Invasive intensive care unit (ICU) treatments for patients with advanced medical illnesses and poor prognoses may prolong suffering with minimal benefit. Unfortunately, the quality of care planning and communication between clinicians and critically ill patients and their families in these situations are highly variable, frequently leading to overutilization of invasive ICU treatments. Time-limited trials (TLTs) are agreements between the clinicians and the patients and decision makers to use certain medical therapies over defined periods of time and to evaluate whether patients improve or worsen according to predetermined clinical parameters. For patients with advanced medical illnesses receiving aggressive ICU treatments, TLTs can promote effective dialogue, develop consensus in decision making, and set rational boundaries to treatments based on patients’ goals of care.The aim of this study will be to examine whether a multicomponent quality-improvement strategy that uses protocoled TLTs as the default ICU care-planning approach for critically ill patients with advanced medical illnesses will decrease duration and intensity of nonbeneficial ICU care without changing hospital mortality.This study will be conducted in medical ICUs of three public teaching hospitals in Los Angeles County. In Aim 1, we will conduct focus groups and semistructured interviews with key stakeholders to identify facilitators and barriers to implementing TLTs among ICU patients with advanced medical illnesses. In Aim 2, we will train clinicians to use protocol-enhanced TLTs as the default communication and care-planning approach in patients with advanced medical illnesses who receive invasive ICU treatments. Eligible patients will be those who the treating ICU physicians consider to be at high risk for nonbeneficial treatments according to guidelines from the Society of Critical Care Medicine. ICU physicians will be trained to use the TLT protocol through a curriculum of didactic lectures, case discussions, and simulations utilizing actors as family members in role-playing scenarios. Family meetings will be scheduled by trained care managers. The improvement strategy will be implemented sequentially in the three participating hospitals, and outcomes will be evaluated using a before-and-after study design. Key process outcomes will include frequency, timing, and content of family meetings. The primary clinical outcome will be ICU length of stay. Secondary outcomes will include hospital length of stay, days receiving life-sustaining treatments , number of attempts at cardiopulmonary resuscitation, frequency of invasive ICU procedures, and disposition from hospitalization.The study began in August 2017. The implementation of interventions and data collection were completed at two of the three hospitals. As of September 2019, the study was at the postintervention stage at the third hospital. We have completed focus groups with physicians at each medical center (N=29) and interviews of family members and surrogate decision makers (N=18). The study is expected to be completed in the first quarter of 2020, and results are expected to be available in mid-2020.The successful completion of the aims in this proposal may identify a systematic approach to improve communication and shared decision making and to reduce nonbeneficial invasive treatments for ICU patients with advanced medical illnesses.DERR1-10.2196/16301 In the United States, 1 in 5 people die using intensive care unit (ICU) services, frequently receiving invasive treatments despite minimal anticipated benefit . InvestiLike many health care systems, ICU overutilization is highly prevalent in the hospitals of the Los Angeles County (LAC) Department of Health Services (DHS), the second-largest public health care system in the United States. A recent study from our group showed that among 808 medical ICU patients at Harbor-UCLA Medical Center (HUMC), over 20% had reduced likelihoods of benefit from ICU care due to advanced medical illnesses, such as advanced dementia and metastatic cancer see  16]. Of. Of16]. In order to understand why patients with advanced medical illnesses received ICU care so frequently, we conducted semistructured interviews of ICU physicians and nurses at LAC DHS hospitals. Key themes that emerged from these interviews were that health care providers do not comprehensively discuss prognoses, risks and benefits, and patient preferences for ICU treatments, which lead to inaccurate expectations from ICU care and unrealistic fears of prematurely forgoing potentially beneficial treatments. Barriers to effective shared decision making included (1) underappreciation of the value of ICU care planning, (2) lack of institutional standards and tools for ICU care planning, and (3) difficulty in scheduling meetings between providers and families.Prior work has shown that developing ICU interventions that change physician behaviors, facilitate communication between providers and families, and improve patient care is challenging ,17,18. AFor patients with advanced illnesses, this approach places them at risk for prolonged suffering with minimal anticipated benefit ,4. Time-In summary, nonbeneficial treatments are frequently delivered in medical ICUs to patients with advanced medical illnesses. Although the appropriateness of ICU care in this population is subject to varying opinions, there is general consensus that intensity of ICU treatments should align with patients’ prognoses, preferences, and values . PreviouThe objective of this proposal is to test an intervention that seeks to reduce invasive and nonbeneficial ICU treatments by improving communication between providers, surrogate decision makers, and critically ill patients with advanced medical illnesses. We propose to implement an intervention that facilitates communication and shared decision making between providers and patients and their families by using protocoled TLTs for ICU patients with advanced medical illnesses who receive aggressive care see .We hypothesize that a multicomponent quality-improvement intervention, informed by stakeholder input and that uses protocoled TLTs as the default ICU care-planning approach for critically ill patients with advanced medical illnesses, will decrease the duration and intensity of nonbeneficial ICU care without changing hospital mortality. We will examine our hypothesis with the specific aims discussed in the following sections.Aim 1 consists of identifying barriers and facilitators to performing TLTs in ICU patients with advanced medical illnesses using focus groups of physicians and semistructured interviews of patients and their families.Aim 2 consists of examining whether a multicomponent quality-improvement intervention using TLTs as the default care-planning approach for ICU patients with advanced medical illnesses reduces duration and intensity of nonbeneficial ICU treatmentsThis proposal will be conducted in the medical ICUs of three public hospitals in LAC DHS: HUMC, Olive View Medical Center (OVMC), and Los Angeles County-University of Southern California (LAC-USC) Medical Center. We will implement the aims sequentially across the medical centers. The sequential implementation strategy will be used to identify ways to improve training and uptake of the interventions with each iteration. For Aim 1, we will conduct focus groups and interviews with key stakeholders to identify facilitators and barriers to implementing TLTs among ICU patients with advanced medical illnesses. This will be performed prior to implementing quality-improvement interventions in Aim 2 see . The infIn the first phase of the proposed study, we will conduct focus groups with ICU physicians and interviews with patients and/or surrogate decision makers to explore attitudes toward ICU care among patients with advanced medical illnesses and strategies to optimally implement TLTs. We anticipate that themes from these sessions will include perceived barriers to conducting family meetings, knowledge and skill deficits among clinicians in conducting meetings, clinical outcomes most effective in decision making, optimal timing and frequency of meetings, optimal duration of TLTs, and communicating sensitive medical topics to lay populations.In-person focus groups with medical ICU physicians will be conducted at HUMC, OVMC, and LAC-USC Medical Center. We will invite all ICU attendings and fellows from each institution; we anticipate that 10-30 people will be invited and that 6-15 will participate per institution. Informed consent will be obtained for audio-recording. The meetings will be held at each medical center, will last approximately 90 minutes, and will be led by two of the study investigators.Moderators will lead discussions in each group. Discussions will begin with an explanation of the risks and benefits of aggressive ICU care for patients with advanced medical illnesses and of the goal of delivering care that aligns with patients’ values and preferences. We will explain the concept of TLTs and elicit responses to a prespecified set of open-ended questions.Sample questions include the following: (1) How are decisions regarding ICU care currently made? (2) Do you believe that TLTs are appropriate interventions? Why or why not? (3) What information is needed to effectively make decisions about continuing aggressive ICU care? (4) What is the best way to communicate that information? (5) Should care providers make recommendations regarding the next steps in care after TLTs? (6) What are barriers to having meetings with patients and their families? (7) What information do you typically provide in family meetings? (8) How do you feel about using a protocol and checklist during family meetings? (9) How comfortable are you with making recommendations for end-of-life care? and (10) How much variability do you perceive between physicians regarding prognoses and goals of care?In-person interviews with patients and/or surrogate decision makers will be conducted at HUMC, OVMC, and LAC-USC Medical Center. We will invite English-speaking patients or family members and surrogate decision makers who are available to participate in interviews; we anticipate that that 20 people will be invited and that 10 will participate per institution. Patients and family members will be invited for interviews after at least 72 hours of ICU hospitalization to provide adequate opportunities for communication and care planning with ICU clinicians. Informed consent will be obtained for audio-recording. The interviews will be held at each medical center, will last approximately 45 minutes, and will be led by one of the study investigators.An investigator will lead semistructured interviews of patients and/or family members, which will explore decision making in the ICU. We will explore factors that played key roles in decision making during ICU hospitalization with a prespecified set of open-ended questions.Sample questions will include the following: (1) Describe the most difficult decision you had to make during this hospitalization, (2) What decision did you make and how did you come to that decision? (3) What did the ICU care providers do that made that decision harder or easier? (4) What clinical events resonated with you regarding whether you or your family member was improving or worsening? (5) What other factors besides those discussed in family meetings affect your decision regarding ICU care? (6) How often were you confused about information that was presented to you during hospitalization? (7) What information was difficult to understand and why? and (8) What can the care providers do to better support you during this time?Analysis of data from focus groups and interviews will be descriptive, summarizing the range of issues that ICU physicians, patients, and surrogate decision makers discuss. Using the audio-recordings and moderators’ notes, content analysis of the group discussions and interviews will be performed to systematically define themes, emphasizing those that represent facilitators and barriers to implementation of our intervention -39. Thescapability, opportunity, motivation to perform a behavior (COM-B) framework by Michie and colleagues .