Dosing of lumbar spinal manipulative therapy and its association with escalated spine care: A cohort study of insurance claims.

OBJECTIVE: The objective of this study was to evaluate the relationship between three distinct spinal manipulative therapy dose groups and escalated spine care by analyzing insurance claims from a cohort of patients with low back pain. METHODS: We compared three distinct spinal manipulative therapy dose groups (low = 1 SMT visits, moderate = 2-12 SMT visits, high = 13+ SMT visits), to a control group (no spinal manipulative therapy) regarding the outcome of escalated spine care. Escalated spine care procedures include imaging studies, injection procedures, emergency department visits, surgery, and opioid medication use. Propensity score matching was performed to address treatment selection bias. Modified Poisson regression modeling was used to estimate the relative risk of spine care escalation among three spinal manipulative therapy doses, adjusting for age, sex, retrospective risk score and claim count. RESULTS: 83,025 claims were categorized into 11,114 unique low back pain episodes; 8,137 claims had 0 spinal manipulative therapy visits, with the remaining episodes classified as low dose (n = 404), moderate dose (n = 1,763) or high dose (n = 810). After propensity score matching, 5,348 episodes remained; 2,454 had 0 spinal manipulative therapy visits with the remaining episodes classified as low dose (n = 404), moderate dose (n = 1,761), or high dose (n = 729). The estimated relative risk (vs no spinal manipulative therapy) for any escalated spine care was 0.45 (95% confidence interval 0.38, 0.55, p <0.001), 0.58 (95% confidence interval 0.53, 0.63, p <0.001), and 1.03 (95% confidence interval 0.95, 1.13, p = 0.461) for low, moderate, and high dose spinal manipulative therapy groups, respectively. CONCLUSIONS: For claims associated with initial episodes of low back pain, low and moderate dose spinal manipulative therapy groups were associated with a 55% and 42% reduction, respectively, in the relative risk of any escalated spine care.

Acupuncture for chronic low back pain in older adults: Design and protocol for the BackInAction pragmatic clinical trial.

BACKGROUND: Back pain prevalence and burden increase with age; approximately one-third of U.S. adults 65 years of age and older experience lower back pain (LBP). For chronic low back pain (cLBP), typically defined as lasting three months or longer, many treatments for younger adults may be inappropriate for older adults given their greater prevalence of comorbidities with attendant polypharmacy. While acupuncture has been demonstrated to be safe and effective for cLBP in adults overall, few studies of acupuncture have either included or focused on adults ≥65 years old. METHODS: The BackInAction study is a pragmatic, multi-site, three-arm, parallel-groups randomized controlled trial designed to test the effectiveness of acupuncture needling for improving back pain-related disability among 807 older adults ≥65 years old with cLBP. Participants are randomized to standard acupuncture (SA; up to 15 treatment sessions across 12 weeks), enhanced acupuncture (EA; SA during first 12 weeks and up to 6 additional sessions across the following 12 weeks), and usual medical care (UMC) alone. Participants are followed for 12 months with study outcomes assessed monthly with the primary outcome timepoint at 6 months. DISCUSSION: The BackInAction study offers an opportunity to further understand the effectiveness, dose-dependence, and safety of acupuncture in a Medicare population. Additionally, study results may encourage broader adoption of more effective, safer, and more satisfactory options to the continuing over-reliance on opioid- and invasive medical treatments for cLBP among older adults. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04982315. Clinical trial registration date: July 29, 2021.

Cost-Effectiveness of Community-to-Clinic Tailored Navigation for Colorectal Cancer Screening in an Underserved Population: Economic Evaluation Alongside a Group-Randomized Trial.

