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1.
J Osteopath Med ; 124(1): 5-11, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-37580988

RESUMO

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.


Assuntos
COVID-19 , Osteoartrite , Humanos , Estados Unidos/epidemiologia , COVID-19/epidemiologia , Pandemias , Osteoartrite/epidemiologia , Osteoartrite/terapia
2.
J Osteopath Med ; 124(2): 69-75, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-37860841

RESUMO

CONTEXT: Social determinants of health (SDOH) are economic, social, and political conditions that affect a person's overall health or the health of a group of people. Researchers have investigated the effects of SDOH on various diseases, such as asthma, obesity, and chronic stress, but few publications have been made regarding its effects on arthritis. OBJECTIVES: Our primary objective was to analyze the implications of SDOH on disease severity relating to pain levels and limitations experienced among people with diagnosed arthritis. METHODS: We performed a cross-sectional analysis of the 2017 Behavioral Risk Factor Surveillance System (BRFSS). We included individuals who reported having arthritis, were over the age of 45, and who also completed the SDOH module. Pain scores from the four-question Arthritis Burden Module were correlated to question responses pertaining to SDOH to determine their associations. RESULTS: For the analysis, our sample size was 25,682, with response rates varying slightly among the SDOH questions. Individuals diagnosed with arthritis were more likely to report functional limitations if they experienced food insecurity (χ2=234.0, p<0.001), financial instability (χ2=149.7, p<0.001), or frequent stress (χ2=297.6, p<0.001). Further, we found that individuals with arthritis experiencing any domain of SDOH reported higher mean pain scores than those not experiencing that domain, with the highest pain score difference among those reporting frequent stress (Coefficient: 1.93, CI=1.74-2.13, t=19.43, p<0.001). CONCLUSIONS: Our results show that SDOH profoundly impact pain levels and limitations experienced by patients with arthritis. Although work has already begun to help alleviate burdens associated with SDOH, more research and actions are required to create equitable health throughout the population.


Assuntos
Artrite , Determinantes Sociais da Saúde , Humanos , Estudos Transversais , Sistema de Vigilância de Fator de Risco Comportamental , Artrite/epidemiologia , Dor/epidemiologia
3.
Int J Cancer ; 154(8): 1464-1473, 2024 Apr 15.
Artigo em Inglês | MEDLINE | ID: mdl-38108216

RESUMO

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.


Assuntos
Anilidas , Piridinas , Humanos , Anilidas/efeitos adversos , Estudos Transversais , Piridinas/efeitos adversos , Estudos Retrospectivos , Ensaios Clínicos como Assunto , Medição de Risco
4.
Pediatr Hematol Oncol ; 40(8): 766-777, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37171885

RESUMO

Finding safer and more effective treatment options are critical in progressing the field of pediatric oncology. These treatment options are discovered through completion and publication of clinical trials. The primary objective of this study was to assess the overall study characteristics of pediatric oncology clinical trials initiated between 2008 and 2021. The secondary objective of our study was to assess rates of discontinuation and reporting of results as required by the Food and Drug Administration (FDA). After acquiring pediatric oncology clinical trials from ClinicalTrials.gov, a cross-sectional study was performed. Included trials have an intervention exclusive to pediatrics and were conducted between 2008 and 2021. The results measured were characteristics of the clinical trials and their rate of discontinuation. Of the 7,930 trials originally returned from the search, 349 trials met inclusion criteria. The majority of the trials were phase 1 and 2 pharmaceutical interventions studying brain and blood cancer. Our study found that 14.9% (52) of the pediatric oncology trials were discontinued. Given the breadth of study within pediatric oncology, our overarching assessment shows that drug trials geared toward treating cancers of the brain and blood were dominant in the field. It is crucial for the advancement of science that results of trials are known. This avoids duplication of studies and waste of funds. Of the trials that were completed, 40.3% (58) did not report results to ClinicalTrials.gov. The nonreporting of this data limits the information available delaying the advancement of treatment options.


