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Cryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy. We report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1–5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239. Between Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital. Results from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results. US National Institutes of Health.

Comprehensive breast cancer management is essential to achieve high breast cancer survival; however, detailed reports of the treatment regimens received by patients are scarce in sub-Saharan Africa where survival is low. We aimed to examine treatment initiation, guideline concordance, and abandonment in patients with non-metastatic breast cancer in sub-Saharan Africa from the African Breast Cancer–Disparities in Outcomes (ABC-DO) prospective cohort. The ABC-DO prospective cohort study recruited women (aged ≥18 years) with newly diagnosed invasive breast cancer in eight hospitals across five sub-Saharan African countries (Namibia, Nigeria, Uganda, South Africa, and Zambia). We analysed treatments received by women who were classified as non-metastatic (M0) at the initial presentation. Data on surgery, radiotherapy, and systemic therapies were obtained from medical records and a self-reported follow-up questionnaire at 6 months after the diagnosis, follow-up calls every 3 months, and a baseline questionnaire. Initiation, completion, and abandonment of treatment modalities and combined therapy regimens were examined overall, by country-specific groups, and by clinical factors relevant for guideline-based treatment. Of 2313 women recruited into the ABC-DO study between Sept 10, 2014, and Dec 31, 2017, 2226 had histologically or clinically confirmed breast cancer. Of these 2226 women, 510 were excluded from the present analysis because 378 had metastatic disease, 37 were prevalent cases (defined as those previously diagnosed with breast cancer >2 years before baseline), 82 had unknown TNM stage, and 13 were White or Asian women in South Africa (number was too small for analysis). After a median follow-up of 5·2 years (IQR 4·6–5·9), 1163 (68%) of 1716 women underwent breast cancer surgery. Surgery and systemic therapy (ie, multimodality treatment) with radiotherapy was initiated in 370 (36%) of 1028 women with localised tumours versus 156 (23%) of 688 women with locally advanced tumours, whereas multimodality treatment without radiotherapy was initiated in 386 (38%) versus 167 (24%) women, respectively. Of 1530 patients requiring chemotherapy (which excludes 105 who died within 6 months after baseline), 1013 (66%) initiated treatment of neoadjuvant chemotherapy or surgery within 3 months after baseline, which was adequately completed by 359 (35%) of 1013 women, marginally completed by 284 (28%), abandoned by 200 (20%), and unknown in 151 (15%). 19 (2%) women died within 6 months after chemotherapy initiation. Of 1375 women in whom endocrine therapy was indicated, this treatment was initiated in 920, and lasted at least 3 years in 367 (40%) women. Treatment disparities between country-specific groups were substantial for all therapy regimens. A high proportion of patients with non-metastatic breast cancer did not initiate, did not fully complete, or abandoned treatment with surgery, systemic therapy, radiotherapy, or an appropriate combination of these, highlighting the need for improved treatment access and completion in sub-Saharan Africa to potentially prevent premature breast cancer deaths. National Institutes of Health (National Cancer Institute), Susan G Komen, and the International Agency for Research on Cancer.

Background Arm and shoulder problems (ASP), including lymphedema, were common among women with breast cancer in high-income countries before sentinel lymph node biopsy became the standard of care. Although ASP impair quality of life, as they affect daily life activities, their frequency and determinants in Sub-Saharan Africa remain unclear. Methods All women newly diagnosed with breast cancer at the Namibian, Ugandan, Nigerian, and Zambian sites of the African Breast Cancer-Disparities in Outcomes (ABC-DO) cohort study were included. At each 3-month follow-up interview, women answered the EORTC-QLQ-Br23 questionnaire, including three ASP items: shoulder/arm pain, arm stiffness, and arm/hand swelling. We estimated the cumulative incidence of first self-reported ASP, overall and stratified by study and treatment status, with deaths treated as competing events. To identify determinants of ASP, we estimated cause-specific hazard ratios using Cox models stratified by study site. Results Among 1476 women, up to 4 years after diagnosis, 43% (95% CI 40–46), 36% (33–38) and 23% (20–25), respectively, self-reported having experienced arm/shoulder pain, stiffness and arm/hand swelling at least once. Although risks of self-reported ASP differed between sites, a more advanced breast cancer stage at diagnosis, having a lower socioeconomic position and receiving treatment increased the risk of reporting an ASP. Conclusion ASP are very common in breast cancer survivors in Sub-Saharan Africa. They are influenced by different factors than those observed in high-income countries. There is a need to raise awareness and improve management of ASP within the African setting.