PURPOSE: Although screening for colorectal cancer (CRC) lowers mortality and morbidity and is generally cost-effective, little is known about the cost-effectiveness of screening promotion. DESIGN: Cost-effectiveness analysis alongside a group-randomized trial. Setting: Multicultural, underinsured communities in the Phoenix, Arizona, area. SUBJECTS: English- or Spanish-speaking adults who were out of compliance for CRC screening guidelines. INTERVENTION: All participants received community-based group education (GE), and the intervention group also received tailored community-to-clinic navigation (GE+TN). MEASURES: Number of participants screened and costs of tailored navigation, clinic visits, and CRC screening tests. ANALYSIS: Incremental cost per additional person screened from the perspective of the healthcare system with bootstrapped confidence intervals. RESULTS: Community sites were recruited and randomized to GE (n = 120) and GE + TN (n = 119). Across these sites 1154 individuals were screened, 504 were eligible, and 345 attended the group education class (n = 134 GE; n = 211 GE + TN). Screening rates (26.5% GE + TN; 10.4% GE; 16.1% increase 95% CI: 7%, 23%) and costs per participant ($271 GE + TN; $167 GE; a net cost increase of $104 95% CI: $1, $189) were significantly higher in the intervention group. Incremental cost-effectiveness was $646 (95% CI: -$68, $953) per additional person screened. CONCLUSION: Depending on the value placed on an additional person screened, the addition of community-to-clinic tailored navigation to a community-based CRC screening promotion program may be highly cost-effective.

Startup and implementation costs of a colorectal cancer screening tailored navigation research study.

BACKGROUND: Colorectal cancer (CRC) is the third leading cause of cancer-related death in the United States. Despite improvements in screening, testing for CRC is underutilized in some populations, suggesting a need to identify efficient test promotion strategies. METHODS: Our intervention guided individuals from low-income, underserved communities into primary care clinics to receive CRC screening referrals. Community sites were randomized to education or education plus navigation. The Phase I community-to-clinic navigation outcome was clinic attendance; the Phase II clinic-to-screening navigation outcome was screening completion. We used micro-costing to determine costs necessary to replicate our project in a similar, non-research setting. RESULTS: Over the 4-year project, startup costs tended to decrease as implementation costs increased. The largest component of startup costs (32 % of total) was community site recruitment. Implementation costs per class attendee were higher in the navigation group ($1084) than control ($798). But costs per participant who made a clinic appointment ($3573 versus $6292) and per participant who completed screening ($4083 versus $7640) were lower in the navigation group. CONCLUSIONS: Our description of startup and implementation costs for this intervention provides decision makers with information needed to plan and budget for a similar project to guide individuals from community into clinics.

Clinical Scenarios for Which Cervical Mobilization and Manipulation Are Considered by an Expert Panel to Be Appropriate (and Inappropriate) for Patients With Chronic Neck Pain.

OBJECTIVES: Cervical mobilization and manipulation are 2 therapies commonly used for chronic neck pain (CNP). However, safety, especially of cervical manipulation, is controversial. This study identifies the clinical scenarios for which an expert panel rated cervical mobilization and manipulation as appropriate and inappropriate. METHODS: An expert panel, following a well-validated modified-Delphi approach, used an evidence synthesis and clinical acumen to develop and then rate the appropriateness of cervical mobilization and manipulation for each of an exhaustive list of clinical scenarios for CNP. Key patient characteristics were identified using decision tree analysis (DTA). RESULTS: Three hundred seventy-two clinical scenarios were defined and rated by an 11-member expert panel as to the appropriateness of cervical mobilization and manipulation. Across clinical scenarios more were rated inappropriate than appropriate for both therapies, and more scenarios were rated inappropriate for manipulation than mobilization. However, the number of patients presenting with each scenario is not yet known. Nevertheless, DTA indicates that all clinical scenarios that included red flags (eg, fever, cancer, inflammatory arthritides, or vasculitides), and some others involving major neurological findings, especially if previous manual therapy was unfavorable, were rated as inappropriate for both cervical mobilization and manipulation. DTA also identified the absence of cervical disk herniation, stenosis, or foraminal osteophytosis on additional testing as the most important patient characteristic in predicting ratings of appropriate. CONCLUSIONS: Clinical guidelines for CNP should include information on the clinical scenarios for which cervical mobilization and manipulation were found inappropriate, including those with red flags, and others involving major neurological findings if previous manual therapy was unfavorable.

Effects of a Community-to-Clinic Navigation Intervention on Colorectal Cancer Screening Among Underserved People.

