People's experiences of cancer within the first year following diagnosis. Final Report

The aim of the study was to explore the experiences of people affected by cancer in the first year following diagnosis with breast, lung, colorectal, prostate or gynaecological cancer. This was a descriptive qualitative study conducted over a period of 18 months during which three serial, longitudinal semi-structured interviews with 66 people, their nominated partner/carer1 (n=43) and healthcare professional (n=20) were conducted. The study included 18 people with colorectal cancer, 12 women with breast cancer, 9 women with gynaecological cancer, 17 people with lung cancer and 10 men with prostate cancer. The sampling strategy was not designed to derive a representative sample but to enable the researchers to understand experience of cancer and cancer care from men and women with a different cancer diagnosis and who had different socio-economic backgrounds and lived either in a rural or urban area. A conscious effort was made to include people from different ethnic minority groups but this was unsuccessful because no or very small numbers of people from these groups were diagnosed with cancer during the period of recruitment in the cancer centres where healthcare professionals were recruiting for the study

More, please, for those with less: why we need to go further on the Universal Credit uplift

Members of the ‘COVID-19 and low-income families: researching together’ Special Interest Group of the COVID Realities project explain why the government must go further in its provision of financial support for families with children in the light of the coronavirus crisis

Effect of Neutralizing Monoclonal Antibody Treatment on Early Trajectories of Virologic and Immunologic Biomarkers in Patients Hospitalized With COVID-19

BACKGROUND: Neutralizing monoclonal antibodies (nmAbs) failed to show clear benefit for hospitalized patients with coronavirus disease 2019 (COVID-19). Dynamics of virologic and immunologic biomarkers remain poorly understood. METHODS: Participants enrolled in the Therapeutics for Inpatients with COVID-19 trials were randomized to nmAb versus placebo. Longitudinal differences between treatment and placebo groups in levels of plasma nucleocapsid antigen (N-Ag), anti-nucleocapsid antibody, C-reactive protein, interleukin-6, and D-dimer at enrollment, day 1, 3, and 5 were estimated using linear mixed models. A 7-point pulmonary ordinal scale assessed at day 5 was compared using proportional odds models. RESULTS: Analysis included 2149 participants enrolled between August 2020 and September 2021. Treatment resulted in 20% lower levels of plasma N-Ag compared with placebo (95% confidence interval, 12%-27%; P \u3c .001), and a steeper rate of decline through the first 5 days (P \u3c .001). The treatment difference did not vary between subgroups, and no difference was observed in trajectories of other biomarkers or the day 5 pulmonary ordinal scale. CONCLUSIONS: Our study suggests that nmAb has an antiviral effect assessed by plasma N-Ag among hospitalized patients with COVID-19, with no blunting of the endogenous anti-nucleocapsid antibody response. No effect on systemic inflammation or day 5 clinical status was observed. CLINICAL TRIALS REGISTRATION: NCT04501978

Effect of Neutralizing Monoclonal Antibody Treatment on Early Trajectories of Virologic and Immunologic Biomarkers in Patients Hospitalized With COVID-19

BACKGROUND: Neutralizing monoclonal antibodies (nmAbs) failed to show clear benefit for hospitalized patients with coronavirus disease 2019 (COVID-19). Dynamics of virologic and immunologic biomarkers remain poorly understood. METHODS: Participants enrolled in the Therapeutics for Inpatients with COVID-19 trials were randomized to nmAb versus placebo. Longitudinal differences between treatment and placebo groups in levels of plasma nucleocapsid antigen (N-Ag), anti-nucleocapsid antibody, C-reactive protein, interleukin-6, and D-dimer at enrollment, day 1, 3, and 5 were estimated using linear mixed models. A 7-point pulmonary ordinal scale assessed at day 5 was compared using proportional odds models. RESULTS: Analysis included 2149 participants enrolled between August 2020 and September 2021. Treatment resulted in 20% lower levels of plasma N-Ag compared with placebo (95% confidence interval, 12%-27%; P \u3c .001), and a steeper rate of decline through the first 5 days (P \u3c .001). The treatment difference did not vary between subgroups, and no difference was observed in trajectories of other biomarkers or the day 5 pulmonary ordinal scale. CONCLUSIONS: Our study suggests that nmAb has an antiviral effect assessed by plasma N-Ag among hospitalized patients with COVID-19, with no blunting of the endogenous anti-nucleocapsid antibody response. No effect on systemic inflammation or day 5 clinical status was observed. CLINICAL TRIALS REGISTRATION: NCT04501978

