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[The REVEIL study: feasibility study of blood pressure self-monitoring. Preliminary results and patient opinions].

The REVEIL study is a pilot studies to determine the feasibility of self blood pressure measurement (SBPM). Feasibility was assessed by the quality of measurements and the patient opinion. This preliminary report focused on the patient opinion. Patients were included in the study by their general practitioner or cardiologist when he thought there was an indication for SBPM. Patients were excluded if their physical or mental autonomy was not sufficient to perform SBPM or if they were arrhythmic. The lending of the device was free (against a guarantee of 800 F) and it was available in one of the 44 drugstores that participated to the study. The physician performed patient education about SBPM and the druggist explained the handling of the device. SBPM was performed over a 7-day period: every day two series of 3 consecutive measurements were requested in the morning before taking the antihypertensive treatment, and in the evening between dinner and bedtime. The device was the validated OMRON 705 CP. 428 patients were included in the study. Among them, 385 (90%) accepted to participate to the study and 43 refused (10%). Almost half of the refusals were due to patients that did not want to take care of them and 16% were justified by a technical problem. Preliminary data included 362 patients aged 55.2 years, 79 of them older than 70 years. 80 patients (22%) experienced difficulties to perform SBPM, 28 of them (7.3%) to perform measurements and 13 (3.4%) to understand how worked the device. At the end of the study, 82 patients (23%) had better understanding of their hypertension, 90 patients (25%) felt themselves more motivated to take their medication and 111 patients (31%) found that their physician took better charge of them. 286 patients (79%) evaluated the overall satisfaction at SBPM. Among them, 276 patients (97%) were very satisfied (57%) or satisfied (40%) with SBPM when only 3% of patients were not. In summary, SBPM was easily performed in the conditions of the REVEIL study, and the majority of patients was satisfied with this experience.

Antihypertensive Agents↗

Feasibility study of hernia surgery in a general practice setting.

BACKGROUND: In the early 1990s, waiting times for some surgical procedures and opinions for such routine problems as groin hernia repair were unacceptably long. General practitioners with a special interest (GPwSIs) in general surgery may improve this, but little evidence exists as to whether such service developments may improve efficiency and effectiveness of care. AIMS: To reduce the waiting time by offering a surgical service from a general practice setting without compromising on quality and safety of patient care. DESIGN OF STUDY: Feasibility study. SETTING: One general practice and the patient population of northwest Norfolk. METHODS: A GPwSI whose special interest was in general surgery started offering a surgical service, including open hernia repair, from a purpose-built operating theatre within general practice premises. RESULTS: Four thousand, nine hundred and sixty-five surgical procedures, including 286 inguinal hernia repairs, were performed. Quality and safety of patient care were not compromised and the waiting time was reduced from 18 months to 4 months. CONCLUSION: It is feasible to perform open inguinal hernia repairs in a general practice setting.

Ambulatory Surgical Procedures↗

Multiple cycles of dose-intensive chemotherapy with repeated stem cell support as induction treatment in metastatic breast cancer: a feasibility study.

The purpose of this trial was to study feasibility and tolerance of a dose-intensive multicyclic alternating induction chemotherapy with repeated stem cell support in a series of 43 metastatic breast cancer patients. Anthracycline-naive patients (n = 21) received cyclophosphamide 2.5 g/m(2) plus doxorubicin 80 mg/m(2) alternating every 14 days with paclitaxel 200-350 mg/m(2) plus cisplatin 120 mg/m(2). Patients who had previously received anthracyclines (n = 22) received cisplatin 120 mg/m(2) plus etoposide 600 mg/m(2) alternating with paclitaxel 200-350 mg/m(2) plus ifosfamide 8 g/m(2). Peripheral blood stem cells were infused after every course except the first, with a median CD34(+) dose of 2.1 x 10(6)/kg per cycle. Positive selection of CD34(+) cells was performed in good mobilizers. The median number of cycles administered was six (4-8), and the time interval between them was 17 days. Median summation dose intensities (SDI) actually administered for the CA-TP and PE-TI protocol were 4.95 and 4.69, respectively (87% of scheduled SDI). There were 15 complete (35%) and 21 partial responses (49%), for an overall response rate of 84% (95% CI, 73%-95%). Infection or neutropenic fever occurred in 50% of the cycles. There was one treatment-related death. After a median follow-up of 26 months, the median event-free-survival was 12 months (95% CI: 10-14) and overall survival was 31 months. These high dose-intensity induction treatments seem to be feasible with sequential stem cell support.

Adult↗

Automated screening for quality of care in the hospital--a feasibility study.

A feasibility study for computer-based quality screening was carried on 497 clinical cases. Rule-directed audit criteria were used. Discharge summaries were analyzed in an effort to detect possible quality problems. The charts of the same cases were also screened by nurses, and the suspected cases of both process es were further reviewed by physicians. The computer-based text analysis compared favorably with the screening by nurses, and showed a rather low false negative rate. The objectives of substantiating the discharge summary as a valid source document for generic quality screening was demonstrated. In addition the economy and feasibility of computer based text analysis and interpretation was proven. Finally the applicability of algorithmic rules in detecting clinical quality indicators showed great promise and presents an area of further research. Thus the feasibility study was highly successful. The potential of computer-based care quality assessment is discussed.

Electronic Data Processing↗

Feasibility studies to control acute diarrhoea in children by feeding fermented milk preparations Actimel and Indian Dahi.

The aim of this work was to study feasibility of diarrhoea control in children (6 months to 5 y of age) by feeding fermented milk preparations. The design used was a randomized controlled clinical trial and the study was carried out at the Delhi University College Hospital providing tertiary care, and a nearby community centre Nand Nagri, a resettlement colony in East Delhi. Children suffering from acute diarrhoea (75 patients from the hospital and 75 from the community) were allocated to three groups by double-blind technique. Group 1 was given a fermented milk, Actimel, containing 10(8) of each Lactobacillus casei DN-114001, Lactobacillus bulgaricus and Streptococcus thermophilus per gram. Group 2 was given Indian Dahi (Lf 40) containing 10(8) of each Lactococcus lactis, Lactococcus lactis cremoris and Leuconostac mesenteroides cremoris per gram. Group 3 was given ultra-heat-treated yoghurt preparation (no live bacteria). Actimel was also used as a starter to prepare the curd in order to study the preventive effect of diarrhoea in children in a community. In the hospital study Indian Dahi and Actimel administration reduced mean duration of diarrhoea by 0.3 and 0.6 day (P<0.001), respectively. The corresponding figures in the community study were 0.2 and 0.5 day (P<0.05), respectively. The families using Actimel as a starter showed a reduction in diarrhoeal morbidity episodes by 40% of the children tested in a 3 month follow-up. In conclusion, Actimel, fermented milk containing Lactobacillus casei DN-114001, and Indian Dahi can significantly reduce the duration of diarrhoea in children; the former preparation being superior.

Acute Disease↗

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↗

Promoting the exclusive feeding of own mother's milk through the use of hindmilk and increased maternal milk volume for hospitalized, low birth weight infants (< 1800 grams) in Nigeria: a feasibility study.

A feasibility study was used to determine (1) if hindmilk feedings of own mother's milk, as reported in the United States, could be instituted in a Nigerian neonatal intensive care unit and result in adequate infant weight gain without exogenous additives; and (2) if the use of a hospital-grade electric breast pump to separate foremilk from hindmilk was feasible in this setting. Mean weight gain for 16 preterm infants during the hindmilk intervention (18.8 g/d) exceeded intrauterine standards without the use of exogenous substances. At the time of hospital discharge, mean maternal daily milk volume was 342 mL/kg/d, indicating that the infants, on average, had 90% more milk available to them than they required. Mean infant weight gains were 14.2 and 16.6 g/d from 1 to 7 and 8 to 23 (x = 14.8) days postdischarge, respectively. Therefore, hindmilk feedings are effective and feasible for hospitalized, low birth weight infants in developing countries, and lactation specialists may use our protocol for further research.

Breast Feeding↗

External audit of photon beams by mailed film dosimetry: feasibility study.

A feasibility study for mailed film dosimetry has been performed. The global reproducibility of the method is better than 2%. It is shown that the normalized sensitometric curve does not depend on photon beam quality in the range from Co-60 gamma-rays to 18 MV x-rays, although the dose per optical density decreases when the energy increases. The fading of the latent image before film processing is only 3% per month and the normalized sensitometric curve is not modified after a period of 51 days between irradiation and processing. Sets of films were mailed to three different institutes for irradiation and returned for processing and evaluation after more than two months in order to verify that mailing of irradiated and unprocessed films does not produce unwanted artefacts. Finally the feasibility of external audits with mailed film dosimetry is illustrated by comparison of beam profiles measured with films and ionization chambers in a polystyrene phantom.

Cobalt Radioisotopes↗

[Autologous peripheral blood stem cell transplantation for Japanese multiple myeloma patients: results of a feasibility study].

A feasibility study on high-dose therapy with autologous peripheral blood stem cell transplantation (HDT/PBSCT) was performed in Japanese patients with multiple myeloma (MM). Twenty evaluable patients younger than 65 years old with stage II/III MM were enrolled in this study. Three courses of VAD were used as initial chemotherapy. High-dose etoposide or cyclophosphamide followed by G-CSF was used for PBSCH, and 1.2-89.3 (median 23.4) x 106/kg of CD34+ cells were collected. Single (11 patients) or tandem (9 patients) HDT with melphalan (MEL) 200 mg/m2 or MEL 140 mg/m2 plus TBI 10 Gy were performed. The incidence of grade 4 toxicity (COG) was 10% and treatment-related mortality was 5%. Complete response and tumor reduction of more than 75% were obtained in 4 (21%) and 16 (84%) out of 19 patients, respectively. The actuarial 3-year overall survival (OS) and event-free survival (EFS) after PBSCT/HDT were 65.6% and 22.0%, respectively. The median EFS duration was 18 months. These preliminary results indicated that HDT/PBSCT is feasible for Japanese MM patients. A prospective randomized clinical trial will be required to assess the efficacy.

Adult↗

Statistical modeling of atherosclerotic plaque in carotid B mode images--a feasibility study.

A feasibility study undertaken to model atherosclerotic plaque in carotid B-mode images is presented. The study is based on 33 regions-of-interest collected from arterial images obtained from four patients. A bimodal gamma distribution with five parameters is proposed to model the statistics of the pixels in the gray-level images. The parameters of the distribution are evaluated for regions containing plaque using curve-fitting techniques. This bimodal distribution appears to be a reasonable fit to the statistics of the pixels. This statistical model may aid in the objective classification of arterial plaque through the use of its parameters.

Algorithms↗

Assessment of small bowel Crohn disease: noninvasive peroral CT enterography compared with other imaging methods and endoscopy--feasibility study.

A feasibility study was conducted to evaluate two biphasic computed tomographic (CT) enterography protocols, a noninvasive CT technique with water administered perorally and CT enteroclysis with methylcellulose administered through a nasojejunal tube, in 23 patients known or suspected to have Crohn disease. Results were compared with the results of fluoroscopic small bowel examination and terminal ileoscopy for the detection of active Crohn disease in the terminal ileum. Luminal distention did not differ significantly between the two CT protocols. Arterial phase imaging was noncontributory in 22 of 23 cases. The noninvasive peroral water CT enterography protocol had similar accuracy (12 of 15 cases, 80%) for enabling the detection of active Crohn disease in comparison with CT enteroclysis with nasojejunal tube (seven of eight, 88%) and fluoroscopic small bowel examination (17 of 23, 74%). No fistulas were missed with use of either CT technique. The authors conclude that noninvasive peroral portal venous phase CT enterography with use of water is an accurate and feasible technique for detecting active small bowel inflammation in patients with Crohn disease.

Administration, Oral↗

Telephone-based guided self-help for binge eating disorder: a feasibility study.

This feasibility study describes a novel form of guided self-help for treating binge eating disorder (BED). Over a 3-month period, a lay therapist provided first weekly (for 1 month) and then biweekly telephone-based guidance to supplement a self-help program. Eligible participants met DSM-IV criteria for BED, based on the Eating Disorder Examination (EDE). Of 9 women initially admitted into the study, 7 completed the self-help program. Upon completion, outcome was determined using the EDE-Questionnaire and the Brief Symptom Inventory (BSI). Binge eating frequency decreased markedly; BSI scores also decreased significantly. All women reported high levels of satisfaction with the intervention. Participants commented favorably about the flexibility, accessibility, and autonomy afforded by the telephone-based administration of guidance. Results suggest that telephone-based guided self-help is a viable mode of service delivery for some women with BED. Recommendations are made for further improvement of this form of self-help.

Adult↗

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↗

Online Internet-based robotic telepathology in the diagnosis of neuro-oncology cases: a teleneuropathology feasibility study.

