Appendix A: How the Recommendations Were Developed

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Appendix A: How the Recommendations Were Developed

The recommendations were developed jointly under the auspices of ob体育's Division of Reproductive Health (DRH) and the Office of Population Affairs (OPA), in consultation with a wide range of experts and key stakeholders. A multistage process that drew on established procedures for developing clinical guidelines (1,2) was used to develop the recommendations. In April 2010, an Expert Work Group (EWG) comprising family planning clinical providers, program administrators, representatives from relevant federal agencies, and representatives from professional medical organizations was created to advise OPA and ob体育 on the structure and content of the revised recommendations and to help make the recommendations more feasible and relevant to the needs of the field. This group made two key initial recommendations: 1) to examine the scientific evidence for three priority areas of focus identified as key components of family planning service delivery, (i.e., counseling and education, serving adolescents, and quality improvement); and 2) to guide providers of family planning services in the use of various recommendations for how to provide clinical care to women and men.

Developing Recommendations on Counseling, Adolescent Services, and Quality Improvement

Systematic reviews of the published literature from January 1985 through December 2010 were conducted for each priority topic to identify evidence-based and evidence-informed approaches to family planning service delivery. Standard methods for conducting the reviews were used, including the development of key questions and analytic frameworks, the identification of the evidence base through a search of the published as well as "gray literature" (i.e., studies published somewhere other than in a peer-reviewed journal), and a synthesis of the evidence in which findings were summarized and the quality of individual studies was considered, using the methodology of the U.S. Preventive Services Task Force (USPSTF) (3). Eight databases were searched (i.e., MEDLINE, PsychInfo, PubMed, CINAHL, Cochrane, EMBASE, POPLINE, and the U.K. National Clearinghouse Service Economic Evaluation Database) and were restricted to literature from the United States and other developed countries. Summaries of the evidence used to prepare these recommendations will appear in background papers that will be published separately.

In May 2011, three technical panels (one for each priority topic) comprising subject matter experts were convened to consider the quality of the evidence and suggest what recommendations might be justified on the basis of the evidence. ob体育 and OPA used this feedback to develop core recommendations for counseling, serving adolescents, and quality improvement. EWG members subsequently reviewed these core recommendations; EWG members differed from the subject matter experts in that they were more familiar with the family planning service delivery context and could comment on the feasibility and appropriateness of the recommendations as well as on their scientific justification. EWG members met to consider the core recommendations using 1) the quality of the evidence; 2) the positive and negative consequences of implementing the recommendations on health outcomes, costs or cost-savings, and implementation challenges; and 3) the relative importance of these consequences (e.g., the ability of the recommendations to have a substantial effect on health outcomes may be weighed more than the logistical challenges of implementing them) (1). In certain cases, when the evidence was inconclusive or incomplete, recommendations were made on the basis of expert opinion (see Appendix B). Finally, ob体育 and OPA staff considered the feedback from EWG members when finalizing the core recommendations and writing this report.

Developing Recommendations on Clinical Services

DRH and OPA staff members synthesized recommendations for clinical care for women and for men that were developed by >35 federal and professional medical organizations. They were assisted in this effort by staff from OPA's Office of Family Planning Male Training Center and from ob体育's Division of STD Prevention, Division of Violence Prevention, Division of Immunization Services, and Division of Cancer Prevention and Control. The synthesis was needed because clinical recommendations are sometimes inconsistent with each other and can vary by the extent to which they are evidence-based. The clinical recommendations addressed contraceptive services, achieving pregnancy, basic infertility services, preconception health services, sexually transmitted disease services, and related health-care services.

An attempt was made to apply the Institute of Medicine's criteria for clinical practice guidelines when deciding which professional medical organizations to include in the review (2). However, many organizations did not articulate the process used to develop the recommendations fully, and many did not conduct comprehensive and systematic reviews of the literature. In the end, to be included in the synthesis, the recommending organization had to be a federal agency or major professional medical organization that represents established medical disciplines. In addition, a recommendation had to be made on the basis of an independent review of the evidence or expert opinion and be considered a primary source that was developed for the United States.

In July 2011, two technical panels comprising subject matter experts on clinical services for women and men were convened to review the synthesis of federal and professional medical recommendations, reconcile inconsistent recommendations, and provide individual feedback to ob体育 and OPA about the implications for family planning service delivery. ob体育 and OPA used this individual feedback to develop core recommendations for clinical services. The core recommendations were subsequently reviewed by EWG members, and feedback was used to finalize the core recommendations and write this report.

