Research integrity in randomized clinical trials: A scoping umbrella review.

BACKGROUND: Randomized clinical trials (RCTs) are experiencing a crisis of confidence in their trustworthiness. Although a comprehensive literature search yielded several reviews on RCT integrity, an overarching overview is lacking. OBJECTIVES: The authors undertook a scoping umbrella review of the research integrity literature concerning RCTs. SEARCH STRATEGY AND SELECTION CRITERIA: Following prospective registration (https://osf.io/3ursn), two reviewers independently searched PubMed, Scopus, The Cochrane Library, and Google Scholar, without language or time restrictions, until November 2021. The authors included systematic reviews covering any aspect of research integrity throughout the RCT lifecycle. DATA COLLECTION AND ANALYSIS: The authors assessed methodological quality using a modified AMSTAR 2 (A Measurement Tool to Assess Systematic Reviews) tool and collated the main findings. MAIN RESULTS: A total of 55 relevant reviews, summarizing 6001 studies (median per review, 63; range, 8-1106) from 1964 to 2021, had an overall critically low quality of 96% (53 reviews). Topics covered included general aspects (15%), design and approval (22%), conduct and monitoring (11%), reporting (38%), postpublication concerns (2%), and future research (13%). The most common integrity issues covered were ethics (18%) and transparency (18%). CONCLUSIONS: Low-quality reviews identified various integrity issues across the RCT lifecycle, emphasizing the importance of high ethical standards and professionalism while highlighting gaps in the integrity landscape. Multistakeholder consensus is needed to develop specific RCT integrity standards.

Decision Aids for Decision Making about Locally Advance Breast Cancer: A Systematic Review.

Locally advanced breast cancer (LABC) is a subset of breast cancer with locoregional progression without distant metastasis. The multimodality treatment (surgery, chemotherapy, radiotherapy, hormonal and targeted therapy if required) could significantly improve results in this specific group of patients. The complex and multiple options of treatment with similar mortality rates but different outcomes depending on the patient's desires, preferences and social environment require aid to facilitate the individual patient's decisions (e.g. Decision Aids (DAs) targeting patients considering primary or adjuvant treatment in LABC). In this context, DAs have been proven fundamental to help patients and clinicians share and agree on the best value option. The current systematic review aimed to evaluate the existing DAs related to these patients with LABC and identify current status and possible improvement areas (possible scarcity and heterogeneity of instruments, the status of their development, explanation of their purpose,…). No previous systematic reviews have been published on this topic. Following Prospero registration no: CRD42021286173, studies about LABC DAs were identified, without data or language restrictions, through a systematic search of bibliographic databases in December 2021. Quality was assessed using Qualsyst criteria (range 0.0-1.0). The quality of the 17 selected studies ranged from 0.46 to 0.95. Of them, 14/17 (82%) were DAs about treatment, only one (6%) about diagnosis, and 2/17 (12%) about the employment of DAs. No screening or follow-up DAs were retrieved. Twelve (70.6%) DAs were online tools. They varied broadly regarding their characteristics and purposes. Most of the studies focused on developing and testing different DAs (5/17; 29.4%) and their impact (7/17; 41.2%). Only 4/17 (23.5%) analysed their implementation and cost. These instruments have proven to improve patient's knowledge and decision-making, decrease patient anxiety, and patients tend to undergo treatment. However, nowadays, there is still a need for further research and consensus on methodology to develop practical DAs.

Clinical practice guidelines and consensus for the screening of breast cancer: A systematic appraisal of their quality and reporting.

INTRODUCTION: Clinical practice guidelines (CPGs) and consensus statements (CSs) are being promoted to provide high-quality healthcare guidance. This systematic review has assessed the breast cancer (BC) screening CPGs and CSs quality and reporting. METHODS: A search of bibliographic databases (MEDLINE, Embase, Web of Science, Scopus and CDSR), 12 guideline databases and 51 professional society websites was performed without language restrictions from January 2017 to June 2020, following prospective registration (Prospero no.: CRD42020203807). AGREE II (% of maximum score) and RIGHT (% of total 35 items) appraised quality and reporting individually, extracting data in duplicate; reviewer agreement was 98% and 93%, respectively. RESULTS: Forty guidances with median overall quality and reporting 51% (interquartile range [IQR] 39-63) and 48% (IQR 35-65), respectively. Twenty-two (55%) and 20 (50%) did not reach the minimum standards (scores <50%). The guidances that deployed systematic reviews had better quality (74.2% vs. 46.9%; p = 0.001) and reporting (80.5% vs. 42.6%; p = 0.001). Guidances reporting a tool referral scored better (AGREE II: 72.8% vs. 43.1%, p = 0.002; RIGHT: 75.0% vs. 46.9%, p = 0.004). CONCLUSION: BC screening CPGs and CSs suffered poor quality and reporting. More than half did not reach the minimum standards. They would improve if systematic reviews were used to underpin the recommendations made.

