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1.
J Osteopath Med ; 2024 Jul 03.
Article in English | MEDLINE | ID: mdl-38954485

ABSTRACT

CONTEXT: Orthopaedic surgery has become increasingly competitive over the years, with the COVID-19 pandemic creating additional challenges for applicants and programs. To promote an equitable match experience, the American Orthopaedic Association (AOA) introduced a formal preference signaling (PS) system into the 2022-2023 application cycle. PS allows applicants to indicate their heightened interest in specific programs, which improves the likelihood of receiving an interview and ultimately matching at their desired residency program. OBJECTIVES: The objective of this anonymous survey is to assess applicants' opinions and perspectives toward PS in orthopaedic surgery prior to the 2022-2023 match results. Additionally, we sought to evaluate the signaling strategies being utilized by applicants. METHODS: An anonymous 22-question survey was distributed to applicants of an orthopaedic surgery residency program (34.2 % response rate). Responses were collected after the application submission deadline but before the match lists and results were available. This survey included questions germane to demographics, signal utilization, signaling reasons and strategies, and opinions toward PS. Descriptive statistics were calculated utilizing R (version 4.2.1) and RStudio. RESULTS: Most respondents (96.1 %) participated in PS, and 96.7 % utilized all 30 signals. Signaling encouraged 24.2 % of applicants to apply to fewer programs. In accordance with guidelines, 83.2 % of respondents signaled each away rotation program; however, only 53 % signaled their home program. Applicants commonly signaled 1-10 "reach" and "safety" programs each. Proximity to Family and Perceived Operative Experience were the most important reasons for signaling, whereas Program Prestige was the least. A program's social presence and virtual interview option did not influence many applicants' decisions for signaling. Most applicants believe that the COVID-19 pandemic and pass/fail licensure examinations influenced PS adoption. Sixty-seven of 149 respondents (45 %) claimed that applicants and programs benefit equally from PS, while 41 % believe programs benefit more. Nearly half (40.94 %) knew very little or nothing about PS. CONCLUSIONS: During the inaugural introduction of PS in orthopaedic surgery, nearly every applicant utilized all 30 signals, prioritizing factors like family proximity and perceived operative experience over program prestige. This shift reflects the importance of geographic location and presumed training quality. Despite unfamiliarity toward PS, personalized signaling strategies were implemented, accompanied by a slight decrease in application volumes. The 30 allotted signals in orthopaedic surgery may serve as an informal application cap due to the necessity of signaling a program for an interview invite. However, improved educational efforts are needed to enhance the understanding and maximize the benefits of PS for both applicants and programs.

2.
Clin Ther ; 2024 Jun 01.
Article in English | MEDLINE | ID: mdl-38825553

ABSTRACT

PURPOSE: In 2013, afatinib was approved for non-small-cell lung cancer with subsequent indication expansion. We investigated published afatinib clinical trials to assess risk and benefit profiles for the drug in its approved indication of non-small-cell lung cancer as well as in off-label uses. Previous literature demonstrates excessive patient burden and limited benefit as afatinib has spread into more indications. A trial analysis is needed to establish efficacy and risk. METHODS: In this investigation, we screened literature databases and clinical trial registries for trials of afatinib as monotherapy or in combination interventions for cancer treatment. We extracted participant demographics, adverse event characteristics, as well as clinical and surrogate endpoints for each trial. Studies were deemed positive, negative, or indeterminate based on their achieving of primary endpoints as well as their safety. RESULTS: Our search yielded 2444 articles; we excluded 2352 articles for a final inclusion of 92 trials of 8859 patients. Our sample had 49 (53%) positive trials, 27 (29%) negative trials, and 16 (17%) indeterminate trials. The most common off-label indications for afatinib were breast cancer and squamous cell carcinoma of head and neck. The median OS for all trials was 8.4 months, median PFS 3.4 months, and the total ORR was 29.6%. Our study found that trials performed in disease states beyond the initial indications were largely negative with little patient benefit. The adverse events within our trial sample appear to be in line with expectations for toxicity. IMPLICATIONS: These results are consistent with other studies that present similar findings, such as in Carlisle et al which indicate limited efficacy in nonapproved indications. Future trials should keep this potential evidence and patient burden in mind before initiation of those trials. This study contributes to the understanding of afatinib's risk-benefit profile across many clinical applications.

