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Results for “Randomized Response Technic”

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PubMed2003

Effect of education level on outcome of patients treated on Radiation Therapy Oncology Group Protocol 90-03.

BACKGROUND: It has been hypothesized that people in lower socioeconomic groups have worse outcomes because they present with advanced-stage cancers or receive inadequate treatment. The authors investigated this hypothesis by using education level as a proxy for socioeconomic status in patients treated on Radiation Therapy Oncology Group (RTOG) Protocol 90-03. METHODS: RTOG 90-03 was a Phase III randomized trial investigating four different radiation fractionation schedules in the treatment of locally advanced head and neck carcinomas. Overall survival and locoregional control rates were analyzed by education level as measured by patient response on the demographic form at study entry. RESULTS: A significant difference was observed in the distribution of patients by education level between the standard fractionated radiation treatment arm and the hyperfractionated radiation treatment arm. More patients in the standard fractionated treatment arm had a higher education level (P = 0.018). Patients attending college had highly and significantly better overall survival and locoregional control than the other groups combined (P = 0.0056 and P = 0.025, respectively: from Cox proportional hazards models stratified by assigned treatment with educational level, T classification, N classification, Karnofsky performance status, primary site, and race). Multivariate analysis revealed that education level was significant for predicting both overall survival and locoregional control when comparing attended college/technical school compared with all other education levels. CONCLUSIONS: Patients attending college or technical school had improved overall survival and locoregional control. These differences cannot be explained by differences in tumor stage or treatment. Poorer overall health or lack of support systems contributing to these results needs to be investigated further.

Adult↗

PubMedDate not supplied

Evaluation of an automated wavelet-based system dedicated to the detection of clustered microcalcifications in digital mammograms.

Mammographic screening programs are delivering reductions in breast cancer mortality. However, breast cancer screening will be cost effective and will provide a real profit only when both high sensitivity and specificity levels are reached. To date, due to human or technical factors, a significant number of breast cancers are still missed or misinterpreted on the mammograms. Computer methodologies, developed to assist radiologists, could represent further amelioration by increasing diagnostic accuracy in the screening programs. We have tested a computerized scheme to detect clustered microcalcifications in digital mammograms, employing 360 mammograms that were randomly selected from the mammographic screening program, currently undergoing at the Galicia Community (Spain). After the digitization process, the breast border was initially determined. A wavelet-based algorithm was employed to detect the clusters of microcalcifications. The performance of the automated system over the test set was evaluated employing Free-response Receiver Operating Characteristic (FROC) methodology. The sensitivity achieved was 74% at a false positive detection rate of 1.83. The corresponding area under the Alternative FROC (AFROC) curve was A1=0.667 +/-0.09.

Algorithms↗

PubMed2004

Assessing the impact of change in the organization of a technical support system for a health information systems (HIS).

OBJECTIVE: Evaluate the impact of the implementation of a new model of Help Desk and technical support in HIS users of the hospital. We carried an anonymous survey on a random sample of 150 users of the new system. The administrative staff (A), doctors (D) and nurses (N) were analysed by strata. We assessed the accessibility both to phone calls and through the institutional intranet; the understanding of the problems; the time taken to fully answer requests; and the degree of satisfaction concerning the change. The results showed that 94%, gained access through the intranet and that it was very satisfactory for the medical group (D80% vs A34% vs N8.7%). The different kinds of users were satisfied with the response time, above all the administrative stratum (A42% vs D38% vs N14%). All of them commented on their satisfaction with the change, above all, the doctors (D68% vs A46% vs N22%), who before this new implementation had expressed dissatisfaction with the old system. CONCLUSIONS: operational changes in the Help Desk contributed to improve how the service was perceived by its users; nevertheless both doctors and nurses required even faster response time.

Computer Communication Networks↗

PubMed2004

Cigarette smoking behavior among male secondary school students in the Central region of Saudi Arabia.

