Medical Eligibility Criteria Research Articles

Guidance on medical eligibility criteria for contraceptive use: identification of research gaps

This article aims to stimulate research to address gaps in the Medical Eligibility Criteria for Contraceptive Use so that more women have access to the most appropriate contraceptive methods based on safety and effectiveness for their particular condition and characteristics. It identifies the three conditions for which further research is needed; contraception for obese women contraception for breastfeeding women and contraception for women with HIV or AIDS. Copyright © 2010 Elsevier Inc. All rights reserved.

Long acting reversible contraception

The lifetime risk of dying due to pregnancy in sub-Saharan Africa is 1 in 22. Many of these pregnancies are unintended. Long acting reversible contraception (LARC) has great potential in reducing these pregnancies as they are highly effective and do not rely a great deal on compliance and correct use. They have better continuation rates than short term hormonal contraception and as per definition require administration less than once per cycle or month. Despite these obvious advantages they remain largely underutilized even in developed countries even though being more cost effective. Lack of knowledge and myths amongst women and health professional remain a barrier to their use especially in adolescents at risk for unintended pregnancy. The World Health Organization (WHO) Medical eligibility criteria for contraceptive use provides guidance to health professionals in selecting the appropriate contraception for women. The LARC methods include copper intrauterine devices (Cu - IUDs), levonorgestrel- intrauterine systems (LNG-IUS), progestogen-only injectable contraceptives (POIC), progestogen-only subdermal implants and combined vaginal rings.Key words: Long acting reversible contraception

Supplemental Security Income (SSI) for Children and Youth With Disabilities

The Supplemental Security Income (SSI) program remains an important source of financial support for low-income families of children with special health care needs and disabling conditions. In most states, SSI eligibility also qualifies children for the state Medicaid program, providing access to health care services. The Social Security Administration (SSA), which administers the SSI program, considers a child disabled under SSI if there is a medically determinable physical or mental impairment or combination of impairments that results in marked and severe functional limitations. The impairment(s) must be expected to result in death or have lasted or be expected to last for a continuous period of at least 12 months. The income and assets of families of children with disabilities are also considered when determining financial eligibility. When an individual with a disability becomes an adult at 18 years of age, the SSA considers only the individual's income and assets. The SSA considers an adult to be disabled if there is a medically determinable impairment (or combination of impairments) that prevents substantial gainful activity for at least 12 continuous months. SSI benefits are important for youth with chronic conditions who are transitioning to adulthood. The purpose of this statement is to provide updated information about the SSI medical and financial eligibility criteria and the disability-determination process. This statement also discusses how pediatricians can help children and youth when they apply for SSI benefits.

Infection risk and intrauterine devices

For most women, intrauterine contraceptive devices (IUCD) are a safe option. Upper genital tract infections (pelvic inflammatory disease, PID) occur when pathogenic microorganisms ascend from the cervix and invade the endometrium and the fallopian tubes, causing an inflammatory reaction. Evidence-based recommendations regarding intrauterine contraception and risk of infection were presented at the Congress of the European Society of Contraception, in Prague, 2008: A clinical history (including sexual history) should be taken as part of the routine assessment for intrauterine contraception to identify women at high risk of sexually transmitted infections (STI); if appropriate a test should be offered; if symptoms or signs are present, appropriate diagnostic tests should be done, results awaited, necessary treatment completed, and IUCD insertion postponed until resolution. Prophylactic antibiotics are not recommended (evidence level II-3). STI screening is not routinely recommended. PID among IUCD users is most strongly related to the insertion process and to the background risk of STI (evidence level II-2). Conditions which represent an unacceptable health risk if an IUCD is inserted (WHO Medical Eligibility Criteria, MEC, Categories 3-4) are current PID, current purulent cervicitis, chlamydial or gonorrheal infection. For continuation as well as initiation, WHO MEC categories 3-4 are allotted to women with known pelvic tuberculosis, puerperal sepsis and septic abortion.

