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Results for “Feasibility study”

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At least 19 recordsLinked to original sources
PubMed1990

Intralesional cis-diamminedichloroplatinum and purified collagen treatment of human metastatic malignancies: a feasibility study.

A feasibility study of the treatment of advanced superficial human malignant tumors utilizing direct intralesional injections of cisplatin mixed with purified bovine collagen was performed. The purpose of using intralesional injection of cisplatin mixed with collagen was to limit the drug exposure to normal tissues while increasing the dose and duration of exposure to the tumor. Fourteen evaluable superficial tumors in four patients (melanoma, breast CA, squamous CA from larynx) received a total of 65 treatments in the outpatient clinic setting. All patients had failed prior treatment with systemic intravenous cisplatin. Lesions were treated at least three times at two-week intervals. After intramuscular meperidine premedication, multiple injections of cisplatin mixed with collagen were made into the tumors. There was minimal normal tissue toxicity and minimal systemic toxicity. Tumor regression or stabilization occurred in 86% (12/14) of tumors; 50% (7/14) of lesions regressed more than 50% in size. This study suggests that intralesional colloidal cisplatin can overcome resistance to systemic intravenous cisplatin.

Adenocarcinoma↗
PubMedDate not supplied

Application of air sampling and ion-mobility spectrometry to narcotics detection: a feasibility study.

A feasibility study of the application of air sampling and ion-mobility spectrometry (IMS) for detection of heroin and cocaine concealed in letter mail showed that a unique IMS signature is associated with each type of drug and that a number of IMS peaks can be used as markers for the presence of drugs. No false reading for cocaine or heroin resulted when innocent items were monitored. Near real-time performance with sampling and analysis times of less than 30 seconds was achieved for the simultaneous detection of cocaine and heroin. The method proved to be a reliable tool for the fast screening of suspect items. Preliminary tests also showed that the method has potential for use in detecting the drugs in suitcases and on people.

Air↗
PubMed1986

A double-blind randomized controlled trial of the effect of a low- versus a middle-tar cigarette on respiratory symptoms--a feasibility study.

A feasibility study of a double-blind, randomized controlled trial of the effect of a low-versus a middle-tar cigarette on respiratory symptoms is described. A smoking questionnaire was sent to 19,366 households. Returned questionnaires (64%) yielded 604 middle-tar cigarette smokers aged 20-44 years; 342 replied to a health warning stating that they did not want to or had failed to stop smoking and of these 183 volunteered for the trial. Thus about every 100 households originally mailed yielded one volunteer. Of the volunteers, 95 men were randomly allocated to be sold a middle-tar cigarette and 88 to be sold a low-tar cigarette of identical appearance. The cigarettes were sold at three different reduced prices and the men were asked to smoke them for five weeks. There was a 22% drop-out and this was unrelated to type of cigarette smoked. A reduction in price of 20% was sufficient incentive for volunteers to participate. Cigarette butts were collected weekly or fortnightly and urine samples were collected initially and after three and five weeks. Compliance with the trial cigarettes was good. The excretion of nicotine metabolites, number of cigarettes smoked and average butt weight for men allocated the low-tar cigarette was not significantly different from that of those allocated the middle-tar cigarette. This suggested that the former compensated for the 37% reduction in the nicotine yield of their cigarette by taking more frequent or deeper puffs from their cigarette. The implications of these results for a large-scale, randomized controlled trial are discussed.

Adult↗
PubMed1988

DSM-III in Ethiopia: a feasibility study.

A feasibility study of DSM-III on 40 Ethiopian visitors to a psychiatric outpatient clinic in Addis Ababa was carried out by a Dutch psychiatrist, with three of his Dutch colleagues. In spite of the highly idiosyncratic way in which Ethiopians present their complaints, the diagnostic criteria of DSM-III appeared to be useful to a certain extent. The outcome of an inter-rater reliability study was comparable with that of an American one. The results were congruent for the classes that are rather well-defined in the DSM-III, like the psychotic and affective disorders. This did not apply to the classes of the somatoform and factitious disorders. Possible reasons for this are discussed.

Adult↗
PubMed1992

The Modification of Diet in Renal Disease Study: design, methods, and results from the feasibility study.

