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Cancer-related pain (C-RP) is a prevalent and debilitating concern among patients with cancer, with conventional treatments limited in their ability to provide adequate relief, and by the adverse effects associated with their use. Complementary and integrative medicine (CIM) modalities have been shown to be potentially effective and safe for the treatment of pain and related symptoms, when used in conjunction with conventional medications and under medical supervision. An increasing number of oncology centers provide CIM within their conventional supportive and palliative care service, in an "Integrative Oncology" (IO) setting. A large body of clinical research, including systematic reviews and guidelines such as those published in 2022 by the Society for Integrative Oncology (SIO), in collaboration with the American Society for Clinical Oncology (ASCO), support the use of some CIM modalities for C-RP and related concerns. These include acupuncture for general and peri-operative/procedural pain, as well as aromatase inhibitor-associated arthralgia (AIA); reflexology or acupressure for pain during systemic therapy for cancer; hypnosis for procedural pain or pain due to diagnostic workup; and massage for pain experienced by patients during palliative and hospice care. Further research is needed, within both randomized control trials and pragmatic non-controlled studies which are more reflective of the real-life IO setting. This review summarizes the evidence supporting the use of CIM for C-RP; the analgesic mechanism of the modalities presented; and the challenges facing IO researchers, as well as the implementation of the 2022 SIO-ASCO guideline recommendations.

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A pragmatic informatics approach was developed to create knowledge tools for co-design of a new model of mental healthcare in cardiac surgery The real-world evidence generation leverages existing technological platforms and routine data collections plus tailored brief tools, surveys and qualitative data.

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Person-specific evidence was developed as a grounded theory by analyzing 20 selected case descriptions from interventions using the guided self-determination method with people with various long-term health conditions. It explains the mechanisms of mobilizing relational capacity by including person-specific evidence in shared decision-making. Person-specific self-insight was the first step, achieved as individuals completed reflection sheets enabling them to clarify their personal values and identify actions or omissions related to self-management challenges. This step paved the way for sharing these insights and challenges in a relationship with a supportive health professional, who could then rely on person-specific evidence instead of assumptions or a narrow disease perspective for shared decision-making. Trust in the evidence encouraged the supportive health professional to transfer it to the interdisciplinary team. Person-specific evidence then enhanced the ability of team members to apply general evidence in a meaningful way. The increased openness achieved by individuals through these steps enabled them to eventually share their new self-insights in daily life with other people, decreasing loneliness they experienced in self-management. Relational capacity, the core of the theory, is mobilized in both people with long-term health conditions and healthcare professionals. Further research on person-specific evidence and relational capacity in healthcare is recommended.

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PURPOSE: Preventive health care, delivered through well child care visits, serves as a universal and primary entry point for promoting child wellbeing, yet children with lower socioeconomic status and children of color receive less consistent and lower quality preventive health care. Currently, limited research exists comparing models for delivering preventive care to children and their impact on longstanding racial/ethnic and socioeconomic inequities. DESCRIPTION: Practice-based research networks can help to advance health equity by more rapidly studying and scaling innovative, local models of care to reduce racial/ethnic and socioeconomic inequities in primary care and preventive care utilization. This paper outlines a framework of community engagement that can be utilized by practice-based research networks to advance health equity and details the application of the framework using the GROWBABY Research Network (GROup Wellness Visits for BABies and FamilY Research Network). ASSESSMENT: The GROWBABY Research Network launched in 2020, engaged clinical practices utilizing this unique model of group well childcare - CenteringParenting® - with the following goals: to promote collaboration among researchers, clinicians, patients, and community members; facilitate practice-based research; and increase the use of shared assessment measures and protocols. As a research collaborative, the GROWBABY Research Network connects clinical partners facing similar challenges and creates opportunities to draw upon the assets and strengths of the collective to identify solutions to the barriers to research participation. CONCLUSION: Primary care, practice-based research networks like the GROWBABY Research Network that intentionally integrate community engagement principles and community-based participatory research methods can advance equitable health care systems and improve child wellbeing.

