scholarly journals Spectrum of Clinical Research in Juvenile Idiopathic Arthritis: A Cross-Sectional Analysis of Registered Studies in Clinicaltrials.gov and Clinicaltrialsregister.eu

Biomedicines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1860
Author(s):  
Ronny Lehmann ◽  
Markus Ries

The management of juvenile idiopathic arthritis (JIA) has improved tremendously in recent years due to the introduction of new drug therapies but remains complex in terms of non-pharmaceutical issues. In order to determine the direction of scientific progress by characterizing the current spectrum of ongoing clinical research in JIA, we analyzed all ongoing studies in the field of JIA—registered in clinicaltrials.gov and clinicaltrialsregister.eu—concerning sponsoring, enrollment, duration, localization, and particularly objectives. The close of the database was 7 January 2021. After identifying double-registered studies, n = 72 went into further analysis. Of these, 61.1% were academia-sponsored and 37.5% were sponsored by the pharma industry. The majority of the studies was of the interventional type (77.8%), while others (22.2%) were observational. The median planned enrollments were 100 participants (interventional studies) and 175 participants (observational studies), respectively. The duration differed remarkably from one month to more than 15 years, with a median of 42.5 months. A total of 61.1% of studies were located in a single country, and 38.9% were in several. Europe and North America clearly dominated the study localizations. The study objectives were DMARDs (56.9%), followed by diagnostics and disease activity measurement (18.1%), and medication other than DMARD (12.5%), besides others. Studies on DMARDs were mainly sponsored by industry, predominantly interventional studies on established and novel biologics, with several on specific issues such as systemic JIA and others. The spectrum of registered studies is currently centered on drug therapy and diagnostics, while other issues in JIA play a subordinated role in current research. Drug development was transferred from adult rheumatology into the JIA population with little innovation for children. Future research should take specific pediatric needs better into account.

Author(s):  
Ronny Lehmann ◽  
Markus Ries

Management of Juvenile idiopathic arthritis (JIA) has improved tremendously in recent years due to the introduction of new drug therapies but remains complex also in terms of non-pharmaceutical issues. In order to determine the direction of scientific progress by characterizing the current spectrum of ongoing clinical research in JIA, we analyzed all ongoing studies in the field of JIA registered in clinicaltrials.gov and clinicaltrialsregister.eu concerning sponsoring, enrollment, duration, localization, and particularly objectives. Close of database was 7 January 2021. After identifying doubled-registered studies, N=72 went into further analysis. Of these, 61.1% were academia-sponsored and 37.5% by pharma industry. The majority of studies was of interventional type (77.8%), while others (22.2%) were observational. Median planned enrollments were 100 participants (interventional studies) and 175 participants (observational studies), respectively. Duration differed remarkably from one month to more than 15 years with a median of 42.5 months. 61.1% of studies were located in a single country, 38.9% were in several. Europe and North America clearly dominated study localizations. Study objectives were DMARDs (56.9%), followed by diagnostics and disease activity measurement (18.1%), and medication other than DMARD (12.5%), besides others. Studies on DMARDs were mainly sponsored by industry, predominantly interventional studies on established and novel biologics, with several on specific issues like systemic JIA and others. The spectrum of registered studies is currently centered on drug therapy and diagnostics, while other issues in JIA play a subordinated role.


