Pulmonary Vein Isolation in Obese Compared to Non-Obese Patients: Real-Life Experience from a Large Tertiary Center.

1. Introduction: Pulmonary vein isolation (PVI) is an established procedure used to achieve rhythm control in atrial fibrillation (AF). In obese patients (pts), in whom AF occurs more frequently, a reduced effectiveness of PVI has been observed. Therefore, this study's aim was to compare the long-term efficacy of PVI between obese and non-obese patients. 2. Methods: We enrolled 111 consecutive pts with a body mass index (BMI) of >30 kg/m2 undergoing PVI from our large registry. Procedural data and outcomes were compared with a matched group of 115 non-obese PVI pts and the long-term outcomes were analyzed. 3. Results: Overall follow-up duration was 314 patient-years in the obese and 378 patient-years in the non-obese group. The follow-up rate was 71% in the obese and 76% in the non-obese group. In both groups, their AF-characteristics did not differ significantly, while known risk factors were significantly more prevalent in the obese group. Procedural characteristics were similar in both groups. During follow-up, the obese pts demonstrated significant weight loss compared to the non-obese pts, while at the same time, the overall recurrence rate during follow-up did not differ significantly between both groups (obese: 39.2% and non-obese: 43.7%). PVI related and long-term complications were comparable between both groups. In the univariate analysis, obesity was not found to be associated with an increased AF recurrence risk. 4. Conclusion: These real-life data demonstrate that obese pts may not show higher AF recurrence rates after PVI compared to pts with normal body weight. Furthermore, PVI was found to be safe and effective in obese patients; thus, a BMI alone may not be a criterion for refusal of PVI.

Non-invasive assessment of fibrosis regression and portal hypertension in patients with advanced chronic hepatitis C virus (HCV)-associated liver disease and sustained virologic response (SVR): 3 years follow-up of a prospective longitudinal study.

Long-term effects on cirrhosis and portal hypertension of direct antiviral agent (DAA)-based eradication of hepatitis C virus (HCV) are still under debate. We analysed dynamics of liver and spleen elastography to assess potential regression of cirrhosis and portal hypertension 3 years post-treatment. Fifty-four patients with HCV-associated cirrhosis and DAA-induced SVR were included. Liver and spleen stiffness were measured at baseline (BL), end of treatment (EOT), 24 weeks after EOT (FU24) and 1, 2 and 3 (FU144) years post-treatment by transient liver elastography (L-TE) and point shear wave elastography (pSWE) using acoustic radiation force impulse (ARFI) of the liver (L-ARFI) and spleen (S-ARFI). Biochemical, virological and clinical data were also obtained. Liver stiffness assessed by L-TE decreased between BL [median (range), 32.5(9.1-75) kPa] and EOT [21.3(6.7-73.5) kPa; p < .0001] and EOT and FU144 [16(4.1-75) kPa; p = .006]. L-ARFI values improved between EOT [2.5(1.2-4.1) m/s] and FU144 [1.7(0.9-4.1) m/s; p = .001], while spleen stiffness remained unchanged. Overall, L-TE improved in 38 of 54 (70.4%) patients at EOT and 29 of 38 (76.3%) declined further until FU144, whereas L-ARFI values decreased in 30/54 (55.6%) patients at EOT and continued to decrease in 28/30 (93.3%) patients at FU144. Low bilirubin and high albumin levels at BL were associated with improved L-ARFI values (p = .048) at EOT or regression of cirrhosis (<12.5 kPa) by L-TE at FU144 (p = .005), respectively. Liver stiffness, but not spleen stiffness, continued to decline in a considerable proportion of patients with advanced liver disease after HCV eradication.

Can the FEAR Index Be Used to Predict Microinstability in Patients Undergoing Hip Arthroscopic Surgery?