4.
J Nephrol ; 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38837001

ABSTRACT

OBJECTIVE: To determine the extent to which nephrology journals recommend and require reporting guideline adherence and clinical trial registration. BACKGROUND: Despite a rising disease burden, research published on chronic kidney disease (CKD) and the field of nephrology has failed to keep pace and is limited. To improve the quality of research in the field of nephrology, reporting guidelines have been developed to minimize such deficits in research quality. However, the extent to which nephrology journals require and use reporting guidelines in addition to clinical trial registration is unknown. METHODS: Sixty-two Nephrology journals were selected through the 2021 Scopus CiteScore tool. Each journal's Instructions for Authors was assessed to determine endorsement of study design-specific reporting guidelines or clinical trial registration. Researchers used R (version 4.2.1) and RStudio to create data summaries of descriptive statistics for nephrology journal reporting guidelines. RESULTS: Clinical trial registration was required by 52% (32/62) of nephrology journals within our sample. The reporting guideline for clinical trials, CONSORT, was required by 17.74% (11/62) of journals. The EQUATOR Network was mentioned by 46.77% (29/62) of journals, while 9.67% (6/62) failed to mention the ICMJE. The reporting guideline for systematic review, PRISMA, was only required by 12.90% (8/62) of journals. When contacting journal editors, 9.67% (6/62) responded and 4.83% (3/62) provided clarifying information. CONCLUSIONS: Reporting guidelines and clinical trial registration are suboptimally required and recommended by nephrology journals. Their adoption may decrease bias and increase research quality. Thus, nephrology journals should consider a more complete endorsement of these safeguards.

5.
Cancer Med ; 13(9): e7130, 2024 May.
Article in English | MEDLINE | ID: mdl-38698690

ABSTRACT

OBJECTIVE: This study aims to evaluate published clinical trials of ramucirumab to assess the risk/benefit profile and burden over time for patients. BACKGROUND: The burden of oncologic drug development on patients paired with increasing clinical trial failure rates emphasizes the need for reform of drug development. Identifying and addressing patterns of excess burden can guide policy, ensure evidence-based protections for trial participants, and improve medical decision-making. METHODS: On May 25, 2023 a literature search was performed on Pubmed/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov for clinical trials using ramucirumab as monotherapy or in combination with other interventions for cancer treatment. Authors screened titles and abstracts for potential inclusion in a masked, duplicate fashion. Following data screening, data was extracted in a masked, duplicate fashion. Trials were classified as positive when meeting their primary endpoint and safety, negative or indeterminate. RESULTS: Ramucirumab was initially approved for gastric cancer but has since been tested in 20 cancers outside of its FDA approved indications. In our analysis of ramucirumab trials, there were a total of 10,936 participants and 10,303 adverse events reported. Gains in overall survival and progression-free survival for patients were 1.5 and 1.2 months, respectively. FDA-approved indications have reported more positive outcomes in comparison to off-label indications. CONCLUSION: We found that FDA-approved indications for ramucirumab had better efficacy outcomes than non-approved indications. However, a concerning number of adverse events were observed across all trials assessed. Participants in ramucirumab randomized controlled trials saw meager gains in overall survival when evaluated against a comparison group. Clinicians should carefully weigh the risks associated with ramucirumab therapy given its toxicity burden and poor survival gains.


Subject(s)
Antibodies, Monoclonal, Humanized , Clinical Trials as Topic , Drug Development , Ramucirumab , Humans , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Monoclonal, Humanized/adverse effects , Risk Assessment , Neoplasms/drug therapy , Neoplasms/mortality , Antineoplastic Agents/therapeutic use , Antineoplastic Agents/adverse effects
6.
BJGP Open ; 2024 May 28.
Article in English | MEDLINE | ID: mdl-38806214

