Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure.

BACKGROUND: Informed consent is an accepted ethical and legal prerequisite for trial participation, yet there is no standardised method of assessing patient understanding for informed consent. The participatory and informed consent (PIC) measure was developed for application to recruitment discussions to evaluate recruiter information provision and evidence of patient understanding. Preliminary evaluation of the PIC indicated the need to improve inter-rater and intra-rater reliability ratings and conduct further psychometric evaluation. This paper describes the assessment, revision and evaluation of the PIC within the context of OPTiMISE, a pragmatic primary care-based trial. METHODS: This study used multiple methods across two phases. In phase one, one researcher applied the existing PIC measure to 18 audio-recorded recruitment discussions from the OPTiMISE study and made detailed observational notes about any uncertainties in application. Appointments were sampled to be maximally diverse for patient gender, study centre, recruiter and before and after an intervention to optimise information provision. Application uncertainties were reviewed by the study team, revisions made and a coding manual developed and agreed. In phase two, the coding manual was used to develop tailored guidelines for applying the PIC to appointments within the OPTiMISE trial. Two researchers then assessed 27 further appointments, purposively sampled as above, to evaluate inter-rater and intra-rater reliability, content validity and feasibility. RESULTS: Application of the PIC to 18 audio-recorded OPTiMISE recruitment discussions resulted in harmonisation of the scales rating recruiter information provision and evidence of patient understanding, minor amendments to clarify wording and the development of detailed generic coding guidelines for applying the measure within any trial. Application of the revised measure using these guidelines to 27 further recruitment discussions showed good feasibility (time to complete), content validity (completion rate) and reliability (inter- and intra-rater) of the measure. CONCLUSION: The PIC provides a means to evaluate the content of information provided by recruiters, patient participation in recruitment discussions and, to some extent, evidence of patient understanding. Future work will use the measure to evaluate recruiter information provision and evidence of patient understanding both across and within trials.

Primary and Community Care Mapping: Helping Communities Collaboratively Plan Health Services in a Patient-Centred Manner.

Primary care, a core feature of sustainable, high-quality healthcare systems, is undergoing significant system changes across Canada. Complex system change often fails without active implementation support. Primary and Community Care (PACC) Mapping is a rapid co-design method that helps community stakeholders engage in planning at various stages of their change. PACC Mapping has been used in multiple provinces for a range of areas, from maternity care to vaccine planning. This paper outlines the PACC Mapping approach, early experiences and scaling through training facilitators.

Finding Primary Care-Repurposing Physician Registration Data to Generate a Regionally Accurate List of Primary Care Clinics: Development and Validation of an Open-Source Algorithm.

BACKGROUND: Some Canadians have limited access to longitudinal primary care, despite its known advantages for population health. Current initiatives to transform primary care aim to increase access to team-based primary care clinics. However, many regions lack a reliable method to enumerate clinics, limiting estimates of clinical capacity and ongoing access gaps. A region-based complete clinic list is needed to effectively describe clinic characteristics and to compare primary care outcomes at the clinic level. OBJECTIVE: The objective of this study is to show how publicly available data sources, including the provincial physician license registry, can be used to generate a verifiable, region-wide list of primary care clinics in British Columbia, Canada, using a process named the Clinic List Algorithm (CLA). METHODS: The CLA has 10 steps: (1) collect data sets, (2) develop clinic inclusion and exclusion criteria, (3) process data sets, (4) consolidate data sets, (5) transform from list of physicians to initial list of clinics, (6) add additional metadata, (7) create working lists, (8) verify working lists, (9) consolidate working lists, and (10) adjust processing steps based on learnings. RESULTS: The College of Physicians and Surgeons of British Columbia Registry contained 13,726 physicians, at 2915 unique addresses, 6942 (50.58%) of whom were family physicians (FPs) licensed to practice in British Columbia. The CLA identified 1239 addresses where primary care was delivered by 4262 (61.39%) FPs. Of the included addresses, 84.50% (n=1047) were in urban locations, and there was a median of 2 (IQR 2-4, range 1-23) FPs at each unique address. CONCLUSIONS: The CLA provides a region-wide description of primary care clinics that improves on simple counts of primary care providers or self-report lists. It identifies the number and location of primary care clinics and excludes primary care providers who are likely not providing community-based primary care. Such information may be useful for estimates of capacity of primary care, as well as for policy planning and research in regions engaged in primary care evaluation or transformation.

