Relationship between guideline treatment and health-related quality of life in asthma.

The aim of this study was to compare the health-related quality of life (HRQL) of asthma patients treated according to the 1997 National Institute of Health (NIH) international asthma guideline and that of asthmatics receiving non-guideline treatment. The suitability of 146 asthmatics' medication regimes was determined according to the 1997 NIH asthma guideline. Quality of life was assessed on a seven-point scale using the Asthma Quality of Life questionnaire. Just over half of the patients were not currently using the treatment considered necessary for controlling their asthma. Patients treated according to the guideline (n=72) had a significantly higher overall HRQL than patients with non-guideline treatment (5.7 versus 5.3). The differences were also significant for the subscales measuring symptoms and environmental exposure, but not for activities or emotional function. An association between non-guideline treatment and a poorer health-related quality of life in asthma patients treated in general practice was observed. This study supports the role of evidence-based guidelines in daily practice. Further studies are needed to determine if guideline treatment is responsible for the increase in health-related quality of life observed in this work.

Role of abdominal sonography in excluding abdominal malignancy in the initial workup of patients with abdominal complaints.

OBJECTIVE: The objective of this study was to evaluate the diagnostic performance and role of abdominal sonography in excluding abdominal malignancy in the initial workup of patients with abdominal complaints. MATERIALS AND METHODS: The sonographic report and follow-up data of 494 patients who had undergone a primary sonographic examination were retrospectively reviewed. Sensitivity and specificity of sonography for the diagnosis of an abdominal malignancy-that is, a primary tumor or metastasis-were determined. Multivariate logistic regression analysis was performed to determine the incremental value of sonography, and a prediction rule was derived. RESULTS: An abnormality on sonography--that is, a mass, ascites, pleural effusion, hydronephrosis, or focal intraparenchymal heterogeneity suggestive of a mass--had a sensitivity for abdominal malignancy of 86% and a specificity of 94%. In the multivariate analysis, the sonographic findings were found to have significant incremental value (odds ratio = 74) after adjustment for the clinical determinants. In patients younger than 38 years with no previous malignancy, no palpable mass, normal liver function test results, and negative findings on sonographic examination, the risk of an abdominal malignancy was less than 1 in 500. CONCLUSION: Our results suggest that sonography may be useful in excluding an abdominal malignancy when used in a primary care setting in patients with abdominal complaints who are at low risk for a malignancy.

Towards improvement of the accuracy and completeness of medication registration with the use of an electronic medical record (EMR).

BACKGROUND: Approximately 80% of GPs use a GP information system (GIS) and an electronic medical record (EMR) in their daily practice. To reap the full benefits of an EMR for patient care, post-graduate education and research, the data input must be well structured and accurately coded. OBJECTIVES: The quality and user-friendliness of the software positively influence the completeness and reliability of the data recorded in the GIS. To assess this in actual practice, this study examined whether or not an increase occurred in the accuracy and completeness of indication-related medication registration after the GIS's software package was upgraded. METHOD: GPs recorded data for the Registration Network Groningen (RNG) concerning four medication groups: insulin, trimethoprim, the contraceptive pill and beta-blocking agents. The completeness and accuracy of the registered data were assessed both before and after the change to the new software package. The completeness is evaluated on the basis of the indications missing for the prescribed medications. To assess accuracy, a check was made to determine whether the indications corresponded to those deemed relevant for that particular medication according to National Pharmaceutical Guidelines. RESULTS: The percentage of missing indications decreased notably, especially in the chronically prescribed medication groups. For insulin, the percentage decreased from 40.5 to 3% and for the contraceptive pill from 34.5 to 1%. For trimethoprim, the percentage decreased from 10 to 1%, and for beta-blocking agents from 22 to 1.5%. Of the indications present, the percentage of relevant indications showed a slight increase, with the largest increase observed for the contraceptive pill where the percentage rose from 86 to 96%. CONCLUSIONS: The completeness of recorded indications improved considerably after the change of software. This is due mostly to the efforts of the GPs, their practice assistants and the support of the RNG organization involved in the conversion procedure. Accuracy improved slightly, especially due to the software modifications which ensured that non-existent codes could not be entered. To summarize, with increased user-friendliness of the software, combined with the training of motivated GPs, the quality of recorded data improved.