ABSTRACT

BACKGROUND: Family medicine, vital for patient care but underfunded, prompts an evaluation of how family medicine journals endorse, require, and advocate for reporting guidelines (RGs), clinical trial, and systematic review registration. AIM: Assess endorsement and requirement of RGs, and the stance on clinical trial and systematic review registration in family medicine journals, impacting research quality and transparency. DESIGN & SETTING: A cross-sectional analysis of 43 "Family Practice" journals, identified through the 2021 Scopus CiteScore. Editors-in-Chief were contacted to confirm article types. Data extracted from "instructions to authors" pages focused on RG recommendations, requirements, and trial registration. METHOD: To ensure confidentiality and prevent bias, authors independently extracted data on RG utilisation, adherence, and clinical trial registration provide a overview of research standards. RESULTS: Of 43 journals, the most recommended guidelines were CONSORT (69%), PRISMA (58%), and STROBE (60%). The most required were PRISMA (16%) and CONSORT (11%). Clinical trial registration was recommended or required by 67% of journals. Additionally, 40 out of the 43 (93%) journals cited at least one reporting guideline in their instructions to authors. CONCLUSION: Family medicine journals exhibit varied endorsement and requirement patterns for RGs and clinical trial registration. While guidelines like CONSORT, PRISMA, and STROBE are acknowledged, caution is needed in presuming a direct link to enhanced research quality. A nuanced approach, promoting diverse reporting guidelines and rigorous study registration, is essential for elevating transparency and advancing research standards in family medicine.

7.
Arch Phys Med Rehabil ; 105(7): 1330-1337, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38561144

ABSTRACT

OBJECTIVE: To assess reporting guideline and clinical trial registration requirements in rehabilitation journals. DESIGN: We examined rehabilitation journals with 5-year impact factors exceeding 1.00 from the 2021 Scopus CiteScore tool, alongside the 28 journals included in the 2014 rehabilitation and disability quality improvement initiative. Journals outside the traditional rehabilitation scope were excluded. SETTING: A publicly-funded academic health center in the United States. PARTICIPANTS AND INTERVENTIONS: N/A. MAIN OUTCOME MEASURE(S): The proportion of journals requiring/recommending reporting guideline use and clinical trial registration. RESULTS: Over 90% (57/63) of journals required/recommended clinical trial reporting guidelines, while 68% (39/57) specified guideline requirements for systematic review/meta-analysis protocols. The 2014 collaborative initiative journals demonstrated higher rates of requiring/recommending reporting guidelines for clinical trials (24/26; 92.3%), systematic reviews/meta-analyses (23/26; 88.5%), observational studies in epidemiology (22/25; 88%), and diagnostic accuracy studies (20/24; 83.3%). Conversely, the 2021 Scopus CiteScore journals displayed higher rates for the remaining study designs. Overall, 52/63 (82.5%) journals required/recommended trial registration. Trial registration policies were comparable, with a slight advantage favoring the 2021 Scopus CiteScore journals. CONCLUSION: Rehabilitation journals variably promoted reporting guideline use and clinical trial registration. Common study designs like clinical trials, observational studies in epidemiology, and diagnostic accuracy studies demonstrated robust requirement/recommendation rates, while less common designs like economic evaluations and animal research had suboptimal rates. Journals can enhance reporting guideline use and trial registration by directing authors to the EQUATOR Network, requiring adherence to registration and reporting standards, and clarifying language in author instructions.


Subject(s)
Clinical Trials as Topic , Periodicals as Topic , Humans , Periodicals as Topic/standards , Clinical Trials as Topic/standards , Guidelines as Topic , Journal Impact Factor , Rehabilitation Research/standards , Registries
8.
Target Oncol ; 19(2): 161-173, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38466535