OBJECTIVE: This study was conducted to examine the smoking habits among male secondary school students in Al-Qassim, Kingdom of Saudi Arabia (KSA) and to assess their knowledge and attitudes towards smoking. METHODS: This cross-sectional study was conducted in Al-Qassim region, KSA during March 2003. Randomly selected was 14 out of 110 government male secondary schools. In the sample section, care was taken to represent urban and rural communities. In urban areas, 8 schools with the largest number of students were selected. This is in addition to 3 schools, which were the only schools with special education on Islamic, Commercial and Technical programs. In the rural areas the 3 most distant schools were included in the sample. Data were obtained through self-administered questionnaires that contained questions on personal background, smoking behavior, knowledge and attitude towards cigarette smoking. A total of 2203 students responded to the questionnaires with 83% response rate. RESULTS: Of the studied group, 606 (29.8%) were current smokers and among these 83.7% started smoking at the age of 15 years or less. Technical and commercial secondary school students had higher prevalence of the habit of smoking than those in general and Islamic secondary schools. It was found that the more pocket money received by the students, the higher was the prevalence of smoking. The most common reason given for cigarette smoking behavior (CSB) was the influence of friends (63.5%). Family factor, especially the brother's smoking habit (24.8%) was also important. Most of the students knew that smoking is harmful to their own health (89.3%), and to others (73.9%). The association between smoking and lung cancer was 84.3%, 80.9% for chest disease and 78.2% for heart disease, while the relation to other diseases was less known. CONCLUSION: We conclude that onset of smoking in the young is alarming. This is of immense importance in formulating health education strategies, which should be directed towards pupils, teachers and parents. The religious aspect should also be an integral part of such programs.

Adolescent↗

PubMed2000

[Assessment of the comprehension of new rephrasing drug package inserts].

BACKGROUND: The information included in drug package inserts is often difficult for users to understand. The impact of rephrasing inserts on comprehension was assessed. SUBJECTS AND METHOD: A community double-blind clinical trial was undertaken with random allocation of subjects to unmodified or modified inserts, in which presentation and structure had been improved and technical content expressed in plain language. A questionnaire on comprehension of the use of four common drugs was administered to all participants. The following aspects were analyzed: indications, interval of administration, administration in relation to meals, contraindications, storage and what to do in cases of missing a dose or improvement in symptoms. RESULTS: 1,560 participants were included, among whom 770 randomly received the unmodified inserts. The mean proportion of correct answers was 45.7% in the unmodified insert group and 75.5% among those who received the modified version. In all groups of age, study level and employment status, participants with modified texts achieved a higher correct response rate than the unmodified group. An improvement > 73% in the correct response rate was observed in interval of administration, administration in relation to meals and what to do in cases of missing a dose. With the modified leaflet the odds ratio of successfully answering more than 70% of questions was 13.5 (95% confidence interval, 10.5-17.5) compared with the unmodified leaflet. CONCLUSIONS: The comprehension of drug package inserts may be considerably improved by making simple changes in their content. These changes may contribute to accident prevention or inappropriate use of commonly prescribed drugs.

Adolescent↗

PubMed2001

Methodological issues for vital rates and population estimates: 1997 OMB standards for data on race and ethnicity.

A workshop in July 2000 explored research needed to address methodological challenges for population estimates and vital rates arising from the revision of the standards for Federal data on race and ethnicity; the use of different standards for Census 2000 and vital records during the implementation of the revised standards; and underlying differences in the collection of race and ethnicity data in censuses and surveys and in vital records. Matching studies were proposed to compare race and ethnicity reports in vital records and in Census 2000 or survey responses. Work on vital records might include exploring enhanced collection of race and ethnicity data and documenting State vital statistics reporting mandates and practices. Key work on sources of error includes identifying, quantifying, and reporting on bias and random errors related to race and ethnicity in population estimates and vital rates. Also needed are comparisons of Census Bureau and State population estimates and more frequent tests of the accuracy of population estimates and projections. Studies on racial and ethnic identity were proposed to examine changes in reporting over time and to explore origins of racial and ethnic identities. More information on these issues should be developed for technical and nontechnical audiences.

Data Collection↗

PubMed1987

The protective effect of hepatic dysfunction on vascularized allograft survival.

Recent studies have demonstrated that hepatic dysfunction, induced by experimental biliary ligation (EBL), impairs lymphocytic responsiveness to PHA stimulation in vitro and to cellular antigens in vivo. This suppression appears to be selective for T-cell mechanisms while B-cell-mediated functions remain intact. The purpose of this study was to determine whether coexisting hepatic insufficiency could exert a protective effect on vascularized or nonvascularized allograft survival in the transplanted recipient. Female Wistar-Furth (Rtlw) 225 g rats were assigned randomly to three groups: EBL, sham operation (Sham) and normal control (NC). Fourteen days following operation animals received heterotopic cardiac or skin allografts from Buffalo (Rtlb) donors. Cardiac and skin graft survival was determined daily, rejection was confirmed histologically, and technical failures were omitted from analysis. Allograft survival was expressed as median survival time +/- SEM. Serum total bilirubin (mean +/- SEM) was significantly elevated at Day 14 in EBL animals compared to Sham and NC groups (15.1 +/- 1.0 vs 0.1 +/- 0 and 0.2 +/- 0.1 mg/dl, respectively, P less than 0.01). Median cardiac allograft survival time by Probit was 10.6 +/- 2.6 vs 5.6 +/- 0.7 and 6.0 +/- 0.9 days, respectively (P less than 0.03). Skin graft survival (mean and range) was similar in all groups. These results demonstrate that EBL in the rat suppresses T-cell function and significantly prolongs vascularized allograft survival, but not skin allograft survival across the Rtl histocompatibility barrier. The mechanism whereby coexisting hepatic dysfunction exerts a protective effect on vascularized allograft survival warrants further investigation.

