Operationalizing and digitizing person-centered daily functioning: a case for functionomics.

An ever-increasing amount of data on a person's daily functioning is being collected, which holds information to revolutionize person-centered healthcare. However, the full potential of data on daily functioning cannot yet be exploited as it is mostly stored in an unstructured and inaccessible manner. The integration of these data, and thereby expedited knowledge discovery, is possible by the introduction of functionomics as a complementary 'omics' initiative, embracing the advances in data science. Functionomics is the study of high-throughput data on a person's daily functioning, that can be operationalized with the International Classification of Functioning, Disability and Health (ICF).A prerequisite for making functionomics operational are the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This paper illustrates a step by step application of the FAIR principles for making functionomics data machine readable and accessible, under strictly certified conditions, in a practical example. Establishing more FAIR functionomics data repositories, analyzed using a federated data infrastructure, enables new knowledge generation to improve health and person-centered healthcare. Together, as one allied health and healthcare research community, we need to consider to take up the here proposed methods.

The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol.

BACKGROUND AND PURPOSE: Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences. METHODS AND ANALYSES: A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10-18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.

Predictors of poor outcome following lumbar spinal fusion surgery: a prospective observational study to derive two clinical prediction rules using British Spine Registry data.

PURPOSE: Lumbar spinal fusion surgery (LSFS) is common for lumbar degenerative disorders. The objective was to develop clinical prediction rules to identify which patients are likely to have a favourable outcome to inform decisions regarding surgery and rehabilitation. METHODS: A prospective observational study recruited 600 (derivation) and 600 (internal validation) consecutive adult patients undergoing LSFS for degenerative lumbar disorder through the British Spine Registry. Definition of good outcome (6 weeks, 12 months) was reduction in pain intensity (Numerical Rating Scale, 0-10) and disability (Oswestry Disability Index, ODI 0-50) > 1.7 and 14.3, respectively. Linear and logistic regression models were fitted and regression coefficients, Odds ratios and 95% CIs reported. RESULTS: Lower BMI, higher ODI and higher leg pain pre-operatively were predictive of good disability outcome, higher back pain was predictive of good back pain outcome, and no previous surgery and higher leg pain were predictive of good leg pain outcome; all at 6 weeks. Working and higher leg pain were predictive of good ODI and leg pain outcomes, higher back pain was predictive of good back pain outcome, and higher leg pain was predictive of good leg pain outcome at 12 months. Model performance demonstrated reasonable to good calibration and adequate/very good discrimination. CONCLUSIONS: BMI, ODI, leg and back pain and previous surgery are important considerations pre-operatively to inform decisions for surgery. Pre-operative leg and back pain and work status are important considerations to inform decisions for management following surgery. Findings may inform clinical decision making regarding LSFS and associated rehabilitation.

Local bone metabolism during the consolidation process of spinal interbody fusion.

INTRODUCTION: Although computed tomography (CT) can identify the presence of eventual bony bridges following lumbar interbody fusion (LIF) surgery, it does not provide information on the ongoing formation process of new bony structures. 18F sodium fluoride (18F-NaF) positron emission tomography (PET) could be used as complementary modality to add information on the bone metabolism at the fusion site. However, it remains unknown how bone metabolism in the operated segment changes early after surgery in uncompromised situations. This study aimed to quantify the changes in local bone metabolism during consolidation of LIF. MATERIALS AND METHODS: Six skeletally mature sheep underwent LIF surgery. 18F-NaF PET/CT scanning was performed 6 and 12 weeks postoperatively to quantify the bone volume and metabolism in the operated segment. Bone metabolism was expressed as a function of bone volume. RESULTS: Early in the fusion process, bone metabolism was increased at the endplates of the operated vertebrae. In a next phase, bone metabolism increased in the center of the interbody region, peaked, and declined to an equilibrium state. During the entire postoperative time period of 12 weeks, bone metabolism in the interbody region was higher than that of a reference site in the spinal column. CONCLUSION: Following LIF surgery, there is a rapid increase in bone metabolism at the vertebral endplates that develops towards the center of the interbody region. Knowing the local bone metabolism during uncompromised consolidation of spinal interbody fusion might enable identification of impaired bone formation early after LIF surgery using 18F-NaF PET/CT scanning.

