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Biomedical subjects

J Hasford

Publications and source records attributed to J Hasford.

At least 37 records · Page 2Linked to original sources
PubMed2003

A prospective randomized comparison of unsedated ultrathin versus standard esophagogastroduodenoscopy in routine outpatient gastroenterology practice: does it work better through the nose?

BACKGROUND AND STUDY AIMS: In an outpatient gastroenterological practice setting, highly effective diagnostic procedures and patient satisfaction play an important role. Ultrathin endoscopy in unsedated patients has been shown to be more cost-effective and time-efficient in comparison with standard endoscopy. A prospective randomized study was carried out in unsedated patients to compare performance, feasibility, safety, and patient tolerance between ultrathin transnasal (UT), ultrathin oral (UO), and standard (SO) esophagogastroduodenoscopy (EGD). PATIENTS AND METHODS: A total of 200 of 600 eligible patients consented to participate in the study, and were randomly assigned to undergo UT, UO, or SO. Patients reported their tolerance of the procedure (anxiety, pain, gagging, and overall satisfaction; Likert scale 1-10), and the endoscopists reported the effectiveness of the procedure (handling, picture quality, and overall performance; Likert scale 1-10). Statistics were calculated using the Kruskal-Wallis test. RESULTS: After randomization, 65, 67, and 68 patients were allocated to the UT, UO, and SO groups, respectively. Failure to achieve complete EGD by the intended route occurred in 14 patients (22 %) in the UT group. Compared to the SO group, patients in the UT and UO groups rated anxiety before the procedure as being more intense - median score (10 % quantile estimate; 90 % quantile estimate): UT, 2.0 (1.0; 4.0); UO, 2.0 (1.0; 4.0); SO, 0.0 (0.0; 2.0); p < 0.0001), whereas SO patients experienced a higher level of anxiety during the procedure ( P < 0.0001). Pain during insertion of the endoscope was the least intense in the UO group: UT, 2.0 (1.0; 5.0); UO, 1.0 (1.0; 3.0); SO, 2.0 (1.0; 4.0); P < 0.001). Gagging during insertion was more pronounced in the UO group: UT, 2.0 (1.0; 4.0); UO, 3.0 (1.0; 7.0); SO, 2.0 (1.0; 5.0); P < 0.01). The patients' score for the overall assessment was better in the SO group ( P < 0.0001). The endoscopists' overall assessment for ultrathin EGD was poorer than for standard EGD: UT, 3.0 (2.0; 5.0); UO, 3.0 (2.0; 5.0); SO, 2.0 (1.0; 3.0); P < 0.0001). CONCLUSIONS: Ultrathin endoscopy through both the transnasal and oral routes has limited use in routine outpatient practice. Techniques for reducing pain and gagging may improve patient tolerance. Further technical improvements are needed to allow routine implementation.

Adult↗
PubMed2002

[Knowledge and attitude of the general public regarding symptoms, etiology and possible treatments of depressive illnesses].

Within the German research network on depression, the Nuremberg Alliance against Depression aims at informing the public about depressive illness and preventing suicidality by carrying out a city-wide information campaign. Before the prevention program started, public attitudes and knowledge had been assessed in a public opinion survey in Nuremberg and in a control region. A total of 1426 randomly chosen inhabitants of Nuremberg and Würzburg completed a computer-assisted telephone interview during November and December 2000. They were asked about their knowledge and attitudes towards symptoms, causes, and treatment of depression. No relevant differences between Nuremberg and Würzburg were found. Depression is regarded as a serious illness. People seemed to be more knowledgeable as compared to the results of earlier surveys, but there are still important information deficits. This is especially true for males over 60, who show unfavorable attitudes. Eighty percent of the population consider antidepressants to be addictive, and 69% were convinced that the use of antidepressants would lead to personality changes. Future information campaigns should aim at describing depression as an often chronic disease similar to hypertonia or diabetes. Public knowledge about antidepressants must be improved.

Adult↗
PubMed2002

Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions.