Team-based care Evaluation and Adoption Model (TEAM) Framework: Supporting the comprehensive evaluation of primary care transformation over time.

OBJECTIVE: To introduce the new Team-based care Evaluation and Adoption Model (TEAM) Framework. QUALITY OF EVIDENCE: The initial TEAM Framework was derived from a series of reviews and consultations with academic and clinical experts. In a parallel process, team-based primary and community care evaluation in Canada was assessed through a structured review of academic literature, followed by a review of policy literature of existing primary care evaluation frameworks. MAIN MESSAGE: The review of academic articles alongside an analysis of policy documents and existing evaluation frameworks in primary care resulted in the development of the 10-dimension TEAM Framework. CONCLUSION: Primary care transformation requires evaluation over time. The TEAM Framework provides a comprehensive framework for assessing evidence needed to support short- and long-term actionable improvements for team-based primary and community care in Canada. This framework will inform the development of an evaluation tool kit for primary care teams.

Patient symptom experience prior to a diagnosis of oesophageal or gastric cancer: a multi-methods study.

BACKGROUND: Late stage diagnosis of oesophageal and gastric cancer is common, which limits treatment options and contributes to poor survival. AIM: To explore patients' understanding, experience and presentation of symptoms before a diagnosis of oesophageal or gastric cancer. DESIGN & SETTING: Between 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. METHOD: Survey and medical record data were analysed descriptively. Interviews were analysed using thematic analysis, informed by the Model of Pathways to Treatment. RESULTS: Participants 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. CONCLUSION: The 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.

The influence of health literacy on the timely diagnosis of symptomatic cancer: A systematic review.

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).

The cost-effectiveness of a novel SIAscopic diagnostic aid for the management of pigmented skin lesions in primary care: a decision-analytic model.

OBJECTIVES: Pigmented skin lesions are commonly presented in primary care. Appropriate diagnosis and management is challenging because the vast majority are benign. The MoleMate system is a handheld SIAscopy scanner integrated with a primary care diagnostic algorithm aimed at improving the management of pigmented skin lesions in primary care. METHODS: This decision-model-based economic evaluation draws on the results of a randomized controlled trial of the MoleMate system versus best practice (ISRCTN79932379) to estimate the expected long-term cost and health gain of diagnosis with the MoleMate system versus best practice in an English primary care setting. The model combines trial results with data from the wider literature to inform long-term prognosis, health state utilities, and cost. RESULTS: Results are reported as mean and incremental cost and quality-adjusted life-years (QALYs) gained, incremental cost-effectiveness ratio with probabilistic sensitivity analysis, and value of information analysis. Over a lifetime horizon, the MoleMate system is expected to cost an extra £18 over best practice alone, and yield an extra 0.01 QALYs per patient examined. The incremental cost-effectiveness ratio is £1,896 per QALY gained, with a 66.1% probability of being below £30,000 per QALY gained. The expected value of perfect information is £43.1 million. CONCLUSIONS: Given typical thresholds in the United Kingdom (£20,000-£30,000 per QALY), the MoleMate system may be cost-effective compared with best practice diagnosis alone in a primary care setting. However, there is considerable decision uncertainty, driven particularly by the sensitivity and specificity of MoleMate versus best practice, and the risk of disease progression in undiagnosed melanoma; future research should focus on reducing uncertainty in these parameters.

Effect of adding a diagnostic aid to best practice to manage suspicious pigmented lesions in primary care: randomised controlled trial.

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. CONCLUSIONS: We 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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79932379.

Patient understanding of moles and skin cancer, and factors influencing presentation in primary care: a qualitative study.

BACKGROUND: Melanoma 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. METHOD: Semi-structured interviews with forty MoleMate Trial participants, analysed using the theoretical framework of the Safer-Andersen model of Total Patient Delay. RESULTS: Patient 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. CONCLUSIONS: Changing 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).

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].

BACKGROUND: 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 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/DESIGN: 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. DISCUSSION: 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.