Methods used to assess outcome consistency in clinical studies: A literature-based evaluation.

Evaluation studies of outcomes used in clinical research and their consistency are appearing more frequently in the literature, as a key part of the core outcome set (COS) development. Current guidance suggests such evaluation studies should use systematic review methodology as their default. We aimed to examine the methods used. We searched the Core Outcome Measures in Effectiveness Trials (COMET) database (up to May 2019) supplementing it with additional resources. We included evaluation studies of outcome consistency in clinical studies across health subjects and used a subset of A MeaSurement Tool to Assess systematic Reviews (AMSTAR) 2 (items 1-9) to assess their methods. Of 93 included evaluation studies of outcome consistency (90 full reports, three summaries), 91% (85/93) reported performing literature searches in at least one bibliographic database, and 79% (73/93) was labelled as a "systematic review". The evaluations varied in terms of satisfying AMSTAR 2 criteria, such that 81/93 (87%) had implemented PICO in the research question, whereas only 5/93 (6%) had included the exclusions list. None of the evaluation studies explained how inconsistency of outcomes was detected, however, 80/90 (88%) concluded inconsistency in individual outcomes (66%, 55/90) or outcome domains (20%, 18/90). Methods used in evaluation studies of outcome consistency in clinical studies differed considerably. Despite frequent being labelled as a "systematic review", adoption of systematic review methodology is selective. While the impact on COS development is unknown, authors of these studies should refrain from labelling them as "systematic review" and focus on ensuring that the methods used to generate the different outcomes and outcome domains are reported transparently

Dietary inflammatory index and prostate cancer risk: MCC-Spain study

Background: The etiology of prostate cancer (PCa) is not well-known, and the role of diet is not well established. We aimed to evaluate the role of the inflammatory power of the diet, measured by the Dietary Inflammatory Index (DII®), on the risk of PCa. Methodology: A population-based multicase-control (MCC-Spain) study was conducted. Information was collected on sociodemographic characteristics, personal and family antecedents, and lifestyles, including diet from a Food Frequency Questionnaire. The inflammatory potential of the diet was assessed using the energy-adjusted Dietary Inflammatory Index (E-DII) based on 30 parameters (a higher score indicates a higher inflammatory capacity of the diet). Tertiles of E-DII were created using the cut-off points from the control group. The International Society of Urology Pathology (ISUP) was grouped as ISUP 1, ISUP 2, or ISUP 3-5. Unconditional logistic regression models were used to estimate adjusted odds ratios (aOR) and 95% confidence intervals (CI) for the association between E-DII score and PCa risk. Results: A total of 928 PCa cases and 1278 population controls were included. Among PCa cases, the mean value of the E-DII score was 0.18 (SD: 1.9) vs. 0.07 (SD: 1.9) in the control group (p = 0.162). Cases with a more pro-inflammatory diet (3rd tertile) had the highest risk of PCa, aORT3vsT1 = 1.30 (95% CI 1.03-1.65) (p-trend = 0.026). When stratifying by ISUP, this risk association was observed only for ISUP 2 and ISUP 3-5, aORT3vsT1 = 1.46 (95% CI 1.02-2.10) and 1.60 (95% CI 1.10-2.34), respectively. Conclusion: A positive association was observed between consuming a pro-inflammatory diet and PCa in the MCC-Spain population, specifically for an ISUP grade greater or equal than 2.Funding: This research was partially funded by the public grants from the Catalan Government (2014SGR756, 2017SGR1085, 2017SGR733, SLT006/17/76), and European Regional Development Fund-ERDF, by the “Acción Transversal del Cancer”, approved on the Spanish Ministry Council on the 11th October 2007, by the Instituto de Salud Carlos III-FEDER (PI08/1770, PI08/0533, PI08/1359, PS09/00773-Cantabria, PS09/01286-León, PS09/01903- Valencia, PS09/02078-Huelva, PS09/ 01662-Granada, PI11/01403, PI11/01889-FEDER, PI11/00226, PI11/01810, PI11/02213, PI12/00488, PI12/00265, PI12/01270, PI12/00715, PI12/00150, PI14/01219, PI14/0613, PI15/00069, PI15/00914, PI15/01032, PIE16/00049, PI17/01179, PI17-00092, PI17CIII/00034), by the Fundación Marqués de Valdecilla (API 10/09), by the Red Temática de Investigación del Cáncer (RTICC) del ISCIII(RD12/0036/0036), by the Junta de Castilla y León (LE22A10-2), by the Consejería de Salud of the Junta de Andalucía (PI-0571-2009, PI-0306-2011, salud201200057018tra), by the Conselleria de Sanitat of the Generalitat Valenciana (AP_061/10), by the Recercaixa (2010ACUP00310), by the Regional Government of the Basque Country, by the Consejería de Sanidad de la Región de Murcia, by the European Commission grants FOOD-CT-2006-036224-HIWATE, by the Spanish Association Against Cancer (AECC) Scientific Foundation – gran GCTRA18022MORE, by the Catalan Government Agency for Management of University and Research Grants (AGAUR) grants 2014SGR647, 2014SGR850 and 2017SGR723. Sample collection of this work was supported by the Xarxa de Bancs de Tumors de Catalunya sponsored by Pla Director d’Oncología de Catalunya (XBTC)”, Plataforma Biobancos PT13/0010/0013" and ICOBIOBANC, sponsored by the Catalan Institute of Oncology. ISGlobal acknowledges support from the Spanish Ministry of Science and Innovation through the “Centro de Excelencia Severo Ochoa 2019-2023” Program (CEX2018-000806-S), and support from the Generalitat de Catalunya through the CERCA Program