-45.43-45The study will be conducted in medical ICUs of three LAC DHS hospitals using a before-and-after study design. The study will be conducted sequentially among the three hospitals to allow investigators to modify and improve the implementation strategy over the course of the study based on clinician feedback see . For eacPhysician-led family meetings will be conducted using a standardized protocol, which includes: (1) introductions, (2) summary of ICU course, (3) discussion of short- and long-term prognosis, (4) risks and benefits of aggressive ICU care, and (5) eliciting patients’ preferences for care during critical illness and/or at the end of life see . Based oAdditional components to the implementation strategy are shown in All outcomes will be collected in both the pre- and postintervention periods. The primary outcome will be ICU length of stay. Secondary outcomes will include hospital length of stay, days receiving life-sustaining treatments , number of attempts at cardiopulmonary resuscitation (CPR), number of invasive procedures , and outcomes of hospitalization . These data will be collected from retrospective chart review by trained case managers using standardized data abstraction forms.2 tests. Other continuous and categorical outcomes will be compared between groups using t tests or χ2 tests, respectively, or equivalent nonparametric approaches for variables that are nonnormally distributed. Multivariable regression models will be used to examine the effects of covariates, such as patient demographics, comorbid conditions, severity of illness, and hospitals, on study outcomes [Primary and secondary outcomes will be compared before and after the intervention -48. Daysoutcomes ,50. PrimWe expect to find fewer ICU days, hospital days, and days of life-sustaining treatments after the TLT intervention. We also expect a fewer number of attempts at CPR and other invasive procedures. We expect mortality rates to remain unchanged before and after the intervention. We expect reductions in ICU days, days receiving life-sustaining treatments, and number of invasive procedures after the intervention to be greater among patients who died during hospitalization than among survivors.We recognize that priority levels used to identify patients are subjective. However, we believe that using clinicians’ general impressions on the likelihood of benefit from ICU care, rather than more objective measures such as prognostic scoring systems or predefined lists of medical conditions, emulates clinical practice and will be more informative regarding the effectiveness of this intervention. If there are fewer priority 3 and 4 patients than anticipated, we will expand the study criteria to include patients who were initially categorized into a different priority level on ICU admission but were assigned priority level 3 or 4 during the ICU hospitalization. Based on our preliminary data, this will make an additional 10% of ICU patients eligible for the study.Our project was approved by the Institutional Review Board (IRB) at the Los Angeles BioMedical Research Institute at HUMC (project number: 043544) with approval at the other two medical centers using a reliance agreement. For Aim 1, informed consent was obtained for participants in focus groups and interviews. For Aim 2, the IRB waived the need for informed consent. There were several key factors involved in the waiver of consent. First, communication between ICU physicians and families is an expected practice; as well, the aim of the quality-improvement intervention was to encourage physicians to discuss elements that are vital to effective shared decision making, such as patient values and preferences, prognosis, and expectations for ICU treatments. As such, the intervention posed minimal risk to participants beyond usual ICU practice. Second, TLTs were not coercive or prescriptive, and maintained patient and family autonomy in decision making: at the end of the TLTs, patients and family members could choose to continue invasive treatments. Third, the quality-improvement intervention created a new default communication approach that applied to all ICU patients with advanced medical illnesses, regardless of participation in the study. Finally, implementation of the quality-improvement program was approved by the LAC DHS. Given these factors, the IRB determined that there was minimal risk to participants, waiver of consent would not adversely affect the rights and welfare of the participants, and the project could not be feasibly performed without the waiver.The study began in August 2017. The implementation of interventions and data collection were completed at HUMC and OVMC. As of September 2019, the study was at the postintervention stage at the LAC-USC Medical Center. We have completed focus groups with physicians at each medical center (N=29) and interviews of family members and surrogate decision makers (N=18). The study is expected to be completed in the first quarter of 2020, and results are expected to be available in mid-2020.Overutilization of ICU treatments among critically ill patients with advanced medical illnesses leads to medical care that is invasive, costly, and potentially misaligned with patient preferences. The successful completion of the aims in this proposal will improve the quality and efficiency of care by reducing unnecessary invasive treatments and decreasing ICU care that does not achieve its intended goals and prolongs suffering. This will be achieved through better communication and alignment of ICU care with patients’ values and preferences. Additionally, these studies will generate preliminary data and a track record of collaboration between researchers, clinicians, and hospital leaders, which will be foundational for future applications that attempt large-scale implementation of interventions that improve ICU communication and care planning. Thus, this proposal has the potential to catalyze the development of an ICU research program that addresses complex challenges in health care systems; this could be done through partnerships between academicians in health services research and frontline physicians and hospital administrators with experience in operationalizing health care improvements.


Supplemental Digital Content is Available in the Text. Evidence-based HIV interventions often fail to reach anticipated impact due to insufficient utilization in real-world health systems. Human-centered design (HCD) represents a novel approach in tailoring innovations to fit end-users, narrowing the gap between efficacious interventions and impact at scale.We combined a narrative literature review of HCD in HIV programs with our experience using HCD to redesign an intervention promoting patient-centered care (PCC) practices among health care workers (HCW) in Zambia. We summarize the use and results of HCD in the global HIV response and share case study insights to advance conceptualization of HCD applications.The literature review identified 13 articles (representing 7 studies) on the use of HCD in HIV. All studies featured HCD hallmarks including empathy development, user-driven inquiry, ideation, and iterative refinement. HCD was applied to mHealth design, a management intervention and pre-exposure prophylaxis delivery. Our HCD application addressed a behavioral service delivery target: changing HCW patient-centered beliefs, attitudes, and practices. Through in-depth developer–user interaction, our HCD approach revealed specific HCW support for and resistance to PCC, suggesting intervention revisions to improve feasibility and acceptability and PCC considerations that could inform implementation in transferable settings.As both a research and implementation tool, HCD has potential to improve effective implementation of the HIV response, particularly for product development; new intervention introduction; and complex system interventions. Further research on HCD application strengths and limitations is needed. Those promoting PCC may improve implementation success by seeking out resonance and anticipating the challenges our HCD process identified. Although an emergency-based response focusing on access largely drove HIV service delivery strategies over the past three decades, future success depends on more effectively engaging end-users with appropriate, desirable, and accessible services.2 For example, although ART is lifesaving, both treatment initiation and retention remain suboptimal, leading to onward transmission, morbidities, and mortality.3 These gaps demand alternative and innovative treatment delivery models—drawing from interdisciplinary perspectives—for advancing the public health response.5Although today's public health response to HIV has a robust set of evidence-based tools with which to address the global epidemic , implementation has failed to achieve the tools' full preventive and therapeutic potential.8 Traditionally, HCD focused on product development using participatory activities emphasizing researcher and user interaction to improve intervention utility, uptake, sustainability, and effectiveness.9 Although no single definition of HCD in health exists,6 there are hallmarks present across HCD applications9 .Human-centered design (HCD) is an emerging approach with roots in industrial design, engineering, psychology, anthropology, business, computer science, ergonomics, and design that hold promise for improving implementation of evidence-based interventions for health. HCD brings end-users and developers together to cocreate health products, services, or delivery strategies that identify, prioritize, and address barriers to usability.s9 Table . HCD use6 no synthetic appraisal of HCD in the public health HIV response yet exists. In this article, we seek to advance the conceptualization of the use of HCD to address HIV through both a literature review and a case study of our own experience using HCD methods to advance patient-centered care (PCC) in HIV treatment in Zambia.17 The literature review summarizes the following: (1) outcomes to which HCD has been applied, (2) methods used, (3) results and effectiveness, and (4) lessons learned. We present HCD-derived case study insights that could be informative to others seeking to optimize the delivery of PCC HIV interventions in transferable contexts. In addition, we hope this article will call attention to opportunities to advance HCD as a tool for adapting implementation strategies to particular contexts and end-user populations to strengthen the public health response to HIV.Despite a growing literature on HCD in health,19 of published articles and the grey literature on HCD in the global HIV response. Article inclusion criteria are as follows: (1) published through the search date of May 22, 2019, (2) related to HIV, and (3) presented data on HCD. Articles were excluded if they did not describe a design process or if they explicitly attributed their methods to non-HCD methodology . To identify the grey literature, we conducted targeted searches of websites from 3 HCD design leaders6 and another organization using HCD for health known to the authors, including any HIV-related cases on the website as of the search date. Case studies not articulating HCD methods or results were excluded. LB screened identified titles, abstracts, and case summaries using the inclusion criteria. LB and AB reviewed relevant full-text articles, abstracting the study author, participants and setting, HCD methods described, results, strengths, limitations, and lessons learned.We conducted a narrative