Foraminifera as a model of the extensive variability in genome dynamics among eukaryotes.

Knowledge of eukaryotic life cycles and associated genome dynamics stems largely from research on animals, plants, and a small number of "model" (i.e., easily cultivable) lineages. This skewed sampling results in an underappreciation of the variability among the many microeukaryotic lineages, which represent the bulk of eukaryotic biodiversity. The range of complex nuclear transformations that exists within lineages of microbial eukaryotes challenges the textbook understanding of genome and nuclear cycles. Here, we look in-depth at Foraminifera, an ancient (∼600 million-year-old) lineage widely studied as proxies in paleoceanography and environmental biomonitoring. We demonstrate that Foraminifera challenge the "rules" of life cycles developed largely from studies of plants and animals. To this end, we synthesize data on foraminiferal life cycles, focusing on extensive endoreplication within individuals (i.e., single cells), the unusual nuclear process called Zerfall, and the separation of germline and somatic function into distinct nuclei (i.e., heterokaryosis). These processes highlight complexities within lineages and expand our understanding of the dynamics of eukaryotic genomes.

Guideline No. 451: Asymptomatic Endometrial Thickening in Postmenopausal Women.

OBJECTIVE: To formulate strategies for clinical assessments for endometrial thickening on ultrasound in a postmenopausal woman without bleeding. TARGET POPULATION: Postmenopausal women of any age. OUTCOMES: To reduce unnecessary invasive interventions and investigations in women with asymptomatic endometrial thickening while selectively investigating women at risk for endometrial cancer. BENEFITS, HARMS, AND COSTS: It is anticipated that the adoption of these recommendations would save postmenopausal women unnecessary anxiety, pain, and risk of procedural complications. It is also expected to decrease the cost to the health care system by eliminating unnecessary interventions. EVIDENCE: English language articles from Medline, Cochrane, and PubMed databases for relevant peer-reviewed articles dating from 1995 to 2022 (e.g., asymptomatic endometrial thickness, endometrial cancer, postmenopausal bleeding, transvaginal ultrasound, endometrial biopsy, cervical stenosis, hormone therapies and the endometrium, tamoxifen, tibolone, aromatase inhibitors). Results were restricted to systematic reviews and meta-analyses, randomized controlled trials/controlled clinical trials, and observational studies. VALIDATION METHODS: The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional [weak] recommendations). INTENDED AUDIENCE: Physicians, including gynaecologists, obstetricians, family physicians, radiologists, pathologists, and internists; nurse practitioners and nurses; medical trainees, including medical students, residents, and fellows; and other providers of health care of the postmenopausal population. SOCIAL MEDIA ABSTRACT: Postmenopausal women often have a thickening of the lining of the uterus found during ultrasound. Without bleeding, an endometrium <11 mm is rarely a serious problem but should be evaluated by a health care provider. SUMMARY STATEMENTS: RECOMMENDATIONS.

"Not just the consequences, but also the pleasurable sex": a review of the content of comprehensive sexuality education for early adolescents in Rwanda.

BACKGROUND: Responding to adolescents' educational needs in sexual and reproductive health and rights (SRHR) is central to their sexual health and achieved through school-based comprehensive sexuality education (CSE). In 2016, Rwanda introduced CSE through the competence-based curriculum in schools to enhance learners' knowledge about sexuality, gender, and reproductive health issues, including HIV/AIDS. However, globally, the content of CSE is sometimes dissimilar, and little evidence surrounds its scope in many settings, including Rwanda. In addition, the extent to which CSE aligns with international guidelines has yet to be well known. This study assesses major areas of CSE for early adolescents in Rwanda, analyses how CSE correlates with international guidelines and makes recommendations accordingly. METHODS: We reviewed the Rwandan competence-based curriculum to map CSE competences for early adolescents and conducted semi-structured interviews with key informants (N = 16). Eleven of the 23 curriculum documents met the selection criteria and were included in the final review. We manually extracted data using a standard form in Microsoft Excel and analysed data using frequency tables and charts. Interviews were thematically analysed in NVivo 11 for Windows. FINDINGS: We found 58 CSE competences for early adolescents across various subjects, increasing with school grades. All recommended CSE areas were addressed but to a variable extent. Most competences fall under four recommended areas: sexual and reproductive health; human body and development; values, rights, and sexuality; and understanding gender. The least represented area is violence and staying safe. Of the 27 expected topics, there are two to six CSE competences for 13 topics, one CSE competence for each of the six others, and none for the eight remaining ones. Qualitative findings support these findings and suggest additional content on locally controversial but recommended areas of sexual pleasure, orientation, desire and modern contraceptive methods. CONCLUSION: This study explores the CSE content for early adolescents in Rwanda and how they align with sexuality education standards. Ensuring equal coverage of CSE areas and addressing missing topics may improve CSE content for this age group and foster their SRHR.

