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Purpose: The purpose of this report is to describe the development of a list of resources necessary to implement a model of care for the management of spine-related concerns anywhere in the world, but especially in underserved communities and low- and middle-income countries. Methods: Contents from the Global Spine Care Initiative (GSCI) Classification System and GSCI care pathway papers provided a foundation for the resources list. A seed document was developed that included resources for spine care that could be delivered in primary, secondary and tertiary settings, as well as resources needed for self-care and community-based settings for a wide variety of spine concerns (e.g., back and neck pain, deformity, spine injury, neurological conditions, pathology and spinal diseases). An iterative expert consensus process was used using electronic surveys. Results: Thirty-five experts completed the process. An iterative consensus process was used through an electronic survey. A consensus was reached after two rounds. The checklist of resources included the following categories: healthcare provider knowledge and skills, materials and equipment, human resources, facilities and infrastructure. The list identifies resources needed to implement a spine care program in any community, which are based upon spine care needs. Conclusion: To our knowledge, this is the first international and interprofessional attempt to develop a list of resources needed to deliver care in an evidence-based care pathway for the management of people presenting with spine-related concerns. This resource list needs to be field tested in a variety of communities with different resource capacities to verify its utility. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material.[Figure not available: see fulltext.].

The purpose of this report is to describe the development of an evidence-based care pathway that can be implemented globally. The Global Spine Care Initiative (GSCI) care pathway development team extracted interventions recommended for the management of spinal disorders from six GSCI articles that synthesized the available evidence from guidelines and relevant literature. Sixty-eight international and interprofessional clinicians and scientists with expertise in spine-related conditions were invited to participate. An iterative consensus process was used. After three rounds of review, 46 experts from 16 countries reached consensus for the care pathway that includes five decision steps: awareness, initial triage, provider assessment, interventions (e.g., non-invasive treatment; invasive treatment; psychological and social intervention; prevention and public health; specialty care and interprofessional management), and outcomes. The care pathway can be used to guide the management of patients with any spine-related concern (e.g., back and neck pain, deformity, spinal injury, neurological conditions, pathology, spinal diseases). The pathway is simple and can be incorporated into educational tools, decision-making trees, and electronic medical records. A care pathway for the management of individuals presenting with spine-related concerns includes evidence-based recommendations to guide health care providers in the management of common spinal disorders. The proposed pathway is person-centered and evidence-based. The acceptability and utility of this care pathway will need to be evaluated in various communities, especially in low- and middle-income countries, with different cultural background and resources. These slides can be retrieved under Electronic Supplementary Material. The Global Spine Care Initiative and this study were funded by grants from the Skoll Foundation and NCMIC Foundation. World Spine Care provided financial management for this project. The funders had no role in study design, analysis, or preparation of this paper. Sí

OBJECTIVE: The purpose of this review was to identify risk factors, prognostic factors, and comorbidities associated with common spinal disorders. METHODS: A scoping review of the literature of common spinal disorders was performed through September 2016. To identify search terms, we developed 3 terminology groups for case definitions: 1) spinal pain of unknown origin, 2) spinal syndromes, and 3) spinal pathology. We used a comprehensive strategy to search PubMed for meta-analyses and systematic reviews of case-control studies, cohort studies, and randomized controlled trials for risk and prognostic factors and cross-sectional studies describing associations and comorbidities. RESULTS: Of 3,453 candidate papers, 145 met study criteria and were included in this review. Risk factors were reported for group 1: non-specific low back pain (smoking, overweight/obesity, negative recovery expectations), non-specific neck pain (high job demands, monotonous work); group 2: degenerative spinal disease (workers' compensation claim, degenerative scoliosis), and group 3: spinal tuberculosis (age, imprisonment, previous history of tuberculosis), spinal cord injury (age, accidental injury), vertebral fracture from osteoporosis (type 1 diabetes, certain medications, smoking), and neural tube defects (folic acid deficit, anti-convulsant medications, chlorine, influenza, maternal obesity). A range of comorbidities was identified for spinal disorders. CONCLUSION: Many associated factors for common spinal disorders identified in this study are modifiable. The most common spinal disorders are co-morbid with general health conditions, but there is a lack of clarity in the literature differentiating which conditions are merely comorbid versus ones that are risk factors. Modifiable risk factors present opportunities for policy, research, and public health prevention efforts on both the individual patient and community levels. Further research into prevention interventions for spinal disorders is needed to address this gap in the literature. The Global Spine Care Initiative (GSCI) was funded by grants from the Skoll Foundation (www.skoll.org) and NCMIC Foundation (www.ncmicfoundation.org) (SH). World Spine Care provided financial management for the GSCI project. The grantors had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Open access funding for this study provided by Brighthall, Inc. BNG and CDJ are officers of Brighthall. Sí

Background Areca (betel) nut is considered a Group 1 human carcinogen shown to be associated with other chronic diseases in addition to cancer. This paper describes the areca (betel) nut chewing trend in Guam, and health behaviors of chewers in Guam and Saipan. Methods The areca (betel) nut module in the Guam Behavioral Risk Factor Surveillance Survey was used to calculate the 5-year (2011–2015) chewing trend. To assess the association between areca (betel) nut chewing and health risks in the Mariana Islands, a cross-section of 300 chewers, ≥18 years old, were recruited from households in Guam and Saipan. Self-reported socio-demographics, oral health behaviors, chronic disease status, diet, and physical activity were collected. Anthropometry was measured. Only areca (betel) nut-specific and demographic information were collected from youth chewers in the household. Results The 5-year areca (betel) nut chewing prevalence in Guam was 11% and increased among Non-Chamorros, primarily other Micronesians, from 2011 (7%) to 2015 (13%). In the household survey, most adult chewers (46%) preferred areca nut with betel leaf, slaked lime, and tobacco. Most youth chewers (48%) preferred areca nut only. Common adult chronic conditions included diabetes (14%), hypertension (26%), and obesity (58%). Conclusion The 5-year areca (betel) nut chewing prevalence in Guam is comparable to the world estimate (10–20%), though rising among Non-Chamorros. Adult and youth chewers may be at an increased risk for oral cancer. Adult chewers have an increased risk of other chronic health conditions. Cancer prevention and intervention strategies should incorporate all aspects of health.

Purpose: The purpose of this review was to synthesize literature on the burden of spinal disorders in rural communities to inform the Global Spine Care Initiative care pathway and model of care for their application in medically underserved areas and low- and middle-income countries. Methods: A systematic review was conducted. Inclusion criteria included all age groups with nonspecific low back pain, neck pain, and associated disorders, nonspecific thoracic spinal pain, musculoskeletal chest pain, radiculopathy, or spinal stenosis. Study designs included observational study design (case-control, cross-sectional, cohort, ecologic, qualitative) or review or meta-analysis. After study selection, studies with low or moderate risk of bias were qualitatively synthesized. Results: Of 1150 potentially relevant articles, 43 were eligible and included in the review. All 10 low and 18 moderate risk of bias studies were cross-sectional, 14 of which included rural residents only. All studies included estimates of low back pain prevalence, one included neck pain and one reported estimates for spinal disorders other than back or neck pain. The prevalence of low back pain appears greater among females and in those with less education, psychological factors (stress, anxiety, depression), and alcohol consumers. The literature is inconsistent as to whether back pain is more common in rural or urban areas. High risk of bias in many studies, lack of data on disability and other burden measures and few studies on conditions other than back and neck pain preclude a more comprehensive assessment of the individual and community-based burden of spinal disorders in less-developed communities. Conclusion: We identified few high-quality studies that may inform patients, providers, policymakers, and other stakeholders about spinal disorders and their burden on individuals and communities in most rural places of the developing world. These findings should be a call to action to devote resources for high-quality research to fill these knowledge gaps in medically underserved areas and low and middle-income countries. Graphical abstract: These slides can be retrieved under Electronic Supplementary Material. [Figure not available: see fulltext.].

The purpose of this review was to develop recommendations for the management of spinal disorders in low-income communities, with a focus on non-invasive pharmacological and non-pharmacological therapies for non-specific low back and neck pain. We synthesized two evidence-based clinical practice guidelines for the management of low back and neck pain. Our recommendations considered benefits, harms, quality of evidence, and costs, with attention to feasibility in medically underserved areas and low- and middle-income countries. Clinicians should provide education and reassurance, advise patients to remain active, and provide information about self-care options. For acute low back and neck pain without serious pathology, primary conservative treatment options are exercise, manual therapy, superficial heat, and nonsteroidal anti-inflammatory drugs (NSAIDs). For patients with chronic low back and neck pain without serious pathology, primary treatment options are exercise, yoga, cognitive behavioral therapies, acupuncture, biofeedback, progressive relaxation, massage, manual therapy, interdisciplinary rehabilitation, NSAIDs, acetaminophen, and antidepressants. For patients with spinal pain with radiculopathy, clinicians may consider exercise, spinal manipulation, or NSAIDs; use of other interventions requires extrapolation from evidence regarding effectiveness for non-radicular spinal pain. Clinicians should not offer treatments that are not effective, including benzodiazepines, botulinum toxin injection, systemic corticosteroids, cervical collar, electrical muscle stimulation, short-wave diathermy, transcutaneous electrical nerve stimulation, and traction. Guidelines developed for high-income settings were adapted to inform a care pathway and model of care for medically underserved areas and low- and middle-income countries by considering factors such as costs and feasibility, in addition to benefits, harms, and the quality of underlying evidence. The selection of recommended conservative treatments must be finalized through discussion with the involved community and based on a biopsychosocial approach. Decision determinants for selecting recommended treatments include costs, availability of interventions, and cultural and patient preferences. These slides can be retrieved under Electronic Supplementary Material.

