Qualitative Assessment CIH Institutions' Engagement With Underserved Communities to Enhance Healthcare Access and Utilization.

Background: In North America, there is a notable underutilization of complementary and integrative health approaches (CIH) among non-White and marginalized communities. Objectives: This study sought to understand how CIH educational instutitions are proactively working to redress this disparity in access and utilization among these communities. Methods: We conducted interviews with 26 key informants, including presidents, clinicians, and research deans across 13 CIH educational institutions across the US and Canada. Thematic analysis included deductive codes based on the interview guide during interview scripts review. Results: Six themes were identified: (1) CIH institutions often had a long and varied history of community engaged care through partnerships to increase access and utilization; (2) CIH institutions' long-standing community outreach had been intentionally designed; (3) CIH institutions provided an array of services to a wide range of demographics and communities; (4) addressing healthcare access and utilization through community partnerships had a strong positive impact; (5) funding, staffing and COVID-19 were significant challenges that impeded efforts to increase CIH access through community engaged work; (6) identified gaps in community partnerships and services to increase access and utilization were recognized. Conclusion: These findings underscore significant efforts made to enhance healthcare access and utilization among marginalized, underserved, and racial and ethnic communities. However, barriers such as funding constraints, resource allocation, and the need for proper measurement and accountability hinder proactive initiatives aimed at redressing disparities in CIH utilization within these communities.

A Pragmatic Historical Assessment Tool: A New Systematic Framework for the Collation and Evaluation of Documented Empirical Effectiveness and Safety of Traditional Plant Medicines in the European Materia Medica.

