The every woman study™ low- and middle-income countries edition protocol: A multi-country observational study to assess opportunities and challenges to improving survival and quality of life for women with ovarian cancer.

BACKGROUND: Ovarian cancer is a challenging disease to diagnose and treat effectively with five-year survival rates below 50%. Previous patient experience research in high-income countries highlighted common challenges and opportunities to improve survival and quality of life for women affected by ovarian cancer. However, no comparable data exist for low-and middle-income countries, where 70% of women with the disease live. This study aims to address this evidence gap. METHODS: This is an observational multi-country study set in low- and middle-income countries. We aim to recruit over 2000 women diagnosed with ovarian cancer across multiple hospitals in 24 countries in Asia, Africa and South America. Country sample sizes have been calculated (n = 70-96 participants /country), taking account of varying national five-year disease prevalence rates. Women within five years of their diagnosis, who are in contact with participating hospitals, are invited to take part in the study. A questionnaire has been adapted from a tool previously used in high-income countries. It comprises 57 multiple choice and two open-ended questions designed to collect information on demographics, women's knowledge of ovarian cancer, route to diagnosis, access to treatments, surgery and genetic testing, support needs, the impact of the disease on women and their families, and their priorities for action. The questionnaire has been designed in English, translated into local languages and tested according to local ethics requirements. Questionnaires will be administered by a trained member of the clinical team. CONCLUSION: This study will inform further research, advocacy, and action in low- and middle-income countries based on tailored approaches to the national, regional and global challenges and opportunities. In addition, participating countries can choose to repeat the study to track progress and the protocol can be adapted for other countries and other diseases.

Neoadjuvant chemotherapy in pregnant patients with cervical cancer: a Latin-American multicenter study.

OBJECTIVE: To describe oncologic and obstetric outcomes in patients diagnosed with cervical cancer during pregnancy who had a successful delivery after neoadjuvant chemotherapy. METHODS: A multicenter retrospective review was conducted in 12 institutions from six Latin American countries, between January 2007 and December 2018. Data collected included clinical characteristics, neoadjuvant chemotherapy agents, treatment, obstetric and oncologic outcomes. RESULTS: Thirty-three patients were included. Median age was 34 years (range 31-36). Twenty (60.6%) women were diagnosed at early stage (IB), and 13 (39.4%) with locally advanced stage (IIA-IIIB) according to FIGO 2009 classification. Carboplatin and paclitaxel was the most frequent combination used (60.6%). Partial and complete response rates were 27.3% and 9.1%, respectively. Median gestational age at delivery was 35 weeks (range 34-36). All patients had live births delivered by cesarean section. Obstetric pathology: pre-term labor, placenta percreta or intra-uterine growth restriction, was documented in seven patients (21.2%). Two (6.1%) neonates had low birth weight. Definitive treatment was primary chemo-radiation in 19 (57.6%) patients, radical hysterectomy in 11 (33.3%), abandoned radical hysterectomy with para-aortic lymphadenectomy and ovarian transposition in 1 patient (3.0%), and no further treatment in 2 (6.1%) patients. After a median follow-up of 16.3 months (range 2.0-36.9), 8 (26.7%) patients had recurrent disease. Of these, four (13.3%) died due to disease. CONCLUSION: Neoadjuvant chemotherapy may be offered to patients wishing to preserve an ongoing pregnancy in order to achieve fetal maturity. Long-term consequences of chemotherapy in the child are yet to be determined.

Alternative management for gynecological cancer care during the COVID-2019 pandemic: A Latin American survey.

