Trajectories of Diabetes-Related Sequelae for Identifying Transition Probabilities, and Optimal Timepoints for Prevention of Ulceration, Infection, and Amputation.

To reduce diabetes-related complications and to avoid futile procedures, foot and ankle surgeons need to understand the relative timings of catastrophic events, their incidence, and probabilities of transitions between disease states in diabetes in different patient populations. For this study, we tracked medical events (including an initial diagnosis of diabetes, ulcer, wound care, osteomyelitis, amputation, and reamputation, in order of severity) and the time between each such event in patients with diabetes, stratifying by sex, race, and ethnicity. We found that the longest average duration between the different lower extremity states was a diagnosis of diabetes to the occurrence of ulcer at 1137 days (38 months). The average durations of amputation to reamputation, osteomyelitis, wound care, and ulcer were 18, 49, 23, and 18 days, respectively. The length of each disease transition for females was greater, while those of the Hispanic population were shorter than in the total cohort. This knowledge may permit surgeons to time and tailor treatments to their patients, and help patients to address, delay, or avoid complications.

Effectiveness of Concurrent Ankle Arthroscopy During Open Reduction and Internal Fixation of Malleolar Fractures in Prevention of Common Short-Term Complications.

Rotational malleolar fractures result in a high prevalence of intra-articular pathologies; therefore, routine arthroscopic assessment may be beneficial in the surgical treatment of ankle fractures. However, the clinical studies regarding the effectiveness of arthroscopy thus far have mixed results. We investigated the efficacy of concurrent arthroscopy during the treatment of malleolar fractures using a large U.S. healthcare data set. Those who had arthroscopy were compared with those who did not, during the surgical treatment of malleolar fractures, while adjusting for covariates of clinical relevance. The analysis showed that concurrent arthroscopy is protective against postoperative repeat surgery (OR = 0.13, 95CI = 0.02-0.41) and wound dehiscence (OR = 0.18, 95CI = 0.03-0.56). The number of added arthroscopy cases needed to avoid one repeat surgery was 74, while that of wound dehiscence was 52. Further studies are needed to determine if routine use of arthroscopy is justifiable in the surgical treatment of malleolar fractures, given the additional costs and time to the healthcare system.

A New Paradigm in Foot and Ankle Outcomes?: Away From Radiographs and Toward Patient-Centered Outcomes.

Having reasonable outcome measures is essential to unbiased research. For years, provider-measured outcomes have been valued as they are more objective and convenient for investigators. However, with the popularity of patient-centered medical care delivery, patient-reported outcome measures are appropriately becoming more popular in foot and ankle research.

The Effect of Limb Salvage Efforts in Different Age Groups: Relationships Between Major and Minor Amputations.

"Limb salvage" efforts, such as performing minor amputations before infections spread proximally from the foot to decrease major lower extremity amputation, are an important part of healthcare today. It is unclear whether these efforts are preventing the number of major amputations and improving patients' quality of life and the cost-effectiveness of the U.S. healthcare system. Rates of non-traumatic lower extremity amputation (NLEA) among patients with diabetes decreased in the early 2000s but rebounded in the 2010s. We analyzed the proportion of major amputations and differences in amputation rates between age groups in Texas. Patient data was extracted from the Texas Hospital Discharge Data Public Use Data File. Population estimates were obtained from the Texas Population Estimates Program from 2011 to 2015 and from intercensal estimates provided by the U.S. Census Bureau from 2006 to 2010. Raw numbers of minor, major, and all NLEA surgeries and the ratio of major amputations to total amputations per year were reported for each age group. Poisson regression and Joinpoint analyses were performed to capture these changes in trends. Rates of amputations increased, with significant decreasing relative prevalence of major amputations. Patients aged 45 to 64 with diabetes are likely driving these increases. Rates of lower extremity amputation in patients with diabetes increased from 2009 to 2015. This holds for all and minor amputations. In contrast, the ratio of major to all amputations decreased from 2010. Utilization of major and minor amputation differs between age groups, remaining stable in the youngest subjects, with minor amputation rates increasing in those aged 45 to 64.

Safe driving recommendations following lower extremity orthopedic surgery: a systematic review.

