Changing the paradigm of cervical cancer prevention through introduction of HPV-testing: evaluation of the implementation process of the Jujuy Demonstration Project in Argentina.

INTRODUCTION: The Jujuy Demonstration Project (JDP) was a project carried out over the course of 4 years (2011-2014) to develop, implement and evaluate the programmatic components of a Human Papilloma Virus (HPV)-based screening programme in Argentina. The aim of this paper is to present a qualitative evaluation of the context and implementation process of the JDP. METHODS: We used an adaptation of the Health System Framework (HSF), which includes interconnected contextual factors that are considered key drivers for successful health interventions. We reviewed secondary documents, which included scientific reports, norms and regulations, information sheets, power point presentations and manuals and recommendations published by the National Programme for Cervical Cancer Prevention. We also carried out semi-structured interviews with key informants to explore their views about technology acceptability. RESULTS: Key components of the JDP implementation process were: a high level of political support and consensus among stakeholders, the demonstrated effectiveness of the technology and its acceptability by health authorities and providers, the funding of tests and diagnosis/treatment services, the implementation of an information system for monitoring and evaluation and the reorganisation of the network of screening, diagnosis and treatment services. CONCLUSION: This analysis examines the policy context in which the JDP was implemented and the system components that were key for the demonstrated effectiveness of the strategy. Such analyses provide useful insights into core components of HPV testing implementation that are needed to guarantee its potential effectiveness to reduce cervical cancer incidence and mortality.

Programmatic human papillomavirus testing in cervical cancer prevention in the Jujuy Demonstration Project in Argentina: a population-based, before-and-after retrospective cohort study.

BACKGROUND: Human papillomavirus (HPV) testing for cervical cancer prevention was introduced in Argentina through the Jujuy Demonstration Project (2011-14). The programme tested women aged 30 years and older attending the public health system with clinician-collected HPV tests. HPV self-collection was introduced as a programmatic strategy in 2014. We aimed to evaluate the effectiveness of programmatic HPV testing to detect cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN2+) in comparison with cytology-based screening. METHODS: We did a population-based, before-and-after retrospective cohort study using data from the National Cervical Cancer Prevention Program for the Jujuy province in northwest Argentina. We obtained data for the cytology-based screening period from Jan 1, 2010, until Dec 31, 2011, and for the HPV-based screening period from Jan 1, 2012, until Dec 31, 2014. The primary outcome was detection of histologically diagnosed CIN2+ among women aged 30 years and older. To assess the outcomes in all individuals included in the study, we used multivariable logistic regression and propensity score matching. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework was used for the before-and-after analysis of programmatic dimensions. FINDINGS: Of the 29 631 women who underwent cytology-based screening in 2010-11, CIN2+ was detected in 236 (0·8%) individuals. Of the 49 565 women HPV tested in 2012-14 (clinician-collected tests, n=44 700; self-collection tests, n=4865), 693 (1·4%; 658 clinician-collected tests; 35 self-collection tests) were found to have CIN2+ after the first round of screening. Compared with cytology-based screening, the odds ratio of being diagnosed with a CIN2+ lesion was 2·34 (95% CI 2·01-2·73; p<0·0010) with clinician-collected tests, and 1·08 (0·74-1·52; p=0·68) when screened with self-collection tests, after controlling for age and health insurance status. Screening coverage was similar in both periods (52·7% vs 53·2%); improvements of programmatic indicators were observed in the HPV testing period in relation to laboratory centralisation, lower overscreening (6·6% vs 0·0%), higher adherance to age recommendations (79·3% vs 98·8%), and a decrease of inadequate samples (3·6% vs 0·2%). INTERPRETATION: HPV testing in middle-income settings increases detection of CIN2+ lesions and allows for improvement of programmatic indicators. Evidence suggests that the introduction of HPV testing will accelerate the reduction of cervical cancer burden. FUNDING: Argentinian National Cancer Institute and National Council of Scientific and Technologic Research.

Evaluation of scaling-up of HPV self-collection offered by community health workers at home visits to increase screening among socially vulnerable under-screened women in Jujuy Province, Argentina.

