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PubMed1986

A three year follow up of patients allocated to placebo, or oral or injectable gold therapy for rheumatoid arthritis.

Ninety patients randomly allocated to receive auranofin, matching placebo, or sodium aurothiomalate have been followed up for three years. Inefficacy led to cessation of treatment in 14 patients receiving auranofin, 27 receiving placebo, and one receiving sodium aurothiomalate. Twenty seven of the patients receiving placebo were reallocated within the study and 16 continued therapy at three years. This group showed similar statistically significant improvement in clinical and laboratory parameters at one, two, and three years to those on an active drug from the outset. Patients who discontinued auranofin because of inefficacy were offered sodium aurothiomalate therapy--eight patients in this group completed three years of treatment on sodium aurothiomalate and showed significant improvement in some but not all parameters. A hand radiograph erosion score showed a deterioration in 80% of patients remaining on auranofin, 75% of those on sodium aurothiomalate, and 80% of the original placebo group who continued an active drug for three years. Although more patients discontinued auranofin over the study period because of inefficacy, no difference could be shown between the degree of improvement in the subgroup who remained on auranofin and those receiving sodium aurothiomalate. No disadvantage in outcome could be shown for patients originally assigned to placebo.

Arthritis, Rheumatoid↗

PubMed1981

Effect on mortality of metoprolol in acute myocardial infarction. A double-blind randomised trial.

The effect of metoprolol on mortality was compared with that of placebo in a double blind randomised trial in patients with definite or suspected acute myocardial infarction. Treatment with metoprolol or placebo started as soon as possible after the patient's arrival in hospital and was continued for 90 days. Metoprolol was given as a 15 mg intravenous dose followed by oral administration of 100 mg twice daily. 1395 patients (697 on placebo and 698 on metoprolol) were included in the trial. Definite acute myocardial infarction developed in 809 and probable infarction in 162. Patients were allocated to various risk groups and within each group patients were randomly assigned to treatment with metoprolol or placebo. There were 62 deaths in the placebo group (8.9%) and 40 deaths in the metoprolol group (5.7%), a reduction of 36% (p less than 0.03). Mortality rates are given according to the treatment group to which the patients were initially randomly allocated.

Adult↗

PubMed2002

Using the Zelen design in randomized controlled trials: debates and controversies.

BACKGROUND: The use of the randomized consent design (commonly known as the Zelen design) is a controversial issue in randomized controlled trials. In the Zelen design, participants are randomly allocated prior to seeking consent. Those participants allocated to the intervention group are then approached and offered the intervention, which they can decline or accept. Zelen first proposed the design in 1979. It has been used infrequently since this time, although there are some notable exceptions in nursing, midwifery and some medical specialities. AIM: This paper describes the Zelen design, including the two forms used (the single and double consent versions) and discusses the advantages and disadvantages of using such a design. METHODS: An explanation of the differences between the Zelen design and a conventional randomized controlled trial is presented. In a conventional design, detailed knowledge of the alternative interventions is given to the prospective participant. The participant gives consent and is allocated to one of the groups. In a Zelen design, participants are randomly allocated and then approached and offered the group to which they were allocated. The Zelen design is used firstly, to reduce disappointment bias in the conventional consent-randomization process, and secondly, to remove subjective bias in the recruitment process. There are concerns relating to the use of the Zelen design, including ethical concerns relating to the timing of random allocation and consent and the collection of clinical data. CONCLUSION: It is hoped that by presenting issues pertaining to the Zelen design, other nursing and midwifery researchers may be prompted to consider its use when designing clinical research. The Zelen design is controversial, and debate about its merits and shortcomings is useful. This paper contributes to the ongoing debate.

Ethics, Nursing↗

PubMed1988

Early and late discharge after hospital birth: father's involvement in infant care.