ABSTRACT

IMPORTANCE: Chemotherapy agents are typically initially tested in their most promising indications; however, following initial US FDA approval, new clinical trials are often initiated in less promising indications where patients experience a worse burden-benefit ratio. The current literature on the burden-benefit profile of lenvatinib in non-FDA-approved indications is lacking. OBJECTIVE: This study aimed to evaluate published clinical trials of lenvatinib in order to determine the burden-benefit profile for patients over time. EVIDENCE REVIEW: On 25 May 2023, we searched the Pubmed/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov databases for clinical trials of lenvatinib used to treat solid cancers. Eligible articles were clinical trials, containing adult participants, published in English, and involving solid tumors. Screening and data collection took place in a masked, duplicate fashion. For each eligible study, we collected adverse event data, trial characteristics, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). Trials were classified as positive when meeting their primary endpoint and safety, negative (not meeting either criteria), or indeterminate (lacking prespecified primary endpoint). FINDINGS: Expansion of clinical trial testing beyond lenvatinib's initial FDA indication demonstrated a consistent rise in cumulative adverse events, along with a decline in drug efficacy. Lenvatinib was tested in 16 cancer indications, receiving FDA approval in 4. A total of 5390 Grade 3-5 adverse events were experienced across 6225 clinical trial participants. Expanded indication testing further demonstrated widely variable ORR (11-69%), OS (6.2-32 months), and PFS (3.6-15.7 months) across all indications. After initial FDA approval, clinical trial results in expanded indications were less likely to meet their primary endpoints, particularly among non-randomized clinical trials. CONCLUSION AND RELEVANCE: Our paper evaluated the effectiveness of lenvatinib for its FDA-approved indications; however, expansion of clinical trials into novel indications was characterized by diminished efficacy, while patients experienced a high burden of adverse events consistent with lenvatinib's established safety profile. Furthermore, clinical trials testing in novel indications was marked by repeated phase I and II clinical trials along with a failure to progress to phase III clinical trials. Future clinical trials using lenvatinib as an intervention should carefully evaluate the potential benefits and burden patients may experience.


Subject(s)
Antineoplastic Agents , Neoplasms , Quinolines , Humans , Antineoplastic Agents/pharmacology , Antineoplastic Agents/therapeutic use , Neoplasms/drug therapy , Phenylurea Compounds/pharmacology , Phenylurea Compounds/therapeutic use , Quinolines/pharmacology , Quinolines/therapeutic use , Clinical Trials as Topic
9.
Osteoarthritis Cartilage ; 32(6): 713-718, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38403154

ABSTRACT

OBJECTIVE: To assess the degree of core outcome set alignment and identify issues with alignment to the 2019 COS among clinical trial registrations focused on knee and/or hip osteoarthritis (OA). METHODS: Our search was performed on registered knee and hip OA randomized controlled trials (RCTs) available on ClinicalTrials.gov and WHO International Clinical Trials Registry Platform. The screening process considered trials registered between 8/2014 and 6/2023. We extracted data on general trial characteristics and the five trial endpoints detailed in the COS (pain, physical function, quality of life, patient global assessment, and adverse events), in a masked and duplicate manner. The frequencies of COS alignment were assessed over time prior to and after COS publication. RESULTS: Of the 10,718 RCTs screened, 481 met inclusion criteria. Most were phase 3 (368/481, 76.51%) and heavily university-funded (184/481, 38.25%). Despite the 2019 COS, no marked enhancement in overall alignment was noted. The outcome 'Pain' exhibited the highest degree of COS alignment (455/481, 94.59%), whereas 'adverse events' lagged behind (89/481, 18.50%). Additionally, trial factors such as 'Continent', 'Funding Type', and 'Recruitment Status' displayed no significant influence on COS alignment. CONCLUSIONS: Despite the acknowledged advantages of using COS in RCTs and the availability of an updated COS, the alignment to these outcomes remains notably low. Significant efforts are needed to encourage broader adoption in future studies on knee and hip OA, with the aim of improving research quality and patient care.


Subject(s)
Osteoarthritis, Hip , Osteoarthritis, Knee , Randomized Controlled Trials as Topic , Humans , Cross-Sectional Studies , Quality of Life , Outcome Assessment, Health Care
11.
Thromb Res ; 234: 113-119, 2024 02.
Article in English | MEDLINE | ID: mdl-38211379

