Aged gametes,adverse pregnancy outcomes and natural family planning: An epidemiologic review

Unconfirmed epidemiologic studies suggest a possible increased risk of birth defects associated with Natural Family Planning (NFP) use, and an increased incidence of spontaneous abortion or frequency of chromosomal abnormalities in abortuses associated with conceptions outside the most “fertile period”. The risk is approximately two- to four-fold, but the evidence is by no means conclusive. The implication for NFP depends on the frequency of method failures in user populations, but is not likely to constitute a major hazard. Further research could utilize a data bank of NFP charts.     

The benefits and barriers associated with a national natural family planning service: the New Zealand experience

This paper provides a case study of a model for expanding natural family planning (NFP) from a small local program to the national level through the creation of a national association and the development of a public-private partnership. The experience of the New Zealand Association of Natural Family Planning (NZANFP) is analyzed in terms of both the benefits and barriers of using this model. Recommendations are given to guide others in developing a similar model.     

A thirty-month clinical experience in natural family planning.

A Natural Family Planning service was evaluated at the end of a 30-month developmental phase. There were 444 women taught and 322 method acceptor of which 248 intended to avoid pregnancy. NFP clients were older (mean age 26.9 vs 22.4 and 23.7 for comparison groups), and a larger percentage were married (83.1 per cent vs 23.0 per cent for the comparison group). After one year of use, the unplanned pregnancy rate was 14.4 per cent and the total dropout rate was 37.6 per cent by life table analysis.     

Natural family planning in New Zealand: a study of continuation rates and characteristics of users

This study has determined long-term continuation rates of clients who attended clinics of the New Zealand Association of Natural Family Planning and became autonomous users. It has also identified factors which might influence the continuation of NFP use.A total of 509 female subjects, 452 of them with their male partners, were enrolled in the study at the beginning of clinic teaching. Once autonomous they were sent questionnaires at 6-monthly intervals for a period of 24 months. Time out was allowed for pregnancy. The number of female subjects entering the 2-year follow-up phase of the study was 406 (79.8%). Of these 164 completed 2 years of use with 102 (20% of study entrants) using NFP and 62 (12.2%) using fertility awareness in combination with a barrier method.Subjects for whom NFP was their first family planning method, who were Catholic or who gave religion as their reason for choosing NFP were more likely to continue long-term use.The majority of subject (> 90%) were highly satisfied with NFP use, with the most common reasons for satisfaction being self-awareness, freedom from drugs, naturalness and effectiveness. The difficulties reported related to abstinence and cycle interpretation.     

The TwoDay Algorithm: a new algorithm to identify the fertile time of the menstrual cycle

Women who monitor their fertility signs and recognize when they are fertile can use this knowledge to conceive or to avoid pregnancy. Studies have shown that there is a rather small fertile window of several days during each menstrual cycle. Established methods of identifying the fertile window, such as the Ovulation and the Symptothermal methods of Natural Family Planning, can be very effective in helping couples avoid pregnancy. A new algorithm for identifying the fertile window has been developed, based on monitoring and recording of cervical secretions. The TwoDay Algorithm appears to be simpler to teach, learn, and use than current natural methods. A large existing data set from a World Health Organization study of the Ovulation Method, along with Natural Family Planning charts from women using the Ovulation Method and the Symptothermal Method, were used to determine the potential effectiveness of the TwoDay Algorithm in identifying the fertile window. Results suggest that the algorithm can be an effective alternative for low literacy populations or for programs that find current Natural Family Planning methods too time consuming or otherwise not feasible to incorporate into their services. Further studies are needed to determine the efficacy of the TwoDay Algorithm in avoiding pregnancy and to assess its acceptability to users and providers.     

Expanded state-funded family planning services: estimating pregnancies averted by the Family PACT Program in California, 1997-1998

OBJECTIVES: The California Family Planning, Access, Care, and Treatment Program was implemented in 1997 to provide family planning services for uninsured, low-income women and men. We estimated the impact on fertility of providing 500 000 women with contraceptives. METHODS: Paid claims and medical record review data were used to estimate pregnancies averted. Pregnancies women experienced while enrolled in the program and pregnancies they would have experienced given methods used before enrollment were modeled as a Markov process. RESULTS: One year of Family Planning, Access, Care, and Treatment services averted an estimated 108 000 unintended pregnancies that would have resulted in 50 000 unintended births and 41 000 induced abortions. CONCLUSIONS: Providing contraceptives to low income, medically indigent women significantly reduced the number of unintended pregnancies in California.     

