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Article: Comment on "Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic".

Collins, Sylva H / Levenson, Mark S

Statistics in biopharmaceutical research

2020 Volume 12, Issue 4, Page(s) 412–413

Language	English
Publishing date	2020-07-06
Publishing country	United States
Document type	Journal Article
ISSN	1946-6315
ISSN	1946-6315
DOI	10.1080/19466315.2020.1779123
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Traumatic rupture of the midportion of the interosseous membrane: a rare cause of acute lower leg pain in two soccer players kicked in the anterior shin.

Collins, Mark S / North, Taylor J / Sellon, Jacob L

Skeletal radiology

2022 Volume 51, Issue 12, Page(s) 2333–2339

Abstract: The interosseous membrane (IOM) of the leg is a component of the tibiofibular syndesmosis that serves an important role in stabilization, as well as transferring forces to the fibula during weight-bearing. We present two separate cases of acute traumatic ...

Abstract	The interosseous membrane (IOM) of the leg is a component of the tibiofibular syndesmosis that serves an important role in stabilization, as well as transferring forces to the fibula during weight-bearing. We present two separate cases of acute traumatic rupture of the midportion of the interosseous membrane in high school soccer players with blunt trauma to the anterior shin with MRI and ultrasound confirmation.
MeSH term(s)	Ankle Injuries/complications ; Ankle Injuries/diagnostic imaging ; Ankle Joint ; Fibula/injuries ; Humans ; Interosseous Membrane ; Leg ; Ligaments, Articular/injuries ; Pain ; Rupture ; Soccer ; Tibia/injuries
Language	English
Publishing date	2022-05-18
Publishing country	Germany
Document type	Journal Article
ZDB-ID	527592-1
ISSN	1432-2161 ; 0364-2348
ISSN (online)	1432-2161
ISSN	0364-2348
DOI	10.1007/s00256-022-04071-z
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 1304: Show issues

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Article ; Online: The burden of schizophrenia in the Middle East and North Africa region, 1990-2019.

Safiri, Saeid / Noori, Maryam / Nejadghaderi, Seyed Aria / Shamekh, Ali / Sullman, Mark J M / Collins, Gary S / Kolahi, Ali-Asghar

Scientific reports

2024 Volume 14, Issue 1, Page(s) 9720

Abstract: Schizophrenia ranks as the third-most common cause of disability among mental disorders globally. This study presents findings on the prevalence, incidence and years lived with disability (YLDs) as a result of schizophrenia in the Middle East and North ... ...

Abstract	Schizophrenia ranks as the third-most common cause of disability among mental disorders globally. This study presents findings on the prevalence, incidence and years lived with disability (YLDs) as a result of schizophrenia in the Middle East and North Africa (MENA), stratified by age, sex and sociodemographic index (SDI). We collected publicly accessible data from the Global Burden of Disease (GBD) study 2019. This study reports the burden of schizophrenia, from 1990 to 2019, for the 21 countries that comprise MENA. In 2019, MENA exhibited an age-standardised point prevalence of 248.2, an incidence rate of 14.7 and an YLD rate of 158.7 per 100,000, which have not changed substantially between 1990 and 2019. In 2019, the age-standardised YLD rate was highest in Qatar and lowest in Afghanistan. No MENA countries demonstrated noteworthy changes in the burden of schizophrenia from 1990 to 2019. Furthermore, in 2019, the highest number of prevalent cases and the point prevalence were observed among those aged 35-39, with a higher prevalence among males in almost all age categories. Additionally, in 2019, the age-standardised YLD rates in MENA were below the worldwide average. Finally, there was a positive correlation between the burden of schizophrenia and the SDI from 1990 to 2019. The disease burden of schizophrenia has remained relatively stable over the past thirty years. Nevertheless, as the regional life-expectancy continues to increase, the burden of schizophrenia is also expected to rise. Therefore, early planning for the increase in the burden of the disease is urgently needed in the region.
MeSH term(s)	Humans ; Middle East/epidemiology ; Africa, Northern/epidemiology ; Schizophrenia/epidemiology ; Male ; Female ; Adult ; Middle Aged ; Prevalence ; Young Adult ; Global Burden of Disease/trends ; Adolescent ; Aged ; Cost of Illness ; Incidence
Language	English
Publishing date	2024-04-27
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-024-59905-8
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Article ; Online: An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the U.S. Food and Drug Administration, 2012-2022.