ABSTRACT

INTRODUCTION: Clinical trials (CTs) guide clinical practice, but inconsistent outcome reporting presents challenges. To increase comparability, a core outcome set (COS) was created for primary Immune thrombocytopenia (ITP) in 2009 to standardize outcome measurements. We aimed to evaluate uptake of the primary ITP COS in CT registries. MATERIALS & METHODS: Our cross-sectional analysis employed a search string on ClinicalTrials.gov and ICTRP for phase III/IV CTs in June 2023. Inclusion criteria consisted of subjects with primary ITP, study was registered five years before COS publication to June 26, 2023, and assessed effectiveness of interventions. Two investigators extracted data in a masked, duplicate manner. Interrupted time series analysis, ANOVAs, and correlation analyses were conducted to assess the main outcome of COS uptake pre/post COS publication. RESULTS: The search identified 131 eligible trials for data extraction. Altogether, 38.2 % (50/131) followed IWG platelet response guidelines. An alternative platelet count measurement was 50,000 × 109 L, with 46.56 % (61/131) of trials reporting it. The most measured outcome was adverse events (106/131, 80.9 %). Remaining secondary outcomes were measured in <50 % of studies. After COS publication, there was a statistically non-significant 0.03 % (p = 0.50, CI 95 % = [-0.06, 0.13]) 0.03 % (p = 0.50, CI 95 % = [-0.06, 0.13]) increase in the monthly trend of COS-defined outcomes. CONCLUSION: We found a non-significant increase in uptake of the ITP COS since its publication and highlighted the lack of standardization among endpoints within ITP clinical trials. Our analysis highlights the need for heightened awareness and a COS update that acknowledges the variability in clinical trials.


Subject(s)
Purpura, Thrombocytopenic, Idiopathic , Humans , Cross-Sectional Studies , Outcome Assessment, Health Care , Platelet Count , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Registries , Clinical Trials as Topic
12.
Diabetes Res Clin Pract ; 207: 111085, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38195041

ABSTRACT

AIMS: This study analyzed uptake of the core outcome set (COS) for type 1 diabetes (T1D) and trends in its use before and after its development in December 2017. METHODS: On June 26, 2023, ClinicalTrials.gov was systematically searched for T1D randomized controlled trials. The Core Outcome Measures in Effectiveness Trials (COMET) database provided a COS of eight key outcomes for analysis. Included trials were analyzed for COS uptake before and after its release in December 2017 in a masked, duplicate fashion by independent reviewers. We also calculated the proportion of trials that measured the complete COS and assessed the most frequently reported COS outcomes. RESULTS: Of 3,792 originally screened articles, 144 RCTs were included in the final sample. Following COS publication, its use steadily decreased. Within the COS, HbA1c and severe hypoglycemia were most frequently implemented as endpoints; other recommended outcomes were rarely used in the published trials. CONCLUSION: Despite the 2017 T1D COS publication, use has decreased over time. This inconsistency negatively influences evidence-based practices and care. Educating researchers on COS and promoting uptake is crucial. Wider COS adoption in T1D trials could enhance clinical research overall. Further study of barriers and facilitators influencing uptake is essential to support consistent use and reporting.


Subject(s)
Diabetes Mellitus, Type 1 , Humans , Diabetes Mellitus, Type 1/therapy , Cross-Sectional Studies , Treatment Outcome , Research Design , Randomized Controlled Trials as Topic , Outcome Assessment, Health Care
13.
J Osteopath Med ; 124(1): 5-11, 2024 Jan 01.
Article in English | MEDLINE | ID: mdl-37580988

ABSTRACT

CONTEXT: The COVID-19 pandemic disrupted clinical research in many medical and surgical fields, resulting in research waste and loss of treatment for patients. Although other areas have been explored, the extent of the pandemic's influence on osteoarthritis (OA) trials is currently unknown. OBJECTIVES: This study aims to explore the reasons for termination of clinical trials investigating OA during the COVID-19 pandemic. METHODS: We searched ClinicalTrials.gov for OA trials and characterized their reason for discontinuation, noting where trialists directly cited the COVID-19 pandemic as the reason for trial discontinuation. We also coded other common reasons for trial discontinuation. Descriptive and inferential statistics were performed to determine the difference in enrollment, funding source, trial phase, allocation, and intervention type between the trials terminated early due to pandemic and nonpandemic reasons. RESULTS: Out of 135 clinical trials, 119 were included and 27 (22.7 %) of them reported the COVID-19 pandemic as a primary reason for discontinuation, which was the overall most common reason for OA trial discontinuation during the study period. We found statistically significant differences for trials discontinued due to pandemic vs. non-pandemic-related reasons, with trials having sites outside the United States, randomized allocation, and drug or device intervention type being most affected. However, there was no statistically significant difference between groups regarding trial phase, funding source, or enrollment. CONCLUSIONS: This study highlights the impact of the COVID-19 pandemic on the clinical trials related to OA. We found that many trials reported discontinuation directly due to the pandemic, which may lead to the loss or delay of novel treatments for OA. To avoid such discontinuation in the future, alternative methods for conducting OA-related clinical trials should be explored and implemented.


