Cardiovascular risk prediction: how useful are web-based tools and do risk representation formats matter?

Cardiovascular risk prediction tools are becoming increasing available on the web for people to use at home. However, research into the most effective ways of communicating cardiovascular risk has been limited. This thesis examined how well web-based cardiovascular risk prediction tools present cardiovascular risk and encourage risk reduction. Variation was found in both the quality of the risk communication and the number of features incorporated into the tools to facilitate decisions about lifestyle change and treatment. Additionally, past literature into the effectiveness of cardiovascular risk representation formats was systematically reviewed. This highlighted the need for more methodologically sound studies, using actual risk assessment rather than hypothetical risk scenarios. This thesis also described a four-armed web-based randomised controlled trial (RCT) conducted to examine the effects of different cardiovascular risk representation formats on patient-based outcomes. It comprised a cardiovascular risk formatter that presented risk in one of three formats: bar graph, pictogram and metonym (e.g. image depicting the seriousness of having a myocardial infarction). There were two control groups to examine the Hawthorne effect. In total, 903 respondents took part in the trial. The most successful recruitment methods were web-based, including staff electronic noticeboards and social networking sites. The RCT found that viewing cardiovascular risk significantly reduces negative emotions in the 'worried well', thus helping to correct inaccurate risk perceptions. There were no main effects of risk representation formats, suggesting that the way risk is presented had little influence on the population that were recruited, in terms of motivating behaviour change, facilitating understanding of risk information or altering emotion. However, a possible type II error occurred as the sample was unrepresentative, highly educated and biased towards those of low cardiovascular risk. Further research is needed to reach target audiences and engage those who would benefit the most from using risk assessment tools

Increasing uptake of hepatitis C virus infection case- finding, testing, and treatment in primary care: evaluation of the HepCATT (Hepatitis C Assessment Through to Treatment) trial

Background Hepatitis C virus (HCV) infection is a key cause of liver disease but can be cured in more than 95% of patients. Around 70 000 people in England may have undiagnosed HCV infection and many more will not have been treated. Interventions to increase case-finding in primary care are likely to be cost-effective; however, evidence of effective interventions is lacking. The Hepatitis C Assessment Through to Treatment (HepCATT) trial assessed whether a complex intervention in primary care could increase case-finding, testing, and treatment of HCV.Aim To investigate the feasibility and acceptability of the HepCATT intervention.Design and setting A qualitative study with primary care practice staff from practices in the south west of England taking part in the HepCATT trial.Method Semi-structured interviews were carried out with GPs, nurses, and practice staff to ascertain their views of the HepCATT intervention at least 1 month after implementing the intervention in their practice. Normalisation process theory, which outlines the social processes involved in intervention implementation, informed thematic data analysis.Results Participants appreciated the HepCATT intervention for increasing knowledge and awareness of HCV. Although some initial technical difficulties were reported, participants saw the benefits of using the audit tool to systematically identify patients with HCV infection risk factors and found it straightforward to use. Participants valued the opportunity to discuss HCV testing with patients, especially those who may not have been previously aware of HCV risk. Future implementation should consider fully integrating software systems and additional resources to screen patient lists and conduct tests.Conclusion When supported by a complex intervention, primary care can play a crucial role in identifying and caring for patients with HCV infection, to help stem the HCV epidemic, and prevent HCV-related illnes

Increasing uptake of Hepatitis C virus infection case-finding, testing and treatment in primary care:HepCATT (Hepatitis C Assessment Through to Treatment Trial) qualitative evaluation

Hepatitis C virus (HCV) infection is a key cause of liver disease but can be cured in more than 95% of patients. Around 70 000 people in England may have undiagnosed HCV infection and many more will not have been treated. Interventions to increase case-finding in primary care are likely to be cost-effective; however, evidence of effective interventions is lacking. The Hepatitis C Assessment Through to Treatment (HepCATT) trial assessed whether a complex intervention in primary care could increase case-finding, testing, and treatment of HCV

