'The way to obtain freedom and equality': Experiences and needs of Thai adolescent mothers in terms of the use smartphone applications for breastfeeding support.

BACKGROUND: Breastfeeding brings about a positive impact on both child and maternal health in the short and long terms. However, adolescent mothers have a lower breastfeeding initiation rate and a shorter breastfeeding duration than adult mothers. Although mobile applications have been found to be the most widely used platform for breastfeeding support, there is still a lack of design specific for adolescents. AIM: To explore the experiences, perspectives and needs of adolescent mothers and professional nurses using smartphone applications for breastfeeding support and the influence of this technology on healthcare in Thailand. METHODS: This formative qualitative research of the 'Development of smartphone application for promoting breastfeeding and learning of infant responsiveness for Thai teenage pregnant women' study intends to design a smartphone application and develop an implementation plan. A purposive sample was used to elicit experiences from adolescent mothers and nurses. Data were collected from 48 adolescent mothers through in-depth interviews with six focus group discussions and 12 nurses, following the data saturation principle. Thematic analysis was conducted, and potential factors and needs were mapped to the capability, opportunity, and motivation model of behaviour change (COM-B). RESULTS: Most adolescent mothers perceived the usefulness of smartphone apps as breastfeeding support resources. The qualitative findings of adolescent mothers were grouped into the following three themes: a friendly breastfeeding tool; allows them to manage their breastfeeding activities; and enhances the accessibility and equality of breastfeeding support. The professional nurses perceived the benefits of using smartphone applications in their work, which included the following three themes: reducing workload and making their work easier; preparation is always better; and increasing the standards of breastfeeding support. CONCLUSION: Adolescent mothers and professional nurses showed favourable attitudes toward smartphone apps for breastfeeding support. These smartphone apps should be tailored to these groups to achieve optimal BF outcomes.

Centering PrEP: utilizing ADAPT-ITT to inform group PrEP care for sex workers in Chicago.

BACKGROUND: Sex workers, those who trade sex for monetary or nonmonetary items, experience high rates of HIV transmission but have not been adequately included in HIV prevention and Pre-Exposure Prophylaxis (PrEP) adherence program development research. Community-empowered (C.E.) approaches have been the most successful at reducing HIV transmission among sex workers. Centering Healthcare (Centering) is a C.E. model proven to improve health outcomes and reduce health disparities in other populations, such as pregnant women, people with diabetes, and sickle cell disease. However, no research exists to determine if Centering can be adapted to meet the unique HIV prevention needs of sex workers. OBJECTIVE: We aim to explain the process by which we collaboratively and iteratively adapted Centering to meet the HIV prevention and PrEP retention needs of sex workers. METHODS: We utilized the Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, Testing (ADAPT-ITT) framework, a model for adapting evidence-based interventions. We applied phases one through six of the ADAPT-ITT framework (Assessment, Decision, Adaptation, Production, Topical Experts, Integration) to the design to address the distinct HIV prevention needs of sex workers in Chicago. Study outcomes corresponded to each phase of the ADAPT-ITT framework. Data used for adaptation emerged from collaborative stakeholder meetings, individual interviews (n = 36) and focus groups (n = 8) with current and former sex workers, and individual interviews with care providers (n = 8). In collaboration with our community advisory board, we used a collaborative and iterative analytical process to co-produce a culturally adapted 3-session facilitator's guide for the Centering Pre-exposure Prophylaxis (C-PrEP +) group healthcare model. RESULTS: The ADAPT-ITT framework offered structure and facilitated this community-empowered innovative adaptation of Centering Healthcare. This process culminated with a facilitator's guide and associated materials ready for pilot testing. CONCLUSIONS: In direct alignment with community empowerment, we followed the ADAPT-ITT framework, phases 1-6, to iteratively adapt Centering Healthcare to suit the stated HIV Prevention and PrEP care needs of sex workers in Chicago. The study represents the first time the first time Centering has been adapted to suit the HIV prevention and PrEP care needs of sex workers. Addressing a gap in HIV prevention care for sex workers, Centering PrEP harnesses the power of community as it is an iteratively adapted model that can be piloted and replicated regionally, nationally, and internationally.

Feasibility of implementing acupuncture in medically underserved breast cancer survivors (FAB): A protocol.

