Principles of patient partnership:integrating patient perspectives into ERS Clinical Research Collaborations

Patient and public involvement in research is increasingly considered a cornerstone of good research practice, and the research community recognises people with lived experience as valuable stakeholders within the research process. European Respiratory Society (ERS) strongly encourages patient input into its research programme and scientific activities, working in partnership with the European Lung Foundation (ELF) to facilitate this. Based on the ERS and ELF experience and best practice in the field of patient and public involvement, we developed a set of principles to which future ERS and ELF collaborations should adhere. These principles provide guidance on how to address key challenges when planning and conducting patient and public involvement in order to develop successful partnerships with patients and drive forward patient-centred research.</p

Association of Physical Activity with Hormone Receptor Status: The Shanghai Breast Cancer Study

Evidence exists that breast tumors differing by estrogen receptor (ER) and progesterone receptor (PR) status may be phenotypically distinct diseases resulting from dissimilar etiologic processes. Few studies have attempted to examine the association of physical activity with breast cancer subtype. Such research may prove instructive into the biological mechanisms of activity. Consequently, this investigation was designed to assess the relationship between physical activity and hormone receptor-defined breast cancers in a population of Asian women in which the distribution of receptor types differed from traditional Western populations. Participants, ages 25 to 64 years, were recruited into this population-based, case-control study of breast cancer conducted in Shanghai, China from August 1996 to March 1998. Histologically confirmed breast cancer cases with available receptor status information (n = 1001) and age frequency-matched controls (n = 1,556) completed in-person interviews. Polytomous logistic regression was used to model the association between measures of activity with each breast cancer subtype (ER+/PR+, ER−/PR−, ER+/PR−, and ER−/PR+) using the control population as the reference group. Exercise in both adolescence and the last 10 years was associated with a decreased risk of both receptor-positive (ER+/PR+) and receptor-negative (ER−/PR−) breast cancers in both premenopausal and postmenopausal women (odds ratios, 0.44 and 0.51 and 0.43 and 0.21, respectively). Sweating during exercise within the last 10 years was also associated with decreased risk for receptor-positive and receptor-negative breast cancers among post-menopausal women (odds ratios, 0.58 and 0.28, respectively). These findings suggest that physical activity may reduce breast cancer risk through both hormonal and nonhormonal pathways

Breast Cancer Survival among Economically Disadvantaged Women: The Influences of Delayed Diagnosis and Treatment on Mortality

Breast cancer affects thousands each year in the United States, and disproportionately affects certain subgroups. For example, the incidence of breast cancer in South Carolina is lower in African American compared with European American women by ~12% to 15%, but their mortality rate is twice as high as in European American women. The purpose of the study was to assess factors associated with breast cancer mortality between African American and European American women. Participants (n = 314) in South Carolina\u27s Breast and Cervical Cancer Early Detection Program (SCBCCEDP), which provides breast cancer screening and treatment services, during the years 1996-2004 were included in the study. Data, including tumor characteristics, delay intervals, and race, were examined using the χ2 test and the Wilcoxon rank-sum test. Cox regression modeling was used to assess the relationship between delay intervals and other factors. No racial differences were found in age at diagnosis, tumor characteristics, or delay intervals. Time delay intervals did not explain differences and mortality rates by race. Survival, however, was affected by prognostic factors as well as by a significant interaction between hormone-receptor status and race. Despite the excellent record of the SCBCCEDP in screening and diagnostic or treatment referrals, the racial disparities in breast cancer mortality continue to exist in South Carolina. These findings highlight the need for future research into the etiology of racial differences, and their impact on breast cancer survival

The Effect of Social Desirability and Social Approval on Self-Reports of Physical Activity

The purpose of this investigation was to examine social desirability and social approval as sources of error in three self-reported physical activity assessments using objective measures of physical activity as reference measures. In 1997, women (n = 81) living in Worcester, Massachusetts, completed doubly labeled water measurements and wore an activity monitor for 14 days. They also completed seven interviewer-administered 24-hour physical activity recalls (PARs) and two different self-administered 7-day PARs. Measures of the personality traits “social desirability” and “social approval” were regressed on 1) the difference between physical activity energy expenditure estimated from doubly labeled water and each physical activity assessment instrument and 2) the difference between monitor-derived physical activity duration and each instrument. Social desirability was associated with overreporting of activity, resulting in overestimation of physical activity energy expenditure by 0.65 kcal/kg/day on the second 7-day PAR (95% confidence interval: 0.06, 1.25) and overestimation of activity durations by 4.15–11.30 minutes/day (both 7-day PARs). Social approval was weakly associated with underestimation of physical activity on the 24-hour PAR (−0.15 kcal/kg/day, 95% confidence interval: −0.30, 0.005). Body size was not associated with reporting bias in this study. The authors conclude that social desirability and social approval may influence self-reported physical activity on some survey instruments

Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

Background: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

Background: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

BACKGROUND: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. METHODS: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). FINDINGS: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29-146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0- 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25-1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39-1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65-1·60]; p=0·92). INTERPRETATION: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention. FUNDING: British Heart Foundation

C-C3-02: Ethnic Differences in Interval Diagnosed Breast Cancers in South Carolina

Background/Aims: The incidence of breast cancer (BrCA) among African-American (AA) women is lower than European-American (EA) women, yet their mortality rate is twice as high. Numerous hypotheses have been proposed to explain this disparity ranging from the biological to factors related to access to care. The relatively under-studied area of interval-diagnosed BrCAs, tumors which arise between regular mammograms and represent one of the most aggressive types of tumors, among AA women may represent such a biological factor. The goal of this investigation was to describe and compare detection patterns of BrCAs and their related histopathology among AA and EA women in South Carolina

Racial Disparities in Breast Cancer Mortality in a Multiethnic Cohort in the Southeast

BACKGROUND: Although much has been done to examine those factors associated with higher mortality among African American women, there is a paucity of literature which examines disparities among rural African Americans in South Carolina. The purpose of this investigation was to examine the association of race and mortality among BrCA patients in a large cohort residing in South Carolina for which treatment regimens are standardized for all patients. METHODS: Subjects included 1209 women diagnosed with BrCA between 2000–2002 at a large, local hospital containing a comprehensive breast center. Kaplan Meier survival curves were calculated to determine survival rates among AA and EA women, stratified by disease stage or other prognostic characteristics. Adjusting for various characteristics, Cox multivariable survival models were used to estimate the hazard ratio (HR) RESULTS: The 5-year overall all-cause mortality survival proportion was ~78% for AA women and ~89% for EA women, p<0.01. In analyses of sub-populations of women with identical disease characteristics, AA women had significantly higher mortality than EA women for the same type of breast cancer disease. In multivariable models, AA women had significantly higher mortality than EA women for both BrCA specific death (HR = 2.41; 1.21–4.79) and all-cause mortality (HR = 1.42; 1.06–1.89). CONCLUSION: AA women residing in rural South Carolina had lower survival for breast cancer even after adjustment for disease-related prognostic characteristics. IMPACT: These findings support health interventions among AA BrCA patients aimed at tertiary prevention strategies or further down-staging of disease at diagnosis