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Peer review of clinical and translational research manuscripts: Perspectives from statistical collaborators
- Phillip J. Schulte, Judith D. Goldberg, Robert A. Oster, Walter T. Ambrosius, Lauren Balmert Bonner, Howard Cabral, Rickey E. Carter, Ye Chen, Manisha Desai, Dongmei Li, Christopher J. Lindsell, Gina-Maria Pomann, Emily Slade, Tor D. Tosteson, Fang Yu, Heidi Spratt
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- Journal:
- Journal of Clinical and Translational Science / Volume 8 / Issue 1 / 2024
- Published online by Cambridge University Press:
- 04 January 2024, e20
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Research articles in the clinical and translational science literature commonly use quantitative data to inform evaluation of interventions, learn about the etiology of disease, or develop methods for diagnostic testing or risk prediction of future events. The peer review process must evaluate the methodology used therein, including use of quantitative statistical methods. In this manuscript, we provide guidance for peer reviewers tasked with assessing quantitative methodology, intended to complement guidelines and recommendations that exist for manuscript authors. We describe components of clinical and translational science research manuscripts that require assessment including study design and hypothesis evaluation, sampling and data acquisition, interventions (for studies that include an intervention), measurement of data, statistical analysis methods, presentation of the study results, and interpretation of the study results. For each component, we describe what reviewers should look for and assess; how reviewers should provide helpful comments for fixable errors or omissions; and how reviewers should communicate uncorrectable and irreparable errors. We then discuss the critical concepts of transparency and acceptance/revision guidelines when communicating with responsible journal editors.
68 The Impact of Pain Catastrophizing on Neuropsychological Performance in Youth with Persistent Post Concussive Symptoms
- Emily E Carter, Jessica Bove, Aliyah Snyder, Meeryo Choe, Chris Giza, Talin Babikian, Robert Asarnow
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- Journal:
- Journal of the International Neuropsychological Society / Volume 29 / Issue s1 / November 2023
- Published online by Cambridge University Press:
- 21 December 2023, pp. 171-172
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Objective:
Patients with persistent post-concussion symptoms (PPCS) experience prolonged recovery (e.g., headache, fatigue, or dizziness) lasting >2 months post injury. These symptoms are thought to be maintained by several biopsychosocial factors including dysregulated stress responses, such as pain catastrophizing, that may drive behavioral avoidance and contribute to mood symptoms and cognitive difficulties. Conditions with similar symptomatology to PPCS (e.g., anxiety disorders, somatosensory disorders, chronic pain, etc.) also exhibit maladaptive thought patterns like pain catastrophizing as well as decrements in certain aspects of cognitive performance; however little is known about how pain catastrophizing might relate to neuropsychological performance in youth with PPCS. Therefore, the purpose of this study was to examine the relationship between pain catastrophizing and neuropsychological performance in youth participants with PPCS.
Participants and Methods:A prospective case-control study design was used to examine 29 participants between the ages of 13 to 23. Participants were divided into two groups: 1) patients with PPCS (2-16 months post-injury; n = 15) and 2) age-matched, non-injured controls (n = 14). Participants completed the Pain Catastrophizing Scale (PCS) to determine degree of catastrophic thinking related to pain experience and the Beck Depression Inventory (BDI). Neuropsychological performance was assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and a modified version of the Paced Auditory Serial Addition Test (PASAT) where performance was evaluated by total correct and error type (i.e., commission and omission) across 5 trials. ANCOVA was used to compare group differences in pain catastrophizing and neuropsychological tests scores while controlling for age and linear regressions examined the relationship between PCS total score and each neuropsychological test score while controlling for level of depression.
Results:Overall, the PPCS group reported significantly higher levels of pain catastrophizing on the PCS compared to the control group (p < 0.01). For neuropsychological performance, the PPCS group scored significantly lower than the control group on List Learning (p < 0.01), Semantic Fluency (p < 0.05), and List Recall (p < 0.01) on the RBANS and made significantly higher omission errors (but not commission) on the PASAT(p <.01). Higher pain catastrophizing was also associated with poorer neuropsychological performance on the exact same tasks the PPCS group performed worse than controls. There was no significant interaction by group in the impact of PCS scores on neurocognitive performance.
Conclusions:Compared to controls, youth PPCS patients reported higher levels of pain catastrophizing. Additionally, pain catastrophizing was associated with poorer neuropsychological performance. These findings suggest that increased pain catastrophizing after head injury could contribute to poorer cognitive performance in youth. As such, interventions that target maladaptive cognitive coping styles like pain catastrophizing may be especially helpful for patients with PPCS.
Childhood adversity predicts black young adults’ DNA methylation-based accelerated aging: A dual pathway model
- Steven R. H. Beach, Frederick X. Gibbons, Sierra E. Carter, Mei Ling Ong, Justin A. Lavner, Man-Kit Lei, Ronald L. Simons, Meg Gerrard, Robert A. Philibert
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- Journal:
- Development and Psychopathology / Volume 34 / Issue 2 / May 2022
- Published online by Cambridge University Press:
- 20 December 2021, pp. 689-703
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We expand upon prior work (Gibbons et al., 2012) relating childhood stressor effects, particularly harsh childhood environments, to risky behavior and ultimately physical health by adding longer-term outcomes – deoxyribonucleic acid (DNA) methylation-based measures of accelerated aging (DNAm-aging). Further, following work on the effects of early exposure to danger (McLaughlin et al., 2014), we also identify an additional pathway from harsh childhood environments to DNAm-aging that we label the danger/FKBP5 pathway, which includes early exposure to dangerous community conditions that are thought to impact glucocorticoid regulation and pro-inflammatory mechanisms. Because different DNAm-aging indices provide different windows on accelerated aging, we contrast effects on early indices of DNAm-aging based on chronological age with later indices that focused on predicting biological outcomes. We utilize data from Family and Community Health Study participants (N = 449) from age 10 to 29. We find that harshness influences parenting, which, in turn, influences accelerated DNAm-aging through the risky cognitions and substance use (i.e., behavioral) pathway outlined by Gibbons et al. (2012). Harshness is also associated with increased exposure to threat/danger, which, in turn, leads to accelerated DNAm-aging through effects on FKBP5 activity and enhanced pro-inflammatory tendencies (i.e., the danger/FKBP5 pathway).
