Model-based Recursive Partitioning for Subgroup Analyses

The identification of patient subgroups with differential treatment effects is the first step towards individualised treatments. A current draft guideline by the EMA discusses potentials and problems in subgroup analyses and formulated challenges to the development of appropriate statistical procedures for the data-driven identification of patient subgroups. We introduce model-based recursive partitioning as a procedure for the automated detection of patient subgroups that are identifiable by predictive factors. The method starts with a model for the overall treatment effect as defined for the primary analysis in the study protocol and uses measures for detecting parameter instabilities in this treatment effect. The procedure produces a segmented model with differential treatment parameters corresponding to each patient subgroup. The subgroups are linked to predictive factors by means of a decision tree. The method is applied to the search for subgroups of patients suffering from amyotrophic lateral sclerosis that differ with respect to their Riluzole treatment effect, the only currently approved drug for this disease.Comment: 26 pages, 6 figure

Does Provision of an Evidence-Based Information Change Public Willingness to Accept a Screening Test ?

The basic requirement for patient decision making is the provision by the physician of an essential relevant and understandable information (Evidence Based) allowing him to decide whether he wish or not to receive the proposed treatment. This analysis shows that the willingness to undergo a doubtful screening test (about 70 % false positive responses) for a rare cancer by the general population change dramatically (60% versus 13,5%) according to the quality of information provided. This result, facing the impressive increase of diagnostic and screening procedures, could have important economical, ethical, clinical, public health and legal implications.health care markets; information; decision making; doctor-patient relationship; screening; diagnostic procedures; evidence based medicine; public health

Interventional radiology treatments for iatrogenic severe bleeding during percutaneous coronary interventions

Purpose: Interventional cardiology and interventional radiology are separate medical disciplines in which intra-arterial contrast media are used. Interventional cardiology has resigned from many types of treatment techniques that are now used and developed in the field of interventional radiology. In the event of iatrogenic bleeding during coronary interventions, there is an urgent need to use safe and efficient rescue procedures that are as efficient as cardiosurgery but use simpler treatment options. Serious perforations require immediate endovascular interventions. Medical history may reveal risk factors for artery perforation. Medicines, location of artery perforation, and extent of bleeding are directly associated with the prognosis. Most often, arterial perforations are due to inappropriate wire manipulation or use of oversized balloons or cutting balloons. Prolonged, artery-occluding balloon inflation, covered stent implantation, and embolisation with different agents are among the available treatment options for artery ruptures. Material and methods: A retrospective analysis was carried out among selected patients with iatrogenic vascular complications during procedures involving either coronary or non-coronary arteries. Results: Only representative cases were selected and presented in the patient subsection. Conclusions: Artery perforation during cardiac catheterisation can lead to dire consequences. To manage this complication, clinicians need pre-established procedures, adequate resources, and knowledge. Interventional radiology can be used as a salvage therapy in such cases

“It’s a matter of building bridges…” – feasibility of a carer involvement intervention for inpatients with severe mental illness

Background Family and friends (carer) involvement in the treatment of people with mental illness is widely recommended. However, the implementation remains poor, especially during hospital treatment, where carers report being excluded from care decisions. Methods We developed structured clinical procedures to maximise carer involvement in inpatient treatment. The aim of this study was to test their feasibility across four inpatient wards in East London and explore experiences of the participants. The intervention was delivered by clinicians (social therapists, nurses and psychiatrists) who were trained by the research team. Thirty patients and thirty carers received the intervention and completed research assessments and qualitative interviews after the intervention. 80% of the patients were followed up after six weeks of admission to complete quantitative questionnaires. Six clinicians were interviewed to explore their views on the intervention. Thematic analysis was used to analyse qualitative data. Results The intervention was found to be feasible to be delivered within the first week of admission in more than a half of the patients (53%) who provided consent. The main reasons why the interventions was not delivered in the remaining 47% of patients included staff or carers not being available, withdrawal of consent from the patient or patient being discharged prior to the intervention. Two themes were identified through thematic analysis. The first captured participant experiences of the intervention as facilitating a three-way collaborative approach to treatment. The second covered how patients’ mental states and practicalities of inpatient care acted as barriers and facilitators to the intervention being implemented. Conclusions Carer involvement in hospital treatment for mental illness is more difficult to implement than is commonly thought. This study has shown that a simple structured approach can facilitate a trialogue and that patients, clinicians and carers appreciate this approach to care. Our intervention provides clear and simple manualised clinical procedures that clinicians can follow. However, even the implementation of such procedures may be challenging in the absence of wider organisational support. The involvement of senior managers and clinical leaders might play a key role in overcoming barriers and support front-line clinicians to prioritise and implement carer involvement

