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Randomized controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (i.e., all important harms or unintended effects in each group). In 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated. Here, we describe CONSORT Harms 2022, which replaces the CONSORT Harms 2004 checklist, and shows how CONSORT Harms 2022 items could be incorporated into the main CONSORT checklist. Thirteen items from the main CONSORT were modified to improve harms reporting. Three new items were added. In this article, we describe CONSORT Harms 2022 and how it was integrated into the main CONSORT checklist and elaborate on each item relevant to complete reporting of harms in randomized controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomized controlled trials should use the integrated checklist presented in this paper.

Many people with fibromyalgia use cannabidiol (CBD) products despite limited rigorous evidence of benefit. In the current study, we conducted a secondary analysis of a cross-sectional survey of N = 878 people with fibromyalgia to investigate naturalistic decision making around CBD product choices, use patterns, and dosing. We subgrouped participants based on use of high-THC cannabis (HTC) in the past year (yes/no) as previous studies have shown that HTC use influences CBD use patterns. The study population was largely female (93.6%), white (91.5%) and 55.5 years old on average. Participants typically purchased CBD products online or at dispensaries, with purchasing driven by personal research (63%) rather than endorsement from medical professionals (16%). Overall, tinctures and topicals were the most common administration routes endorsed. However, participants in the past-year HTC group used inhalation routes far more frequently than those who did not (39.8% vs 7.1%). Among participants using CBD tinctures or edibles, the average dose per session was 16 mg and 24 to 27 mg per day, although approximately one-third of participants did not know what dose of CBD they used. Participants using both inhalation and non-inhalation administration routes reported greater symptom relief than those using non-inhalation routes alone. However, there was no consistent relationship between CBD dose and reported effects, possibly due to expectancy effects around CBD products or interindividual variability. Our granular investigation reveals variability of CBD product dosing practices for fibromyalgia, and how past-year HTC use influences CBD product use. Future clinical trials should investigate the potential benefits of low-dose (50mg) botanical CBD products. PERSPECTIVE: This article shows that past-year HTC use strongly influences how people with fibromyalgia choose and use CBD products. Participants typically used50 mg/d of CBD, and there was no relationship between higher CBD dose and reported therapeutic benefit. Future clinical trials should investigate therapeutic benefits of low dose CBD.

Musculoskeletal (MSK) sequelae of severe acute respiratory syndrome coronavirus 2 infections seem to be common.Mechanisms of such effects are becoming clear.There is a complex interplay of biopsychosocial effects associated with MSK symptoms after acute coronavirus disease 2019.Additional research should focus on completely describing the breadth of these MSK sequelae and related psychosocial symptoms.

People report substituting cannabis for pain medications, but whether cannabidiol (CBD) is used similarly remains unknown. CBD products can be CBD alone (isolate), hemp extract (containing0.3% Δ-9-tetrahydrocannabinol [THC], other cannabinoids, and terpenes), or CBD-cannabis (containing0.3% THC). In a secondary analysis from a cross-sectional survey, we examined substitution patterns among n = 878 individuals with fibromyalgia who currently used CBD. We sub-grouped participants by most commonly used CBD product (CBD isolate, hemp, CBD-cannabis, no preference) and whether they substituted CBD for medications. We investigated rationale for substituting, substitution-driven medication changes, CBD use patterns, and changes in pain-related symptoms (eg, sleep, anxiety). The study population was 93.6% female and 91.5% Caucasian, with an average age of 55.5 years. The majority (n = 632, 72.0%) reported substituting CBD products for medications, most commonly NSAIDs (59.0%), opioids (53.3%), gabapentanoids (35.0%), and benzodiazepines (23.1%). Most substituting participants reported decreasing or stopping use of these pain medications. The most common reasons for substitution were fewer side effects and better symptom management. Age, hemp products, past-year use of marijuana, and higher somatic burden were all associated with substituting (P's ≤ .05). Those who substituted reported larger improvements in health and pain than those who did not. Participants using CBD-cannabis reported significantly more substitutions than any other group (P's ≤ .001) and larger improvements in health, pain, memory, and sleep than other subgroups. This widespread naturalistic substitution for pain medications suggests the need for more rigorous study designs to examine this effect. PERSPECTIVE: This article shows that people with fibromyalgia are deliberately substituting CBD products for conventional pain medications despite the dearth of evidence suggesting CBD products may be helpful for fibromyalgia. CBD's medication-sparing and therapeutic potential should be examined in more rigorous study designs.

BACKGROUND Previous studies have shown that non-surgical management can be an effective treatment strategy for many patients with rotator cuff tears. Despite the prevalence of rotator cuff disease, few studies have examined the patient and tear related factors that predict outcomes of nonsurgical management in this cohort of patients. AIM To identify factors that are associated with changes in patient reported outcomes over time in individuals with full-thickness rotator cuff tears treated without surgery. METHODS A cohort of 59 patients who underwent non-surgical management of full thickness rotator cuff tears with a minimum of 1-year follow-up were identified from our institutional registry. Patient demographics, comorbidities and tear characteristics were collected at initial presentation. Outcome measures were collected at baseline and at each clinical follow-up, which included Western Ontario Rotator Cuff (WORC) index, American Shoulder and Elbow Surgeons score, Visual Analog Scale for pain and Single Assessment Numerical Evaluation. Multi- and univariate regression analyses were used to determine the impact of each patient and tear related variable on final WORC scores and change in WORC scores throughout the study. RESULTS In this non-surgical cohort, all patient-reported outcome measures significantly improved compared to baseline at 1 and 2-year follow-up. There was no significant difference in outcomes between 1 and 2 years. The average improvement surpassed the published minimal clinically important differences values for WORC, American Shoulder and Elbow Surgeons, Visual Analog Scale pain and Single Assessment Numerical Evaluation scores. Regression analysis identified female gender (β = - 19.88, P = 0.003), smoking (β = -29.98, P = 0.014) and significant subscapularis fatty infiltration (β = -15.35, P = 0.024) as predictors of less favorable WORC scores at 1 year, and female gender (β = -19.09, P = 0.015) alone as a predictor of lower WORC scores at 2 years. Patients with symptom duration greater than 1 year at presentation reported less improvement in WORC scores at 1-year follow-up (β = -14.63, P = 0.052) and patients with traumatic tears reported greater improvements in WORC scores at 2-year follow-up (β = 17.37, P = 0.031). CONCLUSION Patients with full thickness rotator cuff tears can achieve and maintain clinically meaningful benefit from non-surgical management through 2-year follow-up. Female patients, smokers, and those with significant subscapularis fatty infiltration tend to have lower overall WORC scores at 1-year follow-up, and females also have lower WORC scores at 2-year follow-up. Patients presenting with symptoms greater than 1 year had less clinical improvement at 1-year follow-up, and those with traumatic tears had greater clinical improvement at 2-year follow-up.

