Core information sets for informed consent to surgical interventions:baseline information of importance to patients and clinicians

Abstract Background Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient’s values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge the information needs of the individual patient. The aim of this paper is to describe ‘core information sets’ which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. Main body The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this ‘core information’. We propose that such information addresses the ‘reasonable patient’ standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. Conclusion The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice

Learning contexts at two UK medical schools: A comparative study using mixed methods

Introduction: The context in which learning takes place exerts a powerful effect on the approach learners take to their work. In some instances learners will be forced by the nature of a task to adopt a less-favoured approach. In this study, we used a combination of qualitative and quantitative methods to compare the effect of context on learning at different UK medical schools. We compared schools with conventional, and problem-based curricula. Method: We had collected data from 30 interviews with third year medical students in one UK medical school with a conventional, lecture-based curriculum in relation to a previous study. The interview guide had explored effects of context and approach to learning. We used the same guide to interview 6 students in another UK medical school with a problem-based curriculum. We then put together a pack of validated questionnaires, which measured the phenomena that had emerged in the interviews. In particular we selected questionnaires which measured the criteria on which students from the different schools appeared to demonstrate greatest variance. Results: There were two areas where students from schools with differing curricula differed - basic learning activity and assessment. Students at the lecture-based school attended lectures where they received information while students at the Problem-based school attended tutorials where they stimulated prior knowledge and identified new learning objectives. Progress -testing at the problem-based school helped students gain a sense of accumulating a body of knowledge needed for their life in medicine while students' at the lecture-based school directed their learning towards passing the next set of exams. The findings from quantitative, questionnaire data correlated with the interview findings. They showed that students at a school with a PBL curriculum scored significantly higher for reflection in learning, self-efficacy in self-directed learning and for deep approach to learning. Conclusion: We set out to determine whether students at different medical schools approach their learning differently. We have succeeded in demonstrating that this is the case. The differences that we detected in learning context and approaches to learning in medical students at the two schools predict that learning at the non PBL school is likely to be via a surface approach and not integrated. These differences have major implications for the outcomes of medical student learning at the two schools in terms of accessibility and sustainability of learning

Core information sets for informed consent to surgical interventions:baseline information of importance to patients and clinicians

Abstract Background Consent remains a crucial, yet challenging, cornerstone of clinical practice. The ethical, legal and professional understandings of this construct have evolved away from a doctor-centred act to a patient-centred process that encompasses the patient’s values, beliefs and goals. This alignment of consent with the philosophy of shared decision-making was affirmed in a recent high-profile Supreme Court ruling in England. The communication of information is central to this model of health care delivery but it can be difficult for doctors to gauge the information needs of the individual patient. The aim of this paper is to describe ‘core information sets’ which are defined as a minimum set of consensus-derived information about a given procedure to be discussed with all patients. Importantly, they are intended to catalyse discussion of subjective importance to individuals. Main body The model described in this paper applies health services research and Delphi consensus-building methods to an idea orginally proposed 30 years ago. The hypothesis is that, first, large amounts of potentially-important information are distilled down to discrete information domains. These are then, secondly, rated by key stakeholders in multiple iterations, so that core information of agreed importance can be defined. We argue that this scientific approach is key to identifying information important to all stakeholders, which may otherwise be communicated poorly or omitted from discussions entirely. Our methods apply systematic review, qualitative, survey and consensus-building techniques to define this ‘core information’. We propose that such information addresses the ‘reasonable patient’ standard for information disclosure but, more importantly, can serve as a spring board for high-value discussion of importance to the individual patient. Conclusion The application of established research methods can define information of core importance to informed consent. Further work will establish how best to incorporate this model in routine practice

Doctors’ perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study

Background The need to involve patients more in decisions about their care, the ethical imperative and concerns about ligation and complaints has highlighted the issue of informed consent and how it is obtained. In order for a patient to make an informed decision about their treatment, they need appropriate discussion of the risks and benefits of the treatment. Objectives To explore doctors’ perspectives of gaining informed consent for routine surgical procedures. Design Qualitative study using semi-structured interviews selected by purposive sampling. Data were analysed thematically. Setting and Participants Twenty doctors in two teaching hospitals in the UK. Results Doctors described that while consent could be taken over a series of consultations, it was common for consent to be taken immediately prior to surgery. Juniors were often taking consent when they were unfamiliar with the procedure. Doctors used a range of communication techniques to inform patients about the procedure and its risks including quantifying risks, personalizing risk, simplification of language and use of drawings. Barriers to effective consent taking were reported to be shortage of time, clinician inexperience and patients’ reluctance to be involved

The systematic development of a novel integrated spiral undergraduate course in general practice

In 2007 Keele University School of Medicine rolled out its novel curriculum to which general practice makes a major contribution. In this paper we describe the systematic approach we took to developing the GP curriculum; from the underlying educational principles which guided its development, the subsequent decisions we made to the curriculum itself. This consists of 23 weeks of clinical placements in general practice; four weeks in year 3, four weeks in year 4 and 15 weeks in year 5. We describe the steps which were necessary to prepare for the implementation of the GP curriculum. We consider that the successful implementation of our general practice contribution is a result of our systematic identification of these principles, the clearly articulated design decisions and the systematic preparation for implementation involving the academic GP team and all our potential teaching practices

