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  • 1
    Online Resource
    Online Resource
    Heterogeneous Treatment Effects of Therapeutic-Dose Heparin in Patients Hospitalized for COVID-19
    American Medical Association (AMA) ; 2023
    In:  JAMA Vol. 329, No. 13 ( 2023-04-04), p. 1066-
    Details
    In: JAMA, American Medical Association (AMA), Vol. 329, No. 13 ( 2023-04-04), p. 1066-
    Abstract: Randomized clinical trials (RCTs) of therapeutic-dose heparin in patients hospitalized with COVID-19 produced conflicting results, possibly due to heterogeneity of treatment effect (HTE) across individuals. Better understanding of HTE could facilitate individualized clinical decision-making. Objective To evaluate HTE of therapeutic-dose heparin for patients hospitalized for COVID-19 and to compare approaches to assessing HTE. Design, Setting, and Participants Exploratory analysis of a multiplatform adaptive RCT of therapeutic-dose heparin vs usual care pharmacologic thromboprophylaxis in 3320 patients hospitalized for COVID-19 enrolled in North America, South America, Europe, Asia, and Australia between April 2020 and January 2021. Heterogeneity of treatment effect was assessed 3 ways: using (1) conventional subgroup analyses of baseline characteristics, (2) a multivariable outcome prediction model (risk-based approach), and (3) a multivariable causal forest model (effect-based approach). Analyses primarily used bayesian statistics, consistent with the original trial. Exposures Participants were randomized to therapeutic-dose heparin or usual care pharmacologic thromboprophylaxis. Main Outcomes and Measures Organ support–free days, assigning a value of −1 to those who died in the hospital and the number of days free of cardiovascular or respiratory organ support up to day 21 for those who survived to hospital discharge; and hospital survival. Results Baseline demographic characteristics were similar between patients randomized to therapeutic-dose heparin or usual care (median age, 60 years; 38% female; 32% known non-White race; 45% Hispanic). In the overall multiplatform RCT population, therapeutic-dose heparin was not associated with an increase in organ support–free days (median value for the posterior distribution of the OR, 1.05; 95% credible interval, 0.91-1.22). In conventional subgroup analyses, the effect of therapeutic-dose heparin on organ support–free days differed between patients requiring organ support at baseline or not (median OR, 0.85 vs 1.30; posterior probability of difference in OR, 99.8%), between females and males (median OR, 0.87 vs 1.16; posterior probability of difference in OR, 96.4%), and between patients with lower body mass index (BMI & amp;lt;30) vs higher BMI groups (BMI ≥30; posterior probability of difference in ORs & amp;gt;90% for all comparisons). In risk-based analysis, patients at lowest risk of poor outcome had the highest propensity for benefit from heparin (lowest risk decile: posterior probability of OR & amp;gt;1, 92%) while those at highest risk were most likely to be harmed (highest risk decile: posterior probability of OR & amp;lt;1, 87%). In effect-based analysis, a subset of patients identified at high risk of harm ( P  = .05 for difference in treatment effect) tended to have high BMI and were more likely to require organ support at baseline. Conclusions and Relevance Among patients hospitalized for COVID-19, the effect of therapeutic-dose heparin was heterogeneous. In all 3 approaches to assessing HTE, heparin was more likely to be beneficial in those who were less severely ill at presentation or had lower BMI and more likely to be harmful in sicker patients and those with higher BMI. The findings illustrate the importance of considering HTE in the design and analysis of RCTs. Trial Registration ClinicalTrials.gov Identifiers: NCT02735707 , NCT04505774 , NCT04359277 , NCT04372589
    Type of Medium: Online Resource
    ISSN: 0098-7484
    URL: Article
    DOI: 10.1001/jama.2023.3651
    RVK:
    XA 10000
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
    detail.hit.zdb_id: 2958-0
    SSG: 5,21
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  • 2
    Online Resource
    Online Resource
    Association of Dietary Nitrate and a Mediterranean Diet With Age-Related Macular Degeneration Among US Adults : The Age-Related Eye Disease Study (AREDS) and AREDS2
    American Medical Association (AMA) ; 2023
    In:  JAMA Ophthalmology Vol. 141, No. 2 ( 2023-02-01), p. 130-
    Details
    In: JAMA Ophthalmology, American Medical Association (AMA), Vol. 141, No. 2 ( 2023-02-01), p. 130-