Background and Objective To evaluate the association between the nature of findings and the switching of registered primary outcomes among randomized controlled trials (RCTs) from mainland China. Methods This is a retrospective cohort study. We retrieved RCTs from trial registries and identified the corresponding journal articles from bibliographic databases until August 2019. Trial registries and journal articles were compared to evaluate whether registered primary outcomes with negative findings were more likely to be switched to secondary outcomes in the subsequent journal articles than those with positive findings. Results Switching of registered primary outcomes occurred in 131 (45%) of 294 RCTs. A total of 450 registered primary outcomes were matched to 522 (37%) primary outcomes and 871 (63%) secondary outcomes in the journal articles. Among RCTs registered before they started, the odds of switching primary outcomes with negative findings were 2.64 (95% CI: 1.16–6.02) times the odds of switching those with positive findings. Among RCTs registered when they were ongoing, the odds of switching primary outcomes with negative findings were 8.84 (95% CI: 3.62–25.93) times the odds of switching those with positive findings. Conclusion The nature of findings may play a role in how likely a prespecified primary outcome is switched subsequently.

BACKGROUND The anterior approach to the cervical spine is commonly used to treat cervical pathology. It is, however, associated with high rates of dysphagia, which may be associated with substantial patient morbidity. Perioperative corticosteroid administration has been advocated to decrease dysphagia rates; its efficacy, however, remains uncertain. We conducted a meta-analysis of randomized trials to determine the efficacy of perioperative corticosteroid administration in reducing postoperative dysphagia as well as any adverse effects, such as pseudarthrosis and infection. METHODS We conducted a systematic search of electronic databases (MEDLINE, Embase, CENTRAL [Cochrane Central Register of Controlled Trials], ClinicalTrials.gov) to identify randomized controlled trials (RCTs) that evaluated corticosteroids versus any comparator for prevention of postoperative dysphagia after anterior cervical spine procedures. Two independent reviewers used the GRADE (Grades of Recommendation Assessment, Development and Evaluation) criteria to assess eligibility and risk of bias, perform data extraction, and rate the quality of evidence. The primary outcome was severity of postoperative dysphagia. We conducted meta-analyses of dysphagia (both overall and by delivery method), pseudarthrosis, and postoperative infection. RESULTS After screening of 927 articles, a total of 7 studies were eligible for final inclusion. These included 431 patients, of whom 247 received corticosteroids and 184 received placebo or a control treatment. Moderate-quality evidence demonstrated a significant improvement in postoperative dysphagia rates (odds ratio, 0.35; 95% confidence interval, 0.20 to 0.63; p < 0.001), and this finding was robust to both permutation analyses and sensitivity analyses removing the studies with a high risk of bias. There was no significant difference between intravenous and local steroid administration (p = 0.16). There were no documented infections. There was no significantly increased risk of pseudarthrosis in those receiving steroids compared with placebo or a control treatment (p = 0.13). CONCLUSIONS This meta-analysis found moderate-quality evidence supporting the use of perioperative corticosteroid administration as an adjunct to anterior cervical spinal procedures. Patients treated with corticosteroids intravenously or locally had significantly decreased severity of dysphagia. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Compare radiographic outcomes, complications, and QoL in neuromuscular early-onset scoliosis (EOS) patients treated with single posterior spinal fusion (PSF) versus growth-friendly surgery and definitive fusion (GFDF). In a retrospective cohort study, children with neuromuscular EOS, age 8–11 years at index surgery with PSF or GF devices, with minimum 2-year follow-up after final fusion were identified from a multicenter database. 16 PSF and 43 GFDF patients were analyzed. Demographics were similar except PSF patients were older at index surgery and had shorter follow-up. PSF patients had greater percentage major curve correction (62% vs 38%, p = 0.001) and smaller major curve at final follow-up (23° vs 40°, p = 0.005). The GFDF group underwent over five times more surgeries (8.7 vs 1.6, p = 0.0001). Four PSF patients (25%) experienced ten complications, resulting in five unplanned returns to the operating room (UPROR) in three patients (19%). 36 GFDF patients (84%) experienced 83 complications, resulting in 45 UPRORs in 24 patients (56%). Poisson regression adjusted for age showed that the GFDF group had more complications (p = 0.001) and UPRORs (p = 0.01). Although the GFDF patients had smaller preoperative T1–T12 and T1–S1 lengths, these were similar to the PSF patients at final follow-up, indicating that the GFDF patients had greater spinal growth. PSF patients had better postoperative EOSQ-24 Financial Impact and Family Burden scores. While there was a difference in age at index surgery, PSF may be more effective than GFDF at controlling neuromuscular EOS. GFDF patients achieved more spinal growth but eight times more complications and nine times more UPRORs.

Previous reports have demonstrated the effectiveness of casting for EOS. Brace treatment for EOS has not been studied. The purpose of this multicenter retrospective study was to compare radiographic outcomes, complications, and rates of conversion to surgery in children with EOS treated with casting or bracing. Children aged 2–6 years with idiopathic or neuromuscular EOS treated with casting or bracing with minimum follow-up of 2 years were identified. 68 patients (36 cast, 32 brace) were analyzed. Diagnosis, age at start of treatment, and duration of follow-up were similar. Although the cast patients had a larger pre-treatment major curve magnitude (50° vs 31°, p

Background Numerous publications describe the clinical manifestations of post-acute sequelae of SARS-CoV-2 (PASC or "long COVID"), but they are difficult to integrate because of heterogeneous methods and the lack of a standard for denoting the many phenotypic manifestations. Patient-led studies are of particular importance for understanding the natural history of COVID-19, but integration is hampered because they often use different terms to describe the same symptom or condition. This significant disparity in patient versus clinical characterization motivated the proposed ontological approach to specifying manifestations, which will improve capture and integration of future long COVID studies. Methods The Human Phenotype Ontology (HPO) is a widely used standard for exchange and analysis of phenotypic abnormalities in human disease but has not yet been applied to the analysis of COVID-19. Findings We identified 303 articles published before April 29, 2021, curated 59 relevant manuscripts that described clinical manifestations in 81 cohorts three weeks or more following acute COVID-19, and mapped 287 unique clinical findings to HPO terms. We present layperson synonyms and definitions that can be used to link patient self-report questionnaires to standard medical terminology. Long COVID clinical manifestations are not assessed consistently across studies, and most manifestations have been reported with a wide range of synonyms by different authors. Across at least 10 cohorts, authors reported 31 unique clinical features corresponding to HPO terms; the most commonly reported feature was Fatigue (median 45.1%) and the least commonly reported was Nausea (median 3.9%), but the reported percentages varied widely between studies. Interpretation Translating long COVID manifestations into computable HPO terms will improve analysis, data capture, and classification of long COVID patients. If researchers, clinicians, and patients share a common language, then studies can be compared/pooled more effectively. Furthermore, mapping lay terminology to HPO will help patients assist clinicians and researchers in creating phenotypic characterizations that are computationally accessible, thereby improving the stratification, diagnosis, and treatment of long COVID. Funding U24TR002306; UL1TR001439; P30AG024832; GBMF4552; R01HG010067; UL1TR002535; K23HL128909; UL1TR002389; K99GM145411 .