Encuesta sobre el uso de la toma de decisiones compartida en el tratamiento del cáncer de mama de los profesionales involucrados en el manejo del cáncer de mama en Argentina / Survey on the use of shared decision-making in the treatment of breast cancer by professionals involved in the management of breast cancer in Argentina

Introducción: La toma de decisiones compartida (TDC) es un proceso colaborativo que involucra al paciente y al profesional para llegar a una decisión conjunta sobre su atención. Objetivos: Evaluar el conocimiento, la actitud y la aplicación de la TDC entre los profesionales de la salud involucrados en el tratamiento del cáncer de mama (CM). Material y método: Estudio transversal basado en un cuestionario online ad hoc envia- do por varias sociedades profesionales relacionadas con el CM. Este evaluó el grado de conocimiento, actitud, aptitud y uso de la TDC por los profesionales implicados en el manejo del CM. Resultados: La mayoría refirieron conocer los conceptos y los fundamentos sobre la TDC, sin embargo, fueron pocos los profesionales (<30%) que usan la TDC en práctica clínica habitual. Los mastólogos y los profesiona- les que trabajan en Unidades de Mastología refirieron tener mayor conocimiento sobre los fundamentos de la TDC (85.6% vs 76.4%; p < 0.05) y tener más experiencia en su utilización (34.4 vs 24.3; p<0.05). Las principales ventajas destacadas fueron la satisfacción del pacien- te, la mejora en la relación médico-paciente y la reducción del estrés del paciente al ayudarlo a comprender su enfermedad. En cuanto a los obstáculos, destacó la falta de apoyo institucional, la falta de recursos y la falta tiempo en la consulta. Todos los encuestados coin- cidieron que la TDC es una herramienta necesaria para proporcionar una asistencia medica de alta calidad. Conclusiones: Se deben diseñar nuevas políticas para la adecuada formación de los profesionales en la integración de la TDC en la práctica clínica, preparándolos para utilizar la TDC con los recursos y el tiempo adecuados.

Introduction: Shared decision making (SDM) is a collaborative process that involves the patient and the professional to reach a joint decision about care. Objetives: To evaluate the knowledge, attitude and application of SDM among health professionals involved in the treatment of breast cancer (BC). Material and method: Cross-sectional study based on an ad hoc online questionnaire sent by various professional societies to professionals involved in the management of BC. A questionnaire was developed to evaluate the degree of knowledge, attitude, aptitude and use of SDM by the parti- cipating professionals. Results: Most reported knowing the concepts and fundamentals of SDM; however, few professionals (<30%) use SDM in routine clinical prac- tice. Mastologists and professionals who work in Mastology Units reported having greater knowledge about the fundamentals of SDM (85.6% vs 76.4%; p <0.05) and having more experience in its use (34.4 vs 24.3; p <0.05). The main advantages highlighted were patient sa- tisfaction, improved doctor-patient relationship, and reduced patient stress by helping them understand their illness. Regarding the obs- tacles, he highlighted the lack of institutional support, resources and time in the consultation. All respondents agreed that SDM is a neces- sary tool to provide high-quality medical care. Conclusions: New policies should be designed for the adequate training of profes- sionals in integrating SDM in clinical practice, preparing them to use SDM with adequate resources and time.

Valor pronóstico de la baja expresión del receptor de estrógeno en pacientes con cáncer de mama LUMINAL HER2 negativo / Prognostic value of low estrogen receptor expression in patients with luminal HER2-negative breast cancer

Introducción: El subtipo luminal de cáncer de mama es sensible a la terapia antiestrógenica y muestra un mejor pronóstico que el del cáncer de mama con receptor del factor de crecimiento epidérmico humano 2 enriquecido (HER2) o triple negativo. Sin embargo, el cáncer de mama tipo luminal es heterogéneo y puede tener características clínicas agresivas. Investigamos las implicaciones clínicas y pronósticas de la baja expresión del receptor de estrógeno en un grupo de carcinomas luminales HER2 negativos. Material y método: Recolectamos los datos de un grupo de 367 cánceres de mama luminales HER2 negativo que eran receptor de estrógeno (RE) positivos y receptor de progesterona (RP) positivos o negativos y los dividimos en RE+ alto (RE) y RE+ bajo (REB). Se definió REB de acuerdo a la úl- tima actualización ASCO /CAP de las recomendaciones del testeo de de RH en cáncer de mama como aquellos con expresión entre 1 y 10%. Analizamos los datos clínico-patológicos y la supervivencia según los grupos de RE y REB. Resultados: Edad media 63,9+12.8 años. Tamaño tumoral: 1,9 +0.9 cm. Se realizó Mastectomía radical modificada en 61% de los pacientes. Tipo histológico más frecuente: Ductal Infiltrante en 89,5% de los casos. Hallazgos que concuerdan con publicaciones de otros centros. Discusión: Los tumores REB resultaron en 1,6%. No hubo diferencias estadísticas en el estadio TNM y tipo histológico. Sin embargo, el grupo REB se asoció con menor edad (47 vs 57 años), tipo luminal B, mayor grado histológico y Ki 67 alto (>30%). Si bien las diferencias en supervivencia global (SG) no fueron significativas (p=0,279), observamos que a partir de los 60 meses de seguimiento la SG fue menor en el grupo REB que en el grupo RE. Conclusiones: La baja expresión del RE se asoció peor pronóstico. Podríamos considerar la baja expresión del RE como marcador pronóstico en el subtipo luminal HER2 negativo de cáncer de mama. Debido a la baja incidencia de casos REB consideramos necesario estudios adicionales con mayor número de pacientes que podrían revelar su papel negativo en el cáncer de mama.