Childhood adversity is linked to adult health among African Americans via adolescent weight gain and effects are genetically moderated
- Steven R. H. Beach, Mei Ling Ong, Man-Kit Lei, Eric Klopack, Sierra E. Carter, Ronald L. Simons, Frederick X. Gibbons, Justin A. Lavner, Robert A. Philibert, Kaixiong Ye
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- Journal:
- Development and Psychopathology / Volume 33 / Issue 3 / August 2021
- Published online by Cambridge University Press:
- 06 May 2020, pp. 803-820
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Identifying the mechanisms linking early experiences, genetic risk factors, and their interaction with later health consequences is central to the development of preventive interventions and identifying potential boundary conditions for their efficacy. In the current investigation of 412 African American adolescents followed across a 20-year period, we examined change in body mass index (BMI) across adolescence as one possible mechanism linking childhood adversity and adult health. We found associations of childhood adversity with objective indicators of young adult health, including a cardiometabolic risk index, a methylomic aging index, and a count of chronic health conditions. Childhood adversities were associated with objective indicators indirectly through their association with gains in BMI across adolescence and early adulthood. We also found evidence of an association of genetic risk with weight gain across adolescence and young adult health, as well as genetic moderation of childhood adversity's effect on gains in BMI, resulting in moderated mediation. These patterns indicated that genetic risk moderated the indirect pathways from childhood adversity to young adult health outcomes and childhood adversity moderated the indirect pathways from genetic risk to young adult health outcomes through effects on weight gain during adolescence and early adulthood.
Confronting Capital and Empire: Rethinking Kyoto School Philosophy. Edited by Viren Murthy, Fabian Schäfer, and Max Ward. Leiden: Koninklijke Brill, 2017. xii + 395 pp. Notes, references, index. Cloth, $152.00. ISBN: 978-90-04-34389-4.
- Robert E. Carter
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- Journal:
- Business History Review / Volume 92 / Issue 2 / Summer 2018
- Published online by Cambridge University Press:
- 25 July 2018, pp. 371-373
- Print publication:
- Summer 2018
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Reducing indwelling urinary catheter use through staged introduction of electronic clinical decision support in a multicenter hospital system
- Brett E. Youngerman, Hojjat Salmasian, Eileen J. Carter, Michael L. Loftus, Rimma Perotte, Barbara G. Ross, E. Yoko Furuya, Robert A. Green, David K. Vawdrey
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- Journal:
- Infection Control & Hospital Epidemiology / Volume 39 / Issue 8 / August 2018
- Published online by Cambridge University Press:
- 13 June 2018, pp. 902-908
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- August 2018
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Objective
To integrate electronic clinical decision support tools into clinical practice and to evaluate the impact on indwelling urinary catheter (IUC) use and catheter-associated urinary tract infections (CAUTIs).
Design, Setting, and ParticipantsThis 4-phase observational study included all inpatients at a multicampus, academic medical center between 2011 and 2015.
InterventionsPhase 1 comprised best practices training and standardization of electronic documentation. Phase 2 comprised real-time electronic tracking of IUC duration. In phase 3, a triggered alert reminded clinicians of IUC duration. In phase 4, a new IUC order (1) introduced automated order expiration and (2) required consideration of alternatives and selection of an appropriate indication.
ResultsOverall, 2,121 CAUTIs, 179,070 new catheters, 643,055 catheter days, and 2,186 reinsertions occurred in 3·85 million hospitalized patient days during the study period. The CAUTI rate per 10,000 patient days decreased incrementally in each phase from 9·06 in phase 1 to 1·65 in phase 4 (relative risk [RR], 0·182; 95% confidence interval [CI], 0·153–0·216; P<·001). New catheters per 1,000 patient days declined from 53·4 in phase 1 to 39·5 in phase 4 (RR, 0·740; 95% CI, 0·730; P<·001), and catheter days per 1,000 patient days decreased from 194·5 in phase 1 to 140·7 in phase 4 (RR, 0·723; 95% CI, 0·719–0·728; P<·001). The reinsertion rate declined from 3·66% in phase 1 to 3·25% in phase 4 (RR, 0·894; 95% CI, 0·834–0·959; P=·0017).
ConclusionsThe phased introduction of decision support tools was associated with progressive declines in new catheters, total catheter days, and CAUTIs. Clinical decision support tools offer a viable and scalable intervention to target hospital-wide IUC use and hold promise for other quality improvement initiatives.
Comparison of Ropewick Applicators for Control of Johnsongrass (Sorghum halepense) in Cotton (Gossypium hirsutum) with Glyphosate
- Paul E. Keeley, Charles H. Carter, Robert J. Thullen, John H. Miller
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- Journal:
- Weed Science / Volume 32 / Issue 4 / July 1984
- Published online by Cambridge University Press:
- 12 June 2017, pp. 431-435
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Three annual applications of glyphosate [N-(phosphonomethyl)glycine] with three ropewick applicators were compared to hoeing and cultivation for the control of johnsongrass [Sorghum halepense (L.) Pers. ♯3 SORHA] in cotton (Gossypium hirsutum L. ‘Acala SJ-2′) in 1980 and 1981. The three applicators provided about equal control of johnsongrass. Averaged over treatments, years, and dates of application, plots treated with glyphosate contained 83% fewer live johnsongrass shoots (14/m2) than cultivated control plots (84/m2) 2 to 3 weeks after each application. Glyphosate-treated plots yielded an average of 81% more seed cotton (2010 kg/ha) than cultivated control plots (1110 kg/ha). However, yields of treated plots averaged 33% less than plots maintained weed-free by hoeing. Although applications of glyphosate reduced johnsongrass populations 83%, the competitive effect of johnsongrass on cotton prior to the initiation of treatments, plus the competition from escape plants between treatments, prevented cotton from yielding normally.