BACKGROUND: Self-collection has been proposed as a strategy to increase cervical screening coverage among hard-to-reach women. However, evaluations of the implementation of this strategy on a large scale are scarce. This paper describes the process and measurement of the scaling-up of self-collection offered by community health workers during home visits as a strategy to reach under-screened women aged 30+ with public health coverage, defined as the target women. METHODS: We used an adaptation of the Health System Framework to analyze key drivers of scaling-up. A content analysis approach was used to collect and analyze information from different sources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) model was used to evaluate the impact of the strategy. RESULTS: HPV self-collection was scaled-up in the province of Jujuy in 2014 after a RCT (Self-collection Modality Trial, initials EMA in Spanish) was carried out locally in 2012 and demonstrated effectiveness of the strategy to increase screening uptake. Facilitators of scaling-up were the organizational capacity of the provincial health system, sustainable funding for HPV testing, and local consensus about the value of the technology. Reach: In 2014, 9% (2983/33,245) of target women were screened through self-collection in the Jujuy public health sector. Effectiveness: In 2014, 17% (n = 5657/33,245) of target women were screened with any HPV test (self-collected and clinician-collected tests) vs. 11.7% (4579/38,981) in 2013, the pre-scaling-up period (p < 0.0001). IMPLEMENTATION: Training about the strategy was provided to 84.2% (n = 609/723) of total community health workers (CHWs). Of 414 HPV+ women, 77.5% (n = 320) had follow-up procedures. Of 113 women with positive triage, 66.4% (n = 75) had colposcopic diagnosis. Treatment was provided to 80.7% of CIN2+ women (n = 21/26). Adoption: Of trained CHWs, 69.3% (n = 422/609) had at least one woman with self-collection; 85.2% (n = 315/368) of CHWs who responded to an evaluation survey were satisfied with self-collection strategy. Maintenance: During 2015, 100.0% (723/723) CHWs were operational and 63.8% (461/723) had at least one woman with self-collection. CONCLUSIONS: The strategy was successfully scaled-up, with a high level of adoption among CHWs, which resulted in increased screening among socially vulnerable under-screened women.

Implementation of HPV-testing for cervical cancer screening in programmatic contexts: The Jujuy demonstration project in Argentina.

The aim of this article is to present results of programmatic introduction of HPV testing with cytologic triage among women 30 years and older in the province of Jujuy, Argentina, including description of the planning phase and results of program performance during the first year. We describe the project implementation process, and calculate key performance indicators using SITAM, the national screening information system. We also compare disease detection rates of HPV testing in 2012 with cytology as performed during the previous year. HPV testing with cytology triage was introduced through a consensus-building process. Key activities included establishment of algorithms and guidelines, creating the HPV laboratory, training of health professionals, information campaigns for women and designing the referral network. By the end of 2012, 100% (n = 270) of public health care centers were offering HPV testing and 22,834 women had been HPV tested, 98.5% (n = 22,515) were 30+. HPV positivity among women over 30 was 12.7%, 807 women were HPV+ and had abnormal cytology, and 281 CIN2+ were identified. CIN2+ detection rates was 1.25 in 2012 and 0.62 in 2011 when the program was cytology based (p = 0.0002). This project showed that effective introduction of HPV testing in programmatic contexts of low-middle income settings is feasible and detects more disease than cytology.

Effect of self-collection of HPV DNA offered by community health workers at home visits on uptake of screening for cervical cancer (the EMA study): a population-based cluster-randomised trial.

BACKGROUND: Control of cervical cancer in developing countries has been hampered by a failure to achieve high screening uptake. HPV DNA self-collection could increase screening coverage, but implementation of this technology is difficult in countries of middle and low income. We investigated whether offering HPV DNA self-collection during routine home visits by community health workers could increase cervical screening. METHODS: We did a population-based cluster-randomised trial in the province of Jujuy, Argentina, between July 1, 2012, and Dec 31, 2012. Community health workers were eligible for the study if they scored highly on a performance score, and women aged 30 years or older were eligible for enrolment by the community health worker. 200 community health workers were randomly allocated in a 1:1 ratio to either the intervention group (offered women the chance to self-collect a sample for cervical screening during a home visit) or the control group (advised women to attend a health clinic for cervical screening). The primary outcome was screening uptake, measured as the proportion of women having any HPV screening test within 6 months of the community health worker visit. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02095561. FINDINGS: 100 community health workers were randomly allocated to the intervention group and 100 were assigned to the control group; nine did not take part. 191 participating community health workers (94 in the intervention group and 97 in the control group) initially contacted 7650 women; of 3632 women contacted by community health workers in the intervention group, 3049 agreed to participate; of 4018 women contacted by community health workers in the control group, 2964 agreed to participate. 2618 (86%) of 3049 women in the intervention group had any HPV test within 6 months of the community health worker visit, compared with 599 (20%) of 2964 in the control group (risk ratio 4·02, 95% CI 3·44-4·71). INTERPRETATION: Offering self-collection of samples for HPV testing by community health workers during home visits resulted in a four-fold increase in screening uptake, showing that this strategy is effective to improve cervical screening coverage. This intervention reduces women's barriers to screening and results in a substantial and rapid increase in coverage. Our findings suggest that HPV testing could be extended throughout Argentina and in other countries to increase cervical screening coverage. FUNDING: Instituto Nacional del Cáncer (Argentina).

Thyroid nodules in acromegaly.

