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Results for “Randomized Response Technic”

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PubMed2004

Health professionals' responses to the introduction of a home telehealth service.

An ethnographic (participant observation) study was undertaken of the socio-technical processes involved in the implementation, within a randomized controlled trial, of a home telehealth nursing service for patients with chronic obstructive pulmonary disease (COPD). Ethnographic field notes were taken about technology-related tasks and the interplay between the research team and the 12 nurses who were to use the telehealth equipment. Views of the technology were linked to views of professional self-image and status. The technology was sometimes seen as unhelpful in establishing effective relationships with patients. Considerable work by all participants, over a period of months, was required to develop the technology in ways that minimized the risk to the stability of the specialist service and existing nurse-patient relationships. Our work highlights the complex problems that health professionals encounter when they try to integrate new technologies into routine service delivery. The concerns arising from the interplay of new technology with existing professional practices and relationships go beyond simple issues of training.

Attitude of Health Personnel↗

PubMed2005

Alcohol screening and brief intervention in primary care settings: implementation models and predictors.

OBJECTIVE: This study compared two different implementation strategies for Cutting Back, a primary care alcohol screening and brief intervention (SBI) program for hazardous and harmful drinkers. It also identified organizational factors contributing to the success or failure of SBI implementation. METHOD: Cutting Back was implemented in 10 primary care practices associated with managed care organizations (MCOs) in five states, through a system of planning, training, technical assistance and clinic feedback. Clinics were randomly assigned to one of two brief intervention systems: In the P Model, medical providers were responsible for delivering interventions, whereas in the S Model mid-level professionals (usually nurses) acted as the clinic specialists to provide that service. Data were collected to measure the performance of screening and delivery of interventions in each clinic. RESULTS: The S Model screened a higher percentage of patients than did the P Model during the best month of program operation (50% vs 44%) and over all months of operation (24% vs 19%). Of those patients who screened positive, more patients in the S condition received an intervention than in the P condition (73.1% vs 57.1%), but there was a considerable range of performance among the five sites within each condition. Results at the clinic level were mixed, with some MCOs performing alcohol SBI significantly better with the S model and others doing better with the P model. The ability of clinics to conduct SBI was significantly correlated with both provider characteristics and organizational factors (e.g., prior SBI experience, MCO stability, number of clinicians trained and the quality of the MCO coordinator's work). Lack of provider time, staff turnover and competing priorities correlated negatively with SBI performance. CONCLUSIONS: The extent to which a given delivery model is likely to work best within an MCO depends on complex provider and organizational characteristics.

Adolescent↗

PubMed1987

The relationship between timing of surgery and operative complications in aneurysmal subarachnoid hemorrhage.

The optimal timing of definitive aneurysm repair following subarachnoid hemorrhage remains a controversial issue. In order to examine whether the timing of surgery alters the incidence of certain technical difficulties and complications associated with intracranial aneurysm repair, data from two recent co-operative studies were examined. The cases submitted to the International Co-operative Study on Timing of Aneurysm Surgery by the University of Toronto hospitals, and the cases submitted from multiple centres to the Three-Dose Multicentre Randomized Double-Blind Nimodipine Study were evaluated with regard to operative difficulties and complications, comparing early (less than or equal to 3 days) and late (greater than or equal to 4 days) surgery following subarachnoid hemorrhage. No significant differences were found in the incidence of such technical problems between the early and late surgical groups. If differences in outcome occur between comparable groups of patients operated early and late after aneurysm rupture, factors other than surgical technical complications may be responsible.

Clinical Trials as Topic↗

PubMed1984

Gallbladder dynamics in response to various meals: is dietary fat restriction necessary in the management of gallstones?

An estimated 20 million Americans have gallstones the majority asymptomatic. Yet traditionally many are often placed on low-fat or fat-free diets, presumably to reduce the risk of biliary colic. To assess the gallbladder dynamics in response to various meals, we studied 15 subjects (ages 21-54), each on 4 separate days. After an overnight fast, each subject was given, at random, either a breakfast containing greater than 30 g fat, less than 15 g fat, totally free of fat, or an infusion of C-terminal octapeptide of cholecystokinin. Gallbladder ejections at regular time intervals were measured using real time ultrasonography and the sum of cylinders technic corrected for the gallbladder shape. Considerable variability in the gallbladder dynamics and time response was noted with all the stimuli. However, among various meals, there were no statistically significant differences in the mean maximum ejection fraction or the mean maximum ejection time (p greater than 0.10). The mean maximum ejection fraction after cholecystokinin was somewhat greater (0.01 less than p less than 0.05) than that after meals, but the mean maximum ejection time was similar (p greater than 0.10). We conclude that the gallbladder dynamics in response to various meals are independent of a meal's fat content. Since the passage of gallstones into the cystic or common duct (biliary colic) is a random event unrelated to the type of food, fat-restricted diets offer no significant therapeutic advantage in the management of the large population with asymptomatic gallstones.