The father's involvement in his baby's care was studied in three groups of fathers: 49 randomly allocated to an experimental group (EG) with mother and infant discharged from hospital 24-48 h after birth, 52 allocated to a control group (CG) with traditional hospital postpartum care, and 237 randomly selected from parents not interested in participating in an evaluative study of early discharge (NPG). The ordinary length of hospital postpartum stay was 5-6 days. Fathers in EG spent more time with the baby (nappy changing, bathing, holding etc...) than fathers in CG during days 2-4 after the birth. No effect of this extended contact was observed measured as father involvement in infant care during the 2nd and 6th week after the birth, and utilization of parental leave during the first year.

Adult↗

PubMed1987

Experimental comparison of the effectivity of individually adapted and standardized dosages of haloperidol.

Experimental tests of whether an individual neuroleptic treatment for compensation of acute schizophrenic disorders is more effective and has fewer side effects than a standard therapy were performed under double-blind conditions. For this purpose, a group of 16 patients was treated with 10 mg haloperidol/day for the duration of 14 days, and another group of 16 patients was treated with 20 mg haloperidol/day for the same period. 16 patients of a third group were treated for 14 days with an individual haloperidol dose adapted to the psychopathological findings. Patients were randomly allocated to the treatment groups. The medication was laid down in accordance with the randomization plan without informing the ward staff and raters by a leading physician of the hospital who was not involved in the data collection in the investigation. The psychological findings were registered by means of the BPRS and the global appraisal by the doctor (CGI) on days 0, 7 and 14. Extrapyramidal side effects were registered by means of the Simpson scale on days 0, 7 and 14. A superiority of the individually adapted treatment over standardized treatment could be demonstrated neither for the therapeutic target parameters nor for the side effect variables. On the contrary, a tendency to superiority in the groups treated with fixed doses was found. The results are discussed in terms of their significance for treatment practice.

Acute Disease↗

PubMed1980

[Early or delayed operation in patients with acute cholecystitis. Results of a prospective randomized controlled clinical trial (author's transl)].

In a prospective controlled randomized clinical trial, 60 patients with acute cholecystitis (diagnosed according to well defined criteria) were allocated randomly to early operation (n=28) or conservative treatment followed by delayed operation (n=30). The formed groups were well balanced. Total duration of hospitalization was 12 days for the early and 22 days for the delayed operation group. One case of death in the second group appeared to be due to pancreatic necrosis. From other complications recorded, only stitch sinus seemed to occur more frequently in the early operation group. For the first time the success of the two therapeutic procedures was evaluated by means of a systematic follow-up 6 weeks and 6 months after operation. The outcome was the same in both groups and "very good" and "good" for all patients. From these results early operation as the routine method for acute cholecystitis can be recommended unconditionally.

Acute Disease↗

PubMedDate not supplied

[Treatment of hemorrhage caused by rupture of esophageal varices in the cirrhotic patient: remote results of a practical controlled study comparing the esophageal clip to conventional medical treatment].

From 1974 to 1979, a prospective controlled study was conducted in 100 patients with cirrhosis and bleeding esophageal varices. The patients were randomly allocated to either portal disconnection of the esophagus with a clip or medical treatment. Randomization and treatment were performed in emergency situation for 50 patients and electively in 50 patients. All survivors had at least 5 years of observation after randomization. Concerning rebleeding, in the group randomized in emergency, 33 p. cent of patients had recurrent bleeding in the surgical group (mean delay: 64.1 +/- 12.4 months) and 84 p. cent among the medically treated patients (mean delay: 10.6 +/- 4.7 months). This difference is statistically significant (p less than 0.001). For the group randomized electively, 25 p. cent of the surgical patients had recurrent bleeding (mean delay: 76.3 +/- 6.4 months) and 92 p. cent of the medically treated patients had recurrent haemorrhage (mean delay: 20 +/- 5.9 months). The difference is statistically significant p less than 0.001). Concerning survival, among the patients randomized in emergency, 20 died in the surgical group (mean survival: 38.9 +/- 9.3 months) and 22 in the medical group (mean survival: 10.8 +/- 4.6 months). Among the patients randomized electively, there were 19 deaths in the surgical group (mean survival: 46.6 +/- 6.8 months) and 21 in the medical group (mean survival: 32.2 +/- 7.6 months). The difference of survival between the medical and the surgical group is not statistically significant.

