The design of a randomised controlled trial to evaluate the (cost-) effectiveness of the posterolateral versus the direct anterior approach for THA (POLADA - trial)

Background: Total hip arthroplasty (THA) is one of the most successful orthopaedic procedures. Because of the increasing number of THAs, a growing demand for faster recovery and a greater emphasis on cost-effectiveness, minimally invasive THAs have been introduced in the last decades. The direct anterior approach is a minimally invasive, tissue-sparing approach in which intermuscular planes are used. Theoretically, this approach should result in a faster recovery of physical functioning and higher health-related quality of life. Methods/design: A randomised controlled trial will be performed. Patients will be randomly allocated to undergo THA by means of the anterior or posterolateral approach. Both the intervention and control group will consist of two subgroups: 1) patients with a good bone stock who will receive an uncemented femoral stem, and 2) patients with a poor bone stock who will receive a cemented femoral stem. Patients between 18 and 90 years with primary or secondary osteoarthritis will be included. Physical functioning and health-related quality of life will be assessed by means of questionnaires. Additionally, performance based tests will be performed to objectively assess the physical functioning. Cost-effectiveness will be assessed by obtaining data on medical costs in and outside the hospital and other nonmedical costs. Measurements will take place preoperatively, two and six weeks, three months and one year postoperatively. Discussion: There is some evidence that the anterior approach results in reduced tissue damage and faster recovery in the direct postoperative period, compared to the posterolateral approach. However, there is still a lack of well-designed studies that have confirmed the better outcomes and cost-effectiveness of the anterior approach. Therefore, the purpose of this study is to assess the physical functioning, health related quality of life and the cost-effectiveness of the anterior approach, compared to the conventional posterolateral approach

Demonstrating functional equivalence of pilot and production scale freeze-drying of BCG

Drug Delivery Technolog

Enhanced Lacto-Tri-Peptide Bio-Availability by Co-Ingestion of Macronutrients

Some food-derived peptides possess bioactive properties, and may affect health positively. For example, the C-terminal lacto-tri-peptides Ile-Pro-Pro (IPP), Leu-Pro-Pro (LPP) and Val-Pro-Pro (VPP) (together named here XPP) are described to lower blood pressure. The bioactivity depends on their availability at the site of action. Quantitative trans-organ availability/kinetic measurements will provide more insight in C-terminal tri-peptides behavior in the body. We hypothesize that the composition of the meal will modify their systemic availability. We studied trans-organ XPP fluxes in catheterized pigs (25 kg; n=10) to determine systemic and portal availability, as well as renal and hepatic uptake of a water-based single dose of synthetic XPP and a XPP containing protein matrix (casein hydrolyte, CasH). In a second experiment (n=10), we compared the CasH-containing protein matrix with a CasH-containing meal matrix and the modifying effects of macronutrients in a meal on the availability (high carbohydrates, low quality protein, high fat, and fiber). Portal availability of synthetic XPP was 0.08 ± 0.01% of intake and increased when a protein matrix was present (respectively 3.1, 1.8 and 83 times for IPP, LPP and VPP). Difference between individual XPP was probably due to release from longer peptides. CasH prolonged portal bioavailability with 18 min (absorption half-life, synthetic XPP: 15 ± 2 min, CasH: 33 ± 3 min, p<0.0001) and increased systemic elimination with 20 min (synthetic XPP: 12 ± 2 min; CasH: 32 ± 3 min, p<0.0001). Subsequent renal and hepatic uptake is about 75% of the portal release. A meal containing CasH, increased portal 1.8 and systemic bioavailability 1.2 times. Low protein quality and fiber increased XPP systemic bioavailability further (respectively 1.5 and 1.4 times). We conclude that the amount and quality of the protein, and the presence of fiber in a meal, are the main factors that increase the systemic bioavailability of food-derived XPP

Are attitudes towards mental health help-seeking associated with service use? Results from the European Study of Epidemiology of Mental Disorders

To investigate the prevailing attitudes towards mental health help-seeking in Europe, their correlates, and whether these attitudes are associated with actual service use for mental health problems. Data were derived from the European Study of Epidemiology of Mental Disorders, a survey representative of the adult population of six countries: Belgium, France, Germany, Italy, the Netherlands and Spain (n = 8,796). The World Mental Health Composite International Diagnostic Interview was used to assess attitudes and DSM-IV diagnoses. The attitudes referred to beliefs that the respondents would seek professional help when faced with a serious emotional problem, would feel comfortable talking about personal problems with a professional, would not be embarrassed if friends knew about the professional help, and respondents' perceived effectiveness of mental health care. Almost a third of the respondents held the view that professional care was worse than or equal to no help when faced with serious emotional problems. Female gender, being younger than 65 years of age, high income, living in Spain or Italy, presence of mood disorder and previous service use were associated with at least two of the four assessed attitudes towards mental health help-seeking. All four attitudes were significantly associated with mental health care use, also after adjustment for previous service use. The low perceived effectiveness of professional care calls for serious action aiming to improve the visibility and credibility of the mental health care sector

Long-Term Weight Changes After Starting Anti-IL-5/5Ra Biologics in Severe Asthma: The Role of Oral Corticosteroids