Perceptions of the COVID-19 pandemic: a qualitative study with South African adults.

INTRODUCTION: In South Africa, public perceptions of the COVID-19 pandemic and risk mitigation measures remain mixed. To better understand health behaviours in the context of COVID-19, a qualitative study was conducted, which aimed to investigate perceptions relating to the COVID-19 pandemic among the South African adult population. METHODS: Twelve online focus groups were conducted across the following age groups: 18-34, 35-54, 55 + years old (total n = 70) in December 2021. Diversity across socioeconomic status, geographical areas, and urban and rural settings was maximised, with an equal representation of men and women. Focus groups were conducted, and audio recorded using an online platform, transcribed verbatim and thematically analysed using MAXQDA. RESULTS: There were mixed perceptions around the pandemic, however, the majority of participants appreciated government actions at the onset of the pandemic and as a result government trust was reported to have initially been high. Nevertheless, as the pandemic progressed, challenges relating to government communication around the pandemic, the inconsistent application of preventative measures by government, the use of soldiers to enforce preventative measures, the banning of alcohol and cigarettes, government corruption and the pervasiveness of social media were reported to have eroded government trust, negatively impacting the uptake of preventative measures. Economic and psychological impacts were experienced differently across income groups. Low-income earners, who already had pre-existing economic challenges reported increased psychological and financial strain. While the once cushioned middle class reported an increase in job insecurity accompanied by psychological challenges. High income earners did not report economic challenges but reported being affected psychologically. Though, low-income earners reported an appreciation of the government financial relief afforded to them middle income earners appeared to not have received adequate financial support. CONCLUSION: With the existing mistrust of government, there is need for government to leverage existing trusted sources in communities to aid in the implementation of preventative measures. These findings support the development of context specific solutions to address challenges faced at different socioeconomic levels.

Participatory prioritisation of interventions to improve primary school food environments in Gauteng, South Africa.

BACKGROUND: In South Africa, overweight and obesity affect 17% of children aged 15-18. School food environments play a vital role in children's health, influencing dietary behaviours and resulting in high obesity rates. Interventions targeting schools can contribute to obesity prevention if evidence-based and context-specific. Evidence suggests that current government strategies are inadequate to ensure healthy school food environments. The aim of this study was to identify priority interventions to improve school food environments in urban South Africa using the Behaviour Change Wheel model. METHODS: A three-phased iterative study design was implemented. First, we identified contextual drivers of unhealthy school food environments through a secondary framework analysis of 26 interviews with primary school staff. Transcripts were deductively coded in MAXQDA software using the Behaviour Change Wheel and the Theoretical Domains Framework. Second, to identify evidence-based interventions, we utilised the NOURISHING framework and matched interventions to identified drivers. Third, interventions were prioritised using a Delphi survey administered to stakeholders (n = 38). Consensus for priority interventions was defined as an intervention identified as being 'somewhat' or 'very' important and feasible with a high level of agreement (quartile deviation ≤ 0.5). RESULTS: We identified 31 unique contextual drivers that school staff perceived to limit or facilitate a healthy school food environment. Intervention mapping yielded 21 interventions to improve school food environments; seven were considered important and feasible. Of these, the top priority interventions were to: 1) "regulate what kinds of foods can be sold at schools", 2) "train school staff through workshops and discussions to improve school food environment", and affix 3) "compulsory, child-friendly warning labels on unhealthy foods". CONCLUSION: Prioritising evidence-based, feasible and important interventions underpinned by behaviour change theories is an important step towards enhanced policy making and resource allocation to tackle South Africa's childhood obesity epidemic effectively.

What values drive communities' nutrition priorities in a resource constrained urban area in South Africa?

BACKGROUND: Voices of under-resourced communities are recognised as important yet are often unheard in decisions about healthcare resource allocation. Deliberative public engagement can serve as an effective mechanism for involving communities in establishing nutrition priorities. This study sought to identify the priorities of community members of a South African township, Soweto, and describe the underlying values driving their prioritisation process, to improve nutrition in the first 1000 days of life. METHODS: We engaged 54 community members (28 men and 26 women aged > 18 years) from Soweto. We conducted seven group discussions to determine how to allocate limited resources for prioritising nutrition interventions. We used a modified public engagement tool: CHAT (Choosing All Together) which presented 14 nutrition intervention options and their respective costs. Participants deliberated and collectively determined their nutritional priorities. Choices were captured quantitatively, while group discussions were audio-recorded. A thematic analysis was undertaken to identify the reasons and values associated with the selected priorities. RESULTS: All groups demonstrated a preference to allocate scarce resources towards three priority interventions-school breakfast provisioning, six-months paid maternity leave, and improved food safety. All but one group selected community gardens and clubs, and five groups prioritised decreasing the price of healthy food and receiving job search assistance. Participants' allocative decisions were guided by several values implicit in their choices, such as fairness and equity, efficiency, social justice, financial resilience, relational solidarity, and human development, with a strong focus on children. Priority interventions were deemed critical to supporting children's optimal development and well-being, interrupting the intergenerational cycle of poverty and poor human development in the community. CONCLUSION: Our study demonstrates how public engagement can facilitate the incorporation of community values and programmatic preferences into nutrition priority setting, enabling a responsive approach to local community needs, especially in resource constrained contexts. Findings could guide policy makers to facilitate more appropriate decisions and to improve nutrition in the first 1000 days of life.