Aged↗

PubMed1988

Statistical properties of randomization in clinical trials.

This is the first of five articles on the properties of different randomization procedures used in clinical trials. This paper presents definitions and discussions of the statistical properties of randomization procedures as they relate to both the design of a clinical trial and the statistical analysis of trial results. The subsequent papers consider, respectively, the properties of simple (complete), permuted-block (i.e., blocked), and urn (adaptive biased-coin) randomization. The properties described herein are the probabilities of treatment imbalances and the potential effects on the power of statistical tests; the permutational basis for statistical tests; and the potential for experimental biases in the assessment of treatment effects due either to the predictability of the random allocations (selection bias) or the susceptibility of the randomization procedure to covariate imbalances (accidental bias). For most randomization procedures, the probabilities of overall treatment imbalances are readily computed, even when a stratified randomization is used. This is important because treatment imbalance may affect statistical power. It is shown, however, that treatment imbalance must be substantial before power is more than trivially affected. The differences between a population versus a permutation model as a basis for a statistical test are reviewed. It is argued that a population model can only be invoked in clinical trials as an untestable assumption, rather than being formally based on sampling at random from a population. On the other hand, a permutational analysis based on the randomization actually employed requires no assumptions regarding the origin of the samples of patients studied. The large sample permutational distribution of the family of linear rank tests is described as a basis for easily conducting a variety of permutation tests. Subgroup (stratified) analyses, analyses when some data are missing, and regression model analyses are also discussed. The Blackwell-Hodges model for selection bias in the composition of the study groups is described. The expected selection bias associated with a randomization procedure is a function of the predictability of the treatment allocations and is readily evaluated for any sequence of treatment assignments. In an unmasked study, the potential for selection bias may be substantial with highly predictable sequences. Finally, the Efron model for accidental bias in the estimate of treatment effect in a linear model is described. This is important because the potential for accidental bias is equivalent to the potential for a covariate imbalance.(ABSTRACT TRUNCATED AT 400 WORDS)

Clinical Trials as Topic↗

PubMed2004

Increased postoperative peritoneal adhesion formation after the treatment of experimental peritonitis with chlorhexidine.

BACKGROUND AND AIMS: Chlorhexidine is known as a substance that produces adhesions. However, in an experimental model of peritoneal injury, lavage with chlorhexidine and saline solutions produced a similar number of adhesions. This study was designed to test the hypothesis that chlorhexidine gluconate 0.05% solution used for the treatment of peritonitis increases formation of postoperative peritoneal adhesions as compared to standard lavage with saline solution. MATERIAL AND METHODS: Forty Wistar rats were randomly allocated to gastric or faecal peritonitis groups. In each group rats were further randomly subdivided into saline or chlorhexidine peritoneal lavage groups. After 30 days the rats were killed and intraperitoneal adhesions were evaluated by adhesion score and grading. RESULTS: Adhesion scores were statistically significantly different between saline and chlorhexidine groups in both gastric and faecal peritonitis models. In the faecal peritonitis chlorhexidine group a 20% small bowel intussusception rate was observed, while there were no such complications in the other study groups. The conglomerate of organs formed by dense adhesions was present in 60% of cases when gastric peritonitis was lavaged by chlorhexidine and in only 10% when saline solution was used ( P<0.05). Neither chlorhexidine nor saline solutions have caused such dense adhesions in faecal peritonitis. CONCLUSION: Peritoneal lavage with chlorhexidine gluconate 0.05% solution in the treatment of experimental peritonitis results in increased adhesion formation.

Animals↗

PubMed2004

Intravenous immunoglobulin for preventing infection in preterm and/or low-birth-weight infants.

