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BMC Medicine

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https://www.readbyqxmd.com/read/28728605/surrogate-endpoints-in-oncology-when-are-they-acceptable-for-regulatory-and-clinical-decisions-and-are-they-currently-overused
#1
Robert Kemp, Vinay Prasad
BACKGROUND: Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to measure than clinically meaningful outcomes. The use of surrogates as an endpoint in clinical trials and basis for regulatory approval is common, and frequently exceeds the guidance given by regulatory bodies. DISCUSSION: In this article, we demonstrate that the use of surrogates in oncology is widespread and increasing. At the same time, the strength of association between the surrogates used and clinically meaningful outcomes is often unknown or weak...
July 21, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28724431/biological-embedding-of-childhood-adversity-from-physiological-mechanisms-to-clinical-implications
#2
REVIEW
Anne E Berens, Sarah K G Jensen, Charles A Nelson
BACKGROUND: Adverse psychosocial exposures in early life, namely experiences such as child maltreatment, caregiver stress or depression, and domestic or community violence, have been associated in epidemiological studies with increased lifetime risk of adverse outcomes, including diabetes, heart disease, cancers, and psychiatric illnesses. Additional work has shed light on the potential molecular mechanisms by which early adversity becomes "biologically embedded" in altered physiology across body systems...
July 20, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28720102/environmental-lifestyle-factors-in-the-pathogenesis-and-prevention-of-type-2-diabetes
#3
REVIEW
Hubert Kolb, Stephan Martin
BACKGROUND: Environmental and lifestyle changes, in addition to the ageing of populations, are generally believed to account for the rapid global increase in type 2 diabetes prevalence and incidence in recent decades. DISCUSSION: In this review, we present a comprehensive overview of factors contributing to diabetes risk, including aspects of diet quality and quantity, little physical activity, increased monitor viewing time or sitting in general, exposure to noise or fine dust, short or disturbed sleep, smoking, stress and depression, and a low socioeconomic status...
July 19, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28716075/the-role-of-tumour-heterogeneity-and-clonal-cooperativity-in-metastasis-immune-evasion-and-clinical-outcome
#4
REVIEW
Deborah R Caswell, Charles Swanton
BACKGROUND: The advent of rapid and inexpensive sequencing technology allows scientists to decipher heterogeneity within primary tumours, between primary and metastatic sites, and between metastases. Charting the evolutionary history of individual tumours has revealed drivers of tumour heterogeneity and highlighted its impact on therapeutic outcomes. DISCUSSION: Scientists are using improved sequencing technologies to characterise and address the challenge of tumour heterogeneity, which is a major cause of resistance to therapy and relapse...
July 18, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28712360/resisting-and-tolerating-p-falciparum-in-pregnancy-under-different-malaria-transmission-intensities
#5
Nicaise Tuikue Ndam, Emmanuel Mbuba, Raquel González, Pau Cisteró, Simon Kariuki, Esperança Sevene, María Rupérez, Ana Maria Fonseca, Anifa Vala, Sonia Maculuve, Alfons Jiménez, Llorenç Quintó, Peter Ouma, Michael Ramharter, John J Aponte, Arsenio Nhacolo, Achille Massougbodji, Valerie Briand, Peter G Kremsner, Ghyslain Mombo-Ngoma, Meghna Desai, Eusebio Macete, Michel Cot, Clara Menéndez, Alfredo Mayor
BACKGROUND: Resistance and tolerance to Plasmodium falciparum can determine the progression of malaria disease. However, quantitative evidence of tolerance is still limited. We investigated variations in the adverse impact of P. falciparum infections among African pregnant women under different intensities of malaria transmission. METHODS: P. falciparum at delivery was assessed by microscopy, quantitative PCR (qPCR) and placental histology in 946 HIV-uninfected and 768 HIV-infected pregnant women from Benin, Gabon, Kenya and Mozambique...
July 17, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28705200/the-prognostic-value-of-lymph-node-yield-in-the-earliest-stage-of-colorectal-cancer-a-multicenter-cohort-study
#6
Yara Backes, Sjoerd G Elias, Bibie S Bhoelan, John N Groen, Jeroen van Bergeijk, Tom C J Seerden, Hendrikus J M Pullens, Bernhard W M Spanier, Joost M J Geesing, Koen Kessels, Marjon Kerkhof, Peter D Siersema, Wouter H de Vos Tot Nederveen Cappel, Niels van Lelyveld, Frank H J Wolfhagen, Frank Ter Borg, G Johan A Offerhaus, Miangela M Lacle, Leon M G Moons
BACKGROUND: In patients with stage II colorectal cancer (CRC) the number of surgically retrieved lymph nodes (LNs) is associated with prognosis, resulting in a minimum of 10-12 retrieved LNs being recommended for this stage. Current guidelines do not provide a recommendation regarding LN yield in T1 CRC. Studies evaluating LN yield in T1 CRC suggest that such high LN yields are not feasible in this early stage, and a lower LN yield might be appropriate. We aimed to validate the cut-off of 10 retrieved LNs on risk for recurrent cancer and detection of LN metastasis (LNM) in T1 CRC, and explored whether this number is feasible in clinical practice...