Background An important cervical cancer prevention strategy in low- and middle-income countries (LMICs) has been single-visit screen-and-treat (SV-SAT) approach, using visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy to manage precancerous lesions. While SV-SAT with VIA and cryotherapy have established efficacy, its population level coverage and impact on reducing cervical cancer burden remains low. In Kenya, the estimated cervical cancer screening uptake among women aged 30–49 is 16% and up to 70% of screen-positive women do not receive treatment. Thermal ablation for treatment of precancerous lesions of the cervix is recommended by the World Health Organization and has the potential to overcome logistical challenges associated with cryotherapy and facilitate implementation of SV-SAT approach and increase treatment rates of screen-positive women. In this 5-year prospective, stepped-wedge randomized trial, we plan to implement and evaluate the SV-SAT approach using VIA and thermal ablation in ten reproductive health clinics in central Kenya. Methods The study aims to develop and evaluate implementation strategies to inform the national scale-up of SV-SAT approach with VIA and thermal ablation through three aims: (1) develop locally tailored implementation strategies using multi-level participatory method with key stakeholders (patient, provider, system-level), (2) implement SV-SAT approach with VIA and thermal ablation and evaluate clinical and implementation outcomes, and (3) assess the budget impact of SV-SAT approach with VIA and thermal ablation compared to single-visit, screen-and-treat method using cryotherapy. Discussion Our findings will inform national scale-up of the SV-SAT approach with VIA and thermal ablation. We anticipate that this intervention, along with tailored implementation strategies will enhance the adoption and sustainability of cervical cancer screening and treatment compared to the standard of care using cryotherapy. Trial registration NCT05472311.

Long delays to diagnosis is a major cause of late presentation of breast diseases in sub-Saharan Africa. We designed and implemented a single-visit breast care algorithm that overcomes health system-related barriers to timely diagnosis of breast diseases. A multidisciplinary team of Zambian healthcare experts trained a team of mid- and high-level Zambian healthcare practitioners how to evaluate women for breast diseases, and train trainers to do likewise. Working collaboratively, the two teams then designed a clinical platform that provides multiple breast care services within a single visit. The service platform was implemented using a breast outreach camp format, during which breast self-awareness, psychosocial counseling, clinical breast examination, breast ultrasound, ultrasound-guided biopsy, imprint cytology of biopsy specimens and surgical treatment or referral, were offered within a single visit. Eleven hundred and twenty-nine (1129) women attended the camps for breast care. Mean age was 35.9 years. The majority were multiparous (79.4%), breast-fed (76.0%), and reported hormone use (50.4%). Abnormalities were detected on clinical breast examination in 122 (10.8%) women, 114 of whom required ultrasound. Of the 114 who underwent ultrasound, 48 had identifiable lesions and were evaluated with ultrasound-guided core needle biopsy (39) or fine-needle aspiration (9). The concordance between imprint cytology and histopathology was 100%, when breast specimens were classified as either benign or malignant. However, when specimens were classified by histopathologic subtype, the concordance between imprint cytology and histology was 85.7% for benign and 100% for malignant lesions. Six (6) women were diagnosed with invasive cancer. Eighteen (18) women with symptomatic breast lesions had next-day surgery. Similar to its impact on cervical cancer prevention services, a single visit breast care algorithm has the potential to overcome health system-related barriers to timely diagnosis of breast diseases, including cancer, in rural African settings.

