Ann Louise Kinmonth

Publications of Ann Louise Kinmonth

• An explanatory randomised controlled trial of a nurse-led, consultation-based intervention to support patients with adherence to taking glucose lowering medication for type 2 diabetes.

  Authors: Andrew Farmer, Wendy Hardeman, Dyfrig Hughes, A Toby Prevost, Youngsuk Kim, Anthea Craven, Jason Oke, Sue Boase, Mary Selwood, Ian Kellar, Jonathan Graffy, Simon Griffin, Stephen Sutton, Ann Louise Kinmonth

  BMC family practice. 04/2012; 13(1):30.

  ABSTRACT: BACKGROUND: Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention toABSTRACT: BACKGROUND: Failure to take medication reduces the effectiveness of treatment leading to increased morbidity and mortality. We evaluated the efficacy of a consultation-based intervention to support objectively-assessed adherence to oral glucose lowering medication (OGLM) compared to usual care among people with type 2 diabetes. METHODS: This was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c[greater than or equal to]7.5% (58 mmol/mol), prescribed at least one OGLM. Participants were allocated to a clinic nurse delivered, innovative consultation-based intervention to strengthen patient motivation to take OGLM regularly and support medicine taking through action-plans, or to usual care. The primary outcome was the percentage of days on which the prescribed dose of medication was taken, measured objectively over 12 weeks with an electronic medicationmonitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-totreat. RESULTS: 211 patients were randomised between July 1, 2006 and November 30, 2008 in 13 British general practices (primary care clinics). Primary outcome data were available for 194 participants (91.9%). Mean (sd) percentage of adherent days was 77.4% (26.3) in the intervention group and 69.0% (30.8) in standard care (mean difference between groups 8.4%, 95% confidence interval 0.2% to 16.7%, p = 0.044). There was no significant adverse impact on functional status or treatment satisfaction. CONCLUSIONS: This well-specified, theory based intervention delivered in a single session of 30 min in primary care increased objectively measured medication adherence, with no adverse effect on treatment satisfaction. These findings justify a definitive trial of this approach to improving medication adherence over a longer period of time, with clinical and cost-effectiveness outcomes to inform clinical practice. Trial registration Current Controlled Trials ISRCTN30522359.

• Predictors of suboptimal glycaemic control in type 2 diabetes patients: The role of medication adherence and body mass index in the relationship between glycaemia and age.

  Authors: Alexander Nagrebetsky, Simon Griffin, Ann Louise Kinmonth, Stephen Sutton, Anthea Craven, Andrew Farmer

  Diabetes research and clinical practice. 01/2012;

  AIMS: To analyse predictors of glycaemic control including medication adherence and body mass index (BMI) in UK general practice patients with sub-optimally controlled type 2 diabetes. METHODS:AIMS: To analyse predictors of glycaemic control including medication adherence and body mass index (BMI) in UK general practice patients with sub-optimally controlled type 2 diabetes. METHODS: Baseline demographic, health- and treatment-related measures were evaluated as predictors of one year glycaemic control defined separately as HbA(1c)≤7.5% and a continuous measure of HbA(1c) concentration, using multivariate regression models. Significant predictors were adjusted for objectively assessed medication adherence and BMI. RESULTS: One-year HbA(1c) concentration was associated with baseline HbA(1c) (p<0.001), BMI (p=0.02), and inversely associated with age (p=0.007) and objectively assessed adherence. Adherent patients had one-year (adjusted) HbA(1c) concentration 0.65% (95% CI -1.04, -0.25; p=0.001) lower than nonadherent. Odds ratios (95% CI) of HbA(1c)≤7.5% for 10-year higher age were 1.63 (1.08, 2.45); for adherent compared to non-adherent patients 1.89 (0.84, 4.25); for patients receiving >5 compared to ≤5 medications 0.32 (0.13, 0.76); and for each 1% increment in baseline HbA(1c) 0.48 (0.31, 0.73). CONCLUSIONS: The lower HbA(1c) achieved from greater adherence to glucose lowering treatment is comparable to that achieved with additional medication. Relationships between older age and better glycaemic control are not explained by better adherence, but may partly relate to lower BMI.

• Effectiveness of physical activity promotion based in primary care: systematic review and meta-analysis of randomised controlled trials.

  Authors: Gillian Orrow, Ann-Louise Kinmonth, Simon Sanderson, Stephen Sutton

  BMJ (Clinical research ed.). 01/2012; 344:e1389.