July 14, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28701188/tall-height-and-obesity-are-associated-with-an-increased-risk-of-aggressive-prostate-cancer-results-from-the-epic-cohort-study
#7
Aurora Perez-Cornago, Paul N Appleby, Tobias Pischon, Konstantinos K Tsilidis, Anne Tjønneland, Anja Olsen, Kim Overvad, Rudolf Kaaks, Tilman Kühn, Heiner Boeing, Annika Steffen, Antonia Trichopoulou, Pagona Lagiou, Maria Kritikou, Vittorio Krogh, Domenico Palli, Carlotta Sacerdote, Rosario Tumino, H Bas Bueno-de-Mesquita, Antonio Agudo, Nerea Larrañaga, Elena Molina-Portillo, Aurelio Barricarte, Maria-Dolores Chirlaque, J Ramón Quirós, Pär Stattin, Christel Häggström, Nick Wareham, Kay-Tee Khaw, Julie A Schmidt, Marc Gunter, Heinz Freisling, Dagfinn Aune, Heather Ward, Elio Riboli, Timothy J Key, Ruth C Travis
BACKGROUND: The relationship between body size and prostate cancer risk, and in particular risk by tumour characteristics, is not clear because most studies have not differentiated between high-grade or advanced stage tumours, but rather have assessed risk with a combined category of aggressive disease. We investigated the association of height and adiposity with incidence of and death from prostate cancer in 141,896 men in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort...
July 13, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28697810/healthcare-system-responses-to-intimate-partner-violence-in-low-and-middle-income-countries-evidence-is-growing-and-the-challenges-become-clearer
#8
LETTER
Angela Taft, Manuela Colombini
The damage to health caused by intimate partner violence demands effective responses from healthcare providers and healthcare systems worldwide. To date, most evidence for the few existing, effective interventions in use comes from high-income countries. Gupta et al. provide rare evidence of a nurse-delivered intimate partner violence screening, supportive care and referral intervention from a large-scale randomised trial in Mexican public health clinics. No difference was found in the primary outcome of reduction in intimate partner violence...
July 12, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28697769/a-nurse-delivered-clinic-based-intervention-to-address-intimate-partner-violence-among-low-income-women-in-mexico-city-findings-from-a-cluster-randomized-controlled-trial
#9
Jhumka Gupta, Kathryn L Falb, Oriana Ponta, Ziming Xuan, Paola Abril Campos, Annabel Arellano Gomez, Jimena Valades, Gisele Cariño, Claudia Diaz Olavarrieta
BACKGROUND: Rigorous evaluations of health sector interventions addressing intimate partner violence (IPV) in low- and middle-income countries are lacking. We aimed to assess whether an enhanced nurse-delivered intervention would reduce IPV and improve levels of safety planning behaviors, use of community resources, reproductive coercion, and mental quality of life. METHODS: We randomized 42 public health clinics in Mexico City to treatment or control arms. In treatment clinics, women received the nurse-delivered session (IPV screening, supportive referrals, health/safety risk assessments) at baseline (T1), and a booster counselling session after 3 months (T2)...
July 12, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28693510/can-china-achieve-a-one-third-reduction-in-premature-mortality-from-non-communicable-diseases-by-2030
#10
Yichong Li, Xinying Zeng, Jiangmei Liu, Yunning Liu, Shiwei Liu, Peng Yin, Jinlei Qi, Zhenping Zhao, Shicheng Yu, Yuehua Hu, Guangxue He, Alan D Lopez, George F Gao, Linhong Wang, Maigeng Zhou
BACKGROUND: The United Nation's Sustainable Development Goals for 2030 include reducing premature mortality from non-communicable diseases (NCDs) by one third. To assess the feasibility of this goal in China, we projected premature mortality in 2030 of NCDs under different risk factor reduction scenarios. METHODS: We used China results from the Global Burden of Disease Study 2013 as empirical data for projections. Deaths between 1990 and 2013 for cardiovascular disease (CVD), diabetes, chronic respiratory disease, cancer, and other NCDs were extracted, along with population numbers...