The spontaneous reporting system (srs) is the most important early warning system of adverse drug reactions. As there is serious under-reporting we studied the respective knowledge and attitudes of two samples of physicians in Germany. Five hundred randomly sampled physicians and 815 physicians who had actually reported an ADR were included; the response rate to the mail questionnaire was 51.4 and 43.9%, respectively; 61.3% said to have reported at least one case in their life. As many as 75-85% of physicians said never to have sent an ADR report to the governmental or professional reporting systems. Reporting to pharmaceutical companies, on the other hand, has been substantially better. Sixty-eight and two-tenths percent indicated to have suspected an ADR without reporting it. Major reasons for not reporting were: ADR well known (75.6%), too trivial (71.1%), causality uncertain (66.3%). The ADR with the highest probability of being reported were serious unknown adverse reactions of a new drug (81.1%) or an established drug (72.9%) and serious known reactions to a new drug (65.2%). Almost 20% of the physicians admitted to not know the spontaneous reporting system and 30% to not know how to report; 54% would rather report an ADR if therapeutic advice was offered. The results indicate that the traditional ways of advertising the srs and communicating with physicians could be improved. Proactive services and professional marketing of srs are needed to reduce underreporting.

Adult↗
PubMed2002

A population-based European cohort study of persistence in newly diagnosed hypertensive patients.

This study assessed the percentage of patients after 1 year who persisted on initially prescribed antihypertensive therapy. Medical records of 2416 patients with newly diagnosed hypertension who were prescribed initial antihypertensive monotherapy by general practitioners in Germany, France, and the United Kingdom were evaluated. Comparisons were made among the angiotensin II receptor antagonist (AIIRA) irbesartan, all other antihypertensive classes (including AIIRAs other than irbesartan), and the AIIRA losartan. Patients initiated on the AIIRA irbesartan scored highest with a persistence rate of 60.8%, followed by patients who received all other AIIRA agents with a persistence rate of 51.3%. Angiotensin-converting enzyme inhibitors, calcium channel blockers, beta-blockers, and losartan were associated with comparable persistence rates, between 42.0% and 49.7%. Patients who received diuretics scored lowest with a persistence rate of 34.4%. Persistence has emerged as an essential factor for blood pressure control. Prescribing an antihypertensive agent that provides a favourable efficacy and tolerability profile may provide greater persistence with therapy and hence a higher level of blood pressure control.

Adrenergic beta-Antagonists↗
PubMed2001

Chronic myeloid leukemia and interferon-alpha: a study of complete cytogenetic responders.

Achieving a complete cytogenetic response (CCgR) is a major target in the treatment of chronic myeloid leukemia (CML) with interferon-alpha (IFN-alpha), but CCgRs are rare. The mean CCgR rate is 13%, in a range of 5% to 33%. A collaborative study of 9 European Union countries has led to the collection of data on 317 patients who were first seen between 1983 and 1997 and achieved CCgRs with IFN-alpha alone or in combination with hydroxyurea. The median time to first CCgR was 19 months (95% CI, 17-21; range, 3-84 months). At last contact, 212 patients were still alive and in continuous CCgR; 105 patients had lost CCgR, but 53% of them were still alive and in chronic phase. IFN-alpha treatment was discontinued permanently in 23 cases for response loss, in 36 cases for chronic toxicity (15 are still in unmaintained continuous CCgR), and in 8 cases because it was believed that treatment was no longer necessary (7 of these 8 patients are still in unmaintained continuous CCgR). The 10-year survival rate from first CCgR is 72% (95% CI, 62%-82%) and is related to the risk profile. High-risk patients lost CCgR more frequently and more rapidly and none survived more than 10 years. Low-risk patients survived much longer (10-year survival probability 89% for Sokal low risk and 81% for Euro low risk). These data point out that a substantial long-term survival in CCgRs is restricted mainly to low-risk and possibly intermediate-risk patients and occurs significantly less often in high-risk patients.