Animals↗

PubMed2000

Access to employment for people with disabilities: findings of a consumer-led project.

PURPOSE: A consumer led initiative which aimed to gather information from local employers and disabled people which might inform future action to improve work opportunities for disabled people. METHOD: (1) A survey of 500 companies with more than 20 employees randomly sampled from 4 locations across Suffolk was undertaken. The survey generated both numerical and verbal data. Response rate was low (25%) but achieved a reasonable spread of organizations in terms of size, type of industry and geographical location. (2) Semi-structured interviews were carried out with nine disabled people. Open-ended questions were used to elicit information about the nature of their disability, experiences of education and experiences of seeking and/or maintaining work. RESULTS: 43% of respondents had one or more disabled employees. Evidence of obstacles to employment included a lack of understanding about the capability of disabled people, lack of knowledge about financial and technical assistance and undifferentiated approaches to access and accommodation. Interview data supported the importance of paid employment to self esteem and quality of life and showed high levels of frustration in their search for work. CONCLUSIONS: This study demonstrates the need for better interagency communication and a more effective information distribution strategy for employers, particularly in relation to the availability of systems of support and the capability of disabled employees.

Attitude to Health↗

PubMed2002

The effects of inhaled albuterol and salmeterol in 2- to 5-year-old asthmatic children as measured by impulse oscillometry.

The functional assessment of the response to bronchodilators in 2- to 5-year-old asthmatic children is technically difficult. For this reason, there have been no reports on the effects of long-acting bronchodilators, such as salmeterol, in this age group. Of the several techniques available for measuring resistance to airflow, forced oscillation remains the most adaptable to young children and the most practical for research and clinical use. In this stud we used the Jaeger MasterScreen Impulse Oscillometry System to assess the response of 2 to 5 year-old asthmatic children to an inhaled long-acting bronchodilator, salmeterol, by comparing it to the effect of a standard dose of the short-acting bronchodilator, albuterol. We performed a placebo-controlled, randomized, crossover study in 10 children aged 2 to 5 years who had a history of physician-diagnosed asthma and who were not on regular controller therapy. At weekly intervals after baseline measurements of reversibility, each child received two inhalations from an albuterol metered-dose inhaler (MDI) with a spacer (200 microg), or placebo MDI with spacer, or two inhalations from a salmeterol MDI (50 microg), or 50 microg from a salmeterol Diskus. Measurements were obtained at 5, 30, 60, 360, and 540 min, the last time interval only on the salmeterol days. Based on previous studies, total respiratory system reactance at 5 Hz (X5), calculated by the MasterScreen computer from mouth pressure and flow data, was used as the primary efficacy variable. The mean intra-individual variability in X5 was 10.5% (range 3.6% to 17.9%). The mean (SE) changes from baseline X5 at each time point were as follows: for placebo, 9.6 (3.0), 10.1 (2.6), 5.1 (2.9), 6.1 (3.5), p=0.36 vs. baseline; after treatment with albuterol, 32.7 (3.8), 53.9 (1.2), 47.3 (5.4), 18.1 (5.8), p<0.01 vs. baseline at all time points; after salmeterol MDI, 16 (6.4), 28.9 (5.2), 32.7 (3.9), 34.6 (4.4), 31.2 (4.8), p<0.05 at 60, 360, and 540 min; and after salmeterol Diskus, 16.4 (4.0), 16.9 (6.6), 27.8 (5.9), 28.6 (5.6), 33.8 (4.0), p<0.05 at 540 min. No significant adverse events or electrocardiographic changes were noted at any time. Impulse oscillometry is an acceptable method of assessing airway responses to bronchoactive drugs in this age group. Compared to albuterol and to its effect in older children and adults, the response to salmeterol Diskus appears to be somewhat blunted in this age group. The MasterScreen system is well suitedfor pharmacodynamic studies and clinical investigations in pre-school-aged children.

