Further Development Of Guidelines Research Articles

Diagnostic Dilemmas: A Review of Reported Cases of Human Herpesvirus 6 Encephalitis in Immunocompetent Adults

Abstract Human herpesvirus 6 (HHV-6) is associated with its presentation in the pediatric population as roseola infantum. Rarely, it is the causative agent of encephalitis, with most cases reported among the immunocompromised population due to reactivation. This review article analyzes the published records of cases labeled HHV-6 encephalitis in immunocompetent adults, aiming to understand the diagnostic methods behind each case and explore the complexities of such a diagnosis. We note significant variability in the methods used to come to a diagnosis of HHV-6 encephalitis, as well as inconsistent approaches to treatment of this condition. Given the rarity of HHV-6 encephalitis in immunocompetent adults, there are no clearly structured diagnostic guidelines for this condition in this patient population. We highlight several diagnostic methods that provide more convincing evidence of true HHV-6 encephalitis and may provide a basis for further development of guidelines for the diagnosis and treatment of this condition.

Communication with mechanically ventilated patients in intensive care units: A concept analysis.

The aim of this study was to perform a concept analysis of communication with mechanically ventilated patients in intensive care units and present a preliminary model for communication practice with these patients. The Im & Meleis approach for concept analysis guided the study. A literature search was performed in January 2022 in MEDLINE, Embase, CINAHL, psycINFO and Scopus, limited to 1998-2022. The main medical subject headings search terms used were artificial respiration, communication and critical care. The search resulted in 10,698 unique references. After a blinded review by two authors, 108 references were included. Core concepts and terminology related to communication with mechanically ventilated patients were defined by content analytic methods. The concepts were then grouped into main categories after proposing relationships between them. As a final step, a preliminary model for communication with mechanically ventilated patients was developed. We identified 39 different phrases to describe the mechanically ventilated patient. A total of 60 relevant concepts describing the communication with mechanically ventilated patients in intensive care were identified. The concepts were categorized into five main categories in a conceptual map. The preliminary model encompasses the unique communication practice when interacting with mechanically ventilated patients in intensive care units. Highlighting different perspectives of the communication between mechanically ventilated patients and providers through concept analysis has contributed to a deeper understanding of the phenomena and the complexity of communication when the patients have limited possibilities to express themselves. A clear definition of concepts is needed in the further development of guidelines and recommendations for patient care in intensive care, as well as in future research. The preliminary model will be tested further. No patient or public contribution, as this is a concept analysis of previous research.

Refugee-migration crisis in Europe and public health

Given the fact that migration is increasingly becoming part of the lives of European citizens and there is an unprecedented flow of refugees and migrants to Europe, the impact of migration on public health and the health of migrants and refugees, must be recognized as an important issue for public health policy making. These people are exposed to a variety of experiences, which affect their health and increase their susceptibility to various diseases during all stages of the migration progress. The purpose of this literature review was to investigate the impact of refugee-migration flow in Europe on public health. The access of these people to health services is an important aspect of their integration into society and of safeguarding public health. However, today, few EU countries provide equal access to health services for both migrants and refugees, as well as for the wider population of the host country. The range of health issues that can be associated with the migration of the populations is inevitably wide. This includes communicable and non-communicable diseases as well as work-related injuries. Further development of guidelines on access to health services is therefore needed, in order to improve the level of health and to avoid the emergence of secondary cases. Thus, the integration of refugees and migrants into the host countries will be reinforced and therefore public health will be safeguarded.

Theoretical fundamentals of quest excursions as an innovative method of providing excursion services