literature review22 and a desire for differentiated care delivery options23 as drivers of poor retention, with high health facility-level variability.24 In response, the PCPH study's intervention was conceived to comprise (1) training of health care workers (HCW) in the principles and practices of patient-centeredness; (2) collecting and sharing data with HCW on the patient experience at the health facility; (3) HCW coaching; (4) supporting facility-level quality improvement; and (5) incentives for improved practice.We supplement the literature review with our experience applying HCD to shape a PCC intervention. The “Person Centred Public Health for HIV Treatment in Zambia Study” (PCPH) is a stepped wedge, cluster-randomized trial of a PCC intervention to improve HIV patient retention in care in Lusaka, Zambia, starting in mid-2019 implemented by the Centre for Infectious Disease Research in Zambia (CIDRZ), a partner to the Ministry of Health in HIV service provision since 2003. Our previous research in Zambia identified poor patient–provider interactions9 (HMW) to guide the workshop:Coaching: How might coaches be best positioned in health facilities to guide and support HCWs in delivering PCC according to best practices and in ways that are appropriate to facility context?;HCW support and motivation: How might we foster a workplace culture that empowers and motivates health care providers to provide PCC?;Information management: How might we make new and existing information on patient experience and patient outcomes accessible, desirable, and useable for facility staff and other key users?Before trial implementation, we undertook a pilot study implementing elements 1–3 of the planned intervention in 2 facilities to understand the context and test and refine the intervention. We conducted formative research on intervention components using interviews and focus-group discussions (FGDs). We then held a 5-day HCD workshop to engage HCWs who experienced the pilot in co-design activities to further refine the study intervention. Key HCD workshop strategies included the following: (1) developers cultivating empathy with HCWs and learning from insights and experiences, (2) developers and HCWs collaborating in investigation and creative problem-solving, and (3) defining actionable approaches for intervention improvement. Drawing on previous research and pilot findings, we defined 3 “How Might We…?” questions25 invited HCWs (users) from the pilot facilities , 6 district health management team representatives (influencers) and 12 research team members (developers). The workshop agenda  included common HCD insight gathering activities such as “journey maps”9 and personas26 to realize the workshop strategies. Workshop facilitation was led by an external HCD expert and co-facilitated by research team members.The design workshop included 31 purposefullyhttp://links.lww.com/QAI/B389). The developers took notes during each workshop session and, each day, reviewed outputs and notes, and dialogued to identify key questions, emergent insights, and direct feedback on intervention components. Developers then categorized the insights through mapping and rapid thematic analysis8 and proposed intervention revisions. Critical insights and themes were discussed with HCWs.To synthesize insights, participants generated visualized activity outputs common to HCD  outcome implementation not informed by users or (2) informed by another formative research approach , the basic form of which was justified by previous research. Two studies,38 both focused on a newer product and a less well-understood user group (PrEP for young women), sought more broadly to understand experiences and approaches relevant to increasing and sustaining PrEP use and then proceeded to design and refine specific PrEP products and processes. Articles reflect that even when specific products are of interest, HCD processes require sufficient flexibility during the user-driven investigation stages to allow for user priorities to guide the focus and form of the final solutions designed. For example, although based on an electronic medical record system, the final HIV-TB integration support tool design utilized paper-based messaging to clinicians as the most feasible form of communication.28In each study, the HCD application was guided by the current state of research and the user behaviors desired by the developers. Most of the studies sought to create and optimize a specific outcome  resonated with HCW but met resistance with some HCWs such as time constraints and beliefs that punitive measures improve patient compliance. During HCD activity dialogues, HCW participants shared stories of using kindness to help struggling patients to re-engage in care, highlighting the ability to implement PCC under less-than-ideal conditions and the benefits of positive interactions. The explicit encouragement of HCD to offer multiple perspectives and dialogues and embrace a co-creative environment allowed for the interactions, which revealed these various perspectives. The key points of resonance with PCC Table  and resiIntervention components that will be tested in our stepped-wedge trial were revised to improve acceptability, appropriateness, and feasibility of PCC practices, including better-using intervention mentoring and data collection to help HCWs feel visible, appreciated, and accountable. For example, HCD insights led us to augment the planned HCW FGD data collection with a quantitative HCW survey to expand and anonymize HCW feedback (additional examples in Table Our review suggested that HCD offers an important and emerging tool for adapting strategies to enhance ART services. While traditionally applied to products or mHealth practices, we and others have also begun to apply these principles to shape and refine the service delivery context and patient experience. Overall, HCD has the potential to improve the HIV response by more closely aligning the implementation of evidence-based products and processes with user priorities and context. In an HIV response that has to date rightly prioritized scale-up and standardization, but which now must shift to a more targeted efforts to continue improvements, HCD offers a theoretically based, robustly mapped set of practices that seek to improve outcomes through active engagement and respect for end-user views; encouragement of broad, creative inquiry; and support for iterative idea refinement in response to testing and feedback. Rigorous, successful HCD outcomes are no panacea however, and likely depend on relationships, time, and other resources required for authentic engagement and responsiveness, which may not always be available.40 The HCD approach in EMOTION37 identified that the medical appearance of PrEP was associated with illness, creating a likely barrier to young women's uptake and use. EMOTION29 thus prototyped PrEP starter kits that resemble make-up bags and stickers to disguise standard labels. User engagement lessons may facilitate use in similar populations.Extant evidence lacks an assessment of the comparative effectiveness of HCD and non-HCD processes in implementation optimization. Recent research, however, offers interesting insight into potential HCD gains. A study of the national scale-up of PrEP in Kenya identified that in addition to other stigma types, product stigma, including the similar appearance of PrEP bottles and ARV bottles, was a barrier to PrEP use.41 There is often overlap in objectives and methods between HCD, more traditional qualitative methodologies43; participatory research11; engineering approaches45; and discrete choice experiments as formative research.46 Although efforts have been made to compare and contrast approaches,8 distinctions are not concrete. Authors struggled to adjudicate use of HCD in some studies in our literature review. The Schnall et al34 study discussed a user-centered design process but grounded their research in the Information System Research Framework and described some of their methods as participatory action research. We erred on the side of inclusion, but the multidisciplinary nature of user-centered approaches requires reviewers' interpretation of methods. HCD distinguishes itself in by focus on empathy; flexibility in inquiry as directed by users; iterative, rapid testing cycles; and emphasis on practical outcomes. Our own case study included both traditional formative research and HCD. Although our more traditional formative research raised the issue of HCW context and the need to avoid blame to increase receptivity of HCWs to PCC, the empathy established and nuance understood through the HCD workshop elevated the HCW experience to formally include improvement in the HCW experience in the study Theory of Change.HCD approaches are not the only user-engagement methods that may support improved implementation. A 2017 landscape mapping of end-user research in HIV prevention for young women in sub-Saharan Africa identified 53 projects, of which 3 were explicitly HCD.47 a metric of qualitative rigor that considers the applicability of findings from one setting to a different setting with a similar context, instead of generalizable. Potential for transferability was noted in several literature review studies,29 as well as our own HCD case study. Critical reflection on HCD limitations would enhance future use. For example, thin preliminary knowledge of the evidence-based intervention may lead to poor design questions. An HCD process that is too rapid to allow for sufficient iteration or diversity of user engagement may produce results that lack rigor. Based on the importance of open discussion in our workshop, we believe that an absence of mutual respect and trust between users and developers could prevent empathetic interactions and produce inauthentic HCD outcomes.The limitations of HCD identified in the literature review including a lack of generalizability and inability to estimate effectiveness are not dissimilar to other qualitative methodologies. Instead of limitations, they are features of the approach. HCD findings may be transferable,28 our team felt that the communication, collaboration, and engagement between planners and users during HCD can support successful intervention implementation subsequent to the design phase.An important HCD insight from our workshop was that effective implementation of an intervention to increase the patient-centeredness of care through HCW behavior change needs to be implemented in a provider-centered way. This does not diminish the central role of patients in their care processes and outcomes. It highlights that just as the lived realities of the patients' need to inform HCW engagement with patients as care partners, the lived realities of the HCWs demand that interventions to change HCW practice prioritize feasible, acceptable, and appropriate implementation strategies. HCD may be particularly appropriate in complex settings that need to consider patient, provider, and systems realities. The compendium of resonance and resistance to PCC Tables  and 5 prOur review may have missed relevant case studies given the limited grey literature search and the practical outputs of many HCD studies, which are less likely to be published in peer-reviewed manuscripts. Similarly, we focused on HIV-related HCD, excluding possible lessons from other health areas. Owing to time and resource constraints, our HCD process did not include patients, the intended intervention beneficiaries, and key actors in their own care and treatment. Inclusion of patients would almost certainly have identified additional insights and intervention revisions. Our choice to focus on the HCWs allowed us to engage with the primary users of the planned intervention, to conduct our HCD approach in limited time, and to manage identified power dynamics within HCW cadres based on shared knowledge and vocabulary from the pilot phase.49 approach to bridge this gap; more studies that document and critically reflect on the use and impact of HCD methods in the global HIV response are needed to guide their effective use. Those seeking to promote PCC may improve implementation success by seeking out the resonance and anticipating and defusing the challenges our HCD process identified.HCD has the potential to improve effective implementation of the HIV response by tailoring implementation strategies to enhance evidence-based interventions in particular service delivery settings. Although HCD is a promising and increasingly advocated