BACKGROUND: Atraumatic hip instability, or microinstability, is a challenging diagnosis for clinicians to make. Several radiographic parameters have been proposed to help identify patients with instability as a means to direct treatment. The Femoro-epiphyseal Acetabular Roof (FEAR) index was recently offered as a parameter to predict instability in a borderline dysplastic population. PURPOSE: To evaluate the FEAR index in a series of predominantly nondysplastic patients undergoing hip arthroscopic surgery to determine if it can accurately predict patients with diagnosed microinstability at the time of surgery. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 2. METHODS: A consecutive series of 200 patients undergoing hip arthroscopic surgery were evaluated for microinstability intraoperatively. Microinstability was diagnosed based on previously published criteria. Retrospectively, radiographic parameters were measured including the lateral center edge angle of Wiberg (LCEA), Tönnis angle, physeal scar angle, and FEAR index. Patients were excluded if they previously had any type of bony procedures performed, underwent prior open hip surgery or total hip arthroplasty of the ipsilateral hip, had osteoarthritis (Tönnis grade >1), or had any radiographic features of moderate-to-severe acetabular dysplasia including an LCEA <18°. RESULTS: After applying exclusion criteria, 167 hips in 150 patients were analyzed. Based on an intraoperative assessment, 96 hips (57.5%) were considered stable, and 71 hips (42.5%) had signs of microinstability (unstable group). Patients in the unstable group had fewer radiographic findings of femoroacetabular impingement and higher rates of borderline dysplasia. All 4 measured angles were found to have excellent interobserver agreement. The FEAR index was significantly more positive in the unstable group compared with the stable group (-7.8° vs -11.3°, respectively; P = .004). A more positive FEAR index was also found in patients meeting intraoperative criteria for instability, with the exception of chondral wear pattern. Unstable nondysplastic patients (LCEA ≥25°, Tönnis angle ≤10°) also were found to have higher FEAR index values (-9.0° vs -12.0°, respectively; P = .012). A FEAR index cut-off of -5.0° was associated with a specificity of 92.4% and accuracy of 69.4% for predicting instability in a nondysplastic population. CONCLUSION: The FEAR index was validated to improve the recognition of unstable patients preoperatively across a population with both borderline dysplastic and nondysplastic features.

Healing, Pain and Function after Midshaft Clavicular Fractures: A Systematic Review of Treatment with Immobilization and Rehabilitation.

OBJECTIVE: To systematically evaluate the scientific literature examining the efficacy of nonoperative management for midshaft clavicular fractures, specifically looking at the effect of immobilization and/or functional rehabilitation. TYPE: Systematic review. LITERATURE SURVEY: MEDLINE (PubMed), EMBASE, CINAHL databases were searched. METHODOLOGY: Inclusion criteria included adult patients enrolled in a controlled study evaluating bony healing, pain and/or function-related improvements after a strict nonoperative treatment plan for management of midshaft clavicle fractures. SYNTHESIS: A total of 10 articles were included in the study. Only four studies contained level I evidence; four studies were prospective case series without a control, and one was a retrospective case series without a control. Half of studies used a strict immobilization period, and most utilized a period of functional rehabilitation. There were no direct comparisons between rehabilitation protocols. Studies without a strict immobilization period had a nonunion rate of 5% to 24% and residual pain in 35% to 83% of patients compared to studies with a strict immobilization period with a nonunion rate of 3% to 29% and residual pain in 14% to 49% of patients. Studies including functional rehabilitation protocol reported functional as measured by the Constant Shoulder Score of 87.8 to 96, out of a maximum of 100 representing no functional limitations, and nonunion rates of 12% to 25% compared to 81 to 85 and 3% to 29% in those without a rehabilitation protocol. CONCLUSIONS: No studies directly examine the effect of immobilization and functional rehabilitation on clinical outcomes for midshaft clavicular fractures. Future studies are needed to better elucidate the most effective treatment. LEVEL OF EVIDENCE: I.

Diagnostic Accuracy of 3 Physical Examination Tests in the Assessment of Hip Microinstability.

