Applying the Exploration, Preparation, Implementation, Sustainment (EPIS) Framework to Safe Surgery 2020 Implementation in Tanzania's Lake Zone.

BACKGROUND: Access to safe, high-quality surgical care in sub-Saharan Africa is a critical gap. Interventions to improve surgical quality have been developed, but research on their implementation is still at a nascent stage. We retrospectively applied the Exploration, Preparation, Implementation, Sustainment framework to characterize the implementation of Safe Surgery 2020, a multicomponent intervention to improve surgical quality. METHODS: We used a longitudinal, qualitative research design to examine Safe Surgery 2020 in 10 health facilities in Tanzania's Lake Zone. We used documentation analysis with confirmatory key informant interviews (n = 6) to describe the exploration and preparation phases. We conducted interviews with health facility leaders and surgical team members at 1, 6, and 12 months (n = 101) post initiation to characterize the implementation phase. Data were analyzed using the constant comparison method. RESULTS: In the exploration phase, research, expert consultation, and scoping activities revealed the need for a multicomponent intervention to improve surgical quality. In the preparation phase, onsite visits identified priorities and barriers to implementation to adapt the intervention components and curriculum. In the active implementation phase, 4 themes related to the inner organizational context-vision for safe surgery, existing surgical practices, leadership support, and resilience-and 3 themes related to the intervention-innovation-value fit, holistic approach, and buy-in-facilitated or hindered implementation. Interviewees perceived improvements in teamwork and communication and intra- and inter-facility learning, and their need to deliver safe surgery evolved during the implementation period. CONCLUSIONS: Examining implementation through the exploration, preparation, implementation, and sustainment phases offers insights into the implementation of interventions to improve surgical quality and promote sustainability.

Blueprint for cancer research: Critical gaps and opportunities.

We are experiencing a revolution in cancer. Advances in screening, targeted and immune therapies, big data, computational methodologies, and significant new knowledge of cancer biology are transforming the ways in which we prevent, detect, diagnose, treat, and survive cancer. These advances are enabling durable progress in the goal to achieve personalized cancer care. Despite these gains, more work is needed to develop better tools and strategies to limit cancer as a major health concern. One persistent gap is the inconsistent coordination among researchers and caregivers to implement evidence-based programs that rely on a fuller understanding of the molecular, cellular, and systems biology mechanisms underpinning different types of cancer. Here, the authors integrate conversations with over 90 leading cancer experts to highlight current challenges, encourage a robust and diverse national research portfolio, and capture timely opportunities to advance evidence-based approaches for all patients with cancer and for all communities.

An Evidence-Based Care Protocol Improves Outcomes and Decreases Cost in Pediatric Appendicitis.

BACKGROUND: Appendicitis is a common indication for urgent abdominal surgery in the pediatric population. The postoperative management varies significantly in time to discharge and cost of care. The objective of this study was to investigate whether implementation of an evidence-based protocol after an appendectomy would lead to decreased length of stay and cost of care. METHODS: In 2014 at the Children's Hospital of Pittsburgh, an initiative to develop an evidenced-based protocol to treat appendicitis was undertaken. A work group was formed of pediatric surgeons and other important personnel to determine best practices. Treatment pathways were created. Pathways differed with recommendation on postoperative antibiotic choice and duration, diet initiation, and discharge criteria. Data were prospectively gathered from all patients (ages 0-18 y) with acute appendicitis from January 2015 to December 2016. Primary outcomes were length of stay and cost of care. Secondary outcomes were surgical site infection, readmission rate, and duration of postoperative antibiotics. RESULTS: Among the 1289 patients, 481 patients were in the preprotocol cohort and 808 patients were in the postprotocol cohort. 27% of patients had an intraoperative diagnosis of complicated appendicitis. There was a significantly shorter length of stay in the postprotocol cohort (P < 0.001). Median costs for the whole cohort decreased 0.6% and 24.6% for patients with complicated appendicitis after protocol initiation (P < 0.01). CONCLUSIONS: This study has demonstrated that introduction of an evidence-based clinical care protocol for pediatric patients with appendicitis leads to shorter hospital stay and decreased hospital costs.

Factors associated with underweight, overweight, and obesity in reproductive age Tanzanian women.