Author(s):  
Robin Lee ◽  
Karen Dahri ◽  
Tim T Y Lau ◽  
Stephen Shalansky

<p><strong>ABSTRACT</strong></p><p><strong>Background: </strong>Few studies have attempted to determine the proportion of Canadian hospital pharmacists involved in clinical research, despite a general consensus that research should be an essential component of a pharmacist’s professional role.</p><p><strong>Objectives: </strong>The primary objective was to characterize the involvement in clinical pharmacy research of hospital pharmacists in the 4 health authorities of the Lower Mainland of British Columbia (collectively known as the Lower Mainland Pharmacy Services). The secondary objective was to identify perceived barriers to conducting research.</p><p><strong>Methods: </strong>Pharmacists employed within Lower Mainland Pharmacy Services were invited to participate in an online cross-sectional survey, for completion in August and September 2015. Descriptive statistics were used to analyze the results. Groups of survey participants were compared to examine differences in measured outcomes.</p><p><strong>Results: </strong>A total of 534 pharmacists were surveyed, with a response rate of 16% (85/534). Overall, 77% (55/71) of the respondents reported having participated in research, and 87% (62/71) expressed interest in conducting future research. Chart reviews (78%, 36/46) and surveys (41%, 19/46) were the most common study designs used in prior research. Participants self-identified their research-related strengths as literature evaluation (46%, 27/59) and hypothesis generation (44%, 26/59). Conversely, 81% (48/59) of respondents self-identified statistical analysis as a weakness. Most respondents stated that personal satisfaction (82%, 49/60) and the opportunity to learn about disease states (78%, 47/60) were the driving factors for conducting research. The most commonly cited barrier to conducting research was lack of time (92%, 55/60). Opportunities to join existing teams (73%, 44/60) and mentorship programs (70%, 42/60) were identified as the most popular arrangements for encouraging future research.</p><p><strong>Conclusions: </strong>Most of the pharmacists who responded to this survey reported having participated in clinical pharmacy research, but a lack of dedicated time appears to be a major hurdle to greater research participation. A targeted program increasing exposure to existing research teams and mentorship opportunities is recommended for promoting future research.</p><p><strong>RÉSUMÉ</strong></p><p><strong>Contexte : </strong>Peu d’études ont cherché à déterminer la proportion de “pharmaciens d’hôpitaux canadiens qui contribuent à la recherché clinique, et ce, malgré un consensus voulant que la recherche doive être un élément essentiel du rôle professionnel des pharmaciens.</p><p><strong>Objectifs : </strong>L’objectif principal était d’offrir un portrait de la contribution à la recherche sur la pharmacie clinique des pharmaciens d’hôpitaux des quatre régies régionales des basses-terres continentales de la Colombie-Britannique (appelées collectivement <em>Lower Mainland Pharmacy Services</em>, c.-à-d. services de pharmacie des basses-terres continentales). L’objectif secondaire était de recenser les éléments perçus comme des obstacles à la réalisation de recherches.</p><p><strong>Méthodes : </strong>Les pharmaciens employés au sein des services de pharmacie des basses-terres continentales ont été invités à participer par voie électronique à une enquête transversale qui devait être complétée en août et en septembre 2015. Des statistiques descriptives ont été employées pour analyser les résultats. On a aussi comparé des groupes de participants à l’enquête afin d’examiner les différences entre les résultats mesurés.</p><p><strong>Résultats : </strong>Au total, 534 pharmaciens ont été sondés et le taux de réponse était de 16 % (85/534). Dans l’ensemble, 77 % (55/71) des répondants indiquaient avoir participé à des recherches et 87 % (62/71) souhaitaient faire de la recherche dans l’avenir. L’analyse de dossiers médicaux (78 %, 36/46) et les sondages (41 %, 19/46) représentaient les plans d’étude les plus utilisés par les répondants au cours de recherches antérieures. Les participants ont indiqué que leurs forces en lien avec la recherche étaient leur capacité d’évaluer la littérature (46 %, 27/59) et de formuler des hypothèses (44 %, 26/59). En revanche, 81 % (48/59) ont signalé l’analyse statistique comme leur point faible. La plupart des répondants croyaient que la satisfaction personnelle (82 %, 49/60) et la perspective d’acquérir des connaissances sur les maladies (78 %, 47/60) représentaient les principaux facteurs les motivant à faire de la recherche. Ce qui était évoqué le plus souvent comme un obstacle à la recherche était le manqué de temps (92 %, 55/60). Les occasions de se joindre à des équipes en place (73 %, 44/60) et les programmes de mentorat (70 %, 42/60) ont été désignés comme les dispositions les plus attrayantes pour encourager à poursuivre de futures recherches.</p><strong>Conclusions : </strong>La plupart des pharmaciens ayant répondu au sondage ont indiqué avoir contribué à des recherches en pharmacie clinique, mais le manque de temps réservé pour la recherche semblait être un obstacle important à une plus grande participation aux activités de recherche. Un programme ciblé multipliant les possibilités de fréquenter des équipes de recherche déjà établies et offrant plus d’occasions de mentorat serait une façon de promouvoir de futures recherches.


BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e039978 ◽  
Author(s):  
Hemalkumar B Mehta ◽  
Stephan Ehrhardt ◽  
Thomas J Moore ◽  
Jodi B Segal ◽  
G Caleb Alexander