BACKGROUND: Nosocomial infections continue to be a significant cause of morbidity and mortality among preterm and/or low birth weight infants. Maternal transport of immunoglobulins to the fetus mainly occurs after 32 weeks gestation and endogenous synthesis does not begin until several months after birth. Administration of intravenous immunoglobulin provides IgG that can bind to cell surface receptors, provide opsonic activity, activate complement, promote antibody dependent cytotoxicity, and improve neutrophilic chemo luminescence. Intravenous immunoglobulin thus has the potential of preventing or altering the course of nosocomial infections. OBJECTIVES: To assess the effectiveness/safety of intravenous immunoglobulin (IVIG) administration (compared to placebo or no intervention) to preterm (< 37 weeks gestational age at birth) and/or low birth weight (LBW) (< 2500 g BW) infants in preventing nosocomial infections. SEARCH STRATEGY: MEDLINE, EMBASE, and The Cochrane Library Databases were searched in September 2003 using the keywords: immunoglobulin and infant-newborn and random allocation or controlled trial or randomized controlled trial (RCT). The reference lists of identified RCTs and personal files were searched. No language restrictions were applied. SELECTION CRITERIA: The criteria used to select studies for inclusion in this overview were: 1) DESIGN: RCTs in which administration of IVIG was compared to a control group that received a placebo or no intervention. 2) POPULATION: preterm (< 37 weeks gestational age) and/or LBW (<2500 g) infants. 3) INTERVENTION: IVIG for the prevention of bacterial/fungal infection during initial hospital stay (8 days or longer). (Studies that were primarily designed to assess the effect of IVIG on humoral immune markers were excluded as were studies in which the follow-up period was one week or less).4) At least one of the following outcomes was reported: sepsis, any serious infection, death from all causes, death from infection, length of hospital stay, intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD). DATA COLLECTION AND ANALYSIS: Two reviewers independently abstracted information for each outcome reported in each study, and one researcher (AO) checked for any discrepancies and pooled the results. Relative risk (RR) and Risk Difference (RD) with 95% confidence intervals (CI) using the fixed effects model are reported. When a statistically significant RD was found the number needed to treat (NNT) was also calculated with 95% CIs. The results include all accepted studies in which the outcome of interest was reported. Statistically significant between study heterogeneity was reported. The results of the inconsistency test (I squared) are also reported when statistically significant heterogeneity was found. MAIN RESULTS: No new trials were identified in September 2003. Nineteen studies met inclusion criteria. These included approximately 5,000 preterm and/or LBW infants and reported on at least one of the outcomes of interest for this systematic review. When all studies were combined there was a statistically significant reduction (p = 0.02) in sepsis, RR [0.85 (95% CI 0.74, 0.98)] and RD [-0.03 (95% CI 0.00, -0.05)], NNT 33. There was statistically significant between-study heterogeneity (p = 0.02); I squared 54%. A statistically significant reduction was found for any serious infection, one or more episodes, when all studies were combined [RR 0.82 (95% CI 0.74, 0.92); RD -0.04 (95% CI -0.02, -0.06,); NNT 25 (95% CI, 16.7, 50). There was statistically significant between-study heterogeneity (p = 0.0006); I squared 50%. There were no statistically significant differences for mortality from all causes, mortality from infection, incidence of NEC, BPD and IVH or length of hospital stay. No major adverse effects of IVIG were reported in any of the studies. REVIEWER'S CONCLUSIONS: IVIG administration results in a 3% reduction in sepsis and a 4% reduction in any serious infection, one or more episodes, but is not associated with reductions in other important outcomes: sepsis, NEC, IVH, or length of hospital stay. Most importantly, IVIG administration does not have any significant effect on mortality from any cause or from infections. Prophylactic use of IVIG is not associated with any short term serious side effects. From a clinical perspective a 3-4% reduction in nosocomial infections without a reduction in mortality or other important clinical outcomes is of marginal importance.The decision to use prophylactic IVIG will depend on the costs and the values assigned to the clinical outcomes. There is no justification for further RCTs testing the efficacy of previously studied IVIG preparations to reduce nosocomial infections in preterm and/or LBW infants. The results of these meta-analyses should encourage basic scientists and clinicians to pursue other avenues to prevent nosocomial infections.

