Publications
229 results found
Simmons RK, Echouffo-Tcheugui JB, Sharp SJ, et al., 2012, Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): a cluster-randomised controlled trial, LANCET, Vol: 380, Pages: 1741-1748, ISSN: 0140-6736
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- Citations: 158
Hollands GJ, Whitwell SCL, Parker RA, et al., 2012, Effect of communicating DNA based risk assessments for Crohn's disease on smoking cessation: randomised controlled trial, BMJ-BRITISH MEDICAL JOURNAL, Vol: 345, ISSN: 0959-535X
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- Citations: 23
Kelly JD, Dudderidge TJ, Wollenschlaeger A, et al., 2012, Bladder Cancer Diagnosis and Identification of Clinically Significant Disease by Combined Urinary Detection of Mcm5 and Nuclear Matrix Protein 22, PLOS One, Vol: 7, ISSN: 1932-6203
BackgroundUrinary biomarkers for bladder cancer detection are constrained by inadequate sensitivity or specificity. Here we evaluate the diagnostic accuracy of Mcm5, a novel cell cycle biomarker of aberrant growth, alone and in combination with NMP22.Methods1677 consecutive patients under investigation for urinary tract malignancy were recruited to a prospective blinded observational study. All patients underwent ultrasound, intravenous urography, cystoscopy, urine culture and cytologic analysis. An immunofluorometric assay was used to measure Mcm5 levels in urine cell sediments. NMP22 urinary levels were determined with the FDA-approved NMP22® Test Kit.ResultsGenito-urinary tract cancers were identified in 210/1564 (13%) patients with an Mcm5 result and in 195/1396 (14%) patients with an NMP22 result. At the assay cut-point where sensitivity and specificity were equal, the Mcm5 test detected primary and recurrent bladder cancers with 69% sensitivity (95% confidence interval = 62–75%) and 93% negative predictive value (95% CI = 92–95%). The area under the receiver operating characteristic curve for Mcm5 was 0.75 (95% CI = 0.71–0.79) and 0.72 (95% CI = 0.67–0.77) for NMP22. Importantly, Mcm5 combined with NMP22 identified 95% (79/83; 95% CI = 88–99%) of potentially life threatening diagnoses (i.e. grade 3 or carcinoma in situ or stage ≥pT1) with high specificity (72%, 95% CI = 69–74%).ConclusionsThe Mcm5 immunoassay is a non-invasive test for identifying patients with urothelial cancers with similar accuracy to the FDA-approved NMP22 ELISA Test Kit. The combination of Mcm5 plus NMP22 improves the detection of UCC and identifies 95% of clinically significant disease. Trials of a commercially developed Mcm5 assay suitable for an end-user laboratory alongside NMP22 are required to assess their potential clinical utility in improving diagnostic and surveillance care pathways.
Walter FM, Morris HC, Humphrys E, et al., 2012, Effect of adding a diagnostic aid to best practice to manage suspicious pigmented lesions in primary care: randomised controlled trial, BMJ-BRITISH MEDICAL JOURNAL, Vol: 344, ISSN: 1756-1833
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- Citations: 50
Griffin N, Addley H, Sala E, et al., 2012, Vascular invasion in hepatocellular carcinoma: is there a correlation with MRI?, BRITISH JOURNAL OF RADIOLOGY, Vol: 85, Pages: 736-744, ISSN: 0007-1285
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- Citations: 11
Naughton F, Prevost AT, Gilbert H, et al., 2012, Randomized Controlled Trial Evaluation of a Tailored Leaflet and SMS Text Message Self-help Intervention for Pregnant Smokers (MiQuit), NICOTINE & TOBACCO RESEARCH, Vol: 14, Pages: 569-577, ISSN: 1462-2203
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- Citations: 106
Marteau TM, Aveyard P, Munafo MR, et al., 2012, Effect on adherence to nicotine replacement therapy of informing smokers their dose is determined by their genotype: a randomised controlled trial, PLoS ONE, Vol: 7, Pages: 1-9, ISSN: 1932-6203
BackgroundThe 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.Methods and FindingsWe 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).ConclusionsInforming 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.