Subject Eligibility Criteria Can Substantially Influence the Results of Alcohol-Treatment Outcome Research

Most alcohol-treatment studies exclude some patients from participation based on particular criteria (e.g., comorbid illegal drug abuse, homelessness). The current study evaluated whether such eligibility criteria can change the outcome results a study obtains. Five widely used treatment research eligibility criteria--(1) psychiatric problems, (2) medical problems, (3) social-residential instability, (4) low motivation/noncompliance, and (5) drug problems--were applied to two samples of real-world alcohol patients whose outcomes were known. Comparing outcomes of the samples with and without the application of eligibility criteria produced estimates of bias in outcome results, as well as an assessment of change in statistical power. Medical and psychiatric eligibility criteria produced a moderate bias in outcome estimates (e.g., a 10% or less change in outcome results). In contrast, social-residential instability, low motivation/noncompliance, and drug use produced a large (e.g., up to an 18% change) to a very large (e.g., up to a 51% change) bias in outcome estimates. Sensitivity analyses showed that these biases are even larger if eligibility criteria are operationalized in a broad rather than a narrow fashion. Contrary to expectation, eligibility criteria did not produce their theoretically expected benefit of increased statistical power. Researchers who use eligibility criteria should do so judiciously and interpret outcome results in light of potential bias introduced by the ineligibility of some patients for study enrollment. Efforts to integrate findings across treatment outcome studies should also consider how conclusions might be affected by the eligibility criteria used in different research areas.

Migraine and stroke: the role of oral contraceptives

The use of oral contraceptives (OCs) confers an increased risk for ischaemic stroke (IS). This risk slightly decreases, but remains significant, if low-dose formulations are used, particularly if other risk factors, such as hypertension or smoking, are associated. Some inherited prothrombotic conditions (e.g., Factor V Leiden, G20210A prothrombin or methylenetetrahydrofolate reductase C677T polymorphism) could also greatly increase the IS risk if present in OC users. Migraine, particularly with aura, is an independent risk factor for IS, and the patient's IS risk is probably affected by other individual risk factors (e.g., age, genetic predisposition to thrombosis, presence of patent foramen ovale or enhanced platelet aggregation) which seem to be over-represented in migraine patients. IS risk among migraineurs is further increased when OCs are currently used and can become very high if associated with smoking. Consequently, in 2004 the WHO stated in its 'Medical Eligibility Criteria for Contraceptive Use' that women suffering from migraine with aura at any age should never use OCs. Moreover, since the exposure to the effects of OCs may greatly increase the IS risk in some migraine subpopulations with specific personal characteristic, testing for these risk factors may allow for more accurate stratification of the population at risk before long-term use of OCs is prescribed.

