"For and against" factors influencing participation in personalized breast cancer screening programs: a qualitative systematic review until March 2022.

BACKGROUND: Personalized breast cancer screening is a novel strategy that estimates individual risk based on age, breast density, family history of breast cancer, personal history of benign breast lesions, and polygenic risk. Its goal is to propose personalized early detection recommendations for women in the target population based on their individual risk. Our aim was to synthesize the factors that influence women's decision to participate in personalized breast cancer screening, from the perspective of women and health care professionals. METHODS: Systematic review of qualitative evidence on factors influencing participation in personalized Breast Cancer Screening. We searched in Medline, Web of science, Scopus, EMBASE, CINAHL and PsycINFO for qualitative and mixed methods studies published up to March 2022. Two reviewers conducted study selection and extracted main findings. We applied the best-fit framework synthesis and adopted the Multilevel influences on the cancer care continuum model for analysis. After organizing initial codes into the seven levels of the selected model, we followed thematic analysis and developed descriptive and analytical themes. We assessed the methodological quality with the Critical Appraisal Skills Program tool. RESULTS: We identified 18 studies published between 2017 and 2022, conducted in developed countries. Nine studies were focused on women (n = 478) and in four studies women had participated in a personalized screening program. Nine studies focused in health care professionals (n = 162) and were conducted in primary care and breast cancer screening program settings. Factors influencing women's decision to participate relate to the women themselves, the type of program (personalized breast cancer screening) and perspective of health care professionals. Factors that determined women participation included persistent beliefs and insufficient knowledge about breast cancer and personalized screening, variable psychological reactions, and negative attitudes towards breast cancer risk estimates. Other factors against participation were insufficient health care professionals knowledge on genetics related to breast cancer and personalized screening process. The factors that were favourable included the women's perceived benefits for themselves and the positive impact on health systems. CONCLUSION: We identified the main factors influencing women's decisions to participate in personalized breast cancer screening. Factors related to women, were the most relevant negative factors. A future implementation requires improving health literacy for women and health care professionals, as well as raising awareness of the strategy in society.

Factors influencing intention to participate in breast cancer screening. An exploratory structural model.

OBJECTIVES: The paper has two objectives. The first one examines whether informing women about the benefits and adverse effects of breast cancer screening could have an effect on three variables: their knowledge, the importance women attach to the future consequences of their current decisions (time perspective), and the degree to which women are worried about developing breast cancer (worry). The second one examines whether these three variables affect their intention to participate in the screening, either directly or indirectly through their feeling of regret if they do not attend the screening (anticipated regret); through their values and the support they receive in making their decisions (decisional conflict); and, through the perceived acceptability and benefits of the screening programme (attitude). METHODS: Partial least squares-structural equation modelling (PLS-SEM) is used to analyse both objectives and to differentiate between direct, indirect, and moderating effects, due to the incorporation in the model of the three mediating variables (anticipated regret, decisional conflict, and attitude) and a moderating variable (educational level). RESULTS: Information affects knowledge (objective variable), but not the behavioural variables (time perspective and worry). On the other hand, the level of knowledge has no direct or indirect effect on intention, but behavioural variables do affect it through the mediating variables. CONCLUSIONS: The variables of the planned behaviour theory are relevant to understand women's decisions and to be able to take appropriate health policy measures. Doing so, the processes of personalised screening would improve, or there would be the incorporation of shared decision-making in this context; these being demands associated with the most recent goals achieved in health programmes in many countries.

Women's preference to apply shared decision-making in breast cancer screening: a discrete choice experiment.

