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1.
J Geriatr Oncol ; 15(3): 101736, 2024 04.
Artigo em Inglês | MEDLINE | ID: mdl-38428186

RESUMO

INTRODUCTION: Frailty, characterized by ageing-related vulnerability, influences outcomes in older adults. Our study aimed to investigate the relationship between frailty and clinical outcomes in older Indian patients with cancer. MATERIALS AND METHODS: Our observational single-centre study, conducted at Tata Memorial Hospital from February 2020 to July 2022, enrolled participants aged 60 years and above with cancer. Frailty was assessed using the Clinical Frailty Scale (CFS), G8, and Vulnerable Elders Survey (VES)-13. The primary objective was to explore the correlation between baseline frailty and overall survival. Statistical analyses include Kaplan-Meier, Cox proportional hazards, and Harrell's C test. RESULTS: A total of 1,177 patients (median age 68, 76.9% male) were evaluated in the geriatric oncology clinic. Common malignancies included lung (40.0%), gastrointestinal (35.8%), urological (11.9%), and head and neck (9.0%), with 56.5% having metastatic disease. Using CFS, G8, and VES-13 scales, 28.5%, 86.4%, and 38.0% were identified as frail, respectively. Median follow-up was 11.6 months, with 43.3% deaths. Patients fit on CFS (CFS 1-2) had a median survival of 28.02 months, pre-frail (CFS 3-4) 13.24 months, and frail (CFS ≥5) 7.79 months (p < 0.001). Abnormal G8 (≤14) and VES-13 (≥3) were associated with significantly lower median survival (p < 0.001). Multivariate analysis confirmed CFS's predictive power for mortality (p < 0.001), with hazard ratios [HRs] for pre-frail at 1.61(95% confidence interval [CI] 1.25 to 2.06) and frail at 2.31 (95%CI 1.74 to 3.05). G8 ≤ 14 had HR 2.00 (95%CI 1.42 to 2.83), and abnormal VES-13 had HR 1.36 (95%CI 1.11-1.67). In the likelihood ratio test, CFS significantly improved the model fit (p < 0.001). Harrell's C index for survival prediction was 0.62 for CFS, 0.54 for G8, and 0.58 for VES-13. DISCUSSION: In conclusion, our study highlights varying frailty prevalence and prognostic implications in older Indian patients with cancer, emphasizing the need for personalized care in oncology for this aging population. We would recommend using CFS as a tool to screen for frailty for older Indian patients with cancer.


Assuntos
Fragilidade , Neoplasias , Humanos , Masculino , Idoso , Feminino , Fragilidade/diagnóstico , Fragilidade/epidemiologia , Neoplasias/terapia , Neoplasias/patologia , Prognóstico , Modelos de Riscos Proporcionais , Inquéritos e Questionários
2.
JCO Clin Cancer Inform ; 7: e2300070, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37976441

RESUMO

PURPOSE: This discussion paper outlines challenges and proposes solutions for successfully implementing prediction models that incorporate patient-reported outcomes (PROs) in cancer practice. METHODS: We organized a full-day multidisciplinary meeting of people with expertise in cancer care delivery, PRO collection, PRO use in prediction modeling, computing, implementation, and decision science. The discussions presented here focused on identifying challenges to the development, implementation and use of prediction models incorporating PROs, and suggesting possible solutions. RESULTS: Specific challenges and solutions were identified across three broad areas. (1) Understanding decision making and implementation: necessitating multidisciplinary collaboration in the early stages and throughout; early stakeholder engagement to define the decision problem and ensure acceptability of PROs in prediction; understanding patient/clinician interpretation of PRO predictions and uncertainty to optimize prediction impact; striving for model integration into existing electronic health records; and early regulatory alignment. (2) Recognizing the limitations to PRO collection and their impact on prediction: incorporating validated, clinically important PROs to maximize model generalizability and clinical engagement; and minimizing missing PRO data (resulting from both structural digital exclusion and time-varying factors) to avoid exacerbating existing inequalities. (3) Statistical and modeling challenges: incorporating statistical methods to address missing data; ensuring predictive modeling recognizes complex causal relationships; and considering temporal and geographic recalibration so that model predictions reflect the relevant population. CONCLUSION: Developing and implementing PRO-based prediction models in cancer care requires extensive multidisciplinary working from the earliest stages, recognition of implementation challenges because of PRO collection and model presentation, and robust statistical methods to manage missing data, causality, and calibration. Prediction models incorporating PROs should be viewed as complex interventions, with their development and impact assessment carried out to reflect this.