Implementing standard-of-care cryotherapy or electrosurgical excision to treat cervical precancers is challenging in resource-limited settings. An affordable technological alternative that is as effective as standard-of-care techniques would greatly improve access to treatment. This randomized controlled trial aims to demonstrate the noninferiority efficacy of a portable, battery-driven thermal ablation (TA) device compared to cryotherapy and electrosurgical excision (large loop excision of transformation zone (LLETZ)) to treat cervical precancer in a screen-and-treat program in Zambia. A total of 3,124 women positive on visual inspection with acetic acid and eligible for ablative therapy were randomized to one of the treatment arms. Human papillomavirus (HPV) testing was performed at baseline and at the follow-up. The primary outcome was treatment success, defined as either type-specific HPV clearance at the follow-up in participants positive for HPV at baseline, or a negative visual inspection with acetic acid test for those who had a negative HPV test at baseline. After a median follow-up of 12 months, treatment success rates were 74.0%, 71.1% and 71.4% for the TA, cryotherapy and LLETZ arms, respectively, thus demonstrating noninferiority ( P  = 0.83). TA was a safe and well-accepted procedure. Only 3.6% of those randomized to TA reported moderate-to-severe pain, compared to 6.5% and 1.9% for the cryotherapy and LLETZ arms, respectively. Thus, our randomized controlled trial demonstrates the safety and efficacy of TA, which is not inferior to cryotherapy or surgical excision. ClinicalTrials.gov registration: NCT02956239 . A randomized controlled trial performed in a screen-and-treat program in Zambia found that a portable, battery-operated thermal ablation device was not inferior to cryotherapy and electrosurgical excision in cervical precancer treatment.

Background Obstetric fistula devastates the lives of women and is found most commonly among the poor in resource-limited settings. Unrepaired third- and fourth-degree perineal lacerations have been shown to be the source of approximately one-third of the fistula burden in fistula camps in Kenya. In this study, we assessed potential barriers to accurate identification by Kenyan nurse-midwives of these complex perineal lacerations in postpartum women. Methods Nurse-midwife trainers from each of the seven sub-counties of Siaya County, Kenya were assessed in their ability to accurately identify obstetric lacerations and anatomical structures of the perineum, using a pictorial assessment tool. Referral pathways, follow-up mechanisms, and barriers to assessing obstetric lacerations were evaluated. Results Twenty-two nurse-midwife trainers were assessed. Four of the 22 (18.2%) reported ever receiving formal training on evaluating third- and fourth-degree obstetric lacerations, and 20 of 22 (91%) reported health-system challenges to adequately completing their examination of the perineum at delivery. Twenty-one percent of third- and fourth-degree obstetric lacerations in the pictorial assessment were incorrectly identified as first- or second-degree lacerations. Conclusion County nurse-midwife trainers in Siaya, Kenya, experience inadequate training, equipment, staffing, time, and knowledge as barriers to adequate diagnosis and repair of third- and fourth-degree perineal tears.

ObjectivesTo evaluate the effect of race and ethnicity on differences in maternal and perinatal outcomes among U.S.-born and foreign-born women, as well as racial and ethnic disparities in outcomes within these groups.MethodsThis retrospective study analyzed singleton pregnancies (n = 11,518) among women delivering at Boston Medical Center from January 2010–March 2015. Outcomes of interest included preterm birth, early preterm birth, cesarean delivery, hypertensive disorders, diabetes, low birth weight at term (LBW, < 2500 g), NICU admission and intrauterine fetal demise (IUFD). Prevalence ratios and 95% confidence intervals comparing outcomes between U.S.- and foreign-born women were calculated and stratified by race. Obstetric outcomes among Black and Hispanic women were compared to those of white women within both U.S.- and foreign-born groups.ResultsPreterm birth, hypertensive disorders, LBW and NICU admission were more likely to occur among U.S.-born women and their neonates compared to foreign-born women. Controlling for sociodemographic characteristics did not significantly impact these disparities. Among foreign-born women, Black women had a higher prevalence of many maternal and neonatal complications, while Hispanic women had a lower prevalence of some complications compared to white women. Black woman and infants consistently exhibit worse outcomes regardless of their nativity, while Hispanic women foreign-born women experience less disparate outcomes.Conclusions for PracticeOverall, women born in the United States are at higher risk of several adverse perinatal outcomes compared to foreign-born women. Racial and ethnic disparities in birth outcomes exist in both groups. However, the complex interplay between biopsychosocial influences that mediate these inequities appear to have different effects among U.S- and foreign- born women. A better understanding of these factors can be used to combat disparities and improve outcomes for all women.

