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Objectives:
The aim was to identify theoretically expected as well as actually reported benefits from drug development and the importance of individual patient benefits compared to the collective benefits to society in general.
Background:
Ethical guidelines require that clinical research involving humans offer the potential for benefit. A number of characteristics can be applied to define research benefit. Often benefit is categorized as being either direct or indirect. Indirect benefits can involve collective benefits for society rather than any benefits to the trial patient or subject. The purpose of this review was to examine which potential individual and societal benefits were mentioned as being expected in publications from government experts and which were mentioned in publications describing completed drug development trial results.
Methods:
Literature on research benefit was first identified by searching the PubMed database using several combinations of the key words benefit and clinical research. The search was limited to articles published in English. A Google search with the same combinations of key words but without any language limitation was then performed. Additionally, the reference lists of promising articles were screened for further thematically related articles. Finally, a narrative review was performed of relevant English- and German-language articles published between 1996 and 2016 to identify which of several potential benefits were either theoretically expected or which were mentioned in publications on clinical drug development trial results.
Results:
The principal benefits from drug development discussed included 2 main types of benefit, namely individual benefits for the patients and collective benefits for society. Twenty-one of an overall total of 26 articles discussing theoretically expected benefits focused on individual patient benefits, whereas 17 out of 26 articles mentioned collective benefits to society. In these publications, the most commonly mentioned theoretically expected individual patient benefit was the chance to receive up-to-date care (38.1%). A general increase in knowledge about health care, treatments, or drugs (70.6%) was the most commonly mentioned theoretically expected benefit for society. In contrast, all 13 publications reporting actual benefits of clinical drug development trials focused on personal benefits and only 1 of these publications also mentioned a societal benefit. The most commonly mentioned individual benefit was an increased quality of life (53.9%), whereas the only mentioned collective benefit to society was a general gain of knowledge (100.0%).
Conclusions:
Both theoretically expected and actually reported benefits in the majority of the included publications emphasized the importance of individual patient benefits from drug development rather than the collective benefits to society in general. The authors of these publications emphasized the right of each individual patient or subject to look for and expect some personal benefit from participating in a clinical trial rather than considering societal benefit as a top priority. From an ethical point of view, the benefits each individual patient receives from his or her participation in a clinical trial might also be seen as a societal benefit, especially when the drug or device tested, if approved for marketing, would eventually be made available for other similar patients from the country in which the clinical trial was conducted.
Roads to Health in Developing Countries: Understanding the Intersection of Culture and Healing
(2017)
Background:
The most important attribute to which all human beings aspire is good health because it enables us to undertake different forms of activities of daily living. The emergence of scientific knowledge in Western societies has enabled scientists to explore and define several parameters of health by drawing boundaries around factors that are known to influence the attainment of good health. For example, the World Health Organization defined health by taking physical and psychological factors into consideration. Their definition of health also included a caveat that says, “not merely the absence of sickness.”
This definition has guided scientists and health care providers in the Western world in the development of health care programs in non-Western societies.
Objective:
However, ethnomedical beliefs about the cause(s) of illness have given rise to alternative theories of health, sickness, and treatment approaches in the developing world. Thus, there is another side to the story.
Method:
Much of the population in developing countries lives in rural settings where the knowledge of health, sickness, and care has evolved over centuries of practice and experience. The definition of health in these settings tends to orient toward cultural beliefs, traditional practices, and social relationships. Invariably, whereas biomedicine is the dominant medical system in Western societies, traditional medicine — or ethno-medicine — is often the first port of call for patients in developing countries.
Results:
The 2 medical systems represent, and are influenced by, the cultural environment in which they exist. On one hand, biomedicine is very effective in the treatment of objective, measurable disease conditions. On the other hand, ethnomedicine is effective in the management of illness conditions or the experience of disease states. Nevertheless, an attempt to supplant 1 system of care with another from a different cultural environment could pose enormous challenges in non-Western societies.
Conclusion:
In general, we, as human beings, are guided in our health care decisions by past experiences, family and friends, social networks, cultural beliefs, customs, tradition, professional knowledge, and intuition. No medical system has been shown to address all of these elements; hence, the need for collaboration, acceptance, and partnership between all systems of care in cultural communities. In developing countries, the roads to health are incomplete without an examination of the intersection of culture and healing. Perhaps mutual exclusiveness rather inclusiveness of these 2 dominant health systems is the greatest obstacle to health in developing countries.
Objective: To evaluate the impact of different dissemination channels on the awareness and usage of hospital performance reports among referring physicians, as well as the usefulness of such reports from the referring physicians’ perspective.
Data sources/Study setting: Primary data collected from a survey with 277 referring physicians (response rate = 26.2%) in Nuremberg, Germany (03–06/2016).