Farmer A, Hardeman W, Hughes D, et al., 2012, 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, BMC Family Practice, Vol: 13, ISSN: 1471-2296
BackgroundFailure 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.MethodsThis was a parallel group randomised trial in adult patients with type 2 diabetes and HbA1c≥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 medication-monitoring device (TrackCap, Aardex, Switzerland). The primary analysis was intention-to-treat.Results211 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.ConclusionsThis 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 registrationCurrent Controlled Trials ISRCTN30522359
White AJS, Kellar I, Prevost AT, et al., 2012, Adherence to hypoglycaemic medication among people with type 2 diabetes in primary care, PRIMARY CARE DIABETES, Vol: 6, Pages: 27-33, ISSN: 1751-9918
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- Citations: 17
Prevost A, Bowden J, 2011, Designing a preliminary adaptive study to inform a biomarker trial in Psoriasis, International Clinical Trials Methodology Conference, Publisher: BioMed Central, ISSN: 1745-6215
Casey N, Thompson S, Prevost A, 2011, Modelling multiple outcomes to improve the detection of causal mediation effects in complex intervention trials, International Clinical Trials Methodology Conference, Publisher: BioMed Central, ISSN: 1745-6215
Casey N, Thompson S, Prevost AT, 2011, Modelling multiple outcomes to improve the detection of causal mediation effects in complex intervention trials, Trials, Vol: 12
Corrie PG, Moody M, Wood V, et al., 2011, Protocol for the OUTREACH trial: A randomised trial comparing delivery of cancer systemic therapy in three different settings - patient's home, GP surgery and hospital day unit, BMC Cancer, Vol: 11, ISSN: 1471-2407
BackgroundThe national Cancer Reform Strategy recommends delivering care closer to home whenever possible. Cancer drug treatment has traditionally been administered to patients in specialist hospital-based facilities. Technological developments mean that nowadays, most treatment can be delivered in the out-patient setting. Increasing demand, care quality improvements and patient choice have stimulated interest in delivering some treatment to patients in the community, however, formal evaluation of delivering cancer treatment in different community settings is lacking. This randomised trial compares delivery of cancer treatment in the hospital with delivery in two different community settings: the patient's home and general practice (GP) surgeries.Methods/designPatients due to receive a minimum 12 week course of standard intravenous cancer treatment at two hospitals in the Anglia Cancer Network are randomised on a 1:1:1 basis to receive treatment in the hospital day unit (control arm), or their own home, or their choice of one of three neighbouring GP surgeries. Overall patient care, treatment prescribing and clinical review is undertaken according to standard local practice. All treatment is dispensed by the local hospital pharmacy and treatment is delivered by the hospital chemotherapy nurses. At four time points during the 12 week study period, information is collected from patients, nursing staff, primary and secondary care teams to address the primary end point, patient-perceived benefits (using the emotional function domain of the EORTC QLQC30 patient questionnaire), as well as secondary end points: patient satisfaction, safety and health economics.DiscussionThe Outreach trial is the first randomised controlled trial conducted which compares delivery of out-patient based intravenous cancer treatment in two different community settings with standard hospital based treatment. Results of this study may better inform all key stakeholders regarding potential costs a
Kellar I, Mann E, Kinmonth AL, et al., 2011, Can informed choice invitations lead to inequities in intentions to make lifestyle changes among participants in a primary care diabetes screening programme? Evidence from a randomized trial, PUBLIC HEALTH, Vol: 125, Pages: 645-652, ISSN: 0033-3506
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- Citations: 5
Farquhar MC, Prevost AT, McCrone P, et al., 2011, Study protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease, Trials, Vol: 12, ISSN: 1745-6215
