Clinical trials are the gateway to scientific advancements for medication treatments in humans. Since the mid-20th century, all trials of novel medications, including those used in orthopedic subspecialties, have had to adhere to regulations from the US Food and Drug Administration. Though many hybrid and adaptive models of clinical trials abound, the conventional clinical trial is split into four phases with a newer, and optional, preceding exploratory phase. The central tenet of the clinical trial process is to ensure the safety of trial participants and each phase is designed to assess different aspects of safety in addition to specific objectives. Sponsors of medication trials (i.e., pharmaceutical companies) file for approval from the Food and Drug Administration following the successful completion of Phase 3 trials. Evaluation of the medical treatment continues in Phase 4 as investigators examine less common side effects and drug effectiveness in a "real-world" context. The entire clinical trial process spans 10 to 15 years from discovery to drug registration and is associated with additional challenges, namely cost and difficulty in recruiting and retaining participants.

Background Patients often turn to online reviews as a source of information to inform their decisions regarding care. Existing literature has analyzed factors associated with positive online patient ratings among hand and wrist surgeons. However, there is limited in-depth analysis of factors associated with low patient satisfaction for hand and wrist surgeons. The focus of this study is to examine and characterize extremely negative reviews of hand and wrist surgeons on Yelp.com.Methods A search was performed using the keywords "hand surgery" on Yelp.com for eight major metropolitan areas including Washington DC, Dallas, New York, Phoenix, Los Angeles, San Francisco, Boston, and Seattle. Only single-star reviews (out of a possible 5 stars) of hand and wrist surgeons were included. The complaints in the 1-star reviews were then categorized into clinical and nonclinical categories.Result A total of 233 single-star reviews were included for analysis, which resulted in 468 total complaints. Of these complaints, 81 (18.8%) were clinically related and 351 (81.3%) were nonclinical in nature. The most common clinical complaints were for complication (24 complaints, 6%), misdiagnosis (16 complaints, 4%), unclear treatment plan (16 complaints, 4%), and uncontrolled pain (15 complaints, 3%). The most common nonclinical complaints were for physician bedside manner (93 complaints, 22%), financially related (80 complaints, 19%), unprofessional nonclinical staff (61 complaints, 14%), and wait time (46 complaints, 11%). The difference in the number of complaints for surgical and nonsurgical patients was statistically significant ( p < 0.05) for complication and uncontrolled pain.

For many years, the new drug application (NDA) has required that every new drug be approved before commercialization in the United States. The purpose of the NDA is to determine the efficacy and safety of new drugs. The NDA is also responsible for determining whether the benefits of the drug outweigh the risks, whether the drug has appropriate labeling, and whether the methods used to manufacture the drug result in a safe, reliable product. Whenever there is an investigational new drug (IND), the data gathered from the associated animal studies and human clinical studies become part of the NDA.

The Food and Drug Administration (FDA) is responsible for protecting public health interests with regard to the efficacy, safety, and security of: foods, medical devices, biologics, pharmaceuticals, cosmetics, veterinary products, and products that emit radiation. The FDA reported a budget of $5.9 billion in 2019, with more than 50% of these resources being allocated to the monitoring and safety of human drugs, biologics, medical devices, and toxicological research. As of November 2020, the FDA is responsible for monitoring and ensuring the safety of more than $2.8 trillion of medical products, food, and tobacco; with nearly one-fifth of every dollar spent in the United States by consumers accounted for by products regulated by the FDA. Currently, there are over 20,000 prescription drug products approved for marketing and 6500 different medical device product categories. This chapter will review what the FDA does, what products are regulated by the FDA, the branches of the FDA, and examples of FDA regulation.

