Elizabeth P. Tolmie

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

Background : 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. Aim : To explore patients’ perspectives on compliance with statin therapy. Setting: Primary care, West of Scotland. Methods: 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. Findings: 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. Conclusions: 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.

Are older patients’ cardiac rehabilitation needs being met?

Aims. The primary aim of this study was to examine the needs of older people in relation to cardiac rehabilitation and to determine if these were currently being met. A secondary aim was to compare illness representations, quality of life and anxiety and depression in groups with different levels of attendance at a cardiac rehabilitation programme. Background. Coronary heart disease accounted for over seven million cardiovascular deaths globally in 2001. Associated deaths increase with age and are highest in those older than 65. Effective cardiac rehabilitation can assist independent function and maintain health but programme uptake rates are low. We have, therefore, focussed specifically on the older patient to determine reasons for the low uptake. Design. Mixed methods. Methods. A purposive sample of 31 older men and women (≥65 years) completed three questionnaires to determine illness representations, quality of life and anxiety and depression. They then underwent a brief clinical assessment and participated in a face-to-face audio-taped interview. Results. Quantitative: Older adults, who did not attend a cardiac rehabilitation programme, had significantly poorer personal control and depression scores (p < 0·01) and lower quality of life scores than those who had attended. Few achieved recommended risk factor reduction targets. Qualitative: The three main themes identified as reflecting the views and experiences of and attendance at the cardiac rehabilitation programme were: ‘The sensible thing to do’, ‘Assessing the impact’ and ‘Nothing to gain’. Conclusions. Irrespective of level of attendance, cardiac rehabilitation programmes are not meeting the needs of many older people either in terms of risk factor reduction or programme uptake. More appropriate programmes are needed. Relevance to clinical practice. Cardiac rehabilitation nurses are ideally placed to identify the rehabilitation needs of older people. Identifying these from the older person’s perspective could help guide more appropriate intervention strategies.

Smoking after coronary artery bypass: high three-year mortality.

BACKGROUND Coronary artery bypass grafting (CABG) is carried out for prognosis and symptomatic relief. Smoking is associated with increased postoperative complications, although its precise influence on long-term survival is unclear. We examined the influence of smoking and other risk factors on survival and myocardial ischaemia seven years after CABG. METHODS 208 patients underwent elective CABG; 25 % were persistent smokers. 165 were alive at seven years. 128 (78 % of survivors) agreed to reexamination and 79 had thallium scans. RESULTS Angina and dyspnoea were reported by 52 % and 69 %, respectively, of survivors; these were associated with smoking ( P = 0.029 and 0.0 009) but with no other risk factors. Smokers had higher stress thallium scores ( P = 0.057) and ischaemia scores (10.6 +/- 6.5 vs. 6.8 +/- 6.0; P = 0.036); ejection fractions were equivalent. Obesity was prevalent and worsened in men. 33 patients (17 %) died during follow-up. Initially there was no survival difference between smokers and nonsmokers but as early as three years postoperation smoking was associated with an increased mortality ( P = 0.011; log-rank test). CONCLUSIONS Patients experienced almost universal improvement with the operation. However, persistent smoking completely removed the prognostic benefits of CABG by accelerating late mortality which was higher than previously reported. Higher indices of ischaemia in smokers were suggested by symptoms and confirmed by perfusion scans.

A study of the prevention and management of pressure sores

Abstract Objectives: (1) To determine if there was an association between pressure sore risk assessment, severity of sore and planning of patient care and (2) to identify the methods used to prevent and treat pressure sores. Design: The study was a two-phase non-experimental design. Methods : All patients had pressure sore risk assessed on admission and discharge. They were scored according to the Waterlow system or the Stirling Pressure Sore Severity Scale. Nominal data were analysed by χ 2 and grouped data by Kruskal–Wallis ANOVAR. Setting: 500 bedded acute care hospital trust in Scotland. Sample: 30 Registered Nurses and 327 patient records. Results: Significant relationships were detected: 1. Between the Waterlow score and pressure relief ( χ 2 =32.92, df=2, p χ 2 =6.04, df=2, p 2. Between care plan type and pressure relief ( χ 2 =38.3, df=2, p χ 2 =12.1, df=2, p χ 2 =40.8, df=2, p Therewas no significant relationship between Waterlow score and mobilisation ( χ 2 =3.2, df=4, p =0.530) or between Waterlow score and severity of sore (df=4, p =0.7265). Conclusion: The initial Waterlow score was not predictive although the Stirling Pressure Sore Severity Scale was indicative of skin status. This study indicates that a number of issues need to be addressed. Of particular concern is that even when risk factors were identified for a patient, they were rarely taken into account when planning care. Furthermore, according to nurses’ own accounts and by patient record analysis, the Waterlow Risk Assessment Scale appears to be unreliable when used in clinical practice.

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

BackgroundThe 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.MethodsThroughout 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.ResultsFrom 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.ConclusionsThe implementation of some simple measures could help improve data quality and lead to significant savings.

