1,595 results on '"Epidemiology and Community Medicine"'
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2. The effect of coarse ambient particulate matter on first, second, and overall hospital admissions for respiratory disease among the elderly
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McGrail, Kimberlyn [University of Ottawa, Ottawa, ON (Canada). Department of Epidemiology and Community Medicine]
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- 2005
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3. The INTEROCC case-control study: risk of meningioma and occupational exposure to selected combustion products, dusts and other chemical agents
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Michelle C. Turner, Jack Siemiatycki, Damien McElvenny, Martie van Tongeren, Sarah Fleming, Marie-Élise Parent, Jordi Figuerola, Elisabeth Cardis, Siegal Sadetzki, Laurel Kincl, Joachim Schüz, Dave McLean, Brigitte Schlehofer, Klaus Schlaefer, Lesley Richardson, Geza Benke, Martine Hours, Daniel Krewski, Institute of Occupational Medicine [Edinburgh] (IOM), Centre for Occupational and Environmental Health, Centre for Epidemiology, Division of Population Health, Health Services Research and Primary Care, School of Health Sciences, Faculty of Medicine, Biology and Health, University of Manchester, Barcelona Institute for Global Health (ISGlobal), Barcelona Institute for Global Health, Monash University [Melbourne], Universitat Pompeu Fabra [Barcelona] (UPF), Leeds Institute of Cardiovascular and Metabolic Medicine, Unité Mixte de Recherche Epidémiologique et de Surveillance Transport Travail Environnement (UMRESTTE UMR T9405), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut Français des Sciences et Technologies des Transports, de l'Aménagement et des Réseaux (IFSTTAR), College of Public Health and Human Sciences, Oregon State University, Corvallis, College of Public Health and Human Sciences, Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa [Ottawa], Centre for Public Health Research, Massey University, Massey University, Institut Armand Frappier (INRS-IAF), Réseau International des Instituts Pasteur (RIIP)-Institut National de la Recherche Scientifique [Québec] (INRS), University of Montreal Hospital Research Centre, Unit of Environmental Epidemiology, German Cancer Research Center, German Cancer Research Center - Deutsches Krebsforschungszentrum [Heidelberg] (DKFZ), Sackler Faculty of Medicine, Tel Aviv University [Tel Aviv], Centre International de Recherche contre le Cancer - International Agency for Research on Cancer (CIRC - IARC), Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), CIBER de Epidemiología y Salud Pública (CIBERESP), and Institut National de la Recherche Scientifique [Québec] (INRS)-Réseau International des Instituts Pasteur (RIIP)
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Adult ,Male ,Job-exposure matrix ,EXPOSITION PROFESSIONNELLE ,Cumulative Exposure ,medicine.disease_cause ,Asbestos ,Toxicology ,Meningioma ,03 medical and health sciences ,0302 clinical medicine ,Sex Factors ,Risk Factors ,Environmental health ,Formaldehyde ,Occupational Exposure ,Smoke ,Surveys and Questionnaires ,medicine ,Meningeal Neoplasms ,Odds Ratio ,Humans ,Aged ,business.industry ,Brain Neoplasms ,Confounding ,Public Health, Environmental and Occupational Health ,Absolute risk reduction ,Case-control study ,PRODUITS DE COMBUSTION ,Dust ,POUSSIERES ,Middle Aged ,medicine.disease ,030210 environmental & occupational health ,3. Good health ,Occupational Diseases ,Logistic Models ,MENINGIOMES ,030220 oncology & carcinogenesis ,Combustion products ,Case-Control Studies ,Female ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,Oils - Abstract
BackgroundLittle is known about occupational risk factors for meningioma.ObjectivesTo study whether risk of meningioma is associated with several occupational exposures, including selected combustion products, dusts and other chemical agents.MethodsThe INTEROCC study was an international case-control study of brain cancer conducted in seven countries. Data collection by interview included lifetime occupational histories. A job exposure matrix was used to derive estimates of exposure for the 12 agents. ORs for ever versus never exposed and for exposure-response using duration of exposure and cumulative exposure were derived using conditional logistic regression stratified by sex, age group, country/region, adjusted for education.ResultsThese analyses included 1906 cases and 5565 controls. For 11 of the 12 agents, no excess risk was found for ever exposed. For ever exposure to oil mists, an elevated OR of 1.57 (95% CI 1.10 to 2.22, 51 exposed cases) was found. Statistically significant exposure-response relationships were observed with cumulative exposure (p=0.01) and duration of exposure (p=0.04). Among women, there were also significant trends for cumulative and duration of exposure to asbestos and excesses in the highest exposure categories for formaldehyde.ConclusionsMost agents examined did not provoke excess risks of meningioma. The main finding from this study is that it is the first study to identify a statistical association between exposure to oil mists and meningioma. This may be a chance finding or could be due to confounding with iron exposure and further research is required to understand whether the relationship is causal.
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- 2018
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4. Folic Acid Supplementation Use and the MTHFR C677T Polymorphism in Orofacial Clefts Etiology: An Individual Participant Data Pooled-Analysis
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Butali, Azeez, Little, Julian, Chevrier, Cécile, Cordier, Sylvian, Steegers-Theunissen, Régine P. M., Jugessur, Astanand, Oladugba, Bola, Mossey, Peter A, Epidemiology and Community Medicine, University of Ottawa [Ottawa], Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), Erasmus University Medical Center [Rotterdam] (Erasmus MC), Department of Epidemiology, and Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
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Adult ,Male ,Ethanol ,Cleft Lip ,Smoking ,Brain ,individual patient data ,Polymorphism, Single Nucleotide ,Article ,Cleft Palate ,Human Reproduction [NCEBP 12] ,Folic Acid ,Maternal Exposure ,Risk Factors ,Case-Control Studies ,MTHFR ,Dietary Supplements ,pooled-analysis ,Humans ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,Female ,Methylenetetrahydrofolate Reductase (NADPH2) ,cleft lip and palate - Abstract
Item does not contain fulltext BACKGROUNDThis study examines gene-environment interaction between the MTHFR C667T polymorphism and folic acid in the etiology of orofacial clefts (OFC). We used a pooled-analytical approach on four studies that used similar methods. METHODSWe used logistic regression to analyze the pooled sample of 1149 isolated cases and 1161 controls. Fetal and maternal MTHFR C677T genotypes, and maternal periconceptional exposure to smoking, alcohol, vitamin containing folic acid and folic acid supplements were contrasted between the cleft types [non-syndromic clefts lip or without cleft palate (CL(P)) and non-syndromic cleft palate (CP)] and control groups. RESULTSThere was a reduced risk of CL(P) with maternal folic acid use (p=0.008; OR=0.70, 95% CI: 0.65-0.94) and with supplements containing folic acid (p=0.028, OR=0.80, 95% CI: 0.65-0.94). Maternal smoking increased the risk of both CL(P) (p
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- 2013
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5. Maternal medication use and the risk of brain tumors in the offspring: The SEARCH international case-control study
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Graziella Filippini, A. H. Cardy, Raphael Peris-Bonet, Margaret R. E. McCredie, William Lijinsky, Beth A. Mueller, Julian Little, N. Won Choi, Elizabeth A. Holly, Flora Lubin, Sylvanie Cordier, Susan Preston-Martin, Annie Arslan, Roberta McKean-Cowdin, Epidemiology and Community Medicine, University of Ottawa [Ottawa], Groupe d'Etude de la Reproduction Chez l'Homme et les Mammiferes (GERHM), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), Instituto Neurologico C. Besta, Chaim Sheba Medical Center, University of Otago [Dunedin, Nouvelle-Zélande], National Childhood Cancer Registry of Spain (RNTI-SEOP), Universitat de València (UV), USC/Norris Comprehensive Cancer Center, University of Southern California (USC), and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Male ,Cancer Research ,MESH: Maternal-Fetal Exchange ,MESH: Pregnancy ,0302 clinical medicine ,Pregnancy ,Risk Factors ,MESH: Risk Factors ,MESH: Child ,Recall bias ,Epidemiology ,Medicine ,030212 general & internal medicine ,Amines ,Child ,Maternal-Fetal Exchange ,education.field_of_study ,Brain Neoplasms ,N-nitroso compounds ,MESH: Amines ,MESH: Infant ,MESH: Amides ,MESH: Case-Control Studies ,MESH: Mothers ,3. Good health ,Oncology ,Child, Preschool ,030220 oncology & carcinogenesis ,MESH: Brain Neoplasms ,Female ,Disease Susceptibility ,Adult ,medicine.medical_specialty ,Adolescent ,Offspring ,case-control study ,Population ,MESH: Disease Susceptibility ,Mothers ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,childhood brain tumors ,03 medical and health sciences ,Internal medicine ,Glioma ,maternal medication ,Humans ,Risk factor ,education ,MESH: Adolescent ,MESH: Humans ,business.industry ,MESH: Child, Preschool ,Case-control study ,Infant ,MESH: Adult ,medicine.disease ,Amides ,MESH: Male ,Case-Control Studies ,business ,MESH: Female - Abstract
International audience; N-nitroso compounds (NOC) have been associated with carcinogenesis in a wide range of species, including humans. There is strong experimental data showing that nitrosamides (R(1)NNO.COR(2)), a type of NOC, are potent neuro-carcinogens when administered transplacentally. Some medications are a concentrated source of amides or amines, which in the presence of nitrites under normal acidic conditions of the stomach can form NOC. Therefore, these compounds, when ingested by women during pregnancy, may be important risk factors for tumors of the central nervous system in the offspring. The aim of the present study was to test the association between maternal use of medications that contain nitrosatable amines or amides and risk of primary childhood brain tumors (CBT). A case-control study was conducted, which included 1,218 cases and 2,223 population controls, recruited from 9 centers across North America, Europe and Australia. Analysis was conducted for all participants combined, by tumor type (astroglial, primitive neuroectodermal tumors and other glioma), and by age at diagnosis (< or =5 years; >5 years). There were no significant associations between maternal intake of medication containing nitrosatable amines or amides and CBT, for all participants combined and after stratification by age at diagnosis and histological subtype. This is the largest case-control study of CBT and maternal medications to date. Our data provide little support for an association between maternal use of medications that may form NOC and subsequent development of CBT in the offspring.