OBJECTIVE: We made a prospective study evaluating the prevalence of thyroid nodular disease in acromegalic patients. SUBJECTS AND METHODS: Thyroid ultrasound and ultrasound-guided fine needle aspiration biopsy were performed when nodules were detected. Nodules were characterized by cytology and histopathology. RESULTS: We found high prevalence of nodular thyroid disorder, 23/34 (67%) in acromegalic patients. High risk and malignant cytology were significantly higher in acromegalic patients than in our non-acromegalic population (25% vs. 9%). Differentiated thyroid carcinoma was present in 11% of the acromegalic patients. CONCLUSIONS: We strongly recommend periodic thyroid evaluation by ultrasound in patients with acromegaly. Fine needle aspiration biopsy should be performed in nodules larger than 10 mm, and in all suspicious nodules, regardless of the size.

Thyroid nodules in acromegaly / Nódulos tiroideanos na acromegalia

OBJECTIVE: We made a prospective study evaluating the prevalence of thyroid nodular disease in acromegalic patients. SUBJECTS AND METHODS: Thyroid ultrasound and ultrasound-guided fine needle aspiration biopsy were performed when nodules were detected. Nodules were characterized by cytology and histopathology. RESULTS: We found high prevalence of nodular thyroid disorder, 23/34 (67%) in acromegalic patients. High risk and malignant cytology were significantly higher in acromegalic patients than in our non-acromegalic population (25% vs. 9%). Differentiated thyroid carcinoma was present in 11% of the acromegalic patients. CONCLUSIONS: We strongly recommend periodic thyroid evaluation by ultrasound in patients with acromegaly. Fine needle aspiration biopsy should be performed in nodules larger than 10 mm, and in all suspicious nodules, regardless of the size.

OBJETIVO: Realizamos um estudo prospectivo avaliando a prevalência de patologia nodular tireói­dea em 34 pacientes acromegálicos. SUJEITOS E MÉTODOS: Avaliamos os pacientes com ecografia tireóidea e punção biópsia com agulha fina quando se detectavam nódulos. RESULTADOS: Encontramos uma alta prevalência de patologia nodular tireóidea 23/34 (67%) em acromegálicos. A citologia tireóidea de alto risco e maligna foi significativamente mais elevada em pacientes acromegálicos que em uma população não acromegálica (25% vs. 9%). O grupo acromegálico apresentou carcinoma diferenciado de tireoides em 11%. CONCLUSÕES: Recomendamos fortemente a ecografia periódica tireóidea em pacientes acromegálicos. Uma punção biópsia aspirativa com agulha fina deve ser realizada em presença de nódulos tireóideos maiores que 10 mm e daqueles com critérios ecográficos suspeitos de malignidade, independentemente do tamanho deles.

Tumores carcinoides: sus localizaciones más frecuentes / Carcinoid tumors: their most frequent

Se estudiaron en forma retrospectiva, desde el año 2000 al 2004, 5 tumores carcinoides diagnosticados por TC y RM. Todos contaron con seguimiento clínico-quirurgico y resultados anátomo-patológico en íleon, yeyuno, colon derecho y bronquio inferior derecho, con metástasis en hígado, mediastino anterior, timo y columna lumbar. Los tumores carcinoides poseen la propiedad de sintetizar, secretar y almacenar sustancias químicas como neuroaminas y neuropéptidos que actúan como neurotransmisores. Presentan un crecimiento lento y asintomático, pudiendo manifestarse a través de metástasis o del Síndrome Carcinoides poseen la propiedad de sintetizar, secretar y almacenar sustancias químicas como neuroaminas y neuropéptidos que actúan como neurotransmisores. Presentan un crecimiento lento y asintomático, pudiendo manifestarse a través de matástasis o del Sindrome Carcinoide. Sus localizaciones más frecuentes son en intestino delgado, colon y bronquio; menos frecuente, en estómago, páncreas, timo e higado. Pueden ser múltiples, especialmente las del íleon. Los tumores menores de 1 cm rara vez metastatizan (2%), pero los mayores de 2 cm lo hacen en el 80% de los casos. La única terapia efectiva es la quirúrgica, con resección completa de la lesión.

Metástasis cutánea sobre cicatriz por carcinoma de esófago en acondroplásica: comunicación de un caso diagnosticado por punción aspiración con aguja fina / Cutaneous metastasis on a scar secondary to esophageal carcinoma in an achondroplasic patient: diagnosis by needle aspiration biopsy

Las metástasis cutáneas son infrecuentes y excepcionalmente provienen de esófago. Muy rara vez asientan sobre una cicatriz o son signo de presentación de un cáncer oculto. Describimos una metástasis cutánea como signo de presentación de cáncer epidermoide de esófago en una anciana acondroplásica. El diagnóstico fue realizado por punción aspiración por aguja fina (PAAF) de la lesión cutánea. Se discute el valor de la PAAF como un método rápido y válido para el diagnóstico de metástasis cutáneas. Asimismo se remarca que la ocurrencia de carcinoma de esófago y acondroplasia en una misma paciente probablemente sea una coincidencia más que una asociación