BACKGROUND: Colorectal cancer screening remains suboptimal among poor and underserved people. PURPOSE: We tested the effectiveness of a community-to-clinic navigator intervention to guide multicultural, underinsured individuals into primary care clinics to complete colorectal cancer screening. METHODS: This two-phase behavioral intervention study was conducted in Phoenix, Arizona (2012-2018). Community sites were randomized to group education or group education plus tailored navigation to increase attendance at primary care clinics (Phase I). Individuals who completed a clinic appointment received the tailored navigation in person or via phone (Phase II). RESULTS: In Phase I (N = 345), 37.9% of the intervention group scheduled a clinic appointment versus 19.4% of the comparison group. In Phase II, 26.5% of the original intervention group were screened versus only 10.4% of the original comparison group. Those in the intervention group were 3.84 times more likely to be screened than were those in the comparison group (odds ratio = 3.84; 95% confidence interval = 1.81-6.92). CONCLUSIONS: Translation of an efficacious tailored navigation intervention for colorectal cancer screening to a community-to-clinic context is associated with significantly increased rates of colorectal cancer screening. Navigation assistance to address barriers to screening may serve as the most important component of any educational program to increase individual adherence to colorectal cancer screening.

Characteristics of Chiropractic Patients Being Treated for Chronic Low Back and Neck Pain.

OBJECTIVES: Chronic low back pain (CLBP) and chronic neck pain (CNP) are the most common types of chronic pain, and chiropractic spinal manipulation is a common nonpharmacologic treatment. This study presents the characteristics of a large United States sample of chiropractic patients with CLBP and CNP. METHODS: Data were collected from chiropractic patients using multistage systematic stratified sampling with 4 sampling levels: regions and states, sites (ie, metropolitan areas), providers and clinics, and patients. The sites and regions were San Diego, California; Tampa, Florida; Minneapolis, Minnesota; Seneca Falls and Upstate New York; Portland, Oregon; and Dallas, Texas. Data were collected from patients through an iPad-based prescreening questionnaire in the clinic and emailed links to full screening and baseline online questionnaires. The goal was 20 providers or clinics and 7 patients with CLBP and 7 with CNP from each clinic. RESULTS: We had 6342 patients at 125 clinics complete the prescreening questionnaire, 3333 patients start the full screening questionnaire, and 2024 eligible patients completed the baseline questionnaire: 518 with CLBP only, 347 with CNP only, and 1159 with both. In general, most of this sample were highly-educated, non-Hispanic, white females with at least partial insurance coverage for chiropractic care who have been in pain and using chiropractic care for years. Over 90% reported high satisfaction with their care, few used narcotics, and avoiding surgery was the most important reason they chose chiropractic care. CONCLUSIONS: Given the prevalence of CLBP and CNP, the need to find effective nonpharmacologic alternatives for chronic pain, and the satisfaction these patients found with their care, further study of these patients is worthwhile.

The National Cancer Institute's Conference on Acupuncture for Symptom Management in Oncology: State of the Science, Evidence, and Research Gaps.

The Division of Cancer Treatment and Diagnosis, Office of Cancer Complementary and Alternative Medicine, at the National Cancer Institute (NCI) held a symposium on "Acupuncture for Cancer Symptom Management" on June 16 and 17, 2016. Invited speakers included 19 scientists and scholars with expertise in acupuncture and cancer research from the United States, Europe, and China. The conference reviewed the NCI's grant funding on acupuncture, analyzed the needs of cancer patients, reviewed safety issues, and assessed both the current scientific evidence and research gaps of acupuncture in oncology care. Researchers and stakeholders presented and discussed basic mechanisms of acupuncture; clinical evidence for specific symptoms; and methodological challenges such as placebo effects, novel biostatistical methods, patient-reported outcomes, and comparative effectiveness research. This paper, resulting from the conference, summarizes both the current state of the science and clinical evidence of oncology acupuncture, identifies key scientific gaps, and makes recommendations for future research to increase understanding of both the mechanisms and effects of acupuncture for cancer symptom management.

Out-Of-Pocket Expenditures on Complementary Health Approaches Associated With Painful Health Conditions in a Nationally Representative Adult Sample.

