Long-term data from the Swiss pulmonary hypertension registry.

BACKGROUND Registries are important for real-life epidemiology on different pulmonary hypertension (PH) groups. OBJECTIVE To provide long-term data of the Swiss PH registry of 1998-2012. METHODS PH patients have been classified into 5 groups and registered upon written informed consent at 5 university and 8 associated hospitals since 1998. New York Heart Association (NYHA) class, 6-min walk distance, hemodynamics and therapy were registered at baseline. Patients were regularly followed, and therapy and events (death, transplantation, endarterectomy or loss to follow-up) registered. The data were stratified according to the time of diagnosis into prevalent before 2000 and incident during 2000-2004, 2005-2008 and 2009-2012. RESULTS From 996 (53% female) PH patients, 549 had pulmonary arterial hypertension (PAH), 36 PH due to left heart disease, 127 due to lung disease, 249 to chronic thromboembolic PH (CTEPH) and 35 to miscellaneous PH. Age and BMI significantly increased over time, whereas hemodynamic severity decreased. Overall, event-free survival was 84, 72, 64 and 58% for the years 1-4 and similar for time periods since 2000, but better during the more recent periods for PAH and CTEPH. Of all PAH cases, 89% had target medical therapy and 43% combination therapy. Of CTEPH patients, 14 and 2% underwent pulmonary endarterectomy or transplantation, respectively; 87% were treated with PAH target therapy. CONCLUSION Since 2000, the incident Swiss PH patients registered were older, hemodynamically better and mostly treated with PAH target therapies. Survival has been better for PAH and CTEPH diagnosed since 2008 compared with earlier diagnosis or other classifications.

New Sites, New Challenges? Ethical and Methodological Questions in the Context of Research on Migration Exclusion

The challenges of research ethics and methodologies have been reflected on extensively, but – aside from the context of feminist methodologies – less so in relation to research on particular migration sites such as in transit, detention centres, at the borders or within migration administration. First attempts in this direction have been made (Düvell et al. 2010, Fresia et al. 2005, Riedner 2014, van Liempt/Bilger2009), however, more reflection and theorization is needed, considering the contested nature of these temporal and volatile sites. In this workshop, we thus aim at examining methodological as well as ethical questions that arise during field work: We attempt to reflect the power relations involved in the research process, the ethics of research design, the dissemination of research results, the question of gaining access to and – whenever necessary – staying in contact with our research subjects. How can we negotiate informed consent with subjects whose life is currently marked by transit and insecurity concerning their own future, and who are in an uncertain situation in which substantial information (legal, social, cultural etc.) is likely to be missing? How do we deal with the dilemma of possibly contributing to knowledge production that might facilitate removals and deportations in the future, considering that the reception of the results is not in the hands of the researchers? How do we deal with the anticipated as well as unexpected impacts of our research on social and political practice? Regarding fieldwork in state institutions, how do we negotiate the multiple loyalties we often find ourselves faced with as social researchers, both with the excluded migrants and with the authorities implementing the exclusions – two groupings considered to be opposite to each other (Lavanchy 2013)? Which different roles do researchers need to take on? The aim of our workshop is first and foremost to exchange experiences on fieldwork with others doing qualitative research on related topics and to consider its possible implications – including affective dimensions – for all participants involved in the research process: the migrants, the security staff of detention centres, its social workers, border police and bureaucrats and, last but not least, the researchers themselves. Furthermore, we generally wish to reflect upon the question of how best to conduct research in this contested field, applying an interdisciplinary perspective.

Hepatitis C and human immunodeficiency virus infections in injecting drug users in drug treatment centers in Vietnam