Exercise modes can be divided into open skill exercise (OSE) and closed skill exercise (CSE). While research has shown that these two exercise modes may have different effects on cognitive function, this possibility has not been systematically reviewed.The purpose of the present review was to objectively evaluate the research literature regarding the effects of OSE versus CSE on cognitive function.Six electronic databases  were searched from inception dates to December 2018 for studies examining the associations of OSE and CSE with cognitive function. The literature searches were conducted using the combinations of two groups of relevant search items related to exercise modes  and cognitive function. Articles were limited to human studies in all age groups. Both intervention and observational studies with full text published in English-language peer-reviewed journals were considered eligible. The search process, study selection, data extraction, and study quality assessment were carried out independently by two researchers.A total of 1,573 articles were identified. Fourteen observational and five intervention studies met the inclusion criteria. Twelve of the 14 observational studies found that OSE benefits cognitive function, and seven of these 14 observational studies supported superior effects of OSE compared with CSE for enhancing cognitive function. Three of the five intervention studies found that OSE (versus CSE) led to greater improvements in cognitive function in both children and older adults.Although the majority of studies in this review were observational cross-sectional designs, the review tends to support that OSE is more effective for improving some aspects of cognitive function compared with CSE. More rigorous randomized control trials with long-term follow-ups are needed in order to confirm these differential cognitive effects of the two exercise modes. The beneficial effects of physical activity and exercise on physical health have been well-documented among all age groups , and an Recently, studies have suggested that the extent of improvements in cognitive function through physical exercise may be related to the motor movement characteristics of the activities involved . AccordiDespite the rapid expansion of interest in this topic, there has been no systematic review of existing literature that has critically evaluated the differential effects of OSE versus CSE on cognitive function across the lifespan. Given a lack of clarity regarding suspected differences in the benefits of these exercise modes for benefiting cognitive function, we undertook the current systematic review of intervention (including acute exercise and chronic exercise) and observational research to date.This systematic review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) . NotablyWe began with a computerized search of six electronic databases  for all research in these databases up to December 2018. Articles were limited to human studies in all age groups. There was no restriction on publication year. We used the combinations of the following two groups of retrieval terms: (a) OSE and CSE, feedback exercise and non-feedback exercise, open loop exercise and closed loop exercise, and planned exercise and incidental exercise, and (b) cognition, cognitive function, executive function, working memory, memory, inhibitory control, and cognitive flexibility. Each (a) item was combined with all (b) items during the search process. In order to exclude duplicate or apparently irrelevant studies, the authors next screened all retrieved titles. From this shorter list, two authors (QG and TH) independently reviewed the abstracts of each remaining study. Having further reduced number of the articles in this manner, the two authors (QG and TH) then independently screened the full text of the remaining studies, using predetermined inclusion and exclusion criteria (see below for details). Disagreements were discussed in all cases until a consensus was reached among the authors. The review authors then searched the bibliographies of all included articles in the same fashion as outlined above to further ensure that relevant articles had been captured.The identified studies were initially screened by two authors (QG and TH) to determine whether they met our inclusion criteria as follows: (a) intervention [assigned into either an experimental arm (OSE or CSE) or control arm] and observational studies with full text published in English-language peer-reviewed journals; (b) both OSE  and CSE  have to be clearly defined and simultaneously examined in the study; (c) study outcomes must include at least one measurement of any aspects of cognitive function . It is worth emphasizing that the participants’ ages, gender, race/ethnicity, etc., were not restricted in this systematic review in order to gain a comprehensive understanding of this new topic based on the inclusion of all relevant articles. This review excluded studies which applied other combined interventions such as OSE or CSE plus a nutrition program. The studies were finally included when a consensus was reached by two authors.Information regarding publication year, participant characteristics, location, intervention program, exercise experience, educational level, outcomes (assessment instruments) and study results were independently extracted by two authors (QG and TH) for later analysis and presentation.Methodological quality was assessed independently by two authors (QG and TH). Any discrepancies in the ratings of the methodological quality were settled by discussion, based on the scoring criteria of the two assessment instruments, among the authors until a consensus was reached. The two authors independently assessed the methodological quality of the intervention studies using the Physiotherapy Evidence Database (PEDro) scale . The PEDA flowchart of our study selection process is shown in As noted above, five of the 19 included studies were intervention studies (including two acute intervention studies) . These fAmong the 14 observational studies , one invSD = 140). The mean age of participants ranged from 9.6 to 70.5 years old. Across these 19 studies, a total of 21 cognitive tasks were used, measuring various aspects of cognitive function including inhibitory control, working memory, cognitive flexibility, planning, decision making, problem solving, processing speed, perception, attention, and memory. These characteristics of the intervention and observational studies are summarized in As an indication of how recently this topic has drawn investigator interest, 18 of these 19 articles were published after 2013. Collectively, within these 19 studies, a total of 1,845 participants were included. Study participants sample sizes ranged from 20 to 660, with an average sample size of 97  showed that OSE group performed better on several aspects of cognitive function than the control group . Nine stOnly one observational study was conducted with participants who were children . This stOf the 14 observational studies, the participants in six studies were adults older than 55 years . Three oFour (80%) intervention studies  demonstrThis systematic review critically evaluated the effects of OSE versus CSE on cognitive function. Collectively, we reviewed 19 study findings and found that 12 of 14 (86%) observational studies and four of five (80%) intervention studies supported cognitive benefits of OSE compared with control conditions. Furthermore, in seven of 14 (50%) observational studies and three of five (60%) intervention studies, participants in OSE groups had superior performance on several aspects of cognitive function compared with participants in CSE groups. Although the existing evidence tends to support that OSE may be more effective in benefiting some aspects of cognitive function  compared with CSE, it is premature to draw a clear picture on the effects of OSE versus CSE on a specific domain of cognitive function.Collectively, the findings of this systematic review suggested that the cognitive benefits of OSE versus CSE may vary across the developmental lifespan. Only three studies compared OSE versus CSE effects on cognitive function in children , and witWith regard to young adults, although most of the included studies supported the beneficial effects of the two modes of exercise on cognitive function compared with sedentary counterparts, evidence for superior cognitive function benefits of OSE (versus CSE) is relatively limited, due to a scarcity of long term or “chronic” intervention studies. Four of the observational studies supported better cognitive performance in OSE (versus CSE) group participants , but in In the older adults, evidence from this review’s six observational studies  and two Taken together, the results of the current systematic review indicate that OSE may be more effective in benefiting some aspects of cognitive function compared with CSE, especially in childhood and later adulthood. The findings not only help to clarify the differential cognitive effects of the two exercise modes, but also have some practical implications. For counteracting the prevalence of physical inactivity and sedentary behavior, it is reasonable to suggest that OSE should be incorporated into exercise promotion programs, as it may maximize the cognitive benefits of exercising.In this systematic review, the findings suggest a superior benefit of OSE for enhancing some aspects of cognitive function, perhaps especially in childhood and in late adulthood, as these two periods either precede the prefrontal lobe brain maturation that supports executive function , or are Physiologically, complex motor leaning and movement seems to exert longer positive influences on the neurotrophic system  in the cerebellum than moderate-intensity running . BDNF plTo the best of our knowledge, this was the first systematic review of the comparative effects of OSE versus CSE on cognitive function across the lifespan. Both intervention and observational studies were included in this review. In order to maximize between-study comparisons, we focused on studies that clearly defined the exercise modes based on a motor skill classification system yielding OSE and CSE categories. Despite the findings regarding cognitive benefits of both exercise modes (particularly to OSE) that we have outlined, the conclusions in this review must be considered within the context of its limitations. First, 14 of the 19 (74%) included studies were cross-sectional in design, and only five intervention studies were identified. These facts lend caution to making causal inferences. Yet, three of five (60%) included intervention studies supported a superior effect of OSE on some aspects of cognitive function compared with CSE, suggesting considerable value in further research pursuits. Second, we did not conduct a meta-analytic review due to the small number of randomized control trial (RCT) studies, the prevalence of diverse outcomes measures, and the wide age range of participants in these studies. Lastly, the search language we used was limited to English, increasing a risk of having omitted important research published in other languages.This review article systematically evaluated the current evidence of the effects of OSE versus CSE on cognitive function based on existing observational and intervention studies. The review tends to support the notion that OSE is superior in improving some aspects of cognitive function compared with CSE. Given that most of the existing studies are observational in design, with relatively few intervention studies, more rigorous RCTs with long-term follow-ups are needed to further confirm the current findings.TH, QG, and LZ conceived the study. All authors contributed to the investigation process, provided the methodology, and wrote, reviewed, and edited the manuscript and approved its final version of the manuscript. QG and TH wrote the original draft of the manuscript. TH supervised the manuscript and acquired funding.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