Introduction: The luminal subtype of breast cancer is sensitive to antiestrogenic therapy and shows a better prognosis than human epidermal grow- th factor receptor 2 (HER2) enriched or triple negative breast cancer. However, luminal type breast cancer is heterogeneous and can have aggressive clinical features. We investigated the clinical and prognostic implications of low estrogen receptor expression in a group of HER2-negative luminal carcinomas. Material and method: We collected data from a group of 367 HER2 negative luminal breast cancers that were estrogen receptor (ER) positive and progesterone receptor (PR) positive or negative and divided them into ER + high (ER) and ER + low (ERL). ERL was defined when RE expression was < 10%. We analyzed the clinical-pathological data and survival accor- ding to the ER and ERL groups. Results: ERL tumors resulted in 1.6%. There were no statistical differences in TNM stage and histological type. However, the ERL group was as- sociated with younger age (47 vs 57 years), luminal type B, higher histological grade, and high Ki 67 (> 30% ). Although the differences in overall survival (OS) were not significant (p = 0.279), we observed that after 60 months of follow-up the OS was lower in the ERL group than in the ER group. Conclusions: Low ER expression was associated with a worse prognosis. We could consider low ER expression as a prognostic marker in the HER2-ne- gative luminal subtype of breast cancer. Due to the low incidence of ERL cases, we consider necessary additional studies with a larger number of patients that could reveal its negative role in breast cancer.

Shared decision making in breast cancer screening guidelines: a systematic review of their quality and reporting.

BACKGROUND: Shared decision making (SDM) is a key component of evidence-based and patient-centred care. The aim of this study is to systematically review the quality of SDM proposals in clinical practice guidelines (CPGs) and consensus statements (CSs) concerning breast cancer (BC) screening. METHODS: Guidances were identified, without language restrictions, using a prospectively planned systematic search (MEDLINE, EMBASE, Web of Science, Scopus and guideline websites) from January 2010 to August 2020. Duplicate data extraction used a 31-item SDM quality assessment tool; reviewer agreement was 98%. RESULTS: SDM appeared only in 38 (49.4%) (33/68 CPGs, 4/9 CSs) documents (overall compliance with the quality tool: mean 5.74, IQR 3-8). CPGs and CSs specifically mentioning the term SDM (n = 12) had higher quality (mean 6.8, IQR 4-9 vs. mean 2.1, IQR 0-3; P = 0.001). No differences were found in mean quality comparing CPGs with CSs (3 vs. 1.6; P = 0.634), use of systematic review (4.2 vs. 2.9; P = 0.929) and publication in a journal (4 vs. 1.9; P = 0.094). Guidances with SDM were more recently reported than those without it (mean 41 vs. 57 months; P = 0.042). CONCLUSION: More than half of all the guidelines did not meet SDM quality criteria. Those that explored it were more recently reported. There is an urgent need for promoting SDM in guidances concerning BC screening issued by institutions, professional associations and medical journals.

Evaluation of the Use of Shared Decision Making in Breast Cancer: International Survey.

OBJECTIVES: To assess shared decision-making (SDM) knowledge, attitude and application among health professionals involved in breast cancer (BC) treatment. MATERIALS AND METHODS: A cross-sectional study based on an online questionnaire, sent by several professional societies to health professionals involved in BC management. There were 26 questions which combined demographic and professional data with some items measured on a Likert-type scale. RESULTS: The participation (459/541; 84.84%) and completion (443/459; 96.51%) rates were high. Participants strongly agreed or agreed in 69.57% (16/23) of their responses. The majority stated that they knew of SDM (mean 4.43 (4.36-4.55)) and were in favour of its implementation (mean 4.58 (4.51-4.64)). They highlighted that SDM practice was not adequate due to lack of resources (3.46 (3.37-3.55)) and agreed on policies that improved its implementation (3.96 (3.88-4.04)). The main advantage of SDM for participants was patient satisfaction (38%), and the main disadvantage was the patients' paucity of knowledge to understand their disease (24%). The main obstacle indicated was the lack of time and resources (40%). CONCLUSIONS: New policies must be designed for adequate training of professionals in integrating SDM in clinical practice, preparing them to use SDM with adequate resources and time provided.