Assuntos
Ensaios Clínicos como Assunto , Oncologia , Neoplasias , Criança , Humanos , Estudos Transversais , National Library of Medicine (U.S.) , Neoplasias/terapia , Resultado do Tratamento , Estados Unidos , Bases de Dados como Assunto
6.
J Osteopath Med ; 123(8): 405-410, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-36943903

RESUMO

CONTEXT: Intimate partner violence (IPV) occurs when an intimate partner inflicts physical, sexual, and/or emotional assault with coercive control and is a traumatic experience with repercussions that can be exacerbated when a woman is pregnant. While screening for IPV during pregnancy is recommended to occur regardless of risk, less than 50% of pregnant women are screened. OBJECTIVES: Identifying clinical factors commonly associated with IPV during pregnancy may improve screening rates, thus our primary objective was to examine associations between IPV and maternal comorbidities. METHODS: We conducted a cross-sectional analysis of the Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 8 spanning 2016 through 2019. Bivariate and multivariable logistic regression was utilized to calculate adjusted odds ratios (AORs) to determine associations between IPV and diabetes, anxiety, hypertension, depression, asthma, polycystic ovary syndrome (PCOS), and thyroid disease. RESULTS: More than 40% of women experiencing IPV reported a history of depression or anxiety. The occurrence of IPV was higher among women with depression (AOR 3.48, CI 3.14-3.85), anxiety (AOR 2.98, CI 2.64-3.37), hypertension (AOR 1.21, CI 1.02-1.44), and asthma (AOR 1.37; CI 1.17-1.59) than women without those respective conditions, but not among diagnoses of diabetes, PCOS, or thyroid disorders. CONCLUSIONS: Our findings show that pregnant individuals reporting having experienced IPV were more likely to report having certain comorbidities compared to those who did not report experiencing IPV. Given the low rates of screening, knowing clinically relevant associations may increase screening sensitivity among clinicians and, in turn, increase the likelihood that individuals experiencing IPV receive supportive care.


Assuntos
Asma , Hipertensão , Violência por Parceiro Íntimo , Gravidez , Feminino , Humanos , Estudos Transversais , Violência por Parceiro Íntimo/psicologia , Medição de Risco
7.
J Trauma Stress ; 36(2): 325-332, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36787385

RESUMO

Failures by researchers and clinicians to overcome barriers in veteran health-related research may result in clinical trial (CT) discontinuation and nonpublication. Such outcomes are a waste of limited academic resources. To determine rates of discontinuation and nonpublication among CTs for posttraumatic stress disorder (PTSD) with pharmaceutical interventions specific to the veteran population, we performed a systematic search of registered trials in ClinicalTrials.gov for pharmaceutical interventions for the treatment of PTSD. Extracted study characteristics included sample size, study design, trial status, phase, and funding source. Studies were classified as completed or discontinued based on the status listed in ClinicalTrials.gov. Descriptive statistics of trials were reported, and associations of trial termination and nonpublication were assessed using logistic regression. The final sample included 54 CTs, 15 of which (27.8%) had not been published within the FDA's required timeframe, and 11 (20.4%) were discontinued. The total number of trial participants was 3,463, with a median of 37 (interquartile range: 15-92). Of the 54 trials, 12 (22.2%) were nonrandomized, and 42 (77.8%) were randomized. There were 25 (46.3%) trials that were in either Phase 3 or Phase 4, and 39 (72.2%) were government-funded. We found high rates of CT discontinuation and nonpublication among PTSD pharmaceutical intervention studies in veterans, as has been shown in other fields of research.


Assuntos
Transtornos de Estresse Pós-Traumáticos , Veteranos , Humanos , Publicações , Projetos de Pesquisa , Preparações Farmacêuticas
8.
Sex Transm Infect ; 99(2): 110-115, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-35459753

RESUMO

OBJECTIVE: We sought to quantify the use of person-centred language (PCL) in research journals that publish high volumes of HIV-related manuscripts. DESIGN: In this cross-sectional study, we searched PubMed for HIV-related articles published between 1 January 2017 and 7 March 2021. After journal reduction and article randomisation, title and abstract screening was conducted among 500 studies in a masked, duplicate fashion. METHODS: Studies that were included were systematically searched for prespecified, stigmatising terms, partial terms and phrases. Prevalence rates of non-person-centred terminology were totalled, and the total number of articles adherent to PCL guidelines were reported. Fisher's exact tests were used to determine associations between PCL adherence and article funding source, type of article, continent of origin and research, among others. RESULTS: Among 237 studies included, 21.52% (51) of HIV-related publications in this cross-sectional analysis were found to be PCL adherent. Stigmatising labels such as 'HIV- or AIDS-infected' and 'HIV- or AIDS-person or patient' were used most frequently, with the former appearing in 57.38% of articles and the latter appearing in 30.80% of articles. CONCLUSION: Despite numerous guidelines and requirements for the use of PCL in research, our findings suggest that an alarming number of HIV-related articles are not following these guidelines. This is concerning because this labelling likely contributes to the persistence of stigma in HIV-centred care. The intentional use of person-centred language in medical research has the potential to minimise the use of stigmatising language among medical professionals, in medical education, in medical records and patient encounters, and thus reduce stigma.


