Helen Eborall

Are people with negative diabetes screening tests falsely reassured? Parallel group cohort study embedded in the ADDITION (Cambridge) randomised controlled trial

Objective To assess whether receiving a negative test result at primary care based stepwise diabetes screening results in false reassurance. Design Parallel group cohort study embedded in a randomised controlled trial. Setting 15 practices (10 screening, 5 control) in the ADDITION (Cambridge) trial. Participants 5334 adults (aged 40-69) in the top quarter for risk of having undiagnosed type 2 diabetes (964 controls and 4370 screening attenders). Main outcome measures Perceived personal and comparative risk of diabetes, intentions for behavioural change, and self rated health measured after an initial random blood glucose test and at 3-6 and 12-15 months later (equivalent time points for controls). Results A linear mixed effects model with control for clustering by practice found no significant differences between controls and people who screened negative for diabetes in perceived personal risk, behavioural intentions, or self rated health after the first appointment or at 3-6 months or 12-15 months later. After the initial test, people who screened negative reported significantly (but slightly) lower perceived comparative risk (mean difference −0.16, 95% confidence interval −0.30 to −0.02; P=0.04) than the control group at the equivalent time point; no differences were evident at 3-6 and 12-15 months. Conclusions A negative test result at diabetes screening does not seem to promote false reassurance, whether this is expressed as lower perceived risk, lower intentions for health related behavioural change, or higher self rated health. Implementing a widespread programme of primary care based stepwise screening for type 2 diabetes is unlikely to cause an adverse shift in the population distribution of plasma glucose and cardiovascular risk resulting from an increase in unhealthy behaviours arising from false reassurance among people who screen negative. Trial registration Current controlled trials ISRCTN99175498.

Influences on the uptake of diabetes screening: a qualitative study in primary care

BACKGROUND To address the increasing global prevalence of type 2 diabetes healthcare organisations have been contemplating different screening and intervention strategies. Patient acceptability is a key criterion of a screening programme. AIM To explore the perspectives of those invited to attend the MY-WAIST screening study for type 2 diabetes, particularly explanations for attending or not, and views on the specific screening strategy. DESIGN AND SETTING Qualitative study of 11 general practices in Leicestershire, UK. METHOD Semi-structured interviews were conducted with 24 individuals (40-69 years) invited to attend the MY-WAIST screening study, comprising 13 who attended and 11 who did not attend the screening. Additional data included reply slips from 73 individuals who declined the offer of screening. Analysis was informed by the constant comparative method. RESULTS Two categories of influence on the decision about attending screening emerged. 1) Beliefs about type 2 diabetes candidacy and type 2 diabetes was more common among those who had attended; lack of perceived severity of type 2 diabetes was more common among those who did not attend. 2) Practical aspects about the screening strategy: the lengthy, early morning screening appointments were a barrier to uptake; screening attendees found the procedure largely acceptable. Pre-screening waist self-measurement was more memorable than the remainder of the risk-score calculation; neither impacted on uptake. CONCLUSION The barriers to screening uptake highlighted contribute to current debates about different screening and diagnostic tests for type 2 diabetes and future risk of type 2 diabetes. The findings are useful for those contemplating implementation of screening programmes for identifying type 2 diabetes and pre-diabetes.

The sociology of medical screening: past, present and future

Medical screening raises fundamental issues for sociological inquiry, but at present a well-developed sociology of medical screening is lacking. This special issue on the sociology of screening brings together an exciting collection of new work that tackles medical screening from a variety of theoretical and methodological approaches. In this opening paper, we begin by explaining what we mean by screening, and why we believe screening merits sociological attention. Secondly, we reflect on the sociology of screening to date and provide an introduction for those new to this area. We then provide an overview of the papers in this collection, highlighting links and contrasts between papers. We conclude by reflecting on sociologys potential contribution to wider debates about screening, and propose future research directions.

