Barriers and Facilitators to Integrating Acupuncture into the U.S. Health Care System: A Scoping Review.

Background: Acupuncture is a widely practiced complementary and integrative health modality that has multiple clinical applications. The use of acupuncture in the United States is rapidly increasing. Although studies have shown the efficacy and effectiveness of acupuncture for various ailments, the integration of acupuncture into the U.S. health care system remains a challenge. Little is known about the factors affecting this integration. Objective: To provide a systematic review of the barriers and facilitators affecting the integration of acupuncture into the U.S. health care system. Methods: Four electronic databases were searched. Three independent reviewers were involved in the screening and data charting processes. Findings were synthesized and categorized into four levels based on the Social Ecological Model. Results: A total of 22 studies were included in the final review. The barriers and facilitators affecting the integration of acupuncture were mapped into four levels (individual, interpersonal, organizational, and policy). The most frequently reported barriers and facilitators were mapped into the Social Ecological Model constructs within the "Individual" level (i.e., beliefs and attitudes of acupuncture, and practical issues) and the "Organizational" level (i.e., credentialing, space and facility, referral system). Conclusion: This review has identified and synthesized the breadth of evidence on the barriers and facilitators to the integration of acupuncture into the U.S. health care system. Results of this review will guide future implementation studies to develop and test implementation strategies to integrate acupuncture into the U.S. health care system.

Relationship Between Treatment Hours of Selected Disciplines And Change in Pain Impact During the Year Following Referral to an Interdisciplinary Pain Management Center: A Latent Class Analysis.

Introduction: Pain management clinics differ in treatments offered, and little evidence exists regarding which combinations of therapies result in best outcomes. This study analyzed clinical encounters and pain outcomes data for associations between treatment composition and outcomes. Methods: Retrospective observational study of 2,142 predominantly active-duty US service members referred to an interdisciplinary pain management center between 2014 and 2021. Latent class analysis was used to identify treatment groups with distinct outcome patterns during the year following initial assessment. The primary outcome measure was the National Institutes of Health Task Force on Research Standards for Chronic Low-Back Pain impact score. Results: Four distinct treatment groups were identified: 1 group engaged in conventional medical therapies alone (n = 726, median 3.5 treatment hours), and 3 groups used a combination of conventional, psychological, rehabilitative, and complementary therapies, with different levels of treatment hours: low (n = 814, median 15.7 h), medium (n = 177, median 40.1 h), and high (n = 425, median 72.5 h). All groups showed significant improvement in pain impact score from baseline up to 9 months but not at 12 months following initial assessment. At the 6-month time point, the group with high multimodal treatment hours had the most improvement in pain impact (-3.1 [95% CI -3.8, -2.4]) compared with the group using only conventional therapies (-1.0 points [95% CI -1.8, -0.1]) or with low multimodal treatment hours (-1.3 points [95% CI -1.9, -0.7]). There were no between-group differences at the 9- or 12-month time points. Conclusion: These results suggest that a combination of pain therapy approaches results in greater reduction in pain impact than the use of conventional medical treatment alone for up to 6 months after initiating therapy and that there may be a threshold of treatment hours that must be exceeded to achieve this benefit. Clinical trial registration: As this study is not a clinical trial, no registration was required.

"We Wanna Be Nurses Because We Want the Human Connection": Acceptability and Usability of a Person-Centered Narrative Intervention in an Acute Care Setting.

The use of narrative interventions in health care is an effective way to communicate connection between patients and clinicians. The electronic health record (EHR) is a primary mode of communicating patient information across clinical teams. Thus, incorporating a person-centered cocreated narrative with patients into the EHR is an opportunity to share a person's cultural values, beliefs, and preferences; provide connection; and foster positive patient-clinician interactions. This study of a person-centered narrative intervention was a randomized controlled trial to test intervention effects on the person's (patient) perceptions of the quality of communication with their nurses and their psychosocial and existential well-being. This article describes the clinical team's experiences and reach of the cocreated person-centered narrative integration into the patient's EHR. The data collected included (1) exit interviews (n = 14), (2) a usability survey (n = 8), and (3) data collected from the EHR for clinicians (n = 600) who accessed the uploaded narratives. Overall, the System Usability Scale and nurse participant's experiences provided confirmation that the person-centered narrative intervention was usable. There were also interprofessional groups of clinicians in the health care system who accessed the narratives. Future research should continue to identify core components and implementation strategies of EHR-integrated person-centered narratives in complex health care settings.