Diocesan-wide NFP program reaches broad population groups

3 natural family planning (NFP) programs in the Diocese of Harrisburg, Pennsylvania -- programs at St. Joseph Hospital in Lancaster, Holy Spirit Hospital, and Catholic Social Services -- have worked together as the principal NFP provider in central Pennsylvania. Since May 1978 the program has provided initial NFP instruction to more than 1300 clients (more than 800 women). Many of those served are farmers and rural people along with small numbers of industrial and government workers. This region comprises the urban areas of Harrisburg, York, and Lancaster and the remaining rural and small town population. These programs have focused on recruiting and training teachers, securing an adequate funding base, developing quality assurance and evaluation procedures to establish credibility in the community, providing fertility awareness instruction in the high schools and NFP services in the community, and marketing the service. Facts and statistics cited are from the unified programs. Instruction in the ovulation (OM) and symptothermal methods (STM) in the format specified by the Human Life and Natural Family Planning Foundation is provided. The program has developed an extensive quality control outline containing basic information on NFP service, client outcome, and record audits -- much of which focuses on the outline for distribution to government-funded family planning clinics. Of those women coming for initial instruction, about 30% never begin charting; 20% chart for fertility awareness only or to plan a pregnancy; and 50% chart to avoid pregnancy. The St. Joseph Hospital's program has measured the success of menstruating 1st interval acceptors in avoiding pregnancy. By life table analysis, at the end of 1 year 18% had unplanned pregnancies and another 30% had dropped out for other reasons, including changing their intention from avoiding pregnancy to planning pregnancy. The majority of unplanned pregnancies are to couples who are in the first months of use and are just learning the methods. These couples may not understand the methods and can make mistakes in method applications. Of those accepting the method over a period of 5 years, 1/3 have stopped charting. Of those who continue, approximately 1/3 are autonomous and need no active follow-up. The other 2/3 are actively being followed. The overall amount spent in the diocese on NFP has more than doubled from 1978-83, from approximately $30,000 to more than $60,000. Public acceptance of NFP is a major problem. Each service site is underused. Support structures need to be developed within all areas of the Catholic community.     

Collecting Patient Race/Ethnicity and Primary Language Data in Ambulatory Care Settings: A Case Study in Methodology

Objective. To collect patient race/ethnicity and language (r/e/l) in an ambulatory care setting.
Data Sources/Study Setting. The Palo Alto Medical Foundation (PAMF), December 2006–May 2008.
Study Design. Three pilot studies: (1) Comparing mail versus telephone versus clinic visit questionnaire distribution; (2) comparing the front desk method (FDM) versus exam room method (ERM) in the clinic visit; and (3) determining resource allocation necessary for data entry.
Data Collection/Extraction Methods. Studies were planned and executed by PAMF's Quality and Planning division.
Principal Findings. Collecting r/e/l data during clinic visits elicited the highest response rate. The FDM yielded higher response rate than the ERM. One full-time equivalent is initially necessary for data entry.
Conclusions. Conducting sequential studies can help guide r/e/l collection in a short time frame.     

The frequency and spectrum of congenital anomalies in natural family planning users in South America: No increase in a case-control study

Users of natural family planning (NFP) practice periodic abstinence,leading many to reason that such couples should show increased anomalies inoffspring as a result of fertilization involving aging gametes. In an effortto complement our NFP cohort study, we currently conducted a case-controlstudy in the same region (South America) in which the largest number ofcases have been recruited for our cohort NFP study. During 1992-94, 5324case-control pairs of mothers were interviewed during the immediatepostpartum period in 18 maternity hospitals participating in theLatin-American Collaborative Study of Congenital Malformations: ECLAMC(Spanish acronym for Latin-American Collaborative Study of CongenitalMalformations). Natural family planning (NFP) usage was recorded in6% of mothers in the ECLAMC sample studied (n = 10 648). Overall, nosignificant differences in frequency of NFP usage were observed betweenmalformed cases (349/5324 = 6.6%) and normal controls (303/5324 =5.7%) (2 = 3.3; df = 1; p > 0.05). No significant differencesin sex ratios were observed between children of NFP user and non-usermothers. Of special interest is the lack of association between NFP and Downsyndrome, the sentinel phenotype for the hypothesis of delayed fertilization(aging gametes).     