A randomised controlled trial of the effects of a web-based PSA decision aid, Prosdex. Protocol

Contains fulltext : 51771.pdf ( ) (Open Access)BACKGROUND: Informed decision making is the theoretical basis in the UK for men's decisions about Prostate Specific Antigen (PSA) testing for prostate cancer testing. The aim of this study is to evaluate the effect of a web-based PSA decision-aid, Prosdex, on informed decision making in men. The objective is to assess the effect of Prosdex on six specific outcomes: (i) knowledge of PSA and prostate cancer-related issues - the principal outcome of the study; (ii) attitudes to testing; (iii) decision conflict; (iv) anxiety; (v) intention to undergo PSA testing; (vi) uptake of PSA testing. In addition, a mathematical simulation model of the effects of Prosdex will be developed. METHODS: A randomised controlled trial with four groups: two intervention groups, one viewing Prosdex and the other receiving a paper version of the site; two control groups, the second controlling for the potential Hawthorn effect of the questionnaire used with the first control group. Men between the ages of 50 and 75, who have not previously had a PSA test, will be recruited from General Practitioners (GPs) in Wales, UK. The principal outcome, knowledge, and four other outcome measures - attitudes to testing, decision conflict, anxiety and intention to undergo testing - will be measured with an online questionnaire, used by men in three of the study groups. Six months later, PSA test uptake will be ascertained from GP records; the online questionnaire will then be repeated. These outcomes, and particularly PSA test uptake, will be used to develop a mathematical simulation model, specifically to consider the impact on health service resources

The systematic development of a novel integrated spiral undergraduate course in general practice

In 2007 Keele University School of Medicine rolled out its novel curriculum to which generalpractice makes a major contribution. In this paper we describe the systematic approach wetook to developing the GP curriculum; from the underlying educational principles whichguided its development, the subsequent decisions we made to the curriculum itself. Thisconsists of 23 weeks of clinical placements in general practice; four weeks in year 3, fourweeks in year 4 and 15 weeks in year 5. We describe the steps which were necessary toprepare for the implementation of the GP curriculum.We consider that the successful implementation of our general practice contribution is aresult of our systematic identification of these principles, the clearly articulated designdecisions and the systematic preparation for implementation involving the academic GPteam and all our potential teaching practices

Phenome-wide association analysis of LDL-cholesterol lowering genetic variants in PCSK9

Abstract: Background: We characterised the phenotypic consequence of genetic variation at the PCSK9 locus and compared findings with recent trials of pharmacological inhibitors of PCSK9. Methods: Published and individual participant level data (300,000+ participants) were combined to construct a weighted PCSK9 gene-centric score (GS). Seventeen randomized placebo controlled PCSK9 inhibitor trials were included, providing data on 79,578 participants. Results were scaled to a one mmol/L lower LDL-C concentration. Results: The PCSK9 GS (comprising 4 SNPs) associations with plasma lipid and apolipoprotein levels were consistent in direction with treatment effects. The GS odds ratio (OR) for myocardial infarction (MI) was 0.53 (95% CI 0.42; 0.68), compared to a PCSK9 inhibitor effect of 0.90 (95% CI 0.86; 0.93). For ischemic stroke ORs were 0.84 (95% CI 0.57; 1.22) for the GS, compared to 0.85 (95% CI 0.78; 0.93) in the drug trials. ORs with type 2 diabetes mellitus (T2DM) were 1.29 (95% CI 1.11; 1.50) for the GS, as compared to 1.00 (95% CI 0.96; 1.04) for incident T2DM in PCSK9 inhibitor trials. No genetic associations were observed for cancer, heart failure, atrial fibrillation, chronic obstructive pulmonary disease, or Alzheimer’s disease – outcomes for which large-scale trial data were unavailable. Conclusions: Genetic variation at the PCSK9 locus recapitulates the effects of therapeutic inhibition of PCSK9 on major blood lipid fractions and MI. While indicating an increased risk of T2DM, no other possible safety concerns were shown; although precision was moderate

Assessment of polygenic architecture and risk prediction based on common variants across fourteen cancers

Abstract: Genome-wide association studies (GWAS) have led to the identification of hundreds of susceptibility loci across cancers, but the impact of further studies remains uncertain. Here we analyse summary-level data from GWAS of European ancestry across fourteen cancer sites to estimate the number of common susceptibility variants (polygenicity) and underlying effect-size distribution. All cancers show a high degree of polygenicity, involving at a minimum of thousands of loci. We project that sample sizes required to explain 80% of GWAS heritability vary from 60,000 cases for testicular to over 1,000,000 cases for lung cancer. The maximum relative risk achievable for subjects at the 99th risk percentile of underlying polygenic risk scores (PRS), compared to average risk, ranges from 12 for testicular to 2.5 for ovarian cancer. We show that PRS have potential for risk stratification for cancers of breast, colon and prostate, but less so for others because of modest heritability and lower incidence