Study design: Cluster-randomised controlled trial at the practice level. Physician practices were randomly assigned to one of two conditions: (1) physicians in the control arm could become aware of the performance reports via mass media channels (Mass Media, npr MM=132, nph MM=147); (2) physicians in the intervention arm also received a printed version of the report via mail (Mass and Special Media, npr MSM=117; nph MSM=130). <br> Principal findings: Overall, 68% of respondents recalled hospital performance reports and 21% used them for referral decisions. Physicians from the Mass and Special Media group were more likely to be aware of the performance reports (OR 4.16; 95% CI 2.16–8.00, p < .001) but not more likely to be influenced when referring patients into hospitals (OR 1.73; 95% CI 0.72–4.12, p > .05). On a 1 (very good) to 6 (insufficient) scale, the usefulness of the performance reports was rated 3.67 (±1.40). Aggregated presentation formats were rated more helpful than detailed hospital quality information.
Conclusions: Hospital quality reports have limited impact on referral practices. To increase the latter, concerns raised by referring physicians must be given more weight. Those principally refer to the underlying data, the design of the reports, and the lack of important information.
Background: Physician-rating websites (PRWs) may lead to quality improvements in case they enable and establish a peer-to-peer communication between patients and physicians. Yet, we know little about whether and how physicians respond on the Web to patient ratings.
Objective: The objective of this study was to describe trends in physicians’ Web-based responses to patient ratings over time, to identify what physician characteristics influence Web-based responses, and to examine the topics physicians are likely to respond to.
Methods: We analyzed physician responses to more than 1 million patient ratings displayed on the German PRW, jameda, from 2010 to 2015. Quantitative analysis contained chi-square analyses and the Mann-Whitney U test. Quantitative content techniques were applied to determine the topics physicians respond to based on a randomly selected sample of 600 Web-based ratings and corresponding physician responses.
Results: Overall, physicians responded to 1.58% (16,640/1,052,347) of all Web-based ratings, with an increasing trend over time from 0.70% (157/22,355) in 2010 to 1.88% (6377/339,919) in 2015. Web-based ratings that were responded to had significantly worse rating results than ratings that were not responded to (2.15 vs 1.74, P<.001). Physicians who respond on the Web to patient ratings differ significantly from nonresponders regarding several characteristics such as gender and patient recommendation results (P<.001 each). Regarding scaled-survey rating elements, physicians were most likely to respond to the waiting time within the practice (19.4%, 99/509) and the time spent with the patient (18.3%, 110/600). Almost one-third of topics in narrative comments were answered by the physicians (30.66%, 382/1246).
Conclusions: So far, only a minority of physicians have taken the chance to respond on the Web to patient ratings. This is likely because of (1) the low awareness of PRWs among physicians, (2) the fact that only a few PRWs enable physicians to respond on the Web to patient ratings, and (3) the lack of an active moderator to establish peer-to-peer communication. PRW providers should foster more frequent communication between the patient and the physician and encourage physicians to respond on the Web to patient ratings. Further research is needed to learn more about the motivation of physicians to respond or not respond to Web-based patient ratings.
For indexing archived documents the Dutch Parliament uses a specialized thesaurus. For good results for full text retrieval and automatic classification it turns out to be important to add more synonyms to the existing thesaurus terms. In the present work we investigate the possibilities to find synonyms for terms of the parliaments thesaurus automatically. We propose to use distributional similarity (DS). In an experiment with pairs of synonyms and non-synonyms we train and test a classifier using distributional similarity and string similarity. Using ten-fold cross validation we were able to classify 75% of the pairs of a set of 6000 word pairs correctly.
A systematic review of the literature on survey questionnaires to assess self-medication practices
(2017)
Self-medication is of great public health importance as it often bypasses regulatory mechanisms to assure quality of health care. Nevertheless there are no established standards on how to assess self-medication. We therefore intended to systematically retrieve questionnaires and survey tools used to capture self-medication, with the aim to identify the scope of information investigated in this context and commonalities between the tools. We conducted a systematic review of the literature on questionnaires used for self-medication assessment by searching PubMed and Web of Science databases using the combinations of following keywords; self-medication, self-prescription, non-prescription, questionnaire. Truncation was used to ensure retrieval of all possible variations of search terms. The search was limited to articles published between 1st January 2000 and 31st December 2015, human studies and English language. Duplicate and irrelevant studies were excluded from the final review. A total of 158 studies were included in the review. Studies were from diverse geographical locations, most of the studies were from Nigeria 16 (10.1%) followed by India 10 (6.3%) and Iran 8 (5%). Forty-three studies (27.2%) focused on antibiotic self-medication. Majority of the studies (106; 67%) were done with adult populations. The components addressed by the questionnaires covered: reasons for self-medications in 147 (93%) studies, purchasing source in 136 (86%) studies, medical conditions to be treated in 153 (96.8%) studies, adverse events in 67 (42.4%) studies, use of prescribing information in 24 (15.1%) studies and antibiotic resistance awareness in 20 (46.5%) antibiotic studies. For 74 (46.8%) studies, survey questionnaires were self-administered and most studies (57; 36%) were done at homes of respondents. Thirty-seven (23.4%) studies did not report any recall period for self-medication practices. Study response rates varied from 17.9% to 100%, and while validity of the study questionnaire was reported for 100 (63.3%) studies, 15 (9.5%) studies reported reliability test of the study questionnaire. There is a large variety of questionnaires being used for investigating self-medication practices making comparability and meta-analyses very difficult. It is desirable to have a basic set of standardized survey questions on this topic to make available for future research groups in this field.