Increased coverage of antenatal care and facility births might not improve maternal and newborn health outcomes if quality of care is sub-optimal. Our study aimed to assess the facility readiness and health worker knowledge required to provide quality maternal and newborn care.Using an audit tool and interviews, respectively, facility readiness and health providers’ knowledge of maternal and immediate newborn care were assessed at all 23 birthing centers (BCs) and the District hospital in the rural southern Nepal district of Sarlahi. Facility readiness to perform specific functions was assessed through descriptive analysis and comparisons by facility type , primary health care center (PHCC), private and District hospital). Knowledge was compared by facility type and by additional skilled birth attendant (SBA) training.Infection prevention items were lacking in more than one quarter of facilities, and widespread shortages of iron/folic acid tablets, injectable ampicillin/gentamicin, and magnesium sulfate were a major barrier to facility readiness. While parenteral oxytocin was commonly provided, only the District hospital was prepared to perform all seven basic emergency obstetric and newborn care signal functions. The required number of medical doctors, nurses and midwives were present in only 1 of 5 PHCCs. Private sector SBAs had significantly lower knowledge of active management of third stage of labor and correct diagnosis of severe pre-eclampsia. While half of the health workers had received the mandated additional two-month SBA training, comparison with the non-trained group showed no significant difference in knowledge indicators.Facility readiness to provide quality maternal and newborn care is low in this rural area of Nepal. Addressing the gaps by facility type through regular monitoring, improving staffing and supply chains, supervision and refresher trainings is important to improve quality. The Lancet [Lancet Global Health Commission on high-quality health systems (HQHS) in the SDG era asserts that providing health services without guaranteeing a minimum level of quality is ineffective, wasteful and unethical [Despite declining maternal mortality ratio (MMR) and neonatal mortality rates (NMR) and increasing rates of facility deliveries, an estimated 303,000 maternal deaths , 2.7 mile Lancet , 9, Midwe Lancet , 11, ande Lancet , 13 highe Lancet , 14, andnethical . This Conethical . Maternanethical .Although greatly reduced from 539 in 1996, the MMR in Nepal remains high at 239 maternal deaths per 100,000 live births and NMR has decreased from 33 in 2006 and 2011 to 21 deaths per 1000 live births in 2016 . AdditioThe rapid expansion of the Nepal Safe Motherhood Program (NSMP) nationwide likely contributed to an increase in institutional deliveries to 57% in 2015 from 9% in 1996 , but thiData were collected from facilities and providers in Sarlahi district  located in the central southern plains of Nepal, bordering India. The annual birth cohort is approximately 18,000 . In termQoC has various definitions and defined differently by various experts and institutions. The Institute of Medicine (IOM) defines quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” . Under tAfter pilot testing the tools in April 2016, we conducted a cross-sectional study on all public and private health facilities that were classified as birthing centers in Sarlahi district between May 4 and August 29, 2016. Through direct observation of the facility and interviews with staff / in-charges, the facility audit focused on the infrastructure, utilities, furniture, medical equipment, and drugs allocated for antenatal care (ANC), labor and delivery, and newborn care services, as well as information on the human resources. All staff  engaged in provision of ANC, labor/delivery care, and/or immediate newborn care, were eligible for the health worker interview. Questions focused on work experience, training, and knowledge of maternal  and newborn  health. Data were recorded using the Research Electronic Data Capture (REDCap) application on a password-encrypted mobile android device. When possible, the birthing center audit and health worker interviews were completed on the same day; in about half of the facilities, some eligible health workers were not met on the first visit  but were conducted subsequently upon their return. The lead author, a native Nepali speaker, conducted all the interviews and facility assessment in Nepali using a Nepali translation of the Health worker interview tool as a guide.N = 24).We conducted descriptive analyses of the infrastructure and utilities , human resource availability, privacy, and capacity to 1) perform the seven signal functions under BEmONC , the mean percentage of correct answers was calculated within each domain, and mean scores were stratified by facility type. Chi-squared or Fisher’s exact tests were used to compare health worker scores across facility types and by whether or not the respondent had received the Ministry of Health and Population (MoHP)-sponsored two-month skilled birth attendant (SBA) training. Stata version 13.0  was used for all analyses.The Johns Hopkins Bloomberg School of Public Health Institutional Review Board  and the Nepal Health Research Council, Ministry of Health and Population  reviewed and approved this study. Written informed consent was obtained from health workers prior to the interview.We included all 22 public facilities with a designated birthing center, reflecting the three tiers of district-level service   and 2 prAll facilities were either directly linked (21 of 24) or within 5 min’ walk (3 of 24) to a road accessible to 4-wheeled vehicles. Six facilities  had a functional ambulance with fuel, while 1 PHCC and 3 HPs had a non-functioning ambulance.While all facilities reported providing 24/7 delivery services (except one HP-level birthing center where no auxiliary nurse midwives (ANMs) were posted), a separate room for night shift staff was available in only 18 facilities. Given the frequency of blackouts, backup electrical capacity is required to prevent gaps in quality services; four HPs had no such backup . Except for one PHCC that was renting space and had only one room dedicated for delivery, ANC, and postnatal services, all other facilities had a single room with visual and auditory privacy for delivery care. Ten facilities had a separate dedicated space for postnatal services; the norm was to share space with the admissions room, where women are admitted right before delivery. Only four HP and 1 PHCC had at least two separate rooms for examination/consultation/admission, in addition to rooms for delivery, postnatal care, utility services/activities, and a room for staff. Laboratory areas to conduct various tests  are required at PHCC level or higher as per MoHP regulations. These were available for all five PHCCs and the District hospital, in addition to three HPs and both private facilities.Most delivery and ANC rooms appeared “clean” upon visual assessment; in 3 HPs, these spaces were characterized as “not clean” based on dirty examination bed, dusty furniture and dirty floor and walls. Only five facilities had a toilet attached to the delivery room; all remaining had a toilet elsewhere at the facility, but in six instances the toilet was either unclean and/or water was not available  provided routine and referral ANC services. Proteinuria and hemoglobin testing were not consistently done, even when laboratory services were available; when laboratory services were not available, most facilities reported referring clients to the nearest private or public laboratory. Tetanus toxoid vaccination was widely available. Iron/folic acid tablets were out of stock in 14 health facilities , mainly due to a nationwide supply shortage, and delayed distribution by MoHP. Similarly, strips for testing proteinuria (i.e. pre-eclampsia screening) were unavailable in 2 of 5 PHCCs.Overall, 16 of the 24 health facilities had all items needed for infection control with both the private facilities having all the items while the District hospital did not have the disinfecting solution at the time of the study. In contrast, the District hospital had all the other elements to support quality whereas both the private health facilities lacked the physical copy of essential guidelines on managing normal labor and birth and emergency obstetric care. Only 9 facilities stocked injectable anticonvulsants and antibiotics for eclampsia and sepsis, respectively, with health posts being particularly understocked (4 of 16).Four facilities  reported having ever performed the six BEmONC signal functions queried , and none reported conducting all six functions within the prior 3 months (data not shown). Mean scores for availability of medications/supplies required for all seven BEmONC signal functions, overall and by facility type are shown in Fig. The MoHP-indicated list of supplies for quality newborn care was either fully or largely met at the District hospital and the private facilities. However, only 9 facilities maintained a functioning heat source for preterm infants, and only half had oxygen available at the time of assessment. Functioning oral thermometers, suction devices , resuscitation table, and bag/mask were missing from a small number of HPs and PHCCs , only 1 of the PHCCs had the requisite staff nurse posted at the time of the audit. Twelve of the sixteen HP level facilities had the required number of ANM/Senior ANM position actually filled while only one of the private facilities had this position filled. At facilities that were not fully staffed, in-charges reported extensive time periods since vacant posts were previously filled  and one HP level facility had no ANMs in the prior year.n = 33), 5 PHCCs (n = 13), 1 District hospital (n = 11) and 2 private clinics (n = 6). The majority of health workers  were ANMs or Senior ANMs, a level which requires grade 10 level education and 18 months training (24 months for Senior certification)  that showed 90% facilities having iron/folic acid tablets . Lack ofThe 2015 NHFS found that centers designated as BEmONC-capable did not necessarily have this capacity due to gaps in drugs and equipment; lack of magnesium sulfate, injectable antibiotics, and MVA/D&C kits were particularly glaring . We haveBirthing centers established without sufficient physical infrastructure (i.e. rooms and laboratories as per NSMP guidelines) result in sharing beds/space across labor and postnatal services, and forces referral to external labs for even basic testing services. Thus, in many facilities, lab tests which are an integral part of ANC, were not done either because they did not have the facilities or did not have the testing supplies. Pregnant women are more likely to not have any laboratory tests done due to distance to nearest referral lab or financial constraint . This can possibly lead to delayed diagnosis or non-diagnosis of a potential pregnancy complication , resulting in inability to take preventive measures or receive treatment in a