    Abstract: Low dietary nitrate intake has previously been suggested to be a risk factor for age-related macular degeneration (AMD) progression; however, this finding has not been replicated in other cohorts or adjusted for dietary patterns. Objective To determine whether there is an association between dietary nitrate intake and AMD progression. Design, Setting, and Participants This cohort study analyzed data from the prospective Age-Related Eye Disease Study (AREDS) and AREDS2 randomized clinical trial cohorts and their extended follow-up studies, which were conducted in multicenter outpatient retinal practices. Participants in both trials had non–late AMD in at least 1 eye. Data were analyzed from March 1, 2020, to September 30, 2022. Exposure Dietary nitrate intake. Main Outcomes and Measures Association between dietary nitrate intake and development of late AMD (neovascular AMD [nAMD] or geographic atrophy [GA] ) or large drusen. The interactions of dietary patterns, with common at-risk single-nucleotide polymorphisms, were also assessed. Results In the combined AREDS/AREDS2 cohort of 7788 participants (4288 AREDS participants and 3610 AREDS2 participants [110 of whom participated in both studies] ), there were 13 511 eligible eyes. The combined cohort comprised 4396 women (56%) and 3392 men (44%), and the combined mean (SD) age was 71.1 (6.6) years. Dietary nitrate intake was associated with a decreased risk of progression to late AMD in the combined AREDS/AREDS2 cohort (hazard ratio [HR], 0.77 [95% CI, 0.69-0.86] for quartile 4 vs quartile 1 of intake) and a decreased risk of GA (HR, 0.71 [95% CI, 0.61-0.83]) and nAMD (HR, 0.85 [95% CI, 0.73-0.99] ). In AREDS, increased nitrate intake (quartile 4 vs quartile 1) was associated with a decreased risk of late AMD (HR, 0.77 [95% CI, 0.65-0.91]) and GA (HR, 0.80 [95% CI, 0.65-0.97] ) but not nAMD; in AREDS2, there was no association between nitrate intake (quartile 4 vs quartile 1) and late AMD (HR, 0.90 [95% CI, 0.80-1.02]) or nAMD (HR, 0.93 [95% CI, 0.78-1.11] ). There was a correlation between Mediterranean dietary patterns and dietary nitrate intake ( r  = 0.52, P   & amp;lt; .001). Conclusions and Relevance The findings of this cohort study suggest that dietary nitrate intake was associated with lower AMD risk. However, this association disappeared after adjusting for Mediterranean dietary patterns. These results are subject to potential bias and are hypothesis-generating in nature; therefore, they are insufficient to support new clinical recommendations. Previously described associations between dietary nitrate intake and AMD may in fact represent overall dietary patterns. Further research is needed before dietary nitrate intake can be recommended as a therapy for AMD.
    Type of Medium: Online Resource
    ISSN: 2168-6165
    URL: Article
    DOI: 10.1001/jamaophthalmol.2022.5404
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
    detail.hit.zdb_id: 2701705-9
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  • 3
    Online Resource
    Online Resource
    Chronology of Hip Dysplasia Development in a Cohort of 48 Labrador Retrievers Followed for Life
    Wiley ; 2012
    In:  Veterinary Surgery Vol. 41, No. 1 ( 2012-01), p. 20-33
    Details
    In: Veterinary Surgery, Wiley, Vol. 41, No. 1 ( 2012-01), p. 20-33
    Abstract: To determine the chronology of radiographic signs of canine hip dysplasia ( CHD ), specifically joint laxity and secondary osteoarthritis ( OA ). Study Design Longitudinal cohort study. Animals Paired littermates, 48 L abrador retrievers. Methods Conventional, ventrodorsal, hip‐extended ( HE ) radiographs were evaluated yearly for CHD according to the subjective criteria of the Orthopedic Foundation for Animals ( OFA ). PennHIP screening was performed at 2 years of age to assess joint laxity by distraction index (DI). Histopathologic evaluation of coxofemoral joints was performed at the dogs’ natural end of life. Results Coxofemoral subluxation, as identified on the HE radiograph occurred by 2 years of age and not thereafter. Accuracy of OFA ‐criteria scoring was poor: 55% of dogs scored “normal” at 2 years of age became radiographically dysplastic by the end of life (45% negative predictive value, NPV ); 92% of the dogs scored as normal at 2 years of age had histopathologic OA of CHD (8% NPV ). The DI predicted all 48 dogs to be susceptible to OA of CHD and 98% had radiographic or histopathologic OA by the end of life. Conclusion OFA ‐criteria score was profoundly influenced by environmental factors, such as diet restriction and age, reducing its value as a selection criterion. DI measurements were not influenced by dietary treatment suggesting higher trait heritability.
