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

Mike Robling¹  Nefyn Williams²  Clare Wilkinson²  Ben Carter¹  Jim Turner³  Nick Stuart³  Matthew Makin³  Simon Gollins³  Maggie Hendry²  Kerenza Hood¹  Diana Pasterfield²  Sadia Nafees²  Richard D Neal² 

[1] School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK;North Wales Centre for Primary Care Research, Bangor University, Gwenfro Unit 5, Wrexham Technology Park, Wrexham LL13 7YP, UK;Betsi Cadwaladr University Health Board, Ysbyty Gwynedd, Penrhosgarnedd, Bangor, Gwynedd LL57 2PW, UK

关键词: Tool development;    Randomised controlled trial;    Diagnosis;    Primary care intervals;    Appraisal;    Patient intervals;    Cancer symptoms;   

Others  :  1134386
DOI  :  10.1186/1472-6963-14-3

 received in 2013-07-26, accepted in 2013-12-20,  发布年份 2014

【 摘 要 】

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

【 授权许可】

   
2014 Neal et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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