Assuntos
Síndrome da Imunodeficiência Adquirida , Infecções por HIV , Humanos , Estudos Transversais , Infecções por HIV/prevenção & controle , Idioma , Estigma Social
9.
J Osteopath Med ; 123(5): 235-242, 2023 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-36520046

RESUMO

CONTEXT: Amputations are routine in orthopedics, specifically during trauma and when patients have recurrent surgical site infections. When undergoing amputations, patients must combat the psychosocial factors associated with the loss of an extremity, including stigmatization. OBJECTIVES: This study analyzes the presence of person-centered language (PCL) within amputation-related orthopedic publications in the top orthopedic journals. METHODS: We conducted a cross-sectional analysis with a database search on February 14, 2021 utilizing PubMed. Utilizing a previously published search string, we isolated studies that were published in the top 20 orthopedic journals based on the Google h5-index. In addition to the top 20 orthopedic journals, we included the top two hand and foot & ankle journals in our search to incorporate more amputation literature. Our search yielded 687 returns. The sample was then randomized, and the first 300 studies that fit our inclusion criteria were examined for prespecified non-PCL terminology. RESULTS: Our results show that 157 (52.2%) studies were adherent to PCL according to the American Medical Association's Manual of Style 10th Edition (AMAMS). Of the 143 (47.7%) studies that were not adherent to PCL, 51 studies (35.7%) had more than one type of non-PCL language. The term "amputee," which is being labeled as identity-first language (IFL), was found in 101 articles (33.7%). Further investigation found that 73.3% (74/101) of the studies containing IFL were found to have other non-PCL terms. Of the other studies in the sample, non-PCL was found 34.7% (88/199) of the time. This analysis was done due to the discrepancies in stigmatization of the term "amputee." No statistical association was found between adherence to PCL and study characteristics. CONCLUSIONS: Our findings show that amputation literature within the top orthopedic journals has limited adherence to PCL. Additionally, the use of the term "amputee," which is widely accepted by the amputation community, resulted in a greater rate of non-PCL terminology within orthopedic amputation literature. Efforts should be implemented within orthopedics to avoid the use of stigmatizing language, regarding individuals that underwent amputations, to minimize psychosocial stressors.


Assuntos
Amputação Cirúrgica , Ortopedia , Humanos , Estados Unidos , Estudos Transversais , Extremidade Inferior/cirurgia
11.
Hand (N Y) ; : 15589447221142895, 2022 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-36564990

RESUMO

BACKGROUND: Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy. Patients often search online for health information regarding common musculoskeletal complaints. Thus, the purpose of this study was to use language processing information from Google to assess the content of CTS frequently asked questions (FAQs) searched online and the transparency and quality of online CTS information. METHODS: On March 11, 2021, we searched Google for 3 terms "carpal tunnel syndrome treatment," "carpal tunnel syndrome surgical treatment," and "carpal tunnel syndrome non-surgical treatment" until a minimum of 100 FAQs and their answer links were extracted from each search. We used Rothwell classification to categorize the FAQs. The Journal of the American Medical Association's benchmark criteria were used to assess information transparency. Information quality was assessed using the Brief DISCERN tool. RESULTS: Our Google search returned 124 unique FAQs. Fifty-six (45.2%) were value based and most were related to the evaluation of treatment options (45/56, 80.4%). The most common source type was medical practices (26.6%). Nearly half of the answer sources (45.9%) were found to be lacking in transparency. One-way analysis of variance revealed a significant difference in mean Brief DISCERN scores among the 5 source types, F(4, 119) = 5.93, P = .0002, with medical practices averaging the worst score (13.73/30). CONCLUSIONS: Patients are most commonly searching Google to gain information regarding CTS treatment options. Online sources such as medical practices should use widely accepted rubrics for ensuring transparency and quality prior to publishing CTS information.