PURPOSE: We analyzed the published literature on return-to-driving (RTD) recommendations following lower extremity orthopedic surgery, including knee and hip arthroplasty and ankle and foot surgery. METHODS: We conducted a PubMed MEDLINE database search for the relevant literature spanning from 1988 to 2022. Data were extracted from the selected articles independently by six investigators, and the mean, standard deviation, and range of RTD recommendations for each surgical region and procedure were calculated. RESULTS: The 34 studies included in our review evaluated brake response time, reaction time, movement time, braking force, and other parameters. Average RTD recommendations in weeks were: hip surgeries, 4.1 (± 2.7); foot surgeries, 6.67 (± 0.94); Achilles surgeries, 6.67 (± 0.25); ankle surgeries, 4 (± 2); knee surgeries, 5.42 (± 0.77); and multiple lower extremity surgeries, 3.85 (± 0.15). CONCLUSION: Our findings can assist physicians in providing informed recommendations to patients, promoting safe driving practices, and optimizing postoperative recovery. LEVEL OF EVIDENCE: Therapeutic, Level III: Retrospective comparative study.

Return to Play Rates Following Operative Ankle Fractures Differ Between High- and Low-Performing National Football League Athletes.

This study investigated predictive factors for return to play among National Football League athletes after operative treatment of ankle fractures and the impacts of these injuries on career longevity and player performance. Athletes who underwent surgery to repair ankle fractures from the 2013 to 2017 seasons were identified from injury reserve lists and press releases. Demographics and season metrics were collected before and after the injury. Statistical analysis assessed for differences in recorded variables between injured and uninjured players. Thirty-one players met study inclusion criteria. Twenty-two (71%) athletes successfully returned to play. Players who did not return showed no significant differences (P>.05) in position, age, body mass index, number of games or seasons played preinjury, or snaps per game the season prior to injury and had a significantly lower (42.6%, P=.013) preinjury season approximate value (SAV) compared with returning players. Returning athletes showed no significant differences (P>.05) in SAV or snaps per game compared with their preinjury season or with uninjured controls. A high preinjury SAV is associated with successful return to play. No difference in game time or performance metrics was detectable between returning players and uninjured controls, or between preinjury and postinjury seasons. [Orthopedics. 2024;47(1):22-27.].

Radiographic Anatomy of the Lateral Ankle Ligament Complex: A Cadaveric Study.

BACKGROUND: When lateral ankle sprains progress into chronic lateral ankle instability (CLAI), restoring precise anatomic relationships of the lateral ankle ligament complex (LALC) surgically is complex. This study quantifies the radiographic relationships between the anterior talofibular ligament (ATFL), calcaneofibular ligament (CFL), and prominent osseous landmarks visible under fluoroscopy to assist in perioperative practices for minimally invasive surgery for CLAI. METHODS: Ten fresh frozen ankle specimens were dissected to expose the LALC and prepared by threading a radiopaque filament through the ligamentous footprints of the ATFL and CFL. Fluoroscopic images were digitally analyzed to define dimensional characteristics of the ATFL and CFL. Directional measurements of the ligamentous footprints relative to the lateral process of the talus and the apex of the posterior facet of the calcaneus were calculated. RESULTS: Dimensional measurements of the ATFL were a mean length of 9.3 mm, fibular footprint of 9.4 mm, and talar footprint of 9.1 mm. Dimensional measurements of the CFL were a mean length of 19.4 mm, fibular footprint of 8.2 mm, and calcaneal footprint of 7.3 mm. From the radiographic apparent tip of the lateral process of the talus, the fibular attachment of the ATFL was found 13.3 mm superior and 4.4 mm posterior, whereas the talar attachment was found 11.5 mm superior and 4.8 mm anterior. From the radiographic apparent posterior apex of the posterior facet of the calcaneus, the fibular attachment of the CFL was found 0.2 mm inferior and 6.8 mm anterior, whereas the calcaneal attachment was found 14.3 mm inferior and 5.9 mm posterior. CONCLUSION: The ATFL and CFL were radiographically analyzed using radiopaque filaments to outline the ligamentous footprints in their native locations. These ligaments were also localized with reference to 2 prominent osseous landmarks. These findings may assist in perioperative practices for keyhole incision placement and arthroscopic guidance. Perfect lateral ankle joint imaging with talar domes superimposed is required to be able to do this. CLINICAL RELEVANCE: Radiographic evaluation of the ATFL and CFL with reference to prominent osseous landmarks identified under fluoroscopy may assist in perioperative practices for minimally invasive surgery to address CLAI for keyhole incision placement and arthroscopic guidance.