The aim of this article is to provide theoretical fundamentals of quest excursions as a means of domestic tourism development.
 Methodology. The author has used systemic and comparative approaches as well as a problem and analytical analysis to examine the principles, focus areas and the research trends at the market of excursion services, in particular — quest excursions.
 Results. The excursion services are an integral part of Ukrainian tourism industry, while the emergence of innovative methods only contributes to the development of the state economy. Quest excursions play an important role in terms of popularization domestic tourism, while demonstrating significant development potential. However, today there are some sporadic attempts to implement this area of excursion services, which can lead to errors in the organization and the formation of a negative attitude to quest excursions among tourists. This article offers theoretical principles that are designed to structure the process of organizing and implementing quest excursions. In particular, it offers a definition of this concept, provides a comparative analysis of traditional excursions and quest excursions and outlines the basic principles of such tours. It is noted that the main functions of the quest excursions include not only educational and informational, but also entertainment and animation functions. A comparative analysis has shown that the organization of quest excursions requires much more preparation, in contrast to traditional excursions. At the same time, the main difference is that during the quest excursions tourists receive information about excursion objects, sights, objects of an excursion route by themselves, in other words they become active participants of educational and entertaining process where the special role is given not only to information, but also to physical activities of the quest excursion. This paper also describes the main features of quest excursions organization which include such aspects: the requirements for the location, the content of quests, variants of routes organizing, requirements for tasks and quests, accompanying materials, advising tour groups in the process of excursion and the importance of analysis and optimization of quest excursions. The results of this study may become the basis for further researches, in particular for the development of guidelines for the organization and implementation of quest excursions.
 Novelty. The author of this paper offers generalized principles of organization and implementation of quest excursions at the Ukrainian market, which can be the basis for further researches.
 The practical significance. The proposed results of the study are important for ensuring a systematic approach to the development of quest excursions in Ukraine. In particular, the theoretical principles suggested in this paper can serve as a basis for further development of guidelines for the organization of quest excursions.

Association of Risk of Mortality in Pediatric Patients Transferred From Scene by Helicopter With Major But Not Minor Injuries.

Helicopter emergency medical services (HEMS) are used for 16% of pediatric trauma. National HEMS guidelines advised that triage criteria be standardized for pediatric patients. A national report found pediatric HEMS associated with decreased mortality compared with ground emergency medical services (GEMS) but did not control for transport time. We hypothesized that the rate of HEMS has decreased nationally and the mortality risk for HEMS to be similar when adjusting for transport time compared with GEMS. The Pediatric Trauma Quality Improvement Program (2014-2016) was queried for patients younger than 16 years transported by HEMS or GEMS. A multivariable logistic regression was used. From 25,647 patients, 4527 (17.7%) underwent HEMS. The rate of HEMS from scene decreased from 21.2% in 2014 to 18.2% in 2016. The rate of HEMS for minor trauma (Injury Severity Score <15) decreased from 14.9% in 2014 to 13.5% in 2016 and major trauma (Injury Severity Score > 15) from 38.4% in 2014 to 35.9% in 2016. After controlling for predictors of mortality and transport time, HEMS was associated with decreased risk of mortality for only those with major injuries transferred from scene (odds ratio, 0.48; 95% confidence interval, 0.26-0.88; P = 0.01) compared with GEMS. The rate of HEMS in pediatric trauma has decreased. However, there is room for improvement as 14% of those with minor trauma are transported by HEMS. Given the similar risk of mortality compared with GEMS, further development of guidelines that avoid the unnecessary use of HEMS appears warranted. However, utilization of HEMS for transport of pediatric major trauma should continue.

Determinants of Health and Safety Management in Construction Industry; the Case of Hengyang City, China

The construction industry promotes the development of national social economy and provides necessary infrastructure and enhanced facilities for social comfort. However, it is the most hazardous industries due to high occupational risks and unsatisfactory state of occupational health and safety. This study ascertains and evaluates the factors affecting health and safety management in the construction industries in area undergoing fast infrastructure development, Hengyang city. Two categories of construction industry were chosen for the quantitative study for which stratified sampling procedure was applied and simple random sampling was further used to select the key project participants from the various professional groups. In addition to the actual on-site observation questionnaires and interviews, the interviewees, opinions can also be derived. Statistical technique Relative Importance Index (RII) and Microsoft excel software are used to analyze the data, while the Kendall’s coefficient of concordance is used as a measure of agreement of ranking among factors affecting health and safety management. The analysis shows that the RII and the rank of factors affecting health and safety management in construction industry are vary with in the company categories. Health and safety policy, work environment, and health and safety inspection were ranked as the first three important factors affecting health and safety management in construction sites, respectively. Therefore, relevant stakeholders need to consider the establishment of a valuable management system based on local conditions to provide a strong guarantee for the health and safety of workers and sustainability maintenance of construction projects. This study will inspire future works to be done on the role of owners and the development of further guidelines to lessen the accidents in construction sites.

Treatment Options for Severe Acute Respiratory Syndrome, Middle East Respiratory Syndrome, and Coronavirus Disease 2019: a Review of Clinical Evidence.