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- 2005
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6. Occupational exposure to crystalline silica and the risk of lung cancer in Canadian men
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Shelley A. Harris, Marie-Élise Parent, Paul J. Villeneuve, Kenneth C. Johnson, Linda Kachuri, Dalla Lana School of Public Health, University of Toronto, Research, Prevention and Cancer Control, Cancer Care Ontario, Department of Health Sciences, Carleton University, Institut Armand Frappier (INRS-IAF), Réseau International des Instituts Pasteur (RIIP)-Institut National de la Recherche Scientifique [Québec] (INRS), Department of Epidemiology and Community Medicine, and University of Ottawa [Ottawa]
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Oncology ,0303 health sciences ,medicine.medical_specialty ,business.industry ,[SDV]Life Sciences [q-bio] ,030302 biochemistry & molecular biology ,Case-control study ,Cancer ,[SDV.CAN]Life Sciences [q-bio]/Cancer ,respiratory system ,medicine.disease ,3. Good health ,03 medical and health sciences ,Internal medicine ,medicine ,General Earth and Planetary Sciences ,Occupational exposure ,Lung cancer ,business ,Carcinogen ,030304 developmental biology ,General Environmental Science - Abstract
International audience; Crystalline silica is a recognised carcinogen, but the association with lung cancer at lower levels of exposure has not been well characterised. This study investigated the relationship between occupational silica exposure and lung cancer, and the combined effects of cigarette smoking and silica exposure on lung cancer risk. A population-based case-control study was conducted in 8 Canadian provinces between 1994 and 1997. Self-reported questionnaires were used to obtain a lifetime occupational history and information on other risk factors. Occupational hygienists assigned silica exposures to each job based on concentration, frequency, and reliability. Data from 1681 incident lung cancer cases and 2053 controls were analysed using logistic regression to estimate odds ratios (OR) and their 95% confidence intervals. Models included adjustments for cigarette smoking, lifetime residential second-hand smoke, and occupational exposure to diesel and gasoline engine emissions. Relative to the unexposed, increasing duration of silica exposure at any concentration was associated with a significant trend in lung cancer risk (OR ≥30 years: 1.67, 1.21-2.24; ptrend=0.002). The highest tertile of cumulative silica exposure was associated with lung cancer (OR: 1.81, 1.34-2.42; ptrend=0.004) relative to the lowest. Men exposed to silica for ≥30 years with ≥40 cigarette pack-years had the highest risk relative to those unexposed with
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- 2014
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7. Non-OO blood type influences the risk of recurrent venous thromboembolism. A cohort study
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Nancy Carson, Marc A. Rodger, Grégoire Le Gal, Philip S. Wells, Susan Solymoss, Marc Carrier, Tim Ramsay, Isabelle Chagnon, David A. Anderson, Mark Crowther, Susan R. Kahn, Nicole Langlois, Esteban Gandara, Julian Little Ma, Michael J. Kovacs, Judy Kovacs, Clinical Epidemiology Unit, Ottawa-The Ottawa Hospital, Thrombosis Program, University of Ottawa [Ottawa], Department of Medicine (LONDON ONTARIO - Med), University of Western Ontario (UWO), Department of Medecine [Montréal], McGill University = Université McGill [Montréal, Canada], Centre for Clinical Epidemiology and Community Studies (CCECS), Jewish General Hospital, Department of Medicine, Dalhousie University [Halifax], University of Montreal, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), McMaster University [Hamilton, Ontario], Institut des Matériaux Jean Rouxel (IMN), Université de Nantes - UFR des Sciences et des Techniques (UN UFR ST), Université de Nantes (UN)-Université de Nantes (UN)-Centre National de la Recherche Scientifique (CNRS)-Institut de Chimie du CNRS (INC)-Ecole Polytechnique de l'Université de Nantes (EPUN), Université de Nantes (UN)-Université de Nantes (UN), Department of Epidemiology and Community Medicine (OTTAWA - Epidemio), and Department of Pediatrics (OTTAWA - Pedia)
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Adult ,Male ,medicine.medical_specialty ,[SDV]Life Sciences [q-bio] ,Administration, Oral ,030204 cardiovascular system & hematology ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Recurrence ,Risk Factors ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,cardiovascular diseases ,Risk factor ,Aged ,Blood type ,First episode ,business.industry ,Hazard ratio ,Anticoagulants ,Hematology ,Venous Thromboembolism ,Middle Aged ,medicine.disease ,Thrombosis ,3. Good health ,Surgery ,Discontinuation ,Blood Grouping and Crossmatching ,Withholding Treatment ,Cohort ,Blood Group Antigens ,Female ,business ,Cohort study ,Follow-Up Studies - Abstract
SummaryThe role of ABO blood type as a risk factor for recurrent venous thromboembolism (VTE) in patients with a first unprovoked VTE who complete oral anticoagulation therapy is unknown. The aim of this study was to determine if non-OO blood type is a risk factor for recurrent VTE in patients with a first unprovoked VTE who completed 5–7 months of anticoagulant therapy. In an ongoing cohort study of patients with unprovoked VTE who discontinued oral anticoagulation after 5–7 months of therapy, six single nucleotide polymorphisms sites were tested to determine ABO blood type using banked DNA. The main outcome was objectively proven recurrent VTE. Mean follow-up for the cohort was 4.19 years (SD 2.16). During 1,553 patient-years of follow-up, 101 events occurred in 380 non-OO patients (6.5 events per 100 patient years; 95% CI 5.3–7.7) compared to 14 events during 560 patient years of follow-up in 129 OO patients (2.5 per 100 patient years; 95% CI 1.2–3.7), the adjusted hazard ratio was 1.98 (1.2–3.8). In conclusion, non-OO blood type is associated with a statistically significant and clinically relevant increased risk of recurrent VTE following discontinuation of anticoagulant therapy for a first episode of unprovoked VTE.