Collins, Grace / McKelvey, Brittany / Andrews, Hillary S / Allen, Jeff D / Stewart, Mark D

Clinical cancer research : an official journal of the American Association for Cancer Research

2023 Volume 30, Issue 5, Page(s) 937–941

Abstract: ... with FDA's expectations for dose optimization, including consideration of the optimal dosage(s), there are ...

Abstract	The FDA's Oncology Center of Excellence's (OCE) launch of Project Optimus signals increased focus on dose optimization approaches in oncology drug development, particularly toward optimization in the premarket setting. Although sponsors continue to adapt premarket study designs and approaches to align with FDA's expectations for dose optimization, including consideration of the optimal dosage(s), there are still instances where questions remain at the time of approval about whether the approved doses or schedules are optimal. In these cases, FDA can exercise regulatory flexibility by issuing postmarketing requirements (PMR) and avoid delaying patient access to promising therapies. This landscape analysis demonstrates that over the past decade (2012-2022), FDA frequently used PMRs to answer additional questions about dosing for novel oncology approvals. We found more than half of drugs (78/132, 59.1%) had a dosing PMR and observed a recent increase in PMRs intended to evaluate whether a lower dose could be more optimal. These results suggest there are opportunities to adapt premarket dose optimization strategies and leverage innovative development tools to ensure timely identification of the optimal dose.
MeSH term(s)	United States ; Humans ; United States Food and Drug Administration ; Drug Development ; Exercise ; Medical Oncology ; Research Design
Language	English
Publishing date	2023-12-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	1225457-5
ISSN	1557-3265 ; 1078-0432
ISSN (online)	1557-3265
ISSN	1078-0432
DOI	10.1158/1078-0432.CCR-23-2268
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Article ; Online: Utility of preoperative MRI for assessing proximal fragment vascularity in scaphoid nonunion.

Meaike, Joshua J / Meaike, Jesse D / Collins, Mark S / Bishop, Allen T / Shin, Alexander Y

The bone & joint journal

2023 Volume 105-B, Issue 6, Page(s) 657–662

Abstract: Aims: The benefit of MRI in the preoperative assessment of scaphoid proximal fragment vascularity remains controversial. The purpose of this study is to compare preoperative MRI findings to intraoperative bleeding of the proximal scaphoid.: Methods: ... ...

Abstract	Aims: The benefit of MRI in the preoperative assessment of scaphoid proximal fragment vascularity remains controversial. The purpose of this study is to compare preoperative MRI findings to intraoperative bleeding of the proximal scaphoid. Methods: A retrospective review of 102 patients who underwent surgery for scaphoid nonunion between January 2000 and December 2020 at a single institution were identified. Inclusion criteria were: isolated scaphoid nonunion; preoperative MRI assessing the proximal fragment vascularity; and operative details of the vascularity of the proximal fragment with the tourniquet deflated. MRI results and intraoperative findings were dichotomized as either 'yes' or 'no' for the presence of vascularity. A four-fold contingency table was used to analyze the utility of preoperative MRI with 95% confidence intervals. Relative risk was calculated for subgroups to analyze the association between variables and MRI accuracy. Results: Preoperative MRI identified 55 proximal scaphoid fragments with ischaemia and 47 with vascularized proximal fragments. After the proximal fragment was prepared, the tourniquet was deflated and assessed for bleeding; 63 proximal fragments had no bleeding and 39 demonstrated bleeding. MRI was not reliable or accurate in the assessment of proximal fragment vascularity when compared with intraoperative assessment of bleeding. No patient or MRI factors were identified to have a statistical impact on MRI accuracy. Conclusion: Current preoperative MRI protocols and diagnostic criteria do not provide a high degree of correlation with observed intraoperative assessment of proximal fragment bleeding. While preoperative MRI may assist in surgical planning, intraoperative assessment remains the best means for assessing proximal fragment vascularity in scaphoid nonunion. Future efforts should focus on the development of objective measures of osseous blood flow that may be performed intraoperatively.
MeSH term(s)	Humans ; Fractures, Ununited/diagnostic imaging ; Fractures, Ununited/surgery ; Scaphoid Bone/diagnostic imaging ; Scaphoid Bone/surgery ; Magnetic Resonance Imaging ; Upper Extremity ; Retrospective Studies ; Bone Transplantation/methods
Language	English
Publishing date	2023-06-01
Publishing country	England
Document type	Journal Article
ZDB-ID	2697156-2
ISSN	2049-4408 ; 2049-4394
ISSN (online)	2049-4408
ISSN	2049-4394
DOI	10.1302/0301-620X.105B6.BJJ-2022-0835.R2
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Zs.A 6989: Show issues

