The article is an in-depth explanation of qualitative research, an approach increasingly prevalent among today's research communities. After discussing its present spread within the health sciences, the author addresses: 1. Its definition. 2. Its characteristics, as well as its theoretical and procedural background. 3. Its procedures. 4. Differences between qualitative and quantitative approaches. 5. Mixed methods incorporating quantitative research. And in conclusion: 6. The importance of establishing an epistemological perspective in qualitative research.
Recently, the practice of active learning has spread, increasingly recognized as an essential component of academic studies. Classes incorporating small group discussion (SGD) are conducted at many universities. At present, assessments of the effectiveness of SGD have mostly involved evaluation by questionnaires conducted by teachers, by peer assessment, and by self-evaluation of students. However, qualitative data, such as open-ended descriptions by students, have not been widely evaluated. As a result, we have been unable to analyze the processes and methods involved in how students acquire knowledge in SGD. In recent years, due to advances in information and communication technology (ICT), text mining has enabled the analysis of qualitative data. We therefore investigated whether the introduction of a learning system comprising the jigsaw method and problem-based learning (PBL) would improve student attitudes toward learning; we did this by text mining analysis of the content of student reports. We found that by applying the jigsaw method before PBL, we were able to improve student attitudes toward learning and increase the depth of their understanding of the area of study as a result of working with others. The use of text mining to analyze qualitative data also allowed us to understand the processes and methods by which students acquired knowledge in SGD and also changes in students’ understanding and performance based on improvements to the class. This finding suggests that the use of text mining to analyze qualitative data could enable teachers to evaluate the effectiveness of various methods employed to improve learning.
The ability to communicate effectively as a healthcare professional has come into greater focus as the role of pharmacists expands from “medicine-based” to “client-based” (e.g., working with patients, their families, and in multidisciplinary interactions). The ability to communicate cannot be acquired solely in the classroom; a large part of acquiring such skill is based on practical experience. Role-playing with simulated patients has already been implemented in pharmaceutical education; in that sense, opportunities to receive education in practical communication are increasing. However, in order to assure that these educational opportunities are more than “experiences” in theory alone, aspects of communications training that are satisfactory or need improvement must be clarified through empirical studies. While data used in pharmaceutical studies have mainly been quantitative in nature, data required for medical communication studies is generally more qualitative. Only recently the importance of qualitative research has been recognized in pharmaceutical studies, a field in which any aspect difficult to express numerically has been considered subjective, and thus less acceptable. Against this backdrop, this report introduces an aspect of communication research that employs the Roter method of interaction process analysis (RIAS), a medical communication analyzing method by Professor Debra Roter at Johns Hopkins University. RIAS is a quantitative analysis of qualitative data. I want to discuss the significance of using results of research based on qualitative data to improve the quality of communication.
When events lead to clinical problems, the mechanisms involved often remain unclear. This is true for medications and therapies, in addition to problems inherent in an underlying disease. However, the recent development of modeling and metric methods makes it possible to estimate the relationship between side effects and various factors to explain inter-individual differences, such as genetic polymorphisms, co-administered drugs, age, gender, dysfunction of the liver/kidney based upon the database for side effects [such as Food and Drug Administration-Adverse Event Reporting System (FDA-AERS)] and the database in a patient's medical records. Once the mechanisms for such clinical problems have been clarified, and after revisiting preclinical studies (animal models, in vitro cell systems, etc.), those outcomes may lead to drug discovery, the development of new therapies, and methods to prevent unique drug induced side effects. Reverse translational research (rTR) is such an approach, and a worthy aim of pharmaceutical scientists skilled at basic research. In this presentation, I would like to share with you our following recent studies: (1) rTR aimed at a therapy for progressive familial intrahepatic cholestasis 2 (PFIC 2). (2) rTR aimed at developing methods to predict drug-induced side effects based on single nucleotide polymorphisms (SNPs) information and a patient's medical records database. And (3) rTR aimed at predicting drug-drug interactions in which clinical outcomes have not been obtained, yet based upon previous clinically relevant drug interaction databases.