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- 2013
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8. Efficacy and safety outcomes of oral anticoagulants and antiplatelet drugs in the secondary prevention of venous thromboembolism: systematic review and network meta-analysis
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Marc A. Rodger, George A. Wells, Doug Coyle, Esteban Gandara, Chris Cameron, Marc Carrier, Philip S. Wells, Tammy Clifford, Grégoire Le Gal, Lana A Castellucci, Thrombosis Program, University of Ottawa [Ottawa], Epidemiology and Community Medicine (OTTAWA - ECM), Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Clinical Epidemiology Unit, Ottawa-The Ottawa Hospital, Canadian Agency for Drugs and Technologies in Health (OTTAWA - CADTH), Ottawa, Department of Medicine, Ottawa Hospital, and Calvez, Ghislaine
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Vitamin K ,[SDV]Life Sciences [q-bio] ,MESH: Calcium Channel Blockers ,030204 cardiovascular system & hematology ,MESH: Venous Thromboembolism ,0302 clinical medicine ,Rivaroxaban ,Recurrence ,Medicine ,MESH: Animals ,030212 general & internal medicine ,MESH: Organ Specificity ,Absolute risk reduction ,Venous Thromboembolism ,General Medicine ,MESH: Muscle, Smooth, Vascular ,MESH: Thiophenes ,Dabigatran ,3. Good health ,[SDV] Life Sciences [q-bio] ,MESH: beta-Alanine ,MESH: Platelet Aggregation Inhibitors ,Meta-analysis ,Anesthesia ,MESH: Chemistry ,Apixaban ,MESH: Cats ,MESH: Hemorrhage ,medicine.drug ,medicine.medical_specialty ,MESH: Terminology as Topic ,MESH: Rats ,Pyridones ,Morpholines ,MEDLINE ,MESH: Morpholines ,Hemorrhage ,Thiophenes ,MESH: Anticoagulants ,Placebo ,MESH: Nervous System Diseases ,03 medical and health sciences ,Internal medicine ,MESH: Pyridones ,Humans ,MESH: Aspirin ,MESH: Humans ,Aspirin ,business.industry ,Anticoagulants ,MESH: Cardiovascular Diseases ,MESH: Vitamin K ,MESH: Chemical Phenomena ,Odds ratio ,MESH: Recurrence ,MESH: Heart ,beta-Alanine ,Pyrazoles ,Benzimidazoles ,business ,MESH: Benzimidazoles ,Platelet Aggregation Inhibitors ,MESH: Pyrazoles - Abstract
International audience; OBJECTIVE: To summarise and compare the efficacy and safety of various oral anticoagulants (dabigatran, rivaroxaban, apixaban, and vitamin K antagonists) and antiplatelet agents (acetylsalicylic acid) for the secondary prevention of venous thromboembolism. DESIGN: Systematic review and network meta-analysis. DATA SOURCES: Literature search using Medline (1950 to present), Embase (1980 to present), and the Cochrane Register of Controlled Trials using the OVID interface. Publications from potentially relevant journals were also searched by hand. REVIEW METHODS: Randomised controlled trials of patients receiving anticoagulants, antiplatelet drugs, or placebo or observation for secondary prevention of venous thromboembolism. Selected outcomes were rates of recurrent venous thromboembolism and major bleeding. Two reviewers independently extracted data onto standardised forms. RESULTS: 12 articles met our inclusion criteria, with 11,999 patients evaluated for efficacy and 12,167 for safety. All treatments reduced the risk of recurrent venous thromboembolism. Compared with placebo or observation, vitamin K antagonists at a standard adjusted dose (target international normalised ratio 2.0-3.0) showed the highest risk difference (odds ratio 0.07; 95% credible interval 0.03 to 0.15) and acetylsalicylic acid showed the lowest risk difference (0.65; 0.39 to 1.03). Risk of major bleeding was higher with a standard adjusted dose of vitamin K antagonists (5.24; 1.78 to 18.25) than with placebo or observation. Fatal recurrent venous thromboembolism and fatal bleeding were rare. Detailed subgroup and individual patient level data were not available. CONCLUSIONS: All oral anticoagulants and antiplatelet agents investigated in this analysis were associated with a reduced recurrence of venous thromboembolism compared with placebo or observation, although acetylsalicylic acid was associated with the lowest risk reduction. Vitamin K antagonists given at a standard adjusted dose was associated with the greatest risk reduction in recurrent venous thromboembolism, but also the greatest risk of major bleeding.
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- 2013
9. The evolution of assessing bias in Cochrane systematic reviews of interventions: celebrating methodological contributions of the Cochrane Collaboration
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Lucy Turner, Douglas G. Altman, David Moher, Asbjørn Hróbjartsson, Isabelle Boutron, BMC, Ed., Ottawa Hospital's Ethics Board, Ottawa Hospital Research Institute [Ottawa] (OHRI), Centre d'Epidémiologie Clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôtel-Dieu-Université Paris Descartes - Paris 5 (UPD5)-PRES Sorbonne Paris Cité-French Cochrane Centre, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Clinical Pharmacology, Epidemiology and Clinical Trials, Nordic Cochrane Centre, Centre for Statistics in Medicine, University of Oxford, Epidemiology and Community Medicine, University of Ottawa [Ottawa], We would like to thank the Canadian Institutes of Health Research for their long-term financial support (2005-2015)-CIHR Funding Reference Number-- CON-105529 this financing has enabled much of the progress of the group in the last decade, Assistance publique - Hôpitaux de Paris (AP-HP) - Hôtel-Dieu - Université Paris Descartes - Paris 5 (UPD5) - PRES Sorbonne Paris Cité - French Cochrane Centre, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 (UP7) - Institut National de la Santé et de la Recherche Médicale (INSERM), University of Oxford [Oxford], University of Ottawa, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7)
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medicine.medical_specialty ,Alternative medicine ,Psychological intervention ,Medicine (miscellaneous) ,030204 cardiovascular system & hematology ,03 medical and health sciences ,0302 clinical medicine ,Nursing ,Bias ,[SDV.SPEE] Life Sciences [q-bio]/Public Health and Epidemiology ,Health care ,medicine ,Humans ,030212 general & internal medicine ,Information Services ,Cochrane collaboration ,Evidence-Based Medicine ,business.industry ,3. Good health ,Review Literature as Topic ,Systematic review ,Research Design ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,Commentary ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,Publication Bias - Abstract
International audience; : The global evidence base for health care is extensive, and expanding; with nearly 2 million articles published annually. One estimate suggests 75 trials and 11 systematic reviews are published daily.
