Jari Forsström

Verifying quality and safety in health informatics services

Information and its handling and transmission form an essential part of health care and are reflected in professional standards. Automated information systems in health care—health informatics services—will improve these functions and bring new opportunities through the harnessing of modern information and communications technologies. Thus, computer support is now essential in many parts of medicine, the US Institute of Medicine has long espoused the value of computerised patient records,1 and many countries have developed strategies on this topic, and there are countless health related internet sites. However, as new information and communication technologies in health bring new opportunities, they also bring new risks. Emphasis has rightly been placed on ensuring appropriate levels of confidentiality in electronic information systems—to the point that the highly exacting requirements being demanded by independent commentators and professional bodies2 are difficult to satisfy without jeopardising the functioning of core services 3 4 or the interests of the most vulnerable groups.5 In contrast, much less thought has been given so far to ensuring the appropriateness of the design and integrity of functioning of health informatics services. #### Summary points Like drugs 40 years ago, products in health informatics are unregulated with regard to safety and efficacy A European project has now recommended ways of accrediting healthcare related software, telemedicine, and internet sites A scheme like CE marking of electrical goods is recommended for software, national regulatory bodies should be identified for telemedicine, and a European certification of integrity scheme developed for websites If informatics systems are increasingly essential in the delivery of health care then their integrity and quality must be of equal importance, but this has been scarcely recognised to date. In 1963 the then UK secretary of state for health stated to the House of Commons: “The House and the public suddenly …

Autonomic neuropathy and vibration exposure in forestry workers.

The variation in heart rate (HRV) at rest and during deep breathing (6 cycles a minute) of 88 professional lumber jacks was studied using a computer technique. The traditional indexes of HRV (CV, CVS, MEAN) were calculated and the spectral components of the HRV were also computed. There was a significant difference (p less than 0.001) between the HRV indexes during the deep breathing test in those with the shortest (CV = 10.1 +/- 1.1) and those with the longest (CV V 6.2 +/- 0.4) exposures to vibration. The values of the HRV indexes decreased with age, but multiple regression analysis showed that the total exposure time to vibration had an independent negative association with the HRV. There were significant differences in all the frequency bands (frequency related power, FRP) of the heart rate between those with the longest and those with the shortest exposures. The HRV during a deep breathing test is associated with the activity of the parasympathetic nervous system and is decreased in autonomic neuropathies. Our results suggest that prolonged exposure to the vibration caused by a chain saw has a negative effect on the parasympathetic activity and thus causes autonomic dysfunction.

Maternal midtrimester serum AFP and free β-hCG levels in in vitro fertilization twin pregnancies

We aimed to compare the levels of alpha‐fetoprotein (AFP) and free β‐human chorionic gonadotrophin (β‐hCG) levels as multiples of the median (MoM) values between spontaneous and in vitro fertilized (IVF) twin pregnancies. The control group of spontaneous singleton pregnancies was used for calculating the gestational age specific median levels of the values. Within a cohort of 19 310 pregnancies, 145 twin pregnancies were identified. The data were collected from Down syndrome (DS) screening programmes in four University catchment areas in Finland between 1994–98. Maternal midtrimester serum marker levels were measured across gestational weeks 14–18. There were no fetal chromosome anomalies in either of the twin groups or the singleton group. Serum AFP of 145 and β‐hCG values of 39 spontaneous twin pregnancies were compared to the values of 6548 singleton pregnancies. In IVF twins 30 AFP and 29 β‐hCG values were compared to the levels of the control group. Both AFP and β‐hCG values were twice as high in the spontaneous twin pregnancies (medians 2.18 and 1.83 MoM respectively) as in the singleton group (medians 1.00 and 1.00 MoM respectively). In IVF twin pregnancies β‐hCG levels were higher (median 2.20 MoM) than in spontaneous twins (p=0.08), whereas no significant difference was found in AFP levels (2.30 MoM). In conclusion, the higher levels of β‐hCG levels in IVF twin pregnancies should be considered in DS screening to avoid high false positive rates. Copyright

Approaches for certification of electronic prescription software

The proper management of drug treatment is essential, since adverse drug reactions are common reasons of hospitalisations. Expenditure on drug therapy has also been growing faster than any other aspect of health care in many countries. Savings and quality improvements in drug treatment could be achieved with computerised prescribing. In this paper, the architecture of an electronic prescription system is described in the light of software certification and registration. An electronic prescription system is an example of a system supporting shared care and therefore it should be person based, integrated, secure and confidential and data should be shared among health care institutions. The system architecture shares the idea of a virtual patient record and a smart card will be used as a key to prescription data located on the network. The certification and registration of medical software is a difficult and costly procedure. Ensuring the quality of software can be based on; certification of development process, voluntary evaluation, and post-market surveillance. Voluntary evaluation practice would be a precious tool for both the customers and software developers, and it would also be an invaluable source of information in terms of developing new software.

Effects of haemodialysis on heart rate variability in chronic renal failure.

The influence of haemodialysis (HD) on the heart rate variability (HRV) was investigated in nine non-diabetic patients on maintenance haemodialysis. The R-R intervals were measured in recordings during spontaneous quiet breathing and during controlled deep breathing before and after a single HD session. The HRV was expressed as the standard deviation of the mean R-R interval in 3 min ECG recordings. Heart rate variability is the irregularity in the heart rate mainly caused by autonomic control mechanisms. The long-term HRV during quiet breathing was statistically significantly (p less than 0.05) higher after the HD than before. The HRV in the intermediate frequency range of 0.075-0.125 Hz was also significantly increased by the HD. This suggests that some metabolic agents interfering with the heart rate regulation are removed by the haemodialysis, and as a result a better function of the autonomic cardiac control is achieved in uraemic patients.