BACKGROUND: Hip microinstability is a diagnosis gaining increasing interest. Physical examination tests to identify microinstability have not been objectively investigated using intraoperative confirmation of instability as a reference standard. PURPOSE: To determine the test characteristics and diagnostic accuracy of 3 physical examination maneuvers in the detection of hip microinstability. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 2. METHODS: A review was conducted of 194 consecutive hip arthroscopic procedures performed by a sports medicine surgeon at a tertiary-care academic center. Physical examination findings of interest, including the abduction-hyperextension-external rotation (AB-HEER) test, the prone instability test, and the hyperextension-external rotation (HEER) test, were obtained from prospectively collected data. The reference standard was intraoperative identification of instability based on previously published objective criteria. Test characteristics, including sensitivity, specificity, positive and negative predictive values, and accuracy, were calculated for each test as well as for combinations of tests. RESULTS: A total of 109 patients were included in the analysis. The AB-HEER test was most accurate, with a sensitivity of 80.6% (95% CI, 70.8%-90.5%) and a specificity of 89.4% (95% CI, 80.5%-98.2%). The prone instability test had a low sensitivity (33.9%) but a very high specificity (97.9%). The HEER test performed second in both sensitivity (71.0%) and specificity (85.1%). The combination of multiple tests with positive findings did not yield significantly greater accuracy. All tests had high positive predictive values (range, 86.3%-95.5%) and moderate negative predictive values (range, 52.9%-77.8%). When all 3 tests had positive findings, there was a 95.0% (95% CI, 90.1%-99.9%) chance that the patient had microinstability. CONCLUSION: The AB-HEER test most accurately predicted hip instability, followed by the HEER test and the prone instability test. However, the high specificity of the prone instability test makes it a useful test to "rule in" abnormalities. A positive result from any test predicted hip instability in 86.3% to 90.9% of patients, but a negative test result did not conclusively rule out hip instability, and other measures should be considered in making the diagnosis. The use of these tests may aid the clinician in diagnosing hip instability, which has been considered a difficult diagnosis to make because of its dynamic nature.

Hip arthroscopy in the United States: an update following coding changes in 2011.

The purpose of this study is to define the incidence of hip arthroscopy-related procedures in the United States prior to and following 2011 and to determine if the rise in incidence has coincided with an increase in the complexity and diversity of procedures performed. Patients who underwent hip arthroscopy were identified from a publicly available US database. A distinction was made between 'traditional' and 'extended' codes. CPT-29999 (unlisted arthroscopy) was considered extended and counted only if associated with a hip pathology diagnosis. Codes directed toward femoroacetabular impingement pathology were also considered extended codes and were analyzed separately based on increased technical skill. Unpaired student t-tests and z-score tests were performed. From 2007 to 2014, there were a total of 2581 hip arthroscopies performed in the database (1.06 cases per 10 000 patients). The number of hip arthroscopies increased 117% from 2007 to 2014 (P < 0.001) and 12.5% from 2011 to 2014 (P = 0.045). Hip arthroscopies using extended codes increased 475% from 2007 to 2014 (P < 0.001) compared to 24% for traditional codes (P < 0.001). Codes addressing femoroacetabular impingement (FAI) pathology increased 55.7% between 2011 to 2014 (P < 0.001). The ratio of labral repair to labral debridement in patients younger than 50 years exceeded >1.0 starting in 2011 (P < 0.001). The total number of hip arthroscopies in addition to the complexity and diversity of hip arthroscopy procedures performed in the United States continues to rise. FAI-based procedures and labral repairs are being performed more frequently in younger patients, likely reflecting both improved technical ability and current evidence-based research.

Humeral Avulsion of the Glenohumeral Ligament: Indications for Surgical Treatment and Outcomes-A Systematic Review.

BACKGROUND: The inferior glenohumeral ligament, the most important static anterior stabilizer of the shoulder, becomes disrupted in humeral avulsion of the glenohumeral ligament (HAGL) lesions. Unfortunately, HAGL lesions commonly go unrecognized. A missed HAGL during an index operation to treat anterior shoulder instability may lead to persistent instability. Currently, there are no large studies describing the indications for surgical repair or the outcomes of patients with HAGL lesions. PURPOSE: To search the literature to identify surgical indications for the treatment of HAGL lesions and discuss reported outcomes. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: Two reviewers completed a comprehensive literature search of 3 online databases (MEDLINE, EMBASE, and Cochrane Library) from inception until May 25, 2016, using the keywords "humeral avulsion of the glenohumeral ligament" or "HAGL" to generate a broad search. Systematic screening of eligible studies was undertaken in duplicate. Abstracted data were organized in table format, with descriptive statistics presented. RESULTS: After screening, 18 studies comprising 118 patients were found that described surgical intervention and outcomes for HAGL lesions. The mean patient was 22 years (range, 12-50 years), and 82% were male. Sports injuries represented 72% of all HAGL injuries. The main surgical indication was primary anterior instability, followed by pain and failed nonoperative management. Commonly associated injuries in patients with identified HAGL lesions included a Bankart lesion (15%), Hill-Sachs lesions (13%), and glenoid bone loss (7%). Reporting of outcome scores varied among the included studies. Meta-analysis was not possible, but all included studies reported significantly improved postoperative stability and function. There were no demonstrated differences in outcomes for patients treated with open versus arthroscopic surgical techniques. All but 2 patients undergoing operative management for HAGL lesions were able to return to sport at their previous levels; these included Olympians and professional athletes. CONCLUSION: HAGL lesions typically occur in younger male patients and are often associated with Bankart lesions and bone loss. Open and arthroscopic management techniques are both effective in preventing recurrent instability.