Dietary Inflammatory Index, Dietary Non-Enzymatic Antioxidant Capacity, and Colorectal and Breast Cancer Risk (MCC-Spain Study)

[EN] Inflammation and antioxidant capacity have been associated with colorectal and breast cancer. We computed the dietary inflammatory index (DII®), and the total dietary non-enzymatic antioxidant capacity (NEAC) and associated them with colorectal and breast cancer risk in the population-based multi case-control study in Spain (MCC-Spain). We included 1852 colorectal cancer and 1567 breast cancer cases, and 3447 and 1486 population controls, respectively. DII score and NEAC were derived using data from a semi-quantitative validated food frequency questionnaire. Unconditional logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (95%CI) for energy-adjusted DII (E-DII), and a score combining E-DII and NEAC. E-DII was associated with colorectal cancer risk (OR = 1.93, highest quartile versus lowest, 95%CI:1.60–2.32; p-trend: 0.10). The combined score of high E-DII scores and low antioxidant values were associated with colorectal cancer risk (OR = 1.48, highest quartile versus lowest, 95%CI: 1.26–1.74; p-trend: <0.001), but not breast cancer. This study provides evidence that a pro-inflammatory diet is associated with increased colorectal cancer risk while findings for breast cancer were less consistent.S

Dietary Inflammatory Index, Dietary Non-Enzymatic Antioxidant Capacity, and Colorectal and Breast Cancer Risk (MCC-Spain Study)