This article summarizes relevant findings related to low back and neck pain from the Global Burden of Disease (GBD) reports for the purpose of informing the Global Spine Care Initiative. We reviewed and summarized back and neck pain burden data from two studies that were published in Lancet in 2016, namely: “Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015” and “Global, regional, and national disability-adjusted life years (DALYs) for 315 diseases and injuries and healthy life expectancy (HALE), 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015.” In 2015, low back and neck pain were ranked the fourth leading cause of disability-adjusted life years (DALYs) globally just after ischemic heart disease, cerebrovascular disease, and lower respiratory infection {low back and neck pain DALYs [thousands]: 94 941.5 [95% uncertainty interval (UI) 67 745.5–128 118.6]}. In 2015, over half a billion people worldwide had low back pain and more than a third of a billion had neck pain of more than 3 months duration. Low back and neck pain are the leading causes of years lived with disability in most countries and age groups. Low back and neck pain prevalence and disability have increased markedly over the past 25 years and will likely increase further with population aging. Spinal disorders should be prioritized for research funding given the huge and growing global burden. These slides can be retrieved under Electronic Supplementary Material.

Despite high asthma prevalence, relatively little is known about the epidemiology of asthma in Hawaii or among Native Hawaiian/Other Pacific Islanders (NHOPI). We sought to better characterize racial/ethnic differences in asthma prevalence and in sociodemographic factors associated with asthma among Hawaii adults.We conducted multivariable logistic regression using 2001-2010 Behavioral Risk Factor Surveillance System data from Hawaii, and computed adjusted prevalence and ratios.Asthma prevalence markedly varied between self-identified census categories of race in Hawaii, with NHOPI having the highest estimates of both lifetime (20.9%, 95% confidence interval [CI]: 19.5%-22.4%) and current (12.2%, CI: 11.2%-13.3%) asthma. Highest asthma prevalence among NHOPI persisted after controlling for potential confounders and within most sociodemographic categories. Among females Asians reported the lowest asthma prevalence, whereas among males point estimates of asthma prevalence were often lowest for Whites. Females often had greater asthma prevalence than males of the same race, but the degree to which gender modified asthma prevalence differed by both race and sociodemographic strata. Gender disparities in asthma prevalence were greatest and most frequent among Whites, and for current asthma among all races. Sociodemographic factors potentially predictive of adult asthma prevalence in Hawaii varied by race and gender.Asthma disproportionately affects or is recognized more often among women and NHOPI adults in Hawaii, and occurs less or is under-reported among Asian women. The sociodemographic characteristics included in this study's model did not explain asthma disparities between races and/or gender. This investigation provides a baseline with which to plan additionally needed prevention programs, epidemiological investigations, and surveillance for asthma in Hawaii.

Introduction Spinal manipulation therapy (SMT) is used throughout the world by chiropractors, osteopaths, physiotherapists and other manual therapists, yet there are no systematic data collection mechanisms in place to monitor and evaluate adverse events (AE) that occur after SMT. We established a reporting and learning system (“SafetyNet”) to fill this void and to address several aims, one of which is a prospective population-based active surveillance study to (a) document AE after SMT, (b) identify potential risk factors, and (c) develop potential strategies to mitigate risk. The purpose of this paper is to describe the development and validation of provider and patient measurement instruments to identify potential SMT AE in provider offices. Methods Instrument development and validation occurred in a step-wise fashion: (1) definition of terms (e.g. adverse event, seriousness); (2) identification and development of key domains, items, and sub-items; and (3) assessment of relevant measurement properties. Results Two provider short instruments, a provider long instrument, and a pre and post treatment patient comment instruments were developed, refined, and pilot tested with 12 providers and 300 patients. Conclusions The development and validation of instruments to evaluate SMT AEs may benefit the SMT research community as well as clinicians and their patients by providing rigorous prospective assessment of potential SMT-related AEs and their risk factors, thus enhancing patient safety and the promotion of a safety culture. Placing the instruments in providers’ offices for use on consecutive patients is next on the SafetyNet research agenda.

The World Spine Care (WSC), established by volunteers from 5 continents, is dedicated to providing sustainable, evidencebased spine care to individuals and communities in low and middle-income countries consistent with available health-care resources and integrated within the local culture. The research committee approves and oversees the WSC's collaborative research and training projects worldwide and serves to create a sustainable research community for underserved populations focused on preventing disability from spinal disorders. The purpose of this article is to describe 4 projects overseen by the WSC research committee and to discuss several challenges and specific facilitators that allowed successful completion of initiatives. These novel projects, which involved establishing spine surgery expertise and data collection in the WSC clinics and surrounding communities, all met their aims. This was achieved by overcoming language and resource challenges, adapting to local customs, and taking time to build mutual respect and to nurture relationships with local investigators and stakeholders.

Background: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is a growth factor known to have in vitro effects on the growth and invasiveness of cancer. It has been approved by the U.S. Food and Drug Administration in limited doses for single-level anterior spinal arthrodesis, but it is commonly used off-label and at high doses. The effect of rhBMP-2 on the risk of cancer has been a concern. We sought to evaluate the risk of new cancers in patients receiving high-dose rhBMP-2. Methods: We used publicly available data from a pivotal, multicenter, randomized controlled trial of patients with degenerative lumbar spine conditions who underwent a single-level instrumented posterolateral arthrodesis with either high-dose rhBMP-2 in a compression-resistant matrix (CRM) (rhBMP-2/CRM; n = 239) or autogenous bone graft (control group; n = 224). We compared the risks of new cancers in the rhBMP-2/CRM and control groups at two and five years after surgery. Results: At two years, with 86% follow-up, there were fifteen new cancer events in eleven patients in the rhBMP-2/CRM group compared with two new cancer events in two patients in the control group treated with autogenous bone graft. The incidence rate of new cancer events per 100 person-years was 3.37 (95% confidence interval [CI], 1.89 to 5.56) in the rhBMP-2/CRM group at two years compared with 0.50 (95% CI, 0.06 to 1.80) in the control group. The incidence rate ratio was 6.75 (95% CI, 1.57 to 60.83; p = 0.0026) at two years. Calculated in terms of the number of patients with one or more cancer events two years after the surgery, the incidence rate per 100 person-years was 2.54 (95% CI, 1.27 to 4.54) in the rhBMP-2/CRM group compared with 0.50 (95% CI, 0.06 to 1.82) in the control group at two years; the incidence rate ratio was 5.04 (95% CI, 1.10 to 46.82; p = 0.0194). At five years, there was a 37% loss of follow-up, but a significantly greater incidence of cancer events was still observed in the rhBMP-2/CRM group. Conclusions: A high dose of 40 mg of rhBMP-2/CRM in lumbar spinal arthrodesis was associated with an increased risk of new cancer. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Breastfeeding is considered the best infant feeding method, yet initiation and duration rates in the United States are lower than recommended by medical and public health professionals. Positive attitudes toward breastfeeding of the male partner are important in a mother's success at initiating and maintaining breastfeeding. This study measured the infant feeding attitudes of low-income women and their male partners using the Iowa Infant Feeding Attitude Scale (IIFAS), investigated the reliability and validity of the measure in male partners, and examined the associations of the partner's attitudes with the mother's attitudes and intention to breastfeed. A convenience sample of 112 pregnant women and their male partners completed a survey including sociodemographic items, the IIFAS, and their intended infant feeding method in the hospital and in the first few weeks after the infant's birth (breastfeeding, formula feeding, mixed, and don't know). Mother's and partner's IIFAS scores were highly correlated, and higher scores of both mothers and partners were significantly associated with their intentions to breastfeed. With each increased point on mother's and partner's IIFAS scores, the odds that the mother and her partner intended to breastfeed in the first few weeks increased 12% and 20%, respectively. This is the first U.S. study to validate the IIFAS with male partners. Future research on breastfeeding attitudes and attitude-changing interventions is needed to see if improving partners' attitudes toward breastfeeding will also improve mothers' attitudes and if that increases initiation and duration of breastfeeding.