Adult↗
PubMed2001

First results from an intensified monitoring system to estimate drug related hospital admissions.

AIMS: An intensified monitoring system was set up to identify drug related hospital admissions and estimate population-based incidences for commonly prescribed medications. METHODS: Pharmacovigilance-centres systematically screened nonelective admissions to emergency rooms or departments of internal medicine for drug related hospitalizations (DRH). Clinical pharmacologists used standardized causality assessment. Service areas of each acute care hospital were defined by 5 digit postal codes that covered 60% of all admissions. Drug dispensing information was available through claims processed by regional pharmacy computing centres. Quarterly incidences were estimated by dividing the number of events by the number of treated patients. RESULTS: 435 DRHs were reported during five quarters. The incidence of ADRs leading to admissions varied for specific drug groups from 1.5/10 000 treated patients to 24/10 000. Quarterly variation of incidences was moderate except for insulin and calcium antagonists. 95% confidence intervals overlap for all quarters within each group. Incidences are sensitive to changes in the definition of the source population. CONCLUSIONS: Our pharmacovigilance monitoring system allows comparisons of population-based incidences of drug-related hospitalizations among drugs and over time. It provides important information for risk management and monitoring outcomes of pharmaceutical quality management programmes.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

Adverse drug reaction monitoring--digitoxin overdosage in the elderly.

Drug-related illness is an everlasting universal problem and also an important cause of admissions to hospitals. Adverse reactions are still grossly underreported by medical professions. Little information is available regarding the frequency or type of ADRs managed in hospitals. Since January 1997, we have taken part in a study, supported by the German Federal Institute for Drugs and Medical Device to improve the spontaneous drug information reporting system in Germany. Three German regionalized Departments of Clinical Pharmacology--Jena, Dresden, Rostock--serve as Pharmacovigilance Centers in collaboration with the Pharmacoepidemiology Research Group of the University of Munich. Since January 1997, the regional group in Jena has been monitoring the University Clinic of Internal Medicine for admissions caused by adverse drug reactions. All emergency cases and patients on intensive care units were checked for adverse drug reactions. We present our results, including clinical and demographic data, concerning intoxications and especially those involving digitoxin in 210 patients with ADR. Forty patients with digitoxin toxicity had an average age of 81 years (81.1+/-6.3), a low body weight (59.7+/-12.7 kg) and 3 out of 4 were women. 75% of all patients with digitoxin side effects had elevated serum digitoxin levels with concentrations higher than 25 microg/ml. The relatively high frequency of digitoxin intoxications in our hospital may reflect the advanced age and low body weight of patients. Patients received digitoxin regardless of age, weight and, sometimes, clinical indication. Physicians should be aware of drugs having a high risk when used in elderly patients. The use of digitoxin assays and keeping serum levels within or near the therapeutic range will diminish the incidence of overdoses.

Adverse Drug Reaction Reporting Systems↗
PubMed2001

Putting the pieces together: using "off-the-shelf" software to safely transfer medical data.

We describe a new computer-based, network-driven system for administering, transferring, and evaluating reports of spontaneous adverse drug reactions and serious adverse events. The system consists of three regional centers, one coordinating center, and a central database at the national drug regulatory authority. In view of its high level of data security, reliability, easy expandability, and inexpensiveness due to the use of standard shareware products, the system can serve as a model for a clinical health information network.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

[Effect of optimized integrated management on long-term effectiveness of cardiologic rehabilitation].

