Prognostic value of natriuretic peptides in heart failure: systematic review and meta-analysis.

Risk models, informing optimal long-term medical management, seldom use natriuretic peptides (NP) in ascertaining the absolute risk of outcomes for HF patients. Individual studies evaluating the prognostic value of NPs in HF patients have reported varying effects, arriving at best estimates requires a systematic review. We systematically summarized the best evidence regarding the prognostic value of brain natriuretic peptide (BNP) and NT-proBNP in predicting mortality and hospitalizations in ambulatory heart failure (HF) patients. We searched bibliographic databases from 2005 to 2018 and included studies evaluating the association of BNP or NT-proBNP with mortality or hospitalization using multivariable Cox proportional hazard models. We pooled hazard ratios using random-effect models, explored heterogeneity using pre-specified subgroup analyses, and evaluated the certainty of evidence using the Grading of Recommendations and Development Evaluation framework. We identified 67 eligible studies reporting on 76,178 ambulatory HF patients with a median BNP of 407 pg/mL (261-574 pg/mL). Moderate to high-quality evidence showed that a 100-pg/mL increase in BNP was associated with a 14% increased hazard of mortality (HR 1.14, 95% CI 1.06-1.22); a 1-log-unit increase was associated with a 51% increased hazard of mortality (HR 1.51, 95% CI 1.41-1.61) and 48% increased hazard of mortality or hospitalization (HR 1.48, 95% CI 1.29-1.69). With moderate to high certainty, we observed a 14% independent relative increase in mortality, translating to a clinically meaningful increase in absolute risk even for low-risk patients. The observed associations may help in developing more accurate risk models that incorporate NPs and accurately prognosticate HF patients.

Prognostic value of blood pressure in ambulatory heart failure: a meta-analysis and systematic review. Ambulatory blood pressure predicts heart failure prognosis.

Previous primary studies have explored the association between blood pressure (BP) and mortality in ambulatory heart failure (HF) patients reporting varying and contrasting associations. The aim is to determine the pooled BP prognostic value and explore potential reasons for between-study inconsistency. We searched Medline, Cochrane, EMBASE and CINAHL from January 2005 to October 2018 for studies with ≥ 50 events (mortality and/or hospitalization) and included BP in a multivariable model in ambulatory HF patients. We pooled hazard ratios (random effects model) for systolic BP (SBP) or diastolic BP (DBP) effect on mortality and/or hospitalization risk. We used a priori defined sub-group analyses to explore heterogeneity and GRADE approach to assess the certainty of the evidence. Seventy-one eligible articles (239,467 screened) at low to moderate risk of bias included 235,752 participants. Higher SBP was associated with reduced all-cause mortality (HR 0.93, 95%CI 0.91-0.95, I2 = 87.13%, moderate certainty), all-cause hospitalization events (HR 0.91, 95%CI 0.88-0.93, I2 = 44.4%, high certainty) and their composite endpoint (HR 0.93 per 10 mmHg, 95%CI 0.91-0.94, I2 = 86.3%, high certainty). DBP did not demonstrate a statistically significant effect for all outcomes. The association strength was significantly weaker in studies following patients with either LVEF > 40%, higher average SBP (> 130 mmHg), increasing age and diabetes. All other a priori subgroup hypotheses did not explain between study differences. Higher ambulatory SBP is associated with reduced risk of all-cause mortality and hospitalization. Patients with lower BP and reduced LVEF are in a high-risk group of developing adverse events with moderate certainty of evidence.

Effects of Perioperative Selective Serotonin Reuptake Inhibitor Use in Primary Total Hip and Knee Arthroplasty.

BACKGROUND: The aim of this study is to compare functional outcomes and perioperative complications between patients on a selective serotonin reuptake inhibitor (SSRI) and those who are not on an SSRI preoperatively at the time of total joint arthroplasty. METHODS: A retrospective study was performed on 28,386 patients who received a primary total hip (THA) or knee (TKA) arthroplasty. Patients were compared based on SSRI utilization. We measured patient-reported function and health-related quality of life using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the EuroQol-5 Dimensions (EQ-5D-5L) instruments. Chi-squared test was used to compare categorical variables and t-test was used to compare the continuous variables of 2 study groups. RESULTS: Patients on SSRIs have lower preoperative baseline WOMAC and EQ-5D-5L scores than those not using SSRI (P < .001). Patient-reported outcomes improved significantly following surgery, but functional outcome scores remained inferior in patients using SSRI. After adjusting for baseline variables, SSRI use in TKA predicted lower EQ-5D-5L scores than non-SSRI users (P = .036) while the WOMAC scores were not different (P = .118). For the THA cohort, SSRI use predicted lower EQ-5D-5L (P = .001) and WOMAC scores than non-SSRI users (P = .008). SSRI use was associated with increased transfusion rate, length of stay, readmission rate, and medical events. About 11.3% of TKA and 13.3% of THA patients stopped using SSRI at 12 months after arthroplasty. CONCLUSION: Patients using an SSRI show improvement comparable to patients not on an SSRI, but their 12-month functional scores continue to be inferior. SSRI utilization was associated with increased adverse events including needing a blood transfusion.