Online Health Communities' Portrayal of Obesity on Social Media Platforms in South Africa.

The rapidly increasing prevalence of obesity in South Africa, intertwined with extensive changes in diet, life expectancy, and nutritional status has led to a complex framing of obesity on social media. This has prompted the prioritization of media-based social and behavior change communication interventions leveraging social media for obesity prevention. This study was conducted to understand how obesity is constructed and represented on social media in South Africa. A media review of Facebook and Twitter platforms in South Africa was conducted over a six-month period using Meltwater software for data collection. The search yielded 13 500 posts and tweets. Data were cleaned and coded in Microsoft Excel. Content and framing analysis were performed to add insight into the nature of obesity discourse on social media. Portrayals of obesity on social media were dominated by stigmatizing imagery blaming individuals for unhealthy lifestyles, poor diets, and lack of physical activity. Future media-based social and behavior change communication interventions for obesity prevention can leverage social media to reach the broader public and insights into media portrayals of obesity have the potential to influence the shape and development of these behavioral interventions.

"Such conversations are not had in the families": a qualitative study of the determinants of young adolescents' access to sexual and reproductive health and rights information in Rwanda.

BACKGROUND: Access to sexual and reproductive health and rights (SRHR) information during adolescence has become a global concern. This study explored factors that enable or prevent young adolescents from accessing to SRHR information from the perspective of the key informants in Rwanda. METHODS: We conducted a qualitative study using semi-structured interviews with 16 purposively selected key informants from public and private institutions in Rwanda. This selection was based on their positions and expertise in delivering SRHR information to adolescents. The interview guide questions were designed based on the social-ecological theoretical framework of adolescent health. The interview transcripts were recorded, transcribed, translated and thematically analysed in Nvivo 11. RESULTS: The study reflected that multiple enablers and barriers at the individual, relationship, community and societal levels determined young adolescents' access to SRHR information. These determinants include information-seeking behaviour and age of starting sexuality education at the individual level; and parents' limited communication with young adolescents due to taboos, lack of skills, limited parental availability, beliefs, lack of appropriate language and peer norms at the relationships level. Enablers and barriers at the community level were the diversity of SRHR sources, the scope of sexuality education programmes, and cultural and religious beliefs. Finally, the perceived enablers and barriers at the societal level consisted of inadequate resources, inappropriate SRHR policy-making processes and unfriendly SRHR laws. CONCLUSION: Enabling access to SRHR information requires addressing multiple factors within the social-ecological environment of young adolescents. Addressing these factors may facilitate improved access to SRHR information for this age group.

Developing and piloting a context-specified ethics framework for health technology assessment: the South African Values and Ethics for Universal Health Coverage approach.

OBJECTIVES: While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The "South African Values and Ethics for Universal Health Coverage" (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts. METHODS: The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies of sample health interventions: opioid substitution therapy and either a novel contraceptive implant or seasonal influenza immunization for children under five. RESULTS: The methodology was fit-for-purpose, resulting in a context-specified ethics framework and producing relevant findings to inform application of the framework for the given HTA context. CONCLUSIONS: The SAVE-UHC approach provides a model for developing, piloting, and refining an ethics framework for health priority-setting that is responsive to national social values. This approach also helps identify key facilitators and challenges for integrating ethics analysis into HTA processes.

Baseline Asymptomatic Malaria Infection and Immunogenicity of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein.

BACKGROUND: The effect of malaria infection on the immunogenicity of the recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein (GP) vaccine (rVSVΔG-ZEBOV-GP) (ERVEBO) is unknown. METHODS: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) vaccinated 7998 asymptomatic adults with rVSVΔG-ZEBOV-GP during the 2014-2016 Ebola epidemic. In STRIVE's immunogenicity substudy, participants provided blood samples at baseline and at 1, 6, and 9-12 months. Anti-GP binding and neutralizing antibodies were measured using validated assays. Baseline samples were tested for malaria parasites by polymerase chain reaction. RESULTS: Overall, 506 participants enrolled in the immunogenicity substudy and had ≥1 postvaccination antibody titer. Of 499 participants with a result, baseline malaria parasitemia was detected in 73 (14.6%). All GP enzyme-linked immunosorbent assay (ELISA) and plaque reduction neutralization test (PRNT) geometric mean titers (GMTs) at 1, 6, and 9-12 months were above baseline, and 94.1% of participants showed seroresponse by GP-ELISA (≥2-fold rise and ≥200 ELISA units/mL), while 81.5% showed seroresponse by PRNT (≥4-fold rise) at ≥1 postvaccination assessment. In participants with baseline malaria parasitemia, the PRNT seroresponse proportion was lower, while PRNT GMTs and GP-ELISA seroresponse and GMTs showed a trend toward lower responses at 6 and 9-12 months. CONCLUSION: Asymptomatic adults with or without malaria parasitemia had robust immune responses to rVSVΔG-ZEBOV-GP, persisting for 9-12 months. Responses in those with malaria parasitemia were somewhat lower.

