To assess the validity of the US Department of Health and Human Services (DHHS) definition of multimorbidity using International Classification of Diseases, ninth edition (ICD-9) codes from administrative data.
Cross-sectional comparison of two ICD-9 billing code algorithms to data abstracted from medical records.
Olmsted County, Minnesota, USA.
An age-stratified and sex-stratified random sample of 1509 persons ages 40-84 years old residing in Olmsted County on 31 December 2010.
Seventeen chronic conditions identified by the US DHHS as important in studies of multimorbidity were identified through medical record review of each participant between 2006 and 2010. ICD-9 administrative billing codes corresponding to the 17 conditions were extracted using the Rochester Epidemiology Project records-linkage system. Persons were classified as having each condition using two algorithms: at least one code or at least two codes separated by more than 30 days. We compared the ICD-9 code algorithms with the diagnoses obtained through medical record review to identify persons with multimorbidity (defined as ≥2, ≥3 or ≥4 chronic conditions).
Use of a single code to define each of the 17 chronic conditions resulted in sensitivity and positive predictive values (PPV) ≥70%, and in specificity and negative predictive values (NPV) ≥70% for identifying multimorbidity in the overall study population. PPV and sensitivity were highest in persons 65-84 years of age, whereas NPV and specificity were highest in persons 40-64 years. The results varied by condition, and by age and sex. The use of at least two codes reduced sensitivity, but increased specificity.
The use of a single code to identify each of the 17 chronic conditions may be a simple and valid method to identify persons who meet the DHHS definition of multimorbidity in populations with similar demographic, socioeconomic, and health care characteristics.

The institutional review board (IRB) is a group federally mandated to review and monitor research involving humans to ensure protection of their rights and welfare as research participants. Clinicians engaged in research require IRB approval for all research involving human participants, whether living individuals, data, or specimens. The process for obtaining IRB approval may seem like a daunting task. However, it is critical for clinical researchers to conduct research in a manner that protects human participants, and it is the mission of the IRB to help researchers accomplish this task. The purpose of this article is to review the role and purpose of the IRB, highlight federal and regulatory standards in human research participants protection, and help clinical researchers have a broader understanding of IRB functions that will help them conduct high-quality research with human participants.

We reviewed the public comments submitted in response to the Department of Health and Human Services\' (DHHS\'s) original and revised proposal for mandated single-IRB review of federally funded multisite research to see who responded to the proposed mandate and to determine what they said and how the agency addressed the public comments in its revised proposal. Our analysis indicates that support for the single-IRB mandate was limited. The most common argument against the proposed mandate came from those concerned with the loss of site-specific institutional review board (IRB) review of the protocol for a multisite study to address issues relevant to local context. Concerns were also raised that the single-IRB approach would replace one inefficient system (that entails, for example, multiple reviews of a single study) with another potentially inefficient system (involving the negotiation and management of multiple interinstitutional agreements). Empirical research about the implementation of DHHS\'s final rule-and the separate rule of the National Institutes of Health-mandating single-IRB review is needed to determine whether the single-IRB model achieves the stated goals.

Community education and engagement are important for informing family planning projects. The objective of this study was to update two prior systematic reviews assessing the impact of community education and engagement interventions on family planning outcomes.
Sixteen electronic databases were searched for studies relevant to a priori determined inclusion/exclusion criteria in high development settings, published from March 2011 through April 2016, updating two reviews that included studies from 1985 through February 2011.
Nine relevant studies were included in this updated review related to community education, in addition to 17 from the prior review. No new community engagement studies met inclusion criteria, as occurred in the prior review. Of new studies, community education modalities included mass media, print/mail, web-based, text messaging, and interpersonal interventions. One study on mass media intervention demonstrated a positive impact on reducing teen and unintended pregnancies. Three of four studies on interpersonal interventions demonstrated positive impacts on medium-term family planning outcomes, such as contraception and condom use. Three new studies demonstrated mostly positive, but inconsistent, results on short-term family planning outcomes.
Findings from this systematic review update are in line with a previous review showing the positive impact of community education using traditional modalities on short-term family planning outcomes, identifying additional impacts on long-term outcomes, and highlighting new evidence for education using modern modalities, such as text messaging and web-based education. More research is necessary to provide a stronger evidence base for directing community education and engagement efforts in family planning contexts.
This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