Members of the technical panels recommended that contraceptive services, pregnancy testing and counseling, services to achieve pregnancy, basic infertility care, STD services, and other preconception health services should be considered family planning services. This feedback considered federal statute and regulation, ob体育 and USPSTF recommendations for clinical care, and EWG members' opinion.

Because ob体育's preconception health recommendations include many services, the panel narrowed the range of preconception services that were included by using the following criteria: 1) the Select Panel on Preconception Care (4) had assigned an A or B recommendation to that service for women, which means that there was either good or fair evidence to support the recommendation that the condition be considered in a preconception care evaluation (Table 1), or 2) the service was included among recommendations made by experts in preconception health for males (5). Services for men that addressed health conditions that affect reproductive capacity or pregnancy outcomes directly were included as preconception health; services that addressed men's health but that were not related directly to pregnancy outcomes were considered to be related preventive health services.

The Expert Work Group noted that more preventive services are recommended than can be offered feasibly in some settings. However, a primary purpose of this report is to set a broad framework within which individual clinics will tailor services to meet the specific needs of the populations that they serve. In addition, EWG members identified specific subgroups that should have the greatest priority for preconception health services (i.e., those trying to achieve pregnancy and those at high risk of unintended pregnancy). Future operational research should provide more information about how to deliver these services most efficiently during multiple visits to clients with diverse needs.

Determining How Clinical Services Should Be Provided

Various federal agencies and professional medical associations have made recommendations for how to provide family planning services. When considering these recommendations, the Expert Work Group used the following hierarchy:

Highest priority was given to ob体育 guidelines because they are developed after a rigorous review of scientific evidence. ob体育 guidelines tailor recommendations for higher risk individuals, (whereas USPSTF focuses on average risk individuals), who are more representative of the clients seeking family planning services.
When no ob体育 guideline existed to guide the recommendations, the relevant USPSTF A or B recommendations (which indicate a high or moderate certainty that the benefit is moderate to substantial) were used. USPSTF recommendations are made on the basis of a thorough review of the available evidence.
If neither a ob体育 nor a USPSTF A or B recommendation existed, the recommendations of selected major professional medical associations were considered as resources. The American Academy of Pediatrics' (AAP) Bright Futures guidelines (6) were used as the primary source of recommendations for adolescents when no ob体育 or USPSTF recommendations existed.
For a limited number of recommendations, there were no federal or major professional medical recommendations, but the service was recommended by EWG members on the basis of expert opinion for family planning clients.

In some cases, a service was graded as an I recommendation by USPSTF for the general population (an I recommendation means that the current evidence is insufficient to assess the balance of benefits and harms of the service, so if the service is offered, patients should be informed of this fact), but either ob体育, EWG members, or another organization recommended the service for women or men seeking family planning services. The situations in which this occurred and the reasons why the service was recommended despite its receiving an I recommendation by USPSTF have been summarized (Table 2). The approach used to consider the evidence and make recommendations that are used by USPSTF have been summarized (Tables 3 and 4) (7).

References

GRADE Working Group. GRADE: going from evidence to recommendations. BMJ 2008;336:1049–51.
Institute of Medicine. Clinical practice guidelines we can trust. Washington, DC: The National Academies Press; 2011. Available at .
US Preventive Services Task Force. USPSTF: methods and processes. Rockville, MD: US Department of Health and Human Services, Agency for Healthcare Research and Quality; 2013. Available at .
Jack BW, Atrash H, Coonrod D, Moos M, O'Donnell J, Johnson K. The clinical content of preconception care: an overview and preparation of this supplement. Am J Obstet Gynecol 2008;199(Suppl 2):S266–79.
Frey KA, Navarro S, Kotelchuck M, Lu M. The clinical content of preconception care: preconception care for men. Am J Obstet Gynecol 2008;199(Suppl 2):S389–95.
Committee on Practice and Ambulatory Medicine, Bright Futures Periodicity Schedule Workgroup. 2014 recommendations for pediatric preventive health care. Pediatrics 2014;133;568.
US Preventive Services Task Force. Grade definitions. Rockville, MD: US Department of Health and Human Services, Agency for Healthcare Research and Quality; 2013. Available at .