Double-duty solutions for optimising maternal and child nutrition in urban South Africa: a qualitative study.

OBJECTIVE: To obtain a community perspective on key nutrition-specific problems and solutions for mothers and children. DESIGN: A qualitative study comprising nine focus group discussions (FGD) following a semi-structured interview guide. SETTING: The township of Soweto in South Africa with a rising prevalence of double burden of malnutrition. PARTICIPANTS: Men and women aged ≥18 years (n 66). Three FGD held with men, six with women. RESULTS: Despite participants perceived healthy diet to be important, they felt their ability to maintain a healthy diet was limited. Inexpensive, unhealthy food was easier to access in Soweto than healthier alternatives. Factors such as land use, hygiene and low income played a fundamental role in shaping access to foods and decisions about what to eat. Participants suggested four broad areas for change: health sector, social protection, the food system and food environment. Their solutions ranged from improved nutrition education for women at clinic visits, communal vegetable gardens and government provision of food parcels to regulatory measures to improve the healthiness of their food environment. CONCLUSIONS: South Africa's current nutrition policy environment does not adequately address community-level needs that are often linked to structural factors beyond the health sector. Our findings suggest that to successfully address the double burden of malnutrition among women and children, a multifaceted approach is needed combining action on the ground with coherent policies that address upstream factors, including poverty. Further, there is a need for public engagement and integration of community perspectives and priorities in developing and implementing double-duty actions to improve nutrition.

Utility, Appropriateness, and Content of Electronic Consultations Across Medical Subspecialties.

BACKGROUND: Electronic consultations (e-consults) can facilitate patient access to specialists, minimize travel, and reduce unnecessary in-person visits. However, metrics to enable study of e-consults and their effect on processes and patient care are lacking. OBJECTIVE: To assess novel metrics of e-consult appropriateness and utility. DESIGN: Retrospective cohort study. SETTING: Primary and specialty care practices at 2 large academic and 2 community hospitals of an integrated health system. PARTICIPANTS: Patients with e-consult requests to 5 specialties-hematology, infectious disease, dermatology, rheumatology, and psychiatry-between October 2017 and November 2018. MEASUREMENTS: The appropriateness of e-consult inquiries was assessed by review of medical records and defined as meeting the following 4 criteria: not answerable by reviewing evidence-based summary sources ("point-of-care resource test"), not merely requesting logistic information, having appropriate clinical urgency, and having appropriate patient complexity. Interrater agreement in assessments of e-consult appropriateness was assessed by the κ statistic. Utility of e-consults was assessed by the rate of avoided visits (AVs), defined by the absence of an in-person visit to the same specialty within 120 days. RESULTS: Overall, 6512 eligible e-consults were made by 1096 referring providers to 121 specialist consultants. Inquiries were characterized as diagnostic, therapeutic, for provider education, or at the request of the patient. Most consultations were answered within 1 day, with variation across specialties (73.1% for psychiatry to 87.8% for infectious disease). Overall, 70.2% of e-consults met all 4 criteria for appropriateness; the frequency of unmet criteria varied among specialties. Raters agreed on the appropriateness of 94% of e-consults (κ = 0.57 [95% CI, 0.36 to 0.79]), indicating moderate agreement. The overall rate of AVs across the 5 specialties was 81.2%; the highest rate was in psychiatry (92.6%) and the lowest in dermatology (61.9%). LIMITATION: Generalizability is unknown outside a single integrated health system, where requesting and consulting providers share a common electronic health record. CONCLUSION: Novel metrics to assess the appropriateness and utility of e-consults provide meaningful insight into practice, provide a rubric for comparison in future studies in additional settings, and suggest areas to improve resource use and patient care. PRIMARY FUNDING SOURCE: None.

The roles of men and women in maternal and child nutrition in urban South Africa: A qualitative secondary analysis.

