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PubMed2002

Cellular cholesterol flux studies: methodological considerations.

Reverse cholesterol transport (RCT) is the process in which peripheral cells release cholesterol to an extracellular acceptor such as high-density lipoprotein (HDL) which then mediates cholesterol delivery to the liver for excretion. RCT represents a physiological mechanism by which peripheral tissues are protected against excessive accumulation of cholesterol. The first step in RCT is the interaction of the cell with lipoprotein particles, a process that results in both the cellular uptake and release of cholesterol. The various components of this cholesterol flux can be viewed as efflux, influx and net flux. Experimental protocols for measuring each of these components of cholesterol flux are very different, and a number of considerations are required to design experimental approaches for the quantitation of flux parameters. Although many flux studies have been conducted in the past, the recent discoveries of the scavenger receptor B1 (SR-B1) and ATP binding cassette 1 (ABCA1), which mediate the movement of cholesterol between cells and extracellular acceptors, has led to increased interest in studies of cellular cholesterol flux. The aim of this review is to present a discussion of the methodological considerations that should be evaluated during the design and analysis of cellular cholesterol flux experiments.

Animals↗
PubMed2004

[In-patient treatment decisions].

BACKGROUND AND OBJECTIVE: The aim of this study was to identify the extent to which treatment decisions for medical in-patients in three hospitals in Catalunya are supported by published evidence. PATIENTS AND METHOD: In a retrospective, cross-sectional study, main diagnosis-treatment pairs (DTPs) were identified for 980 hospital discharges. The Cochrane library and MEDLINE from 1966 to 1998 were searched for systematic reviews or, in their absence, randomized controlled clinical trials (RCT) that supported the treatment given for each diagnosis. The level of evidence found for each DTP was classified. Descriptive analyses for patients and different DTP were performed. RESULTS: A systematic review or RCT (level I) was found for 65.4% of the 980 patients. In 32.6% of cases, there was only non-experimental or consensus evidence (level II) and in 2% there was no good evidence for the treatment given (level III). An analysis of the 598 unique pairs reduced the percentage of cases supported by level I evidence (55.7) with a proportionate increase in level II (41%). There were some differences in the proportion of cases in each evidence level by diagnostic group. CONCLUSIONS: For about two thirds of patients and a half therapeutic decisions in these three centres, there was a published RCT or a systematic review, with variations according to diagnostic groups. More robust and objective instruments are needed to assess the degree to which scientific evidence is applied in clinical practice.

Cross-Sectional Studies↗
PubMed1999

Apparent fracture toughness of acrylic bone cement: effect of test specimen configuration and sterilization method.

The plane strain fracture toughness of Palacos R bone cement was determined using linear elastic fracture mechanics (LEFM) principles and three different test specimen configurations: single edge notched three-point (SENB), rectangular compact tension (RCT), and chevron notched short rod (CNSR). Another aspect of the study was an investigation of the effect of three methods used to sterilize the powder constituents of the cement-none, gamma irradiation and ethylene oxide--on the fracture toughness of the fully polymerized material. A detailed justification is provided for using LEFM. The fracture toughness results obtained using the CNSR specimens were, on average, 14 and 16% higher than those obtained using the SENB and RCT types, respectively. These differences are accounted for in terms of differences in four aspects of these specimen configuration (namely, residual stress effects, loading rate, material inhomogeneity, and the nature of the test). For a given specimen configuration, gamma irradiation produced a statistically significant decrease in fracture toughness which, it is suggested, is due to the concomitant depreciation in molecular weight. For a given cement type, there is no statistically significant difference in fracture toughness results obtained using SENB and RCT specimens. It is thus suggested that either of these configurations can be used to determine the fracture toughness of acrylic bone cement.

Bone Cements↗
PubMed2000

Amylin receptors mediate the anorectic action of salmon calcitonin (sCT).