African-born immigrants comprise one of the fastest growing populations in the U.S., nearly doubling its population size in recent years. However, it is also one of the most underrepresented groups in health-care research, especially research focused on gynecologic and breast malignancies. While the opportunity exists for access to an advanced health-care system, as immigrants migrate to the U.S., they encounter the same health-care inequalities that are faced by the native-born population based on ethnicity and social class, potentiated by limitations of health literacy and lack of familiarity with U.S. health systems. Given the continued influx of African-born immigrants in the U.S., we sought to understand the representation of this population in cervical and breast cancer research, recognizing the population's high risk for these diseases at baseline while residing in their native countries. We determined that there is limited research in these diseases that disproportionately affect them; yet, there are identifiable and potentially modifiable factors that contribute to this paucity of evidence. This clinical commentary seeks to underscore the clear lack of research available involving African-born immigrants with respect to gynecologic and breast malignancies in the existing literature, demonstrate the need for more robust research in this population, and provide fundamental insights into barriers and solutions critical to the continued health of this growing population.

The knowledge and perceptions of cervical cancer among HIV negative and positive women, aged 25-49 years, from rural and urban locations in Zambia was systematically accessed in this study to determine any differences. Data were coded and analyzed using NVivo software. Compared to HIV negative women, HIV positive women had more accurate information about cervical cancer. They were more likely to cite male circumcision as the best approach to cervical cancer prevention. HPV infection was more commonly mentioned as a risk factor among HIV positive women. However, HIV positive women displayed little knowledge about HPV being the major cause of cervical cancer. Among HIV positive women, lack of time was the major screening barrier cited while HIV negative women mentioned being symptomatic as a determinant for early detection. Compared to rural residents, urban residents cited a wider range of cervical cancer information sources, including media and workplace although all of the participants who stated that they had no knowledge of cervical cancer were urban residents. Overall, knowledge and perceptions of cervical cancer among study participants was high, although differences exist between subgroups. Sharing accurate and standardized information on cervical cancer would improve participation in cervical cancer screening services. Les connaissances et les perceptions du cancer du col utérin chez les femmes séropositives et les personnes séropositives, âgées de 25 à 49 ans originaires des milieux ruraux et urbains en Zambie, ont été systématiquement utilisées dans cette étude pour déterminer les différences. Les données ont été codées et analysées à l'aide du logiciel NVivo. Comparativement aux femmes séronégatives, les femmes séropositives avaient des informations plus précises sur le cancer du col utérin. Elles étaient plus susceptibles de citer la circoncision masculine comme la meilleure approche pour la prévention du cancer du col utérin. L'infection à VPH a été plus souvent mentionnée comme facteur de risque chez les femmes séropositives. Cependant, les femmes séropositives ont démontré peu de connaissances sur le fait que le VPH était la principale cause du cancer du col utérin. Chez les femmes séropositives, le principal obstacle au dépistage a été le manque de temps, tandis que les femmes séronégatives ont indiqué qu'elles étaient symptomatiques en tant que facteur déterminant du dépistage précoce. Comparés aux résidentes rurales, les citadines citent une gamme plus large de sources d'informations sur le cancer du col utérin, y compris les médias et le lieu de travail, alors que toutes les participantes qui ont déclaré qu'elles n'ont pas de connaissances à l'égard du cancer du col utérin étaient des résidentes urbaines. Dans l'ensemble, les connaissances et les perceptions du cancer du col utérin chez les participantes à l'étude étaient élevées, bien qu'il existe des différences entre les sous-groupes. Le partage d'informations précises et normalisées sur le cancer du col utérin améliorerait la participation aux services de dépistage du cancer du col utérin.