Background. Injecting drug users (IDUs) are at risk of infection with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). Independently, each of these viruses is a serious threat to health, with HIV ravaging the body’s immune system, and HCV causing cirrhosis, liver cancer and liver failure. Co-infection with HIV/HCV weakens the response to antiretroviral therapy in HIV patients. IDUs with HIV/HCV co-infection are at a 20 times higher risk of having liver-related morbidity and mortality than IDUs with HIV alone. In Vietnam, studies to ascertain the prevalence of HIV have found high rates, but little is known about their HCV status. ^ Purpose. To measure the prevalence of HCV and HIV infection and identify factors associated with these viruses among IDUs at drug treatment centers in northern Vietnam. ^ Methods. A cross-sectional study was conducted from November 2007 to February 2008 with 455 injecting drug users aged 18 to 39 years, admitted no more than two months earlier to one of four treatment centers in Northern Vietnam (Hatay Province) (response rate=95%). Participants, all of whom had completed detoxification and provided informed consent, completed a risk assessment questionnaire and had their blood drawn to test for the presence of antibody-HCV and antibody-HIV with enzyme immuno assays. Univariate and multivariable logistic regression models were utilized to explore the strength of association using HIV, HCV infections and HIV/HCV co-infection as outcomes and demographic characteristics, drug use and sexual behaviors as factors associated with these outcomes. Unadjusted and adjusted odds ratios and 95% confidence intervals were calculated. ^ Results. Among all IDU study participants, the prevalence of HCV alone was 76.9%, HIV alone was 19.8%. The prevalence of HIV/HCV co-infection was 92.2% of HIV-positive and 23.7% of HCV-positive respondents. No sexual risk behaviors for lifetime, six months or 30 days prior to admission were significantly associated with HCV or HIV infection among these IDUs. Only duration of injection drug use was independently associated with HCV and HIV infection, respectively. Longer duration was associated with higher prevalence. Nevertheless, while HCV infection among IDUs who reported being in their first year of injecting drugs were lower than longer time injectors, their rates were still substantial, 67.5%. ^ Compared with either HCV mono-infection or HIV/HCV non-infection, HIV/HCV co-infection was associated with the length of drug injection history but was not associated with sexual behaviors. Higher education was associated with a lower prevalence of HIV/HCV co-infection. When compared with HIV/HCV non-infection, current marriage was associated with a lower prevalence of HIV/HCV co-infection. ^ Conclusions. HCV was prevalent among IDUs from 18 to 39 years old at four drug treatment centers in northern Vietnam. Co-infection with HCV was predominant among HIV-positive IDUs. HCV and HIV co-infection were closely associated with the length of injection drug history. Further research regarding HCV/HIV co-infection should include non-injecting drug users to assess the magnitude of sexual risk behaviors on HIV and HCV infection. (At these treatment centers non-IDUs constituted 10-20% of the population.) High prevalence of HCV prevalence among IDUs, especially among HIV-infected IDUs, suggests that drug treatment centers serving IDUs should include not only HIV prevention education but they should also include the prevention of viral hepatitis. In addition, IDUs who are HIV-positive need to be tested for HCV to receive the best course of therapy and achieve the best response to HIV treatment. These data also suggest that because many IDUs get infected with HCV in the first year of their injection drug career, and because they also engaged in high risk sexual behaviors, outreach programs should focus on harm reduction, safer drug use and sexual practices to prevent infection among drug users who have not yet begun injecting drugs and to prevent further spread of HCV, HIV and co-infection. ^

Factors contributing to the attrition of women in the African-American Nutrition for Life study

Background. There is currently a push to increase the number of minorities in cancer clinical trials in an effort to reduce cancer health disparities. Overcoming barriers to clinical trial research for minorities is necessary if we are to achieve the goals of Healthy People 2010. To understand the unexpectedly high rate of attrition in the A NULIFE study, the research team examined the perceived barriers to participation among minority women. The purpose of this study was to determine if either personal or study-related factors influenced healthy pre-menopausal women aged 25-45 years to terminate their participation in the A NULIFE Study. We hypothesized that personal factors were the driving forces for attrition rates in the prevention trial.^ Methods. The target population consisted of eligible women who consented to the A NULIFE study but withdrew prior to being randomized (N= 46), as well as eligible women who completed the informed consent process for the A NULIFE study and withdrew after randomization (N= 42). Examination of attrition rates in this study occurred at a time point when 10 out of 12 participant groups had completed the A NULIFE study. Data involving the 2 groups that were actively engaged in study activities were not used in this analysis. A survey instrument was designed to query the personal and study-related factors that were believed to have contributed to the decision to terminate participation in the A NULIFE study.^ Results. Overall, the highest ranked personal reason that influenced withdrawal from the study was being “too busy” with other obligations. The second highest ranked factor for withdrawal was work obligations. Whereas, more than half of all participants agreed that they were well-informed about the study and considered the study personnel to be approachable, 54% of participants would have been inclined to remain in the study if it were located at a local community center.^ Conclusions. Time commitment was likely a major factor for withdrawal from the A NULIFE study. Future investigators should implement trials within participant communities where possible. Also, focus group settings may provide detailed insight into factors that contribute to the attrition of minorities in cancer clinical trials.^

