Top PDF Medical databases in studies of drug teratogenicity: methodological issues

Medical databases in studies of drug teratogenicity: methodological issues

Medical databases in studies of drug teratogenicity: methodological issues

Since birth defects are rare, assembling cohorts to observe their occurrence is expensive in terms of time, money, and resources, leading to widespread use of the case-control design. Case-control studies, often based on interviews or questionnaires, are susceptible to selection and recall bias, and they do not allow estimation of abso- lute risks (prevalences) of birth defects. Existing medical databases are increasingly being used to conduct pharmacoepidemiologic cohort studies, including studies of drug teratogenicity. 8 Medical databases, some of which have been in existence
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Methodological issues in the observational studies conducted in older population: a narrative review

Methodological issues in the observational studies conducted in older population: a narrative review

In response to the poor generalizability of the RCT’s results to the elderly population [5], about 30 years ago, the geriatric research developed the comprehensive geriatric assessment (CGA) [6], a standardized evaluation methodology to perform a global assessment of patients in different care settings. CGA does provide information on various problematic areas of the elderly patient including co-morbidities, syndromes, socio-economic problems, functional and cognitive deficits not covered by the traditional medical assessment. The systematic adoption of CGA instruments for clinical, administrative and/or research purposes, has resulted in more detailed evaluation, improved care planning and guaranteed overall better quality of care. It also contributed to the collection of massive and reliable amounts of information [7]. These high quality clinical databases have been commonly used to conduct observational studies as an alternative methodology to randomized clinical trials in order to address the multifaceted problems of the elderly population in different settings [8, 9].
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Perception of drug teratogenicity among general practitioners and specialists in obstetrics/gynecology: a regional and national questionnaire based survey

Perception of drug teratogenicity among general practitioners and specialists in obstetrics/gynecology: a regional and national questionnaire based survey

Knowledge about the risk of medications being teratogenic became apparent after the thalidomide disaster [1, 2] some 50 years ago. The tragedy gave rise to concerns on the safety of drugs during preg- nancy and prompted international agencies to develop systematic preclinical reproductive testing protocols [2]. Estimating the true risk of fetal malformations at- tributable to the use of medications is difficult and controversial. While randomized controlled trials are seen as the gold standard for assessing safety and effi- cacy of medications, pregnant women are routinely excluded from such trials [3]. This places a heavy re- liance on observational studies and pharmacoepide- miological data to provide evidence in support of informed decision making on medication use during pregnancy [3]. Perception of risk by health professionals will impact their level of counseling and treatment of pa- tients who need medication during pregnancy. Overesti- mating this risk can lead to insufficient treatment of patients, whereas underestimating may lead to hazardous practice. Legal medical issues may additionally complicate matters, and in case of Bendectin such issue led to the market withdrawal of a documented safe and effective product [4]. Perceptions of risk by patients impact their decision on whether or not to use medicine during preg- nancy, and the risk perceived by patients has been shown to be heavily dependent on the information received from their physician [5–7]. In recent surveys, 77 % of women stated that they needed information about drug use during their pregnancy, and 62 % of women believed it would be better for the fetus if they refrained from using drugs that they would otherwise have used if not pregnant [8, 9]. Teratogenic risk perception among health care profes- sionals has only been subject to small-scale studies mostly pertaining to general practitioners (GP) while only about 200 obstetricians/gynecologists (OB/GYN) have been sub- ject to such study on teratogenic drug risk-perception on a world-wide scale [10–15].
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Methodological and ethical issues in research using social media: a metamethod of Human Papillomavirus vaccine studies

Methodological and ethical issues in research using social media: a metamethod of Human Papillomavirus vaccine studies

The second principle identified in the TCPS2, respect for person , involves the moral obligation to respect and protect the autonomy of research participants as well as those individuals whose data are used for research purposes [28]. Obtaining free, informed, and ongoing consent is an accepted mechanism for doing this. The TCPS2 devotes minimal attention to research in virtual settings, equating these spaces with observational studies conducted in natural settings “where people have a rea- sonable or limited expectation of privacy” [28]. In these situations the researcher must justify the exception to the requirement to obtain consent. Our metamethod indicates that ethics approval was only sought for the cyberethno- graphy, leading us to think that researchers involved in the other five studies assumed that virtual communities were public spaces where users had no little or no expect- ation of privacy. There was an absence of discussion about the potential privacy incursion even when users’ comments were cited. Failing to engage users about the subsequent use or interpretation of data they posted may have unin- tended negative implications. For instance, Ache and Wallace directly quote negative and positive viewer-posted comments about HPV videos appearing on YouTube [18], making it possible to identify the accounts of those individ- uals whose comments were cited.
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Medical specialist attendance in nursing homes