  To determine whether trials of physical activity promotion based in primary care show sustained effects on physical activity or fitness in sedentary adults, and whether exercise referralTo determine whether trials of physical activity promotion based in primary care show sustained effects on physical activity or fitness in sedentary adults, and whether exercise referral interventions are more effective than other interventions. Systematic review and meta-analysis of randomised controlled trials. Medline, CINAHL, PsycINFO, EMBASE, SPORTDiscus, Centre for Reviews and Dissemination, the Cochrane Library, and article reference lists. Review of randomised controlled trials of physical activity promotion in sedentary adults recruited in primary care, with minimum follow-up of 12 months, reporting physical activity or fitness (or both) as outcomes, and using intention to treat analyses. Two reviewers independently assessed studies for inclusion, appraised risk of bias, and extracted data. Pooled effect sizes were calculated using a random effects model. We included 15 trials (n=8745). Most interventions took place in primary care, included health professionals in delivery, and involved advice or counselling given face to face or by phone (or both) on multiple occasions. Only three trials investigated exercise referral. In 13 trials presenting self reported physical activity, we saw small to medium positive intervention effects at 12 months (odds ratio 1.42, 95% confidence interval 1.17 to 1.73; standardised mean difference 0.25, 0.11 to 0.38). The number needed to treat with an intervention for one additional sedentary adult to meet internationally recommended levels of activity at 12 months was 12 (7 to 33). In four trials reporting cardiorespiratory fitness, a medium positive effect at 12 months was non-significant (standardised mean difference 0.51, -0.18 to 1.20). Three trials of exercise referral found small non-significant effects on self reported physical activity at 12 months (odds ratio 1.38; 0.98 to 1.95; standardised mean difference 0.20, -0.21 to 0.61). Promotion of physical activity to sedentary adults recruited in primary care significantly increases physical activity levels at 12 months, as measured by self report. We found insufficient evidence to recommend exercise referral schemes over advice or counselling interventions. Primary care commissioners should consider these findings while awaiting further trial evaluation of exercise referral schemes and other primary care interventions, with longer follow-up and use of objective measures of outcome.

• Effect on adherence to nicotine replacement therapy of informing smokers their dose is determined by their genotype: a randomised controlled trial.

  Authors: Theresa M Marteau, Paul Aveyard, Marcus R Munafò, A Toby Prevost, Gareth J Hollands, David Armstrong, Stephen Sutton, Chloe Hill, Elaine Johnstone, Ann Louise Kinmonth

  PloS one. 01/2012; 7(4):e35249.

  The behavioural impact of pharmacogenomics is untested. We tested two hypotheses concerning the behavioural impact of informing smokers their oral dose of NRT is tailored to analysis of DNA. WeThe behavioural impact of pharmacogenomics is untested. We tested two hypotheses concerning the behavioural impact of informing smokers their oral dose of NRT is tailored to analysis of DNA. We conducted an RCT with smokers in smoking cessation clinics (N = 633). In combination with NRT patch, participants were informed that their doses of oral NRT were based either on their mu-opioid receptor (OPRM1) genotype, or their nicotine dependence questionnaire score (phenotype). The proportion of prescribed NRT consumed in the first 28 days following quitting was not significantly different between groups: (68.5% of prescribed NRT consumed in genotype vs 63.6%, phenotype group, difference  =  5.0%, 95% CI -0.9,10.8, p  =  0.098). Motivation to make another quit attempt among those (n  =  331) not abstinent at six months was not significantly different between groups (p  =  0.23). Abstinence at 28 days was not different between groups (p = 0.67); at six months was greater in genotype than phenotype group (13.7% vs 7.9%, difference  =  5.8%, 95% CI 1.0,10.7, p  =  0.018). Informing smokers their oral dose of NRT was tailored to genotype not phenotype had a small, statistically non-significant effect on 28-day adherence to NRT. Among those still smoking at six months, there was no evidence that saying NRT was tailored to genotype adversely affected motivation to make another quit attempt. Higher abstinence rate at six months in the genotype arm requires investigation. Controlled-Trials.com ISRCTN14352545.

• What determines Self-Rated Health (SRH)? A cross-sectional study of SF-36 health domains in the EPIC-Norfolk cohort.

  Authors: Nahal Mavaddat, Ann Louise Kinmonth, Simon Sanderson, Paul Surtees, Sheila Bingham, Kay Tee Khaw

  Journal of epidemiology and community health. 09/2011; 65(9):800-6.

