Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study.

BACKGROUND: Data sharing among stakeholders in the development, access, and use of drug therapies is critical but the current system and process are inefficient. METHODS: We take a Systems Engineering approach with a realistic use case to propose a scalable design for multi-stakeholder data sharing. RESULTS: We make three major contributions to the drug development and healthcare communities: first, a methodology for developing a multi-stakeholder data sharing system, with its focus on high-level requirements that influence the design of the system architecture and technology choice; second, the development of a realistic use case for long-term patient and therapy data tracking and sharing in the use of potentially curative and durable gene and cell therapies. Further, a bridge for the 'awareness gap' was found between the payer (Payer is organization which takes care of financial and operational aspects (which include insurance plans, provider network) of providing health care to US citizens. Or refer to health care insurers.) and the regulator communities by illustrating the common data tracking needs, which highlights the need for coordinated data activities; and third, a proposed system architecture for scalable, multi-stakeholder data sharing. Next steps are briefly discussed. CONCLUSION: We present a system design for multiple stakeholders such as the payer, the regulator, the developer (drug manufacturer), and the healthcare provider to share data for their decision-making. The stakeholder community would benefit from collaboratively moving the system development proposal forward for efficient and cost-effective data sharing.

'I won't be able to go home being pregnant': sex work and pregnancy in Dhaka, Bangladesh.

Sex workers report high rates of unintended pregnancy that are inconsistent with widespread reports of condom use. Greater understanding of the implications of an unintended pregnancy and barriers to contraceptive use is needed to better meet the broader sexual and reproductive health needs of this population. We conducted in-depth interviews with 20 women sex workers in Dhaka, Bangladesh. Findings reveal that most women are trying to conform to societal norms and protect their reputations. They fear pregnancy would reveal that they are having unsanctioned sex and that they are sex workers. This could lead to ostracism from families and society, resulting in homelessness and abandonment by partners. Pregnancy may affect a sex worker's ability to work and leave her unable to meet financial obligations. All study participants were using condoms but most acknowledged they could not use them consistently. They had all tried other contraceptive methods, notably injectables and the pill, but some noted experience of side-effects, difficulties in adherence and the desire to use other methods. Understanding the context of sex workers' lives is an important step in informing stakeholders about the range of services needed to improve their sexual and reproductive health.

A nonsurgical permanent contraception stakeholder advisory committee: FHI 360's experience.

As part of its research program on nonsurgical permanent contraception, FHI 360, a nonprofit human development organization, created a stakeholder advisory committee to help address the controversy surrounding quinacrine. This committee contributed to FHI 360's research agenda, liaised with other stakeholders and provided input on key decisions. This report summarizes the process for establishing the committee, delineates the successes and challenges that arose and specifies recommendations for other organizations considering stakeholder collaboration.

Understanding the Broader Sexual and Reproductive Health Needs of Female Sex Workers in Dhaka, Bangladesh.

CONTEXT: Little is known about the sexual and reproductive health care needs of female sex workers in Dhaka, Bangladesh. METHODS: Survey data were collected from 354 hotel-based and 323 street-based female sex workers using a venue-based stratified cluster sampling approach. In addition, in-depth interviews were conducted with 20 female sex workers recruited from drop-in centers. We calculated unmet need for family planning and examined fertility desires, use of condoms and other contraceptive methods, experiences with gender-based violence, sexual and reproductive health service needs, and preferences on where to receive services. RESULTS: The prevalence of unmet need was 25% among hotel-based female sex workers and 36% among street-based female sex workers. Almost all participants reported having used condoms in the past 30 days, and 44% of hotel-based sex workers and 30% of street-based sex workers reported dual method use during that period. Condom use was inconsistent, however, and condom breakage and nonuse for extra money were common. Many women reported experiencing gender-based violence. Sexual and reproductive health services had been obtained by 64% of hotel-based and 89% of street-based sex workers in the past six months; drop-in centers were their preferred site for receiving health services. CONCLUSIONS: Female sex workers in Dhaka need family planning and other sexual and reproductive health services and prefer receiving them from drop-in centers.

Methodological quality of World Health Organization medical eligibility criteria for contraceptive use.

It presents an article talking about the WHO medical eligibility criteria for the use of contraceptive, strengths and weaknesses, industrialized and developing countries, and methodological quality and family planning.

Methodological quality of WHO medical eligibility criteria for contraceptive use.

The use of consensus recommendations and clinical guidelines is now widespread in industrialized countries and is becoming more common in developing countries. As guidance documents have become more influential, their methodological rigor has come under closer scrutiny. Using two independently developed scales, we assessed the methodological quality of an important set of guidelines developed by the World Health Organization (WHO). The consensus recommendation document called Improving Access to Quality Care in Family Planning: Medical Eligibility Criteria for Contraceptive Use has become the basis for national guidelines in dozens of countries. We compared the quality of the WHO guidelines to that of over 300 previously assessed, published guidelines. In most categories of quality, the WHO document exceeded the mean scores for other published guidelines. We discuss these comparisons, as well as the strengths and weaknesses of the WHO guidelines.

Reproductive health knowledge and use of services among young adults in Dakar, Senegal.

A study was conducted in Dakar, Senegal, to measure reproductive health knowledge and contraceptive use among young adults, and access to family planning services. A household survey was conducted with 1973 single and married women aged 15-24 and 936 single men aged 15-19. Two focus groups and a simulated client study were also conducted. The survey and focus groups noted gaps in knowledge of family planning methods and reproductive health. There were misconceptions about methods and only one-third of men and women aged 15-19 correctly identified the time of the menstrual cycle when a women is most likely to get pregnant. Contraceptive use at time of first premarital sexual experience was less than 30%. The simulated client study noted many barriers to services. 'Clients' felt uncomfortable in the clinics and felt that providers were reluctant to take care of them. None of the 'clients' who requested contraception received it.