Correlación entre características clinicopatológicas e inmunohistoquímicas del cáncer de mama en mujeres argentinas / Correlation between clinicopathological and immunohistochemical characteristics of breast cancer in Argentine women

Introducción: El cáncer de mama se clasifica en 4 subgrupos moleculares de tumores. Estos factores biológicos junto al grado histológico, han tomado importancia en la nueva clasificación TNM ya que permite establecer pronósticos de sobrevida. Objetivo: Analizar la correlación entre los distintos subtipos moleculares de los carcinomas de mama con factores clínico-patológico, la presencia de metástasis axilares y en la re-estadificación de los tumores según la nueva Clasificación TNM de la AJCC. Material y método: Estudio observacional y descriptivo de series de casos, registrados en Registro de Cáncer de Mama (RCM), en Argentina entre los años 2006 a 2016. Resultados: La mayoría de los tumores fueron Luminales. Los estadios avanzados fueron en edades tempranas. El mayor compromiso axilar perteneció a HER2 neu positivos. Se consiguió re estadificar las pacientes aumentando el número de pacientes con estadios IA y IB y descendiendo los estadios IIA, IIIA, IIIB y IIIC. Conclusiones: De los subtipos moleculares con factores clinicopatológicos más desfavorables fueron los Triples Negativos y Her2 neu. La importancia de los factores biológicos a la hora de re estadificar los pacientes según TNM 8° edición, favorece los tratamientos conservadores y específicos contra el tumor evitando el sobre tratamiento e implican menores costos que las plataformas genómcias.

Introduction: Breast cancer is classified into 4 molecular subgroups. These biological factors, together with the histological grade, are important factors in the 8th edition of the TNM Classification, and allow establishing survival prognoses in patients with breast cancer. Objetive: The main objetive was to analyse the correlation between different molecular subtypes of breast carcinomas, the presence of axillary metastases and the correlation of tumours in the new TNM Classification. Material and method: Observational and descriptive restrospective study of case series registred in RCM, in Argentina between 2006 and 2016. Results: Most of the tumours were Luminals. The clinical presentation of advanced stages was more frequent at early ages. The molecular subtypes with the highest axillary involvement were HER2 neu tumours. We managed to re-stage the patients to the TNM Classification 8th edition, increasing the number of patients with stages IA and IB and decreasing the stage IIA, IIIA, IIIB and IIIC. Conclusions: Triples negative tumours were diagnosed in more advanced stages, according to the new TNM Classification, than the Luminals. The surgical decision was not modified according to the molecular subtype. We conclude the importance of biological factors when re-staging patients according to the new TNM Classification 8th edition because it increases the number of conservative treatments, and more targets treatment.

Quality and reporting of clinical guidelines for breast cancer treatment: A systematic review.

BACKGROUND: High-quality, well-reported clinical practice guidelines (CPGs) and consensus statements (CSs) underpinned by systematic reviews are needed. We appraised the quality and reporting of CPGs and CSs for breast cancer (BC) treatment. METHODS: Following protocol registration (Prospero no: CRD42020164801), CPGs and CSs on BC treatment were identified, without language restrictions, through a systematic search of bibliographic databases (MEDLINE, EMBASE, Web of Science, Scopus, CDSR) and online sources (12 guideline databases and 51 professional society websites) from January 2017 to June 2020. Data were extracted in duplicate assessing overall quality using AGREE II (% of maximum score) and reporting compliance using RIGHT (% of total 35 items); reviewer agreement was 98% and 96% respectively. RESULTS: There were 59 relevant guidance documents (43 CPGs, 16 CSs), of which 20 used systematic reviews for evidence synthesis. The median overall quality was 54.0% (IQR 35.9-74.3) and the median overall reporting compliance was 60.9% (IQR 44.5-84.4). The correlation between quality and reporting was 0.9. Compared to CSs, CPGs had better quality (55.4% vs 44.2%; p = 0.032) and reporting (67.18% vs 44.5%; p = 0.005). Compared to subjective methods of evidence analysis, guidance documents that used systematic reviews had better quality (76.3% vs 51.4%; p = 0.001) and reporting (87.1% vs 59.4%; p = 0.001). CONCLUSION: The quality and reporting of CPGs and CSs in BC treatment were moderately strong. Systematic reviews should be used to improve the quality and reporting of CPGs and CSs.

Shared decision making in breast cancer treatment guidelines: Development of a quality assessment tool and a systematic review.

BACKGROUND: It is not clear whether clinical practice guidelines (CPGs) and consensus statements (CSs) are adequately promoting shared decision making (SDM). OBJECTIVE: To evaluate the recommendations about SDM in CPGs and CSs concerning breast cancer (BC) treatment. SEARCH STRATEGY: Following protocol registration (Prospero no.: CRD42018106643), CPGs and CSs on BC treatment were identified, without language restrictions, through systematic search of bibliographic databases (MEDLINE, EMBASE, Web of Science, Scopus, CDSR) and online sources (12 guideline databases and 51 professional society websites) from January 2010 to December 2019. INCLUSION CRITERIA: CPGs and CSs on BC treatment were selected whether published in a journal or in an online document. DATA EXTRACTION AND SYNTHESIS: A 31-item SDM quality assessment tool was developed and used to extract data in duplicate. MAIN RESULTS: There were 167 relevant CPGs (139) and CSs (28); SDM was reported in only 40% of the studies. SDM was reported more often in recent publications after 2015 (42/101 (41.6 %) vs 46/66 (69.7 %), P = .0003) but less often in medical journal publications (44/101 (43.5 %) vs 17/66 (25.7 %), P = .009). In CPGs and CSs with SDM, only 8/66 (12%) met one-fifth (6 of 31) of the quality items; only 14/66 (8%) provided clear and precise SDM recommendations. DISCUSSION AND CONCLUSIONS: SDM descriptions and recommendations in CPGs and CSs concerning BC treatment need improvement. SDM was more frequently reported in CPGs and CSs in recent years, but surprisingly it was less often covered in medical journals, a feature that needs attention.