Critical Realism in Symptom Science - A Scoping Review.

There has been an increasing interest in research positioned within critical realism (CR). This analysis aimed to determine how CR has been applied in symptom science through a scoping review of the literature. Fifty-two articles were identified through searches in seven databases and search engines, and grey literature. Quantitative and qualitative analyses were performed using Excel and ATLAS.ti 8.0. Review findings indicate that CR has been used to examine two key aspects of symptoms - symptom experiences and symptom interventions. The details of how CR was operationalized are presented. This first scoping review highlights how a critical realist lens would help examine individual and contextual factors that influence symptom experiences, response to interventions, and outcomes.

Role of Pain Catastrophizing in the Effects of Cognitive Behavioral Therapy for Chronic Pain in Different Subgroups: An Exploratory Secondary Data Analysis Using Finite Mixture Models.

INTRODUCTION: Providing effective treatment for debilitating chronic pain is a challenge among many populations including military service members. Cognitive behavioral therapy for chronic pain (CBT-CP) is a leading psychological pain treatment. Pain catastrophizing is a pivotal mediator of pain-related outcomes. The purpose of this study was (1) to identify patient subgroups who differ in response to CBT-CP and (2) to explore the characteristics that define these patient subgroups. The overall goal was to obtain a better understanding of factors that may influence response to CBT-CP. MATERIALS AND METHODS: This study was a secondary analysis of data from a clinical trial of 149 U.S. active duty service members with chronic pain. Participants underwent group-based CBT-CP for 6 weeks and completed pre- and posttreatment assessments. Finite mixture models were employed to identify subgroups in treatment response, with pain impact score as the primary outcome measure. RESULTS: We identified two classes of nearly equal size with distinct pain impact responses. One class reported improved pain impact scores following CBT-CP. This improvement was significantly associated with lower (better) baseline depression scores and greater improvement in posttreatment pain catastrophizing. In contrast, the other class reported slightly worse mean pain impact scores following CBT-CP treatment; this response was not related to baseline depression or change in pain catastrophizing. CONCLUSIONS: Our findings demonstrate that a sizable proportion of individuals with chronic pain may not respond to group-based CBT-CP and may require a more individualized treatment approach.

The Gut Microbiome and Symptom Burden After Kidney Transplantation: An Overview and Research Opportunities.

Many kidney transplant recipients continue to experience high symptom burden despite restoration of kidney function. High symptom burden is a significant driver of quality of life. In the post-transplant setting, high symptom burden has been linked to negative outcomes including medication non-adherence, allograft rejection, graft loss, and even mortality. Symbiotic bacteria (microbiota) in the human gastrointestinal tract critically interact with the immune, endocrine, and neurological systems to maintain homeostasis of the host. The gut microbiome has been proposed as an underlying mechanism mediating symptoms in several chronic medical conditions including irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and psychoneurological disorders via the gut-brain-microbiota axis, a bidirectional signaling pathway between the enteric and central nervous system. Post-transplant exposure to antibiotics, antivirals, and immunosuppressant medications results in significant alterations in gut microbiota community composition and function, which in turn alter these commensal microorganisms' protective effects. This overview will discuss the current state of the science on the effects of the gut microbiome on symptom burden in kidney transplantation and future directions to guide this field of study.

An Intervention to Reduce Sedentary Behavior in Adults with Chronic Kidney Disease: A Feasibility Study.

Adults with chronic kidney disease (CKD) tend to be extremely sedentary. We investigated the feasibility and acceptability of a sedentary-reducing intervention for adults with CKD. The intervention utilized telephone-delivered coaching and a consumer wearable device to support participants to reduce their sedentary time. The mean age of participants in the sample was 60.5 years; 72% were women, and 83% had CKD Stage 3. At baseline, participants spent 73% of their waking time sedentary. Inter vention phone call attendance was 100%, study retention was 82%, and the intervention was rated as enjoyable (9.1/10). A telephone-delivered, sedentary-reducing intervention is feasible and acceptable in adults with CKD. Future work is needed investigating the efficacy of sedentary-reducing interventions for adults with CKD.

Feasibility of In-Home Virtual Reality for Chronic Pain in Sickle Cell Disease.