The purpose of this paper is to synthesize and evaluate the evidence on the effectiveness of repeat teen pregnancy prevention programs offered in clinical settings.
Multiple databases were searched for peer-reviewed articles published from January 1985 to April 2016 that included key terms related to adolescent reproductive health services. Analysis of these studies occurred in 2017. Studies were excluded if they focused solely on sexually transmitted disease/HIV prevention services, or occurred outside of a clinic setting or the U.S., Canada, Europe, Australia, or New Zealand. Inclusion and exclusion criteria further narrowed the studies to those that included information on at least one short-term (e.g., increased knowledge); medium-term (e.g., increased contraceptive use); or long-term (e.g., decreased repeat teen pregnancy) outcome, or identified contextual barriers or facilitators for providing adolescent-focused family planning services. Standardized abstraction methods and tools were used to synthesize the evidence and assess its quality. Only studies of clinic-based programs focused on repeat teen pregnancy prevention were included in this review.
The search strategy identified 27,104 citations, 940 underwent full-text review, and 120 met the adolescent-focused family planning services inclusion criteria. Only five papers described clinic-based programs focused on repeat teen pregnancy prevention. Four studies found positive (n=2) or null (n=2) effects on repeat teen pregnancy prevention; an additional study described facilitators for helping teen mothers remain linked to services.
This review identified clinic-based repeat teen pregnancy prevention programs and few positively affect factors that may reduce repeat teen pregnancy. Access to immediate postpartum contraception or home visiting programs may be opportunities to meet adolescents where they are and reduce repeat teen pregnancy.
This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Youth-friendly family planning services may improve youth reproductive health outcomes. A systematic review conducted in 2011 was updated in 2016 to incorporate recent data examining the effects of youth-friendly family planning services on reproductive health outcomes and the facilitators and barriers facing young people in accessing family planning services.
PubMed, POPLINE, EMBASE, and other databases were used to identify relevant articles published from March 2011 through April 2016.
Eighteen studies met inclusion criteria and were added to 19 studies from the review conducted in 2011. Of these, seven assessed the effect of youth-friendly services on outcomes: two showed a positive effect on reducing teen pregnancy, three on contraceptive use, and three on knowledge and patient satisfaction (not mutually exclusive). Facilitators or barriers were described in 32 studies. However, none were RCTs and most were at high risk for bias due to selection, self-report, and recall bias among others.
The studies in this review suggest some positive effects of youth-friendly family planning services on reproductive health outcomes, but the need for more rigorous research persists. This review identified numerous factors relevant to young people\'s access to family planning services, reaffirming findings from the initial review: young people value confidentiality, supportive provider interaction, specialized provider training, and the removal of logistic barriers. Further, it illuminates the importance young people place on receiving comprehensive, client-centered family planning counseling. These findings should be considered when developing, implementing, and evaluating reproductive health services for young people.
This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

