How well do participants in clinical trials represent the U.S. population with chronic neck or back pain?

BACKGROUND: Randomized clinical trials (RCTs) are the gold standard for assessing treatment effectiveness; however, they have been criticized for generalizability issues such as how well trial participants represent those who receive the treatments in clinical practice. We assessed the representativeness of participants from eight RCTs for chronic spine pain in the U.S., which were used for an individual participant data meta-analysis on the cost-effectiveness of spinal manipulation for spine pain. In these clinical trials, spinal manipulation was performed by chiropractors. METHODS: We conducted a retrospective secondary analysis of RCT data to compare trial participants' socio-demographic characteristics, clinical features, and health outcomes to a representative sample of (a) U.S. adults with chronic spine pain and (b) U.S. adults with chronic spine pain receiving chiropractic care, using secondary data from the National Health Interview Survey (NHIS) and Medical Expenditure Panel Survey (MEPS). We assessed differences between trial and U.S. spine populations using independent t-tests for means and z-tests for proportions, accounting for the complex multi-stage survey design of the NHIS and MEPS. RESULTS: We found the clinical trials had an under-representation of individuals from health disparity populations with lower percentages of racial and ethnic minority groups (Black/African American 7% lower, Hispanic 8% lower), less educated (No high school degree 19% lower, high school degree 11% lower), and unemployed adults (25% lower) with worse health outcomes (physical health scores 2.5 lower and mental health scores 5.3 lower using the SF-12/36) relative to the U.S. population with spine pain. While the odds of chiropractic use in the U.S. are lower for individuals from health disparity populations, the trials also under-represented these populations relative to U.S. adults with chronic spine pain who visit a chiropractor. CONCLUSIONS: Health disparity populations are not well represented in spine pain clinical trials. Embracing key community-based approaches, which have shown promise for increasing participation of underserved communities, is needed.

Cross-Sectional Survey of Acupuncturists in the United States Who Prescribed Chinese Herbal Medicine for Patients with Symptoms Likely Related to COVID-19.

Objective: The objective of this study was to examine the prescribing of Chinese herbal medicine (CHM) by licensed acupuncturists in the United States during the COVID-19 pandemic. Methods: A 28-question survey with nine branching questions was disseminated through collegial networks, paid advertisements, and a study website in April-July 2021. Participants indicated that they were licensed acupuncturists who treated more than five patients for symptoms likely related to COVID-19 to gain entry to the full survey. Surveys were undertaken electronically through the Research Electronic Data Capture (REDCap) system. Results: The survey was undertaken by 103 participants representing all US geographic regions and had an average of 17 years in practice. Sixty-five percent received or intended to receive the COVID-19 vaccine. Phone and videoconference were the predominant methods of patient contact; granules and pill forms of CHM were the most prescribed. A wide variety of information sources were used in devising patient treatments inclusive of anecdotal, observational, and scientific sources. Most patients were not receiving biomedical treatment. Ninety-seven percent of participants reported that they had no patients die of COVID-19, and the majority reported that <25% of their patients developed long hauler syndrome (post-acute sequelae SARS-CoV-2 infection). Conclusions: This study demonstrates that licensed acupuncturists were treating COVID-19 infected individuals in the United States during the early stages of the pandemic, and for many such patients this was the only therapeutic intervention they had access to from a licensed health care provider. Information disseminated from China through collegial networks, along with published sources including scientific studies, informed the approach to treatment. This study provides insight into an unusual circumstance in which clinicians needed to establish evidence-based approaches to the treatment of a new disease during a public health emergency.

Survey analysis to determine the impact of evidence informed practice education upon East Asian medicine faculty clinical instruction and students' skills, knowledge, attitudes and behaviors within a master's degree program.

