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Representation of Racial and Ethnic Minorities in Nephrology Clinical Trials: A Systematic Review and Meta-Analysis

Soomro, Qandeel H; McCarthy, Angela; Varela, Dalila; Keane, Colin; Ways, Javaughn; Charytan, Amalya M; Ramos, Giana; Nicholson, Joey; Charytan, David M
SIGNIFICANCE STATEMENT:Racial and ethnic disparities in clinical trial enrollment are well described. However, whether these disparities are present in nephrology randomized clinical trials has not been previously reported. We performed a systematic review and meta-analysis of 380 randomized clinical trials involving different aspects of kidney disease published between 2000 and 2021. Our results indicate that worldwide reporting of race and ethnicity is poor and that White individuals account for most of the randomized participants with decreased enrollment of Black participants in more recent trials. However, trials conducted in the United States have representation of Black and Hispanic participants consistent with the population prevalence of disease and under-representation of Asian participants. BACKGROUND:Under-representation of racial and ethnic minorities in clinical trials could worsen disparities, but reporting and enrollment practices in nephrology randomized clinical trials have not been described. METHODS:PubMed was searched to capture randomized clinical trials for five kidney disease-related conditions published between 2000 and 2021 in ten high-impact journals. We excluded trials with <50 participants and pilot trials. Outcomes of interest were the proportion of trials reporting race and ethnicity and the proportions of enrolled participants in each race and ethnicity category. RESULTS:Among 380 trials worldwide, race was reported in just over half and ethnicity in 12%. Most enrolled participants were White, and Black individuals accounted for ≤10% of participants except in dialysis trials where they accounted for 26% of participants. However, Black participants were enrolled at high proportions relative to disease and population prevalence in US CKD, dialysis, and transplant trials representing 19% of participants in AKI, 26% in CKD, 44% in GN, 40% in dialysis, and 26% in transplant trials. Enrollment of Asian participants was low worldwide except in GN trials with marked under-representation in US CKD, dialysis, and transplant trials. Hispanic individuals represented only 13% of participants in US dialysis trials compared with 29% of US dialysis population. CONCLUSION:More complete reporting of race and ethnicity in nephrology trials is needed. Black and Hispanic patients are well-represented in kidney disease trials in the United States. Asian patients are poorly represented in kidney trials both globally and in the United States.
PMID: 37022114
ISSN: 1533-3450
CID: 5537172

Clinician communication strategies associated with increased uptake of the human papillomavirus (HPV) vaccine: A systematic review

Constable, Catherine; Ferguson, Kyle; Nicholson, Joey; Quinn, Gwendolyn P
Human papillomavirus (HPV) is currently linked to almost 35,000 new cases of cancer in women and men each year in the United States. Gardasil-9 (Merck & Company), the only HPV vaccine now available in the United States, is nearly 100% effective at preventing precancers caused by oncogenic HPV types. In the United States, however, only about one half of adolescents are up to date with HPV vaccination. It is well known that health care clinicians' recommendations play a significant role in parents' decisions regarding HPV vaccination. A growing body of literature examines specific communication strategies for promoting uptake of the HPV vaccine. A comprehensive review of the evidence for each of these strategies is needed. The authors searched the PubMed, EMBASE, Cochrane Central Register of Controlled Trials, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Web of Science Complete databases for original articles with a defined clinician communication strategy and an outcome of HPV vaccine uptake or intention to vaccinate (PROSPERO registry no. CRD42020107602). In total, 46 studies were included. The authors identified two main strategies with strong evidence supporting their positive impact on vaccine uptake: strong recommendation and presumptive recommendation. Determinations about a causal relationship were limited by the small numbers of randomized controlled trials. There is also opportunity for more research to determine the effects of motivational interviewing and cancer-prevention messaging.
PMID: 35969145
ISSN: 1542-4863
CID: 5299772

Cochlear Implantation Outcomes in Patients With Retrocochlear Pathology: A Systematic Review and Pooled Analysis