To the Editor: Dermoscopy has been shown to improve the benign to malignant ratio for suspected melanoma,1Bafounta M.L. Beauchet A. Aegerter P. Saiag P. Is dermoscopy (epiluminescence microscopy) useful for the diagnosis of melanoma? Results of a meta-analysis using techniques adapted to the evaluation of diagnostic tests.Arch Dermatol. 2001; 137: 1343-1350Crossref PubMed Google Scholar,2Carli P. De Giorgi V. Crocetti E. et al.Improvement of malignant/benign ratio in excised melanocytic lesions in the 'dermoscopy era': a retrospective study 1997-2001.Br J Dermatol. 2004; 150: 687-692Crossref PubMed Scopus (198) Google Scholar but not all dermatologists use dermoscopy.3Murzaku E.C. Hayan S. Rao B.K. Methods and rates of dermoscopy usage: a cross-sectional survey of US dermatologists stratified by years in practice.J Am Acad Dermatol. 2014; 71: 393-395Abstract Full Text Full Text PDF PubMed Scopus (29) Google Scholar Previously, we reported the clinical accuracy for identifying melanoma in our institution in 2005,4Soares T.F. Laman S.D. Yiannias J.A. et al.Factors leading to the biopsy of 1547 pigmented lesions at Mayo Clinic, Scottsdale, Arizona, in 2005.Int J Dermatol. 2009; 48: 1053-1056Crossref PubMed Scopus (14) Google Scholar when dermoscopy use and training was limited in the department. In 2006, our department made formal comprehensive formal training available to all providers with annual review. We aimed to review the outcomes and clinical accuracy for identifying melanoma in 2019 to assess the benefit of the comprehensive dermoscopy curriculum. After approval of the Institution Review Board, we conducted a retrospective chart review of patients who underwent biopsy of melanocytic lesions for diagnostic purposes in 2019 at our institution. The 2005 data from the prior publication4Soares T.F. Laman S.D. Yiannias J.A. et al.Factors leading to the biopsy of 1547 pigmented lesions at Mayo Clinic, Scottsdale, Arizona, in 2005.Int J Dermatol. 2009; 48: 1053-1056Crossref PubMed Scopus (14) Google Scholar was incorporated into our data analysis for comparison. We used the Kruskal–Wallis test to analyze continuous variables among different groups, and the Chi-Square test to analyze categorical variables. All analyses were two-sided and considered statistically significant at the P < .05 level. We identified 1546 melanocytic biopsies in 1120 patients in 2005 and 1107 melanocytic biopsies in 901 patients in 2019. The overall severity of architectural disorder of nevi and number of invasive melanomas significantly rose between 2005 and 2019 (Table I). More pT1a melanomas were found in 2019 (Table II). Dermoscopy findings were more frequently documented in 2019 compared to 2005 (79.8% vs 53.9%; P < .001), and when documented, the pathology was more often abnormal in 2019 versus 2005 (90.7% vs 67.8%; P < .001). Provider level of training is found in Supplementary Table I, available via Mendeley at https://doi.org/10.17632/bscwtbvvgn.1.Table IPatient and biopsy characteristics between 2005 and 2019 cohortVariablesCohort yearP value20052019Patient characteristics(n = 1120)(n = 901) Age, median (IQR)57 (43, 70)62 (51, 71)<.0001 Sex, n (%)<.0001Female578 (51.6%)377 (41.8%)Male542 (48.4%)524 (58.2%) Number of study biopsies (IQR)1 (1, 2)1 (1, 1).01 Melanoma (personal history), n (%)<.0001No936 (83.6%)586 (65.0%)Yes184 (16.4%)251 (27.9%) Atypical mole (personal history), n (%)<.0001No918 (82.0%)702 (77.9%)Yes202 (18.0%)183 (20.3%) First degree family history of melanoma, n (%)<.0001No1029 (92.0%)679 (75.4%)Yes90 (8.0%)135 (15.0%) Unknown0 (0.0%)87 (9.7%) Current immunosuppression, n (%)<.0001No1080 (96.4%)829 (92.0%)Yes40 (3.6%)70 (7.8%) Whole body photography, n (%).40No1012 (90.4%)824 (91.5%)Yes108 (9.6%)77 (8.5%)Biopsy characteristics(n = 1546)(n = 1107) Nevi, n (%)1396 (90.3%)870 (78.6%)<.0001No Atypia788 (56.4%)534 (61.4%)Mild atypia548 (39.3%)78 (9.0%)Moderate atypia34 (2.4%)156 (17.9%)Moderate to Severe0 (0%)31 (3.6%)Severe atypia26 (1.9%)71 (8.2%) Melanoma, n (%)146 (9.4%)216 (19.5%).02In situ64 (49.2%)78 (36.1%)Invasive62 (47.7%)135 (62.5%)Metastatic4 (3.1%)3 (1.4%) Atypical melanocytic proliferations n (%)4 (0.3%)21 (0.5%)<.0001 Dermoscopy documented, %53.9%82.9%<.0001IQR, Interquartile range; n, number in subgroups. Open table in a new tab Table IIInvasive melanoma pathologic tumor stage 2005 versus 20192005 (n = 62)2019 (n = 78)P valueStage.048 pT1a51 (82.3%)125 (92.6%) pT1b3 (4.8%)5 (3.7%) pT2a2 (3.2%)4 (3.0%) pT2b2 (3.2%)0 (0.0%) pT3a0 (0.0%)1 (0.7%) pT3b1 (1.6%)0 (0.0%) pT4a1 (1.6%)0 (0.0%) pT4b2 (3.2%)0 (0.0%) Open table in a new tab IQR, Interquartile range; n, number in subgroups. Excluding irritated or cosmetic indications, the nevus to melanoma ratio in 2005 was 9.28:1 and in 2019, it was 3.98:1. Of histopathologic benign lesions, the percentage that displayed moderate to severe atypia was 4.3% in 2005 and in 2019, it was 26.1%. In addition, there were 21 reports of atypical melanocytic proliferation in 2019 and in 2005, there were 4. As this is a retrospective review from 2 different time periods, there are possible confounding factors. The patient populations may have changed over the 14-year period with possibly a higher risk patient cohort in 2019. Age, number of immunosuppressed patients, and evidence of personal or family history of melanoma increased from 2005 to 2019. This may have increased the positive predictive value that a biopsied lesion was malignant. Additionally, there were different providers in the department in 2019 than in 2005. Our favored explanation for striking improvement in the benign nevus to malignant ratio and the increased likelihood of atypical pathology is greater training, experience, and utilization of dermoscopy in the department over the past 14 years. The documentation regarding dermoscopy in the physical exam increased significantly in 2019 compared to 2005, reflecting an adoption of dermoscopy by the clinicians and acceptance of dermoscopy as a diagnostic standard supporting the indication for biopsy. Our findings support the opinion that dermoscopy should be an essential part of dermoscopy residency training curriculum and certification, and dermatologists who have graduated from residency without dermoscopy training should receive appropriate instruction. None disclosed.