BACKGROUND AND OBJECTIVE: Long-term risk factor (RF) modification after cardiac rehabilitation (CR) is less than satisfactory. Problems of communication between the CR centre and the practising physician (GP) are one potential source of sub-optimal management. The goal of the PROTECT-study was to evaluate the influence of improved communication between rehabilitation centres and the GP on the quality of RF-modification. PATIENTS AND METHODS: In 50 specialized CR centres 882 patients in the group with intensified communication were compared to 160 patients in the usual care group. All patients underwent a course of residential CR. Intensified communication was attempted by a total of four phone calls to the GP, a RF booklet in which the RF profile, the individual RF treatment goals and the current RF status were delineated. Main treatment goals with respect to RF-modification after 6 months were: Blood pressure < 140/90 mmHg, LDL-Cholesterol < 100 mg/dl or at least 115 mg/dl and a body mass index of < 25 or at least < 30. RESULTS: The percentage of of patients with adequate blood pressure control (< 140/90 mmHg) was 85.1% vs. 85%, with LDL-cholesterol < 100 mg/dl 27.2% vs. 23.9%, with good body-mass index (< 25) 32.4% vs. 28.2% (intensified communication vs. control group; p = ns). The treatment initiated by the CR centres was continued in about 90% of patients. CONCLUSION: The study has shown that improved communication between the CR centres and the GP's after CR had only a marginal effect on the quality of RF-management. One key element of secondary prevention could be to get the patient more strongly involved in reaching the targets of therapy.

Aged↗
PubMed2000

Perception of traffic accident risk and decision to drive under light alcohol consumption--a double-blind experimental study.

PURPOSE: Public traffic safety campaigns in Germany have focussed on the changing risk perception of young drivers. While there is some consensus that perceptions of risk affect driving, less is understood about the relationship and interaction of alcohol consumption and risk perception on the decision to drive. We examined the influence of light alcohol consumption on risk perception and decision to drive, and the interaction of alcohol consumption and cognitive feedback on the handicapping effect of alcohol on risk perception and decision to drive. METHOD: In a double-blind block-randomized experimental study of 104 young drivers between 19 and 24 years of age, with two experimentally manipulated independent factors of alcohol consumption (three levels: 0% BAC, 0.015% BAC, 0.03% BAC) and feedback (positive or negative), we assessed three dependent variables: perception of traffic accident risk, subjective judgement about driving-relevant cognitive performance, decision to drive a car. Analyses of variance and covariance were used to analyze differences between levels of experimental factors. RESULTS: We found that persons with 0.015 BAC performed better than persons in both other alcohol conditions on the standardized risk perception task. Perceived handicap of driving was significantly more pronounced for negative feedback compared to positive feedback with no influence of the level of alcohol consumption. No significant influence on decision to drive was found of either level of alcohol consumption, feedback or sex. IMPLICATIONS: Decision to drive in young drivers could not be influenced by feedback or light consumption. Public health approaches have to find better determining factors.

Accidents, Traffic↗
PubMed2000

Assessing the safety of drugs in pregnancy: the role of prospective cohort studies.

Since, for obvious reasons, systematic testing of the teratogenic properties of drugs in humans is not possible in the premarketing phase, the epidemiological approaches to postmarketing risk evaluation are of major importance. Cohort studies, with their prospective exposure assessment, their ability to study even exposure to drugs not commonly used in pregnancy, and their ability to monitor both adverse and beneficial fetal outcomes, seem to be the most promising study type from a methodological viewpoint. Although there are numerous cohort studies on the harmful effects of drug use in pregnant women, only a few have been able to demonstrate a risk in terms of an increase in the prevalence of malformations. Most studies with significant findings were those investigating the risk potential of one group of drugs, the anticonvulsants. The lack of cohort studies showing a risk for drug use in pregnancy, however, is not necessarily indicative of some methodological deficiency. Rather, it may suggest that, for the majority of drugs, their use in pregnancy is not associated with an increased risk of congenital malformations.

Abnormalities, Drug-Induced↗
PubMed1999

Interferon-alpha before allogeneic bone marrow transplantation in chronic myelogenous leukemia does not affect outcome adversely, provided it is discontinued at least 90 days before the procedure.

