Reproductive health in central and eastern Europe: priorities and needs

The countries in Central and Eastern Europe combine induced abortion as the method of choice for family planning with low contraceptive use (Hungary and Slovenia excepted). This widespread use of induced abortion has a negative influence on reproductive and general public health, and an effort should be made to introduce modern, effective family planning. Both information, education and communication (IEC) programmes (for the users) and training in contraceptive technology and counselling (for the providers) is badly needed, as well as a continuing supply of contraceptives. In order to design optimal programmes, more research into knowledge, attitude and practice with regard to sexuality, sexual behaviour and contraception is urgently needed. So far, little research into contraceptive behaviour and its determinants has been done in Central and Eastern Europe, but the few data that are available point towards a lack of contraceptive knowledge in both the population and amongst contraception providers. The cultural differences between Western and Eastern industrialized countries are often underestimated or ignored, but because of the special situation in the countries in Central and Eastern Europe, education programmes which were successful elsewhere in the world may not work in these countries and may require extensive adaption to local needs and customs. Alternatively, special education programmes need to be developed. Programmes, especially those addressing contraception, should be combined with a long-term commitment for support and the provision of contraceptives.     

Clinical evaluation of drugs used in fertility regulation

The clinical evaluation of drugs used In fertility regulationis initially assessed in Phase I, II and III trials. The designof each phase and the investigative staff must be adequate.In Phase I, normal, healthy human volunteers meeting specificguidelines are usually studied. Numbers vary between 20 and80 and the purpose is to determine the acute toxicity of thecompound. In Phase II, efficacy and safety are examined in aclinical target population, and emphasis may be placed on pharmacologicaland mechanistic studies. Usually between 50 and 200 patientsare involved. In Phase III, large-scale clinical studies forlocal registration and the introduction of drugs to variouscountries are included. This paper describes the evaluationof various drugs used in contraception, induding NORPLANT^®implants, and considers the efficiency, safety and acceptabilityof such drugs. Phase IV studies are usually needed to revealchronic toxicities or rare events. ^*Based on a paper presented at the conference in Post-MarketingSurveillance of Drugs used in Fertility Regulation, organizedby the International Committee for Research in Reproduction,Leuven, 17–19 October 1985.     

Factors in the regulation of fertility in deprived populations

Background: Real differences in the duration of post-partum amenorrhoea for similar breastfeeding practices are observed in different populations.

Aim: The present study investigated the role of energetics in the regulation of fertility among lactating women with high levels of physical activity and poor nutritional status.

Subjects and methods: From 1996 to 1998, we carried out a longitudinal survey on the factors regulating fertility in lactating women. All women in our sample (n=150) had poor nutritional status and high levels of physical activity, and most of them were illiterate. Half of them were tea workers, and the other half were housewives of male tea workers. They lived in the same villages inside the tea plantation, and were highly comparable.

Results: Survival analysis revealed a very significant longer median duration of post-partum amenorrhoea for tea workers (636 days) compared with non-workers (375 days) although the tea workers cannot breastfeed during the working day. These durations are much longer than those of the WHO multinational study, carried out with a similar protocol, where the medians ranged between 122 and 282 days.

Conclusion: We suggest that our findings highlight the effect of energetics on the regulation of fertility in lactating women.     

Materializing research promises: opportunities,priorities and conflicts in translational medicine

There is considerable evidence that the translation rate of major basic science promises to clinical applications has been inefficient and disappointing. The deficiencies of translational science have often been proposed as an explanation for this failure. An alternative explanation is that until recently basic science advances have made oversimplified assumptions that have not matched the true etiological complexity of most common diseases; while clinical science has suffered from poor research practices, overt biases and conflicts of interest. The advent of molecular medicine and the recasting of clinical science along the principles of evidence-based medicine provide a better environment where translational research may now materialize its goals. At the same time, priority issues need to be addressed in order to exploit the new opportunities. Translational research should focus on diseases with global impact, if true progress is to be made against human suffering. The health outcomes of interest for translational efforts need to be carefully defined and a balance must be struck between the subjective needs of healthcare consumers and objective health outcomes. Development of more simple, practical and safer interventions may be as important a target for translational research as the development of cures for diseases where no effective interventions are available at all. Moreover, while the role of the industry is catalytic in translating research advances to licensed interventions, academic independence needs to be sustained and strengthened at a global level. Conflicts of interest may stifle translational research efforts internationally. The profit motive is unlikely to be sufficient alone to advance biomedical research towards genuine progress.     

Determining priorities for change in primary care: the value of practice-based needs assessment.

