Patient-reported measurement of time to diagnosis in cancer: development of the Cancer Symptom Interval Measure (C-SIM) and randomised controlled trial of method of delivery

BMC Health Services Research Patient-reported measurement of time to diagnosis in cancer: development of the Cancer Symptom Interval Measure (C-SIM) and randomised controlled trial of method of delivery Richard D Neal 0 Sadia Nafees 0 Diana Pasterfield 0 Kerenza Hood 2 Maggie Hendry 0 Simon Gollins 1 Matthew Makin 1 Nick Stuart 1 Jim Turner 1 Ben Carter 2 Clare Wilkinson 0 Nefyn Williams 0 Mike Robling 2 0 North Wales Centre for Primary Care Research, Bangor University , Gwenfro Unit 5, Wrexham Technology Park, Wrexham LL13 7YP , UK 1 Betsi Cadwaladr University Health Board, Ysbyty Gwynedd , Penrhosgarnedd, Bangor, Gwynedd LL57 2PW , UK 2 School of Medicine, Cardiff University , Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS , UK Background: The duration between first symptom and a cancer diagnosis is important because, if shortened, may lead to earlier stage diagnosis and improved cancer outcomes. We have previously developed a tool to measure this duration in newly-diagnosed patients. In this two-phase study, we aimed further improve our tool and to conduct a trial comparing levels of anxiety between two modes of delivery: self-completed versus researcher-administered. Methods: In phase 1, ten patients completed the modified tool and participated in cognitive debrief interviews. In phase 2, we undertook a Randomised Controlled Trial (RCT) of the revised tool (Cancer Symptom Interval Measure (C-SIM)) in three hospitals for 11 different cancers. Respondents were invited to provide either exact or estimated dates of first noticing symptoms and presenting them to primary care. The primary outcome was anxiety related to delivery mode, with completeness of recording as a secondary outcome. Dates from a subset of patients were compared with GP records. Results: After analysis of phase 1 interviews, the wording and format were improved. In phase 2, 201 patients were randomised (93 self-complete and 108 researcher-complete). Anxiety scores were significantly lower in the researcher-completed group, with a mean rank of 83.5; compared with the self-completed group, with a mean rank of 104.0 (Mann-Whitney U = 3152, p = 0.007). Completeness of data was significantly better in the researcher-completed group, with no statistically significant difference in time taken to complete the tool between the two groups. When comparing the dates in the patient questionnaires with those in the GP records, there was evidence in the records of a consultation on the same date or within a proscribed time window for 32/37 (86%) consultations; for estimated dates there was evidence for 23/37 consultations (62%). Conclusions: We have developed and tested a tool for collecting patient-reported data relating to appraisal intervals, help-seeking intervals, and diagnostic intervals in the cancer diagnostic pathway for 11 separate cancers, and provided evidence of its acceptability, feasibility and validity. This is a useful tool to use in descriptive and epidemiological studies of cancer diagnostic journeys, and causes less anxiety if administered by a researcher. Trial registration: ISRCTN04475865 Cancer symptoms; Patient intervals; Appraisal; Primary care intervals; Diagnosis; Randomised controlled trial; Tool development - Background Mortality from cancer is worse in the UK than most other European countries [1,2]. The reasons for this are multi-factorial, but diagnostic delays and consequent later stage diagnoses are likely to be major contributory factors [3]. Interventions to reduce diagnostic delays, which result in a less advanced stage at diagnosis, have the potential to improve cancer survival [4], although tumour biology is also important. Interventions need to account for lead-time bias whereby more timely diagnosis may improve survival by bringing forward the diagnosis rather than delaying mortality. Diagnostic delays (perhaps better referred to as time-intervals since there is not always a delay) may occur throughout the cancer diagnostic pathway. Whilst a minority of patients are diagnosed through screening (in some cancers), and some present as an emergency to A&E or via inter-specialty referral (without consulting in primary care), the majority of diagnoses are made for patients who follow the typical cancer journey involving symptomatic presentation through primary care [5-8]. In the UK, and elsewhere, there has been a drive in policy towards early, and more timely diagnosis of cancer; for example the National Awareness and Early Diagnosis Initiative (England), the Detect Cancer Early Initiative (Scotland) and the International Cancer Benchmarking Partnership (several countries). The duration between first symptom and cancer diagnosis is important because, if shortened, it may lead to earlier stage diagnosis and improved cancer outcomes [9,10]. Measurement is complex because some symptoms are simply present or absent (e.g. a breast lump or rectal bleeding), whilst others are not instantly noticeable (e.g. tiredness or weight loss). Most studies reporting both appraisal intervals (time taken to interpret bodily changes/symptoms) and help seeking intervals (time taken to act on those interpretations and seek help) [11] use tools that ignore existing models of patient behaviour [12,13], are poorly or inadequately validated, and are open to bias. There is a well-recognised need to develop valid instruments for measuring delay [11], and this is one of the recommendations of the Aarhus checklist on the design and reporting of early cancer diagnosis studies that has recently been published [14]. We previously reported the first phase of the pilot work to develop and pilot a postal version of such a tool (the DELAYS tool) [15]. This questionnaire was tailored to individual cancers and asked patients to recall the dates of the onset of symptoms (based on referral guidance symptoms) and their presentation to primary care, in addition to socio-demographic and health questions. One issue that arose (predominantly from phone calls from potential respondents to the research team) was the potential anxiety that may be generated by use of the tool (for example asking patients to recall when they first experienced symptoms may cause upset if they feel that their diagnosis was unduly delayed). The other main issue was that the response rate to the postal questionnaire was only moderate (46.2%). Hence, the aim of this paper is to report the further development of the DELAYS tool, now renamed the Cancer Symptom Interval Measure (C-SIM), through in depth cognitive testing, and its testing in a randomised controlled trial (RCT) comparing different methods of delivery (on the premise that anxiety may be less in the presence of a researcher). The primary objective of this RCT was to compare the level of patients anxiety between two methods of delivery (self-completed and researchercompleted) of administering a tool, which measures time from first symptom to cancer diagnosis. Secondary objectives o (...truncated)