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Vikki A Entwistle

Publications and source records attributed to Vikki A Entwistle.

13 recordsLinked to original sources
PubMed2006

Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study.

BACKGROUND: Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS). METHODS: In-depth semi-structured telephone interviews were conducted in 2003-04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. RESULTS: The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion) were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. CONCLUSION: This study highlights complex financial aspects of planning and conducting trials, especially where multiple funders are involved. Recognition of the importance of financial stability and of the need for appropriate training in this area should be paralleled by further similar research with a broader range of trials, aimed at understanding and facilitating the conduct of clinical research.

Journal Article↗
PubMed2006

Patient involvement in treatment decision-making: the case for a broader conceptual framework.

OBJECTIVE: To consider the conceptualisation of patient involvement in treatment decision-making. METHOD: Conceptual review. RESULTS: Current models and measures of patient involvement in treatment decision-making tend to focus on communication within consultations and/or on the patient's use of information to consider the selection of one treatment option from a well-defined set. These narrowly focused models and measures may obscure the relevance of patient involvement in decision-making for some health care contexts and limit investigations of the relationships between patient involvement in decision-making and health care outcomes. We outline a broader conceptual framework that reflects more of the complexity of the concept of involvement. It acknowledges that patients can be involved not only because of what they say and do to influence a decision, but also by virtue of what they think and feel about their roles, efforts and contributions to decision-making and their relationships with their clinicians. The framework encompasses the full range of activities associated with decision-making. CONCLUSION: The proposed conceptual framework may broaden the relevance of patient involvement in decision-making and encourage a more comprehensive characterisation that may facilitate more sophisticated investigations of the relationships between patient involvement in decision-making and health care outcomes. PRACTICE IMPLICATIONS: Clinicians who aspire to facilitate patient involvement in decision-making need to look beyond the way they discuss health care options with patients. They should also consider how they might enable patients to engage in the full range of decision-making activities and to develop a positive sense of involvement in these activities and with their clinicians.

Decision Making↗
PubMed2006

The significance for decision-making of information that is not exchanged by patients and health professionals during consultations.

Information exchange between patients and health professionals is fundamental to achieving patient participation in decision-making and shared decision-making is said to require the exchange of "all information relevant to decision-making". This paper reports on a qualitative investigation of instances in which information that was potentially relevant to decision-making was not exchanged in consultations. Consultations from 5 diverse clinical areas in the UK were video-recorded and the health professionals and patients involved were interviewed separately before and after their consultations. This analysis is based on cases involving 20 patients. It draws on data from their 26-recorded consultations and from the 137 associated interviews. Several strategies were used to identify instances in which patients and/or health professionals did not disclose information that was potentially relevant to decision-making. Analysis focussed on the types of information not disclosed, the reasons that health professionals and patients gave for non-disclosure, and the apparent or potential significance of the non-disclosure. We identified 34 instances of non-disclosure of information relating to the patient's problem and 52 instances of non-disclosure of information relating to treatment or management options. The types of information not disclosed were diverse and the reasons given for non-disclosure varied. Some, but not all, instances of non-disclosure had negative implications for the quality of decision-making and/or the patient's healthcare experience. Our findings have implications for future attempts to examine information exchange in consultations-whether for research or for professional assessment purposes. In particular, they highlight the importance of appraising instances of non-disclosure of information in context and of recognising the limitations of approaches that rely on single consultations and/or single perspectives for assessments of information exchange.

Adult↗
PubMed2006

Protocol for stage 1 of the GaP study (Genetic testing acceptability for Paget's disease of bone): an interview study about genetic testing and preventive treatment: would relatives of people with Paget's disease want testing and treatment if they were available?