PURPOSE:To quantify trends in ophthalmology practice consolidation in the United States. DESIGN:A retrospective cross-sectional study. PARTICIPANTS:Providers in the Centers for Medicare and Medicaid Services (CMS) National Downloadable File with a primary specialty designation of ophthalmology. METHODS:We used the CMS database to determine national practice consolidation trends in ophthalmology on individual physician and group practice levels and analyzed by region, sex, and years spent in practice. We used the Cochran-Armitage test to determine the statistical significance of practice size differences between 2015 and 2022. MAIN OUTCOME MEASURES:Temporal practice size trends for physicians and practices in ophthalmology and regional, sex-specific, and age-related trends. RESULTS:Between 2015 and 2022, the number of ophthalmologists decreased from 17 656 to 17 615 (-0.2%), whereas the number of practices decreased from 7149 to 5890 (-18%). The percentage of ophthalmologists in practices of 1 to 2 members decreased from 35% to 28%, whereas those in groups of 50 or more increased from 7% to 11%. The percentage of practices with 1 to 2 members decreased from 75% to 71%, and those with 50 or more increased from 0.2% to 0.4%. Consolidation trends were significant on individual ophthalmologist (P < 0.001) and group practice (P < 0.001) levels. All regions, sexes, and subgroups of years spent in practice demonstrated consolidation (P < 0.001). The Northeast showed the greatest increase in groups of 50 or more physicians (+7%) between 2015 and 2022. Proportionally fewer female than male ophthalmologists were associated with practice sizes of 1 to 2 members in 2015 (29% and 36%, respectively) and 2022 (23% and 30%, respectively). Proportionally fewer ophthalmologists with 0 to 10 years of experience in practice were associated with practice sizes of 1 to 2 members than those with more than 30 years in practice in 2015 (18% and 48%, respectively) and 2022 (14% and 40%, respectively). CONCLUSIONS:Ophthalmology has undergone practice consolidation from 2015 to 2022. A decrease in the proportion of physicians affiliated with smaller practice sizes seems to have occurred. FINANCIAL DISCLOSURE(S):Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Abstract Context Osteopathic manipulative treatment (OMT) has been established as a beneficial and noninvasive treatment option for multiple conditions. With the total number of osteopathic providers tripling and the subsequent increase in osteopathic physician representation, we would expect the clinical use of OMT to increase accordingly. Objectives To that end, we evaluated the utilization and reimbursement of OMT services among Medicare beneficiaries. Methods Current procedural terminology (CPT) codes 98925 to 98929 were accessed from the Center for Medicare and Medicaid Services (CMS) from 2000 to 2019. These codes indicate OMT treatment, 98925 (1–2 body regions treated), 98926 (3–4 body regions treated), 98927 (5–6 body regions treated), 98928 (7–8 body regions treated), and 98929 (9–10 body regions treated). Monetary reimbursement from Medicare was adjusted for inflation, and total code volume was scaled to codes per 10,000 beneficiaries to account for the increase in Medicare enrollment. Results Overall OMT utilization declined between 2000 and 2019 by 24.5%. A significant downward trend in the utilization of CPT codes for OMT involving fewer body regions (98925–98927) was observed, and was contrasted by a slight upward trend in the use of codes for more body regions (98928, 98929). The adjusted sum reimbursement of all codes decreased by 23.2%. Lower value codes showed a higher rate of decline, whereas higher value codes changed less dramatically. Conclusions We conjecture that lower remuneration for OMT has disincentivized physicians financially and may have contributed to the overall decline in OMT utilization among Medicare patients, along with a decreased number of residencies offering specific training in OMT, and increased billing complexity. In considering the upward trend of higher-value code usage, it is possible that some physicians are increasing the comprehensiveness of their physical assessment and associated OMT to reduce the overall financial impact of reimbursement cuts.