The influence of interferon-alpha (IFN) pretreatment on the outcome after allogeneic bone marrow transplantation (BMT) in chronic myelogenous leukemia (CML) is controversial. One goal of the German randomized CML Studies I and II, which compare IFN +/- chemotherapy versus chemotherapy alone, was the analysis of whether treatment with IFN as compared to chemotherapy had an influence on the outcome after BMT. One hundred ninety-seven (23%) of 856 Ph/bcr-abl-positive CML patients were transplanted. One hundred fifty-two patients transplanted in first chronic phase were analyzed: 86 had received IFN, 46 hydroxyurea, and 20 busulfan. Forty-eight patients (32%) had received transplants from unrelated donors. Median observation time after BMT was 4.7 (0.7 to 13.5) years. IFN and chemotherapy cohorts were compared with regard to transplantation risks, duration of treatments, interval from discontinuation of pretransplant treatment to BMT, conditioning therapy, graft-versus-host disease prophylaxis and risk profiles at diagnosis and transplantation, and IFN cohorts also with regard to performance and resistance to IFN. Outcome of patients receiving related or unrelated transplants pretreated with IFN, hydroxyurea, or busulfan was not significantly different. Five-year survival after transplantation was 58% for all patients (57% for IFN, 60% for hydroxyurea and busulfan patients). The outcome within the IFN group was not different by duration of prior IFN therapy more or less than 5 months, 1 year, or 2 years. In contrast, a different impact was observed in IFN-pretreated patients depending on the time of discontinuation of IFN before transplantation. Five-year survival was 46% for the 50 patients who received IFN within the last 90 days before BMT and 71% for the 36 patients who did not (P =.0057). Total IFN dosage had no impact on survival after BMT. We conclude that outcome after BMT is not compromised by pretreatment with IFN if it is discontinued at least 3 months before transplantation. Clear candidates for early transplantation should not be pretreated with IFN.

Adolescent↗
PubMed1999

Regional reporting of adverse drug reactions: a new computer-based network.

The use of drugs is always accompanied by the risk of adverse drug reactions (ADRs) and adverse events (AE). Generally physicians, pharmaceutical manufacturers, and pharmacists use a paper-based form for sending spontaneous ADR and AE reports to the national drug regulatory authority. Besides underreporting, reporting lag-time and errors through data transformation are a major issue. In order to improve the current reporting situation we have set up a new computer-based, network-driven system for storing, transferring, and evaluating ADR reports. The system consists of three regional centres, one coordinating centre, and the central ADR database of the national drug regulatory authority. In the regional centres, clinical pharmacologists collect ADR data in local databases. There is a comfortable user-interface with an online help-function available. New reports are sent automatically to the Federal Agency using EUROSCAPE as a standardized electronic report form of the EU. The coordinating centre in Munich is responsible for overall performance and quality assurance. This model for a clinical health information network is of a high level of data security, is reliable and easily expandable through the use of standard tools, is fast and also inexpensive by using standard shareware products.

Journal Article↗
PubMed1998

A new prognostic score for survival of patients with chronic myeloid leukemia treated with interferon alfa. Writing Committee for the Collaborative CML Prognostic Factors Project Group.

BACKGROUND: Interferon alfa is a conservative and widely used alternative to bone marrow transplantation in treatment of patients with early chronic myeloid leukemia (CML). A meta-analysis was conducted to develop a reliable prognostic scoring system for estimation of survival of patients with CML treated with interferon alfa. METHODS: Patients treated in prospective studies, including major randomized trials, were separated into learning and validation samples. Cox regression analysis and the minimum P-value approach were used to identify prognostic factors for patient survival and to discover groups in the learning sample with the greatest differences in survival. These findings were then validated by applying the new scoring system to patients in the validation sample. RESULTS: We collected data on 1573 patients who were participants in 14 studies involving 12 institutions; 1303 patients (learning sample, n = 981; validation sample, n = 322) were eligible for inclusion in this analysis, and their median survival time was 69 months (range, 1-117 months). Because two previously described prognostic scoring systems failed to discriminate risk groups satisfactorily, we developed a new scoring system that utilizes the following covariates: age, spleen size, blast count, platelet count, eosinophil count, and basophil count. Among 908 patients with complete data in the learning sample, three distinct risk groups were identified (median survival times of 98 months [n = 369; 40.6%], 65 months [n = 406; 44.7%], or 42 months [n = 133;14.6%]; two-sided logrank test, P< or =.0001). The ability of the new scoring system to discriminate these risk groups was confirmed by analysis of 285 patients with complete data in the validation sample (two-sided logrank test, P = .0002). CONCLUSIONS: A new prognostic scoring system for estimating survival of patients with CML treated with interferon alfa has been developed and validated through use of a large dataset.