Assuntos
Neoplasias , Humanos , Prognóstico , Neoplasias/diagnóstico , Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Atenção à Saúde , Registros Eletrônicos de Saúde
3.
Cancers (Basel) ; 15(19)2023 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-37835476

RESUMO

Cancer is a disease associated with ageing. Managing cancer in older adults may prove challenging owing to pre-existing frailty, comorbidity, and wider holistic needs, as well as the unclear benefits and harms of standard treatment options. With the ongoing advances in oncology and the increasing complexity of treating older adults with cancer, the geriatric oncology field must be a priority for healthcare systems in education, research, and clinical practice. However, geriatric oncology is currently not formally taught in undergraduate education or postgraduate training programmes in the United Kingdom (UK). In this commentary, we outline the landscape of geriatric oncology undergraduate education and postgraduate training for UK doctors. We highlight current challenges and opportunities and provide practical recommendations for better preparing the medical workforce to meet the needs of the growing population of older adults with cancer. This includes key outcomes to be considered for inclusion within undergraduate and postgraduate curricula.

4.
Intern Med J ; 53(4): 540-549, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-34668307

RESUMO

BACKGROUND: There is an absence of clinically relevant epidemiological data in regional Australia pertaining to haematological malignancies. AIM: To determine the incidence and geographical variation of haematological malignancies in North Queensland using a clinically appropriate disease classification. METHODS: Retrospective, observational study of individual patient data records of all adults diagnosed with a haematological malignancy between 2005 and 2014 and residing within The Townsville Hospital Haematology catchment region. We report descriptive summaries, incidence rates and incidence-rate ratios of haematological malignancies by geographic regions. RESULTS: One thousand, five hundred and eighty-one haematological malignancies (69% lymphoid, 31% myeloid) were diagnosed over the 10-year study period. Descriptive data are presented for 58 major subtypes, as per the WHO diagnostic classification of tumours of haemopoietic and lymphoid tissues. The overall median age at diagnosis was 66 years with a male predominance (60%). We demonstrate a temporal increase in the incidence of haematological malignancies over the study period. We observed geographical variations in the age-standardised incidence rates per 100 000 ranging from 0.5 to 233.5. Our data suggest an increased incidence rate ratio for haematological malignancies in some postcodes within the Mackay area compared with other regions. CONCLUSION: The present study successfully reports on the incidence of haematological malignancies in regional Queensland using a clinically meaningful diagnostic classification system and identifies potential geographic hotspots. We advocate for such contemporary, comprehensive and clinically meaningful epidemiological data reporting of blood cancer diagnoses in wider Australia. Such an approach will have significant implications towards developing appropriate data-driven management strategies and public health responses for haematological malignancies.


Assuntos
Neoplasias Hematológicas , Neoplasias , Adulto , Humanos , Masculino , Idoso , Feminino , Estudos Retrospectivos , Queensland/epidemiologia , Neoplasias Hematológicas/epidemiologia , Neoplasias/epidemiologia , Incidência
5.
J Geriatr Oncol ; 13(3): 287-293, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34955446