OBJECTIVE: To analyse women's stated preferences for establishing the relative importance of each attribute of shared decision-making (SDM) and their willingness to pay (WTP) for more participatory care in breast cancer screening programmes (BCSP). DESIGN: A discrete choice experiment was designed with 12 questions (choice tasks). It included three attributes: 'How the information is obtained', regarding benefits and harms; whether there is a 'Dialogue for scheduled mammography' between the healthcare professional and the woman; and, 'Who makes the decision', regarding participation in BCSP. Data were obtained using a survey that included 12 choice tasks, 1 question on WTP and 7 socioeconomic-related questions. The analysis was performed using conditional mixed-effect logit regression and stratification according to WTP. SETTING: Data collection related to BCSP was conducted between June and November 2021 in Catalonia, Spain. PARTICIPANTS: Sixty-five women aged between 50 and 60. MAIN OUTCOME MEASURES: Women's perceived utility of each attribute, trade-off on these attributes and WTP for SDM in BCSP. RESULT: The only significant attribute was 'Who makes the decision'. The decision made alone (coefficient=2.879; 95% CI=2.297 to 3.461) and the decision made together with a healthcare professional (2.375; 95% CI=1.573 to 3.177) were the options preferred by women. The former contributes 21% more utility than the latter. Moreover, 52.3% of the women stated a WTP of €10 or more for SDM. Women's preferences regarding attributes did not influence their WTP. CONCLUSIONS: The participant women refused a current paternalistic model and preferred either SDM or informed decision-making in BCSP.

Feasibility and Acceptability of Personalized Breast Cancer Screening (DECIDO Study): A Single-Arm Proof-of-Concept Trial.

The aim of this study was to assess the acceptability and feasibility of offering risk-based breast cancer screening and its integration into regular clinical practice. A single-arm proof-of-concept trial was conducted with a sample of 387 women aged 40-50 years residing in the city of Lleida (Spain). The study intervention consisted of breast cancer risk estimation, risk communication and screening recommendations, and a follow-up. A polygenic risk score with 83 single nucleotide polymorphisms was used to update the Breast Cancer Surveillance Consortium risk model and estimate the 5-year absolute risk of breast cancer. The women expressed a positive attitude towards varying the frequency of breast screening according to individual risk and, especially, more frequently inviting women at higher-than-average risk. A lower intensity screening for women at lower risk was not as welcome, although half of the participants would accept it. Knowledge of the benefits and harms of breast screening was low, especially with regard to false positives and overdiagnosis. The women expressed a high understanding of individual risk and screening recommendations. The participants' intention to participate in risk-based screening and satisfaction at 1-year were very high.

Avances hacia el cribado personalizado del cáncer de mama: el papel de la Atención Primaria / Moving toward personalized breast cancer screening: The role of Primary Care

El cáncer de mama es la primera causa de muerte en el mundo entre las mujeres. El Sistema Nacional de Salud (SNS) introdujo el cribado poblacional de cáncer de mama en 1990. Como en la mayoría de los programas europeos, el riesgo se identifica con base en la edad y se ofrece una mamografía cada dos años a mujeres de 50 a 69 años. La evidencia científica está avanzando hacia un cribado personalizado, basado en el riesgo individual. En este artículo se presentan los ensayos clínicos que evaluarán la eficacia del cribado personalizado y algunos estudios realizados en nuestro entorno sobre el efecto de informar a las mujeres de los beneficios y efectos adversos del cribado o la aceptabilidad y viabilidad de ofrecer cribado personalizado, que incluya la toma de decisiones compartidas. El Programa de Actividades Preventivas y Promoción de la Salud puede ayudar a transformar el cribado en nuestro SNS.(AU)

Breast cancer is the leading cause of death in the world among women. The Spanish National Health System (SNHS) introduced population-based breast cancer screening in 1990. As in most European programs, risk is identified on the basis of age and a mammogram is offered every two years to women aged 50–69 years. Scientific evidence is moving toward personalized screening, based on individual risk. This article presents the clinical trials that will evaluate the efficacy of personalized screening and some studies carried out in our environment on the effect of informing women of the benefits and adverse effects of screening or the acceptability and feasibility of offering personalized screening, in the Shared Decision Making context. The Preventive Activities and Health Promotion Program can help transform screening in our SNHS.(AU)

[Moving toward personalized breast cancer screening: The role of Primary Care]. / Avances hacia el cribado personalizado del cáncer de mama: el papel de la Atención Primaria.