Rendimiento de la ecografía axilar en cáncer de mama / Axillary ultrasound performance in breast cancer

Objetivo El estatus axilar sigue siendo el factor pronóstico más importante en cáncer de mama. Nuestro objetivo fue evaluar el rendimiento diagnóstico de la ecografía axilar para la detección de ganglio metastásico. Material y método Se evaluaron por ecografía axilar preoperatoria 530 pacientes con cáncer de mama menor o igual a 5 cm con axila clínicamente negativa. Se consideró sospechoso, todo ganglio que cumpliera con la clasificación de Bedi 3, 4, 5 y 6. La sospecha se corroboró con biopsia axilar bajo guía ecográfica, biopsia selectiva del ganglio centinela intraoperatorio y/o disección axilar. Resultados Obtuvimos una sensibilidad del 67,11% y una especificidad del 97,88%. Conclusiones El rendimiento diagnóstico de la ecografía axilar preoperatoria en pacientes con cáncer de mama y axila clínicamente negativa es sensible y específica en la detección de ganglio metastásico

Objective Axillary status remains the most important prognostic factor in breast cancer. Our objective was to evaluate the diagnostic performance of axillary ultrasound for the detection of metastatic nodes. Materials and methods 530 patients with breast cancer less than or equal to 5 cm with clinically negative axilla were evaluated by preoperative axillary ultrasound. It was considered suspicion any node that complies with the Bedi classification 3, 4, 5 and 6. The suspicion was corroborated with axillary biopsy under ultrasound guidance, selective biopsy of the intraoperative sentinel node and / or axillary dissection. Results We obtained a sensitivity of 67.11% and a specificity of 97.88%. Conclusions The diagnostic performance of preoperative axillary ultrasound in patients with breast cancer and clinically negative axillary is sensitive and specific in the detection of metastatic nodes

Características clínico-patológicas y de tratamiento en pacientes de edad avanzada con cáncer de mama atendidas en el Policlínico pami I de Rosario / Tumor characteristics and treatment in elderly patients with breast cancer attended at pami I Polyclinic, Rosario

Introducción Las mujeres de edad avanzada con cáncer de mama se encuentran subrepresentadas en la mayoría de los ensayos aleatorizados. Por lo tanto, los datos sobre las características y el tratamiento del cáncer en este subgrupo de pacientes suelen ser inconsistentes. En este estudio retrospectivo, comparamos las características clínico-patológicas y de tratamiento en mujeres ≥70 años vs mujeres más jóvenes. Objetivos El objetivo general del presente estudio es analizar las características tumorales clínicas e histopatológicas y el tratamiento administrado a mujeres posmenopáusicas de edad avanzada con cáncer de mama invasivo, no metastásico, diagnosticadas y tratadas en el Policlínico pami I de la ciudad de Rosario durante el periodo comprendido entre el 1 de enero de 2012 y el 31 de diciembre de 2017. Material y método Se analizaron las historias clínicas de 112 mujeres ≥70 años con cáncer de mama invasivo, no metastásico y de 65 mujeres posmenopáusicas de menor edad (49-69 años) atendidas en el Policlínico pami I de la ciudad de Rosario entre enero de 2012 y diciembre de 2017. Resultados Comparadas con las más jóvenes, las pacientes de edad avanzada se presentan con tumores de mayor tamaño al diagnóstico (pT 25 mm vs 18 mm, p=0,007) y sin mayor compromiso axilar (p=0,967). Existe una prevalencia alta de tumores luminales (87,04%) y baja prevalencia de subtipos agresivos (9,3% de tn y 3,7% de her2+), ilv (33,7%) y tumores de alto grado histopronóstico (19,6% GIII). Las mujeres mayores reciben más mastectomías (p=0,018), menos tratamiento adyuvante (p=0,001) y, en casos seleccionados, son pasibles de omitir tratamientos considerados estándar como la cirugía primaria, la bgc y la rdt post cirugía conservadora. No se encontraron diferencias significativas en sobrevida global (p=0,109), sobrevida específica por cáncer de mama (p=0,793) y sobrevida libre de enfermedad (p=0,974) entre ambos grupos. Conclusiones Existe una tendencia a sobretratar quirúrgicamente a las pacientes de edad avanzada y subtratarlas en términos de tratamiento adyuvante. El impacto de esta estrategia terapéutica en la sobrevida de las pacientes debe ser evaluado en estudios prospectivos, a gran escala y con seguimiento prolongado