RESUMO

INTRODUCTION: Research into the optimal management of frail patients with cancer is limited and treatment decision-making in this cohort can be difficult. A number of measures have been developed to assess frailty, but few studies explore the correlation between frailty measures and cancer treatment outcomes. METHODS: This retrospective cohort study is an exploratory analysis of the GO2 randomised controlled trial. GO2 recruited both older and frail younger patients commencing first-line palliative chemotherapy for advanced gastro-oesophageal (aGO) cancer. This analysis aims to explore the correlation between baseline frailty and treatment outcome. Baseline frailty measures were derived from clinical data and included ECOG Performance Status (PS), the GO2 Frailty Score (GO2FS), Geriatric-8 (G8), Cancer and Aging Research Group (CARG) toxicity score and a 'modified' Rockwood Clinical Frailty Scale (mCFS). Novel patient-centred composite measure Overall Treatment Utility (OTU) was the primary endpoint. Ordinal logistic regression was undertaken to give odds ratios for poor vs good/intermediate OTU. Secondary endpoints were progression-free and overall survival. Models were adjusted for age, sex, histology, metastases, Trastuzumab and renal/hepatic function. RESULTS: In GO2, 514 patients were randomised between three chemotherapy dose-levels; all of these patients were assessed for OTU and are included in this analysis. Worse GO2FS, mCFS and G8 scores all had a statistically significant association with poor (vs good/intermediate) OTU, progression and death, which persisted after adjustment. Adjusted odds ratios for poor OTU amongst those with the worst GO2FS and mCFS and best G8 scores were as follows: 1.85 (95% confidence interval [CI] 1.20-2.88) for GO2FS ≥3 ('severely frail'), 1.72 (1.19-2.50) for mCFS 5+ ('frail') and 0.57 (0.32-1.00) for G8 > 14 ('normal'). Worse ECOG PS and CARG scores did not have a statistically significant association with poor OTU/progression/death. CONCLUSION: In this study, frailty identified via GO2FS, mCFS and G8 conveyed a statistically significant increased risk of worse treatment outcome in older and frail younger patients with aGO cancer. Frailty assessment provides information over and above PS and should be integrated alongside routine assessments in research and clinical practice. In the absence of prospective data, frailty measures can be derived retrospectively to build the evidence base around optimal care of frailer patients.


Assuntos
Neoplasias Esofágicas , Fragilidade , Neoplasias Gástricas , Idoso , Neoplasias Esofágicas/tratamento farmacológico , Idoso Fragilizado , Avaliação Geriátrica , Humanos , Estudos Prospectivos , Estudos Retrospectivos , Neoplasias Gástricas/tratamento farmacológico , Resultado do Tratamento
6.
Palliat Med ; 35(1): 59-75, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33118448

RESUMO

BACKGROUND: Opioids are essential medicines. Despite international and national laws permitting availability, opioid access remains inadequate, particularly in South, Southeast, East and Central Asia. AIM: To review evidence of perceptions and experiences of regulatory enablers and barriers to opioid access in South, Southeast, East and Central Asia. DESIGN: Systematic review of post-2000 research according to PRISMA guidelines. Data were subjected to critical interpretive synthesis. International, national and sub-national barriers were organised developing a conceptual framework of opioid availability. DATA SOURCES: PsycINFO, Medline, Embase, The Cochrane Library. CINAHL, Complete and ASSIA from 2000 until 20th May 2019. RESULTS: 21/14097 studies included: quantitative n = 15, qualitative n = 3 and mixed-methods n = 3. Four barrier/enabler themes were developed: Legal, regulatory, socio-political; lack of laws explicitly enabling opioid access, restrictive international controls and clinician prescribing concerns. Opioid availability; limited availability, poor policymaker and clinician education regarding opioid benefits, poor continuity of supply. Opioid Accessibility; medicine costs, distance to prescribing centres. Prescribing; extensive bureaucratic barriers, lack of human resources for prescribing. We present a novel framework of a self-perpetuating model of inadequate opioid provision. The Single Convention on Narcotics provides the context of restrictive laws and negative attitudes amongst policymakers. A consequent lack of prescribers and clinicians' negative attitudes at sub-national levels, results in inadequate access to and use of opioids. Data of inadequate consumption informs annual requirement estimates used by the International Narcotics Control Board to determine future opioid availability. CONCLUSIONS: Regulatory and socio-political actions unintentionally limit opioid access. International and national laws explicitly enabling opioid access are required, to assuage concerns, promote training and appropriate prescribing.