Clinical pharmacology and pharmacoepidemiology research may converge in practise. Pharmacoepidemiology is the study of pharmacotherapy and risk management in patient groups. For many drugs, adverse reaction(s) that were not seen and/or clarified during research and development stages have been reported in the real world. Pharmacoepidemiology can detect and verify adverse drug reactions as reverse translational research. Recently, development and effective use of medical information databases (MID) have been conducted in Japan and elsewhere for the purpose of post-marketing safety of drugs. The Ministry of Health, Labour and Welfare, Japan has been promoting the development of 10-million scale database in 10 hospitals and hospital groups as “the infrastructure project of medical information database (MID-NET)”. This project enables estimation of the frequency of adverse reactions, the distinction between drug-induced reactions and basal health-condition changes, and usefulness verification of administrative measures of drug safety. However, because the database information is different from detailed medical records, construction of methodologies for the detection and evaluation of adverse reactions is required. We have been performing database research using medical information system in some hospitals to establish and demonstrate useful methods for post-marketing safety. In this symposium, we aim to discuss the possibility of reverse translational research from clinical settings and provide an introduction to our research.
Proteins such as membrane transporters, enzymes, receptors and channels play key roles in drug absorption, distribution, metabolism, and elimination, and also influence efficacy and the likelihood of adverse reactions. Therefore, if we can quantify the activities of these molecules, it may be possible to predict the behavior of candidate drugs in humans in disease states; such methodology would be extremely helpful for efficient drug development. We have developed an in silico method to select appropriate peptides within amino acid sequences in order to quantify targeted proteins by LC-MS/MS in selected reaction monitoring (SRM) mode. We have applied this method for the quantification of functional proteins in order to validate various in vitro and in vivo models. We found fairly good correlation between protein amounts and the enzymatic activities of microsomal cytochrome P450 (CYP) isoforms and uridine 5′-diphospho-glucuronosyltransferase (UGT) in human liver, as well as between protein amounts and the transport activities of multiple transporters in human lung cells. These results suggest that protein quantification can be useful in predicting activity. We have applied this approach to evaluate the usefulness and limitations of an immortalized human brain capillary endothelial cell line (D3 cells) and a P-glycoprotein humanized (hMDR1) mouse model by comparing the amounts of functional proteins in the models with those in isolated capillaries from human brain. In order to obtain sufficient human tissue specimens for further studies leading to clinical applications, we believe that international collaboration will be crucial.
Corresponding with accelerated computing power, such as that found in supercomputers, simulation and big data are becoming increasingly important to modern science, second only to experimental and theoretical sciences research. The field of medicine is said to have entered the era of big data, with significant progress in recent years in the development of increasingly sophisticated equipment for measurement, observation, and information and communication technology (ICT). In particular, greater precision in personalized medicine will require the analysis of a large quantity of individual genome sequences. Research and development of techniques to analyze big data with respect to individual genome sequences are an urgent need. In clinical medicine and epidemiology, the analysis of clinical big data or real-world data has attracted attention as a new approach, which can be applied to examining occurrences at an actual clinical site. In this review, we have discussed the challenges and potential of an in silico approach for reverse translational research.
Since more than 70% of clinically used drugs are excreted from the body through metabolic processes, drug metabolism is a key determinant of pharmacokinetics, drug response and drug toxicity. Much progress has been made in understanding drug-drug interactions via the inhibition or induction of cytochrome P450s (P450, CYP), as well as the effects of genetic polymorphisms of P450s on pharmacokinetics, and this has facilitated the progress of optimized pharmacotherapy in the clinic. Now, similar information is needed for non-CYP enzymes, especially concerning Phase I enzymes, based on advanced basic and clinical studies. Recently, it was revealed that post-transcriptional regulation by microRNAs or RNA editing plays a significant role in regulating the expression of drug-metabolizing enzymes, thus conferring variability in the detoxification and metabolic activation of drugs or chemicals. Changes in the expression profile of microRNAs in tissues or body fluids can be a biomarker of drug response and toxicity; therefore, such studies could also be useful for drug repositioning. In addition, microRNAs are involved in pharmacogenetics, because single nucleotide polymorphisms in microRNA binding sites of mRNAs, or microRNAs themselves, may cause changes in gene expression. Some microRNA-related polymorphisms could be biomarkers of the clinical outcome of pharmacotherapy. In this review article, recent progress and future directions for drug metabolism studies are discussed.
The formation of bacterial biofilms and their disinfection and removal have been important subjects in the maintenance of water quality in areas such as public spas, swimming pools, food processing lines, industrial water systems, and in the hygienic control of medical devices, hospital procedures, etc. Presented here is an outline of biofilm formation, as well as studies on the disinfection and removal of biofilms by oxidizing biocides using established biofilms. These studies using established biofilms may increase the understanding of the variable response of biofilms to planktonic bacteria, and the unique aspects of oxidizing biocides in the disinfection and removal of biofilms.