Frequency and clinical outcome of potentially harmful drug metabolic interactions in patients hospitalized on internal and pulmonary medicine wards: focus on warfarin and cisapride.

Drug metabolic interactions present potential risks in patient care, but their frequency and relative importance as a clinical problem remains unclear. To assess the frequency and clinical outcome of potentially harmful drug metabolic interactions in hospitalized patients, the authors performed a survey of the medication data of patients treated on internal and pulmonary medicine wards in a university hospital. The database was searched for concomitantly administered drug pairs that would, according to Hansten and Horns drug interaction database, carry a high risk for a clinically harmful metabolic drug interaction. Coadministrations involving warfarin or cisapride were subjected to further analysis regarding clinical outcome. A total of 142 patients were exposed to 150 interactions with potentially harmful clinical outcome, resulting in a frequency of 0.9% (95% CI 0.7% to 1.0%). Inhibition of warfarin metabolism by metronidazole produced significant overanticoagulation as evidenced by elevated international normalized ratio values, whereas inducers (rifampicin and phenobarbital) of warfarin metabolism significantly reduced the efficacy of warfarin. One case of minor bleeding and one case of clavicular vein thrombosis were detected as possible consequences of disturbed anticoagulation. The coadministration of cisapride and erythromycin significantly prolonged the corrected QT (QTc) interval and was associated with clinical symptoms of cardiac arrhythmias. Coadministration of cisapride with fluconazole or miconazole was not associated with prolongation of the QTc interval or cardiac sequelae. Evaluations of patient materials are needed to assess the clinical relevance of metabolic drug interactions.

Teleconsultations: who uses them and how?

A literature survey was carried out to identify papers describing teleconsulting applications. From 1259 potentially relevant articles identified through Medline, 128 articles were selected for review. The majority of these had been published in the Journal of Telemedicine and Telecare (50 articles, or 39%). We analysed different user groups, equipment and implementation issues, and the type of connections. In 101 studies (79%) the teleconsultations were between doctors, in 11 they were between patient and doctor, in seven between patient and nurse, and in nine between nurse and doctor. Studies of consultations between patients and health-care professionals were thus quite rare. Surgery was the most common specialty in which teleconsultation was described. The teleconsultations were realtime or mainly realtime in 72% of articles. In 39% of studies the primary focus was on videoconferencing. The most common means of connection was by ISDN digital lines (38%). There were very few mentions of how to ensure data protection or to maintain patient confidentiality. We conclude that, for the majority of teleconsultation needs, asynchronous communication is the most flexible and cost-effective approach. Realtime videoconferencing can be justified only in particular circumstances.

Application of neural networks to the ranking of perinatal variables influencing birthweight

In this paper we compare Multi-Layer Perceptrons (a neural network type) with Multivariate Linear Regression in predicting birthweight from nine perinatal variables which are thought to be related. Results show, that seven of the nine variables, i.e., gestational age, mothers body-mass index (BMI), sex of the baby, mothers height, smoking, parity and gravidity, are related to birthweight. We found no significant relationship between birthweight and each of the two variables, i.e., maternal age and social class.

Serum cysteine proteinase inhibitors with special reference to kidney failure

Serum levels of proteins reactive in radioimmunoassay with an antiserum prepared in rabbits against purified human spleen neutral cysteine proteinase inhibitor (NCPI) was determined in 70 healthy controls and from 80 patients suffering from suspected or proven kidney failure. The values varied from less than 0.2 mg/l in normal sera to levels over 2 mg/l in some patient sera. Serum level of NCPI was found to roughly correlate with serum creatinine values. However, there were sera with high NCPI levels which did not have increased serum creatinine values. In sera with high NCPI levels subjected to double radial immunodiffusion two precipitin lines, one completely and the other partially identical to NCPI were registered. After fractionating of serum proteins with gel chromatography on Sephadex G 100, two protein peaks of immunological similarity to purified NCPI were found: one low molecular weight (MW around 12,000) and one high molecular weight (MW around 100,000). The low molecular weight NCPI-like material appeared to inhibit human cathepsin B and papain and is thus free serum NCPI. alpha-Cysteine proteinase inhibitor did not increase with serum creatinine as did NCPI.

Using computerized individual medication data to detect drug effects on clinical laboratory tests

In clinical practice, thousands of drugs are used daily. Clinicians know the therapeutic effects of drugs but other minor drug effects are often ignored either because of inadequate knowledge of these effects or simply because of the limited memory capacity of a human being. This problem can be solved by using a computerized information system, which includes medication data of individual patients as well as information about non-therapeutic drug-effects. One of these non-therapeutic confusing drug effects is the influence of drugs on laboratory tests; a problem that should be taken into account in clinical practice and diagnostics. Other complicating drug effects include drug interactions and patient related adverse drug reactions. In a computerized information system, it is possible to build decision support modules that automatically give alarms or alerts of important drug effects other than therapeutic effects. If these warnings concern laboratory tests they are checked by a laboratory physician and only those with clinical significance are sent to clinicians. Warnings of drug interactions and adverse drug reactions are immediately evaluated by the physician responsible for the treatment. By means of the computerized information system, it is also possible to get better information of current medication practice which in turn gives better chances to agree on common guidelines and enables better quality assurance.