July 11, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28689496/rapidly-increasing-end-of-life-care-needs-a-timely-warning
#11
LETTER
Geoffrey Mitchell
Current trends in population ageing show that, in the near future, while more people will live longer, more will also die at any one time. Health systems, as well as individual practitioners, are only just becoming aware of the extent of this problem. Health systems will have to rapidly change practice to manage the number of people dying in the coming years, many with complex multimorbid conditions. The changes involved should include a personal recognition by all health professionals of their role in caring for the dying, and healthcare education must include end-of-life care management as part of the core curriculum...
July 10, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28683750/use-of-malaria-rapid-diagnostic-tests-by-community-health-workers-in-afghanistan-cluster-randomised-trial
#12
Toby Leslie, Mark Rowland, Amy Mikhail, Bonnie Cundill, Barbara Willey, Asif Alokozai, Ismail Mayan, Anwar Hasanzai, Sayed Habibullah Baktash, Nader Mohammed, Molly Wood, Habib-U-Rahman Rahimi, Baptiste Laurent, Cyril Buhler, Christopher J M Whitty
BACKGROUND: The World Health Organisation (WHO) recommends parasitological diagnosis of malaria before treatment, but use of malaria rapid diagnostic tests (mRDTs) by community health workers (CHWs) has not been fully tested within health services in south and central Asia. mRDTs could allow CHWs to diagnose malaria accurately, improving treatment of febrile illness. METHODS: A cluster randomised trial in community health services was undertaken in Afghanistan. The primary outcome was the proportion of suspected malaria cases correctly treated for polymerase chain reaction (PCR)-confirmed malaria and PCR negative cases receiving no antimalarial drugs measured at the level of the patient...
July 7, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28676103/pre-diagnostic-metabolite-concentrations-and-prostate-cancer-risk-in-1077-cases-and-1077-matched-controls-in-the-european-prospective-investigation-into-cancer-and-nutrition
#13
Julie A Schmidt, Georgina K Fensom, Sabina Rinaldi, Augustin Scalbert, Paul N Appleby, David Achaintre, Audrey Gicquiau, Marc J Gunter, Pietro Ferrari, Rudolf Kaaks, Tilman Kühn, Anna Floegel, Heiner Boeing, Antonia Trichopoulou, Pagona Lagiou, Eleutherios Anifantis, Claudia Agnoli, Domenico Palli, Morena Trevisan, Rosario Tumino, H Bas Bueno-de-Mesquita, Antonio Agudo, Nerea Larrañaga, Daniel Redondo-Sánchez, Aurelio Barricarte, José Maria Huerta, J Ramón Quirós, Nick Wareham, Kay-Tee Khaw, Aurora Perez-Cornago, Mattias Johansson, Amanda J Cross, Konstantinos K Tsilidis, Elio Riboli, Timothy J Key, Ruth C Travis
BACKGROUND: Little is known about how pre-diagnostic metabolites in blood relate to risk of prostate cancer. We aimed to investigate the prospective association between plasma metabolite concentrations and risk of prostate cancer overall, and by time to diagnosis and tumour characteristics, and risk of death from prostate cancer. METHODS: In a case-control study nested in the European Prospective Investigation into Cancer and Nutrition, pre-diagnostic plasma concentrations of 122 metabolites (including acylcarnitines, amino acids, biogenic amines, glycerophospholipids, hexose and sphingolipids) were measured using targeted mass spectrometry (AbsoluteIDQ p180 Kit) and compared between 1077 prostate cancer cases and 1077 matched controls...
July 5, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28669352/impact-of-comorbidities-on-gout-and-hyperuricaemia-an-update-on-prevalence-and-treatment-options
#14
REVIEW
Thomas Bardin, Pascal Richette
Gout, the most prevalent inflammatory arthritis worldwide, is associated with cardiovascular and renal diseases, and is an independent predictor of premature death. The frequencies of obesity, chronic kidney disease (CKD), hypertension, type 2 diabetes, dyslipidaemias, cardiac diseases (including coronary heart disease, heart failure and atrial fibrillation), stroke and peripheral arterial disease have been repeatedly shown to be increased in gout. Therefore, the screening and care of these comorbidities as well as of cardiovascular risk factors are of outmost importance in patients with gout...
July 3, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28662646/effect-of-transmission-intensity-on-hotspots-and-micro-epidemiology-of-malaria-in-sub-saharan-africa
#15
Polycarp Mogeni, Irene Omedo, Christopher Nyundo, Alice Kamau, Abdisalan Noor, Philip Bejon
BACKGROUND: Malaria transmission intensity is heterogeneous, complicating the implementation of malaria control interventions. We provide a description of the spatial micro-epidemiology of symptomatic malaria and asymptomatic parasitaemia in multiple sites. METHODS: We assembled data from 19 studies conducted between 1996 and 2015 in seven countries of sub-Saharan Africa with homestead-level geospatial data. Data from each site were used to quantify spatial autocorrelation and examine the temporal stability of hotspots...
