An Introduction to Implementing and Conducting the Study.

Editor's note: This is the 21st article in a series on clinical research by nurses. The series is designed to be used as a resource for nurses to understand the concepts and principles essential to research. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. To see all the articles in the series, go to https://links.lww.com/AJN/A204.

Ethical Research and the Institutional Review Board: An Introduction.

Editor's note: This is the 20th article in a series on clinical research by nurses. The series is designed to be used as a resource for nurses to understand the concepts and principles essential to research. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. To see all the articles in the series, go to https://links.lww.com/AJN/A204.

The Cluster Randomized Trial Study Design.

Editor's note: This is the 17th article in a series on clinical research by nurses. The series is designed to be used as a resource for nurses to understand the concepts and principles essential to research. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. To see all the articles in the series, go to https://links.lww.com/AJN/A204.

Delivery of acupuncture in clinical trials: Research acupuncturists' perspectives.

Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine (TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM- and Western-trained practitioners, that would help to standardize the research acupuncturist's role and help to strengthen the design and execution of acupuncture studies. Please cite this article as: Anastasi JK, Capili B, Neumaier J, Hackett L. Delivery of acupuncture in clinical trials: Research acupuncturists' perspectives. J Integr Med. 2023; 21(4):315-319.

Efficacy Randomized Controlled Trials.

Editor's note: This is the 14th article in a series on clinical research by nurses. The series is designed to be used as a resource for nurses to understand the concepts and principles essential to research. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. To see all the articles in the series, go to https://links.lww.com/AJN/A204.

Improving the Validity of Causal Inferences in Observational Studies.

Editor's note: This is the 13th article in a series on clinical research by nurses. The series is designed to be used as a resource for nurses to understand the concepts and principles essential to research. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. To see all the articles in the series, go to https://links.lww.com/AJN/A204.

Recruitment and retention of clinical trial participants: understanding motivations of patients with chronic pain and other populations.

This paper aims to present and discuss the issues, challenges, and strategies related to recruitment and retention in clinical trials involving participants with chronic pain. The randomized controlled clinical trial (RCT) is widely regarded as the gold standard for evaluating clinical interventions. However, it is crucial to acknowledge and address the challenges associated with recruiting and retaining participants. To prioritize the experience of the study population, targeted outreach strategies and a patient-centric approach are necessary. Researchers should consider incorporating recruitment and retention strategies during the study design phase. Implementing multi-pronged recruitment methods, leveraging relationships with community providers, and involving representatives of the patient population are helpful approaches. Effective communication and maintaining a professional environment are vital for optimizing engagement and supporting the successful execution of clinical trials involving participants with chronic pain.

Development and evaluation of a clinical research nursing module for undergraduate nursing schools: expanding Clinical Research Nurses' outreach.

Background: Clinical Research Nurses (CRNs) care for study participants and manage clinical research studies; yet the CRN practice role is rarely covered in undergraduate nursing curricula in the United States. Despite a burgeoning need for CRNs, the pipeline of clinical research nurse positions remains sparse. The International Association of Clinical Research Nurses's (IACRN) strategic goal to "engage with nursing schools to heighten awareness and inclusion of the CRN role competencies in nursing education" prompted the development of an educational lecture module to be disseminated to nursing schools. This project is a pilot launch of the module. Methods: A task force of IACRN was formed to develop educational materials that could be used as outreach to undergraduate nursing schools. The content included a slide presentation covering an overview of clinical research, the CRN practice, three embedded videos showing CRN and study participant perspectives, and coverage of the care of participants of research by staff nurses. Due to COVID-19 we revised our live lecture approach using either a live synchronous webinar presentation, or an embedded asynchronous course module with YouTube videos for course learning management systems. We presented the content to 408 nursing students attending three academic programs. To evaluate effectiveness and satisfaction, an anonymous, post-presentation survey using web-based QualtricsXM was distributed to students. Results: Content and delivery of the module was positively evaluated. There was an improvement in knowledge in each topic. Evaluation responses showed that the content could likely or very likely improve care for their patients (87.4%) and improve patient education for patients in clinical trials (95%). Conclusions: Delivering a synchronous or asynchronous module about the CRN practice role to nursing students in academic nursing programs is valuable to increasing awareness of the care of patients in clinical trials, the CRN role, and future professional development.