BOOK REVIEW

Glasier Anna and Gebbie Ailsa, editors: Handbook of Family Planning and Reproductive Healthcare, 5th edition, 448 pages. Churchill Livingstone, N 2007. ISBN 9780443068874. Price €44.99/GBP 24.99. In his foreword, John Guillebaud stresses the importance of the subject of this book by quoting James Grant of UNICEF, who in 1992 declared that “family planning could bring more benefits to more people at less cost than any other single technology now available to the human race”. More than half a million women die each year from unsafe abortion, pregnancy and childbirth. Furthermore, there are now more young people on the Earth than ever before, and unless they get knowledge about and access to safe and effective contraception, the global population will continue to grow with escalating demands on energy, food and water supply and most likely further stress on the environment. The first chapter of the book describes different fertility control strategies and emphasizes how women's needs vary over the course of their lives and with the culture they live in. There is also an interesting part on the subject of measuring effectiveness, pointing out the great difference between effectiveness with perfect use and with typical use – abstinence, for instance, is only 75% effective with typical use! The problems with using Pearl index as a measure of effectiveness are described, as well as safety, costs and user considerations. In chapters 3 – 16, all different contraceptive methods known to this reviewer are described with regard to mode of action, effectiveness, side effects, non-contraceptive benefits and user adherence. There are practical guidelines for insertion and removal of IUDs, IUSs and implants and for management of side effects such as breakthrough bleeding. The UK medical eligibility criteria for each contraceptive method are stated on a 4-category scale, from no restriction to unacceptable health risk if the method is used. This is clearly shown in tables for each method described and will be in line with required standards in most countries, although cultural differences may influence the guidelines. There are separate chapters on fertility awareness and postpartum contraception, emergency contraception, abortion and sterilization. The chapter on sexual health services for young people emphasizes the impact of socio-economic factors, sexually transmitted infections, unsafe abortion and sexual abuse, and on the culturally determined gender inequalities which can make it impossible for women to control their sexual activity. The last seven chapters deal with as different subjects as screening, menopause, genital infections, premenstrual syndrome, sexuality and contraception of the future. I find it difficult to identify the target group for this part of the book. The chapter on screening describes the guidelines in the UK, but will be of limited interest in other countries. The other subjects are generally dealt with on a level that is too low to be of interest for specialists. To non-specialists, the chapters may be of help when a quick overview is wanted, but many large and complicated areas are getting such a cursory treatment that it could be more confusing than informative. This is for instance the case for endometriosis, which is covered by one page of text. The probably limited usefulness of the last chapters does not change the fact that this handbook is an extremely thorough and practical guide to family planning. It is also up to date, well written, systematic and easy to find one's way around in. It is highly recommended for these qualities and will be of use both to medical students and health professionals.

Medical eligibility criteria for contraceptive use and The medical eligibility criteria wheel: tools for choosing the correct contraceptive for a patient

Medical eligibility criteria for contraceptive use and The medical eligibility criteria wheel: tools for choosing the correct contraceptive for a patient

Improving Access to Quality Care in Family Planning: WHO's Four Cornerstones of Evidence-based Guidance

The four cornerstones of guidance in technique service of family planning are established by WHO based on high quality evidences. They have been updated according to the appearing new evidences, and the consensuses were reached by the international experts in this field. The four documents include Medical Eligibility Criteria for Contraceptive Use, Selected Practice Recommendations for Contracep-tive Use, Decision-making Tool for Family Planning Clients and Providers and The Global Handbook for Family Planning Providers. The first two documents mainly face to the policy-makers and programme managers and were treated as the important references for creating the local guideline. The other two documents were developed for the front-line health-care and family planning providers at different levels, which include plenty of essential technical information to help providers improve their ability in service delivery and counselling. China paid great attention to the introduction and application of WHO guidelines. As soon as the newer editions of these documents were available, the Chinese version would be followed. WHO guidelines have been primarily adapted with the newly issued national guideline, The Clinical Practical Skill Guidelines- Family Planning Part, which was established by China Medical Association. At the same time, the WHO guidelines have been introduced to some of the clinicians and family planning providers at different levels. In the future, more special training courses will be introduced to the township level based on the needs of grass-root providers.

Contraception

Contraception

Provider views on the acceptability of an IUD checklist screening tool

IntroductionFamily Health International developed a simple checklist to help family planning providers apply the new medical eligibility criteria (MEC) of the World Health Organization (WHO) for the use of the intrauterine device (IUD) contraceptive method. MethodsOne hundred thirty-five providers in four countries participated in focus groups to field test the checklist. Before participating in a discussion about the checklist, each provider was given a copy of the checklist, its instructions and hypothetical client scenarios. Providers used the checklist to answer questions about the client scenarios in order to determine if they understood the checklist and if they would correctly determine IUD eligibility for women in updated categories of eligibility on the basis of the checklist. ResultsProviders found the checklist easy to use and thought that it would enhance identification of eligible IUD users. Nevertheless, many providers relied on prior knowledge of IUD eligibility rather than the checklist recommendations. Providers only correctly determined eligibility for new categories of IUD use 69% of the time. ConclusionsThe IUD checklist is a useful job tool for providers, but training and effective dissemination of the WHO MEC should precede its introduction to ensure that it is correctly used.