Background: The evidence in support of operative versus nonoperative management of rotator cuff tears (RCTs) is limited, based primarily on observational studies of lower scientific merit. Purpose: To (1) compare the efficacy of operative versus nonoperative management of full-thickness RCTs across time and (2) detect variables that predict success within each group. Study Design: Cohort study; Level of evidence, 2. Methods: We included patients with symptomatic full-thickness RCTs who were enrolled in an institutional shoulder registry. Patient enrollment began in 2009 and continued until early 2018. The following outcome measures were collected at baseline, then 6 months, 1 year, and annually up to 5 years postoperatively: Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score, Veterans RAND 12-Item Health Survey (VR-12) mental and physical component subscales (MCS and PCS, respectively), 100-point Single Assessment Numeric Evaluation (SANE) rating, and 100-point visual analog scale (VAS) for pain and for patient satisfaction. We performed regression models for all outcome variables across all 5 years of follow-up and included the following predictor variables: treatment type (operative vs nonoperative), sex, age, symptom duration, smoking status, diabetes status, injury side, and obesity status. Results: A total of 595 patients were included. Longitudinal mixed-effects regression revealed that patients who received operative treatment did better across time on all outcomes. Women (n = 242; 40.7%) did not fare as well as did men on the ASES, WORC, or VR-12 PCS. Older patients tended to improve less on the VR-12 PCS and more on the VR12-MCS. Patients with longer symptom duration at baseline had better scores across time on the ASES, WORC, VAS for pain, and SANE. Current or recent smokers and patients with diabetes tended to have lower scores on all measures across time. For changes in scores from baseline, patients in the operative group improved to a larger degree out to 3 years compared with those in the nonoperative group. Conclusion: Patients with RCTs tended to improve regardless of whether they received operative or nonoperative treatment, but patients who underwent operative treatment improved faster. There appear to be several predictors of improved and worsened outcomes for patients with RCTs undergoing operative or nonoperative treatment.

Purpose: To develop a set of consensus and empirically based reporting recommendations for primary studies of the measurement properties of patient-reported outcome measures (PROMs). Methods: This study included four phases: 1. Conducting an extensive literature review of recommendations for reporting of studies testing measurement properties of PROMs; 2. Preparing for the Delphi study by identifying experts; 3. Conducting three Delphi rounds aiming for consensus on the item list of recommendations found in phase 1; 4. Developing the COSMIN reporting guideline and user manual. Results: The literature review resulted in 93 reporting items, included in the first Delphi round. A total of 84 individuals (from 12 countries) agreed to participate in the Delphi study, with 47, 30 and 25 responding in rounds one, two and three, respectively. After three rounds, we achieved consensus on a set of 71 items separated into a set of 35 "common" items (relevant to all studies on measurement properties) and 41 "specific" items (exclusively relevant to one of the nine measurement properties). Conclusion: Consensus was achieved on a set of 71 items for inclusion in a reporting guideline for studies on measurement properties of PROMs. These items will guide researchers on the necessary information to include in their reports of investigations of measurement properties of PROMs. This guideline will likely improve the completeness of reporting of these important studies.

Background Radiographically assessing skeletal maturity is of paramount importance to guide appropriate management for patients with adolescent idiopathic scoliosis. The reported advantages of the Humeral Head Ossification System (HHOS) are an even distribution around peak growth age (PGA), the presence of an optimal view of the humeral head in most scoliosis radiographs, and an interobserver and intraobserver reliability of 0.95 and 0.96, respectively. The goal of this study was to determine whether similar reliability could be achieved at an institution other than the one at which the HHOS was originally described. Methods Six raters used the HHOS to stage the humeral head on 30 deidentified posteroanterior spine radiographs. This process was repeated 2 weeks later. All raters were provided with a document demonstrating the radiographic parameters of each stage, as well as annotations to aid with classification. Intraclass coefficients were calculated. A secondary analysis was then performed grouping stages 1-2 as "pre-PGA" and 3-5 as "post-PGA." Results Fair to moderate interobserver and intraobserver reliability was achieved when determining each individual HHOS stage. This improved to good to excellent when the humeral was classified as pre-PGA or post-PGA. Subanalysis did not show any correlation between intraobserver reliability and level of orthopaedic experience. Conclusions We found fair to moderate interobserver and intraobserver reliability with the HHOS and this was independent of level of orthopaedic experience. This is much lower than reported by the authors who developed the system, and suggests that the HHOS might not be as easy to incorporate into a scoliosis management algorithm as previously noted. The improved reliability achieved when staging the humeral head as pre-PGA or post-PGA might be the true benefit of this system. Level of evidence Level III-diagnostic.

Purpose Higher pedicle screw density posterior spinal fusion (PSF) constructs have not been shown to result in improved curve correction in Lenke 1 and 5 adolescent idiopathic scoliosis (AIS) but do increase cost. The purpose of this study questioned whether higher screw density constructs improved curve correction and maintenance of correction in Lenke 2 AIS. Secondary goals were to identify predictive factors for correction and postoperative magnitude of curves in Lenke 2 AIS. Methods We identified patients 11 to 17 years old who underwent primary PSF for Lenke 2 AIS between 2007 and 2017 who had minimum follow-up of 2 years. Demographic and radiographic data were collected to perform regression and elimination analysis. Results Thirty patients (21 females, 9 males) were analyzed. Average age and SD at time of surgery was 14.0 ± 1.8 years (range, 11–17 years), and median follow-up was 2.8 years (IQR 2.1–4.0 years). Implant density did not predict final postoperative curve magnitude. Predictors of final postoperative curve magnitude were sex and preoperative curve magnitude. Predictors of percentage of correction of major curve were sex and age at the time of surgery. Predictors of final postoperative thoracic kyphosis were sex and percent flexibility preop. Females had lower final postoperative major curve magnitude, a higher percent curve correction, and lower postoperative thoracic kyphosis. Conclusions Increased implant density is not predictive of postoperative curve magnitude in Lenke 2 AIS. Predictors of postoperative curve magnitude are sex and preoperative curve magnitude. Level of evidence Level III, retrospective observational

To develop a set of consensus and empirically based reporting recommendations for primary studies of the measurement properties of patient-reported outcome measures (PROMs).This study included four phases: 1. Conducting an extensive literature review of recommendations for reporting of studies testing measurement properties of PROMs; 2. Preparing for the Delphi study by identifying experts; 3. Conducting three Delphi rounds aiming for consensus on the item list of recommendations found in phase 1; 4. Developing the COSMIN reporting guideline and user manual.The literature review resulted in 93 reporting items, included in the first Delphi round. A total of 84 individuals (from 12 countries) agreed to participate in the Delphi study, with 47, 30 and 25 responding in rounds one, two and three, respectively. After three rounds, we achieved consensus on a set of 71 items separated into a set of 35 "common" items (relevant to all studies on measurement properties) and 41 "specific" items (exclusively relevant to one of the nine measurement properties).Consensus was achieved on a set of 71 items for inclusion in a reporting guideline for studies on measurement properties of PROMs. These items will guide researchers on the necessary information to include in their reports of investigations of measurement properties of PROMs. This guideline will likely improve the completeness of reporting of these important studies.