Co-morbidity of 'clinical trial' versus 'real-world' patients using cardiovascular drugs.

PURPOSE: To examine discrepancies between co-morbidity of patients included in pre-marketing clinical trials of cardiovascular drugs and patients from daily practice, representing the actual users after marketing, and to investigate the availability of data regarding co-morbidity in registration files. METHODS: Data were collected from phase III trials of registration files of 16 drugs, registered in the Netherlands in the period 1985 through 1994 for the indications hypertension, angina pectoris or hypercholesterolemia, and from a general practitioners database. Patients were selected who used drugs from the same therapeutic classes for the same indication as the patients in the pre-marketing trials. Prevalences of concomitant cardiovascular, endocrine and metabolic diseases were compared between pre- and postmarketing populations. Discrepancies were defined as more than 10% difference in prevalences. RESULTS: Data regarding co-morbidity were present in 13 out of 16 registration files and differed in format of reporting. For all indications, coexisting cardiovascular, endocrine and metabolic diseases were less prevalent in the pre-marketing populations, except ischemic heart disease, which was more prevalent coexisting with angina pectoris and hypercholesterolemia. Discrepancies were found for hypertensive disease, heart failure, diabetes mellitus and myocardial infarction. CONCLUSIONS: Phase III trials testing cardiovascular drugs included patients with concomitant cardiovascular, endocrine and metabolic diseases, but discrepancies were present with patients in daily practice. Development of guidelines for uniform collection and reporting of co-morbidity data in pre-marketing trials is recommended, as well as further utilization of data.

Cardiovascular drugs: discrepancies in demographics between pre- and post-registration use.

OBJECTIVES: To study discrepancies in demographic characteristics between patients participating in pre-registration phase III trials of cardiovascular drugs, registered in the Netherlands, and patient populations in daily practice representing the actual users of the drugs after registration. METHODS: Comparison of age and sex distribution in registration files of 15 cardiovascular drugs [angiotensin-converting enzyme (ACE)inhibitors/angiotensin II receptor antagonists, calcium channel blockers, beta-adrenergic blocking agents, vasodilators, HMG-CoA reductase inhibitors and thrombolytics] with patients selected from a general practitioner (GP) registration database, who had received prescriptions for drugs from the therapeutic classes for the registered indications (hypertension, hypercholesterolaemia or angina pectoris) or were diagnosed with myocardial infarction. Moderate discrepancy was defined as more than 10% difference between the populations, large discrepancy by more than 20% difference. Clinical trials were also analysed by region of trial performance with respect to patient selection criteria, differences in male/female ratios and ethnic origin of patients. RESULTS: Phase III clinical trials in registration files of drugs registered for hypertension, angina pectoris and myocardial infarction had a moderate to large under-representation of female patients. Patients aged more than 65 years, who accounted for more than 50% of drug use indicated for hypertension, angina pectoris and myocardial infarction, were under-represented in the clinical trials of drugs registered for all indications. Trials performed in North America included relatively fewer female patients compared with European trials, and showed different patterns in the ethnic origin between indications. CONCLUSIONS: Clinically relevant subgroups of cardiovascular patients are under-represented in pre-registration phase III trials. These findings concern major areas of cardiovascular diseases, i.e. hypertension, hypercholesterolaemia, angina pectoris and myocardial infarction. Widely used therapeutic classes of drugs are affected and regional differences in trial performance are present.

[Management of psoriasis in family practice is now in closer agreement with the guidelines of the Netherlands Society of Family Physicians]. / Beleid bij psoriasis in de huisartspraktijk nu meer in overeenstemming met de standaard van het Nederlands Huisartsen Genootschap.