PURPOSE: This study assessed the feasibility of an in-home virtual reality intervention for chronic pain in adults with sickle cell disease. DESIGN: Two-group, parallel, randomized, multiple methods design with surveys, and interviews. METHODS: Participants were randomized to virtual reality or audio control, with 2-16-minute daily modules for 8 weeks, a daily pain diary survey, and a post study interview. Chronic pain and pain correlates were evaluated at baseline and every 4 weeks for 3 months. Feasibility outcomes were participant enrollment (set at > 50%), questionnaire response (> 50%), intervention use, and cybersickness (< 20%). RESULTS: Of the individuals approached, 67.8% (n = 19) were enrolled. Questionnaire response rates were 100% at baseline, 57.8% at week 4, and < 50% at weeks 8 and 12. The intervention was used for a median of 781 minutes and 210 minutes in the virtual reality and audio groups, respectively. Participants reported slight symptoms of cybersickness with no reports of severe symptoms, and the intervention was acceptable. CONCLUSIONS: Home-based virtual reality can be used in future sickle cell disease research. To further strengthen evaluations of virtual reality in adults with sickle cell who experience chronic pain, future trials should address sample size limitations and incorporate recommended strategies to address cybersickness and questionnaire response. CLINICAL IMPLICATIONS: The first known application of in-home virtual reality for chronic pain in adults with sickle cell disease was successful. Findings can inform future in-home investigations of virtual reality in this underserved population.

Prevalence and clinical implications of sarcopenia in breast cancer: a systematic review and meta-analysis.

PURPOSE: The impact of sarcopenia in oncology is increasingly recognized, yet little is known about its clinical implications in breast cancer. This systematic review and meta-analysis estimates the overall prevalence of sarcopenia in breast cancer, quantifies skeletal muscle index (SMI), and comprehensively evaluates sarcopenia's impact on clinical outcomes. METHODS: We systematically searched primary original research published before June 2023 in four databases: the Cochrane Library via Wiley, CINAHL Plus with Full Text, Embase via Elsevier Excerpta Medica, and Medline via Ovid. Standardized mean SMI and 95% confidence interval (CI) were calculated by applying the random-effects model. The methodological quality of the included studies was assessed using the National Institutes of Health quality assessment checklist. RESULTS: The systematic review included 17 studies with a total of 9863 patients; the meta-analysis included 12 of these studies. The mean prevalence of sarcopenia in breast cancer (stages I-III) was 32.5%. The mean SMI assessed by CT was 43.94 cm2/m2 (95% CI 42.87, 45.01; p < .01). Overall, low muscle mass was associated with chemotherapy toxicities, dose reductions, dose delays, or treatment discontinuation. Low muscle mass was generally associated with poor survival, but in some studies, this association was not significant or reversed direction. CONCLUSION: Sarcopenia is not just a state of muscle mass loss, but an influencing factor on therapeutic effects and survival rates in oncology. It is thus necessary to recognize the risk of sarcopenia throughout the trajectory of cancer treatment, identify low muscle mass early, and manage it from a prehabilitation perspective.

Associations Between Gut Microbial Features and Sickness Symptoms in Kidney Transplant Recipients.

PURPOSE: The study investigated the relationship of gut microbiome features and sickness symptoms in kidney transplant recipients. METHODS: Employing a prospective, longitudinal design, we collected data from 19 participants who had undergone living-donor kidney transplant at three timepoints (pre-transplant and 1 week and 3 months post-transplant). Sickness symptom data and fecal specimens were collected at each timepoint. Participants were grouped either as high or low sickness symptom severity at baseline. Shotgun metagenomics sequencing characterized gut microbial structure and functional gene content. Fecal microbial features, including alpha (evenness and richness within samples) and beta (dissimilarities between samples) diversity and relative abundances, were analyzed using R statistical packages. Cross-sectional and longitudinal analyses examined relationships between gut microbial features and sickness symptoms. RESULTS: Although our exploratory findings revealed no significant differences in alpha and beta diversity between groups, the high-severity group showed lower microbial richness and evenness than the low-severity group. The high-severity group had enriched relative abundance of bacteria from the genera Citrobacter and Enterobacter and reduced relative abundance of bacteria from the genus Akkermansia across timepoints. No functional genes differed significantly between groups or timepoints. CONCLUSIONS: Kidney transplant recipients with high symptom burden displayed increased putative proinflammatory bacteria and decreased beneficial bacteria. This study provides an effect size that future large cohort studies can employ to confirm associations between gut microbial features and sickness symptom experiences in the kidney transplant population. The study findings also have implications for future interventional studies aiming to alleviate the sickness symptom burden in this population.

A network analysis of pain intensity and pain-related measures of physical, emotional, and social functioning in US military service members with chronic pain.