EVIDENCE OF HUMAN ENDOGENOUS RETROVIRUS K INVOLVEMENT IN HUMAN CANCER

Many lines of clinical and experimental evidence indicate a viral role in carcinogenesis (1-6). Our access to patient plasma, serum, and tissue samples from invasive breast cancer (N=19), ductal carcinoma in situ (N=13), malignant ovarian cancer (N=12), and benign ovarian tumors (N=9), via IRB-approved and informed consent protocols through M.D. Anderson Cancer Center, as well as normal donor plasmas purchased from Gulf Coast Regional Blood Center (N=6), has allowed us to survey primary patient blood and tissue samples, healthy donor blood from the general population, as well as commercially available human cell lines for the presence of human endogenous retrovirus K (HERV-K) Env viral RNA (vRNA), protein, and viral particles. We hypothesize that HERV-K proteins are tumor-associated antigens and as such can be profiled and targeted in patients for diagnostic and therapeutic purposes. To test this hypothesis, we employed isopycnic ultracentrifugation, a microplate-based reverse transcriptase enzyme activity assay, reverse transcription – polymerase chain reaction (RT-PCR), cDNA sequencing, SDS-PAGE and western blotting, immunofluorescent staining, confocal microscopy, and transmission electron microscopy to evaluate v HERV-K activation in cancer. Data from large numbers of patients tested by reverse transcriptase activity assay were analyzed statistically by t-test to determine the potential use of this assay as a diagnostic tool for cancer. Significant reverse transcriptase enzyme activity was detected in 75% of ovarian cancer patients, 53.8% of ductal carcinoma in situ patient, and 42.1% of invasive breast cancer patient samples. Only 11.1% of benign ovarian patient and 16.7% of normal donor samples tested positive. HERV-K Env vRNA, or Env SU were detected in the majority of cancer types screened, as demonstrated by the results shown herein, and were largely absent in normal controls. These findings support our hypothesis that the presence of HERV-K in patient blood circulation is an indicator of cancer or pre-malignancy in vivo, that the presence of HERV-K Env on tumor cell surfaces is indicative of malignant phenotype, and that HERV-K Env is a tumor-associated antigen useful not only as a diagnostic screening tool to predict patient disease status, but also as an exploitable therapeutic target for various novel antibody-based immunotherapies.

Long Term Follow-up of Morbidity and Quality of Life Associated with Isolated Gastroschisis

Gastroschisis is a birth defect in which an opening in the abdominal wall allows herniation of the viscera. Prenatal counseling regarding gastroschisis typically discusses that, although these infants often endure a difficult neonatal course, they experience few long-term complications. However, information regarding long-term outcomes is based on limited studies that lack specificity. Therefore, we aimed to study the long-term morbidity and quality of life in children born with gastroschisis in a large and diverse population drawn from the Texas Birth Defects Registry (TBDR). Study packets with informed consent, a questionnaire, and the Pediatric Quality of Life Inventory Generic Core Scale 4.0 (PedsQL 4.0) in English and Spanish were mailed to 1,112 parents of children born with isolated gastroschisis in Texas between 1999 and 2008 via the TBDR. Information was abstracted from the TBDR for 58 mothers of children with gastroschisis who returned study materials. Three hundred fifty five packets were returned to sender, giving a response rate of 7.7%. Children born with gastroschisis had quality of life scores that were not significantly different than expected (p = 0.981). However, factors such as having a learning disability (p = 0.001) and missing school due to gastrointestinal issues (p = 0.020) were found to significantly decrease quality of life. Overall, children with gastroschisis had a significantly increased risk for learning disabilities regardless of whether they were preterm (p = 0.021) or full term (p = 0.021). Additionally, there appeared to be an increased risk for auditory impairment in Caucasian children (p < 0.0005). Therefore, while overall long-term quality of life is not significantly altered for children born with gastroschisis, the previously unreported increased risk for learning disabilities and possible association with hearing impairment are important findings that should be conveyed to prospective parents.