Adult↗

PubMed1992

Development of patient satisfaction questionnaires: I. Methodological issues.

OBJECTIVES: To develop a method for conducting postal surveys of patients' views and experiences of general practitioner care and to produce an off the shelf tool for general practice audit. DESIGN: Prospective study of performance of two patient questionnaires assessing accessibility to services (questionnaire 1) and interpersonal aspects of care (questionnaire 2) in comparing general practices. SETTING: Five general practices in Newcastle upon Tyne. PATIENTS: 3800 patients aged 16 and over, 1900 randomly drawn from family health services authority lists for each practice (questionnaire 1) and 1900 drawn from practice records (questionnaire 2). MAIN MEASURES: Response rates and technical evaluation of performance of the questionnaires (reliability, item nonresponse, ineligible response, sensitivity, and validity). RESULTS: Response rate for questionnaire 1 was 77% (range 69% to 83%) and to questionnaire 2, 82% (77% to 86%). Analysis of respondents and nonrespondents showed that significantly more women, people aged 65 or more, and those consulting in the past six months returned the questionnaires. Technical evaluation indicated good face validity and content validity and good internal consistency. CONCLUSIONS: A standardised off the shelf tool for audit was developed, and it will be a valuable model for future audits in general practice.

England↗

PubMed2002

Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors.

BACKGROUND: Constitutive activation of KIT receptor tyrosine kinase is critical in the pathogenesis of gastrointestinal stromal tumors. Imatinib mesylate, a selective tyrosine kinase inhibitor, has been shown in preclinical models and preliminary clinical studies to have activity against such tumors. METHODS: We conducted an open-label, randomized, multicenter trial to evaluate the activity of imatinib in patients with advanced gastrointestinal stromal tumor. We assessed antitumor response and the safety and tolerability of the drug. Pharmacokinetics were assessed in a subgroup of patients. RESULTS: A total of 147 patients were randomly assigned to receive 400 mg or 600 mg of imatinib daily. Overall, 79 patients (53.7 percent) had a partial response, 41 patients (27.9 percent) had stable disease, and for technical reasons, response could not be evaluated in 7 patients (4.8 percent). No patient had a complete response to the treatment. The median duration of response had not been reached after a median follow-up of 24 weeks after the onset of response. Early resistance to imatinib was noted in 20 patients (13.6 percent). Therapy was well tolerated, although mild-to-moderate edema, diarrhea, and fatigue were common. Gastrointestinal or intraabdominal hemorrhage occurred in approximately 5 percent of patients. There were no significant differences in toxic effects or response between the two doses. Imatinib was well absorbed, with pharmacokinetics similar to those reported in patients with chronic myeloid leukemia. CONCLUSIONS: Imatinib induced a sustained objective response in more than half of patients with an advanced unresectable or metastatic gastrointestinal stromal tumor. Inhibition of the KIT signal-transduction pathway is a promising treatment for advanced gastrointestinal stromal tumors, which resist conventional chemotherapy.

Adolescent↗

PubMed1988

The nasolabial flap. Axial or random?

Considerable confusion exists regarding the nature of the blood supply of the inferiorly based nasolabial flap. This report seeks to clarify the situation. Anatomic dissections were performed on 12 cadaveric specimens and microangiography on six others. We confirmed that the facial artery passes deep to the facial mimetic muscles and is not normally included within the flap. Although the vasculature of the flap is technically random, the small vessels of the subdermal plexus are generally oriented along its long axis giving it a "degree of axiality." We believe this vascular orientation is responsible for the flap's reliability.

Angiography↗

PubMed2001

Lumbar micro disc surgery with and without autologous fat graft. A prospective randomized trial evaluated with reference to clinical and social factors.