Breast cancer is the leading cause of death in the world among women. The Spanish National Health System (SNHS) introduced population-based breast cancer screening in 1990. As in most European programs, risk is identified on the basis of age and a mammogram is offered every two years to women aged 50-69 years. Scientific evidence is moving toward personalized screening, based on individual risk. This article presents the clinical trials that will evaluate the efficacy of personalized screening and some studies carried out in our environment on the effect of informing women of the benefits and adverse effects of screening or the acceptability and feasibility of offering personalized screening, in the Shared Decision Making context. The Preventive Activities and Health Promotion Program can help transform screening in our SNHS.

The Effect of Clusters of Double Triggering and Ineffective Efforts in Critically Ill Patients.

OBJECTIVES: To characterize clusters of double triggering and ineffective inspiratory efforts throughout mechanical ventilation and investigate their associations with mortality and duration of ICU stay and mechanical ventilation. DESIGN: Registry-based, real-world study. BACKGROUND: Asynchronies during invasive mechanical ventilation can occur as isolated events or in clusters and might be related to clinical outcomes. SUBJECTS: Adults requiring mechanical ventilation greater than 24 hours for whom greater than or equal to 70% of ventilator waveforms were available. INTERVENTIONS: We identified clusters of double triggering and ineffective inspiratory efforts and determined their power and duration. We used Fine-Gray's competing risk model to analyze their effects on mortality and generalized linear models to analyze their effects on duration of mechanical ventilation and ICU stay. MEASUREMENTS AND MAIN RESULTS: We analyzed 58,625,796 breaths from 180 patients. All patients had clusters (mean/d, 8.2 [5.4-10.6]; mean power, 54.5 [29.6-111.4]; mean duration, 20.3 min [12.2-34.9 min]). Clusters were less frequent during the first 48 hours (5.5 [2.5-10] vs 7.6 [4.4-9.9] in the remaining period [p = 0.027]). Total number of clusters/d was positively associated with the probability of being discharged alive considering the total period of mechanical ventilation (p = 0.001). Power and duration were similar in the two periods. Power was associated with the probability of being discharged dead (p = 0.03), longer mechanical ventilation (p < 0.001), and longer ICU stay (p = 0.035); cluster duration was associated with longer ICU stay (p = 0.027). CONCLUSIONS: Clusters of double triggering and ineffective inspiratory efforts are common. Although higher numbers of clusters might indicate better chances of survival, clusters with greater power and duration indicate a risk of worse clinical outcomes.

Views of health professionals on risk-based breast cancer screening and its implementation in the Spanish National Health System: A qualitative discussion group study.

BACKGROUND: With the aim of increasing benefits and decreasing harms, risk-based breast cancer screening has been proposed as an alternative to age-based screening. This study explores barriers and facilitators to implementing a risk-based breast cancer screening program from the perspective of health professionals, in the context of a National Health Service. METHODS: Socio-constructivist qualitative research carried out in Catalonia (Spain), in the year 2019. Four discussion groups were conducted, with a total of 29 health professionals from primary care, breast cancer screening programs, hospital breast units, epidemiology units, and clinical specialties. A descriptive-interpretive thematic analysis was performed. RESULTS: Identified barriers included resistance to reducing the number of screening exams for low-risk women; resistance to change for health professionals; difficulties in risk communication; lack of conclusive evidence of the benefits of risk-based screening; limited economic resources; and organizational transformation. Facilitators include benefits of risk-based strategies for high and low-risk women; women's active role in their health care; proximity of women and primary care professionals; experience of health professionals in other screening programs; and greater efficiency of a risk-based screening program. Organizational and administrative changes in the health system, commitment by policy makers, training of health professionals, and educational interventions addressed to the general population will be required. CONCLUSIONS: Despite the expressed difficulties, participants supported the implementation of risk-based screening. They highlighted its benefits, especially for women at high risk of breast cancer and those under 50 years of age, and assumed a greater efficiency of the risk-based program compared to the aged-based one. Future studies should assess the efficiency and feasibility of risk-based breast cancer screening for its transfer to clinical practice.