Medical specialist attendance in nursing homes

The other two scientifically initiated pilot projects be- longed to topic 3 (assuring evidence based care) of the Leuchtturmprojekt Demenz financed by the Federal Ministry of Health during 2008/2009. The project InDemA (Interdisziplinäre Implementierung von Qualitätsinstru- menten zur Versorgung von Menschen mit Demenz in Altenheimen) targeted the improvement of dealing with challenging behaviours displayed by nursing homes resi- dents. The intervention comprised implementation of basic recommendations for nursing staff and the guideline Demenz of the DEGAM with primary care physicians. Ef- fectiveness of the intervention, e. g. referring to the end- points prescription rates of psychotropic drugs (especially neuroleptics) and prevalence of provocative behaviour, was evaluated in a prospective investigation using a pre- post design. For both endpoints after nine months statistically significant and clinically relevant improve- ments were reported. From a methodological point of view the pre-post design, high drop-out rates and the unclear influence of contextual factors hampered inter- pretability of results.
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STUDIES ON ACUTE TOXICITY PROFILE AND UTERINE HISTOPATHOLOGICAL CHANGES AFTER UTERINE IMPLANTATION OF SMA COATED AND NON COATED COPPER T (CU T) IN RATS

STUDIES ON ACUTE TOXICITY PROFILE AND UTERINE HISTOPATHOLOGICAL CHANGES AFTER UTERINE IMPLANTATION OF SMA COATED AND NON COATED COPPER T (CU T) IN RATS

Previous studies have shown that chemical occlusion of the vas deferens by RISUG has been considered to be an ideal male contraceptive method where the polymer SMA can be used to block the lumen of the vas deferens and spermatozoa activity over an extended period of time. The male gamete, spermatozoa and its morphology play a significant role in fertilization process, especially the anterior part, acrosome which secrets three important key enzymes – 5’-nucleotidase (5’-NT), hyaluronidase and proacrosin-acrosin system which facilitate sperm-oocyte interaction. Any change in it by means of antifertility agents, acrosin/hylronidase inhibitors and spermicides leads to impairment of gamete interaction and fertilization of ova. [9,33-35] The treatment of RISUG have been shown to cause significant inhibition in plasma membrane-associated enzymes, 5’-Nucleotise, hyaluronidase and acrosin from the acrosomal membrane [9] leading to spermicidal action. [36] Its systemic toxicity evaluation had been studied in detail in rat, rabbit and rhesus monkeys previously. Findings indicated that SMA-injection did not cause any systemic toxicity, male mediated teratogenicity and multigenerational teratogenicity in experimental animals. [3,5,37,41]
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Existing data sources for clinical epidemiology: The Danish National Database of Reimbursed Prescriptions

Existing data sources for clinical epidemiology: The Danish National Database of Reimbursed Prescriptions

However, relatively low completeness was observed for “Dermatologicals” (68.7%), “Genito-urinary system and sex hormones” (40.9%), “Antiparasitic products, insecticides, and repellents” (57.2%), and “Sensory organs” (51.0%). A closer examination of the differences at the second level of the ATC code (the therapeutic subgroup) suggests that lack of completeness for these drug types is largely attributable to their reimbursement status (non-reimbursed medications are included in the data from Statistics Denmark). 10 For example,

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THE METHODOLOGICAL ISSUES OF ECONOMIC MANAGEMENT DECISIONS

THE METHODOLOGICAL ISSUES OF ECONOMIC MANAGEMENT DECISIONS

The necessity of economic ground of administrative decisions related to the operation, staff, financial, invest- ment, information & telecommunication, innovative, marketing and inte[r]

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Privacy and Confidentiality Issues in Healthcare Databases

Privacy and Confidentiality Issues in Healthcare Databases

Figure1 below shows various kinds of security attacks and threats which can happen with the various users while accessing the information stored in healthcare databases. In healthcare databases the information stored may be sensed information, monitored information or analysed report information of a patient by a doctor. The stored information is shared or monitored through mobile services to check real time response of a patient. Figure below shows users from various fields accessing the healthcare databases for analysis or business purposes through mobile and electronic equipments. The actual purpose to access healthcare databases is to get more details regarding health and health related queries. Researchers can utilize patient medical records for their research. Pharmaceutical companies can use such information to understand the impact of drugs or medicines through the history of patient. Healthcare database is very useful to government and various organizations to collect and analyse the medical records and identify various diseases which are affecting the people health. Using such useful information, government can take necessary measures to release the funds or other facilities to the people.
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Challenges and Security Issues of NOsql Databases