Subject(s)
COVID-19 , Osteoarthritis , Humans , United States/epidemiology , COVID-19/epidemiology , Pandemics , Osteoarthritis/epidemiology , Osteoarthritis/therapy
14.
Rheumatol Int ; 44(5): 909-917, 2024 May.
Article in English | MEDLINE | ID: mdl-37861727

ABSTRACT

The purpose of this study was to investigate the instructions for authors of rheumatology journals and analyze their endorsement of reporting guidelines and clinical trial registration. Sixty rheumatology journals were selected by a research librarian and an investigator through the 2021 Scopus CiteScore tool. The instructions for authors' subsection of each journal was assessed to determine endorsement of study design-specific reporting guidelines or clinical trial registration. Descriptive statistics were calculated using R (version 4.2.1) and RStudio. Of the 58 journals analyzed, 34 (34/58; 59%) mentioned the EQUATOR Network: an online compendium of best practice reporting guidelines. The most commonly mentioned reporting guidelines were CONSORT with 44 journals (44/58; 75%), and PRISMA with 35 journals (35/58; 60%). The least mentioned guidelines were QUOROM with 56 journals not mentioning the guideline (56/58; 97%), and SRQR with 53 journals not mentioning the guideline (53/57, 93%). Clinical trial registration was required by 38 journals (38/58; 66%) and recommended by 8 journals (8/58; 14%). Our study found that endorsement of reporting guidelines and clinical trial registration within rheumatology journals was suboptimal with great room for improvement. Endorsement of reporting guidelines have shown to not only mitigate bias, but also improve research methodologies. Therefore, we recommend rheumatology journals broadly expand their endorsement of reporting guidelines and clinical trial registration to improve the quality of evidence they publish.


Subject(s)
Periodicals as Topic , Rheumatology , Humans , Cross-Sectional Studies , Publishing , Bibliometrics , Guideline Adherence
15.
BJOG ; 131(6): 795-802, 2024 May.
Article in English | MEDLINE | ID: mdl-37798815

ABSTRACT

OBJECTIVE: Analyse uptake of the core outcome set (COS) within preterm birth (PTB) clinical trials. DESIGN: On 26 June 2023, we conducted a systematic search of phase III/IV trial registry entries regarding PTB interventions via ClinicalTrials.gov and the International Clinical Trial Registry Platform. These trials were analysed for the outcomes measured. SETTING: N/A. SAMPLE: After searching the two databases, 5257 randomised controlled trials (RCTs) were screened, resulting in 92 RCTs for analysis. METHODS: Inclusion criteria were the following: subjects were patients receiving an intervention for PTB, study enrolment began within 5 years prior to publication of PTB COS to 26 June 2023, and evaluated the efficacy of interventions. Authors screened and extracted data in masked, duplicate fashion, then performed an interrupted time series analysis, analysis of variance and correlation analysis. MAIN OUTCOME MEASURES: We extracted outcomes measured by each clinical trial in our sample. Trials were analysed for the percentage of adopted outcomes from PTB COS. RESULTS: After COS publication, there was no significant change in percentage of COS outcomes measured. The most measured outcome was 'offspring mortality' (54.34%, 50/92) and the least measured outcome was 'late neonatal neurodevelopment morbidity' (3.26%, 3/92). Additionally, 22.83% (21/92) of trials measured zero outcomes related to the PTB COS. CONCLUSION: Our results demonstrated no significant change in outcome measurement before or after PTB COS publication. We recommend focusing on both the measurement of outcomes and the assessments that are used.