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Article: Outcomes in patients with clinically suspected pedal osteomyelitis based on bone marrow signal pattern on MRI.

Tiegs-Heiden, Christin A / Anderson, Tanner C / Collins, Mark S / Johnson, Matthew P / Osmon, Douglas R / Wenger, Doris E

Journal of bone and joint infection

2023 Volume 8, Issue 2, Page(s) 99–107

Abstract: ... ...

Abstract	Objective
Language	English
Publishing date	2023-03-22
Publishing country	Germany
Document type	Journal Article
ISSN	2206-3552
ISSN	2206-3552
DOI	10.5194/jbji-8-99-2023
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Comment on “Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic”

Collins, Sylva H. / Levenson, Mark S.

Stat. Biopharm. Res.

Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #574711
Database	COVID19

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Article ; Online: Comment on “Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic”

Collins, Sylva H. / Levenson, Mark S.

Statistics in Biopharmaceutical Research

2020 Volume 12, Issue 4, Page(s) 412–413

Keywords	covid19
Language	English
Publisher	Informa UK Limited
Publishing country	uk
Document type	Article ; Online
ISSN	1946-6315
DOI	10.1080/19466315.2020.1779123
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: The burden of low back pain and its association with socio-demographic variables in the Middle East and North Africa region, 1990-2019.

Safiri, Saeid / Nejadghaderi, Seyed Aria / Noori, Maryam / Sullman, Mark J M / Collins, Gary S / Kaufman, Jay S / Hill, Catherine L / Kolahi, Ali-Asghar

BMC musculoskeletal disorders

2023 Volume 24, Issue 1, Page(s) 59

Abstract: Background: Low back pain (LBP) is the most common musculoskeletal disorder globally. Providing region- and national-specific information on the burden of low back pain is critical for local healthcare policy makers. The present study aimed to report, ... ...

Abstract	Background: Low back pain (LBP) is the most common musculoskeletal disorder globally. Providing region- and national-specific information on the burden of low back pain is critical for local healthcare policy makers. The present study aimed to report, compare, and contextualize the prevalence, incidence and years lived with disability (YLDs) of low back pain in the Middle East and North Africa (MENA) region by age, sex and sociodemographic index (SDI), from 1990 to 2019. Methods: Publicly available data were obtained from the Global Burden of Disease (GBD) study 2019. The burden of LBP was reported for the 21 countries located in the MENA region, from 1990 to 2019. All estimates were reported as counts and age-standardised rates per 100,000 population, together with their corresponding 95% uncertainty intervals (UIs). Results: In 2019, the age-standardised point prevalence and incidence rate per 100,000 in MENA were 7668.2 (95% UI 6798.0 to 8363.3) and 3215.9 (95%CI 2838.8 to 3638.3), which were 5.8% (4.3 to 7.4) and 4.4% (3.4 to 5.5) lower than in 1990, respectively. Furthermore, the regional age-standardised YLD rate in 2019 was 862.0 (605.5 to 1153.3) per 100,000, which was 6.0% (4.2 to 7.7) lower than in 1990. In 2019, Turkey [953.6 (671.3 to 1283.5)] and Lebanon [727.2 (511.5 to 966.0)] had the highest and lowest age-standardised YLD rates, respectively. There was no country in the MENA region that showed increases in the age-standardised prevalence, incidence or YLD rates of LBP over the measurement period. Furthermore, in 2019 the number of prevalent cases were highest in the 35-39 age group, with males having a higher number of cases in all age groups. In addition, the age-standardised YLD rates for males in the MENA region were higher than the global estimates in almost all age groups, in both 1990 and 2019. Furthermore, the burden of LBP was not associated with the level of socio-economic development during the measurement period. Conclusion: The burden attributable to LBP in the MENA region decreased slightly from 1990 to 2019. Furthermore, the burden among males was higher than the global average. Consequently, more integrated healthcare interventions are needed to more effectively alleviate the burden of low back pain in this region.
MeSH term(s)	Male ; Humans ; Low Back Pain/diagnosis ; Low Back Pain/epidemiology ; Prevalence ; Incidence ; Global Burden of Disease ; Africa, Northern/epidemiology ; Turkey ; Global Health ; Quality-Adjusted Life Years
Language	English
Publishing date	2023-01-23
Publishing country	England
Document type	Journal Article
ZDB-ID	2041355-5
ISSN	1471-2474 ; 1471-2474
ISSN (online)	1471-2474
ISSN	1471-2474
DOI	10.1186/s12891-023-06178-3
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Grip strength is inversely associated with DNA methylation age acceleration.