Nearly 94% of breast cancer survivors experience one or more symptoms or side effects during or after endocrine therapy. Joint pain, hot flashes, sleep disturbance, fatigue, depression, and anxiety are the most common concurrent symptoms, some of which can persist for 5 to 10 years. Acupuncture is a holistic modality that addresses multiple symptoms and side effects in a single therapy. Acupuncture has not yet been investigated for its effectiveness in treating the multiple symptoms experienced by breast cancer survivors receiving endocrine therapy. Medically underserved breast cancer survivors typically have limited access to acupuncture. The barriers limiting access to acupuncture need to be removed to enable equal access to breast cancer survivors for this evidence-based treatment. Thus, we developed a randomized controlled trial with a 5-week acupuncture intervention versus usual care for medically underserved breast cancer survivors. Mixed methods (semi-structured interviews, surveys, study notes) will be used to obtain in-depth understanding of barriers and facilitators for eventual implementation of the acupuncture intervention. This study will facilitate the widespread implementation, dissemination, and sustained utilization of acupuncture for symptom management among medically underserved breast cancer survivors receiving endocrine therapy.

Collecting patient-reported outcome measures in the electronic health record: Lessons from the NIH pragmatic trials Collaboratory.

The NIH Pragmatic Trials Collaboratory supports the design and conduct of 27 embedded pragmatic clinical trials, and many of the studies collect patient reported outcome measures as primary or secondary outcomes. Study teams have encountered challenges in the collection of these measures, including challenges related to competing health care system priorities, clinician's buy-in for adoption of patient-reported outcome measures, low adoption and reach of technology in low resource settings, and lack of consensus and standardization of patient-reported outcome measure selection and administration in the electronic health record. In this article, we share case examples and lessons learned, and suggest that, when using patient-reported outcome measures for embedded pragmatic clinical trials, investigators must make important decisions about whether to use data collected from the participating health system's electronic health record, integrate externally collected patient-reported outcome data into the electronic health record, or collect these data in separate systems for their studies.

Adapting group care to the postpartum period using a human-centered design approach in Malawi.

BACKGROUND: Responsive and resilient strategies to reduce high rates of maternal and infant mortality and clinician shortages are needed in low- and middle-income countries (LMICs). Malawi has some of the highest maternal and infant mortality rates globally. Group healthcare is a service delivery model that integrates these strategies. Although primarily implemented during the prenatal period, its potential for improving both maternal and infant health outcomes during the postpartum period has not been realized. The purpose of this study was to adapt and co-design the prototype for an evidence-based group care model for the postpartum period using a human-centered design approach with key stakeholders in Malawi. METHODS: We completed steps of a framework guiding the use of human-centered design: 1) define the problem and assemble a team; 2) gather information through evidence and inspiration; 3) synthesize; and 4) intervention design: guiding principles and ideation. Qualitative methods were used to complete steps 2-4. In-depth interviews (n = 24), and incubator sessions (n = 6) that employed free listing, pile sorting and ranking were completed with key stakeholders. Data analysis consisted of content analysis of interviews and framework analysis for incubator sessions to produce the integrated group postpartum and well-child care model prototype. The fifth step is detailed in a separate paper. RESULTS: All stakeholders reported a desire to participate in and offer group care in the postpartum period. Stakeholders worked collaboratively to co-create the prototype that included a curriculum of health promotion topics and interactive activities and the service delivery structure. Health promotion topic priorities were hygiene, breastfeeding, family planning, nutrition, and mental health. The recommended schedule included 6 sessions corresponding with the child vaccination schedule over the 12-month postpartum period. CONCLUSIONS: Using a human-centered design approach to adapt an evidence-based group care model in an LMIC, specifically Malawi, is feasible and acceptable to key stakeholders and resulted in a prototype curriculum and practical strategies for clinic implementation.

Monitoring and responding to signals of suicidal ideation in pragmatic clinical trials: Lessons from the GRACE trial for Chronic Sickle Cell Disease Pain.

Sickle cell disease (SCD) is a hemoglobin disorder and the most common genetic disorder that affects 100,000 Americans and millions worldwide. Adults living with SCD have pain so severe that it often requires opioids to keep it in control. Depression is a major global public health concern associated with an increased risk in chronic medical disorders, including in adults living with sickle cell disease (SCD). A strong relationship exists between suicidal ideation, suicide attempts, and depression. Researchers enrolling adults living with SCD in pragmatic clinical trials are obligated to design their methods to deliberately monitor and respond to symptoms related to depression and suicidal ideation. This will offer increased protection for their participants and help clinical investigators meet their fiduciary duties. This article presents a review of this sociotechnical milieu that highlights, analyzes, and offers recommendations to address ethical considerations in the development of protocols, procedures, and monitoring activities related to suicidality in depressed patients in a pragmatic clinical trial.