    Type of Medium: Online Resource
    ISSN: 0161-3499 , 1532-950X
    URL: Issue
    URL: Article
    DOI: 10.1111/vsu.2012.41.issue-1
    DOI: 10.1111/j.1532-950X.2011.00935.x
    Language: English
    Publisher: Wiley
    Publication Date: 2012
    detail.hit.zdb_id: 759964-X
    detail.hit.zdb_id: 1491071-8
    SSG: 22
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  • 4
    Online Resource
    Online Resource
    Encephalopathy following bone marrow transplantation
    Elsevier BV ; 1977
    In:  European Journal of Cancer (1965) Vol. 13, No. 6 ( 1977-6), p. 623-625
    Details
    In: European Journal of Cancer (1965), Elsevier BV, Vol. 13, No. 6 ( 1977-6), p. 623-625
    Type of Medium: Online Resource
    ISSN: 0014-2964
    URL: Article
    DOI: 10.1016/0014-2964(77)90125-6
    RVK:
    XA 42017
    Language: English
    Publisher: Elsevier BV
    Publication Date: 1977
    detail.hit.zdb_id: 82061-1
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  • 5
    Online Resource
    Online Resource
    Un‐United Medial Epicondyle of the Humerus: Radiographic Prevalence and Association with Elbow Osteoarthritis in a Cohort of Labrador Retrievers
    Wiley ; 2009
    In:  Veterinary Surgery Vol. 38, No. 2 ( 2009-02), p. 169-172
    Details
    In: Veterinary Surgery, Wiley, Vol. 38, No. 2 ( 2009-02), p. 169-172
    Abstract: Objective— To longitudinally characterize the radiographic appearance of un‐united medial epicondyle (UME) of the humerus, evaluate UME association with osteoarthritis (OA) and consider its relevance to the elbow dysplasia complex. Study Design— Longitudinal cohort study. Animals— Labrador retrievers (n=48) from 7 litters. Methods— Forty‐eight same‐sex littermates were paired for this lifetime feeding study. One of each pair was control‐fed; the pair mate was fed 25% less than the control each day. Elbows of 46 surviving dogs were radiographed at ages 6 and 8 years, and/or at end‐of‐life (EOL). Elbow histopathology was done EOL, although UME lesions were not evaluated histologically. Results— Seven dogs (15%) had UME, representing 5 litters; 4 were control‐fed, 3 diet‐restricted. Six (86%) dogs had unilateral lesions; 1 was bilateral. UME was evident on craniocaudal (CrCd) radiographic projections by 8 years in all dogs. UME was detected in only 1 elbow by mediolateral radiographic projection. Elbow OA frequency in UME affected dogs was not significantly different from the remaining study population. Histopathologic lesions were bilateral in dogs with unilateral UME. Conclusions— UME may be more common than previously thought. Most cases were unilateral and diet restriction had no effect on frequency. The CrCd view was critical for diagnosis. Elbow OA was not directly associated with UME. Clinical Relevance— Infrequent diagnosis of UME could result from infrequent radiography and use of only the flexed lateral radiographic projection required by the Orthopedic Foundation for Animals for elbow screening. Like hip evaluations, screening for UME should be continued for life, until genetics are better understood. Lack of association between UME and elbow OA suggests that UME is not likely a component of elbow dysplasia.