12.
Child Abuse Negl ; 134: 105868, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36113375

RESUMO

INTRODUCTION: More than 1 in 7 children in the United States experience abuse annually with rates remaining consistent over the past 2 decades. During this timeframe, several high-profile cases of child abuse and neglect were publicized in national media in addition to multiple investigations uncovering Indigenous children dying from abuse at Indian Boarding Schools. Increased media attention among other public health and medical topics has been linked to increased public interest, thus, our objective was to investigate trends in public interest from 2004 to 2022. METHODS: To assess trends in public interest, we extracted monthly relative search interest in child abuse from Google Trends. We constructed linear regression to determine the long-term trajectory of interest, and also compared the slope of the trend to other topics, such as domestic violence. Further, we compared mean relative search interest (RSI) from Child Abuse Awareness Month (April) to other months via t-test. Lastly, we assess by-state correlations of RSI and number of children abused. RESULTS: Since 2004, search interest in child abuse has significantly declined in the United States-more than other related search terms. Child Abuse Awareness Month showed spikes in RSI which were greater than other months. By-state correlations of RSI and abuse were moderate to weak. CONCLUSION: Despite heavy media attention covering stories of child abuse during the past 2 decades, search interest in child abuse has significantly declined. This trend may be related to aversion to secondary traumatic stress as news broadcasts often include stories of violence-of which child abuse stories may be most provoking. Following journalism guidance from the Centers for Disease Control and Prevention, reporting with focus on resiliency and prevention, rather than the individuals who perpetrated the crime, may provide more community support and increased public interest.


Assuntos
Maus-Tratos Infantis , Ferramenta de Busca , Criança , Estados Unidos/epidemiologia , Humanos , Infodemiologia , Maus-Tratos Infantis/prevenção & controle , Violência , Saúde Pública
13.
Autism Res ; 15(8): 1560-1564, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35670304

RESUMO

Due to uncertainties associated with the COVID-19 public health crisis, several clinical trials had to be withdrawn or postponed. Our investigation aimed to assess the rate of discontinuation of clinical trials focusing on Autism Spectrum Disorder. Of the 197 registered trials included in our systematic review, 15 (7.6%) were discontinued, with nearly half of these explicitly citing COVID-19 as their reason for discontinuation. Pharmacological trials were six times more likely to be discontinued during the pandemic than non-pharmacological studies. The difference between the likelihood of discontinuation was statistically significant (OR: 6.13; 95% CI: 1.22-30.71). There was no evidence of association between funding source and reasons for discontinuation. Limitations, along with implications for future trials are discussed. LAY SUMMARY: We investigated the impact of the COVID-19 pandemic on the discontinuation rate of autism clinical trials. We found that drug trials were six times more likely to be discontinued during the pandemic compared to behavioral, diagnostic, and nutritional trials. The overall discontinuation rate was notably lower in autism clinical trials than in other areas of medical research. We recommend an examination of the methodology of the continued autism trials to assess their applicability in other fields.


Assuntos
Transtorno do Espectro Autista , Transtorno Autístico , COVID-19 , Transtorno do Espectro Autista/epidemiologia , Transtorno Autístico/epidemiologia , Estudos Transversais , Humanos , Pandemias
15.
J Osteopath Med ; 122(8): 393-399, 2022 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-35363445

