Gender comparisons in non-acute cardiac symptom recognition and subsequent help-seeking decisions: a mixed methods study protocol

Introduction: Coronary heart disease (CHD) is one of the leading causes of death in both men and women worldwide. Despite the common misconception that CHD is a ‘man's disease’, it is now well accepted that women endure worse clinical outcomes than men following CHD-related events. A number of studies have explored whether or not gender differences exist in patients presenting with CHD, and specifically whether women delay seeking help for cardiac conditions. UK and overseas studies on help-seeking for emergency cardiac events are contradictory, yet suggest that women often delay help-seeking. In addition, no studies have looked at presumed cardiac symptoms outside an emergency situation. Given the lack of understanding in this area, an explorative qualitative study on the gender differences in help-seeking for a non-emergency cardiac events is needed. Methods and analysis: A purposive sample of 20–30 participants of different ethnic backgrounds and ages attending a rapid access chest pain clinic will be recruited to achieve saturation. Semistructured interviews focusing on help-seeking decision-making for apparent cardiac symptoms will be undertaken. Interview data will be analysed thematically using qualitative software (NVivo) to understand any similarities and differences between the way men and women construct help-seeking. Findings will also be used to inform the preliminary development of a cardiac help-seeking intentions questionnaire. Ethics and dissemination: Ethical approvals were sought and granted. Namely, the University of Westminster (sponsor) and St Georges NHS Trust REC, and the Trust Research and Development Office granted approval to host the study on the Queen Mary's Roehampton site. The study is low risk, with interviews being conducted on hospital premises during working hours. Investigators will disseminate findings via presentations and publications. Participants will receive a written summary of the key findings.

Swiss clinical practice guidelines on field cancerization of the skin.

Actinic keratosis (AK) affects millions of people worldwide, and its prevalence continues to increase. AK lesions are caused by chronic ultraviolet radiation exposure, and the presence of two or more AK lesions along with photodamage should raise the consideration of a diagnosis of field cancerization. Effective treatment of individual lesions as well as field cancerization is essential for good long-term outcomes. The Swiss Registry of Actinic Keratosis Treatment (REAKT) Working Group has developed clinical practice guidelines for the treatment of field cancerization in patients who present with AK. These guidelines are intended to serve as a resource for physicians as to the most appropriate treatment and management of AK and field cancerization based on current evidence and the combined practical experience of the authors. Treatment of AK and field cancerization should be driven by consideration of relevant patient, disease, and treatment factors, and appropriate treatment decisions will differ from patient to patient. Prevention measures and screening recommendations are discussed, and special considerations related to management of immunocompromised patients are provided.

International survey of acute stroke imaging used to make revascularization treatment decisions.

BACKGROUND: To assess the differences across continental regions in terms of stroke imaging obtained for making acute revascularization therapy decisions, and to identify obstacles to participating in randomized trials involving multimodal imaging. METHODS: STroke Imaging Repository (STIR) and Virtual International Stroke Trials Archive (VISTA)-Imaging circulated an online survey through its website, through the websites of national professional societies from multiple countries as well as through email distribution lists from STIR and the above mentioned societies. RESULTS: We received responses from 223 centers (2 from Africa, 38 from Asia, 10 from Australia, 101 from Europe, 4 from Middle East, 55 from North America, 13 from South America). In combination, the sites surveyed administered acute revascularization therapy to a total of 25,326 acute stroke patients in 2012. Seventy-three percent of these patients received intravenous (i.v.) tissue plasminogen activator (tPA), and 27%, endovascular therapy. Vascular imaging was routinely obtained in 79% (152/193) of sites for endovascular therapy decisions, and also as part of standard IV tPA treatment decisions at 46% (92/198) of sites. Modality, availability and use of acute vascular and perfusion imaging before revascularization varied substantially between geographical areas. The main obstacles to participate in randomized trials involving multimodal imaging included: mainly insufficient research support and staff (50%, 79/158) and infrequent use of multimodal imaging (27%, 43/158) . CONCLUSION: There were significant variations among sites and geographical areas in terms of stroke imaging work-up used tomake decisions both for intravenous and endovascular revascularization. Clinical trials using advanced imaging as a selection tool for acute revascularization therapy should address the need for additional resources and technical support, and take into consideration the lack of routine use of such techniques in trial planning.