Natural family planning in the Philippines

The calendar rhythm method of natural family planning (NFP) is one of the most popular contraceptive methods in the Philippines. As a result, the Philippines has one of the highest NFP prevalence rates in the developing world. In recent years, family planning program officials have become increasingly interested in improving the practice of NFP, both by improving the quality of rhythm practice and by introducing newer, more accurate NFP methods. Over the years a substantial body of research data related to NFP practice in the Philippines has accumulated. This paper presents major findings from past research on NFP in the Philippines, discusses their implications for program management, describes current research, and suggests needs for future research.     

Die Bedeutung von Biobanken für die klinische Entwicklung

Access to samples in biobanks and collection of samples for evaluation of biomarkers in clinical trials are an essential basis for the identification and development of biomarkers. From the perspective of a research-based pharmaceutical company identification of biomarkers and the accompanying diagnostics are an essential prerequisite for the further evolution of personalised healthcare—and the key to more effective and efficient healthcare. Research-based pharmaceutical companies can basically use four types of biobanks: biobanks of university hospitals, commercial providers, collaborative groups and company-owned biobanks. Areas of application, arising from the use of biobanks in the context of clinical development, are collection of prevalence data, evaluation of biomarker stability in different disease stages, technical validation of assays, an optimized course of clinical studies by focusing on defined, biomarker-stratified groups of patients and pharmacogenetic research. Challenges are, in particular, the availability of clinically annotated samples and tissue matching blood samples, in addition to sample quality, number and amount. An acceptable legal and regulatory framework, as well as the positive perception of biomarker data by politicians and the public, are important prerequisites for translational research for identification of biomarkers in clinical studies. Also, the early establishment of research alliances between academia and the pharmaceutical industry are required to transfer research results in new strategies for prevention, diagnosis and treatment of patients.     

The Aboriginal Birth Cohort Study: When is a cohort study not a cohort design?

Aims: The paper describes how a variety of different epidemiological study designs can be applied to data arising from a single prospective study. Methods: An overview of the data collection phases of the Aboriginal Birth Cohort Study is given. We illustrate how different research questions that require different analytical designs can be asked of the data collected in the present study. Results: With reference to five generic questions in health research, we showed how sixteen specific questions could be addressed in the Aboriginal Birth Cohort Study. These referred to a range of analytical designs. Conclusion: Readers need to take care not to confuse the overall design of a study with the design of a specific analysis. When conducting systematic literature reviews, studies should be classified according to the analytical design used in the specific report included in the review and not according to the design of the overall project.     

The new politics of natural family planning

There has been an increase in interest in natural family planning (NFP) in recent years. The Roman Catholic Church and other groups sympathetic to NFP philosophy have pressured the US Agency for International Development (AID) to increase emphasis on NFP, and AID has responded by increasing funding devoted to NFP from US$0.8 to US$7.8 million from 1981-85. In 1985, AID exempted NFP providers from the requirement of providing direct or referral services for other methods, but repealed the exemption in 1986. Several methods fall under the NFP umbrella: rhythm, the estimation of ovulation time by the counting of days elapsed in relation to menstruation; and the more precise cervical musus; basal body temperature; and sympto-thermal methods. Because NFP requires considerable training, recording, and willingness to abstain, recruitment is difficult and dropout rates high. A 5-country World Health Organization study found that 17% of women dropped out during training, and 36% discontinued during the following year. At the 4th International Congress of the International Federation for Family Life Promotion (IFFLP), it was stressed that data on NFP prevalence classed by type of NFP are lacking. Questions raised included whether populations of countries that have achieved or hope to achieve a low birth rate will be interested in NFP; whether NFP can increase the risks of birth defects through fertilization by "aged gametes;" and whether NFP is capable of helping couples to select the sex of the child. The implications of the contraceptive effects of breastfeeding were reviewed. Some problems arise concerning evaluation of effectiveness: NFP advocates often do not consider couples who "break the rules" as acceptors, and when these couples are excluded from data the method appears much more effective. Traditionalists emphasize the increased quality that NFP brings to a marital relationship. Some participants maintained that rigid moral advocacy would deter many couples.     