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BACKGROUND: Changes in pain sensitivity are a commonly suggested mechanism for the clinical effect of spinal manipulative therapy (SMT). Most research has examined pressure pain thresholds (PPT) and has primarily been conducted in controlled experimental setups and on asymptomatic populations. Many important factors are likely to differ between research and clinical settings, which may affect PPT changes following SMT. Therefore, we planned to investigate PPT before and after clinical chiropractic care and investigate relationships with various potentially clinically-relevant factors. METHODS: We recruited participants from four Danish chiropractic clinics between May and August 2021. A total of 129 participants (72% of the invited) were included. We measured PPT at eight pre-determined test sites (six spinal and two extra-spinal) immediately before (pre-session) and immediately after (post-session) the chiropractic consultation. We used regression analyses to investigate PPT changes, including the following factors: (i) vertebral distance to the nearest SMT site, (ii) rapid clinical response, (iii) baseline PPT, (iv) number of SMTs performed, (v) at the region of clinical pain compared to other regions, and (vi) if other non-SMT treatment was provided. We also performed topographic mapping of pre-session PPTs. RESULTS: After the consultation, there was a non-significant mean increase in PPT of 0.14 kg (95% CIs = - 0.01 to 0.29 kg). No significant associations were found with the distance between the PPT test site and nearest SMT site, the clinical response of participants to treatment, the pre-session PPT, the total number of SMTs performed, or the region/s of clinical pain. A small increase was observed if myofascial treatment was also provided. Topographic mapping found greater pre-session PPTs in a caudal direction, not affected by the region/s of clinical pain. CONCLUSIONS: This study of real-world chiropractic patients failed to demonstrate a substantial local or generalized increase in PPT following a clinical encounter that included SMT. This runs counter to prior laboratory research and questions the generalizability of highly experimental setups investigating the effect of SMT on PPT to clinical practice.

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Background: Attendance rates for eye clinics are low across low- and middle-income countries (LMICs) and exhibit marked sociodemographic inequalities. We aimed to quantify the association between a range of sociodemographic domains and attendance rates from vision screening in programmes launching in Botswana, India, Kenya and Nepal. Methods: We performed a literature review of international guidance on sociodemographic data collection. Once we had identified 13 core candidate domains (age, gender, place of residence, language, ethnicity/tribe/caste, religion, marital status, parent/guardian status, place of birth, education, occupation, income, wealth) we held workshops with researchers, academics, programme implementers, and programme designers in each country to tailor the domains and response options to the national context, basing our survey development on the USAID Demographic and Health Survey model questionnaire and the RAAB7 eye health survey methodology. The draft surveys were reviewed by health economists and piloted with laypeople before being finalised, translated, and back-translated for use in Botswana, Kenya, India, and Nepal. These surveys will be used to assess the distribution of eye disease among different sociodemographic groups, and to track attendance rates between groups in four major eye screening programmes. We gather data from 3,850 people in each country and use logistic regression to identify the groups that experience the worst access to community-based eye care services in each setting. We will use a secure, password protected android-based app to gather sociodemographic information. These data will be stored using state-of-the art security measures, complying with each country's data management legislation and UK law. Discussion: This low-risk, embedded, pragmatic, observational data collection will enable eye screening programme managers to accurately identify which sociodemographic groups are facing the highest systematic barriers to accessing care at any point in time. This information will be used to inform the development of service improvements to improve equity.

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AIMS: Our objectives were to perform a population pharmacokinetic analysis of dexmedetomidine in children using remnant specimens and electronic health records (EHRs) and explore the impact of patient's characteristics and pharmacogenetics on dexmedetomidine clearance. METHODS: Dexmedetomidine dosing and patient data were gathered from EHRs and combined with opportunistically sampled remnant specimens. Population pharmacokinetic models were developed using nonlinear mixed-effects modelling. Stage 1 developed a model without genotype variables; Stage 2 added pharmacogenetic effects. RESULTS: Our final study population included 354 post-cardiac surgery patients aged 0-22 years (median 16 mo). The data were best described with a 2-compartment model with allometric scaling for weight and Hill maturation function for age. Population parameter estimates and 95% confidence intervals were 27.3 L/h (24.0-31.1 L/h) for total clearance, 161 L (139-187 L) for central compartment volume of distribution, 26.0 L/h (22.5-30.0 L/h) for intercompartmental clearance and 7903 L (5617-11 119 L) for peripheral compartment volume of distribution. The estimate for postmenstrual age when 50% of adult clearance is achieved was 42.0 weeks (41.5-42.5 weeks) and the Hill coefficient estimate was 7.04 (6.99-7.08). Genotype was not statistically or clinically significant. CONCLUSION: Our study demonstrates the use of real-world EHR data and remnant specimens to perform a population pharmacokinetic analysis and investigate covariate effects in a large paediatric population. Weight and age were important predictors of clearance. We did not find evidence for pharmacogenetic effects of UGT1A4 or UGT2B10 genotype or CYP2A6 risk score.