Immediate patient perceptions following lumbar spinal fusion surgery: semi-structured multi-centre interviews exploring the patient journey and experiences of lumbar fusion surgery (FuJourn).

PURPOSE: To understand the patient journey to Lumbar Spinal Fusion Surgery (LSFS) and patients' experiences of surgery. METHODS: Qualitative study using interpretive phenomenological analysis. Adult participants following LSFS were recruited from 4 UK clinical sites using purposive sampling to ensure representation of key features (e.g. age). Semi-structured interviews informed by a piloted topic guide developed from the literature were audio-recorded and transcribed verbatim. Framework analysis for individual interviews and then across participants (deductive and inductive) identified emerging themes. Trustworthiness of data analyses was enhanced using multiple strategies (e.g. attention to negative cases). RESULTS: Four emerging themes from n = 31 patients' narratives were identified: decision for surgery, coping strategies, barriers to recovery and recovery after surgery. Decision for surgery and recovery after surgery themes are distinguished by the point of surgery. However, barriers to recovery and coping strategies are key to the whole patient journey encompassing long journeys to surgery and their initial journey after surgery. The themes of coping strategies and barriers to recovery were inter-related and perceived by participants as parallel concepts. The 4 multifactorial themes interacted with each other and shaped the process of an individual patient's recovery. Factors such as sporadic interventions prior to surgery, time-consuming wait for diagnosis and surgery and lack of information regarding recovery strongly influenced perceptions of outcome. CONCLUSION: Patient driven data enables insights to inform research regarding surgery/rehabilitation through depth of understanding of the patient journey. Awareness of factors important to patients is important; ensuring that patient-driven data informs research and patient care.

Exploring Associations of Preoperative Physical Performance With Postoperative Outcomes After Lumbar Spinal Fusion: A Machine Learning Approach.

OBJECTIVE: To explore the association between preoperative physical performance with short- and long-term postoperative outcomes in patients undergoing lumbar spinal fusion (LSF). DESIGN: Retrospective cohort. SETTING: University hospital. PARTICIPANTS: Seventy-seven patients (N=77) undergoing elective LSF were preoperatively screened on patient demographics, patient-reported outcome measures, and physical performance measures (movement control, back muscle endurance strength and extensor strength, aerobic capacity, flexibility). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Associations between preoperative variables and inpatient functional recovery, hospital length of stay (LOS), and 1- to 2-year postoperative pain reduction were explored using random forest analyses assessing the relative influence of the variable on the outcome. RESULTS: Aerobic capacity was associated with fast functional recovery <4 days and prolonged functional recovery >5 days (median z scores=7.1 and 12.0). Flexibility (median z score=4.3) and back muscle endurance strength (median z score=7.8) were associated with fast functional recovery <4 days. Maximum back extensor strength was associated with prolonged functional recovery >5 days (median z score=8.6). Flexibility (median z score=5.1) and back muscle endurance strength (median z score=13.5) were associated with short LOS <5 days. Aerobic capacity (median z score=8.7) was associated with prolonged LOS >7 days. Maximum back extensor strength (median z score=3.8) was associated with 1- to 2-year postoperative pain reduction and aerobic capacity (median z score=2.8) was tentative. CONCLUSIONS: Physical performance measures were associated with both short- and long-term outcomes after LSF. Adding these measures to prediction models predicting outcomes after LSF may increase their accuracy.

Development and validation of a prediction tool for pain reduction in adult patients undergoing elective lumbar spinal fusion: a multicentre cohort study.