Correction: The influence of neurological examination timing within hours after acute traumatic spinal cord injuries: an observational study.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

The influence of neurological examination timing within hours after acute traumatic spinal cord injuries: an observational study.

STUDY DESIGN: Cohort study. OBJECTIVES: It is widely accepted that the prediction of long-term neurologic outcome after traumatic spinal cord injury (SCI) can be done more accurately with neurological examinations conducted days to weeks post injury. However, modern clinical trials of neuroprotective interventions often require patients be examined and enrolled within hours. Our objective was to determine whether variability in timing of neurological examinations within 48 h after SCI is associated with differences in observations of follow-up neurologic recovery. SETTING: Level I trauma hospital. METHODS: An observational analysis testing for differences in AIS conversion rates and changes in total motor scores by neurological examination timing, controlling for potential confounders with multivariate stepwise regression. RESULTS: We included 85 patients, whose mean times from injury to baseline and follow-up examinations were 11.8 h (SD 9.8) and 208.2 days (SD 75.2), respectively. AIS conversion by 1+ grade was significantly more likely in patients examined at ≤4 h in comparison with later examination (78% versus 47%, RR = 1.66, p = 0.04), even after controlling for timing of surgery, age, and sex (OR 5.0, 95% CI 1.1-10, p = 0.04). We failed to identify any statistically significant associations for total motor score recovery in unadjusted or adjusted analyses. CONCLUSIONS: AIS grade conversion was significantly more likely in those examined ≤4 h of injury; the effect of timing on motor scores remains uncertain. Variability in neurological examination timing within hours after acute traumatic SCI may influence observations of long-term neurological recovery, which could introduce bias or lead to errors in interpretation of studies of therapeutic interventions.

Causes and Frequencies of Reoperations After Endoprosthetic Reconstructions for Extremity Tumor Surgery: A Systematic Review.

BACKGROUND: Excision of bone tumors and endoprosthetic reconstruction allow patients early weightbearing and a potential functional advantage compared with amputation. These reconstructions do not restore the limb to normal status, however, and patients are subject to complications that may result in revision or loss of the limb. Because better understanding of these complications based on current information might help the patient and surgeon in decision-making, we undertook a systematic review of studies published on this topic. QUESTIONS/PURPOSES: (1) What are the primary modes and proportion of failure of tumor endoprostheses in patients undergoing reconstruction after excision of primary extremity bone sarcomas? METHODS: We systematically searched MEDLINE, Embase, and the Cochrane Library for all studies published from April 15, 1998, to April 15, 2018. Three reviewers independently reviewed studies reporting endoprosthetic reconstruction survival and events requiring revision for primary extremity bone tumors treated with endoprosthetic reconstruction for inclusion and performed independent data extraction. We excluded all studies with fewer than five patients, any systematic review/meta-analyses, and any study not reporting on primary extremity bone tumors. All discrepancies were resolved by the study's senior author. Data extracted from included studies were any reoperation event for wound dehiscence, any operative fixation for a pathologic fracture, and any revision of the primary endoprosthesis for implant wear or breakage, deep infection not amenable to prosthesis retention, or for local recurrence. We assessed the overall quality of the evidence with the Methodological Index for Non-Randomized Studies (MINORS) approach with a higher MINORS score representative of a more methodologically rigorous study with a total possible score of 16 points for noncomparative and 24 points for comparative studies. Forty-nine studies met criteria for inclusion from an initial search return of 904 studies, of which no studies were randomized controlled trials. From a total patient population of 2721, there was a mean followup of 93 months (range, 1-516 months) with loss to followup or death occurring in 447 of 2118 (21%) patients with six studies not providing loss to followup data. The mean MINORS score was 14 for prospective studies and 11 for retrospective studies. RESULTS: Overall, there were 1283 reoperations among the 2721 (47%) patients. Reoperation for mechanical endoprosthetic events (soft tissue dehiscence or periarticular soft tissue instability, aseptic loosening, or implant wear/fracture) occurred in 907 of 2721 (33%) patients. Aseptic loosening occurred at a mean of 75 months (range, 1-376 months) in 212 of 315 patients (67%). Deep infection requiring removal of the initial prosthesis occurred in 247 of 2721 (9%) patients with deep infection occurring at a mean of 24 months (range, 1-372 months) in the 190 infections (77%) with time to infection data available. Local recurrence rates requiring revision or amputation occurred in 129 (5%) of all patients. There was an overall primary endoprosthesis survival rate without any surgical reintervention of 63% among reporting studies at a mean of 79 months followup. CONCLUSIONS: Failures of endoprosthetic reconstructions after extremity tumor surgery are common, most often resulting from implant wear or fracture, aseptic loosening, and infection. Importantly, the aggregated data are the first to attempt to quantify the time to specific complication types within this patient population. Deep infection not amenable to endoprosthesis retention appears to occur approximately 2 years postoperatively in most patients, with aseptic loosening occurring most commonly at 75 months. Although endoprosthetic reconstruction is one of the most common forms of reconstruction after bone tumor resection, the quality of published evidence regarding this procedure is of low quality with high loss to followup and data quality limiting interstudy analysis. The quality of the evidence is low with high loss to followup and inconsistent reporting of times to reintervention events. Although the most common modes of endoprosthetic failure in this population are well known, creation of quality prospective, collaborative databases would assist in clarifying and informing important elements of the followup process for these patients. LEVEL OF EVIDENCE: Level IV, therapeutic study.