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- 2013
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10. Strengthening the reporting of genetic risk prediction studies (GRIPS): Explanation and elaboration
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Christopher J. O'Donnell, David F. Ransohoff, Muin J. Khoury, Jeremy M. Grimshaw, Stephanie Melillo, Caroline F. Wright, Deborah M. Winn, Sara Bedrosian, Daniela Seminara, John P. A. Ioannidis, Holly Janes, Michael J. Pencina, Siobhan M. Dolan, Mark A. Hlatky, Paolo Boffetta, Jeffrey R. Gulcher, Andrew N. Freedman, Isabel Fortier, Nicole F. Dowling, Julian Little, Peter Kraft, A. Cecile J.W. Janssens, Marta Gwinn, Sheri D. Schully, Cornelia M. van Duijn, Janssens, A.C.J.W., Ioannidis, J.P.A., Bedrosian, S., Boffetta, P., Dolan, S.M., Dowling, N., Fortier, I., Freedman, A.N., Grimshaw, J.M., Gulcher, J., Gwinn, M., Hlatky, M.A., Janes, H., Kraft, P., Melillo, S., O'Donnell, C.J., Pencina, M.J., Ransohoff, D., Schully, S.D., Seminara, D., Winn, D.M., Wright, C.F., Van Duijn, C.M., Little, J., Khoury, M.J., Department of Epidemiology [Rotterdam], Erasmus University Medical Center [Rotterdam] (Erasmus MC), Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Biomedical Research Institute, Foundation for Research and Technology, Department of Medicine, Tufts University School of Medicine, Center for Genetic Epidemiology and Modeling and Tufts CTSI, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Stanford Prevention Research Center, Stanford Medicine, Stanford University-Stanford University, Office of Public Health Genomics, Centers for Disease Control and Prevention, The Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai [New York] (MSSM), International Prevention Research Institute (IPRI), Department of Obstetrics & Gynecology and Women's Health, Albert Einstein College of Medicine, Montefiore Medical Center, Public Population Project in Genomics (P3G), National Cancer Institute [Bethesda] (NCI-NIH), National Institutes of Health [Bethesda] (NIH), Clinical Epidemiology Program, Ottawa Hospital Research Institute [Ottawa] (OHRI), University of Ottawa [Ottawa], deCODE Genetics, deCODE genetics [Reykjavik], Department of Health Research and Policy, Stanford University, Fred Hutchinson Cancer Research Center [Seattle] (FHCRC), Department of Epidemiology, Harvard School of Public Health, Framingham Heart Study, Boston University [Boston] (BU)-National Heart, Lung, and Blood Institute [Bethesda] (NHLBI), Cardiology Division, Massachusetts General Hospital, Harvard Medical School [Boston] (HMS), Department of Biostatistics, Boston University [Boston] (BU), Harvard Clinical Research Institute, University of North Carolina at Chapel Hill School of Medicine, University of North Carolina [Chapel Hill] (UNC), University of North Carolina System (UNC)-University of North Carolina System (UNC), PHG Foundation, Epidemiology and Community Medicine, O'donnell, C.J., and Epidemiology
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Gerontology ,Male ,Epidemiology ,Genome-wide association study ,Strengthening the reporting of observational studies in epidemiology ,Bioinformatics ,computer.software_genre ,genetic risk ,0302 clinical medicine ,Multidisciplinary approach ,STROBE ,Disease ,030212 general & internal medicine ,Genetic risk ,Genetics (clinical) ,Randomized Controlled Trials as Topic ,CURVE ,0303 health sciences ,medicine.diagnostic_test ,GRIPS ,ASSOCIATION ,Genomics ,Middle Aged ,Checklist ,Risk prediction ,3. Good health ,Policy ,Risk analysis (engineering) ,Strengthening reporting genetic risk prediction studies GRIPS ,Strengthening ,Female ,Data mining ,Risk assessment ,Psychology ,Adult ,Genetic Research ,medicine.medical_specialty ,MODELS ,Guidelines as Topic ,Disclosure ,Guidelines ,Risk Assessment ,Article ,EXPLANATION ,Education ,03 medical and health sciences ,Genetic ,SDG 3 - Good Health and Well-being ,Genetics ,medicine ,Humans ,Genetic Predisposition to Disease ,Genetic Testing ,Elaboration ,Genetic testing ,Aged ,030304 developmental biology ,Publishing ,Models, Genetic ,Genome, Human ,business.industry ,Public health ,Methodology ,Epidemiologic Studies ,Reporting ,MARKER ,Genomics/*methods ,Interdisciplinary Communication ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,computer ,Strengths and weaknesses ,Genome-Wide Association Study - Abstract
The rapid and continuing progress in gene discovery for complex diseases is fuelling interest in the potential application of genetic risk models for clinical and public health practice. The number of studies assessing the predictive ability is steadily increasing, but they vary widely in completeness of reporting and apparent quality. Transparent reporting of the strengths and weaknesses of these studies is important to facilitate the accumulation of evidence on genetic risk prediction. A multidisciplinary workshop sponsored by the Human Genome Epidemiology Network developed a checklist of 25 items recommended for strengthening the reporting of Genetic RIsk Prediction Studies (GRIPS), building on the principles established by prior reporting guidelines. These recommendations aim to enhance the transparency, quality and completeness of study reporting and thereby to improve the synthesis and application of information from multiple studies that might differ in design, conduct or analysis. © 2011 The Authors. European Journal of Clinical Investigation © 2011 Stichting European Society for Clinical Investigation Journal Foundation.
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- 2011
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11. Strengthening the reporting of genetic risk prediction studies: the GRIPS statement
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A Cecile J W, Janssens, John P A, Ioannidis, Cornelia M, van Duijn, Julian, Little, Muin J, Khoury, Epidemiology, Department of Epidemiology, Erasmus University Medical Center [Rotterdam] (Erasmus MC), Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Biomedical Research Institute, Foundation for Research and Technology, Department of Medicine, Tufts University School of Medicine, Center for Genetic Epidemiology and Modeling and Tufts CTSI, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Stanford Prevention Research Center, Stanford Medicine, Stanford University-Stanford University, Epidemiology and Community Medicine, University of Ottawa [Ottawa], Office of Public Health Genomics, and Centers for Disease Control and Prevention
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Epidemiology ,Statement (logic) ,Applied psychology ,Psychological intervention ,Genome-wide association study ,Disease ,Strengthening the reporting of observational studies in epidemiology ,0302 clinical medicine ,Multidisciplinary approach ,Health care ,Medicine ,Genetics(clinical) ,Genetic risk ,General Environmental Science ,0303 health sciences ,GRIPS ,Genomics ,General Medicine ,Reporting guideline ,3. Good health ,Systematic review ,Risk analysis (engineering) ,030220 oncology & carcinogenesis ,DOAJ:Health Sciences ,Cardiology and Cardiovascular Medicine ,Genetic Markers ,medicine.medical_specialty ,Guidelines as Topic ,Human genomics ,Disclosure ,Genetics and Genomics/Complex Traits ,Guidelines ,Risk Assessment ,Education ,Molecular Genetics ,03 medical and health sciences ,Genetic ,SDG 3 - Good Health and Well-being ,Drugs: Cardiovascular System ,Correspondence ,Genetics ,Humans ,Genetic Testing ,Molecular Biology ,Developing Countries ,Genetic testing ,Genetic association ,Models, Statistical ,Public health ,lcsh:R ,Methodology ,Genetic risk models ,lcsh:RA1-1270 ,Guideline ,body regions ,Epidemiologic Studies ,Genetic epidemiology ,Reporting ,Public Health and Epidemiology/Preventive Medicine ,Observational study ,Gene Discovery ,Research design ,Public Health and Epidemiology/Screening ,Operations research ,lcsh:Medicine ,030204 cardiovascular system & hematology ,Bioinformatics ,Guidelines and Guidance ,Risk model ,Risk Factors ,030212 general & internal medicine ,Genetics (clinical) ,Framingham Risk Score ,medicine.diagnostic_test ,lcsh:Public aspects of medicine ,General Engineering ,Risk factor (computing) ,Risk prediction ,Checklist ,Predictive factor ,Policy ,Research Design ,Practice Guidelines as Topic ,Molecular Medicine ,Psychology ,Risk assessment ,Genetic Research ,Digital content ,Genetic counseling ,MEDLINE ,Internal Medicine ,Research Methods & Reporting ,Genetic Predisposition to Disease ,030304 developmental biology ,Publishing ,Actuarial science ,Models, Genetic ,Extramural ,Genome, Human ,business.industry ,Research ,Genetics and Genomics ,DOAJ:Public Health ,General Earth and Planetary Sciences ,Interdisciplinary Communication ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,Artificial intelligence ,Public Health and Epidemiology/Epidemiology ,business ,Forecasting ,Genome-Wide Association Study - Abstract