INTRODUCTION: Traditional plant medicines (TPMs) are plant-derived therapeutic products prepared and applied according to longstanding medical customs. Around the world they are widely used in primary and preventative health care. The World Health Organization (WHO) calls in its Traditional Medicine Strategy 2014-2023 for Member States to provide a regulatory framework so that the formal contribution of traditional therapeutics can be advanced in national systems of health care. Evidence of effectiveness and safety is paramount for the regulatory integration of TPMs; however, a presumed lack of such "evidence" is one obstacle for full integration. The consequential health policy question is how to systematically evaluate therapeutic claims relating to herbal remedies when the extant evidence is predominantly based on historical and contemporary clinical usage, i.e., is empiricist in nature. This paper introduces a new method along with several illustrative examples. METHOD: Our research design employs a longitudinal, comparative textual analysis of standard textbooks of the professional European medical literature from the early modern period (1588/1664) onwards to today. It then triangulated these intergenerationally documented clinical observations on two exemplars (Arnica and St. John's Wort) with corresponding listings in multiple qualitative and quantitative sources. A Pragmatic Historical Assessment (PHA) tool was developed and tested as a method to systematically collate the large amount of pharmacological data recorded in these judiciously selected sources. The evidential validity of longstanding professional clinical knowledge could thus be compared with therapeutic indications approved in official and authoritative sources (pharmacopoeias, monographs) and with those supported by contemporary scientific research (randomised-controlled trials [RCTs], experimental research). RESULTS: There was high congruency between therapeutic indications that are based on repeated empirical observations from professional patient care (empirical evidence), those approved in pharmacopoeias and monographs, and modern scientific evidence based on RCTs. The extensive herbal triangulation confirmed parallel records of all main therapeutic indications of the exemplars across all qualitative and quantitative sources over the past 400 years. CONCLUSIONS: Historical clinical medical textbooks and contemporary phytotherapeutic equivalents are the key repository of repeatedly evaluated therapeutic plant knowledge. The professional clinical literature proved to be a reliable and verifiable body of empirical evidence that harmonised with contemporary scientific assessments. The newly developed PHA tool provides a coding framework for the systematic collation and evaluation of empirical data on the effectiveness and safety of TPMs. It is suggested as a feasible and efficient tool to extend evidence typologies that substantiate therapeutic claims for TPMs as part of an evidence-based regulatory framework that formally integrates these medically and culturally important therapeutics.Traditionelle pflanzliche Arzneimittel sind aus Pflanzen gewonnene Heilmittel, die gemäß langjähriger medizinischer Praxis zubereitet und angewendet werden. Weltweit sind sie in der primären und präventiven Gesundheitsversorgung weit verbreitet. Die Weltgesundheitsorganisation (WHO) ruft in ihrer Traditional Medicine Strategy 2014­2023 die Mitgliedstaaten dazu auf, regulatorische Rahmenbedingungen zu schaffen, welche den formellen Beitrag traditioneller Therapeutika in den nationalen Gesundheitssystemen fördern. Der Nachweis von Wirksamkeit und Sicherheit ist von zentraler Bedeutung für die regulatorische Integration traditioneller pflanzlicher Arzneimittel, doch das angebliche Fehlen solcher "Nachweise" ist eine der Hürden für die vollständige Integration. Daraus ergibt sich die gesundheitspolitische Frage, wie man therapeutische Anwendungsgebiete pflanzlicher Heilmittel systematisch evaluieren kann, wenn die vorliegende Evidenz überwiegend auf deren historischer und aktueller klinischen Verwendung beruht, also empirischer Natur ist. In dieser Arbeit wird eine neue Methode mitsamt veranschaulichenden Beispielen vorgestellt.Unser Forschungsansatz beruhte auf einer longitudinalen, vergleichenden Textanalyse von Standard-Lehrwerken der europäischen medizinischen Fachliteratur ausgehend von der frühen Neuzeit (1588/1664) bis heute. Die über Generationen dokumentierten klinischen Beobachtungen wurden anhand von zwei Beispielen (Arnika and Johanniskraut) mit den diesbezüglichen Angaben in unterschiedlichen qualitativen und quantitativen Quellen trianguliert. Ein Pragmatisch­Historisches Auswertungstool (PHA) wurde als Methode entwickelt und getestet, um die großen Mengen der in diesen kritisch ausgewählten Quellen enthaltenen pharmakologischen Daten systematisch zu erfassen. Die Evidenzvalidität des langjährigen klinischen Fachwissens konnte so mit den therapeutischen Anwendungsgebieten verglichen werden, die in offiziellen und autoritativen Quellen (Pharmakopöen, Monografien) zugelassen sind, sowie mit denjenigen, die durch zeitgenössische wissenschaftliche Forschung gestützt werden (randomisierte kontrollierte Studien [RCTs], experimentelle Forschung).Es bestand ein hohes Maß an Kongruenz zwischen den therapeutischen Anwendungsgebieten, welche auf wiederholte empirische Beobachtung aus der professionellen Patientenversorgung beruhen (empirische Evidenz), den zugelassenen Indikationen in Pharmakopöen und Monographien sowie der aktuellen wissenschaftlichen Evidenz basierend auf klinischen Studien. Die umfassende pflanzenbezogene Triangulation bestätigte parallele Aufzeichnungen aller wesentlichen Anwendungsgebiete der untersuchten Beispiele in allen qualitativen und quantitativen Quellen über die letzten 400 Jahre hinweg.Historische Lehrbücher für klinische Medizin und zeitgenössische phytotherapeutische Äquivalente sind die wichtigsten Quellen von wiederholt evaluiertem therapeutischem Wissen zu Heilpflanzen. Die klinische Fachliteratur erwies sich als zuverlässiger und verifizierbarer Korpus empirischer Evidenz, der mit aktuellen wissenschaftlichen Untersuchungen übereinstimmte. Das neu entwickelte PHA-Verfahren bietet ein Kodierungs­Instrument für das systematische Erfassen und Auswerten empirischer Daten zur Wirksamkeit und Sicherheit von traditionellen pflanzlichen Arzneimitteln. Das PHA­Verfahren wird als praktikables und effizientes Instrument zur Erweiterung der Evidenz­Typologien empfohlen, indem es therapeutische Indikationen für traditionelle pflanzliche Arzneimittel untermauern kann, so dass diese medizinisch und kulturell wichtigen Therapeutika in einen evidenz-basierten regulatorischen Rahmen integriert werden können.

Initial Choice of Spinal Manipulation Reduces Escalation of Care for Chronic Low Back Pain Among Older Medicare Beneficiaries.

STUDY DESIGN: We combined elements of cohort and crossover-cohort design. OBJECTIVE: The objective of this study was to compare longterm outcomes for spinal manipulative therapy (SMT) and opioid analgesic therapy (OAT) regarding escalation of care for patients with chronic low back pain (cLBP). SUMMARY OF BACKGROUND DATA: Current evidence-based guidelines for clinical management of cLBP include both OAT and SMT. For long-term care of older adults, the efficiency and value of continuing either OAT or SMT are uncertain. METHODS: We examined Medicare claims data spanning a five-year period. We included older Medicare beneficiaries with an episode of cLBP beginning in 2013. All patients were continuously enrolled under Medicare Parts A, B, and D. We analyzed the cumulative frequency of encounters indicative of an escalation of care for cLBP, including hospitalizations, emergency department visits, advanced diagnostic imaging, specialist visits, lumbosacral surgery, interventional pain medicine techniques, and encounters for potential complications of cLBP. RESULTS: SMT was associated with lower rates of escalation of care as compared to OAT. The adjusted rate of escalated care encounters was approximately 2.5 times higher for initial choice of OAT vs. initial choice of SMT (with weighted propensity scoring: rate ratio 2.67, 95% confidence interval 2.64-2.69, P < .0001). CONCLUSION: Among older Medicare beneficiaries who initiated long-term care for cLBP with opioid analgesic therapy, the adjusted rate of escalated care encounters was significantly higher as compared to those who initiated care with spinal manipulative therapy.Level of Evidence: 3.