BACKGROUND: Primary care is being expected to expand the range of services it provides, and to take on many of the tasks traditionally provided in secondary care. At the same time, general practitioners (GPs) will become increasingly responsible for assessing their patients' health care needs and commissioning care from other providers. This article describes an approach taken in one general practice to meet these difficult challenges. AIM: To examine whether information on health and health care needs, when used as the basis for a priority setting exercise, can provide a useful first step in planning primary care provision within a practice. METHOD: A three-stage process of information-gathering from a number of sources, including continuous data recording of patient contacts and a postal survey of all adults registered with the practice, identification of key findings and discussion of associated issues, and priority setting of proposals for practice development using the nominal group technique. RESULTS: Continuous data recording of patient contacts with GPs and the practice nurse provided data on 4489 GP contacts with 2027 patients, 1000 district nurse contacts with 101 patients, and 361 health visitor contacts with 172 clients. More than 70% of patient records had been computerized, with 600 diagnostic READ codes identified and 11,500 separate entries made. The socioeconomic and health survey questionnaire achieved an 84% response rate. Following the priority-setting exercise, 28 proposed practice developments were identified. These were reduced to a final list of eight. CONCLUSION: A comprehensive method of practice-based needs assessment, when used as the basis for some form of priority setting, has great potential in helping to plan primary care services within a practice. The success of such initiatives will require a substantial investment of resources in primary care and fundamental changes to the way in which primary care is funded.     

Effects on the breast of drugs used in fertility regulation

The action of fertility-regulating drugs on the breast is discussed.Compounds such as steroids act directly on breast tissues, whereasothers, such as clomiphene or gonadotrophin, act indirectly.There can be differential responses of the alveolar and ductalsystems. Tissues of a breast tumour typical of epithelial tissueswere analysed for changes in cytosolic and nuclear receptorsfor oestradkl-17 and progesterone following its exposure tothese steroids. Effects on cell multiplication and receptordensity were identified. The relationship of these findingsto benign breast disease and oral contraceptives is discussed.     

N-ethyl-N-nitrosourea (ENU) mutagenesis and male fertility research

Male infertility affects about 1 in 25 men in the western world. Conversely, there is an urgent requirement for additional male-based contraceptives, yet progress in both areas has been severely hampered by a lack of knowledge of the biochemistry and physiology of male reproductive function. It is only through a thorough knowledge of these processes that we can hope to insightfully regulate male reproductive function. Without doubt, mouse models will form an important foundation in any future process. In recent years, the chemical mutagen N-ethyl-N-nitrosourea (ENU) has been used widely to identify genes essential for a range of biological systems including male infertility. These studies have shown random mutagenesis is an attractive means of identifying key genes for male fertility. This technique has distinct, but complementary advantages compared to knockout technologies. Specifically, it allows the removal of researcher bias whereby only pre-conceived genes are tested for function; it produces mice with a guaranteed phenotype and allows for the production of allelic series of mice to dissect all aspects of gene function. ENU mouse mutagenesis programs will enable advances in the diagnosis and treatment of human male infertility and ultimately aid in the development of novel male-based contraceptives.     

Organizational principles of fertility regulation in the USSR. A review

The author describes the organization of family planning services in the USSR, including contraception, induced abortion, and treatment for infertility.     

Antenatal needs of couples following fertility treatment: a qualitative study in primary care

Background

It is known that couples may experience emotional distress while undergoing infertility treatment, but less is known about their experience of pregnancy following successful conception. Typically, couples are discharged from the fertility clinic to receive standard antenatal care. Recent research has raised questions about whether this care adequately meets their needs.

Aim

To explore the antenatal experiences of females and males who have successfully conceived through infertility treatment.

Design and setting

An exploratory qualitative approach was undertaken, using individual, in-depth interviews with females and males who had successfully undergone infertility treatment in one of three fertility clinics in the south of England.

Method

Twenty participants were interviewed (12 females and eight male partners) when their pregnancy had reached 28 weeks’ gestation. Participants were asked about their experiences of infertility treatment, pregnancy, and antenatal care. Interviews were audiorecorded, transcribed, and analysed thematically.

Results

Analysis of the interviews suggested females and males experienced a ‘gap’ in their care, in terms of time and intensity, when discharged from the fertility clinic to standard antenatal care. This gap, combined with their previous experience of infertility treatment, heightened their fear of pregnancy loss and increased their need for support from their health professionals. Participants’ previous experience of infertility treatment also appeared to deter them from preparing for the birth and parenthood, and disclosing negative feelings to others about the pregnancy.

Conclusion

Females and males who have successfully undergone infertility treatment may require additional support in primary care to address anxiety during pregnancy, enable disclosure of negative feelings, and to help them prepare for childbirth and parenthood.     

Setting priorities in global child health research investments: assessment of principles and practice

This article reviews theoretical and practical approaches for setting priorities in global child health research investments. It also provides an overview of previous attempts to develop appropriate tools and methodologies to define priorities in health research investments. A brief review of the most important theoretical concepts that should govern priority setting processes is undertaken, showing how different perspectives, such as medical, economical, legal, ethical, social, political, rational, philosophical, stakeholder driven, and others will necessarily conflict each other in determining priorities. We specially address present research agenda in global child health today and how it relates to United Nation's (UN) Millennium Development Goal 4, which is to reduce child mortality by two-thirds between 1990 and 2015. The outcomes of these former approaches are evaluated and their benefits and shortcomings presented. The case for a new methodology for setting priorities in health research investments is presented, as proposed by Child Health and Nutrition Research Initiative, and a need for its implementation in global child health is outlined. A transdisciplinary approach is needed to address all the perspectives from which investments into health research can be seen as priorities. This prioritization requires a process that is transparent, systematic, and that would take into account many perspectives and build on advantages of previous approaches.     