The recent successes of genome-wide association studies and the promises of whole genome sequencing fuel interest in the translation of this new wave of basic genetic knowledge to health care practice. Knowledge about genetic risk factors may be used to target diagnostic, preventive, and therapeutic interventions for complex disorders based on a person's genetic risk, or to complement existing risk models based on classical nongenetic factors, such as the Framingham risk score for cardiovascular disease. Implementation of genetic risk prediction in health care requires a series of studies that encompass all phases of translational research,1,2 starting with a comprehensive evaluation of genetic risk prediction. With increasing numbers of discovered genetic markers that can be used in future genetic risk prediction studies, it is crucial to enhance the quality of the reporting of these studies, since valid interpretation could be compromised by the lack of reporting of key information. Information that is often missing includes details in the description of how the study was designed and conducted (eg, how genetic variants were selected and coded, how risk models or genetic risk scores were constructed, and how risk categories were chosen), or how the results should be interpreted. An appropriate assessment of the study's strengths and weaknesses is not possible without this information. There is ample evidence that prediction research often suffers from poor design and bias, and these may also have an impact on the results of the studies and on models of disease outcomes based on these studies.3–5 Although most prognostic studies published to date claim significant results,6,7 very few translate to clinically useful applications. Just as for observational epidemiological studies,8 poor reporting complicates the use of the specific study for research, clinical, or public health purposes and hampers the …
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- 2011
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12. Difluorodeoxyuridine plasma concentrations after low-dose gemcitabine during chemoradiation in head and neck cancer patients
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Jan B. Vermorken, Pol Specenier, J. Dyck, D. Van den Weyngaert, Gunther Guetens, K. Aelbrecht, G. De Boeck, Joost Weyler, Medical Oncology, Antwerp University Hospital [Edegem] (UZA), Laboratory of Cancer Research and Clinical Oncology, University of Antwerp (UA), Epidemiology and Community Medicine, and Radiotherapy
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Male ,Radiation-Sensitizing Agents ,Cancer Research ,medicine.medical_treatment ,Toxicology ,Deoxycytidine ,0302 clinical medicine ,Pharmacology (medical) ,dFdU ,Head and neck cancer ,ComputingMilieux_MISCELLANEOUS ,Aged, 80 and over ,0303 health sciences ,Chemistry ,Pharmacology. Therapy ,Area under the curve ,Middle Aged ,Combined Modality Therapy ,3. Good health ,Oncology ,Chemoradiation ,Head and Neck Neoplasms ,030220 oncology & carcinogenesis ,Toxicity ,Female ,medicine.drug ,Antimetabolites, Antineoplastic ,medicine.medical_specialty ,medicine.drug_class ,Urology ,Antimetabolite ,03 medical and health sciences ,Pharmacokinetics ,medicine ,Mucositis ,Humans ,Aged ,030304 developmental biology ,Pharmacology ,Chemotherapy ,Radiosensitizing ,Dose-Response Relationship, Drug ,business.industry ,medicine.disease ,Gemcitabine ,Human medicine ,Floxuridine ,Nuclear medicine ,business - Abstract
Purpose The aim of this study was to investigate whether relevant plasma levels of dFdU could be detected during concurrent chemoradiation (CRT) with low doses of dFdC administered in patients with head and neck cancer and to assess the toxicity related to dose. Methods dFdC was administered at doses of 5 mg/m² twice weekly or 10, 50, or 100 mg/m² weekly. Plasma concentrations of dFdU were determined daily for 7 days after the first administration and before each administration, thereafter. A high-performance liquid chromatographic method was used. During CRT, skin and mucosal toxicity were scored weekly according to the RTOG toxicity scoring system. Results Eight patients were sampled at the 1050 mg/m² dose and nine at the 5100 mg/m² dose. dFdU levels were in the micromolar range, inducing RS in vitro. There was a strong correlation between the area under the curve of dFdU and the dose of dFdC (r = 0.803, P < 0.001) and a weak correlation between trough concentrations and total dose of dFdC (r = 0.408, P = 0.017). Duration of severe mucositis correlated with dFdC dose. Conclusions During CRT with 10100 mg/m2 of dFdC weekly or 5 mg/m2 twice weekly, dFdU remains detectable at potentially radiosensitizing concentrations.
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- 2010
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13. Neglected external validity in reports of randomized trials: The example of hip and knee osteoarthritis
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Isabelle Pitrou, Nizar Ahmad, Philippe Ravaud, Isabelle Boutron, Carine Roy, David Moher, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Epidemiology and Community Medicine, University of Ottawa [Ottawa], Gillet, Catherine, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7)
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Immunology ,Psychological intervention ,Osteoarthritis ,Preoperative care ,Osteoarthritis, Hip ,Article ,law.invention ,External validity ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Randomized controlled trial ,law ,Arthropathy ,medicine ,Immunology and Allergy ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Data reporting ,Randomized Controlled Trials as Topic ,Rehabilitation ,business.industry ,Reproducibility of Results ,Osteoarthritis, Knee ,medicine.disease ,3. Good health ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,Physical therapy ,Female ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,030217 neurology & neurosurgery - Abstract
Objective To evaluate data reporting related to external validity from randomized controlled trials (RCTs) assessing pharmacologic and nonpharmacologic treatment for hip and knee osteoarthritis (OA). Methods All RCTs assessing pharmacologic treatments and nonpharmacologic treatments for hip and knee OA indexed between January 2002 and December 2006 were selected. A sample of 120 articles were randomly selected: 30 each assessing pharmacologic treatments, surgery or technical interventions, rehabilitation, and nonimplantable devices. Results The country was clearly reported in 25 (21%) reports, the setting described in 40 (33%) reports, and the number of centers in 54 (45%). Details about the centers (volume of care) were given in 24 (20%) reports. Rates were lower for surgical trials for the country (3%), the setting (3%), the number of centers (13%), and details about the centers (7%). The intervention was adequately described in all pharmacologic reports and in >80% of rehabilitation reports. The technical procedure was given in all surgical intervention trial reports, but the type of anesthesia was reported in 4 (13%), preoperative care in 2 (7%), and postoperative care in 15 (50%). The device was described in 93% of device trial reports, but the manufacturer was reported in only 33%. Conclusion There is low reporting of data related to external validity in reports of RCTs assessing pharmacologic and nonpharmacologic treatments for hip and knee OA.
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- 2009
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14. Minimal clinically important improvement and patient acceptable symptom state for subjective outcome measures in rheumatic disorders
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Tubach, Florence, Ravaud, Philippe, Beaton, Dorcas, Boers, Maarten, Bombardier, Claire, Felson, David, Van Der Heijde, Desireé, Wells, George, Dougados, Maxime, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institute for Work and Health (IWH), University of Toronto-St. Michael's Hospital-Institute of Medical Sciences, Department of Clinical Epidemiology and Biostatistics, VU University Medical Center [Amsterdam], Clinical Epidemiology Research and Training Unit, Boston University School of Medicine (BUSM), Boston University [Boston] (BU)-Boston University [Boston] (BU)-Arthritis Center, Department of Rheumatology, University Hospital Maastricht, Epidemiology and Community Medicine, University of Ottawa [Ottawa], and Hôpital Cochin [AP-HP]
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[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie - Abstract
The concepts of minimal clinically important improvement (MCII) and patient acceptable symptomatic state (PASS) could help in interpreting results of trials involving patient-reported outcomes by translating the response at the group level (change in mean scores) into more clinically meaningful information by addressing the patient level as "therapeutic success (yes/no)." The aims of the special interest group (SIG) at OMERACT 8 were to discuss specific issues concerning the MCII and PASS concepts, especially the wording of the external anchor questions used to determine the MCII and PASS estimates, and to move toward a consensus for the cutoff values to use as the MCII and PASS in the different outcome criteria. The purpose of this SIG at OMERACT 8 was to inform participants of the MCII and PASS concepts and to agree on MCII and PASS values for pain, patient global assessment, and functional impairment.