Distinct Dysphagia Profiles in Patients With Oral Cancer After Surgery.

OBJECTIVES: To determine distinct profiles based on symptom severity in patients undergoing surgery for oral cancer and examine whether these profiles differ by participant characteristics. SAMPLE & SETTING: 300 patients who underwent surgery for oral cancer at two outpatient clinics between June and December 2021. METHODS & VARIABLES: Symptoms were assessed using the MD Anderson Symptom Inventory-Head and Neck Cancer Module. Sociodemographic and clinical characteristics were collected. Latent profile analysis was performed. RESULTS: Five distinct dysphagia profiles were identified, which qualitatively differed regarding co-occurrence patterns of dysphagia, mucus-related symptoms, speech disturbances, and psychoneurologic symptoms. Significant differences were reported in interference to function, number of co-occurring symptoms, time since diagnosis and treatment completion, use of symptom management medications, oral cancer stage and site, and treatment completed. IMPLICATIONS FOR NURSING: Identifying distinct dysphagia profiles can improve patient outcomes and help in planning specific nursing interventions to influence nutritional and functional status in oral cancer survivors. Dysphagia and dry mouth can persist beyond one year post-treatment, so follow-up dysphagia assessments are needed.

Condom use increased after a peer group intervention implemented by community volunteers in Malawi.

Background: HIV prevention remains a global priority, especially in sub-Saharan Africa. Our research team previously developed an evidence-based peer group program for HIV prevention called Mzake ndi Mzake (Friend to Friend). A community-engaged collaboration adapted the program for community ownership and implementation. Here we report whether this HIV prevention program, implemented by community volunteers, increased condom use among sexually active individuals in rural Malawi. Methods: Three communities sequentially rolled out the program. Effectiveness was evaluated using repeated surveys. At Time 1, no community had offered the intervention. At Time 2, the first community had offered the intervention and two had not (control group). At Time 3, two communities had offered the intervention and one had not (control group). We used two condom use indicators; condom use frequency in the last 2 months (N = 776) and condom use at last sex (N = 880). For each indicator, the sample included all sexually active persons answering that question at one or more time points. Regression analyses were used to model the two condom indicators over time, controlling for demographic factors, UNAIDS HIV knowledge, safer sex self-efficacy and partner communication. Results: This peer group intervention implemented by trained community volunteers increased both condom use indicators at Times 2 and 3. In the final regression models. Other predictors of greater condom use for at least one condom use indicator included younger age group (13-19), male gender, not married/cohabiting, high involvement in religiously affiliated activities, higher safer sex self-efficacy, and greater partner communication. Although the intervention increased UNAIDS HIV knowledge, knowledge did not predict condom use. Conclusions: This community engaged implementation study found that an evidence-based peer group program for HIV prevention increased condom use when delivered by trained community volunteers. Leveraging community strengths and human capital resources facilitated implementation of this effective HIV prevention program in rural Malawi. Community ownership and program delivery by trained local volunteers offers an innovative and cost-effective strategy to address ongoing HIV prevention needs without overburdening heathcare systems in sub. Trial registration: Clinical Trials.gov NCT02765659 Registered May 6, 2016.

Experiences of Sex Workers in Chicago during COVID-19: A Qualitative Study.

COVID-19 exacerbated health disparities, financial insecurity, and occupational safety for many within marginalized populations. This study, which took place between 2019 and 2022, aimed to explore the way in which sex workers (n = 36) in Chicago were impacted by COVID-19. We analyzed the transcripts of 36 individual interviews with a diverse group of sex workers using thematic analysis. Five general themes emerged regarding the detrimental impact of COVID-19 on sex workers: (1) the impact of COVID-19 on physical health; (2) the economic impact of COVID-19; (3) the impact of COVID-19 on safety; (4) the impact of COVID-19 on mental health; and (5) adaptive strategies for working during COVID-19. Participants reported that their physical and mental health, economic stability, and safety worsened due to COVID-19 and that adaptive strategies did not serve to improve working conditions. Findings highlight the ways in which sex workers are particularly vulnerable during a public health crisis, such as COVID-19. In response to these findings, targeted resources, an increased access to funding, community-empowered interventions and policy changes are needed to protect the health and safety of sex workers in Chicago.

Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory.

Embedded pragmatic clinical trials (ePCTs) play a vital role in addressing current population health problems, and their use of electronic health record (EHR) systems promises efficiencies that will increase the speed and volume of relevant and generalizable research. However, as the number of ePCTs using EHR-derived data grows, so does the risk that research will become more vulnerable to biases due to differences in data capture and access to care for different subsets of the population, thereby propagating inequities in health and the healthcare system. We identify 3 challenges-incomplete and variable capture of data on social determinants of health, lack of representation of vulnerable populations that do not access or receive treatment, and data loss due to variable use of technology-that exacerbate bias when working with EHR data and offer recommendations and examples of ways to actively mitigate bias.

Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain.

Objective: This study aimed to explore perspectives of people living with sickle cell disease (SCD) and SCD clinic providers and staff about the use of acupuncture and guided relaxation for treating chronic SCD pain. Data obtained were to inform an implementation blueprint for an effectiveness implementation clinical trial (GRACE Trial) testing whether acupuncture or guided relaxation reduces chronic pain when compared with usual care. Design: Qualitative research design. Methods: We conducted 33 semistructured interviews with people with SCD and SCD clinic providers and staff. Interviews were transcribed and coded. A deductive content analysis process was used to identify themes. Results: Four themes were identified: Receptivity to Acupuncture and Guided Relaxation, Limited Awareness, Complementary and Integrative Health (CIH) Therapy Preference, and Access Barriers. Both patients and clinic providers and staff were open to the use of acupuncture and guided relaxation for chronic pain treatment. After learning about these CIH therapies, some patients expressed a preference for one therapy over the other. They also discussed their ability to successfully engage with each therapy. There is a need to dispel misconceptions about the therapies by increasing understanding of how each therapy is implemented and functions to reduce pain. We identified several potential barriers that might affect the success of the trial and future health system integration, including time, transportation, and technology. Conclusion: This study is one of the first to present perspectives of both patients with SCD and clinic providers and staff on the use of acupuncture and guided relaxation for chronic SCD pain. Stakeholders' early input and perspectives highlighted that they welcome nonpharmacological CIH therapies. Implementation of a clinical trial and future health system integration will require the addressing misinformation and identifying strategies to overcome access barriers. Clinical trial registration number: NCT04906447.

How Perspectives on Food Safety of Vendors and Consumers Translate into Food-Choice Behaviors in 6 African and Asian Countries.

Background: Consumption of unsafe foods increases morbidity and mortality and is currently an issue, particularly in low- and middle-income countries. Policy actions to ensure food safety are dominated by mitigation of biological and chemical hazards through supply-side risk management, lessening the degree to which consumer perspectives of food safety are considered. Objectives: This study aimed to provide an in-depth understanding, from vendor and consumer perspectives, of how food-safety concerns of consumers translate into their subsequent food-choice behaviors in 6 diverse low- and middle-income countries. Methods: Six Drivers of Food Choice projects (2016-2022) provided transcripts from 17 focus group discussions and 343 interviews conducted in Ghana, Guinea, India, Kenya, Tanzania, and Vietnam. Qualitative thematic analysis was used to identify emerging themes important to food safety. Results: The analysis suggests that consumers constructed meaning about food safety through personal lived experience and social influences. Community and family members contributed knowledge about food safety. Concerns about food safety were influenced by reputations of and relationships with food vendors. Consumers' mistrust of food vendors was amplified by purposeful adulteration or unsafe selling practices and new methods used to produce food. Moreover, consumers were reassured of food safety by positive relationships with vendors; meals cooked at home; implementation of policies and following regulations; vendor adherence to environmental sanitation and food-hygiene practices; cleanliness of vendors' appearance; and vendors' or producers' agency to use risk mitigation strategies in production, processing, and distribution of food. Conclusions: Consumers integrated their meanings, knowledge, and concerns about food safety to achieve assurance about the safety of their foods when making food-choice decisions. The success of food-safety policies hinges on consideration of consumers' food-safety concerns in their design and implementation, alongside actions to reduce risk in food supply.