Coronaviruses have caused serious Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), and Coronavirus Disease 2019 (COVID-19) outbreaks, and only remdesivir has been recently indicated for the treatment of COVID-19. In the line of therapeutic options for SARS and MERS, this study aims to summarize the current clinical evidence of treatment options for COVID-19. In general, the combination of antibiotics, ribavirin, and corticosteroids was considered as a standard treatment for patients with SARS. The addition of this conventional treatment with lopinavir/ritonavir, interferon, and convalescent plasma showed potential clinical improvement. For patients with MERS, ribavirin, lopinavir/ritonavir, interferon, and convalescent plasma were continuously recommended. However, a high-dose of corticosteroid was suggested for severe cases only. The use of lopinavir/ritonavir and convalescent plasma was commonly reported. There was limited evidence for the effect of corticosteroids, other antiviral drugs like ribavirin, and favipiravir. Monoclonal antibody of tocilizumab and antimalarial agents of chloroquine and hydroxychloroquine were also introduced. Among antibiotics for infection therapy, azithromycin was suggested. In conclusion, this study showed the up-to-date evidence of treatment options for COVID-19 that is helpful for the therapy selection and the development of further guidelines and recommendations. Updates of on-going clinical trials and observational studies may confirm the current findings.

Analytical validation of tests in laboratories of anatomic pathology: a Belgian population-based study

Laboratories of anatomic pathology have to validate each analytical test before it is implemented in daily routine. However, evidence-based guidelines regarding validation of analytical tests are limited. A 2016 survey on test validation was performed in all 77 licensed Belgian anatomic pathology laboratories in order to evaluate the implementation and to highlight the current issues of test validation in Belgian anatomic pathology laboratories. Therefore, standard operating procedures for test validation and validation reports were evaluated for the presence of predefined items. Separate validation procedures for CE/IVD-labeled, laboratory-modified and laboratory-developed tests and a description of how each performance characteristic was validated were lacking in 51 (66 %) laboratories. Moreover, only 9 (12 %) laboratories reported to have written procedures for when and how analytical tests need to be revalidated. Better results were observed regarding the description of the performance characteristics, the co-workers involved, recording and archiving of results and raw data, the content of the validation report, ongoing validation, release and implementation into daily routine. Contrary to the evaluation results of the procedures for test validation, better results for the content of the validation reports were obtained. A lack of clear and predefined objective acceptance criteria for each determined performance characteristic was the most common shortcoming observed in validation reports in Belgian anatomic pathology laboratories. In conclusion, there appears to be a need for further development of guidelines for validation and revalidation of analytical tests performed in anatomic pathology laboratories.

Governance of rapid response teams in Australia and New Zealand.

Rapid response systems (RRS) in hospitals in Australia and New Zealand (ANZ) have been present for more than 20 years but governance of the efferent limb-the rapid response team (RRT)-has not been previously reported in detail. The objectives of this study were to describe current governance arrangements for RRTs within ANZ and contrast those against expected implementation, using the Australian Commission for Safety and Quality in Health Care National Standard 9 (S9) as a benchmark. Assessment focused on S9 subclauses 9.1.1 (governance and oversight), 9.1.2 (RRT implementation), 9.2.3 (data collection and dissemination), 9.2.4 (quality improvement), 9.5.2 (call reviews), 9.6.1 and 9.6.2 (basic and advanced life support [ALS] skill set). We identified public and private hospitals across ANZ from government-maintained registers. Those reasonably expected to have an RRT were contacted and invited to participate. Responses were obtained via an online anonymised questionnaire. Three hundred and forty-two hospitals were contacted, of whom 284 (83.0%) responded. Two hundred and thirty-two hospitals submitted data, and the other 52 declined to participate or did not have an RRT. In hospitals with an intensive care unit (ICU), intensivist attendance at RRT calls occurred less often outside office hours (odds ratio, OR, 0.49, 95% confidence interval, CI, 0.32 to 0.75]). Where intensivists were not on the RRT, consultation with them about calls also occurred less often outside office hours (OR 0.39, 95% CI 0.22 to 0.66). Consultation with patients' admitting specialists occurred more often during office hours versus out of hours RRT calls and in private versus public hospitals. The presence of ICU staff on the RRT decreased the likelihood of admitting specialists being consulted about RRT calls (OR 0.66, 95% CI 0.47 to 0.93). Most hospitals maintained databases of RRT calls and regularly audited RRT activity (92% and 90% respectively). However, most (63.7%) did not make that information available beyond their hospital or local network. We concluded that the majority of hospitals in the ANZ region had governance mechanisms for their RRT. However, there was a notable lack of consistency, especially around specialist involvement and audit processes. Although some findings from this study are reassuring, there is still potential for improvement. Further development of guidelines and the establishment of a regional RRS database may assist with achieving this.

