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PubMed2005

Assessment of risks related to medicine dispensing by nonprofessionals in Colombia: clinical case simulations.

BACKGROUND: Appropriate dispensing is one of the steps for rational drug use, so it is generally advised that the dispenser should have relevant and updated knowledge, skills, and attitudes. OBJECTIVE: To assess pharmacies and nonprofessional employees' (NEs) skills and knowledge, as well as their response to several specific case simulations in Bogota, Colombia. METHODS: A descriptive cross-sectional study was performed on a random sample of 371 pharmacies in Bogota. Information from each pharmacy was obtained using 2 approaches: (1) direct interview to collect data on organizational aspects of the store and characteristics of NEs, and (2) simulation (both by direct interview and by telephone) to assess dispensing responses in 6 simulated clinical cases. RESULTS: More than half of the simulated clinical situations resulted in inappropriate dispensing (direct simulations 57%; telephone simulations 55%). The proportion of correct answers to theoretical questions regarding a specific therapeutic problem during interviews was higher than the response when a simulation presented that same case and a dispensing act was expected. The educational background of the NEs included in the study points to a specific problem: two-thirds of the individuals selling medicines had completed only secondary-level education and only 2% of the sample had a pharmacist as technical director. Continuing education courses were either directly organized by drug manufacturers (one-third of the courses attended by pharmacists) or sponsored by them (more than an additional one-third). CONCLUSIONS: NEs should be considered part of the therapeutic chain and, if appropriately updated or instructed, could play a very important role in the always difficult promotion of rational drug use. Public health institutions and universities should be more actively involved in the provision of independent, unbiased, and essential information on common therapeutic problems, safety concerns, and new drug prescription restrictions.

Adult↗

PubMed1997

The effectiveness of a needleless intravenous connection system: an assessment by injury rate and user satisfaction.

OBJECTIVE: To assess the impact of a needleless intravenous (i.v.) connection system on the rate of reported intravenous-connection-related (IVCR) percutaneous injuries, and to assess user satisfaction, frequency of use, and barriers to use. DESIGN: A pre-post intervention design, with injury incidence rates being compared 3 years before and 1 year after hospital wide device implementation; and a cross-sectional descriptive user satisfaction survey. SETTING: Two tertiary-care teaching hospitals, one general and one pediatric, located in a large metropolitan medical center. OUTCOME VARIABLE: All IVCR percutaneous injuries reported to the employee health services at both hospitals during the years from 1989 to 1991 and 1993. STUDY POPULATION: Survey participants were selected randomly from licensed nursing employees at both hospitals. INTERVENTION: i.v. connection system consisting of blunt plastic cannulas and compressed latex injection sites. RESULTS: After device implementation, the IVCR injury rate was reduced 62.4% (rate ratio [RR], 0.38; 95% confidence interval [CI95], 0.27-0.53) at the general hospital and 70.2% (RR, 0.30; CI95, 0.17-0.53) at the pediatric hospital. After adjusting for the reduction in injury rate due to factors other than device implementation, the IVCR injury rate was reduced 54.5% (adjusted RR, 0.46; CI95, 0.32-0.65) at the general hospital and 57.2% (adjusted RR, 0.43; CI95, 0.24-0.78) at the pediatric hospital. Approximately 94% of survey respondents (n = 478, response rate = 51%) were satisfied with the device and recommended continued use. However, needles still were being used for activities that could have been performed with the needleless system because of compatibility, accessibility, and other technical problems related to the device. CONCLUSIONS: The device was effective in reducing the rate of reported IVCR percutaneous injuries and users were satisfied with the device, but barriers to universal use were identified.

Cross-Sectional Studies↗

PubMed2003

Failure of simulation training to change residents' management of oesophageal intubation.