Barriers and Facilitators to the Implementation of a Personalized Breast Cancer Screening Program: Views of Spanish Health Professionals.

This study explored the barriers and facilitators to the implementation of a risk-based breast cancer screening program from the point of view of Spanish health professionals. A cross-sectional study with 220 Spanish health professionals was designed. Data were collected in 2020 via a web-based survey and included the advantages and disadvantages of risk-based screening and barriers and facilitators for the implementation of the program. Descriptive statistics and Likert scale responses analyzed as category-ordered data were obtained. The risk-based screening was considered important or very important to reduce breast cancer mortality and promote a more proactive role for women in breast cancer prevention, to increase coverage for women under 50 years, to promote a breast cancer prevention strategy for women at high risk, and to increase efficiency and effectiveness. Switching to a risk-based program from an age-based program was rated as important or very important by 85% of participants. As barriers for implementation, risk communication, the workload of health professionals, and limited human and financial resources were mentioned. Despite the barriers, there is good acceptance, and it seems feasible, from the perspective of health professionals, to implement a risk-based breast cancer screening program in Spain. However, this poses a number of organizational and resource challenges.

Longitudinal Changes in Patient-Ventilator Asynchronies and Respiratory System Mechanics Before and After Tracheostomy.

BACKGROUND: This was a pilot study to analyze the effects of tracheostomy on patient-ventilator asynchronies and respiratory system mechanics. Data were extracted from an ongoing prospective, real-world database that stores continuous output from ventilators and bedside monitors. Twenty adult subjects were on mechanical ventilation and were tracheostomized during an ICU stay: 55% were admitted to the ICU for respiratory failure and 35% for neurologic conditions; the median duration of mechanical ventilation before tracheostomy was 12 d; and the median duration of mechanical ventilation was 16 d. METHODS: We compared patient-ventilator asynchronies (the overall asynchrony index and the rates of specific asynchronies) and respiratory system mechanics (respiratory-system compliance and airway resistance) during the 24 h before tracheostomy versus the 24 h after tracheostomy. We analyzed possible differences in these variables among the subjects who underwent surgical versus percutaneous tracheostomy. To compare longitudinal changes in the variables, we used linear mixed-effects models for repeated measures along time in different observation periods. A total of 920 h of mechanical ventilation were analyzed. RESULTS: Respiratory mechanics and asynchronies did not differ significantly between the 24-h periods before and after tracheostomy: compliance of the respiratory system median (IQR) (47.9 [41.3 - 54.6] mL/cm H2O vs 47.6 [40.9 - 54.3] mL/cm H2O; P = .94), airway resistance (9.3 [7.5 - 11.1] cm H2O/L/s vs 7.0 [5.2 - 8.8] cm H2O/L/s; P = .07), asynchrony index (2.0% [1.1 - 3.6%] vs 4.1% [2.3 - 7.6%]; P = .09), ineffective expiratory efforts (0.9% [0.4 - 1.8%] vs 2.2% [1.0 - 4.4%]; P = .08), double cycling (0.5% [0.3 - 1.0%] vs 0.9% [0.5 - 1.9%]; P = .24), and percentage of air trapping (7.6% [4.2 - 13.8%] vs 10.6% [5.9 - 19.2%]; P = .43). No differences in respiratory mechanics or patient-ventilator asynchronies were observed between percutaneous and surgical procedures. CONCLUSIONS: Tracheostomy did not affect patient-ventilator asynchronies or respiratory mechanics within 24 h before and after the procedure.

Elección informada en el cribado del cáncer de mama: el papel del nivel educativo / Informed choice in breast cancer screening: the role of education

Objetivo: Evaluar el efecto de recibir información sobre los beneficios y los efectos adversos del cribado del cáncer de mama en la elección informada, en función del nivel educativo. Método: Análisis secundario de un estudio experimental aleatorizado y controlado, en cuatro programas de cribado en Cataluña y Canarias. Se analizaron 400 mujeres que iban a ser invitadas a participar por primera vez. El grupo de intervención recibió una herramienta informativa que mostraba los beneficios y los efectos adversos del cribado. El grupo control recibió un folleto estándar que recomendaba participar en el cribado. El nivel de estudios se agrupó en dos categorías: bajo y alto. La variable principal fue la elección informada definida como un conocimiento adecuado y la concordancia entre las actitudes y las intenciones. Resultados: La intervención produjo un mayor aumento del conocimiento en las mujeres con nivel educativo alto respecto a las de menor nivel educativo. Entre las mujeres que recibieron la intervención, la elección informada fue casi tres veces superior en las de nivel educativo alto (27% vs. 11%). No se observaron diferencias entre niveles educativos en los grupos de intervención y control en cuanto a conflicto decisional, confianza en la decisión, ansiedad y preocupación por el cáncer de mama. Conclusiones: Una herramienta informativa para el cribado del cáncer de mama tuvo mucho más impacto sobre la elección informada en las mujeres con nivel educativo alto. En aquellas con nivel educativo bajo mejoró la actitud frente al cribado y produjo un aumento en la intención de participar en él. (AU)

Objective: To evaluate the effect of receiving information about the benefits and harms of breast cancer screening in informed choice, according to educational level. Method: Secondary analysis of a randomized, controlled study, in four screening programs, in Catalonia and the Canary Islands (Spain). We analyzed 400 women who were going to be invited to participate for the first time. The intervention group received a decision aid that showed the benefits and harms of screening. The control group received a standard brochure that recommended participating in the screening program. Educational level was grouped into two categories, low and high. The primary outcome was informed choice defined as adequate knowledge and consistency between attitudes and intentions. Results: The intervention produced a greater increase in knowledge in women with a high educational level compared to those with a lower educational level. Among women who received the intervention, informed choice was almost three times higher in those with a high educational level (27% versus 11%). No differences were observed between educational levels in decisional conflict, confidence in the decision, anxiety and worry about breast cancer, in the intervention and control groups. Conclusions: A decision aid for breast cancer screening had much more impact on informed choice among women with a high educational level. In women with low educational level, the attitude towards screening improved and there was an increase in the intention to be screened. (AU)

[Informed choice in breast cancer screening: the role of education]. / Elección informada en el cribado del cáncer de mama: el papel del nivel educativo.

OBJECTIVE: To evaluate the effect of receiving information about the benefits and harms of breast cancer screening in informed choice, according to educational level. METHOD: Secondary analysis of a randomized, controlled study, in four screening programs, in Catalonia and the Canary Islands (Spain). We analyzed 400 women who were going to be invited to participate for the first time. The intervention group received a decision aid that showed the benefits and harms of screening. The control group received a standard brochure that recommended participating in the screening program. Educational level was grouped into two categories, low and high. The primary outcome was informed choice defined as adequate knowledge and consistency between attitudes and intentions. RESULTS: The intervention produced a greater increase in knowledge in women with a high educational level compared to those with a lower educational level. Among women who received the intervention, informed choice was almost three times higher in those with a high educational level (27% versus 11%). No differences were observed between educational levels in decisional conflict, confidence in the decision, anxiety and worry about breast cancer, in the intervention and control groups. CONCLUSIONS: A decision aid for breast cancer screening had much more impact on informed choice among women with a high educational level. In women with low educational level, the attitude towards screening improved and there was an increase in the intention to be screened.

Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial.

INTRODUCTION: Personalised cancer screening aims to improve benefits, reduce harms and being more cost-effective than age-based screening. The objective of the DECIDO study is to assess the acceptability and feasibility of offering risk-based personalised breast cancer screening and its integration in regular clinical practice in a National Health System setting. METHODS AND ANALYSIS: The study is designed as a single-arm proof-of-concept trial. The study sample will include 385 women aged 40-50 years resident in a primary care health area in Spain. The study intervention consists of (1) a baseline visit; (2) breast cancer risk estimation; (3) a second visit for risk communication and screening recommendations based on breast cancer risk and (4) a follow-up to obtain the study outcomes.A polygenic risk score (PRS) will be constructed as a composite likelihood ratio of 83 single nucleotide polymorphisms. The Breast Cancer Surveillance Consortium risk model, including age, race/ethnicity, family history of breast cancer, benign breast disease and breast density will be used to estimate a preliminary 5-year absolute risk of breast cancer. A Bayesian approach will be used to update this risk with the PRS value.The primary outcome measures will be attitude towards, intention to participate in and satisfaction with personalised breast cancer screening. Secondary outcomes will include the proportions of women who accept to participate and who complete the different phases of the study. The exact binomial and the Student's t-test will be used to obtain 95% CIs. ETHICS AND DISSEMINATION: The study protocol was approved by the Drug Research Ethics Committee of the University Hospital Arnau de Vilanova. The trial will be conducted in compliance with this study protocol, the Declaration of Helsinki and Good Clinical Practice.The results will be published in peer-reviewed scientific journals and disseminated in scientific conferences and media. TRIAL REGISTRATION NUMBER: NCT03791008.

Publisher Correction: Development and validation of a sample entropy-based method to identify complex patient-ventilator interactions during mechanical ventilation.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Development and validation of a sample entropy-based method to identify complex patient-ventilator interactions during mechanical ventilation.

Patient-ventilator asynchronies can be detected by close monitoring of ventilator screens by clinicians or through automated algorithms. However, detecting complex patient-ventilator interactions (CP-VI), consisting of changes in the respiratory rate and/or clusters of asynchronies, is a challenge. Sample Entropy (SE) of airway flow (SE-Flow) and airway pressure (SE-Paw) waveforms obtained from 27 critically ill patients was used to develop and validate an automated algorithm for detecting CP-VI. The algorithm's performance was compared versus the gold standard (the ventilator's waveform recordings for CP-VI were scored visually by three experts; Fleiss' kappa = 0.90 (0.87-0.93)). A repeated holdout cross-validation procedure using the Matthews correlation coefficient (MCC) as a measure of effectiveness was used for optimization of different combinations of SE settings (embedding dimension, m, and tolerance value, r), derived SE features (mean and maximum values), and the thresholds of change (Th) from patient's own baseline SE value. The most accurate results were obtained using the maximum values of SE-Flow (m = 2, r = 0.2, Th = 25%) and SE-Paw (m = 4, r = 0.2, Th = 30%) which report MCCs of 0.85 (0.78-0.86) and 0.78 (0.78-0.85), and accuracies of 0.93 (0.89-0.93) and 0.89 (0.89-0.93), respectively. This approach promises an improvement in the accurate detection of CP-VI, and future study of their clinical implications.

Association of premenopausal risk-reducing salpingo-oophorectomy with breast cancer risk in BRCA1/2 mutation carriers: Maximising bias-reduction.

BACKGROUND: Whether risk-reducing salpingo-oophorectomy (RRSO) in BRCA1/2 carriers reduces the breast cancer (BC) risk is conflicting, potentially due to methodological issues of prior analysis. We analysed the association between premenopausal RRSO and BC risk in BRCA1/2 carriers after adjusting for potential biases. METHODS: We analysed data from 444 BRCA1 and 409 BRCA2 carriers under age 51 with no cancer prior to genetic testing or during first 6 months of surveillance (to avoid cancer-induced testing bias and prevalent-cancer bias). Observation started 6 months after genetic testing (to avoid event-free time bias), until BC diagnosis, risk-reducing mastectomy (RRM) or death. A multistate model with four states (non-RRSO, RRSO, RRM and BC) and five transitions was fitted to characterise outcomes and to calculate the BC risk reduction after premenopausal RRSO (before age 51). A systematic review was performed to assess the association between premenopausal RRSO and BC. RESULTS: During a mean follow-up of 4.3 years, 96 women (11.3%) developed BC (54 BRCA1, 42 BRCA2). The risk of BC after premenopausal RRSO decreased significantly in BRCA1 carriers (hazard ratio (HR) = 0.45 [95% confidence interval (CI):0.22-0.92]), but was not conclusive in BRCA2 carriers (HR = 0.77 [95%CI:0.35-1.67]). The systematic review suggested that premenopausal RRSO is associated with a decrease of BC risk in both BRCA1 and BRCA2 carriers. CONCLUSIONS: Premenopausal RRSO was associated with BC risk reduction in BRCA1 carriers, which can help guide cancer risk-reducing strategies in this population. Longer follow-up and larger sample size may be needed to estimate the potential benefit in BRCA2 carriers.

Effects of sedatives and opioids on trigger and cycling asynchronies throughout mechanical ventilation: an observational study in a large dataset from critically ill patients.

BACKGROUND: In critically ill patients, poor patient-ventilator interaction may worsen outcomes. Although sedatives are often administered to improve comfort and facilitate ventilation, they can be deleterious. Whether opioids improve asynchronies with fewer negative effects is unknown. We hypothesized that opioids alone would improve asynchronies and result in more wakeful patients than sedatives alone or sedatives-plus-opioids. METHODS: This prospective multicenter observational trial enrolled critically ill adults mechanically ventilated (MV) > 24 h. We compared asynchronies and sedation depth in patients receiving sedatives, opioids, or both. We recorded sedation level and doses of sedatives and opioids. BetterCare™ software continuously registered ineffective inspiratory efforts during expiration (IEE), double cycling (DC), and asynchrony index (AI) as well as MV modes. All variables were averaged per day. We used linear mixed-effects models to analyze the relationships between asynchronies, sedation level, and sedative and opioid doses. RESULTS: In 79 patients, 14,166,469 breaths were recorded during 579 days of MV. Overall asynchronies were not significantly different in days classified as sedatives-only, opioids-only, and sedatives-plus-opioids and were more prevalent in days classified as no-drugs than in those classified as sedatives-plus-opioids, irrespective of the ventilatory mode. Sedative doses were associated with sedation level and with reduced DC (p < 0.0001) in sedatives-only days. However, on days classified as sedatives-plus-opioids, higher sedative doses and deeper sedation had more IEE (p < 0.0001) and higher AI (p = 0.0004). Opioid dosing was inversely associated with overall asynchronies (p < 0.001) without worsening sedation levels into morbid ranges. CONCLUSIONS: Sedatives, whether alone or combined with opioids, do not result in better patient-ventilator interaction than opioids alone, in any ventilatory mode. Higher opioid dose (alone or with sedatives) was associated with lower AI without depressing consciousness. Higher sedative doses administered alone were associated only with less DC. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03451461.

Effect of information about the benefits and harms of mammography on women's decision making: The InforMa randomised controlled trial.

BACKGROUND: In 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. METHODS: Two-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. RESULTS: In 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. CONCLUSIONS: Women 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 REGISTRATION: Trial identifier NCT03046004 at ClinicalTrials.gov registry. Registered on February 4 2017. Trial name: InforMa study.

Economic evaluations of screening strategies for the early detection of colorectal cancer in the average-risk population: A systematic literature review.

BACKGROUND: Colorectal cancer (CRC) screening has proven effective in reducing CRC mortality. This study aimed to systematically review, and evaluate the reporting quality, of the economic evidence regarding CRC screening in average-risk individuals. METHODS: Databases searched included Medline, EMBASE, National Health Service Economic Evaluation, Database of Abstracts of Reviews of Effects, Cost-Effectiveness Analysis registry, EconLit, and Health Technology Assessment database. Eligible studies were cost-effectiveness and cost-utility analyses comparing CRC screening strategies in average-risk individuals, published in English or Spanish, between January 2012 and November 2018. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. RESULTS: Of 1,993 publications initially retrieved, 477 were excluded by duplicate review, 1,449 by title/abstract review, and 34 by full-text review. Finally, 33 publications were included in the qualitative synthesis. Most studies were conducted in Europe (36,4%), followed by United States (24,2%) and Asia (24,2%). The main screening modalities considered were fecal immunochemical tests (70%), colonoscopy (67%), guaiac fecal occult blood test (42%) and flexible sigmoidoscopy (30%). In most studies, CRC screening was deemed cost-effective compared to no screening. Sensitivity analyses indicated that cost of CRC screening tests, adherence to screening, screening test sensitivity, and cost of CRC treatment had the greatest impact on cost-effectiveness results across studies. The majority of studies (73%) adequately reported at least 50% of the items included in the CHEERS checklist. Least well reported items included setting, study perspective, discount rate, model choice, and methods to identify effectiveness data or to estimate resource use and costs. CONCLUSIONS: CRC screening is an efficient alternative to no screening. Nevertheless, it is not possible to conclude which strategy should be preferred for population-based screening programs. Although we observed an overall good adherence to CHEERS recommendations, there is still room for improvement in economic evaluations reporting in this field.

Double Cycling During Mechanical Ventilation: Frequency, Mechanisms, and Physiologic Implications.

OBJECTIVES: Double cycling generates larger than expected tidal volumes that contribute to lung injury. We analyzed the incidence, mechanisms, and physiologic implications of double cycling during volume- and pressure-targeted mechanical ventilation in critically ill patients. DESIGN: Prospective, observational study. SETTING: Three general ICUs in Spain. PATIENTS: Sixty-seven continuously monitored adult patients undergoing volume control-continuous mandatory ventilation with constant flow, volume control-continuous mandatory ventilation with decelerated flow, or pressure control-continuous mandatory mechanical ventilation for longer than 24 hours. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We analyzed 9,251 hours of mechanical ventilation corresponding to 9,694,573 breaths. Double cycling occurred in 0.6%. All patients had double cycling; however, the distribution of double cycling varied over time. The mean percentage (95% CI) of double cycling was higher in pressure control-continuous mandatory ventilation 0.54 (0.34-0.87) than in volume control-continuous mandatory ventilation with constant flow 0.27 (0.19-0.38) or volume control-continuous mandatory ventilation with decelerated flow 0.11 (0.06-0.20). Tidal volume in double-cycled breaths was higher in volume control-continuous mandatory ventilation with constant flow and volume control-continuous mandatory ventilation with decelerated flow than in pressure control-continuous mandatory ventilation. Double-cycled breaths were patient triggered in 65.4% and reverse triggered (diaphragmatic contraction stimulated by a previous passive ventilator breath) in 34.6% of cases; the difference was largest in volume control-continuous mandatory ventilation with decelerated flow (80.7% patient triggered and 19.3% reverse triggered). Peak pressure of the second stacked breath was highest in volume control-continuous mandatory ventilation with constant flow regardless of trigger type. Various physiologic factors, none mutually exclusive, were associated with double cycling. CONCLUSIONS: Double cycling is uncommon but occurs in all patients. Periods without double cycling alternate with periods with clusters of double cycling. The volume of the stacked breaths can double the set tidal volume in volume control-continuous mandatory ventilation with constant flow. Gas delivery must be tailored to neuroventilatory demand because interdependent ventilator setting-related physiologic factors can contribute to double cycling. One third of double-cycled breaths were reverse triggered, suggesting that repeated respiratory muscle activation after time-initiated ventilator breaths occurs more often than expected.