Assuntos
Analgésicos Opioides , Acessibilidade aos Serviços de Saúde , Ásia , Controle de Medicamentos e Entorpecentes , Humanos , Percepção
7.
Blood Adv ; 3(19): 2804-2811, 2019 10 08.
Artigo em Inglês | MEDLINE | ID: mdl-31570492

RESUMO

Management practices in early-stage (I/II) follicular lymphoma (FL) are variable and include radiation (RT), systemic therapy, or combined modality therapy (CMT). There is a paucity of data regarding maintenance rituximab in this cohort. We conducted an international retrospective study of patients with newly diagnosed early-stage FL staged with positron emission tomography (PET)-computed tomography and bone marrow biopsy. Three hundred sixty-five patients (stage I, n = 221), median age 63 years, treated from 2005-2017 were included, with a median follow-up of 45 months. Management included watchful waiting (WW; n = 85) and active treatment (n = 280). The latter consisted of RT alone (n = 171) or systemic therapy (immunochemotherapy [n = 63] or CMT [n = 46]). Forty-nine systemically treated patients received maintenance rituximab; 72.7% of stage I patients received RT alone, compared to 42.6% with stage II (P < .001). Active therapies yielded comparable overall response rates (P = .87). RT alone and systemic therapy without maintenance rituximab yielded similar progression-free survival (PFS) (hazard ratio [HR], 1.32; 95% confidence interval [CI], 0.77-2.34; P = .96). Maintenance rituximab improved PFS (HR, 0.24; 95% CI, 0.095-0.64; P = .017). The incidence of transformation was lower with systemic therapy compared to RT or WW (HR, 0.20; 95% CI, 0.070-0.61; P = .034). Overall survival was similar among all practices, including WW (P = .40). In the largest comparative assessment of management practices in the modern era, variable practices each resulted in similar excellent outcomes. Randomized studies are required to determine the optimal treatment in early-stage FL.


Assuntos
Linfoma Folicular/diagnóstico por imagem , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Austrália , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Resultado do Tratamento
8.
Future Healthc J ; 6(1): 47-51, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31098586

RESUMO

Newly graduated doctors may be expected to conduct ward rounds alone, yet studies exploring this are limited. A regional cross-sectional study was undertaken to explore foundation year 1 doctors' (FY1s) experiences of conducting ward rounds alone; all 289 FY1s on medical rotations in Yorkshire and the Humber Foundation School were invited to participate in an online survey in November 2016. Thirty-four percent (n=98) responded. The majority (62%, n=61) of respondents reported conducting the daily ward round alone (without a more senior doctor present) two or more times a week. However, 56% (n=55) reported that they had never received teaching on ward round conduct and only 7% (n=7) reported feeling prepared for conducting ward rounds alone at the start of their medical rotation. FY1-led ward rounds are a regular occurrence yet training is not commonplace; widespread, early training should be considered to prepare future doctors for their role.

9.
Clin Teach ; 16(6): 610-614, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-30746854

RESUMO

BACKGROUND: Care of the dying patient is an intrinsic part of the role of Foundation Year doctors (FYs). This study aimed to explore FYs' experiences of training and their perceived training needs for their role in care of the dying. Care of the dying patient is an intrinsic part of the role of Foundation Year doctors METHODS: All FYs in one Foundation school were invited to take part in semi-structured group or individual interviews. A total of 8 group interviews and 21 individual interviews were conducted with 47 participants. Interview recordings were transcribed verbatim and framework analysis was undertaken. FINDINGS: Key themes derived from the interviews included FYs' teaching opportunities regarding care of the dying and their learning methods for this subject matter which included learning from experience, observation, simulation, written guidance and supervision. Areas for further training was another key theme and training needs identified included prescribing, communication, recognising dying, documentation, societal perspective and emotional resilience. DISCUSSION: FYs' training experiences in this area vary. This study identifies training needs that can be used to inform both undergraduate and postgraduate curricula.