Long-Term Medicare Costs Associated With Opioid Analgesic Therapy vs Spinal Manipulative Therapy for Chronic Low Back Pain in a Cohort of Older Adults.

OBJECTIVES: The purpose of this study was to compare Medicare healthcare expenditures for patients who received long-term treatment of chronic low back pain (cLBP) with either opioid analgesic therapy (OAT) or spinal manipulative therapy (SMT). METHODS: We conducted a retrospective observational study using a cohort design for analysis of Medicare claims data. The study population included Medicare beneficiaries enrolled under Medicare Parts A, B, and D from 2012 through 2016. We assembled cohorts of patients who received long-term management of cLBP with OAT or SMT (such as delivered by chiropractic or osteopathic practitioners) and evaluated the comparative effect of OAT vs SMT upon expenditures, using multivariable regression to control for beneficiary characteristics and measures of health status, and propensity score weighting and binning to account for selection bias. RESULTS: The study sample totaled 28,160 participants, of whom 77% initiated long-term care of cLBP with OAT, and 23% initiated care with SMT. For care of low back pain specifically, average long-term costs for patients who initiated care with OAT were 58% lower than those who initiated care with SMT. However, overall long-term healthcare expenditures under Medicare were 1.87 times higher for patients who initiated care via OAT compared with those initiated care with SMT (95% CI 1.65-2.11; P < .0001). CONCLUSIONS: Adults aged 65 to 84 who initiated long-term treatment for cLBP via OAT incurred lower long-term costs for low back pain but higher long-term total healthcare costs under Medicare compared with patients who initiated long-term treatment with SMT.

Spinal Manipulation vs Prescription Drug Therapy for Chronic Low Back Pain: Beliefs, Satisfaction With Care, and Qualify of Life Among Older Medicare Beneficiaries.

OBJECTIVE: The objective of this study was to compare patients' perspectives on the use of spinal manipulative therapy (SMT) compared to prescription drug therapy (PDT) with regard to health-related quality of life (HRQoL), patient beliefs, and satisfaction with treatment. METHODS: Four cohorts of Medicare beneficiaries were assembled according to previous treatment received as evidenced in claims data: SMT, PDT, and 2 crossover cohorts (where participants experienced both types of treatments). A total of 195 Medicare beneficiaries responded to the survey. Outcome measures used were a 0-to-10 numeric rating scale to measure satisfaction, the Low Back Pain Treatment Beliefs Questionnaire to measure patient beliefs, and the 12-item Short Form Health Survey to measure HRQoL. RESULTS: Recipients of SMT were more likely to be very satisfied with their care (84%) than recipients of PDT (50%; P = .002). The SMT cohort self-reported significantly higher HRQoL compared to the PDT cohort; mean differences in physical and mental health scores on the 12-item Short Form Health Survey were 12.85 and 9.92, respectively. The SMT cohort had a lower degree of concern regarding chiropractic care for their back pain compared to the PDT cohort's reported concern about PDT (P = .03). CONCLUSION: Among older Medicare beneficiaries with chronic low back pain, long-term recipients of SMT had higher self-reported rates of HRQoL and greater satisfaction with their modality of care than long-term recipients of PDT. Participants who had longer-term management of care were more likely to have positive attitudes and beliefs toward the mode of care they received.

Update of Markov Model on the Cost-effectiveness of Nonpharmacologic Interventions for Chronic Low Back Pain Compared to Usual Care.