The Statin Breakthrough—Remembering to Involve the Patient

A revolution in the management of dyslipidaemia was sparked by the introduction of the first HMG CoA reductase inhibitors or statins in the 1980s. Until that time the therapeutic options were limited in large part to the bile acid sequestrant resins and the older fibric acid derivatives. The statins provided healthcare professionals with the option of once daily dosing, low side-effect profiles and impressive lipid lowering efficacy. The arguments for and against the use of lipid lowering drugs were finally silenced with the publication of the five major statin intervention trials (4S, WOSCOPS, CARE. LIPID and AFCAPS/TexCAPS) [1–5]. Finally, the lipid hypothesis, that cholesterol lowering would reduce cardiovascular disease, had been proven and a group of safe and highly effective drugs were available to allow this breakthrough to be translated into routine clinical practice. However, it is this process of translation that has become a major focus of attention in recent years. While we have unequivocal evidence of the benefits of statin therapy, we have equally clear evidence that shows patient concordance or compliance with these drugs is often very poor. Statin discontinuation rates as high as 35% [6] have been reported, but unfortunately the bias towards using quantitative methodology in studies investigating compliance with lipidlowering drugs has meant that patients reasons for not complying with their prescribed regimens have been investigated only superficially or not at all. As poor compliance with these drugs has clear implications for both cost and effectiveness of cardiovascular disease prevention, insights into patients perspectives could help guide appropriate education, communication and improve health care delivery practices. In this issue Yilmaz and colleagues report on a cohort of patients at risk of cardiovascular disease and prescribed statin therapy who were evaluated to assess their awareness of statin therapy [7]. Interestingly, while most patients knew that statins were prescribed to lower cholesterol this study shows that more than half did not know how long they were to continue receiving statin therapy, and the majority had no idea about potential side effects. This analysis, while relatively superficial, does serve to reinforce the need for robust information transfer between healthcare professionals and patients. The study did not explore in detail the reasons for non-compliance with medication amongst those prescribed statin therapy and this is an important issue that remains to be addressed. Relatively few studies have investigated compliance behaviours with prescribed lipid-lowering therapy and even fewer have limited their investigation to prescribed statin therapy, but these have recently been reviewed by us [8]. Although many factors have been associated with compliance, the overall results remain inconclusive, perhaps as a result of the different methods used, the drugs prescribed, and the country of origin. Most studies fail to acknowledge the multidimensional and potential interactive relationship between different healthcare systems and individual patient factors. Those that have focused exclusively on either qualitative factors or psychological factors, without considering other aspects of the problem, are limited and prohibit determination of the extent to which the factors identified act as inhibitors or determinants of compliance. Poor compliance may be unintentional, occurring because of uncontrollable factors such as age, poor memory or serious illness; or intentional, when the individual actively chooses not to take the drug as prescribed. Although discontinuation of treatment might appear illogical to some practitioners patients will use the inherent or learned information available to them to come to a decision about whether or not to take their medication. While there may be little scope for changing many factors such as age, or the presence of chronic disease, the patients perspective remains to be fully explored. We need to

Health locus of control in patients undergoing coronary artery surgery - changes and associated outcomes: a seven-year cohort study.

Introduction: Health locus of control is a measure of an individual’s beliefs in factors that are thought to determine health experiences. Scores are generated and form a graduated linear scale from external to internal control, with respect to their views on health causality. Health locus of control has been considered to be a relatively stable entity. However, it is not clear if this status changes in the advent of serious health challenges, such as coronary artery bypass graft surgery. The aim of this study is to explore the variability of health locus of control and its association with postoperative health in this context. Methods: In a longitudinal cohort study of patients undergoing coronary artery bypass graft surgery, a purposive sample (n=215) were recruited from the waiting list and followed up postoperatively, at approximately one year and seven years later. Results: Patients undergoing coronary artery bypass graft surgery demonstrated marked fluctuations in health locus of control in their peri-operative and rehabilitative phases. Mean health locus of control became more external (often associated with poorer outcomes) peri-operatively, and more internal (generally associated with better health outcomes) in the rehabilitative period. Conclusions: Health locus of control scores were shown to be changeable during a major health care intervention, with possible consequences for patient outcomes and care needs. The significant health belief upheaval demonstrated in this cohort should be considered in assessing patients preoperatively, and managed as part of the patients’ clinical journey by both acute and rehabilitation staff. It is likely to have particular importance in individualised assessment and management of future prevention advice for patients.

Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom

The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting.In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Office with dedicated staff and resources within our organisation. This office is supported by an electronic pharmacovigilance reporting infrastructure developed to facilitate the receipt and processing of safety information, the onward reporting in compliance with legislation and the provision of sponsor institution oversight of clinical trial participant safety. An education and training programme has also been set up to ensure that all relevant staff in the organisation are fully aware of the pharmacovigilance service and are appropriately trained in its use.We discuss possible alternatives to this approach and why we consider our solution to be the most appropriate to ensure that a non-commercial sponsor organisation and investigators are operating in a fully compliant way.