timely manner. An assessment of service readiness of health facilities in ten countries, including Nepal, found that only 2% of facilities surveyed between 2007 and 2015 had eight diagnostic tests defined as essential for basic service readiness by the WHO, including those necessary for antenatal care, such as urine dipsticks for protein and glucose, syphilis rapid diagnostic tests, and HIV diagnostic capacity . In manyLong-standing staffing gaps or sub-optimal distribution of human resource assets in many PHCC and HP level facilities is a result of insufficient SBA training programs, ineffective deployment, and poor worker retention, and reflects typical health system bottlenecks in quality care in many developing countries like Nepal . SkilledOur evaluation showed that the private birthing centers had high standards of care in terms of cleanliness, infrastructure, infection control, medicines/supplies and human resource, but did not necessarily have high performance in some of the maternal and newborn knowledge indicators. This may in part be due to the exclusion of the private sector in the refresher trainings and SBA trainings. In Sarlahi district, pregnant women who deliver in either one of the private clinics are eligible to receive the transportation cost reimbursement from MoHP but the exclusion of the private sector staff in trainings is a service gap that could be strengthened through public-private partnership (PPP) efforts . One exaCompared to the HPs/PHCCs, the district hospital had better service readiness, especially in terms of medicines and supplies, basic infrastructure and human resources. Similar findings of better service readiness in hospitals compared to primary care facilities is evident in other settings as well , 45. StuThe MoHP and key stakeholders should establish standard regulations and routinely monitor readiness by type of health facility, identify gaps and areas for improvement, and intervene accordingly at the district level. Currently, MoHP monitors the Safe Motherhood Program through service coverage indicators collected monthly at the facility level; such indicators include the % of women who received a 180 day supply of iron/folic acid during pregnancy, % institutional deliveries (out of population-based estimate of expected livebirths), ANC coverage , etc. . HoweverStrengths of our study include utilizing existing tools allowing comparison at the national level on key indicators, universal sampling of all birthing centers in the district, and interviews with all the health workers employed in the birthing centers during the study period, thus providing a complete picture of health worker knowledge in this district, which is typical of much of rural Nepal. Limitations include the use of self-reported information on the performance of BEmONC signal functions and the lack of observation-based measures of obstetric care, which is considered the gold standard for measuring process quality but is resource-intensive to implement. Other important dimensions of quality, including communication among providers, both within and between facilities, the quality of documentation, and the strengths and weaknesses of referral systems were not directly assessed. Our more narrow focus, however, was still able to identify several inputs needed to provide high-quality obstetric care were not in place and provided actionable data on health facility readiness to health officials. The Commission on HQHS argues that quality measurements have predominantly focused on inputs and that they provide a insight into quality of care and proposes accountability and action as the guiding purposes of quality improvement . Our stuWe assessed health worker knowledge about key aspects of maternal and newborn health. Knowledge (assessed through test and case scenarios) and performance are not very closely correlated , 55, 56:In Nepal, financial incentives for women, performance-based financing for providers and facilities, and removal of user fees have increased facility births and ANC visits. Such rapid increase in utilization is likely to place a considerable burden on the facilities and may compromise quality , 58. ThiAdditional file 1. Health Facility Audit Tool and Health Worker Knowledge Interview Guide. This additional file contains the health facility audit tool and the interview guide to assess health worker knowledge on maternal and newborn care.Additional file 2: Labor/delivery room and ANC examination room setting. This additional file includes Table S1. which shows the results on the setting of the labor/delivery room and ANC examination room and basic infrastructure in those rooms.Additional file 3: Capacity to perform BEmONC signal functions and immediate newborn care. This additional file includes Table S2., which shows the detail breakdown of the availability of the medicines and supplies to perform each of the seven BEmONC signal functions as well as the availability of medicines/supplies to deal with common or serious complications and immediate newborn care.Additional file 4: Health worker training and work experience. This additional file shows the detailed breakdown on the type and years of training the health workers have received along with their number of years of experience working in ANC, delivery care and newborn care. Table S3A. and S3B. displays the results on training and work experience of the health workers by health facility type and SBA training respectively.Additional file 5: Health worker knowledge on maternal health. This additional file shows the detailed breakdown on health worker knowledge on various topics of maternal health by type of health facility (Table S4A.) and by SBA training (Table S4B).Additional file 6: Health worker knowledge on newborn health. This additional file shows the detailed breakdown on health worker knowledge on various topics of newborn care by type of health facility (Table S5A.) and by SBA training (Table S5B).


Harmful social norms and lack of knowledge contribute to risky pregnancies in older and high-parity women in low- and middle-income countries. A social and behavior change communication resource combining technical guidance with tangible client and provider materials was designed to address and prevent such pregnancies in Niger and Togo. Harmful social norms and lack of knowledge contribute to risky pregnancies in older and high-parity women in low- and middle-income countries. A social and behavior change communication resource combining technical guidance with tangible client and provider materials was designed to address and prevent such pregnancies in Niger and Togo. Pregnancy among women of advanced maternal age (those 35 years or older) or among women of high parity (those having had 5 or more births) is linked to maternal and infant mortality. Yet little is known about the drivers of these pregnancies as they are often neglected in existing family planning and reproductive health programs. To better understand the context in which advanced maternal age and high parity pregnancies occur and the acceptability of discussing associated pregnancy risks, the Health Communication Capacity Collaborative (HC3) conducted formative qualitative research between January and March 2015 on the perception and determinants of such pregnancies in rural and urban areas of Niger and Togo. We supplemented this research with secondary analyses of data from Demographic and Health Surveys and a 2014 Niger survey. Our formative research showed that urban Togolese participants demonstrated more knowledge about advanced maternal age and high parity pregnancy risks than did participants in Niger as a whole. We found that such pregnancies were generally seen as part of reproductive norms in situations where fertility rates remain exceptionally high, especially in Niger. Social, gender, and religious norms, including competition between co-wives, also drove women into high parity and advanced maternal age situations, particularly in Niger, highlighting the need to bring men and community and religious leaders into family planning conversations to increase acceptance. The study also provided important insights needed to address these high-risk pregnancies through culturally appropriate health communication interventions. A main insight was that providers often had incomplete information about advanced maternal age and high parity pregnancies and lacked communication skills, protocols, and tools to appropriately discuss such pregnancy risks with clients. HC3 used these and additional findings to create an Implementation Kit (I-Kit) for family planning and maternal and child health program managers with guidance and tangible tools to address advanced maternal age and high parity pregnancy through social and behavior change communication. The I-Kit includes health communication materials to engage women, men, decision makers, communities, health care providers, journalists, and others. In 2016 and 2017, one organization each in Niger and Togo piloted the I-Kit, integrated selected I-Kit tools into their unique programs, and documented their experiences. Both organizations credited the I-Kit with expanding the scope of their programs to now address advanced maternal age and high parity pregnancy and provided concrete suggestions for adapting the materials according to activity and intended audience. Family planning remains a key aspect of the global health agenda. Following a decline in global funding in the late 2000s, family planning has regained momentum and international attention in recent years.–While these efforts have increased family planning programs in developing countries, there remain distinct neglected needs, risk factors, and population segments. For example, while much attention is given to preventing pregnancy among women before age 18, increasing voluntary contraceptive uptake, and establishing healthy spacing intervals between pregnancies,Family planning programs typically place less attention on addressing pregnancies among women of advanced maternal age or high parity.Advanced maternal age and high parity pregnancies are prevalent in sub-Saharan African countries where parity rates are high and childbearing often continues until menopause.,A review of the literature shows that while advanced maternal age- and high parity-specific research exists, much is from high-income settings in the West. Only a few studies from sub-Saharan Africa exist,https://sbccimplementationkits.org/htsp/) to help program managers address these high-risk pregnancies in their programs using social and behavior change communication.Given the risks and region-specific information gaps, the Health Communication Capacity Collaborative (HC3) project of the Johns Hopkins Center for Communication Programs conducted formative research and created and piloted a Healthy Timing and Spacing of Pregnancies: Addressing Advanced Maternal Age and High Parity in Family Planning Programs Implementation Kit (I-Kit)  reports.,Another reason we focused on Niger and Togo is that both countries have critical family planning needs. Contraceptive use is relatively low in both Niger (14% of married women)Finally, both countries have NGO and government support for family planning programs. In addition to being FP2020 focus countries, both Niger and Togo are members of the Ouagadougou Partnership. The Government of Niger has committed to increase the contraceptive prevalence rate to 50% in 2020, from 10.8% in 2012. The Niger government plans to achieve this by increasing contraceptive availability , strengthening demand for family planning methods and services , and creating a more favorable family planning environment through policy and other structural efforts.The overall goals of the formative research were to: (1) understand the knowledge, attitudes, and behaviors that contribute to advanced maternal age and