomized trials: looking the needle in the eye.

BACKGROUND: The role of sclerotherapy for acute variceal bleeding is challenged by vasoactive drugs and by ligation. AIM: A meta-analysis was performed to evaluate whether sclerotherapy remains a gold standard in acute variceal bleeding. METHODS: Sclerotherapy was evaluated across four randomized trial groups: (a) combined with vasoconstrictors vs. vasoconstrictors alone (five trials, with 400 patients); (b) vs. vasoconstrictors alone (15 trials, with 1296 patients); (c) vs. combination of vasoconstrictors and sclerotherapy (eight trials, with 1026 patients); (d) vs. ligation (12 trials, with 1309 patients). We used the risk difference (absolute risk reduction) as our main effect measure. RESULTS: The efficacy of acute sclerotherapy was highest vs. ligation at 95 %, with a small advantage for ligation (an overtube was used in eight trials) of 2.5 % (95 % CI 0.4 % to 4.6 %) ( P = 0.018), but no survival difference. Efficacy of sclerotherapy combined with vasoconstrictors vs. vasoconstrictors alone was 86 %, whereas it was 83 % for sclerotherapy vs. vasoconstrictors alone. In both these groups sclerotherapy was superior for control of bleeding at, respectively, 16.3 % (95 % CI 8.7 % to 23.9 % ( P = 0.0001) and 5.9 % (95 % CI, 1.5 % to 10.3 %) ( P = 0.008), with increased survival in the latter. In the combination group of sclerotherapy with vasoconstrictors, the efficacy of sclerotherapy alone was 69 %, with the combination superior in controlling bleeding, at 13.2 % (95 % CI, 8.4 % to 18.1 %) ( P < 0.0001) but with no survival difference. CONCLUSION: This comparison of sclerotherapy across trials demonstrates a problem in defining its real efficacy. The conclusive evidence for substituting banding ligation or the combination of vasoconstrictors with sclerotherapy as better therapeutic approaches has not been provided in randomized trials. Sclerotherapy can remain a gold standard in variceal bleeding but there is scope for further studies of ligation and vasoactive drugs.

Emergency Treatment↗

PubMed1998

A prospective randomized trial of Teflon versus polyethylene stents for distal malignant biliary obstruction.

BACKGROUND AND STUDY AIMS: Clogging of biliary stents continues to be a major clinical problem. Different polymer materials may have different effects on clogging. In vitro studies have shown a direct relation between the frictional coefficient of a polymer and the amount of encrusted material. Teflon appeared to be the best polymer for biliary stents. Two different types of stents made of Teflon have been tested in clinical practice and showed favourable patency rates. However, a randomized trial has never been performed. We compared the patency of an Amsterdam-type polyethylene stent with a Teflon stent in a prospective randomized trial. PATIENTS AND METHODS: Between September 1995 and November 1996, 42 patients received a Teflon stent and 42 patients a polyethylene stent. All patients had a distal malignant biliary stricture without a previous drainage procedure. Diagnoses included carcinoma of the pancreas (n = 76), papilla (n = 1), bile duct (n = 5) and metastases (n = 2). The internal and external diameter (10 Fr), length (9 cm) and stent design (a straight stent with two side flaps and one side hole at each end) were similar for both stents. RESULTS: A reduction in bilirubin of more than 20% within one week was seen in 91% of the patients. Early complication rates were similar in both groups (10%). The median follow-up was 142 days. Stent dysfunction occurred in 28 Teflon and 29 polyethylene stents. The thirty-day mortality was 14% in both groups. Patient survival did not differ significantly between the groups (median survival: Teflon 165 days, polyethylene 140 days). The median stent patency was 83 days for Teflon and 80 days for polyethylene stents, and was not significantly different either. CONCLUSION: Teflon material did not improve patency in biliary stents with an Amsterdam-type design.

Aged↗

PubMed1990

A randomized trial to improve compliance in urinary tract infection patients in the emergency department.

A randomized trial was used to evaluate two forms of a health belief model (HBM) intervention aimed at increasing compliance among 139 patients with urinary tract infections who presented to the emergency department. Patients who received an HBM clinical intervention administered in the ED, HBM telephone intervention two to four days after the ED visit, or both interventions were much more likely than control patients to both schedule and keep a follow-up referral appointment. Both the clinical and telephone interventions were designed to increase perceived susceptibility to complications of the urinary tract infection, seriousness of the complications, and benefits and costs of action. Other factors predicting compliance include age of the patient, urgency of the urinary tract infection as rated subjectively by the emergency physician, need for child care, whether transportation was available, and questioning the nurse about the referral appointment.

Acute Disease↗