Peterson, Mark D / Collins, Stacey / Meier, Helen C S / Brahmsteadt, Alexander / Faul, Jessica D

Journal of cachexia, sarcopenia and muscle

2022 Volume 14, Issue 1, Page(s) 108–115

Abstract: Background: There is a large body of evidence linking muscular weakness, as determined by low grip strength, to a host of negative ageing-related health outcomes. Given these links, grip strength has been labelled a 'biomarker of aging'; and yet, the ... ...

Abstract	Background: There is a large body of evidence linking muscular weakness, as determined by low grip strength, to a host of negative ageing-related health outcomes. Given these links, grip strength has been labelled a 'biomarker of aging'; and yet, the pathways connecting grip strength to negative health consequences are unclear. The objective of this study was to determine whether grip strength was associated with measures of DNA methylation (DNAm) age acceleration. Methods: Middle age and older adults from the 2006 to 2008 waves of the Health and Retirement Study with 8-10 years of follow-up were included. Cross-sectional and longitudinal regression modelling was performed to examine the association between normalized grip strength (NGS) and three measures of DNAm age acceleration, adjusting for cell composition, sociodemographic variables and smoking. Longitudinal modelling was also completed to examine the association between change in absolute grip strength and DNAm age acceleration. The three DNAm clocks used for estimating age acceleration include the established DunedinPoAm, PhenoAge and GrimAge clocks. Results: There was a robust and independent cross-sectional association between NGS and DNAm age acceleration for men using the DunedinPoAm (β: -0.36; P < 0.001), PhenoAge (β: -8.27; P = 0.01) and GrimAge (β: -4.56; P = 0.01) clocks and for women using the DunedinPoAm (β: -0.36; P < 0.001) and GrimAge (β: -4.46; P = 0.01) clocks. There was also an independent longitudinal association between baseline NGS and DNAm age acceleration for men (β: -0.26; P < 0.001) and women (β: -0.36; P < 0.001) using the DunedinPoAm clock and for women only using the PhenoAge (β: -8.20; P < 0.001) and GrimAge (β: -5.91; P < 0.001) clocks. Longitudinal modelling revealed a robust association between change in grip strength from wave 1 to wave 3 was independently associated with PhenoAgeAA (β: -0.13; 95% CI: -0.23, -0.03) and GrimAgeAA (β: -0.07; 95% CI: -0.14, -0.01) in men only (both P < 0.05). Conclusions: Our findings provide some initial evidence of age acceleration among men and women with lower NGS and loss of strength over time. Future research is needed to understand the extent to which DNAm age mediates the association between grip strength and chronic disease, disability and mortality.
MeSH term(s)	Male ; Middle Aged ; Humans ; Female ; Aged ; DNA Methylation ; Cross-Sectional Studies ; Aging/genetics ; Hand Strength ; Biomarkers
Chemical Substances	Biomarkers
Language	English
Publishing date	2022-11-09
Publishing country	Germany
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2586864-0
ISSN	2190-6009 ; 2190-5991
ISSN (online)	2190-6009
ISSN	2190-5991
DOI	10.1002/jcsm.13110
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