ANALYSIS OF THE NATURE OF WORKS TO NEAR MISS EVENT AT CARING UNIT OF CIMACAN GENERAL HOSPITAL

Patient safety is an injury prevention system for patients by reducing the risk of adverse events associated with exposure to the diagnostic environment or medical treatment conditions. One of the factors that contribute to the patient's safety incident is the nature of work.The aim of this study is to analyze of the nature of works on near miss event (NME) at Cimacan General Hospital. This researchwas a descriptive quantitative research using secondary data from incident report and related document.There were 7 reports of NME in caring unit at Cimacan general hospital. Data analysis used descriptive analysis. Result of descriptive analysis, 5 respondents (71,83%) was non complex treatment, 2 respondents (28,73%) was complex treatment. Six respondents (85.7%) did not comply on procedures, 1 respondent (14.3%) adhered to procedures. Seven respondents (100%) were present at the time of near miss. Analysis of the nature of work on NME is an uncomplicated treatment, non-compliance with procedure, and present at the time of NME. Keywords: nature of work, near miss event, patient safet

Slathered, Zapped, Nipped, and Tucked: An Ethical Analysis of Cosmetic Dermatology

It has become common practice for dermatologists to offer cosmetic enhancing products and procedures and to do so alongside the medically required services offered (e.g., annual skin checks, treatment of rashes, removal of pre-cancerous moles, etc.). As a patient, it is likely that a visit to the dermatologist will include exposure to advertisements for these cosmetic products and procedures. Advertisements are found in the waiting area, examination room, and, in some cases, even at checkout in the form of a coupon for future use, all situated where the patient is a captive audience. This practice may not be the cause of our society’s ubiquitous focus on beauty as perfection; however, these practices arguably contribute to this culture, harming not only individual patients but also society as a whole. Further, since the physician’s endorsement of these products and procedures carries added weight, above and beyond that of a normal citizen or another non-medical professional, the impact on perpetuating a culture of beauty as perfection is even greater. Given this, in this essay I argue that the practice of dermatologists advertising, offering, and profiting from cosmetic enhancing products and procedures is unethical, violating the most basic bioethical principles. To demonstrate how this is the case I unpack how the culture of beauty as perfection is oppressive and therefore problematic; how dermatologist feed into, perpetuate, and profit from this culture; and how this practice is an ethical violation. Central to my analysis is an account of the commonly accepted bioethical principles within a framework of a social conception of the self. The implications of this analysis and findings include a need for clear guidelines offered by various medical oversight associations including the American Academy of Dermatology (AAD), the American Society for Dermatological Surgery (ASDS) and the American Medical Association (AMA). These guidelines should reflect a robust ethical analysis of this practice, ideally in conversation with the analysis offered herein. Once offered, physicians should follow these guidelines and, until then, should proceed with an abundance of caution, ideally ceasing to advertise, promote, or use biotechnologies in their practices for solely cosmetic reasons until more nuanced guidelines are available

At-home Cosmeceutical Application and Outpatient Treatments: A 3D Stepwise Facial Rejuvenation Approach

BACKGROUND: Aging affects the 3-dimensional structure of all the facial tissues: Bones, muscles, ligaments, adipose tissue, and skin. AIM: To customize minimally invasive treatments for facial rejuvenation, we present a standardized holistic approach characterized by at-home treatments in associations with outpatient procedures. METHODS: Forty-four patients underwent 3-dimensional stepwise facial rejuvenation and were evaluated prospectively. Each patient received a customized treatment plan based on a clinical examination and consultation. Treatment outcomes were evaluated from patient photographs with and skin analysis was performed with an A-One Smart automated skin analysis system. RESULTS: The mean age of the patients was 41.7 years and the approximate mean duration of treatment was 160 days. Patients applied cosmeceuticals such as retinoic acid. Outpatient procedures included the delivery of botulinum toxin or dermal fillers, thread lifting, chemical peels, etc. Upon treatment completion, significant improvements were noted in multiple domains: Skin elasticity and hydration increased, areas of hyper-pigmentation were less extensive, and there were fewer visible wrinkles and pores. CONCLUSION: Outcomes of the present article suggest how important is to customize facial anti-aging treatments. Nonsurgical treatments carried out progressively, involving the patient to perform at-home treatments in associations with outpatient procedures, let to achieve facial improvements in terms of increased skin elasticity and hydration, reduction of hyperpigmentation, wrinkles, and pores