Assuntos
Educação Médica/métodos , Estudantes de Medicina/psicologia , Assistência Terminal/psicologia , Competência Clínica , Comunicação , Humanos , Entrevistas como Assunto , Aprendizagem , Guias de Prática Clínica como Assunto , Assistência Terminal/métodos , Reino Unido
10.
Clin Teach ; 16(2): 147-151, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-29664168

RESUMO

BACKGROUND: Ward rounds are fundamental to the care of medical inpatients, and newly graduated doctors may be expected to conduct them alone. There are no studies exploring the frequency with which this occurs, however, or how prepared they feel for this task. METHODS: Newly graduated (Foundation Year-1, FY1) doctors in Northern Lincolnshire and Goole (NLaG) National Health Service Foundation Trust were surveyed at the end of their FY1 year. An online survey asked: how often they conducted medical ward rounds alone; how prepared they felt to do so; and how often they considered 13 important aspects of care. An aide-memoire outlining aspects to consider on ward rounds was introduced during induction for a second cohort of FY1s, and the survey was repeated. FINDINGS: In the initial survey (2015), 42% (n = 19) of the 45 FY1s in NLaG responded: 84% (n = 16) reported conducting ward rounds alone twice or more each week, with 5% (n = 1) feeling prepared and 89% (n = 17) feeling unprepared to do so. In the second survey (2016), following the introduction of the aide-memoire, 52% (n = 25) of the 48 FY1s responded: 32% (n = 7) reported feeling prepared with the aide-memoire (a 27% increase from 2015). There was also a statistically significant increase in the frequency with which they reported considering three of 13 important aspects of care: nutrition, mobility and discharge planning. There are no studies exploring the frequency with which newly graduated doctors conduct ward rounds alone DISCUSSION: The FY1s were regularly conducting ward rounds alone, and felt unprepared for this. An aide-memoire is a low-cost intervention with some value in improving preparedness, and could be further developed and used elsewhere.


Assuntos
Corpo Clínico Hospitalar/psicologia , Sistemas de Alerta , Visitas de Preceptoria/organização & administração , Atitude do Pessoal de Saúde , Competência Clínica , Humanos
11.
Aust J Gen Pract ; 47(9): 625-631, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-30244561

RESUMO

BACKGROUND AND OBJECTIVES: Hereditary haemochromatosis is a chronic inherited iron overload disorder that is primarily treated with venesection. The aim of this study was to investigate factors associated with optimal haemochromatosis self-management. METHOD: A national online questionnaire was developed. Questions covered demographics, and individual haemochromatosis history and management. The theory of planned behaviour also guided question development. Two logistic regression models were developed for the binary outcomes of serum ferritin within target range and intention to continue venesection. RESULTS: There were 378 complete responses collected. Questions measuring factors of importance (P = 0.022; odds ratio [OR]: 2.284; 95% confidence interval [CI]: 1.125, 4.637), preventing complications (P = 0.017; OR: 2.967; 95% CI: 1.211, 7.265), feeling involved with doctors' decisions (P = 0.006; OR: 1.482; 95% CI: 1.121, 1.958) and control of iron levels (P <0.001; OR: 1.868; 95% CI: 1.399, 2.493) were positively associated with dependent variables. Significant factors related to having a positive attitude and perceived control over haemochromatosis management. DISCUSSION: A positive attitude and sense of behavioural control contribute to successful self-management. Doctors are in an important position to provide self-management support and education.


Assuntos
Hemocromatose/terapia , Autogestão/métodos , Adolescente , Adulto , Idoso , Austrália , Feminino , Hemocromatose/sangue , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Flebotomia/métodos , Saúde Pública/métodos , Fatores de Risco , Inquéritos e Questionários
12.
Aust J Gen Pract ; 47(1-2): 64-69, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29429306

RESUMO

DISCUSSION: Hereditary haemochromatosis is a common inherited disorder of iron metabolism with avoidable long-term sequalae if it is detected early and managed well. Semi-structured focus group interviews were held in local community libraries. Data were transcribed verbatim, uploaded to NVivo data management software, descriptively coded and thematically analysed. Participants talked about living with haemochromatosis as an individual journey that requires balancing their changing symptoms, treatment and the demands of their daily life. Data analysis revealed four major themes: 'Discovering my haemochromatosis', 'Talking about venesection', 'Managing with diet', and 'Living with haemochromatosis'. People living with haemochromatosis had a positive attitude to the condition, but there were individual variations in the ways they engaged in self-management. A doctor–patient partnership is crucial in the management of haemochromatosis, especially in rural areas. Patients' symptom experiences and self­management decisions need to be seriously considered.