STUDY DESIGN: Markov model. OBJECTIVE: Further validity test of a previously published model. SUMMARY OF BACKGROUND DATA: The previous model was built using data from ten randomized trials and examined the 1-year effectiveness and cost-effectiveness of 17 nonpharmacologic interventions for chronic low back pain (CLBP), each compared to usual care alone. This update incorporated data from five additional trials. METHODS: Based on transition probabilities that were estimated using patient-level trial data, a hypothetical cohort of CLBP patients transitioned over time among four defined health states: high-impact chronic pain with substantial activity limitations; higher (moderate-impact) and lower (low-impact) pain without activity limitations; and no pain. As patients transitioned among health states, they accumulated quality-adjusted life-years, as well as healthcare and productivity costs. Costs and effects were calculated incremental to each study's version of usual care. RESULTS: From the societal perspective and assuming a typical patient mix (25% low-impact, 35% moderate-impact, and 40% high-impact chronic pain), most interventions-including those newly added-were cost-effective (<$50,000/QALY) and demonstrated cost savings. From the payer perspective, fewer were cost-saving, but the same number were cost-effective. Results for the new studies generally mirrored others using the same interventions-for example, cognitive behavioral therapy (CBT) and physical therapy. A new acupuncture study had similar effectiveness to other acupuncture studies, but higher usual care costs, resulting in higher cost savings. Two new yoga studies' results were similar, but both differed from those of the original yoga study. Mindfulness-based stress reduction was similar to CBT for a typical patient mix but was twice as effective for those with high-impact chronic pain. CONCLUSION: Markov modeling facilitates comparisons across interventions not directly compared in trials, using consistent outcome measures after balancing the baseline mix of patients. Outcomes also differed by pain impact level, emphasizing the need to measure CLBP subgroups. LEVEL OF EVIDENCE: N/A.

The impact of patient preferences and costs on the appropriateness of spinal manipulation and mobilization for chronic low back pain and chronic neck pain.

BACKGROUND: Although the delivery of appropriate healthcare is an important goal, the definition of what constitutes appropriate care is not always agreed upon. The RAND/UCLA Appropriateness Method is one of the most well-known and used approaches to define care appropriateness from the clinical perspective-i.e., that the expected effectiveness of a treatment exceeds its expected risks. However, patient preferences (the patient perspective) and costs (the healthcare system perspective) are also important determinants of appropriateness and should be considered. METHODS: We examined the impact of including information on patient preferences and cost on expert panel ratings of clinical appropriateness for spinal mobilization and manipulation for chronic low back pain and chronic neck pain. RESULTS: The majority of panelists thought patient preferences were important to consider in determining appropriateness and that their inclusion could change ratings, and half thought the same about cost. However, few actually changed their appropriateness ratings based on the information presented on patient preferences regarding the use of these therapies and their costs. This could be because the panel received information on average patient preferences for spinal mobilization and manipulation whereas some panelists commented that appropriateness should be determined based on the preferences of individual patients. Also, because these therapies are not expensive, their ratings may not be cost sensitive. The panelists also generally agreed that preferences and costs would only impact their ratings if the therapies were considered clinically appropriate. CONCLUSIONS: This study found that the information presented on patient preferences and costs for spinal mobilization and manipulation had little impact on the rated appropriateness of these therapies for chronic low back pain and chronic neck pain. Although it was generally agreed that patient preferences and costs were important to the appropriateness of M/M for CLBP and CNP, it seems that what would be most important were the preferences of the individual patient, not patients in general, and large cost differentials.

Health Care Costs and Opioid Use Associated With High-impact Chronic Spinal Pain in the United States.

STUDY DESIGN: A descriptive analysis of secondary data. OBJECTIVE: The aim of this study was to estimate health care costs and opioid use for those with high-impact chronic spinal (back and neck) pain. SUMMARY OF BACKGROUND DATA: The US National Pain Strategy introduced a focus on high-impact chronic pain-that is, chronic pain associated with work, social, and self-care restrictions. Chronic neck and low-back pain are common, costly, and associated with long-term opioid use. Although chronic pain is not homogenous, most estimates of its costs are averages that ignore severity (impact). METHODS: We used 2003 to 2015 Medical Expenditures Panel Survey (MEPS) data to identify individuals with chronic spinal pain, their health care expenditures, and use of opioids. We developed prediction models to identify those with high- versus moderate- and low-impact chronic spinal pain based on the variables available in MEPS. RESULTS: We found that overall and spine-related health care costs, and the use and dosage of opioids increased significantly with chronic pain impact levels. Overall and spine-related annual per person health care costs for those with high-impact chronic pain ($14,661 SE: $814; and $5979 SE: $471, respectively) were more than double that of those with low-impact, but still clinically significant, chronic pain ($6371 SE: $557; and $2300 SE: $328). Those with high-impact chronic spinal pain also use spine-related opioids at a rate almost four times that of those with low-impact pain (48.4% vs. 12.4%), and on average use over five times the morphine equivalent daily dose (MEDD) in mg (15.3 SE: 1.4 vs. 2.7 SE: 0.6). Opioid use and dosing increased significantly across years, but the increase in inflation-adjusted health care costs was not statistically significant. CONCLUSION: Although most studies of chronic spinal pain do not differentiate participants by the impact of their chronic pain, these estimates highlight the importance of identifying chronic pain levels and focusing on those with high-impact chronic pain. LEVEL OF EVIDENCE: 3.