RESUMO

CONTEXT: The COVID-19 pandemic has reduced the capacity to conduct medical research due to recruitment difficulties, supply chain shortages, and funding deficits. The clinical practice of otolaryngology was especially impacted due to a reduction in elective procedures, such as facial plastic surgeries and vocal fold injections. OBJECTIVES: The primary objective was to examine the extent of clinical trial (CTs) disruption secondary to the COVID-19 pandemic in the field of otolaryngology. METHODS: On August 1, 2021, we conducted a systematic search utilizing ClinicalTrials.gov for CTs related to common otolaryngology disorders. We utilized the date range January 1, 2020 through August 1, 2021 to identify all trials potentially affected by the COVID-19 pandemic. Investigators performed screening and data extraction in a duplicate, masked fashion. Trials resulting from the search were extracted for trial status, condition treated, enrollment number, funding, study type, study design, last update posted date, and trial location. Trials that explicitly mentioned COVID-19 as a reason for discontinuation or suspension were coded as such. For trials that did not explicitly mention COVID-19, we coded the reason provided from ClinicalTrials.gov. The Oklahoma State University Center for Health Science Institutional Review Board determined that this project did not qualify as human subject research. RESULTS: A total of 1,777 CTs met the inclusion criteria, and 223 CTs were discontinued between January 1, 2020 and August 1, 2021. Thirty-three (14.8%) of the 223 CTs reported discontinuation explicitly due to the COVID-19 pandemic. The 33 studies had 1,715 participants enrolled in total. Among the primary interventions, 11 (33.3%) were devices, 10 (30.3%) were drugs, 5 (15.2%) were behavioral, 4 (12.1%) were diagnostic tests, 1 (3.0%) was dietary, and 2 (6.1%) were labeled as "other." Regarding the CT location, 20 (60.6%) were conducted in the United States, and 13 (39.4%) were conducted internationally. Of the 33 CTs, 19 (57.6%) were suspended, 9 (27.3%) were terminated, and 5 (15.2%) were withdrawn. The overall most common reason for trial disruption was recruitment difficulties (24.2%). Median enrollment for discontinued trials due to COVID-19 was 37 (interquartile range [IQR], 19-71) and for other reasons was 6 (IQR, 0-27), for which the Mann-Whitney test showed a statistically significant difference between the two (z=-3.913, p<0.001). There were no significant associations between trial location, funding source, randomization, or whether a study involved masked vs unmasked participants. CONCLUSIONS: The COVID-19 pandemic has incited an impact on clinical research in the field of otolaryngology. To preserve trial continuation amid future threats to participant interaction and communication, we recommend further exploration of remote monitoring practices and virtual procedures-those that will maintain the effectiveness and accuracy needed to establish novel therapeutics. We encourage future trials to gauge which remote assessments show the greatest validity, with the long-term goal of establishing innovative study designs resilient to future pandemics.


Assuntos
COVID-19 , Otolaringologia , COVID-19/epidemiologia , Ensaios Clínicos como Assunto , Estudos Transversais , Humanos , Pandemias , SARS-CoV-2
16.
JMIR Perioper Med ; 5(1): e34936, 2022 Apr 05.
Artigo em Inglês | MEDLINE | ID: mdl-35358057

RESUMO

BACKGROUND: The COVID-19 pandemic drastically altered perioperative medical practice owing to safety concerns, postponing elective or nonemergent procedures, supply chain shortages, and reallocating perioperative staff to care for patients with COVID-19. However, the impact of the pandemic on the conduct on anesthesiology clinical research is unknown. OBJECTIVE: The primary objective was to quantify the magnitude of the COVID-19 pandemic's impact on anesthesiology clinical research. METHODS: We performed a systematic search using ClinicalTrials.gov to identify clinical trials related to the practice of anesthesiology. We screened trials with status updates from January 1, 2020, through October 1, 2021, to capture trials potentially affected by the COVID-19 pandemic by the time of our search. Investigators screened for relevant studies and extracted trial characteristics along with the reason for discontinuation reported on the clinical trial registry. RESULTS: A total of 823 clinical trials met inclusion criteria, and 146 clinical trials were discontinued within the designated date range. In total, 24 (16.4%) of the 146 clinical trials were halted explicitly owing to the COVID-19 pandemic. A significant association existed between trial enrollment numbers and the likelihood of discontinuation due to the COVID-19 pandemic, as larger trials were more likely to be disrupted (z=-2.914, P=.004). CONCLUSIONS: The COVID-19 pandemic is reportedly associated with the discontinuation of anesthesiology-related clinical trials. With the uncertain course of the COVID-19 pandemic, developing anesthesia trial protocols to help minimize social interaction and prevent premature trial disruption are imperative.