The objective of this systematic review was to update a prior review and summarize the evidence on the impact of family planning reminder systems (e.g., daily text messages reminding oral contraception users to take a pill).
Multiple databases, including PubMed, were searched during 2016-2017 for articles published from March 1, 2011, to November 30, 2016, describing studies of reminder systems.
The search strategy identified 24,953 articles, of which two studies met the inclusion criteria. In total with the initial review, four studies (including two RCTs) examined reminder systems among oral contraception users, with two of three that examined correct use finding a statistically significant positive impact, and one RCT finding a positive impact on knowledge and continuation. Of three studies (including two RCTs) that examined reminder systems among depot medroxyprogesterone acetate users, one of three that examined correct use found a statistically significant positive impact on timely injections at 3 months, and one study found no effect on continued use at 12 months.
Although this review found mixed support for the effectiveness of reminder systems on family planning behaviors, the highest quality evidence yielded null findings related to correct use of oral contraception and timely depot medroxyprogesterone acetate injections beyond 3 months, and found positive findings related to oral contraception continuation and knowledge. Future studies would be strengthened by objectively measuring outcomes and examining additional contraceptive methods and outcomes at least 12 months post-intervention.
This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Educational interventions can help individuals increase their knowledge of available contraceptive methods, enabling them to make informed decisions and use contraception correctly. This review updates a previous review of contraceptive education.
Multiple databases were searched for articles published March 2011-November 2016. Primary outcomes were knowledge, participation in and satisfaction/comfort with decision making, attitudes toward contraception, and selection of more effective methods. Secondary outcomes included contraceptive behaviors and pregnancy. Excluded articles described interventions that had no comparison group, could not be conducted feasibly in a clinic setting, or were conducted outside the U.S. or similar country.
A total of 24,953 articles were identified. Combined with the original review, 37 articles met inclusion criteria and described 31 studies implementing a range of educational approaches (interactive tools, written materials, audio/videotapes, and text messages), with and without healthcare provider feedback, for a total of 36 independent interventions. Of the 31 interventions for which knowledge was assessed, 28 had a positive effect. Fewer were assessed for their effect on attitudes toward contraception, selection of more effective methods, contraceptive behaviors, or pregnancy-although increased knowledge was found to mediate additional outcomes (positive attitudes toward contraception and contraceptive continuation).
This systematic review is consistent with evidence from the broader healthcare field in suggesting that a range of interventions can increase knowledge. Future studies should assess what aspects are most effective, the benefits of including provider feedback, and the extent to which educational interventions can facilitate behavior change and attainment of reproductive health goals.
This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Providers can help clients achieve their personal reproductive goals by providing high-quality, client-centered contraceptive counseling. Given the individualized nature of contraceptive decision making, provider attention to clients\' preferences for counseling interactions can enhance client centeredness. The objective of this systematic review was to summarize the evidence on what preferences clients have for the contraceptive counseling they receive.
This systematic review is part of an update to a prior review series to inform contraceptive counseling in clinical settings. Sixteen electronic bibliographic databases were searched for studies related to client preferences for contraceptive counseling published in the U.S. or similar settings from March 2011 through November 2016. Because studies on client preferences were not included in the prior review series, a limited search was conducted for earlier research published from October 1992 through February 2011.
In total, 26 articles met inclusion criteria, including 17 from the search of literature published March 2011 or later and nine from the search of literature from October 1992 through February 2011. Nineteen articles included results about client preferences for information received during counseling, 13 articles included results about preferences for the decision-making process, 13 articles included results about preferences for the relationship between providers and clients, and 11 articles included results about preferences for the context in which contraceptive counseling is delivered.
Evidence from the mostly small, qualitative studies included in this review describes preferences for the contraceptive counseling interaction. Provider attention to these preferences may improve the quality of family planning care; future research is needed to explore interventions designed to meet preferences.
This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

The objective of this systematic review was to update a prior review and summarize the evidence (newly identified and cumulative) on the impact of contraceptive counseling provided in clinical settings.
Multiple databases, including PubMed, were searched during 2016-2017 for articles published from March 1, 2011, to November 30, 2016.
The search strategy identified 24,953 articles; ten studies met inclusion criteria. Two of three new studies that examined contraceptive counseling interventions (i.e., enhanced models to standard of care) among adolescents and young adults found a statistically significant positive impact on at least one outcome of interest. Five of seven new studies that examined contraceptive counseling, in general, or specific counseling interventions or aspects of counseling (e.g., personalization) among adults or mixed populations (adults and adolescents) found a statistically significant positive impact on at least one outcome of interest. In combination with the initial review, six of nine studies among adolescents and young adults and 16 of 23 studies among adults or mixed populations found a statistically significant positive impact of counseling on at least one outcome of interest.
Overall, evidence supports the utility of contraceptive counseling, in general, and specific interventions or aspects of counseling. Promising components of contraceptive counseling were identified. The following would strengthen the evidence base: improved documentation of counseling content and processes, increased attention to the relationships between client experiences and behavioral outcomes, and examining the comparative effectiveness of different counseling approaches to identify those that are most effective.
This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.