Agreement between women's and providers' assessment of hormonal contraceptive risk factors

To measure agreement between women's self-administered risk factor questionnaire and their providers' evaluation of their medical eligibility for hormonal contraceptive use. This was an anonymous cross-sectional study. Participants were women 15-45 years old who completed a 20-item self-administered questionnaire. Women were recruited from six public health family planning clinics in the Seattle Metropolitan area. A matching medical evaluation questionnaire was completed concurrently by each participant's health care provider. Using provider evaluation as the "gold standard" against which we compared self-reported medical history, we calculated participant-provider agreement with point estimates and 95% confidence interval (CI). Of 399 participant and provider pairs, participant-provider agreement was obtained for 392 participant pairs. The majority of the participants (90.3%) were 15-30 years old and 77.7% had used a hormonal contraceptive method for more than 1 year. The estimated proportion of the overall agreement was 96% (95% CI, 0.92-0.98). Women were more likely to report severe headaches (12.4% vs. 3.3%), possible pregnancy (7.3% vs. 3.5%) and smoking (6.2% vs. 2.1%) than providers, but less likely to report smoking more than 15 cigarettes per day (2.6% vs. 9.2%) and irregular menses (6.5% vs. 9.9%). Overall, a high proportion of the women in this study completed our medical history questionnaire in concordance with their health care providers' same-day medical evaluation. Agreement on critical medical eligibility criteria such as hypertension was well above 90%. For criteria on which there was disagreement, women were more likely to identify contraindications than were their providers.

Missed contraceptive pills and the critical pill-free interval

The UK Faculty of Family Planning and Reproductive Health Care has just issued new guidance on what to advise when combined oral contraceptive pills are missed.1 This new guidance is part of a continuing series produced by the Faculty's Clinical Effectiveness Unit and is based on WHO publications. These publications include Medical Eligibility Criteria for Contraceptive Use and Selected Practice Recommendations for Contraceptive Use.2,3

Scaling up HIV Testing: Ethical Issues

H 1IV testing is not an end in itself. It is instead a means to an end, in which the ethically acceptable ends are care and access to treatment for people found to be infected and access to adequate preventive means for those who are uninfected. It is obvious that testing is required in order to know who is eligible for treatment. Critical to the testing process, however, is systematically linking testing with existing or planned treatment or prevention programs. Failure to do so would be to treat the individuals tested merely as a means, which would be a violation of the ethical principle of respect for persons. When individuals consent to undergo HIV testing, and their consent appears to be both voluntary and properly informed, the situation seems to be one in which they are serving their own ends by agreeing to be tested. In principle, that may well be true, but additional conditions have to be met. These include adequate information provided in pretest counseling; full voluntariness of consent to be tested; and accurate understanding and expectations on the part of individuals tested. If these conditions are fulfilled, then individuals are serving their own ends in agreeing to be tested. These conditions are necessary for testing to be ethically sound, but they are not sufficient. The major benefit to individuals' learning that they are HIV-positive is access to anti-retroviral therapy (ART), if they meet the medical eligibility criteria and if ART is available. Without the likelihood of receiving treatment, however, being informed of an