Are Nonpharmacologic Interventions for Chronic Low Back Pain More Cost Effective Than Usual Care? Proof of Concept Results From a Markov Model.

STUDY DESIGN: Markov model. OBJECTIVE: Examine the 1-year effectiveness and cost-effectiveness (societal and payer perspectives) of adding nonpharmacologic interventions for chronic low back pain (CLBP) to usual care using a decision analytic model-based approach. SUMMARY OF BACKGROUND DATA: Treatment guidelines now recommend many safe and effective nonpharmacologic interventions for CLBP. However, little is known regarding their effectiveness in subpopulations (e.g., high-impact chronic pain patients), nor about their cost-effectiveness. METHODS: The model included four health states: high-impact chronic pain (substantial activity limitations); no pain; and two others without activity limitations, but with higher (moderate-impact) or lower (low-impact) pain. We estimated intervention-specific transition probabilities for these health states using individual patient-level data from 10 large randomized trials covering 17 nonpharmacologic therapies. The model was run for nine 6-week cycles to approximate a 1-year time horizon. Quality-adjusted life-year weights were based on six-dimensional health state short form scores; healthcare costs were based on 2003 to 2015 Medical Expenditure Panel Survey data; and lost productivity costs used in the societal perspective were based on reported absenteeism. Results were generated for two target populations: (1) a typical baseline mix of patients with CLBP (25% low-impact, 35% moderate-impact, and 40% high-impact chronic pain) and (2) high-impact chronic pain patients. RESULTS: From the societal perspective, all but two of the therapies were cost effective (<$50,000/quality-adjusted life-year) for a typical patient mix and most were cost saving. From the payer perspective fewer were cost saving, but the same number was cost-effective. Assuming all patients in the model have high-impact chronic pain increases the effectiveness and cost-effectiveness of most, but not all, therapies indicating that substantial benefits are possible in this subpopulation. CONCLUSION: Modeling leverages the evidence produced from clinical trials to provide more information than is available in the published studies. We recommend modeling for all existing studies of nonpharmacologic interventions for CLBP. LEVEL OF EVIDENCE: 4.

Patient Willingness to Pay for Reductions in Chronic Low Back Pain and Chronic Neck Pain.

Many recommended nonpharmacologic therapies for patients with chronic spinal pain require visits to providers such as acupuncturists and chiropractors. Little information is available to inform third-party payers' coverage policies regarding ongoing use of these therapies. This study offers contingent valuation-based estimates of patient willingness to pay (WTP) for pain reductions from a large (n = 1,583) sample of patients using ongoing chiropractic care to manage their chronic low back and neck pain. Average WTP estimates were $45.98 (45.8) per month per 1-point reduction in current pain for chronic low back pain and $37.32 (38.0) for chronic neck pain. These estimates met a variety of validity checks including that individuals' values define a downward-sloping demand curve for these services. Comparing these WTP estimates with patients' actual use of chiropractic care over the next 3 months indicates that these patients are likely "buying" perceived pain reductions from what they believe their pain would have been if they didn't see their chiropractor-that is, they value maintenance of their current mild pain levels. These results provide some evidence for copay levels and their relationship to patient demand, but call into question ongoing coverage policies that require the documentation of continued improvement or of experienced clinical deterioration with treatment withdrawal. PERSPECTIVE: This study provides estimates of reported WTP for pain reduction from a large sample of patients using chiropractic care to manage their chronic spinal pain and compares these estimates to what these patients do for care over the next 3 months, to inform coverage policies for ongoing care.

Researching the Appropriateness of Care in the Complementary and Integrative Health Professions Part 2: What Every Researcher and Practitioner Should Know About the Health Insurance Portability and Accountability Act and Practice-based Research in the United States.