A prospective cohort study of blood donors: methodological issues in the investigation of injuries and chronic diseases

Blood donors have made important contributions to research, most notably in cross-sectional seroprevalence studies. The proposed New Zealand Blood Donors Health Study is a prospective cohort study of 30,000 New Zealand donors designed to investigate the determinants of common injuries, cardiovascular disease and cancer. While robust from an analytic perspective, the execution of prospective cohort studies in many settings is impeded by methodological, economic and organisational barriers. We examined the operational considerations of implementing a large-scale cohort study at a transfusion centre and evaluated measures taken to optimise data collection procedures. A pilot study of 1,000 participants revealed donor motivation to participate in this research was high (91% response rate). Comprehensive exposure data on lifestyle, behavioural and psychosocial factors were obtained from 95% of participants. Substantial heterogeneity in levels of potential risk factors was noted among respondents. Detailed dietary habit information and a study blood sample were obtained from 67% and 100% of participants, respectively. Study recruitment and baseline data collection was feasible during routine donor visits with minimal interruption to donor centre staff and procedures. We conclude the study design and characteristics of the regional donor program enhance the efficiency and significance of the proposed research.     

The financial performance of selected investor-owned and not-for-profit system hospitals before and after Medicare prospective payment.

This article analyzes determinants of cost and profitability, including the influence of Medicare prospective payment (PPS), between 1983 and 1985 for nearly 300 hospitals belonging to investor-owned (IO) and not-for-profit (NFP) systems. Using approaches that assure comparability of financial data, and including case mix, quality, competition, and regulation measures, the findings indicate that (1) in both years, competitive environment, case mix, age of facility, and scope of diversified services were important determinants of average cost, while a process measure of quality was insignificant and the independent effect of ownership type was insignificant for cost; (2) effects of HMO competition and hospital strategy were stronger in 1985 than in 1983; (3) operating margins for all types of hospitals showed increases, with a somewhat greater improvement for NFP system members; and (4) significantly greater declines in volume of care occurred for IO system members. Implications for future research are discussed.     

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.     

《中国计划生育学杂志》论文中医学伦理意识的调查与思考

目的:从科技论文角度探讨我国计划生育科研工作中存在的医学伦理学问题。方法:查阅2005～2009年《中国计划生育学杂志》发表的学术论文,统计作者自述"通过伦理委员会审查""研究对象知情同意"情况。结果:5年间共出版60期(月刊),发表了以人为研究对象、前瞻性研究论文681篇,其中论文说明研究"经过伦理委员会审查"仅4篇(0.59%),"研究对象知情同意"49篇(7.20%)。结论:本次调查论文有关医学伦理学阐述的比例很低,反映出计划生育科研论文作者和编辑者的伦理学意识相当薄弱,与国外生物医学期刊差距较大。提示科技管理部门应重视对科研人员伦理学知识的宣传教育,加强计划生育科研工作伦理学规范。通过完善期刊编审程序,加强科研伦理学审查提高论文质量,促进我国人口和计划生育科学研究健康持续发展。     

Mode of questionnaire administration can have serious effects on data quality

BACKGROUND: One of the main primary data collection instruments in social, health and epidemiological research is the survey questionnaire. Modes of data collection by questionnaire differ in several ways, including the method of contacting respondents, the medium of delivering the questionnaire to respondents, and the administration of the questions. These are likely to have different effects on the quality of the data collected. METHODS: This paper is based on a narrative review of systematic and non-systematic searches of the literature on the effects of mode of questionnaire administration on data quality. RESULTS: Within different modes of questionnaire administration, there were many documented potential, biasing influences on the responses obtained. These were greatest between different types of mode (e.g. self-administered versus interview modes), rather than within modes. It can be difficult to separate out the effects of the different influences, at different levels. CONCLUSIONS: The biasing effects of mode of questionnaire administration has important implications for research methodology, the validity of the results of research, and for the soundness of public policy developed from evidence using questionnaire-based research. All users of questionnaires need to be aware of these potential effects on their data.