Background:Recent evidence suggests that patients prefer subjective and crowd-sourced information over data-driven or quality-based outcomes when choosing a surgeon. Online physician rating and review websites continue to increase in popularity, and over half of patients use them to research physicians. Specifically, Yelp.com is the most frequently utilized online resource by patients. Data regarding the characteristics of negative reviews for spine surgeons and practices is lacking.Methods:Orthopedic Spine surgeons and practices in 8 major US metropolitan regions were surveyed for one-star reviews on Yelp.com. The factors noted in the reviews were recorded and they were classified according to their clinical or nonclinical nature. Reviews were also subclassified into nonsurgical or surgical episodes of care.Results:A total of 6,286 Yelp reviews were discovered, 671 (10.6%) of which were rated one-star. The majority of negative reviews (76.4%) were from patients who did not report surgery by the surgeon or practice. Of all comments, 491 (77.6%) related to nonclinical complaints. The most common factors noted in negative reviews were related to bedside manner, rude or unprofessional staff, and wait time.Conclusion:Choosing a surgeon is a complex process for patients. The large majority of negative reviews were related to nonclinical issues such as poor bedside manner or rude staff and most of these were written by patients that did not undergo a surgical procedure. This may explain the large discrepancy that has been observed between quality metrics and online crowd-sourced reviews. Paying attention to these nonclinical factors may represent the most feasible and valuable targets to improve a surgeon's practice and attract future patients.