17.
J Matern Fetal Neonatal Med ; 35(25): 9622-9630, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35282754

RESUMO

BACKGROUND: Pregnant women with COVID-19 are at increased risk for adverse maternal and pregnancy outcomes, and birth complications. Given the health outcome disparities among pregnant women of racial and ethnic minorities and the reliance of medical practice on systematic reviews and meta-analyses (SRMAs)-as they are the apical component in the hierarchy of evidence in medical research-the primary objective of the study is to examine the inclusion of the equity reporting in SRMAs focused on pregnancy outcomes and COVID-19 using PROGRESS-Plus equity framework. PROGRESS represents equity measures of Place, Race, Occupation, Gender, Religion, Education, Social capital, and Socio-economic status. METHODS: We conducted a systematic search of three databases to identify SRMAs related to maternal and pregnancy outcomes related to COVID-19. We extracted whether SRMAs reported or analyzed PROGRESS-Plus components among other study characteristics. RESULTS: Nearly 85% of SRMAs did not include any equity items to account for racial or geographic disparities. Reporting of race was absent from 95% of the studies. Place was the most common PROGRESS item and maternal age was the most common PROGRESS-Plus item reported overall. CONCLUSION: When research is performed and reported in a way that fails to address disparities, the downstream repercussions may include medical care in the form of new protocol-driven hospital management, pharmacologic interventions, and other treatment options that mirror this absence in reporting. The absence of adequate reporting widens gaps in health outcomes among at-risk groups, such as pregnant women of racial and ethnic minorities.


Assuntos
COVID-19 , Humanos , Feminino , Gravidez , COVID-19/epidemiologia , Revisões Sistemáticas como Assunto , Parto , Resultado da Gravidez/epidemiologia , Estudos Epidemiológicos
18.
Subst Abus ; 43(1): 906-912, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35226594

RESUMO

Objective: With approximately 15 million individuals in the United States meeting criteria for Alcohol Use Disorder (AUD), advancing effective medication-assisted treatment options is crucial. This advancement stems from the publication of clinical trial (CT) results. The primary objective of this study was to assess the rates of discontinuation and non-publication of results in CTs focused on the pharmacologic treatment of AUD and to assess associated factors. Design: A cross-sectional study was completed after acquiring trials focused on AUD within the ClinicalTrials.gov database. Inclusion criteria for CTs were the use of a pharmaceutical intervention with an outcome measure of alcohol intake or craving, conducted between October 2008 through September 2018. The primary outcome measures were the frequency of trial discontinuation and non-publication. Discontinuation was assessed as the listed status on ClinicalTrials.gov. Publications were identified through verification of listings on ClinicalTrials.gov, or via searches of PubMed, Embase, and Google Scholar. If publications were not found, correspondence to trial contacts were sent. Data analysis occurred on December 5th, 2020. Results: Of 235 trials returned from the search, 87 met inclusion criteria. Our study found that 12.6% (11) of CTs involving pharmaceutical treatments for AUD were prematurely terminated, and 39.1% (34) had no published results. Recruitment and lower cutoff of targeted age groups were significantly associated with discontinuation and non-publication, respectively. Conclusions: Scientific evidence advances faster when all results are known-furthering the progress of positive studies, while avoiding duplicative efforts to test the same hypotheses with the same methods, thereby reducing scientific waste. Given the number of unpublished AUD trials, potentially useful information regarding treatment for individuals with AUD may be inaccessible to clinicians while also adding to the abundance of research waste.Key pointsQuestion: What are the rates of discontinuation or non-publication of clinical trials for pharmacological treatments for AUD and associated factors?Findings: Among 87 trials, 11 (12.6%) were prematurely terminated and 34 (39.1%) did not reach publication, with trials that included participants 21 years and older more likely to reach publication than those with younger participants.Meaning: Low publication rates of CTs for pharmacological treatments of AUD may (1) stunt the advancement of AUD research, (2) decrease the value in funding AUD research from government entities, and (3) needlessly expose participants to potentially harmful interventions.