Introduction Older women with breast cancer are underrepresented in most randomized trials. Therefore, data on the characteristics and treatment of cancer in this subgroup of patients are often inconsistent. In this retrospective study, we compared the clinic pathological and treatment characteristics in women ≥70 years vs younger women. Objectives The general objective of the present study is to analyze the clinical and histopathological tumor characteristics and the treatment administered to postmenopausal elderly women with invasive, non-metastatic breast cancer, diagnosed and treated at the pami I Polyclinic in the city of Rosario during the period between January 1, 2012 and December 31, 2017. Materials and method We analyzed the medical records of 112 women ≥ 70 years with invasive, non-metastatic breast cancer and 65 younger postmenopausal women (49-69 years) attended at the pami I Polyclinic in the city of Rosario from January 2012 to December 2017. Results Compared with the youngest, elderly patients have larger tumors at diagnosis (pT 25 mm vs 18 mm, p=0.007) but no major axillary involvement (p=0.967). There is a high prevalence of luminal tumors (87.04%) and low prevalence of aggressive subtypes (9.3% of tn and 3.7% of her2+), ilv (33.7%) and highgrade histopronostic tumors (19.6% GIII). Older women receive more mastectomies (p=0.018), less adjuvant treatment (p=0.001) and, in selected cases, they are able to omit standard treatments such as primary surgery; bgc and adjuvant rdt post conservative surgery. No significant differences were found in overall survival (p=0.109), specific survival for breast cancer (p=0.793) and disease-free survival (p=0.974). Conclusions There is a trend to over treat surgically elderly patients and under treat them in terms of adjuvant treatment. The impact of this therapeutic strategy on the survival of patients should be evaluated in prospective, large-scale trials and with prolonged follow-up

Barreras y facilitadores en las trayectorias de mujeres con cáncer de mama usuarias de hospitales públicos / Barriers And Facilitators of Health Seeking Behavior Among Women with Breast Cancer Users of Public Hospitals

El cáncer de mama (CM) es el segundo más común en el mundo y el más frecuente entre las mujeres. La incidencia varía entre regiones. Además, el CM es la quinta causa de muerte por cáncer a nivel mundial, la más frecuente en las regiones menos desarrolladas y la segunda en las más desarrolladas y en Sudamérica. En Argentina, registra las mayores tasas de incidencia y mortalidad entre las mujeres. OBJETIVOS: Comprender los motivos de las demoras, las consecuencias y las estrategias usadas por mujeres con diagnóstico de CM para afrontar barreras durante sus trayectorias de atención. MÉTODOS: Se realizó un estudio descriptivo transversal con abordaje cualitativo, basado en mujeres diagnosticadas con CM en dos hospitales públicos de la provincia de Santa Fe. Se efectuaron entrevistas semiestructuradas, que fueron grabadas previo consentimiento informado. Se utilizó el programa Atlas-ti (V.7.2) para el análisis del material. RESULTADOS: Se identificaron barreras a nivel personal (cuestiones financieras, creencias de las pacientes), interpersonal (cuestiones laborales, responsabilidad familiar, comunicación médico-paciente) y del sistema de salud (organización de servicios, calidad de atención). CONCLUSIONES: La investigación aporta evidencia para comprender las barreras que enfrentan las mujeres diagnosticadas con CM y muestra las oportunidades para implementar la estrategia de navegación de pacientes a fin de reducir o mitigar las demoras en la atención

Estudio del complejo aréola-pezón con resonancia magnética y microbobinas / Study of the nipple-areolar complex through magnetic resonance imaging with microcoils

Objetivo. Evaluar la utilidad de la resonancia magnética con microbobina en el estudio del complejo aréola/pezón y su lugar en el algoritmo de exámenes en derrames de significación clínica (telorragia). Pacientes y método. Estudio descriptivo de pacientes con derrames uniporos por pezón utilizando microbobinas disponibles comercialmente en secuencias con y sin contraste en resonador magnético, presentando los hallazgos en reconstrucción tridimensional compartidos con el cirujano y analizando con el patólogo las resecciones quirúrgicas cuando fueron indicadas, en el periodo comprendido entre noviembre de 2013 y marzo de 2015. Resultados. Se estudiaron 25 pacientes. En 15 se encontraron lesiones benignas (6 papilomas centrales, 4 galactoceles, 2 proliferaciones papilares sin atipia, una mastopatía quística, un absceso, un fibroadenoma), y en 9 pacientes (36%), carcinomas en su mayoría con patrones micropapilar y cribiforme. La mayoría de lesiones benignas (papilomas) se asociaron con conductos dilatados con señal hemática o serosa y el defecto de relleno por la proliferación y realzado con el gadolinio. La mayoría de las lesiones malignas presentaron ductos no tan dilatados, con señal hemática principalmente y realces no-masa de anillos conglomerados cuyas reconstrucciones volumétricas los presentaron como «esponjas/corales». Conclusiones. El método se presenta eficaz y efectivo e impulsa a considerarlo como indicación primaria, simple y sencilla, en el estudio de las telorragias y en el examen global del complejo aréola/pezón (AU)