Preoperative Serum Albumin and Other Risk Factors Related to 30-Day Postoperative Complications in Total Ankle Arthroplasty.

This study investigates effects of preoperative albumin on 30-day total ankle arthroplasty (TAA) outcomes. Additionally, other preoperative risk factors are addressed, including American Anesthesia Society (ASA) class, functional status, chronic obstructive pulmonary disease (COPD), diabetes, smoking status, time of operation, and age. Outcomes assessed were readmission, return to operating room, surgical site infection, wound dehiscence, and total length of stay (TLOS). Data were extracted from the National Surgical Quality Improvement Program database. Bivariate comparisons were analyzed using correlation coefficients, t tests, or chi-squared tests; multivariate comparisons used linear or logistic regression. Our data showed no significant correlation between serum albumin and patients with readmission (odds ratio -0.14, P = 0.06), return to operating room (-0.07, P = 0.61), or surgical site infection (-0.08, P = 0.56). With bivariate analysis, functional status and COPD were significant for readmission (12.67, P < 0.001 and 7.83, P < 0.001, respectively) and dehiscence (30.52, P < 0.001 and 6.74, P = 0.05, respectively), while high ASA class (0.4, P = 0.01), increased age (0.1, P < 0.001), and longer time of operation (0.19, P < 0.001) were associated with longer TLOS. With multivariate analysis, functional status showed higher odds of readmission (7.42, P = 0.02) and dehiscence (20.47, P = 0.01), while COPD showed higher odds for readmission (6.65, P < 0.001) and longer TLOS (0.31, P = 0.05). High ASA class (0.42, P < 0.001) and female sex (0.32, P < 0.001) also had higher odds for longer TLOS. In summary, low albumin was not significant for readmission, return to operating room, or surgical site infection in TAA. COPD, functional status, high ASA class, longer time of operation, increased age, and female sex were all correlated with adverse outcomes in TAA.

The Effects of COVID-19 on Orthopaedic Surgery Training Programs in the United States.

INTRODUCTION: This study investigates the effects of the COVID-19 pandemic on medical education, research opportunities, and mental health in orthopaedic surgical training programs. METHODS: A survey was sent to the 177 Electronic Residency Application Service-participating orthopaedic surgery training programs. The survey contained 26 questions covering demographics, examinations, research, academic activities, work settings, mental health, and educational communication. Participants were asked to assess their difficulty in performing activities relative to COVID-19. RESULTS: One hundred twenty-two responses were used for data analysis. Difficulties were experienced in collaborating with others (49%), learning through online web platforms (49%), maintaining the attention span of others through online web platforms (75%), and in gaining knowledge as a presenter or participating through online web platforms (56%). Eighty percent reported that managing time to study was the same or easier. There was no reported change in difficulty for performing activities in the clinic, emergency department, or operating room. Most respondents reported greater difficulty in socializing with others (74%), participating in social activities with coresidents (82%), and seeing their family (66%). Coronavirus disease 2019 has had a significant effect on the socialization of orthopaedic surgery trainees. DISCUSSION: Clinical exposure and engagement were marginally affected for most respondents, whereas academic and research activities were more greatly affected by the transition from in-person to online web platforms. These conclusions merit investigation of support systems for trainees and evaluating best practices moving forward.

Delayed Diagnosis of Charcot Foot: A Systematic Review.

This study aims to examine the duration and rate of delayed diagnosis in Charcot foot. We systematically reviewed articles published in Medline, SCOPUS, and Cumulative Index of Nursing and Allied Health Literature to identify articles discussing delayed or misdiagnosis of Charcot foot. Random-effects models were generated to determine the average time from symptom onset to correct diagnosis (diagnostic delay duration) and proportion of patients misdiagnosed prior to being correctly diagnosed (delayed diagnosis rate). Our search identified 142 articles, 7 of which are included in this review. The review found that 53.2% of cases of Charcot osteoarthropathy experienced a delay in diagnosis (95% CI: 28.9%-77.4%). Overall, the duration of diagnostic delay was determined to be 86.9 days (95% CI: 10.5-162.1). We found that patients with Charcot foot experienced prolonged delays from symptom onset to correct diagnosis, and a majority of patients are misdiagnosed. These delays in diagnosis contribute to worse patient outcomes.

An Updated Epidemiology of Foot and Ankle Fractures in the United States: Complications, Mechanisms, and Risk Factors.