    Type of Medium: Online Resource
    ISSN: 0161-3499 , 1532-950X
    URL: Issue
    URL: Article
    DOI: 10.1111/vsu.2009.38.issue-2
    DOI: 10.1111/j.1532-950X.2008.00484.x
    Language: English
    Publisher: Wiley
    Publication Date: 2009
    detail.hit.zdb_id: 759964-X
    detail.hit.zdb_id: 1491071-8
    SSG: 22
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  • 6
    Online Resource
    Online Resource
    A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen
    SAGE Publications ; 2011
    In:  Clinical Trials Vol. 8, No. 2 ( 2011-04), p. 183-195
    Details
    In: Clinical Trials, SAGE Publications, Vol. 8, No. 2 ( 2011-04), p. 183-195
    Abstract: Background Clinical trials are widely considered the gold standard in comparative effectiveness research (CER) but the high cost and complexity of traditional trials and concerns about generalizability to broad patient populations and general clinical practice limit their appeal. Unsuccessful implementation of CER results limits the value of even the highest quality trials. Planning for a trial comparing two standard strategies of insulin administration for hospitalized patients led us to develop a new method for a clinical trial designed to be embedded directly into the clinical care setting thereby lowering the cost, increasing the pragmatic nature of the overall trial, strengthening implementation, and creating an integrated environment of research-based care. Purpose We describe a novel randomized clinical trial that uses the informatics and statistics infrastructure of the Veterans Affairs Healthcare System (VA) to illustrate one key component (called the point-of-care clinical trial – POC-CT) of a ‘learning healthcare system,’ and settles a clinical question of interest to the VA. Methods This study is an open-label, randomized trial comparing sliding scale regular insulin to a weight-based regimen for control of hyperglycemia, using the primary outcome length of stay, in non-ICU inpatients within the northeast region of the VA. All non-ICU patients who require in-hospital insulin therapy are eligible for the trial, and the VA’s automated systems will be used to assess eligibility and present the possibility of randomization to the clinician at the point of care. Clinicians will indicate their approval for informed consent to be obtained by study staff. Adaptive randomization will assign up to 3000 patients, preferentially to the currently ‘winning’ strategy, and all care will proceed according to usual practices. Based on a Bayesian stopping rule, the study has acceptable frequentist operating characteristics (Type I error 6%, power 86%) against a 12% reduction of median length of stay from 5 to 4.4 days. The adaptive stopping rule promotes implementation of a successful treatment strategy. Limitations Despite clinical equipoise, individual healthcare providers may have strong treatment preferences that jeopardize the success and implementation of the trial design, leading to low rates of randomization. Unblinded treatment assignment may bias results. In addition, generalization of clinical results to other healthcare systems may be limited by differences in patient population. Generalizability of the POC-CT method depends on the level of informatics and statistics infrastructure available to a healthcare system. Conclusions The methods proposed will demonstrate outcome-based evaluation of control of hyperglycemia in hospitalized veterans. By institutionalizing a process of statistically sound and efficient learning, and by integrating that learning with automatic implementation of best practice, the participating VA Healthcare Systems will accelerate improvements in the effectiveness of care.
    Type of Medium: Online Resource
    ISSN: 1740-7745 , 1740-7753
    URL: Article
    DOI: 10.1177/1740774511398368
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2011
    detail.hit.zdb_id: 2159773-X
    detail.hit.zdb_id: 2138796-5
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  • 7
    Online Resource
    Online Resource
    Prediagnostic 25-Hydroxyvitamin D in Association with Cancer-specific and All-cause Mortality among Low-income, Non-Hispanic Black Americans with Colorectal Cancer
    American Association for Cancer Research (AACR) ; 2023
    In:  Cancer Epidemiology, Biomarkers & Prevention Vol. 32, No. 8 ( 2023-08-01), p. 1061-1068
    Details
    In: Cancer Epidemiology, Biomarkers & Prevention, American Association for Cancer Research (AACR), Vol. 32, No. 8 ( 2023-08-01), p. 1061-1068