Background context Retrograde ejaculation (RE) is a complication of anterior lumbar interbody fusion (ALIF) techniques. Most commonly, this results from mechanical or inflammatory injury to the superior hypogastric plexus near the aortic bifurcation. Bone morphogenetic protein-2 (BMP-2) has been used in spinal fusions and has been associated with inflammatory and neuroinflammatory adverse reactions, which may contribute to RE development after anterior lumbar surgery. Purpose While controlling for anterior approach technique, we compared the incidence of RE with and without rhBMP-2 exposure, in large, matched cohorts of patients after ALIF. Study design Retrospective analysis of 10 years of prospectively gathered outcomes data on consecutive-patient cohorts having the same anterior exposure technique for ALIF with and without rhBMP-2 use. Patient sample All male patients without baseline sexual incapacity and having ALIF for lumbar spondylosis or spondylolisthesis of the lowest one or two lumbar levels with and without rhBMP-2, from 2002 through 2011. Outcome measures Diagnosis of RE as a new finding after ALIF compared against BMP-2 exposure, comorbid conditions, and other urological complications after ALIF surgery. Methods From the comprehensive surgical database at a high volume, university practice, male subjects having ALIF at one (L5/S1) or two levels (L4/5, L5/S1) from 2002 to 2011 were identified. Baseline comorbid factors, postoperative urinary catheter/retention events, and RE events were recorded and comparative incidence compared. Results There were four consecutive-patient cohorts identified: one before rhBMP-2 use was adopted (n=174), two cohorts in which BMP-2 use was routine (n=88 and n=151), and one final cohort after BMP-2 use was discontinued from routine use (n=59). The cohorts with and without BMP-2 exposure were closely comparable for age, approach, levels of surgery, comorbid factors affecting RE. Of 239 patients with ALIF and exposure to BMP-2, RE was diagnosed in 15 subjects (6.3%), compared with an RE diagnosis rate of two of 233 control patients without BMP-2 exposure (0.9%; p=.0012). Urinary retention after bladder catheter removal was also more frequently observed in patients exposed to BMP-2 (9.7%) compared with control patients (4.6%; p=.043). Of the baseline comorbid factors, medical or surgical treatment for prostatic hypertrophy disease was associated with an increased risk of RE in the BMP-2 patients (p=.034). Conclusions This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2 and an open anterior approach to the spine. This effect may be associated with an increased risk of postoperative urinary retention after BMP-2 exposure. The magnitude of the RE effect may be increased with concomitant prostatic disease treatments.

Spinal disorders and especially back and neck pain affect more people and have greater impact on work capacity and health-care costs than any other musculoskeletal condition. One of the difficulties in reducing the burden of spinal disorders is the wide and heterogeneous range of specific diseases and non-specific musculoskeletal disorders that can involve the spinal column, most of which manifest as pain. Despite, or perhaps because of its impact, spinal disorders remain one of the most controversial and difficult conditions for clinicians, patients and policymakers to manage. This paper provides a brief summary of advances in the understanding of back and neck pain over the past decade as evidenced in the current literature. This paper includes the following sections: a classification of spinal disorders; the epidemiology of spine pain in the developed and developing world; key advancements in biological and biomechanical sciences in spine pain; the current status of potential methods for the prevention of back and neck pain; rheumatological and systemic disorders that impact the spine; and evidence-based surgical and non-surgical management of spine pain. The final section of this paper looks to the future and proposes actions and strategies that may be considered by the international Bone and Joint Decade (BJD), by providers, institutions and by policymakers so that we may better address the burden of spine disorders at global and local levels.

Factors at birth and infancy may increase risk of being overweight in childhood. The aim of this study was to examine the relationship of birth size and infant growth (2-24 months) with BMI at age 5 years in a multiethnic population.This was a retrospective study (using electronic medical records of a health maintenance organization in Hawaii) of singleton children born in 2004-2005, with linked maternal and birth information, infant weights (n = 597) and lengths (n = 473) in the first 2 years, and BMI measures at age 5 years (n = 894). Multiple regression models were used to estimate the association of BMI at age 5 years with birth size and infant growth.Birth weight was positively associated with BMI at age 5 years, adjusting for gestational age, sex, race/ethnicity, and maternal prepregnancy weight, age, education, and smoking. A greater change in infant weight was associated with a higher BMI at age 5 years, though the effect of birth weight on BMI was neither mediated nor modified by infant growth rate. Birth weight, change in infant weight, and BMI at age 5 years varied by race/ethnicity. Change in infant BMI in the first 2 years was higher in other Pacific Islanders and whites (Δ = 0.966; confidence interval [CI] = 0.249-1.684; p = 0.02) than in Asian, other, and part Native Hawaiian race/ethnic groups.Early biological measures of birth weight and infant weight gain varied by race/ethnicity and positively predicted BMI at age 5 years.

The world lacks sustainable models of care to manage spinal disorders in poor and underserved communities. The purpose of this article is to: (1) review the rationale and importance of developing a sustainable evidence-based model of care at low cost for people with spinal disorders in underserved and poor communities, and (2) describe the process and challenges of establishing such a program in these communities. Given that burden of disease studies rank spinal disorders among the leading causes of disability and the finding that low-income countries have much need but few resources for delivering adequate care, World Spine Care (WSC) was established to "improve lives in underserved communities through sustainable, integrated, evidence-based, spinal care." WSC is comprised of volunteers and institutions from 6 continents and several countries, and incorporates a Board of Directors, an executive committee, a clinical team and a research committee. WSC opened its first clinic in 2012 in Botswana, and now has a clinic in the Dominican Republic and a memorandum of understanding to open a clinic in Tanzania. Clinical programs, research projects, and education-based capacity-building initiatives are adapted to and integrated within each community in collaboration with local decision makers, existing health care workers and traditional healers. Cornerstones of WSC's emphasis on long-term sustainability are (1) education of community partners, governments and local health professionals, and (2) facilitation of opportunities for training graduate students in a variety of health-related fields. World Spine Care has (a) recognized the enormous need to establish clinical programs aimed at easing the suffering and disability associated with spinal disorders in resource-poor communities, (b) shown widespread support for an organization devoted to reducing the global burden of disease caused by spinal disorders, and (c) shown that establishing successful evidence-based, culturally appropriate programs in cooperation with local governments and communities are possible. Challenges remain, but with sound leadership, research and a model of care, there is an opportunity to help reduce the burden of the leading cause of disability in the world.

Objective The purposes of this study were to investigate whether a screening procedure could capture important psychologic factors with minimum burden to the patient and to investigate whether correlations exist among the various psychologic factors. Methods A screening procedure consisting of the 11-item Tampa Scale for Kinesiophobia, a 2-question coping strategies screen, and the depression and anxiety subscales of the Bournemouth Disability Questionnaire was provided to consecutive patients with neck pain (NP) or low back pain (LBP) as part of the usual initial assessment process at a busy spine center, which includes chiropractic and physical therapy. Correlations and associations between these variables were determined. Results Data were collected on 95 patients with NP and 260 patients with LBP. Statistically significant correlations and associations were found between all measures in both cohorts with the exception of depression and coping in patients with NP. Statistically significant associations were found among all measures in both cohorts with the exception of depression and coping and coping and fear in patients with NP. Conclusion This study showed that a screening procedure may provide useful clinical information regarding psychologic factors that are of potential relevance in patients with NP and LBP.

Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight.To compare the conclusions regarding the safety and related efficacy published in the original rhBMP-2 industry-sponsored trials with subsequently available Food and Drug Administration (FDA) data summaries, follow-up publications, and administrative and organizational databases.Systematic review.Results and conclusions from original industry-sponsored rhBMP-2 publications regarding safety and related efficacy were compared with available FDA data summaries, follow-up publications, and administrative and organizational database analyses.There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efficacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. No rhBMP-2-associated adverse events (0%) were reported in any of these studies (99% confidence interval of adverse event rate0.5%). The study designs of the industry-sponsored rhBMP-2 trials for use in posterolateral fusions and posterior lateral interbody fusion were found to have potential methodological bias against the control group. The reported morbidity of iliac crest donor site pain was also found to have serious potential design bias. Comparative review of FDA documents and subsequent publications revealed originally unpublished adverse events and internal inconsistencies. From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. Anterior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. Posterior lumbar interbody fusion use was associated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. In posterolateral fusions, the risk of adverse effects associated with rhBMP-2 use was equivalent to or greater than that of iliac crest bone graft harvesting, and 15% to 20% of subjects reported early back pain and leg pain adverse events; higher doses of rhBMP-2 were also associated with a greater apparent risk of new malignancy.Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications.

Background Context The commercially available growth factor recombinant bone morphogenic protein-2 (rhBMP-2) used in spinal fusion has been associated with numerous adverse reactions, including inflammatory reactions in soft tissue, heterotopic bone formation, radiculitis, osteolysis, and cage or graft subsidence. The original Food and Drug Administration Summary of anterior lumbar interbody fusion (ALIF) reported 12 retrograde ejaculation (RE) events (8%) in the rhBMP-2 groups compared with (1.4%) in the control group. It had been debated whether this finding was related to rhBMP-2 use. Purpose To compare the incidence of RE after ALIF in patients with and without rhBMP-2 use. Study design Retrospective analysis of prospectively gathered outcomes data on consecutive subjects having ALIF with and without rhBMP-2 use. Patient sample Male patients with lumbar spondylosis or spondylolisthesis having ALIF of the lowest one or two lumbar levels with and without rhBMP-2. Outcome measure Report of RE as a new finding after ALIF. Methods From the comprehensive outcome database at a high-volume university practice, male subjects having ALIF for one- (L5/S1) or two-level (L4/L5, L5/S1) lumbar fusion were identified. Retrograde ejaculation events were recorded and comparative incidence compared. Results The two groups were comparable for age and additional procedures performed. There were 69 L5/S1 ALIFs performed with rhBMP-2 and 174 ALIFs performed without rhBMP-2 during the study period. Of those, 24 and 64 were two-level ALIFs performed with and without rhBMP-2, respectively. There were five RE events (7.2%) reported in the rhBMP-2 group and 1 (0.6%) in the control group. Comparing single-level L5/S1 ALIF, there was a 6.7% and 0% rate of RE in the rhBMP-2 versus control groups, respectively. At 1 year after surgery, three of six affected subjects reported resolution of the RE. Conclusion This study confirms previous reports of a higher rate of RE in ALIF procedures using rhBMP-2. This may be an important consideration in subjects concerned with sterility after surgery.