Objective. To evaluate the use of magnetic resonance imaging (MRI) with microcoils in the study of the nipple-areolar complex and its importance in the examination algorithm in cases of clinically significant discharge (thelorrhagia). Patients and method. Descriptive study of a group of patients with single-pore nipple discharge by using commercially available microcoils, with and without contrast, in a magnetic resonator. Three-dimensional reconstruction of the findings, with the very high resolution provided by microcoils, was shared with the surgeon, and surgical resections were analysed with the pathologist, when indicated, from November 2013 to March 2015. Results. Twenty-five patients were included. Of these, benign lesions were found in 15 patients (6 central papillary tumors, 4 galactoceles, 2 papillary proliferations without atypia, 1 cystic mastopathy, 1 abscess, and 1 fibroadenoma). Carcinomas were found in 9 patients (36%), mostly with micro papillary and cribriform patterns. Most nonmalignant lesions (papillary tumours) were associated with dilated ducts, with haematogenous or serous signs and filling defect due to proliferation and gadolinium enhancement. Most malignant lesions showed less dilated vessels, mainly with haematogenous signs and non-mass enhancement of clustered rings whose volume reconstructions showed them as «sponge or corals». Conclusions. The method is simple and effective and could be used as a first line indication for the treatment of thelorrhagia and in the global examination of the nipple-areolar complex (AU)

Accuracy of Onsite Tests to Detect Asymptomatic Bacteriuria in Pregnancy: A Systematic Review and Meta-analysis.

OBJECTIVE: To estimate the accuracy of onsite tests to detect asymptomatic bacteriuria among pregnant women. DATA SOURCES: We searched MEDLINE, EMBASE, Web of Science, Scopus, and Latin-American Literature from inception until June 2015 without language restrictions. The ClinicalTrials.gov register database was screened to identify any recently completed studies. METHODS OF STUDY SELECTION: Two independent reviewers selected studies that recruited asymptomatic pregnant women to evaluate the accuracy of onsite tests in detecting the presence of bacteria in the urine using urine culture as a reference standard. TABULATION, INTEGRATION, AND RESULTS: Women's characteristics, study design, urine sample collection, and handling were extracted along with the test accuracy data. Where possible, we pooled the data using a bivariate, hierarchical random-effects model. Of 1,360 screened references, 27 articles (13,641 women) with test accuracy data on nine tests met the inclusion criteria. The most commonly evaluated test was urine dipstick. The pooled sensitivity and specificity of nitrites detected by dipstick to detect asymptomatic bacteriuria were 0.55 (95% confidence interval [CI] 0.42-0.67) and 0.99 (95% CI 0.98-0.99), respectively. The Griess test to detect nitrites had a sensitivity of 0.65 (95% CI 0.50-0.78) and specificity of 0.99 (95% CI 0.98-1.00). Dipslide with Gram staining had a pooled sensitivity of 0.86 (95% CI 0.80-0.91) and specificity of 0.97 (95% CI 0.93-0.99). CONCLUSION: The specificity of onsite tests is high; however, the sensitivity is not with the result that they will fail to detect a substantial number of cases of asymptomatic bacteriuria. CLINICAL TRIAL REGISTRATION: PROSPERO International prospective register of systematic reviews, http://www.crd.york.ac.uk/PROSPERO/, CRD42015027905.

Demoras en el proceso de atención de pacientes con cáncer de mama en dos hospitales públicos de la provincia de Santa Fe / Delays in the process of care of patients with breast cancer in two public hospitals in the province of Santa Fe

INTRODUCCIÓN: el retraso en el inicio de untratamiento efectivo del cáncer de mama reduce la tasa desupervivencia y está asociado a estadios más avanzados aldiagnóstico y a la necesidad de tratamientos más agresivos ycostosos. OBJETIVOS: Describir la trayectoria de la atención médicade mujeres con diagnóstico de cáncer de mama desde la apariciónde un signo o síntoma hasta la finalización del tratamiento.MÉTODOS: Se realizó un estudio descriptivo retrospectivo, quecombinó técnicas cuantitativas y cualitativas. Se estimaron lostiempos utilizados en cada etapa del proceso de atención de cáncerde mama en mujeres diagnosticadas y/o tratadas durante 2012 endos hospitales de la provincia de Santa Fe. RESULTADOS: Se incluyóa 62 pacientes en la muestra. El 20,3% obtuvo su diagnósticodentro del mes posterior a la mamografía y/o ecografía, y sólola mitad fue operada dentro del mes posterior al diagnóstico. El60% de las pacientes con necesidad de quimioterapia adyuvantey el 72,4% con necesidad de radioterapia tras la cirugía tuvierondemoras mayores a 60 días. Ninguna de las pacientes en estadio IVcomenzó el tratamiento antes de los 30 días. CONCLUSIONES: Si secompara con los parámetros establecidos en la guía del ProgramaNacional de Cáncer de Mama, hay demoras en todas las etapas. Esnecesario establecer estrategias que reduzcan los tiempos para laconfirmación diagnóstica en mujeres con sospecha, así como lostiempos de tratamiento en pacientes con cáncer confirmado.