The fragility of statistically significant findings from randomised controlled trials in the urological literature.

OBJECTIVES: To use the Fragility Index to evaluate the robustness of statistically significant findings from urological randomised controlled trials (RCTs). MATERIALS AND METHODS: The 'Fragility Index' is defined as the minimum number of patients in one arm of a trial whose status would have to change from 'event' to 'non-event', such that a statistically significant result becomes non-significant. We identified all RCTs published in four major urology journals between 2011 and 2015, and we determined the Fragility Index values for those trials reporting statistically significant results of dichotomous outcomes using the Fisher's exact test. RESULTS: In all, 332 RCTs were identified, and 41 studies met the inclusion criteria. The median (interquartile range) Fragility Index was 3 (1, 4.5), indicating that an addition of only three alternate events to one arm of a typical trial would have eliminated its statistical significance. In 27/40 cases (67.5% of cases), the number of patients lost to follow-up was larger than its Fragility Index. CONCLUSIONS: The results of urology RCTs that study dichotomous outcomes and report statistically significant differences between groups are sometimes fragile and depend on few events. Urologists should interpret these RCTs cautiously, particularly when the number of participants lost to follow-up exceeds the Fragility Index. Routine reporting of Fragility Index values alongside P values may provide additional guidance about the robustness of statistically significant findings.

A Cost-Effectiveness Analysis of Reverse Total Shoulder Arthroplasty versus Hemiarthroplasty for the Management of Complex Proximal Humeral Fractures in the Elderly.

BACKGROUND: There is ongoing debate regarding the optimal surgical treatment of complex proximal humeral fractures in elderly patients. OBJECTIVES: To evaluate the cost-effectiveness of reverse total shoulder arthroplasty (RTSA) compared with hemiarthroplasty (HA) in the management of complex proximal humeral fractures, using a cost-utility analysis. METHODS: On the basis of data from published literature, a cost-utility analysis was conducted using decision tree and Markov modeling. A single-payer perspective, with a willingness-to-pay (WTP) threshold of Can$50,000 (Canadian dollars), and a lifetime time horizon were used. The incremental cost-effectiveness ratio (ICER) was used as the study's primary outcome measure. RESULTS: In comparison with HA, the incremental cost per quality-adjusted life-year gained for RTSA was Can$13,679. One-way sensitivity analysis revealed the model to be sensitive to the RTSA implant cost and the RTSA procedural cost. The ICER of Can$13,679 is well below the WTP threshold of Can$50,000, and probabilistic sensitivity analysis demonstrated that 92.6% of model simulations favored RTSA. CONCLUSIONS: Our economic analysis found that RTSA for the treatment of complex proximal humeral fractures in the elderly is the preferred economic strategy when compared with HA. The ICER of RTSA is well below standard WTP thresholds, and its estimate of cost-effectiveness is similar to other highly successful orthopedic strategies such as total hip arthroplasty for the treatment of hip arthritis.

