Validity of self-reported smoking status: comparison of patients admitted to hospital with acute coronary syndrome and the general population

Many studies rely on self-reported smoking status. We hypothesized that patients with acute coronary syndrome (ACS), a smoking-related condition, would be more prone to misclassify themselves as ex-smokers, because of pressure to quit. We compared patients admitted with ACS with a general population survey conducted in the same country at a similar time. We determined whether ACS patients who classified themselves as ex-smokers (n = 635) were more likely to have cotinine levels suggestive of smoking deception than self-reported ex-smokers in the general population (n = 289). On univariate analysis, the percentage of smoking deceivers was similar among ACS patients and the general population (11% vs. 12%, p = .530). Following adjustment for age, sex and exposure to environmental tobacco smoke, ACS patients were significantly more likely to misclassify themselves (adjusted OR = 14.06, 95% CI 2.13-93.01, p = .006). There was an interaction with age whereby the probability of misclassification fell significantly with increasing age in the ACS group (adjusted OR = 0.95, 95% CI 0.93-0.97, p<.001), but not in the general population. Overall, smoking deception was more common among ACS patients than the general population. Studies comparing patients with cardiovascular disease and healthy individuals risk introducing bias if they rely solely on self-reported smoking status. Biochemical confirmation should be undertaken in such studies

Archiving approach in the UK: the proper storage of research documents remains an essential aspect of the clinical trials process

Clinical trials involve a complex series of steps from inception through protocol design, recruitment, follow-up, data collection, analysis, and the final presentation of results. An important final component of this process is the archiving of the trial documents. Unfortunately, this is an often neglected function that is dealt with as an afterthought. Despite this, archiving is a legal and regulatory requirement that should be planned and carried out with the same attention to detail as every other aspect of the trial. It can also be a very labor intensive and expensive exercise. In this article what exactly is meant by archiving, what needs to be done to archive, and how it should be executed will be examined. We will focus on the practicalities and will draw upon our experience of archiving large clinical trials in the United Kingdom

Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial

Abstract Background The UK Clinical Trial Regulations and Good Clinical Practice guidelines specify that the study sponsor must ensure clinical trial data are accurately reported, recorded and verified to ensure patient safety and scientific integrity. The methods that are utilised to assess data quality and the results of any reviews undertaken are rarely reported in the literature. We have recently undertaken a quality review of trial data submitted to a Clinical Endpoint Committee for adjudication. The purpose of the review was to identify areas that could be improved for future clinical trials. The results are reported in this paper. Methods Throughout the course of the study, all data queries were logged. Following study close out, queries were coded and categorised. A descriptive and comparative analysis was conducted to determine the frequency of occurrence for each category by country of origin. Results From 1595 endpoint packages reviewed, 782 queries were generated. No source data queries were generated for countries with ≤ 25 recruited subjects, but both low recruiting and high recruiting countries had a high number of queries relating to subject identifiers. Conclusions The implementation of some simple measures could help improve data quality and lead to significant savings.</p

Coronary artery bypass graft operation: patients' experience of health and well-being over time

Background: The aim of the coronary artery bypass graft operation is to relieve anginal symptoms and improve functional ability, quality of life and survival. However, having the surgery does not always have the desired outcomes. Although numerous studies have investigated the outcomes of coronary artery bypass graft operation, little attention has been given to patients' perceptions of the outcomes or effects of the operation on health and well-being over time. Aim: To explore patients' perspectives on the effects of coronary artery bypass surgery on health and well-being over time. Methods: As part of a larger mixed methods study, 62 in-depth audio-taped interviews with men and women who had undergone coronary artery bypass approximately 7 years earlier were conducted. Interviews were audio-taped and transcribed. Data were analysed thematically. This paper reports the findings from the qualitative component of the larger study. Findings: The four main themes: ‘Recovery and Rehabilitation’, ‘Seven Years On’, ‘Maintaining a Positive Approach’, and ‘Health Behaviour Change’ reflect the main areas of focus emerging across the interviews and provide credible overarching descriptors of the sub-themes they encompass. The 11 sub-themes identified were recognised as central to the patients' experiences of their health and well-being over the longer-term. Conclusions: Although most patients report improved health and well-being after coronary artery bypass operation, many have described their recovery and rehabilitation as a complex process with both short and long term effects. The insights provided by participants help improve our understanding of the impact of the operation on patients' health and well-being over time. We believe these insights will help us to anticipate the possible needs of future patients and enable us develop appropriate interventions that may facilitate self-management for optimal recovery and health maintenance

Patients' perspectives on statin therapy for treatment of hypercholesterolaemia: a qualitative study

&lt;b&gt;BACKGROUND:&lt;/b&gt; Health Care Practitioners' attempts to implement secondary prevention targets for coronary heart disease (CHD) may be restricted by low rates of persistence with statin therapy. There is a need to understand why some patients, despite having established CHD and elevated cholesterol, do not comply with their prescribed statin regimen. &lt;b&gt;AIM:&lt;/b&gt; To explore patients' perspectives on compliance with statin therapy. &lt;b&gt;SETTING:&lt;/b&gt; Primary care, West of Scotland. &lt;b&gt;METHODS:&lt;/b&gt; The research approach was qualitative. Thirty-three patients prescribed statin therapy and identified as having different patterns of compliance (poor moderate and good) were interviewed. The in-depth interviews were conducted on a one to one basis. Patients prescribed statin therapy for less than three months were excluded. Data were analysed thematically with the assistance of QSR Nudist. &lt;b&gt;FINDINGS:&lt;/b&gt; From analysis of the narrative data, two broad categories, i.e. 'Patient-health care provider communication' and 'Health beliefs' were identified. These categories encompassed six main themes: 'Initiation of therapy'; 'Subsequent feedback'; 'Sources of misconceptions'; 'Unconditional acceptance'; 'Conditional acceptance'; 'Deferment and Rejection'. Acceptance of and compliance with statin therapy appeared to be associated with the provision, interpretation and feedback of information during patient-practitioner consultations, and patients' beliefs about personal health status, cholesterol, and recommended cholesterol-lowering strategies. &lt;b&gt;CONCLUSIONS:&lt;/b&gt; Patients' beliefs and understanding about cholesterol, and the role of cholesterol modifying strategies should be determined prior to the initiation of therapy and at appropriate intervals thereafter