PURPOSE: On average, 56% of patients report a clinically relevant reduction in pain after lumbar spinal fusion (LSF). Preoperatively identifying which patient will benefit from LSF is paramount to improve clinical decision making, expectation management and treatment selection. Therefore, this multicentre study aimed to develop and validate a clinical prediction tool for a clinically relevant reduction in pain 1 to 2 years after elective LSF. METHODS: The outcomes were defined as a clinically relevant reduction in predominant (worst reported pain in back or legs) pain 1 to 2 years after LSF. Patient-reported outcome measures and patient characteristics from 202 patients were used to develop a prediction model by logistic regression. Data from 251 patients were used to validate the model. RESULTS: Nonsmokers (odds ratio = 0.41 [95% confidence interval = 0.19-0.87]), with lower Body Mass Index (0.93 [0.85-1.01]), shorter pain duration (0.49 [0.20-1.19]), lower American Society of Anaesthesiologists score (4.82 [1.35-17.25]), higher Visual Analogue Scale score for predominant pain (1.05 [1.02-1.08]), lower Oswestry Disability Index (0.96 [0.93-1.00]) and higher RAND-36 mental component score (1.03 [0.10-1.06]) preoperatively had a higher chance of a clinically relevant reduction in predominant pain. The area under the curve of the externally validated model yielded 0.68. A nomogram was developed to aid clinical decision making. CONCLUSIONS: Using the developed nomogram surgeons can estimate the probability of achieving a clinically relevant pain reduction 1 to 2 years after LSF and consequently inform patients on expected outcomes when considering treatment.

Gait in patients with symptomatic osteoporotic vertebral compression fractures over 6 months of recovery.

BACKGROUND: One factor related to disability in people with spinal deformity is decreased postural control and increased risk of falling. However, little is known about the effect of osteoporotic vertebral compression fractures (OVCFs) and their recovery on gait and stability. Walking characteristics of older adults with and without vertebral fractures have not yet been compared. AIMS: The purpose of the current study was to examine the spatiotemporal gait parameters and their variability in patients with an OVCF and healthy participants during treadmill walking at baseline and after 6 months of recovery. METHODS: Twelve female patients suffering a symptomatic OVCF were compared to 11 matched controls. Gait analysis was performed with a dual-belt instrumented treadmill with a 180° projection screen providing a virtual environment (computer-assisted rehabilitation environment). Results of patients with an OVCF and healthy participants were compared. Furthermore, spatiotemporal gait parameters were assessed over 6 months following the fracture. RESULTS: Patients suffering from an OVCF appeared to walk with significantly shorter, faster and wider strides compared to their healthy counterparts. Although stride time and length improved over time, the majority of the parameters analysed remained unchanged after 6 months of conservative treatment. DISCUSSION: Since patients do not fully recover to their previous level of mobility after 6 months of conservative treatment for OVCF, it appears of high clinical importance to add balance and gait training to the treatment algorithm of OVCFs. CONCLUSIONS: Patients suffering from an OVCF walk with shorter, faster and wider strides compared to their healthy counterparts adopt a less stable body configuration in the anterior direction, potentially increasing their risk of forward falls if perturbed. Although stride time and stride length improve over time even reaching healthy levels again, patients significantly deviate from normal gait patterns (e.g. in stability and step width) after 6 months of conservative treatment.

Pain and disability after first-time spinal fusion for lumbar degenerative disorders: a systematic review and meta-analysis.

PURPOSE: Lumbar spinal fusion (LSF) is frequently and increasingly used in lumbar degenerative disorders despite conflicting results and recommendations. A thorough understanding of patient outcomes after LSF is required to inform decisions regarding surgery and to improve post-surgery management. The current study aims to evaluate the course of pain and disability in patients with degenerative disorders of the lumbar spine after first-time LSF. METHODS: A systematic review and meta-analysis of pain and disability outcomes in prospective cohort studies up to 31 March 2017 is identified in four electronic databases. Two independent researchers determined study eligibility, extracted data, and assessed risk of bias (modified Quality in Prognostics tool). A random effects model (maximum likelihood) was used to calculate means and 95% confidence intervals. The primary analysis was performed on complete data, and a sensitivity analysis was performed on all data. RESULTS: Twenty-five studies (n = 1777 participants) were included. The mean (95% confidence interval) Visual Analogue Scale (VAS) back pain (n = 9 studies) decreased from 64 (57-71) pre-surgery to 20 (16-24) at 24-month follow-up. Leg pain (n = 9 studies) improved from VAS 70 (65-74) pre-surgery to 17 (12-23) at 24-month interval. Disability (n = 12 studies), measured with the Oswestry Disability Index, decreased from 44.8 (40.1-49.4) pre-surgery to 17.3 (11.9-22.8) at 24-month follow-up. The sensitivity analysis yielded similar results. CONCLUSION: There is a substantial improvement in pain and disability after first-time LSF for degenerative disorders. However, long-term outcomes indicate that leg pain might be more reduced and for a longer period of time than axial back pain and disability. Registration PROSPERO CRD42015026922. These slides can be retrieved under Electronic Supplementary Material.