Women’s views and experiences of a patient preference trial in surgery: a qualitative study of the CARPET1 trial

Background The randomized controlled trial (RCT) has a well-established role in assessing drug therapies, but its adoption in developing surgical interventions has been slow. Patients’ perspectives on surgical RCTs, especially those including a patient preference option, have received little attention. Purpose To characterize participants’ experiences and views of recruitment to a pilot trial (CARPET1) of two surgical treatments for urinary incontinence and vaginal prolapse that included a patient preference option. Methods Semi-structured qualitative interviews with 16 women who participated in the CARPET1 trial. Data analysis was based on the constant comparative method. Main outcome measures Women’s experiences of taking part in a patient preference trial. Results Women’s motives for participating in CARPET1 focused on the possibility of additional care and, as a secondary motive, the wish to help with research. Most participants expressed a treatment preference rather than accepting randomization. Most were pleased with the information they received, and acknowledged the principle of equipoise, but there was substantial variability in their understanding of aspects of the trial, including randomization. Randomization was considered by women to be appropriate only when both treatments were equally suitable and they had no strong preference. Women suggested that the main influence on their willingness to be randomized was the recruiting clinician’s opinion. Importantly, despite the recruiting clinicians being heavily involved in conception of CARPET1, they did not seem to be in equipoise at the level of the individual patient. Limitations This being a small study it was not possible to interview women who declined trial participation or to observe consultations between surgeons and patients. Conclusions CARPET1 appears to have been more a surgeon preference trial than a patient preference trial. Substantial challenges may remain in conducting RCTs in surgery, particularly where surgeons have preferences about what they perceive as the best option for an individual patient. Clinical Trials 2010; 7: 696—704. http://ctj.sagepub.com

Predictors of anxiety and depression among people attending diabetes screening: a prospective cohort study embedded in the ADDITION (Cambridge) randomized control trial.

OBJECTIVE This study aimed to identify factors predicting anxiety and depression among people who attend primary care-based diabetes screening. DESIGN A prospective cohort study embedded in the ADDITION (Cambridge) randomized control trial. METHODS Participants (N= 3,240) at risk of diabetes were identified from 10 primary care practices and invited to a stepwise screening programme as part of the ADDITION (Cambridge) trial. Main outcome measures were anxiety and depression at 12 months post-screening assessed using the Hospital Anxiety and Depression Scale (HADS). RESULTS Hierarchical linear regressions showed that demographic, clinical, and psychological variables collectively accounted for 52% of the variance in HADS anxiety scores and 53% of the variance in HADS depression scores 12 months after diabetes screening. Screening outcome (positive or negative for diabetes) was not related to differences in anxiety or depression at 12 months. Higher number of self-reported (diabetes) symptoms after first attendance was associated with higher anxiety and depression at 12-month follow-up, after controlling for anxiety and depression after first attendance. CONCLUSION Participants in a diabetes screening programme showed low scores on anxiety and depression scales after first appointment and 1 year later. Diagnosis of diabetes was shown to have a limited psychological impact and may be less important than symptom perception in determining emotional outcomes after participation in diabetes screening.

The face of equipoise - delivering a structured education programme within a randomized controlled trial: qualitative study

BackgroundIn trials of behavioural interventions, the individuals who deliver the intervention are in a position of key influence on the success of the trial. Their fidelity to the intervention is crucial. Yet little is understood about the experiences of this group of trial personnel. This study aimed to investigate the views and experiences of educators who delivered a structured education intervention to people with type 2 diabetes, which incorporated training in self-monitoring of either blood glucose (SMBG) or urine glucose (SMUG) as part of a randomized controlled trial (RCT).MethodsEducators’ views were explored through focus groups before and after training (N = 18) and approximately 1 year into the trial (N = 14), and semi-structured telephone interviews at approximately 2 years (N = 7). Analysis was based on the constant comparative method.ResultsEducators held preferences regarding the intervention variants; thus, they were not in individual equipoise. Training raised awareness of preferences and their potential to impact on delivery. Educators were confident in their unbiased delivery, but acknowledged the challenges involved. Concealing their preferences was helped by a sense of professionalism, the patient-centred nature of the intervention, and concessions in the trial protocol (enabling participants to swap monitoring methods if needed). Commitment to unbiased delivery was explained through a desire for evidence-based knowledge in the contentious area of SMBG.ConclusionsThe findings provide insight into a previously unexplored group of trial personnel - intervention deliverers in trials of behavioural interventions - which will be useful to those designing and running similar trials. Rather than individual equipoise, it is intervention deliverers’ awareness of personal preferences and their potential impact on the trial outcome that facilitates unbiased delivery. Further, awareness of community equipoise, the need for evidence, and relevance to the individual enhance commitment to the RCT.Trial registrationISRCTN95696668

Patient Involvement in Patient Safety: Current experiences, insights from the wider literature, promising opportunities?