Antimicrobial resistance in livestock is a matter of general concern. To develop hygiene measures and methods for resistance prevention and control, epidemiological studies on a population level are needed to detect factors associated with antimicrobial resistance in livestock holdings. In general, regression models are used to describe these relationships between environmental factors and resistance outcome. Besides the study design, the correlation structures of the different outcomes of antibiotic resistance and structural zero measurements on the resistance outcome as well as on the exposure side are challenges for the epidemiological model building process. The use of appropriate regression models that acknowledge these complexities is essential to assure valid epidemiological interpretations. The aims of this paper are (i) to explain the model building process comparing several competing models for count data (negative binomial model, quasi-Poisson model, zero-inflated model, and hurdle model) and (ii) to compare these models using data from a cross-sectional study on antibiotic resistance in animal husbandry. These goals are essential to evaluate which model is most suitable to identify potential prevention measures. The dataset used as an example in our analyses was generated initially to study the prevalence and associated factors for the appearance of cefotaxime-resistant Escherichia coli in 48 German fattening pig farms. For each farm, the outcome was the count of samples with resistant bacteria. There was almost no overdispersion and only moderate evidence of excess zeros in the data. Our analyses show that it is essential to evaluate regression models in studies analyzing the relationship between environmental factors and antibiotic resistances in livestock. After model comparison based on evaluation of model predictions, Akaike information criterion, and Pearson residuals, here the hurdle model was judged to be the most appropriate model.
Background: Fall events contribute significantly to mortality, morbidity and costs in our ageing population. In order to identify persons at risk and to target preventive measures, many scores and assessment tools have been developed. These often require expertise and are costly to implement. Recent research investigates the use of wearable inertial sensors to provide objective data on motion features which can be used to assess individual fall risk automatically. So far it is unknown how well this new method performs in comparison with conventional fall risk assessment tools. The aim of our research is to compare the predictive performance of our new sensor-based method with conventional and established methods, based on prospective data.
Methods: In a first study phase, 119 inpatients of a geriatric clinic took part in motion measurements using a wireless triaxial accelerometer during a Timed Up&Go (TUG) test and a 20 m walk. Furthermore, the St. Thomas Risk Assessment Tool in Falling Elderly Inpatients (STRATIFY) was performed, and the multidisciplinary geriatric care team estimated the patients’ fall risk. In a second follow-up phase of the study, 46 of the participants were interviewed after one year, including a fall and activity assessment. The predictive performances of the TUG, the STRATIFY and team scores are compared. Furthermore, two automatically induced logistic regression models based on conventional clinical and assessment data (CONV) as well as sensor data (SENSOR) are matched.
Results: Among the risk assessment scores, the geriatric team score (sensitivity 56%, specificity 80%) outperforms STRATIFY and TUG. The induced logistic regression models CONV and SENSOR achieve similar performance values (sensitivity 68%/58%, specificity 74%/78%, AUC 0.74/0.72, +LR 2.64/2.61). Both models are able to identify more persons at risk than the simple scores.
Conclusions: Sensor-based objective measurements of motion parameters in geriatric patients can be used to assess individual fall risk, and our prediction model’s performance matches that of a model based on conventional clinical and assessment data. Sensor-based measurements using a small wearable device may contribute significant information to conventional methods and are feasible in an unsupervised setting. More prospective research is needed to assess the cost-benefit relation of our approach.
Background: In many research areas it is necessary to find differences between treatment groups with several variables. For example, studies of microarray data seek to find a significant difference in location parameters from zero or one for ratios thereof for each variable. However, in some studies a significant deviation of the difference in locations from zero (or 1 in terms of the ratio) is biologically meaningless. A relevant difference or ratio is sought in such cases.
Results: This article addresses the use of relevance-shifted tests on ratios for a multivariate parallel two-sample group design. Two empirical procedures are proposed which embed the relevanceshifted test on ratios. As both procedures test a hypothesis for each variable, the resulting multiple testing problem has to be considered. Hence, the procedures include a multiplicity correction. Both procedures are extensions of available procedures for point null hypotheses achieving exact control of the familywise error rate. Whereas the shift of the null hypothesis alone would give straight-forward solutions, the problems that are the reason for the empirical considerations discussed here arise by the fact that the shift is considered in both directions and the whole parameter space in between these two limits has to be accepted as null hypothesis.
Conclusion: The first algorithm to be discussed uses a permutation algorithm, and is appropriate for designs with a moderately large number of observations. However, many experiments have limited sample sizes. Then the second procedure might be more appropriate, where multiplicity is corrected according to a concept of data-driven order of hypotheses.