Industrialization and urbanization processes have challenged deeply held traditional gender norms and facilitated the emergence of modern ideologies in South Africa. This paper seeks to explore the gendered roles of family members on maternal and child nutrition and investigate indications of perceived change in related practices. A qualitative secondary analysis was conducted of data from nine focus group discussions (FGDs) held with men (n = 3) and women (n = 6) aged ≥18. Data from the FGD were coded and thematic analysis conducted. We found that elderly women seem to have a central advisory role with respect to maternal and child nutrition and that men and elderly women upheld patriarchal gender divisions of labour, which entrust mothers with the primarily responsibility for young children's nutrition. Young mothers relied on elderly women for provision of childcare and nutritious foods for children; however, they demonstrated some resistance to traditionally feminized forms of food preparation. We found that men's involvement in children's nutrition was limited, though they expressed a preference to be more involved in maternal and child nutrition and care practices. A gender transformative approach to policy development, which includes elderly women and men, has the potential to promote more gender-equitable nutrition practices, increase young women's self-efficacy and support them to overcome barriers that could be limiting their decision making power in achieving optimal nutrition for themselves and their children.

Pregnancy Outcomes among Women Receiving rVSVΔ-ZEBOV-GP Ebola Vaccine during the Sierra Leone Trial to Introduce a Vaccine against Ebola.

Little information exists regarding Ebola vaccine rVSVΔG-ZEBOV-GP and pregnancy. The Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE) randomized participants without blinding to immediate or deferred (18-24 weeks postenrollment) vaccination. Pregnancy was an exclusion criterion, but 84 women were inadvertently vaccinated in early pregnancy or became pregnant <60 days after vaccination or enrollment. Among immediate vaccinated women, 45% (14/31) reported pregnancy loss, compared with 33% (11/33) of unvaccinated women with contemporaneous pregnancies (relative risk 1.35, 95% CI 0.73-2.52). Pregnancy loss was similar among women with higher risk for vaccine viremia (conception before or <14 days after vaccination) (44% [4/9]) and women with lower risk (conception >15 days after vaccination) (45% [10/22]). No congenital anomalies were detected among 44 live-born infants examined. These data highlight the need for Ebola vaccination decisions to balance the possible risk for an adverse pregnancy outcome with the risk for Ebola exposure.

'I'd say I'm fat, I'm not obese': obesity normalisation in urban-poor South Africa.

OBJECTIVE: In the past decade, South Africa's obesity epidemic has increased in both children and adults, and being overweight is becoming the norm. Several contributing factors lead to the normalisation of obesity. One of these is the culturally entrenched likeness of larger body sizes or shapes within a milieu of easily accessible unhealthy food and beverages. This qualitative study advances knowledge about the influence of socio-cultural norms and obesogenic environments on weight under estimation and 'obesity normalisation' amongst black South Africans living in an urban setting. DESIGN: A theory-based qualitative study used focus group discussions (FGDs) with a semi-structured interview guide. FGDs were transcribed verbatim and analysed thematically using a constant comparison method. SETTING: Soweto, Johannesburg, South Africa, is a setting which has undergone rapid urbanisation and nutrition transition with ubiquitous availability of processed and fast-foods. PARTICIPANTS: Adults older than 18 years living in Soweto (n 57). RESULTS: There is a wide misperception about obesity amongst black Africans living in an urban setting in Soweto. Participants who admitted to being fat or overweight did not view themselves as such. This could be attributed to unchanging socio-cultural factors that reinforce the acceptability of bigger bodies and living in obesogenic environment. CONCLUSIONS: Without addressing socio-cultural norms that attribute bigger bodies to beauty and wealth, motivating individuals to address weight gain will prove difficult especially for populations living in obesogenic environments. A multi-faceted strategy is required to address obesity in urban South African settings.

No. 385-Indications for Pelvic Examination.