Effect of Neutralizing Monoclonal Antibody Treatment on Early Trajectories of Virologic and Immunologic Biomarkers in Patients Hospitalized With COVID-19

Background: Neutralizing monoclonal antibodies (nmAbs) failed to show clear benefit for hospitalized patients with coronavirus disease 2019 (COVID-19). Dynamics of virologic and immunologic biomarkers remain poorly understood.// Methods: Participants enrolled in the Therapeutics for Inpatients with COVID-19 trials were randomized to nmAb versus placebo. Longitudinal differences between treatment and placebo groups in levels of plasma nucleocapsid antigen (N-Ag), anti-nucleocapsid antibody, C-reactive protein, interleukin-6, and D-dimer at enrollment, day 1, 3, and 5 were estimated using linear mixed models. A 7-point pulmonary ordinal scale assessed at day 5 was compared using proportional odds models.// Results: Analysis included 2149 participants enrolled between August 2020 and September 2021. Treatment resulted in 20% lower levels of plasma N-Ag compared with placebo (95% confidence interval, 12%–27%; P < .001), and a steeper rate of decline through the first 5 days (P < .001). The treatment difference did not vary between subgroups, and no difference was observed in trajectories of other biomarkers or the day 5 pulmonary ordinal scale.// Conclusions: Our study suggests that nmAb has an antiviral effect assessed by plasma N-Ag among hospitalized patients with COVID-19, with no blunting of the endogenous anti-nucleocapsid antibody response. No effect on systemic inflammation or day 5 clinical status was observed.// Clinical Trials Registration NCT04501978

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

Transient Ischaemic attack Emergency Referral (TIER): randomised feasibility trial results

Background: Early assessment of patients with suspected transient ischaemic attack (TIA) is crucial to provision of effective care, including initiation of preventive therapies and identification of stroke mimics. Many patients with TIA present to emergency medical services (EMS) but may not require hospitalisation. Paramedics could identify and refer patients with low-risk TIA, without conveyance to the ED. Safety and effectiveness of this model is unknown. Aim: To assess the feasibility of undertaking a fully powered randomised controlled trial (RCT) to evaluate clinical and cost-effectiveness of paramedic referral of patients who call EMS with low-risk TIA to TIA clinic, avoiding transfer to ED. Methods: The Transient Ischaemic attack Emergency Referral (TIER) intervention was developed through a survey of UK ambulance services, a scoping review of evidence of prehospital care of TIA and convening a specialist clinical panel to agree its final form. Paramedics in South Wales, UK, were randomly allocated to trial intervention (TIA clinic referral) or control (usual care) arms, with patients’ allocation determined by that of attending paramedics. Predetermined progression criteria considered: proportion of patients referred to TIA clinic, data retrieval, patient satisfaction and potential cost-effectiveness. Results: From December 2016 to September 2017, eighty-nine paramedics recruited 53 patients (36 intervention; 17 control); 48 patients (31 intervention; 17 control) consented to follow-up via routine data. Three intervention patients, of seven deemed eligible, were referred to TIA clinic by paramedics. Contraindications recorded for the other intervention arm patients were: Face/Arms/Speech/Time positive (n=13); ABCD2 score >3 (n=5); already anticoagulated (n=2); crescendo TIA (n=1); other (n=8). Routinely collected electronic health records, used to report further healthcare contacts, were obtained for all consenting patients. Patient-reported satisfaction with care was higher in the intervention arm (mean 4.8/5) than the control arm (mean 4.2/5). Health economic analysis suggests an intervention arm quality-adjusted life-year loss of 0.0094 (95% CI −0.0371, 0.0183), p=0.475. Conclusion: The TIER feasibility study did not meet its progression criteria, largely due to low patient identification and referral rates. A fully powered RCT in this setting is not recommended. Trial registration number: ISRCTN85516498

“Working the System”—British American Tobacco's Influence on the European Union Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents

Katherine Smith and colleagues investigate the ways in which British American Tobacco influenced the European Union Treaty so that new EU policies advance the interests of major corporations, including those that produce products damaging to health