Administration, Inhalation↗

PubMed2004

Electrical nerve localization: effects of cutaneous electrode placement and duration of the stimulus on motor response.

BACKGROUND: Recommendations regarding the technical aspects of nerve stimulator-assisted nerve localization are conflicting. The objectives of this study were to determine whether the placement of the cutaneous electrode affects nerve stimulation and to determine the duration and intensity of an electrical stimulus that allows nerve stimulation with minimal discomfort. METHODS: Ten healthy volunteers underwent an interscalene and a femoral nerve block. After obtaining a clearly visible motor response of the biceps (interscalene) and quadriceps (femoral) muscles at the minimal current (0.1 ms, 2 Hz), the position of the cutaneous electrode was varied. Next, the duration of the stimulating current was set at 0.05, 0.1, 0.3, 0.5, or 1.0 ms, in random order. Intensity of the motor response and discomfort on stimulation were recorded. RESULTS: The minimal current at which a visible motor response was obtained was 0.32 +/- 0.1 mA (0.23-0.38 mA) for the inter-scalene block and 0.29 +/- 0.1 mA (0.15-0.4 mA) for the femoral block. Changing the position of the return electrodes did not result in any change in the grade of the motor response or in the current required to maintain it. Currents of longer duration caused discomfort and more forceful contraction at a lower current intensity as compared with currents of shorter duration (P < 0.01). When the current was adjusted to maintain the same visible motor response, there was no significant discomfort among studied current durations. CONCLUSION: Site of placement of the cutaneous electrode is not important when constant current nerve stimulators are used during nerve localization in regional anesthesia. There is an inverse relation between the current required to obtain a visible motor response and current duration. Selecting a current duration between 0.05 and 1.0 ms to specifically stimulate sensory or motor components of a mixed nerve does not seem to be important in clinical practice.

Adult↗

PubMed1999

[Evidence-based medicine in antimicrobial surgical prophylaxis].

INTRODUCTION: The main objective of antibiotic prophylaxis in surgery is to reduce morbidity and mortality associated with wound infection, which has a favorable impact on quality of care and overall health-care costs. The bases of antibiotic prophylaxis have been known for decades, but the appearance of new pharmacological agents, alternative routes of administration, modern surgical procedures, and previously unknown antimicrobial resistances involve the need for reviewing these bases. OBJECTIVE: To re-evaluate some of the general principles of the use of antibiotic prophylaxis in surgery and highlight the quality of the evidence supporting our clinical decisions found in the literature. METHOD: Review of the literature with special attention to prospective, randomized, evidence-based clinical trials on the need for antibiotic prophylaxis in surgery, mainly general surgery. RESULTS: The method for demonstrating the effectiveness of an antibiotic in prophylaxis continues to be the prospective, randomized clinical trial. Evidence of the need for antibiotic prophylaxis in clean-contaminated surgery and when prosthetic materials are used is good. CONCLUSIONS: Most studies on the general principles of prophylaxis have been carried out in general surgery and it is difficult to extrapolate their results to other fields or surgical specialties. Therefore, new clinical trials in each specialty are needed to establish specific recommendations. However, the standardization of aseptic, antiseptic, and technical procedures in surgery has produced a notable decrease in the wound infection rate compared to historical controls, so now it is difficult to demonstrate significant differences in the results of clinical trials. Finally, the response to the fundamental question of "What do we propose to prevent and to what degree?" with which the antibiotic era began is either difficult to formulate or described ambiguously when referring to advanced procedures, such as endoprostheses, endoscopic retrograde cholangiography, or dental implants.

Abdominal Injuries↗

PubMed1974

A followup report of a prospective evaluation of vagotomy-pyloroplasty and vagotomy-antrectomy for treatment of duodenal ulcer.