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- 2007
15. MCII and PASS
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Tubach, F., Philippe Ravaud, Beaton, D., Boers, M., Bombardier, C., Felson, D. T., Heijde, D., Wells, G., Dougados, M., Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institute for Work and Health (IWH), University of Toronto-St. Michael's Hospital-Institute of Medical Sciences, Department of Clinical Epidemiology and Biostatistics, VU University Medical Center [Amsterdam], Clinical Epidemiology Research and Training Unit, Boston University School of Medicine (BUSM), Boston University [Boston] (BU)-Boston University [Boston] (BU)-Arthritis Center, Department of Rheumatology, University Hospital Maastricht, Epidemiology and Community Medicine, University of Ottawa [Ottawa], Hôpital Cochin [AP-HP], Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques, Université Paris Diderot - Paris 7 ( UPD7 ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Assistance publique - Hôpitaux de Paris (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Institute for Work and Health ( IWH ), University Medical Center, Boston University School of Medicine-Arthritis Center, University of Ottawa, and CHU Cochin [AP-HP]
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Treatment Outcome ,Patient Satisfaction ,Health Status ,Rheumatic Diseases ,Outcome Assessment, Health Care ,Remission Induction ,Humans ,[ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,Severity of Illness Index ,Article - Abstract
The concepts of minimal clinically important improvement (MCII) and patient acceptable symptomatic state (PASS) could help in interpreting results of trials involving patient-reported outcomes by translating the response at the group level (change in mean scores) into more clinically meaningful information by addressing the patient level as "therapeutic success (yes/no)." The aims of the special interest group (SIG) at OMERACT 8 were to discuss specific issues concerning the MCII and PASS concepts, especially the wording of the external anchor questions used to determine the MCII and PASS estimates, and to move toward a consensus for the cutoff values to use as the MCII and PASS in the different outcome criteria. The purpose of this SIG at OMERACT 8 was to inform participants of the MCII and PASS concepts and to agree on MCII and PASS values for pain, patient global assessment, and functional impairment.
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- 2007
16. Reporting methods of blinding in randomized trials assessing nonpharmacological treatments
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David Moher, Candice Estellat, Philippe Ravaud, Isabelle Boutron, Asbjørn Hróbjartsson, Lydia Guittet, Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques (U738 / UMR_S738), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Diderot - Paris 7 (UPD7), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Departement of Pediatrics, University of Ottawa [Ottawa]-Children's hospital of Eastern Ontario Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa [Ottawa], Nordic Cochrane Centre, Rigshospitalet [Copenhagen], Copenhagen University Hospital-Copenhagen University Hospital, Gillet, Catherine, and Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)
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Research design ,medicine.medical_specialty ,Blinding ,Epidemiology ,MEDLINE ,Public Health and Epidemiology ,lcsh:Medicine ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,Rheumatology ,law ,Research Methods ,Medicine ,Humans ,030212 general & internal medicine ,Randomized Controlled Trials as Topic ,Systematic reviews and meta-analyses ,Evidence-Based Healthcare ,business.industry ,lcsh:R ,General Medicine ,3. Good health ,Clinical trial ,Treatment evaluation ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,Research Design ,Meta-analysis ,Physical therapy ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,Surgery ,Public Health ,business ,030217 neurology & neurosurgery ,Research Article - Abstract
Background Blinding is a cornerstone of treatment evaluation. Blinding is more difficult to obtain in trials assessing nonpharmacological treatment and frequently relies on “creative” (nonstandard) methods. The purpose of this study was to systematically describe the strategies used to obtain blinding in a sample of randomized controlled trials of nonpharmacological treatment. Methods and Findings We systematically searched in Medline and the Cochrane Methodology Register for randomized controlled trials (RCTs) assessing nonpharmacological treatment with blinding, published during 2004 in high-impact-factor journals. Data were extracted using a standardized extraction form. We identified 145 articles, with the method of blinding described in 123 of the reports. Methods of blinding of participants and/or health care providers and/or other caregivers concerned mainly use of sham procedures such as simulation of surgical procedures, similar attention-control interventions, or a placebo with a different mode of administration for rehabilitation or psychotherapy. Trials assessing devices reported various placebo interventions such as use of sham prosthesis, identical apparatus (e.g., identical but inactivated machine or use of activated machine with a barrier to block the treatment), or simulation of using a device. Blinding participants to the study hypothesis was also an important method of blinding. The methods reported for blinding outcome assessors relied mainly on centralized assessment of paraclinical examinations, clinical examinations (i.e., use of video, audiotape, photography), or adjudications of clinical events. Conclusions This study classifies blinding methods and provides a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment, and provides information for readers assessing the quality of results of such trials., An assessment of blinding methods used in nonpharmacological trials published in one year in high-impact factor journals classifies methods used and describes methods that could overcome some barriers of blinding., Editors' Summary Background. Well-conducted “randomized controlled trials” are generally considered to be the most reliable source of information about the effects of medical treatments. In a randomized trial, the play of chance is used to decide whether each patient receives the treatment under investigation, or whether he/she is assigned to a “control” group receiving the standard treatment for their condition. This helps makes sure that the two groups of patients receiving the different treatments are equivalent at the start of the trial. Proper randomization also prevents doctors from deciding which treatment individual patients are given, which could distort the results. An additional technique used is “blinding,” which involves taking steps to prevent patients, doctors, or other people involved in the trial (e.g., those recording measurements) from finding out which patients have received which treatment. Properly done, blinding should make sure the results of a trial are more accurate. This is because in an unblinded study, participants may respond better if they know they have received a promising new treatment (or worse if they only got a placebo or an old drug). In addition, doctors and others in the research team may “want” a particular treatment to perform better in the trial, and unthinking bias could creep into their measurements or actions. However, blinding is not a simple, single step; the people carrying out the trial often have to set up a variety of different procedures. Why Was This Study Done? The authors of this study had already conducted research into the way in which blinding is done in trials involving drug (“pharmacological”) treatment. Their work was published in October 2006 in PLoS Medicine. However, concealing from patients the type of pill that they are being given is much easier than, for example, concealing whether or not they are having surgery or whether or not they are having psychotherapy. The authors therefore set out to look at the methods that are in use for blinding in nonpharmacological trials. They hoped that a better understanding of the different blinding methods would help people doing trials to design better trials in the future, and also help readers to interpret the quality of completed trials. What Did the Researchers Do and Find? The authors systematically searched the published medical literature to find all randomized, blinded drug trials published in just one year (2004) in a number of different “high-impact” journals (well-regarded journals whose articles are often mentioned in other articles). Then, they classified information from the published trial reports. They ended up with 145 trial reports, of which 123 described how blinding was done. The trials covered a wide range of medical conditions and types of treatment. The blinding methods used mainly involved the use of “sham” procedures. Thus, in 80% of the studies in which the treatment involved a medical device, a pretend device had been used to make patients in the control group think they were receiving treatment. In many of the treatments involving surgery, researchers had devised elaborate ways of making patients think they had had an operation. When the treatment involved manipulation (e.g. physiotherapy or chiropractic), fake “hands-on” techniques were given to the control patients. The authors of this systematic review classify all the other techniques that were used to blind both the patients and members of the research teams. They found that some highly innovative ideas have been successfully put into practice. What Do These Findings Mean? The authors have provided a detailed description of methods that could overcome some barriers of blinding in clinical trials assessing nonpharmacological treatment. The classification of the techniques used will be useful for other researchers considering what sort of blinding they will use in their own research. Additional Information. Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040061. The James Lind Library has been created to help patients and researchers understand fair tests of treatments in health care by illustrating how fair tests have developed over the centuries ClinicalTrials.gov, a trial registry created by the US National Institutes of Health, has an introduction to understanding clinical trials The UK National Health Service National Electronic Library for Health has an introduction to controlled clinical trials The CONSORT statement is intended to strengthen evidence-based reporting of clinical trials