OBJECTIVE: This paper describes a process for ensuring and documenting Health Insurance Portability and Accountability Act (HIPAA) compliance in clinical practice-based research. METHODS: The Center of Excellence for Research in Complementary and Alternative Medicine was funded by National Center for Complementary and Integrative Health to develop the methods for researching the appropriateness of care in complementary and integrative health, which previously was known as complementary and alternative medicine. We recruited 125 participating chiropractic clinics for enrolling patients and gathering their data via the online surveys. Chiropractic clinics completed the following: (1) obtained the files of patients who provided prior consent (the prospective sample), (2) obtained the files of the patients selected randomly using specified randomization procedures (the retrospective sample), and (3) transferred all patient data to the RAND Corporation via an encrypted file. RESULTS: Most of the doctors of chiropractic from clinical practices had no concerns about obtaining and transferring the files of patients who provided informed consent. However, some doctors were uneasy about allowing the researchers to access the randomly selected files of patients who had not provided prior authorization. This led us to develop a set of forms to provide clinics about HIPAA compliance. CONCLUSION: For this study, we provided clinics with information about the rules under HIPAA, demonstrated how the study complied with those rules, explained the logic behind the necessity for collecting files from both the prospective and retrospective samples, and, if requested, provided clinics with a confidentiality agreement signed by the study principal investigator and an organizational contracts representative. The process we developed may assist other complementary and integrative health researchers and practitioners in future studies.

Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial.

BACKGROUND: Low back pain is highly prevalent and one of the most common causes of disability in U.S. armed forces personnel. Currently, no single therapeutic method has been established as a gold standard treatment for this increasingly prevalent condition. One commonly used treatment, which has demonstrated consistent positive outcomes in terms of pain and function within a civilian population is spinal manipulative therapy provided by doctors of chiropractic. Chiropractic care, delivered within a multidisciplinary framework in military healthcare settings, has the potential to help improve clinical outcomes for military personnel with low back pain. However, its effectiveness in a military setting has not been well established. The primary objective of this study is to evaluate changes in pain and disability in active duty service members with low back pain who are allocated to receive usual medical care plus chiropractic care versus treatment with usual medical care alone. METHODS/DESIGN: This pragmatic comparative effectiveness trial will enroll 750 active duty service members with low back pain at three military treatment facilities within the United States (250 from each site) who will be allocated to receive usual medical care plus chiropractic care or usual medical care alone for 6 weeks. Primary outcomes will include the numerical rating scale for pain intensity and the Roland-Morris Disability Questionnaire at week 6. Patient reported outcomes of pain, disability, bothersomeness, and back pain function will be collected at 2, 4, 6, and 12 weeks from allocation. DISCUSSION: Because low back pain is one of the leading causes of disability among U.S. military personnel, it is important to find pragmatic and conservative treatments that will treat low back pain and preserve low back function so that military readiness is maintained. Thus, it is important to evaluate the effects of the addition of chiropractic care to usual medical care on low back pain and disability. TRIAL REGISTRATION: The trial discussed in this article was registered in ClinicalTrials.gov with the NCT01692275 Date of registration: 6 September 2012.

Counting the cost of negligence in neurosurgery: Lessons to be learned from 10 years of claims in the NHS.

INTRODUCTION: Despite substantial progress in modernising neurosurgery, the specialty still tops the list of medico-legal claims. Understanding the factors associated with negligence claims is vital if we are to identify areas of underperformance and subsequently improve patient safety. Here we provide data on trends in neurosurgical negligence claims over a 10-year period in England. METHODS: We used data provided by the National Health Service Litigation Authority to analyse negligence claims related to neurosurgery from the financial years 2002/2003 to 2011/2012. Using the abstracts provided, we extracted information pertaining to the underlying pathology, injury severity, nature of misadventure and claim value. RESULTS: Over the 10-year period, the annual number of claims increased significantly. In total, there were 794 negligence claims (range 50-117/year); of the 613 closed cases, 405 (66.1%) were successful. The total cost related to claims during the 10 years was £65.7 million, with a mean claim per successful case of £0.16 million (total damages, defence and claimant costs of £45.1, £6.36 and £14.3 million, respectively). Claims related to emergency cases were more costly compared to those of elective cases (£209,327 vs. £112,627; P=0.002). Spinal cases represented the most frequently litigated procedures (350; 44.1% of total), inadequate surgical performance the most common misadventure (231; 29.1%) and fatality the commonest injury implicated in claims (102; 12.8%). Negligence claims related to wrong-site surgery and cauda equina syndrome were frequently successful (26/26; 100% and 14/16; 87.5% of closed cases, respectively). CONCLUSION: In England, the number of neurosurgical negligence claims is increasing, the financial cost substantial, and the burden significant. Lessons to be learned from the study are of paramount importance to reduce future cases of negligence and improve patient care.