The Modification of Diet in Renal Disease (MDRD) Study is a multicenter clinical trial designed to assess acceptance, safety, and efficacy of restricted protein and phosphorus diets in patients with progressive renal disease. The Feasibility Study was designed to test procedures and recruitment strategies and to estimate sample size for the Full-Scale Trial. The Feasibility Study was not designed to compare rates of progression of renal disease among diet groups. Patients aged 18 to 75 years, with a glomerular filtration rate (GFR; measured by 125I-iothalamate clearance) between 7.5 and 80 mL/min/1.73 m2, and a previous progressive increase in serum creatinine, were eligible for enrollment. Compliance with prescribed dietary protein intake was calculated from urea nitrogen appearance (UNA). Nutritional status was monitored by anthropometry and serum proteins. Progression of renal disease was calculated as the rate of decline of GFR. Ninety-six patients met all of the eligibility requirements and were randomized to study diets. Follow-up was conducted for a mean duration of 14 months (range, 2 to 22 months). Although most patients did not achieve the prescribed protein intake, marked changes in intake were observed among patients assigned to the low-protein diets, and mean estimated protein intake differed significantly among diet groups. No patients became malnourished. Mean rates of decline in GFR were relatively slow, and variability among individuals was high. As expected, the number of patients enrolled was too small to determine if the rate of decline in GFR was significantly slower among patients assigned to the restricted protein and phosphorus diets. The rate of decline in GFR was significantly inversely correlated with long-term average mean arterial blood pressure (MAP), even among patients whose blood pressure was controlled to levels within the normal range. However, because patients were not randomly assigned blood pressure goals, it was not possible to determine whether a causal relationship exists. Based on the experience gained during the Feasibility Study, the design for the Full-Scale Study includes two studies of defined by patients' baseline levels of renal function. Within each study, patients will be assigned randomly to one of two diets, and within each diet group, to one of two levels of blood pressure control. Based on variability of rates of decline in GFR slopes observed during the Feasibility Study, 800 patients with follow-up periods of up to 4 years will be required for the Full-Scale Trial.

Adult↗
PubMed1992

Automated prescreening of conventionally prepared cervical smears: a feasibility study.

The feasibility of an automated screening device that will analyze conventionally prepared cervical smears was examined. Consecutive normal and abnormal cervical smears were selected retrospectively and analyzed on a customized microscope imaging workstation system. Specialized image processing, feature extraction, and object classification algorithms were integrated on the imaging workstation to provide an Analysis Score for each slide analyzed. A threshold was set for the Analysis Score, and all slides with a score less than the threshold were classified as normal. Examination of the distribution of the Analysis Score for normal and abnormal cervical smears provided an estimate that 50% of all slides will be sorted as normal, and consequently need no cytologist review. With the Analysis Score threshold set for a 50% sort rate, zero false-negative slides were found in this slide set. This study has shown that a large percentage of slides can be correctly classified as normal while maintaining a high sensitivity to abnormal slides. Given the current workload problems in cytology laboratories, reducing the screening workload by one half will be beneficial. This study has shown that it is now feasible with current technology to provide a clinically useful device to automate screening of conventional cervical smears.

Algorithms↗
PubMed1988

Computerized telephone assessment of the "concrete" needs of chemotherapy outpatients: a feasibility study.

The feasibility of using a computer-automated telephone outreach system to routinely assess the needs of chemotherapy outpatients was evaluated. The automated intervention was designed as a cost-efficient strategy for assessing patients' needs on a periodic basis so that emerging needs could be identified in a timely way. Ninety-seven chemotherapy outpatients were surveyed at least once over the telephone by a computer in a high-quality, digitally stored voice asking 12 questions regarding the patients' "concrete" needs. Early results of this larger ongoing study, in which patients are scheduled to be called every 4 to 6 weeks for approximately four months, indicated that computer-automated surveys had broad-based acceptance among our outpatients and that patients were able to comply accurately with the survey's instructions. Furthermore, the speech recognition system was found to be reliable, and patients' response patterns to the automated surveys valid. Nonparticipation in this study (28.0%) was not substantially higher than in our previous research within this patient population and neither nonparticipation nor attrition appeared significantly attributable to the automation itself. This method offers the potential for cost-efficient, universal, and ongoing assessment of patient needs, facilitating timely intervention, and efficient use of professional staff.

Ambulatory Care↗
PubMed1987

Application of case management to the control of acute respiratory infections in low-birth-weight infants: a feasibility study.

The feasibility of introducing a case management programme for acute respiratory infections among low-birth-weight infants at the primary health care level was investigated in 37 villages in the Indian state of Haryana. Twenty-one of the villages served as the intervention area, while the remaining 16 formed the control area. All low-birth-weight infants born in the two areas between January 1982 and September 1983 (199 in the intervention area and 211 in the control area) were included in the study. Primary health care workers were contacted in 38% of episodes of acute respiratory infections in the intervention area, in contrast to only 1% of episodes in the control area. Also, the mean duration of infections in the intervention area was significantly lower (P<0.01), while the case fatality was about 33% of that in the control area. The results indicate that the programme can be successfully incorporated into existing primary health care infrastructures.

Acute Disease↗
PubMed2026

Continuous Intravenous Lidocaine for Refractory Cancer Pain in Palliative Care: A Multicenter Feasibility Study.