Hormonal Contraception in Women with Diabetes Mellitus

Contraception is an important issue for women with diabetes mellitus as unplanned pregnancy can present major maternal and perinatal complications. The rising incidence of diabetes worldwide means increasing thought needs to be given to contraceptive options for these women. This article reviews current evidence and recommends best practice for prescribing hormonal contraceptives in women with diabetes. Women with diabetes have the same choice of contraceptives as the general population, but the potential metabolic effects of hormonal methods need to be considered in relation to an individual's diabetic profile and their need for effective contraception. Currently, there appear to be wide variations in the way that professionals evaluate the risk-benefit equation, and significant differences in prescribing practice have been identified. The World Health Organization (WHO) has established medical eligibility criteria to assist in assessing such risks. Cardiovascular disease is a major concern, and for women with diabetes who have macrovascular or microvascular complications, nonhormonal methods are recommended. Studies of young women with diabetes and no vascular changes who are taking low-dose combined oral contraceptives (COCs) have been reassuring, although larger long-term studies are needed. There is little evidence that any changes in glycemic control caused by COCs are of clinical relevance. While low-dose COCs appear to cause minimal change in the lipid profile and may even be beneficial in this respect, there are some concerns in relation to progestogen only pills and injectable contraceptives in certain women. There is little evidence of best practice for the follow-up of women with diabetes prescribed hormonal contraception. It is generally agreed that blood pressure, weight, and body mass index measurements should be ascertained, and blood glucose levels and baseline lipid profiles assessed as relevant. Research on hormonal contraception has been carried out in healthy populations; more studies are needed in women with diabetes and women who have increased risks of cardiovascular disease.

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.

Predictors of withdrawal from hospice.

Hospice is designed to provide end-of-life care to patients who are terminally ill. However, some patients withdraw from hospice even though they are medically eligible. Little is known about these patients, and the factors associated with their withdrawal have not been described. To identify predictors of withdrawal from hospice in a diverse cohort of hospice patients who are eligible to receive service. Retrospective cohort study. Between January 1997 and January 1999 1,691 patients enrolled in an urban, nonprofit hospice program were identified and data were gathered until discharge or death. Time to discharge of eligible patients from hospice. Over the study period, 15% of patients were discharged from hospice while they still met medical eligibility criteria. Patients were more likely to withdraw if they were male, unmarried, and younger than 65, if they did not have cancer, and if they lacked a do-not-resuscitate order, intravenous access, and symptoms requiring intervention. A substantial proportion of hospice patients who meet medical criteria for services choose to withdraw. Further research is needed to define more clearly the reasons for withdrawal and to investigate whether withdrawal is consistent with patient preferences.

Contraception in Practice

The approach of Contraception in Practice is refreshingly different from that of existing texts. Instead of covering the methods one-by-one, it selects medical conditions and patient groups and looks at their contraceptive needs and the interaction between disease and method. The book highlights the many benefits of contraceptives, often badly neglected in textbooks. The topics seem to have been chosen somewhat at random, but they are all situations encountered quite often and are therefore relevant to many clinicians. Medical conditions range from cancers to subfertility. Patient groups include those at risk of sexually transmitted infections and couples whom nothing seems to suit. The editor has chosen five chapters of gynaecological orientation, reflecting his own interest. Equally he could have examined physical disability, autoimmune disorders, diabetes, inflammatory bowel disease, haematological disorders, psychiatric disorders or epilepsy—all of which present complex management issues. Anyway, the contributors have been picked because they are leading authorities and the approach is very practical—what you do with the patient in front of you. Throughout, the diagrams are exceptionally clear and the references are comprehensive. Each chapter ends with two case histories which are well presented and give a sense of how the guidance can be used in the sometimes confusing world of clinical practice where there seem to be limitless numbers of situations to be faced. Detracting from this is inconsistent editing, with IUCD being used as an abbreviation in some chapters instead of the internationally approved IUD for intrauterine device, and sexually transmitted diseases in some chapters instead of the more up-to-date sexually transmitted infections. The chapter on arterial disease (chapter 4) seems to me the least satisfactory, and its deficiencies are aggravated by the use of crossheads which I suspect were not proof-read by the editor. Some of these, I think, summarize the publisher's interpretation of what the authors mean, but in fact have a rather different sense. The authors of chapter 4 do not quote the MICA study which shows no difference in risk of myocardial infarction for combined oral contraceptive (COC) users taking gestodene or desogestrel pills compared with levonorgestrel formulations. This is not because the book was written before this paper was published since it is cited in the previous chapter. The crosshead announces that ‘COCs containing third generation progestogens may have a lower rate of myocardial infarction’. On stroke, the crosshead states ‘modern low dose COCs do not increase the risk of any kind of stroke in healthy non-smokers’. The consensus summarized by a World Health Organization (WHO) Scientific Group is that the risk of ischaemic stroke is increased 1.5-fold in those without risk factors and more in those with risk factors. Next, the authors of chapter 4 quote from the WHO publication on medical eligibility criteria for contraceptive methods, reassuring readers that it is safe to prescribe the combined oral contraceptive pill to well-controlled hypertensives. In my view this should be qualified a bit more to read something like ‘young women with uncomplicated mild essential hypertension whose blood pressure is well-controlled by therapy may on occasions be given low-dose combined oral contraception under close specialist supervision’. Later these authors, who are based in the USA, claim that obesity is not a contraindication to oral contraception. This conflicts with advice in the UK which generally regards a body mass index of 40 and above as an absolute contraindication to the combined pill because obesity is a risk factor for both arterial disease and venous thromboembolism. Finally, it is said that the antidiabetic troglitazone (not available in the UK) increases the metabolism of contraceptive steroids, implying that this agent might cause breakthrough pregnancies. In fact, thiazolidinediones and other antidiabetics have their hypoglycaemic effect antagonized by oral contraceptives but there is no clinically important effect on steroid levels. Elsewhere the book is well written and informative. Overall I enjoyed it and would recommend in particular the elegant chapter on migraine and the sensitively written chapters on teenagers and those with learning disability.