Subject(s)
Premature Birth , Infant, Newborn , Female , Humans , Premature Birth/prevention & control , Cross-Sectional Studies , Outcome Assessment, Health Care , Interrupted Time Series Analysis , Randomized Controlled Trials as Topic
16.
Int J Cancer ; 154(8): 1464-1473, 2024 Apr 15.
Article in English | MEDLINE | ID: mdl-38108216

ABSTRACT

Drug development is complex and costly. Clinical trial participants take on risks, making it essential to maximize trial efficiency and maintain participant safety. Identifying periods of excessive burden during drug development can inform trial design, ensure patient benefit and prevent harm. This study aims to examine all published clinical trials for cabozantinib to assess patient benefit and burden over time. We conducted a retrospective cross-sectional review of interventional clinical trials of cabozantinib for solid cancer treatment. We searched PubMed/MEDLINE, Embase, Cochrane (CENTRAL) and ClinicalTrials.gov. We extracted adverse event rates, median progression-free survival (PFS), median overall survival and objective response rate (ORR) for each included trial. We calculated frequencies of trial characteristics, cumulative grade 3-5 adverse event rates and cumulative ORRs. Out of 1735 studies, 54 publications were included that involved 6372 participants and 21 cancers. Of the 54 studies in our sample, 31 (57.41%) were single-arm trials and 23 (42.60%) had negative results. Trials among and within various indications had conflicting results over time. Cumulative risk to participants increased over time, and clinical benefit decreased. The findings suggest that the risk profile of cabozantinib increased from 2011 to 2016 and has remained elevated but stable while benefit has decreased over time. The use of non-randomized and single-arm trials is concerning, and more methodologically rigorous trials are needed. The results of trials for different indications are inconsistent, and empirical administration may reduce the drug's efficacy.


Subject(s)
Anilides , Pyridines , Humans , Anilides/adverse effects , Cross-Sectional Studies , Pyridines/adverse effects , Retrospective Studies , Clinical Trials as Topic , Risk Assessment
17.
J Clin Pathol ; 77(2): 87-95, 2024 Jan 18.
Article in English | MEDLINE | ID: mdl-38123966

ABSTRACT

AIMS: Pathology education is a core component of medical training, and its literature is critical for refining educational modalities. We performed a cross-sectional bibliometric analysis to explore publications on pathology education, focusing on new medical education technologies. METHODS: The analysis identified 64 pathology journals and 53 keywords. Relevant articles were collected using a web application, PaperScraper, developed to accelerate literature search. Citation data were collected from multiple sources. Descriptive statistics, with time period analysis, were performed using Microsoft Excel and visualised with Flourish Studio. Two article groups were further investigated with a bibliometric software, VOSViewer, to establish co-authorship and keyword relationships. RESULTS: 8946 citations were retrieved from 905 selected articles. Most articles were published in the last decade (447, 49.4%). The top journals were Archives of Pathology & Laboratory Medicine (184), Human Pathology (122) and the American Journal of Clinical Pathology (117). The highest number of citations was found for Human Pathology (2120), followed by Archives of Pathology & Laboratory Medicine (2098) and American Journal of Clinical Pathology (1142). Authors with different backgrounds had the greatest number of articles and citations. 12 co-authorship, 3 keyword and 8 co-citation clusters were found for the social media/online resources group, 8 co-authorship, 4 keyword and 7 co-citation clusters for the digital pathology/virtual microscopy/mobile technologies group. CONCLUSIONS: The analysis revealed a significant increase in publications over time. The emergence of digital teaching and learning resources played a major role in this growth. Overall, these findings underscore the transformative potential of technology in pathology education.


Subject(s)
Bibliometrics , Humans , United States , Cross-Sectional Studies
18.
Ageing Res Rev ; 91: 102081, 2023 11.
Article in English | MEDLINE | ID: mdl-37774933

ABSTRACT

BACKGROUND: Parkinson's Disease (PD) affects more than 10 million individuals, with increasing incidence worldwide. As PD's incidence rises, research funding is increasing substantially. PD's core outcome set (COS) provides standardization for PD clinical trial outcomes, improves research quality, and study comparability. Our study aimed to analyze COS uptake rate before and after the PD COS publication. METHODS: We searched ClinicalTrials.gov to retrieve phase III/IV adult PD trials published between 2013 and 2023. Screening for inclusion and data extraction occurred in a masked, duplicate fashion. Trial characteristics and COS uptake rate were extracted from this sample. RESULTS: In our 111 included trials, the COS uptake rate was highest for the 'Walking and Balance' outcome and lowest for the 'Hospital Admissions' outcome. Overall, there was a non-significant monthly increase of 0.26 % (P = 0.266, CI = [-0.20, 0.72]) in "COS-defined outcome" measurement when comparing pre- and post-COS publication. CONCLUSION: Our study found no significant increase in COS uptake in PD clinical trials. We found multiple outcomes to be vastly unmeasured and heterogeneity among the measurement instruments used. These findings complicate standardizing and comparing RCT outcomes. Overcoming these barriers is vital to improving the usefulness of PD research.