BACKGROUND: There are few scientific reports documenting the effects of simulation training on learning. Issues of scientific validity challenge investigators who measure such outcomes. We perceived a failure of residents to change their technical management of oesophageal intubation after simulation training and sought clarification of this observation. METHODS: Twenty-one residents were randomly exposed to two deliberate oesophageal intubation scenarios, first as a junior assistant (JS group) or as a senior managing resident (SS group), and secondly as a senior managing resident. After the first episode, residents were given an explanation and demonstration of the suggested technical management strategy, including: (i) confirmation of oesophageal intubation with a second direct laryngoscopy; and (ii) concurrent insertion of a second tube into the trachea. After the second episode, we retrospectively sought to confirm improvement in technical management within the SS group by measuring videotaped performances. Questionnaires were sent to the residents before and after reporting their performance results. RESULTS: There were 14 SS and seven JS subjects. Within SS, there was no improvement in "confirmation of oesophageal intubation with direct laryngoscopy" (8/14 vs 9/14) or any improvement in "concurrent insertion of a second ETT (tracheal) tube" (1/14 vs 2/14). Questionnaire responses offered considerable insight into these negative results. CONCLUSIONS: This failure to change may have been secondary to a lack of criterion validity, lack of repetition or a long duration between episodes. The expectations for management were not regarded as being advantageous in simulation, but they were successfully adopted in actual clinical emergencies.

Anesthesiology↗

PubMedDate not supplied

Design and rationale of the PREVENT III clinical trial: edifoligide for the prevention of infrainguinal vein graft failure.

Surgical bypass of peripheral arterial occlusive disease with autologous vein grafts provides an effective means of restoring blood flow to the lower extremity, and has been a standard therapy for patients with disabling claudication or critical limb ischemia (CLI). However, failure rates may run as high as 50% within 5 years. These graft failures occur as a result of neointimal hyperplasia, a ubiquitous biologic response of blood vessel walls to injury, which is characterized by the migration and proliferation of smooth muscle cells (SMC). The E2F family of transcription factors regulates the expression of genes controlling SMC proliferation. Edifoligide (E2F Decoy) is a novel therapy that inhibits E2F function, thus attenuating neointimal hyperplasia. Its use in conjunction with a patented drug delivery pressurization chamber is under investigation. Using this system, edifoligide is administered to vein grafts in a single, ex vivo treatment following vein harvest and before implantation, resulting in minimal systemic drug exposure and excellent patient compliance. This Phase 3, randomized, double-blind, multicenter clinical trial is designed to evaluate the safety and efficacy of edifoligide in a population of approximately 1400 patients with CLI undergoing infrainguinal bypass for peripheral arterial disease (PAD). The primary outcome measure will be the time to occurrence of non-technical graft failure resulting in either graft revision or major amputation at 12 months after enrollment. A governing Clinical Events Classification committee (CEC) will adjudicate each graft failure to determine its etiology. The PREVENT III trial is the largest multicenter trial ever performed in patients receiving autologous vein bypass grafts for CLI. This landmark study will determine if edifoligide is safe and effective at preventing vein graft failure in patients undergoing lower extremity bypass, but it also provides a unique opportunity to observe current treatment practices in vascular surgery.

Arterial Occlusive Diseases↗

PubMed1990

Interstitial thermoradiotherapy: review on technical and clinical aspects.

Interstitial hyperthermia (IHT) combined with brachycurietherapy (thermoradiotherapy) has gained increasing popularity among radiation oncologists due to its potential as an effective radio- and chemosensitizer. IHT offers considerable advantages over percutaneous methods: confined treatment volume, better sparing of normal tissue, accessibility of deeper tumors, more homogeneous therapeutic temperature distribution, and better control and evaluation of thermal parameters using extensive "thermal mapping" procedures. This article addresses technical principles and clinical applications of IHT methods, radiofrequency (RF), microwave (MW), and hot source (HS) hyperthermia. Clinical phase I/II studies have used IHT palliatively for primary advanced, persistent, or local recurrent tumors, which have responded poorly to conventional treatment. The preliminary clinical data on greater than 500 patients treated with interstitial thermoradiotherapy are extremely promising despite the broad variation among the different treatment approaches. The observed complete response (CR) rate in various clinical trials ranges between 11 and 74%. The differences between the various techniques are minor, with a CR of 57% for interstitial RF hyperthermia (169 of 299 patients) and 60% for interstitial MW hyperthermia (130 of 215 patients). Despite extensive pretreatment, the total observed compliation rate of 22% for RF hyperthermia (67 of 299) and 21% for MW hyperthermia (45 of 215) is acceptable. The prognostic treatment factors identified are tumor volume, applied radiation dose, sufficiently high minimum tumor temperatures, and good thermal parameters, i.e., good quality of the hyperthermia treatment sessions. Technical innovations may facilitate and improve clinical applications and should allow broad clinical implementations of IHT, e.g., intraoperative hyperthermia, and even intracavitary hyperthermia. From these experiences it would appear that IHT is an effective and safe treatment modality, especially when combined with radiotherapy for tumor palliation. Prospective randomized multicentric studies have already been initiated to investigate its role in palliative and adjuvant tumor therapy.

