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

Design, Implementation, and Response Rates From an Online Patient Survey to Assess Genitourinary Symptoms and Related Health Care Experiences of Postmenopausal Women

Background/Aims: Nearly 50% of postmenopausal women experience symptoms related to genitourinary syndrome of menopause (GSM), including vulvovaginal dryness and irritation, painful intercourse and urinary incontinence. As part of a clinician-focused intervention to improve diagnosis and management of GSM at Kaiser Permanente Northwest, we conducted an online survey of women with a well-woman visit to primary care and obstetrics/gynecology (OB/GYN) to assess patient vulvovaginal, urinary and sexual symptoms and related health care experiences. Our goal was to maximize patient participation while minimizing staffing requirements. Methods: Electronic communication was used for all contact with patients, including recruitment, consent, eligibility screening, survey and thank you gift cards. REDCap was used for everything except e-gift card ($5) delivery, which required a separate system. We sent an email invitation to all women ≥ 55 years old with a well-woman visit to primary care or OB/GYN during the previous week and an email address on file. Eligible patients were identified from the electronic medical record and uploaded to REDCap weekly. An initial recruitment email, which included a link to the survey, was sent each Tuesday morning. Patients who did not respond were re-sent the email the next Monday afternoon. Patients who clicked the survey link were taken to the REDCap site, which explained the study and contained the IRB-required consent language. Participants who actively agreed to participate then completed an eligibility screening page and, finally, the survey. For security, only one-time access was allowed to the survey. E-gift cards were sent weekly to all new respondents. REDCap and SAS software reports were run weekly to track recruitment patterns and watch for data anomalies. Results: Email addresses were found for 80% of eligible women (5,961/7,483). The overall response rate was 25% (1,483/5,961) and varied across the 18 randomized clinics from 19% to 34%. The response rate was lower for women ≥ 75 years old (18% vs. 26% for \u3c 75). The active refusal rate was 2%. Conclusion: Electronic surveys can successfully be used at relatively low cost, even for topics that are sensitive in nature. Lessons learned and copies of recruitment, consent, screening and survey materials as well as recruitment reports will be presented

Design, Implementation, and Response Rates From an Online Patient Survey to Assess Genitourinary Symptoms and Related Health Care Experiences of Postmenopausal Women

Background/Aims: Nearly 50% of postmenopausal women experience symptoms related to genitourinary syndrome of menopause (GSM), including vulvovaginal dryness and irritation, painful intercourse and urinary incontinence. As part of a clinician-focused intervention to improve diagnosis and management of GSM at Kaiser Permanente Northwest, we conducted an online survey of women with a well-woman visit to primary care and obstetrics/gynecology (OB/GYN) to assess patient vulvovaginal, urinary and sexual symptoms and related health care experiences. Our goal was to maximize patient participation while minimizing staffing requirements. Methods: Electronic communication was used for all contact with patients, including recruitment, consent, eligibility screening, survey and thank you gift cards. REDCap was used for everything except e-gift card ($5) delivery, which required a separate system. We sent an email invitation to all women ≥ 55 years old with a well-woman visit to primary care or OB/GYN during the previous week and an email address on file. Eligible patients were identified from the electronic medical record and uploaded to REDCap weekly. An initial recruitment email, which included a link to the survey, was sent each Tuesday morning. Patients who did not respond were re-sent the email the next Monday afternoon. Patients who clicked the survey link were taken to the REDCap site, which explained the study and contained the IRB-required consent language. Participants who actively agreed to participate then completed an eligibility screening page and, finally, the survey. For security, only one-time access was allowed to the survey. E-gift cards were sent weekly to all new respondents. REDCap and SAS software reports were run weekly to track recruitment patterns and watch for data anomalies. Results: Email addresses were found for 80% of eligible women (5,961/7,483). The overall response rate was 25% (1,483/5,961) and varied across the 18 randomized clinics from 19% to 34%. The response rate was lower for women ≥ 75 years old (18% vs. 26% for \u3c 75). The active refusal rate was 2%. Conclusion: Electronic surveys can successfully be used at relatively low cost, even for topics that are sensitive in nature. Lessons learned and copies of recruitment, consent, screening and survey materials as well as recruitment reports will be presented

Design and Implementation of a Clinician-Focused Intervention to Improve Diagnosis and Management of Symptomatic Vulvovaginal Atrophy in a Large Health System