TABLE 1. Select Panel on Preconception Care grading system
Quality of the evidence*
I-a	Evidence was obtained from at least one properly conducted, randomized, controlled trial that was performed with subjects who were not pregnant.
I-b	Evidence was obtained from at least one properly conducted, randomized, controlled trial that was done not necessarily before pregnancy.
II-1	Evidence was obtained from well-designed, controlled trials without randomization.
II-2	Evidence was obtained from well-designed cohort or case-control analytic studies, preferably conducted by more than one center or research group.
II-3	Evidence was obtained from multiple-time series with or without the intervention, or dramatic results in uncontrolled experiments.
III	Opinions were gathered from respected authorities on the basis of clinical experience, descriptive studies and case reports, or reports of expert committees.
Strength of the recommendation
A	There is good evidence to support the recommendation that the condition be considered specifically in a preconception care evaluation.
B	There is fair evidence to support the recommendation that the condition be considered specifically in a preconception care evaluation.
C	There is insufficient evidence to recommend for or against the inclusion of the condition in a preconception care evaluation, but recommendation to include or exclude may be made on other grounds.
D	There is fair evidence to support the recommendation that the condition be excluded in a preconception care evaluation.
E	There is good evidence to support the recommendation that the condition be excluded in a preconception care evaluation.
Source: Jack B, Atrash H, Coonrod D, Moos M, O'Donnell J, Johnson K. The clinical content of preconception care: an overview and preparation of this supplement. Am J Obstet Gynecol 2008;199(6 Suppl 2):S266–79.

TABLE 2. Services included in these recommendations that received a U.S. Preventive Services Task Force (USPSTF) I recommendation
Service/screen	USPSTF recommendation	Why the service is recommended despite a USPSTF I recommendation
Alcohol	I for adolescents	The recommendations are consistent with ob体育's recommendations on preconception health and AAP's Bright Futures* guidelines.
Other drugs	I for adolescents and adults	The recommendations are consistent with ob体育's recommendations on preconception health and AAP's Bright Futures guidelines.
Clinical breast exam	I for all women	No ob体育 recommendation exists, but ACOG and ACS recommend conducting clinical breast exams, and the Expert Work Group endorsed the ACOG recommendation.
Chlamydia	I for all males	The recommendations are consistent with ob体育's STD treatment guidelines.
Gonorrhea	I for all males	The recommendations are consistent with ob体育's STD treatment guidelines.
Source: US Preventive Services Task Force. USPSTF recommendations. Available at . Abbreviations: AAP = American Academy of Pediatrics; ACS = American Cancer Society; ACOG = American Congress of Obstetricians and Gynecologists; STD = sexually transmitted disease. * Source: Committee on Practice and Ambulatory Medicine, Bright Futures Periodicity Schedule Workgroup. 2014 recommendations for pediatric preventive health care. Pediatrics 2014;133;568.

TABLE 3. U.S. Preventive Services Task Force (USPSTF) grades, definitions, and suggestions for practice
Grade	Definition	Suggestions for practice
A	USPSTF recommends the service. There is high certainty that the net benefit is substantial.	This service should be offered or provided.
B	USPSTF recommends the service. There is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial.	This service should be offered or provided.
C	Clinicians may provide this service to selected patients depending on individual circumstances. However, for a majority of persons without signs or symptoms there is likely to be only a limited benefit from this service.	This service should be offered or provided only if other considerations support the offering or providing the service in an individual patient.
D	USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.	Use of this service should be discouraged.
I Statement	USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.	The clinical considerations section of USPSTF recommendation statement should be consulted. If the service is offered, patients should be educated about the uncertainty of the balance of benefits and harms.
Source: US Preventive Services Task Force. USPSTF: methods and processes. Available at .

TABLE 4. Levels of certainty regarding net benefit
Level of certainty*	Description
High	The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies.
Moderate	The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by such factors as the number, size, or quality of individual studies; inconsistency of findings across individual studies; limited generalizability of findings to routine primary care practice; and lack of coherence in the chain of evidence. As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.
Low	The available evidence is insufficient to assess effects on health outcomes is insufficient because of the limited number or size of studies, important flaws in study design or methods, inconsistency of findings across individual studies, gaps in the chain of evidence, findings not generalizable to routine primary care practice, lack of information on important health outcomes, or more information required to allow estimation of effects on health outcomes.
Source: US Preventive Services Task Force. USPSTF: methods and processes. Available at . * The US Preventive Services Task Force (USPSTF) defines certainty as the likelihood that the USPSTF assessment of the net benefit of a preventive service is correct. The net benefit is defined as benefit minus harm of the preventive service as implemented in a general, primary care population. USPSTF assigns a certainty level on the basis of the nature of the overall evidence available to assess the net benefit of a preventive service.

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