The impact of consent on observational research: a comparison of outcomes from consenters and non consenters to an observational study

Background Public health benefits from research often rely on the use of data from personal medical records. When neither patient consent nor anonymisation is possible, the case for accessing such records for research purposes depends on an assessment of the probabilities of public benefit and individual harm. Methods In the late 1990s, we carried out an observational study which compared the care given to affluent and deprived women with breast cancer. Patient consent was not required at that time for review of medical records, but was obtained later in the process prior to participation in the questionnaire study. We have re-analysed our original results to compare the whole sample with those who later provided consent. Results Two important findings emerged from the re-analysis of our data which if presented initially would have resulted in insufficient and inaccurate reporting. Firstly, the reduced dataset contains no information about women presenting with locally advanced or metastatic cancer and we would have been unable to demonstrate one of our initial key findings: namely a larger number of such women in the deprived group. Secondly, our re-analysis of the consented women shows that significantly more women from deprived areas (51 v 31%, p = 0.018) received radiotherapy compared to women from more affluent areas. Previously published data from the entire sample demonstrated no difference in radiotherapy treatment between the affluent and deprived groups. Conclusion The risk benefit assessment made regarding the use of medical records without consent should include the benefits of obtaining research evidence based on 100% of the population and the possibility of inappropriate or insufficient findings if research is confined to consented populations

Help seeking for cancer 'alarm' symptoms: a qualitative interview study of primary care patients in the UK.

Delay in help seeking for cancer 'alarm' symptoms has been identified as a contributor to delayed diagnosis

Cancer detection in primary care: Insights from general practitioners

© 2015 Cancer Research UK. Background: General practitioners (GPs) have a key role in cancer detection as the usual first point of contact for patients with potential cancer symptoms. Nevertheless, there is limited work that investigates their perceptions of their role in the early detection of cancer. To address this gap, we aimed to gain an in-depth understanding of cancer diagnosis from the perspective of GPs. Methods: Individual face-to-face semi-structured interviews were conducted with 55 GPs from the North and North East of England and Greater London. All interviews were recorded and professionally transcribed verbatim. Repeated reading and co-coding engendered systematic thematic analysis across the interview material. Results: Three main themes emerged from the analysis of our data. First, we identified the burden of early cancer detection in general practice, both related to the anxiety and symptoms patients bring to GPs and the need for GPs to recognise patterns of cancer symptoms and refer appropriately; second, this burden is intensified by a perceived fragmentation of services within the National Health Service (NHS); and third, it is made more complex by the interface between general practice and public health. Conclusions: GPs occupy a challenging but pivotal role in cancer detection. It is crucial that this role be supported by policy and research

Factors contributing to the time taken to consult with symptoms of lung cancer: a cross-sectional study

<b>Objectives</b>: To determine what factors are associated with the time people take to consult with symptoms of lung cancer, with a focus on those from rural and socially deprived areas. <b>Methods</b>: A cross-sectional quantitative interview survey was performed of 360 patients with newly diagnosed primary lung cancer in three Scottish hospitals (two in Glasgow, one in NE Scotland). Supplementary data were obtained from medical case notes. The main outcome measures were the number of days from (1) the date participant defined first symptom until date of presentation to a medical practitioner; and (2) the date of earliest symptom from a symptom checklist (derived from clinical guidelines) until date of presentation to a medical practitioner. <b>Results</b>: 179 participants (50%) had symptoms for more than 14 weeks before presenting to a medical practitioner (median 99 days; interquartile range 31–381). 270 participants (75%) had unrecognised symptoms of lung cancer. There were no significant differences in time taken to consult with symptoms of lung cancer between rural and/or deprived participants compared with urban and/or affluent participants. Factors independently associated with increased time before consulting about symptoms were living alone, a history of chronic obstructive pulmonary disease (COPD) and longer pack years of smoking. Haemoptysis, new onset of shortness of breath, cough and loss of appetite were significantly associated with earlier consulting, as were a history of chest infection and renal failure. <b>Conclusion</b>: For many people with lung cancer, regardless of location and socioeconomic status, the time between symptom onset and consultation was long enough to plausibly affect prognosis. Long-term smokers, those with COPD and/or those living alone are at particular risk of taking longer to consult with symptoms of lung cancer and practitioners should be alert to this

Do colorectal cancer patients diagnosed as an emergency differ from non-emergency patients in their consultation patterns and symptoms? A longitudinal data-linkage study in England

