BackgroundIn Spain, women invited to breast screening are not usually informed about potential harms of screening. The objective of the InforMa study is to assess the effect of receiving information about the benefits and harms of breast screening on informed choice and other decision-making outcomes, in women approaching the age of invitation to mammography screening.MethodsTwo-stage randomised controlled trial. In the first stage, 40 elementary territorial units of the public healthcare system were selected and randomised to intervention or control. In the second stage, women aged 49-50 years were randomly selected. The target sample size was 400 women. Women in the intervention arm received a decision aid (DA) with detailed information on the benefits and harms of screening. Women in the control arm received a standard leaflet that did not mention harms and recommended accepting the invitation to participate in the Breast Cancer Screening Program (BCSP). The primary outcome was informed choice, defined as adequate knowledge and intentions consistent with attitudes. Secondary outcomes included decisional conflict, worry about breast cancer, time perspective, opinions about the DA or the leaflet, and participation in the BCSP.ResultsIn the intervention group, 23.2% of 203 women made an informed choice compared to only 0.5% of 197 women in the control group (p < 0.001). Attitudes and intentions were similar in both study groups with a high frequency of women intending to be screened, 82.8% vs 82.2% (p = 0.893). Decisional conflict was significantly lower in the intervention group. No differences were observed in confidence in the decision, anxiety, and participation in BCSP.ConclusionsWomen in Spain lack knowledge on the benefits and harms of breast screening. Providing quantitative information on benefits and harms has produced a considerable increase in knowledge and informed choice, with a high acceptance of the informative materials.Trial registrationTrial identifier NCT03046004 at ClinicalTrials.gov registry. Registered on February 4 2017. Trial name: InforMa study.
This qualitative study evaluates a decision aid that includes the benefits and harms of breast cancer screening and analyses women's perception of the information received and healthcare professionals' perceptions of the convenience of providing it. Seven focus groups of women aged 40-69 years (n = 39) and two groups of healthcare professionals (n = 23) were conducted in Catalonia and the Canary Islands. The focus groups consisted of guided discussions regarding decision-making about breast cancer screening, and acceptability and feasibility of the decision aid. A content analysis was performed. Women positively value receiving information regarding the benefits and harms of breast cancer screening. Several women had difficulties understanding some concepts, especially those regarding overdiagnosis. Women preferred to share the decisions on screening with healthcare professionals. The professionals noted the lack of inclusion of some harms and benefits in the decision aid, and proposed improving the clarity of the statistical information. The information on overdiagnosis generates confusion among women and controversy among professionals. Faced with the new information presented by the decision aid, the majority of women prefer shared decision-making; however, its feasibility might be limited by a lack of knowledge and attitudes of rejection from healthcare professionals.
Background There are approximately 72,000 people living with HIV/AIDS (PLHIV) in Peru. Non-adherence to antiretroviral therapy (ART) is the most important factor for therapeutic failure and the development of resistance. Peru has achieved moderate progress in meeting the 90-90-90 targets, but only 60% of PLHIV receiving ART are virally suppressed. The purpose of this study was to understand ART adherence in the Peruvian context, including developing sociodemographic and clinical profiles, evaluating the clinical management strategies, and analyzing the relationships between the variables and adherence of PLHIV managed at a regional HIV clinic in Lambayeque Province (Northern Peru). Methods This was a cross-sectional study with 180 PLHIV adults, non-randomly but consecutively selected with self-reported ART compliance (78.2% of the eligible population). The PLHIV profile (PLHIV-Pro) and the Simplified Medication Adherence Questionnaire (SMAQ) were used to collect sociodemographic information, clinical variables, and data specific to ART adherence. Descriptive analysis of sociodemographic and clinical characteristics was performed. Bivariate analysis was performed with the Mann–Whitney test, Chi square test, and Yates correction. Results The 180 PLHIV sample included 78.9% men, 49.4% heterosexual, 45% with a detectable HIV-1 viral load less than 40 copies/ml, 58.3% not consistently adherent, and only 26.1% receiving Tenofovir + Lamivudine + Efavirenz. Risk factors significant for non-adherence included concurrent tuberculosis, discomfort with the ART regime, and previous pauses in ART. Multivariate analysis of nested models indicated having children is a protector factor for adherence. Conclusions Self-reported adherence appeared to be low and the use of first-line therapy is not being prescribed homogeneously. Factors associated with nonadherence are both medical and behavioral, such as having tuberculosis, pausing ART, or experiencing discomfort with ART. The Peruvian government needs to update national technical standards, monitor medication availability, and provide education to health care professionals in alignment with evidence-based guidelines and international recommendations. Instruments to measure adherence need to be developed and evaluated for use in Latin America.
Introduction The aim is to describe the health and psychosocial risk factors of Spanish healthcare workers during the COVID-19 pandemic. Methods: A cross-sectional study by means of an online questionnaire (April–May 2020). The data comes from the database resulting from the COTS project “Working conditions, insecurity, and health in the context of the COVID-19 pandemic”. The sample consisted of 1,989 health care workers. Results: Women, young people (doctors and nurses) and the middle-aged (assistants) had poorer health and greater exposure to psychosocial risks. Geriatric assistants were the most-affected occupational group. Conclusions: gender, occupation, and age are focuses of inequality in the exposure of health care workers to psychosocial risks.
BackgroundThe decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences.The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening.MethodsA two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP.The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2–3 weeks after the intervention.DiscussionThis is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country.Trial registrationClinicalTrials.gov registry, ID: NCT03046004. Retrospectively registered on 4 February 2017. Trial name: InforMa study.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2161-7) contains supplementary material, which is available to authorized users.
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