Collective learning within nursing clinical groups /

This qualitative study examined collective learning within nursing clinical groups. Specifically, it explored the influence of the individual on the group and the impact of the group on the individual. The study was organized using the concepts from Debbie Kilgore's theory of collective learning (1999). The sample consisted of 1 8 second-year university nursing students and 3 clinical instructors. Data were collected via individual interviews with each participant and researcher's observations during a group conference. The interviews were tape-recorded, transcribed, and analyzed using key concepts from Kilgore's framework. Several interesting findings emerged. Overall, it appeared that individual components and group components contributed to the quality and quantity of collective learning that occurred in the groups. Individually, each person's past group experiences, personality, culture, and gender influenced how that individual acted in the group, their roles, and how much influence they had over group decisions. Moreover, the situation which seemed to cause the greatest sense of helplessness and loss of control was when one of their group members was breaking a norm. They were unable to deal with such situations constructively. Also, the amount of sense of worthiness (respect) and sense of agency (control) the member felt within the group had an impact on the person's role in group decisions. Finally, it seemed that students felt more connected with their peers within the clinical setting when they were close with them on a personal and social level. With respect to the group elements, it seemed that the instructors' values and way of being were instrumental in shaping the group's identity. In group 2, there were clear examples of group consciousness and the students' need to go along with the majority viewpoint, even when it was contrary to their own beliefs. Finally, the common goal of passing clinical and dealing with the fears of being in the clinical setting brought solidarity among the group members, and there seemed to be a high level of positive interdependence among them. From the discussion and analysis of the findings, recommendations were given on how to improve the learning within clinical groups.

A Psychosocial Approach to Understanding Causality Assessment in Early Phase Oncology Clinical Trials: A Phenomenological Study

Research Question: What are the psychosocial factors that affect causality assessment in early phase oncology clinical trials? Methods: Thirty-two qualitative interviews were explicated with the aid of “Naturalistic Decision Making”. Data explication consisted of phenomenological reduction, delineating and clustering meaning units, forming themes, and creating a composite summary. Participants were members of the National Cancer Institute of Canada’s Clinical Trial Group Investigative New Drug committee. Results: The process of assigning causality is extremely subjective and full of uncertainty. Physicians had no formal training, nor a tool to assist them with this process. Physicians were apprehensive about their decisions and felt pressure from their patients, as well as the pharmaceutical companies sponsoring the trial. Conclusions: There are many problem areas when attributing causality, all of which have serious consequences, but clinicians used a variety of methods to cope with these problem areas.

An illustration of the modelling of cost and efficacy data from a clinical trial

Health care providers, purchasers and policy makers need to make informed decisions regarding the provision of cost-effective care. When a new health care intervention is to be compared with the current standard, an economic evaluation alongside an evaluation of health benefits provides useful information for the decision making process. We consider the information on cost-effectiveness which arises from an individual clinical trial comparing the two interventions. Recent methods for conducting a cost-effectiveness analysis for a clinical trial have focused on the net benefit parameter. The net benefit parameter, a function of costs and health benefits, is positive if the new intervention is cost-effective compared with the standard. In this paper we describe frequentist and Bayesian approaches to cost-effectiveness analysis which have been suggested in the literature and apply them to data from a clinical trial comparing laparoscopic surgery with open mesh surgery for the repair of inguinal hernias. We extend the Bayesian model to allow the total cost to be divided into a number of different components. The advantages and disadvantages of the different approaches are discussed. In January 2001, NICE issued guidance on the type of surgery to be used for inguinal hernia repair. We discuss our example in the light of this information. Copyright © 2003 John Wiley & Sons, Ltd.

Assessing behavioural manifestations prior to clinical diagnosis of Huntington disease: "anger and irritability" and "obsessions and compulsions"

The Functional Rating Scale Taskforce for pre-Huntington Disease (FuRST-pHD) is a multinational, multidisciplinary initiative with the goal of developing a data-driven, comprehensive, psychometrically sound, rating scale for assessing symptoms and functional ability in prodromal and early Huntington disease (HD) gene expansion carriers. The process involves input from numerous sources to identify relevant symptom domains, including HD individuals, caregivers, and experts from a variety of fields, as well as knowledge gained from the analysis of data from ongoing large-scale studies in HD using existing clinical scales. This is an iterative process in which an ongoing series of field tests in prodromal (prHD) and early HD individuals provides the team with data on which to make decisions regarding which questions should undergo further development or testing and which should be excluded. We report here the development and assessment of the first iteration of interview questions aimed to assess "Anger and Irritability" and "Obsessions and Compulsions" in prHD individuals.