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BACKGROUND AND PURPOSE: Delayed cerebral ischemia (DCI) and angiographic vasospasm following subarachnoid hemorrhage (SAH) have been associated for more than 50years. We aimed to examine whether the knowledge gained by theoretical research on vasospasm has actually translated into better patient outcomes in practice. METHODS: This is a narrative review of the concept of vasospasm as a cause of DCI after SAH. We discuss recent studies that have assessed the accuracy and reliability of the diagnostic tests (transcranial Doppler ultrasound [TCD], CT angiography, and catheter angiography), which are used to identify SAH patients at-risk of DCI. RESULTS: Both the diagnostic accuracy of TCD and the reliability of CT angiography to identify patients in severe vasospasm are poor. For the gold standard catheter angiography, the repeatability of the diagnosis of vasospasm, made by multiple raters, is only fair. Interventions on angiographic vasospasm have never been proven to improve patient outcomes. A pragmatic trial integrating the meaning of the diagnosis of vasospasm into a study protocol that assesses the value of endovascular interventions in the prevention of DCI after SAH seems to be in order. Such a trial could provide a pragmatic definition of clinically meaningful vasospasm. CONCLUSION: We must move beyond research conceived as an enterprise aiming to acquire theoretical knowledge to one where research is integrated into clinical practice to improve clinical outcomes in real time.

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BACKGROUND: Mixed methods research studies continue to pervade the field of health care, where pragmatism as a research paradigm and patient-oriented research (POR) as an engagement strategy are combined to strengthen the process and outcomes of the research. Pragmatists use the most appropriate research methods to address issues at hand, where complex social problems need multipronged approaches. As an emerging healthcare research strategy, POR actively engages individuals with lived experience across all stages of the research process. While POR continues to garner attention within mixed-methods research designs, there is a paucity of literature that considers POR in relation to pragmatism. OBJECTIVE: As POR grows in popularity within the field of health care, there is a need to explore the theoretical and epistemological alignment with pragmatism and the implications to research. METHODS: To address this need, we provide a critical review of the literature to examine the synergies between POR and pragmatism, and argue for the adoption of pragmatism as a paradigm for conducting POR. MAIN RESULTS: This article begins with a discussion of the philosophical underpinnings informing the pragmatic paradigm. It then identifies key alignments between POR and pragmatism across three intersecting concepts: democratic values, collaborative approaches to problem-solving and the pursuit of social justice. DISCUSSION AND CONCLUSIONS: Reflecting on our experiences engaging with patient partners in a mixed-methods POR study titled READY2Exit, we illustrate the relevance of pragmatism to POR by applying these concepts to practice. Implications and considerations for conducting POR within the pragmatic paradigm are also described. PATIENT OR PUBLIC CONTRIBUTION: This paper provides a critical review of the literature and did not directly involve patients or the public. The authors reflected on their experiences collaborating with five young adult patient partners in the READY2Exit study (case exemplar described in this article) to demonstrate the relevance of the pragmatic paradigm to POR. We acknowledge and thank the young adult patient partners for their contributions to the research, for encouraging us to think critically about patient engagement in research, and for sharing their experiences.

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BACKGROUND: This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations. METHODS: We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics. RESULTS: In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings. CONCLUSIONS: We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research. TRIAL REGISTRATION: Clinicaltrials.gov Registration ID: NCT03590041 .

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BACKGROUND: Implementation science (IS) and quality improvement (QI) inhabit distinct areas of scholarly literature, but are often blended in practice. Because practice-based research networks (PBRNs) draw from both traditions, their experience could inform opportunities for strategic IS-QI alignment. OBJECTIVE: To systematically examine IS, QI, and IS/QI projects conducted within a PBRN over time to identify similarities, differences, and synergies. DESIGN: Longitudinal, comparative case study of projects conducted in the Oregon Rural Practice-based Research Network (ORPRN) from January 2007 to January 2019. APPROACH: We reviewed documents and conducted staff interviews. We classified projects as IS, QI, IS/QI, or other using established criteria. We abstracted project details (e.g., objective, setting, theoretical framework) and used qualitative synthesis to compare projects by classification and to identify the contributions of IS and QI within the same project. KEY RESULTS: Almost 30% (26/99) of ORPRN's projects included IS or QI elements; 54% (14/26) were classified as IS/QI. All 26 projects used an evidence-based intervention and shared many similarities in relation to objective and setting. Over half of the IS and IS/QI projects used randomized designs and theoretical frameworks, while no QI projects did. Projects displayed an upward trend in complexity over time. Project used a similar number of practice change strategies; however, projects classified as IS predominantly employed education/training while all IS/QI and most QI projects used practice facilitation. Projects including IS/QI elements demonstrated the following contributions: QI provides the mechanism by which the principles of IS are operationalized in order to support local practice change and IS in turn provides theories to inform implementation and evaluation to produce generalizable knowledge. CONCLUSIONS: Our review of projects conducted over a 12-year period in one PBRN demonstrates key synergies for IS and QI. Strategic alignment of IS/QI within projects may help improve care quality and bridge the research-practice gap.