OBJECTIVE: To determine the acceptance rate of treatment alternatives for women with either preinvasive conditions or gynecologic cancers during the COVID-19 pandemic among Latin American gynecological cancer specialists. METHODS: Twelve experts in gynecological cancer designed an electronic survey, according to recommendations from international societies, using an online platform. The survey included 22 questions on five topics: consultation care, preinvasive cervical pathology, and cervical, ovarian, and endometrial cancer. The questionnaire was distributed to 1052 specialists in 14 Latin American countries. A descriptive analysis was carried out using statistical software. RESULTS: A total of 610 responses were received, for an overall response rate of 58.0%. Respondents favored offering teleconsultation as triage for post-cancer treatment follow-up (94.6%), neoadjuvant chemotherapy in advanced stage epithelial ovarian cancer (95.6%), and total hysterectomy with bilateral salpingo-oophorectomy and defining adjuvant treatment with histopathological features in early stage endometrial cancer (85.4%). Other questions showed agreement rates of over 64%, except for review of pathology results in person and use of upfront concurrent chemoradiation for early stage cervical cancer (disagreement 56.4% and 58.9%, respectively). CONCLUSION: Latin American specialists accepted some alternative management strategies for gynecological cancer care during the COVID-19 pandemic, which may reflect the region's particularities. The COVID-19 pandemic led Latin American specialists to accept alternative management strategies for gynecological cancer care, especially regarding surgical decisions.

Potential and clinical relevant drug-drug interactions among elderly from nursing homes: a multicentre study in Murcia, Spain.

This study purposes to determine the prevalence of potential and clinical relevant Drug-Drug-Interactions (pDDIs) in institutionalized older adults and to identify the pertinent factors associated. We conduct an observational, multicenter and cross-sectional study during the last quarter of 2010. We selected a sample of 275 subjects (aged ≥ 65 years) from 10 nursing homes of Murcia (Spain) by a two-stage complex sampling. pDDIs were identified using the College of Pharmacists Database. We only considered pDDIs of clinical relevance, and thereafter the relevant factors were identified through uni-level and multi-level regression analyses. A total of 210 pDDIs were identified, 120 of which were considered clinically relevant (57.1%), affecting a total of 70 elderly (25.8%). Eight pharmacological groups made up 70.2% of the clinically relevant pDDIs. More clinically relevant DDIs were found in people suffering several pathologies (OR = 2.3; 95%CI = 1.4-4.5), and also in people who take ten or more drugs daily (OR = 9.6; 95%CI = 4.8-19.1), and people who take anti-inflammatory drugs (OR = 3.9; 95%CI = 1.4-10.4). This study reveals that clinically relevant pDDIs are very common in institutionalized elderly people, and that caregivers should aim at improving their practice in order to reduce the prevalence of this phenomenon.

Potential and clinical relevant drug-drug interactions among elderly from nursing homes: a multicentre study in Murcia, Spain / Interações medicamentosas potenciais e clinicamente relevantes em instituições de longa permanência para idosos: um estudo multicêntrico em Murcia, Espanha

Abstract This study purposes to determine the prevalence of potential and clinical relevant Drug-Drug-Interactions (pDDIs) in institutionalized older adults and to identify the pertinent factors associated. We conduct an observational, multicenter and cross-sectional study during the last quarter of 2010. We selected a sample of 275 subjects (aged ≥ 65 years) from 10 nursing homes of Murcia (Spain) by a two-stage complex sampling. pDDIs were identified using the College of Pharmacists Database. We only considered pDDIs of clinical relevance, and thereafter the relevant factors were identified through uni-level and multi-level regression analyses. A total of 210 pDDIs were identified, 120 of which were considered clinically relevant (57.1%), affecting a total of 70 elderly (25.8%). Eight pharmacological groups made up 70.2% of the clinically relevant pDDIs. More clinically relevant DDIs were found in people suffering several pathologies (OR = 2.3; 95%CI = 1.4-4.5), and also in people who take ten or more drugs daily (OR = 9.6; 95%CI = 4.8-19.1), and people who take anti-inflammatory drugs (OR = 3.9; 95%CI = 1.4-10.4). This study reveals that clinically relevant pDDIs are very common in institutionalized elderly people, and that caregivers should aim at improving their practice in order to reduce the prevalence of this phenomenon.