Schlacter, Jamie A; Kay-Rivest, Emily; Nicholson, Joseph; Santacatterina, Michele; Zhang, Yan; Jethanamest, Daniel; Friedmann, David R; McMenomey, Sean O; Roland, J Thomas
OBJECTIVE:To review the current literature regarding cochlear implantation in patients with retrocochlear pathologies and extract speech perception scores between 6 months and 1 year after surgery. DATABASES REVIEWED/UNASSIGNED:PubMed/MEDLINE, Embase and Cochrane CENTRAL via Ovid, CINAHL Complete via Ebsco, and Web of Science. METHODS:The review was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Search strategies included keywords and subject headings to maximize retrieval and reflect cochlear implants and retrocochlear pathologies. Patients with previously resected vestibular schwannoma (VS) were excluded. RESULTS:There were 2,524 abstracts screened against inclusion criteria, and 53 studies were included, with individual data available for 171 adult patients. Pathologies included were either observed or irradiated VS (previously operated tumors were excluded) (n = 99, 57.9%), superficial siderosis (n = 39, 22.8%), neurosarcoidosis (n = 11, 6.4%), and previous central nervous system or skull base radiation (n = 22, 12.9%). Mean (standard deviation) postoperative consonant-nucleus-consonant (CNC) word scores were 45.4% (24.2) for observed VS, 44.4% (20.8) for irradiated VS, 43.6% (21.0) for superficial siderosis, 89.5% (3.0) for neurosarcoidosis, and 30.0% (30.2) in patients with previous central nervous system or skull base irradiation. Irradiated compared with observed VS had similar postoperative CNC word scores (effect size, 0.06; p = 0.71). Age, sex, maximal tumor dimension, and neurofibromatosis type 2 status did not significantly impact cochlear implant performance in patients with VS. Eighty-two percent of patients with reported device usage were daily users, and overall, 82% of cases benefitted from cochlear implantation. CONCLUSION/CONCLUSIONS:Cochlear implantation in patients with concomitant retrocochlear pathology generally results in improved speech discrimination scores sustained over time.
PMID: 36047686
ISSN: 1537-4505
CID: 5335012

Physician Training for Electrocardiogram Interpretation: A Systematic Review and Meta-Analysis

Oh, So-Young; Cook, David A; Van Gerven, Pascal W M; Nicholson, Joseph; Fairbrother, Hilary; Smeenk, Frank W J M; Pusic, Martin V
PURPOSE/OBJECTIVE:Using electrocardiogram (ECG) interpretation as an example of a widely taught diagnostic skill, the authors conducted a systematic review and meta-analysis to demonstrate how research evidence on instruction in diagnosis can be synthesized to facilitate improvement of educational activities (instructional modalities, instructional methods, and interpretation approaches), guide the content and specificity of such activities, and provide direction for research. METHOD/METHODS:The authors searched PubMed/MEDLINE, EMBASE, Cochrane CENTRAL, PsycInfo, CINAHL, ERIC, and Web of Science databases through February 21, 2020, for empirical investigations of ECG interpretation training enrolling medical students, residents, or practicing physicians. They appraised study quality with the Medical Education Research Study Quality Instrument and pooled standardized mean differences (SMDs) using random effects meta-analysis. RESULTS:Of 1,002 articles identified, 59 were included (enrolling 17,251 participants). Among 10 studies comparing instructional modalities, 8 compared computer-assisted and face-to-face instruction, with pooled SMD 0.23 (95% CI, 0.09, 0.36) indicating a small, statistically significant difference favoring computer-assisted instruction. Among 19 studies comparing instructional methods, 5 evaluated individual versus group training (pooled SMD 0.35 favoring group study [95% CI, 0.06, 0.63]); 4 evaluated peer-led versus faculty-led instruction (pooled SMD 0.38 favoring peer instruction [95% CI, 0.01, 0.74]); and 4 evaluated contrasting ECG features (e.g., QRS width) from 2 or more diagnostic categories versus routine examination of features within a single ECG or diagnosis (pooled SMD 0.23 not significantly favoring contrasting features [95% CI, -0.30, 0.76]). Eight studies compared ECG interpretation approaches, with pooled SMD 0.92 (95% CI, 0.48, 1.37) indicating a large, statistically significant effect favoring more systematic interpretation approaches. CONCLUSIONS:Some instructional interventions appear to improve learning in ECG interpretation; however, many evidence-based instructional strategies are insufficiently investigated. The findings may have implications for future research and design of training to improve skills in ECG interpretation and other types of visual diagnosis.
PMID: 35086115
ISSN: 1938-808x
CID: 5154732

Management of pediatric atopic dermatitis by primary care providers: A systematic review