Cross Infection↗

PubMed1995

Ovarian function following abdominal hysterectomy with and without unilateral oophorectomy.

There is no consensus concerning optimal adnexal surgery during abdominal hysterectomy, when continued hormonal function is desired, associated with reduced sequelae in the future. The aim of the study was to compare residual ovarian function following abdominal hysterectomy with preservation of one or both ovaries, in a prospective randomized study. Forty patients were allocated randomly and sequentially into two groups: those undergoing abdominal hysterectomy with unilateral oophorectomy, and those undergoing abdominal hysterectomy only. Ovarian function was evaluated by measuring FSH, TLH and E2 before, and 1 week, 1 month, 3 months and 6 months after the operation. Thirty-five percent of the patients undergoing abdominal hysterectomy with unilateral oophorectomy demonstrated impaired ovarian function 6 months after the operation. None of the patients with both preserved ovaries showed impaired ovarian function 6 months later. Therefore, when continued ovarian function following abdominal hysterectomy is desired, preservation of both ovaries seems to be more beneficial.

Adult↗

PubMedDate not supplied

The value of adding sciatic block to continuous femoral block for analgesia after total knee replacement.

BACKGROUND AND OBJECTIVES: The benefit of adding a sciatic nerve block to the femoral block to improve analgesia after total knee replacement is controversial. The aim of this study is to address this controversy in a prospective, comparative, and randomized study. METHODS: Patients were allocated randomly to receive a continuous femoral nerve block or continuous blocks of both the femoral and sciatic nerves. Stimulating catheters were used in all cases. A loading dose of 15 mL ropivacaine 0.75% was injected into each catheter, followed by administration of ropivacaine 0.2% (2-5 mL/h infusion via the femoral catheter; bolus 10 mL repeated every 12 hours in the sciatic catheter). The primary outcome was visual analog scale (VAS) scores (0 = no pain, 100 mm = worst pain) in postanesthesia care unit and in the 48-hour period after surgery. The secondary outcomes were amplitude of knee flexion, morphine consumption, and occurrence of postoperative nausea and vomiting (PONV). RESULTS: The VAS scores at rest were significantly higher when there was only continuous femoral nerve block than when there was both continuous femoral and sciatic nerve blocks. This difference progressively decreased and disappeared at 36 hours after surgery. The combined femoral and sciatic blocks decreased the morphine consumption by 81% and significantly decreased the occurrence of PONV. CONCLUSION: During the 36 hours immediately after total knee replacement, the combination of continuous femoral and sciatic nerve blocks improves analgesia while decreasing morphine consumption and PONV.

Aged↗

PubMed2006

Low-dose bupivacaine spinal anaesthesia for percutaneous nephrolithotomy: the suitability and impact of adding intrathecal fentanyl.