Influence of Glyphosate on Resprouting of Parent Tubers of Cyperus esculentus
- Paul E. Keeley, Charles H. Carter, Robert J. Thullen
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- Journal:
- Weed Science / Volume 34 / Issue 1 / January 1986
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- 12 June 2017, pp. 25-29
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Yellow nutsedge (Cyperus esculentus L. # CYPES) was treated with unlabeled and 14C-labeled glyphosate [N-(phosphonomethyl)glycine] to study the toxicity and translocation of glyphosate into parent tubers of this weed. When plants of 2 and 4 weeks of age were treated with 0.6 kg ai/ha of glyphosate, fewer parent tubers from treated plants resprouted (14 and 32%) than tubers from control plants (73 and 59%, respectively) of equal age. Also, fewer tubers resprouted from 2-week than from 4-week-old treated plants. The radioactivity of parent tubers from plants treated at 2 weeks of age, which exceeded that of tubers from plants of 4 and 6 weeks of age, indicated that translocation of 14C into parent tubers decreased as the treated plants increased in age. The differential amounts of 14C translocated appear to explain why applications of glyphosate were more effective in suppressing resprouting of parent tubers from 2-week than 4-week-old plants.
Influence of Planting Date on Growth of Ivyleaf Morningglory (Ipomoea hederacea) in Cotton (Gossypium hirsutum)
- Paul E. Keeley, Robert J. Thullen, Charles H. Carter
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- Journal:
- Weed Science / Volume 34 / Issue 6 / November 1986
- Published online by Cambridge University Press:
- 12 June 2017, pp. 906-910
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Ivyleaf morningglory [Ipomoea hederacea (L.) Jacq. # IPOHE], planted in 1984 and 1985 the first of each month from April through August, began emerging in cotton (Gossypium hirsutum L. ‘Acala SJ-2’) 1 week after planting. Morningglory, at a density of 1 plant/2 m of row, emerging in April and May became so competitive to cotton by harvest in September that the total crop was lost. June plantings, although less competitive than earlier plantings, still reduced yields by 11%. Later plantings did not reduce yields of cotton. Morningglory plantings that produced seed (April through July) began flowering within 7 weeks, and viable seed was collected for the first time 9 weeks after planting. Ivyleaf morningglory plants that emerged in April and May produced about 11 000 seed/plant by cotton harvest. This compared to 3000 and 93 seed/plant for morningglory that emerged in June and July, respectively. The earliest that morningglory might be expected to produce seed in cotton planted in early April would be late May to early June, and morningglory emerging as late as the first of July could produce some seed by cotton harvest.
Control of Johnsongrass (Sorghum halepense) in Cotton (Gossypium hirsutum) with Glyphosate
- Paul E. Keeley, Robert J. Thullen, Charles H. Carter, John H. Miller
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- Journal:
- Weed Science / Volume 32 / Issue 3 / May 1984
- Published online by Cambridge University Press:
- 12 June 2017, pp. 306-309
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Three applications/yr of glyphosate [N-(phosphonomethyl)glycine] with a ropewick applicator (RWA), a roller applicator (RA), and a recirculating sprayer (RCS) were compared to hoeing and cultivation for the control of johnsongrass [Sorghum halepense (L.) Pers. ♯3 SORHA] in cotton (Gossypium hirsutum L. ‘Acala SJ-2′) in six field experiments from 1979 to 1981. Averaged over the 3 yr and dates of application, plots treated with glyphosate contained 78% fewer live johnsongrass shoots (15/m2) than cultivated-control plots (68/m2). Although applications of glyphosate with the RWA and RA improved or tended to improve yields of cotton, only plots treated with the RWA yielded significantly more seed cotton than cultivated control plots in all years. However, yields of plots treated with the RWA still averaged 38% less than hoed plots. Plots treated with the RA produced significantly more cotton than cultivated-control plots only in 1981.
Influence of Planting Date on Growth of Palmer Amaranth (Amaranthus palmeri)
- Paul E. Keeley, Charles H. Carter, Robert J. Thullen
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- Journal:
- Weed Science / Volume 35 / Issue 2 / March 1987
- Published online by Cambridge University Press:
- 12 June 2017, pp. 199-204
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Palmer amaranth (Amaranthus palmeri S. Wats. # AMAPA) planted in a field at monthly intervals from March through October at Shafter, CA, began to emerge in March when soil temperatures at a depth of 5 cm reached 18 C. With the exception of March and April plantings, at least 50% of the seed of later plantings produced seedlings within 2 weeks after planting. Although growth of plants was initially slower for early plantings, plantings from March to July reached 2 m or greater in height by fall. Due to longer growing times, plantings from March to June eventually produced more dry matter and a greater number of inflorescences than later plantings. Plants began flowering 5 to 9 weeks after planting in March through June and 3 to 4 weeks after planting in July through October. Some viable seed was produced as early as 2 to 3 weeks after flowering began. Total seed production in the fall ranged from 200 000 to 600 000 seed/plant for the March through June plantings, and 115 to 80 000 seed/plant for the July through September plantings. Killing frosts in November prevented Palmer amaranth planted in October from producing seed.
Yellow Nutsedge (Cyperus esculentus) Control with Herbicides
- Paul E. Keeley, Charles H. Carter, Robert J. Thullen
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- Journal:
- Weed Technology / Volume 1 / Issue 2 / April 1987
- Published online by Cambridge University Press:
- 12 June 2017, pp. 133-139
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The relatively new micro-encapsulated formulation of alachlor [2-chloro-N-(2,6-diethylphenyl)-N-(methoxymethyl)acetamide] and diethatyl [N-(chloroacetyl)-N-(2,6-diethylphenyl)glycine] were soil-applied for yellow nutsedge (Cyperus esculentus L. #3 CYPES) control in cotton (Gossypium hirsutum L. ‘Acala SF-2’). Both herbicides at rates of 1.68 to 3.36 kg ai/ha provided 60 to 80% control of yellow nutsedge for 6 weeks. Although control declined to 50 to 70% by cotton harvest, plots treated with herbicides usually yielded more seed cotton than cultivated control plots. Yields were similar from herbicide-treated and hand-weeded plots. Fewer tubers were counted in herbicide-treated than in cultivated-control plots in the fall. Based on yellow nutsedge control and seed cotton yields, alachlor and diethatyl could be helpful in controlling nutsedge and protecting cotton yields.