Equity and bias in electronic health records data.

Embedded pragmatic clinical trials (ePCTs) are conducted during routine clinical care and have the potential to increase knowledge about the effectiveness of interventions under real world conditions. However, many pragmatic trials rely on data from the electronic health record (EHR) data, which are subject to bias from incomplete data, poor data quality, lack of representation from people who are medically underserved, and implicit bias in EHR design. This commentary examines how the use of EHR data might exacerbate bias and potentially increase health inequities. We offer recommendations for how to increase generalizability of ePCT results and begin to mitigate bias to promote health equity.

Evaluation of implementation outcomes of an integrated group postpartum and well-child care model at clinics in Malawi.

BACKGROUND: Persistently elevated rates of maternal and infant mortality and morbidities in Malawi indicate the need for increased quality of maternal and well-child care services. The first-year postpartum sets the stage for long-term health for the childbearing parent and infant. Integrated group postpartum and well-child care may improve maternal and infant health outcomes. The purpose of this study was to examine implementation outcomes for this model of care. METHODS: We used mixed methods to examine implementation outcomes of integrated group postpartum and well-child care. We piloted sessions at three clinics in Blantyre District, Malawi. During each session we evaluated fidelity using a structured observation checklist. At the end of each session, we administered three surveys to health care workers and women participants, the Acceptability of Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Focus groups were conducted to gain greater understanding of people's experience with and evaluation of the model. RESULTS: Forty-one women with their infants participated in group sessions. Nineteen health care workers across the three clinics co-facilitated group sessions, 9 midwives and 10 health surveillance assistants. Each of the 6 sessions was tested once at each clinic for a total of 18 pilot sessions. Both women and health care workers reported group postpartum and well-child care was highly acceptable, appropriate, and feasible across clinics. Fidelity to the group care model was high. During each session as part of structured observation the research team noted common health issues, the most common one among women was high blood pressure and among infants was flu-like symptoms. The most common services received within the group space was family planning and infant vaccinations. Women reported gaining knowledge from health promotion group discussions and activities. There were some challenges implementing group sessions. CONCLUSION: We found that clinics in Blantyre District, Malawi were able to implement group postpartum and well-child care with fidelity and that it was highly acceptable, appropriate, and feasible to women and health care workers. Due to these promising results, we recommend future research examine the effectiveness of the model on maternal and child health outcomes.

Symptom Cluster Experiences of Patients Operated for Oral Cancer: A Mixed Methods Study.

OBJECTIVE: This convergent mixed methods study aimed to obtain a comprehensive understanding of symptom cluster experiences in patients with oral cancer. Survey and phenomenological interviews were conducted in parallel to identify distinct patient subgroups based on symptom cluster experiences along with their predictors and explore experiences of living with symptom clusters, respectively. DATA SOURCES: A convenience sample of 300 patients with oral cancer who had completed surgery provided the quantitative data, and a maximum variation purposive subsample of 20 participants, drawn from the survey sample, provided the qualitative data. Agglomerative hierarchical cluster analysis was used to identify subgroups, multivariate analyses were done to identify predictors, and thematic analysis was used for patient narratives. CONCLUSION: Almost 94% of the survey participants had two or more co-occurring symptoms. The four most severe and prevalent symptoms were dysphagia, problems with teeth or gums, speech difficulty, and dry mouth. A distinct subgroup consisting of 61% of patients reported severe dysphagia and teeth problems, which was associated with age, oral cancer stage and site. Interviews revealed the causes and the context influencing the perception and response to these symptoms. Thus, the quantitative data provided information on severity and patient subgroups based on symptom cluster experiences, while the qualitative data validated these conclusions and additionally provided in-depth details and meaningful insight on perceived causes and contextual influences of their experiences. This comprehensive picture of symptom cluster experiences can aid in the development of patient-centered interventions for people with oral cancer. IMPLICATIONS FOR NURSING PRACTICE: An interdisciplinary approach to targeting concurrent symptoms incorporating psychological and physical interventions is necessary. Older patients treated for Stage IV cancers and for buccal mucosa tumors are at high-risk of having severe dysphagia postoperatively, and these patients should be targeted for dysphagia interventions. The contextual factors play an important role in developing patient-centered interventions.