The teleost salmon calcitonin (sCT), but not mammalian CT, shows similar biologic actions in the skeletal muscle as amylin and calcitonin gene-related peptide (CGRP). The peptides have also been shown to reduce food intake in rams. Because sCT, but not amylin, binds irreversibly to amylin binding sites, the aim of the present study was to compare the anorectic potency of both peptides. To determine whether sCT reduces food intake through interaction with amylin binding sites, we also tested whether appropriate antagonists (CORP 8-37, AC 187) attenuate the anorectic effect of sCT. Finally, we wanted to know whether rat calcitonin (rCT) and sCT reduce food intake to the same extent. Peptides were injected intraperitoneally at dark onset in 24 h food-deprived rats. At doses of 5 or 0.5 microg/kg, the anorectic effect of sCT was more potent and lasted much longer (e.g. 5 microg/kg: sCT > 10 h; amylin approx. 2 h) than that of amylin. Both CORP 8-37 and AC 187 (10 microg/kg) markedly reduced the anorectic action of sCT (0.5 microg/kg). In contrast to sCT, rCT (0.5 microg/kg) had no effect on food intake. It is concluded that sCT s anorectic effect is partly mediated by amylin receptors. Irreversible binding of sCT to amylin receptors may lead to a stronger and prolonged effect in comparison to amylin due to a sustained activation of the binding sites. Similar to other actions of CTs, the anorectic potency of sCT in rats was higher than that of mammalian (rat) CT. This agrees with binding profiles of amylin, sCT, and rCT at amylin binding sites as observed in in vitro studies.

Amyloid↗
PubMed2001

[Transdermal nitroglycerin versus corticosteroid infiltration for rotator cuff tendinitis].

AIMS: To compare transdermal nitroglycerin (NTG) and corticosteroid infiltration in patients with rotator cuff tendinitis (RCT). DESIGN: Experimental, randomized controlled study. SETTING: Semirural basic health area in the Garraf region of Barcelona province, Spain, with a population of public health service users of 12000. PATIENTS AND METHODS: Patients diagnosed as having RCT of less than 6 weeks' evolution who had not responded to treatment with oral nonsteroid antiinflammatory drugs. The patients were distributed randomly into two groups: a) group A, local infiltration via a posterior approach with a depot corticosteroid and local anesthesia, and b) group B, treated for 3 days with a 5-mg NTC patch. MAIN MEASURES: Age, sex, pain (measured with an analog visual scale) and adverse events. In patients who showed a partial response, treatment was repeated up to 3 times at 15-day intervals. Pain was tested after 7-10 days of treatment. Complete improvement was considered a reduction in pain of more than 5 points on the analog visual scale; partial improvement was considered a reduction of 3-5 points, and treatment failure was recorded when there was no improvement in pain or when there was a decrease of less than 3 points. RESULTS: A total of 48 patients were included; 33 (69%) were women and 15 (31%) were men. Mean age was 61 years. In group A, complete improvement was seen in 19 patients and partial improvement in 3; treatment failed in 2 patients. In group B complete improvement was seen in 5 patients, partial improvement in 5, and failure of treatment in 14. The difference between groups was statistically significant. Adverse events were mild pain at the injection site in 4 patients from group A, and headache in 15 patients from group B, 8 of whom abandoned treatment for this reason. CONCLUSION: Treatment with NTG is not a clear alternative to infiltration of corticosteroids in patients with RCT, because of its lack of effectiveness and because of the greater number of patients who had adverse events that lead them to abandon treatment.

Analgesics↗
PubMed2003

A pilot study to quantify parental anxiety associated with enrollment of an infant or toddler in a phase III vaccine trial.

We sought to measure the anxiety felt by parents at the time of entry into a randomized controlled vaccine trial, and to determine if anxiety level was associated with parental demographic variables or past experience. The children were 2-month-old infants entering a randomized controlled clinical trial (RCT) of a diphtheria-tetanus toxoid-acellular pertussis vaccine adsorbed with Haemophilus influenzae B conjugate, or toddlers enrolling in a RCT of a Meningococcal C conjugate vaccine. Nurses interviewed parents to collect demographic data and parents self-administered the Spielberger Self-evaluation Questionnaire (State Anxiety STAI-Y-I) [Manual for the State-Trait Anxiety Inventory (Form Y) (Self-evaluation Questionnaire), Consulting Psychologists Press Inc., Palo Alto, 1983], a validated instrument measuring the temporary condition of "state anxiety." A regression tree (CART) (S-Plus) was used to identify factors associated with higher anxiety scores. Parents of 97 children enrolled. Anxiety scores ranged from 22.75 (lower anxiety) to 36.43 (higher anxiety). The regression tree identified a structured tree with six branches. The highest anxiety scores occurred in fathers with education less then grade 8, mothers with education less than high school, birth order of the child less then the third, previous serious illness in the family, or lack of experience with research. In a group of parents agreeing to enroll their infant or toddler in a vaccine study, certain attributes and experiences were associated with higher anxiety at the time of immunization in the context of a RCT. These factors should be considered by vaccine researchers in the recruitment process of clinical trials.