  Self-Rated Health (SRH) as assessed by a single-item measure is an independent predictor of health outcomes. However, it remains uncertain which elements of the subjective health experience it mostSelf-Rated Health (SRH) as assessed by a single-item measure is an independent predictor of health outcomes. However, it remains uncertain which elements of the subjective health experience it most strongly captures. In view of its ability to predict outcomes, elucidation of what determines SRH is potentially important in the provision of services. This study aimed to determine the extent to which dimensions of physical, mental and social functioning are associated with SRH. We studied 20,853 men and women aged 39-79 years from a population-based cohort study (European Prospective Investigation of Cancer study) who had completed an SRH (Short Form (SF)-1) measure and SF-36 questionnaire. SF-36 subscales were used to quantify dimensions of health best predicting poor or fair SRH within a logistic regression model. In multivariate models adjusting for age, gender, social class, medical conditions and depression, all subscales of the SF-36 were independently associated with SRH, with the Physical Functioning subscale more strongly associated with poor or fair compared with excellent, very good or good health (OR 3.7 (95% CI 3.3 to 4.1)) than Mental Health (OR 1.4 (95% CI 1.2 to 1.5)) or Social Functioning subscales (OR 1.8 (95% CI 1.6 to 2.0)) for those below and above the median. This study confirms that physical functioning is more strongly associated with SRH than mental health and social functioning, even where the relative associations between each dimension and SRH may be expected to differ, such as in those with depression. It suggests that the way people take account of physical, mental and social dimensions of function when rating their health may be relatively stable across groups.

• Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care.

  Authors: Simon J Griffin, Rebecca K Simmons, Kate M Williams, A Toby Prevost, Wendy Hardeman, Julie Grant, Fiona Whittle, Sue Boase, Imogen Hobbis, Soren Brage, Kate Westgate, Tom Fanshawe, Stephen Sutton, Nicholas J Wareham, Ann Louise Kinmonth

  BMC public health. 04/2011; 11:211.

  The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. EvidenceThe increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year. ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i) intensive treatment alone (n = 239), or (ii) intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239). Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking), including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing), change in objectively measured dietary intake (plasma vitamin C), medication adherence (plasma drug levels), and smoking status (plasma cotinine levels) at one year. We will undertake an intention-to-treat analysis of the effect of the intervention on these measures, an assessment of cost-effectiveness, and analyse predictors of behaviour change in the cohort. The ADDITION-Plus trial will establish the medium-term effectiveness and cost-effectiveness of adding an externally facilitated intervention tailored to support change in multiple behaviours among intensively-treated individuals with recently diagnosed type 2 diabetes in primary care. Results will inform policy recommendations concerning the management of patients early in the course of diabetes. Findings will also improve understanding of the factors influencing change in multiple behaviours, and their association with health outcomes.

• Theory of planned behaviour cognitions do not predict self-reported or objective physical activity levels or change in the ProActive trial.

  Authors: Wendy Hardeman, Ann Louise Kinmonth, Susan Michie, Stephen Sutton

  British journal of health psychology. 02/2011; 16(Pt 1):135-50.

  The objective was to test, in a trial cohort of sedentary adults at risk of Type 2 diabetes, whether theory of planned behaviour (TPB) cognitions about becoming more physically active predictedThe objective was to test, in a trial cohort of sedentary adults at risk of Type 2 diabetes, whether theory of planned behaviour (TPB) cognitions about becoming more physically active predicted objective and self-reported activity levels and change. Participants of a randomized controlled trial underwent measurement at baseline, 6 and 12 months. Participants (N= 365, 30-50 years) were recruited via their parent or family history registers at 20 general practices in the UK. Energy expenditure was measured objectively at baseline and 1 year. Participants completed questionnaires assessing physical activity and beliefs about becoming more physically active over the next year at baseline, 6 and 12 months. Between baseline and 12 months, objective energy expenditure in the cohort increased by an average of 20 minutes of brisk walking per day. Based on the 252 participants who provided complete data, affective attitude and perceived behavioural control consistently predicted intention, but intention and perceived behavioural control failed to predict physical activity levels or change (p-values > .05). Failure of the theory to predict behaviour and behaviour change may be due to inapplicability of the theory to this at-risk population or to trial participation and intensive measurement facilitating behaviour change without affecting measured cognitions, or lack of correspondence between cognitive and behavioural measures. A wide range of potential personal and environmental mediators should be considered when designing physical activity interventions among at-risk groups. High-quality experimental tests of the theory are needed in clinical populations.

• Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking.

  Authors: Sophia C L Whitwell, Christopher G Mathew, Cathryn M Lewis, Alastair Forbes, Sally Watts, Jeremy Sanderson, Gareth J Hollands, A Toby Prevost, David Armstrong, Ann Louise Kinmonth, Stephen Sutton, Theresa M Marteau

  BMC public health. 01/2011; 11:44.