ObjectivesTo assess the feasibility and tolerability of continuous low-dose intravenous lidocaine infusion in patients with opioid-refractory cancer pain receiving palliative care, and to explore its potential impact on pain outcomes in real-world clinical conditions.MethodsWe conducted a multicenter, randomized, double-blind, placebo-controlled feasibility study in palliative care units to evaluate continuous intravenous lidocaine infusion in patients with opioid-refractory cancer pain. Patients were randomized to receive lidocaine (5&#x2005;mg/kg/day, increased to 8&#x2005;mg/kg/day if pain reduction was <30% after 24&#x2005;h) or placebo for 48&#x2005;h. Pain intensity was assessed using the Numeric Pain Intensity Scale, with a clinically meaningful response defined as a&#x2009;&#x2265;30% reduction from baseline at 40&#x2005;min. Secondary outcomes included pain evolution over time, neuropathic pain, symptom burden, and tolerability.ResultsThirty-five patients were included in the final analysis (18 lidocaine, 17 placebo). No significant difference was observed between lidocaine and placebo for the primary endpoint or for secondary pain outcomes. Reductions in pain intensity were observed in both groups. In the lidocaine group, 61% of patients required dose escalation to 8&#x2005;mg/kg/day. Continuous intravenous lidocaine infusion was generally well tolerated, with mostly mild adverse events and no unexpected toxicity.ConclusionIn this multicenter feasibility study, continuous low-dose intravenous lidocaine did not demonstrate a clinically meaningful analgesic benefit over placebo. As the planned sample size was not reached, the study was underpowered. These findings highlight the challenges of randomized trials in palliative care and may inform future feasibility-oriented designs.

Humans↗
PubMed1975

Postoperative extradural analgesia following thoracic surgery: a feasibility study.

The feasibility of providing postoperative analgesia using thoracic extradural blockade following thoracotomy has been assessed. Extradural block was produced by intermittent injections of 0.5% bupivacaine with adrenaline 1:200,000 or a continuous infusion of 0.25% or 0.125% bupivacaine. The only toxic symptom was drowsiness which was most frequent after a continuous infusion of 0.25% bupivacaine and with arterial plasma bupivacaine concentrations above 1.5 mug/ml. Arterial hypotension was a troublesome complication with all techniques although stability of arterial pressure was more easily achieved with a continuous infusion technique. However, this produced a high incidence of urinary retention. Practical aspects and effectiveness of providing extradural analgesia in patients following thoracotomy are discussed.

Aged↗
PubMed1976

Liver volume determination by ultrasound: a feasibility study.

The feasibility and precision of an ultrasound method for determining the volume of the liver have been assessed using a Nuclear Enterprises B-scan machine. A relation between estimated liver volume and body weight has been established, showing that liver volume can be determined with a precision of +/- 195 cm3 (P less than or equal 0-05). With the standard non-grey-scale imaging technique employed there is a degree of uncertainty in deciding the liver boundaries, and this constitutes the major source of error.

Anthropometry↗
PubMed2026

Evaluation of muscle microvascular perfusion in primary mitochondrial disease by contrast-enhanced ultrasound: Feasibility study.

BACKGROUND: Primary mitochondrial disease (PMD) are genetic disorders characterized by impaired oxidative metabolism and microvascular abnormalities that contribute to the myopathy. OBJECTIVES: This study evaluates the feasibility and utility of contrast-enhanced ultrasound (CEUS) for quantifying skeletal muscle perfusion in patients with PMD. In addition, we assessed exercise-induced changes following cardiopulmonary exercise testing (CPET) to characterize dynamic vascular responses. DESIGN: Prospective pilot feasibility study. METHODS: We enrolled genetically confirmed PMD and healthy control participants with ability to complete the CPET protocol. CEUS of the vastus lateralis muscle was performed at rest and following CPET. Imaging parameters were standardized across all CEUS scans, with a fixed mechanical index of 0.13. Perfusion parameters, including perfusion index (PI), peak enhancement (PE), and area under the curve (AUC) were quantified using delta projection analysis, and compared between PMD and control participants, and within each group, pre- and post-exercise. RESULTS: A total of 5 PMD and 5 control participants were evaluated. At rest, CEUS demonstrated a trend in higher muscle perfusion in PMD as compared to control participants on comparing PI (13.7 &#xb1; 2.7 vs. 10.7 &#xb1; 3.2; p = 0.42), PE (24.9 &#xb1; 11.5 vs. 14.3 &#xb1; 6.8; p = 0.22), and AUC (95,253.4 &#xb1; 35,072.8 vs. 73,591.2 &#xb1; 32,820.6; p = 0.31), which did not reach statistical significance, likely in part due to the small cohort size. Following CPET, PMD participants demonstrated exaggerated percentage increases in PI (+21.1% vs. +16.0%), PE (+11.2% vs. +7.6%), and AUC (+20.2% vs. +12.5%) as compared to control participants. Within group analysis revealed a significant post-exercise increase in AUC among PMD participants (p = 0.01) but did not reach significance in control participants. CONCLUSION: This is the first study to demonstrate the feasibility and utility of conducting CEUS to assess skeletal muscle perfusion in ambulatory PMD patients. The distinct perfusion patterns and exaggerated exercise-induced responses observed in PMD as compared to control participants suggest that reactive hyperemia occurs in PMD at rest and is further exaggerated by exercise. CEUS may serve as a sensitive tool for detecting microvascular alterations in PMD.

cardiopulmonary exercise testing (CPET)↗
PubMed1991

[Feasibility study of quality of life (QOL) instrument in patients with advanced lung cancer].