Adult↗
PubMed1998

Postobturation pain after single- and multiple-visit endodontic therapy. A prospective study.

OBJECTIVES: This prospective study was conducted to determine whether there is any significant difference in the incidence of postobturation pain after single- and multiple-visit root canal treatment (RCT). METHODS: The frequency of postobturation pain was recorded and evaluated over an observation period of 30 days in 291 of 300 consecutive patients receiving RCT. The patients were assigned randomly and consecutively into either single- or multiple-visit groups. The canals of all teeth were prepared and filled by a single operator using the step-back and lateral condensation techniques. The data were analysed statistically to determine the relationship, if any, between the pain experienced and pulpal vitality, tooth type, pre-operative pain, and the sex and age of the patient. RESULTS: Nine of the 300 patients were excluded from the analysis as they failed to attend for postoperative reviews. A significantly higher incidence (P < 0.01) of postobturation pain was found in the multiple-visit group (38%) than in the single-visit group (27%) within 24 h of obturation. The incidence of pain decreased thereafter, with all patients being sysmptom free at the end of the observation period. No significant correlation was found between postobturation pain and any other factor, with the exception that teeth which had nonvital pulp prior to treatment were associated with a significantly greater (P < 0.005) incidence of postobutration pain. CONCLUSIONS: Pain was significantly higher in the multiple-visit RCT group and significantly associated with the treatment of the nonvital pulp.

Adolescent↗
PubMed1998

Effects of calcitonin and calcitonin gene-related peptide on the substance P-mediated secretion of fluid from the rat submandibular gland.

1. The effects of rat calcitonin gene-related peptide (rCGRP), rat calcitonin (rCT) and salmon calcitonin (sCT) on the substance P-mediated (SP-mediated) secretion of fluid from the rat submandibular gland were investigated. 2. Rat CGRP potentiated and prolonged the SP-mediated secretion of fluid from the rat submandibular gland in a dose-dependent manner. CGRP also enhanced methacholine- and phenylephrine-mediated secretion of fluid. 3. The potentiating effect of the combination of rCGRP and SP was somewhat reduced by pretreatment with spantide, human CGRP8-37 and atropine but not by pretreatment with phentolamine or with propranolol. 4. Salmon CT at a low dose mimicked the effect of rCGRP on the SP-mediated secretion of fluid, but its potency was lower than that of rCGRP. However, rCT had no effect on the SP-mediated secretion of fluid. 5. These results suggest that the potentiating effects of rCGRP and SP might involve cholinergic receptors, as well as CGRP and tachykinin receptors, and that sCT, but not rCT, is able to mimic rCGRP in potentiating the secretion of fluid induced by SP.

Animals↗
PubMed2000

Randomized clinical trial on the use of antispasmodic drugs in barium enema: impact on radiological practice.