high parity pregnancy incidence/prevalence, and (2) understand how the findings could be used to improve maternal and child health and family planning programs through a pilot intervention focused on social and behavior change communication.The formative, qualitative research took place between January and March 2015 in 1 urban and 2 rural locations in Niger and Togo . The selFocus group discussions were conducted with women of advanced maternal age and/or high parity and with male partners of women in these risk categories to gather data about collective perceptions and attitudes that influence choices about reproduction, particularly advanced maternal age and/or high parity pregnancies.Case studies were collected from individual women of advanced maternal age and/or high parity who had difficult pregnancies or deliveries. These histories highlighted knowledge and attitudes of these women about risks with such pregnancies and how these impacted their pregnancies and deliveries.In-depth interviews were conducted with:Advanced maternal age and high parity couples to understand how marriage, gender dynamics, and individual, cultural, economic, and other factors impacted fertility desires and reproductive health decision making regarding advanced maternal age and high parity pregnancies.Maternal and infant health service providers to understand their perception and knowledge of advanced maternal age and high parity pregnancies, and how they communicated with their clients about these types of pregnancies.Community leaders to understand their maternal health and family planning perspectives, as well as their view of advanced maternal age and/or high parity pregnancies.In Niger, we conducted the study in Niamey (urban), Koygoro , and Mokko  in the Dosso region, which is approximately 130 km from the capital city of Niamey. Villages in the north of the Dosso region were selected due to safety concerns. In Togo, we conducted the study in Lomé (urban), Aouda , and Adjengre  in the Plateaux region, located 169 km from the capital Lomé. This region was chosen because of its mix of religions . We conducted focus group discussions, case studies, and in-depth interviews with 285  health care service providers, women of advanced maternal age and/or high parity, male partners of women in these risk categories, and community leaders. In each study site:We supplemented the qualitative research with data from the “Customer Insights Research for Family Planning Demand Generation in Niger,” a nationwide survey of 2,000 women between the ages of 15 and 49, conducted in 2014 by Hope Consulting (which merged with SwitchPoint to form Camber Collective in July 2015).The research protocol was approved by the Johns Hopkins University Institutional Review Board (IRB) and by local IRBs in Niger and Togo. We conducted focus group discussions and in-depth interviews in Zharma and Hausa languages in Niger and in Mina and Kabiye languages in Togo; all were recorded and transcribed in the field into French. A resource person (often the main facilitator who spoke the language in which the interview was conducted) checked and evaluated the transcripts. Finally, we conducted content analysis using Microsoft Word and coded responses thematically.Participants in both rural and urban Niger believed advanced maternal age pregnancies were common in their communities. In Togo, responses were mixed; while most viewed such pregnancies as a “rural problem.” others reported they were also prevalent in cities.In Niger, most participants reported high parity was common in both urban and rural settings. One man from urban Niger explained in an in-depth interview:Personally, 5 children is good. But if God arranged for us to have more, that would not be a problem.The Niger survey confirmed the participants' perceptions that high parity was common, showing 42% of women between the ages of 15 and 49 in a relationship at the time of the survey were high parity. Among these, 71% said they wanted more children. In Togo, participants generally acknowledged the high number of high parity pregnancies in their country, but were divided about high parity pregnancy frequency in urban areas.In Niger, participants saw pregnancy itself as a perilous situation for women but did not perceive age or parity to compound the risk. Those who did associate dangers with advanced maternal age and high parity pregnancies did so generally, and referred mostly to the death of the mother and, secondarily, to that of the baby. These 2 risks were perceived as the most common and the most serious. Togo participants were somewhat more aware of age- and parity-related risks and were also concerned about advanced maternal age and high parity women dying as a result of pregnancies. They mentioned infant mortality, the likelihood of genetic defects, and even social consequences of such pregnancies.Participants in Niger recognized pregnancy as a perilous situation for women but did not perceive age or parity to compound the risk.We found that religious beliefs contributed to advanced maternal age and high parity pregnancy, particularly among Muslim participants in both countries, and more prominently in Niger than in Togo. Many believed Islam forbids any interference with reproduction and mandates that women have the number of children “God gave them,” regardless of their desired fertility. Religion was scarcely mentioned as a factor among non-Muslim participants.In both countries, male and female participants reported an unfavorable cultural norm toward limiting births or did not feel it was their place to prevent births. These norms were stronger in Niger and in rural Togo. One man from urban Niger, who did not use family planning, explained:Really it's not good to limit births to 3, 4, or 5 children. It's not our culture. So those of us who have 4 wives—and if we only want 4 children? So every woman will stop after a single child? (Hum!) In any case, we would like every woman to have 16 children. … Really, [limiting births] is not normal, [and] not just in Niger.decreased sizably from 123 per 1,000 live births in 1998 to 51 in 2012 in Niger, and from 80 in 1998 to 49 in 2013/2014 in Togo.increased from 7.2 to 7.6 between 1998 and 2012, and have dropped only slightly in Togo from 5.2 to 4.8 between 1998 and 2013/2014. In urban Togo, we did see evidence that norms are shifting toward acceptance of and desire for using family planning to have smaller families.In Niger, and to a lesser extent in Togo, participants felt having a large family helped them to be perceived positively and as “blessed by God” in their community. Participants also felt that having more children added to a family's monetary wealth, ensuring that parents would be cared for in their old age. Finally, participants in both countries favored large families because of perceived high infant mortality rates; the thought is to give birth to many children in the hopes of always having some children should others succumb to illness or death. According to each country's DHS, however, infant mortality rates have Participants in Niger and Togo favored large families because of perceived infant mortality rates, yet infant mortality has decreased sizably in both countries.More common in Niger than in Togo, our research revealed women in polygamous situations feared real consequences if they had too few children—fears that some men confirmed. One man from urban Togo explained in a focus group discussion:If you do not want to raise your hands to implore God because your husband wants to take another wife, you must agree to lift your legs. Yes, if the woman wants to close her legs instead of providing all the children she can have, the man will want to take a second wife. If she doesn't want him to take a second wife, she is forced to open her legs. That's why instead of raised hands “alolédji” it's instead lifted legs “afolédji,” you see?Having many children therefore served to (1) prevent the husband from attempting to take another wife or (2) have a competitive edge over co-wives for the husband's attention, resources, and eventual social status and inheritance should the husband die.Niger has the highest rate of child marriage in the world, with 76% of girls marrying by age 18,Interviews with maternal and infant health care professionals in both countries revealed inconsistent and unstructured communication with clients about advanced maternal age and high parity pregnancy risks. Providers had low or very general knowledge about age- and parity-related complications, though knowledge levels were acceptable among midwives compared with community health workers and other lower-level cadre providers, who demonstrated a poor understanding of advanced maternal age and high parity pregnancy risks. Further, providers reported that no guidelines existed on when or how to discuss advanced maternal age and high parity pregnancy with clients, and lamented a lack of materials to support such counseling. Finally, providers seemed to lack the skills needed to communicate risk in culturally appropriate ways. This sometimes led clients to fear or mistrust providers. One service provider in rural Togo told of a particular health center where women no longer wanted to visit. Women believed that when a particular midwife at the facility discussed potential pregnancy complications with women, she was wishing misfortune on them, which would then surely come true.Providers in Niger and Togo had low or very general knowledge about age- and parity-related pregnancy complications.Overall, the study showed that urban locations had more accepting cultural norms about family planning use compared with rural locations and that urban participants in Togo demonstrated more knowledge about advanced maternal age and high parity pregnancy risks than Niger participants as a whole. We found such pregnancies are generally seen as part of reproductive norms, and limiting is forbidden in contexts where fertility rates remain exceptionally high, such as in Niger. In some urban settings, however, particularly in Togo, these norms were shifting as some “positive deviant” men and women were recognizing the social, health, and economic value of planning pregnancies and having smaller families. Pregnancy risks, such as the death of the mother or the child, were key fears among men and women in both countries. In Togo, these were already understood by some to be elevated risks in advanced maternal age and high parity pregnancy. However, these risks were inconsistently or poorly communicated at the service delivery level.Advocate for addressing advanced maternal age and high parity pregnancy risks in national health agendas and developing data-driven, comprehensive communication strategies accordingly. Such strategies and associated messaging should be designed to address a country's specific context—for example, according to attitudes about spacing and limiting pregnancies, prevailing marriage dynamics (such as polygamy), and prevalence of advanced maternal age compared with high parity.Increase capacity among providers who interact with clients on maternal and child health and family planning matters, including community health workers, midwives, and facility-based providers, to communicate advanced maternal age and high parity pregnancy risks by improving counseling and clinical skills during pre- and in-service trainings.Include advanced maternal age and high parity pregnancy information in maternal, newborn, and child health programs, including child health and immunization visits, and in family planning programs, including postpartum family planning programs. This way, programs can better reach clients at a time when they may be thinking about current family size and a future pregnancy, or family health, respectively.Work with local organizations and structures, including religious leaders, to