A prospective randomized study of 200 consecutive patients who required elective operation for treatment of duodenal ulcer was conducted. Truncal vagotomy and drainage (V-D) was done in 108 patients with a 2% mortality and truncal vagotomy and antrectomy (V-R) were performed in 92 patients with no mortality. Ninety-four per cent of these patients were followed 5-8 years after operation or until their death if that preceded the termination of the study. The immediate postoperative morbidity including stomal dysfunction and reoperation was greater after V-D than after V-R. In the opinion of the patients and independent investigators, the number of gastrointestinal complaints was similar throughout the study for the two groups of patients. In the opinion of the author, however, more gastrointestinal complaints occurred in patients from the V-R group than from the V-D group. Because of the subjectivity involved in the evaluation of these complaints, it is unknown whether a real difference existed between the two groups of patients. No patient in either group was symptomatically disabled after operation. There were nine recurrent ulcers requiring reoperation after V-D and one after V-R. The insulin test was positive in 58% of patients after V-D and 14% after V-R. These figures were essentially unchanged from those in the first report made three to five years after operation. The basal acid output and the response to histalog stimulation also remained unchanged in the two groups of patients during the same period. This study suggests that if one abstains from resection in patients where technical difficulties with the duodenum can be expected, V-R can be performed in the remaining patients with a mortality rate equally as low as that usually reported for V-D. It is concluded that V-R is superior to V-D for the majority of patients because it is associated with fewer recurrent ulcers without a significant difference in the severity of other postoperative gastrointestinal complaints.

Body Weight↗

PubMed1985

Review of clinical results of fast neutron therapy in the USA.

Fast neutron radiotherapy in the United States is entering a new era in which dedicated hospital-based generators with isocentric beam capability are replacing treatment facilities based on fixed beams extracted from physics accelerators. All available clinical data, however, come from the older facilities. The majority of randomized trials conducted in the U.S. have used neutrons in a mixed schedule with photons, in which the aim was to deliver two-fifths of the total dose with neutrons; the neutron dose per fraction was set as the estimated equivalent of 2 Gy photons in terms of late normal tissue injury. Overall treatment time was held constant compared with the control photon therapy regimens (usually six to eight weeks). Random studies of this type showed no evidence of a therapeutic gain in the treatment of advanced primary carcinomas of the head and neck, lung, uterine cervix, or pancreas. A statistically significant benefit in favor of the mixed schedule is presently apparent for local control and survival in patients with advanced prostate cancer, and for clearance of neck nodes in patients with advanced squamous carcinoma of the head and neck. Based on encouraging results in a pilot study of mixed scheduled irradiation preoperatively for bladder cancer, a random study was begun in 1981, but too few cases have been accrued for analysis. Other randomized trials comparing protracted neutron only regimens with photon therapy have been conducted. These were negative for lung and pancreatic cancer, but a suggestion of a therapeutic gain (with small patient numbers) has been observed for treatment of inoperable salivary gland tumors and advanced squamous carcinomas of the head and neck. Two large randomized studies of various neutron doses delivered as a boost to high grade astrocytomas after or concurrently with photon irradiation have failed to define any therapeutic window between tumor destruction and brain necrosis. Based on a reassessment of all the available clinical and radiobiological data, and taking advantage of the greater technical flexibility offered by hospital-based facilities, the strategy of fast neutron therapy for future trials has been changed. In these trials neutrons are being used in a twelve fraction, four week regimen to treat gross disease, with elective therapy being given wherever possible using low LET irradiation. Concomitantly, research is proceeding to define predictors of tumor response to high LET radiations in order to better select patients for fast neutron radiotherapy.

Fast Neutrons↗

PubMed1990

[Insuject-X for children. A clinical trial of the NPH insulin pen].

The use of Insuject-X for NPH insulin was tested by 21 children, age less than or equal to 10 years with insulin dependent diabetes mellitus less than or equal to 1 year, on conventional treatment with NPH insulin once or twice daily. After a preliminary period of one month the syringe injection regimen was changed to injections by Insuject-X for a four-month "pen" period. We observed no significant changes in metabolic control. The mean potency of NPH insulin in partly used cartridges was 103.6 +/- 5.6 IU/ml (range 91.0-118.1, n = 39) with no correlation to the residual volume or days of use. Measurements over 110 IU/ml were seen at the end of the study indicating the need of repeated instruction in use of the pen by children. No microbial contamination of the cartridges, nor any local reactions at injection sites were found. We observed more technical problems than in adult studies indicating that children handle the pen more roughly. The accept of Insuject-X was good as a more convenient means of injecting. All of the children preferred to continue using it.

Adolescent↗

PubMed1987

A controlled experiment in teaching students to respond to patients' emotional concerns.