OBJECTIVE: The primary objective of this document is to clarify the indications for pelvic examination. INTENDED USERS: Physicians, including gynaecologists, obstetricians, family physicians, and emergency physicians; nurses, including registered nurses and nurse practitioners; midwives, including midwives in clinical practice and midwifery trainees; medical trainees, including medical students, residents, and fellows; and all other health care providers who care for women. TARGET POPULATION: This publication provides evidence and expert-based recommendations for pelvic examination in adult women (18 years and older) both with and without gynaecologic symptoms. OUTCOMES: This publication clarifies indications for pelvic examination in the context of recently published national task force statements on the utility of pelvic examination. We aim to ensure that women who have clinical indications for examination receive proper clinical investigation with minimal delays to diagnosis of treatable disease. EVIDENCE: For this committee opinion, relevant studies were identified in PubMed and Medline using the following terms, either alone or in combination, with the search limited to English-language materials and human subjects and no publication date cut-off: pelvic examination, bimanual examination, speculum examination, rectovaginal examination, ovarian cancer screening, asymptomatic women, periodic health examination. The search was performed in May and June 2018. Relevant evidence was selected for inclusion in the following order: meta-analyses, systematic reviews, guidelines and national task force statements, randomized controlled trials, prospective cohort studies, observational studies, non-systematic reviews, case series, and reports. Additional articles were identified by cross-referencing the identified publications. A formal systematic review was not conducted for all topics discussed due to the paucity of evidence and number of different subtopics discussed. The total number of publications included in this review was 66. VALIDATION METHODS: The content and recommendations were drafted and agreed upon by the principal authors. The Boards of the Society of Gynecologic Oncology of Canada (GOC), the College of Family Physicians of Canada (CFPC), and the Society of Obstetricians and Gynaecologists of Canada (SOGC) approved the final draft for publication after review by their respective representative committees. The quality of evidence was rated using the criteria described in the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology framework (Tables 1 and 2). The Summary of Findings is available upon request. BENEFITS, HARMS, AND COSTS: This committee opinion should benefit all women with and without gynaecologic symptoms who present to gynaecologists and primary care practitioners. It will help guide practitioners in identifying indications for pelvic examination to reduce unnecessary examination with related potential harm while also increasing indicated examination to reduce delays in diagnosis of treatable gynaecologic conditions. GUIDELINE UPDATE: This SOGC Committee Opinion will be automatically reviewed 5 years after publication to determine if all or part of the committee opinion should be updated. However, this review may be performed earlier if new high-impact research is published in the interim. SUMMARY STATEMENTS: 1. National and international statements and guidelines on pelvic examination should not be interpreted to suggest that the pelvic examination is irrelevant or noncontributory to physical assessment or that the pelvic examination in symptomatic women should be omitted. 2. Pelvic examination may include visual inspection, speculum examination, bimanual examination, single digit examination, and/or rectovaginal examination depending on the indication for examination. 3. No study published to date has adequately evaluated any component of the pelvic examination as a screening method for any type of malignant gynaecologic disease, except for the speculum examination for cervical cancer cytology screening. As such, any universal recommendations for or against pelvic examinations for other indications can only be made based on expert opinion and low-quality evidence. 4. In asymptomatic women at average risk for cervical cancer, cervical cytology screening reduces both the incidence of, and mortality from, cervical cancer by detecting pre-invasive, treatable lesions. 5. In asymptomatic women at average risk of malignancy, a visual and bimanual examination at the time of obtaining cervical cytology samples may add value to this screening manoeuvre: Women might not raise certain gynaecologic concerns until the time of pelvic examination; the examination provides an opportunity for patient education and practitioner skill maintenance; and, although inadequately studied to date, there may be positive effects on ovarian and vulvar malignancy that require further investigation. These potential benefits should be weighed against potential harms like patient discomfort and false positives/negatives that may result in inappropriate reassurance or unnecessary investigations/interventions. RECOMMENDATIONS: Symptomatic Women. 1) Any woman with gynaecologic complaints including, but not limited to, vulvar complaints, vaginal discharge, abnormal premenopausal bleeding, postmenopausal bleeding, infertility, pelvic organ prolapse symptoms, urinary incontinence, new and unexplained gastrointestinal symptoms (abdominal pain, increased abdominal size/bloating, and difficulty eating/early satiety), pelvic pain, or dyspareunia should undergo appropriate components of the pelvic examination to identify benign or malignant disease (strong, low). 2) Health care providers may consider discussing the risks and benefits of performing a baseline pelvic examination including visual and bimanual examination prior to prescribing hormonal replacement therapy/menopausal hormonal treatment (weak, very low). Asymptomatic Women. 3) Health care practitioners should perform cervical cytology cancer screening in accordance with provincial/territorial guidelines (strong, strong). 4) There is insufficient evidence to guide recommendations on screening pelvic examination for noncervical gynaecologic malignancy or any benign gynaecologic disease in healthy, asymptomatic women with average risk of malignancy. However, health care practitioners may consider performing a screening pelvic examination including visual, speculum, and bimanual examinations in concert with cervical cytology sampling intervals as recommended by provincial/territorial guidelines. This practice may identify clinically important benign or malignant disease not recognized or reported by the patient (weak, very low). 5) In women over age 70 who no longer require screening with cervical cytology, health care practitioners should consider continuing periodic screening of asymptomatic women for vulvar disease with inspection of the vulva, perineum, and anus to identify benign or malignant disease unrecognized by this population. There is insufficient evidence to guide recommendations on frequency of this examination (weak, low). 6) Women with a personal history of gynaecologic malignancy, a genetic diagnosis that increases gynaecologic malignancy risk, or a history of in utero diethylstilbestrol exposure may benefit from more frequent screening pelvic examinations to identify early primary, recurrent, or metastatic malignancy in the absence of symptoms. Because there is inadequate evidence to define these screening intervals, they should be in accordance with provincial/territorial guidelines and expert opinion (weak, very low). 7. Non-invasive and self-collection screening options for chlamydia and gonorrhea are acceptable in asymptomatic women, but pelvic examination, including visual inspection, speculum examination, and bimanual examination, is required in the presence of symptoms to rule out pelvic inflammatory disease or tubo-ovarian abscess (strong, low). 8) No pelvic examination is required prior to prescription of hormonal contraception in a healthy woman with no gynaecologic symptoms (strong, low).