Resumo Este estudo pretende identificar a prevalência de interações medicamentosas potenciais (IMP) em idosos institucionalizados e seus fatores associados. Realizamos um estudo observacional, multicêntrico e transversal, durante o último trimestre de 2010. Selecionamos uma amostra de 275 sujeitos (≥ 65 anos) de 10 instituições para idosos de Murcia (Espanha) mediante amostragem aleatória complexa em duas etapas. As IMP foram identificadas usando a base de dados do College of Pharmacists. Estimamos a prevalência de IMP de relevância clínica e analisamos os fatores associados com análise de regressão uni e multinível. Identificamos 210 IMP, das quais 120 foram consideradas clinicamente relevantes (57,1%) e afetaram 70 idosos (25,8%). Oito grupos farmacológicos constituíram 70,2% das IMP clinicamente relevantes. A prevalência de IMP esteve associada à multimorbidade (OR = 2,3; IC 95% = 1,4-4,5) e tomar dez ou mais medicamentos diariamente (OR = 9,6; IC95% = 4,8-19,1) e uso de medicamentos anti-inflamatórios (OR = 3,9; IC 95% = 1,4-10,4). Este estudo revela que as IMP clinicamente relevantes são muito comuns em idosos institucionalizados e que os serviços devem melhorar seus processos para reduzir a prevalência deste fenômeno.

Fluoxetine for motor recovery after acute intracerebral hemorrhage (FMRICH): study protocol for a randomized, double-blind, placebo-controlled, multicenter trial.

BACKGROUND: Spontaneous, nontraumatic intracerebral hemorrhage (ICH) is a subtype of stroke that causes a great amount of disability and economic and social burden. This is particularly true in developing countries where it accounts for between 20% and 50% of all strokes. Pharmacological and surgical interventions have been attempted to reduce the mortality and disability caused by ICH, with unsuccessful results. Recently, the use of fluoxetine in addition to physical rehabilitation has been proven useful to improve motor recovery following cerebral infarct. The purpose of this study is to test whether a 3-month treatment with fluoxetine enhances motor recovery in nondepressed patients with acute intracerebral hemorrhage. METHODS/DESIGN: Our study is a randomized, double-blind, placebo-controlled, multicenter clinical trial. We will recruit 86 patients with intracerebral hemorrhage of both sexes, aged >18 years, from four Mexican hospitals. The patients will receive either 20 mg of fluoxetine or a placebo once daily for 90 days. The primary outcome is the mean change in the Fugl-Meyer Motor Scale score between inclusion (day 0) and day 90. The secondary outcomes will be changes in the Barthel Index, the Modified Rankin scale and the National Institutes of Health stroke scale. The outcomes will be measured at day 42 ± 7 days and at day 90, for a total of four visits with each subject (at screening and at 0, 42 and 90 days). DISCUSSION: Current guidelines recommend early supported hospital discharge and home-based rehabilitation programs as the only cost-effective intervention to aid the recovery of patients with intracerebral hemorrhage. Nevertheless, such interventions are dependent on available resources and funding, which make them very difficult to implement in developing countries. We believe that the identification of a helpful pharmacological intervention to aid the motor recovery of these patients will constitute a breakthrough that will have a major impact in reducing the burden of disease caused by this subtype of stroke worldwide, especially in the developing world. TRIAL REGISTRATION: Current Controlled Trials NCT01737541.

Decreased transfusion requirements in patients given stem cell allografts using a non-myeloablative conditioning regimen: a single institution experience.

We report our experience of allogeneic peripheral blood stem cell transplantation using non-myeloablative conditioning regimens delivered and supported on an outpatient basis. A group of 44 patients underwent 47 allograft procedures using peripheral blood stem cells. Approximately one third of the individuals did not require red blood cells transfusions: the median of transfused red blood cells units was 1 (range 0-10). In addition one out of three did not require platelet transfusions either, the median of platelet transfusions being 1 (range 0-6). In fourteen allografts (30%) neither red blood cells nor platelet transfusions were used. An inverse correlation was found between the number of CD34 cells infused and the PRBC and PLT transfusion requirements, those patients receiving high numbers of CD34 cells needing fewer transfusions of both PRBC and platelets. The possibility of conducting allografts without transfusion of blood products in some patients may result in a decrease in both cost and the risks stemming from exposure to human blood derivatives.