Repeated Annual Applications of Herbicides for Control of Rhizome Johnsongrass (Sorghum halepense) in Cotton (Gossypium hirsutum)
- Paul E. Keeley, Robert J. Thullen, Charles H. Carter
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- Journal:
- Weed Science / Volume 35 / Issue 1 / January 1987
- Published online by Cambridge University Press:
- 12 June 2017, pp. 75-80
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When postemergence applications of sethoxydim {2-[1-(ethoxyimino) butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one} were compared with DSMA (disodium salt of methylarsonic acid), MSMA (monosodium salt of methylarsonic acid), and glyphosate [N-(phosphonomethyl)glycine] for control of johnsongrass [Sorghum halepense (L.) Pers. # SORHA] in cotton (Gossypium hirsutum L. ‘Acala SJ-2′), repeated annual applications of sethoxydim were more successful than other herbicides in protecting yields of cotton and reducing populations of rhizome johnsongrass over time. After the first year of treatment with sethoxydim in 1982, when an 18% yield loss of cotton occurred, populations of rhizome johnsongrass were reduced to the extent that they were no longer a threat to yields in plots treated with sethoxydim in 1983 and 1984. Although DSMA and glyphosate improved yields when compared to cultivated control plots, substantial yield losses occurred every year, and populations of johnsongrass remained unchanged after 3 yr of treatment. Averaged over 3 yr, plots treated with sethoxydim produced 94% as much cotton as weed-free plots, compared to 60 and 45% for plots treated with glyphosate and DSMA/MSMA, respectively.
Statistical competencies for medical research learners: What is fundamental?
- Felicity T. Enders, Christopher J. Lindsell, Leah J. Welty, Emma K. T. Benn, Susan M. Perkins, Matthew S. Mayo, Mohammad H. Rahbar, Kelley M. Kidwell, Sally W. Thurston, Heidi Spratt, Steven C. Grambow, Joseph Larson, Rickey E. Carter, Brad H. Pollock, Robert A. Oster
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- Journal:
- Journal of Clinical and Translational Science / Volume 1 / Issue 3 / June 2017
- Published online by Cambridge University Press:
- 09 May 2017, pp. 146-152
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Introduction
It is increasingly essential for medical researchers to be literate in statistics, but the requisite degree of literacy is not the same for every statistical competency in translational research. Statistical competency can range from ‘fundamental’ (necessary for all) to ‘specialized’ (necessary for only some). In this study, we determine the degree to which each competency is fundamental or specialized.
MethodsWe surveyed members of 4 professional organizations, targeting doctorally trained biostatisticians and epidemiologists who taught statistics to medical research learners in the past 5 years. Respondents rated 24 educational competencies on a 5-point Likert scale anchored by ‘fundamental’ and ‘specialized.’
ResultsThere were 112 responses. Nineteen of 24 competencies were fundamental. The competencies considered most fundamental were assessing sources of bias and variation (95%), recognizing one’s own limits with regard to statistics (93%), identifying the strengths, and limitations of study designs (93%). The least endorsed items were meta-analysis (34%) and stopping rules (18%).
ConclusionWe have identified the statistical competencies needed by all medical researchers. These competencies should be considered when designing statistical curricula for medical researchers and should inform which topics are taught in graduate programs and evidence-based medicine courses where learners need to read and understand the medical research literature.
Anomalous Radiocarbon Ages from a Holocene Detrital Organic Lens in Alaska and their Implications for Radiocarbon Dating and Paleoenvironmental Reconstructions in the Arctic
- Robert E. Nelson, L. David Carter, Stephen W. Robinson
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- Journal:
- Quaternary Research / Volume 29 / Issue 1 / January 1988
- Published online by Cambridge University Press:
- 20 January 2017, pp. 66-71
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Eleven radiocarbon age determinations clearly show that a lens of Holocene fluvial organic debris on the Alaskan Arctic Coastal Plain contains mostly pre-Holocene organic material. Radio-carbon ages of identified plant macrofossils indicate the material was deposited about 9000 to 9500 yr B.P. Radiocarbon analyses of bulk samples from this deposit, however, range from 13,300 to 30,300 yr B.P. Most of the old organic matter seems to be in the smaller size fractions in the deposit, particularly in the fraction between 0.25 and 0.5 mm, but all size fractions are contaminated. Particular caution must be exercised in submitting bulk samples for radiocarbon dating from areas where conditions favor redeposition of isotopically “dead” carbon.
Pollen Analysis of a Late Pliocene and Early Pleistocene Section from the Gubik Formation of Arctic Alaska
- Robert E. Nelson, L. David Carter
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- Journal:
- Quaternary Research / Volume 24 / Issue 3 / November 1985
- Published online by Cambridge University Press:
- 20 January 2017, pp. 295-306
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A 14-m-thick section of marine and nonmarine sediments of the Gubik Formation of northern Alaska, exposed in bluffs near Ocean Point on the Colville River, has been studied by means of pollen analysis. Pollen from the marine sediments, of probable late Pliocene age, records a boreal forest of spruce and birch with minor amounts of alder in the adjacent terrestrial vegetation. Pine and perhaps true fir were probably at or near their northern limit here, but hemlocks and hardwoods were absent. The suggested environment for the Arctic Slope during the time represented by the marine sediments is similar to that of present-day Anchorage. Pollen floras from the overlying fluvial strata, of early or middle Pleistocene age, record predominantly herbaceous taxa indicating tundra conditions probably more severe than those of the present day. These deposits were most likely contemporaneous with glacial conditions in the Brooks Range to the south. Pollen of woody taxa (spruce, alder, birch, heaths) is rare through most of the section, although birch and alder percentages similar to those found in modern river sediments indicate an interstadial or interglacial warming in midsection. Inland climates during glacial episodes may have been similar to those of the present Arctic coast.