The diagnostic accuracy of imaging modalities to detect pseudarthrosis after spinal fusion-a systematic review and meta-analysis of the literature.

OBJECTIVE: The aim of the study was to determine the diagnostic accuracy of imaging modalities to detect pseudarthrosis after thoracolumbar spinal fusion, with surgical exploration as reference standard. MATERIALS AND METHODS: A systematic literature search for original studies was performed on the diagnostic accuracy of imaging as index test compared to surgical exploration as reference standard to diagnose pseudarthrosis after thoracolumbar spinal fusion. Diagnostic accuracy values were extracted and methodologic quality of studies was evaluated by the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Per modality, clinically comparable studies were included in subgroup meta-analysis and weighted odds ratios (ORs) were calculated using the random effects model. RESULTS: Fifteen studies were included. Risk of bias was classified as high/unclear in 58% of the studies. Concerns of applicability was classified as high/unclear in 40% of the studies. Four scintigraphy studies including 93 patients in total were pooled to OR = 2.91 (95% confidence interval [CI]: 0.93-9.13). Five studies on plain radiography with 398 patients in total were pooled into OR = 7.07 (95% CI: 2.97-16.86). Two studies evaluating flexion-extension radiography of 75 patients in total were pooled into OR = 4.00 (95% CI: 0.15-105.96). Two studies of 68 patients in total were pooled for CT and yielded OR = 17.02 (95% CI: 6.42-45.10). A single study reporting on polytomography, OR = 10.15 (95% CI 5.49-18.78), was also considered to be an accurate study. CONCLUSIONS: With a pooled OR of 17.02, CT can be considered the most accurate imaging modality for the detection of pseudarthrosis after thoracolumbar spinal fusion from this review.

No Transfer of Pressure to Adjacent Discs During Human Low-Pressure Controlled Discography: A Prospective Clinical Study.

Background: A substantial part of low back pain (LBP) originates from degeneration of the intervertebral disc. To confirm the diagnosis of discogenic pain, provocation discography seems the best available tool. However, provocation discography is also considered to be a controversial and subjective test because the patient's personal pain response is the most crucial for the result of the test. Recently, an in vivo porcine study and a study in nine human subjects showed passing of pressure to the adjacent discs during discography. This could mean that the concordant pain the patient describes originates from an adjacent disc. The object of this study is to assess if during human lumbar pressure-controlled provocation discography there is pressure transmission to adjacent discs. Methods: Consecutive patients between age 18 and 65 years with intractable low back pain and at least 50% preserved height of the suspected painful disc were included. Exclusion criteria were prior lumbar surgery of the suspected level, use of anticoagulants, pregnancy, local infection, and iodine allergy. An arterial blood pressure monitoring system simultaneously assessed the pressure in the adjacent discs while low-speed flow, pressure-controlled discography was performed. Results: In 50 patients with a positive discography, the average intradiscal peak pressure was 15.1 psi (SD = 11.1). In 48 procedures, no pressure rise in the adjacent discs was found. A small pressure rise (1.1 psi) in the adjacent disc during discography was recorded in two patients. Conclusions: Pressure rise in adjacent discs does not seem to occur during low-speed flow pressure-controlled lumbar provocation discography. False-positive pain reactions caused by potentially painful adjacent discs are therefore unlikely during pressure-controlled discography.

Distal radius plate of CFR-PEEK has minimal effect compared to titanium plates on bone parameters in high-resolution peripheral quantitative computed tomography: a pilot study.