Brachytherapy↗

PubMed1996

Phase III study of interstitial thermoradiotherapy compared with interstitial radiotherapy alone in the treatment of recurrent or persistent human tumors. A prospectively controlled randomized study by the Radiation Therapy Group.

PURPOSE: The objectives of this randomized trial were to determine if interstitial thermoradiotherapy (ITRT) improves tumor regression/control in accessible lesions in comparison with interstitial radiotherapy (IRT) alone and to assess the skin and soft tissue complications with either modality. METHODS AND MATERIALS: From January 1986 to June 1992, 184 patients with persistent or recurrent tumors after previous radiotherapy and/or surgery, which were amenable to interstitial radiotherapy, were accessioned to a protocol developed by the Radiation Therapy Oncology Group (RTOG). One hundred seventy-three cases were analyzed (87 patients in the IRT group and 86 in the ITRT arm). The two arms were well balanced regarding stratification criteria. Most tumors were in the head and neck (40% in the IRT group and 46% in the ITRT group), and pelvis (42% and 43%, respectively). Eighty-four percent of patients in both arms had prior radiation therapy (> or = 40 Gy); 50% and 40%, respectively, had prior surgery, and 34% in each arm had prior chemotherapy. The dose of radiation therapy administered was dependent on the previous radiation dose and did not exceed a total cumulative dose of 100 Gy. Hyperthermia was delivered in one or two sessions, either before or before and after interstitial implant. The intended goal of the hyperthermia was to maintain a minimal tumor temperature of 42.5 degrees C for 30 to 60 min. RESULTS: There was no difference in any of the study end points between the two arms. Complete response (CR) was 53% and 55% in both arms. Two-year survival was 34% and 35%, respectively. Complete response rate for persistent lesions was 69% and 63% in the two treatment arms as compared with 40% and 48% for recurrent lesions. A set of minimal adequacy criteria for the delivery of hyperthermia was developed. When these criteria were applied, only one patient had an adequate hyperthermia session. Acute Grade 3 and 4 toxicities were 12% for IRT and 22 % for ITRT. Late Grade 3 and 4 toxicities were 15% for IRT and 20% for ITRT. The difference was not significant. CONCLUSIONS: Interstitial hyperthermia, as applied in this randomized study, did not show any additional beneficial effects over interstitial radiotherapy alone. Delivery of hyperthermia remains a major obstacle (since only one patient met the basic minimum adequacy criteria as defined in this study). The benefit of hyperthermia in addition to radiation therapy still remains to be proven in properly randomized prospective clinical trials after substantial technical improvements in heat delivery and dosimetry are achieved.

Adult↗

PubMed1998

Spontaneous variability of left ventricular outflow tract gradient in hypertrophic obstructive cardiomyopathy.

BACKGROUND: Improvement in the left ventricular outflow tract (LVOT) gradient has been used as a means of assessing response to therapy in patients with hypertrophic obstructive cardiomyopathy (HOCM). To our knowledge, no data exist regarding the spontaneous day-to-day variability of the LVOT gradient in patients with HOCM. Defining the magnitude of such variability is critical to properly understand how much improvement in LVOT gradient must be present to invoke a therapeutic response. METHODS AND RESULTS: We studied the spontaneous variation in the continuous-wave, Doppler-derived pressure gradient on 5 consecutive days in 12 HOCM patients and 5 aortic stenosis control subjects. While in some patients the day-to-day variability in resting gradient was small, in others it varied markedly. The 95% confidence interval for attributing a change in LVOT gradient to factors other than random variation is +/-32 mm Hg for resting gradient and +/-50 mm Hg for provoked gradient. The mean coefficient of variation for gradient across 5 days for the group was 0.52+/-0.33 for resting gradient and 0.46+/-0.16 for provoked gradient. The day-to-day variability in pressure gradient could not be explained by changes in heart rate, blood pressure, or left ventricular end-diastolic dimension, each of which had a coefficient of variation <.11. Moreover, technical factors related to the performance or interpretation of the studies did not account for it because the coefficient of variation for gradient in aortic stenosis was <10% and interobserver and intraobserver agreement was excellent (r=.96 and .98, respectively). CONCLUSIONS: The LVOT pressure gradient varies considerably from day to day in stable patients with HOCM. A single measurement of pressure gradient is not adequate to define the severity of dynamic LVOT obstruction in HOCM.