BACKGROUND CONTEXT Although patient-reported outcomes (PROs) have become important in the evaluation of spine surgery patients, the accuracy of patient recall of pre or post-intervention symptoms following epidural steroid injection remains unknown. PURPOSE The purpose of this study was 1) to characterize the accuracy of patient recollection of back/leg pain following epidural steroid injection; 2) characterize the direction and magnitude of recall bias; 3) characterize factors that impact patient recollection. STUDY DESIGN/SETTING Prospective cohort study. PATIENT SAMPLE Consecutive patients 18 years and older undergoing lumbar epidural steroid injection presenting with neurogenic claudication or radiculopathy secondary to degenerative lumbar spinal stenosis OUTCOME MEASURES Numeric pain scale (NPS) for back pain and leg pain. METHODS Using standardized questionnaires, we recorded numeric pain scores (NPS) for patients undergoing lumbar epidural steroid injections at our institution. Baseline pain scores were obtained prior to injection, 4 hours and 24-hours post-injection. At a minimum of 2 weeks following the injection, patients were asked to recall their symptoms pre-injection and at 4 hours and 24-hours post-injection. Actual and recalled scores at each time point were compared using paired t-tests. Multivariable linear regression was used to identify factors that impacted recollection. RESULTS Sixty-one patients with a mean age of 61.4 years (56% female) were included. Compared to their pre-injection pain score, patients showed considerable improvement at both 4 hours [Mean Difference (MD) = 2.18, 95% Confidence Interval (CI) 1.42 to 2.94)) and 24 hours (MD = 2.64, 95% CI 1.91 to 3.34) post-injection. Patient recollection of pre-injection symptoms was significantly more severe than actual (MD = 1.39, 95% CI 4.82 to 6.08). The magnitude of recall bias was moderate to severe and exceeded the minimal clinically important difference (MCID). Patient recollection of symptoms was also significantly more severe than actual at 24 hours (MD = 0.63, 95% CI -1.17 to -0.07), mild magnitude of bias that did not exceed MCID. No significant recall bias was noted on patient recollection of post-injection symptoms at 4 hours (MD = 0.41, 95% CI -1.05 to 0.23). Linear regression models for differences between actual and recalled pain scores reveal that for recall at 4 hours post-injection, older patients were better at recalling pain. CONCLUSIONS Relying on patient recollection does not provide an accurate measure of pre-injection status after lumbar epidural steroid injection, although patients did recall their 4 hour and 24-hour post-injection status. These findings support previous studies indicating that relying on patient recollection does not provide an accurate measure of pre-intervention symptoms. Patient recollection of post-intervention symptoms, however, may have some clinical utility and requires further study. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

Introduction: The world’s opioid epidemic has gotten increasingly severe over the last several decades and projects to continue worsening. Orthopedic surgery is the largest contributor to this epidemic, accounting for 8.8% of postoperative opioid dependence cases. Total knee arthroplasty (TKA) and anterior cruciate ligament (ACL) reconstruction are commonly performed orthopedic operations heavily reliant on opioids as the primary analgesic in the peri- and immediate postoperative period. These downfalls highlight the pressing need for an alternate, non-pharmacologic analgesic to reduce postoperative opioid use in orthopedic patients. The presented systematic review aimed to analyze and compare the most promising non-pharmacologic analgesic interventions in the available literature to guide future research in such a novel field. Methods: A systematic search of PubMed, MEDLINE, Embase, Cochrane, and Web of Science was performed for studies published before July 2020 based on the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines, and the obtained manuscripts were evaluated for inclusion or exclusion against strict, pre-determined criteria. Risk-of-bias and GRADE (grades of recommendation, assessment, development, and evaluation) assessments were then performed on all included studies. Results: Six studies were deemed fit for inclusion, investigating three non-pharmacologic analgesics: percutaneous peripheral nerve stimulation, cryoneurolysis, and auricular acupressure. All three successfully reduced postoperative opioid use while simultaneously maintaining the safety and efficacy of the procedure. Discussion: The results indicate that all three presented non-pharmacologic analgesic interventions are viable and warrant future research. That said, because of its slight advantages in postoperative pain control and operational outcomes, cryoneurolysis seems to be the most promising. Further research and eventual clinical implementation of these analgesics is not only warranted but should be a priority because of their vast potential to reduce orthopedics surgeries’ contribution to the opioid epidemic.

Cannabidiol (CBD) is widely advertised as helpful for chronic pain management but research is limited. Using a cross-sectional, anonymous survey, we examined patterns of naturalistic CBD use among individuals with fibromyalgia (FM) and other chronic pain conditions. Our objective was to better understand rates of CBD use, reasons for use and discontinuation, communication with healthcare professionals about CBD, and perceptions of CBD effectiveness and safety among people with FM. After excluding incomplete surveys, our study population consisted of N = 2,701 participants with fibromyalgia, primarily in the United States. Overall, 38.1% reported never using CBD, 29.4% reported past CBD use, and 32.4% reported current CBD use. Past-year cannabis use was strongly associated with past or current CBD use. Those using CBD typically did so due to inadequate symptom relief, while those not using CBD typically cited safety concerns as their reason for not using CBD. Two-thirds of participants disclosed CBD use to their physician, although only 33% asked for physician advice on using CBD. Participants used CBD for numerous FM-related symptoms (most commonly pain), and generally reported slight to much improvement across symptom domains. Around half of participants reported side effects, which were typically minor. Our findings are limited by selection bias and our cross-sectional design, which prevents causal associations. In conclusion, CBD use is common among individuals with FM and many individuals using CBD report improvements across numerous FM-related symptoms. Our findings highlight the need for additional rigorous studies to better understand CBD's potential for FM management. Perspective This article indicates that CBD use is common among people with fibromyalgia, and the results suggest that many derive benefit from using CBD across multiple symptoms domains. Clinicians should discuss CBD use with fibromyalgia patients, and future studies are needed to rigorously assess CBD's therapeutic value for fibromyalgia symptoms.

Objectives: There has been a rise in elbow ulnar collateral ligament (UCL) injuries in youth pitchers over recent years. With forearm flexor-pronator mass fatigue, the dynamic stability provided could be diminished placing greater stress on the UCL. Pitch count limits have been instituted in an attempt to help curtail this rise in throwing injuries, especially in youth athletes. In order to provide more objective data regarding current pitch count limits for youth pitchers, the purpose of this pilot study was to evaluate for potential fatigue of the flexor-pronator mass by assessing changes in medial elbow laxity, noninvasively characterizing changes in muscle glycogen storage within the forearm flexor-pronator mass, and evaluating changes in subjective fatigue, strength, range of motion (ROM), pitching velocity, and accuracy with increasing number of pitches thrown by 10-year-old pitchers up to their recommended 75 pitch count limit. Methods: After appropriate power analysis, male pitchers 10 years of age were recruited for the study (n=22). Pitchers threw a total of 75 pitches divided into sets of 25 pitches, with standardized periods of rest in between throws and sets to best simulate a game. Bilateral medial elbow laxity was measured by applying 10 decanewtons of valgus force with a standardized stress device and utilizing ultrasound imaging (Figures 1A-B) prior to pitching and after each pitching set. The change in medial ulnohumeral joint distance (Figure 1C) after stress was applied was calculated from baseline without stress. Relative changes in muscle glycogen storage, detected as changes in echogenicity, within the flexor carpi radialis (FCR) and the flexor digitorum superficialis (FDS)/flexor carpi ulnaris (FCU) muscles were measured non-invasively with ultrasound-based software (Figures 1D-E) and recorded as fuel percentile. Repeated measures analysis of variance and post-hoc testing were used to determine statistical significance (alpha=0.05). Results: There were no significant differences in medial elbow laxity between arms or time points. There was a trend for similar decline in FCR fuel percentile values between each arm, indicating relative decreases in glycogen storage bilaterally. However, only the throwing arm demonstrated a statistically significant decline in fuel percentile from baseline to after 75 pitches (p=0.05). There were no statistically significant differences across time points for FDS/FCU fuel percentile values. Fatigue measurements for both arms were significantly higher at all time points compared to baseline (p≤0.03). Grip strength of the dominant arm after 75 pitches was significantly decreased compared to after 25 pitches (p=0.02). There were no statistically significant changes in other strength measurements, ROM, velocity, or accuracy between all time points. Conclusions: By the recommended 75 pitch count limit in 10-year-olds, subjective fatigue and a decrease in grip strength had occurred. Furthermore, relative glycogen storage of the flexor-pronator mass of the throwing arm decreased between pitching 50 to 75 pitches, but without an increase in medial elbow gapping. This study provides a foundation and raises questions for further objective testing of physiologic changes that occur throughout increasing pitching to better guide pitch count limits and ensure the safety of young athletes