BACKGROUND: Unilateral spinal anaesthesia has been used for lower limb surgery with a stable cardiovascular state and a short recovery unit stay. We sought to test the suitability of low-dose bupivacaine spinal anaesthesia for percutaneous nephrolithotomy, a procedure hitherto performed under general anaesthesia. Furthermore, we hypothesized that adding intrathecal fentanyl to bupivacaine may improve the quality of anaesthesia. METHODS: We randomly allocated, through computer-generated randomization, 108 patients subjected to percutaneous nephrolithotomy to receive either 7.5 mg of hyperbaric bupivacaine 5 mg/ml alone or with the addition of 10 microg of fentanyl. Drugs were given at the L(2)-L(3) interspace with the patient in the lateral decubitus position. The patients remained in this position for 10 min, after which the sensory and motor blocks were assessed. Intra-operative analgesic supplementation, when deemed necessary, was achieved with intravenous fentanyl boluses (25 microg). RESULTS: The sensory and motor blocks after intrathecal bupivacaine and bupivacaine-fentanyl were similar. Sensory block, in both groups, reached the fifth and eighth thoracic dermatomes on the operative and non-operative sides, respectively. Deep motor block occurred on the operative side in all patients and in nearly 50% of patients on the non-operative side. The patients in the bupivacaine-fentanyl group required less intra-operative and post-operative analgesics, and both patients and endoscopists were better satisfied. CONCLUSION: This study demonstrated, for the first time, that intrathecal low-dose bupivacaine and fentanyl offers a reliable neuraxial block for patients subjected to percutaneous nephrolithotomy, with stable haemodynamics, good post-operative analgesia and acceptable patient and endoscopist satisfaction.

Analgesics, Opioid↗

PubMed1985

[Isolated stenosis of the anterior interventricular artery. Comparison of the effects of medical and surgical treatment (in a randomised series)].

Forty-five patients presenting with unstable angina having 70 p. 100 stenosis of the left anterior descending artery judged acceptable for coronary bypass surgery were randomly allocated, using a table of random numbers, for medical (21 patients) or surgical treatment (24 patients). There were no significant differences between the two groups with regards to age (53 +/- 10 years for the medical group; 55 +/- 9 years for the surgical group), the length of follow-up (55 +/- 26 vs 61 +/- 28 months), left ventricular end diastolic volumes (87 +/- 27 vs 84 +/- 18 ml/m2) or ejection fraction (62 +/- 8 vs 59 +/- 11 p. 100). There were no deaths in the medical group; two patients developed uncomplicated myocardial infarction 19 days and 7 months after coronary angiography, respectively. 5 patients had recurrent angina and were referred for surgery. This operation of second intention did not pose any special problems. 6 of the 14 patients with stenosis of the LAD before the origin of the first septal artery had complications (infarction in 1 case, recurrent angina in 5 cases). In the surgical group, 1 patient died in the immediate postoperative period, of resistant cardiac arrhythmia; 2 patients developed uncomplicated peroperative myocardial infarction; 21 patients had no complications at all. The surgical patients were heparinised in the immediate postoperative period and anticoagulant therapy was continued with oral vitamin K antagonists for 6 months to 1 year, followed in some cases, by platelet antiaggregant therapy. 20 patients in this group underwent maximal exercise stress testing which was negative in 19 cases.(ABSTRACT TRUNCATED AT 250 WORDS)

Adrenergic beta-Antagonists↗

PubMed1986

Comparison of diethylstilbestrol, cyproterone acetate and medroxyprogesterone acetate in the treatment of advanced prostatic cancer: final analysis of a randomized phase III trial of the European Organization for Research on Treatment of Cancer Urological Group.

Patients with previously untreated category T3 to T4 Mo or Ml prostatic cancer were allocated randomly to receive 250 mg. cyproterone acetate per day, a loading dose of 500 mg. medroxyprogesterone acetate intramuscularly 3 times weekly for 8 weeks followed by 100 mg. orally twice daily, or 1 mg. diethylstilbestrol 3 times daily in a phase III trial (protocol 30761) performed by the genitourinary tract cooperative group of the European Organization for Research on the Treatment of Cancer. Of 236 patients entered 210 were eligible: 75 received cyproterone acetate, 71 medroxyprogesterone acetate and 64 diethylstilbestrol. Local and distant tumor response, time to progression, survival and toxicity were assessed. Patients treated with medroxyprogesterone acetate had a less favorable course with a shorter duration of survival and time to progression than those treated with the other 2 drugs. There was no significant difference between diethylstilbestrol and cyproterone acetate. Cardiovascular side effects were reported more often in patients treated with diethylstilbestrol than in those treated with cyproterone acetate but severe and lethal cardiovascular toxicity was relatively low in all groups. Other side effects were negligible. Further studies are required to establish the influence of effective hormonal treatment upon survival.