June 30, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28655311/diagnostic-delay-for-giant-cell-arteritis-a-systematic-review-and-meta-analysis
#16
James A Prior, Hoda Ranjbar, John Belcher, Sarah L Mackie, Toby Helliwell, Jennifer Liddle, Christian D Mallen
BACKGROUND: Giant cell arteritis (GCA), if untreated, can lead to blindness and stroke. The study's objectives were to (1) determine a new evidence-based benchmark of the extent of diagnostic delay for GCA and (2) examine the role of GCA-specific characteristics on diagnostic delay. METHODS: Medical literature databases were searched from inception to November 2015. Articles were included if reporting a time-period of diagnostic delay between onset of GCA symptoms and diagnosis...
June 28, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28651606/about-the-practice-of-psychiatric-euthanasia-a-commentary
#17
LETTER
Jorge Lopez-Castroman
Euthanasia motivated by mental disorders is legal in only a few countries and has a short history. In a recent report of all psychiatric euthanasia cases in Belgium between 2002 and 2013, Dierickx and colleagues suggest that the number of these cases is increasing, and provide a profile of the applicants. To date, knowledge of the practice of psychiatric euthanasia is limited, but rising public awareness might increase the number of requests. The authors reveal several shortcomings in cases of psychiatric euthanasia and open avenues for future research...
June 27, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28648142/overcoming-intratumoural-heterogeneity-for-reproducible-molecular-risk-stratification-a-case-study-in-advanced-kidney-cancer
#18
Alexander L R Lubbock, Grant D Stewart, Fiach C O'Mahony, Alexander Laird, Peter Mullen, Marie O'Donnell, Thomas Powles, David J Harrison, Ian M Overton
BACKGROUND: Metastatic clear cell renal cell cancer (mccRCC) portends a poor prognosis and urgently requires better clinical tools for prognostication as well as for prediction of response to treatment. Considerable investment in molecular risk stratification has sought to overcome the performance ceiling encountered by methods restricted to traditional clinical parameters. However, replication of results has proven challenging, and intratumoural heterogeneity (ITH) may confound attempts at tissue-based stratification...
June 26, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28641578/methylome-analysis-of-extreme-chemoresponsive-patients-identifies-novel-markers-of-platinum-sensitivity-in-high-grade-serous-ovarian-cancer
#19
Tushar Tomar, Nicolette G Alkema, Leroy Schreuder, Gert Jan Meersma, Tim de Meyer, Wim van Criekinge, Harry G Klip, Heidi Fiegl, Els van Nieuwenhuysen, Ignace Vergote, Martin Widschwendter, Ed Schuuring, Ate G J van der Zee, Steven de Jong, G Bea A Wisman
BACKGROUND: Despite an early response to platinum-based chemotherapy in advanced stage high-grade serous ovarian cancer (HGSOC), the majority of patients will relapse with drug-resistant disease. Aberrant epigenetic alterations like DNA methylation are common in HGSOC. Differences in DNA methylation are associated with chemoresponse in these patients. The objective of this study was to identify and validate novel epigenetic markers of chemoresponse using genome-wide analysis of DNA methylation in extreme chemoresponsive HGSOC patients...
June 23, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28633672/influence-of-the-number-and-timing-of-malaria-episodes-during-pregnancy-on-prematurity-and-small-for-gestational-age-in-an-area-of-low-transmission
#20
Kerryn A Moore, Julie A Simpson, Jacher Wiladphaingern, Aung Myat Min, Mupawjay Pimanpanarak, Moo Kho Paw, Jathee Raksuansak, Sasithon Pukrittayakamee, Freya J I Fowkes, Nicholas J White, François Nosten, Rose McGready
BACKGROUND: Most evidence on the association between malaria in pregnancy and adverse pregnancy outcomes focuses on falciparum malaria detected at birth. We assessed the association between the number and timing of falciparum and vivax malaria episodes during pregnancy on small-for-gestational-age (SGA) and preterm birth. METHODS: We analysed observational data collected from antenatal clinics on the Thailand-Myanmar border (1986-2015). We assessed the effects of the total number of malaria episodes in pregnancy on SGA and the effects of malaria in pregnancy on SGA, very preterm birth, and late preterm birth, by the gestational age at malaria detection and treatment using logistic regression models with time-dependent malaria variables (monthly intervals)...
June 21, 2017: BMC Medicine
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