Challenges and Security Issues of NOsql Databases

In this paper we will be discussing about what are the security problems in NOSQL, what concerns has to be taken care to solve the security issues in NOSQL while the data is in moving or in rest, during authentication and authorization. This paper also includes the vulnerabilities in NOSQL as well as Injections in NOSQL from which un-authorized person can breach the security. Multi model Heterogeneous problems explain the detail concept of the security issue when types of databases merge with each other. It includes the explanation of different layers exist in NOSQL with some particular databases issue. In last some currents issues or breaches in NOSQL has been explained.
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Exploring Knowledge and Perception of Drug Teratogenicity among Community of Pharmacist in Casablanca, Morocco

Exploring Knowledge and Perception of Drug Teratogenicity among Community of Pharmacist in Casablanca, Morocco

The respondents estimated the teratogenic risk of each therapeutic class based on the trimester of pregnancy (Table 2). The lowest perception of teratogenic risk was found to be associated with Penicillins. The highest perception of teratogenic risk was found to be related with antidepressants, neuroleptics, benzodiazepines and aminoglycosides. 84% of pharmacists thought there is no risk with using IEC during first trimester of pregnancy. 25% answered that there is no risk with oral antidiabetic agents versus 42% for technicians. Nearly 26% of technician considered there is no risk with anti-epileptic drugs. Concerning non-steroidal anti-inflammatory drug 16% of technician reported there is safe throughout the pregnancy.
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The use of questionnaires for acquiring information on public perception of natural hazards and risk mitigation – a review of current knowledge and practice

The use of questionnaires for acquiring information on public perception of natural hazards and risk mitigation – a review of current knowledge and practice

Abstract. Questionnaires are popular and fundamental tools for acquiring information on public knowledge and percep- tion of natural hazards. Questionnaires can provide valuable information to emergency management agencies for devel- oping risk management procedures. Although many natu- ral hazards researchers describe results generated from ques- tionnaires, few explain the techniques used for their devel- opment and implementation. Methodological detail should include, as a minimum, response format (open/closed ques- tions), mode of delivery, sampling technique, response rate and access to the questionnaire to allow reproduction of or comparison with similar studies. This article reviews current knowledge and practice for developing and implementing questionnaires. Key features include questionnaire design, delivery mode, sampling techniques and data analysis. In or- der to illustrate these aspects, a case study examines methods chosen for the development and implementation of question- naires used to obtain information on knowledge and percep- tion of volcanic hazards in a tourist region in southern Ice- land. Face-to-face interviews highlighted certain issues with respect to question structure and sequence. Recommenda- tions are made to overcome these problems before the ques- tionnaires are applied in future research projects. In conclu- sion, basic steps that should be disclosed in the literature are provided as a checklist to ensure that reliable, replicable and valid results are produced from questionnaire based hazard knowledge and risk perception research.
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ASSESSMENT OF DRUG UTILIZATION PATTERN AND TERATOGENICITY RISK AMONG PREGNANT WOMEN ATTENDING A TERTIARY CARE HOSPITAL, ANDHRA PRADESH

ASSESSMENT OF DRUG UTILIZATION PATTERN AND TERATOGENICITY RISK AMONG PREGNANT WOMEN ATTENDING A TERTIARY CARE HOSPITAL, ANDHRA PRADESH

In spite of the fact that drugs should be avoided as much as possible during pregnancy, such women are exposed to one or more number of drugs. 11 Medications prescribed to pregnant women can affect the foetus in different ways. They may cause foetal damage, birth defects or death. They might hamper placental function, thereby diminishing supply of oxygen and nutrients to the foetus resulting in delivery of an underweight and/ or underdeveloped baby. 3 In 1979, USFDA, devised a system to determine the teratogenic risk of drugs based on the quality of data obtained from animal and human studies which would provide therapeutic guidance to the clinicians. 2
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Research methodological issues in evaluating herbal interventions