New WHO medical eligibility criteria for contraceptives: adaptation for use in a local service in UK

The medical eligibility criteria are based on the work of a group of international experts who reviewed all the clinical evidence on methods of contraception ‐ looking for the circumstances...

Sharable Representation of Clinical Guidelines in GLIF: Relationship to the Arden Syntax

Clinical guidelines are intended to improve the quality and cost effectiveness of patient care. Integration of guidelines into electronic medical records and order-entry systems, in a way that enables delivery of patient-specific advice at the point of care, is likely to encourage guideline acceptance and effectiveness. Among the methodologies for modeling guidelines and medical decision rules, the Arden Syntax for Medical Logic Modules and the GuideLine Interchange Format version 3 (GLIF3) emphasize the importance of sharing encoded logic across different medical institutions and implementation platforms. These two methodologies have similarities and differences; in this paper we clarify their roles. Both methods can be used to support sharing of medical knowledge, but they do so in complementary situations. The Arden Syntax is suitable for representing individual decision rules in self-contained units called Medical Logic Modules (MLMs), which are usually implemented as event-driven alerts or reminders. In contrast, GLIF3 is designed for encoding complex multistep guidelines that unfold over time. As a consequence, GLIF3 has several mechanisms for complexity management and additional constructs that may require overhead unnecessary for expressing simple alerts and reminders. Unlike the Arden Syntax, GLIF3 encourages a top-down process of guideline modeling consisting of three levels that are created in order: Level 1 comprises a human-readable flowchart of clinical decisions and actions. Level 2 comprises a computable specification that can be verified for logical consistency and completeness; and Level 3 comprises an implementable specification that includes information required for local adaptation of guideline logic as well as for mapping guideline variables onto institutional medical records. A major emphasis of the current GLIF3 development process has been to create the computable specification that formally represents medical decision and eligibility criteria. We based GLIF3's formal expression language on the Arden Syntax's logic grammar, making the necessary extensions to the Arden Syntax's data structures and operators to support GLIF3's object-oriented data model. We discuss why the process of generating a set of MLMs from a GLIF-encoded guideline cannot be automated, why it can result in information loss, and why simple medical rules are best represented as individual MLMs. We thus show that the Arden Syntax and GLIF3 play complementary roles in representing medical knowledge for clinical decision support.