BACKGROUND: Carbon-fiber-reinforced poly-ether-ether-ketone (CFR-PEEK) has superior radiolucency compared to other orthopedic implant materials, e.g. titanium or stainless steel, thus allowing metal-artifact-free postoperative monitoring by computed tomography (CT). Recently, high-resolution peripheral quantitative CT (HRpQCT) proved to be a promising technique to monitor the recovery of volumetric bone mineral density (vBMD), micro-architecture and biomechanical parameters in stable conservatively treated distal radius fractures. When using HRpQCT to monitor unstable distal radius fractures that require volar distal radius plating for fixation, radiolucent CFR-PEEK plates may be a better alternative to currently used titanium plates to allow for reliable assessment. In this pilot study, we assessed the effect of a volar distal radius plate made from CFR-PEEK on bone parameters obtained from HRpQCT in comparison to two titanium plates. METHODS: Plates were instrumented in separate cadaveric human fore-arms (n = 3). After instrumentation and after removal of the plates duplicate HRpQCT scans were made of the region covered by the plate. HRpQCT images were visually checked for artifacts. vBMD, micro-architectural and biomechanical parameters were calculated, and compared between the uninstrumented and instrumented radii. RESULTS: No visible image artifacts were observed in the CFR-PEEK plate instrumented radius, and errors in bone parameters ranged from -3.2 to 2.6%. In the radii instrumented with the titanium plates, severe image artifacts were observed and errors in bone parameters ranged between -30.2 and 67.0%. CONCLUSIONS: We recommend using CFR-PEEK plates in longitudinal in vivo studies that monitor the healing process of unstable distal radius fractures treated operatively by plating or bone graft ingrowth.

Patient expectations for management of chronic non-cancer pain: A systematic review.

BACKGROUND: Chronic pain is a major economic and social health problem. Up to 79% of chronic pain patients are unsatisfied with their pain management. Meeting patients' expectations is likely to produce greater satisfaction with care. The challenge is to explore patients' genuine expectations and needs. However, the term expectation encompasses several concepts and may concern different aspects of health-care provision. OBJECTIVE: This review aimed to systematically collect information on types and subject of patients' expectations for chronic pain management. SEARCH STRATEGY: We searched for quantitative and qualitative studies. Because of the multidimensional character of the term "expectations," the search included subject headings and free text words related to the concept of expectations. DATA EXTRACTION AND SYNTHESIS: A framework for understanding patients' expectations was used to map types of expectations within structure, process or outcome of health care. MAIN RESULTS: Twenty-three research papers met the inclusion criteria: 18 quantitative and five qualitative. This review found that assessment of patients' expectations for treatment is mostly limited to outcome expectations (all 18 quantitative papers and four qualitative papers). Patients generally have high expectations regarding pain reduction after treatment, but expectations were higher when expressed as an ideal expectation (81-93% relief) than as a predicted expectation (44-64%). DISCUSSION AND CONCLUSIONS: For health-care providers, for pain management and for pain research purposes, the awareness that patients express different types of expectations is important. For shared decision making in clinical practice, it is important that predicted expectations of the patient are known to the treating physician and discussed. Structure and process expectations are under-represented in our findings. However, exploring and meeting patients' expectations regarding structure, process and outcome aspects of pain management may increase patient satisfaction.

Reduction of intradiscal pressure by the use of polycarbonate-urethane rods as compared to titanium rods in posterior thoracolumbar spinal fixation.

Loss of sagittal alignment and balance in adult spinal deformity can cause severe pain, disability and progressive neurological deficit. When conservative treatment has failed, spinal fusion using rigid instrumentation is currently the salvage treatment to stop further curve progression. However, fusion surgery is associated with high revision rates due to instrumentation failure and proximal junctional failure, especially if patients also suffer from osteoporosis. To address these drawbacks, a less rigid rod construct is proposed, which is hypothesized to provide a more gradual transition of force and load distribution over spinal segments in comparison to stiff titanium rods. In this study, the effect of variation in rod stiffness on the intradiscal pressure (IDP) of fixed spinal segments during flexion-compression loading was assessed. An ex vivo multisegment (porcine) flexion-compression spine test comparing rigid titanium rods with more flexible polycarbonate-urethane (PCU) rods was used. An increase in peak IDP was found for both the titanium and PCU instrumentation groups as compared to the uninstrumented controls. The peak IDP for the spines instrumented with the PCU rods was significantly lower in comparison to the titanium instrumentation group. These results demonstrated the differences in mechanical load transfer characteristics between PCU and titanium rod constructs when subjected to flexion-compression loading. The concept of stabilization with a less rigid rod may be an alternative to fusion with rigid instrumentation, with the aim of decreasing mechanical stress on the instrumented segments and the possible benefit of a decrease in the incidence of screw pullout.