Foot and ankle fractures are prevalent emergent injuries, about which there remains a lack of in-depth epidemiological information. This analysis of the epidemiology of foot and ankle injuries in the United States updates a previously conducted study. Data from the National Trauma Data Bank (2012-2017) were used for analysis. Demographic variables, mechanism of injuries, and comorbidities were analyzed to determine risk factors for complications after foot and ankle injuries. Young adults aged 21 to 30 years had the highest injury rates; however, in general, older individuals were more at risk for complications. Black individuals were more at risk for certain complications, while Asians were at lower risk, when compared to White individuals. The comorbidities of bleeding disorders, diabetes, smoking, hypertension, and chronic obstructive pulmonary disease all increased risk of at least 1 complication. In terms of mechanism, traffic incidents were found to be the most strongly associated with complications.

Diabetes-Specific Dementia: A Structured Literature Review of Cognitive Assessment Methods.

Diabetes mellitus is a known risk factor for the development of multiple subtypes of dementia and mild cognitive impairment. Recent research identifies a cause-specific diabetes-related dementia with a unique set of characteristics. Currently, there is no standard cognitive assessment battery recommended to specifically assess dementia that is a direct consequence of chronic diabetes, and some evaluations have been used for decades with minimal revisions, regardless of appropriateness. We performed a systematic review of the dementia/cognition evaluation methods most commonly used in the literature for assessing diabetic patients and identified which cognitive domains are typically assessed in this setting, and whether cognitive changes were more reflective of a vascular pathology, Alzheimer's pathology, or something else entirely. Search results yielded 1089 articles. After screening for appropriateness, a total of 11 full-text articles were assessed. In general, subjects in the reviewed studies were assessed using a variety of testing methods, examining different combinations of cognitive domains. A standard, clear definition of which cognitive domains are the most important to assess in diabetic patients is needed in order to determine what combination of assessment tools are most pertinent. Given the growing subset of the US population, careful reconsideration of cognitive assessment methods is needed to create self-care plans that take into account a specific collection of cognitive challenges for those with diabetes.

A Pilot Survey: Knowledge of Charcot Neuroarthropathy Among Family and Internal Medicine Practitioners.

Charcot neuroarthropathy secondary to diabetes mellitus is a serious complication, requiring specialist management. As a relatively rare pathology bearing similarity to other, more common diseases, it may be misdiagnosed at initial presentation, potentially leading to delays in appropriate management. We conducted a 2-part online survey of primary care physicians within an academic medical institution to assess knowledge of presentation, complications, diagnosis, and treatment of Charcot neuropathy. The first section was designed to assess physician knowledge of Charcot foot, while the second section was completed only by physicians who were familiar with the condition and was designed to gauge their level of knowledge. Most clinicians were familiar with Charcot, encountering it at least annually. They identified common signs of Charcot (eg, swelling, pain) and complications due to its mismanagement (eg, ulcer, amputation). However, there was some disagreement on how to diagnose the pathology, with some relying on film, others referring to specialists, and some saying they were unsure. There was uncertainty on when to choose surgical options; fewer than half referred to specialists for help with this decision, and a quarter were unsure how to make the decision. While, in general, clinicians were aware of Charcot and its characteristics, there was confusion regarding how to diagnose or appropriate nonsurgical treatment.

Thromboprophylaxis and Bleeding Complications in Orthopedic and Trauma Patients: A Systematic Review.

This systematic review was conducted to investigate the effects of currently used chemoprophylactic modalities to assess concerns regarding their usage. Preventive benefits of thromboprophylaxis were weighed against potential complications in orthopedic and trauma patients. The Ovid MEDLINE® database was used to identify relevant studies. The authors independently screened the initial study articles by title and abstract, eliminating articles not dealing with venous thromboembolism (VTE) chemoprophylaxis in orthopedic or trauma populations. The remaining articles were assessed for eligibility through full-text analysis. The analyzed studies within this review suggested that Factor Xa inhibitors and direct oral anticoagulants hold promise as safe and potentially more effective thromboprophylactic entities when compared to low molecular weight heparin in trauma and orthopedic patients. Thromboprophylaxis had little to no effect on major bleeding incidence, although we could not definitively conclude there was no effect on overall bleeding. Early thromboprophylaxis, especially when identifiable risk factors are present, can improve VTE prevention without changing major bleeding rates. Additionally, we could not conclude whether extended prophylaxis affects VTE incidence, although it seemed to have no effect on major bleeding. Finally, we determined that thromboprophylaxis in the lower extremity trauma population is questionable without the presence of underlying risk factors.