ObjectivesThe coronavirus disease 2019 (COVID-19) pandemic has prompted many initiatives to identify safe and efficacious treatments, yet little is known regarding where early efforts have focused. We aimed to characterise registered clinical trials assessing drugs or plasma treatments for COVID-19.Design, setting and participantsCross-sectional analysis of clinical trials for the treatment of COVID-19 that were registered in the USA or in countries contributing to the WHO’s International Clinical Trials Registry Platform. Relevant trial entries of drugs or plasma were downloaded on 26 March 2020, deduplicated, verified with reviews of major medical journals and WHO websites and independently analysed by two reviewers.Main outcome(s)Trial intervention, sponsorship, critical design elements and specified outcomesResultsOverall, 201 clinical trials were registered for testing the therapeutic benefits of 92 drugs or plasma, including 64 in monotherapy and 28 different combinations. Only eight (8.7%) products or combinations involved new molecular entities. The other test therapies had a wide range of prior medical uses, including as antivirals, antimalarials, immunosuppressants and oncology treatments. In 152 trials (75.7%), patients were randomised to treatment or comparator, including 55 trials with some form of blinding and 97 open-label studies. The 49 (24.4%) of trials without a randomised design included 29 single armed studies and 20 trials with some comparison group. Most trial designs featured multiple endpoints. Clinical endpoints were identified in 134 (66.7%) of trials and included COVID-19 symptoms, death, recovery, required intensive care and hospital discharge. Clinical scales were being used in 33 (16.4%) trials, most often measures of oxygenation and critical illness. Surrogate endpoints or biomarkers were studied in 88 (42.3%) of trials, primarily assays of viral load. Although the trials were initiated in more than 17 countries or regions, 100 (49.8%) were registered in China and 78 (37.8%) in the USA. Registered trials increased rapidly, with the number of registered trials doubling from 1 March to 26 March 2020.ConclusionsWhile accelerating morbidity and mortality from the COVID-19 pandemic has been paralleled by early and rapid clinical investigation, many trials lack features to optimise their scientific value. Global coordination and increased funding of high-quality research may help to maximise scientific progress in rapidly discovering safe and effective treatments.


2018 ◽  
pp. 1-4
Author(s):  
A. Stanton ◽  
J. Buckley ◽  
A. Villani

Adherence to a Mediterranean Diet (MedDiet) is inversely associated with sarcopenia. The aim of this study was to examine the association between adherence to a MedDiet and sarcopenic symptomology in obese older adults. For confirmation of sarcopenia, low appendicular skeletal muscle (ASM: males, ≤7.25kg/m2; females, ≤5.5kg/m2) accompanied low handgrip strength (males, ≤30kg; females, ≤20kg) or low physical performance (Short Physical Performance Battery [SPPB]: ≤8; or gait speed: ≤0.8m/sec). Adherence to a MedDiet was determined using the Mediterranean Diet Adherence Screener (MEDAS). Sixty-five older adults were included. Adherence to a MedDiet was not associated with a decreased risk of sarcopenic symptomology (SPPB: OR = 0.20; 95% CI: 0.01-3.1; P = 0.234; Muscle strength: OR = 1.81; 95% CI: 0.32-10.15; P = 0.499; Gait speed: OR = 0.58; 95% CI: 0.13-2.50; P = 0.468). Future research should investigate whether a Mediterranean-style intervention can prevent or improve sarcopenic symptomology, including in non-Mediterranean populations.


2017 ◽  
Vol 27 (1) ◽  
pp. 3 ◽  
Author(s):  
Valerie J. Silfee ◽  
Christina F. Haughton ◽  
Stephenie C. Lemon ◽  
Vilma Lora ◽  
Milagros C. Rosal

<p class="Pa7"><strong>Objective: </strong>To examine the relationships be­tween spirituality and physical activity and sedentary behavior in a sample of Latino adults in Massachusetts.</p><p class="Pa7"><strong>Design: </strong>This is a cross-sectional analysis of the Lawrence Health and Well Being Study; a study that was conducted among patients at the Greater Lawrence Family Health Cen­ter (GLFHC) in Lawrence, Massachusetts.</p><p class="Pa7"><strong>Participants: </strong>602 Latino or Hispanic adults aged 21 to 85 years completed the study.</p><p class="Pa7"><strong>Results: </strong>There was a significant nega­tive relationship between spirituality and sedentary behavior (β= -.12, p = .004). Although not statistically significant, higher spirituality was associated with increased odds of engaging in physical activity. There were no significant associations between spirituality and physical activity among men or women. Men with greater spirituality were significantly less sedentary (β = -.17, P = .005). There was no relationship between sedentary behavior and spirituality among women.</p><p><strong>Conclusions: </strong>This study found that indi­viduals who are more spiritual are also less sedentary, and this association was stronger in men than women. Findings provide insight for developing future interventions to promote activity in this high-risk popula­tion, which has been greatly understudied. Future research endeavors should consider investigating the impact of spirituality-based messages to reduce sedentary behavior among Latinos.</p><p><em>Ethn Dis. </em>2017;27(1):3-10; doi:10.18865/ed.27.1.3.</p>


2021 ◽  
Vol 12 (2) ◽  
pp. 204380872110152
Author(s):  
Blair E. Wisco ◽  
David R. Harp