BACKGROUND: Paget's disease of bone (PDB) is characterised by focal increases in bone turnover, affecting one or more bones throughout the skeleton. This disrupts normal bone architecture and causes pain, deformity, deafness, osteoarthritis, and fractures. Genetic factors are recognised to play a role in PDB and it is now possible to carry out genetic tests for research. In view of this, it is timely to investigate the clinical potential for a programme of genetic testing and preventative treatment for people who have a family history of PDB, to prevent or delay the development of PDB. Evidence from non-genetic conditions, that have effective treatments, demonstrates that patients' beliefs may affect the acceptability and uptake of treatment. Two groups of beliefs (illness and treatment representations) are likely to be influential. Illness representations describe how people see their illness, as outlined in Leventhal's Self-Regulation Model. Treatment representations describe how people perceive potential treatment for their disease. People offered a programme of genetic testing and treatment will develop their own treatment representations based on what is offered, but the beliefs rather than the objective programme of treatment are likely to determine their willingness to participate. The Theory of Planned Behaviour is a theoretical model that predicts behaviours from people's beliefs about the consequences, social pressures and perceived control over the behaviour, including uptake of treatment. METHODS/DESIGN: This study aims to examine the acceptability of genetic testing, followed by preventative treatment, to relatives of people with PDB. We aim to interview people with Paget's disease, and their families, from the UK. Our research questions are:1. What do individuals with Paget's disease think would influence the involvement of their relatives in a programme of genetic testing and preventative treatment? What do relatives of Paget's disease sufferers think would influence them in accepting an offer of a programme of genetic testing and preventative treatment? DISCUSSION: Our research will be informed by relevant psychological theory: primarily the Self-Regulation Model and the Theory of Planned Behaviour. The results of these interviews will inform the development of a separate questionnaire-based study to explore these research questions in greater detail.

Adult↗
PubMed2006

What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies.

BACKGROUND: A commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme. METHODS: The cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fisher's exact test where appropriate. RESULTS: Less than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed. CONCLUSION: Recruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.

Journal Article↗
PubMed2005

A centralised public information resource for randomised trials: a scoping study to explore desirability and feasibility.

BACKGROUND: There are currently several concerns about the ways in which people are recruited to participate in randomised controlled trials, the low acceptance rates among people invited to participate, and the experiences of trial participants. An information resource about on-going clinical trials designed for potential and current participants could help overcome some of these problems. METHODS: We carried out a scoping exercise to explore the desirability and feasibility of establishing such a resource. We sought the views of a range of people including people who were considering taking part in a trial, current trial participants, people who had been asked but refused to participate in a trial, consumer group representatives and researchers who design and conduct trials. RESULTS: There was broad-based support for the concept of a centralised information resource for members of the public about on-going and recently completed clinical trials. Such an information resource could be based on a database containing standardised information for each trial relating to the purpose of the trial; the interventions being compared; the implications of participation for participants; and features indicative of scientific quality and ethical probity. The usefulness of the database could be enhanced if its search facility could allow people to enter criteria such as a disease and geographic area and be presented with all the trials relevant to them, and if optional display formats could allow them to view information in varying levels of detail. Access via the Internet was considered desirable, with complementary supported access via health information services. The development of such a resource is technically feasible, but the collation of the required information would take a significant investment of resources. CONCLUSION: A centralised participant oriented information resource about clinical trials could serve several purposes. A more detailed investigation of its feasibility and exploration of its potential impacts are required.

Databases as Topic↗
PubMed2005

Advising patients about patient safety: current initiatives risk shifting responsibility.

BACKGROUND: Many health care providers now disseminate advisories telling patients what they can do to avoid errors and harms in their care. METHODS: The content of five leading safety advisories for patients was analyzed and a critique of their development, content, and impact was developed, drawing on published literature and 40 interviews with a diverse sample of 50 key informants. FINDINGS: Very little is known about the effects of the distribution of safety advisories to patients, but several grounds for concern were identified. There was a lack of attention to patients' perspectives during the development of advisory messages, and the advisories say little about what health care providers should do to ensure patient safety. Patients are given little practical support to carry out the recommended actions, and health professionals' responses may render their attempts to act to secure their own safety ineffective. Some messages suggest an inappropriate shifting of responsibility onto patients. Advice that involves checking on or challenging health professionals' actions appears to be particularly problematic for patients. Such behaviors conflict with the expectations many people have--and think health professionals have--of patients' roles. DISCUSSION: A serious commitment to optimizing patients' contributions to safe care requires a research-based understanding of patients' perspectives and more practical facilitation of patient involvement.