COMMENTARY ON Singh K, Nandyala SV, Marquez-Lara A, et al. A perioperative cost analysis comparing single-level minimally invasive and open transforaminal lumbar interbody fusion. Spine J 2014;14:1694–701 ( in this issue ).

BACKGROUND CONTEXT Spinal disorders contribute to the global burden of disease and are especially burdensome for medically underserved communities and low- and middle-income countries (LMIC). A model of care (MoC) that could be implemented in these regions may help to relieve this burden. PURPOSE The purpose of this study was to develop a MoC for spine-related complaints that could be implemented globally, especially in medically underserved areas and LMICs. A secondary purpose was to develop recommendations to implement this MoC at a local level. STUDY DESIGN/SETTING Expert consensus. METHODS The Global Spine Care Initiative (GSCI) development team applied an evidence-based and expert consensus process to develop a MoC. A seed document was created by the lead authors using published GSCI papers to inform the process, which included a classification of spine-related complaints, a spine care pathway, resources lists to deliver primary or secondary or tertiary spine care. Evidence-based papers by the GSCI on the topics of rural health, psychological and social factors for spine pain, prevention strategies, assessment of spine-complaints, noninvasive and invasive treatments for spine disorders also informed this process. An international and multidisciplinary team of 70 experts were invited. Survey invitations were sent through Survey Monkey. Each expert who accepted the invitation reviewed and provided input to the MoC. The document was revised and the revision was redistributed for additional review and input. Items with no change requests were classified as ‘agreement.’ The document was revised further and the final draft was agreed upon by all coauthors after three consensus rounds. RESULTS Sixty-six experts participated, representing 23 countries, major geographic regions, a wide range of professional roles, and organization types from across the continuum of care. The GSCI MoC principles include: biopsychosocial approach, person and patient-centered care, multifactorial and functional values, best practices, collaboration among participants, proactive health care, obtaining health metrics, and that it should be self-sustaining. The model is tiered to address the variety of needs of the local community: self-care and community preventive care (needs of the majority), primary spine care (needs of many), secondary spine care (needs of some), and tertiary spine care (needs of few). Each level of spine care is integrated with the other to conserve resources so the patient receives the best possible care. The implementation recommendations include: identifying spine care needs in the local community, establishing a feasible plan, small scale implementation then full implementation and program evaluation. These flexible steps can be applied in a variety of settings and are especially well-suited to areas with low resources. The model and implementation strategies are compatible with the World Health Organization global strategy on integrated and people-centered health services and are applicable specifically to spine care. CONCLUSIONS The GSCI MoC offers a practical model for spine care that may be implemented in any region but especially in underserved areas. The eight transformative principles assist with the implementation of the MoC. Due to the flexibility and recommendations for local-engagement of the implementation plan, this model also has the potential for scaling up.

Purpose To elicit neck pain (NP) patients’ preference scores for their current health, and investigate the association between their scores and NP disability. Methods Rating scale scores (RSs) and standard gamble scores (SGs) for current health were elicited from chronic NP patients (n = 104) and patients with NP following a motor vehicle accident (n = 116). Patients were stratified into Von Korff Pain Grades: Grade I (low-intensity pain, few activity limitations); Grade II (high-intensity pain, few activity limitations); Grade III (pain with high disability levels, moderate activity limitations); and Grade IV (pain with high disability levels, several activity limitations). Multivariable regression quantified the association between preference scores and NP disability. Results Mean SGs and RSs were as follows: Grade I patients: 0.81, 0.76; Grade II: 0.70, 0.60; Grade III: 0.64, 0.44; Grade IV: 0.57, 0.39. The association between preference scores and NP disability depended on type of NP and preference-elicitation method. Chronic NP patients’ scores were more strongly associated with depressive symptoms than with NP disability. In both samples, NP disability explained little more than random variance in SGs, and up to 51% of variance in RSs. Conclusion Health-related quality-of-life is considerably diminished in NP patients. Depressive symptoms and preference-elicitation methods influence preference scores that NP patients assign to their health.

Dietary indexes to assess accordance with the Dietary Approaches to Stop Hypertension (DASH) dietary pattern are useful tools in studies with health-related outcomes. However, scoring algorithms of the dietary index can affect the range of its applications.The purposes of this study were to develop a DASH dietary index with calorie-based standards in equivalent units and to evaluate the validity and reliability of the index.Calorie-based standards for nine components were determined based on recommended intakes in the DASH eating plan and dietary intakes estimated from two 24-hour dietary recalls of adult participants in the National Health and Nutrition Examination Survey 2007-2008, 2009-2010 (n=9,720). Evaluation tests included descriptive analyses of index scores among US adults stratified by sex and smoking status. Spearman's rank correlations were used to examine the relationships among components and total scores. The developed index was compared with two DASH dietary indexes that use different scoring algorithms to examine the association between total scores and blood pressure status through multivariable regression models.The newly developed index consisted of seven food group and two nutrient components. The mean and median of total scores among US adults were 42.3 (95% CI 41.6 to 43.0) and 41.6 of 90 points, respectively. The mean total scores among adult women and non-current smokers were higher than their counterparts (P0.001). The absolute correlation coefficients among the components and between each component and the sum of other components were ≤0.33 and ≤0.35, respectively. After adjusting for age and race/ethnicity, an association between total scores and blood pressure status was found in adult women (P0.001), but not in adult men. The same pattern was found when the two indexes were used, but the strength of the association varied across the three indexes.The developed index appeared to measure accordance with the DASH dietary pattern based on the dietary data from US adults. Further studies are warranted for various applications of the index.

Objective This study presents the outcomes of patients with lumbar radiculopathy secondary to disk herniation treated after a diagnosis-based clinical decision rule. Methods A prospective observational cohort study was conducted at a multidisciplinary, integrated clinic that includes chiropractic and physical therapy health care services. Data on 49 consecutive patients were collected at baseline, at the end of conservative, nonsurgical treatment and a mean of 14.5 months after cessation of treatment. Disability was measured using the Bournemouth Disability Questionnaire (BDQ) and pain using the Numerical Rating Scale for pain. Fear beliefs were measured with the Fear-Avoidance Beliefs Questionnaire (FABQ). Patients also self-rated improvement. Results Mean duration of complaint was 60.5 weeks. Mean self-rated improvement at the end of treatment was 77.5%. Improvement was described as “good” or “excellent” in nearly 90% of patients. Mean percentage improvement on the BDQ was 60.4%. Numerical Rating Scale improved 4.1 points and FABQ improved 4.8 points. Clinically meaningful improvements in pain and disability were seen in 79% and 70% of patients, respectively. Mean number of visits was 13.2. After an average long-term follow-up of 14.5 months, mean self-rated improvement was 81.1%. “Good” or “excellent” improvement was reported by 80% of patients. Mean percentage improvement in BDQ was 67.4%. Numerical Rating Scale improved 4.2 points and FABQ 4.5 points. Clinically meaningful improvements in pain and disability were seen in 79% and 73% of patients, respectively. Conclusions Management based on the decision rule yielded favorable outcomes in this cohort study. Improvement appeared to be maintained over the long term.

Objective The purpose of this study was to describe the clinical outcomes of patients with pregnancy-related lumbopelvic pain (PRLP) treated according to a diagnosis-based clinical decision rule. Methods This was a prospective observational cohort of consecutive patients with PRLP. Data on 115 patients were collected at baseline and on 78 patients at the end of the active treatment. Disability was measured using the Bournemouth Disability Questionnaire (BDQ). Pain intensity was measured using the Numerical Rating Scale for pain (NRS). Patients were also asked to self-rate their improvement. Care was provided by a chiropractic physician/physical therapist team. Results Fifty-seven patients (73%) reported their improvement as either “excellent” or “good.” The mean patient-rated improvement was 61.5%. The mean improvement in BDQ was 17.8 points. The mean percentage of improvement in BDQ was 39% and the median was 48%. Mean improvement in pain was 2.9 points. Fifty-one percent of the patients had experienced clinically significant improvement in disability and 67% patients had experienced clinically significant improvement in pain. Patients were seen an average 6.8 visits. Follow-up data for an average of 11 months after the end of treatment were collected on 61 patients. Upon follow-up, 85.5% of patients rated their improvement as either “excellent” or “good.” The mean patient-rated improvement was 83.2%. The mean improvement in BDQ was 28.1 points. The mean percentage of improvement in BDQ was 68% and the median was 87.5%. Mean improvement in pain was 3.5 points. Seventy-three percent of the patients had experienced clinically significant improvement in disability and 82% patients had experienced clinically significant improvement in pain. Conclusions The management strategy used in this study appeared to yield favorable outcomes in this patient population and appears to be a safe option for patients with PRLP, although because of this study's sample size, rare complications are not likely to be detected. In addition, the absence of randomization and a control group limits interpretation with regard to clinical effectiveness. Randomized, controlled trials are necessary to distinguish treatment effects from the natural history of PRLP.