Purpose:To investigate the characteristics of shoulder and elbow fellowship directors (FDs). Methods:FDs for shoulder and elbow fellowship programs in the United States were identified. Demographic, educational, and professional background data were collected from available curricula vitarum, institutional biographies, and the Scopus database. Data collected included age, sex, race/ethnicity, training locations, graduation years, advanced degrees, current institutional information, and personal research H-index. Results:Thirty current orthopaedic shoulder and elbow FDs were identified. The mean Scopus H-index was 25.5. The mean age of FDs was 52.1 years. In total, 29 FDs (96.7%) were male and 1 (3.3%) was female. In addition, 25 of the 30 (83.3%) were White (83.3%), 4 were Asian, and 1 (3.3%) was Hispanic. Two (6.7%) had a military affiliation. Mean time from fellowship training graduation to FD appointment was 13.5 years. Mean number of years as FD was 6.1 years, whereas the number of years tenure with an FD-affiliated institution was 13.0 years. Mean calendar years for completion of orthopaedic residency training and fellowship training were 1998 and 2000, respectively. The residencies that produced the most future FDs were Hospital of the University of Pennsylvania (n = 2) and University of Nebraska Medical Center/Creighton University Health Foundation (n = 2). The fellowship that produced the most future FDs was Columbia University (n = 6). Moderate correlation was found between age and Scopus H-index (r = 0.48; P = .04) and years as FD and Scopus H-index (r = 0.42; P = .03). Conclusions:Women and minorities are under-represented in leadership positions in shoulder and elbow surgery. Shoulder and elbow FDs have the highest H-index of any subspecialty reported in the orthopaedic literature. Research productivity is an important qualification when considering the characteristics of shoulder and elbow FDs. Clinical Relevance:Fellowship directors can have a profound influence on current and future orthopaedic surgeons. It is important to identify the traits that characterize current fellowship directors to have a better understanding of who we choose as leaders in our field.

PURPOSE:To perform a retrospective characterization of one-star reviews of ophthalmologists on Yelp.com and to increase understanding of patient complaints on Yelp.com. METHODS:A search was performed for reviews on Yelp.com using the keyword "ophthalmologist" for the top 8 most population-dense metropolitan areas in the United States. One-star reviews were collected and classified as procedural or nonprocedural. Complaints were also categorized as clinical, nonclinical, or both. Clinical complaints cited issues such as complications, reoperations, uncontrolled pain, misdiagnosis, unclear treatment plan, etc. Nonclinical complaints included comments such as physician bedside manner, other staff interpersonal manner, wait time, brevity of appointment time, etc. RESULTS:5,532 total reviews were assessed, of which 477 (9%) one-star reviews were included in the study for analysis. These reviews amounted to 1,120 distinct complaints. 287 (26%) were clinical in nature and 833 (74%) were nonclinical. Technical incompetence or error (50: 4%), unsatisfactory results (46: 4%), and complications (43: 4%) represented the most common clinical complaints while office staff interpersonal manner (182: 16%), wait time (174: 16%), and physician interpersonal manner (141: 13%) were the most common nonclinical complaints. Refractive surgery was the most frequently mentioned subspecialty (89: 8%). Patients undergoing an ophthalmic procedure (surgery, injection, etc.) wrote 64 reviews that resulted in 193 (17%) complaints. Nonprocedural patients wrote 413 reviews that resulted in 927 (83%) complaints. Compared with procedural reviews, nonprocedural reviews were less likely to include a clinical complaint (rate ratio, 0.3: P < .001). DISCUSSION:The majority of one-star reviews of ophthalmologists included in this study were nonclinical. Complaints referencing a procedural episode were more likely to include a clinical component in the review. In the era of intense medical consumerism and increased physician and health care institution competition for patient acquisition and retention, the characterization of excessively negative reviews allows identification of potential areas of concern for patients that use online review sites such as Yelp.com.

Background: We previously reported the ratio of melanoma to nevus biopsy findings at our institution and the factors leading to biopsy. In this study, we aimed to determine if that ratio has changed since 2005 with more provider dermoscopy experience and if the factors leading to biopsy have changed.