PURPOSE: To assess the willingness of radiologists to change their practice when the results of a randomized clinical trial (RCT) on the use of antispasmodic drugs in barium enema are presented. MATERIALS AND METHODS: During the years 1994 and 1995 two postal questionnaires were sent to 481 practicing radiologists who were all members of the Netherlands Society of Radiology. In the first questionnaire the respondents were asked to give the characteristics of their practices in performing daily barium enema. The data from this questionnaire was used as a reference. The second questionnaire was sent to the respondents together with an abstract on the randomized clinical trial supporting the use of antispasmodic drugs in barium enema. We also indicated a preference for Buscopan over Glucagon as the antispasmodic drug. The willingness to change prescription habits was measured by comparing the data of the two questionnaires. RESULTS: Of 481 practicing radiologists, 312 responded to the first questionnaire and gave information of their prescription habits (response rate 64%). These 312 responders were sent an abstract of the RCT and were asked to fill out a second questionnaire to determine their willingness to change their practice. Two hundred and sixty-seven radiologists responded (response rate 86%). A significant number of 119 (51%) were willing to increase the use of antispasmodic drugs. A significant number of 128 (55%) chose to increase the use of Buscopan, while a significant number of 81 (32%) were willing to decrease the use of Glucagon. CONCLUSION: Direct exposure to the results of an RCT recommending the use of antispasmodic drugs in barium enema, especially Buscopan, is likely to increase its use by practicing radiologists.

Attitude of Health Personnel↗
PubMed2002

Patient education for preventing diabetic foot ulceration. A systematic review.

OBJECTIVE: Ulceration of the feet, which can result in loss of limbs and death, is a major health problem for people with diabetes mellitus. The objective of this review is to assess the effectiveness of patient education to prevent diabetic foot ulcers. RESEARCH DESIGN AND METHODS: We conducted a systematic review of randomized controlled trials (RCTs) that evaluated educational programmes for the prevention of foot ulcers in people with diabetes mellitus. We used standard search methods of the Cochrane "Wounds Groups". Two reviewers working independently extracted data and assessed study quality. RESULTS: The methodologic quality of the 8 included RCTs was poor. The internal validity score (range 0-10) of individual RCTs ranged from 2 to 4. Four trials compared the effect of intensive with brief educational interventions; 2 of these reported clinical endpoints. One study involving high-risk patients reported a reduction in ulcer incidence (OR 0.28, 95% confidence interval [CI] 0.13-0.59) and amputation rate (OR 0.32, 95% CI 0.14-0.71) after 1 year. The other RCT did not find an effect after 7 years of follow-up. Two trials showed that participants' foot care knowledge significantly improved with education. In one trial, foot care knowledge was significantly worse at 6 months, although foot care behavior improved significantly. One RCT, that compared patient foot care education as part of a general diabetes education program to usual care, showed no reduction in the risk of foot ulceration. In one RCT, patient education as part of a complex intervention targeted at both people with diabetes and doctors reduced the prevalence of serious foot lesions at 1 year (OR 0.41, 95% CI 0.16-1.00) and improved foot care behavior. Evidence from two RCTs comparing the effect of patient-tailored education in addition to usual care was conflicting. SUMMARY: Evidence, limited by poor methodologic quality and conflicting results, suggests that patient education may have positive but short-lived effects on foot care knowledge and behavior of patients and may reduce foot ulceration and amputations, especially in high-risk patients. High-quality randomized controlled trials are needed to establish the efficacy of patient education to prevent diabetic foot ulcerations.

Diabetic Foot↗
PubMed1997

Are community health interventions evaluated appropriately? A review of six journals.

OBJECTIVES: To determine if Randomized Controlled Trial (RCT) methodology was used appropriately in community health, we: (1) determined the proportion of non-randomized studies that should have been RCTs, and (2) assessed the quality of the RCTs. METHODS: The 1992 issues of six community health journals were manually searched. Intervention studies were analyzed. Studies that did not use randomization were analyzed for feasibility and practicality of RCT methods; RCTs were analyzed for quality using a checklist. RCTs were compared with community health RCTs from The New England Journal of Medicine. The proportion of studies meeting each criterion was determined. RESULTS: Fourteen percent of 603 studies were interventions and 4% were RCTs. Of those not using randomization, 42% should have. Mean RCT scores were significantly lower for the community health journals than for The New England Journal of Medicine. Many criteria important to quality scored poorly. CONCLUSIONS: RCTs are underused and lack methodologic rigor in community health. Conclusions regarding the effectiveness of interventions are therefore suspect.

Community Medicine↗
PubMed1999

Testing complementary and alternative therapies within a research protocol.