Moving Forward Through Consensus: A Modified Delphi Approach to Determine the Top Research Priorities in Orthopaedic Oncology.

BACKGROUND: Several challenges presently impede the conduct of prospective clinical studies in orthopaedic oncology, including limited financial resources to support their associated costs and inadequate patient volume at most single institutions. This study was conducted to prioritize research questions within the field so that the Musculoskeletal Tumor Society (MSTS), and other relevant professional societies, can direct the limited human and fiscal resources available to address the priorities that the stakeholders involved believe will have the most meaningful impact on orthopaedic oncology patient care. QUESTIONS/PURPOSES: The purpose of this study was to use a formal consensus-based approach involving clinician-scientists and other stakeholders to identify the top priority research questions for future international prospective clinical studies in orthopaedic oncology. METHODS: A three-step modified Delphi process involving multiple stakeholder groups (including orthopaedic oncologists, research personnel, funding agency representation, and patient representation) was conducted. First, we sent an electronic questionnaire to all participants to solicit clinically relevant research questions (61 participants; 54% of the original 114 individuals invited to participate returned the questionnaires). Then, participants rated the candidate research questions using a 5-point Likert scale for five criteria (60 participants; 53% of the original group participated in this portion of the process). Research questions that met a priori consensus thresholds progressed for consideration to an in-person consensus meeting, which was attended by 44 participants (39% of the original group; 12 countries were represented at this meeting). After the consensus panel's discussion, members individually assigned scores to each question using a 9-point Likert scale. Research questions that met preset criteria advanced to final ranking, and panel members individually ranked their top three priority research questions, resulting in a final overall ranking of research priorities. RESULTS: A total of 73 candidate research questions advanced to the consensus meeting. In the end, the consensus panel identified four research priorities: (1) Does less intensive surveillance of patients with sarcoma affect survival? (2) What are the survival outcomes over time for orthopaedic oncology implants? (3) Does resection versus stabilization improve oncologic and functional outcomes in oligometastatic bone disease? (4) What is the natural history of untreated fibromatosis? CONCLUSIONS: The results of this study will assist in developing a long-term research strategy for the MSTS and, possibly, the orthopaedic oncology field as a whole. Furthermore, the results of this study can assist researchers in guiding their research efforts and in providing a justified rationale to funding agencies when requesting the resources necessary to support future collaborative research studies that address the identified orthopaedic oncology priorities.

Has the Level of Evidence of Podium Presentations at the Musculoskeletal Tumor Society Annual Meeting Changed Over Time?

BACKGROUND: Level of evidence (LOE) framework is a tool with which to categorize clinical studies based on their likelihood to be influenced by bias. Improvements in LOE have been demonstrated throughout orthopaedics, prompting our evaluation of orthopaedic oncology research LOE to determine if it has changed in kind. QUESTIONS/PURPOSES: (1) Has the LOE presented at the Musculoskeletal Tumor Society (MSTS) annual meeting improved over time? (2) Over the past decade, how do the MSTS and Orthopaedic Trauma Association (OTA) annual meetings compare regarding LOE overall and for the subset of therapeutic studies? METHODS: We reviewed abstracts from MSTS and OTA annual meeting podium presentations from 2005 to 2014. Three independent reviewers evaluated a total of 1222 abstracts for study type and LOE; there were 577 abstracts from MSTS and 645 from OTA. Changes in the distributions of study type and LOE over time were evaluated by Pearson chi-square test. RESULTS: There was no change over time in MSTS LOE for all study types (p = 0.13) and therapeutic (p = 0.36) study types during the reviewed decade. In contrast, OTA LOE increased over this time for all study types (p < 0.01). The proportion of Level I therapeutic studies was higher at the OTA than the MSTS (3% [14 of 413] versus 0.5% [two of 387], respectively), whereas the proportion of Level IV studies was lower at the OTA than the MSTS (32% [134 of 413] versus 75% [292 of 387], respectively) during the reviewed decade. The proportion of controlled therapeutic studies (LOE I through III) versus uncontrolled studies (LOE IV) increased over time at OTA (p < 0.021), but not at MSTS (p = 0.10). CONCLUSIONS: Uncontrolled case series continue to dominate the MSTS scientific program, limiting progress in evidence-based clinical care. Techniques used by the OTA to improve LOE may be emulated by the MSTS. These techniques focus on broad participation in multicenter collaborations that are designed in a comprehensive manner and answer a pragmatic clinical question.