A paucity of data exists regarding reimbursement trends in pediatric ophthalmology, especially regarding the consequences of national policy enacted to minimize the COVID-19 pandemic's effect on access to healthcare. The purpose of this study was to evaluate monetary trends for common pediatric ophthalmology procedures among the Arizona Medicaid population, compared to Medicare data.

Osteoarthritis (OA), formerly understood to be a result of passive wear, is now known to be associated with chronic inflammation. Cigarette smoking promotes systemic inflammation and has been implicated in increased joint OA incidence in some studies, though the recent observational data on the association are contradictory. We hypothesize that second-hand smoke (SHS) treatment will increase the incidence of OA in a mouse model that has been subjected to a surgical destabilization of the medial meniscus (DMM). To test this hypothesis, we applied either SHS treatment or room air (RA) to mice for 28 days post-DMM surgery. Histopathology findings indicated that the knees of SHS mice exhibited more severe OA than their control counterparts. Increased expression of matrix metalloprotease-13 (MMP-13), an important extracellular protease known to degrade articular cartilage, and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB), an intracellular effector of inflammatory pathways, were observed in the SHS group. These findings provide greater understanding and evidence for a detrimental role of cigarette smoke on OA progression and systemic inflammation.

BackgroundMost medical school applicants use the internet as a source of information when applying for medical school. Previous analyses have evaluated residency and fellowship websites, however, an in-depth analysis regarding medical school websites is lacking.MethodsWe evaluated 192 United States medical school websites for presence or absence of 39 items relevant to medical school applicants. Items fell into 7 general categories: curriculum, research, demographics of incoming class, admissions information, faculty, financial aid, and social.ResultsOf the 192 websites evaluated (152 allopathic and 40 osteopathic schools), websites contained a mean of 23 items (59%) with a standard deviation of 4.2 items. ConclusionOur study examining United States Medical School websites revealed a lack of online information for medical school applicants. As medical school interviews transition to being online during the COVID-19 pandemic, the importance of the medical school website to applicants becomes increasingly crucial. The information contained in our study could be used to improve accessibility and information on medical school websites, which could help both applicants and medical schools themselves.

PURPOSE:To examine and characterize extremely negative Yelp reviews of orthopedic sports surgeons in the United States. METHODS:A search for reviews was performed using the keywords "Orthopedic Sports Medicine" on Yelp.com for 8 major metropolitan areas. Single-star reviews were isolated for analysis, and individual complaints were then categorized as clinical or nonclinical. The reviews were classified as surgical or nonsurgical. RESULTS:A total of 11,033 reviews were surveyed. Of these, 1,045 (9.5%) were identified as 1-star, and 289 were ultimately included in the study. These reviews encompassed 566 total complaints, 133 (23%) of which were clinical, and 433 (77%) of which were nonclinical in nature. The most common clinical complaints concerned complications (32 complaints; 6%), misdiagnosis (29 complaints; 5%), and uncontrolled pain (21 complaints; 4%). The most common nonclinical complaints concerned physicians' bedside manner (120 complaints; 21%), unprofessional staff (98 complaints; 17%), and finances (78 complaints; 14%). Patients who had undergone surgery wrote 47 reviews that resulted in 114 complaints (20.5% of total complaints), whereas nonsurgical patients were responsible for 242 reviews and a total of 452 complaints (81.3% of total complaints). The difference in the number of complaints by patients after surgery and patients without surgery was statistically significant (P < 0.05) for all categories except for uncontrolled pain, delay in care, bedside manner of midlevel staff, and facilities. CONCLUSION:Our study of extremely negative Yelp reviews found that 77% of negative complaints were nonclinical in nature. The most common clinical complaints were complications, misdiagnoses and uncontrolled pain. Only 16% of 1-star reviews were from surgical patients. CLINICAL RELEVANCE:Patients use online review platforms when choosing surgeons. A comprehensive understanding of factors affecting patient satisfaction and dissatisfaction is needed. The results of our study could be used to guide future quality-improvement measures and to assist surgeons in maintaining favorable online reputations.