Counseling↗
PubMed2005

Patients' experiences with partial dentures: a qualitative study.

OBJECTIVE: The aim of the study was to gain insight into people's experiences of being given and using partial dentures. METHODS: In-depth semi-structured interviews were carried out with 23 people of varied age, social background and denture wearing experience in Tayside, Scotland. Participants were encouraged to discuss how they came to have partial dentures, their day-to-day denture use and their interactions with dentists. The interview data were systematically coded using key theme headings, and summary charts were constructed to facilitate analysis. RESULTS: The initial decision that a partial denture was needed was generally difficult to accept. People perceived the main benefits of partial dentures to be improved appearance and confidence, but experienced a variety of difficulties with their dentures and often coped with these by only wearing them on social occasions. Participants had not always told their dentists about the difficulties they experienced. Barriers to seeking help with denture problems included financial constraints, previous experience of rushed appointments or poor communication from dentists and a perceived lack of entitlement to help when partial dentures were issued free. CONCLUSIONS: Partial dentures can be difficult to cope with. People experience a range of difficulties in wearing them, not all of which have been discussed with dentists. Informative and supportive communication when partial dentures are first needed, and subsequently, can improve the quality of patients' experiences and may help promote effective use and appropriate help-seeking by partial denture wearers.

Adaptation, Psychological↗
PubMed2004

Assessing patients' participation and quality of decision-making: insights from a study of routine practice in diverse settings.

In the context of a qualitative study exploring patients' participation in decision-making, we investigated how people interpret and respond to structured questions about decision-making about their health care. Seventy-four participants who attended consultations in five clinical areas completed structured measures of decision-making and discussed their responses during interviews. They identified a range of decisions as having being made in their consultations. People who picked particular responses on measures of participation in and satisfaction with decision-making gave varied explanations for these, not all of which were consistent with the way their responses are usually interpreted. The interview data suggest that people's evaluations of decisions to follow a particular course of action were influenced by various factors including what they focused on as the alternative, their perceptions of constraints on choices, and their assessment of how good the best possible solution was. Responses to simple structured measures of participation in and satisfaction with decision-making should be interpreted with caution. They are not reliably attributable to health care providers' actions and are thus unsuitable for performance assessment purposes.

Attitude of Health Personnel↗
PubMed2003

The requirement for prior consent to participate on survey response rates: a population-based survey in Grampian.

BACKGROUND: A survey was carried out in the Grampian region of Scotland with a random sample of 10,000 adults registered with a General Practitioner in Grampian. The study complied with new legislation requiring a two-stage approach to identify and recruit participants, and examined the implications of this for response rates, non-response bias and speed of response. METHODS: A two-stage survey was carried out consistent with new confidentiality guidelines. Individuals were contacted by post and asked by the Director of Public Health to consent to receive a postal or electronic questionnaire about communicating their views to the NHS. Those who consented were then sent questionnaires. Response rates at both stages were measured. RESULTS: 25% of people returned signed consent forms and were invited to complete questionnaires. Respondents at the consent stage were more likely to be female (odds ratio (OR) response rate of women compared to men = 1.5, 95% CI 1.4, 1.7), less likely to live in deprived postal areas (OR = 0.59, 95% CI 0.45, 0.78) and more likely to be older (OR for people born in 1930-39 compared to people born in 1970-79 = 2.82, 95% CI 2.36, 3.37). 80% of people who were invited to complete questionnaires returned them. Response rates were higher among older age groups. The overall response rate to the survey was 20%, relative to the original number approached for consent (1951/10000). CONCLUSION: The requirement of a separate, prior consent stage may significantly reduce overall survey response rates and necessitate the use of substantially larger initial samples for population surveys. It may also exacerbate non-response bias with respect to demographic variables.

Adolescent↗