BackgroundBreathlessness in advanced disease causes significant distress to patients and carers and presents management challenges to health care professionals. The Breathlessness Intervention Service (BIS) seeks to improve the care of breathless patients with advanced disease (regardless of cause) through the use of evidence-based practice and working with other healthcare providers. BIS delivers a complex intervention (of non-pharmacological and pharmacological treatments) via a multi-professional team. BIS is being continuously developed and its impact evaluated using the MRC's framework for complex interventions (PreClinical, Phase I and Phase II completed). This paper presents the protocol for Phase III.Methods/DesignPhase III comprises a pragmatic, fast-track, single-blind randomised controlled trial of BIS versus standard care. Due to differing disease trajectories, the service uses two broad service models: one for patients with malignant disease (intervention delivered over two weeks) and one for patients with non-malignant disease (intervention delivered over four weeks). The Phase III trial therefore consists of two sub-protocols: one for patients with malignant conditions (four week protocol) and one for patients with non-malignant conditions (eight week protocol). Mixed method interviews are conducted with patients and their lay carers at three to five measurement points depending on randomisation and sub-protocol. Qualitative interviews are conducted with referring and non-referring health care professionals (malignant disease protocol only). The primary outcome measure is 'patient distress due to breathlessness' measured on a numerical rating scale (0-10). The trial includes economic evaluation. Analysis will be on an intention to treat basis.DiscussionThis is the first evaluation of a breathlessness intervention for advanced disease to have followed the MRC framework and one of the first palliative care trials to use fast track methodology and single
Griffin SJ, Simmons RK, Williams KM, et al., 2011, 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, BMC Public Health, Vol: 11, Pages: 1-12, ISSN: 1471-2458
BackgroundThe 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.Methods/DesignADDITION-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 undertak
Potluri S, Jefferies SJ, Jena R, et al., 2011, Residual Postoperative Tumour Volume Predicts Outcome after High-dose Radiotherapy for Chordoma and Chondrosarcoma of the Skull Base and Spine, CLINICAL ONCOLOGY, Vol: 23, Pages: 199-208, ISSN: 0936-6555
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- Citations: 54
Paddison CAM, Eborall HC, French DP, et al., 2011, Predictors of anxiety and depression among people attending diabetes screening: A prospective cohort study embedded in the ADDITION (Cambridge) randomized control trial, BRITISH JOURNAL OF HEALTH PSYCHOLOGY, Vol: 16, Pages: 213-226, ISSN: 1359-107X
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- Citations: 17
Whitwell SCL, Mathew CG, Lewis CM, et al., 2011, Trial Protocol: Communicating DNA-based risk assessments for Crohn's disease: a randomised controlled trial assessing impact upon stopping smoking, BMC Public Health, Vol: 11, Pages: 1-8, ISSN: 1471-2458
BackgroundEstimates 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.Methods/designA 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, orii. Family history of CD and smoking statusThe 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.DiscussionThis 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.
Morley AP, Nalla BP, Vamadevan S, et al., 2010, The Influence of Duration of Fluid Abstinence on Hypotension During Propofol Induction, ANESTHESIA AND ANALGESIA, Vol: 111, Pages: 1373-1377, ISSN: 0003-2999
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- Citations: 8
Marteau TM, Munafo MR, Aveyard P, et al., 2010, Trial Protocol: Using genotype to tailor prescribing of nicotine replacement therapy: a randomised controlled trial assessing impact of communication upon adherence, BMC Public Health, Vol: 10, Pages: 1-10, ISSN: 1471-2458
BackgroundThe 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:IAdherence 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.Methods/DesignAn 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 betw
Rodriguez-Acebes S, Proctor I, Loddo M, et al., 2010, Targeting DNA Replication before it Starts <i>Cdc7 as a Therapeutic Target in p53</i>-<i>Mutant Breast Cancers</i>, AMERICAN JOURNAL OF PATHOLOGY, Vol: 177, Pages: 2034-2045, ISSN: 0002-9440
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- Citations: 40
Lloyd SKW, Kasbekar AV, Kenway B, et al., 2010, Cochlear rotation and its relevance to cochlear implantation, Pages: 57-63, ISSN: 1467-0100
Objectives: To investigate changes in cochlear orientation with age and discuss the implications of any change with respect to cochlear implantation. Study Design: Cross-sectional study of computerized tomography scans of the temporal bones in patients with no congenital abnormalities. Patients: 159 patients were included in the study making a total of 318 ears. The age range was nine months to eighty five years. Intervention: Axial compututed tomography scans showing the basal turn of the cochlea were identified. The angle of the basal turn of the cochlea was measured by drawing a line through the long axis of the basal turn and measuring its angle with a line drawn through the midsagittal plane. The patients were grouped according to age and a one way analysis of variance was used to identify any statistically significant change in basal