Depression is a common problem with debilitating effects. Both negative interpretation biases and rumination are related to depression, but how these factors interact to produce depression is unclear. Prior cross-sectional research indicates that negative interpretation biases have an indirect effect on depression symptoms through rumination, but to date, no longitudinal studies have examined this indirect effect, and prior studies have not differentiated between rumination subtypes. To examine these questions, data were collected online at three time points from undergraduates. Simple mediational models examined whether negative interpretation bias had an indirect effect on depression symptoms through rumination and rumination subtypes (brooding and reflection), and reverse models examined direction of effects. Cross-sectional analysis supported prior findings that interpretation bias had an indirect effect on depression symptoms through rumination, β = −.19, 95%CI [−.23, −.14], through both brooding, β = −.14, 95%CI [−.18, −.10], and reflection subtypes, β = −.09, 95%CI [−.12, −.05]. However, longitudinal analyses found no indirect effects of interpretation bias on depression symptoms through rumination, β = −.02, 95%CI [−.07, .02]; brooding: β = −.02, 95%CI [−.06, .01], reflection: β = .01, 95%CI [−.02, .04]. These longitudinal results contradict findings that cognitive biases lead to depression symptoms through rumination. The complex interplay between cognitive biases, rumination, and depression remains an important direction for future research.


2019 ◽  
Author(s):  
Marina Attanasi ◽  
Marta Lucantoni ◽  
Daniele Rapino ◽  
Marianna I. Petrosino ◽  
Manuela Marsili ◽  
...  

Nutrients ◽  
2018 ◽  
Vol 10 (11) ◽  
pp. 1767 ◽  
Author(s):  
Michael Essman ◽  
Barry Popkin ◽  
Camila Corvalán ◽  
Marcela Reyes ◽  
Lindsey Taillie

Background: Chile has the highest sugar-sweetened beverage (SSB) sales of any country and a growing burden of childhood obesity. This study examines SSB intake in Chilean children after a 5% SSB tax increase in 2014 but prior to marketing, labeling, and school policies implemented in 2016. Methods: 24-h recalls were collected in 2016 from two cohorts comprised of preschoolers 3–5 years of age (n = 961) and adolescents 12–14 years of age (n = 770) from low–moderate income neighborhoods. Beverages were categorized as regulated or unregulated according to whether they exceeded nutrient thresholds established by the 2016 policies. Results: Preschoolers consumed mainly beverage calories from regulated dairy beverages and substitutes (109 kcal, SD 30), unregulated dairy beverages (102 kcal, SD 24), and regulated fruit and vegetables drinks (44 kcal, SD 20). For adolescents, the greatest contributions came from regulated sodas (77 kcal, SD 47), regulated dairy beverages and substitutes (41 kcal, SD 16), and unregulated coffee and tea (41 kcal, SD 11). Overall, regulated beverages provided a greater proportion of calories than unregulated for preschoolers (15.0% vs. 11.8%) and for adolescents (9.1% vs. 5.0%). Conclusions: Before major policy implementation, regulated beverages accounted for a higher percentage of energy intake than unregulated beverages among both age groups. Future research will be needed to evaluate the impact of Chile’s new policies on sugary beverage intake in children.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Joris Poels ◽  
Marc Verschueren ◽  
Koen Milisen ◽  
Ellen Vlaeyen

Abstract Background Although leadership is considered as a key factor in health care, leadership styles and outcomes in nursing homes often remain a black box. Therefore, this study explored leadership styles and leadership outcomes of head nurses and directors of nursing (DoN) in nursing homes based on well-defined leadership concepts. Methods A multicenter cross-sectional analysis was conducted on baseline data of an ongoing cohort study comprising a convenience sample of nursing home staff (n = 302). Leadership styles and leadership outcomes of head nurses and DoN were measured through the rater form of the Multifactor Leadership Questionnaire 5X (MLQ-5X). Based on the Full Range of Leadership Model, the MLQ-5X visualizes transformational (relation and change focused), transactional (task-focused) and passive-avoidant (absence of leadership) leadership styles. Scores of head nurses and DoN for leadership styles and outcomes were compared with European Reference Scores (ERS) using two-sided one-sample t-tests. Results Compared with ERS, head nurses and DoN scored significantly lower (p < 0.001) on transformational and transactional leadership styles and significantly higher (p < 0.001) on passive-avoidant leadership styles. All leadership outcomes were significantly lower (p < 0.001) for head nurses. Similar results, however not statistically significant, were found concerning leadership outcomes of DoN. Conclusions Results indicate that passive-avoidant leadership styles are excessively present in contrast to transformational leadership styles in nursing homes. This highlights an urgent need to invest in leadership development. Therefore, future research should focus on interventions for the development of transformational leadership.


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