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Two articles in the March-April 2021 issue of the Hastings Center Report consider alterations to traditional informed consent. In "The Consent Continuum: A New Model of Consent, Assent, and Nondissent for Primary Care," Marc Tunzi and colleagues argue that, in primary care settings, patient consent should be understood as taking a range of forms depending on the procedure, the patient, and the patient-care context. Traditional informed consent is at the ceremonious end; for many things done in these settings, the authors assert, assent or even nondissent is fine. In the lead article, health policy scholars Stephanie Morain and Emily Largent consider another continuum for informed consent, this one occurring with pragmatic research, at the intersection of clinical care with research.

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BACKGROUND/OBJECTIVE: Partnerships between healthcare providers and researchers may accelerate the translation of interventions into widespread practice by testing them under real-world conditions, but depend on provider's willingness to engage with researchers and ability to fully implement an intervention. AIM: To understand nursing home leader's motivations for participating in a research study and perceptions of the process and value. METHODS: After a feasibility study of tuned lighting in a nursing home, we conducted semi-structured telephone interviews with six facility leaders. Interviews were audio-recorded, transcribed, and independently coded by four investigators. RESULTS: Three themes emerged: (1) The importance of the nursing home's culture and context: the facility had stable leadership, clear processes for prioritizing and implementing new initiatives, and an established interest in the study's topic. (2) The importance of leader's belief in the value of the intervention: leaders perceived research generally and the intervention specifically as positively impacting their facility and residents. (3) The importance of ongoing collaboration and flexibility throughout the study period: leaders served as champions to catalyze the project and overcome implementation barriers. CONCLUSION: Nursing home leader's perspectives about their participation in a feasibility study underscore the importance of establishing strong researcher-provider partnerships, understanding the environment in which the intervention will be implemented, and employing pragmatic methods that allow for flexibility in response to real-world implementation barriers. We recommend eliciting qualitative information to understand the environment in which an intervention will be implemented and to engage opinion leaders who can inform the protocol and champion its success.

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The National Institutes of Health estimated that $3-$4 billion is spent supporting clinical trials annually, yet an average of 17 years is required for research evidence to be implemented into practice. Study designs that balance external and internal validity, based on the goals of the study and relative to the state of the science, may accelerate knowledge translation. The purpose of this case study was to evaluate two randomized control trials on the effectiveness-efficacy continuum using the PRagmatic Explanatory Continuum Indicator Summary and the Research Effectiveness Adoption Implementation Maintenance model. Findings provided insight into strategies that may lead to more balanced approaches to research design. Incorporating tools such as PRECIS-2 and RE-AIM when designing and implementing research interventions may accelerate knowledge translation to close the gap between scientific knowledge and clinical practice.

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Research does not occur in a vacuum. Effective stakeholder engagement occurs on several levels, including outside influence and cooperation inside the institution. Little guidance around designing and implementing pragmatic mental health research exists. The following paper outlines lessons learned during the initial stages of research design and implementation for a project focused on mental health treatment outcomes.

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While conducting a set of large-scale multi-site pragmatic clinical trials involving high-impact public health issues such as end-stage renal disease, opioid use, and colorectal cancer, there were substantial changes to both policies and guidelines relevant to the trials. These external changes gave rise to unexpected challenges for the trials, including decisions regarding how to respond to new clinical practice guidelines, increased difficulty in implementing trial interventions, achieving separation between treatment groups, and differential responses across sites. In this article, we describe these challenges and the approaches used to address them. When deliberating appropriate action in the face of external changes during a pragmatic clinical trial, we recommend considering the well-being of the participants, clinical equipoise, and the strength and quality of the evidence associated with the change; involving those charged with data and safety monitoring; and where possible, planning for potential external changes as the trial is being designed. Any solution must balance the primary obligation to protect the well-being of participants with the secondary obligation to protect the integrity of the trial in order to gain meaningful answers to important public health questions.