    Abstract: Observational studies show high prediagnosis 25-hydroxyvitamin D is associated with lower mortality after colorectal cancer diagnosis. Results from clinical trials suggest vitamin D supplementation may improve outcomes among patients with colorectal cancer. Most studies included few Black Americans, who typically have lower 25-hydroxyvitamin D. We evaluated associations between serum 25-hydroxyvitamin D and mortality after colorectal cancer diagnosis among Black American cases. Methods: Data arose from 218 Black Americans from the Southern Community Cohort Study diagnosed with colorectal cancer during follow-up (age 40–79 at enrollment). Prediagnostic 25-hydroxyvitamin D was measured at enrollment and categorized as deficient ( & lt;12 ng/mL), insufficient (12–19.9 ng/mL), or sufficient (≥20 ng/mL). Mortality was determined from the National Death Index. Cox proportional hazards were used to estimate HRs and 95% confidence intervals (CI) for associations between 25-hydroxyvitamin D and mortality. Results: As a continuous exposure, higher 25-hydroxyvitamin D was associated with overall mortality [HR = 0.79 (0.65–0.96) per-SD increase, Ptrend = 0.02] and colorectal cancer–specific mortality [HR = 0.83 (0.64–1.08), Ptrend = 0.16] . For overall mortality, associations were strongest among females [HR = 0.65 (0.42–0.92)], current smokers [HR = 0.61 (0.38–0.98)] , and obese participants [HR = 0.47 (0.29–0.77)]. Compared with those with deficiency, participants with sufficient 25-hydroxyvitamin D had lower overall mortality after multivariable adjustment [HR: 0.61 (0.37–1.01)] . Conclusions: Prediagnosis 25-hydroxyvitamin D is inversely associated with overall and colorectal cancer–specific mortality among Black Americans with colorectal cancer. Correcting vitamin D deficiency may improve survival of these patients, particularly for obese individuals and smokers. Impact: Our results support including more Black Americans in trials of vitamin D supplementations to improve colorectal cancer outcomes.
    Type of Medium: Online Resource
    ISSN: 1055-9965 , 1538-7755
    URL: Article
    DOI: 10.1158/1055-9965.EPI-23-0252
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2023
    detail.hit.zdb_id: 2036781-8
    detail.hit.zdb_id: 1153420-5
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  • 8
    Online Resource
    Online Resource
    Within- and between-examiner repeatability of distraction indices of the hip joints in dogs
    American Veterinary Medical Association (AVMA) ; 1997
    In:  American Journal of Veterinary Research Vol. 58, No. 10 ( 1997-10-01), p. 1076-1077
    Details
    In: American Journal of Veterinary Research, American Veterinary Medical Association (AVMA), Vol. 58, No. 10 ( 1997-10-01), p. 1076-1077
    Abstract: To evaluate in vivo repeatability of the distraction index method of evaluating hip joint laxity in dogs. Animals 31 two-year-old Labrador Retrievers. Procedure Each dog was anesthetized and radiographically evaluated for hip joint laxity 4 times: twice by an experienced examiner and twice by an examiner who had no previous knowledge of or training in the technique prior to the first day of testing. Distraction indices (DI) were determined from the radiographs and intraclass correlation coefficients were calculated to evaluate the repeatability of DI measurements between and within examiners. Results Intraclass correlation coefficients were high (range, 0.85 to 0.94). Lower limits of the 95% confidence intervals for the intraclass correlation coefficients ranged from 0.75 to 0.89. Conclusions Between- and within-examiner repeatabilities of DI measurements were high, suggesting that the technique is clinically reliable. Clinical Relevance Distraction index is a reliable measure of hip joint laxity and a good predictor of the risk of development of degenerative joint disease associated with hip dysplasia in dogs. Establishment of high repeatability of DI measurements suggests that the stress-radiographic method may be used by multiple examiners with the expectation of comparable and consistent results. ( Am J Vet Res 1997;58:1076–1077)
    Type of Medium: Online Resource
    ISSN: 0002-9645
    URL: Article
    DOI: 10.2460/ajvr.1997.58.10.1076
    Language: Unknown
    Publisher: American Veterinary Medical Association (AVMA)
    Publication Date: 1997
    detail.hit.zdb_id: 390796-X
    SSG: 22
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  • 9