A shift toward a value-driven health-care model has made prospective collection of patient-reported outcome measures (PROMs) inextricably tied to measuring the success of orthopaedic surgery and patient satisfaction. While progress has been made in optimizing the utilization of PROM data, including establishing appropriate PROMs for a procedure and determining the clinical importance of unique tools, if these PROMs are not accurately analyzed and reported, a proportion of patients who do not reach the clinical thresholds may go unnoticed. Furthermore, parameters are unclear for setting a statistically and clinically important PROM threshold along with a minimum period for follow-up data collection.In this forum, we walk through simulated data sets modeling PROMs with the example of total joint arthroplasty. We discuss how the commonly used method of reporting PROMs by mean change can overestimate the treatment effects for the cohort as a whole and fail to capture distinct populations that are below a clinically relevant threshold. We demonstrate that when a study's outcome is PROMs, clinical importance should be reported using clinical thresholds such as the minimum clinically important difference (MCID), the smallest change in the treatment outcome that a patient perceives as beneficial, and the patient acceptable symptom state (PASS), the highest level of symptoms beyond which a patient considers himself or herself well. Finally, we propose a standardized reporting of PROMs that incorporates both the MCID and the PASS, and introduce a "clinical relevance ratio," which relies on a clinically relevant threshold to dichotomize outcomes and reports the number of patients achieving clinical importance at a given time point divided by the total number of patients included in the study. Unlike other common PROM-reporting approaches, the clinical relevance ratio is not skewed by patients who are lost to follow-up with increased time.

Patient reported outcome measures (PROMs) are key tools when performing clinical research and PROM data are increasingly used to inform clinical decision-making, patient-centered care, health policy and more recently, reimbursement decisions. PROMs must possess particular properties before they are used. Thus purpose of this paper is to give an overview of PROMs, their definition, how their evidence can be assessed, how they should be reported in clinical research, how to choose PROMs, the types of PROMs available in orthopaedics, where these measures can be found, PROMs in orthopaedic clinical practice and what are some key next steps in this field. If PROMs are used in accordance with the guidance in this article, I believe we will gain considerable insight into PROMs in orthopaedics and will advance this field in a way that can contribute to science, improve patient care and save considerable resources. This article is protected by copyright. All rights reserved

© 2017 Elsevier Inc. Background Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 2011–2012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages. Objectives This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports. Article Design and Setting Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers. Results and Conclusion This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports.

Physiological systems like bone respond to many genetic and environmental factors by adjusting traits in a highly coordinated, compensatory manner to establish organ-level function. To be mechanically functional, a bone should be sufficiently stiff and strong to support physiological loads. Factors impairing this process are expected to compromise strength and increase fracture risk. We tested the hypotheses that individuals with reduced stiffness relative to body size will show an increased risk of fracturing and that reduced strength arises from the acquisition of biologically distinct sets of traits (ie, different combinations of morphological and tissue-level mechanical properties). We assessed tibial functionality retrospectively for 336 young adult women and men engaged in military training, and calculated robustness (total area/bone length), cortical area (Ct.Ar), and tissue-mineral density (TMD). These three traits explained 69% to 72% of the variation in tibial stiffness (p

Background The CONSORT statement is intended to improve reporting of randomised controlled trials and focuses on minimising the risk of bias (internal validity). The applicability of a trial’s results (generalisability or external validity) is also important, particularly for pragmatic trials. A pragmatic trial (a term first used in 1967 by Schwartz and Lellouch) can be broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice. This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability. Methods At two, two-day meetings held in Toronto in 2005 and 2008, we reviewed the CONSORT statement and its extensions, the literature on pragmatic trials and applicability, and our experiences in conducting pragmatic trials. Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials: the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings. These extensions are presented, along with illustrative examples of reporting, and an explanation of each extension. Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of randomised controlled trials are to their own conditions. Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions. In the meantime we recommend that those who support, conduct, and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care., Pragmatic trials are designed to inform decisions about practice, but poor reporting can reduce their usefulness. The CONSORT and Practihc groups describe modifications to the CONSORT guidelines to help readers assess the applicability of the results

Background A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Primary Objective Develop, disseminate, and implement systematic reporting guidelines for case reports. Methods We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. Results This consensus process involved 27 participants and resulted in a 13-item checklist - a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. Conclusions We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. © 2014 Elsevier Inc. All rights reserved.

Systematic review of randomized controlled trials (RCTs).To determine the effectiveness of herbal medicine for nonspecific low back pain (LBP).Many people with chronic LBP use complementary and alternative medicine (CAM), visit CAM practitioners, or both. Several herbal medicines have been purported for use in treating people with LBP. This is an update of a Cochrane Review first published in 2006.We searched numerous electronic databases up to September 2014; checked reference lists in review articles, guidelines and retrieved trials; and personally contacted individuals with expertise in this area. We included RCTs examining adults (over 18 years of age) suffering from acute, sub-acute, or chronic nonspecific LBP. The interventions were herbal medicines that we defined as plants used for medicinal purposes in any form. Primary outcome measures were pain and function. Two review authors assessed risk of bias, GRADE criteria (GRADE 2004), and CONSORT compliance and a random subset were compared with assessments by a third individual. Two review authors assessed clinical relevance and resolved any disagreements by consensus.Fourteen RCTs (2050 participants) were included. Capsicum frutescens (cayenne) reduces pain more than placebo. Although Harpagophytum procumbens (devil's claw), Salix alba (white willow bark), Symphytum officinale L. (comfrey), Solidago chilensis (Brazilian arnica), and lavender essential oil also seem to reduce pain more than placebo, evidence for these substances was of moderate quality at best. No significant adverse events were noted within the included trials.Additional well-designed large trials are needed to test these herbal medicines against standard treatments. In general, the completeness of reporting in these trials was poor. Trialists should refer to the CONSORT statement extension for reporting trials of herbal medicine interventions.N/A.