  Estimates of the risk of developing Crohn's disease (CD) can be made using DNA testing for mutations in the NOD2 (CARD15) gene, family history, and smoking status. Smoking doubles the risk of CD, aEstimates of the risk of developing Crohn's disease (CD) can be made using DNA testing for mutations in the NOD2 (CARD15) gene, family history, and smoking status. Smoking doubles the risk of CD, a risk that is reduced by stopping. CD therefore serves as a timely and novel paradigm within which to assess the utility of predictive genetic testing to motivate behaviour change to reduce the risk of disease. The aim of the study is to describe the impact upon stopping smoking of communicating a risk of developing CD that incorporates DNA analysis. We will test the following main hypothesis:Smokers who are first degree relatives (FDRs) of CD probands are more likely to make smoking cessation attempts following communication of risk estimates of developing CD that incorporate DNA analysis, compared with an equivalent communication that does not incorporate DNA analysis. A parallel groups randomised controlled trial in which smokers who are FDRs of probands with CD are randomly allocated in families to undergo one of two types of assessment of risk for developing CD based on either: i. DNA analysis, family history of CD and smoking status, or ii. Family history of CD and smoking status. The primary outcome is stopping smoking for 24 hours or longer in the six months following provision of risk information. The secondary outcomes are seven-day smoking abstinence at one week and six month follow-ups. Randomisation of 470 smoking FDRs of CD probands, with 400 followed up (85%), provides 80% power to detect a difference in the primary outcome of 14% between randomised arms, at the 5% significance level. This trial provides one of the strongest tests to date of the impact of communicating DNA-based risk assessment on risk-reducing behaviour change. Specific issues regarding the choice of trial design are discussed.

• Do increases in physical activity encourage positive beliefs about further change in the ProActive cohort?

  Authors: Wendy Hardeman, Susan Michie, Ann Louise Kinmonth, Stephen Sutton

  Psychology & health. 01/2011; 26(7):899-914.

  Effects of behaviour change on cognitions are rarely examined within the Theory of Planned Behaviour. We tested whether increases in physical activity resulted in more positive beliefs about furtherEffects of behaviour change on cognitions are rarely examined within the Theory of Planned Behaviour. We tested whether increases in physical activity resulted in more positive beliefs about further change among a cohort of sedentary adults participating in a behavioural intervention trial (ProActive). At baseline, 6 and 12 months, 365 adults completed questionnaires assessing physical activity and cognitions about becoming more active over the coming year. Objective activity was assessed at baseline and 12 months. Participants reporting larger increases in activity were no more positive about making further increases than those reporting less behaviour change (p-values>0.05). Participants with larger increases in objective activity reported weaker perceived control (β=-0.342; p=0.001) and more negative instrumental attitudes (β=-0.230; p=0.017) at 12 months. Participants may have felt that they had changed enough or measures of perceived success may be more sensitive to behaviour change. Alternatively, long measurement intervals may have missed immediate cognitive and affective consequences of behaviour change, or such effects may require participants to consistently self-monitor or receive feedback on performance. Future studies could test the effect of such techniques on physical activity and a wider range of cognitive, affective and physiological consequences, using more frequent measurement intervals.

• Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence.

  Authors: Theresa M Marteau, Marcus R Munafò, Paul Aveyard, Chloe Hill, Sophia Whitwell, Thomas A Willis, Rachel A Crockett, Gareth J Hollands, Elaine C Johnstone, Alison J Wright, A Toby Prevost, David Armstrong, Stephen Sutton, Ann Louise Kinmonth

  BMC public health. 11/2010; 10:680.

  The behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. TheThe behavioural impact of pharmacogenomics is untested; informing smokers of genetic test results for responsiveness to smoking cessation medication may increase adherence to this medication. The objective of this trial is to estimate the impact upon adherence to nicotine replacement therapy (NRT) of informing smokers that their oral dose of NRT has been tailored to a DNA analysis. Hypotheses to be tested are as follows: I Adherence to NRT is greater among smokers informed that their oral dose of NRT is tailored to an analysis of DNA (genotype), compared to one tailored to nicotine dependence questionnaire score (phenotype). II Amongst smokers who fail to quit at six months, motivation to make another quit attempt is lower when informed that their oral dose of NRT was tailored to genotype rather than phenotype. An open label, parallel groups randomised trial in which 630 adult smokers (smoking 10 or more cigarettes daily) using National Health Service (NHS) stop smoking services in primary care are randomly allocated to one of two groups:i. NRT oral dose tailored by DNA analysis (OPRM1 gene) (genotype), orii. NRT oral dose tailored by nicotine dependence questionnaire score (phenotype)The primary outcome is proportion of prescribed NRT consumed in the first 28 days following an initial quit attempt, with the secondary outcome being motivation to make another quit attempt, amongst smokers not abstinent at six months. Other outcomes include adherence to NRT in the first seven days and biochemically validated smoking abstinence at six months. The primary outcome will be collected on 630 smokers allowing sufficient power to detect a 7.5% difference in mean proportion of NRT consumed using a two-tailed test at the 5% level of significance between groups. The proportion of all NRT consumed in the first four weeks of quitting will be compared between arms using an independent samples t-test and by estimating the 95% confidence interval for observed between-arm difference in mean NRT consumption (Hypothesis I). Motivation to make another quit attempt will be compared between arms in those failing to quit by six months (Hypothesis II). This is the first clinical trial evaluating the behavioural impact on adherence of prescribing medication using genetic rather than phenotypic information. Specific issues regarding the choice of design for trials of interventions of this kind are discussed. TRIAL DETAILS: Funder: Medical Research Council (MRC)Grant number: G0500274. ISRCTN: 14352545. Date trial stated: June 2007. Expected end date: December 2009. Expected reporting date: December 2010.