Contributors
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- By Tom Abbott, Gareth L. Ackland, Hollman D. Aya, Berthold Bein, Karim Bendjelid, Matthieu Biais, Elizabeth J. Bridges, Maxime Cannesson, Cédric Carrié, Alice Carter, Maurizio Cecconi, Daniel Chappell, Jason H. Chua, Gary Colins, Diego Orbegozo Cortes, Lester A. H. Critchley, Daniel De Backer, Katia Donadello, Eric Edison, Byron D. Fergerson, Tong J. Gan, Michael T. Ganter, Leslie M. Garson, Christoph K. Hofer, Christoph Ilies, James M. Isbell, Matthias Jacob, Mazyar Javidroozi, Zeev N. Kain, Elisa Kam, Gautam Kumar, Yannick Le Manach, Sheldon Magder, Aman Mahajan, Gerard R. Manecke, Paul E. Marik, Joseph Meltzer, Debra R. Metter, Timothy E. Miller, Xavier Monnet, Michael Mythen, Rudolph Nguyen, Rupert Pearse, Michael R. Pinsky, Davinder Ramsingh, Steffen Rex, Andrew Rhodes, Joseph Rinehart, Mathieu Sèrié, Aryeh Shander, Nils Siegenthaler, Ann B. Singleton, Faraz Syed, Jean-Louis Teboul, Robert H. Thiele, Shermeen B. Vakharia, Trung Vu, Nathan H. Waldron, David Walker, William Wilson
- Edited by Maxime Cannesson, University of California, Irvine, Rupert Pearse
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- Book:
- Perioperative Hemodynamic Monitoring and Goal Directed Therapy
- Published online:
- 05 September 2014
- Print publication:
- 04 September 2014, pp vii-x
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- By J. Todd Arnedt, Nazem Atassi, Judith Bebchuk, Devin L. Brown, Rickey E. Carter, Rick Chappell, William R. Clarke, Christopher S. Coffey, Peter G. Como, Merit Cudkowicz, Jeffrey Cummings, Gary R. Cutter, Gerald J. Dal Pan, E. Ray Dorsey, Susan S. Ellenberg, Jordan Elm, Changyong Feng, Elizabeth Fisher, Jacqueline A. French, Jean-Michel Germain, Joshua D. Grill, Robert G. Holloway, Karen C. Johnston, S. Claiborne Johnston, Cornelia L. Kamp, Russell Katz, Kathryn M. Kellogg, Karl Kieburtz, Scott Y. H. Kim, Jonathan Kimmelman, Bruce Levin, Michael P. McDermott, Eric A. Mann, John Markman, D. Troy Morgan, Gilmore N. O’Neill, Yuko Y. Palesch, John R. Pollard, R. Michael Poole, Mary E. Putt, Bemard Ravina, Richard A. Rudick, David Schoenfeld, Andrew D. Siderowf, Janet Wittes, Robert F. Woolson, Michael E. Yurcheshen
- Edited by Bernard Ravina, Jeffrey Cummings, Michael McDermott, R. Michael Poole
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- Book:
- Clinical Trials in Neurology
- Published online:
- 05 May 2012
- Print publication:
- 12 April 2012, pp ix-xii
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14 - Monitoring of Clinical Trials:
- from Section 3
- Edited by Bernard Ravina, Jeffrey Cummings, Michael McDermott, R. Michael Poole
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- Book:
- Clinical Trials in Neurology
- Published online:
- 05 May 2012
- Print publication:
- 12 April 2012, pp 147-159
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Summary
This chapter highlights some important aspects of the design and analysis of clinical trials, and sketches a number of relevant statistical concepts. A controlled clinical trial of a medical intervention should have at least one primary hypothesis that drives its design. Well-designed and well-executed trials include an unambiguous protocol approved by the Institutional Review Boards (IRBs) or Ethics Committees of the participating clinics, laboratories, and data centers. The chapter also describes the basic frequentist statistical testing paradigm used by the typical randomized clinical trial with particular reference to ideas necessary in selecting sample size. Most clinical trials study more than one outcome of interest. Many neurological clinical trials compare therapies with respect to time to occurrence of the primary outcome. In the past, few clinical trials were performed in the Bayesian framework, but Bayesian methods have become more widely used recently.
Contributors
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- By Rose Teteki Abbey, K. C. Abraham, David Tuesday Adamo, LeRoy H. Aden, Efrain Agosto, Victor Aguilan, Gillian T. W. Ahlgren, Charanjit Kaur AjitSingh, Dorothy B E A Akoto, Giuseppe Alberigo, Daniel E. Albrecht, Ruth Albrecht, Daniel O. Aleshire, Urs Altermatt, Anand Amaladass, Michael Amaladoss, James N. Amanze, Lesley G. Anderson, Thomas C. Anderson, Victor Anderson, Hope S. Antone, María Pilar Aquino, Paula Arai, Victorio Araya Guillén, S. Wesley Ariarajah, Ellen T. Armour, Brett Gregory Armstrong, Atsuhiro Asano, Naim Stifan Ateek, Mahmoud Ayoub, John Alembillah Azumah, Mercedes L. García Bachmann, Irena Backus, J. Wayne Baker, Mieke Bal, Lewis V. Baldwin, William Barbieri, António Barbosa da Silva, David Basinger, Bolaji Olukemi Bateye, Oswald Bayer, Daniel H. Bays, Rosalie