Promotion of research in human reproduction: global needs and perspectives

The WHO Special Programme of Research, Development and ResearchTraining in Human Reproduction was established in 1972, to respondto a global expansion in research needs in human reproduction,especially in the area of fertility regulation. The Programme'slimited resources come from voluntary contributions by governmentsand International agencies. The emphasis is always on the needsof developing countries. The Programme has to keep the fieldunder continuous review, and to direct its limited resourcesto the major unmet needs. This paper presents, from a globalperspective, the needs and priorities in the promotion of researchin human reproduction. It Is emphasized that research has tobe backed up by political commitment and resources if it isto have an impact on reproductive health. The role of determinantsof health, other than and beyond the medical services, has alsoto be recognized. Promotion of research in human reproduction,to serve developing country needs, has to move into two directions.One is the mobilization of a global effort to develop and testtechnologies, where the available technologies are not satisfactoryto meet the needs and where the research is slackening. Thesecond is the strengthening of in-country resources for researchto deal with country-specific problems and to enable countriesto utilize, to the best, available technologies.     

Setting priorities in global child health research investments: addressing values of stakeholders

Aim

To identify main groups of stakeholders in the process of health research priority setting and propose strategies for addressing their systems of values.

Methods

In three separate exercises that took place between March and June 2006 we interviewed three different groups of stakeholders: 1) members of the global research priority setting network; 2) a diverse group of national-level stakeholders from South Africa; and 3) participants at the conference related to international child health held in Washington, DC, USA. Each of the groups was administered different version of the questionnaire in which they were asked to set weights to criteria (and also minimum required thresholds, where applicable) that were a priori defined as relevant to health research priority setting by the consultants of the Child Health and Nutrition Research initiative (CHNRI).

Results

At the global level, the wide and diverse group of respondents placed the greatest importance (weight) to the criterion of maximum potential for disease burden reduction, while the most stringent threshold was placed on the criterion of answerability in an ethical way. Among the stakeholders’ representatives attending the international conference, the criterion of deliverability, answerability, and sustainability of health research results was proposed as the most important one. At the national level in South Africa, the greatest weight was placed on the criterion addressing the predicted impact on equity of the proposed health research.

Conclusions

Involving a large group of stakeholders when setting priorities in health research investments is important because the criteria of relevance to scientists and technical experts, whose knowledge and technical expertise is usually central to the process, may not be appropriate to specific contexts and in accordance with the views and values of those who invest in health research, those who benefit from it, or wider society as a whole.When decisions on investments in health research are made, the term “stakeholders” refers to all individuals and/or groups who have interest in prioritization of those investments. The stakeholders will therefore comprise a large and highly heterogeneous group. Some apparent examples may include research funding agencies (eg, governmental agencies, private organizations, public-private partnerships, international and regional organizations, and taxpayers of a certain region), direct recipients of the funding (eg, researchers and research institutions), beneficiaries of the research (eg, policy makers and the general population of a country), and any other group with interest in prioritization process (eg, advocacy groups, journalists and media, lawyers, economists, experts in ethics, and many others).Two fundamental characteristics of any acceptable and successful priority setting process are legitimacy and fairness (1). In order to ensure the legitimacy and fairness of the priority setting decisions in health research investments, involvement of a wide range of stakeholders (and/or eliciting their values) is needed. Unfortunately, health research priorities are presently mainly driven by technical experts (2-5). The results of prioritization are therefore in danger of being mostly influenced by their personal views, with minimal input from representatives from the wider community who also may have interest in the process but lack technical expertise. Since the values and criteria important to scientists and technical experts may vary remarkably from those of other relevant stakeholders (6-8), the relevance of eliciting wider stakeholders’ input is increasingly being acknowledged (9-11). However, the main challenge is to develop a systematic, flexible, and repeatable strategy on how this can be achieved in different contexts.The literature on priority setting for health interventions identifies two main strategies: 1) stakeholders’ values may impact decisions through procedural processes (by having access to the decisions and the rationales behind the decisions, and by having the authority to deliberate on the decisions and influence the final outcome); 2) stakeholders’ values can be directly elicited using quantitative methods (through surveys where respondents rank, weigh, or rate their values) and qualitative methods (involving individual interviews, Delphi technique, complaints procedures or group discussions, concept mapping, citizen’s jury, and public meetings) (12). The main challenges in those attempts have mainly been the lack of capacity for some stakeholders to engage in meaningful deliberations (13) and how to practically incorporate the elicited stakeholders’ values in decision-making (12,14). This paper presents our suggestions and experiences on how the values and interests of large and diverse group of stakeholders could still be incorporated in decisions on health research investment priorities. We specified thresholds and weights needed to address stakeholders’ values within CHNRI methodology using three different versions of a questionnaire. We aimed to assess stakeholders’ values for priority setting in global health research investments. We tested questionnaires that presented different levels of complexity and detail of the questions that stakeholders’ representatives would be asked. We also aimed to evaluate different strategies of turning their responses into numerical thresholds and weights.