A Conceptual Framework for Group Well-Child Care: A Tool to Guide Implementation, Evaluation, and Research.

OBJECTIVE: To use scoping review methods to construct a conceptual framework based on current evidence of group well-child care to guide future practice and research. METHODS: We conducted a scoping review using Arksey and O'Malley's (2005) six stages. We used constructs from the Consolidated Framework for Implementation Research and the quadruple aim of health care improvement to guide the construction of the conceptual framework. RESULTS: The resulting conceptual framework is a synthesis of the key concepts of group well-child care, beginning with a call for a system redesign of well-child care to improve outcomes while acknowledging the theoretical antecedents structuring the rationale that supports the model. Inputs of group well-child care include health systems contexts; administration/logistics; clinical setting; group care clinic team; community/patient population; and curriculum development and training. The core components of group well-child care included structure (e.g., group size, facilitators), content (e.g., health assessments, service linkages). and process (e.g., interactive learning and community building). We found clinical outcomes in all four dimensions of the quadruple aim of healthcare. CONCLUSION: Our conceptual framework can guide model implementation and identifies several outcomes that can be used to harmonize model evaluation and research. Future research and practice can use the conceptual framework as a tool to standardize model implementation and evaluation and generate evidence to inform future healthcare policy and practice.

A peer group intervention implemented by community volunteers increased HIV prevention knowledge.

BACKGROUND: HIV prevention knowledge levels are low in sub-Saharan Africa. In our efficacy study, the Mzake ndi Mzake (Friend-to-Friend; hereafter Mzake) 6-session peer group intervention, delivered by health workers, improved HIV prevention knowledge and other outcomes in Malawi. To expand HIV prevention approaches, this implementation study tested whether the intervention remained effective when implemented by trained community volunteers. HIV prevention knowledge findings are presented. METHODS: Using a stepped wedge design, three communities implemented the Mzake program sequentially in randomly assigned order. Repeated surveys assessed outcomes, and participants served as controls until they completed the program. At Time 2, Community 1 became the intervention group, and at Time 3, Communities 1 and 2 were the intervention group. HIV prevention knowledge, the primary outcome, was assessed through two indicators: UNAIDS comprehensive knowledge (UNAIDS Knowledge), defined as correctly answering five HIV prevention questions (Yes/No), and a 9-item HIV/PMTCT Knowledge Index (number correct). Multivariate generalized estimating equation logistic regression (UNAIDS Knowledge) and mixed-effects regression models (HIV/PMTCT Knowledge Index) were used to assess knowledge controlling for five sociodemographic factors. RESULTS: In bivariate analyses of UNAIDS Knowledge, more persons answered correctly in the intervention group than the control group at Time 2 (56.8% vs. 47.9%, p < 0.01), but the difference was not significant at Time 3. In logistic regression, there was a significant linear increase in the proportion who correctly answered all questions in the control group, but the increase was significantly higher in the intervention group (log-odds estimate = 0.17, SE = 0.06, p-value < 0.01). The HIV/PMTCT Knowledge Index scores increased over time for both groups, but in the intervention group the increase was significantly higher than the control group (0.11 at Time 2; 0.21 at Time 3). In youth and adult subsamples analyses, the intervention was highly effective in increasing knowledge for youth, but not for adults. CONCLUSION: This implementation study showed that Mzake was effective in increasing HIV prevention knowledge when delivered by community members. Community approaches offer an important strategy to increase HIV prevention in rural communities without burdening healthcare systems. TRIAL REGISTRATION: ClinicalTrials.gov NCT02765659. Registered 06/05/2016.

Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol.

Background: People with sickle cell disease frequently use complementary and integrative therapies to cope with their pain, yet few studies have evaluated their effectiveness. The 3-arm, 3-site pragmatic Hybrid Effectiveness-implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE) has 3 priorities: (1) evaluate guided relaxation and acupuncture to improve pain control; (2) determine the most appropriate and effective treatment sequence for any given patient based on their unique characteristics; and (3) describe the processes and structures required to implement guided relaxation and acupuncture within health care systems. Methods: Participants (N = 366) are being recruited and randomized 1:1:1 to one of 2 intervention groups or usual care. The acupuncture intervention group receives 10 sessions over approximately 5 weeks. The guided relaxation intervention group receives access to video sessions ranging from 2 to 20 min each viewed daily over 5 weeks. The usual care group receives the standard of clinical care for sickle cell disease. Participants are re-randomized at 6 weeks depending on their pain impact score. Assessments occur at 6 weeks, 12 weeks, and 24 weeks. The primary outcome is the change in pain impact score and secondary measures include opioid use, anxiety, depression, sleep, pain catastrophizing, substance use, global impression of change, constipation, and hospitalizations. The GRACE study uses the Consolidated Framework for Implementation Research to plan, execute, and evaluate the associated implementation processes. Conclusion: The results from GRACE will represent a critical step toward improving management of pain affecting patients with sickle cell disease.ClinicalTrials.gov Identifier: NCT04906447.