No 385 - Indications de l'examen pelvien.

OBJECTIF: L'objectif principal du présent document est de clarifier les indications de l'examen pelvien. UTILISATEURS CONCERNéS: Médecins, y compris les gynécologues, obstétriciens, médecins de famille, urgentologues; infirmières, y compris les infirmières autorisées et les infirmières praticiennes; sages-femmes, y compris les sages-femmes en pratique clinique et les apprenties sages-femmes et les apprentis en médecine, y compris les étudiants de médecine, résidents, stagiaires (fellows); et tous les autres fournisseurs de soins de santé qui prodiguent des soins aux femmes. POPULATION CIBLE: La présente publication fournit des données probantes et des recommandations fondées sur des avis d'experts sur l'examen pelvien chez les femmes adultes (18 ans et plus) avec et sans symptômes gynécologiques. ISSUES: La présente publication clarifie les indications de l'examen pelvien dans le contexte des déclarations de groupes d'étude nationaux récemment publiées sur l'utilité de l'examen pelvien. L'objectif est de veiller à ce que les femmes qui présentent des indications cliniques d'examen fassent rapidement l'objet d'une évaluation clinique adéquate pour diagnostiquer les maladies traitables. DONNéES PROBANTES: Pour la présente opinion de comité, les études pertinentes ont été repérées dans PubMed et Medline à l'aide des termes suivants, seuls ou combinés, et les recherches ont été limitées aux publications en anglais portant sur des humains sans date limite de publication : pelvic examination, bimanual examination, speculum examination, rectovaginal examination, ovarian cancer screening, asymptomatic women, periodic health examination. La recherche a été effectuée en mai et en juin 2018. Les données probantes pertinentes ont été retenues dans l'ordre suivant : méta-analyses, revues systématiques, lignes directrices et déclarations des groupes d'étude nationaux, essais cliniques randomisés, études de cohorte prospective, études observationnelles, revues non systématiques, études de série de cas et rapports. Des articles supplémentaires ont été repérés en consultant les notices bibliographiques des publications sélectionnées. Une revue systématique officielle n'a pas été menée pour tous les sujets discutés en raison du manque de données probantes et du nombre de différents sous-thèmes abordés. Le nombre total de publications examinées dans le cadre de cette revue était de 66. MéTHODES DE VALIDATION: Les auteurs principaux ont rédigé le contenu et les recommandations et ils se sont entendus sur ces derniers. Les conseils d'administration de la Society of Gynecologic Oncology of Canada (GOC), de Collège des médecins de famille du Canada (CMFC) et de la Société des obstétriciens et gynécologues du Canada (SOGC) ont approuvé la version définitive aux fins de publication après que leurs comités représentatifs respectifs l'aient passée en revue. La qualité des données probantes utilisées dans le présent document a été évaluée au moyen des critères du cadre méthodologique GRADE (Grading of Recommendations, Assessment, Development, and Evaluation). (Tableaux 1 et 2) Le résumé des conclusions est disponible sur demande. AVANTAGES, PRéJUDICE ET COûTS: La présente opinion de comité devrait aider toutes les femmes qui souffrent ou non de symptômes gynécologiques qui se présentent chez le gynécologue et un fournisseur de soins primaires. Elle aidera les praticiens à déterminer les indications d'examen pelvien afin de réduire le nombre d'examens inutiles et susceptibles de porter préjudice tout en augmentant le nombre d'examens indiqués afin de réduire les retards de diagnostic des affections gynécologiques traitables. MISE à JOUR DE LA DIRECTIVE CLINIQUE: La présente opinion de comité de la SOGC sera automatiquement passée en revue cinq ans après sa publication pour déterminer si une partie ou l'ensemble de l'opinion de comité devrait être mis à jour. Cependant, cette revue peut être effectuée plus tôt si de nouvelles recherches révolutionnaires sont publiées entre-temps. DÉCLARATIONS SOMMAIRES: 1) Les déclarations et les directives nationales et internationales sur l'examen pelvien ne devraient pas être interprétées comme si l'examen pelvien est superflu, qu'il ne contribue pas à l'évaluation physique ou que l'examen pelvien chez les femmes symptomatiques devrait être omis. 2) L'examen pelvien peut comprendre les examens visuels, au spéculum, bimanuel, à un doigt ou rectovaginal selon l'indication d'examen. 3) Aucune étude publiée à ce jour n'a évalué adéquatement quelque composante que ce soit de l'examen pelvien comme méthode de dépistage pour quelconque type de maladie gynécologique maligne, à l'exception de l'examen au spéculum pour le dépistage cytologique du cancer du col de l'utérus. Ainsi, toute recommandation universelle, pour ou contre les examens pelviens pour d'autres indications ne peut qu'être faite selon l'opinion des spécialistes et des données probantes de faible qualité. 