Study Design. Prospective, match-cohort study of disc degeneration progression over 10 years with and without baseline discography. Objectives. To compare progression of common degenerative findings between lumbar discs injected 10 years earlier with those same disc levels in matched subjects not exposed to discography. Summary of Background Data. Experimental disc puncture in animal and in vivo studies have demonstrated accelerated disc degeneration. Whether intradiscal diagnostic or treatment procedures used in clinical practice causes any damage to the punctured discs over time is currently unknown. Methods. Seventy-five subjects without serious low back pain illness underwent a protocol MRI and an L3/4, L4/5, and L5/S1 discography examination in 1997. A matched group was enrolled at the same time and underwent the same protocol MRI examination. Subjects were followed for 10 years. At 7 to 10 years after baseline assessment, eligible discography and controlled subjects underwent another protocol MRI examination. MRI graders, blind to group designation, scored both groups for qualitative findings (Pfirrmann grade, herniations, endplate changes, and high intensity zone). Loss of disc height and loss of disc signal were measured by quantitative methods. Results. Well matched cohorts, including 50 discography subjects and 52 control subjects, were contacted and met eligibility criteria for follow-up evaluation. In all graded or measured parameters, discs that had been exposed to puncture and injection had greater progression of degenerative findings compared to control (noninjected) discs: progression of disc degeneration, 54 discs (35%) in the discography group compared to 21 (14%) in the control group (P = 0.03); 55 new disc herniations in the discography group compared to 22 in the control group (P = 0.0003). New disc herniations were disproportionately found on the side of the anular puncture (P = 0.0006). The quantitative measures of disc height and disc signal also showed significantly greater loss of disc height (P = 0.05) and signal intensity (P = 0.001) in the discography disc compared to the control disc. Conclusion. Modern discography techniques using small gauge needle and limited pressurization resulted in accelerated disc degeneration, disc herniation, loss of disc height and signal and the development of reactive endplate changes compared to match-controls. Careful consideration of risk and benefit should be used in recommending procedures involving disc injection.

Postpartum depression affects 10-20% of women and causes significant morbidity and mortality among mothers, children, families, and society, but little is known about postpartum depression among the individual Asian and Pacific Islander racial/ethnic groups. This study sought to indentify the prevalence of postpartum depression among common Asian and Pacific Islander racial/ethnic groups. Data from the Hawaii Pregnancy Risk Assessment and Monitoring System (PRAMS), a population-based surveillance system on maternal behaviors and experiences before, during, and after the birth of a live infant, were analyzed from 2004 through 2007 and included 7,154 women. Questions on mood and interest in activities since giving birth were combined to create a measure of Self-reported Postpartum Depressive Symptoms (SRPDS). A series of generalized logit models with maternal race or ethnicity adjusted for other sociodemographic characteristics evaluated associations between SRPDS and an intermediate level of symptoms as possible indicators of possible SRPDS. Of all women in Hawaii with a recent live birth, 14.5% had SRPDS, and 30.1% had possible SRPDS. The following Asian and Pacific Islander racial or ethnic groups were studied and found to have higher odds of SRPDS compared with white women: Korean (adjusted odds ratio [AOR] = 2.8;95% confidence interval [CI]: 2.0-4.0), Filipino (AOR = 2.2;95% CI: 1.7-2.8), Chinese (AOR = 2.0;95% CI: 1.5-2.7), Samoan (AOR = 1.9;95% CI: 1.2-3.2), Japanese (AOR = 1.6;95% CI: 1.2-2.2), Hawaiian (AOR = 1.7;95% CI: 1.3-2.1), other Asian (AOR = 3.3;95% CI: 1.9-5.9), other Pacific Islander (AOR = 2.2;95% CI: 1.5-3.4), and Hispanic (AOR = 1.9;95% CI: 1.1-3.4). Women who had unintended pregnancies (AOR = 1.4;95% CI: 1.2-1.6), experienced intimate partner violence (AOR = 3.7;95% CI: 2.6-5.5), smoked (AOR = 1.5;95% CI: 1.2-2.0), used illicit drugs (AOR = 1.9;95% CI: 1.3-3.9), or received Women, Infant, and Children (WIC) benefits during pregnancy (AOR = 1.4;95% CI: 1.2-2.6) were more likely to have SRPDS. Several groups also were at increased risk for possible SRPDS, although this risk was not as prominent as seen with the risk for SRPDS. One in seven women reported SRPDS, and close to a third reported possible SRPDS. Messages about postpartum depression should be incorporated into current programs to improve screening, treatment, and prevention of SRPDS for women at risk.

Objective The most widely used neck-specific measure in intervention trials is the 10-item Neck Disability Index (NDI), which is assumed to be a unidimensional interval scale, as shown by how NDI data are scored, analyzed, and interpreted. Our objective was to use modern measurement methods to test this assumption (and thereby to also test the validity of calculating summed scores and parametric statistics on NDI data) through Rasch analysis. Methods NDI data from 521 trial subjects with neck pain were fit to the Rasch model. We examined threshold ordering of NDI items, fit of data to model expectations, presence of differential item functioning, and whether or not the set of NDI items collectively measure a single construct, which is a requirement for calculating summative scores. Results There was a lack of fit of data to the Rasch model (χ2 = 140.35, 70 df; P < 0.001). Five items (personal care, lifting, headaches, work, and recreation) had disordered response thresholds. Differential item functioning was detected for age and sex. The NDI items did not contribute to a single construct. Unidimensionality and interval scaling were achieved by removing 2 of the 10 items (resulting in the NDI-8), and converting NDI-8 ordinal (paper) summative scores to NDI-8 interval (Rasch-weighted) scores. Conclusion As originally proposed and conventionally used, the NDI is not a unidimensional scale, and has only ordinal scaling. This raises fundamental doubts about the practice of calculating change scores and other parametric statistics on NDI data. A revised 8-item version provides unidimensional interval-level measurement of neck pain disability.

Study Design Best evidence synthesis. Objective To undertake a best evidence synthesis on the burden and determinants of whiplash-associated disorders (WAD) after traffic collisions. Summary of Background Data Previous best evidence synthesis on WAD has noted a lack of evidence regarding incidence of and risk factors for WAD. Therefore there was a warrant of a reanalyze of this body of research. Methods A systematic search of Medline was conducted. The reviewers looked for studies on neck pain and its associated disorders published 1980–2006. Each relevant study was independently and critically reviewed by rotating pairs of reviewers. Data from studies judged to have acceptable internal validity (scientifically admissible) were abstracted into evidence tables, and provide the body of the best evidence synthesis. Results The authors found 32 scientifically admissible studies related to the burden and determinants of WAD. In the Western world, visits to emergency rooms due to WAD have increased over the past 30 years. The annual cumulative incidence of WAD differed substantially between countries. They found that occupant seat position and collision impact direction were associated with WAD in one study. Eliminating insurance payments for pain and suffering were associated with a lower incidence of WAD injury claims in one study. Younger ages and being a female were both associated with filing claims or seeking care for WAD, although the evidence is not consistent. Preliminary evidence suggested that headrests/car seats, aimed to limiting head extension during rear-end collisions had a preventive effect on reporting WAD, especially in females. Conclusion WAD after traffic collisions affects many people. Despite many years of research, the evidence regarding risk factors for WAD is sparse but seems to include personal, societal, and environmental factors. More research including, well-defined studies with accurate denominators for calculating risk, and better consideration of confounding factors, are needed.

Study Design Best evidence synthesis. Objective To identify, critically appraise, and synthesize literature from 1980 through 2006 on noninvasive interventions for neck pain and its associated disorders. Summary of Background Data No comprehensive systematic literature reviews have been published on interventions for neck pain and its associated disorders in the past decade. Methods We systematically searched Medline and screened for relevance literature published from 1980 through 2006 on the use, effectiveness, and safety of noninvasive interventions for neck pain and associated disorders. Consensus decisions were made about the scientific merit of each article; those judged to have adequate internal validity were included in our best evidence synthesis. Results Of the 359 invasive and noninvasive intervention articles deemed relevant, 170 (47%) were accepted as scientifically admissible, and 139 of these related to noninvasive interventions (including health care utilization, costs, and safety). For whiplash-associated disorders, there is evidence that educational videos, mobilization, and exercises appear more beneficial than usual care or physical modalities. For other neck pain, the evidence suggests that manual and supervised exercise interventions, low-level laser therapy, and perhaps acupuncture are more effective than no treatment, sham, or alternative interventions; however, none of the active treatments was clearly superior to any other in either the short- or long-term. For both whiplash-associated disorders and other neck pain without radicular symptoms, interventions that focused on regaining function as soon as possible are relatively more effective than interventions that do not have such a focus. Conclusion Our best evidence synthesis suggests that therapies involving manual therapy and exercise are more effective than alternative strategies for patients with neck pain; this was also true of therapies which include educational interventions addressing self-efficacy. Future efforts should focus on the study of noninvasive interventions for patients with radicular symptoms and on the design and evaluation of neck pain prevention strategies.