BACKGROUND Many patients with severe asthma are overweight or obese, often attributed to unintentional weight gain as a side effect of oral corticosteroids (OCSs). Anti-IL-5/5Ra biologics significantly reduce OCS use, but their long-term effects on weight are unknown. OBJECTIVES To examine (1) weight change up to 2 years after anti-IL-5/5Ra initiation in subgroups on the basis of maintenance OCS use at start of treatment and (2) whether cumulative OCS exposure before or changes in OCS exposure during treatment are related to weight change. METHODS Real-world data on weight and cumulative OCS dose from adults included in the Dutch Registry of Adult Patients with Severe asthma for Optimal DIsease management before and at least 2 years after starting anti-IL-5/5Ra were analyzed using linear mixed models and linear regression analyses. RESULTS For the included 389 patients (55% female; mean body mass index, 28 ± 5 kg/m$^{2}$; 58% maintenance OCS), mean weight decreased -0.27 kg/y (95% CI, -0.51 to -0.03; P = .03), with more weight loss in patients with maintenance OCS use than in those without maintenance OCS use (-0.87 kg/y [95% CI, -1.21 to -0.52; P < .001] vs +0.54 kg/y [0.26 to 0.82; P < .001]). Greater weight loss at 2 years was associated with higher cumulative OCS dose in the 2 years before anti-IL-5/5Ra initiation (β = -0.24 kg/g; 95% CI, -0.38 to -0.10; P < .001) and, independently, greater reduction in cumulative OCS dose during follow-up (β = 0.27 kg/g; 95% CI, 0.11 to 0.43; P < .001). CONCLUSIONS Anti-IL-5/5Ra therapy is associated with long-term weight reduction, especially in patients with higher OCS exposure before treatment and those able to reduce OCS use during treatment. However, the effect is small and does not apply to all patients, and so additional interventions seem necessary if weight change is desired

Clinical Ethics in Gabon: The Spectrum of Clinical Ethical Issues Based on Findings from In-Depth Interviews at Three Public Hospitals

Introduction Unlike issues in biomedical research ethics, ethical challenges arising in daily clinical care in Sub-Saharan African countries have not yet been studied in a systematic manner. However this has to be seen as a distinct entity as we argue in this paper. Our aim was to give an overview of the spectrum of clinical ethical issues and to understand what influences clinical ethics in the Sub-Saharan country of Gabon. Materials and Methods In-depth interviews with 18 health care professionals were conducted at three hospital sites in Gabon. Interview transcripts were analyzed using a grounded theory approach (open and axial coding),giving a qualitative spectrum of categories for clinical ethical issues. Validity was checked at a meeting with study participants and other health care experts in Gabon after analysis of the data. Results Twelve main categories (with 28 further-specified subcategories) for clinical ethical issues were identified and grouped under three core categories: A) micro level: "confidentiality and information","interpersonal, relational and behavioral issues","psychological strain of individuals",and "scarce resources";B) meso level: "structural issues of medical institutions","issues with private clinics","challenges connected to the family",and "issues of education, training and competence";and C) macro level: "influence of society, culture, religion and superstition","applicability of western medicine","structural issues on the political level",and "legal issues". Discussion Interviewees reported a broad spectrum of clinical ethical issues that go beyond challenges related to scarce financial and human resources. Specific socio-cultural, historical and educational backgrounds also played an important role. In fact these influences are central to an understanding of clinical ethics in the studied local context. Further research in the region is necessary to put our study into perspective. As many participants reported a lack of awareness of ethical issues amongst other health care professionals in daily clinical practice, we suggest that international organizations and national medical schools should consider infrastructure and tools to improve context-sensitive capacity building in clinical ethics for Sub-Saharan African countries like Gabon

In what direction should we go to promote health in mental health care?

There is a growing recognition of the need for health promotion interventions in all health care today. In spite of this, health promotion interventions among patients with mental illnesses have been scarce in research, practice, and policies. There is also an ambiguous interpretation of the definition of health promotion in the literature. The emphasis in this paper is thus to (1) discuss why we should pay attention to the interpretations of the concept of health promotion and (2) present a possible model for what nurses do when they intend to promote health in mental health care. This paper was presented at the Nordic Conference of Mental Health Nursing in Helsinki, Finland in 2010

An overview of ethical frameworks in public health: can they be supportive in the evaluation of programs to prevent overweight?

Background. The prevention of overweight sometimes raises complex ethical questions. Ethical public health frameworks may be helpful in evaluating programs or policy for overweight prevention. We give an overview of the purpose, form and contents of such public health frameworks and investigate to which extent they are useful for evaluating programs to prevent overweight and/or obesity. Methods. Our search for frameworks consisted of three steps. Firstly, we asked experts in the field of ethics and public health for the frameworks they were aware of. Secondly, we performed a search in Pubmed. Thirdly, we checked literature references in the articles on frameworks we found. In total, we thus found six ethical frameworks. We assessed the area on which the available ethical frameworks focus, the users they target at, the type of policy or intervention they propose to address, and their aim. Further, we looked at their structure and content, that is, tools for guiding the analytic process, the main ethical principles or values, possible criteria for dealing with ethical conflicts, and the concrete policy issues they are applied to. Results. All frameworks aim to support public health professionals or policymakers. Most of them provide a set of values or principles that serve as a standard for evaluating policy. Most frameworks articulate both the positive ethical foundations for public health and ethical constraints or concerns. Some frameworks offer analytic tools for guiding the evaluative process. Procedural guidelines and concrete criteria for solving important ethical conflicts in the particular area of the prevention of overweight or obesity are mostly lacking. Conclusions. Public health ethical frameworks may be supportive in the evaluation of overweight prevention programs or policy, but seem to lack practical guidance to address ethical conflicts in this particular area