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Hospital care is the single, largest contributor to health spending, yet evidence to guide value transformation is lacking. The large, real-world studies required to fill this void are challenging to conduct in the complex and fast-paced acute care environment. To address these challenges, we created a framework that combines Lean manufacturing methodology and Applied Research principles. We deployed this framework to design, pilot, and iteratively improve a study protocol testing the effectiveness of an innovative care pathway for patients hospitalized with acute exacerbations of Chronic Obstructive Pulmonary Disease. Over a three month period, the protocol was successfully piloted and refined at a single site, subsequently becoming the basis for a large system-wide randomized controlled trial. This framework combining Lean and Applied Research methods resulted in synergies that neither method could accomplish alone and may serve as a template for learning healthcare systems to efficiently generate real-world evidence in the acute care setting.

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BACKGROUND: Despite years of intense focus, inpatient and observation readmission rates remain high and largely unchanged. Hospitals have little, robust evidence to guide the selection of interventions effective at reducing 30-day readmissions in real-world settings. OBJECTIVE: To evaluate if implementation of recent recommendations for hospital transition programs is effective at reducing 30-day readmissions in a population discharged to home and at high-risk for readmission. DESIGN: A non-blinded, pragmatic randomized controlled trial ( Clinicaltrials.gov : NCT02763202) conducted at two hospitals in Charlotte, North Carolina. PATIENTS: A total of 1876 adult patients, under the care of a hospitalist, and at high risk for readmissions. INTERVENTION: Random allocation to a Transition Services (TS) program (n = 935) that bridges inpatient, outpatient, and home settings, providing patients virtual and in-person access to a dedicated multidisciplinary team for 30-days, or usual care (n = 941). MAIN MEASURE: Thirty-day, unplanned, inpatient, or observation readmission rate. KEY RESULTS: The 30-day readmission rate was 15.2% in the TS group and 16.3% in the usual care group (RR 0.93; 95% [CI, 0.76 to 1.15]; P = 0.52). There were no significant differences in readmissions at 60 and 90 days or in 30-day Emergency Department visit rates. Patients, who were referred to TS and readmitted, had less Intensive Care Unit admissions 15.5% vs. 26.8% (RR 0.74; 95% [CI, 0.59 to 0.93]; P = 0.02). CONCLUSIONS: An intervention inclusive of contemporary recommendations does not reduce a high-risk population's 30-day readmission rate. The high crossover to usual care (74.8%) reflects the challenge of non-participation that is ubiquitous in the real-world implementation of population health interventions. TRIAL REGISTRY: ClinicalTrials.gov ; registration ID number: NCT02763202, URL: https://clinicaltrials.gov/ct2/show/NCT02763202.

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BACKGROUND: A questionnaire is a commonly used data collection method and is a very crucial part of the research. However, designing a questionnaire can be a daunting task for postgraduate students. METHODS: This manuscript illustrates the various steps required in questionnaire designing and provides an insight into the essentials of questionnaire construction and validation. Data from a questionnaire should be able to comprehend the objectives of the study; else it may lead to wrong interpretation or bias, decreased power of study and inability to generalize the study results. CONCLUSION: Since it is equally important to verify the usefulness of the designed questionnaire, the article briefly describes the process of psychometric evaluation of a questionnaire.

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BACKGROUND: Pragmatic dissemination and implementation (D&I) research approaches can benefit patient care because they emphasize real-world settings and populations. Nurse scientists have an opportunity to reduce the gap between science and practice by using pragmatic D&I research and sustainability strategies. PURPOSE: This article discusses pragmatic models, methods, and measures used in D&I research and their relevance for nursing research and enhancing population health. METHODS: Summary of pragmatic D&I models and related methods for designing a pragmatic studies. We discuss the RE-AIM framework and the PRECIS-2 planning aid and figure in detail. A case study is provided and application to nursing research is discussed. DISCUSSION: Successful translation of pragmatic D&I research demands an approach that addresses external validity, and customization at multiple levels including the patient, clinician, and setting. Context is critically important, and it is never too early to design for dissemination. CONCLUSIONS: Pragmatic D&I approaches are needed to speed research translation, reduce avoidable waste of funding, improve clinical care, and enhance population health. Pragmatic D&I research is an area of tremendous opportunity for the nursing science community.

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