Adult↗

PubMed1992

Staffing patterns in hospital clinical dietetics and nutrition support: a survey conducted by the Dietitians in Nutrition Support dietetic practice group.

The Dietitians in Nutrition Support dietetic practice group of The American Dietetic Association administered a questionnaire to evaluate changes in nutrition support services provided to hospitalized patients and home patients in 1989 and compared the results with results of a survey administered in 1986. The 1986 survey documented an increase in tube feeding to inpatients during 1984 to 1986 and greater dietitian staffing in tertiary care hospitals than in primary care hospitals and in larger hospitals in 1986. The 1989 questionnaire was mailed to clinical nutrition managers from a nationwide random sample of 1,000 hospitals from American Hospital Association members; 271 responses were received. Full-time equivalent (FTE) registered dietitians (RDs)--including clinical RDs, nutrition support service RDs, and clinical nutrition managers--decreased 11% from 1986 to 1989. FTE dietetic technicians decreased 22%. The number of FTE nutrition support service RDs and clinical nutrition managers decreased significantly (P less than .05). The mean number of FTE clinical dietitians per 100 beds decreased from 1.4 to 1.0 from 1986 to 1989. These decreases in dietetics staffing occurred despite an overall increase in total hospital FTE staff of 2.9%. Reported daily provision of nutrition support modalities to inpatients was 3.5% for parenteral nutrition, 4.9% for enteral tube feeding, and 9.6% for oral supplements. Decreased dietetics staffing was accompanied by other factors that negatively affect productivity (and therefore ability to provide adequate patient care), including inadequate delegation of technical tasks to dietetic technicians, limited availability of secretarial and computer support, and minimal provision of pocket pagers. These trends may be evidence of inadequacy of dietetics staffing to meet the needs of the US population for nutrition care.

Dietary Services↗

PubMed2003

Influence of menthol on caffeine disposition and pharmacodynamics in healthy female volunteers.

OBJECTIVES: The present study was undertaken to determine whether a single oral dose of menthol affects the metabolism of caffeine, a cytochrome P(450) 1A2 (CYP1A2) substrate, and pharmacological responses to caffeine in people. METHODS: Eleven healthy female subjects participated in a randomized, double-blind, two-way crossover study, comparing the kinetics and effects of a single oral dose of caffeine (200 mg) in coffee taken together with a single oral dose of menthol (100 mg) or placebo capsules. Serum caffeine concentrations and cardiovascular and subjective parameters were measured throughout the study. RESULTS: Co-administration of menthol resulted in an increase of caffeine t(max) values from 43.6+/-20.6 min (mean+/-SD) to 76.4+/-28.0 min ( P<0.05). The C(max) values of caffeine were lower in the menthol phase than in the placebo phase, but this effect was not statistically significant ( P=0.06). (AUC)(0-24), (AUC)(0- infinity ), terminal half-life and oral clearance were not affected by menthol. Only nine subjects' cardiovascular data were included in the analysis because of technical problems during the measurements. After caffeine, heart rate decreased in both treatment phases. The maximum decrease in heart rate was less in the menthol phase (-8.9+/-3.9 beats/min) than in the placebo phase (-13.1+/-2.1 beats/min) ( P=0.024). There were no statistically significant differences in systolic and diastolic blood pressures between the two treatments. CONCLUSIONS: We conclude that a single oral dose of pure menthol (100 mg) delays caffeine absorption and blunts the heart-rate slowing effect of caffeine, but does not affect caffeine metabolism. The possibility that menthol slows the absorption of other drugs should be considered.

Administration, Oral↗

PubMed1987

[Regional chemotherapy of liver metastases].