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- 2006
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17. Inclusion of unaffected sibs increases power in model-free linkage analysis of a behavioral trait
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Sabine Plancoulaine, Alexandre Alcaïs, Yue Chen, Laurent Abel, France Gagnon, Génétique Humaine des Maladies Infectieuses (Inserm U980), Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Epidemiology and Community Medicine, University of Ottawa [Ottawa], Génétique Humaine des Maladies Infectieuses ( Inserm U980 ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Paris Descartes - Paris 5 ( UPD5 ), Ottawa University, and Autard, Delphine
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lcsh:QH426-470 ,Locus (genetics) ,Single-nucleotide polymorphism ,[SDV.GEN] Life Sciences [q-bio]/Genetics ,Biology ,Quantitative trait locus ,Polymorphism, Single Nucleotide ,03 medical and health sciences ,Quantitative Trait, Heritable ,Gene mapping ,Genetic linkage ,[SDV.BBM] Life Sciences [q-bio]/Biochemistry, Molecular Biology ,Genetics ,Humans ,Genetics(clinical) ,[SDV.BBM]Life Sciences [q-bio]/Biochemistry, Molecular Biology ,[ SDV.BBM ] Life Sciences [q-bio]/Biochemistry, Molecular Biology ,Genetics (clinical) ,030304 developmental biology ,Behavior ,0303 health sciences ,[SDV.GEN]Life Sciences [q-bio]/Genetics ,Models, Genetic ,Siblings ,030305 genetics & heredity ,Chromosome Mapping ,lcsh:Genetics ,Proceedings ,Genetic marker ,Trait ,Microsatellite ,Lod Score ,[ SDV.GEN ] Life Sciences [q-bio]/Genetics ,Microsatellite Repeats - Abstract
Study design strategies are of critical importance in the search for genes underlying complex diseases. Two important design choices in planning gene mapping studies are the analytic strategy to be used, which will have an impact on the type of data to be collected, and the choice of genetic markers. In the present paper, we used the simulated behavioral trait data provided in the Genetic Analysis Workshop14 to: 1) investigate the usefulness of incorporating unaffected sibs in model-free linkage analysis and, 2) compare linkage results of genome scans using a 7-cM microsatellite map with a 3-cM single nucleotide polymorphisms map. To achieve these aims, we used the maximum-likelihood-binomial method with two different coding approaches. We defined the unaffected sibs as those totally free of phenotypes correlated to the disease. Without prior knowledge of the answers, we were able to correctly localize 2 out of 5 loci (LOD > 3) in a sample of 200 families that included the unaffected sibs but only one locus when based on an affected-only strategy, using either microsatellite or SNPs genome scan. LOD scores were considerably higher using the analytic strategy which incorporated the unaffected sibs. In conclusion, including unaffected sibs in model-free linkage analysis of complex binary traits is helpful, at least when complete parental data are available, whereas there are no striking advantages in using single nucleotide polymorphisms over microsatellite map at marker densities used in the current study.
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- 2005
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18. Disclosure of Investigators' Recruitment Performance in Multicenter Clinical Trials: A Further Step for Research Transparency
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Shaun Treweek, Rafael Dal-Ré, Jacques Demotes-Mainard, David Moher, Christian Gluud, Xavier Carné, Early Detection Research Program, Alzheimer's Disease, Pasqual Maragall Foundation, Epidemiology and Community Medicine, University of Ottawa [Ottawa], Copenhagen Trial Unit (CTU), Copenhagen University Hospital-Centre for Clinical Intervention Research-Danish Clinical Research Infrastructures Network, Division of Clinical Population Sciences and Education, Institut Thématique Santé Publique, Institut National de la Santé et de la Recherche Médicale (INSERM), European Clinical Research Infrastructures Network (ECRIN), Ecrin, Clinical Pharmacology Service, University of Barcelona, Universitat de Barcelona, and Autard, Delphine
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Biomedical Research ,Epidemiology ,Medical ethics ,030204 cardiovascular system & hematology ,Ètica mèdica ,law.invention ,Clinical trials ,0302 clinical medicine ,Medicine research ,Randomized controlled trial ,law ,Multicenter Studies as Topic ,Medicine ,030212 general & internal medicine ,Research Integrity ,Ciències de la salut ,Policy Forum ,Clinical Trials as Topic ,General Medicine ,Research Personnel ,MESH: Conflict of Interest ,Meta-analysis ,Publication ethics ,MESH: Disclosure ,medicine.medical_specialty ,MESH: Clinical Trials as Topic ,Science Policy ,Investigació mèdica ,Disclosure ,Medical sciences ,03 medical and health sciences ,Humans ,MESH: Patient Selection ,Trial registration ,MESH: Humans ,Conflict of Interest ,business.industry ,Patient Selection ,MESH: Biomedical Research ,Bioethics ,Transparency (behavior) ,Clinical trial ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,Family medicine ,MESH: Research Personnel ,MESH: Multicenter Studies as Topic ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,business ,Assaigs clínics - Abstract
Transparency: A Fundamental Social Obligation for Clinical Research .After 60 years devoted to enhancing the methodology and ethics in clinical research, the last decade has been crucial to the scientific community in refining the transparency on conducting clinical trials (CTs), from their inception to the publication of results. A myriad of articles have been published on the design, conduct, conflicts of interest, reporting, and publication of CTs...
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- 2011
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19. Differences between private and public primary health care centers and differences between men and women in antihypertensive care and cardiovascular prevention in all patients with hypertension treated in primary care in Stockholm County, Sweden.
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Wändell P, Norrman A, Eriksson J, Ivarsson C, Gudjonsdottir H, Hagströmer M, Lundh L, Hasselström J, Brynedal B, Sandlund C, and Carlsson AC
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- Humans, Female, Sweden epidemiology, Male, Middle Aged, Aged, Adult, Public Sector, Cardiovascular Diseases prevention & control, Cardiovascular Diseases epidemiology, Sex Factors, Aged, 80 and over, Hypertension drug therapy, Hypertension epidemiology, Primary Health Care statistics & numerical data, Antihypertensive Agents therapeutic use, Private Sector
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Aims: To study differences in cardiovascular prevention and hypertension management in primary care in men and women, with comparisons between public and privately operated primary health care (PHC)., Methods: We used register data from Region Stockholm on collected prescribed medication and registered diagnoses, to identify patients aged 30 years and above with hypertension. Age-adjusted logistic regression was used to calculate odds ratios (ORs) with 99% confidence intervals (99% CIs) using public PHC centers as referents., Results: In total, 119,267 patients with a registered hypertension diagnosis at their primary care center were included; 58,239 men and 61,028 women. In terms of co-morbidities and medications, there were some differences between privately and publicly run PHC: registered diagnosis of dementia, which was higher at private PHC, age-adjusted OR 1.80 (1.24-2.69). For lifestyle counseling, privately run PHC had a higher rate of registered counseling for tobacco 1.17 (1.06-1.29), physical activity 1.13 (1.06-1.17), unhealthy diet 1.08 (1.04-1.13), and counseling according to highest prioritized level of advice stated by national guidelines 1.14 (1.09-1.18). Differences in comorbidities between men and women were found, with higher frequencies of coronary heart disease, congestive heart failure, atrial fibrillation, stroke, diabetes, and gout among men. Regarding antihypertensive treatment, women received less treatment of calcium channel blockers and ACE inhibitors, but more of angiotensin receptor blockers., Conclusions: These findings highlight the need for targeted preventive efforts in PHC, especially for male patients, to address disparities in cardiovascular health outcomes. Small differences in preventive measures between public and privately run PHC suggest generally consistent care across healthcare ownership models., Competing Interests: Declarations. Ethics approval and consent to participate: This study received ethical approval from Zhongshan Hospital, Fudan University (B2021-605). The online questionnaire includes a checkbox for respondents to make sure whether they give their voluntary informed consent before their involvement. The study was conducted in accordance with the Declaration of Helsinki. All authors gave their consent for publication. Ethical approval was obtained from the Ethics Review Authority, number 2020–07076 with an amendment 2121-06102-02. Consent to Participate declarations from the participants were not applicable as we used data from health record register, however, the use of these data was approved from Ethics Review in Stockholm. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)
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- 2025
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20. Exploring socio-economic inequalities in mental healthcare utilization in adults with self-reported psychological distress: a survey-registry linked cohort design.