develop community-centered programs that address social, religious, and cultural norms that perpetuate advanced maternal age and high parity pregnancy , and emphasize positive, existing norms  through proven communication strategies.Engage male partners  to understand advanced maternal age and high parity pregnancy risks and help prevent such pregnancies in their households, where strict gender roles elevate men as family planning decision makers.Develop health communication tools specific to advanced maternal age and high parity pregnancy for women's health gatekeepers to promote awareness, change attitudes , and catalyze lifesaving behavior change among key audiences.Health communication is an indispensable tool for increasing understanding about advanced maternal age and high parity pregnancy prevalence and risks, and it is key to catalyzing improved behaviors and strengthening existing family planning programs. The study findings suggest clear opportunities to:With many of these implications in mind, we created the Healthy Timing and Spacing of Pregnancies I-Kit, focused exclusively on addressing advanced maternal age and high parity pregnancy risks. The I-Kit is adaptable, with source files  available upon request. The I-Kit is designed to save program managers the time and money of creating materials on advanced maternal age and high parity from scratch and to enable them to expand their projects' breadth and impact by including communication activities on such pregnancies in their existing family planning and maternal and child health work. The I-Kit is grounded in the formative research findings described in this article, and includes a guide for program managers that explains how to integrate risk information, key messages, and calls to action into existing relevant projects using social and behavior change communication theories and processes. It also includes a collection of ready-to-use or adaptable health communication tools including client brochures, a community mobilization guide, counseling assessment guides, a provider poster, a guide for researchers, a guide for journalists, and infographics.We developed the Healthy Timing and Spacing of Pregnancies Implementation Kit to address advanced maternal age and high parity pregnancy risks.In 2015, the I-Kit was pretested in Niger and Togo with advanced maternal age and high parity women, male partners, community and facility health workers, journalists, program implementers, and other NGO and government representatives to gauge the materials' clarity, cultural appropriateness, and usefulness. We conducted focus groups, working sessions, user observations, and interviews. Based on participant feedback, we revised resources to trim text, add or adjust images for more conservative audiences, and adjusted translations to use preferred and more common or regionally acceptable terminology. We also expanded certain resources to be more inclusive of men, youth, religious leaders, community health workers, and TV and print (rather than just radio) journalists. The I-Kit was finalized in 2016. We then contracted with Marie Stopes International (MSI) in Niger and the Association Togolaise pour le Bien-Être Familiale (ATBEF) in Togo to pilot selected I-Kit elements and tools and identify opportunities to adapt the I-Kit's materials based on on-the-ground use.The Implementation Kit was pretested in Niger and Togo with women, male partners, community and facility health workers, journalists, program implementers, and other NGO and government representatives.MSI, active in Niger since 2013, provides quality reproductive health services in and around Maradi, Niamey, and Tillaberi. MSI operates primarily through its Niamey clinic and a series of mobile outreach workers, including mobile clinic teams, social mobilization agents, and community-based promoters. ATBEF is a member of the International Planned Parenthood Federation and has been delivering sexual and reproductive health services throughout Togo since 1975. ATBEF operates through 5 clinics, 2 mobile teams, and a cadre of community health workers.To prepare for the pilot, each organization reviewed the entire I-Kit and chose specific tools to incorporate into existing project activities to share advanced maternal age and high parity information with their clients and communities. Both MSI and ATBEF initiated the pilot by holding a staff and stakeholder workshop to review the program manager guide, and orient their teams on advanced maternal age and high parity pregnancy, why it should be a priority, and how to address it through social and behavior change communication. These types of communication activities were somewhat new to both organizations, arguably more so to ATBEF. Despite this initial challenge—surmounted through virtual technical support sessions and additional French-language social and behavior change communication references—each organization successfully employed the I-Kit tools into their work.Supplements 1 and 2).Overall, MSI reached 12,757 women and men with the pilot activities through mobile clinic outreach, community discussions, individual counseling, and workshops with journalists. ATBEF reached 3,337 individuals through client counseling and community education sessions and provider and community health worker training sessions. These numbers are impressive both considering the short implementation period, but particularly when considering that for most, if not all, beneficiaries, this was the first time receiving complete and correct information about advanced maternal age and high parity pregnancy risks  have expressed interest in using the I-Kit in their context. Our pilot and adaptation activities, as well as these requests to use the materials, show that while discussing advanced maternal age and high parity pregnancy risks can be sensitive due to social and cultural taboos regarding birth limiting and modern contraceptive use, there is undeniable receptiveness to addressing these pregnancies in low- and middle-income countries. These opportunities should not be ignored and must be instead fanned as sparks to a momentous fire for action and constructive change.


National surveys of adolescents, college students, and other young adults in the United States reveal high rates of alcohol use among these age groups as well as high rates of dangerous drinking practices such as binge drinking and daily drinking. Additional health-compromising behaviors such as tobacco use and drinking and driving often co-occur with alcohol use in these populations. The physical locations or drinking contexts where alcohol use occurs can predict drinking practices and consequences. This information can be used to identify appropriate targets for effective interventions and social policies. Alcohol use during adolescence and young adulthood remains a prominent public health problem in the United States. National survey results indicate that 28.6 percent of 12th graders and 40.1 percent of college students reported binge drinking  during the 2-week period preceding the survey a,b. AlcoIn 1999, more than 32 percent of young people reported beginning to drink before age 13 . EarlierFindings from the Monitoring the Future Survey (MFS) a—for whiResearchers have suggested that the differences in alcohol use between males and females are converging , but it Children attending alternative high schools constitute a distinctive subpopulation of adolescents who may be at increased risk for the development of serious alcohol problems. Alternative high schools serve students at risk for failing or dropping out of regular school and students who have been removed from their regular high schools because of behavior problems such as violence or substance use. About 2 percent  of all high school students attend alternative schools . GrunbauRates of drinking among college students and other young adults are also high. College students are often undergoing role transitions—such as moving away from the family home for the first time, residing with other students, and experiencing reduced adult supervision—that may increase the risk of alcohol use and abuse. College students also frequently reside in different physical and social environments and encounter new social and institutional factors  that may foster heavy alcohol use.As noted previously, the MFS followup b is limiAnother study of college drinking, the 1995 National College Health Risk Behavior Survey , investiBoth the prevalence of alcohol use during the last 30 days and the prevalence of binge drinking were higher among students at 4-year institutions than among students at 2-year institutions. The prevalence of daily drinking was slightly higher for women at 2-year institutions, compared with those at 4-year institutions, and was the same for men at the two types of institutions. Living conditions  and the increased role of fraternities and sororities on 4-year campuses compared with 2-year campuses may be important factors influencing the differences in rates of binge drinking and 30-day alcohol use at the two types of institutions.As reviewed above, survey data provide a consistent picture of high rates of alcohol use, binge drinking, and daily drinking on college campuses. Another important index of alcohol use by college students is the extent of alcohol-related adverse consequences. Standard surveys about the prevalence of alcohol use generally do not gather information about key situational or contextual conditions, such as the location of drinking. This information, however, may have a significant bearing on the interpretation of survey findings and on the identification of appropriate targets for effective interventions and social policies.Adolescents consume alcohol in a variety of contexts, including their own homes, homes of friends or acquaintances, bars or restaurants, outdoor settings , at school or work, and in moving cars or trucks. Based on a sample of 1,914 high school seniors, Several studies have indicated that living circumstances are a major contextual influence on college student drinking behaviors . For exaIn another study of drinking contexts, Alcohol use among adolescents co-occurs with a range of other risky behaviors including tobacco use, sexual activity, violence, drinking and driving, and suicide . Based oFindings from the National College Health Risk Behavior Survey  have alsEpidemiological findings on adolescent and young adult alcohol use reveal several disturbing trends. National data indicate not only that there are high rates of alcohol use among these age groups, but also that many adolescents and young adults engage in drinking practices  associated with major contributors to youth mortality  and with disruptions in significant contexts  that are important for healthy development. The findings also indicate that there are important secondary effects  for abstainers and nonbinge drinkers on college campuses with high rates of binge drinking. The findings regarding gender differences indicate that almost as many females as males are consuming alcohol, but that males in adolescent, college, and noncollege samples have a higher prevalence than females of more serious drinking patterns such as binge drinking and daily drinking. Racial/ethnic group differences indicate the highest prevalence of use among Whites, with Hispanics second, and African Americans at substantially lower levels. These racial/ethnic group findings were consistent across the multiple probability samples referred to in this article.In addition to the high rates of alcohol use among these youthful populations, survey data demonstrate the common co-occurrence of additional health-compromising behaviors  among heavier users. This information should be integrated in subsequent intervention efforts and social policies regarding the health and well-being of youth . These f