Cholesterol Granuloma of the Abdominal Wall: An Unusual Finding in the Setting of Renal Cell Carcinoma.

Cholesterol granulomas are composed of a distinct type of granulation tissue that contains lipids and cholesterol crystals. They are not believed to be a pathological entity, but rather an inflammatory tissue reaction to the presence of trapped blood secondary to localized hemorrhage.1 Cholesterol granulomas can be identified histologically by the presence of multi-nucleated giant cells, hemosiderin, and red blood cells along with their associated break-down products.1 Recognizing cholesterol granulomas can provide clinical utility as they demonstrate a tendency to mimic carcinoma both clinically and radiologically.

Complication Rates for Hip Arthroscopy Are Underestimated: A Population-Based Study.

PURPOSE: To identify major and minor complication rates associated with hip arthroscopy from a payer-based national database and compare with the rates reported in the existing literature. METHODS: Patients who underwent hip arthroscopy between 2007 and 2014 were identified using PearlDiver, a publicly available database. Rates of major and minor complications, as well as conversion to total hip arthroscopy (THA), were determined by using Current Procedural Terminology (CPT) and International Classification of Diseases, Ninth Revision (ICD-9), codes. Incidence rates of select major complications across the entire database were used as a comparison group. Statistical significance was set at P < .05. RESULTS: Of 18 million patients screened from 2007 to 2014, a total of 2,581 hip arthroscopies were identified. The rates of major and minor complications within a 1-year postoperative period were 1.74% and 4.22%, respectively. Complications included heterotopic ossification (2.85%), bursitis (1.23%), proximal femur fracture (1.08%), deep vein thrombosis (0.79%), and hip dislocation (0.58%). The rate of conversion to THA within 1 year was 2.85%. When compared to rates in the general population, the relative risks [RRs] of requiring a THA (age <50 years, RR = 57.66, P < .001; age >50 years, RR = 22.05, P < .001), sustaining a proximal femur fracture (age <50 years, RR = 18.02, P < .001; age >50 years, RR = 2.23, P < .001), or experiencing a hip dislocation (RR 19.60, P < .001) at 1 year after hip arthroscopy were significantly higher in all age groups. CONCLUSIONS: Higher major complication rates after hip arthroscopy were observed using a national payer-based database than previously reported in the literature, especially in regard to hip dislocations and proximal femur fractures. Rates of total hip arthroplasty were similar to prior studies, whereas the rates of revision hip arthroscopy were higher. LEVEL OF EVIDENCE: Level IV, case series.

Odds ratios deconstructed: A new way to understand and explain odds ratios as conditional risk ratios.

OBJECTIVES: The aim of this analysis was to provide an alternative derivation of the odds ratio (OR) to provide an intuitive meaning, freeing it from any mention of odds, which may make it a more useful concept for clinicians to use when describing treatment effect. STUDY DESIGN AND SETTING: By examining the four possible combinations of treatment/control and corresponding outcomes, we considered the conditional risk ratio (RR, also known as relative risk) of an event with the treatment compared with an event with the control for pairs of patients for whom treatment and control would yield different results. Both matched and unmatched studies are considered. RESULTS: We found that the OR could be derived as the RR of an outcome with treatment compared with an outcome with control conditional on the treatment and control resulting in different outcomes, thus providing a measure of the net benefit of treatment. CONCLUSION: It has been claimed that the OR comparing the effect of treatment vs. control does not have the same clinical interpretability as RR because it involves ratios of odds and so is difficult to explain in terms of patient numbers. This new derivation provides an interpretation of the OR as an RR but conditional on treatment and control resulting in different outcomes. This may help explain the reason ORs cause interpretation difficulties in practice. Moreover, the OR may be a more clinically useful parameter to patients because it deals with only those situations where the outcome differs between the two groups.

Bilateral Osteonecrosis of the Femoral Head During Pregnancy Following Two Corticosteroid Injections: A Case Report and Review of the Literature.