Credibility and quality of meta-analyses addressing graft choice in anterior cruciate ligament reconstruction: a systematic review.

PURPOSE: This systematic review examined the methodological credibility and quality of reporting of all meta-analyses which have compared bone-patellar tendon-bone (BPTB) versus hamstring tendon (HT) for anterior cruciate ligament (ACL) reconstruction (ACLR). METHODS: EMBASE, MEDLINE, and The Cochrane Library were systematically searched, and two reviewers independently assessed eligibility, credibility according to the Users' Guide to medical literature, and completeness of reporting according to the preferred reporting items for systematic review and meta-analyses (PRISMA) checklist. Inter-rater agreement was quantified using Kappa, and we used Pearson's correlation coefficient to evaluate potential associations. RESULTS: Seventeen meta-analyses were identified comparing BPTB versus HT for ACLR. The majority of meta-analyses were published in 2011 (5; 29 %), and North America was the most common continent of publication (6; 35 %). The three most commonly reported outcomes were stability (82 %), complications (76 %), and function (return to sport, IKDC score) (71 %). The median number of satisfactorily reported items in the Users' Guide was three out of seven (IQR 2-4). The median number of satisfactorily reported items in PRISMA for the meta-analyses was 20 out of 27 (IQR 19-22). CONCLUSION: The credibility of the meta-analyses comparing BPTB versus HT autograft for ACLR although limited is improving with time. Earlier studies had limited methodological rigour; however, the more recent studies have shown promise in improved methodology. The study findings suggest that decisions should be made on a case-to-case basis with coordination of patient factors and preferences as well as surgeon experience on the background of the best available evidence. LEVEL OF EVIDENCE: IV.

Corticosteroid Therapy for Patients Hospitalized With Community-Acquired Pneumonia: A Systematic Review and Meta-analysis.

BACKGROUND: Community-acquired pneumonia (CAP) is common and often severe. PURPOSE: To examine the effect of adjunctive corticosteroid therapy on mortality, morbidity, and duration of hospitalization in patients with CAP. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through 24 May 2015. STUDY SELECTION: Randomized trials of systemic corticosteroids in hospitalized adults with CAP. DATA EXTRACTION: Two reviewers independently extracted study data and assessed risk of bias. Quality of evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation system by consensus among the authors. DATA SYNTHESIS: The median age was typically in the 60s, and approximately 60% of patients were male. Adjunctive corticosteroids were associated with possible reductions in all-cause mortality (12 trials; 1974 patients; risk ratio [RR], 0.67 [95% CI, 0.45 to 1.01]; risk difference [RD], 2.8%; moderate certainty), need for mechanical ventilation (5 trials; 1060 patients; RR, 0.45 [CI, 0.26 to 0.79]; RD, 5.0%; moderate certainty), and the acute respiratory distress syndrome (4 trials; 945 patients; RR, 0.24 [CI, 0.10 to 0.56]; RD, 6.2%; moderate certainty). They also decreased time to clinical stability (5 trials; 1180 patients; mean difference, -1.22 days [CI, -2.08 to -0.35 days]; high certainty) and duration of hospitalization (6 trials; 1499 patients; mean difference, -1.00 day [CI, -1.79 to -0.21 days]; high certainty). Adjunctive corticosteroids increased frequency of hyperglycemia requiring treatment (6 trials; 1534 patients; RR, 1.49 [CI, 1.01 to 2.19]; RD, 3.5%; high certainty) but did not increase frequency of gastrointestinal hemorrhage. LIMITATIONS: There were few events and trials for many outcomes. Trials often excluded patients at high risk for adverse events. CONCLUSION: For hospitalized adults with CAP, systemic corticosteroid therapy may reduce mortality by approximately 3%, need for mechanical ventilation by approximately 5%, and hospital stay by approximately 1 day. PRIMARY FUNDING SOURCE: None.

Chronology of the Radiographic Appearances of the Calcium Sulfate-Calcium Phosphate Synthetic Bone Graft Composite Following Resection of Bone Tumors: A Follow-up Study of Postoperative Appearances.