La relación médico-paciente en las organizaciones sanitarias de atención primaria españolas. Una aproximación cualitativa

Antecedentes. La relación médico-paciente es aquella que se produce durante la interacción entre el usuario y el profesional. Esta ha ido cambiando a lo largo de la historia. En la actualidad, el paradigma emergente es el que autonomiza y empodera al usuario, en contraposición al tradicional paradigma paternalista. Objetivo. El objetivo de este trabajo es averiguar el estado del fenómeno sociológico del empoderamiento del paciente en España, desde el punto de vista de los profesionales sanitarios. Metodología. Se realizó un estudio exploratorio mediante una metodología cualitativa. La recolección de datos se basó en entrevistas estructuradas no estandarizadas. Se procedió al análisis del contenido a través de un proceso circular simultáneamente a la recolección de datos. Se complementó con un estudio de fuentes documentales bibliográficas a propósito de la temática abordada. Resultados. Los profesionales muestran una actitud positiva hacia el fenómeno del empoderamiento del paciente. Todavía se muestran escépticos ante la fiabilidad de la información sobre salud que se encuentra en internet y del criterio de los propios pacientes. Aun así, el máximo de autonomía del paciente, el consentimiento informado, sigue siendo considerado como una herramienta de protección del profesional. Discusión. Tras este estudio exploratorio se ha podido observar un cambio de actitud en el profesional respecto a la percepción que tiene sobre la evolución en la relación con el paciente. Se empieza a constatar que el fenómeno social se encuentra en un estado en el que los actores adquieren posturas más simétricas jerárquicamente.

Perspective maternelle de la consultation anténatale pour travail préterme : une approche relationnelle

Une femme à risque d’un accouchement prématuré vit un enjeu de santé très éprouvant et stressant ; elle sera souvent hospitalisée pour recevoir des traitements médicaux visant à prolonger la grossesse et améliorer le pronostic du bébé. Dans ce contexte, une consultation avec un néonatalogiste est demandée. Plusieurs associations professionnelles médicales ont émis des lignes directrices sur cette consultation, insistant sur le besoin d’informer les parents au sujet des complications potentielles de la prématurité pour leur enfant. Ces recommandations s’inspirent du point de vue médical, et très peu d’études ont examiné la perspective, les attentes et les besoins des parents à risque d’un accouchement prématuré. Ce projet de thèse a pour objectif de proposer un modèle de relation médecin-patient informé de la perspective maternelle de la consultation anténatale, pour développer une approche clinique répondant à leurs besoins. Afin d’examiner cette problématique de façon complète, un travail constant de va-et-vient a été effectué entre la recension de données empiriques et une réflexion normative bioéthique féministe. Un projet de recherche empirique a d’abord permis d’explorer les attentes et le vécu de ces femmes. Les participantes espéraient recevoir plus que de l’information sur les complications de la prématurité. Elles souhaitaient que le néonatologiste soit attentif à leur situation particulière et qu’il développe une relation de confiance avec elles, leur permettant d’explorer leurs futurs rôles de mères et les encourageant à formuler leurs propres questions. Le cadre théorique féministe d’autonomie relationnelle a ensuite permis de proposer une approche de soin qui sache répondre aux besoins identifiés par les patientes, tout en adressant des enjeux de pouvoir intrinsèques à la clinique, qui influencent la santé et l’autonomie de ces femmes. Cette approche insiste sur l’importance de la relation de soin en clinique, contrastant avec un modèle encourageant une vision réductrice de l’autonomie, dans laquelle un simple transfert de données scientifiques serait équivalent au respect de la norme médicolégale du consentement éclairé. Ce modèle relationnel propose des actions concrètes et pratiques, encourageant les cliniciens à entrer en relation avec chaque patiente et à considérer l’influence qu’ils exercent sur l’autonomie relationnelle de leurs patientes.