In patients with cancer, the demand for complementary and alternative medicine (CAM) is considerable. Unfortunately, however, for many of these interventions there is a lack of evidence for efficacy, effectiveness and safety in patients with cancer. This review focuses on the prospective, randomised, controlled trial (RCT) as a tool for evaluating CAM. Although a number of difficulties and limitations are acknowledged, the RCT will continue to be the gold standard for evaluating the efficacy, effectiveness and safety of CAM. Developments in clinical trial methodology and in psychosocial oncology have made it more appropriate and feasible to evaluate CAM using RCT methodology. Two different kinds of RCTs are now accepted as valid, namely explanatory and pragmatic trials. The latter does not necessarily require that the patient or the therapist is 'blind' to the treatment being given. Furthermore, pragmatic trials can be designed to take patient preferences into account. A number of practical issues are discussed, including the choice of comparator or control interventions, ways of assessing the effects of individual differences, minimising therapist variability, the problem of finding acceptable inclusion-exclusion criteria and the assessment of treatment outcome. A number of randomised, controlled trials have demonstrated the efficacy, effectiveness and safety of various complementary and alternative interventions (the Cochrane Data Base has now established a CAM field). The publication of positive results from randomised trials of complementary interventions that have not yet been studied using this methodology would do a great deal to alleviate the scepticism of conventional practitioners towards these types of CAM and would facilitate further the integration of complementary and conventional interventions.

Complementary Therapies↗
PubMed2001

Impaired visual function in glaucoma.

OBJECTIVE: This work aims to evaluate whether glaucomatous visual field defects could be related to an impaired retinal function, to a delayed neural conduction in postretinal visual pathways, or both. METHODS: Visual field by Humphrey perimeter (central 24-2 threshold test) and simultaneous recordings of visual evoked potential (VEP) and pattern electroretinogram (PERG) were assessed in 21 subjects with open angle glaucoma (POAG) and in 15 age-matched controls (C). RESULTS: VEP: in POAG eyes we found P100 latency significantly (P<0.01) delayed when compared with controls and correlated with mean deviation (index of global visual field damage, MD) of 24-2 Humphrey perimetry (P<0.001); the P100 amplitudes were significantly (P<0.01) lower in POAG eyes than in control eyes and correlated with MD (P<0.001). PERG: POAG eyes showed P50 latency significantly (P<0.01) delayed when compared with controls and correlated with MD (P=0.002); the P50 and N95 amplitudes were significantly (P<0.01) lower in POAG than in control eyes and correlated with MD (P50: P=0.006; N95: P=0.002). Retinocortical time (RCT: difference between VEP P100 and PERG P50 latencies) and latency window (LW: difference between VEP N75 and PERG P50 latencies) were significantly (P<0.01) longer in POAG eyes than in control eyes and correlated with MD (RCT: P<0.001; LW: P<0.001). No significant correlations (P>0.05) were found between electrophysiological parameters and the corrected pattern standard deviation (index of localized visual field damage) of 24-2 Humphrey perimetry. CONCLUSION: In patients with open angle glaucoma the reduction of the index of global visual field damage (MD) could be ascribed to two sources of functional impairment: one retinal (impaired PERG) and one postretinal (delayed RCT and LW). In the postretinal impairment, a postsynaptic degeneration at the level of the lateral geniculate nucleus could be suggested.

Electroretinography↗
PubMed2003

Macrophage apolipoprotein A-I expression protects against atherosclerosis in ApoE-deficient mice and up-regulates ABC transporters.

The antiatherogenic effect of high-density lipoprotein (HDL) and its major protein component apolipoprotein A-I (apoA-I) has been largely attributed to their key roles in reverse cholesterol transport (RCT) and cellular cholesterol efflux. Substantial evidence shows that overexpression of human apoA-I reduces atherosclerosis in animal models. However, it is uncertain whether this protection is due to an increase in plasma HDL level or to a local effect in the artery wall. To test the hypothesis that expression of human apoA-I in macrophages can promote RCT in the artery wall, we used a retroviral construct expressing human apoA-I cDNA (MFG-HAI) to transduce ApoE(-/-) bone marrow cells and then transplanted these cells into ApoE(-/-) mice with preexisting atherosclerosis. ApoE(-/-) mice reconstituted with MFG-HAI marrow had a significant reduction (30%) in atherosclerotic lesions in the proximal aorta compared to control mice that received marrow expressing MFG parental virus. Peritoneal macrophages isolated from MFG-HAI mice showed a four- to fivefold increase in mRNA expression levels of both ATP-binding cassette (ABC) A1 and ABCG1 compared to controls. Our data demonstrate that gene transfer-mediated expression of human apoA-I in macrophages can compensate in part for apoE deficiency and delay the progression of atherosclerotic lesions by stimulating ABC-dependent cholesterol efflux and RCT.