Young, Trevor K; Glick, Alexander F; Yin, H Shonna; Kolla, Avani M; Velazquez, Jessica J; Nicholson, Joey; Oza, Vikash S
BACKGROUND:Primary care providers (PCPs), including pediatricians and general practitioners, are often the first to see children with eczema/atopic dermatitis (AD). Little is known about management of pediatric AD by PCPs and adherence to national guidelines. OBJECTIVE:To review existing literature examining management components of pediatric AD (topical corticosteroids [TCS], topical calcineurin inhibitors [TCIs], antihistamines, bathing, emollients, and diet) by PCPs. DATA SOURCES/METHODS:PubMed/Medline and Embase. STUDY ELIGIBILITY CRITERIA/METHODS:English-language articles dated 2015-2020 reporting outcomes addressing management of pediatric AD by PCPs. STUDY APPRAISAL AND SYNTHESIS METHODS/METHODS:Two authors independently screened titles/abstracts, reviewed full-text articles, extracted relevant data, and evaluated study quality. Disagreements were resolved by a third author. RESULTS:20 articles were included. Surveys and national database analyses were the most common methodologies (n=7 each). PCPs commonly prescribed TCS but had a preference for low-potency agents, overprescribed non-sedating antihistamines, and avoided TCIs. PCPs commonly recommended emollients, although this was not universal. Data characterizing non-medication management were limited. LIMITATIONS/CONCLUSIONS:Most studies did not examine individual patient encounters, but rather relied on providers reporting their general behaviors. Provider behavior may vary based on country of practice. CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS/UNASSIGNED:Knowledge and management gaps exist among PCPs in treating pediatric AD in key areas including knowledge of TCS safety profiles and prescribing of TCIs. The current literature is largely limited to small studies that evaluate prescribing behaviors with limited data characterizing non-medication management, highlighting the need for future research in this area.
PMID: 34280477
ISSN: 1876-2867
CID: 4947942

The Role of Gender in Careers in Medicine: a Systematic Review and Thematic Synthesis of Qualitative Literature

Winkel, Abigail Ford; Telzak, Beatrice; Shaw, Jacquelyn; Hollond, Calder; Magro, Juliana; Nicholson, Joseph; Quinn, Gwendolyn
BACKGROUND:Gender disparities exist in the careers of women in medicine. This review explores the qualitative literature to understand how gender influences professional trajectories, and identify opportunities for intervention. METHODS:A systematic review and thematic synthesis included articles obtained from PubMed, Cochrane Central Register of Controlled Trials (Ovid), EMBASE (Ovid), APA PsycInfo (Ovid), and GenderWatch (ProQuest) on June 26 2020, updated on September 10, 2020. Included studies explored specialty choice, leadership roles, practice setting, burnout, promotion, stigma, mentoring, and organizational culture. Studies taking place outside of the USA, using only quantitative data, conducted prior to 2000, or focused on other health professions were excluded. Data were extracted using a standardized extraction tool and assessed for rigor and quality using a 9-item appraisal tool. A three-step process for thematic synthesis was used to generate analytic themes and construct a conceptual model. The study is registered with PROSPERO (CRD42020199999). FINDINGS/RESULTS:Among 1524 studies identified, 64 were eligible for analysis. Five themes contributed to a conceptual model for the influence of gender on women's careers in medicine that resembles a developmental socio-ecological model. Gender influences career development externally through culture which valorizes masculine stereotypes and internally shapes women's integration of personal and professional values. CONCLUSION/CONCLUSIONS:Medical culture and structures are implicitly biased against women. Equitable environments in education, mentoring, hiring, promotion, compensation, and support for work-life integration are needed to address gender disparities in medicine. Explicit efforts to create inclusive institutional cultures and policies are essential to support a diverse workforce.
PMID: 33948802
ISSN: 1525-1497
CID: 4866392

Authors' Reply to: Redundancy of Terms in Search Strategies. Comment on "Searching PubMed to Retrieve Publications on the COVID-19 Pandemic: Comparative Analysis of Search Strings"

Rasmussen, Lauge Neimann; Norgaard, Ole; Andersen, Tue Helms; Palayew, Adam; Nicholson, Joey; Lazarus, Jeffrey V
PMID: 33989168
ISSN: 1438-8871
CID: 4889402

Searching PubMed to Retrieve Publications on the COVID-19 Pandemic: Comparative Analysis of Search Strings