turn angulation. Inter- and intra-observer errors were calculated and presented as repeatability co-efficients. The basal turn angles of 3 difficult cases of cochlear implantation were related to the findings. Results: The mean basal turn angle was 54.6° (range 46.8-63.8°; SD 3.5°). There was a statistically significant reduction in the angulation of the basal turn with increasing age (F=10.1; p=0.002). The majority of the change occurs between the ages of eleven and fifteen. The inter-observer reliability co-efficient was 4.8. The intra-observer reliability co-efficient was 2.0. The 3 difficult cases all had basal turn angles that were at the upper limit of the normal range. Conclusions: There is a statistically significant reduction in basal turn angulation relative to the midsagittal plane with increasing age. However, care should be taken in interpreting these results in light of the inherent error in the measuring technique although the intra-observer repeatability coefficient was only 2.0. The more obtuse angulation of the basal turn in children may have implications for cochlear implantation. © 2010 W. S. M
Mangat J, Standley T, Prevost A, et al., 2010, A comparison of technologies used for estimation of body temperature, PHYSIOLOGICAL MEASUREMENT, Vol: 31, Pages: 1105-1118, ISSN: 0967-3334
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- Citations: 18
Sargeant LA, Simmons RK, Barling RS, et al., 2010, Who attends a UK diabetes screening programme? Findings from the <i>ADDITION-Cambridge</i> study, DIABETIC MEDICINE, Vol: 27, Pages: 995-1003, ISSN: 0742-3071
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- Citations: 51
Dudderidge TJ, Kelly JD, Wollenschlaeger A, et al., 2010, Diagnosis of prostate cancer by detection of minichromosome maintenance 5 protein in urine sediments, British Journal of Cancer, Vol: 103, Pages: 701-707, ISSN: 0007-0920
Background:The accuracy of prostate-specific antigen (PSA) testing in prostate cancer detection is constrained by low sensitivity and specificity. Dysregulated expression of minichromosome maintenance (Mcm) 2–7 proteins is an early event in epithelial multistep carcinogenesis and thus MCM proteins represent powerful cancer diagnostic markers. In this study we investigate Mcm5 as a urinary biomarker for prostate cancer detection.Methods:Urine was obtained from 88 men with prostate cancer and from two control groups negative for malignancy. A strictly normal cohort included 28 men with complete, normal investigations, no urinary calculi and serum PSA <2 ng ml–1. An expanded control cohort comprised 331 men with a benign final diagnosis, regardless of PSA level. Urine was collected before and after prostate massage in the cancer patient cohort. An immunofluorometric assay was used to measure Mcm5 levels in urine sediments.Results:The Mcm5 test detected prostate cancer with 82% sensitivity (confidence interval (CI)= 72–89%) and with a specificity ranging from 73 (CI=68–78%) to 93% (CI=76–99%). Prostate massage led to increased Mcm5 signals compared with pre-massage samples (median 3440 (interquartile range (IQR) 2280 to 5220) vs 2360 (IQR <1800 to 4360); P=0.009), and was associated with significantly increased diagnostic sensitivity (82 vs 60%; P=0.012).Conclusions:Urinary Mcm5 detection seems to be a simple, accurate and noninvasive method for identifying patients with prostate cancer. Large-scale prospective trials are now required to evaluate this test in diagnosis and screening.
Lancaster GA, Campbell MJ, Eldridge S, et al., 2010, Trials in primary care: statistical issues in the design, conduct and evaluation of complex interventions, STATISTICAL METHODS IN MEDICAL RESEARCH, Vol: 19, Pages: 349-377, ISSN: 0962-2802
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- Citations: 33
Lloyd SKW, Kasbekar AV, Kenway B, et al., 2010, Developmental Changes in Cochlear Orientation-Implications for Cochlear Implantation, OTOLOGY & NEUROTOLOGY, Vol: 31, Pages: 902-907, ISSN: 1531-7129
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- Citations: 38
Marteau TM, Mann E, Prevost AT, et al., 2010, Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): randomised trial, BMJ-BRITISH MEDICAL JOURNAL, Vol: 340, ISSN: 1756-1833
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- Citations: 33
Walter FM, Morris HC, Humphrys E, et al., 2010, Study protocol Protocol for the MoleMate (TM) UK Trial: a randomised controlled trial of the MoleMate system in the management of pigmented skin lesions in primary care [ISRCTN 79932379], BMC Family Practice, Vol: 11, Pages: 1-9, ISSN: 1471-2296
BackgroundSuspicious 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.Methods/designThe 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.DiscussionThe MoleMate UK Trial tests a new technology designed to improve the management of suspicious pigmented lesions in primary care. If effective, the MoleMate
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