Adult↗
PubMed1998

Survival with bone marrow transplantation versus hydroxyurea or interferon for chronic myelogenous leukemia. The German CML Study Group.

Hydroxyurea, interferon, and HLA-identical sibling bone marrow transplantation are common therapies for chronic myelogenous leukemia (CML) in chronic phase. Which is best is controversial. The purpose of this study was to compare survival of patients with CML receiving HLA-identical sibling transplants versus hydroxyurea or interferon. The transplant cohort included 548 recipients of HLA-identical sibling transplants, reported to the International Bone Marrow Transplant Registry. The nontransplant cohort included 196 patients receiving hydroxyurea (n = 121) or interferon (n = 75) on a randomized trial of the German CML Study Group. Survivals were compared using proportional hazards regression with fixed and time-dependent variables to adjust for patient differences and changing risks over time. For the first 18 months after diagnosis, mortality was higher in the transplant than the nontransplant cohort (relative risk [RR], 5.85; P < .0001). From 18 to 56 months, mortality was similar (RR, 0.80; P = .38). After 56 months, mortality was lower in the transplant cohort (RR, 0.16; P < .0001). Seven-year survival probabilities (95% confidence interval) were 58% (50% to 66%) with transplant and 32% (22% to 41%) with hydroxyurea or interferon. There was a significant survival advantage for hydroxyurea or interferon in the first 4 years after diagnosis and for transplants starting 5.5 years after diagnosis. For transplants done within 1 year of diagnosis, the survival advantage for transplantation began earlier. Survival advantage for transplants was greater and occurred earlier in patients with intermediate- and high-risk prognostic features than in those with low-risk features. This study confirms higher early mortality, but a long-term survival advantage for HLA-identical sibling transplants over hydroxyurea or interferon in CML.

Adolescent↗
PubMed1998

Company observational post-marketing studies: drug risk assessment and drug research in special populations--a study-based analysis.

OBJECTIVES: Company observational post-marketing studies (COPS) claim to provide essential data about drug risks and effectiveness in special populations not admitted to pre-approval clinical trials. Since COPS are often mainly regarded as a marketing activity, this study-based analysis tries to evaluate the scientific contributions of COPS. MATERIAL AND METHODS: Thirty-five COPS were identified by hand-searching through medical journals, writing to pharmaceutical manufacturers and using MEDLINE. Fourteen COPS evaluated cardiovascular drugs, 9 evaluated NSAIDs and 12 evaluated various other indications. RESULTS: Thirty-five COPS listed effectiveness, 31 listed safety and 8 listed patient compliance as principal objectives. Not a single COPS included a control group. Seventeen of 21 evaluable COPS mentioned extensive exclusion criteria similar to those in clinical trials. Median observation time was 8 weeks, too short for chronic diseases and for adverse drug reactions with longer latency periods. One new adverse event was regarded. Global assessments of the outcomes by physicians dominated and were not based on objective clinical findings. None of the studies specified any details concerning the standardisation of observations or quality-control procedures. DISCUSSION AND CONCLUSION: The current COPS scheme does not contribute significantly to our knowledge of drug safety and the effects in special populations. Despite serious criticism over the past 20 years, the poor quality of COPS compared with dramatic improvements of pre-approval trials - implies a need for detailed guidelines for non-experimental phase IV research, similar to the Good Clinical Practice-Guideline of the European Community.

Anti-Inflammatory Agents, Non-Steroidal↗