PURPOSE: The objective of the study was to characterize the radiographic appearance of graft resorption and new bone incorporation into a postresection defect of the calcium-sulfate calcium-phosphate synthetic bone graft composite following resection of benign bone tumours. METHODS: Twenty-five patients who underwent treatment with the CaSO4/CaPO4 synthetic graft following bone tumour resection were retrospectively identified from our oncology database. Postoperative radiographs were assessed for: 1) combined partial graft resorption and ingrowth at the graft site; 2) complete graft resorption with complete incorporation of new bone into the defect. After chronologically grouping radiographs, the volume of graft material used to fill bony defects, radiographic evidence of complications, and patterns of resorption were recorded. RESULTS: Partial resorption of graft material/partial ingrowth of new bone was seen in 21 patients at 2.5 months postoperatively. Complete resorption of graft with complete new bone incorporation at the graft site was seen in 94% of cases (15 of 16) by 10 months after surgery. Mean time to complete incorporation of new bone was 6.7 months. Time to resorption of the graft with new bone ingrowth was found to be related to the volume of graft used with smaller volumes showing earlier resorption. For all cases demonstrating resorption (21 of 21), the pattern observed was peripheral to central. Five patients developed complications, including tumour recurrence, cyst formation, and graft site infection. CONCLUSION: Our study suggests a characteristic time and volume related radiographic pattern of resorption and new bone ingrowth with the CaSO4/CaPO4 synthetic graft. Findings that deviate from this pattern may represent complication and warrant additional follow-up.

Intrawound vancomycin to prevent infections after spine surgery: a systematic review and meta-analysis.

PURPOSE: Post-operative spine surgical site infections are associated with substantial morbidity, mortality, and economic burden. Intrawound vancomycin may prevent infections after spine surgery, but recent studies have reported conflicting results. The objectives of this systematic review and meta-analysis were to determine: (1) In patients undergoing spine surgery, does the application of intrawound vancomycin lead to reduced rates of post-operative surgical site infections? (2) Are there differences in the estimates of effect between observational studies and randomized trials? (3) What adverse events are reported in the literature? METHODS: All published comparative studies of intrawound vancomycin in spine surgery were included. Two reviewers independently screened eligible articles and assessed study quality. Observational studies and randomized trials were pooled separately using a random-effects model. RESULTS: Eight observational studies and one randomized controlled trial met the inclusion criteria. Across observational studies, the odds of infection with intrawound vancomycin was 0.19 times the odds of infection without intrawound vancomycin (95 % CI 0.08-0.47, p = 0.0003, I (2) = 52 %). The single randomized controlled trial produced a conflicting result (OR 0.96, 95 % CI 0.34-2.66, p = 0.93). There were no adverse events attributable to intrawound vancomycin. The quality of the evidence was low or very low. CONCLUSIONS: There is a lack of high-quality evidence to inform the use of intrawound vancomycin in spine surgery. Surgeons should be cautious before widely adopting this intervention and should be vigilant in monitoring for adverse effects. Further investigation with additional randomized controlled trials is justified.

Arthroscopic surgery for degenerative tears of the meniscus: a systematic review and meta-analysis.

BACKGROUND: Arthroscopic surgery for degenerative meniscal tears is a commonly performed procedure, yet the role of conservative treatment for these patients is unclear. This systematic review and meta-analysis evaluates the efficacy of arthroscopic meniscal débridement in patients with knee pain in the setting of mild or no concurrent osteoarthritis of the knee in comparison with nonoperative or sham treatments. METHODS: We searched MEDLINE, Embase and the Cochrane databases for randomized controlled trials (RCTs) published from 1946 to Jan. 20, 2014. Two reviewers independently screened all titles and abstracts for eligibility. We assessed risk of bias for all included studies and pooled outcomes using a random-effects model. Outcomes (i.e., function and pain relief) were dichotomized to short-term (< 6 mo) and long-term (< 2 yr) data. RESULTS: Seven RCTs (n = 805 patients) were included in this review. The pooled treatment effect of arthroscopic surgery did not show a significant or minimally important difference (MID) between treatment arms for long-term functional outcomes (standardized mean difference [SMD] 0.07, 95% confidence interval [CI] -0.10 to 0.23). Short-term functional outcomes between groups were significant but did not exceed the threshold for MID (SMD 0.25, 95% CI 0.02 to 0.48). Arthroscopic surgery did not result in a significant improvement in pain scores in the short term (mean difference [MD] 0.20, 95% CI -0.67 to 0.26) or in the long term (MD -0.06, 95% CI -0.28 to 0.15). Statistical heterogeneity was low to moderate for the outcomes. INTERPRETATION: There is moderate evidence to suggest that there is no benefit to arthroscopic meniscal débridement for degenerative meniscal tears in comparison with nonoperative or sham treatments in middle-aged patients with mild or no concomitant osteoarthritis. A trial of nonoperative management should be the first-line treatment for such patients.