Who owns the child in hospital? A preliminary discussion

Aim. To 'own' a person is considered an infringement of human rights, but we suggest that concepts of ownership influence interactions between parents and staff when a child is admitted to hospital. This paper aims to stimulate debate and contains an explanation of the exploration of the literature for research and discussion of ownership of the child. Method. A wide variety of library indexes, databases and populist media were examined although it was impossible to examine all literature which may have contained references to this topic, and, apart from databases which contained abstracts in English, we could not include literature written in any language other than English, Swedish, and Icelandic. Findings. We found no research that examines how concepts of ownership of a child affects communication between health professionals and parents and, ultimately, the delivery of health care. This paper begins discussion on the issues. Discussion. Historical literature shows that ownership of humans has been a part of many cultures, and parents were once considered to own their children. Ownership of another has legal connotations, for instance in guardianship struggles of children during marriage breakup and in ethical debates over surrogacy and products of assisted conception. Within health care, it becomes a contentious issue in transplantation of body parts, in discourse on autonomy and informed consent, and for religious groups who refuse blood transfusions. In health care, models such as family centred care and partnership in care depend on positive communication between parents and staff. If a hospital staff member feels that he/she owns a child for whom he/she is caring, then conflict between the staff member and the parents over who has the 'best interests of the child' at heart is possible. Conclusion. We encourage debate about concepts of who owns the hospitalized child - the parents or the staff? Should it be argued at all? Is the whole concept of ownership of another, be it adult or child, the ethical antithesis to modern beliefs about human rights? Comment on this issue is invited.

Randomized trial of 8 Gy in 1 versus 20 Gy in 5 fractions of radiotherapy for neuropathic pain due to bone metastases (Trans-Tasman Radiation Oncology Group, TROG 96.05)

Background and purpose: Despite numerous randomized trials investigating radiotherapy (RT) fractionation schedules for painful bone metastases, there are very few data on RT for bone metastases causing pain with a neuropathic component. The Trans-Tasman Radiation Oncology Group undertook a randomized trial comparing the efficacy of a single 8 Gy (8/1) with 20 Gy in 5 fractions (20/5) for this type of pain. Materials and methods: Eligible patients had radiological evidence of bone metastases from a known malignancy with no change in systemic therapy within 6 weeks before or anticipated within 4 weeks after RT, no other metastases along the distribution of the neuropathic pain and no clinical or radiological evidence of cord/cauda equina compression. All patients gave written informed consent. Primary endpoints were pain response within 2 months of commencement of RT and time to treatment failure (TTF). The hypothesis was that 8/1 is at least as effective as 20/5 and the planned sample size was 270 patients. Results: Between February 1996 and December 2002, 272 patients were randomized (8/1:20/5 = 137:135) from 15 centres (Australia 11, New Zealand 3, UK 1). The commonest primary cancers were lung (31%), prostate (29%) and breast (8%); index sites were spine (89%), rib (9%), other (2%); 72% of patients were males and the median age was 67 (range 2989). The median overall survival (95% CI) for all randomized patients was 4.8 mo (4.2-5.7 mo). The intention-to-treat overall response rates (95% Cl) for 8/1 vs 20/5 were 53% (45-62%) vs 61% (53-70%), P = 0.18. Corresponding figures for complete response were 26% (18-34%) vs 27% (19-35%), P = 0.89. The estimated median TTFs (95% CI) were 2.4 mo (2.0-3.3 mo) vs 3.7 mo (3.1-5.9 mo) respectively. The hazard ratio (95% Cl) for the comparison of TTF curves was 1.35 (0.99-1.85), log-rank P = 0.056. There were no statistically significant differences in the rates of re-treatment, cord compression or pathological fracture by arm. Conclusions: 8/1 was not shown to be as effective as 20/5, nor was it statistically significantly worse. Outcomes were generally poorer for 8/1, although the quantitative differences were relatively small. (c) 2004 Elsevier Ireland Ltd. All rights reserved.

Access to death certificates: What should research ethics committees require for approval?

PURPOSE: To present and discuss the reactions of research ethics committees (RECs) in a number of countries when asked for approval Of a study requiring access to death certificates to identify the physicians signing the certificates and to send them a four-page questionnaire about medical decisions made at the patient's end-of-life that could possibly have hastened death. METHODS: A simple questionnaire were sent to the responsible national investigator in an international study (Australia, Belgium, Denmark, Italy, the Netherlands, Sweden, Switzerland) asking about the interactions between the national research group and the national/regional REC(s). RESULTS: Different laws or guidelines were used by the RECs. Denmark, the Netherlands, and Switzerland did not require an application to a REC. In Australia and Sweden, the RECs wanted changes in the research protocol, and one national research group had to refrain from publishing its results because the attrition rate became too high, probably due to the required changes in the protocol. RECOMMENDATIONS: Generally, similar demands from all RECs in relation to one project are strongly desirable. In epidemiological research, in which Voluntary completion of an anonymous questionnaire demonstrates consent, additional prior informed consent about being approached should not be required.