Intraarterial regional chemotherapy of the liver by implantable pumps and port-systems is currently applied predominantly in patients with isolated colorectal metastases. Therapy and evaluation of results must consider the following factors: natural course of the disease; classification of tumor extent in the liver; evidence of isolated liver metastases; vascular anatomy, optimal catheter-implantation technique, complete perfusion; choice of drugs and dosage; technical complications; local toxicity, extra-hepatic recurrence, definition of therapeutic success. Our own experiences with regional chemotherapy in 145 patients with metastases to the liver and in 9 patients with hepatocellular carcinoma are reported. Using different therapeutic modalities we found a significantly enlarged response rate and at this time a true prolongation of life of about 8 months. Further prospective studies are necessary. The use of regional chemotherapy for liver metastases seems to be recommended at this time only under study conditions.

Antineoplastic Agents↗

PubMed1998

Estimating the market for nursing personnel in North Carolina.

PURPOSE: To facilitate nurse workforce planning in the United States at the state level, the North Carolina Center for Nursing conducted a statewide survey of nurse employers to describe the current market for nurses; identify the types of nursing personnel in short supply; estimate the effect of organizational changes on nursing demand; examine preferences for RNs with varying levels of education; and identify the specific skills or competencies desired by employers. DESIGN: Descriptive. METHODS: A geographically stratified random sample of 909 nurse-employing organizations in North Carolina was surveyed in 1996 by telephone. A total of 667 interviews were completed for a response rate of 78%. Descriptive statistics and correlation analyses are reported. RESULTS: A nursing labor market was found characterized by uncertainty in hospitals, particularly those undergoing reorganization, but of definite growth outside of hospitals. Demand is increasing for unlicensed assistive personnel, RNs with baccalaureate degrees, some advanced practice RNs, and in hospitals, for RNs with master's degrees in management. Recruitment continues to be a major challenge to hospitals in specialty areas, particularly critical care and surgery. In the community sector, demand is strong for all types of nursing personnel. Tests for substitution of specific types of nursing personnel revealed no systematic substitution by employers. Critical thinking and management skills were competencies most valued by hospital employers while specific clinical competencies, including assessment skills and technical skills, received priority emphasis by community-based employers. CONCLUSIONS: Although change is occurring in the health system of North Carolina, there remains a strong demand for nursing personnel. The findings pose a challenge to produce a nursing workforce sufficient in numbers and education.

Educational Status↗

PubMed1995

Spinal cord stimulation in cardiovascular disease.

Spinal cord stimulation in ischemic pain conditions has proved to be an effective method of treatment for many patients. The indications are ischemic pain in the extremities from peripheral vascular disease and angina pectoris. The long-term results show that the response rate for ischemic pain is 70% to 90%, while the corresponding results for neuropathic pain average approximately 50% to 70%, which actually makes ischemic pain a very good indication for SCS. SCS system implantation is a safe and quick operation performed under local anesthesia and well tolerated by the patient. A total implant of the lead and the pulse-generator in one stage seldom takes more than 1 hour. High sterility and prophylactic antibiotics are prerequisites to avoid postoperative problems. In atherosclerosis, SCS should be regarded as a method supplementary to vascular surgery, to be used for symptom recurrence after treatment or when there are technical obstacles to reconstructive surgery. SCS has proven to be extremely effective for the relief of ischemic rest pain, which constitutes the most severe problem for these patients. Today it is estimated that more than 7000 implants for PVD have been done in Europe. In a prospective randomized study, Jivegård et al have shown that SCS is a limb-saving treatment. For angina pectoris, SCS by now has become a routine supplementary method to conventional medical and surgical treatment. The technique is clinically effective, and several studies have shown decreased myocardial ischemia and decreased anginal pain during treatment. It is probable that the use of SCS in refractory angina will increase considerably in the 1990s.

Cardiovascular Diseases↗

PubMed1996

Multiple myeloma, high-dose treatment and autologous stem cell transplantation--current status.