Optimization of surface measurement for metal additive manufacturing using coherence scanning interferometry

Surface topography measurement for metal additive manufacturing (AM) is a challenging task for contact and non-contact methods. In this paper, we present an experimental investigation of the use of coherence scanning interferometry (CSI) for measurement of AM surfaces. Our approach takes advantage of recent technical enhancements in CSI, including high dynamic range for light level and adjustable data acquisition rates for noise reduction. The investigation covers several typical metal AM surfaces made from different materials and AM processes. Recommendations for measurement optimisation balance three aspects: data coverage, measurement area and measurement time. This study also presents insight into areas of interest for future rigorous examination, such as measurement noise and further development of guidelines for the measurement of metal AM surfaces.

How much does it cost residents to prepare their property for wildfire?

Wildfire has resulted in significant loss of property and lives. Residents can improve the probability of survival of structures and themselves by undertaking suitable preparation. Only a small proportion of residents adequately prepare for wildfire with monetary and time costs cited as significant impediments. Few studies have quantified the monetary and time costs for residents to prepare. Here we use an online survey to estimate the extent to which cost drives the probability of a resident undertaking preparatory actions. Cost was found to be a significant driver if preparatory actions were being undertaken primarily for wildfire, but not if the preparatory actions were partially or primarily for other purposes, e.g. landscape maintenance. Approximate average costs for a resident to prepare for wildfire was $AUD 10,000, with a subsequent annual maintenance cost of $AUD 1000. Largest costs were related to altering landscaping features, e.g. fencing, positioning of garden beds. The paper argues that risks from landscape features could be reduced through further development of guidelines or standards for building in fire prone landscapes. Overall, two primary factors were found to predict the extent of preparation of a resident – planned future actions and their risk perception. Residents who intend to evacuate in the event of a wildfire are less likely to prepare than those that plan to stay and defend, which points to a problematic gap between official advice to prepare regardless of intended actions and public tendencies to only prepare if they intend to stay and defend.

Views of HIV-negative partners in heterosexual serodiscordant relationships regarding HIV pre-exposure prophylaxis: a qualitative study.

Background: Pre-exposure prophylaxis (PrEP) may be an effective option for HIV prevention among heterosexual serodiscordant couples. However, there are knowledge gaps in social research about PrEP in heterosexual serodiscordant relationships, including motivations and barriers to its use and possible impacts of PrEP uptake on the sexual practices of these couples. The aim of this study was to explore the views of HIV-negative men and women in stable serodiscordant heterosexual relationships about the possible use of PrEP. Methods: Semi-structured interviews were used to understand participants' views on the use of PrEP. Interviews were conducted face-to-face or by telephone and transcribed verbatim for thematic analysis. Results: In total, 13 HIV-negative partners were interviewed; six men and seven women. Participants demonstrated a high interest in the use of PrEP for conception. PrEP was also considered an option for general HIV prevention, although men saw more benefits for this use than women. Participants' main concerns around PrEP usage were about cost, efficacy, daily adherence and side-effects. HIV-positive partner support is likely to play a central role for PrEP uptake and adherence. Conclusions: This study is one of the first studies to explore the views of HIV-negative heterosexual partners in serodiscordant relationships around the use of PrEP while trying to conceive, as well as for general HIV prevention. These study results provide new insights for the further development of guidelines governing the use of PrEP for serodiscordant couples.

The Impact of an eHealth Portal on Health Care Professionals' Interaction with Patients: Qualitative Study.