Beck, Nancy Elizabeth Bedford, Guy-Thomas Bedouelle, Chorbishop Seely Beggiani, Wolfgang Behringer, Christopher M. Bellitto, Byard Bennett, Harold V. Bennett, Teresa Berger, Miguel A. Bernad, Henley Bernard, Alan E. Bernstein, Jon L. Berquist, Johannes Beutler, Ana María Bidegain, Matthew P. Binkewicz, Jennifer Bird, Joseph Blenkinsopp, Dmytro Bondarenko, Paulo Bonfatti, Riet en Pim Bons-Storm, Jessica A. Boon, Marcus J. Borg, Mark Bosco, Peter C. Bouteneff, François Bovon, William D. Bowman, Paul S. Boyer, David Brakke, Richard E. Brantley, Marcus Braybrooke, Ian Breward, Ênio José da Costa Brito, Jewel Spears Brooker, Johannes Brosseder, Nicholas Canfield Read Brown, Robert F. Brown, Pamela K. Brubaker, Walter Brueggemann, Bishop Colin O. Buchanan, Stanley M. Burgess, Amy Nelson Burnett, J. Patout Burns, David B. Burrell, David Buttrick, James P. Byrd, Lavinia Byrne, Gerado Caetano, Marcos Caldas, Alkiviadis Calivas, William J. Callahan, Salvatore Calomino, Euan K. Cameron, William S. Campbell, Marcelo Ayres Camurça, Daniel F. Caner, Paul E. Capetz, Carlos F. Cardoza-Orlandi, Patrick W. Carey, Barbara Carvill, Hal Cauthron, Subhadra Mitra Channa, Mark D. Chapman, James H. Charlesworth, Kenneth R. Chase, Chen Zemin, Luciano Chianeque, Philip Chia Phin Yin, Francisca H. Chimhanda, Daniel Chiquete, John T. Chirban, Soobin Choi, Robert Choquette, Mita Choudhury, Gerald Christianson, John Chryssavgis, Sejong Chun, Esther Chung-Kim, Charles M. A. Clark, Elizabeth A. Clark, Sathianathan Clarke, Fred Cloud, John B. Cobb, W. Owen Cole, John A Coleman, John J. Collins, Sylvia Collins-Mayo, Paul K. Conkin, Beth A. Conklin, Sean Connolly, Demetrios J. Constantelos, Michael A. Conway, Paula M. Cooey, Austin Cooper, Michael L. Cooper-White, Pamela Cooper-White, L. William Countryman, Sérgio Coutinho, Pamela Couture, Shannon Craigo-Snell, James L. Crenshaw, David Crowner, Humberto Horacio Cucchetti, Lawrence S. Cunningham, Elizabeth Mason Currier, Emmanuel Cutrone, Mary L. Daniel, David D. Daniels, Robert Darden, Rolf Darge, Isaiah Dau, Jeffry C. Davis, Jane Dawson, Valentin Dedji, John W. de Gruchy, Paul DeHart, Wendy J. Deichmann Edwards, Miguel A. De La Torre, George E. Demacopoulos, Thomas de Mayo, Leah DeVun, Beatriz de Vasconcellos Dias, Dennis C. Dickerson, John M. Dillon, Luis Miguel Donatello, Igor Dorfmann-Lazarev, Susanna Drake, Jonathan A. Draper, N. Dreher Martin, Otto Dreydoppel, Angelyn Dries, A. J. Droge, Francis X. D'Sa, Marilyn Dunn, Nicole Wilkinson Duran, Rifaat Ebied, Mark J. Edwards, William H. Edwards, Leonard H. Ehrlich, Nancy L. Eiesland, Martin Elbel, J. Harold Ellens, Stephen Ellingson, Marvin M. Ellison, Robert Ellsberg, Jean Bethke Elshtain, Eldon Jay Epp, Peter C. Erb, Tassilo Erhardt, Maria Erling, Noel Leo Erskine, Gillian R. Evans, Virginia Fabella, Michael A. Fahey, Edward Farley, Margaret A. Farley, Wendy Farley, Robert Fastiggi, Seena Fazel, Duncan S. Ferguson, Helwar Figueroa, Paul Corby Finney, Kyriaki Karidoyanes FitzGerald, Thomas E. FitzGerald, John R. Fitzmier, Marie Therese Flanagan, Sabina Flanagan, Claude Flipo, Ronald B. Flowers, Carole Fontaine, David Ford, Mary Ford, Stephanie A. Ford, Jim Forest, William Franke, Robert M. Franklin, Ruth Franzén, Edward H. Friedman, Samuel Frouisou, Lorelei F. Fuchs, Jojo M. Fung, Inger Furseth, Richard R. Gaillardetz, Brandon Gallaher, China Galland, Mark Galli, Ismael García, Tharscisse Gatwa, Jean-Marie Gaudeul, Luis María Gavilanes del Castillo, Pavel L. Gavrilyuk, Volney P. Gay, Metropolitan Athanasios Geevargis, Kondothra M. George, Mary Gerhart, Simon Gikandi, Maurice Gilbert, Michael J. Gillgannon, Verónica Giménez Beliveau, Terryl Givens, Beth Glazier-McDonald, Philip Gleason, Menghun Goh, Brian Golding, Bishop Hilario M. Gomez, Michelle A. Gonzalez, Donald K. Gorrell, Roy Gottfried, Tamara Grdzelidze, Joel B. Green, Niels Henrik Gregersen, Cristina Grenholm, Herbert Griffiths, Eric W. Gritsch, Erich S. Gruen, Christoffer H. Grundmann, Paul H. Gundani, Jon P. Gunnemann, Petre Guran, Vidar L. Haanes, Jeremiah M. Hackett, Getatchew Haile, Douglas John Hall, Nicholas Hammond, Daphne Hampson, Jehu J. Hanciles, Barry Hankins, Jennifer Haraguchi, Stanley S. Harakas, Anthony John Harding, Conrad L. Harkins, J. William Harmless, Marjory Harper, Amir Harrak, Joel F. Harrington, Mark W. Harris, Susan Ashbrook Harvey, Van A. Harvey, R. Chris Hassel, Jione Havea, Daniel Hawk, Diana L. Hayes, Leslie Hayes, Priscilla Hayner, S. Mark Heim, Simo Heininen, Richard P. Heitzenrater, Eila Helander, David Hempton, Scott H. Hendrix, Jan-Olav Henriksen, Gina Hens-Piazza, Carter Heyward, Nicholas J. Higham, David Hilliard, Norman A. Hjelm, Peter C. Hodgson, Arthur Holder, M. Jan Holton, Dwight N. Hopkins, Ronnie