Epidural scarring is one of the possible complications after lumbar disc surgery. Perineural scar tissue has been considered responsible for recurrent neurological symptoms in patients operated on for disc herniation and leads to a high rate of unsatisfactory results. In addition, postoperative scars may increase the technical difficulty and risk of subsequent procedures. Various materials have been used in animal studies to try to affect the degree of epidural scar tissue with controversial results. In particular, free fat transplantation has been described to reduce the degree of intraspinal scar tissue. We therefore performed a prospective, double-blind, randomized study comparing clinical and social factors of patients being operated on for the first time for lumbar disc herniation. A total of 92 patients received an implantation of autologous fat graft, 94 did not. After a median of 24.2 months after their surgery, an objective examinator compared various clinical parameters and the social situation of patients in both groups without knowing the operation method used. We found no significant differences between the fat-graft group and the control group regarding either the clinical outcome or the social aspects.

Adipose Tissue↗

PubMed1996

The electromyographic responses to dorsal rootlet stimulation during partial dorsal rhizotomy are inconsistent.

Concerns have arisen regarding the ability of physiologic techniques to select rootlets mediating spasticity in children undergoing partial dorsal rhizotomy (PDR) for the treatment of spastic gait from cerebral palsy. To determine whether these physiologic responses are reproducible, 60 rootlets in 6 patients were graded from 0 to 4+ according to the system first reported by Phillips and Park, and then retested and graded using a randomized, blinded paradigm. Two thirds of the rootlets had one or more grade difference between the two trials, and 25% had a grade change of 3 or more. Only 4 of 23 rootlets with a "normal' response (grade 0) on one test were also graded normal on the other test. Only 2 of 14 rootlets with a bilateral response (grade 4+) had a bilateral response on both trials. Statistical analysis demonstrated no correlation and poor agreement between trials. Regardless of whether responses are reflex in origin with technical or physiologic variability, or the consequence of stimulus spread to ventral roots, we found inconsistent responses with commonly used methods and the criteria most agreed upon. These findings suggest that currently used techniques are not reliable for rootlet "selection' and result only in a random partial rhizotomy.

Cerebral Palsy↗

PubMed2003

Noninvasive in vivo investigative probes of adaptive mechanisms of neuroendocrine regulation: the paradigm of the hypothalamo-pituitary-gonadal axis in the aging male.

Intermittent signal exchange serves to encode repeated incremental adjustments among central-neural centers and the ensemble of glands comprising any given axis. Interglandular communication proceeds dynamically via pulsatile and basal modes of hormone release, deterministic (dose-responsive) interfaces, and apparently stochastic (randomly varying) processes. Physiological investigations of the time-dependent control of neurohormone secretion and action depend upon valid reconstruction of such interactive signaling. Recent technical and experimental advances afford new and fundamental insights into such composite mechanisms that maintain precise homeostasis in health, and show susceptibility to disruption in disease. Underlying concepts are becoming more readily understandable intuitively without full rehearsal of detailed analytical and statistical facets that undergird computer-assisted methods. Accordingly, the present overview highlights core precepts that guide the implementation of sensitive, specific and utilitarian technologies to quantitate neuroendocrine adaptations in pathophysiology. The aging male gonadal axis provides a well studied paradigmatic platform to illustrate the formulation and implementation of analytical strategies in diverse systems.

Adaptation, Physiological↗

PubMed2002

Coronary artery bypass grafting supported with intracardiac microaxial pumps versus normothermic cardiopulmonary bypass: a prospective randomized trial.