In recent years, biological products (biologics), including blood components, recombinant therapeutic proteins, antibodies, gene therapeutic materials, and so on, have been produced by biotechnology methods and other novel technologies. These products are essential therapeutic materials in progressive medicine. However, we often encounter the lower permeability of these biologics through biomembranes, due to their high molecular mass. In the last three decades, we have investigated drug delivery systems, including several enhancement methods for the permeability of biologics such as recombinant therapeutic proteins and viral vectors in epithelial cells. This review focuses the development of novel delivery systems for biologics in rectal and nasal administration, and includes an interesting observation of modulators of the tight junction (TJ) function. From cellular biology perspective, the interaction between permeability enhancing materials and targeted molecules in the TJ of epithelial cells was investigated. We elucidated that a TJ modulator will interact with a major constituent protein, for instance claudins, in playing an essential role in the tissue-specific barrier function of the TJ. Furthermore, useful enhancement of gene transfer in cells (for instance, in Caco-2 cells) was found in the combination of an adenovirus vector and capric acid sodium salt (C10), a TJ modulator.
Collaboration with multiple healthcare professionals is important to provide safer and higher quality care. Interprofessional education (IPE) promotes the practice of team-based care. The establishment of Tsurumai-Meijo IPE, including interprofessional education and practice (IPEP) and video-teaching materials, was conducted in collaboration with school of medicine/nursing in Nagoya University and Fujita Health University, because Meijo University does not have its own clinical settings and faculties except for pharmacy. In the established Tsurumai-Meijo IPE, pharmacy, medicine, and nursing students interviewed simulated patients (SP) together or separately and practiced team-based care through Tsurumai-Meijo IPEP. Students could learn in advance and on their own about each professional's knowledge related to patient care by using video-teaching materials from the Meijo IPE homepage. Using a questionnaire survey at the end of program, this study was examined whether Tsurumai-Meijo IPEP, and video-teaching materials were useful for understanding importance of team-based care. More than 83% of students indicated that Tsurumai-Meijo IPE is useful on future clinical practice. This suggests that the program and materials are beneficial to the medical student education. In the optional survey of some clinical pharmacists, who had participated in Tsurumai-Meijo IPE before graduation, they utilized it in their work and it facilitated their work related to team-based care. Tsurumai-Meijo IPE collaborating with SP is likely to contribute to provide high quality and safe team-based care by taking advantage of specialized professional ability of healthcare professionals.
Pharmacy education comprises basic pharmacy (organic chemistry, biochemistry, and physical chemistry) and applied pharmacy (clinical pharmacy, pharm aceutics, and chemical hygiene). Students are expected to apply these subjects studied in pharmacy school during their practical pharmacy training. However, knowledge gained in university does not appear to be fully utilized in practice. We hypothesized that this is due to a lack of connection between pre-practical training education and actual practical training. Thus, we conducted a questionnaire study among pharmacy students to verify this hypothesis. We sent a questionnaire to 601 students in their sixth year of the pharmacy course at Chiba University, Teikyo University, or Kobe Pharmaceutical University who had undergone long-term practical training. The questionnaire asked about the utility of each subject of study and the reason for the judgement regarding the utility. Four hundred and forty-two students replied (response rate, 73.5%). A small proportion of students found the basic pharmacy subjects useful: physical chemistry, 5%; organic chemistry, 10%; and biochemistry, 24%. In contrast, more than half of the students found the clinical pharmacy subjects useful: pharmacology, 85%; pharmaceutics, 55%; pathophysiology, 75%; pharmacotherapeutics, 84%; and pharmaceutical regulations, 58%. Analysis of the comments left in the free-description section on the questionnaire revealed that most students did not have any opportunity to use their knowledge of the basic subjects during practical training, and furthermore, did not learn the processes involving the use of such subjects to solve clinical problems. Universities and pharmacists need to collaborate so that students can learn such processes.
The purpose of this study was to determine the density distribution of scored and round-faced tablets using synchrotron X-ray computed tomography. The tablets were made by direct compression of standard formulations. The density distribution of scored flat-faced tablets was uniform in the whole cross-sectional image. However, the tablet formulated using microcrystalline cellulose (MCC) was very dense at the tip of the score only. It is caused by the poor fluidity of MCC particles. In the case of round-faced tablets, the density in the central section of the tablet was relatively low, compared with those of peripheral areas. These observations correlated well with the results obtained by the finite element method simulation using appropriate material models.