Study Design Best evidence synthesis. Objective To identify, critically appraise, and synthesize literature from 1980 through 2006 on surgical interventions for neck pain alone or with radicular pain in the absence of serious pathologic disease. Summary of Background Data There have been no comprehensive systematic literature or evidence-based reviews published on this topic. Methods We systematically searched Medline for literature published from 1980 to 2006 on percutaneous and open surgical interventions for neck pain. Publications on the topic were also solicited from experts in the field. Consensus decisions were made about the scientific merit of each article; those judged to have adequate internal validity were included in our Best Evidence Synthesis. Results Of the 31,878 articles screened, 1203 studies were relevant to the Neck Pain Task Force mandate and of these, 31 regarding treatment by surgery or injections were accepted as scientifically admissible. Radiofrequency neurotomy, cervical facet injections, cervical fusion and cervical arthroplasty for neck pain without radiculopathy are not supported by current evidence. We found there is support for short-term symptomatic improvement of radicular symptoms with epidural corticosteroids. It is not clear from the evidence that long-term outcomes are improved with the surgical treatment of cervical radiculopathy compared to nonoperative measures. However, relatively rapid and substantial symptomatic relief after surgical treatment seems to be reliably achieved. It is not evident that one open surgical technique is clearly superior to others for radiculopathy. Cervical foramenal or epidural injections are associated with relatively frequent minor adverse events (5%–20%); however, serious adverse events are very uncommon ( Conclusion Surgical treatment and limited injection procedures for cervical radicular symptoms may be reasonably considered in patients with severe impairments. Percutaneous and open surgical treatment for neck pain alone, without radicular symptoms or clear serious pathology, seems to lack scientific support.

Study Design Best evidence synthesis. Objective To undertake a best evidence synthesis of the published evidence on the burden and determinants of neck pain and its associated disorders in the general population. Summary of Background Data The evidence on burden and determinants of neck has not previously been summarized. Methods The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and Its Associated Disorders performed a systematic search and critical review of literature published between 1980 and 2006 to assemble the best evidence on neck pain. Studies meeting criteria for scientific validity were included in a best evidence synthesis. Results We identified 469 studies on burden and determinants of neck pain, and judged 249 to be scientifically admissible; 101 articles related to the burden and determinants of neck pain in the general population. Incidence ranged from 0.055 per 1000 person years (disc herniation with radiculopathy) to 213 per 1000 persons (self-reported neck pain). Incidence of neck injuries during competitive sports ranged from 0.02 to 21 per 1000 exposures. The 12-month prevalence of pain typically ranged between 30% and 50%; the 12-month prevalence of activity-limiting pain was 1.7% to 11.5%. Neck pain was more prevalent among women and prevalence peaked in middle age. Risk factors for neck pain included genetics, poor psychological health, and exposure to tobacco. Disc degeneration was not identified as a risk factor. The use of sporting gear (helmets, face shields) to prevent other types of injury was not associated with increased neck injuries in bicycling, hockey, or skiing. Conclusion Neck pain is common. Nonmodifiable risk factors for neck pain included age, gender, and genetics. Modifiable factors included smoking, exposure to tobacco, and psychological health. Disc degeneration was not identified as a risk factor. Future research should concentrate on longitudinal designs exploring preventive strategies and modifiable risk factors for neck pain.

Study Design Best-evidence synthesis. Objective To perform a best evidence synthesis on the course and prognostic factors for neck pain and its associated disorders in workers. Summary of Background Data Knowledge of the course of neck pain in workers guides expectations for recovery. Identifying prognostic factors assists in planning effective workplace policies, formulating interventions and promoting lifestyle changes to decrease the frequency and burden of neck pain in the workplace. Methods The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) conducted a critical review of the literature published between 1980 and 2006 to assemble the best evidence on neck pain and its associated disorders. Studies meeting criteria for scientific validity were included in a best evidence synthesis. Results We found 226 articles related to course and prognostic factors in neck pain and its associated disorders. After a critical review, 70 (31%) were accepted on scientific merit; 14 of these studies related to course and prognostic factors in working populations. Between 60% and 80% of workers with neck pain reported neck pain 1 year later. Few workplace or physical job demands were identified as being linked to recovery from neck pain. However, workers with little influence on their own work situation had a slightly poorer prognosis, and white-collar workers had a better prognosis than blue-collar workers. General exercise was associated with better prognosis; prior neck pain and prior sick leave were associated with poorer prognosis. Conclusion The Neck Pain Task Force presents a report of current best evidence on course and prognosis for neck pain. Few modifiable prognostic factors were identified; however, having some influence over one's own job and being physically active seem to hold promise as prognostic factors.

Study Design Best evidence synthesis. Objective To report on gaps in the literature and make methodologic recommendations based on our review of the literature on frequency and risk factors, assessment, intervention, and course and prognostic factors for neck pain and its associated disorders. Summary of Background Data The scientific literature on neck pain is large and of variable quality. We reviewed 1203 studies and judged 46% to be of sufficient scientific validity to be included in the best evidence synthesis. Scientific quality varied across study topics, and fundamental questions remain about important issues. Methods The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) conducted a critical review of the literature published between 1980 and 2006 to assemble the best evidence on neck pain and its associated disorders. Studies meeting criteria for scientific validity were included in a best evidence synthesis. Results We outline a large number of gaps in the current literature. For example, we found important gaps in our knowledge about neck pain in children (risk factors, screening criteria to rule out serious injury, management, course and prognosis); and in the prevention of neck pain-related activity limitations. Few studies addressed the impact of culture or social policies (such as governmental health policies or insurance compensation policies) on neck pain. A number of important questions remain about the effectiveness of commonly used interventions for neck pain. Conclusion The Neck Pain Task Force undertook a best evidence synthesis to establish a baseline of the current best evidence on the course and prognosis for whiplash-associated disorders. We identify a number of gaps in the current knowledge, and provide recommendations for the conduct of future studies.

Study Design Best evidence synthesis. Objective To provide a detailed description of the methods undertaken in a systematic search and perform a best evidence synthesis on the frequency, determinants, assessment, interventions, course and prognosis of neck pain, and its associated disorders. Summary of Background Data Neck pain is an important cause of health burden; however, the published information is vast, and stakeholders would benefit from a summary of the best evidence. Methods The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and its Associated Disorders conducted a systematic search and critical review of the literature published between 1980 and 2006 to assemble the best evidence on neck pain. Citations were screened for relevance to the Neck Pain Task Force mandate, using a priori criteria, and relevant studies were critically reviewed for their internal scientific validity. Findings from studies meeting criteria for scientific validity were synthesized into a best evidence synthesis. Results We found 31,878 citations, of which 1203 were relevant to the mandate of the Neck Pain Task Force. After critical review, 552 studies (46%) were judged scientifically admissible and were compiled into the best evidence synthesis. Conclusion The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and its Associated Disorders undertook a best evidence synthesis to establish a baseline of the current best evidence on the epidemiology, assessment and classification of neck pain, as well as interventions and prognosis for this symptom. This article reports the methods used and the outcomes from the review. We found that 46% of the research literature was of acceptable scientific quality to inform clinical practice, policy-making, and future research.

Study Design Best evidence synthesis. Objective To perform a best evidence synthesis on the course and prognostic factors for neck pain and its associated disorders in Grades I–III whiplash-associated disorders (WAD). Summary of Background Data Knowledge of the course of recovery of WAD guides expectations for recovery. Identifying prognostic factors assists in planning management and intervention strategies and effective compensation policies to decrease the burden of WAD. Methods The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) conducted a critical review of the literature published between 1980 and 2006 to assemble the best evidence on neck pain and its associated disorders. Studies meeting criteria for scientific validity were included in a best evidence synthesis. Results We found 226 articles related to course and prognostic factors in neck pain and its associated disorders. After a critical review, 70 (31%) were accepted on scientific merit; 47 of these studies related to course and prognostic factors in WAD. The evidence suggests that approximately 50% of those with WAD will report neck pain symptoms 1 year after their injuries. Greater initial pain, more symptoms, and greater initial disability predicted slower recovery. Few factors related to the collision itself (for example, direction of the collision, headrest type) were prognostic; however, postinjury psychological factors such as passive coping style, depressed mood, and fear of movement were prognostic for slower or less complete recovery. There is also preliminary evidence that the prevailing compensation system is prognostic for recovery in WAD. Conclusion The Neck Pain Task Force undertook a best evidence synthesis to establish a baseline of the current best evidence on the course and prognosis for WAD. Recovery of WAD seems to be multifactorial.