Detecting Peripheral Neuropathy in Patients with Diabetes, Prediabetes and other High-Risk Conditions: An Advanced Practice Nurse's Perspective.

A common complication of diabetes, HIV infection, and other chronic systemic conditions and exposures, distal sensory peripheral neuropathy is increasingly prevalent worldwide; the physical, mental, and economic burdens are significant. As no curative therapies exist to date, early detection of peripheral neuropathy (PN) affords patients the best chance to reverse it through education, intensive lifestyle modifications, and multidisciplinary management. Concerning diabetic PN, obstacles to effective screening include low clinical priority, failure to screen patients during prediabetes, confusion regarding methods and goals of testing, and possibly inexperience with thermal testing. Providers and advanced practice nurses are well-positioned to advocate for and implement early PN detection programs, screen for complications including sleep and mood disorders, promote multidisciplinary management, identify strategies to reduce pain and other PN symptoms, and counsel patients regarding many aspects of safety and self-care for improved quality of life. This manuscript provides a brief overview of PN with an emphasis on diabetic PN, a discussion of the aforementioned obstacles to effective screening, and a summary of recommendations to improve PN identification in clinical practice.

An Analysis of Peripheral Neuropathy Symptom Characteristics in HIV.

OBJECTIVES: A gap remains in understanding the association among the symptoms of distal sensory peripheral neuropathy (DSPN) (pain, aching, burning, pins and needles, numbness), comorbidities, and medication use among persons living with People Living with HIV/AIDS (PLWH) with DSPN. This report describes the symptom characteristics associated with prescribed treatment regimens (HIV and non-HIV medications) and comorbidities from a cohort of PLWH experiencing symptoms of DSPN who reside in New York City. METHODS: Our sample (n=353) included PLWH who were 18 years or older, and with painful lower limb (LL) peripheral neuropathy screened for an ongoing clinical trial to reduce DSPN symptoms using acupuncture/moxibustion. The trial participants completed a screening interview where they reported age, gender, race, ethnicity, HIV status, presence of LL DSPN and DSPN symptoms, current medications, and comorbidities. RESULTS: Of 465 persons screened, 353 provided information for inclusion in this analysis. Seventy-eight percent rated their LL DSPN in the "severe" or "very severe" discomfort/pain range. Nearly half of those were taking prescribed or over-the-counter medication, such as nonnarcotic analgesics, antidepressants, and anticonvulsants, to manage their DSPN discomfort/pain. Despite the use of OTC and or prescription pain relievers, participants reported insufficient symptom relief. DISCUSSION: Combination Antiretroviral Therapies (CART) effectively control viral load and maintain healthy T-cell levels in individuals with HIV. It has made HIV a chronic disease for many. However, HIV DPSN remains prevalent and has a negative impact on the lives of PLWH. Our findings highlight that, despite the availability and the use of CART, DSPN remains prevalent and not well managed. A critical need exists for the development of effective interventions to manage DSPN symptoms.

The Rockefeller Team Science Leadership training program: Curriculum, standardized assessment of competencies, and impact of returning assessments.

The ability to effectively lead an interdisciplinary translational team is a crucial component of team science success. Most KL2 Clinical Scholars have been members of scientific teams, but few have been team science leaders. There is a dearth of literature and outcome measures of effective Team Science Leadership in clinical and translational research. We focused our curriculum to emphasize Team Science Leadership, developed a list of Team Science Leadership competencies for translational investigators using a modified Delphi method, and incorporated the competencies into a quantitative evaluation survey. The survey is completed on entry and annually thereafter by the Scholar; the Scholar's primary mentor and senior staff who educate and interact with the Scholar rate the Scholar at the end of each year. The program leaders and mentor review the results with each Scholar. The survey scales had high internal consistency and good factor structure. Overall ratings by mentors and senior staff were generally high, but ratings by Scholars tended to be lower, offering opportunities for discussion and career planning. Scholars rated the process favorably. A Team Science Leadership curriculum and periodic survey of attained competencies can inform individual career development and guide team science curriculum development.