Determining clinical practice of expert physiotherapy for patients undergoing lumbar spinal fusion: a cross-sectional survey study.

PURPOSE: To determine the content of current Dutch expert hospital physiotherapy practice for patients undergoing lumbar spinal fusion (LSF), to gain insight into expert-based clinical practice. METHODS: At each hospital where LSF is performed, one expert physiotherapist received an e-mailed questionnaire, about pre- and postoperative physiotherapy and discharge after LSF. The level of uniformity in goals and interventions was graded on a scale from no uniformity (50-60 %) to very strong uniformity (91-100 %). RESULTS: LSF was performed at 34 of the 67 contacted hospitals. From those 34 hospitals, 28 (82 %) expert physiotherapists completed the survey. Twenty-one percent of the respondents saw patients preoperatively, generally to provide information. Stated postoperative goals and administered interventions focused mainly on performing transfers safely and keeping the patient informed. Outcome measures were scarcely used. There was no uniformity regarding advice on the activities of daily living. CONCLUSION: Dutch perioperative expert physiotherapy for patients undergoing LSF is variable and lacks structural outcome assessment. Studies evaluating the effectiveness of best-practice physiotherapy are warranted.

Dutch Multidisciplinary Guideline for Invasive Treatment of Pain Syndromes of the Lumbosacral Spine.

OBJECTIVES: When conservative therapies such as pain medication or exercise therapy fail, invasive treatment may be indicated for patients with lumbosacral spinal pain. The Dutch Society of Anesthesiologists, in collaboration with the Dutch Orthopedic Association and the Dutch Neurosurgical Society, has taken the initiative to develop the guideline "Spinal low back pain," which describes the evidence regarding diagnostics and invasive treatment of the most common spinal low back pain syndromes, that is, facet joint pain, sacroiliac joint pain, coccygodynia, pain originating from the intervertebral disk, and failed back surgery syndrome. METHODS: The aim of the guideline is to determine which invasive treatment intervention is preferred for each included pain syndrome when conservative treatment has failed. Diagnostic studies were evaluated using the EBRO criteria, and studies on therapies were evaluated with the Grading of Recommendations Assessment, Development and Evaluation system. For the evaluation of invasive treatment options, the guideline committee decided that the outcome measures of pain, function, and quality of life were most important. RESULTS: The definition, epidemiology, pathophysiological mechanism, diagnostics, and recommendations for invasive therapy for each of the spinal back pain syndromes are reported. DISCUSSION: The guideline committee concluded that the categorization of low back pain into merely specific or nonspecific gives insufficient insight into the low back pain problem and does not adequately reflect which therapy is effective for the underlying disorder of a pain syndrome. Based on the guideline "Spinal low back pain," facet joint pain, pain of the sacroiliac joint, and disk pain will be part of a planned nationwide cost-effectiveness study.

Evidence and practice in spine registries.