UNLABELLED: National surveys suggest that millions of adults in the United States use complementary health approaches such as acupuncture, chiropractic manipulation, and herbal medicines to manage painful conditions such as arthritis, back pain, and fibromyalgia. Yet, national and per person out-of-pocket (OOP) costs attributable to this condition-specific use are unknown. In the 2007 National Health Interview Survey, the use of complementary health approaches, the reasons for this use, and the associated OOP costs were captured in a nationally representative sample of 5,467 adults. Ordinary least square regression models that controlled for comorbid conditions were used to estimate aggregate and per person OOP costs associated with 14 painful health conditions. Individuals using complementary approaches spent a total of $14.9 billion (standard error [SE] = $.9 billion) on these approaches to manage these painful conditions. Total OOP expenditures by those using complementary approaches for their back pain ($8.7 billion, SE = $.8 billion) far outstripped OOP expenditures for any other condition; the majority of these costs ($4.7 billion, SE = $.4 billion) were for visits to complementary providers. Annual condition-specific per person OOP costs varied from a low of $568 (SE = $144) for regular headaches to a high of $895 (SE = $163) for fibromyalgia. PERSPECTIVE: Adults in the United States spent $14.9 billion on complementary health approaches (eg, acupuncture, chiropractic manipulation, and herbal medicines) to manage painful conditions including back pain ($8.7 billion). This back pain estimate is almost one-third of the total conventional health care expenditure for back pain ($30.4 billion) and two-thirds higher than conventional OOP expenditures ($5.1 billion).

Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.

BACKGROUND: The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. METHODS/DESIGN: In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. DISCUSSION: If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01467843.

A cancer screening intervention for underserved Latina women by lay educators.

OBJECTIVES: Inadequate screening adherence for breast, cervical, and colorectal cancer among Latinas places them at greater risk for poor survival rates, once diagnosed. The purpose of this study was to examine two delivery methods of lay health educators (promotoras de salud) to increase screening behavior and evaluate costs. METHODS: This community-based group randomized trial assigned Latinas due for breast, cervical, or colorectal cancer screening (n=1006) to promotora-taught cancer screening/prevention classes delivered individually (IND) or in social support groups (SSG) over 8 weeks. Screening behaviors were assessed immediately after and 3 and 15 months after intervention. Intervention costs per study arm were compared. RESULTS: Screening and maintenance behaviors were not significantly different between SSG and IND for any one type of cancer screening, but with a study entry requirement that participants were either never screened or due for screening, postintervention screening rates (that is, completing a screening that was due) were notable (39.4% and 45.5%, respectively). The cost of achieving any one screening was much higher for IND participants. CONCLUSIONS: SSG vs. IND delivery did not significantly affect cancer screening behaviors, but both interventions produced robust achievement of screenings for previously nonadherent participants. Group-based promotora-led interventions supporting social involvement are recommended as a more cost-effective approach to achieving cancer screening among Latina women.

Hospital admissions for acute myocardial infarction, angina, stroke, and asthma after implementation of Arizona's comprehensive statewide smoking ban.

OBJECTIVES: We examined the impact of Arizona's May 2007 comprehensive statewide smoking ban on hospital admissions for diagnoses for which there is evidence of a causal relationship with secondhand smoke (SHS) exposure (acute myocardial infarction [AMI], angina, stroke, and asthma). METHODS: We compared monthly hospital admissions from January 2004 through May 2008 for these primary diagnoses and 4 diagnoses not associated with SHS (appendicitis, kidney stones, acute cholecystitis, and ulcers) for Arizona counties with preexisting county or municipal smoking bans and counties with no previous bans. We attributed reductions in admissions to the statewide ban if they occurred only in diagnoses associated with SHS and if they were larger in counties with no previous bans. We analyzed the data with Poisson regressions, controlling for seasonality and admissions trends. We also estimated cost savings. RESULTS: Statistically significant reductions in hospital admissions were seen for AMI, angina, stroke, and asthma in counties with no previous bans over what was seen in counties with previous bans. No ban variable coefficients were statistically significant for diagnoses not associated with SHS. CONCLUSIONS: Arizona's statewide smoking ban decreased hospital admissions for AMI, stroke, asthma, and angina.

Are cost-inclusive evaluations worth the effort?

Relative costs are as important as relative effectiveness when choosing between program alternatives or among a set of programs competing for scarce funds. Nevertheless, the number of cost-inclusive evaluations remains comparatively small. This article presents the results of three first-time cost-inclusive evaluations each performed by an experienced evaluator. Each evaluator performed a different type of cost-inclusive evaluation using different tobacco control programs as examples: "standard" cost-effectiveness analysis, threshold or break-even analysis, and a simulation model. Results are presented in terms of the challenges faced, and informational and insight benefits gained, as well as in terms of program cost-effectiveness. All three evaluators agreed that the benefits from performing cost-inclusive evaluations are well worth time and effort involved. They also found that this type of evaluation provides abundant information that can be used to improve program effectiveness and cost-effectiveness.