Aged↗

PubMedDate not supplied

Combined radiation therapy and surgery in the management of advanced head and neck cancer: final report of study 73-03 of the Radiation Therapy Oncology Group.

Between March 1973 and June 1979, patients with advanced operable squamous cell carcinoma of the supraglottic larynx or hypopharynx were randomly allocated to receive either preoperative radiation therapy (5,000 rad) or postoperative radiation therapy (6,000 rad). Patients with oral cavity or oropharynx lesions were randomly assigned either preoperative radiation, postoperative radiation, or definitive radiation therapy (6,500-7,000 rad), with surgery reserved for salvage if residual disease was present 6 weeks after completion of irradiation. Three hundred twenty patients were evaluable with a median follow-up of 60 months. Based on results in 277 patients across all four regions combined, locoregional control was significantly better for patients assigned to receive postoperative radiation therapy (65%) compared with those assigned to receive preoperative radiation therapy (48%, P = 0.04). This was due to a higher rate of both persistent and recurrent local and regional disease in the preoperative group. Survival also showed a trend to be better in the postoperative group (38%) compared with the preoperative group (33%, P = 0.10). Rates of severe surgical and radiation therapy complications were similar overall. Forty-three patients were evaluable for each of the three treatment regimens assigned to patients with oral cavity or oropharynx lesions. Due to the small number of patients available for this portion of the trial, the observed differences for overall survival (4-year percentage 33% overall; 30% preoperative, 36% postoperative, 33% definitive radiation therapy) and for locoregional control (45% overall; 43% preoperative, 52% postoperative, 38% definitive radiation therapy) were not statistically significant. The use of definitive radiation therapy with surgical rescue as an ethically justified alternative treatment for these tumors remains a question for further research.

Carcinoma, Squamous Cell↗

PubMed1991

Practice randomization and clinical research. The Indiana experience.

Thoughtful preparation of a research laboratory is an early step in designing a program for scientific investigation. The Division of General Internal Medicine at Indiana University has maintained a "laboratory" for outpatient clinical investigation for more than 15 years. In this report, we describe the structure and function of the General Medicine Practice in the Regenstrief Health Center on the campus of the Indiana University School of Medicine in Indianapolis. Specifically, we discuss the ongoing random allocation of subjects, the local resources for data management and tracking of patients' use of clinical services, and how combining this information system into a randomized primary care system has fostered successful ventures in clinical investigation.

Health Services Research↗

PubMed1992

Efficacy of milbemycin oxime against experimentally induced Ancylostoma caninum and Uncinaria stenocephala infections in dogs.

Twenty-eight helminth-naive Beagles, 16 to 26 weeks old, were inoculated with 200 third-stage larvae each of Ancylostoma caninum and Uncinaria stenocephala 5 times at weekly intervals. Dogs were randomly allocated to 4 groups of 7 on the basis of fecal egg counts, and treatments were randomly assigned. Groups 1 and 3 were given milbemycin oxime at a dosage of 500 micrograms/kg of body weight, PO, on day 0 and on days 0 and 30, respectively; groups 2 and 4 were nontreated controls. Fecal egg counts were evaluated before and after treatments. Feces were collected daily for 7 days after the final treatment for recovery of worms passed, and all dogs were euthanatized 7 days after the final treatment for recovery of worms retained. A 65.7% reduction from the pretreatment value for geometric mean hookworm egg count was found 7 days after the first treatment, and a 97.1% reduction 7 days after the second treatment. Although milbemycin oxime had 96.5% and 99.5% controlled efficacy against A caninum after 1 or 2 treatments, respectively, it lacked efficacy against U stenocephala. The geometric mean number of U stenocephala and the total number of hookworms retained after 1 or 2 treatments were not significantly different from the numbers retained by the corresponding control groups.

Ancylostoma↗