Economic analysis of complementary, alternative, and integrative medicine: considerations raised by an expert panel.

BACKGROUND: An international panel of experts was convened to examine the challenges faced in conducting economic analyses of Complementary, Alternative and Integrative Medicine (CAIM). METHODS: A one and a half-day panel of experts was convened in early 2011 to discuss what was needed to bring about robust economic analysis of CAIM. The goals of the expert panel were to review the current state of the science of economic evaluations in health, and to discuss the issues involved in applying these methods to CAIM, recognizing its unique characteristics. The panel proceedings were audiotaped and a thematic analysis was conducted independently by two researchers. The results were then discussed and differences resolved. This manuscript summarizes the discussions held by the panel members on each theme. RESULTS: The panel identified seven major themes regarding economic evaluation that are particularly salient to determining the economics of CAIM: standardization (in order to compare CAIM with conventional therapies, the same basic economic evaluation methods and framework must be used); identifying the question being asked, the audience targeted for the results and whose perspective is being used (e.g., the patient perspective is especially relevant to CAIM because of the high level of self-referral and out-of-pocket payment); the analytic methods to be used (e.g., the importance of treatment description and fidelity); the outcomes to be measured (e.g., it is important to consider a broad range of outcomes, particularly for CAIM therapies, which often treat the whole person rather than a specific symptom or disease); costs (e.g., again because of treating the whole person, the impact of CAIM on overall healthcare costs, rather than only disease-specific costs, should be measured); implementation (e.g., highlighting studies where CAIM allows cost savings may help offset its image as an "add on" cost); and generalizability (e.g., proper reporting can enable study results to be useful beyond the study sample). CONCLUSIONS: The business case for CAIM depends on economic analysis and standard methods for conducting such economic evaluations exist. The challenge for CAIM lies in appropriately applying these methods. The deliberations of this panel provide a list of factors to be considered in meeting that challenge.

US spending on complementary and alternative medicine during 2002-08 plateaued, suggesting role in reformed health system.

Complementary and alternative medicine services in the United States are an approximately $9 billion market each year, equal to 3 percent of national ambulatory health care expenditures. Unlike conventional allopathic health care, complementary and alternative medicine is primarily paid for out of pocket, although some services are covered by most health insurance. Examining trends in demand for complementary and alternative medicine services in the United States reported in the Medical Expenditure Panel Survey during 2002-08, we found that use of and spending on these services, previously on the rise, have largely plateaued. The higher proportion of out-of-pocket responsibility for payment for services may explain the lack of growth. Our findings suggest that any attempt to reduce national health care spending by eliminating coverage for complementary and alternative medicine would have little impact at best. Should some forms of complementary and alternative medicine-for example, chiropractic care for back pain-be proven more efficient than allopathic and specialty medicine, the inclusion of complementary and alternative medicine providers in new delivery systems such as accountable care organizations could help slow growth in national health care spending.

Comparative effectiveness research: does the emperor have clothes?

With the recent allocation ofa $1.1 billion "down payment" to fund comparative effectiveness research (CER) from the American Recovery and Reinvestment Act of 2009 (generally referred to as the stimulus package) and with $300 million being allocated for the Agency for Healthcare Research and Quality (AHRQ), $400 million for the National Institutes of Health, and $400 million for allocation at the discretion of the Secretary of Health and Human Services and with the National Center for Complementary Alternative Medicine putting out a request for research proposals for Comparative Effectiveness Studies of Complementary and Alternative Medicine, it is safe to say CER has entered a new era. CER solves two historical concerns for complementary and alternative medicine (CAM) researchers; first it focuses on effectiveness not efficacy; second it tests holistic approaches to care. Because it allows the providers to give care in any way they choose, it avoids the problem of reductionism inherent in standard random controlled trials. In CER, the provider can continue to practice holistically and to use individualized medicine to treat the patient. However, amid the largely positive responses to this move among researches in CAM, a more critical evaluation might be in order. This article argues that while the move to effectiveness research is a positive move for CAM, CER as currently being talked about and funded may just be a new form of privileging certain forms of evidence at the expense of other equally important and perhaps more relevant evidence.

Exploring socioeconomic disparities in self-reported oral health among adolescents in california.