BACKGROUND: Underweight, overweight, and obesity are major public health challenges among reproductive-age women of lower- and middle-income countries (including Tanzania). In those settings, obesogenic factors (attributes that promote excessive body weight gain) are increasing in the context of an existing high burden of undernutrition. The present study investigated factors associated with underweight, overweight, and obesity among reproductive age women in Tanzania. METHODS: This study used 2015-16 Tanzania Demographic and Health Survey data (n = 11735). To account for the hierarchical nature of the data (i.e., reproductive age women nested within clusters), multilevel multinomial logistic regression models were used to investigate the association between individual-level (socioeconomic, demographic and behavioural) and community-level factors with underweight, overweight, and obesity. RESULTS: Reproductive age women who were informally employed (relative risk ratio [RRR] = 0.79; 95% confidence interval [CI]: 0.64, 0.96), those who were currently married (RRR = 0.59; 95% CI: 0.43, 0.82) and those who used contraceptives (RRR = 0.70; 95% CI: 0.54, 0.90) were less likely to be underweight. Reproductive age women who attained secondary or higher education (RRR = 1.48; 95% CI: 1.11, 1.96), those who resided in wealthier households (RRR = 2.31; 95% CI: 1.78, 3.03) and those who watched the television (RRR = 1.26; 95% CI: 1.06, 1.50) were more likely to be overweight. The risk of experiencing obesity was higher among reproductive age women who attained secondary or higher education (RRR = 1.79; 95% CI: 1.23, 2.61), those who were formally employed (RRR = 1.50; 95% CI: 1.14, 1.98), those who resided in wealthier households (RRR = 4.77; 95% CI: 3.03, 7.50), those who used alcohol (RRR = 1.43; 95% CI: 1.12, 1.82) and/or watched the television (RRR = 1.70; 95% CI: 1.35, 2.13). CONCLUSION: Our study suggests that relevant government jurisdictions need to identify, promote, and implement evidence-based interventions that can simultaneously address underweight and overweight/obesity among reproductive age women in Tanzania.

Brief evidence-based interventions for universal child health services: a restricted evidence assessment of the literature.

BACKGROUND: Universal child health services (UCHS) provide an important pragmatic platform for the delivery of universal and targeted interventions to support families and optimize child health outcomes. We aimed to identify brief, evidence-based interventions for common health and developmental problems that could be potentially implemented in UCHS. METHODS: A restricted evidence assessment (REA) of electronic databases and grey literature was undertaken covering January 2006 to August 2019. Studies were eligible if (i) outcomes related to one or more of four areas: child social and emotional wellbeing (SEWB), infant sleep, home learning environment or parent mental health, (ii) a comparison group was used, (iii) universal or targeted intervention were delivered in non-tertiary settings, (iv) interventions did not last more than 4 sessions, and (v) children were aged between 2 weeks postpartum and 5 years at baseline. RESULTS: Seventeen studies met the eligibility criteria. Of these, three interventions could possibly be implemented at scale within UCHS platforms: (1) a universal child behavioural intervention which did not affect its primary outcome of infant sleep but improved parental mental health, (2) a universal screening programme which improved maternal mental health, and (3) a targeted child behavioural intervention which improved parent-reported infant sleep problems and parental mental health. Key lessons learnt include: (1) Interventions should impart the maximal amount of information within an initial session with future sessions reinforcing key messages, (2) Interventions should see the family as a holistic unit by considering the needs of parents with an emphasis on identification, triage and referral, and (3) Brief interventions may be more acceptable for stigmatized topics, but still entail considerable barriers that deter the most vulnerable. CONCLUSIONS: Delivery and evaluation of brief evidence-based interventions from a UCHS could lead to improved maternal and child health outcomes through a more responsive and equitable service. We recommend three interventions that meet our criteria of "best bet" interventions.

Evolution of the AMCP Format for Formulary Submissions.

DISCLOSURES: No funding was required for this project. The authors are or have been members of the Format Executive Committee.

The use of real-world effectiveness measurements in clinical settings at Helsinki University Hospital: a systematic literature review.

Aim: Patient reported outcomes collected alongside clinical trials do not reflect real-world effectiveness (RWE). This review assessed the use of RWE measurements in routine clinical treatment and the instruments applied to collect that data. Materials & methods: The RWE articles published from HUS (Helsinki University Hospital) were extracted from several databases. Results: Out of 170 eligible articles, generic health-related quality of life instruments were used in 87 (51.2%) and disease-specific health-related quality of life instruments in 58 (34.1%) articles as a primary measurement. Most of the articles pertained to surgery, gynecology and pediatric surgery. Conclusion: The number of articles assessing RWE is very limited compared with all the articles published from HUS. Thus, we still have limited information about the effectiveness of the treatment in real life.