Parental perceptions and understanding of information provision, management options and factors influencing the decision-making process in the treatment of children with glue ear

Objectives Otitis media with effusion (OME) is a common cause of hearing loss and possible developmental delay in children, and there are a range of ‘preference sensitive’ treatment options. We aimed to evaluate the attitudes and beliefs of parents of affected children to treatment options including watchful-waiting, hearing aids, grommets, and, oral steroids with the intention of developing our understanding of decision-making and the factors influencing it, sources of parental information, and satisfaction with information provision. Design We recruited a convenience sample of twelve parents of eleven children with OME at a single ENT department of a teaching hospital into a qualitative research study. The children of the parents interviewed had already been recruited into the Oral Steroids for the Resolution of Otitis Media with effusion In Children (OSTRICH) study. Semi structured interviews were audio recorded, transcribed and then coded using an inductive, thematic approach. Results Parents were satisfied with the verbal provision of information during the treatment consultation, although many were keen to receive supplementary printed information. Discussion with family and friends helped the decision-making process, whereas insufficient information and a paternalistic approach were viewed as obstacles. Parents were particularly influenced by the following: the immediacy of the treatment option effect, perceived efficacy, perceived risks and adverse effects, social implications (especially with hearing aids) and past personal and informant experience. Conclusions Parents appreciate clinicians tailoring information provision to parents' information needs and preferred format. Clinicians should also elicit parental attitudes towards the different management options for OME and the factors influencing their decisions, in order to optimise shared-decision making and ultimately provide a better standard of clinical care

Exploring patients’ experiences of analgesia after major lower limb amputation: A qualitative study

OBJECTIVES: To explore patient experiences, understanding and perceptions of analgesia following major lower limb amputation. DESIGN: Qualitative interview study, conducted as part of a randomised controlled feasibility trial. SETTING: Participants were recruited from two general hospitals in South Wales. PARTICIPANTS: Interview participants were patients enrolled in PLACEMENT (Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial): a randomised controlled feasibility trial comparing the use of perineural catheter (PNC) versus standard care for postoperative pain relief following major lower limb amputation. PLACEMENT participants who completed 5-day postoperative follow-up, were able and willing to participate in a face-to-face interview, and had consented to be contacted, were eligible to take part in the qualitative study. A total of 20 interviews were conducted with 14 participants: 10 male and 4 female. METHODS: Semi-structured, face-to-face interviews were conducted with participants over two time points: (1) up to 1 month and (2) at least 6 months following amputation. Interviews were audio-recorded, transcribed verbatim and analysed using a framework approach. RESULTS: Interviews revealed unanticipated benefits of PNC usage for postoperative pain relief. Participants valued the localised and continuous nature of this mode of analgesia in comparison to opioids. Concerns about opioid dependence and side effects of pain relief medication were raised by participants in both treatment groups, with some reporting trying to limit their intake of analgesics. CONCLUSIONS: Findings suggest routine placement of a PNC following major lower limb amputation could reduce postoperative pain, particularly for patient groups at risk of postoperative delirium. This method of analgesic delivery also has the potential to reduce preoperative anxiety, alleviate the burden of pain management and minimise opioid use. Future research could further examine the comparison between patient-controlled analgesia and continuous analgesia in relation to patient anxiety and satisfaction with pain management. TRIAL REGISTRATION NUMBER: ISRCTN: 85710690; EudraCT: 2016-003544-37

Hepatitis C – Assessment to Treatment Trial (HepCATT) in primary care:study protocol for a cluster randomised controlled trial

BACKGROUND: Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. METHODS/DESIGN: A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients' and health care workers' experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. DISCUSSION: This trial has the potential to make an important impact on patient care and will provide high-quality evidence to help general practitioners make important decisions on HCV testing and onward referral. If found to be effective and cost-effective the intervention is readily scalable and can be used to support the implementation of NICE recommendations on HCV case-finding. TRIAL REGISTRATION: ISRCTN61788850 . Registered on 24 April 2015; Protocol Version: 2.0, 22 May 2015

Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT)

Background: Our patient and public involvement activities were part of a project aiming to develop a master protocol and National Institute for Health and Care research application for the PROTECT trial aiming to assess the effectiveness, implementation, and efficiency of antimicrobial stewardship interventions, to safely reduce unnecessary antibiotic usage by excluding severe bacterial infection in acutely unwell patients. Methods: Three public involvement sessions were held with representation from young people and parents, people from diverse backgrounds and people with experience of presenting to the emergency department with undifferentiated illness. The teleconference meetings lasted between 60-90 minutes, were recorded, notes were subsequently taken, and findings summarised. The data was collected on September 13, 2023, October 14, 2023 and February 28, 2024. Results: Working with public involvement contributors and public involvement groups at the protocol development stage provided an opportunity for the public to shape and influence the trial. We were able to establish the feasibility of the trial in the proposed setting and gain insights into how it would be perceived by potential trial participants. Antibiotic resistance was viewed as an urgent problem and research evaluating new technologies was deemed timely and important. The platform design was considered appropriate, time and cost-effective. Deferred and electronic methods of consent were viewed as acceptable if a clear and inclusive explanation is provided

Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): Protocol for a randomised controlled trial

Introduction Procalcitonin (PCT) is a biomarker more specific for bacterial infection and responds quicker than other commonly used biomarkers such as C reactive protein, but is not routinely used in the National Health Service (NHS). Studies mainly in adults show that using PCT to guide clinicians may reduce antibiotic use, reduce hospital stay, with no associated adverse effects such as increased rates of hospital re-admission, incomplete treatment of infections, relapse or death. A review conducted for National Institute for Health and Care Excellence recommends further research on PCT testing to guide antibiotic use in children.Methods and analysis Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection is a multi-centre, prospective, two-arm, individually Randomised Controlled Trial (RCT) with a 28-day follow-up and internal pilot. The intervention is a PCT-guided algorithm used in conjunction with best practice. The control arm is best practice alone. We plan to recruit 1942 children, aged between 72 hours and up to 18 years old, who are admitted to the hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Coprimary outcomes are duration of antibiotic use and a composite safety measure. Secondary outcomes include time to switch from broad to narrow spectrum antibiotics, time to discharge, adverse drug reactions, health utility and cost-effectiveness. We will also perform a qualitative process evaluation. Recruitment commenced in June 2018 and paused briefly between March and May 2020 due to the COVID-19 pandemic

PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation – a collaboratiVE study (PERCEIVE): Protocol for the PERCEIVE qualitative study

INTRODUCTION: Deciding whether to proceed with a major lower limb amputation is life-changing and complex, and it is crucial that the right decision is made at the right time. However, medical specialists are known to poorly predict risk when assessing patients for major surgery, and there is little guidance and research regarding decisions about amputation. The process of shared decision-making between doctors and patients during surgical consultations is also little understood. Therefore, the aim of this study is to analyse in depth the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation. METHODS AND ANALYSIS: Consultations between patients and surgeons at which major lower limb amputation is discussed will be audio-recorded for 10–15 patients. Semi-structured follow-up interviews with patients (and relatives/carers) will then be conducted at two time points: as soon as possible/appropriate after a decision has been reached regarding surgery, and approximately 6 months later. Semi-structured interviews will also be conducted with 10–15 healthcare professionals working in the UK National Health Service (NHS) involved in amputation decision-making. This will include surgeons, anaesthetists and specialist physiotherapists at 2–4 NHS Health Boards/Trusts in Wales and England. Discourse analysis will be used to analyse the recorded consultations; interviews will be analysed thematically. Finally, workshops will be held with patients and healthcare professionals to help synthesise and interpret findings. ETHICS AND DISSEMINATION: The study has been approved by Wales REC 7 (20/WA/0351). Study findings will be published in international peer-reviewed journal(s) and presented at national and international scientific meetings. Findings will also be disseminated to a wide NHS and lay audience via presentations at meetings and written summaries for key stakeholder groups