We have studied the feasibility of the QOL measurement for the group of patients with advanced lung cancer using the QOL questionnaires modified from FLIC (Functional Living Index Cancer). The 16-items instrument showed that the Cronbach's alpha of all categories were over 0.6. as the quality of reliability. Using the principal component method of multivariate analysis, four major factors were identified as a part of the construct validity. We concluded that the QOL of patients with advanced lung cancer under the clinical research setting can be evaluated using this questionnaires even in Japan which has different cultural background from the Western Countries.

Adult↗
PubMed1990

ARIC hemostasis study--II. Organizational plan and feasibility study.

In our previous paper, we reported the development of a blood collection and processing system (BCPS) suitable for the ARIC multicenter hemostasis study. As an additional step of preparation for the ARIC study, we incorporated this BCPS into an organizational plan to increase efficiency and minimize errors. We initially designed organizational trays for blood collection tubes and aliquot tubes and developed a coordinated step-by-step plan for the orderly processing of blood samples. Once the plan was considered workable, we carried out a pilot study to test the feasibility of this integrated organizational plan. Included in the pilot study were 95 healthy subjects randomly selected from 4 ARIC field centers, whose age and gender were comparable to those projected for the ARIC population. We determined the time lapse of filling the first tube as an index of blood flow. The overall mean time-lapse was 23 s (S.D. = 5). There was no significant difference among the field centers. We also determined the entire time lapse required for completing the sample processing. The total processing time was always less than 60 min. By performing the processing of samples in pairs, all the samples from two subjects could be completely processed in 70 min. This greatly increased the efficiency of field center operation. We evaluated the potential in vitro hemostasis activation by measuring plasma beta-thromboglobulin and platelet factor 4 levels. The geometric means of both proteins were comparable to our previously reported results. Fibrinogen, factor VII, factor VIII, von Willebrand factor, antithrombin III, protein C and activated partial thromboplastin time were analyzed.(ABSTRACT TRUNCATED AT 250 WORDS)

Arteriosclerosis↗
PubMed1988

Usefulness of comprehensive feasibility studies in environmental epidemiology investigations: a case study in Minnesota.

Episodes of public water supply contamination with industrial or agricultural chemicals frequently give rise to public concerns about adverse health effects. These concerns may precipitate epidemiologic or clinical investigations requiring large expenditures of state and federal resources regardless of whether such investigations are justified by scientific criteria. An alternative is a comprehensive feasibility study, utilizing all available information to determine whether large-scale studies are warranted or feasible. At a relatively modest cost, a feasibility study allows health officials to identify information needs and deficiencies, outline potential study options and costs, clearly establish the rationale for a proposed study or, conversely, prevent unwarranted expenditures of public resources. Furthermore, a feasibility study may in itself resolve many community and scientific concerns. This article provides a case study of the usefulness of a formal feasibility study in a situation involving an elevated cancer rate and contaminated municipal water supply wells surrounding a federal superfund site.

Costs and Cost Analysis↗
PubMed1987

The value of DSM-III for psychotherapy. A feasibility study.

Establishing the usefulness of DSM-III for psychotherapy will probably require numerous studies. This paper reports a feasibility study for one kind of investigation: the use of clinical records to survey the DSM-III diagnoses and therapy outcome of 30 patients who had outpatient psychotherapy. We were interested in what range of DSM-III diagnoses was represented by patients in outpatient therapy; whether judgments of diagnosis and outcome could be made reliably from clinical records; how well patients in the therapy fit DSM-III diagnoses; if patients did not fit well, why not? We found that an exploration of the relationship between DSM-III diagnosis and outcome from clinical records is feasible; a relatively wide range (13) of DSM-III diagnoses was represented by the 30 patients; 80% of the patients fit well or moderately well into a DSM-III diagnosis; most of the 20% who did not fit well represent the class of problems of living, which does not mean, however, that their problems were minor or unimportant; in some cases the diagnosis--even when it fit the patient well--did not express the essence of the problem for which he or she was to be treated; there was a small correlation (.19) between the patient's rating on axis V and therapy outcome. The findings are discussed in terms of the pro and con arguments that have been made about DSM-III.

Adolescent↗