The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics.

FDA has launched a Real World Evidence (RWE) Program for using real-world evidence (RWE) to help support new indications for already approved drugs or biologics and postapproval studies. The plan also includes stakeholder engagement efforts, demonstration projects, leadership activities, and development of guidance documents to assist developers interested in using real-world data (RWD) to develop RWE to support FDA regulatory decisions. This plan was mandated by the Cures Act passed in 2016. Over the 24-month period from passage of the law until FDA officially announced their program, FDA has gone to considerable efforts to educate the public about the benefits of RWE and encourage researchers to consider situations where RWE trials can generate useful information. Through a variety of stakeholder engagement projects, including publication of articles in medical journals, participation in public meetings, and development of initiatives, FDA has put more effort into preparing the medical community for its new emphasis on RWE than any other new policy that I can recall.

Enabling individualised health in learning healthcare systems.

The rising burden of healthcare costs suggests that the healthcare system could benefit from novel methods that allow for continuous learning to provide more data-driven, individualised care at lower costs and with improved outcomes. Here, we present our synergistic Learning approach for Prediction, Interpretation/Inference and Communication (Learning PIC) framework to address the challenges hindering the successful implementation of learning healthcare systems and to enable the effective delivery of evidence-based medicine.

Creating a community-based comprehensive intervention to improve asthma control in a low-income, low-resourced community.

Introduction: Asthma evidence-based interventions (EBI) are implemented in the home, school, community or primary care setting. Although families are engaged in one setting, they often have to navigate challenges in another setting.Objective: Our objective is to design and implement a comprehensive plan which integrates EBI's and connects the four sectors in underserved communities such as Philadelphia.Methods: September 2015-April 2016 we implemented a three-pronged strategy to understand needs and resources of the community including 1) focus groups and key informant interviews, 2) secondary data analysis and 3) pilot testing for implementation to determine gaps in care, and opportunities to overcome those gaps.Results: Analysis of the focus group and key informant responses showed themes: diagnosis fear, clinician time, home and school asthma trigger exposures, school personnel training and communication gaps across all four sectors. EBI's were evaluated and selected to address identified themes. Pilot testing of a community health worker (CHW) intervention to connect home, primary care and school resulted in an efficient transfer of asthma medications and medication administration forms to the school nurse office for students with uncontrolled asthma addressing a common delay leading to poor asthma management in school.Conclusion: Thus far there has been limited success in reducing asthma disparities for low-income minority children. This study offers hope that strategically positioning CHWs may work synergistically to close gaps in care and result in improved asthma control and reduced asthma disparities.

Evolving Vision of Regulatory Science in the Global Medical Community.

"Regulatory science" (RS) has been defined in various ways, but, nevertheless, the definitions of RS in different parts of the world include many common elements. It seems to be a common view that RS is not basic or applied science but, rather, focuses on the estimation and prediction of safety and efficacy. Thus, we think RS overall should incorporate not only RS specifically for medical product assessment but also RS engineering to provide prediction and estimation tools for those purposes, including guideline/guidance development. It is important as well to consider the potential contribution of RS to rational medicine (i.e., to evidence-based medicine in a broader context), and especially to real-world evidence generation. We will look at how definitions of RS have evolved, and how we believe RS might develop in the future. Taking a patient-centric view, we re-emphasize RS is an ethical science contributing to society and human welfare.

Translating Team-Based Breastfeeding Support into Primary Care Practice.

BACKGROUND: Team-based care facilitates efficient, evidence-based, patient-centered practice. An outpatient, integrated lactation consultant (LC) and primary care provider (PCP) model improves breastfeeding support, yet practices need assistance with implementation. METHOD: Based on experience with team-based breastfeeding support at a suburban practice serving mainly well-educated and privately insured families, we constructed and piloted a 6-step needs assessment that informed implementation of the model at a federally qualified health center (FQHC). Practice assessment included baseline data collection of practice newborn volume, breastfeeding intent, breastfeeding rates, provider survey, and financial variables. Postimplementation outcome measurements included provider satisfaction and visit volume. RESULTS: Analysis using newborn volume, breastfeeding intent, and average insurance reimbursement enabled business calculation, which estimated additional 400 visits per year and revenue to cover staff training costs. The baseline provider survey (n = 20) assessed knowledge, practice resources, and barriers. The main barriers identified to providing lactation support were "not enough time" (80%) and patients "not receiving adequate help" (80%) with 58% noting "inadequate LC staffing at the clinic." After team-based LC/PCP implementation, monthly lactation visit volume doubled. Provider postintervention assessment surveys (n = 20) demonstrated a positive response with providers reporting a perception of "providing better breastfeeding support" (100%) and that "patients had a positive breastfeeding support experience" (84%). CONCLUSION: Team-based LC and PCP health care is a promising approach for delivering efficient, patient-centered, face-to-face counseling and support. Practice assessment informs financial feasibility and confirms provider interest in change. An integrated LC/PCP model can be implemented in a FQHC while enhancing patient breastfeeding support and provider satisfaction.