INTRODUCTION: the delay to start an effectivetreatment for breast cancer reduces survival rate and is associatedto advanced stages at diagnosis and to the need for moreaggressive and costly treatments. OBJECTIVES: To describe thehealth care path of women with diagnosis of breast cancersince the first sign or symptom until the end of the treatment.METHODS: A retrospective descriptive study was performed,combining quantitative and qualitative techniques. It estimatedthe time used in each stage of the health care process amongwomen with breast cancer, diagnosed and/or treated during2012 in two hospitals of the province of Santa Fe, Argentina.RESULTS: A total of 62 patients were included in the sample.Of them, 20.3% received her diagnosis within 30 days of themammogram and/or ultrasound and 50% were operatedwithin one month of the diagnosis. There were delays of morethan 60 days in 60% and 72.4% of the patients who had toundergo adjuvant chemotherapy and radiotherapy, respectively.None of the patients with stage IV began the treatment withinthe first 30 days. CONCLUSIONS: Compared to the guidelinesof the National Program of Breast Cancer, there are delaysat all stages. It is necessary to develop strategies to shortenthe time for diagnosis confirmation in women with suspectedbreast cancer and for the access to treatment in patients withcancer confirmed.

Graphical displays for effective reporting of evidence quality tables in research syntheses.

BACKGROUND: When generating guidelines, quality of the evidence is tabulated to capture its several domains, often using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. We developed a graphic display to capture deficiencies, outliers and similarities across comparisons contained in GRADE tables. METHODS: Based on a systematic literature review capturing the effects of 32 different therapeutic comparisons on dysmenorrhoea, we synthesised evidence quality in tables and graphs. We evaluated time taken to accurately assess evident quality and preference for tables vs. graphs. RESULTS: The plots provided visually striking displays of strengths and weaknesses of the evidence across the spectrum of comparisons on a single page. Equivalent tabulated information spread over 4 pages. Participants preferred and interpreted graphs quicker and more accurately than tables. CONCLUSIONS: The graphic approach we developed makes interpreting evidence easier. Large tables are dry and cumbersome to read and assimilate. When guideline statements are accompanied by these plots, they have the scope for improving the credibility of the recommendations made, as the strength of the evidence used can be clearly seen. Further empirical research will establish the place for graphic displays.

Duration of treatment for asymptomatic bacteriuria during pregnancy.

BACKGROUND: A previous Cochrane systematic review has shown that antibiotic drug treatment of asymptomatic bacteriuria in pregnant women substantially decreases the risk of pyelonephritis and reduces the risk of preterm delivery. However, it is not clear whether single-dose therapy is as effective as longer conventional antibiotic treatment. OBJECTIVES: To assess the effects of different durations of treatment for asymptomatic bacteriuria in pregnancy. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2015) and reference lists of identified articles. SELECTION CRITERIA: Randomized and quasi-randomized trials comparing antimicrobial therapeutic regimens that differed in duration (particularly comparing single dose with longer duration regimens) in pregnant women diagnosed with asymptomatic bacteriuria. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We included 13 studies, involving 1622 women. All were comparisons of single-dose treatment with short-course (four- to seven-day) treatments. The risk of bias of trials included in this review was largely unclear, and most trials were at high risk of performance bias. The quality of the evidence was assessed using the GRADE approach. When the any antibiotic agent was used, the 'no cure' rate for asymptomatic bacteriuria in pregnant women was slightly lower for the short-course treatment over the single-dose treatment, although there was evidence of statistical heterogeneity (average risk ratio (RR) 1.28, 95% confidence interval (CI) 0.87 to 1.88; women = 1502, studies = 13; I² = 56%; very low quality evidence). Data from only good quality trials also showed better cure rates with short (four- to seven-day) regimens of the same microbial agent (average RR 1.72, 95% CI 1.27 to 2.33; women = 803, studies = two; I² = 0%; high quality evidence). There was no clear difference in the recurrence of asymptomatic bacteriuria rate between treatment and control groups, whether the same or different microbial agents were used (RR 1.13, 95% CI 0.77 to 1.66; 445 women studies = eight; I² = 0%; very low quality evidence). Differences were detected for low birthweight babies, favoring a short course (four- to seven-day treatment) of the same microbial agent, although the data come from a single trial (RR 1.65, 95% CI 1.06 to 2.57; 714 women; high quality evidence), but no differences were observed for preterm delivery (RR 1.17, 95% CI 0.77 to 1.78; women = 804; studies = three; I² = 23%; moderate quality) or pyelonephritis (RR 3.09, 95% CI 0.54 to 17.55; women = 102; studies = two; I² = 0%; very low quality evidence). Finally, single-dose treatment of any microbial agent was associated with a decrease in reports of 'any side effects' (RR 0.70, 95% CI 0.56 to 0.88; 1460 women, studies = 12; I² = 9%; low quality evidence). Evidence was downgraded for risk of bias concerns in trials contributing data and for imprecise effect estimates (wide confidence intervals crossing the line of no effect, and in some cases, small studies with few events). AUTHORS' CONCLUSIONS: A single-dose regimen of antibiotics may be less effective than a short-course (four- to seven-day) regimen, but more evidence is needed from large trials measuring important outcomes, such as cure rate. Women with asymptomatic bacteriuria in pregnancy should be treated by the standard regimen of antibiotics until more data become available testing seven-day treatment compared with shorter courses of three- or five-day regimens.