BackgroundPeople who undergo weight loss surgery require a comprehensive treatment program to achieve successful outcomes. eHealth solutions, such as secure online portals, create new opportunities for improved health care delivery and care, but depend on the organizational delivery systems and on the health care professionals providing it. So far, these have received limited attention and the overall adoption of eHealth solutions remains low. In this study, a secure eHealth portal was implemented in a bariatric surgery clinic and offered to their patients. During the study period of 6 months, 60 patients and 5 health care professionals had access. The portal included patient information, self-management tools, and communication features for online dialog with peers and health care providers at the bariatric surgery clinic.ObjectiveThe aim of this study was to characterize and assess the impact of an eHealth portal on health care professionals’ interaction with patients in bariatric surgery.MethodsThis qualitative case study involved a field study consisting of contextual interviews at the clinic involving observing and speaking with personnel in their actual work environment. Semi-structured in-depth interviews were conducted with health care professionals who interacted with patients through the portal. Analysis of the collected material was done inductively using thematic analysis.ResultsThe analysis revealed two main dimensions of using an eHealth portal in bariatric surgery: the transparency it represents and the responsibility that follows by providing it. The professionals reported the eHealth portal as (1) a source of information, (2) a gateway to approach and facilitate the patients, (3) a medium for irrevocable postings, (4) a channel that exposes responsibility and competence, and (5) a tool in the clinic.ConclusionsBy providing an eHealth portal to patients in a bariatric surgery program, health care professionals can observe patients’ writings and revelations thereby capturing patient challenges and acting and implementing measures. Interacting with patients through the portal can prevent dropouts and deterioration of patients’ health. However, professionals report on organizational challenges and personal constraints related to communicating with patients in writing online. Further development of guidelines and education of health care professionals about how to handle, prioritize, communicate, and facilitate patients online is required in addition to increased attention to the organizational infrastructures and incentives for enabling such solutions in health care.

A case study of Facebook use: Outlining a multi-layer strategy for higher education

Many students are looking to appropriate social networking sites, amongst them, Facebook, to enhance their learning experience. A growing body of literature reports on the motivation of students and staff to engage with Facebook as a learning platform as well as mapping such activities to pedagogy and curricula. This paper presents student opinions of the use of a Facebook strategy within higher education through the use of focus groups. Results show that the Facebook strategy is useful in promoting collaborative learning alongside the face-to-face delivery of content. Participants rebuked the perceived blurring of educational and social purposes, which is prevalent in the literature, with the current structure allowing a clear divide between their different uses of the site. The development of further guidelines for the use of Facebook for education is encouraged and recommendations are provided.

Assessing children’s competence to consent in research by a standardized tool: a validity study

BackgroundCurrently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents.Methods/designIn this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment.DiscussionA validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish a reference standard of children’s competence to consent, combined with validation of an assessment instrument. Results can facilitate responsible involvement of children in clinical trials by further development of guidelines, health-care policies and legal policies.

Approaches to investigating common bleeding disorders: An evaluation of North American coagulation laboratory practices

Bleeding disorders commonly result from deficiencies or defects in von Willebrand factor (VWF), platelets, coagulation factors, or fibrinolytic proteins. The primary goal of our study was to assess current North American coagulation laboratory practices for diagnosing bleeding disorders, using an on-line patterns-of-practice survey of diagnostic laboratory members of the North American Specialized Coagulation Laboratory Association. The survey examined laboratory approaches to evaluating bleeding disorders, with specific questions about the tests and test panels offered and compliance to recent guideline recommendations on diagnosing von Willebrand disease (VWD) and platelet function disorders. All laboratories responding to the survey performed a prothrombin time/international normalized ratio, an activated partial thromboplastin time, and coagulation factor assays, and many tested for VWD and platelet disorders. However, few laboratories had test panels that evaluated the more common bleeding disorders and few performed some assays, including VWF multimer assessments and assays for fibrinolytic disorders. Additionally, the cutoffs used by laboratories to diagnose type 1 VWD varied considerably, with only a minority following the National Heart Lung Blood Institute recommendations. In contrast, laboratories that tested for platelet function disorders mostly complied with aggregation testing recommendations, as published in the recent North American guidelines. Our results indicate that there are some gaps in the strategies used by laboratories to diagnose bleeding disorders that might be addressed by development of further guidelines and test algorithms that emphasize evaluations for common bleeding disorders. Laboratories may also benefit from guidelines on test interpretation, and external evaluation of their bleeding disorder testing strategies.

Guidelines for rating Global Assessment of Functioning (GAF)