Lazarus, Jeffrey V; Palayew, Adam; Rasmussen, Lauge Neimann; Andersen, Tue Helms; Nicholson, Joey; Norgaard, Ole
BACKGROUND:Since it was declared a pandemic on March 11, 2020, COVID-19 has dominated headlines around the world and researchers have generated thousands of scientific articles about the disease. The fast speed of publication has challenged researchers and other stakeholders to keep up with the volume of published articles. To search the literature effectively, researchers use databases such as PubMed. OBJECTIVE:The aim of this study is to evaluate the performance of different searches for COVID-19 records in PubMed and to assess the complexity of searches required. METHODS:We tested PubMed searches for COVID-19 to identify which search string performed best according to standard metrics (sensitivity, precision, and F-score). We evaluated the performance of 8 different searches in PubMed during the first 10 weeks of the COVID-19 pandemic to investigate how complex a search string is needed. We also tested omitting hyphens and space characters as well as applying quotation marks. RESULTS:The two most comprehensive search strings combining several free-text and indexed search terms performed best in terms of sensitivity (98.4%/98.7%) and F-score (96.5%/95.7%), but the single-term search COVID-19 performed best in terms of precision (95.3%) and well in terms of sensitivity (94.4%) and F-score (94.8%). The term Wuhan virus performed the worst: 7.7% for sensitivity, 78.1% for precision, and 14.0% for F-score. We found that deleting a hyphen or space character could omit a substantial number of records, especially when searching with SARS-CoV-2 as a single term. CONCLUSIONS:Comprehensive search strings combining free-text and indexed search terms performed better than single-term searches in PubMed, but not by a large margin compared to the single term COVID-19. For everyday searches, certain single-term searches that are entered correctly are probably sufficient, whereas more comprehensive searches should be used for systematic reviews. Still, we suggest additional measures that the US National Library of Medicine could take to support all PubMed users in searching the COVID-19 literature.
PMCID:7695541
PMID: 33197230
ISSN: 1438-8871
CID: 4698562

Diabetes mellitus and colorectal carcinoma outcomes: a meta-analysis

Becker, Daniel J; Iyengar, Arjun D; Punekar, Salman R; Kaakour, Dalia; Griffin, Megan; Nicholson, Joseph; Gold, Heather T
OBJECTIVES/OBJECTIVE:The impact of diabetes mellitus (DM) on colorectal cancer (CRC) outcomes remains unknown. We studied this by conducting a meta-analysis to evaluate (1) CRC outcomes with and without DM and (2) treatment patterns. METHODS:We searched PubMed, EMBASE, Google Scholar, and CINAHL for full-text English studies from 1970 to 12/31/2017. We searched keywords, subject headings, and MESH terms to locate studies of CRC outcomes/treatment and DM. Studies were evaluated by two oncologists. Of 14,332, 48 met inclusion criteria. In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method, we extracted study location, design, DM definition, covariates, comparison groups, outcomes, and relative risks and/or hazard ratios. We utilized a random-effects model to pool adjusted risk estimates. Primary outcomes were all-cause mortality (ACM), disease-free survival (DFS), relapse-free survival (RFS), and cancer-specific survival (CSS). The secondary outcome was treatment patterns. RESULTS:Forty-eight studies were included, 42 in the meta-analysis, and 6 in the descriptive analysis, totaling > 240,000 patients. ACM was 21% worse (OR 1.21, 95% CI 1.15-1.28) and DFS was 75% worse (OR 1.75, 95% CI: 1.33-2.31) in patients with DM. No differences were detected in CSS (OR 1.10, 95% CI 0.98-1.23) or RFS (OR 1.12, 95% CI 0.91-1.38). Descriptive analysis of treatment patterns in CRC and DM suggested potentially less adjuvant therapy use in cases with DM and CRC. CONCLUSIONS:Our meta-analysis suggests that patients with CRC and DM have worse ACM and DFS than patients without DM, suggesting that non-cancer causes of death in may account for worse outcomes.
PMID: 32564124
ISSN: 1432-1262
CID: 4492662

Systematic review with meta-analysis: a history of smoking is not associated with a higher risk of pouchitis

Kani, H Tarik; Ramai, Daryl; Caniglia, Ellen; Hudesman, David; Axelrad, Jordan; Nicholson, Joseph; Hong, Simon; Chang, Shannon
BACKGROUND:Ileal pouch-anal anastomosis is a common surgical procedure in patients with an initial diagnosis of ulcerative colitis or indeterminate colitis. Tobacco smoking has been associated with protection from onset of ulcerative colitis. Smoking has been reported to be both a protective factor and a risk factor for the development of pouchitis. AIM/OBJECTIVE:To examine the influence of smoking on the risk of pouchitis. METHODS:We identified 15 studies evaluating smoking as a risk factor for developing pouchitis in ulcerative colitis or indeterminate colitis patients with a history of ileal pouch-anal anastomosis in a systematic search performed from inception through May 4, 2020. A meta-analysis was then performed using a random-effects model to generate risk ratios (RR) and 95% confidence intervals (CI). RESULTS: = 78.5%). CONCLUSIONS:Smoking, past or present, is not associated with an increased risk for the development of pouchitis in patients with ulcerative colitis or indeterminate colitis.
PMID: 32780484
ISSN: 1365-2036
CID: 4557092