Study Design Best evidence synthesis. Objective To provide evidence-based guidance to primary care clinicians about how to best assess and treat patients with neck pain. Summary of Background Data There is a need to translate the results of clinical and epidemiologic studies into meaningful and practical information for clinicians. Methods Based on best evidence syntheses of published studies on the risk, prognosis, assessment, and management of people with neck pain and its associated disorders, plus additional research projects and focused literature reviews reported in this supplement, the 12-member multidisciplinary Scientific Secretariat of the Neck Pain Task Force followed a 4-step approach to develop practical guidance for clinicians. Results The Neck Pain Task Force recommends that people seeking care for neck pain should be triaged into 4 groups: Grade I neck pain with no signs of major pathology and no or little interference with daily activities; Grade II neck pain with no signs of major pathology, but interference with daily activities; Grade III neck pain with neurologic signs of nerve compression; Grade IV neck pain with signs of major pathology. In the emergency room after blunt trauma to the neck, triage should be based on the NEXUS criteria or the Canadian C-spine rule. Those with a high risk of fracture should be further investigated with plain radiographs and/or CT-scan. In ambulatory primary care, triage should be based on history and physical examination alone, including screening for red flags and neurologic examination for signs of radiculopathy. Exercises and mobilization have been shown to provide some degree of short-term relief of Grade I or Grade II neck pain after a motor vehicle collision. Exercises, mobilization, manipulation, analgesics, acupuncture, and low-level laser have been shown to provide some degree of short-term relief of Grade I or Grade II neck pain without trauma. Those with confirmed Grade III and severe persistent radicular symptoms might benefit from corticosteroid injections or surgery. Those with confirmed Grade IV neck pain require management specific to the diagnosed pathology. Conclusion The best available evidence suggests initial assessment for neck pain should focus on triage into 4 grades, and those with common neck pain (Grade I and Grade II) might be offered the listed noninvasive treatments if short-term relief is desired.

Study Design Systematic review and best evidence synthesis. Objectives To describe the prevalence and incidence of neck pain and disability in workers; to identify risk factors for neck pain in workers; to propose an etiological diagram; and to make recommendations for future research. Summary of Background Data Previous reviews of the etiology of neck pain in workers relied on cross-sectional evidence. Recently published cohorts and randomized trials warrant a re-analysis of this body of research. Methods We systematically searched Medline for literature published from 1980–2006. Retrieved articles were reviewed for relevance. Relevant articles were critically appraised. Articles judged to have adequate internal validity were included in our best evidence synthesis. Results One hundred and nine papers on the burden and determinants of neck pain in workers were scientifically admissible. The annual prevalence of neck pain varied from 27.1% in Norway to 47.8% in Quebec, Canada. Each year, between 11% and 14.1% of workers were limited in their activities because of neck pain. Risk factors associated with neck pain in workers include age, previous musculoskeletal pain, high quantitative job demands, low social support at work, job insecurity, low physical capacity, poor computer workstation design and work posture, sedentary work position, repetitive work and precision work. We found preliminary evidence that gender, occupation, headaches, emotional problems, smoking, poor job satisfaction, awkward work postures, poor physical work environment, and workers' ethnicity may be associated with neck pain. There is evidence that interventions aimed at modifying workstations and worker posture are not effective in reducing the incidence of neck pain in workers. Conclusion Neck disorders are a significant source of pain and activity limitations in workers. Most neck pain results from complex relationships between individual and workplace risk factors. No prevention strategies have been shown to reduce the incidence of neck pain in workers.

Study Design Best evidence synthesis. Objective To undertake a best evidence synthesis on course and prognosis of neck pain and its associated disorders in the general population. Summary of Background Data Knowing the course of neck pain guides expectations for recovery. Identifying prognostic factors assists in planning public policies, formulating interventions, and promoting lifestyle changes to decrease the burden of neck pain. Methods The Bone and Joint Decade 2000–2010 Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) conducted a critical review of literature published between 1980 and 2006 to assemble the best evidence on neck pain. Findings from studies meeting criteria for scientific validity were abstracted into evidence tables and included in a best evidence synthesis. Results We found 226 articles on the course and prognostic factors in neck pain and its associated disorders. After critical review, 70 (31%) of these were accepted on scientific merit. Six studies related to course and 7 to prognostic factors in the general population. Between half and three quarters of persons in these populations with current neck pain will report neck pain again 1 to 5 years later. Younger age predicted better outcome. General exercise was unassociated with outcome, although regular bicycling predicted poor outcome in 1 study. Psychosocial factors, including psychologic health, coping patterns, and need to socialize, were the strongest prognostic factors. Several potential prognostic factors have not been well studied, including degenerative changes, genetic factors, and compensation policies. Conclusion The Neck Pain Task Force undertook a best evidence synthesis to establish a baseline of the current best evidence on the course and prognosis for this symptom. General exercise was not prognostic of better outcome; however, several psychosocial factors were prognostic of outcome.

Reports of pain and physical exam findings for musculoskeletal disorders (MSDs) are two common outcome measures independently used to assess work-related MSDs in the scientific literature. How these measures correlate with each other, however, is largely unknown. We recruited 520 sewing machine operators to describe the correlation between subjective self- reported pain and physical findings of MSDs in three upper body regions including the neck/shoulder, elbow/forearm, and hand/wrist. Self-reports of pain and physical findings resulted in different and partly non-overlapping classifications of subjects as MSD cases in our study. Both outcome measures were found to be consistently associated with 'having a medical history of MSDs', 'perceived physical exertion', 'perceived job insecurity' (neck/shoulder), being of older age (arm/forearm), and female gender (arm/forearm and hand/wrist); however, we observed inconsistency for the measures for a number of other job related factors such as 'operating a single machine' and 'number of work hours per week'. Because to date no agreed upon "gold standard" for diagnosing MSDs exists, our findings suggest that research results can be very different when using self-reported measures versus physical exam findings. Also, in order to evaluate the success of an intervention, screening, or surveillance program for work related MSDs, it is important to define clearly which outcome measure best to employ.

Best evidence synthesis. To identify, critically appraise, and synthesize literature from 1980 through 2006 on noninvasive interventions for neck pain and its associated disorders. No comprehensive systematic literature reviews have been published on interventions for neck pain and its associated disorders in the past decade. We systematically searched Medline and screened for relevance literature published from 1980 through 2006 on the use, effectiveness, and safety of noninvasive interventions for neck pain and associated disorders. Consensus decisions were made about the scientific merit of each article; those judged to have adequate internal validity were included in our best evidence synthesis. Of the 359 invasive and noninvasive intervention articles deemed relevant, 170 (47%) were accepted as scientifically admissible, and 139 of these related to noninvasive interventions (including health care utilization, costs, and safety). For whiplash-associated disorders, there is evidence that educational videos, mobilization, and exercises appear more beneficial than usual care or physical modalities. For other neck pain, the evidence suggests that manual and supervised exercise interventions, low-level laser therapy, and perhaps acupuncture are more effective than no treatment, sham, or alternative interventions; however, none of the active treatments was clearly superior to any other in either the short-or long-term. For both whiplash-associated disorders and other neck pain without radicular symptoms, interventions that focused on regaining function as soon as possible are relatively more effective than interventions that do not have such a focus. Our best evidence synthesis suggests that therapies involving manual therapy and exercise are more effective than alternative strategies for patients with neck pain; this was also true of therapies which include educational interventions addressing self-efficacy. Future efforts should focus on the study of noninvasive interventions for patients with radicular symptoms and on the design and evaluation of neck pain prevention strategies.

STUDY DESIGN: Best evidence synthesis. OBJECTIVE: To provide evidence-based guidance to primary care clinicians about how to best assess and treat patients with neck pain. SUMMARY OF BACKGROUND DATA: There is a need to translate the results of clinical and epidemiologic studies into meaningful and practical information for clinicians. METHODS: Based on best evidence syntheses of published studies on the risk, prognosis, assessment, and management of people with neck pain and its associated disorders, plus additional research projects and focused literature reviews reported in this supplement, the 12-member multidisciplinary Scientific Secretariat of the Neck Pain Task Force followed a 4-step approach to develop practical guidance for clinicians. RESULTS: The Neck Pain Task Force recommends that people seeking care for neck pain should be triaged into 4 groups: Grade I neck pain with no signs of major pathology and no or little interference with daily activities; Grade II neck pain with no signs of major pathology, but interference with daily activities; Grade III neck pain with neurologic signs of nerve compression; Grade IV neck pain with signs of major pathology. In the emergency room after blunt trauma to the neck, triage should be based on the NEXUS criteria or the Canadian C-spine rule. Those with a high risk of fracture should be further investigated with plain radiographs and/or CT-scan. In ambulatory primary care, triage should be based on history and physical examination alone, including screening for red flags and neurologic examination for signs of radiculopathy. Exercises and mobilization have been shown to provide some degree of short-term relief of Grade I or Grade II neck pain after a motor vehicle collision. Exercises, mobilization, manipulation, analgesics, acupuncture, and low-level laser have been shown to provide some degree of short-term relief of Grade I or Grade II neck pain without trauma. Those with confirmed Grade III and severe persistent radicular symptoms might benefit from corticosteroid injections or surgery. Those with confirmed Grade IV neck pain require management specific to the diagnosed pathology. CONCLUSION: The best available evidence suggests initial assessment for neck pain should focus on triage into 4 grades, and those with common neck pain (Grade I and Grade II) might be offered the listed noninvasive treatments if short-term relief is desired. Language: en