Medical education faces increasing criticism because of the perception that it is difficult to produce physicians who are both technically competent and compassionate. One approach to addressing this problem is to train physicians to address the emotional concerns that patients experience as a result of their medical problems. Results of the authors' randomized, controlled experiment in training medical students to respond to patients' emotional concerns provide evidence of the efficacy and feasibility of such training. Only students who received small-group instruction in addition to large-group lectures exhibited statistically significant (p less than .001) improvement in their ability to respond to the emotional concerns of patients in hypothetical cases. The students who received only the lectures exhibited significant improvement (p less than .001) in their preference for responses that addressed patients' emotional concerns but not in their responses to written, hypothetical patient cases. Even though these students' preferences for responses to emotional concerns on the average did increase significantly, the preferences were significantly (p less than .001) less favorable than the preferences of the students who received small-group instruction. The small group instruction consisted of both interviews with elderly nursing home residents, who served as simulated patients, and structured practice and review sessions.

Clinical Competence↗

PubMed1994

Haemolyzed samples: responsibility of short catheters.

The haemolysis of blood samples is a source of error in the electrolytic and enzymatic determination in clinical biochemistry. This circumstance seems dependent on the material used for the venepuncture. In this study we compared three kinds of material in 350 patients who were sampled in the emergency department. This randomized study compared the haemolysis of blood samples collected with stainless steel needles and short catheters, either Teflon FEP (Cathlon Critikon) or polyurethane Vialon (Insyte Becton-Dickinson). Quantification of hemolysis was performed by assay of the optical density of plasma haemoglobin. Results were analysed, after verification of the randomization, by one-way analysis of variance by ranks. This study demonstrated a highly significant relation between occurrence of haemolysis and the sampling material, used according to its technical obligations. Haemolysis occurred frequently when short catheters were used in 42% and 55% of cases with the Teflon and Vialon catheters, respectively. Haemolysis was much less frequent with stainless steel needles (12%). This difference was even more marked for haemoglobin levels above 1.5 milligrams of plasma, where the incidence was 4.2%, 9% and 30%, respectively, for the stainless steel needles, the Teflon catheter and the Vialon catheter. This study induced our emergency department to take more blood samples with a needle, even if an infusion was to be given subsequently, or to take them using a Teflon catheter.

Adolescent↗

PubMed2000

[Reliability of the response rate in oncology: analysis of the causes for variation].

We evaluated the impact of an evaluation committee (EC) on patients' overall response status in a large multicenter trial in oncology. We identified reasons for disagreements between investigators and the EC. The Cancer Renal Cytokine (CRECY) study was a French multicenter trial that tested cytokine therapy in 489 patients with metastatic renal cell carcinoma. Objective response (OR) evaluation included medical imaging and was studied according to international guidelines. A blinded peer review of all responders and litigious cases was performed by an EC. Major disagreements occurred in 43% and minor disagreements in 10.5% of the reviewed files. The number of significant tumor responses was reduced by 23.2% after review by the EC. Reasons for disagreements included errors in tumor measurements, errors in selection of measurable targets, intercurrent diseases, and radiologic technical problems. These reasons for disagreements are analyzed and discussed. We conclude that all therapeutic trial results should be reviewed by peer analysis of all presumed responders by an EC. International guidelines for response evaluation should be updated by including more reliable methods of measurements and definition of minimal imaging procedures.

Antineoplastic Agents↗

PubMed2003

Design, methods, and evaluation directions of a multi-access service for the management of diabetes mellitus patients.

Recent advances in information and communication technology allow the design and testing of new models of diabetes management, which are able to provide assistance to patients regardless of their distance from the health care providers. The M2DM project, funded by the European Commission, has the specific aim to investigate the potential of novel telemedicine services in diabetes management. A multi-access system based on the integration of Web access, telephone access through interactive voice response systems, and the use of palmtops and smart modems for data downloading has been implemented. The system is based on a technological platform that allows a tight integration between the access modalities through a middle layer called the multi-access organizer. Particular attention has been devoted to the design of the evaluation scheme for the system: A randomized controlled study has been defined, with clinical, organizational, economic, usability, and users' satisfaction outcomes. The evaluation of the system started in January 2002. The system is currently used by 67 patients and seven health care providers in five medical centers across Europe. After 6 months of usage of the system no major technical problems have been encountered, and the majority of patients are using the Web and data downloading modalities with a satisfactory frequency. From a clinical viewpoint, the hemoglobin A1c (HbA1c) of both active patients and controls decreased, and the variance of HbA1c in active patients is significantly lower than the control ones. The M2DM system allows for the implementation of an easy-to-use, user-tailored telemedicine system for diabetes management. The first clinical results are encouraging and seem to substantiate the hypothesis of its clinical effectiveness.

Diabetes Mellitus↗