Microbiota Detection Patterns Correlate With Presence and Severity of Barrett's Esophagus.

Background: The microbiome has been increasingly associated with different disease processes, but its role in esophagus is largely unknown. Our goal was to determine the associations of the esophageal microbiota with Barrett's esophagus. Methods: A total of 74 patients were included in this prospective study, including 34 patients with Barrett's esophagus and 40 patients without Barrett's esophagus. Esophageal swabs were obtained from the uvula, and mucosal biopsies were obtained from the proximal esophagus and distal esophagus in each patient. The microbiome of each sample was assessed using a customized Esophageal Microbiome qPCR array (EMB). For each clinical sample, we completed a detection/non-detection analysis for each organism in the EMB. The limit of detection (LOD) for each target was established by analysis of plasmid dilutions. Results: Average age was 60.2 years. There were significantly different microbial detection patterns in patients with Barrett's esophagus compared to the control population. There were a greater number of organisms which had different likelihoods of detection in the distal esophagus, compared to the proximal esophagus or uvula. In addition, as the length of the Barrett's column increased, multiple organisms were less likely to be detected. This decreased likelihood occurred only in the distal esophagus. Beside Barrett's esophagus, no other demographic factors were associated with differences in detection patterns. Conclusions: Microbial community structures differ between patients with and without Barrett's esophagus. Certain organisms are less likely to be detected as the severity of Barrett's esophagus worsens. These results suggest that particular organisms may have a protective effect against the development of Barrett's esophagus.

Predisposing Factors for 30-Day Complications Following Leg Amputation.

BACKGROUND: Although amputation rates, morbidity, and mortality have been established for select populations, the impact of general demographic factors on postoperative surgical complications remains little studied. METHODS: The American College of Surgeons' National Surgical Quality Improvement Program database was searched for leg amputations from 2012 to 2017 using CPT codes 27881, 27882, 27884, and 27886, identifying 4162 patients. A total of 29 demographic variables with 4 complications (surgical infection, additional service, and deep-vein thrombosis [DVT], and sepsis) were analyzed. RESULTS: Preoperative open, contaminated, or dirty/infected wounds; longer intraoperative times; development of sepsis prior to surgery; and admission of patients from home or another hospital influenced postoperative infection rates. Preoperative open, infected, or dirty/infected wounds; height; weight; total length of hospital stay; and ethnicity affected postoperative additional service incidence. Preoperative congestive heart failure, large decreases in body weight, and total length of hospital stay influenced postoperative DVT rates. Preoperative functional heath status, total length of hospital stay, amputations conducted as emergency cases, preoperative acute renal failure, open or infected wounds, sepsis, and contaminated or dirty/infected wounds affected postoperative sepsis rates. BACKGROUND: Conclusion. Understanding these risk factors may allow providers to anticipate and address higher rates of complications in certain patient populations. LEVEL OF EVIDENCE: Level III: Prognostic.

Minor vs. major leg amputation in adults with diabetes: Six-month readmissions, reamputations, and complications.

AIMS: The objective of this study was comparing medium-term outcomes between comparable minor and major amputations in adults with diabetes. METHODS: We used data from the 2016-2017 National Readmissions Database to construct a representative cohort of 15,581 adults with diabetes with lower extremity amputations. Patients were categorized by level of index amputation (major/minor), and propensity score matched to compare outcomes in candidates for either level of amputation. Readmission and reamputations were assessed at 1, 3, and 6 months following index amputation. RESULTS: In the 6 months following index amputation, large proportions of patients were readmitted (n = 7597, 48.8%) or had reamputations (n = 1990, 12.8%). Patients with minor amputations had greater odds of readmission (OR = 1.25; 95% CI 1.18-1.31), reamputation (OR = 3.71; 95% CI 3.34-4.12), and more proximal reamputation (OR = 2.61; 95% 2.33-2.93) (all P < 0.001). Further, minor amputation patients had higher and lower odds of readmission for postoperative infection (OR = 4.45; 95% CI 3.27-6.05), or sepsis (OR = 0.79; 95% CI 0.68-0.93), respectively. CONCLUSION: Patients desire to save as much limb as possible and should be counseled on higher risk for reamputation, readmission, and infection with minor amputations.