Background: Anterior cruciate ligament (ACL) injuries are common, result in significant morbidity, and are expensive to repair surgically and to rehabilitate. Several randomized and observational studies have tested neuromuscular interventions as preventive measures for these injuries. Purpose: To conduct a systematic review and meta-analysis of all known comparative studies for estimating and testing the effect of neuromuscular and educational interventions on the incidence of ACL injuries in adolescents and adults, both male and female. Study Design: Systematic review and meta-analysis. Methods: Several databases were used to identify eligible studies through July 4, 2011: MEDLINE, EMBASE, SPORTDiscus, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Central Register of Controlled Trials, and Health Technology Assessment. Eligible studies were assessed for risk of bias, and meta-analyses were performed on the estimated intervention effect (log incidence rate ratio) using inverse-variance weighting, subgroup analysis, and random-effects meta-regression to estimate the overall (pooled) effect and explore heterogeneity of effect across studies (measured by I2 and tested with the Q statistic). Results: Eight cohort (observational) studies and 6 randomized trials were included, involving a total of approximately 27,000 participants. The random-effects meta-analysis yielded a pooled rate-ratio estimate of 0.485 (95% confidence interval [CI], 0.299-0.788; P = .003), indicating a lower ACL rate in the intervention groups, but there was appreciable heterogeneity of the estimated effect across studies ( I2 = 64%; P = .001). In the meta-regressions, the estimated effect was stronger for studies that were not randomized, performed in the United States, conducted in soccer players, had a longer duration of follow-up (more than 1 season), and had more hours of training per week in the intervention group, better compliance, and no dropouts. Nevertheless, residual heterogeneity was still observed within subgroups of those variables ( I2 > 50%; P < .10). Conclusion: The authors found that various types of neuromuscular and educational interventions appear to reduce the incidence rate of ACL injuries by approximately 50%, but the estimated effect varied appreciably among studies and was not able to explain most of that variability. Clinical Relevance: Neuromuscular and educational interventions appear to reduce the incidence rate of ACL injuries by approximately 50%.

Background The direct anterior approach (DAA) for total hip arthroplasty (THA) has rapidly become popular, but there is little consensus regarding the risks and benefits of this approach in comparison with a modern posterior approach (PA). Methods A total of 2147 patients who underwent DAA THA were propensity score matched with patients undergoing PA THA on the basis of age, gender, body mass index, and American Society of Anesthesia classification using data from a state joint replacement registry. Mean age of the matched cohort was 64.8 years, mean body mass index was 29.1 kg/m 2 , and 53% were female. Multilevel logistic regression models using generalized estimating equations to control for grouping at the hospital level were used to identify differences in various outcomes. Results There was no difference in the dislocation rate between patients undergoing DAA (0.84%) and PA (0.79%) THA. Trends indicating a slightly longer length of stay with the PA and a slightly greater risk of fracture, increased blood loss, and hematoma with the DAA are consistent with previous studies. Conclusion On the basis of short-term outcome and complication data, neither approach has a compelling advantage over each other, including no difference in the dislocation risk.

Introduction - Natural health products (e.g., vitamins, minerals, herbal medicines) are frequently used for musculoskeletal pain and there is an increasing amount of high quality research being done to test the efficacy of these interventions. Low back pain is a very common condition and individuals suffering from these conditions are frequently seeking out these products. Objective - The objective of this paper is to review and summarize the evidence surrounding natural health products for chronic non-specific low back pain. Methods - We searched for systematic reviews and randomized controlled trials in PubMed and the Cochrane Library. We performed a best evidence synthesis of the resulting papers. Results - We included two systematic reviews and 2 additional randomized controlled trials published subsequently to these reviews. We found strong evidence for 50 mg harpagoside per dose of an aqueous extract of Harpagophytum procumbens per day reduces pain more than placebo. We found moderate evidence for 100 mg harpagoside per dose of an aqueous extract of Harpagophytum procumbens compared to placebo, for an extract of willow bark yielding 120 mg salicin per day compared with placebo, for 240 mg of salicin per day in reducing pain to a greater extent than placebo, for 240 mg of salicin per day as equivalent to 120 mg salicin, for no differences in pain and function between a 60 mg daily harpagoside dose of an aqueous extract of Harpagophytum procumbens and 12.5 mg rofecoxib per day, for no difference in pain and overall improvement between Spiroflor SRL homeopathic gel (SRL) and Cremor Capsici Compositus FNA, the capsici oleoresin gel, for intramuscular B12 when compared with placebo. We found limited evidence for topical Capsicum frutescens in the form of Rado-Salil cream or a Capsicum plaster for reducing pain more than placebo, for lavender oil in the treatment of chronic NSLBP, or vitamin C, zinc, and manganese in addition to prolotherapy. Adverse events for all interventions appeared to be mild and transient though we did not attempt to identify all relevant literature concerning adverse events. Conclusions - There is some evidence for several natural health products in the treatment of chronic non-specific low back pain. More research is needed for all of these interventions before they are incorporated into routine clinical practice and their reporting must be improved by referring to the recently published extensions of the CONSORT statement.

STUDY DESIGN. A systematic review of randomized controlled trials. OBJECTIVES. To determine the effectiveness of herbal medicine compared with placebo, no intervention, or "standard/accepted/conventional treatments" for nonspecific low back pain. SUMMARY OF BACKGROUND DATA. Low back pain is a common condition and a substantial economic burden in industrialized societies. A large proportion of patients with chronic low back pain use complementary and alternative medicine (CAM) and/or visit CAM practitioners. Several herbal medicines have been purported for use in low back pain. METHODS. The following databases were searched: Medline (1966 to April 2003), Embase (1980 to April 2003), Cochrane Controlled Trials Register (Issue 1, 2003), and Cochrane Complementary Medicine (CM) field Trials Register. Additionally, reference lists in review articles, guidelines, and in the retrieved trials were checked. Randomized controlled trials (RCTs), using adults (>18 years of age) suffering from acute, subacute, or chronic nonspecific low back pain. Types of interventions included herbal medicines defined as a plant that is used for medicinal purposes in any form. Primary outcome measures were pain and function. Two reviewers (J.J.G. and M.W.T.) conducted electronic searches in all databases. One reviewer (J.J.G.) contacted content experts and acquired relevant citations. Authors, title, subject headings, publication type, and abstract of the isolated studies were downloaded or a hard copy was retrieved. Methodologic quality and clinical relevance were assessed separately by two individuals (J.J.G. and M.W.T.). Disagreements were resolved by consensus. RESULTS. Ten trials were included in this review. Two high-quality trials utilizing Harpagophytum procumbens (Devil's claw) found strong evidence for short-term improvements in pain and rescue medication for daily doses standardized to 50 mg or 100 mg harpagoside with another high-quality trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Two moderate-quality trials utilizing Salix alba (White willow bark) found moderate evidence for short-term improvements in pain and rescue medication for daily doses standardized to 120 mg or 240 mg salicin with an additional trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Three low-quality trials using Capsicum frutescens (Cayenne) using various topical preparations found moderate evidence for favorable results against placebo and one trial found equivalence to a homeopathic ointment. CONCLUSIONS. Harpagophytum procumbens, Salix alba, and Capsicum frutescens seem to reduce pain more than placebo. Additional trials testing these herbal medicines against standard treatments will clarify their equivalence in terms of efficacy. The quality of reporting in these trials was generally poor; thus, trialists should refer to the CONSORT statement in reporting clinical trials of herbal medicines. © 2007 Lippincott Williams & Wilkins, Inc.