Evaluation of implementation outcomes of an integrated group postpartum and well-child care model at clinics in Malawi.

Background Persistently elevated rates of maternal and infant mortality and morbidities in Malawi indicate the need for increased quality of maternal and well-child care services. The first-year postpartum sets the stage for long-term health for the childbearing parent and infant. Integrated group postpartum and well-child care may improve maternal and infant health outcomes. The purpose of this study was to examine implementation outcomes for this model of care. Methods We used mixed methods to examine implementation outcomes of integrated group postpartum and well-child care. We piloted sessions at three clinics in Blantyre District, Malawi. During each session we evaluated fidelity using a structured observation checklist. At the end of each session, we administered three surveys to health care workers and women participants, the Acceptability of Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Focus groups were conducted to gain greater understanding of people’s experience with and evaluation of the model. Results Forty-one women with their infants participated in group sessions. Nineteen health care workers across the three clinics co-facilitated group sessions, 9 midwives and 10 health surveillance assistants. Each of the 6 sessions was tested once at each clinic for a total of 18 pilot sessions. Both women and health care workers reported group postpartum and well-child care was highly acceptable, appropriate, and feasible across clinics. Fidelity to the group care model was high. During each session as part of structured observation the research team noted common health issues, the most common one among women was high blood pressure and among infants was flu-like symptoms. The most common services received within the group space was family planning and infant vaccinations. Women reported gaining knowledge from health promotion group discussions and activities. There were some challenges implementing group sessions. Conclusion We found that clinics in Blantyre District, Malawi were able to implement group postpartum and well-child care with fidelity and that it was highly acceptable, appropriate, and feasible to women and health care workers. Due to these promising results, we recommend future research examine the effectiveness of the model on maternal and child health outcomes.

On a pathway to resigned acceptance: Patients' experiences of living with symptom clusters in oral cancer.

PURPOSE: Patients treated for oral cancer experience multiple concurrent symptoms. A larger mixed-methods study was conducted among patients who were treated with surgery alone or in combination with other modalities. The aim of the qualitative strand was to explore the experiences of living with symptom clusters. METHODS: A phenomenological design was used to explore the lived experiences. Participants were recruited for the larger study from two outpatient units of a tertiary teaching hospital (N = 300). After completion of a survey, a maximum variation purposive subsample of 20 participants was drawn from the larger sample and were interviewed in-depth about their experiences. Thematic analysis was conducted. FINDINGS: All participants experienced multiple concurrent symptoms, commonly including chewing difficulties + dry mouth + speech difficulties; chewing difficulties + dry mouth + diminished taste; and chewing difficulties + dry mouth + speech difficulties + trismus. Analysis of their experiences of living with these symptom clusters revealed six themes: Acknowledged Disruptions, Inner Dialogue, Shifting Expectations, Floods of Emotions, Exercising Control over Life, and Resigned Acceptance. These themes portrayed that time and living with symptom clusters lead to what we describe as a pathway to resigned acceptance. This pathway is intermingled with disruptions, self-reflections on 'why me' and karma, negative emotions, and failed expectations regarding symptom recovery. Attempts to exercise control over their lives were also revealed through coping strategies, watchful living, future planning, and being health advocates. On realizing with time that further symptom alleviation is unlikely, and considering symptom-cluster experiences as being written in their fate, they move towards a state of resigned acceptance. However, unlike passive acceptance, their belief in fate was accompanied with resilience, evidenced by their ongoing efforts to explore pragmatic ways to live with symptom clusters. CONCLUSIONS: Findings provide key insights into patient perspectives which most often remain unexpressed in clinical settings. Further research is required to explore watchful living, fate as a coping strategy, and intertwining of faith, fate, and karma.