OBJECTIVE: To analyze the difference in coronary artery bypass grafting (CABG) performed with normothermic cardiopulmonary bypass (CPB) and CABG supported with the intracardiac microaxial pump (ICP, Impella, Aachen, Germany). METHODS: A prospective randomized study was conducted in seven centers. The study population consists of 199 patients undergoing isolated primary CABG (CPB group 94 patients, ICP group 105 patients). Both groups are equal in demographic variables, number of bypasses performed, and Euroscore predicted mortality. We analyzed clinical outcome, myocardial enzymes and blood parameters of hemolysis, organ function and inflammatory response. RESULTS: Seventeen patients (16%), randomized in the ICP group, were switched to the CPB group. This was due to the inability to position the right side catheter adequately (n=8), to a pump failure (n=1) or to the perioperative decision that beating heart surgery is technically not possible (n=8). There was no significant difference between the two study arms regarding the pump assistance time (CPB 67.1+/-22.9 min; ICP 67.7+/-30.3 min; P=0.88861), the number of grafts (CPB 2.4+/-0.7; ICP 2.3+/-0.8) and the number of grafts to the back wall (CFX; both groups n=37). There is no significant difference in clinical outcome, evolution of myocardial enzymes, indices of organ function and hemolysis. There is a reduced inflammatory response in the ICP group as indicated in the postoperative release of granulocyte elastase (CPB 259+/-195; ICP 150+/-126 microg/l; P<0.00001) and complement C3 (CPB 0.73+/-0.2; ICP 0.65+/-0.2g/l; P=0.008). CONCLUSION: The intracardiac pump for the right heart is difficult to introduce. As a consequence the right side pump underwent design modifications. There were no differences in clinical outcome between both groups. The inflammatory response is significantly reduced in the ICP group.

Aged↗

PubMed1976

Randomized clinical trials. Perspectives on some recent ideas.

In spite of the controversy over the role of randomized clinical trials in medical research, the rationale underlying such trials remains persuasive as compared to recent suggestions for alternative non-randomized studies such as those relying on the use of historical controls and adjustment technics. Others have suggested that recent statistical innovations for improving clinical trials, including adaptive allocation of treatment to patients and sequential stopping procedures, are underutilized. These innovations, though theoretically interesting, are not easily adapted to large-scale, complex medical trials in which there may be multiple end points and delayed response times. Ethical considerations suggest that randomized trials are more suitable than uncontrolled experimentation in protecting the interests of patients. Randomized clinical trials remain the most reliable method for evaluating the efficacy of therapies.

Biometry↗

PubMedDate not supplied

Randomized control trials on chemoembolization for hepatocellular carcinoma: is there room for new studies?

Hepatocellular carcinoma (HCC) generally occurs in patients with cirrhosis. Curative options, such as liver transplantation, hepatic resection, and percutaneous alcohol injection, are applicable to a minority of cases. Because systemic chemotherapy and radiation therapy provide dismal results, transarterial chemoembolization (TACE) remains the sole approach to antagonizing the cancer growth in most patients. Although most tumors show an extensive necrosis after TACE, the beneficial effect on survival has not been properly substantiated, so that its application still remains a matter of debate. This review analyzes the results of randomized clinical trials on TACE. In most studies, TACE did not increase the survival of patients as compared with the palliative treatment. However, several methodologic and technical pitfalls may have adversely affected the results of these trials, such as inadequate patient selection and statistical power of the study design, a nonoptimal procedure, and treatment repetition not tailored to the cancer response and patient tolerance. Nonetheless, the literature will hardly be enriched by new trials including untreated patients because, wrong or right, TACE is currently considered the standard treatment of unresectable HCC. It seems more realistic to expect randomized studies comparing different techniques and time schedules of treatment, as well as TACE alone versus combined procedures.

Carcinoma, Hepatocellular↗

PubMed2002

Hepatic artery chemotherapy for colorectal liver metastases: technical considerations and review of clinical trials.

Hepatic artery infusion (HAI) of chemotherapeutic agents for colorectal hepatic metastases is associated with significantly higher response rates compared to systemic chemotherapy. However, response rates have not consistently translated into improved survival. Several randomized trials have evaluated the implantable pump for treating unresectable colorectal hepatic metastases. Meta-analysis of these studies have demonstrated an improved survival advantage with pump therapy as well as improved quality of life. Recent studies of HAI of chemotherapy as adjuvant therapy following liver metastases resection have also demonstrated a potential survival advantage. Toxicities of HAI can be treatment limiting, but measures have emerged for overcoming these side effects. These randomized clinical trials have established HAI as a reasonable therapeutic option in patients with unresectable disease, and as adjuvant therapy in patients with resectable disease.

Antineoplastic Agents↗

PubMed2000

Patient perception of quality following a visit to a doctor in a primary care unit.