Subject(s)
Parkinson Disease , Humans , Parkinson Disease/diagnosis , Parkinson Disease/complications , Randomized Controlled Trials as Topic , Outcome Assessment, Health Care
19.
Foot Ankle Orthop ; 8(3): 24730114231198837, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37767008

ABSTRACT

Background: Approximately 1 in 4 adults will develop hallux valgus (HV). Up to 80% of adult Internet users reference online sources for health-related information. Overall, with the high prevalence of HV combined with the numerous treatment options, we believe patients are likely turning to Internet search engines for questions relevant to HV. Using Google's people also ask (PAA) or frequently asked questions (FAQs) feature, we sought to classify these questions, categorize the sources, as well as assess their levels of quality and transparency. Methods: On October 9, 2022, we searched Google using these 4 phrases: "hallux valgus treatment," "hallux valgus surgery," "bunion treatment," and "bunion surgery." The FAQs were classified in accordance with the Rothwell Classification schema and each source was categorized. Lastly, transparency and quality of the sources' information were evaluated with the Journal of the American Medical Association's (JAMA) Benchmark tool and Brief DISCERN, respectively. Results: Once duplicates and FAQs unrelated to HV were removed, our search returned 299 unique FAQs. The most common question in our sample was related to the evaluation of treatment options (79/299, 26.4%). The most common source type was medical practices (158/299, 52.8%). Nearly two-thirds of the answer sources (184/299; 61.5%) were lacking in transparency. One-way analysis of variance revealed a significant difference in mean Brief DISCERN scores among the 5 source types, F(4) = 54.49 (P < .001), with medical practices averaging the worst score (12.1/30). Conclusion: Patients seeking online information concerning treatment options for HV search for questions pertaining to the evaluation of treatment options. The source type encountered most by patients is medical practices; these were found to have both poor transparency and poor quality. Publishing basic information such as the date of publication, authors or reviewers, and references would greatly improve the transparency and quality of online information regarding HV treatment. Level of Evidence: Level V, mechanism-based reasoning.

20.
J Surg Res ; 288: 21-27, 2023 08.
Article in English | MEDLINE | ID: mdl-36948029

ABSTRACT

INTRODUCTION: Clinical trial registry searches for unpublished clinical trial data are a means of mitigating publication bias within systematic reviews (SRs). The purpose of our study is to look at the rate of clinical trial registry searches conducted by SRs in the top five Plastic and Reconstructive Surgery journals. METHODS: We identified the top five plastic and reconstructive surgery journals using the Google h-5 index. We then searched Pubmed for SRs published in these journals and compared them to plastic surgery SRs published in the Cochrane Collaboration for SRs over the last 5 y. We included all SRs that were published within these top five journals and Cochrane between December 6, 2016 and December 6, 2021. We then conducted a secondary analysis on clinicaltrials.gov looking for unpublished clinical trials for 100 randomized SRs that did not conduct a clinical trial registry search. RESULTS: In SRs, 3.3% (17/512) from plastic surgery journals conducted trial registry searches. In comparison, 95.0% (38/40) of Cochrane Collaboration SRs conducted trial registry searches. Our secondary analysis found that 50% (50/100) of SRs could have included at least one unpublished clinical trial data set. CONCLUSIONS: We found that plastic surgery SRs rarely include searches for unpublished clinical trial data in clinical trial registries. To improve the data completeness of SRs in plastic surgery journals, we recommend journals alter their author guidelines to require a clinical trial registry search for unpublished literature.


Subject(s)
Plastic Surgery Procedures , Surgery, Plastic , Publication Bias , Epidemiologic Studies , Registries
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