Identifying risk factors for missed compartment syndrome in patients with tibia shaft fractures: An analysis of the national trauma data bank.

OBJECTIVES: Acute compartment syndrome (CS) is a common complication of tibia shaft fractures (TSFs), and occurs when the pressure inside a myofascial compartment rises and impairs tissue perfusion. If treatment is delayed due to a missed diagnosis, amputation or permanent loss of function can result. This study aims to determine the incidence, clinical associations, and risk factors for missed CS following surgical stabilization of tibia shaft fractures (TSFs) using data from the National Trauma Data Bank (NTDB). METHODS: NTDB data files from 2007 to 2016 were accessed to collect information on patients undergoing surgical fixation of TSFs. Patients with an Injury Severity Score (ISS) > 15 or inferred Gustilo-Anderson IIIB/IIIC fractures were excluded to create a more homogenous sample of lower-grade TSFs. Compartment syndrome that was originally missed leading to late intervention was the main outcome under investigation. Bivariate tests were used to assess the relationships between missed CS and the preoperative variables. If a variable and a complication had an association with a P ≤ 0.2, it was included in a multivariate logistic regression model. RESULTS: A total of 184,612 patients met our inclusion criteria, and 1,269 patients (0.76%) had a missed CS diagnosis. Bivariate analysis demonstrated that male gender had a significant positive association with a missed CS diagnosis, while older age had a significant negative association (odds ratio [OR] = 2.17, 0.99; P < 0.001). Multivariate analysis revealed that male gender was the most significant independent risk factor for a missed diagnosis of compartment syndrome (OR = 1.84, P < 0.00001), followed by alcoholism, penetrating trauma, and smoking (OR = 1.51, 1.46, 1.43; P < 0.02). The only significant protective factor was open fracture (OR = 0.70, P < 0.0001). CONCLUSIONS: Our research identified several significant risk factors for missed CS after TSF, as well as positive and negative associations. Male gender, age, and lifestyle choices such as alcohol use and smoking conferred increased risks. These variables may assist physicians in identifying at-risk patients who may benefit from increased monitoring, and potentially prevent the high morbidity associated with this condition.

Predisposing Factors for 30-Day Complications Following Achilles Tendon Repair.

Certain risk factors for Achilles tendon repair complications, including tobacco use, diabetes mellitus, steroid use, and obesity, have been well-reviewed. This study analyzes the impact of a range of demographic factors on unique surgical complications within the 30-day postoperative period. We extracted data from the American College of Surgeons National Surgical Quality Improvement Program database from 2012 to 2017 and searched for Achilles tendon repairs using CPT codes 27650, 27652, and 27654, identifying 4,040 patients. Twenty-two demographic variables and their association with each of 4 complications were analyzed using t tests or chi-squared tests. A logistic regression was conducted to determine independent risk factors for each outcome, based on results from the bivariate analyses. Variables having p <.2 on bivariate analysis were included in the multivariate analysis of the corresponding surgical complication. Patients with open or infected wounds preoperatively were more likely to return with a postoperative surgical infection (p< .001). Likewise, each additional year of the patient's age increased their likelihood of developing a surgical infection (p= .03). Patients with "clean/contaminated" wound sites prior to repair were more likely to return for an additional service (p= .02). Furthermore, each additional inch of the patient's height (p= .03) and every additional minute of operative time increased a patient's risk of developing a new-onset deep vein thrombosis (p= .01). This study offers providers a more complete picture of which preoperative characteristics affect Achilles tendon repair patients, directing management to reduce postoperative complication rates.

A Critical Look at a Diabetic Foot Randomized Controlled Trial: Can You Ever Have Too Many Patients?

The objective of this article series is to teach approaches for critical appraisal to consumers of medical literature. The aim is to build a deeper understanding of standard procedure in clinical research so clinicians can determine whether medical evidence can be applied to their practices. We will choose published articles with methodological flaws to serve as discussion points. In the first article of this series, we will proceed section by section through an article to teach readers what is usually reported, and illustrate what was done correctly and what was not. Subsequently, later articles in this series of critical appraisals will discuss more focused topics. There were several interesting flaws in our first examined paper. This study provides the unusual flaw of reporting a sample size justification and then exceeding enrollment. In addition, the authors enrolled a relatively large number of subjects (n = 16) that evidently completed the study but were subsequently excluded from analysis because they did not fit the inclusion and exclusion criteria.