Qualitative Evidence Synthesis (QES) for Guidelines: Paper 1 - Using qualitative evidence synthesis to inform guideline scope and develop qualitative findings statements.

BACKGROUND: WHO has recognised the need to ensure that guideline processes are transparent and evidence based, and that the resulting recommendations are relevant and applicable. Along with decision-making criteria that require findings from effectiveness reviews, WHO is increasingly using evidence derived from qualitative evidence syntheses (QES) to inform the values, acceptability, equity and feasibility implications of its recommendations. This is the first in a series of three papers examining the use of QES in developing clinical and health systems guidelines. METHODS: WHO convened a group of methodologists involved in developing recent (2010-2018) guidelines that were informed by QES. Using a pragmatic and iterative approach that included feedback from WHO staff and other stakeholders, the group reflected on, discussed and identified key methods and research implications from designing QES and using the resulting findings in guideline development. Our aim in this paper is to (1) describe and discuss how the findings of QES can inform the scope of a guideline and (2) develop findings for key guideline decision-making criteria. RESULTS: QES resulted in the addition of new outcomes that are directly relevant to service users, a stronger evidence base for decisions about how much effective interventions and related outcomes are valued by stakeholders in a range of contexts, and a more complete database of summary evidence for guideline panels to consider, linked to decisions about values, acceptability, feasibility and equity. CONCLUSIONS: Rigorously conducted QES can be a powerful means of improving the relevance of guidelines, and of ensuring that the concerns of stakeholders, at all levels of the healthcare system and from a wide range of settings, are taken into account at all stages of the process.

Qualitative Evidence Synthesis (QES) for Guidelines: Paper 3 - Using qualitative evidence syntheses to develop implementation considerations and inform implementation processes.

BACKGROUND: This is the third in a series of three papers describing the use of qualitative evidence syntheses (QES) to inform the development of clinical and health systems guidelines. WHO has recognised the need to improve its guideline methodology to ensure that decision-making processes are transparent and evidence based, and that the resulting recommendations are relevant and applicable to end users. In addition to the standard data on effectiveness, WHO guidelines increasingly use evidence derived from QES to provide information on acceptability and feasibility and to develop important implementation considerations. METHODS: WHO convened a group drawn from the technical teams involved in formulating recent (2010-2018) guidelines employing QES. Using a pragmatic and iterative approach that included feedback from WHO staff and other stakeholders, the group reflected on, discussed and identified key methods and research implications from designing QES and using the resulting findings in guideline development. As members of WHO guideline technical teams, our aim in this paper is to explore how we have used findings from QES to develop implementation considerations for these guidelines. RESULTS: For each guideline, in addition to using systematic reviews of effectiveness, the technical teams used QES to gather evidence of the acceptability and feasibility of interventions and, in some cases, equity issues and the value people place on different outcomes. This evidence was synthesised using standardised processes. The teams then used the QES to identify implementation considerations combined with other sources of information and input from experts. CONCLUSIONS: QES were useful sources of information for implementation considerations. However, several issues for further development remain, including whether researchers should use existing health systems frameworks when developing implementation considerations; whether researchers should take confidence in the evidence into account when developing implementation considerations; whether qualitative evidence that reveals implementation challenges should lead guideline panels to make conditional recommendations or only point to implementation considerations; and whether guideline users find it helpful to have challenges pointed out to them or whether they also need solutions. Finally, we need to explore how QES findings can be incorporated into derivative products to aid implementation.

Qualitative Evidence Synthesis (QES) for Guidelines: Paper 2 - Using qualitative evidence synthesis findings to inform evidence-to-decision frameworks and recommendations.