Inflammation and antioxidant capacity have been associated with colorectal and breast cancer. We computed the dietary inflammatory index (DII®), and the total dietary non-enzymatic antioxidant capacity (NEAC) and associated them with colorectal and breast cancer risk in the population-based multi case-control study in Spain (MCC-Spain). We included 1852 colorectal cancer and 1567 breast cancer cases, and 3447 and 1486 population controls, respectively. DII score and NEAC were derived using data from a semi-quantitative validated food frequency questionnaire. Unconditional logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (95%CI) for energy-adjusted DII (E-DII), and a score combining E-DII and NEAC. E-DII was associated with colorectal cancer risk (OR = 1.93, highest quartile versus lowest, 95%CI:1.60-2.32; p-trend: 0.10). The combined score of high E-DII scores and low antioxidant values were associated with colorectal cancer risk (OR = 1.48, highest quartile versus lowest, 95%CI: 1.26-1.74; p-trend: <0.001), but not breast cancer. This study provides evidence that a pro-inflammatory diet is associated with increased colorectal cancer risk while findings for breast cancer were less consistent.This research was partially funded by the public grants from the Catalan Government (2014SGR756, 2017SGR1085, 2017SGR733, SLT006/17/76), and European Regional Development Fund-ERDF, by the “Acción Transversal del Cancer”, approved on the Spanish Ministry Council on the 11th October 2007, by the Instituto de Salud Carlos III-FEDER (PI08/1770, PI08/0533, PI08/1359, PS09/00773-Cantabria, PS09/01286-León, PS09/01903-Valencia, PS09/02078-Huelva, PS09/ 01662-Granada, PI11/01403, PI11/01889-FEDER, PI11/00226, PI11/01810, PI11/02213, PI12/00488, PI12/00265, PI12/01270, PI12/00715, PI12/00150, PI14/01219, PI14/0613, PI15/00069, PI15/00914, PI15/01032, PI11/01810, PI14/01219, PI11/02213, PIE16/00049, PI17/01179, PI17-00092), by the Fundación Marqués de Valdecilla (API 10/09), by the Red Temática de Investigación del Cáncer (RTICC) del ISCIII(RD12/0036/0036), by the Junta de Castilla y León (LE22A10-2), by the Consejería de Salud of the Junta de Andalucía (PI-0571-2009, PI-0306-2011, salud201200057018tra), by the Conselleria de Sanitat of the Generalitat Valenciana (AP_061/10), by the Recercaixa (2010ACUP00310), by the Regional Government of the Basque Country, by the Consejería de Sanidad de la Región de Murcia, by the European Commission grants FOOD-CT-2006-036224-HIWATE, by the Spanish Association Against Cancer (AECC) Scientific Foundation – grant GCTRA18022MORE, by the Catalan Government-Agency for Management of University and Research Grants (AGAUR) grants 2014SGR647, 2014SGR850 and 2017SGR723. Sample collection of this work was supported by the Xarxa de Bancs de Tumors de Catalunya sponsored by Pla Director d’Oncología de Catalunya (XBTC)”, Plataforma Biobancos PT13/0010/0013" and ICOBIOBANC, sponsored by the Catalan Institute of Oncology. We thank CERCA Program, Generalitat de Catalunya for institutional support. Mireia Obón-Santacana received a post-doctoral fellow from “Fundación Científica de la Asociación Española Contra el Cáncer (AECC)”

Dietary Inflammatory Index, Dietary Non-Enzymatic Antioxidant Capacity, and Colorectal and Breast Cancer Risk(Mcc-Spain Study)

Inflammation and antioxidant capacity have been associated with colorectal and breast cancer. We computed the dietary inflammatory index (DII®), and the total dietary non-enzymatic antioxidant capacity (NEAC) and associated them with colorectal and breast cancer risk in the population-based multi case-control study in Spain (MCC-Spain). We included 1852 colorectal cancer and 1567 breast cancer cases, and 3447 and 1486 population controls, respectively. DII score and NEAC were derived using data from a semi-quantitative validated food frequency questionnaire. Unconditional logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (95%CI) for energy-adjusted DII (E-DII), and a score combining E-DII and NEAC. E-DII was associated with colorectal cancer risk (OR = 1.93, highest quartile versus lowest, 95%CI:1.60–2.32; p-trend:0.10). The combined score of high E-DII scores and low antioxidant values were associated with colorectal cancer risk (OR = 1.48, highest quartile versus lowest, 95%CI: 1.26–1.74; p-trend