• More than measurement: practice team experiences of screening for type 2 diabetes.

  Authors: Jonathan Graffy, Julie Grant, Kate Williams, Simon Cohn, Sara Macbay, Simon Griffin, Ann Louise Kinmonth

  Family practice. 08/2010; 27(4):386-94.

  The feasibility, cost-effectiveness and best means to implement population screening for type 2 diabetes remain to be established. To learn from the experiences of practice staff undertaking aThe feasibility, cost-effectiveness and best means to implement population screening for type 2 diabetes remain to be established. To learn from the experiences of practice staff undertaking a diabetes screening programme in order to inform future screening initiatives. Qualitative analysis of interviews with staff in six general practices in the 'ADDITION-Cambridge' trial; three randomly allocated to intensively manage screen-detected patients and three providing usual care. We conducted semi-structured interviews with seven nurses, four doctors, three health care assistants and four managers. Four researchers analysed the transcripts practice by practice, preparing vignettes and comparing interpretations. Participants commented on a summary report. Each practice team implemented the screening and intervention programme differently, depending on numbers at risk and decisions about staff contributions. Several emphasized the importance of administrative support. As they screened, they extended the reach of the programme, testing patients outside the target group if requested, checking other risk factors, providing health information and following up people with impaired glucose tolerance. Staff felt that patients accepted the screening and subsequent management as any other clinical activity. Although those developing screening programmes attempt to standardize them, primary care teams need to adapt the work to fit local circumstances. Staff need a sense of ownership, training, well-designed information technology systems and protected time. Furthermore, screening is more than measurement; at the individual level, it is a complete health care interaction, requiring individual explanations, advice on health-related behaviour and appropriate follow-up. The UK 'NHS Health Checks' programme should embrace these findings.

• Impact of informed-choice invitations on diabetes screening knowledge, attitude and intentions: an analogue study.

  Authors: Eleanor Mann, Ian Kellar, Stephen Sutton, Ann Louise Kinmonth, Matthew Hankins, Simon Griffin, Theresa M Marteau

  BMC public health. 01/2010; 10:768.

  Despite concerns that facilitating informed choice would decrease diabetes screening uptake, 'informed choice' invitations that increased knowledge did not affect attendance (the DICISION trial). WeDespite concerns that facilitating informed choice would decrease diabetes screening uptake, 'informed choice' invitations that increased knowledge did not affect attendance (the DICISION trial). We explored possible reasons using data from an experimental analogue study undertaken to develop the invitations. We tested a model of the impact on knowledge, attitude and intentions of a diabetes screening invitation designed to facilitate informed choices. 417 men and women aged 40-69 recruited from town centres in the UK were randomised to receive either an invitation for diabetes screening designed to facilitate informed choice or a standard type of invitation. Knowledge of the invitation, attitude towards diabetes screening, and intention to attend for diabetes screening were assessed two weeks later. Attitude was a strong predictor of screening intentions (β = .64, p = .001). Knowledge added to the model but was a weak predictor of intentions (β = .13, p = .005). However, invitation type did not predict attitudes towards screening but did predict knowledge (β = -.45, p = .001), which mediated a small effect of invitation type on intention (indirect β = -.06, p = .017). These findings may explain why information about the benefits and harms of screening did not reduce diabetes screening attendance in the DICISION trial.

• Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials.

  Authors: Jonathan Graffy, Peter Bower, Elaine Ward, Paul Wallace, Brendan Delaney, Ann-Louise Kinmonth, David Collier, Julia Miller

  BMC medical research methodology. 01/2010; 10:38.

  Trials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternativeTrials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternative methods using a randomized trial, 'nested' in an ongoing 'host' trial. There are potential scientific, logistical and ethical obstacles to such studies. Telephone interviews were undertaken with four groups of stakeholders (funders, principal investigators, trial managers and ethics committee chairs) to explore their views on the practicality and acceptability of undertaking nested trials of recruitment methods. These semi-structured interviews were transcribed and analysed thematically. Twenty people were interviewed. Respondents were familiar with recruitment difficulties in primary care and recognised the case for 'nested' studies to build an evidence base on effective recruitment strategies. However, enthusiasm for this global aim was tempered by the challenges of implementation. Challenges for host studies included increasing complexity and management burden; compatibility between the host and nested study; and the impact of the nested study on trial design and relationships with collaborators. For nested recruitment studies, there were concerns that host study investigators might have strong preferences, limiting the nested study investigators' control over their research, and also concerns about sample size which might limit statistical power. Nested studies needed to be compatible with the main trial and should be planned from the outset. Good communication and adequate resources were seen as important. Although research on recruitment was welcomed in principle, the issue of which study had control of key decisions emerged as critical. To address this concern, it appeared important to align the interests of both host and nested studies and to reduce the burden of hosting a recruitment trial. These findings should prove useful in devising a programme of research involving nested studies of recruitment interventions.