BACKGROUND: Socioeconomic factors are associated with disparities in oral health among adolescents; however, the underlying reasons are not clear. The authors conducted a study to determine if known indicators of oral health can explain such disparities. METHODS: The authors examined data from a 2007 California Health Interview Survey of adolescents. The outcome of interest was self-reported condition of the teeth; covariates were socioeconomic status (SES) (that is, family poverty level and parental education) and a range of other variables representing health-influencing behaviors, dental care and other social factors. The authors conducted analyses by using logistic regression to explain disparities in self-reported condition of the teeth associated with SES. RESULTS: The authors found that socioeconomic disparities decreased substantially after they added all potential explanatory variables to the model, leaving poverty level as the only variable associated with differences in the self-reported condition of the teeth. Adolescents living below the federal poverty guidelines were more likely to report that the condition of their teeth was fair or poor than were adolescents who were least poor (odds ratio = 1.58; 95 percent confidence interval, 1.04-2.41). In multivariate analyses, further oral health disparities existed in relation to behaviors that influence health, social environment and dental care. CONCLUSIONS: The results of this study showed that a number of factors decreased, but did not eliminate, the observed relationship between SES and oral health in Californian adolescents. Most of these explanatory factors are modifiable, indicating that socioeconomic differences associated with oral health among adolescents may be amenable to change. Practice Implications. By promoting a healthy lifestyle (including healthy diet, exercise and regular dental attendance) and conveying to patients in languages other than English how to maintain oral health, dentists may be able to ameliorate the effects of socioeconomic disparities in oral health.

Patient-based outcome assessment instruments in acupuncture research.

BACKGROUND: Outcome assessment can support the therapeutic process by providing a way to track symptoms and functionality over time, providing insights to clinicians and patients, as well as offering a common language to discuss patient behavior/functioning. OBJECTIVES: In this article, we examine the patient-based outcome assessment (PBOA) instruments that have been used to determine outcomes in acupuncture clinical research and highlight measures that are feasible, practical, economical, reliable, valid, and responsive to clinical change. The aims of this review were to assess and identify the commonly available PBOA measures, describe a framework for identifying appropriate sets of measures, and address the challenges associated with these measures and acupuncture. Instruments were evaluated in terms of feasibility, practicality, economy, reliability, validity, and responsiveness to clinical change. METHODS: This study was a systematic review. A total of 582 abstracts were reviewed using PubMed (from inception through April 2009). RESULTS: A total of 582 citations were identified. After screening of title/abstract, 212 articles were excluded. From the remaining 370 citations, 258 manuscripts identified explicit PBOA; 112 abstracts did not include any PBOA. The five most common PBOA instruments identified were the Visual Analog Scale, Symptom Diary, Numerical Pain Rating Scales, SF-36, and depression scales such as the Beck Depression Inventory. CONCLUSIONS: The way a questionnaire or scale is administered can have an effect on the outcome. Also, developing and validating outcome measures can be costly and difficult. Therefore, reviewing the literature on existing measures before creating or modifying PBOA instruments can significantly reduce the burden of developing a new measure.

Radiologic follow-up of non-functioning pituitary adenomas: rationale and cost effectiveness.

Patients with non-functioning pituitary adenomas (NFPAs) are followed-up with serial endocrine, ophthalmologic and radiological assessment. There is a lack of evidence based guidance regarding the frequency and duration of radiological assessment during follow-up. We retrospectively analysed the details of follow-up radiological scanning in a cohort of patients diagnosed with NFPAs in an attempt to devise a rational and cost effective scanning schedule for use in routine clinical practice. 49 patients were identified using the hospital endocrine register. A detailed review of the case notes and follow up scans was undertaken. The data was analysed using descriptive statistics and Kaplan-Meier survival analysis using SPSS ver 13.0 (SPSS Inc. Chicago, IL). The time in which the tumor size in the followed up patients reached a state of 'no change' which persisted for at least two further scans was calculated. 41 patients, followed up for a median duration of 70 months were ultimately analysed. 33 patients had surgery while eight were conservatively managed. The time taken by 50% of tumors to achieve a steady state of 'no change' in tumor size on scans was 30 months. 90% of tumours achieved this state in 88 months. Surgical management did not significantly influence the time required to attain the steady state on a Kaplan-Meier analysis (Log rank test P = 0.06). NFPAs need extended follow-up since late recurrences after treatment are known. Routine radiologic follow up may be uneconomical after the steady state is achieved. Regular Goldmann perimetry beyond this time may be of greater use in selecting patients who actually need repeat surgical debulking. This method of follow up is likely to be more cost effective and reduce the number of scans performed.