Metástasis cutánea sobre cicatriz por carcinoma de esófago en acondroplásica: comunicación de un caso diagnosticado por punción aspiración con aguja fina / Cutaneous metastasis on a scar secondary to esophageal carcinoma in an achondroplasic patient: diagnosis by needle aspiration biopsy

Las metástasis cutáneas son infrecuentes y excepcionalmente provienen de esófago. Muy rara vez asientan sobre una cicatriz o son signo de presentación de un cáncer oculto. Describimos una metástasis cutánea como signo de presentación de cáncer epidermoide de esófago en una anciana acondroplásica. El diagnóstico fue realizado por punción aspiración por aguja fina (PAAF) de la lesión cutánea. Se discute el valor de la PAAF como un método rápido y válido para el diagnóstico de metástasis cutáneas. Asimismo se remarca que la ocurrencia de carcinoma de esófago y acondroplasia en una misma paciente probablemente sea una coincidencia más que una asociación (AU)

Valoración de la punción biopsia con aguja fina y de la biopsia por congelación en el diagnóstico y tratamiento del nódulo tiroideo / Determine the role of frozen section and fine needle aspiration biopsy of thyroid nodules

Antecedentes: el advenimiento de la PBA ha posibilitado una mejor selección de pacientes portadores de patología tiroidea para la cirugía. Objetivo: determinar el rol de la punción y la biopsia por congelación en el manejo quirúrgico de la patología tiroidea. Lugar de aplicación: Servicio de Cirugía General División A; Servicio de Endocrinología y Servicio de Anatomía Patológica del Hospital de Agudos J.M. Ramos Mejía. Diseño: retrospectivo consecutivo. Método: se evaluó la correlación de los hallazgos de la PBA, la congelación y el estudio histopatológico final en el diagnóstico de la patología tiroidea. Población: se analizaron 541 pacientes estudiados con PBA y congelación operados en el Hospital Ramos Mejía. Resultados: de los 541 operados se diagnosticó cáncer en 163 pacientes (30 por ciento). La PBA diagnosticó 111 que fueron confirmados por la congelación e informó 104 casos como dudosos de los cuales 31 fueron cáncer. Dentro del grupo de los "dudosos" hubo mayor prevalencia de carcinoma en los subgrupos "sospechoso de malignidad" y en las "proliferaciones foliculares de alto grado". Conclusiones: se podría prescindir de la utilización de la biopsia por congelación ante una PBA maligna. En cambio ante una benigna o dudosa consideramos completar con la congelación intraoperatoria. Debido a la diferencia de prevalencia de carcinoma en el grupo de los dudosos justificamos mantener separadas las categorías citológicas: SM (sospechoso de malignidad), PFAG (proliferación folicular de alto grado), PFBG (proliferación folicular de bajo grado), PFH (proliferación folicular de Hürthle)

Valoración de la punción biopsia con aguja fina y de la biopsia por congelación en el diagnóstico y tratamiento del nódulo tiroideo / Determine the role of frozen section and fine needle aspiration biopsy of thyroid nodules

Antecedentes: el advenimiento de la PBA ha posibilitado una mejor selección de pacientes portadores de patología tiroidea para la cirugía. Objetivo: determinar el rol de la punción y la biopsia por congelación en el manejo quirúrgico de la patología tiroidea. Lugar de aplicación: Servicio de Cirugía General División A; Servicio de Endocrinología y Servicio de Anatomía Patológica del Hospital de Agudos J.M. Ramos Mejía. Diseño: retrospectivo consecutivo. Método: se evaluó la correlación de los hallazgos de la PBA, la congelación y el estudio histopatológico final en el diagnóstico de la patología tiroidea. Población: se analizaron 541 pacientes estudiados con PBA y congelación operados en el Hospital Ramos Mejía. Resultados: de los 541 operados se diagnosticó cáncer en 163 pacientes (30 por ciento). La PBA diagnosticó 111 que fueron confirmados por la congelación e informó 104 casos como dudosos de los cuales 31 fueron cáncer. Dentro del grupo de los "dudosos" hubo mayor prevalencia de carcinoma en los subgrupos "sospechoso de malignidad" y en las "proliferaciones foliculares de alto grado". Conclusiones: se podría prescindir de la utilización de la biopsia por congelación ante una PBA maligna. En cambio ante una benigna o dudosa consideramos completar con la congelación intraoperatoria. Debido a la diferencia de prevalencia de carcinoma en el grupo de los dudosos justificamos mantener separadas las categorías citológicas: SM (sospechoso de malignidad), PFAG (proliferación folicular de alto grado), PFBG (proliferación folicular de bajo grado), PFH (proliferación folicular de H³rthle) (AU)