Abstract Patient involvement in patient safety is emerging as an area of growing policy, practice, and academic interest. In this article, we review the existing literature on patient involvement and patient safety and seek to highlight some of the key areas of challenge in this emergent field by relating it to themes identified in the wider, more mature, literature on patient and public involvement in health care in general. Insights from the wider literature illuminate key issues for involvement in patient safety and suggest promising ways of circumventing these challenges and achieving involvement in patient safety in a way that maximizes impact while avoiding unintended consequences.

Accrual and drop out in a primary prevention randomised controlled trial: qualitative study

BackgroundRecruitment and retention of participants are critical to the success of a randomised controlled trial. Gaining the views of potential trial participants who decline to enter a trial and of trial participants who stop the trial treatment is important and can help to improve study processes. Limited research on these issues has been conducted on healthy individuals recruited for prevention trials in the community.MethodsSemi-structured interviews with people who were eligible but had declined to participate in the Aspirin for Asymptomatic Atherosclerosis (AAA) trial (N = 11), and AAA trial participants who had stopped taking the trial medication (N = 11). A focus group with further participants who had stopped taking the trial medication (N = 6). (Total participants N = 28).ResultsExplanations for declining to participate could be divided into two groups: the first group were characterised by a lack of necessity to participate and a tendency to prioritise other largely mundane problems. The second groups concern was with a high level of perceived risk from participating.Explanations for stopping trial medication fell into four categories: side effects attributed to the trial medication; starting on aspirin or medication contraindicating to aspirin; experiencing an outcome event, and changing ones mind.ConclusionsThese results indicate that when planning trials (especially in preventive medicine) particular attention should be given to designing appropriate recruitment materials and processes that fully inform potential recruits of the risks and benefits of participation.Trial registrationISRCTN66587262

Does self monitoring of blood glucose as opposed to urinalysis provide additional benefit in patients newly diagnosed with type 2 diabetes receiving structured education? The DESMOND SMBG randomised controlled trial protocol

BackgroundThe benefit of self-monitoring of blood glucose (SMBG) in people with type 2 diabetes on diet or oral agents other than sulphonylureas remains uncertain. Trials of interventions incorporating education about self-monitoring of blood glucose have reported mixed results. A recent systematic review concluded that SMBG was not cost-effective. However, what was unclear was whether a cheaper method of self-monitoring (such as urine glucose monitoring) could produce comparable benefit and patient acceptability for less cost.Methods/DesignThe DESMOND SMBG trial is comparing two monitoring strategies (blood glucose monitoring and urine testing) over 18 months when incorporated into a comprehensive self-management structured education programme. It is a multi-site cluster randomised controlled trial, conducted across 8 sites (7 primary care trusts) in England, UK involving individuals with newly diagnosed Type 2 diabetes.The trial has 80% power to demonstrate equivalence in mean HbA1c (the primary end-point) at 18 months of within ± 0.5% assuming 20% drop out and 20% non-consent. Secondary end-points include blood pressure, lipids, body weight and psychosocial measures as well as a qualitative sub-study.Practices were randomised to one of two arms: participants attend a DESMOND programme incorporating a module on self-monitoring of either urine or blood glucose. The programme is delivered by accredited educators who received specific training about equipoise. Biomedical data are collected and psychosocial scales completed at baseline, and 6, 12, and 18 months post programme. Qualitative research with participants and educators will explore views and experiences of the trial and preferences for methods of monitoring.DiscussionThe DESMOND SMBG trial is designed to provide evidence to inform the debate about the value of self-monitoring of blood glucose in people with newly diagnosed type 2 diabetes. Strengths include a setting in primary care, a cluster design, a health economic analysis, a comparison of different methods of monitoring while controlling for other components of training within the context of a quality assured structured education programme and a qualitative sub-study.Trial registrationISRCTN: ISRCTN95696668.

Self-monitoring of blood glucose versus self-monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes receiving structured education: a cluster randomized controlled trial.

To compare the effectiveness and acceptability of self‐monitoring of blood glucose with self‐monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes.