Shared decision-making for supporting women's decisions about breast cancer screening.

BACKGROUND: In breast cancer screening programmes, women may have discussions with a healthcare provider to help them decide whether or not they wish to join the breast cancer screening programme. This process is called shared decision-making (SDM) and involves discussions and decisions based on the evidence and the person's values and preferences. SDM is becoming a recommended approach in clinical guidelines, extending beyond decision aids. However, the overall effect of SDM in women deciding to participate in breast cancer screening remains uncertain. OBJECTIVES: To assess the effect of SDM on women's satisfaction, confidence, and knowledge when deciding whether to participate in breast cancer screening. SEARCH METHODS: We searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 8 August 2023. We also screened abstracts from two relevant conferences from 2020 to 2023. SELECTION CRITERIA: We included parallel randomised controlled trials (RCTs) and cluster-RCTs assessing interventions targeting various components of SDM. The focus was on supporting women aged 40 to 75 at average or above-average risk of breast cancer in their decision to participate in breast cancer screening. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion and conducted data extraction, risk of bias assessment, and GRADE assessment of the certainty of the evidence. Review outcomes included satisfaction with the decision-making process, confidence in the decision made, knowledge of all options, adherence to the chosen option, women's involvement in SDM, woman-clinician communication, and mental health. MAIN RESULTS: We identified 19 studies with 64,215 randomised women, mostly with an average to moderate risk of breast cancer. Two studies covered all aspects of SDM; six examined shortened forms of SDM involving communication on risks and personal values; and 11 focused on enhanced communication of risk without other SDM aspects. SDM involving all components compared to control The two eligible studies did not assess satisfaction with the SDM process or confidence in the decision. Based on a single study, SDM showed uncertain effects on participant knowledge regarding the age to start screening (risk ratio (RR) 1.18, 95% confidence interval (CI) 0.61 to 2.28; 133 women; very low certainty evidence) and frequency of testing (RR 0.84, 95% CI 0.68 to 1.04; 133 women; very low certainty evidence). Other review outcomes were not measured. Abbreviated forms of SDM with clarification of values and preferences compared to control Of the six included studies, none evaluated satisfaction with the SDM process. These interventions may reduce conflict in the decision made, based on two measures, Decisional Conflict Scale scores (mean difference (MD) -1.60, 95% CI -4.21 to 0.87; conflict scale from 0 to 100; 4 studies; 1714 women; very low certainty evidence) and the proportion of women with residual conflict compared to control at one to three months' follow-up (rate of women with a conflicted decision, RR 0.75, 95% CI 0.56 to 0.99; 1 study; 1001 women, very low certainty evidence). Knowledge of all options was assessed through knowledge scores and informed choice. The effect of SDM may enhance knowledge (MDs ranged from 0.47 to 1.44 higher scores on a scale from 0 to 10; 5 studies; 2114 women; low certainty evidence) and may lead to higher rates of informed choice (RR 1.24, 95% CI 0.95 to 1.63; 4 studies; 2449 women; low certainty evidence) compared to control at one to three months' follow-up. These interventions may result in little to no difference in anxiety (MD 0.54, 95% -0.96 to 2.14; scale from 20 to 80; 2 studies; 749 women; low certainty evidence) and the number of women with worries about cancer compared to control at four to six weeks' follow-up (RR 0.88, 95% CI 0.73 to 1.06; 1 study, 639 women; low certainty evidence). Other review outcomes were not measured. Enhanced communication about risks without other SDM aspects compared to control Of 11 studies, three did not report relevant outcomes for this review, and none assessed satisfaction with the SDM process. Confidence in the decision made was measured by decisional conflict and anticipated regret of participating in screening or not. These interventions, without addressing values and preferences, may result in lower confidence in the decision compared to regular communication strategies at two weeks' follow-up (MD 2.89, 95% CI -2.35 to 8.14; Decisional Conflict Scale from 0 to 100; 2 studies; 1191 women; low certainty evidence). They may result in higher anticipated regret if participating in screening (MD 0.28, 95% CI 0.15 to 0.41) and lower anticipated regret if not participating in screening (MD -0.28, 95% CI -0.42 to -0.14). These interventions increase knowledge (MD 1.14, 95% CI 0.61 to 1.62; scale from 0 to 10; 4 studies; 2510 women; high certainty evidence), while it is unclear if there is a higher rate of informed choice compared to regular communication strategies at two to four weeks' follow-up (RR 1.27, 95% CI 0.83 to 1.92; 2 studies; 1805 women; low certainty evidence). These interventions result in little to no difference in anxiety (MD 0.33, 95% CI -1.55 to 0.99; scale from 20 to 80) and depression (MD 0.02, 95% CI -0.41 to 0.45; scale from 0 to 21; 2 studies; 1193 women; high certainty evidence) and lower cancer worry compared to control (MD -0.17, 95% CI -0.26 to -0.08; scale from 1 to 4; 1 study; 838 women; high certainty evidence). Other review outcomes were not measured. AUTHORS' CONCLUSIONS: Studies using abbreviated forms of SDM and other forms of enhanced communications indicated improvements in knowledge and reduced decisional conflict. However, uncertainty remains about the effect of SDM on supporting women's decisions. Most studies did not evaluate outcomes considered important for this review topic, and those that did measured different concepts. High-quality randomised trials are needed to evaluate SDM in diverse cultural settings with a focus on outcomes such as women's satisfaction with choices aligned to their values.

Serenoa repens for the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Enlargement: An Updated Cochrane Review.

PURPOSE: To assess the effects of Serenoa repens in the treatment of men with lower urinary tract symptoms (LUTS) consistent with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: We performed a comprehensive search using multiple databases up to September 2022 with no language or publication status restrictions. We included parallel-group randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment. We used standard Cochrane methods, including a GRADE assessment of the certainty of the evidence (CoE). RESULTS: We included 27 studies involving a total of 4,656 participants. Serenoa repens results in little to no difference in urologic symptoms at short-term follow-up (International Prostate Symptom Score [IPSS]: mean difference [MD] -0.90, 95% confidence interval [CI] -1.74 to -0.07; I²=68%; 9 studies, 1,681 participants; high CoE). Serenoa repens results in little to no difference in the quality of life at short-term follow-up (high CoE). Serenoa repens probably results in little to no difference in adverse events (moderate CoE). Different phytotherapeutic agents that include Serenoa repens may result in little to no difference in urologic symptoms compared to placebo at short-term follow-up (IPSS: MD -2.41, 95% CI -4.54 to -0.29; I²=67%; 4 studies, 460 participants; low CoE). We are very uncertain about the effects of these agents on quality of life (very low CoE). These agents may result in little to no difference in the occurrence of adverse events (low CoE). CONCLUSIONS: Serenoa repens alone provides little to no benefits for men with LUTS due to benign prostatic enlargement. There is more uncertainty about the role of Serenoa repens in combination with other phytotherapeutic agents.

Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement.

BACKGROUND: Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH. OBJECTIVES: To assess the effects of Serenoa repens in the treatment of men with LUTS consistent with BPH. SEARCH METHODS: We performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 16 September 2022, with no restrictions on language or publication status. SELECTION CRITERIA: We included randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion at each stage and undertook data extraction and risk of bias assessment and GRADE assessment of the certainty of the evidence. We considered review outcomes measured up to 12 months after randomization as short term, and beyond 12 months as long term. Our main outcomes included urologic symptom scores, quality of life, and adverse events. MAIN RESULTS: For this update, we narrowed the review question to only comparisons with placebo. We included 27 studies (of which 9 were new) involving a total of 4656 participants, 19 studies comparing Serenoa repens with placebo, and 8 studies comparing Serenoa repens in combination with other phytotherapeutic agents versus placebo. Most studies included men aged > 50 (mean age range 52 to 68) with moderate urologic symptoms (International Prostate Symptom Score [IPSS] range 8 to 19). Ten studies were funded by the pharmaceutical industry; two studies were funded by government agencies; and the remaining studies did not specify funding sources. Serenoa repens versus placebo or no intervention Results for this comparison are based on predefined sensitivity analyses limited to studies at low risk of bias. Serenoa repens results in little to no difference in urologic symptoms at short-term follow-up (3 to 6 months; IPSS score range 0 to 35, higher scores indicate worse symptoms; mean difference (MD) -0.90, 95% confidence interval (CI) -1.74 to -0.07; I2 = 68%; 9 studies, 1681 participants; high-certainty evidence). Serenoa repens results in little to no difference in the quality of life at short-term follow-up (3 to 6 months; IPSS quality of life domain range 0 to 6, higher scores indicate worse quality of life; MD -0.20, 95% CI -0.40 to -0.00; I2 = 39%; 5 studies, 1001 participants; high-certainty evidence). Serenoa repens probably results in little to no difference in adverse events (1 to 17 months; risk ratio (RR) 1.01, 95% CI 0.77 to 1.31; I2 = 18%; 12 studies, 2399 participants; moderate-certainty evidence). Based on 164 cases per 1000 men in the placebo group, this corresponds to 2 more (38 fewer to 51 more) per 1000 men in the Serenoa repens group. Serenoa repens results in little to no difference in urologic symptoms at long-term follow-up (12 to 17 months, IPSS score, MD 0.07, 95% CI -0.75 to 0.88; I2 = 34%; 3 studies, 898 participants; high-certainty evidence). Serenoa repens results in little to no difference in quality of life at long-term follow-up (12 to 17 months, IPSS quality of life, MD -0.11, 95% CI -0.41 to 0.19; I2 = 65%; 3 studies, 882 participants; high-certainty evidence). There were no data on long-term adverse events for this comparison. Serenoa repens in combination with other phytotherapy versus placebo or no intervention Different phytotherapeutic agents that include Serenoa repens may result in little to no difference in urologic symptoms compared to placebo at short-term follow-up (12 to 24 weeks, IPSS score, MD -2.41, 95% CI -4.54 to -0.29; I2 = 67%; 4 studies, 460 participants; low-certainty evidence). We are very uncertain about the effects of these agents on quality of life (very low-certainty evidence). These agents may result in little to no difference in the occurrence of adverse events; however, the CIs included substantial benefits and harms (12 to 48 weeks, RR 0.91, 95% CI 0.58 to 1.41; I2 = 0%; 4 studies, 481 participants; low-certainty evidence). Based on 132 cases per 1000 men in the placebo group, this corresponds to 12 fewer (55 fewer to 54 more) per 1000 men in the combined phytotherapeutic agents with Serenoa repens group. AUTHORS' CONCLUSIONS: Serenoa repens alone provides little to no benefits for men with lower urinary tract symptoms due to benign prostatic enlargement. There is more uncertainty about the role of Serenoa repens in combination with other phytotherapeutic agents.

Validity and reliability of the Spanish version of the ACE tool for assessing competencies in evidence-based medicine in medical students.

OBJECTIVE: To translate and culturally adapt the tool 'Assessing Competency in evidence-based medicine (EBM)' (ACE) to Spanish and to implement it in a cohort of medical students for the evaluation of the instrument's psychometric properties. DESIGN: Bilingual translators produced a translation and backtranslation of the original instrument, with interim consensus in each stage with oversight and input by a group of experts. We then performed cognitive interviews to adapt the wording of the tool culturally. Finally, we implemented the final version in a cohort of medical students on a virtual general practice course with EBM modules. SETTING: Medical School in Buenos Aires, Argentina. Due to restrictions to in-person teaching during the COVID-19 pandemic, we conducted this study in the context of virtual learning. PARTICIPANTS: We included 125 fourth and fifth-year medical students. MAIN OUTCOME MEASURES: We measured internal consistency with the Kuder-Richardson coefficient (>0.6 as a threshold for reliability) and construct validity through a Pearson's correlation between the examinations carried out with the translated instrument and the results of the regular examinations of EBM in the same students (expected values of at least 0.3 to 0.7). We also compared the total score of the instrument of fifth-year students to fourth-year students. RESULTS: As for measurements for internal consistency, the coefficient Kuder-Richardson resulted in a value of 0.268, below our prespecified threshold. For construct validity, the Pearson correlation between the sum of the items and regular examinations was 0.139, also below our prespecified threshold. However, fifth-year students averaged 0.94 points more than fourth-year students (95% CI 0.24 more to 1.65 more). CONCLUSION: The translated and cross-culturally adapted version of the ACE tool into Spanish had low reliability and validity in an MBE course taught and evaluated in a virtual environment. TRIAL REGISTRATION: Not applicable.

Short and Long-Term Wellbeing of Children following SARS-CoV-2 Infection: A Systematic Review.

Post-COVID conditions in children and adolescents were mostly investigated as the incidence of individual or clusters of symptoms. We aimed to describe the findings of studies assessing key outcomes related to global wellbeing and recovery in children and adolescents from a public health perspective. We searched the Cochrane COVID-19 Study Register and WHO COVID-19 Global literature on coronavirus disease database on 5 November 2021 and tracked ongoing studies published after this date. We included observational studies on children and adolescents with a follow-up greater than 12 weeks and focused on the outcomes of quality of life, recovery/duration of symptoms, school attendance and resource use/rehabilitation. We assessed their methodological quality, and we prepared a narrative synthesis of the results. We included 21 longitudinal and 4 cross-sectional studies (6 with a control group) with over 68 thousand unvaccinated children and adolescents with mostly asymptomatic or mild disease. Study limitations included convenience sampling, a poor description of their study population and heterogeneous definitions of outcomes. Quality of life was not largely affected in adolescents following COVID-19, but there might be greater impairment in young children and in those with more severe forms of the disease (4 studies). There might also be an impairment in daily activities and increased school absenteeism following COVID-19, but the findings were heterogeneous (5 studies). A total of 22 studies provided highly variable estimates based on heterogeneous definitions of overall persistence of symptoms (recovery), ranging from 0 to 67% at 8-12 weeks and 8 to 51% at 6-12 months. We found limited data on resource use and the need for rehabilitation. One controlled study indicated that the quality of life of infected children and adolescents might not substantially differ from controls. All controlled studies found a higher burden of persistent symptoms in COVID-19 cases compared with test-negative controls or cases of influenza. There is limited evidence on the short and long-term well-being of children following SARS-CoV-2 infection. High-quality longitudinal studies with control groups are needed to describe the outcomes in this population, especially in vaccinated children and those affected by new variants of the virus.

Systematic reviews: Key concepts for health professionals. / Revisiones sistemáticas: conceptos clave para profesionales de la salud.

The exponential growth of currently available evidence has made it necessary to collect, filter, critically appraise, and synthesize biomedical information to keep up to date. In this sense, systematic reviews are a helpful tool and can be reliable sources to assist in evidence-based decision-making. Systematic reviews are defined as secondary research or syntheses of evidence focused on a specific question that -- based on a structured methodology -- make it possible to identify, select, critically appraise, and summarize findings from relevant studies. Systematic reviews have several potential advantages, such as minimizing biases or obtaining more accurate results. The reliability of the evidence presented in systematic reviews is determined, amongst other factors, by the quality of their methodology and the included studies. To conduct a systematic review, a series of steps must be followed: the formulation of a research question using the participants, interventions, comparisons, outcomes (PICO) format; an exhaustive literature search; the selection of relevant studies; the critical appraisal of the data obtained from the included studies; the synthesis of results, often using statistical methods (meta-analysis); and finally, estimating the certainty of the evidence for each outcome. In this methodological note, we will define the basic concepts of systematic reviews, their methods, and their limitations.

El crecimiento exponencial de evidencia disponible actualmente ha hecho necesario recopilar, filtrar, valorar críticamente y sintetizar la información biomédica para mantenerse actualizado. En este sentido, las revisiones sistemáticas constituyen una herramienta útil y pueden ser fuentes confiables para asistir a la toma de decisiones basadas en evidencia. Definimos como revisiones sistemáticas a aquellas investigaciones secundarias o síntesis de evidencia focalizadas en una pregunta específica que, a partir de una metodología estructurada, permiten identificar, seleccionar, valorar críticamente y resumir los hallazgos de estudios relevantes. Las revisiones sistemáticas presentan varias ventajas potenciales, tales como la minimización de sesgos o la obtención de resultados de mayor precisión. La confiabilidad de la evidencia presentada en las revisiones sistemáticas está determinada, entre otros factores, por su calidad metodológica, pero también por la calidad de los estudios incluidos. Para realizar una revisión sistemática, se debe seguir una serie de pasos que incluyen la formulación de una pregunta de investigación a partir del formato PICO; una búsqueda bibliográfica exhaustiva; la selección de los estudios relevantes; la valoración crítica de los datos obtenidos a partir de los estudios incluidos; la síntesis de resultados, a menudo mediante métodos estadísticos (metanálisis); y finalmente una estimación de la certeza de evidencia para cada desenlace. En esta nota metodológica definiremos los conceptos básicos sobre revisiones sistemáticas, sus métodos y sus limitaciones.

Revisiones sistemáticas: conceptos clave para profesionales de la salud / Systematic reviews: Key concepts for health professionals

El crecimiento exponencial de evidencia disponible actualmente ha hecho necesario recopilar, filtrar, valorar críticamente y sintetizar la información biomédica para mantenerse actualizado. En este sentido, las revisiones sistemáticas constituyen una herramienta útil y pueden ser fuentes confiables para asistir a la toma de decisiones basadas en evidencia. Definimos como revisiones sistemáticas a aquellas investigaciones secundarias o síntesis de evidencia focalizadas en una pregunta específica que, a partir de una metodología estructurada, permiten identificar, seleccionar, valorar críticamente y resumir los hallazgos de estudios relevantes. Las revisiones sistemáticas presentan varias ventajas potenciales, tales como la minimización de sesgos o la obtención de resultados de mayor precisión. La confiabilidad de la evidencia presentada en las revisiones sistemáticas está determinada, entre otros factores, por su calidad metodológica, pero también por la calidad de los estudios incluidos. Para realizar una revisión sistemática, se debe seguir una serie de pasos que incluyen la formulación de una pregunta de investigación a partir del formato PICO; una búsqueda bibliográfica exhaustiva; la selección de los estudios relevantes; la valoración crítica de los datos obtenidos a partir de los estudios incluidos; la síntesis de resultados, a menudo mediante métodos estadísticos (metanálisis); y finalmente una estimación de la certeza de evidencia para cada desenlace. En esta nota metodológica definiremos los conceptos básicos sobre revisiones sistemáticas, sus métodos y sus limitaciones.

The exponential growth of currently available evidence has made it necessary to collect, filter, critically appraise, and synthesize biomedical information to keep up to date. In this sense, systematic reviews are a helpful tool and can be reliable sources to assist in evidence-based decision-making. Systematic reviews are defined as secondary research or syntheses of evidence focused on a specific question that -- based on a structured methodology -- make it possible to identify, select, critically appraise, and summarize findings from relevant studies. Systematic reviews have several potential advantages, such as minimizing biases or obtaining more accurate results. The reliability of the evidence presented in systematic reviews is determined, amongst other factors, by the quality of their methodology and the included studies. To conduct a systematic review, a series of steps must be followed: the formulation of a research question using the participants, interventions, comparisons, outcomes (PICO) format; an exhaustive literature search; the selection of relevant studies; the critical appraisal of the data obtained from the included studies; the synthesis of results, often using statistical methods (meta-analysis); and finally, estimating the certainty of the evidence for each outcome. In this methodological note, we will define the basic concepts of systematic reviews, their methods, and their limitations.

Long-Term Health Symptoms and Sequelae Following SARS-CoV-2 Infection: An Evidence Map.

Post-COVID-19 conditions, also known as 'Long-COVID-19', describe a longer and more complex course of illness than acute COVID-19 with no widely accepted uniform case definition. We aimed to map the available evidence on persistent symptoms and sequelae following SARS-CoV-2 in children and adults. We searched the Cochrane COVID-19 Study Register and the WHO COVID-19 Global literature on coronavirus disease database on 5 November 2021. We included longitudinal and cross-sectional studies and we extracted their characteristics, including the type of core outcomes for post-COVID-19 conditions. We included 565 studies (657 records). Most studies were uncontrolled cohort studies. The median follow-up time was 13 weeks (IQR 9 to 24). Only 72% of studies were conducted in high-income countries, 93% included unvaccinated adults with mild-to-critical disease, only 10% included children and adolescents, and less than 5% included children under the age of five. While most studies focused on health symptoms, including respiratory symptoms (71%), neurological symptoms (57%), fatigue (54%), pain (50%), mental functioning (43%), cardiovascular functioning (40%), and post-exertion symptoms (28%), cognitive function (26%), fewer studies assessed other symptoms such as overall recovery (24%), the need for rehabilitation (18%), health-related quality of life (16%), changes in work/occupation and study (10%), or survival related to long-COVID-19 (4%). There is a need for controlled cohort studies with long-term follow-up and a focus on overall recovery, health-related quality of life, and the ability to perform daily tasks. Studies need to be extended to later phases of the pandemic and countries with low resources.

Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement: A systematic review and meta-analysis.

PURPOSE: To assess the effects of Serenoa repens alone or in combination with other phytotherapy compared to placebo in men with LUTS due to benign prostatic enlargement. MATERIALS AND METHODS: Following a registered protocol (CRD42021226655), we searched (December 2020) MEDLINE, CENTRAL, Embase, ClinicalTrials.gov, WHO-ICTRP trials platform and other sources with no restrictions on language, publication date or status. We included randomized controlled trials, and we critically appraised them using the Cochrane Tool for Risk of Bias Assessment (RoB 2). We conducted random-effects meta-analysis when appropriate. The primary outcomes included urinary symptoms score, quality of life, and adverse events. The certainty of the evidence was rated using GRADE. RESULTS: We included 27 trials with 4,853 participants. S. repens results in little to no difference in urinary symptoms, quality of life, and adverse events at short- and long-term follow-up. S. repens combined with other phytotherapy may slightly reduce urinary symptoms at short-term follow-up, but the results are uncertain. The results on quality of life and adverse events are also very uncertain. CONCLUSIONS: S. repens alone may result in no clinical benefits for men with LUTS. There is greater uncertainty in the effects of S. repens in combination with other phytotherapy.

Hipotiroidismo subclínico en mujeres en edad reproductiva y embarazadas / Subclinical hypothyroidism in women of reproductive age and in pregnancy

El hipotiroidismo subclínico suele ser identificado como un cuadro que disminuye la capacidad reproductiva de las mujeresy está asociado a un riesgo aumentado de complicaciones perinatales. A partir de un caso clínico real, revisamos laevidencia disponible y encontramos que existen pruebas que contradicen este conocimiento tradicional sobre el pronósticoy la necesidad de tratamiento de este cuadro. (AU)

Subclinical hypothyroidism is usually identified as a condition that decreases the reproductive capacity of women and isassociated with a higher risk of perinatal complications. From a real clinical case, we review the available evidence andfound that there is evidence that contradicts this traditional knowledge about the prognosis and the need for treatment ofthis condition. (AU)