Selection and Implementation of Outcome Measurements.

Editor's note: This is the fifth article in a series on clinical research by nurses. The series is designed to give nurses the knowledge and skills they need to participate in research, step by step. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. The articles will be accompanied by a podcast offering more insight and context from the author. To see all the articles in the series, go to http://links.lww.com/AJN/A204.

Cohort Studies.

Editor's note: This is the seventh article in a series on clinical research by nurses. The series is designed to give nurses the knowledge and skills they need to participate in research, step by step. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. The articles will be accompanied by a podcast offering more insight and context from the authors. To see all the articles in the series, go to http://links.lww.com/AJN/A204.

Cross-Sectional Studies.

Editor's note: This article is one in a series on clinical research by nurses. The series is designed to give nurses the knowledge and skills they need to participate in research, step by step. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. The articles will be accompanied by a podcast offering more insight and context from the author. To see all the articles in the series, go to http://links.lww.com/AJN/A204.

Selection of the Study Participants.

Editor's note: This is the second article in a new series on clinical research by nurses. The series is designed to give nurses the knowledge and skills they need to participate in research, step by step. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. The articles will also be accompanied by a podcast offering more insight and context from the author.

How Does Research Start?

Editor's note: This is the first article in a new series on clinical research by nurses. The series is designed to give nurses the knowledge and skills they need to participate in research, step by step. Each column will present the concepts that underpin evidence-based practice-from research design to data interpretation. The articles will also be accompanied by a podcast offering more insight and context from the author.

CE: Opioid Use Disorder: Pathophysiology, Assessment, and Effective Interventions.

Opioid use disorder (OUD) is a chronic, relapsing disease. Genetic variability, dysregulated stress system response, and history of opioid experimentation or escalating exposure all contribute to the likelihood of developing OUD, which produces complex brain changes that make it difficult to stop opioid use. Understanding the neurobiology of OUD helps nurses anticipate the behaviors of patients with OUD and approach them with empathy. Here, the authors discuss the pathophysiology of OUD, available screening tools, medical treatments, and behavioral interventions that have demonstrated efficacy in reducing substance use.

Development of Acupuncture and Moxibustion Protocol in a Clinical Trial for Irritable Bowel Syndrome.

Traditional Chinese medicine encompasses many different practices, most notably acupuncture and moxibustion. Traditionally, these modalities are used in combination to augment treatment but seldom are they tested together in clinical studies. Numerous acupuncture studies have been conducted in Asia, Europe, and the United States but there have been few randomized controlled trials utilizing moxibustion outside of East Asia. Limited studies have described the use of a moxibustion control or placebo procedure. The methods for developing an acupuncture and moxibustion protocol used in a randomized controlled trial for irritable bowel syndrome, diarrhea predominant in adults are described here. Our approach conformed to the scientific rigor for a clinical trial and was consistent to the foundations of traditional Chinese medicine.

Addressing the Role of Food in Irritable Bowel Syndrome Symptom Management.

Patients with irritable bowel syndrome (IBS) have often associated the worsening of symptoms with specific foods. Research is starting to catch up with what patients have reported about food interaction and their symptoms and the role of diet is being increasingly recognized for the management of IBS. Clinical guidance for nurse practitioners can be challenging due to limited data and guideline consensus along with the nuances of symptoms associated with IBS subtypes. This article summarizes some of the key themes and dietary recommendations by various gastrointestinal (GI) organizations, public health agencies, and dietary associations. By addressing the relevance of diet for symptom alleviation, nurse practitioners are able to better support patients and collaborate with dietitians to improve symptom management.