ATP-Binding Cassette Transporters↗
PubMed2006

'Complementary ENT': a systematic review of commonly used supplements.

OBJECTIVE: To assess the evidence surrounding the use of certain complementary supplements in otolaryngology. We specifically focussed on four commonly used supplements: spirulina, Ginkgo biloba, Vertigoheel and nutritional supplements (cod liver oil, multivitamins and pineapple enzyme). MATERIALS AND METHODS: A systematic review of the English and foreign language literature. INCLUSION CRITERIA: in vivo human studies. EXCLUSION CRITERIA: animal trials, in vitro studies and case reports. We also excluded other forms of 'alternative medicine' such as reflexology, acupuncture and other homeopathic remedies. RESULTS: Lack of common outcome measures prevented a formal meta-analysis. Three studies on the effects of spirulina in allergy, rhinitis and immunomodulation were found. One was a double-blind, placebo, randomised, controlled trial (RCT) of patients with allergic rhinitis, demonstrating positive effects in patients fed spirulina for 12 weeks. The other two studies, although non-randomised, also reported a positive role for spirulina in mucosal immunity. Regarding the use of Ginkgo biloba in tinnitus, a Cochrane review published in 2004 showed no evidence for this. The one double-blind, placebo-controlled trial that followed confirmed this finding. Regarding the use of Vertigoheel in vertigo, two double-blind RCTs and a meta-analysis were identified. The first RCT suggested that Vertigoheel was equally effective in reducing the severity, duration and frequency of vertigo compared with betahistine. The second RCT suggested that Vertigoheel was a suitable alternative to G. biloba in the treatment of atherosclerosis-related vertigo. A meta-analysis of only four clinical trials confirms that Vertigoheel was equally effective compared with betahistine, G. biloba and dimenhydrinate. Regarding multivitamins and sinusitis, two small paediatric pilot studies reported a positive response for chronic sinusitis and otitis media following a course of multivitamins and cod liver oil. Regarding bromelain (pineapple enzyme) and sinusitis, one randomised, multicentre trial including 116 children compared bromelain monotherapy to bromelain with standard therapy and standard therapy alone, for the treatment of acute sinusitis. The bromelain monotherapy group showed a faster recovery compared with the other groups. CONCLUSION: The positive effects of spirulina in allergic rhinitis and of Vertigoheel in vertigo are based on good levels of evidence, but larger trials are required. There is overwhelming evidence that G. biloba may play no role in tinnitus. There is limited evidence for the use of multivitamins in sinus symptoms, and larger randomised trials are required.

Bromelains↗
PubMed2006

Randomized trials and collaborative research in epilepsy surgery: future directions.

BACKGROUND: Although randomized controlled trials (RCTs) are the gold standard for evaluating therapeutic interventions, surgical RCTs are particularly challenging and few have been done in the field of epilepsy surgery. We assess the level of RCT activity in epilepsy surgery and propose feasible alternatives to develop sustainable research initiatives in this area. METHODS: We undertook a systematic review of the world literature to assess the level of RCT activity in epilepsy surgery. Previous personal experience with RCTs in epilepsy surgery and examples of successful Canadian multicentre research networks were reviewed to propose initiatives for sustainable, valid research in epilepsy surgery. RESULTS: We identified 12 RCTs in epilepsy surgery, including 692 patients, of whom 416 were involved in vagus nerve stimulation, 16 in various brain electrostimulation procedures, 180 in comparisons of different surgical techniques, and 80 in a comparison of medical versus surgical therapy. Most studies were of short duration (median=3 months, range 3-12 months). In the area of resective surgery, only temporal lobe epilepsy has been subjected to any type of RCT comparison. All RCTs have been done within the last 13 years. There were no multicentre Canadian surgical studies. CONCLUSIONS: The adoption of RCTs in epilepsy surgery has been slow and difficult worldwide. Because of its universal health care system and its well established epilepsy surgery centres, Canada is in a strong position to create a national epilepsy surgery research initiative capable of undertaking high quality, sustainable research in epilepsy surgery.