Osteonecrosis of the femoral head during pregnancy, or shortly thereafter, is a rare clinical problem. Little is known about pregnancy as an etiological factor for femoral head osteonecrosis with only 40 reported cases in the literature. Furthermore, single or dual dose steroid-induced multifocal osteonecrosis is a controversial topic with only a handful of published cases. We present a case of a 34-year-old female with bilateral femoral head osteonecrosis that developed during the peripartum period. She received two large intramuscular injections of steroids for fetal lung maturity because early delivery was required as a result of eclampsia. She underwent total arthroplasty of the left hip due to unremitting pain and functional disability, which achieved good clinical results--relieving her pain and improving her range of motion. Literature is scarce with regard to single or dual dose steroid-induced osteonecrosis of the hip as well as pregnancy as a general etiologic factor. This case highlights the need for high clinical suspicion of osteonecrosis as a cause of postpartum hip pain.

YouTube as an information source for femoroacetabular impingement: a systematic review of video content.

PURPOSE: This study was carried out to assess the quality of information available on YouTube regarding femoroacetabular impingement (FAI). METHODS: YouTube was searched on September 7, 2013 using the search terms FAI, femoroacetabular impingement, and hip impingement. Analysis was restricted to the first 3 pages of results for each search term. English language was a prerequisite for inclusion. Videos were evaluated by 2 independent reviewers (M.G.M., D.J.H.) using novel scoring checklists for diagnosis and treatment of FAI. Interobserver reliability analysis was evaluated using the intraclass correlation coefficient (ICC). Videos were grouped according to quality assessment score, and the group means were analyzed for differences in video characteristics using the analysis of variance (ANOVA) model. Videos were characterized by the source of content. RESULTS: After filtering 1,288,324 potential videos, 52 videos were identified and included for analysis. The mean video quality assessment scores were 3.1 for diagnosis and 2.9 for treatment (maximum score = 16). No videos were scored as excellent (quality assessment score > 12). Effective resources included 3 videos on diagnosis and one video on treatment. No statistically significant differences were found between high- and low-scoring videos for duration, days online, views per day, likes, likes per day, likes per view, dislikes, or likes-dislikes difference for either diagnosis or treatment (P > .05 for all). The source of most of the videos was educational (67%), and most of these included physicians (66%). CONCLUSIONS: Patients searching YouTube for videos pertaining to FAI will be presented with a sizeable repository of content of overall low quality. As such, physicians need to recognize the potential influence of YouTube videos on patients' preconceptions of their conditions and the effect on the physician-patient consultation. This review highlights the need for evidence-based, comprehensive educational videos addressing FAI diagnosis and treatment. LEVEL OF EVIDENCE: Level V, systematic review of non-peer-reviewed resources.

Delayed versus early motion after arthroscopic rotator cuff repair: a meta-analysis.

BACKGROUND: We conducted a meta-analysis of randomized trials to compare delayed vs early motion therapy on function after arthroscopic rotator cuff repair. METHODS: We searched 4 electronic databases (Medline, Embase, Cochrane, and Physiotherapy Evidence Database [PEDro]). The methodologic quality of the included studies was assessed, and the relevant data were extracted. Data were pooled for functional outcomes, rotator cuff tear recurrence, and shoulder range of motion. Complications were reported descriptively. RESULTS: Three level I and 1 level II randomized trials were eligible and included. Pooled analysis revealed no statistically significant differences in American Shoulder and Elbow Surgeons scores between delayed vs early motion rehabilitation (mean difference [MD], 1.4; 95% confidence interval [CI], -1.8 to 4.7; P = .38, I(2) = 34%). The risk of retears after surgery did not differ statistically between treatment groups (risk ratio, 1.01; 95% CI, 0.63-1.64; P = .95). Early passive motion led to a statistically significant, although clinically unimportant, improvement in forward elevation between groups (MD, -1°; 95% CI, -2° to 0°; P = 0.04, I(2) = 0%). There was no difference in external rotation between treatment groups (MD, 1°; 95% CI, -2° to 4°; P = 0.63, I(2) = 0%). None of the included studies identified any cases of postoperative shoulder stiffness. CONCLUSIONS: The current meta-analysis did not identify any significant differences in functional outcomes and relative risks of recurrent tears between delayed and early motion in patients undergoing arthroscopic rotator cuff repairs. A statistically significant difference in forward elevation range of motion was identified; however, this difference is likely clinically unimportant.

The learning curve for hip arthroscopy: a systematic review.