BACKGROUND: Assessment of the quality of primary care services may be enhanced by including patient perceptions as well as professional judgment of quality. There is a need for reliable and valid instruments to measure these perceptions. OBJECTIVES: (i) To present a scale for measuring patient perception of quality of care following a visit to a doctor; and (ii) to analyse the responses given by patients recruited in primary care units in the Montreal region. The scale is composed of 22 items regrouped into three sub-scales referring to the patient-physician relationship (five items); the technical aspects of care (12 items); and the outcomes of the visit (five items). Distinctive features of the scale are that it focuses on patients' opinions about quality rather than on satisfaction, and that it includes items related to outcomes of the visit. METHODS: A survey was conducted on 473 patients who visited a physician in 11 primary care units in the Montreal region. Randomly selected patients received mailed questionnaires 5-7 days following their visit. Various statistical procedures were used to assess the reliability and the validity of the global scale and the sub-scales, and to analyse patients' patterns of response. RESULTS: The analysis of the psychometric properties of the global scale and the three sub-scales provides favourable evidence concerning their reliability and validity. The results of the factor analysis, the inter-item correlations and the Cronbach's alpha coefficients all support the distinction made between the interpersonal processes, the technical processes and the outcomes, and, at the same time, confirm the complex nature of the notion of perceived quality. The analysis of patients' responses allows the identification of items associated with global perception about quality of care. This global perception results from patients' perception of the physician's professional and interpersonal skills as well as from the outcomes of care. CONCLUSION: The scale can be used by physicians or primary health care units and has a wide range of applications.

Attitude to Health↗

PubMed1999

A regulatory perspective on pharmacokinetic/pharmacodynamic modelling.

We present an integrated summary from statistical and pharmacological perspectives of pharmacokinetic/pharmacodynamic (PK/PD) modelling and its use in drug development and regulation for guiding appropriate dosing. An overview of the technical aspects of PK/PD modelling describes how structural models are constructed and refined using pharmacokinetic and pharmacodynamic principles and how random effects models are used to account for individual differences in desired (and undesired) responses due to patient characteristics. Lastly, we describe applications of PK/PD modelling for the purposes of drug labelling, for resolving a safety concern, and for improving therapeutic monitoring of anaesthetic depth during surgery.

Biometry↗

PubMed2004

Off-pump coronary artery bypass grafting: simple concept but potentially sublime scientific value.

This review discusses the available scientific evidence of the physiological changes and clinical outcomes with off-pump coronary artery bypass grafting. Off-pump coronary artery bypass grafting is more technically demanding, and its prognostic advantage has not been clearly elucidated. This paper examines the evolution of off-pump coronary artery bypass grafting and the technical challenges of 'bypassing' the cardiopulmonary bypass machine. A search of the Medline database of English-language literature yielded a huge number of articles from which those relating to physiological and biochemical changes, and clinical outcomes of coronary artery bypass grafting were selected for this review. There are few prospective randomized trials, mostly studying physiological and biochemical changes, and assessing specific clinical outcomes. Avoidance of cardiopulmonary bypass results in a significantly reduced systemic inflammatory response. Myocardial, renal and neurological functions, amongst others, are better preserved. A rapid advance in beating heart surgery technology occurred in the past 5 yrs enabling off-pump multivessel coronary bypass grafting to be performed with relative technical ease, thereby offsetting the propensity to incomplete revascularization which can be a major setback. The clinical outcome of patients with varying surgical risks who have off-pump coronary artery bypass grafting are comparable to those who have surgical revascularization with cardiopulmonary bypass. With the technical challenges of off-pump coronary bypass grafting surmounted, the simple concept of avoiding cardiopulmonary bypass can yield impressive results that would help to establish the routine use of this technique for myocardial revascularization.

Cardiopulmonary Bypass↗

PubMed1998

Dental practitioners' experiences on the usefulness of restorative materials in Finland 1992-1996.

OBJECTIVE: To analyse general dentists' choice of restorative materials in Finland, where the use of amalgam has significantly decreased and the use of composites increased during the past 10 years. DESIGN AND SETTING: Postal survey in 1997 to a random sample of general dental practitioners mainly working with adult patients. MAIN OUTCOME MEASURES: Percentage distribution of dentists' opinions. RESULTS: The response rate was 82%. Tooth-coloured restorations were considered to be more time consuming, technically complicated and to have shorter life spans. Most dentists were not willing to return to the wide-scale use of amalgam restorations. CONCLUSIONS: The rapid changes in the restorative material selection have not resulted in serious problems in restorative therapy.

Adult↗