4) Chez les femmes asymptomatiques dont le risque de cancer du col de l'utérus est moyen, le dépistage cytologique du cancer du col de l'utérus réduit à la fois son incidence et son taux de mortalité en détectant les lésions préinvasives traitables. 5) Chez les femmes asymptomatiques dont le risque de tumeur ou affection maligne est moyen, un examen visuel et bimanuel au moment d'obtenir des échantillons cytologiques cervicaux peut apporter une valeur ajoutée à cette méthode de dépistage. Les femmes peuvent ne pas soulever certaines inquiétudes sur le plan gynécologique jusqu'au moment de l'examen pelvien; l'examen offre une occasion de sensibiliser les patientes et de maintenir les compétences du praticien; de plus, même si le sujet n'a pas encore été étudié adéquatement, il pourrait comporter des effets positifs sur les tumeurs ou affections malignes ovariennes et vulvaires qui nécessiteraient des analyses plus poussées. Ces avantages potentiels devraient être soupesés par rapport aux préjudices potentiels comme l'inconfort de la patiente et les faux positifs ou négatifs qui pourraient la rassurer à tort ou entraîner des analyses et des interventions non justifiées. RECOMMANDATIONS: Femmes symptomatiques 1) Toute femme qui exprime des plaintes de nature gynécologique, y compris, mais sans s'y limiter, des plaintes concernant la vulve, des pertes vaginales, des saignements préménopausiques anormaux, des saignements postménopausiques, l'infertilité, des symptômes de prolapsus des organes pelviens, l'incontinence urinaire, de nouveaux symptômes gastro-intestinaux inexpliqués (douleur abdominale, distension abdominale ou ballonnement et difficulté à manger ou satiété précoce), la douleur pelvienne ou la dyspareunie, devrait subir des composantes pertinentes de l'examen pelvien afin de détecter les maladies bénignes ou malignes (forte, basse). 2) Les fournisseurs de soins de santé peuvent envisager de discuter des risques et avantages de l'exécution d'un examen pelvien de base qui comprend un examen visuel et un examen bimanuel avant de prescrire une hormonothérapie substitutive ou un traitement hormonal de la ménopause (faible, très basse). Femmes asymptomatiques 3) Les professionnels de la santé devraient faire le dépistage cytologique du cancer du col de l'utérus conformément aux lignes directrices provinciales ou territoriales (forte, forte). 4) Les données sont insuffisantes pour orienter les recommandations sur l'examen pelvien aux fins de dépistage de tumeurs ou affections malignes de nature gynécologique non cervicales ou de toute maladie gynécologique bénigne chez les femmes asymptomatiques en santé dont le risque de tumeur ou affection maligne est moyen. Cependant, les professionnels de la santé peuvent envisager d'effectuer un examen pelvien aux fins de dépistage comprenant les examens visuel, bimanuel et au spéculum conjointement avec le prélèvement d'échantillons cytologiques cervicaux selon les intervalles recommandés dans les lignes directrices provinciales ou territoriales. Cette pratique pourrait permettre de détecter d'importantes maladies bénignes ou malignes non reconnues ou signalées par la patiente (faible, très basse). 5) Chez les femmes âgées de plus de 70 ans qui n'ont plus à subir de dépistage cytologique cervical, les professionnels de la santé devraient envisager de continuer chez les femmes asymptomatiques le dépistage périodique des maladies vulvaires en examinant la vulve, le périnée et l'anus afin de détecter les maladies bénignes ou malignes méconnues de cette population. Les données sont insuffisantes pour déterminer des recommandations sur la fréquence de cet examen (faible, basse). 6) Des examens pelviens de dépistage plus fréquents pour déceler les signes précoces de tumeurs ou affections malignes primitives, récidivantes ou métastatiques en l'absence de symptômes pourraient s'avérer bénéfiques pour les femmes qui ont des antécédents personnels de tumeurs malignes de nature gynécologique, un diagnostic génétique qui augmente le risque de tumeurs ou affections malignes gynécologiques ou des antécédents d'exposition in utero au diéthylstilbestrol. Puisque les données pour déterminer ces intervalles de dépistage sont inadéquates, on devrait les déterminer en fonction des lignes directrices provinciales ou territoriales et de l'opinion des spécialistes (faible, très basse). 7) Les options non effractives et par auto-prélèvement de dépistage de la chlamydia et de la gonorrhée sont acceptables chez les femmes asymptomatiques, mais l'examen pelvien, qui comprend les examens visuel, bimanuel et au spéculum, est requis en présence de symptômes pour écarter la possibilité d'une maladie inflammatoire pelvienne ou d'un abcès tubo-ovarien (forte, basse). 8) Aucun examen pelvien n'est requis avant la prescription de contraception hormonale chez une femme en santé qui ne présente aucun symptôme gynécologique (forte, basse).

Utilizing Nurses to Staff an Ebola Vaccine Clinical Trial in Sierra Leone during the Ebola Outbreak.

Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

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Clinical Trials Registration: ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].