High-dose chemo-radiotherapy with autologous stem cell transplantation (ASCT) has introduced the concept of complete remission for multiple myeloma, and can improve survival and life quality for selected groups of myeloma patients. A number of prognostic factors have been identified, where ASCT in early disease, i.e. as part of front-line treatment, seems to be of particular importance for a favourable outcome. Even so, most myeloma patients will not be cured by high-dose therapy, but new strategies such as repeated autografting and post-graft alpha-interferon maintenance treatment seem to add additional advantages with respect to survival and freedom of disease progression. The technical development has enabled efficient in vitro myeloma cell depletion of the autograft as well as highly sensitive detection of minimal residual disease after treatment, but the clinical significance of these issues remains to be determined, and this question is addressed in ongoing gene marking studies. The application of novel therapeutic principles, e.g. gene therapy and immunotherapy, might further ameliorate the outcome for patients with multiple myeloma.

Chemotherapy, Adjuvant↗

PubMed1992

Combined-modality therapies for non-small cell lung cancer.

Regionally advanced stage III non-small cell lung cancer (NSCLC) accounts for nearly 40% of all presentations of NSCLC. In the past, such patients received radiotherapy alone, but the median and long-term survival durations were disappointingly poor. Past attempts at combining chemotherapy and radiation were also disappointing, and were troubled by low doses of radiation or orthovoltage equipment or both. Recently, cisplatin-containing regimens have shown some efficacy in stage IV disease. The response rate for these combinations in stage III disease is nearly double that in stage IV disease. The greater response in stage III has led to a series of trials of sequenced chemotherapy and radiotherapy for treatment of regionally advanced (unresectable stage IIIA and IIIB) NSCLC. Several randomized trials have now shown a statistically significant advantage for the combined modality over radiation alone regarding time to treatment failure, median survival duration, and percent of long-term survivors. Other trials have focused on the concurrent use of chemotherapy and radiotherapy. Several pilot studies have suggested that concurrent cisplatin plus chest irradiation can produce apparently beneficial results with respect to local control and are the subject of ongoing clinical trials. At the University of Maryland Cancer Center, we have combined weekly carboplatin 100 mg/m2 with concurrent chest irradiation. The preliminary results are very encouraging. The toxicity of this treatment program is very manageable, and preliminary data suggest excellent local control and survival. Other pilot studies have suggested that combination chemotherapy with concurrent radiotherapy is also technically feasible.(ABSTRACT TRUNCATED AT 250 WORDS)

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2001

Asking the gatekeepers: a national survey of judges on judging expert evidence in a post-Daubert world.

Drawing on the responses provided by a survey of state court judges (N = 400), empirical evidence is presented with respect to judges' opinions about the Daubert criteria, their utility as decision-making guidelines, the level to which judges understand their scientific meaning, and how they might apply them when evaluating the admissibility of expert evidence. Proportionate stratified random sampling was used to obtain a representative sample of state court judges. Part I of the survey was a structured telephone interview (response rate of 71%) and in Part II, respondents had an option of completing the survey by telephone or receiving a questionnaire in the mail (response rate of 81%). Survey results demonstrate that judges overwhelmingly support the "gatekeeping" role as defined by Daubert, irrespective of the admissibility standard followed in their state. However, many of the judges surveyed lacked the scientific literacy seemingly necessitated by Daubert. Judges had the most difficulty operationalizing falsifiability and error rate, with only 5% of the respondents demonstrating a clear understanding of falsifiability and only 4% demonstrating a clear understanding of error rate. Although there was little consensus about the relative importance of the guidelines, judges attributed more weight to general acceptance as an admissibility criterion. Although most judges agreed that a distinction could be made between "scientific" and "technical or otherwise specialized" knowledge, the ability to apply the Daubert guidelines appeared to have little bearing on whether specific types of expert evidence were designated as "science" or "nonscience." Moreover, judges' "bench philosophy of science" seemed to reflect the rhetoric, rather than the substance, of Daubert. Implications of these results for the evolving relationship between science and law and the ongoing debates about Frye, Daubert, Joiner, and Kumho are discussed.

Attitude↗

PubMed2004

Thêta-Cream versus Bepanthol lotion in breast cancer patients under radiotherapy. A new prophylactic agent in skin care?