Prevalence of the use of cancer related self-tests by members of the public:A community survey

Background: Self-tests are those where an individual can obtain a result without recourse to a health professional, by getting a result immediately or by sending a sample to a laboratory that returns the result directly. Self-tests can be diagnostic, for disease monitoring, or both. There are currently tests for more than 20 different conditions available to the UK public, and self-testing is marketed as a way of alerting people to serious health problems so they can seek medical help. Almost nothing is known about the extent to which people self-test for cancer or why they do this. Self-tests for cancer could alter perceptions of risk and health behaviour, cause psychological morbidity and have a significant impact on the demand for healthcare. This study aims to gain an understanding of the frequency of self-testing for cancer and characteristics of users. Methods: Cross-sectional survey. Adults registered in participating general practices in the West Midlands Region, will be asked to complete a questionnaire that will collect socio-demographic information and basic data regarding previous and potential future use of self-test kits. The only exclusions will be people who the GP feels it would be inappropriate to send a questionnaire, for example because they are unable to give informed consent. Freepost envelopes will be included and non-responders will receive one reminder. Standardised prevalence rates will be estimated. Discussion: Cancer related self-tests, currently available from pharmacies or over the Internet, include faecal occult blood tests (related to bowel cancer), prostate specific antigen tests (related to prostate cancer), breast cancer kits (self examination guide) and haematuria tests (related to urinary tract cancers). The effect of an increase in self-testing for cancer is unknown but may be considerable: it may affect the delivery of population based screening programmes; empower patients or cause unnecessary anxiety; reduce costs on existing healthcare services or increase demand to investigate patients with positive test results. It is important that more is known about the characteristics of those who are using self-tests if we are to determine the potential impact on health services and the public. © 2006 Wilson et al; licensee BioMed Central Ltd.

Joint purchasers and the presumption of joint beneficial ownership:a matter of informed choice?

This paper examines the ruling of Jones v Kernott and shows the results of an empirical survey of conveyancing solicitors and their practices where so affected by the ruling. In particular the paper considers how conveyancing practitioners deal with the issue of organising trusts of land and giving advice to clients in relation to the co-purchase of land.

Diabetes Self Management: Are Cuban Americans Receiving Quality Health Care?

Objectives: We investigated the relationship among factors predicting inadequate glucose control among 182 Cuban-American adults (Females=110, Males=72) with type 2 diabetes mellitus (CAA). Study Design: Cross-sectional study of CAA from a randomized mailing list in two counties of South Florida Methods: Fasted blood parameters and anthropometric measures were collected during the study. BMI was calculated (kg/ m2). Characteristics and diabetes care of CAA were self-reported Participants were screened by trained interviewers for heritage and diabetes status (inclusion criteria: self-reported having type 2 diabetes; age  35 years, male and female; not pregnant or lactating; no thyroid disorders; no major psychiatric disorders). Participants signed informed consent form. Statistical analyses used SPSS and included descriptive statistic, multiple logistic and ordinal logistic regression models, where all CI 95%. Results: Eighty-eight percent of CAA had BMI of ≥ 25 kg/ m2. Only 54% reported having a diet prescribed/told to schedule meals. We found CAA told to schedule meals were 3.62 more likely to plan meals (1.81, 7.26), p<0.001) and given a prescribed diet, controlling for age, corresponded with following a meal plan OR 4.43 (2.52, 7.79, p<0.001). The overall relationship for HbA1c < 8.5 to following a meal plan was OR 9.34 (2.84, 30.7. p<0.001). Conclusions: The advantage of having a medical professional prescribe a diet seems to be an important environmental support factor in this sample’s diabetes care, since obesity rates are well above the national average. Nearly half CAA are not given dietary guidance, yet our results indicate CAA may improve glycemic control by receiving dietary instructions.