 
.


Assuntos
Hemocromatose/diagnóstico , Autogestão/métodos , Adulto , Idoso , Austrália , Diagnóstico Tardio , Feminino , Grupos Focais , Hemocromatose/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa
13.
Med Educ ; 51(10): 1025-1036, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28744956

RESUMO

CONTEXT: Foundation Year doctors (FYs), who are newly qualified, are expected to provide care for dying patients. Experiences at this early mandatory stage of training may form the foundation for future encounters, but little is documented about what these experiences involve. The aim of this research was to explore the experiences of FYs in caring for the dying, using the recently published Priorities for Care of the Dying Person as a conceptual framework, to identify areas for improvement in education and clinical practice. METHODS: Semi-structured group and individual interviews were conducted to explore the experiences of FYs and how these relate to the five aspects of Priorities for Care of the Dying Person: 'recognise', 'communicate', 'involve', 'support' and 'plan and do'. All FYs in the North Yorkshire and East Coast Foundation School (n=335) were invited to participate and 47 FYs were recruited from five sites through convenience sampling and snowballing. Recordings were transcribed verbatim and a framework analysis approach was used with the published Priorities for Care of the Dying Person guidelines as a conceptual framework. RESULTS: Five main themes and 13 subthemes emerged from the data. The five main themes, which mapped to the conceptual framework, were: recognition that the patient is dying; communication with the patient, family and other staff; involvement of the patient and family in their care; support for the dying person and their family; and planning and carrying out good care of the dying. Examples of when things are done poorly or done well were shared, giving context to experience. CONCLUSIONS: Areas for improvement were identified around all five main themes. These will be useful for informing those involved in undergraduate and foundation training on how to improve the experiences of Foundation Year doctors and thereby improve patient care.


Assuntos
Comunicação , Médicos/psicologia , Competência Profissional , Assistência Terminal , Adulto , Feminino , Humanos , Masculino , Pacientes , Exame Físico , Relações Médico-Paciente , Relações Profissional-Família , Pesquisa Qualitativa
14.
Curr Opin Obstet Gynecol ; 29(4): 218-224, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28537948

RESUMO

PURPOSE OF REVIEW: To describe the current data regarding effectiveness, complications, postoperative evaluation, and surgical interventions associated with Essure hysteroscopic sterilization. RECENT FINDINGS: Hysteroscopic sterilization is a commonly performed procedure that is offered as a well tolerated, effective, outpatient method of permanent sterilization. Over the past several years, concerns have been raised regarding correct placement and postoperative complications. This has led to statements by both the Food and Drug Administration (FDA) in October, 2016 and American Association of Gynecologic Laparoscopists in February, 2017, as a significant portion of women seek removal of these devices. A current black-box warning issued by the FDA in 2016 recommends discussion of 'the probabilities of rates or events' of adverse outcomes associated with Essure placement. SUMMARY: Although hysteroscopic sterilization is usually a safe, effective option for permanent contraception, new evidence regarding complications has emphasized the need for proper education and counseling. Appropriate patient selection and knowledge of potential complications is paramount to ensuring patients, and medical providers are well informed and have realistic expectations regarding potential placement and postoperative issues.


Assuntos
Histeroscopia/métodos , Esterilização Reprodutiva/métodos , Esterilização Tubária/métodos , Anticoncepção/efeitos adversos , Feminino , Humanos , Histeroscopia/efeitos adversos , Dispositivos Intrauterinos/efeitos adversos , Laparoscopia , Educação de Pacientes como Assunto , Seleção de Pacientes , Complicações Pós-Operatórias , Gravidez , Fatores de Risco , Sociedades Médicas , Esterilização Reprodutiva/efeitos adversos , Esterilização Tubária/efeitos adversos , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration
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