Electric Stimulation Therapy↗
PubMed1998

Subcortical vascular dementia: survey of treatment patterns and research considerations.

BACKGROUND: Since few studies have examined the effectiveness of therapies for subcortical vascular dementia, treatment guidelines are not available. Current patterns in the treatment of such dementias have not been studied. OBJECTIVE: To determine the practice patterns of Canadian specialists for the treatment of subcortical vascular dementia, and to survey their opinions regarding issues which are important in the design of a randomized controlled trial (RCT) in this field. DESIGN: National survey of all specialists certified in Neurology or Geriatric Medicine. RESULTS: Of responding physicians (78%) prescribed antithrombotic therapy for patients with vascular dementia. Most begin treatment with aspirin 325 mg daily (64%). The next three most common initial treatments were; no pharmacotherapy (12%), aspirin 650 mg daily (11%), and aspirin 1300 mg daily (11%). If the dementia continued to progress despite initial therapy, the treatment options were more varied. Most specialists (69%) believed that an RCT to assess the efficacy of aspirin in vascular dementia is warranted. The majority (69%) also felt that serial neuroimaging would be required for participants in such a trial, with magnetic resonance imaging being cited most frequently (41%). The majority of specialists considered three years as the minimum duration for such a trial. CONCLUSIONS: Specialist physician practice patterns vary significantly for the treatment of patients with subcortical vascular dementia. Most physicians believe that an RCT testing the efficacy of aspirin in this condition is required. However, before such a trial can be conducted, many methodological difficulties need to be addressed.

Aspirin↗
PubMed2000

Assessment in multisite randomized clinical trials of patients with autistic disorder: the Autism RUPP Network. Research Units on Pediatric Psychopharmacology.

Assessment of autistic disorder (autism) symptoms, primary and secondary, poses more challenging problems than ordinarily found in multisite randomized clinical trial (RCT) assessments. For example, subjects may be uncommunicative and extremely heterogeneous in problem presentation, and current pharmacological treatments are not likely to alter most core features of autism. The Autism Research Units on Pediatric Psychopharmacology (RUPP Autism Network) resolved some of these problems during the design of a risperidone RCT in children/adolescents. The inappropriateness of the usual anchors for a Clinical Global Impression of Severity (CGI-S) was resolved by defining uncomplicated autism without secondary symptoms as a CGI-S of 3, mildly ill. The communication problems, compromising use of the patient as an informant, were addressed by several strategies, including careful questioning of care providers, rating scales, laboratory tests, and physical exams. The broad subject heterogeneity requires outcome measures sensitive to individual change over a wide spectrum of treatment response and side effects. The problems of neuropsychologically testing nonverbal, lower functioning, sometimes noncompliant subjects requires careful instrument selection/adaptation and flexible administration techniques. The problems of assessing low-end IQs, neglected by most standardized test developers, was resolved by an algorithm of test hierarchy. Scarcity of other autism-adapted cognitive and neuropsychological tests and lack of standardization required development of a new, specially adapted battery. Reliability on the Autism Diagnostic Interview (currently the most valid diagnostic instrument) and other clinician instruments required extensive cross-site training (in-person, videotape, and teleconference sessions). Definition of a treatment responder required focus on individually relevant target symptoms, synthesis of possible modest improvements in many domains, and acceptance of attainable though imperfect goals. The assessment strategy developed is implemented in a RCT of risperidone (McDougle et al., 2000) for which the design and other methodological challenges are described elsewhere (Scahill et al., 2000). Some of these problems and solutions are partially shared with RCTs of other treatments and other disorders.

Antipsychotic Agents↗