Effect of patient age on management decisions in breast cancer: consensus from a national consultation

This qualitative study investigated the attitudes, perceptions, and practices of breast cancer specialists with reference to the effect of patient age on management decisions in breast cancer, and attempted to identify national consensus on this issue. One hundred thirty-three relevant specialists, including 75 surgeons and 43 oncologists, participated in a virtual consultation using e-mailed questionnaires and open-ended discussion documents, culminating in the development of proposed consensus statements sent to participants for validation. A strong consensus was seen in favor of incorporating minimum standards of diagnostic services, treatment, and care for older patients with breast cancer into relevant national guidance, endorsed by professional bodies. Similarly, an overwhelming majority of participants agreed that simple, evidence-based protocols or guidelines on standardizing assessment of biological and chronological age should be produced by the National Institute for Health and Clinical Excellence and the Scottish Medicines Consortium, developed in collaboration with specialist oncogeriatricians, and endorsed by professional bodies. A further recommendation that all breast cancer patient treatment and diagnostic procedures be undertaken in light of up-to-date, relevant scientific data met with majority support. This study was successful in gauging national specialist opinion regarding the effect of patient age on management decisions in breast cancer in the U.K.

Are clinical documents optimised for patient safety? A critical analysis of patient safety outcomes using the EDA error model

Iatrogenic errors and patient safety in clinical processes are an increasing concern. The quality of process information in hardcopy or electronic form can heavily influence clinical behaviour and decision making errors. Little work has been undertaken to assess the safety impact of clinical process planning documents guiding the clinical actions and decisions. This paper investigates the clinical process documents used in elective surgery and their impact on latent and active clinical errors. Eight clinicians from a large health trust underwent extensive semi- structured interviews to understand their use of clinical documents, and their perceived impact on errors and patient safety. Samples of the key types of document used were analysed. Theories of latent organisational and active errors from the literature were combined with the EDA semiotics model of behaviour and decision making to propose the EDA Error Model. This model enabled us to identify perceptual, evaluation, knowledge and action error types and approaches to reducing their causes. The EDA error model was then used to analyse sample documents and identify error sources and controls. Types of knowledge artefact structures used in the documents were identified and assessed in terms of safety impact. This approach was combined with analysis of the questionnaire findings using existing error knowledge from the literature. The results identified a number of document and knowledge artefact issues that give rise to latent and active errors and also issues concerning medical culture and teamwork together with recommendations for further work.

Incorporating semiotics into fuzzy logic to enhance Clinical Decision Support Systems

In order to enhance the quality of care, healthcare organisations are increasingly resorting to clinical decision support systems (CDSSs), which provide physicians with appropriate health care decisions or recommendations. However, how to explicitly represent the diverse vague medical knowledge and effectively reason in the decision-making process are still problems we are confronted. In this paper, we incorporate semiotics into fuzzy logic to enhance CDSSs with the aim of providing both the abilities of describing medical domain concepts contextually and reasoning with vague knowledge. A semiotically inspired fuzzy CDSSs framework is presented, based on which the vague knowledge representation and reasoning process are demonstrated.

Culture, compassion and clinical neglect: probity in the NHS after Mid Staffordshire

Speaking of the public response to the deaths of children at the Bristol Royal Infirmary before 2001, the BMJ commented that the NHS would be 'all changed, changed utterly'. Today, two inquiries into the Mid Staffordshire Foundation Trust suggest nothing changed at all. Many patients died as a result of their care and the stories of indifference and neglect there are harrowing. Yet Bristol and Mid Staffordshire are not isolated reports. In 2011, the Health Services Ombudsman reported on the care of elderly and frail patients in the NHS and found a failure to recognise their humanity and individuality and to respond to them with sensitivity, compassion and professionalism. Likewise, the Care Quality Commission and Healthcare Commission received complaints from patients and relatives about the quality of nursing care. These included patients not being fed, patients left in soiled bedding, poor hygiene practices, and general disregard for privacy and dignity. Why is there such tolerance of poor clinical standards? We need a better understanding of the circumstances that can lead to these outcomes and how best to respond to them. We discuss the findings of these and other reports and consider whether attention should be devoted to managing individual behaviour, or focus on the systemic influences which predispose hospital staff to behave in this way. Lastly, we consider whether we should look further afield to cognitive psychology to better understand how clinicians and managers make decisions?

Autofluorescence spectroscopy in liver transplantation: Preliminary results from a pilot clinical study

The evaluation of graft function at various stages after transplantation is relevant, particularly at the moment of organ harvest, when a decision must be made whether to use the organ. Autofluorescence spectroscopy is noninvasive technique to monitor the metabolic condition of a liver graft throughout its course, from an initial evaluation in the donor, through cold ischemia transportation, to reperfusion and reoxygenation in the recipient. Preliminary results are presented in six liver transplantations spanning the periods from liver harvest to implant. The laser-induced fluorescence spectrum at 532-mn excitation was investigated before cold perfusion (autofluorescence), during cold ischemia, at the back table procedure, as well as 5 and 60 minutes after reperfusion. The results showed that the fluorescence analysis was sensitive to changes during the transplantation procedure. Fluorescence spectroscopy potentially provides a real-time, noninvasive technique to monitor liver graft function. The information could potentially be valuable for surgical decisions and transplant success.