BACKGROUND: Between 2013 and 2018 Pacific College of Health and Science (formerly Pacific College of Oriental Medicine) trained faculty and developed curriculum in evidence informed practice (EIP), with support from a grant from the National Institutes of Health (NIH). A three-credit (45 h) Foundations of EIP course, and online EIP learning modules (developed as part of a previous NIH R25 award), were used for faculty and student training. In addition, EIP was incorporated into 73% of the East Asian medicine degree program. Clinical integration of EIP in the College clinic was enhanced by improving access to reference sources, including additional EIP-related questions to the patient intake forms, requiring the use of a patient-centered outcome instrument, and assessing students' clinical EIP competencies. METHODS: Master's degree students' self-reported EIP skills, knowledge, attitudes and behaviors were assessed before and after taking the Foundations of EIP course using a 17-question paper-based survey with an additional open-ended comments section. The survey was administered in 29 courses across all three Pacific College campuses. Clinical faculty self-reported EIP instruction, focusing on the EIP content and instructional approaches that were utilized, was evaluated on the New York City campus using a paper-based survey before and after changes were made to enhance the clinical integration of EIP. RESULTS: A total of 1181 completed EIP-course surveys consisting of 657 pre-EIP course surveys and 524 post-EIP course surveys were analyzed. There was a statistically significant improvement in students' EIP skills, knowledge and behaviors after completing the EIP course. Students' perception of the importance of EIP was high before and after the EIP course. Little change in Faculty's EIP-related clinical instruction was evident following the EIP-related changes that were made to the Clinic. CONCLUSION: Our study suggests that the three-credit (45 h) EIP course was effective at improving the EIP skills, knowledge and behaviors of this group of East Asian medicine students who were undertaking a master's degree that qualified them for licensure in acupuncture in the US. These students also demonstrated a high level of recognition for the importance of research and EIP both before and after the course. Training faculty clinical supervisors and providing greater access to evidence sources in the College clinic did not appear to increase EIP instructional activity.

Complementary and integrative healthcare for patients with mechanical low back pain in a U.S. hospital setting.

OBJECTIVES: Complementary and integrative healthcare (CIH) is commonly used to treat low back pain (LBP). While the use of CIH within hospitals is increasing, little is known regarding the delivery of these services within inpatient settings. We examine the patterns of CIH services among inpatients with mechanical LBP in a hospital setting. METHODS: This is a retrospective, practice-based study conducted at Abbot Northwestern hospital in Minnesota. Using electronic health record data from July 2009 to December 2012, 8095 inpatients with mechanical LBP were identified using ICD-9 codes. We classified patients by reason for hospitalization. We examined demographic and clinical characteristics by receipt of CIH services. Then, we estimated the prevalence of types of CIH delivered and clinical foci for CIH visits among inpatients with mechanical LBP. RESULTS: Most inpatients with mechanical LBP (>90%) were hospitalized for surgical procedures. Overall, 14.2% received inpatient CIH services. All demographic and clinical characteristics differed by receipt of CIH (P<0.001), except race/ethnicity. CIH recipients were in poorer health than those who did not. Most commonly delivered CIH services were massage (62.1%), relaxation techniques (42.0%) and acupuncture (25.7%). Pain (45.1%), relaxation (17.5%), and comfort (8.2%) were the top three reasons for CIH visits. CONCLUSION: There are important differences between CIH recipients and non-CIH recipients among patients with mechanical LBP within a hospital setting. The reasons documented for CIH visits included addressing physical, emotional and/or mental conditions of patients. Future studies are needed to determine the effectiveness of CIH services health and wellbeing outcomes in this population.

Exploring patient satisfaction: a secondary analysis of a randomized clinical trial of spinal manipulation, home exercise, and medication for acute and subacute neck pain.

OBJECTIVE: The purpose of this study was to assess satisfaction with specific aspects of care for acute neck pain and explore the relationship between satisfaction with care, neck pain, and global satisfaction. METHODS: This study was a secondary analysis of patient satisfaction from a randomized trial of spinal manipulation therapy (SMT) delivered by doctors of chiropractic, home exercise and advice (HEA) delivered by exercise therapists, and medication (MED) prescribed by a medical doctors for acute/subacute neck pain. Differences in satisfaction with specific aspects of care were analyzed using a linear mixed model. The relationship between specific aspects of care and (1) change in neck pain (primary outcome of the randomized trial) and (2) global satisfaction were assessed using Pearson's correlation and multiple linear regression. RESULTS: Individuals receiving SMT or HEA were more satisfied with the information and general care received than MED group participants. Spinal manipulation therapy and HEA groups reported similar satisfaction with information provided during treatment; however, the SMT group was more satisfied with general care. Satisfaction with general care (r = -0.75 to -0.77; R(2) = 0.55-0.56) had a stronger relationship with global satisfaction compared with satisfaction with information provided (r = -0.65 to 0.67; R(2) = 0.39-0.46). The relationship between satisfaction with care and neck pain was weak (r = 0.17-0.38; R(2) = 0.08-0.21). CONCLUSIONS: Individuals with acute/subacute neck pain were more satisfied with specific aspects of care received during spinal manipulation therapy or home exercise interventions compared to receiving medication. The relationship between neck pain and satisfaction with care was weak.