• Protocol for the MoleMate UK Trial: a randomised controlled trial of the MoleMate system in the management of pigmented skin lesions in primary care [ISRCTN 79932379].

  Authors: Fiona M Walter, Helen C Morris, Elka Humphrys, Per N Hall, Ann Louise Kinmonth, A Toby Prevost, Edward Cf Wilson, Nigel Burrows, Paul Norris, Margaret Johnson, Jon Emery

  BMC family practice. 01/2010; 11:36.

  Suspicious pigmented lesions are a common presenting problem in general practice consultations; while the majority are benign a small minority are melanomas. Differentiating melanomas from otherSuspicious pigmented lesions are a common presenting problem in general practice consultations; while the majority are benign a small minority are melanomas. Differentiating melanomas from other pigmented lesions in primary care is challenging: currently, 95% of all lesions referred to a UK specialist are benign. The MoleMate system is a new diagnostic aid, incorporating a hand-held SIAscopy scanner with a primary care diagnostic algorithm. This trial tests the hypothesis that adding the MoleMate system to current best primary care practice will increase the proportion of appropriate referrals of suspicious pigmented lesions to secondary care compared with current best practice alone. The MoleMate UK Trial is a primary care based multi-centre randomised controlled trial, with randomisation at patient level using a validated block randomisation method for two age groups (45 years and under; 46 years and over). We aim to recruit adult patients seen in general practice with a pigmented skin lesion that cannot immediately be diagnosed as benign and the patient reassured. The trial has a 'two parallel groups' design, comparing 'best practice' with 'best practice' plus the MoleMate system in the intervention group. The primary outcome is the positive predictive value (PPV) of referral defined as the proportion of referred lesions seen by secondary care experts that are considered 'clinically significant' (i.e. biopsied or monitored). Secondary outcomes include: the sensitivity, specificity and negative predictive value (NPV) of the decision not to refer; clinical outcomes (melanoma thickness, 5 year melanoma incidence and mortality); clinician outcomes (Index of Suspicion, confidence, learning effects); patient outcomes (satisfaction, general and cancer-specific worry), and cost-utility. The MoleMate UK Trial tests a new technology designed to improve the management of suspicious pigmented lesions in primary care. If effective, the MoleMate system could reduce the burden on skin cancer clinics of patients with benign pigmented skin lesions, and improve patient care in general practice.

• Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): randomised trial.

  Authors: Theresa M Marteau, Eleanor Mann, A Toby Prevost, Joana C Vasconcelos, Ian Kellar, Simon Sanderson, Michael Parker, Simon Griffin, Stephen Sutton, Ann Louise Kinmonth

  BMJ (Clinical research ed.). 01/2010; 340:c2138.

  To compare the effect of an invitation promoting informed choice for screening with a standard invitation on attendance and motivation to engage in preventive action. Randomised controlledTo compare the effect of an invitation promoting informed choice for screening with a standard invitation on attendance and motivation to engage in preventive action. Randomised controlled trial. Four English general practices. 1272 people aged 40-69 years, at risk for diabetes, identified from practice registers using a validated risk score and invited to attend for screening. Intervention was a previously validated invitation to inform the decision to attend screening, presenting diabetes as a serious potential problem, and providing details of possible costs and benefits of screening and treatment in text and pie charts. This was compared with a brief, standard invitation simply describing diabetes as a serious potential problem. The primary end point was attendance for screening. The secondary outcome measures were intention to make changes to lifestyle and satisfaction with decisions made among attenders. The primary end point was analysed for all 1272 participants. 55.8% (353/633) of those in the informed choice group attended for screening, compared with 57.6% (368/639) in the standard invitation group (mean difference -1.8%, 95% confidence interval -7.3% to 3.6%; P=0.51). Attendance was lower among the more deprived group (most deprived third 47.5% v least deprived third 64.3%; P<0.001). Interaction between deprivation and effect of invitation type on attendance was not significant. Among attenders, intention to change behaviour was strong and unaffected by invitation type. Providing information to support choice did not adversely affect attendance for screening for diabetes. Those from more socially deprived groups were, however, less likely to attend, regardless of the type of invitation received. Further attention to invitation content alone is unlikely to achieve equity in uptake of preventive services. Current Controlled Trials ISRCTN 73125647.

• Improving recruitment to health research in primary care.