BACKGROUND: WHO has recognised the need to improve its guideline methodology to ensure that guideline decision-making processes are transparent and evidence based, and that the resulting recommendations are relevant and applicable. To help achieve this, WHO guidelines now typically enhance intervention effectiveness data with evidence on a wider range of decision-making criteria, including how stakeholders value different outcomes, equity, gender and human rights impacts, and the acceptability and feasibility of interventions. Qualitative evidence syntheses (QES) are increasingly used to provide evidence on this wider range of issues. In this paper, we describe and discuss how to use the findings from QES to populate decision-making criteria in evidence-to-decision (EtD) frameworks. This is the second in a series of three papers that examines the use of QES in developing clinical and health system guidelines. METHODS: WHO convened a writing group drawn from the technical teams involved in its recent (2010-2018) guidelines employing QES. Using a pragmatic and iterative approach that included feedback from WHO staff and other stakeholders, the group reflected on, discussed and identified key methods and research implications from designing QES and using the resulting findings in guideline development. RESULTS: We describe a step-wise approach to populating EtD frameworks with QES findings. This involves allocating findings to the different EtD criteria (how stakeholders value different outcomes, equity, acceptability and feasibility, etc.), weaving the findings into a short narrative relevant to each criterion, and inserting this summary narrative into the corresponding 'research evidence' sections of the EtD. We also identify areas for further methodological research, including how best to summarise and present qualitative data to groups developing guidelines, how these groups draw on different types of evidence in their decisions, and the extent to which our experiences are relevant to decision-making processes in fields other than health. CONCLUSIONS: This paper shows the value of incorporating QES within a guideline development process, and the roles that qualitative evidence can play in integrating the views and experiences of relevant stakeholders, including groups who may not be otherwise represented in the decision-making process.

Patient-focused Solutions in Rosacea Management: Treatment Challenges in Special Patient Groups

Rosacea is among the most common facial skin conditions diagnosed by dermatologists. Typical clinical features include erythema, flushing, telangiectasia, papules, and pustules distributed on the central face. While the prevalence of rosacea is highest among white populations of Northern European descent, recent reports have found that rosacea frequently occurs in people from a broad range of racial/ethnic backgrounds and skin types. When rosacea presents in darker skin types, the diagnosis is often more challenging due to masking of features by increased epidermal melanin. As such, under-diagnosis and underreporting may contribute to misconceptions about the prevalence of rosacea in populations with skin of color. Recognizing the unique presentations and complications associated with darker skin types is necessary to reduce the disparities in rosacea treatment, especially as the American population continues to become increasingly heterogeneous. Although rosacea is most common in middle-aged females, patients of other demographics may have more negative impacts on quality of life due to their disease. In this article, we review rosacea management with a focus on special patient groups: people with skin of color, and less common forms of rosacea, in order to diminish the physical and psychosocial burden of rosacea in all patient groups. Due to the variability inherent to rosacea, we advocate for an individualized, patient-centered approach to disease management.

Cancers in Vietnam-Burden and Control Efforts: A Narrative Scoping Review.

Although the burden of cancer is rapidly growing in Vietnam, there was no up-to-date review that describes cancer burden and control in Vietnam throughout the literature. By identifying various risk factors, means of prevention, and methods for early detection, this review seeks to systematically summarize the evidence for the future planning and management of cancer occurrence in Vietnam. Additionally, this report aims to identify improvements which are necessary for the treatment and palliative care of patients with cancer in Vietnam. We employed a hybrid approach including both a scoping review and narrative synthesis for this study. Information was identified, extracted, and charted from various sources, which include international and domestically published studies, in addition to gray literature. Our results illustrate that the burden of cancer in Vietnam has tripled in the past 30 years, and this situation could be partly explained by the growing prevalence of both old and new risk factors. Besides hepatitis B virus, various other important risk factors such as human papilloma virus, tobacco usage, physical inactivity, and improper diets are still not under control in Vietnam. There is presently a lack of national cancer screening programs, and the capacity of cancer care services could not maintain pace with the demands of a rapidly increasing Vietnamese population. Overall, policy frameworks for cancer control in Vietnam are in place, but there is still a lack of proper financing and governing models necessary to support a sustainable program. In conclusion, Cancer and its associated consequences are both persistent and emerging problems in Vietnam, and the results of cancer control programs are limited. A comprehensive and evidence-based approach toward the prevention and treatment of cancer should be the future direction for Vietnam.