BackgroundGlobal Assessment of Functioning (GAF) is a scoring system for the severity of illness in psychiatry. It is used clinically in many countries, as well as in research, but studies have shown several problems with GAF, for example concerning its validity and reliability. Guidelines for rating are important. The present study aimed to identify the current status of guidelines for rating GAF, and relevant factors and gaps in knowledge for the development of improved guidelines.MethodsA thorough literature search was conducted.ResultsFew studies of existing guidelines have been conducted; existing guidelines are short; and rating has a subjective element. Seven main categories were identified as being important in relation to further development of guidelines: (1) general points about guidelines for rating GAF; (2) introduction to guidelines, with ground rules; (3) starting scoring at the top, middle or bottom level of the scale; (4) scoring for different time periods and of different values (highest, lowest or average); (5) the finer grading of the scale; (6) different guidelines for different conditions; and (7) different languages and cultures. Little information is available about how rules for rating are understood by different raters: the final score may be affected by whether the rater starts at the top, middle or bottom of the scale; there is little data on which value/combination of GAF values to record; guidelines for scoring within 10-point intervals are limited; there is little empirical information concerning the suitability of existing guidelines for different conditions and patient characteristics; and little is known about the effects of translation into different languages or of different cultural understanding.ConclusionsFew studies have dealt specifically with guidelines for rating GAF. Current guidelines for rating GAF are not comprehensive, and relevant points for new guidelines are presented. Theoretical and empirical studies, and international expert panels would be valuable, as well as production of a manual with more information about scoring. Computerised assessment may well be the future.

Out of hospital anticoagulant therapy in patients with acute pulmonary embolism is frequently practised but not perfect

Introduction Traditionally, patients with pulmonary embolism (PE) are treated in-hospital until they reach an adequate international normalized ratio (INR). Analogous to patients with a deep venous thrombosis, therapy with low-molecular-weight heparin facilitates out of hospital treatment of PE. We retrospectively analysed the current practice of early anticoagulant therapy in 86 acute PE patients with emphasis on the occurrence and safety of outpatient treatment. Methods Data were collected from two large regional teaching hospitals and from a specialized anticoagulation clinical, where patients were followed in the period after hospital discharge. The course of hospitalization and LMWH transitioning therapy and the quality of treatment in the first three months after diagnosis were compared between patients discharged before and patients discharged after reaching adequate INR. Results Forty-four patients (51.2%) were discharged early, before reaching an adequate INR, and 42 patients (48.8%) were discharged after reaching adequate INR. Early discharged patients needed more time to reach adequate INR compared to other patients (13 versus 6 days). In 28 patients (32.6%), the LMWH transitioning therapy was stopped prematurely; 21 patients were from the early discharged group. During the first 3 months, the mean individual times below, in and above the INR range were equal between the two groups. Conclusion Enhanced compliance to existing guidelines and tools, and further development of guidelines, with focus on intensification of monitoring of INR values in an outpatient setting and preventing premature discontinuation of transitioning therapy, are warranted for a safe and early discharge of stable patients with PE.

The Way Forward in Package Insert User Tests from a CRO’s Perspective

Introduction: A significant increase in the amount of text in package inserts has been observed over the last years. This study investigated the consequences of this increase. Method: Five package inserts available on the German medicine market in 2002 and five developed model versions were investigated in a crossover procedure using the written readability test.Results: The more extensive the package inserts, the worse patients feel informed. Increasing the amount of text significantly decreases the ability to locate information, thus putting people off from reading the contents (P ≤ 0.021).Discussion: The results suggest that decreasing the amount of text is a key factor, whereby a maximum of 1,500 words per package insert should be the aim. Conclusion: The way forward in package insert user testing is to concentrate on patient requirements and package insert improvements. Appropriate solutions are required for the further development of guidelines, templates, and directives.

Implications of the sentinel lymph node procedure for local and systemic adjuvant treatment

The objective of the sentinel lymph node procedure in breast cancer is to perform an accurate axillary staging and provide good local control, while sparing the patients the morbidity of an axillary lymph node dissection. Since its routine clinical use, questions were raised concerning the implications for local and systemic adjuvant treatment. This review provides an update of the recent literature. As a result of a more detailed histopathologic work-up of the sentinel lymph node, higher rates of lymph node metastases are detected. This leads to an upstaging of a subset of node-negative patients and an increase in the overall percentage of node-positive patients. However, the clinical implications of micrometastases and isolated tumor cells remain unclear. Furthermore, sentinel lymph nodes may be found in the internal mammary lymph node chain but the treatment of these nodes is subject of debate. Current guidelines recommend axillary lymph node dissection in patients with a positive sentinel node. The surgical removal of the internal mammary lymph node is only indicated in the context of a clinical trial. Radiation therapy of the axilla is an acceptable alternative for patients who refuse an axillary lymph node dissection (clinical trial). The value of radiotherapy to the internal mammary lymph node has never been established. Systemic treatment decisions in patients with a macrometastasis or micrometastasis in the sentinel lymph node follow the guidelines of node-positive patients, whereas in patients with isolated tumor cells only, guidelines for node-negative patients are followed. The results of ongoing clinical trials will be important for the development of further guidelines.