OBJECTIVE: To assess changes in incidence of psoriasis and to study changes in the management of psoriasis in general practice after the sending of guidelines on management of psoriasis to general practitioners (GPs) by the NHG. DESIGN: Secondary data analysis. SETTING: Netherlands Institute for Health Care Research (NIVEL), Utrecht, the Netherlands. METHOD: Data on the incidence of psoriasis and its management by general practitioners were collected from a file predating the publication of the NHG guideline 'Psoriasis' in 1994, namely the 'Dutch National Survey of General Practice' (NS; 1987/'88), and from a subsequent file, the 'Registration Network Groningen' (RNG; 1995). RESULTS: In the NS there were 106 new patients with psoriasis (incidence: 1.3/1000/year; 95% confidence interval (95% CI): 1.2-1.4) while in the RNG there were 24 (incidence: 1.2/1000/year; 95% CI: 0.7-1.9). In all, there were 466 psoriasis patients in the NS and 125 in the RNG. The number of referrals to dermatologists was halved in 1995 (7.2%) compared with 1987/'88 (14.4%; p < 0.05). The most frequently prescribed dermatologica in psoriasis was in 1995 corticosteroid group 3 (32.8%; in 1987/'88: 28.5%), but the rise was stronger in corticosteroid group 2 (29.6%; in 1987/'88: 16.0%; p < 0.001) and group 4 (16.0%; in 1987/'88: 8.8%; p < 0.05). CONCLUSION: The incidence of psoriasis in general practice had not changed between 1987/'88 en 1995. Referral pattern and prescription shifted towards the guidelines issued by the NHG.

[ The family physician's sentinel function studied with reference to referrals and referral cards]. / De poortwachtersfunctie van de huisarts onderzocht met verwijzingen en verwijskaarten.

OBJECTIVE: To study the gatekeeper function of Dutch general practitioners (GPs) by investigating the relation between the referring GP, referrals, and referral cards. (In the Netherlands, it is customary that patients only see a specialist after referral by their GP. In this way the GP acts as a gatekeeper between primary and secondary care. Specialists are paid by the patient's insurance company which they send a so-called referral card stating the name of the referring GP.) DESIGN: Descriptive. SETTING: Hospitals in Groningen and Hoogeveen and four general practices in the area. METHOD: The study questions were answered using data for 1993 of the computerized morbidity Registration Network Groningen (RNG) of the Department of Family Medicine of Groningen University and data of two regional health insurance companies (RZG and Het Groene Land). RESULTS: For 1993 the RNG showed a referral-referral card ratio of 34%, ranging from 24% to 42% among different practices; and from 17-46% among the various specialties. For the surgical specialties, the range of indications for which patients were actively referred to the various specialties varied from 21-33 per 100 referrals, for the non-surgical specialties it ranged from 25 to 56 per 100 referrals. The number of referrals by the 'own' GP accounted for an average of three-quarters of the referral cards attributed to the own GP. The last five years the number of referrals varied showing no clear increase or decrease. DISCUSSION: GPs appeared to have difficulty in acting as gatekeeper once patients were being treated by the specialist. In studies of referrals. research into specialists' follow-up strategies should be an integral part. A back referral or return card could facilitate this type of study.

Use of cimetidine; parallels and discrepancies between the views of drug regulatory agencies and practicing physicians.

The use of cimetidine in general practice was studied in relation to the guidelines approved by the Dutch National Drug Regulatory Agency (DRA). National and regional figures showed that the frequency with which cimetidine was prescribed in general practice was greater than could be explained on the basis of approved indications alone. Analysis of its employment in 14 hypothetical cases suggested however, that general practitioners in The Netherlands chose their indications for cimetidine and the duration of cimetidine treatment according to the guidelines for its use approved by the DRA; only 12.7% of the prescriptions related to indications that had not been approved in The Netherlands, the most prominent finding being the case of a possible gastric carcinoma. It was estimated that less than half of all cimetidine prescriptions in general practice will be issued for indications approved by the Dutch DRA. Some discrepancy exists with regard to the dose employed; contrary to the recommendations of the DRA, the dose chosen varied little from indication to indication.