  Authors: Peter Bower, Paul Wallace, Elaine Ward, Jonathan Graffy, Julia Miller, Brendan Delaney, Ann Louise Kinmonth

  Family practice. 07/2009;

  BACKGROUND: Recruitment to health research is known to be problematic. However, evidence concerning ways of improving recruitment is sparse. OBJECTIVE: To outline the process of recruitment, factorsBACKGROUND: Recruitment to health research is known to be problematic. However, evidence concerning ways of improving recruitment is sparse. OBJECTIVE: To outline the process of recruitment, factors impacting on recruitment success and key areas for further research and development. METHODS: Narrative literature review. RESULTS: This paper argues that three ways of improving recruitment should form the focus of future work: developing a repository of evidence-based techniques and methods which can be introduced by research teams; developing the infrastructure to support recruitment, especially new technologies around the electronic patient record; and increasing public engagement with research, to improve participation by both clinicians and patients. CONCLUSION: Recruitment to health research in primary care remains a major hurdle, and key research and development priorities must be addressed.

• The ADDITION-Cambridge trial protocol - a cluster randomised controlled trial of screening for type 2 diabetes and intensive treatment for screen-detected patients.

  Authors: Justin Echouffo-Tcheugui, Rebecca Simmons, Kate Williams, Roslyn Barling, A Toby Prevost, Ann Louise Kinmonth, Nicholas Wareham, Simon Griffin

  BMC public health. 06/2009; 9(1):136.

  ABSTRACT: BACKGROUND: The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growingABSTRACT: BACKGROUND: The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, the benefits of such a strategy remain uncertain. METHODS: The ADDITION-Cambridge study aims to evaluate the effectiveness and cost-effectiveness of (i) a stepwise screening strategy for type 2 diabetes; and (ii) intensive multifactorial treatment for people with screen-detected diabetes in primary care. 63 practices in the East Anglia region participated. Three undertook the pilot study, 33 were allocated to three groups: no screening (control), screening followed by intensive treatment (IT) and screening plus routine care (RC) in an unbalanced (1:3:3) randomisation. The remaining 27 practices were randomly allocated to IT and RC. A risk score incorporating routine practice data was used to identify people aged 40-69 years at high-risk of undiagnosed diabetes. In the screening practices, high-risk individuals were invited to take part in a stepwise screening programme. In the IT group, diabetes treatment is optimised through guidelines, target-led multifactorial treatment, audit, feedback, and academic detailing for practice teams, alongside provision of educational materials for newly diagnosed participants. Primary endpoints are modelled cardiovascular risk at one year, and cardiovascular mortality and morbidity at five years after diagnosis of diabetes. Secondary endpoints include all-cause mortality, development of renal and visual impairment, peripheral neuropathy, health service costs, self-reported quality of life, functional status and health utility. Impact of the screening programme at the population level is also assessed through measures of mortality, cardiovascular morbidity, health status and health service use among high-risk individuals. DISCUSSION: ADDITION-Cambridge is conducted in a defined high-risk group accessible through primary care. It addresses the feasibility of population-based screening for diabetes, as well as the benefits and costs of screening and intensive multifactorial treatment early in the disease trajectory. The intensive treatment algorithm is based on evidence from studies including individuals with clinically diagnosed diabetes and the education materials are informed by psychological theory. ADDITION-Cambridge will provide timely evidence concerning the benefits of early intensive treatment and will inform policy decisions concerning screening for type 2 diabetes. Trial registration: Current Controlled trials ISRCTN86769081.

• An implementation research agenda.

  Authors: Martin Eccles, David Armstrong, Richard Baker, Kevin Cleary, Huw Davies, Stephen Davies, Paul Glasziou, Irene Ilott, Ann Louise Kinmonth, Gillian Leng, Stuart Logan, Theresa Marteau, Susan Michie, Hugh Rogers, Jo Rycroft-Malone, Bonnie Sibbald

  Implementation science : IS. 05/2009; 4(1):18.

  ABSTRACT: In October 2006, the Chief Medical Officer (CMO) of England asked Professor Sir John Tooke to chair a High Level Group on Clinical Effectiveness in response to the chapter 'Waste not, wantABSTRACT: In October 2006, the Chief Medical Officer (CMO) of England asked Professor Sir John Tooke to chair a High Level Group on Clinical Effectiveness in response to the chapter 'Waste not, want not' in the CMOs 2005 annual report 'On the State of the Public Health'. The high level group made recommendations to the CMO to address possible ways forward to improve clinical effectiveness in the UK National Health Service (NHS) and promote clinical engagement to deliver this. The report contained a short section on research needs that emerged from the process of writing the report, but in order to more fully identify the relevant research agenda Professor Sir John Tooke asked Professor Martin Eccles to convene an expert group -- the Clinical Effectiveness Research Agenda Group (CERAG) -- to define the research agenda. The CERAG's terms of reference were 'to further elaborate the research agenda in relation to pursuing clinically effective practice within the (UK) National Health Service'. This editorial presents the summary of the CERAG report and recommendations.