Background: More than 20% of colorectal cancers are diagnosed following an emergency presentation. We aimed to examine pre-diagnostic primary-care consultations and related symptoms comparing patients diagnosed as emergencies with those diagnosed through non-emergency routes. Methods: Cohort study of colorectal cancers diagnosed in England 2005 and 2006 using cancer registration data individually linked to primary-care data (CPRD/GPRD), allowing a detailed analysis of clinical information referring to the 5-year pre-diagnostic period. Results: Emergency diagnosis occurred in 35% and 15% of the 1029 colon and 577 rectal cancers. ‘Background’ primary-care consultations (2–5 years before diagnosis) were similar for either group. In the year before diagnosis, >95% of emergency and non-emergency presenters had consulted their doctor, but emergency presenters had less frequently relevant symptoms (colon cancer: 48% vs 71% (P<0.001); rectal cancer: 49% vs 61% (P=0.043)). ‘Alarm’ symptoms were recorded less frequently in emergency presenters (e.g., rectal bleeding: 9 vs 24% (P=0.002)). However, about 1/5 of emergency presenters (18 and 23% for colon and rectal cancers) had ‘alarm’ symptoms the year before diagnosis. Conclusions: Emergency presenters have similar ‘background’ consultation history as non-emergency presenters. Their tumours seem associated with less typical symptoms, however opportunities for earlier diagnosis might be present in a fifth of them

Family Caregivers Who Would Be Unwilling to Provide Care at the End of Life Again: Findings from the Health Survey for England Population Survey

BACKGROUND: Family caregivers provide significant care at the end of life. We aimed to describe caregiver characteristics, and of those unwilling to repeat this role under the same circumstances.METHODS: Observational study of adults in private households (Health Survey for England [HSE]). Caregiving questions included: whether someone close to them died within past 5 years; relationship to the deceased; provision, intensity and duration of care; supportive/palliative care services used; willingness to care again; able to carry on with life. Comparison between those willing to care again or not used univariable analyses and an exploratory multiple logistic regression. A descriptive comparison with Health Omnibus Survey (Australia) data was conducted.FINDINGS: HSE response was 64%. 2167/8861 (25%) respondents had someone close to them die in the previous 5 years. Some level of personal care was provided by 645/8861 (7.3%). 57/632 (9%) former caregivers would be unwilling to provide care again irrespective of time since the death, duration of care, education and income. Younger age (≤65; odds ratio [OR] 2.79; 95% CI 136, 5.74) and use of palliative care services (odds ratio: 1.95, 95% CI: 1.09, 3.48) showed greater willingness to provide care again. Apart from use of palliative care services, findings were remarkably similar to the Australian data.CONCLUSIONS: A significant group of caregivers would be unwilling to provide care again. Older people and those who had not used palliative care services were more likely to be unwilling to care again. Barriers preventing access for disadvantaged groups need to be overcome

Developing a community-based intervention to improve quality of life in people with colorectal cancer: a complex intervention development study

Objectives: To develop and pilot a theory and evidence-based intervention to improve quality of life (QoL) in people with colorectal cancer. Design: A complex intervention development study. Setting: North East Scotland and Glasgow. Participants: Semistructured interviews with people with colorectal cancer (n=28), cancer specialists (n=16) and primary care health professionals (n=14) and pilot testing with patients (n=12). Interventions: A single, 1 h nurse home visit 6–12 weeks after diagnosis, and telephone follow-up 1 week later (with a view to ongoing follow-up in future). Primary and secondary outcome measures: Qualitative assessment of intervention feasibility and acceptability. Results: Modifiable predictors of QoL identified previously were symptoms (fatigue, pain, diarrhoea, shortness of breath, insomnia, anorexia/cachexia, poor psychological well-being, sexual problems) and impaired activities. To modify these symptoms and activities, an intervention based on Control Theory was developed to help participants identify personally important symptoms and activities; set appropriate goals; use action planning to progress towards goals; self-monitor progress and identify (and tackle) barriers limiting progress. Interview responses were generally favourable and included recommendations about timing and style of delivery that were incorporated into the intervention. The pilot study demonstrated the feasibility of intervention delivery. Conclusions: Through multidisciplinary collaboration, a theory-based, acceptable and feasible intervention to improve QoL in colorectal cancer patients was developed, and can now be evaluated

Public awareness of cancer in Britain: a population-based survey of adults

*_Objective:_* To assess public awareness of cancer warning signs, anticipated delay, and perceived barriers to seeking medical advice in the British population. &#xd;&#xa;Methods: We carried out a population-based survey using face-to-face, computer-assisted interviews to administer the Cancer Awareness Measure (CAM), a newly-developed, validated measure of cancer awareness. The sample included 2216 adults (970 male and 1246 female) recruited as part of the Office for National Statistics Opinions Survey using stratified probability sampling.&#xd;&#xa;&#xd;&#xa;*_Results:_* Awareness of cancer warning signs was low when open-ended (recall) questions were used and higher with closed (recognition) questions; but on either measure, awareness was lower in those who were male, younger, and from lower socioeconomic status (SES) groups or ethnic minorities. The most commonly endorsed barriers to help-seeking were difficulty making an appointment, worry about wasting the doctor&#x2019;s time and worry about what would be found. Emotional barriers were more prominent in lower SES groups and practical barriers (e.g. too busy) more prominent in higher SES groups. Anticipated delay was lower in ethnic minority and lower SES groups. In multivariate analysis, higher symptom awareness was associated with lower anticipated delay, and more barriers with greater anticipated delay.&#xd;&#xa;&#xd;&#xa;*_Conclusions:_* A combination of public education about symptoms and empowerment to seek medical advice, as well as support at primary care level, could enhance early presentation and improve cancer outcomes