Research methodological issues in evaluating herbal interventions

Abstract: Randomized controlled trials provide the best evidence, and is seen as the gold standard for allopathic research. Herbal therapies are not an integral part of conventional care although they are still used by patients in their health care management. These medicines need to be subjected to rigorous research to establish their effectiveness and safety. Clearly defined treatments are required and should be recorded in a manner that enables other suit- ably trained researchers to reproduce them reliably. Quality control of herbal products is also a prerequisite of credible clinical trials. Methodological strategies for investigating the herbal interventions and the issues regarding appropriate patient selection, randomization and blind- ing, placebo effects and choice of comparator, occupational standardization and the selection of appropriate study endpoints to prove efficacy are being discussed. This paper will review research options and propose some suggestions for future research design.
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Research with children as theologians: Ethical and methodological issues

Research with children as theologians: Ethical and methodological issues

An answer to this critique, which is particularly developed within feminist theology, is the perspective of intersectionality. This is an approach which stimulates researchers to see differences between, for example, groups of women and take into account the various, intersecting axes of gender, ethnicity, social economic status, age, religion, etc. Such an intersectional approach, which also takes into account the power balances and the privileges related to certain positions, is needed for theological approaches in childhood studies as well. A white Catholic child, coming from a higher middle-class family, living in Belgium, might have other views than a Muslim child in Malawi, who lost his parents. This difference is evident, but also within the group of Catholic children in Flanders, even those in the same class in school, there might be differences. These varieties need to be reflected in the theological work. This does not prevent the possibility of doing research with children as theologians. The more difficult question which cannot be answered easily by choosing adequate research methods is whether doing research with children is worthwhile at all, whether children really have something to offer. The answer to this question depends on the image of children. There is plenty of literature arguing for newer concepts of children, as active subjects, living in a context and in relations with others. It is possible that one does not accept these positions but sticks to a more classical paradigm (e.g. children are first of all vulnerable beings, in need of protection and socialisation).
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Conceptual and Methodological Issues for Behavioral Pediatrics Research

Conceptual and Methodological Issues for Behavioral Pediatrics Research

Child Health Behavior A Behavioral Pediatrics Perspective. Culture and ethnicity[r]

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Evaluation of Greek psychiatric reforms: methodological issues

Evaluation of Greek psychiatric reforms: methodological issues

substantial service transformation towards developing modern community based mental health services fo- cussed on deinstitutionalisation with extensive reduction of hospital-based long s[r]

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Developing the atlas of cancer in Queensland: methodological issues

Developing the atlas of cancer in Queensland: methodological issues

Since the 1978 declaration of Alma-Ata which high- lighted the need to address inequalities in health status [1], there have been important advancements for cancer outcomes. Many developed nations have seen improve- ments in cancer survival, notably for colorectal cancer, breast cancer, prostate cancer, non-Hodgkin lymphoma and leukaemia [2,3]. Also, incidence and mortality rates for some cancers have declined [4]. However, notable inequalities in these outcomes persist, with numerous international studies reporting disparities in cancer out- comes across socioeconomic status or urban/rural cate- gories [5-7].
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Protocol for a systematic review on the extent of non-publication of research studies and associated study characteristics

Protocol for a systematic review on the extent of non-publication of research studies and associated study characteristics

In response to these concerns the OPEN Project (To Overcome failure to Publish nEgative fiNdings) was de- veloped with the goal of elucidating the scope of non- publication of studies. The OPEN Project is a 24-month project co-funded by the European Commission under the Seventh Framework Programme. With an internatio- nal work group composed of key opinion leaders (for detailed information see Appendix), the project will first examine the current evidence on publication bias through a series of systematic reviews such as the one described in this protocol. Second, the OPEN Project will examine current practices by key groups in the field of biomedical research (namely funding agencies, the (pharmaceutical) industry, research ethics committees, research institutions, researchers, trial registries, biomedical journals, regulatory agencies, and benefit assessment agencies), through sur- veys, interviews, and analysis of current policies and gui- delines. These findings will be presented and discussed during an international workshop, which aims to develop recommendations for implementing effective measures to avoid non-publication of studies and related publication bias at all levels.
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Methodological issues in measures of imitative reaction times

Methodological issues in measures of imitative reaction times

Evidence for the existence of ‘mirror neurons’ (MNs) that might serve such a function has come from a range of neurophysiological and neuroimaging studies of human and non- human primates (Rizzolatti et al, 2001 ; Buccino et al, 2001), and the nature of these neurons has motivated much behavioural work. Nevertheless, whilst MNs have been shown to serve action-understanding their role in imitation is less clear. Monkeys with MNs do not imitate and thus simple matching of perceived action to motor representation appears to be insufficient for imitation to occur. Rather, imitation is a complex function that requires intentional commission rather than simple removal of inhibitory function.
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