    Online Resource
    Online Resource
    A Longitudinal Study of the Influence of Lifetime Food Restriction on Development of Osteoarthritis in the Canine Elbow
    Wiley ; 2009
    In:  Veterinary Surgery Vol. 38, No. 2 ( 2009-02), p. 192-198
    Details
    In: Veterinary Surgery, Wiley, Vol. 38, No. 2 ( 2009-02), p. 192-198
    Abstract: Objective— To report the effects of age and lifetime calorie restriction on development and progression of osteoarthritis (OA) in elbow joints of Labrador retrievers. Study Design— Longitudinal cohort study. Animals— Labrador retriever dogs (n=48). Methods— Puppies from 7 litters were allotted to 2 groups of 24 dogs each. Diet‐restricted (DR) dogs received 25% fewer calories than control‐fed (CF) pair mates. Elbow radiographs were taken at 6 and 8 years of age and end of life (EOL). Gross and histopathologic evaluations for OA occurred at EOL. Results— There was no statistical difference in radiographic OA frequency between groups at any of the time points. Radiographic OA severity was greater for CF dogs at 6 years only ( P 〈 .05). There was no significant difference between feeding groups for histopathologic prevalence or severity of OA. Similarly, there were no differences in gross OA lesions between the groups ( P 〉 .05). Fragmented medial coronoid process, un‐united anconeal process, and osteochondrosis were not present in any elbow. Conclusion— No differences in prevalence or severity of radiographic and histopathologic elbow OA were found between feeding groups. Diet restriction resulted in a 1.8‐year extension in median lifespan but no additional incremental worsening of elbow disease. Evaluation at time points 〈 6 years may have revealed larger differences in OA prevalence and severity between the dietary groups. Clinical Relevance— These findings support calorie restriction as a clinical tool to slow progression of elbow OA.
    Type of Medium: Online Resource
    ISSN: 0161-3499 , 1532-950X
    URL: Issue
    URL: Article
    DOI: 10.1111/vsu.2009.38.issue-2
    DOI: 10.1111/j.1532-950X.2008.00487.x
    Language: English
    Publisher: Wiley
    Publication Date: 2009
    detail.hit.zdb_id: 759964-X
    detail.hit.zdb_id: 1491071-8
    SSG: 22
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  • 10
    Online Resource
    Online Resource
    The Effects of Lifetime Food Restriction on the Development of Osteoarthritis in the Canine Shoulder
    Wiley ; 2008
    In:  Veterinary Surgery Vol. 37, No. 1 ( 2008-01), p. 102-107
    Details
    In: Veterinary Surgery, Wiley, Vol. 37, No. 1 ( 2008-01), p. 102-107
    Abstract: Objective— To report effects of age and lifetime food restriction on development and progression of shoulder joint osteoarthritis (OA) in Labrador retriever dogs. Study Design— Longitudinal life‐span, cohort study. Animals— Labrador retriever dogs (n=48). Methods— Littermates were paired (gender, weight) to make 24 pairs of genetically similar dogs. Each diet‐restricted (DR) pair‐mate was fed daily 75% of the same diet consumed by its control‐fed (CF) pair‐mate for life. Shoulders were evaluated radiographically at years 6, 8, and end of life (EOL). At EOL shoulders were evaluated grossly and by histopathology for OA. Results— Radiographic evidence of shoulder OA was identified in 78% of dogs. Severity of radiographic shoulder OA at 6 ( P 〈 .03) and 8 years ( P 〈 .02) was significantly lower among DR dogs compared with CF dogs. Pooled gross evaluation results revealed 40 of 46 dogs had cartilage erosion on the caudal aspect of the humeral head. By EOL, 91% of dogs had histopathologic changes consistent with OA. Conclusion— There was a high overall prevalence of radiographic, gross, and histologic OA among dogs. Substantial disparity was found between radiographic evidence of OA (at EOL) and characteristic changes visible by gross and histologic examination. Clinical Relevance— Radiographic evaluation correlates poorly with severity of shoulder joint pathology. The benefits of DR on shoulder OA are consistent with the demonstrated effect of DR in delaying species‐ and strain‐specific diseases of aging.
    Type of Medium: Online Resource
    ISSN: 0161-3499 , 1532-950X
    URL: Issue
    URL: Article
    DOI: 10.1111/vsu.2008.37.issue-1
    DOI: 10.1111/j.1532-950X.2007.00354.x
    Language: English
    Publisher: Wiley
    Publication Date: 2008
    detail.hit.zdb_id: 759964-X
    detail.hit.zdb_id: 1491071-8
    SSG: 22
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