OBJECTIVE: The purpose of this study was to apply network analysis methodology to better understand the relationships between pain-related measures among people with chronic pain. METHODS: We analyzed data from a cross-sectional sample of 4614 active duty service members with chronic pain referred to 1 military interdisciplinary pain management center between 2014 and 2021. Using a combination of Patient-Reported Outcomes Measurement Information System measures and other pain-related measures, we applied the "EBICglasso" algorithm to create regularized partial correlation networks that would identify the most influential measures. RESULTS: Pain interference, depression, and anxiety had the highest strength in these networks. Pain catastrophizing played an important role in the association between pain and other pain-related health measures. Bootstrap analyses showed that the networks were very stable and the edge weights accurately estimated in 2 analyses (with and without pain catastrophizing). CONCLUSIONS: Our findings offer new insights into the relationships between symptoms using network analysis. Important findings highlight the strength of association between pain interference, depression and anxiety, which suggests that if pain is to be treated depression and anxiety must also be addressed. What was of specific importance was the role that pain catastrophizing had in the relationship between pain and other symptoms suggesting that pain catastrophizing is a key symptom on which to focus for treatment of chronic pain.

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.

The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis.

The HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis (HOPE Trial) is a multicenter randomized trial addressing chronic pain among patients receiving maintenance hemodialysis for end-stage kidney disease. The trial uses a sequential, multiple assignment design with a randomized component for all participants (Phase 1) and a non-randomized component for a subset of participants (Phase 2). During Phase 1, participants are randomized to Pain Coping Skills Training (PCST), an intervention designed to increase self-efficacy for managing pain, or Usual Care. PCST consists of weekly, live, coach-led cognitive behavioral therapy sessions delivered by video- or tele-conferencing for 12 weeks followed by daily interactive voice response sessions delivered by telephone for an additional 12 weeks. At 24 weeks (Phase 2), participants in both the PCST and Usual Care groups taking prescription opioid medications at an average dose of ≥20 morphine milligram equivalents per day are offered buprenorphine, a partial opioid agonist with a more favorable safety profile than full-agonist opioids. All participants are followed for 36 weeks. The primary outcome is pain interference ascertained, for the primary analysis, at 12 weeks. Secondary outcomes include additional patient-reported measures and clinical outcomes including falls, hospitalizations, and death. Exploratory outcomes include acceptability, tolerability, and efficacy of buprenorphine. The enrollment target of 640 participants was met 27 months after trial initiation. The findings of the trial will inform the management of chronic pain, a common and challenging issue for patients treated with maintenance hemodialysis. NCT04571619.

Pain Catastrophizing and Its Association with Military Medical Disability Among US Active Duty Service Members with Chronic Predominately Musculoskeletal Pain: A Retrospective Cohort Analysis.

Context: Pain catastrophizing is characterized by negative emotional and cognitive responses to pain and is a predictor of work-related disability. Its association with military medical disability has not been studied. Objective: To (1) identify the pain catastrophizing scale (PCS) score cut point most strongly associated with military medical disability, (2) measure the difference in rate of disability between service members with baseline PCS scores above versus below the cut point, and (3) determine if improvement in PCS score during pain specialty care is associated with decreased likelihood of disability. Methods: This was a retrospective cohort analysis comparing PCS scores collected from US Army active duty service members at time of initial visit to an interdisciplinary pain management center and periodically during pain treatment. Outcome was determination during the following year of a military service-disqualifying disability. Results: Receiver operating characteristic (ROC) curves determined that a PCS score of 20 was the single cut point most closely associated with subsequent disability. Kaplan-Meier curves showed significantly higher disability rate during the following year among those with baseline PCS scores ≥20 (52%) compared to those with lower scores (26%). Scheffe-adjusted contrasts showed that service members with PCS scores ≥20 whose scores improved to <20 at follow-up were significantly less likely to have a medical disability (42.6%; 95% CI, 0.07-0.58) than those whose PCS score remained ≥20 (76.3%; 95% CI, 68.0%-84.7%). Conclusion: A PCS score cut point of 20 distinguishes between high versus low likelihood of disability among service members. Those with high baseline PCS score had twice the likelihood of disability than those with low scores. Service members who decreased their PCS score from high to low during pain specialty care had lower likelihood of disability. Prospective research is needed to determine if treatments that lower pain catastrophizing yield reduced likelihood of subsequent disability.

Predictors of Sustained Response to Functional Restoration in a Military Population.