BACKGROUND AND PURPOSE: We performed a systematic review and a survey in order to (1) evaluate the evidence for the impact of spine registries on the quality of spine care, and with that, on patient-related outcomes, and (2) evaluate the methodology used to organize, analyze, and report the "quality of spine care" from spine registries. METHODS: To study the impact, the literature on all spinal disorders was searched. To study methodology, the search was restricted to degenerative spinal disorders. The risk of bias in the studies included was assessed with the Newcastle-Ottawa scale. Additionally, a survey among registry representatives was performed to acquire information about the methodology and practice of existing registries. RESULTS: 4,273 unique references up to May 2014 were identified, and 1,210 were eligible for screening and assessment. No studies on impact were identified, but 34 studies were identified to study the methodology. Half of these studies (17 of the 34) were judged to have a high risk of bias. The survey identified 25 spine registries, representing 14 countries. The organization of these registries, methods used, analytical approaches, and dissemination of results are presented. INTERPRETATION: We found a lack of evidence that registries have had an impact on the quality of spine care, regardless of whether intervention was non-surgical and/or surgical. To improve the quality of evidence published with registry data, we present several recommendations. Application of these recommendations could lead to registries showing trends, monitoring the quality of spine care given, and ultimately improving the value of the care given to patients with degenerative spinal disorders.

A proposed set of metrics for standardized outcome reporting in the management of low back pain.

BACKGROUND AND PURPOSE: Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set. PATIENTS AND METHODS: An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions. RESULTS: Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on pre-existing tools. INTERPRETATION: The outcome measures recommended here are structured around specific etiologies of LBP, span a patient's entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver.

The Evidence for the Use of Osteobiologics in Hybrid Constructs (Anterior Cervical Discectomy and Fusion and Total Disc Replacement) in Multilevel Cervical Degenerative Disc Disease: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVE: Examine the clinical evidence for the use of osteobiologics in hybrid surgery (combined anterior cervical discectomy and fusion (ACDF) and total disc replacement (TDR)) in patients with multilevel cervical degenerative disc disease (DDD). METHODS: PubMed and Embase were searched between January 2000 and August 2020. Clinical studies investigating 18-80 year old patients with multilevel cervical DDD who underwent hybrid surgery with or without the use of osteobiologics were considered eligible. Two reviewers independently screened and assessed the identified articles. The methodological index for non-randomized studies (MINORS) tool and the risk of bias (RoB 2.0) assessment tool were used to assess risk of bias. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) was used to evaluate quality of evidence across studies per outcome. RESULTS: Eleven studies were included. A decrease in cervical range of motion was observed in most studies for both the hybrid surgery and the control groups consisting of stand-alone ACDF or TDR. Fusion rates of 70-100% were reported in both the hybrid surgery and control groups consisting of stand-alone ACDF. The hybrid surgery group performed better or comparable to the control group in terms of adjacent segment degeneration. Studies reported an improvement in visual analogue scale for pain and neck disability index values after surgery compared to preoperative scores for both treatment groups. The included studies had moderate methodological quality. CONCLUSIONS: There is insufficient evidence for assessing the use of osteobiologics in multilevel hybrid surgery and additional high quality and controlled research is deemed essential.

How a broken vertebra can lead to a fatal hemorrhage: a case report.

BACKGROUND: Unintentional falls are common among the elderly and given the expected increase of the aging population, these falls contribute to a high number of admissions to the emergency department. Relatively low-energy trauma mechanisms can lead to serious injuries in the elderly, with contributing factors being comorbidities, medication use and degenerative abnormalities. CASE PRESENTATION: A 94-year-old female suffered an unintentional fall at home. Upon arrival of the ambulance at her house she was hemodynamically stable and mobilized to the gurney with assistance. During primary survey at the emergency department, her blood pressure and oxygen saturation decreased, she was not able to move her legs anymore and lost consciousness. A full-body CTA was performed, which showed a fracture through the vertebral body of L2 with significant dislocation and a large active bleeding of the corpus, extending to the retroperitoneum and the epidural space. Despite resuscitation, her vital signs deteriorated and given the severe abnormalities on CTA, it was decided to discontinue further treatment, after which she deceased. The performed CTA and an x-ray from 2016 suggested diffuse idiopathic skeletal hyperostosis, which might have contributed to the severity and instability of the vertebral fracture. Mobilization after the fall might have increased the dislocation of the fracture. The use of oral anticoagulants worsened the subsequent bleeding and the extension to the epidural space caused the paralysis of the legs. CONCLUSIONS: It is important to be aware of the possible serious consequences of unintentional falls in the elderly population and to provide strict immobilization of the spinal column until proper imaging.