Tropical tree growth driven by dry-season climate variability

Interannual variability in the global land carbon sink is strongly related to variations in tropical temperature and rainfall. This association suggests an important role for moisture-driven fluctuations in tropical vegetation productivity, but empirical evidence to quantify the responsible ecological processes is missing. Such evidence can be obtained from tree-ring data that quantify variability in a major vegetation productivity component: woody biomass growth. Here we compile a pantropical tree-ring network to show that annual woody biomass growth increases primarily with dry-season precipitation and decreases with dry-season maximum temperature. The strength of these dry-season climate responses varies among sites, as reflected in four robust and distinct climate response groups of tropical tree growth derived from clustering. Using cluster and regression analyses, we find that dry-season climate responses are amplified in regions that are drier, hotter and more climatically variable. These amplification patterns suggest that projected global warming will probably aggravate drought-induced declines in annual tropical vegetation productivity. Our study reveals a previously underappreciated role of dry-season climate variability in driving the dynamics of tropical vegetation productivity and consequently in influencing the land carbon sink.We acknowledge financial support to the co-authors provided by Agencia Nacional de Promoción Científica y Tecnológica, Argentina (PICT 2014-2797) to M.E.F.; Alberta Mennega Stichting to P.G.; BBVA Foundation to H.A.M. and J.J.C.; Belspo BRAIN project: BR/143/A3/HERBAXYLAREDD to H.B.; Confederação da Agricultura e Pecuária do Brasil - CNA to C.F.; Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPES, Brazil (PDSE 15011/13-5 to M.A.P.; 88881.135931/2016-01 to C.F.; 88887.199858/2018-00 to G.A.-P.; Finance Code 001 for all Brazilian collaborators); Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq, Brazil (ENV 42 to O.D.; 1009/4785031-2 to G.C.; 311874/2017-7 to J.S.); CONACYT-CB-2016-283134 to J.V.-D.; CONICET to F.A.R.; CUOMO FOUNDATION (IPCC scholarship) to M.M.; Deutsche Forschungsgemeinschaft - DFG (BR 1895/15-1 to A.B.; BR 1895/23-1 to A.B.; BR 1895/29-1 to A.B.; BR 1895/24-1 to M.M.); DGD-RMCA PilotMAB to B.T.; Dirección General de Asuntos del Personal Académico of the UNAM (Mexico) to R.B.; Elsa-Neumann-Scholarship of the Federal State of Berlin to F.S.; EMBRAPA Brazilian Agricultural Research Corporation to C.F.; Equatorian Dirección de Investigación UNL (21-DI-FARNR-2019) to D.P.-C.; São Paulo Research Foundation FAPESP (2009/53951-7 to M.T.-F.; 2012/50457-4 to G.C.; 2018/01847‐0 to P.G.; 2018/24514-7 to J.R.V.A.; 2019/08783-0 to G.M.L.; 2019/27110-7 to C.F.); FAPESP-NERC 18/50080-4 to G.C.; FAPITEC/SE/FUNTEC no. 01/2011 to M.A.P.; Fulbright Fellowship to B.J.E.; German Academic Exchange Service (DAAD) to M.I. and M.R.; German Ministry of Education, Science, Research, and Technology (FRG 0339638) to O.D.; ICRAF through the Forests, Trees, and Agroforestry research programme of the CGIAR to M.M.; Inter-American Institute for Global Change Research (IAI-SGP-CRA 2047) to J.V.-D.; International Foundation for Science (D/5466-1) to M.I.; Lamont Climate Center to B.M.B.; Miquelfonds to P.G.; National Geographic Global Exploration Fund (GEFNE80-13) to I.R.; USA’s National Science Foundation NSF (IBN-9801287 to A.J.L.; GER 9553623 and a postdoctoral fellowship to B.J.E.); NSF P2C2 (AGS-1501321) to A.C.B., D.G.-S. and G.A.-P.; NSF-FAPESP PIRE 2017/50085-3 to M.T.-F., G.C. and G.M.L.; NUFFIC-NICHE programme (HEART project) to B.K., E.M., J.H.S., J.N. and R. Vinya; Peru ‘s CONCYTEC and World Bank (043-2019-FONDECYT-BM-INC.INV.) to J.G.I.; Peru’s Fondo Nacional de Desarrollo Científico, Tecnológico y de Innovación Tecnológica (FONDECYT-BM-INC.INV 039-2019) to E.J.R.-R. and M.E.F.; Programa Bosques Andinos - HELVETAS Swiss Intercooperation to M.E.F.; Programa Nacional de Becas y Crédito Educativo - PRONABEC to J.G.I.; Schlumberger Foundation Faculty for the Future to J.N.; Sigma Xi to A.J.L.; Smithsonian Tropical Research Institute to R. Alfaro-Sánchez.; Spanish Ministry of Foreign Affairs AECID (11-CAP2-1730) to H.A.M. and J.J.C.; UK NERC grant NE/K01353X/1 to E.G.Peer reviewe