• Impact of a physical activity intervention program on cognitive predictors of behaviour among adults at risk of Type 2 diabetes (ProActive randomised controlled trial).

  Authors: Wendy Hardeman, Ann Louise Kinmonth, Susan Michie, Stephen Sutton, On Behalf Of The Proactive Project Team

  The international journal of behavioral nutrition and physical activity. 04/2009; 6(1):16.

  ABSTRACT: BACKGROUND: In the ProActive Trial an intensive theory-based intervention program was no more effective than theory-based brief advice in increasing objectively measured physical activityABSTRACT: BACKGROUND: In the ProActive Trial an intensive theory-based intervention program was no more effective than theory-based brief advice in increasing objectively measured physical activity among adults at risk of Type 2 diabetes. We aimed to illuminate these findings by assessing whether the intervention program changed cognitions about increasing activity, defined by the Theory of Planned Behaviour, in ways consistent with the theory. METHODS: N=365 sedentary participants aged 30-50 years with a parental history of Type 2 diabetes were randomised to brief advice alone or to brief advice plus the intervention program delivered face-to-face or by telephone. Questionnaires at baseline, 6 and 12 months assessed cognitions about becoming more physically active. Analysis of covariance was used to test intervention impact. Bootstrapping was used to test multiple mediation of intervention impact. RESULTS: At 6 months, combined intervention groups (face-to-face and telephone) reported that they found increasing activity more enjoyable (affective attitude, d=.25), and they perceived more instrumental benefits (e.g., improving health) (d=.23) and more control (d=.32) over increasing activity than participants receiving brief advice alone. Stronger intentions (d=.50) in the intervention groups than the brief advice group at 6 months were partially explained by affective attitude and perceived control. At 12 months, intervention groups perceived more positive instrumental (d=.21) and affective benefits (d=.29) than brief advice participants. The intervention did not change perceived social pressure to increase activity. CONCLUSIONS: Lack of effect of the intervention program on physical activity over and above brief advice was consistent with limited and mostly small short-term effects on cognitions. Targeting affective benefits (e.g., enjoyment, social interaction) and addressing barriers to physical activity may strengthen intentions, but stronger intentions did not result in more behaviour change. More powerful interventions which induce large changes in TPB cognitions may be needed. Other interventions deserving further evaluation include theory-based brief advice, intensive measurement of physical and psychological factors, and monitoring of physical activity. Future research should consider a wider range of mediators of physical activity change, assess participants' use of self-regulatory strategies taught in the intervention, and conduct experimental studies or statistical modelling prior to trial evaluation. ISRCTN61323766.

• Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): trial protocol.

  Authors: Eleanor Mann, A Toby Prevost, Simon Griffin, Ian Kellar, Stephen Sutton, Michael Parker, Simon Sanderson, Ann Louise Kinmonth, Theresa Marteau

  BMC public health. 03/2009; 9(1):63.

  ABSTRACT: BACKGROUND: Screening invitations have traditionally been brief, providing information only about population benefits. Presenting information about the limited individual benefits andABSTRACT: BACKGROUND: Screening invitations have traditionally been brief, providing information only about population benefits. Presenting information about the limited individual benefits and potential harms of screening to inform choice may reduce attendance, particularly in the more socially deprived. At the same time, amongst those who attend, it might increase motivation to change behavior to reduce risks. This trial assesses the impact on attendance and motivation to change behavior of an invitation that facilitates informed choices about participating in diabetes screening in general practice. Three hypotheses are tested: 1. Attendance at screening for diabetes is lower following an informed choice compared with a standard invitation. 2. There is an interaction between the type of invitation and social deprivation: attendance following an informed choice compared with a standard invitation is lower in those who are more rather than less socially deprived. 3. Amongst those who attend for screening, intentions to change behavior to reduce risks of complications in those subsequently diagnosed with diabetes are stronger following an informed choice invitation compared with a standard invitation. METHODS: 1500 people aged 40-69 years without known diabetes but at high risk are identified from four general practice registers in the east of England. 1200 participants are randomized by households to receive one of two invitations to attend for diabetes screening at their general practices. The intervention invitation is designed to facilitate informed choices, and comprises detailed information and a decision aid. A comparison invitation is based on those currently in use. Screening involves a finger-prick blood glucose test. The primary outcome is attendance for diabetes screening. The secondary outcome is intention to change health related behaviors in those attenders diagnosed with diabetes. A sample size of 1200 ensures 90% power to detect a 10% difference in attendance between arms, and in an estimated 780 attenders, 80% power to detect a 0.2 sd difference in intention between arms. DISCUSSION: The DICISION trial is a rigorous pragmatic denominator based clinical trial of an informed choice invitation to diabetes screening, which addresses some key limitations of previous trials.