BACKGROUND AND PURPOSE: In radiotherapy of the breast following breast-conserving surgery, the adverse reaction predominantly found is confined to the skin. After phase II studies, Thêta-Cream, containing CM Glucan, Hydroxyprolisilan C und Matrixyl as active substances, was said to have prophylactic properties of preventing acute radiation side effects in skin tissue. In a prospective randomized study, Thêta-cream was compared with standard skin care using Bepanthol lotion. PATIENTS AND METHODS: 20 breast cancer patients were randomly assigned to use Thêta-Cream or Bepanthol lotion during radiotherapy. At 0, 30, and 50 Gy, acute skin toxicity was scored with a modified RTOG scoring system. The patients' content with the skin care and the technical assistants' content with the skin marks were recorded. RESULTS: For single aspects of toxicity and their sums in defined skin areas, no differences in median and range between study groups were found. The maximal toxicity anywhere in the breast averaged in a moderate erythema, mild elevation of skin temperature, no desquamation in both groups. Mild itchiness and sporadic efflorescences were more frequently seen with Thêta-Cream. According to a ranking of anonymized breast photos at 50 Gy by independent investigators, side effects were equal. Patients' content was high with both skin care regimens (1.25 on a scale from 0 to 10). With Thêta-Cream a trend toward worse skin marks was noted. Adverse events exclusively occurred in Thêta-Cream users: suspected allergic reaction once, and the necessity for resimulation twice. CONCLUSION: In direct comparison with dexpanthenol-containing lotion, no advantage for Thêta-Cream was found. Higher costs and problems with skin marks prevent a general recommendation.

Administration, Topical↗

PubMed1988

Development, validation and application of computer-linked knowledge questionnaires in diabetes education.

Multiple choice questionnaires (MCQs) capable of being marked manually or by a newly developed optical mark reader, or by use of an inexpensive inter-active microcomputer system have been developed for the separate assessment of insulin-dependent and non-insulin-dependent patient knowledge. Forty-six insulin-related and non-insulin-related multiple choice questions covering six main areas of knowledge were constructed for inclusion into draft questionnaires. From the responses of a total of 180 completed questionnaires, piloted in 18 randomly selected clinics in 14 Regional Health Authorities in England, psychometric analysis was performed to determine reliability, discrimination coefficients, and facility indices. Seventy-three per cent of insulin-dependent diabetic patients (IDDM) and 92% of non-insulin-dependent diabetic patients (NIDDM) MCQ correct options had facility indices within the acceptable range of 30 to 90%. 82% IDDM and 93% NIDDM correct options had discrimination coefficients exceeding 0.2. Questionnaire reliability (internal consistency) using the Kudor-Richardson (KR20) formula was IDDM 0.87 and NIDDM 0.82. Evidence in support of the IDDM questionnaire's criterion validity was based on significant differences (p less than 0.05) identified between a number of knowledge area scores stratified according to HbA1 levels. Prescriptive correction for screen display and automatic hard copy feedback was designed for both incorrect and omitted question options, providing both educational (patient) and analytical (clinic) documentation. Both technical and psychometric properties of these knowledge assessment instruments should be acceptable for diabetic knowledge evaluation and instruction.

Diabetes Mellitus, Type 1↗

PubMed2001

Evolutionary engineering of industrially important microbial phenotypes.

The tremendous complexity of dynamic interactions in cellular systems often impedes practical applications of metabolic engineering that are largely based on available molecular or functional knowledge. In contrast, evolutionary engineering follows nature's 'engineering' principle by variation and selection. Thus, it is a complementary strategy that offers compelling scientific and applied advantages for strain development and process optimization, provided a desired phenotype is amenable to direct or indirect selection. In addition to simple empirical strain development by random mutation and direct selection on plates, evolutionary engineering also encompasses recombination and continuous evolution of large populations over many generations. Two distinct evolutionary engineering applications are likely to gain more relevance in the future: first, as an integral component in metabolic engineering of strains with improved phenotypes, and second, to elucidate the molecular basis of desired phenotypes for subsequent transfer to other hosts. The latter will profit from the broader availability of recently developed methodologies for global response analysis at the genetic and metabolic level. These methodologies facilitate identification of the molecular basis of evolved phenotypes. It is anticipated that, together with novel analytical techniques, bioinformatics, and computer modeling of cellular functions and activities, evolutionary engineering is likely to find its place in the metabolic engineer's toolbox for research and strain development. This review presents evolutionary engineering of whole cells as an emerging methodology that draws on the latest advances from a wide range of scientific and technical disciplines.

Biological Evolution↗