What are the levels of evidence on which we base decisions for surgical management of lower extremity bone tumors?

BACKGROUND: Benign and malignant lower extremity primary bone tumors are among the least common conditions treated by orthopaedic surgeons. The literature supporting their surgical management has historically been in the form of observational studies rather than prospective controlled studies. Observational studies are prone to confounding bias, sampling bias, and recall bias. QUESTIONS/PURPOSES: (1) What are the overall levels of evidence of articles published on the surgical management of lower extremity bone tumors? (2) What is the overall quality of reporting of studies in this field based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist? (3) What are the most common pitfalls in reporting that authors might improve on? METHODS: All studies describing the surgical management of lower extremity primary bone tumors from 2002 to 2012 were systematically reviewed. Two authors independently appraised levels of evidence. Quality of reporting was assessed with the STROBE checklist. Pitfalls in reporting were quantified by determining the 10 most underreported elements of research study design in the group of studies analyzed, again using the STROBE checklist as the reference standard. Of 1387 studies identified, 607 met eligibility criteria. RESULTS: There were no Level I studies, two Level II studies, 47 Level III studies, 308 Level IV studies, and 250 Level V studies. The mean percentage of STROBE points reported satisfactorily in each article as graded by the two reviewers was 53% (95% confidence interval, 42%-63%). The most common pitfalls in reporting were failures to justify sample size (2.2% reported), examine sensitivity (2.2%), account for missing data (9.8%), and discuss sources of bias (14%). Followup (66%), precision of outcomes (64%), eligibility criteria (55%), and methodological limitations (53%) were variably reported. CONCLUSIONS: Observational studies are the dominant evidence for the surgical management of primary lower extremity bone tumors. Numerous deficiencies in reporting limit their clinical use. Authors may use these results to inform future work and improve reporting in observational studies, and treating surgeons should be aware of these limitations when choosing among the various options with their patients.

Stand-Alone Anchored Spacer vs Anterior Plate Construct in the Management of Adjacent Segment Disease after Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta-Analysis of Comparative Studies.

STUDY DESIGN: Systematic Review and Meta-Analysis. OBJECTIVES: This study aimed to evaluate the clinical and radiological outcomes of surgically treated adjacent segment disease (ASDis) following ACDF with either anterior plate construct (APC) or stand-alone anchored spacers (SAAS). METHOD: Multiple databases were searched until December 2022 for pertinent studies. The primary outcome was health-related quality of life outcomes [JOA, NDI, and VAS], whereas, the secondary outcomes included operative characteristics [estimated blood loss (EBL) and operative time (OT)], radiological outcomes [C2-C7 Cobb angle, disc height index (DHI) changes, fusion rate], and complications. RESULTS: A total of 5 studies were included, comprising 210 patients who had been surgically treated for cervical ASDis. Among them, 113 received APC, and 97 received SAAS. Postoperative dysphagia was significantly higher in the APC group [47% vs 11%, OR = 7.7, 95% CI = 3.1-18.9, P < .05]. Similarly, operative time and blood loss were higher in the APC group compared to the SAAS group; [MD = 16.96, 95% CI = 7.87-26.06, P < .05] and [MD = 5.22, 95% CI = .35 - 10.09, P < .05], respectively. However, there was no difference in the rate of prolonged dysphagia and clinical outcomes in terms of JOA, NDI, and VAS. Furthermore, there was no difference in the radiological parameters including the C2-7 Cobb angle and DHI as well as the fusion rate. CONCLUSION: Our meta-analysis demonstrated that both surgical techniques (APC and SAAS) are effective in treating ASDis. However, with low certainty of the evidence, considering patients are at high risk of dysphagia following revision cervical spine surgery SAAS may be the preferred choice.

A Clinical Practice Guideline on the Timing of Surgical Decompression and Hemodynamic Management of Acute Spinal Cord Injury and the Prevention, Diagnosis, and Management of Intraoperative Spinal Cord Injury: Introduction, Rationale, and Scope.