In Vitro Evaluation of ICDAS and Radiographic Examination of Occlusal Surfaces and Their Association With Treatment Decisions

This in vitro study evaluated the performance of visual (International Caries Detection and Assessment System [ICDAS]) and radiographic (bitewing [BW]) examinations for occlusal caries detection and their associations with treatment decision (TD). Permanent teeth (n=104) with occlusal surfaces varying from sound to cavitated were selected. Sites were identified from 10x occlusal surface photographs. Standardized bitewing (BW) radiographs were taken. Four dentists with at least five years of experience scored all teeth twice (one-week interval) for ICDAS (0-6), BW (0=sound, 1=caries restricted to enamel, 2=caries in outer third dentin, 3=caries in inner third dentin), and TD (0=no treatment, 1=sealant, 2=microabrasion and sealant, 3=round bur sealant, 4a=resin, 4b=amalgam). Histological validation was performed by observation under a light microscope, with lesions classified on a five-point scale. Intraexaminer and inter-examiner repeatability were assessed using two-way tables and intraclass correlation coefficients (ICCs). Comparisons between percentage correct, specificity, sensitivity, and area under the receiver-operating characteristic (ROC) curve were performed using bootstrap analyses. ICCs for intraexaminer and interexaminer repeatability indicated good repeatability for each examiner, ranging from 0.78 to 0.88, and among examiners, ranging from 0.74 to 0.81. Correlation between ICDAS and TD was 0.85 and between BW and TD was 0.78. Correlation between the methods and histological scores was moderate (0.63 for ICDAS and 0.61 for BW). The area under the ROC curve was significantly greater for ICDAS than for BW (p<0.0001). ICDAS had significantly lower specificity than BW did (p=0.0269, 79% vs 94%); however, sensitivity was much higher for ICDAS than for BW (p<0.0001, 83% vs 44%). Data from this investigation suggested that the visual examination (ICDAS) showed better performance than radiographic examination for occlusal caries detection. The ICDAS was strongly associated with TD. Although the correlation between the ICDAS and BW was lower, it is still valuable in the clinical decision-making process.

Using Machine Learning Classifiers to Assist Healthcare-Related Decisions: Classification of Electronic Patient Records

Surveillance Levels (SLs) are categories for medical patients (used in Brazil) that represent different types of medical recommendations. SLs are defined according to risk factors and the medical and developmental history of patients. Each SL is associated with specific educational and clinical measures. The objective of the present paper was to verify computer-aided, automatic assignment of SLs. The present paper proposes a computer-aided approach for automatic recommendation of SLs. The approach is based on the classification of information from patient electronic records. For this purpose, a software architecture composed of three layers was developed. The architecture is formed by a classification layer that includes a linguistic module and machine learning classification modules. The classification layer allows for the use of different classification methods, including the use of preprocessed, normalized language data drawn from the linguistic module. We report the verification and validation of the software architecture in a Brazilian pediatric healthcare institution. The results indicate that selection of attributes can have a great effect on the performance of the system. Nonetheless, our automatic recommendation of surveillance level can still benefit from improvements in processing procedures when the linguistic module is applied prior to classification. Results from our efforts can be applied to different types of medical systems. The results of systems supported by the framework presented in this paper may be used by healthcare and governmental institutions to improve healthcare services in terms of establishing preventive measures and alerting authorities about the possibility of an epidemic.

ESMO Consensus Guidelines for management of patients with colon and rectal cancer. A personalized approach to clinical decision making

Colorectal cancer (CRC) is the most common tumour type in both sexes combined in Western countries. Although screening programmes including the implementation of faecal occult blood test and colonoscopy might be able to reduce mortality by removing precursor lesions and by making diagnosis at an earlier stage, the burden of disease and mortality is still high. Improvement of diagnostic and treatment options increased staging accuracy, functional outcome for early stages as well as survival. Although high quality surgery is still the mainstay of curative treatment, the management of CRC must be a multi-modal approach performed by an experienced multi-disciplinary expert team. Optimal choice of the individual treatment modality according to disease localization and extent, tumour biology and patient factors is able to maintain quality of life, enables long-term survival and even cure in selected patients by a combination of chemotherapy and surgery. Treatment decisions must be based on the available evidence, which has been the basis for this consensus conference-based guideline delivering a clear proposal for diagnostic and treatment measures in each stage of rectal and colon cancer and the individual clinical situations. This ESMO guideline is recommended to be used as the basis for treatment and management decisions.