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

The association of cancer survival with four socioeconomic indicators: a longitudinal study of the older population of England and Wales 1981–2000

BACKGROUND: Many studies have found socioeconomic differentials in cancer survival. Previous studies have generally demonstrated poorer cancer survival with decreasing socioeconomic status but mostly used only ecological measures of status and analytical methods estimating simple survival. This study investigate socio-economic differentials in cancer survival using four indicators of socioeconomic status; three individual and one ecological. It uses a relative survival method which gives a measure of excess mortality due to cancer. METHODS: This study uses prospective record linkage data from The Office for National Statistics Longitudinal Study for England and Wales. The participants are Longitudinal Study members, recorded at census in 1971 and 1981 and with a primary malignant cancer diagnosed at age 45 or above, between 1981 and 1997, with follow-up until end 2000. The outcome measure is relative survival/excess mortality, compared with age and sex adjusted survival of the general population. Relative survival and Poisson regression analyses are presented, giving models of relative excess mortality, adjusted for covariates. RESULTS: Different socioeconomic indicators detect survival differentials of varying magnitude and definition. For all cancers combined, the four indicators show similar effects. For individual cancers there are differences between indicators. Where there is an association, all indicators show poorer survival with lower socioeconomic status. CONCLUSION: Cancer survival differs markedly by socio-economic status. The commonly used ecological measure, the Carstairs Index, is adequate at demonstrating socioeconomic differentials in survival for combined cancers and some individual cancers. A combination of car access and housing tenure is more sensitive than the ecological Carstairs measure at detecting socioeconomic effects on survival – confirming Carstairs effects where they occur but additionally identifying effects for other cancers. Social class is a relatively weak indicator of survival differentials

The relation between socioeconomic and demographic factors and tumour stage in women diagnosed with breast cancer in Denmark, 1983–1999

The authors investigated the association between socioeconomic position and stage of breast cancer at the time of diagnosis in a nationwide Danish study. All 28 765 women with a primary invasive breast cancer diagnosed between 1983 and 1999 were identified in a nationwide clinical database and information on socioeconomic variables was obtained from Statistics Denmark. The risk of being diagnosed with a high-risk breast cancer, that is size >20 mm, lymph-node positive, ductal histology/high histologic grade and hormone receptor negative, was analysed by multivariate logistic regression. The adjusted odds ratio (OR) for high-risk breast cancer was reduced with longer education with a 12% reduced risk (95% confidence interval (CI), 0.80,0.96) in women with higher education and increased with reduced disposable income (low income group: OR, 1.22; 95% CI, 1.10,1.34). There was an urban–rural gradient, with higher risk among rural women (OR 1.10; 95 % CI, 1.02, 1.18) and lower risk among women in the capital suburbs (OR, 0.85; 95% CI, 0.78, 0.93) and capital area (OR, 0.93; 95% CI, 0.84–1.02). These factors were significant only for postmenopausal women, although similar patterns were observed among the premenopausal women, suggesting a subgroup of aggressive premenopausal breast cancers less influenced by socioeconomic factors

Socioeconomic background in relation to stage at diagnosis, treatment and survival in women with breast cancer

In a large population-based series of invasive breast cancer patients, we investigated socioeconomic background (SEB) in relation to (a) stage at diagnosis; (b) treatment pattern; and (c) 5-year survival. Women diagnosed during 1998–2000 and resident in the Northern and Yorkshire regions of England were identified from the cancer registry database (N=12 768). Logistic regression and Cox proportional hazards analyses were used to estimate associations between SEB (defined using the Townsend Index for area of residence) and tumour stage, treatment pattern, and survival. Living in a more deprived area was associated with increased likelihood of being diagnosed with stage III or IV disease (age-adjusted odds ratio (OR) 1.13; 95% confidence interval (CI) 1.08–1.18 per quartile increase in Townsend score), and, after adjustment for age and stage, reduced odds of having surgery (OR 0.85; 95% CI 0.80–0.91), and receiving radiotherapy (OR 0.91; 95% CI 0.88–0.94). Amongst patients receiving surgery, those living in more deprived areas had decreased odds of having breast conserving surgery (age plus stage-adjusted OR 0.92; 95% CI 0.89–0.95). Living in a more deprived area was also associated with increased mortality (age- plus stage-adjusted hazard ratio 1.08; 95% CI 1.05–1.11). These effects may operate through several pathways, such as later presentation leading to advanced disease

How do we measure consumer opinions of outpatient clinics?

Consumer opinion of care in outpatient departments is increasingly seen as an important measure in the process of quality assurance. However, there are many ways of measuring consumer opinion. The aim of this series of studies was to compare different methods so as to throw light on when and where to use them. What is revealed is that there is no one right answer; instead, a combination of methods will allow the development of a balanced view of consumer opinion and an agenda for action.link_to_subscribed_fulltex

Geographical variation in breast cancer survival rates for women diagnosed in England between 1992 and 1994

The 5-year relative survival rates of women diagnosed with breast cancer between 1992 and 1994 were compared among the 99 Health Authorities (1999 boundaries) of England. Substantial variation, with evidence of geographical clustering was observed. Part of this variation was explained by differences in deprivation between Health Authorities, in particular by the percentage of class IV and V households

Anxiety and support in breast cancer: is this different for affluent and deprived women? A questionnaire study

A postal questionnaire was sent to affluent and deprived women with breast cancer in order to compare psychosocial aspects of care with the purpose of understanding the balance of care and explaining why deprived women have poorer outcomes. Data were collected regarding reported sources of information, SF-36 scores and ongoing causes of anxiety. The results demonstrate that affluent women were more likely to have received information from their hospital specialist (94.8 vs 76.0%) and from a breast care nurse (70.1 vs 40.0%) than deprived women. They were also more likely to have received information from magazines (50.6 vs 33.0%), newspapers (45.5 vs 22.0%) and television news (45.5 vs 26.0%). Deprived women had poorer SF-36 scores than affluent women, and reported greater anxiety about money (12.2 vs 2.8%), other health problems (22.1 vs 8.2%) and family problems (17.5 vs 6.9%). Personal and professional support is clearly important for patients with breast cancer. Health professionals need to be aware of the greater psychological distress demonstrated by deprived women, even some years after diagnosis with breast cancer, and seek to address it