With medical economics in the national sociopolitical spotlight, we conducted a study to assess patients' understanding of the cost of 2 common orthopedic procedures: total hip and knee arthroplasty (THA, TKA). We surveyed 284 consecutive THA or TKA patients, at their first postoperative visit, regarding their understanding of reimbursement and cost. On average, patients estimated surgeon reimbursement at $12,014. They estimated that the hospital was reimbursed $28,392 for their perioperative care and that it cost the hospital $24,389 to provide it. The cost of the implant used was estimated at $6447. There is wide variation in patients' estimates and understanding of health care costs. However, patients substantially overestimate reimbursement to the surgeon both in isolation and as a proportion of the total cost of the surgical procedure.

This study characterizes the strain patterns and safe arcs for passive range of motion (ROM) in the superior and inferior subscapularis tendon in seven cadaveric shoulders, mounted for controlled ROM, after deltopectoral approach to the glenohumeral joint, including tenotomy of the subscapularis tendon 1 cm medial to its insertion on the lesser tuberosity. The tenotomy was repaired with end-to-end suture in neutral rotation. Strain patterns were measured during passive ROM in external rotation (ER), ER with 30° abduction (ER+30), abduction, and forward flexion in the scapular plane (SP) before and after surgery. Percentages were calculated from 35 trials corresponding to five trials of each motion across seven specimens. With ER of 0-30°, 89% of trials of superior subscapularis tendon and 100% of trials of inferior subscapularis tendon achieved strains3%, with very similar patterns noted in ER+30. In abduction of 0-90°, 5.8% of trials of superior and 85.3% of trials of inferior tendon achieved3% strain. With passive ROM in SP, 26.5% of trials reached 3% strain in superior tendon compared to 100% in inferior tendon. Strain patterns in abduction and SP differed significantly (p0.001). Selective tenotomy and repair of the superior subscapularis tendon with open reparative or reconstructive shoulder procedures, when feasible, may be favorable for protected early passive ROM and rehabilitation postoperatively.

A case report is a detailed narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or several patients. Case reports present clinical observations customarily collected in healthcare delivery settings. They have proved helpful in the identification of adverse and beneficial effects, the recognition of new diseases, unusual forms of common diseases, and the presentation of rare diseases (1). For example, our understanding of the relationship between thalidomide and congenital abnormalities (2) and the use of propranolol for the treatment of infantile hemangiomas began with case reports (3). Case reports may generate hypotheses for future clinical studies, prove useful in the evaluation of global convergences of systems-oriented approaches, and guide the individualization and personalization of treatments in clinical practice (4, 5) Furthermore, case reports offer a structure for case-based learning in healthcare education and may facilitate the comparison of healthcare education and delivery across cultures. Case reports are common and account for a growing number of articles in medical journals (6); however their quality is uneven (7, 8). For example, one study evaluated 1316 case reports from four peer-reviewed emergency-medicine journals and found that more than half failed to provide information related to the primary treatment that would have increased transparency and replication (9). Written without the benefit of reporting guidelines, case reports often are insufficiently rigorous to be aggregated for data analysis, inform research design, or guide clinical practice (7, 9). Reporting guidelines exist for a variety of study designs including randomized controlled trials (Consolidated Standards of Reporting Trials, CONSORT) (10), observational studies (Strengthening the Reporting of Observational studies in Epidemiology, STROBE) (11), and systematic reviews and meta-analyses (Preferred Reporting Items for Systematic Reviews and Meta-Analyses, PRISMA) (12). Empirical evidence suggests that a journal’s adoption of the CONSORT statement as a guide to authors is associated with an increase in the completeness of published randomized trials (13). Guidelines have been developed for adverse-event case reports (14); however, general reporting guidelines for case reports do not exist. Our primary objective was to develop reporting guidelines for case reports through a consensus-based process.

Background Studies have demonstrated a higher risk of complications when children with fractures in the proximal third of the femur and length-unstable fractures are treated with titanium elastic nails. Alternative treatment methods include open plating and submuscular plating. We are not aware of any published studies that directly compare titanium elastic nail and plate fixation of pediatric subtrochanteric femur fractures. The purpose of the present study was to retrospectively compare the outcomes and complications of titanium elastic nail and plate fixation of subtrochanteric femur fractures in children and young adolescents. Methods A total of 54 children aged 5 to 12 years with subtrochanteric femur fractures treated with titanium elastic nails or plating at 2 institutions between 2003 and 2010 were identified. We retrospectively compared 25 children treated with titanium elastic nails to 29 children treated with either open plating or submuscular plating. Similar to previous studies, a fracture that was located within 10% of the total femur length below the lesser trochanter was classified as subtrochanteric. Outcomes were classified as excellent, satisfactory, or poor. A major complication was defined as any complication that led to unplanned surgery. Minor complications were defined as complications that resolved with nonoperative treatment or did not require any treatment. Results Outcome scores were significantly better in the plating group (P=0.03), but both groups demonstrated high rates of excellent and satisfactory results. The overall complication rate was significantly higher in the titanium elastic nails group (48%; 12 of 25) when compared with the plating group (14%; 4 of 29) (P=0.008). Patients in the titanium elastic nails group were advanced to full weightbearing significantly earlier (6.6 vs. 9.9 wk) (P=0.005). The major complication rate, length of hospitalization, and time to radiographic union were similar for the 2 groups. Conclusions Our results indicate that plate fixation of pediatric subtrochanteric femur fractures is associated with better outcome scores and a lower overall complication rate when compared with titanium elastic nails. Level of evidence Therapeutic Level III.

This meta-analysis compares the clinical outcomes of joint preservation versus arthroplasty in the treatment of displaced proximal humerus fractures.Medline, CINAHL, and EMBASE were searched for studies published between 1970 and 2011 reporting outcomes of the treatment of 3- or 4-part proximal humerus fractures using the Constant-Murley score in skeletally mature patients. Randomised and cohort studies with ≥ 1-year follow-up were included. Two individuals independently extracted data, and study results were divided into subgroups based on type of treatment.A meta-analysis with meta regressions was performed on the mean Constant score. Of 610 total participants in the studies analysed, 340 were treated with joint-preserving techniques. The random-effects mean Constant score across all treatment types was 62.7 (95% CI, 61.6-63.9, P0.001), with joint-preserving treatments demonstrating higher scores than arthroplasty (70 vs. 49, P0.001). The studies displayed significant heterogeneity (Q statistic=516, P0.001, I(2)=94.8). In the meta-regression analyses, Constant scores decreased significantly with increasing age, fracture severity, and rate of osteonecrosis (P0.001).In the existing literature, displaced proximal humerus fractures demonstrate improved Constant scores when treated with joint-preserving options. Age, fracture pattern, and complication rate are significant predictors of the Constant score independent of the selected treatment. Given the observed heterogeneity and variance in treatment techniques in the included studies, more comparative studies are needed to definitively recommend joint-preserving techniques versus arthroplasty for specific fracture patterns.