Background/Aims: Nearly 50% of postmenopausal women experience symptoms related to vulvovaginal atrophy (VVA). However, despite the availability of effective treatment options, studies show that few women seek treatment for, and few providers ask women about, these symptoms. Our paired abstract describes clinician-reported barriers to diagnosis and management. Here we describe the prevalence of VVA diagnoses among women seen for well care within Kaiser Permanente Northwest (KPNW). We also describe the design of a clinician-focused intervention to improve diagnosis and management of symptomatic VVA. Methods: Using electronic medical record (EMR) data, we identified well visits among women 55 years or older occurring within 17 KPNW primary care and OB/GYN clinics between June 2013 and May 2014. We computed the proportion of women who received a VVA-related diagnosis at the index visit. We then stratified the clinics based on visit volume and randomized them to an immediate versus delayed clinician-focused intervention. The intervention includes online and in-person education for clinicians regarding: 1) diagnosis and management of symptomatic VVA, and 2) new EMR-based clinical support tools (Smartsets and Smarttexts). Results: We identified 14,274 unique well visits over the 1-year period of time. Of these, 80.5% (11,500/14,274) occurred in primary care. Only 5.7% (769/13,544) of visits by women not already using vaginal estrogen contained a VVA-related diagnosis. There are 371 clinicians; education for those in the intervention clinics is ongoing (Fall 2014). After the education period, we’ll prospectively collect EMR data to compare groups on the following outcomes: 1) proportion of well visits with VVA diagnoses; 2) proportion of women receiving vaginal estrogen prescriptions; and 3) proportion of visits that used the clinical support tools. We will also conduct an online survey of patients to determine if women in the intervention clinics are more likely than those in the control clinics to discuss VVA symptoms with their providers and to receive education and treatment options if symptomatic. Discussion: The proportion of postmenopausal women with a VVA-related diagnosis was lower than expected. The purpose of our ongoing study is to evaluate whether active outreach to providers with education and clinical support tools leads to improved diagnosis and management of VVA

Design and Implementation of a Clinician-Focused Intervention to Improve Diagnosis and Management of Symptomatic Vulvovaginal Atrophy: Clinician-Reported Barriers

Background/Aims: Nearly 50% of postmenopausal women experience symptoms related to vulvovaginal atrophy (VVA) including vulvovaginal dryness and irritation, painful intercourse, dysuria, urinary urgency and incontinence, and recurrent urinary tract infection. Effective treatment options are available, however few women seek treatment for these symptoms and few providers ask women if they are symptomatic. As part of the development of a clinician-focused intervention to improve diagnosis and management of symptomatic VVA among Kaiser Permanente Northwest patients, we conducted a survey of primary care and OB/GYN clinicians to assess provider knowledge about VVA and barriers to its diagnosis and treatment. Methods: We sent an email invitation to take a short online survey to all 353 Kaiser Permanente Northwest primary care and OB/GYN clinicians with valid email addresses. The survey included VVA knowledge questions related to symptoms, diagnosis and treatment, and practice assessment questions. We asked clinicians to report all potential barriers to VVA diagnosis and treatment in their practice. A list of potential barriers and an open-ended response option were provided. Results: The response rate was 34% (120/353). Knowledge about VVA was good; 67% (641/953) of responses were correct. Only 39.5% (47/119) of clinicians were likely to assess VVA in a postmenopausal patient if she did not mention symptoms. Most clinicians rated their confidence in counseling their patients as medium or less regarding menopause-related vaginal discomfort (56.1%; 67/118) and the risks/benefits of vaginal estrogen therapy (58%; 69/119). Commonly reported barriers were lack of time during the visit (75.4%; 86/114), lack of patient education materials (45.6%; 52/114) and clinical tools (18.4%; 21/114), patient discomfort with discussing vulvovaginal concerns (41.2%; 47/114), warnings about risks of estrogen medication in elderly women (36.8%; 42/114), and the clinicians’ lack of knowledge about VVA (32.5%; 37/114). Discussion: Provider knowledge about VVA symptoms and treatment is generally good. Barriers to patient care such as time, lack of clinical support tools, and patient-provider discomfort with discussion of VVA may explain why this easily treated condition is frequently underdiagnosed and undertreated. Our second abstract describes the intervention phase of our study, which includes the design and implementation of a clinician-focused intervention to improve diagnosis and management of symptomatic VVA

HIV infection as a cofactor for severe falciparum malaria in adults living in a region of unstable malaria transmission in South Africa.

BACKGROUND: Malaria and HIV are two of the most important diseases facing Africa. It remains uncertain whether HIV-related immunosuppression adversely affects the clinical outcome of malaria. OBJECTIVE: To measure the association between HIV status and outcome from malarial infection in adults living in a region of unstable malaria transmission. DESIGN: Observational cohort study. SETTING: Four community clinics and the Government hospital in Hlabisa district, KwaZulu-Natal, South Africa; a region of high HIV prevalence. METHODS: Consecutive febrile adults were screened for malaria with a rapid antigen test. Those with malaria provided blood spots for HIV testing, a thick blood film for confirmation of malaria and clinical data. Outcome was established following management according to South African government guidelines. RESULTS: Malaria was microscopically confirmed in 613. HIV prevalence was 29.9% (180/613); 110 (18%) had severe/complicated malaria and 28 (4.6%) died. HIV-infected patients were more likely to vomit or be confused and were more likely to be admitted to hospital (P = 0.05). In patients admitted to hospital, HIV infection was associated with severe/complicated malaria [adjusted odds ratio (OR) 2.3; 95% confidence interval (CI), 1.4-3.9] and with death (OR 7.5; 95% CI, 2.2-25.1). Acidosis and coma were also strong independent risk factors for death. CONCLUSION: HIV infection had an unexpectedly large association with the outcome of falciparum malaria in a region of unstable transmission. Both diseases are widespread in Africa and these results add to the body of knowledge suggesting an interaction of significant public health importance between HIV and malaria in Africa

Viktor Krivulin. Concerto a richiesta e altre poesie, a cura di Marco Sabbatini

Prima raccolta antologica in italiano di Viktor Krivulin, con saggio introduttivo, nota bio-bibliografica, note ai testi e traduzioni a cura di Marco Sabbatin