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.

The Case for Moxibustion for Painful Syndromes: History, principles and rationale.

Traditional Chinese Medicine (TCM) has evolved over thousands of years. TCM practitioners use various approaches (such as acupuncture and tai chi) as well as herbal products to address health problems. Though lesser known in the west, the practice of Moxibustion is an integral part of Traditional East Asian Medicine. Moxibustion is an important non-invasive treatment that has shown to be beneficial in treating painful syndromes including neuropathy. It has been suggested that moxibustion may alleviate neuroinflammation by inhibiting NF-kB and by activating Nrf2. These anti-inflammatory and protective mechanisms could be key to exploring the use of moxibustion in treating other etiologies of neuropathy including HIV. There is ample scope for future study in this area and consideration of the history, development and practical applications of moxibustion therapy may be of help in this regard. This article seeks to explore the background, principles, and application of moxibustion in the clinical setting with particular emphasis on its potential for symptom management in the treatment of neuropathy and pain.

Exploring the Evidence: Symptom Burden in Chronic Kidney Disease.

Chronic kidney disease (CKD) is more prevalent in individuals with obesity, diabetes mellitus, or hypertension. Individuals with CKD are prone to kidney failure, with symptom experiences that rival those of patients with cancer. We explored symptom burden in individuals with CKD via a systematic review of 30 quantitative and qualitative articles. The most common CKD symptoms were fatigue, weakness, pain, sleep disturbances and itchy skin. Instruments used to assess symptoms were the Kidney Disease Quality of Life (KDQOL)-36, the Palliative Outcome Symptom-Scale renal (POS-r)-13, and the Dialysis Symptom Index (DSI)-10. The included qualitative studies expand and expound on the quantitative data presented. This article describes the prevalence of symptom burden in individuals with CKD in relation to psychosocial and demographic factors and discuss the importance of symptom management.

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.

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.

Diabetic peripheral neuropathy: Person-centered care.

ABSTRACT: Patients with diabetes mellitus may experience painful and nonpainful diabetic peripheral neuropathy (DPN). This article offers an overview of DPN and the clinical assessment and management of patients with DPN, as well as the nurse's role in supporting these patients.

Assessment and Management of HIV Distal Sensory Peripheral Neuropathy: Understanding the Symptoms.

Distal sensory peripheral neuropathy (HIV-DSP) affects upwards of 50% of people living with HIV. Causing often debilitating symptoms of tingling, numbness and burning, HIV-DSP can result in disability, unemployment and low quality of life. Comorbidities further complicate nursing care, heightening risk of polypharmacy and symptom exacerbation. Therefore, a neurological sensory assessment, combined with the patient's self-report of symptoms, can help nurse practitioners visualize, quantify and understand symptoms. Common pharmacological interventions include antiepileptics, antidepressants, analgesics and medical marijuana. The complexity of care for individuals with HIV-DSP merits a comprehensive approach. Implications for practice include interdisciplinary management with neurologists, podiatrists, mental health providers, and nurse-led counseling inclusive of patient safety teaching.

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.

Tongue Inspection in TCM: Observations in a Study Sample of Patients Living with HIV.

Background: One of the principal diagnostic methods in Traditional Chinese Medicine (TCM) is the inspection of the tongue. This method involves examination of the shape, size, color, and texture of the tongue body and coat and helps reveal the state of organ functions and progression of conditions. Literature on tongue observations for patients who have human immunodeficiency virus (HIV) is minimal. Objective: The goal of this study was to provide a clinical "snapshot" of initial tongue assessments of 159 patients living with HIV, who participated in an acupuncture clinical trial for chronic nausea. The aim was to explore the similarities and differences observed in tongue assessments. Design: This study was part of a prospective, randomized, controlled, double-blinded (subjects and evaluators), parallel-groups, acupuncture clinical trial for treating chronic nausea. Setting: The study was conducted at a large urban New York City academic health center. Patients: The patients in this study were 159 individuals who had HIV infections and who had histories of chronic nausea for ≥3 months. Main Outcome Measures: Initial tongue assessments were recorded for seven basic characteristics: (1) tongue color; (2) tongue shape; (3) tongue body quality; (4) coat color; (5) coat weight; (6) coat surface; and (7) tongue action. Results: The overall tongue picture seen in these patients was that the tongue was swollen and toothmarked, had a pink body with cracks, and had a thick, dry white coat. Conclusions: The HIV disease itself and the use of long term medications affect the Blood, Qi, Yin, and Yang. The observation of the tongue provides a window into the process of the disease and, ultimately, insight for clinical care. This sample population snapshot illustrates the complex processes seen in long-term chronic conditions managed by pharmacologic medications.

A Clinical Update: Nonceliac Gluten Sensitivity-Is It Really the Gluten?

Gluten-free diets are increasing in popularity among consumers and fueling a global market of gluten-free products. A gluten-free diet is the only treatment for celiac disease (CD). However, many patients are self-reporting and suspecting "gluten sensitivity" after gastrointestinal symptoms, such as bloating, abdominal pain, or diarrhea, resolve on a gluten-free diet without formal evaluation testing for food allergies or CD. The terms related to gluten and/or wheat intolerance, nonceliac gluten sensitivity or wheat sensitivity, CD, and wheat allergy can be confusing. These forms of intolerance combined affect approximately 10% of the United States population. In this article we clarify the range of gluten and/or wheat disorders, clinical features, diagnosis, and management.