Po-chia Hsia, Po-Ho Huang, James Hudnut-Beumler, Jennifer S. Hughes, Leonard M. Hummel, Mary E. Hunt, Laennec Hurbon, Mark Hutchinson, Susan E. Hylen, Mary Beth Ingham, H. Larry Ingle, Dale T. Irvin, Jon Isaak, Paul John Isaak, Ada María Isasi-Díaz, Hans Raun Iversen, Margaret C. Jacob, Arthur James, Maria Jansdotter-Samuelsson, David Jasper, Werner G. Jeanrond, Renée Jeffery, David Lyle Jeffrey, Theodore W. Jennings, David H. Jensen, Robin Margaret Jensen, David Jobling, Dale A. Johnson, Elizabeth A. Johnson, Maxwell E. Johnson, Sarah Johnson, Mark D. Johnston, F. Stanley Jones, James William Jones, John R. Jones, Alissa Jones Nelson, Inge Jonsson, Jan Joosten, Elizabeth Judd, Mulambya Peggy Kabonde, Robert Kaggwa, Sylvester Kahakwa, Isaac Kalimi, Ogbu U. Kalu, Eunice Kamaara, Wayne C. Kannaday, Musimbi Kanyoro, Veli-Matti Kärkkäinen, Frank Kaufmann, Léon Nguapitshi Kayongo, Richard Kearney, Alice A. Keefe, Ralph Keen, Catherine Keller, Anthony J. Kelly, Karen Kennelly, Kathi Lynn Kern, Fergus Kerr, Edward Kessler, George Kilcourse, Heup Young Kim, Kim Sung-Hae, Kim Yong-Bock, Kim Yung Suk, Richard King, Thomas M. King, Robert M. Kingdon, Ross Kinsler, Hans G. Kippenberg, Cheryl A. Kirk-Duggan, Clifton Kirkpatrick, Leonid Kishkovsky, Nadieszda Kizenko, Jeffrey Klaiber, Hans-Josef Klauck, Sidney Knight, Samuel Kobia, Robert Kolb, Karla Ann Koll, Heikki Kotila, Donald Kraybill, Philip D. W. Krey, Yves Krumenacker, Jeffrey Kah-Jin Kuan, Simanga R. Kumalo, Peter Kuzmic, Simon Shui-Man Kwan, Kwok Pui-lan, André LaCocque, Stephen E. Lahey, John Tsz Pang Lai, Emiel Lamberts, Armando Lampe, Craig Lampe, Beverly J. Lanzetta, Eve LaPlante, Lizette Larson-Miller, Ariel Bybee Laughton, Leonard Lawlor, Bentley Layton, Robin A. Leaver, Karen Lebacqz, Archie Chi Chung Lee, Marilyn J. Legge, Hervé LeGrand, D. L. LeMahieu, Raymond Lemieux, Bill J. Leonard, Ellen M. Leonard, Outi Leppä, Jean Lesaulnier, Nantawan Boonprasat Lewis, Henrietta Leyser, Alexei Lidov, Bernard Lightman, Paul Chang-Ha Lim, Carter Lindberg, Mark R. Lindsay, James R. Linville, James C. Livingston, Ann Loades, David Loades, Jean-Claude Loba-Mkole, Lo Lung Kwong, Wati Longchar, Eleazar López, David W. Lotz, Andrew Louth, Robin W. Lovin, William Luis, Frank D. Macchia, Diarmaid N. J. MacCulloch, Kirk R. MacGregor, Marjory A. MacLean, Donald MacLeod, Tomas S. Maddela, Inge Mager, Laurenti Magesa, David G. Maillu, Fortunato Mallimaci, Philip Mamalakis, Kä Mana, Ukachukwu Chris Manus, Herbert Robinson Marbury, Reuel Norman Marigza, Jacqueline Mariña, Antti Marjanen, Luiz C. L. Marques, Madipoane Masenya (ngwan'a Mphahlele), Caleb J. D. Maskell, Steve Mason, Thomas Massaro, Fernando Matamoros Ponce, András Máté-Tóth, Odair Pedroso Mateus, Dinis Matsolo, Fumitaka Matsuoka, John D'Arcy May, Yelena Mazour-Matusevich, Theodore Mbazumutima, John S. McClure, Christian McConnell, Lee Martin McDonald, Gary B. McGee, Thomas McGowan, Alister E. McGrath, Richard J. McGregor, John A. McGuckin, Maud Burnett McInerney, Elsie Anne McKee, Mary B. McKinley, James F. McMillan, Ernan McMullin, Kathleen E. McVey, M. Douglas Meeks, Monica Jyotsna Melanchthon, Ilie Melniciuc-Puica, Everett Mendoza, Raymond A. Mentzer, William W. Menzies, Ina Merdjanova, Franziska Metzger, Constant J. Mews, Marvin Meyer, Carol Meyers, Vasile Mihoc, Gunner Bjerg Mikkelsen, Maria Inêz de Castro Millen, Clyde Lee Miller, Bonnie J. Miller-McLemore, Alexander Mirkovic, Paul Misner, Nozomu Miyahira, R. W. L. Moberly, Gerald Moede, Aloo Osotsi Mojola, Sunanda Mongia, Rebeca Montemayor, James Moore, Roger E. Moore, Craig E. Morrison O.Carm, Jeffry H. Morrison, Keith Morrison, Wilson J. Moses, Tefetso Henry Mothibe, Mokgethi Motlhabi, Fulata Moyo, Henry Mugabe, Jesse Ndwiga Kanyua Mugambi, Peggy Mulambya-Kabonde, Robert Bruce Mullin, Pamela Mullins Reaves, Saskia Murk Jansen, Heleen L. Murre-Van den Berg, Augustine Musopole, Isaac M. T. Mwase, Philomena Mwaura, Cecilia Nahnfeldt, Anne Nasimiyu Wasike, Carmiña Navia Velasco, Thulani Ndlazi, Alexander Negrov, James B. Nelson, David G. Newcombe, Carol Newsom, Helen J. Nicholson, George W. E. Nickelsburg, Tatyana Nikolskaya, Damayanthi M. A. Niles, Bertil Nilsson, Nyambura Njoroge, Fidelis Nkomazana, Mary Beth Norton, Christian Nottmeier, Sonene Nyawo, Anthère Nzabatsinda, Edward T. Oakes, Gerald O'Collins, Daniel O'Connell, David W. Odell-Scott, Mercy Amba Oduyoye, Kathleen O'Grady, Oyeronke Olajubu, Thomas O'Loughlin, Dennis T. Olson, J. Steven O'Malley, Cephas N. Omenyo, Muriel Orevillo-Montenegro, César Augusto Ornellas Ramos, Agbonkhianmeghe E. Orobator, Kenan B. Osborne, Carolyn Osiek, Javier Otaola Montagne, Douglas F. Ottati, Anna May Say Pa, Irina Paert, Jerry G. Pankhurst, Aristotle Papanikolaou, Samuele