Assuntos
Alcoolismo , Consumo de Bebidas Alcoólicas , Alcoolismo/tratamento farmacológico , Estudos Transversais , Bases de Dados Factuais , Humanos , Preparações Farmacêuticas , Estados Unidos
19.
J Addict Med ; 16(5): 527-533, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35120059

RESUMO

INTRODUCTION: Stigmatizing language used to describe patients and medical conditions is associated with poorer health outcomes. A recent investigation showed that approximately 80% of medical literature focused on alcohol use disorder (AUD) contained stigmatizing terms related to individuals; however, the quantification of stigmatizing terminology for outcomes and processes (STOP) among AUD research is unknown. Thus, our primary objective was to evaluate publications of clinical trials for their inclusion of STOP. METHODS: We performed a systematic search of PubMed for AUD clinical trials between January 1, 2017 and June 30, 2021. Article screening and data extraction were performed in a masked, duplicate manner by 2 investigators. We searched the full text of included manuscripts for STOP. We reported the frequency and percentage of manuscripts with STOP and individual terms. We evaluated associations between STOP usage and several clinical trial characteristics via logistic regression. RESULTS: Our search returned 1552 articles, which were then randomized and the first 500 were screened for inclusion. Of 147 included articles, 115 (78.2%) included STOP. The most common STOP were "drop out" (38.78%; 57/147), "relapse" (36.05%; 53/ 147), and "adherent, nonadherence" (35.37%; 52/147). No significant associations were found between STOP usage and trial characteristics. DISCUSSION: STOP was found in a majority of AUD clinical trial publications. As AUD is highly stigmatized, steps should be taken to eliminate usage of STOP in literature pertaining to AUD treatments. Many stigmatizing terms can be replaced by person-centered, more clinically accurate terms to further combat AUD stigma.


Assuntos
Alcoolismo , Manuscritos Médicos como Assunto , Consumo de Bebidas Alcoólicas/prevenção & controle , Alcoolismo/terapia , Ensaios Clínicos como Assunto , Humanos , Idioma , Recidiva
20.
J Osteopath Med ; 122(5): 219-227, 2022 02 18.
Artigo em Inglês | MEDLINE | ID: mdl-35179005

RESUMO

CONTEXT: Osteopathic medicine in the United States continues to produce a substantial number of physicians and medical educators. However, recently popularized misconceptions about osteopathic medical practice, education, and manual therapy suggest an unsettling prevalence of inaccurate beliefs held by the public. The public often searches the internet to find out information about osteopathic medicine, but the content of questions and the transparency of the resulting information is unknown. OBJECTIVES: We sought to explore frequently asked questions (FAQs) generated by Google to assess commonly searched questions about the osteopathic profession and to determine the level of information transparency associated with resulting sources. METHODS: On June 16, 2021, we searched Google for three terms: "osteopathic medicine," "doctor of osteopathic medicine," and "DO," until a minimum of 100 FAQs and their answer links were extracted from each search. After excluding irrelevant FAQs, we used Rothwell's Classification of Questions to categorize the FAQs. We then used the Journal of the American Medical Association's Benchmark Criteria to assess information transparency for each corresponding answer source provided by Google. The answer sources were screened for the inappropriate use of "osteopathy" in place of "osteopathic medicine" and for "osteopath" in place of "DO," "Doctor of Osteopathic Medicine," or "Osteopathic Physician." We performed statistical tests to ascertain the differences in information transparency between osteopathic and nonosteopathic information sources. RESULTS: Our Google search revealed 110 unique FAQs about osteopathic medicine. The majority of FAQs were classified as fact-based (82/110; 74.55%), nearly half of which (45.12%) were related to the medical practicing privileges of DOs. The FAQs were most commonly answered by academic institutions (44/110, 40.0%). Nearly half (49.09%) of the linked answer sources were deemed inadequate by JAMA benchmark criteria. Of the 110 linked answer sources, 19 (17.27%) misused either osteopathy, osteopath, or both to describe osteopathic physicians. Only 30 sources were linked to US-based osteopathic organizations. Osteopathic organizations were statistically less likely to meet high-transparency criteria than nonosteopathic organizations (p=0.002). CONCLUSIONS: Our study shows that the US public may be unsure about the physician status of DOs, which may prevent securing the professional identity of osteopathic physicians in the eyes of the public. Osteopathic organizations should tailor awareness campaigns toward addressing the common misconceptions revealed by our study. Osteopathic organizations should use transparency criteria as a rubric when publishing information to enhance transparency.


Assuntos
Internato e Residência , Osteopatia , Medicina Osteopática , Médicos Osteopáticos , Médicos , Humanos , Medicina Osteopática/educação , Estados Unidos/epidemiologia
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