PURPOSE: The learning curve for hip arthroscopy is consistently characterized as "steep." The purpose of this systematic review was to (1) identify the various learning curves reported in the literature, (2) examine the evidence supporting these curves, and (3) determine whether this evidence supports an accepted number of cases needed to achieve proficiency. METHODS: The electronic databases Embase and Medline were screened for any clinical studies reporting learning curves in hip arthroscopy. Two reviewers conducted a full-text review of eligible studies and a hand search of conference proceedings and reference sections of the included articles. Inclusion/exclusion criteria were applied, and a quality assessment was completed for each included article. Descriptive statistics were compiled. RESULTS: We identified 6 studies with a total of 1,063 patients. Studies grouped surgical cases into "early" versus "late" in a surgeon's experience, with 30 cases being the most common cutoff used. Most of these studies used descriptive statistics and operative time and complication rates as measures of competence. Five of 6 studies showed improvement in these measures between early and late experience, but only one study proposed a bona fide curve. CONCLUSIONS: This review shows that when 30 cases was used as the cutoff point to differentiate between early and late cases in a surgeon's experience, there were significant reductions in operative time and complication rates. However, there was insufficient evidence to quantify the learning curve and validate 30, or any number of cases, as the point at which the learning curve plateaus. As a result, this number should be interpreted with caution. LEVEL OF EVIDENCE: Level IV, systematic review of Level IV studies.

What we call what we do affects how we do it: a new nomenclature for simulation research in medical education.

Rapid technological advances and concern for patient safety have increased the focus on simulation as a pedagogical tool for educating health care providers. To date, simulation research scholarship has focused on two areas; evaluating instructional designs of simulation programs, and the integration of simulation into a broader educational context. However, these two categories of research currently exist under a single label-Simulation-Based Medical Education. In this paper we argue that introducing a more refined nomenclature within which to frame simulation research is necessary for researchers, to appropriately design research studies and describe their findings, and for end-point users (such as program directors and educators), to more appropriately understand and utilize this evidence.

The use of video before arthroscopic shoulder surgery to enhance patient recall and satisfaction: a randomized-controlled study.

BACKGROUND: Historically, the preoperative consultation has consisted of a discussion between patient and surgeon. There is a growing literature describing efforts to integrate multimedia into surgical patient education. This study aimed to assess the efficacy of an educational video tutorial on early learning of information specific to patients undergoing shoulder arthroscopy when it was used as an adjunct to the standard preoperative consultation. METHODS: This study was a surgeon-blinded, randomized controlled trial involving 40 consecutive patients requiring shoulder arthroscopy. After a preoperative consultation with an orthopaedic surgeon, patients were randomized in a 1:1 ratio to either a control group or a treatment group. The treatment group viewed a 10-minute video, which covered the expected preoperative, intraoperative, and postoperative experience. Immediately afterward, both groups completed a questionnaire measuring satisfaction and recall of information received. All patients completed a second questionnaire at the first postoperative visit that assessed overall satisfaction with their experience. RESULTS: Thirty-four patients were available for follow-up. The video group (N = 15) answered 87% of the knowledge questions correctly, whereas the control group (N = 19) answered only 56% (P = .000). There was stronger agreement in the video group that the preoperative consultation contained an appropriate amount of information (P = .039). Postoperatively, there was agreement that the video was an effective preparation tool for all stages of the surgical experience. However, there was no difference between the groups in satisfaction with their overall surgical experience. CONCLUSIONS: Video can enhance patients' operative experiences and improve their retained knowledge when it is used as an adjunct to the preoperative consultation. LEVEL OF EVIDENCE: Basic science, education methodology study, devices to improve learning.

Hierarchy of evidence: where observational studies fit in and why we need them.

Although randomized controlled designs are considered the so-called gold standard in medical trials and sit atop the hierarchy of evidence in evidence-based medicine, there are situations in which they are impractical or unethical to undertake, especially in surgical trials. Then, observational studies often provide the best source of information. In this paper, we use examples from the literature to explain the importance of observational studies in furthering the boundaries of orthopaedic surgery and knowledge of musculoskeletal disorders.

Making decisions about prognosis in evidence-based practice.

Prognostic studies are designed to investigate factors that impact the outcome of a disease or its treatment. These factors include, but are not limited to, inherent patient characteristics, the state of the disease, and severity of symptoms. The results of prognostic studies can be used to guide the treatment of patients with similar conditions and overall characteristics. It is the purpose of this paper to provide an outline of how to perform an unbiased appraisal of a prognostic study, allowing the physician to assess the applicability of the results to their patient and thereby assist with decision making in clinical practice.