Steroid ointments are frequently mixed with moisturizer. It was reported that steroid ointments mixed with moisturizer increase permeability. There are only few studies done on the permeability of the moisturizer. We researched moisturizing effect of heparinoid ointment (Hirudoid Soft ointment) diluted with white petrolatum (Propeto) on the dry skin models by measuring water content of stratum. Two to four fold dilution of Hirudoid to white petrolatum resulted in a significant decrease in the moisturizing effect of the active ingredient. There was no significant difference in moisturizing effect between four times diluted mixture and white petrolatum alone. This leads to the conclusion that steroid ointment mixture with moisturizer is frequently used, but we should take more caution regarding the decrease of moisturizing effect.
We evaluated the effects of pharmacist intervention for adverse drug reaction detection and exacerbation avoidance, as well as the severity and outcome of reactions based on analyses of pharmacist involvement in a collaborative approach to medicine. Of 5436 cases with pharmacist involvement, adverse drug reaction prevention was seen in 440, accounting for 8.1%, and exacerbation avoidance in 213, accounting for 3.9%. We concluded that pharmacist involvement contributes to detect adverse drug reactions and avoid exacerbation, and improves pharmacotherapy safety. We also analyzed 131 cases in which the course after intervention was followed. When categorized by adverse drug reaction severity, Grade 1 and 2 were the same at 45.8%, Grade 3 at 8.4%, respectively. Those findings suggested that pharmacist intervention contributes to early detection of an adverse drug reaction. Also, the relationship between clues for detecting adverse drug reactions by a pharmacist and their severity showed that objective evaluations such as clinical laboratory test results, physical assessments and medication history were important for detecting reactions that became more serious. Patients recovered or recovering from an adverse reaction comprised 76.4%, indicating that pharmacist intervention contributed to exacerbation avoidance and improvement. Our findings revealed the effects of pharmacist intervention for adverse drug reaction detection and exacerbation avoidance, and for safety improvement of pharmacotherapy. Additionally, we considered it necessary for the future pharmacist intervention to improve skills of assessing an adverse drug reaction objectively.
Nowadays, a lot of food ingredients are marketed as dietary supplements for health. Because the effectiveness and mechanisms of these compounds have not been fully characterized, they might have unknown functions. Therefore, we investigated the effect of several food ingredients (Bergamottin, Chrysin, L-Citrulline and β-Carotene) known as health foods on adipocyte differentiation by using 3T3-L1 preadipocytes. In this study, we found that Bergamottin, a furanocoumarin isolated from grapefruit juice, promotes adipocyte differentiation. In addition, Bergamottin increases the expression of adiponectin, an anti-inflammatory adipokine, and peroxisome proliferator activated receptor γ (PPARγ), a nuclear receptor regulating adipocyte differentiation. Furthermore, the anti-inflammatory activity of Bergamottin was demonstrated by its inhibition of the activation of nuclear factor-κB (NF-κB), an inflammatory transcription factor. Stimulation of mature 3T3-L1 adipocytes by tumor necrosis factor-α (TNF-α) decreased the expression of the endogeneous NF-κB inhibitor, IκBα. Treatment with Bergamottin further decreased the TNF-α-induced change in IκBα expression, suggesting that Bergamottin mediated the inhibition of NF-κB activation. In addition, Bergamottin decreased the TNF-α-induced increase in the mRNA levels of pro-inflammatory adipokines, monocyte chemoattractant protein-1 and interleukin-6. Taken together, our results show that Bergamottin treatment could inhibit inflammatory activity through promoting adipocyte differentiation, which in turn suggests that Bergamottin has the potential to minimize the risk factors of metabolic syndrome.
As a major chronic non-communicable disease, hypertension is the most important risk factor for cardiovascular disease, chronic kidney disease, stroke and, if not treated appropriately, premature death. A population-based approach aimed at decreasing high blood pressure among the general population is an important component of any comprehensive plan to prevent hypertension. However, few studies have investigated generational differences in knowledge about, and consciousness of, hypertension. Thus, we conducted a questionnaire survey about hypertension, with the aim of clarifying differences of understanding about hypertension between high school students and elderly people. The results of this investigation suggested that there is indeed a generational difference: knowledge about hypertension, and awareness of its relationship with salt intake, was higher in elderly people than in high school students. Furthermore, our study showed that among high school students, salt intake consciousness correlated with a family history of hypertension. By contrast, in elderly people, salt intake consciousness is related to age and to an awareness of recommended daily salt intake. This study strongly showed that knowledge and consciousness of hypertension varied among generations, with the elderly being more aware and conscientious about salt intake. Acknowledgement of this generational diversity is critical to developing an effective overall preventive strategy for hypertension.