F. Pardini, Stefano Parenti, Peter Paris, Sung Bae Park, Cristián G. Parker, Raquel Pastor, Joseph Pathrapankal, Daniel Patte, W. Brown Patterson, Clive Pearson, Keith F. Pecklers, Nancy Cardoso Pereira, David Horace Perkins, Pheme Perkins, Edward N. Peters, Rebecca Todd Peters, Bishop Yeznik Petrossian, Raymond Pfister, Peter C. Phan, Isabel Apawo Phiri, William S. F. Pickering, Derrick G. Pitard, William Elvis Plata, Zlatko Plese, John Plummer, James Newton Poling, Ronald Popivchak, Andrew Porter, Ute Possekel, James M. Powell, Enos Das Pradhan, Devadasan Premnath, Jaime Adrían Prieto Valladares, Anne Primavesi, Randall Prior, María Alicia Puente Lutteroth, Eduardo Guzmão Quadros, Albert Rabil, Laurent William Ramambason, Apolonio M. Ranche, Vololona Randriamanantena Andriamitandrina, Lawrence R. Rast, Paul L. Redditt, Adele Reinhartz, Rolf Rendtorff, Pål Repstad, James N. Rhodes, John K. Riches, Joerg Rieger, Sharon H. Ringe, Sandra Rios, Tyler Roberts, David M. Robinson, James M. Robinson, Joanne Maguire Robinson, Richard A. H. Robinson, Roy R. Robson, Jack B. Rogers, Maria Roginska, Sidney Rooy, Rev. Garnett Roper, Maria José Fontelas Rosado-Nunes, Andrew C. Ross, Stefan Rossbach, François Rossier, John D. Roth, John K. Roth, Phillip Rothwell, Richard E. Rubenstein, Rosemary Radford Ruether, Markku Ruotsila, John E. Rybolt, Risto Saarinen, John Saillant, Juan Sanchez, Wagner Lopes Sanchez, Hugo N. Santos, Gerhard Sauter, Gloria L. Schaab, Sandra M. Schneiders, Quentin J. Schultze, Fernando F. Segovia, Turid Karlsen Seim, Carsten Selch Jensen, Alan P. F. Sell, Frank C. Senn, Kent Davis Sensenig, Damían Setton, Bal Krishna Sharma, Carolyn J. Sharp, Thomas Sheehan, N. Gerald Shenk, Christian Sheppard, Charles Sherlock, Tabona Shoko, Walter B. Shurden, Marguerite Shuster, B. Mark Sietsema, Batara Sihombing, Neil Silberman, Clodomiro Siller, Samuel Silva-Gotay, Heikki Silvet, John K. Simmons, Hagith Sivan, James C. Skedros, Abraham Smith, Ashley A. Smith, Ted A. Smith, Daud Soesilo, Pia Søltoft, Choan-Seng (C. S.) Song, Kathryn Spink, Bryan Spinks, Eric O. Springsted, Nicolas Standaert, Brian Stanley, Glen H. Stassen, Karel Steenbrink, Stephen J. Stein, Andrea Sterk, Gregory E. Sterling, Columba Stewart, Jacques Stewart, Robert B. Stewart, Cynthia Stokes Brown, Ken Stone, Anne Stott, Elizabeth Stuart, Monya Stubbs, Marjorie Hewitt Suchocki, David Kwang-sun Suh, Scott W. Sunquist, Keith Suter, Douglas Sweeney, Charles H. Talbert, Shawqi N. Talia, Elsa Tamez, Joseph B. Tamney, Jonathan Y. Tan, Yak-Hwee Tan, Kathryn Tanner, Feiya Tao, Elizabeth S. Tapia, Aquiline Tarimo, Claire Taylor, Mark Lewis Taylor, Bishop Abba Samuel Wolde Tekestebirhan, Eugene TeSelle, M. Thomas Thangaraj, David R. Thomas, Andrew Thornley, Scott Thumma, Marcelo Timotheo da Costa, George E. “Tink” Tinker, Ola Tjørhom, Karen Jo Torjesen, Iain R. Torrance, Fernando Torres-Londoño, Archbishop Demetrios [Trakatellis], Marit Trelstad, Christine Trevett, Phyllis Trible, Johannes Tromp, Paul Turner, Robert G. Tuttle, Archbishop Desmond Tutu, Peter Tyler, Anders Tyrberg, Justin Ukpong, Javier Ulloa, Camillus Umoh, Kristi Upson-Saia, Martina Urban, Monica Uribe, Elochukwu Eugene Uzukwu, Richard Vaggione, Gabriel Vahanian, Paul Valliere, T. J. Van Bavel, Steven Vanderputten, Peter Van der Veer, Huub Van de Sandt, Louis Van Tongeren, Luke A. Veronis, Noel Villalba, Ramón Vinke, Tim Vivian, David Voas, Elena Volkova, Katharina von Kellenbach, Elina Vuola, Timothy Wadkins, Elaine M. Wainwright, Randi Jones Walker, Dewey D. Wallace, Jerry Walls, Michael J. Walsh, Philip Walters, Janet Walton, Jonathan L. Walton, Wang Xiaochao, Patricia A. Ward, David Harrington Watt, Herold D. Weiss, Laurence L. Welborn, Sharon D. Welch, Timothy Wengert, Traci C. West, Merold Westphal, David Wetherell, Barbara Wheeler, Carolinne White, Jean-Paul Wiest, Frans Wijsen, Terry L. Wilder, Felix Wilfred, Rebecca Wilkin, Daniel H. Williams, D. Newell Williams, Michael A. Williams, Vincent L. Wimbush, Gabriele Winkler, Anders Winroth, Lauri Emílio Wirth, James A. Wiseman, Ebba Witt-Brattström, Teofil Wojciechowski, John Wolffe, Kenman L. Wong, Wong Wai Ching, Linda Woodhead, Wendy M. Wright, Rose Wu, Keith E. Yandell, Gale A. Yee, Viktor Yelensky, Yeo Khiok-Khng, Gustav K. K. Yeung, Angela Yiu, Amos Yong, Yong Ting Jin, You Bin, Youhanna Nessim Youssef, Eliana Yunes, Robert Michael Zaller, Valarie H. Ziegler, Barbara Brown Zikmund, Joyce Ann Zimmerman, Aurora Zlotnik, Zhuo Xinping
- Edited by Daniel Patte, Vanderbilt University, Tennessee
-
- Book:
- The Cambridge Dictionary of Christianity
- Published online:
- 05 August 2012
- Print publication:
- 20 September 2010, pp xi-xliv
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