Objectives To assess whether adding a novel computerised diagnostic tool, the MoleMate system (SIAscopy with primary care scoring algorithm), to current best practice results in more appropriate referrals of suspicious pigmented lesions to secondary care, and to assess its impact on clinicians and patients.Design Randomised controlled trial.Setting 15 general practices in eastern England.Participants 1297 adults with pigmented skin lesions not immediately diagnosed as benign.Interventions Patients were assessed by trained primary care clinicians using best practice (clinical history, naked eye examination, seven point checklist) either alone (control group) or with the MoleMate system (intervention group).Main outcome measures Appropriateness of referral, defined as the proportion of referred lesions that were biopsied or monitored. Secondary outcomes related to the clinicians (diagnostic performance, confidence, learning effects) and patients (satisfaction, anxiety). Economic evaluation, diagnostic performance of the seven point checklist, and five year follow-up of melanoma incidence were also secondary outcomes and will be reported later.Results 1297 participants with 1580 lesions were randomised: 643 participants with 788 lesions to the intervention group and 654 participants with 792 lesions to the control group. The appropriateness of referral did not differ significantly between the intervention or control groups: 56.8% (130/229) v 64.5% (111/172); difference −8.1% (95% confidence interval −18.0% to 1.8%). The proportion of benign lesions appropriately managed in primary care did not differ (intervention 99.6% v control 99.2%, P=0.46), neither did the percentage agreement with an expert decision to biopsy or monitor (intervention 98.5% v control 95.7%, P=0.26). The percentage agreement with expert assessment that the lesion was benign was significantly lower with MoleMate (intervention 84.4% v control 90.6%, P<0.001), and a higher proportion of lesions were referred (intervention 29.8% v control 22.4%, P=0.001). Thirty six histologically confirmed melanomas were diagnosed: 18/18 were appropriately referred in the intervention group and 17/18 in the control group. Clinicians in both groups were confident, and there was no evidence of learning effects, and therefore contamination, between groups. Patients in the intervention group ranked their consultations higher for thoroughness and reassuring care, although anxiety scores were similar between the groups. ConclusionsWe found no evidence that the MoleMate system improved appropriateness of referral. The systematic application of best practice guidelines alone was more accurate than the MoleMate system, and both performed better than reports of current practice. Therefore the systematic application of best practice guidelines (including the seven point checklist) should be the paradigm for management of suspicious skin lesions in primary care. IntroductionDifferentiating melanomas from other pigmented skin lesions in primary care is challenging. 1 ...

BackgroundMelanoma incidence in the UK has doubled over two decades, yet there is conflicting evidence about factors which prompt or delay patients seeking advice. Aim: To explore patient understanding of pigmented skin lesions (moles) and skin cancer, and factors which influence seeking help in primary care.MethodSemi-structured interviews with forty MoleMate Trial participants, analysed using the theoretical framework of the Safer-Andersen model of Total Patient Delay.ResultsPatient understanding and awareness was influenced by personal, family and friends' experiences of moles, skin cancer and other cancers, knowledge of risk factors, and the lay media. The route to consulting was complex and often iterative. For lesions that people could see, detecting and appraising change was influenced by comparisons with a normal mole on themselves, a family member, friend or image. Inferring illness came about with recognition of changes (particularly size) as serious, and associated 'internal' symptoms such as pain. For lesions that people could not see, family, friends and health professionals detected and appraised changes. Deciding to seek help was often prompted by another person or triggered by rapid or multiple changes in a mole. Three of four people subsequently diagnosed with melanoma did not seek help; instead, their GP opportunistically noticed the lesion.ConclusionsChanging moles are often perceived as trivial and not signifying possible skin cancer. This study contributes to current national strategies to improve patient awareness and earlier diagnosis of cancer by highlighting factors that can trigger or act as barriers to seeking help.(ISRCTN79932379)

Low health literacy has been associated with poor cancer screening uptake, difficulty in making treatment choices and reduced quality of life following a cancer diagnosis, yet it is unclear whether and how health literacy influences the pathway to diagnosis for patients with cancer symptoms. This systematic review aimed to evaluate the influence of health literacy on the timely diagnosis of symptomatic cancer. Literature was searched between January 1990 and May 2017 using MEDLINE, Embase, Scopus, ASSIA, CINAHL and PsycINFO. Only three papers met the inclusion criteria. These reported two qualitative studies and one quantitative, with adult patients diagnosed with gastrointestinal (colon, rectum and pancreas), cervical and breast cancer. The definition and assessment of health literacy varied between the studies, as did the descriptions of the pathway to diagnosis. Due to the methodological weaknesses identified, the conclusions are limited; however, the studies did highlight important considerations in the definition and measurement of health literacy. Further research is required that clearly defines health literacy and follows the principles of the Aarhus Statement to assess the influence of health literacy on the pathway to cancer diagnosis. The protocol for this review was registered with PROSPERO (CRD42016048917).

BackgroundLate stage diagnosis of oesophageal and gastric cancer is common, which limits treatment options and contributes to poor survival.AimTo explore patients' understanding, experience and presentation of symptoms before a diagnosis of oesophageal or gastric cancer.Design & settingBetween May 2016 and October 2017, all patients newly diagnosed with oesophageal or gastric cancer were identified at weekly multidisciplinary team meetings at two large hospitals in England. A total of 321 patients were invited to participate in a survey and secondary care medical record review; 127 (40%) participants responded (102 patients had oesophageal cancer and 25 had gastric cancer). Of these, 26 participated in an additional face-to-face interview.MethodSurvey and medical record data were analysed descriptively. Interviews were analysed using thematic analysis, informed by the Model of Pathways to Treatment.ResultsParticipants experienced multiple symptoms before diagnosis. The most common symptom associated with oesophageal cancer was dysphagia (n = 66, 65%); for gastric cancer, fatigue or tiredness (n = 20, 80%) was the most common symptom. Understanding of heartburn, reflux and indigestion, and associated symptoms differed between participants and often contrasted with clinical perspectives. Bodily changes attributed to personal and/or lifestyle factors were self-managed, with presentation to primary care prompted when symptoms persisted, worsened, or impacted daily life, or were notably severe or unusual. Participants rarely presented all symptoms at the initial consultation.ConclusionThe patient interval may be lengthened by misinterpretation of key terms, such as heartburn, or misattribution or non-recognition of important bodily changes. Clearly defined symptom awareness messages may encourage earlier help-seeking, while eliciting symptom experience and meanings in primary care consultations could prompt earlier referral and diagnosis.