This feasibility study examined the diagnostic accuracy of Internet-based dynamic-robotic telepathology using neuropathology cases. Randomly, 83 cases were selected from the routine diagnostic workload of the Neurosurgical Pathology Laboratory in Poznan, Poland. Telepathology diagnoses were compared with conventional paraffin section diagnosis. The neuropathologists, operating a robotically controlled motorized microscope over the Internet from 3 different Polish cities, individually reviewed the cases using computer workstations. Viewing times ranged from 2 minutes 54 seconds to 32 minutes 12 seconds per case. The mean diagnostic accuracy for telepathology diagnosis was 95%, with 2 of 3 observers achieving 100% diagnostic accuracy. Image quality was judged to be sufficient for correct evaluation, and the viewing times required to establish a final diagnosis by remote video microscopy were acceptable. Generally, user acceptance of robotic telepathology was high.

Adolescent↗

Self-administered automatic sight-testing. A feasibility study.

A feasibility study to estimate the extent to which self-administered computerized sight-testing instruments would be acceptable to patients and staff in a hospital outpatient eye department has been carried out. Visual acuity was measured in two ways for each of 86 patients in the age range 20-79 years; Snellen acuity was compared with the screen-based Landolt C test. The patient was seated in front of the computer controlled display, supplied with tape-recorded instructions: his/her progress was monitored without intervention unless there were obvious difficulties. The mean acuities as measured by the two methods did not differ significantly from each other, with similar variances. More than 70% of patients managed the self-administered test without any help at all, only 4-5% failing completely. The computerized test was favoured by most except the oldest patients. It forms therefore a sound basis for further development on a large scale.

Adult↗

Comparison of MRI with CT for the radiotherapy planning of prostate cancer: a feasibility study.

This feasibility study was performed to evaluate the suitability of MRI in defining appropriate pelvic radiotherapy treatment volumes, and to compare MRI sequences with CT for prostate cancer radiotherapy. Five patients with localized prostate cancer, imaged with four MRI sequences (spin echo (SE) T1, turbo SE (TSE) T2, high resolution TSE (HR) T2, and FLASH 3D (F3D)), compared with their corresponding CT planning scans. Segmentation ability of the following pelvic structures: prostatic apex (PA), prostate, rectum, bladder and seminal vesicles (SV), were evaluated by three independent observers. They used a five point grading scale based on the anatomical definition of the organ boundary, tissue contrast and multiplanar display. Results were averaged for the group and for each sequence. There was no significant interobserver variation in the assessed scores (p > 0.1). The average scores (+/- 1 SD) for all pelvic structures assessed by each imaging sequence were CT 1.3 +/- 0.6; SE T1 2.4 +/- 0.9; TSE T2 2.4 +/- 0.7; HR T2 2.2 +/- 0.7 and F3D 3.4 +/- 0.6. Compared with CT, the average MR score for each assessed pelvic structure was higher with a trend for all transaxial MR sequences to provide improved segmentation of the PA and rectum. The F3D sequence scored highest as it provided multiplanar views and avoided the problem of partial volume averaging. MRI, compared with CT, appears to provide improved definition of pelvic treatment volumes but further work is required to confirm this and to address the issues of MRI associated distortion and dosimetry before MRI can be used routinely for pelvic radiotherapy planning.

Aged↗

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↗

Recruitment strategies in the women's health trial: feasibility study in minority populations. WHT:FSMP Investigators Group. Women's Health Trial:Feasibility Study in Minority Populations.

The Women's Health Trial:Feasibility Study in Minority Populations (WHT:FSMP) examined the feasibility of recruiting postmenopausal women from a broad range of racial and socioeconomic backgrounds into a primary prevention trial requiring marked reductions in dietary fat. Postmenopausal women aged 50-79 yr who had no history of cardiovascular disease or cancer and who consumed 36% or more total energy from fat qualified to participate. We randomized the women into dietary intervention (60%) or control (40%) groups; we aimed to randomize 750 women in 18 months in each of the three clinical centers. All centers achieved goals for randomization based on ethnicity, and two centers exceeded overall recruitment goals. The greatest source of randomized participants was mass mailing, followed by items in the media, referrals, and community outreach. Recruitment yields were generally similar for the ethnic groups but lower for less-educated participants. The experience of WHT:FSMP indicates that postmenopausal women from the African-American, Hispanic, and non-Hispanic white communities can be recruited into dietary intervention studies for the prevention of disease.

Black or African American↗