INTRODUCTION: The purpose of this study was to determine if improvement in pain impact and functional performance following a functional restoration (FR) program was sustained up to 6 months posttreatment and to identify predictors of sustained improvement. MATERIALS AND METHODS: Secondary analysis of data collected during randomized clinical trial. Study population included 108 US active duty service members who completed an FR program, as well as 3- and/or 6-month follow-up assessments. Primary outcome measure was the NIH Research Task Force (pain) impact score (PIS). Secondary outcome was a composite functional performance measure of treadmill, lifting, and carrying tolerances. Variables analyzed to determine their predictive value included demographics; treatment hours; measures of pain intensity, function, mood, sleep, social satisfaction, pain catastrophizing, kinesiophobia, self-efficacy, pain acceptance, patient activation, functional performance, and neuropathic pain. RESULTS: Mean PIS and functional performance improved significantly immediately following FR, but after 6 months, only improvement in functional performance sustained. Responder analysis showed that 6 months after FR, 42% of participants reported improvement that exceeded the minimal clinically important difference in PIS or functional performance. Predictors of sustained PIS improvement included younger age, absence of neuropathic pain features, less self-rated disability, better baseline functional performance, and worse baseline PIS. Predictors of sustained functional performance improvement included more treatment hours, lower baseline pain catastrophizing, and lower baseline functional performance. CONCLUSIONS: This study supports the investment of treatment time in FR to yield sustained clinically meaningful improvement, as observed in over 40% of this study's military participants. Pretreatment predictors of sustained response included lower pain catastrophizing and absence of neuropathic pain. Further research is needed to determine if treatments that improve pain catastrophizing and neuropathic pain will result in sustained improvement in pain impact and functional performance following FR program participation.

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.

Use of a Person-Centered Narrative Intervention in an Outpatient Palliative Care Setting: A Feasibility Study.

Person-centered narrative interventions offer potential solutions to facilitate a connection between the person receiving care and the person delivering the care, to improve quality of care, and positively impact a patient's biopsychosocial well-being. This single-arm feasibility study investigates patient-reported outcomes and barriers/facilitators to the implementation of an all-virtually delivered person-centered narrative intervention into the person's electronic health record. Overall, electronic data collection for the patient-reported outcomes was feasible. All 15 participants felt participating in the study was "easy" and "enjoyable," and "not a burden." The facilitators of implementation included: "helpful to the clinician," "appreciated looking at me as whole person," "be seen and heard," "had a connection and trust," and "felt comfortable and relaxing." The barriers to implementation included: "completing all the paperwork," "being rushed for time to complete the PCNI," and some "emotion" during collection of narrative. The use of person-centered narrative interventions is a way to deploy dedicated tools to shift dehumanized healthcare delivery to a more humanized person-centered care that treats people as experts in their own life narratives by incorporating their beliefs, values, and preferences into their plan of care.

Integration of Person-Centered Narratives Into the Electronic Health Record.

BACKGROUND: Care delivery that is not person-centered has been called discordant care . There has been a shift to incorporate more of a person's narrative into their individual healthcare treatment plan to reduce discordant care. Aligning with this shift in healthcare delivery, we developed a person-centered narrative intervention (PCNI) to address existing gaps in delivery of person-centered care. OBJECTIVES: This study aimed to evaluate the feasibility of conducting a randomized study and describe the outcomes of PCNI to usual care on the following person (patient)-reported outcomes: perceptions of the quality of communication with their nurses and their psychosocial and existential well-being. METHODS: This study's design was an Obesity-Related Behavioral Intervention Trials model Phase II proof-of-concept randomized study. The participants were people admitted to an acute care hospital diagnosed with heart failure and/or end-stage renal disease. RESULTS: Despite COVID-19 challenges, the PCNI was feasible in an acute care setting; it showed a moderate positive difference between conditions in the person's perception of their quality of communication and a small positive difference in their perception of feeling heard and understood. For our secondary outcomes of anxiety, depression, and psychosocial illness effect, there were small or no effects in the acute care setting. DISCUSSION: Using a person-centered narrative, such as the PCNI, can help inform delivery of care that incorporates a person's (patient's) beliefs, values, and preferences into their healthcare. This study used a pragmatic approach to evaluate the PCNI in real time in an acute care setting to assess patient-reported outcomes. These positive results in a small sample indicate the need for continued testing of the PCNI. These promising effects require further testing in a Phase III efficacy study within a larger randomized controlled clinical trial.