STUDY DESIGN: Protocol for the development of clinical practice guidelines following the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) standards. OBJECTIVES: Acute SCI or intraoperative SCI (ISCI) can have devastating physical and psychological consequences for patients and their families. The treatment of SCI has dramatically evolved over the last century as a result of preclinical and clinical research that has addressed important knowledge gaps, including injury mechanisms, disease pathophysiology, medical management, and the role of surgery. In an acute setting, clinicians are faced with critical decisions on how to optimize neurological recovery in patients with SCI that include the role and timing of surgical decompression and the best strategies for hemodynamic management. The lack of consensus surrounding these treatments has prevented standardization of care across centers and has created uncertainty with respect to how to best manage patients with SCI. ISCI is a feared complication that can occur in the best of hands. Unfortunately, there are no systematic reviews or clinical practice guidelines to assist spine surgeons in the assessment and management of ISCI in adult patients undergoing spinal surgery. Given these limitations, it is the objective of this initiative to develop evidence-based recommendations that will inform the management of both SCI and ISCI. This protocol describes the rationale for developing clinical practice guidelines on (i) the timing of surgical decompression in acute SCI; (ii) the hemodynamic management of acute SCI; and (iii) the prevention, identification, and management of ISCI in patients undergoing surgery for spine-related pathology. METHODS: Systematic reviews were conducted according to PRISMA standards in order to summarize the current body of evidence and inform the guideline development process. The guideline development process followed the approach proposed by the GRADE working group. Separate multidisciplinary, international groups were created to perform the systematic reviews and formulate the guidelines. All potential conflicts of interest were vetted in advance. The sponsors exerted no influence over the editorial process or the development of the guidelines. RESULTS: This process resulted in both systematic reviews and clinical practice guidelines/care pathways related to the role and timing of surgery in acute SCI; the optimal hemodynamic management of acute SCI; and the prevention, diagnosis and management of ISCI. CONCLUSIONS: The ultimate goal of this clinical practice guideline initiative was to develop evidence-based recommendations for important areas of controversy in SCI and ISCI in hopes of improving neurological outcomes, reducing morbidity, and standardizing care across settings. Throughout this process, critical knowledge gaps and future directions were also defined.

An Overview of the Methodology Used to Develop Clinical Practice Guidelines for the Management of Acute and Intraoperative Spinal Cord Injury.

STUDY DESIGN: An overview of the methods used to develop clinical practice guidelines (CPGs). OBJECTIVES: Acute spinal cord injury (SCI) and intraoperative SCI (ISCI) can have devastating physical and psychological consequences for patients and their families. To date, there are several studies that have discussed the diagnostic and management strategies for both SCI and ISCI. CPGs in SCI help to distill and translate the current evidence into actionable recommendations, standardize care across centers, optimize patient outcomes, and reduce costs and unnecessary interventions. Furthermore, they can be used by patients to assist in making decisions about certain treatments and by policy makers to inform allocation of resources. The objective of this article is to summarize the methods used to develop CPGs for the timing of surgery and hemodynamic management of acute SCI, as well as the identification and treatment of ISCI. METHODS: The CPGs were developed using standards established by the Institute of Medicine (now the National Academy of Medicine), the Guideline International Network and several other organizations. Systematic reviews were conducted according to accepted methodological standards (eg, Institute of Medicine, Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute) in order to summarize the current body of evidence and inform the guideline development process. Protocols for each guideline were created. A multidisciplinary guideline development group (GDG) was formed that included individuals living with SCI as well as clinicians from the broad range of specialties that encounter patients with SCI: spine or trauma surgeons, critical care physicians, rehabilitation specialists, neurologists, anesthesiologists and other healthcare professionals. Individuals living with SCI were also included in the GDG. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to rate the certainty of the evidence for each critical outcome. The "evidence to recommendation" framework was then used to translate the evidence obtained from the systematic review to an actionable recommendation. This framework provides structure when assessing the body of evidence and considers several additional factors when rating the strength of the recommendation, including the magnitude of benefits and harms, patient preferences, resource use, health equities, acceptability and feasibility. Finally, the CPGs were appraised both internally and externally. RESULTS: The results of the CPGs for SCI are provided in separate articles in this focus issue. CONCLUSIONS: Development of these CPGs for SCI followed the methodology proposed by the Institute of Medicine the Guideline International Network and the GRADE Working Group. It is anticipated that these CPGs will assist clinicians implement the best evidence into practice and facilitate shared-decision making with patients.