Physiological systems like bone respond to many genetic and environmental factors by adjusting traits in a highly coordinated, compensatory manner to establish organ-level function. To be mechanically functional, a bone should be sufficiently stiff and strong to support physiological loads. Factors impairing this process are expected to compromise strength and increase fracture risk. We tested the hypotheses that individuals with reduced stiffness relative to body size will show an increased risk of fracturing and that reduced strength arises from the acquisition of biologically distinct sets of traits (ie, different combinations of morphological and tissue-level mechanical properties). We assessed tibial functionality retrospectively for 336 young adult women and men engaged in military training, and calculated robustness (total area/bone length), cortical area (Ct.Ar), and tissue-mineral density (TMD). These three traits explained 69% to 72% of the variation in tibial stiffness (p 0.0001). Having reduced stiffness relative to body size (body weight × bone length) was associated with odds ratios of 1.5 (95% confidence interval [CI], 0.5-4.3) and 7.0 (95% CI, 2.0-25.1) for women and men, respectively, for developing a stress fracture based on radiography and scintigraphy. K-means cluster analysis was used to segregate men and women into subgroups based on robustness, Ct.Ar, and TMD adjusted for body size. Stiffness varied 37% to 42% among the clusters (p 0.0001, ANOVA). For men, 78% of stress fracture cases segregated to three clusters (p 0.03, chi-square). Clusters showing reduced function exhibited either slender tibias with the expected Ct.Ar and TMD relative to body size and robustness (ie, well-adapted bones) or robust tibias with reduced residuals for Ct.Ar or TMD relative to body size and robustness (ie, poorly adapted bones). Thus, we show there are multiple biomechanical and thus biological pathways leading to reduced function and increased fracture risk. Our results have important implications for developing personalized preventative diagnostics and treatments.

Background. Back pain is a common problem and a major cause of disability and health care utilization.Purpose. To evaluate the efficacy, harms, and costs of the most common CAM treatments (acupuncture, massage, spinal manipulation, and mobilization) for neck/low-back pain.Data Sources. Records without language restriction from various databases up to February 2010.Data Extraction. The efficacy outcomes of interest were pain intensity and disability.Data Synthesis. Reports of 147 randomized trials and 5 nonrandomized studies were included. CAM treatments were more effective in reducing pain and disability compared to no treatment, physical therapy (exercise and/or electrotherapy) or usual care immediately or at short-term follow-up. Trials that applied sham-acupuncture tended towards statistically nonsignificant results. In several studies, acupuncture caused bleeding on the site of application, and manipulation and massage caused pain episodes of mild and transient nature.Conclusions. CAM treatments were significantly more efficacious than no treatment, placebo, physical therapy, or usual care in reducing pain immediately or at short-term after treatment. CAM therapies did not significantly reduce disability compared to sham. None of the CAM treatments was shown systematically as superior to one another. More efforts are needed to improve the conduct and reporting of studies of CAM treatments.

Background Herbal medicine interventions have been identified as having potential benefit in the treatment of rheumatoid arthritis (RA). Objectives To update an existing systematic (Cochrane) review of herbal therapies in RA. Search methods We searched electronic databases Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, AMED, CINAHL, Web of Science, Dissertation Abstracts (1996 to 2009), unrestricted by language, and the WHO International Clinical Trials Registry Platform in October 2010. Selection criteria Randomised controlled trials of herbal interventions compared with placebo or active controls in RA. Data collection and analysis Two authors selected trials for inclusion, assessed risk of bias and extracted data. Main results Twelve new studies were added to the update, a total of 22 studies were included. Evidence from seven studies indicate potential benefits of gamma linolenic acid (GLA) from evening primrose oil, borage seed oil, or blackcurrent seed oil, in terms of reduced pain intensity (mean difference (MD) -32.83 points, 95% confidence interval (CI) -56.25 to -9.42,100 point pain scale); improved disability (MD -15.75% 95% CI -27.06 to -4.44%); and an increase in adverse events (GLA 20% versus placebo 3%), that was not statistically different (relative risk 4.24, 95% CI 0.78 to 22.99). Three studies compared Tripterygium wilfordii (thunder god vine) to placebo and one to sulfasalazine and indicated improvements in some outcomes, but data could not be pooled due to differing interventions, comparisons and outcomes. One study reported serious side effects with oral Tripterygium wilfordii Hook F. In the follow-up studies, all side effects were mild to moderate and resolved after the intervention ceased. Two studies compared Phytodolor® N to placebo but poor reporting limited data extraction. The remaining studies each considered differing herbal interventions. Authors' conclusions Several herbal interventions are inadequately justified by single studies or non-comparable studies in the treatment of rheumatoid arthritis. There is moderate evidence that oils containing GLA (evening primrose, borage, or blackcurrant seed oil) afford some benefit in relieving symptoms for RA, while evidence for Phytodolor® N is less convincing.Tripterygium wilfordii products may reduce some RA symptoms, however, oral use may be associated with several side effects. Many trials of herbal therapies are hampered by research design flaws and inadequate reporting. Further investigation of each herbal therapy is warranted, particularly via well designed, fully powered, confirmatory clinical trials that use American College of Rheumatology improvement criteria to measure outcomes and report results according to CONSORT guidelines.

Herbal medicinal products (HMPs) that interact with the mediators of inflammation are used in the treatment of rheumatoid arthritis (RA). The aim of this study was to update a previous systematic review published in 2000. We searched electronic databases (MEDLINE, EMBASE, CISCOM, AMED, CINAHL, Cochrane registers) to June 2007, unrestricted by date or language, and included randomized controlled trials that compared HMPs with inert (placebo) or active controls in patients with rheumatoid arthritis. Five reviewers contributed to data extraction. Disagreements were discussed and resolved by consensus with reference to Cochrane guidelines and advice from the Cochrane Collaboration. Twenty studies (10 identified for this review update, and 10 of the 11 studies of the original review) investigating 14 HMPs were included. Meta-analysis was restricted to data from previous seven studies with oils from borage, blackcurrant and evening primrose containing gamma linolenic acid (GLA). GLA doses equal or higher than 1400 mg/day showed benefit in the alleviation of rheumatic complaints whereas lower doses ( approximately 500 mg) were ineffective. Three studies compared products from Tripterygium wilfordii (thunder god vine) to placebos and returned favorable results but data could not be pooled because the interventions and measures differed. Serious adverse effects occurred in one study. In a follow-up study all side effects were mild to moderate and resolved after the intervention ceased, but time to resolution was variable. Two studies comparing Phytodolor NR to placebo were of limited use because some measures were poorly defined. The remaining studies, each considering differing HMPs, were assessed individually. For most HMPs used in the treatment of RA, the evidence of effectiveness was insufficient to either recommend or discourage their use. Interventions with HMPs containing GLA or Tripterygium wilfordii extract appear to produce therapeutic effects but further investigations are warranted to prove their effectiveness and safety.