Best evidence synthesis. To undertake a best evidence synthesis on course and prognosis of neck pain and its associated disorders in the general population. Knowing the course of neck pain guides expectations for recovery. Identifying prognostic factors assists in planning public policies, formulating interventions, and promoting lifestyle changes to decrease the burden of neck pain. The Bone and Joint Decade 2000 –2010 Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) conducted a critical review of literature published between 1980 and 2006 to assemble the best evidence on neck pain. Findings fromstudiesmeeting criteria for scientific validity were abstracted into evidence tables and included in a best evidence synthesis. We found 226 articles on the course and prognostic factors in neck pain and its associated disorders. After critical review, 70 (31) of these were accepted on scientific merit. Six studies related to course and 7 to prognostic factors in the general population. Between half and three quarters of persons in these populations with current neck pain will report neck pain again 1 to 5 years later. Younger age predicted better outcome. General exercise was unassociated with outcome, although regular bicycling predicted poor outcome in 1 study. Psychosocial factors, including psychologic health, coping patterns, and need to socialize, were the strongest prognostic factors. Several potential prognostic factors have not been well studied, including degenerative changes, genetic factors, and compensation policies. The Neck Pain Task Force undertook a best evidence synthesis to establish a baseline of the current best evidence on the course and prognosis for this symptom. General exercise was not prognostic of better outcome; however, several psychosocial factors were prognostic of outcome.

Study design Best evidence synthesis. Objective To report on gaps in the literature and make methodologic recommendations based on our review of the literature on frequency and risk factors, assessment, intervention, and course and prognostic factors for neck pain and its associated disorders. Summary of background data The scientific literature on neck pain is large and of variable quality. We reviewed 1203 studies and judged 46% to be of sufficient scientific validity to be included in the best evidence synthesis. Scientific quality varied across study topics, and fundamental questions remain about important issues. Methods The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) conducted a critical review of the literature published between 1980 and 2006 to assemble the best evidence on neck pain and its associated disorders. Studies meeting criteria for scientific validity were included in a best evidence synthesis. Results We outline a large number of gaps in the current literature. For example, we found important gaps in our knowledge about neck pain in children (risk factors, screening criteria to rule out serious injury, management, course and prognosis); and in the prevention of neck pain-related activity limitations. Few studies addressed the impact of culture or social policies (such as governmental health policies or insurance compensation policies) on neck pain. A number of important questions remain about the effectiveness of commonly used interventions for neck pain. Conclusion The Neck Pain Task Force undertook a best evidence synthesis to establish a baseline of the current best evidence on the course and prognosis for whiplash-associated disorders. We identify a number of gaps in the current knowledge, and provide recommendations for the conduct of future studies.

STUDY DESIGN: Best evidence synthesis. OBJECTIVE: To perform a best evidence synthesis on the course and prognostic factors for neck pain and its associated disorders in Grades I-III whiplash-associated disorders (WAD). SUMMARY OF BACKGROUND DATA: Knowledge of the course of recovery of WAD guides expectations for recovery. Identifying prognostic factors assists in planning management and intervention strategies and effective compensation policies to decrease the burden of WAD. METHODS: The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and its Associated Disorders (Neck Pain Task Force) conducted a critical review of the literature published between 1980 and 2006 to assemble the best evidence on neck pain and its associated disorders. Studies meeting criteria for scientific validity were included in a best evidence synthesis. RESULTS: We found 226 articles related to course and prognostic factors in neck pain and its associated disorders. After a critical review, 70 (31%) were accepted on scientific merit; 47 of these studies related to course and prognostic factors in WAD. The evidence suggests that approximately 50% of those with WAD will report neck pain symptoms 1 year after their injuries. Greater initial pain, more symptoms, and greater initial disability predicted slower recovery. Few factors related to the collision itself (for example, direction of the collision, headrest type) were prognostic; however, postinjury psychological factors such as passive coping style, depressed mood, and fear of movement were prognostic for slower or less complete recovery. There is also preliminary evidence that the prevailing compensation system is prognostic for recovery in WAD. CONCLUSION: The Neck Pain Task Force undertook a best evidence synthesis to establish a baseline of the current best evidence on the course and prognosis for WAD. Recovery of WAD seems to be multifactorial. Language: en

Objectives. We examined barriers to influenza vaccination among long-term care facility (LTCF) health care workers in Southern California and developed simple, effective interventions to improve influenza vaccine coverage of these workers. Methods. In 2002, health care workers at LTCFs were surveyed regarding their knowledge and attitudes about influenza and the influenza vaccine. Results were used to develop 2 interventions, an educational campaign and Vaccine Day (a well-publicized day for free influenza vaccination of all employees at the worksite). Seventy facilities were recruited to participate in an intervention trial and randomly assigned to 4 study groups. Results. The combination of Vaccine Day and an educational campaign was most effective in increasing vaccine coverage (53% coverage; prevalence ratio [PR]=1.45; 95% confidence interval [CI]=1.24, 1.71, compared with 27% coverage in the control group). Vaccine Day alone was also effective (46% coverage; PR= 1.41; 95% CI=1.17, 1.71). The educational campaign alone was not effective in improving coverage levels (34% coverage; PR=1.18; 95% CI=0.93, 1.50). Conclusion. Influenza vaccine coverage of LTCF health care workers can be improved by providing free vaccinations at the worksite with a well-publicized Vaccine Day.

The validation of diagnostic testing is critical to understanding disease and scientifically advancing treatment. Recent surveys have found that many studies on diagnostic validity are poorly designed or executed, resulting in exaggerated or biased results regarding diagnostic accuracy [1]. In the world of axial pain syndromes many questionable diagnoses are made in clinical practice. Which of these may be right or wrong is usually unknown. With serious diseases, such as infection or tumor, the clinician may conclusively determine the correct diagnosis. Yet, in the overwhelming majority of axial pain syndromes there is little evidence supporting confidence in diagnostic test validity. The clinician may be left with little more to judge diagnostic accuracy than the clinical course revealing no serious destructive process, the possible evolution of generalized central-pain illness, or perhaps, the response to specific treatments. This issue of The Spine Journal presents another attempt to resolve disputed claims between different camps purporting high diagnostic certainty in axial pain. Dr. Bogduk and colleagues (pages 22‐26, this issue) point out that one study in 1988 [2] ‘‘claimed that manual examination of the neck had 100% sensitivity and 100% specificity for diagnosing painful zygapophyseal joints.’’ This is, of course, an astounding rate for any clinical test. These authors believe, and it stands to reason, that manual medicine techniques are not nearly that accurate. However, the same authors then contend that the same diagnosis is ‘‘diagnosed definitively’’ by their own method of facet injections: an equally unlikely proposition. Nonetheless, the authors go on to compare the outcome of manual testing, whose proponents claim high accuracy, against anesthetic blocks, which Dr. Bogduk and colleagues claim is the actual ‘‘definitive’’ determinant of a true-positive or negative study. Their results show that manual testing and injection testing results are frequently at odds. As Abraham Lincoln noted when both Federal and Confederate partisans claimed God was on their side: one side may be wrong, or the other may be wrong, but certainly both cannot be right. The diagnostic injection method used in this study as the gold standard for the diagnosis was comparative anesthetic injections: a ‘‘positive’’ joint being one in which pain relief was obtained with anesthetic blockade with both short (lignocaine) and long (bupivacaine) acting anesthetic and

Background Studies suggest Pacific Islander women have disparate rates of preterm birth, primary cesarean delivery, preeclampsia, gestational diabetes, and low birthweight infants. However, data is limited. In order to improve the health of Pacific Islanders, it is essential to better understand differences in obstetric outcomes in this diverse population Methods This study compared perinatal outcomes between Pacific Islander (9,646) and White (n = 5,510) women who delivered a singleton liveborn in any Hawaii hospital from January 2010 to December 2011 using the Hawaii Health Information Corporation (HHIC) database. Pacific Islanders were disaggregated into the following groups: Native Hawaiian, Samoan, Micronesian, and Other Pacific Islanders. Perinatal outcomes (e.g. hypertensive diseases, birthweight, mode of delivery) were compared using multivariable logistic models controlling for relevant sociodemographic and health risk factors (e.g. age and payer type). Results Significant differences in perinatal outcomes between Pacific Islander and White women and newborns were noted. All Pacific Islander groups had an increased risk of hypertension. Outcome differences were also seen between Pacific Islanders groups. Native Hawaiians had the highest risk of low birthweight infants, Samoans had the highest risk of macrosomic infants and Micronesians had the highest risk of cesarean delivery. Conclusions Important differences in perinatal outcomes among Pacific Islanders exist. It is important to examine Pacific Islander populations separately in future research, public health interventions, and policy. Electronic supplementary material The online version of this article (doi:10.1186/s12884-015-0671-4) contains supplementary material, which is available to authorized users.