A method for describing and evaluating naturopathic whole practice.

CONTEXT: Even though complementary and alternative medicine (CAM) is generally practiced as distinct systems of medicine, almost all CAM research has focused on single therapies. In order to more adequately evaluate the effectiveness of these medical systems, studies that evaluate the outcome of intact whole systems are needed. One challenge lies in defining the whole medical system (and any medical system it is compared to) in a way that ensures treatment fidelity. OBJECTIVE: This paper presents a proposed method to measure treatment fidelity (treatment criteria) in studies of the naturopathic medical system. DESIGN: Illustrative example of the theory-based development and post-hoc "testing" of treatment criteria against an existing database of actual treatments prescribed by a random sample of naturopathic physicians. MAIN OUTCOME MEASURES: Treatment criteria for 3 conditions--menopausal symptoms, bowel dysfunction, and fatigue/fibromyalgia--and their comparison to actual treatments prescribed. RESULTS: A set of meaningful, measurable treatment criteria based on the naturopathic practice principles were defined that could have generated the majority (82%-93%) of treatment prescriptions given at visits for these conditions. Several of the treatment criteria components are common across the 3 conditions studied, and might be appropriate for all visits to doctors of naturopathy (NDs). Others are specific to each condition. In addition to ensuring model validity, these criteria help identify critical components of care, enable study replication, provide a measure of quality of care, and are one step toward allowing CAM to be studied as it is generally practiced-as distinct systems of medicine. SETTING: Work was performed at Bastyr University and the University of Arizona.

Effects of an art-based curriculum on clinical trials attitudes and breast cancer prevention knowledge.

Although Latinos now comprise the largest minority in the U.S. population, they continue to be seriously underrepresented in clinical trials. A nonrandomized controlled study of an innovative community-developed clinical trial and breast cancer education program targeting Latinas tested whether use of an art-based curriculum could increase willingness to enroll in six clinical trial scenarios and increase breast health and clinical trial knowledge. The art-based curriculum resulted in a larger increase in stated willingness to enroll across all clinical trial scenarios, and the difference was statistically significant (p<.05) in three. Breast health and clinical trials knowledge increased similarly and significantly for both groups. The results of this study show promise for the use of a community-developed art-based curriculum in the Latina population to increase willingness to enroll in clinical trials.

Is complementary and alternative medicine (CAM) cost-effective? A systematic review.

BACKGROUND: Out-of-pocket expenditures of over 34 billion dollars per year in the US are an apparent testament to a widely held belief that complementary and alternative medicine (CAM) therapies have benefits that outweigh their costs. However, regardless of public opinion, there is often little more than anecdotal evidence on the health and economic implications of CAM therapies. The objectives of this study are to present an overview of economic evaluation and to expand upon a previous review to examine the current scope and quality of CAM economic evaluations. METHODS: The data sources used were Medline, AMED, Alt-HealthWatch, and the Complementary and Alternative Medicine Citation Index; January 1999 to October 2004. Papers that reported original data on specific CAM therapies from any form of standard economic analysis were included. Full economic evaluations were subjected to two types of quality review. The first was a 35-item checklist for reporting quality, and the second was a set of four criteria for study quality (randomization, prospective collection of economic data, comparison to usual care, and no blinding). RESULTS: A total of 56 economic evaluations (39 full evaluations) of CAM were found covering a range of therapies applied to a variety of conditions. The reporting quality of the full evaluations was poor for certain items, but was comparable to the quality found by systematic reviews of economic evaluations in conventional medicine. Regarding study quality, 14 (36%) studies were found to meet all four criteria. These exemplary studies indicate CAM therapies that may be considered cost-effective compared to usual care for various conditions: acupuncture for migraine, manual therapy for neck pain, spa therapy for Parkinson's, self-administered stress management for cancer patients undergoing chemotherapy, pre- and post-operative oral nutritional supplementation for lower gastrointestinal tract surgery, biofeedback for patients with "functional" disorders (eg, irritable bowel syndrome), and guided imagery, relaxation therapy, and potassium-rich diet for cardiac patients. CONCLUSION: Whereas the number and quality of economic evaluations of CAM have increased in recent years and more CAM therapies have been shown to be of good value, the majority of CAM therapies still remain to be evaluated.