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Muwonge JJ, Dalman C, Burström B, Jablonska B, and Hollander AC
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- Humans, Adult, Middle Aged, Sweden epidemiology, Male, Female, Young Adult, Adolescent, Healthcare Disparities statistics & numerical data, Health Services Accessibility statistics & numerical data, Surveys and Questionnaires, Cohort Studies, Stress, Psychological epidemiology, Stress, Psychological psychology, Psychological Distress, Patient Acceptance of Health Care statistics & numerical data, Patient Acceptance of Health Care psychology, Mental Health Services statistics & numerical data, Registries, Socioeconomic Factors, Self Report
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Aims: Although individuals with lower socio-economic position (SEP) have a higher prevalence of mental health problems than others, there is no conclusive evidence on whether mental healthcare (MHC) is provided equitably. We investigated inequalities in MHC use among adults in Stockholm County (Sweden), and whether inequalities were moderated by self-reported psychological distress., Methods: MHC use was examined in 31,433 individuals aged 18-64 years over a 6-month follow-up period, after responding to the General Health Questionnaire-12 (GHQ-12) in 2014 or the Kessler Six (K6) in 2021. Information on their MHC use and SEP indicators, education, and household income, were sourced from administrative registries. Logistic and negative binomial regression analyses were used to estimate inequalities in gained MHC access and frequency of outpatient visits, with psychological distress as a moderating variable., Results: Individuals with lower education or income levels were more likely to gain access to MHC than those with high SEP, irrespective of distress levels. Education-related differences in gained MHC access diminished with increasing distress, from a 74% higher likelihood when reporting no distress (odds ratio, OR = 1.74 [95% confidence interval, 95% CI: 1.43-2.12]) to 30% when reporting severe distress (OR = 1.30 [0.98-1.72]). Comparable results were found for secondary care but not primary care i.e., lower education predicted reduced access to primary care in moderate-to-severe distress groups (e.g., OR = 0.63 [0.45-0.90]), and for physical but not digital services. Income-related differences in gained MHC access remained stable or increased with distress, especially for secondary care and physical services., Conclusions: Overall, individuals with lower education and income used MHC services more than their counterparts with higher socio-economic status; however, low-educated individuals faced inequities in primary care and underutilized non-physician services such as visits to psychologists.
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- 2025
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21. Risk Stratification for Cardiovascular Disease: A Comparative Analysis of Cluster Analysis and Traditional Prediction Models.
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Yacaman Mendez D, Zhou M, Brynedal B, Gudjonsdottir H, Tynelius P, Lagerros YT, and Lager A
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Aim: Primary prevention of cardiovascular disease (CVD) relies on effective risk stratification to guide interventions. Current models, primarily developed using regression analysis, can lead to inaccurate estimates when applied to external populations. This study evaluates the utility of cluster analysis as an alternative method for developing CVD risk stratification models, comparing its performance with established CVD risk prediction models., Methods: Using data from 3,416 individuals (mean age of 66 years and no prior CVD) followed for an average of 5.2 years for incidence of CVD, we developed a risk stratification model using cluster analysis based on established CVD risk factors. We compared our model to the Systematic Coronary Risk Evaluation (SCORE2), the Pooled Cohort Equations (PCE) and the Predicting Risk of Cardiovascular Disease Events (PREVENT) models. We used Poisson and Cox regression to compare CVD risk between risk categories in each model. Predictive accuracy of the models was evaluated using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and C-statistic., Results: During the study, 161 CVD events were detected. The high-risk cluster had a sensitivity of 59.0%, a PPV of 7.5% a specificity of 64.2% and NPV of 96.9% to predict CVD. Compared to the high-risk groups of the SCORE2, PCE and PREVENT, the high-risk cluster had a high sensitivity and NPV, but a low specificity and PPV. No statistically significant differences were found in C-statistic between models., Conclusions: Cluster analysis performed comparably to existing models and identified a larger high-risk group that included more individuals who developed CVD, though with more false positives. Further studies in larger, diverse cohorts are needed to validate the clinical utility of cluster analysis in CVD risk stratification., (© The Author(s) 2025. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2025
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22. Correction: A descriptive epidemiological study of the prevalence of self-reported sensory difficulties by age group, sex, education, disability, and migration status in Sweden in 2020.
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Badache AC, Mäki-Torkko E, Widen S, and Fors S
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- 2025
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23. Trajectories of Change, Illness Understanding, and Parental Worries in Children and Adolescents Undergoing Internet-Delivered Cognitive-Behavioral Therapy for Functional Abdominal Pain Disorders: Protocol for a Single-Case Design and Explorative Pilot Study.
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Skovslund Nielsen E, Kallesøe K, Bennedsen Gehrt T, Bjerre-Nielsen E, Lalouni M, Frostholm L, Bonnert M, and Rask CU
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- Adolescent, Child, Female, Humans, Male, Anxiety therapy, Anxiety psychology, Internet, Internet-Based Intervention, Pilot Projects, Quality of Life psychology, Clinical Trials as Topic, Abdominal Pain therapy, Abdominal Pain psychology, Cognitive Behavioral Therapy methods, Parents psychology, Parents education
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Background: Functional abdominal pain disorders (FAPDs) are common in young people and are characterized by persistent or recurrent abdominal symptoms without apparent structural or biochemical abnormalities. FAPDs are associated with diminished quality of life, school absence, increased health care use, and comorbid anxiety and depression. Exposure-based internet-delivered cognitive behavioral therapy (ICBT) has demonstrated efficacy in alleviating abdominal symptoms and improving quality of life. However, a deeper understanding of effect mechanisms and identification of possible additional treatment targets could refine treatment., Objective: This protocol paper aims to describe a study focusing on children and adolescents undergoing ICBT for FAPDs, aiming to further investigate the underlying mechanisms of effect., Methods: Children (8-12 years), adolescents (13-17 years) with FAPDs, and their respective parents will be included for 10 weeks for ICBT. First, detailed trajectories of effect are examined through a randomized single-case design study involving 6 children and 6 adolescents (substudy 1). Following this, an open-ended explorative pilot study with 30 children and 30 adolescents explores potential illness-related cognitive biases and interoceptive accuracy before and after treatment (substudy 2). Finally, spanning across these 2 substudies, including all parents from substudies 1 and 2, we will assess parental distress and illness worries before and after treatment, and how these factors impact the treatment adherence and outcomes of the child or adolescent (substudy 3)., Results: Recruitment of participants began in June 2022 and is finalized for substudy 1 and ongoing for substudies 2 and 3. Recruitment is expected to be completed by January 2025, with final data collection during April 2025., Conclusions: The findings have the potential to contribute to the ongoing improvement of specialized psychological treatment for FAPDs in young people., Trial Registration: ClinicalTrials.gov NCT05237882; https://clinicaltrials.gov/study/NCT05237882; ClinicalTrials.gov NCT05486585; https://clinicaltrials.gov/study/NCT05486585; OSF Registries osf.io/c49k7; https://osf.io/c49k7., International Registered Report Identifier (irrid): DERR1-10.2196/58563., (©Eva Skovslund Nielsen, Karen Kallesøe, Tine Bennedsen Gehrt, Ellen Bjerre-Nielsen, Maria Lalouni, Lisbeth Frostholm, Marianne Bonnert, Charlotte Ulrikka Rask. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 07.01.2025.)
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- 2025
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24. Effects on Body Mass Index After the Philadelphia Beverage Tax.
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Janson A and Elinder LS
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- 2025
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25. Men's Attitudes Towards Participation in Organised Prostate Cancer Testing: An Abductive Thematic Analysis.
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Arvendell M, Phillips L, Delilovic S, Enelius MB, Olsson K, Bolejko A, Akre O, Carlsson S, Richter A, and Lantz A
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Background and Objective: Organised prostate cancer (PCa) testing (OPT) was introduced in Sweden to gain knowledge in preparation for a potential national PCa screening programme. This study aims to explore men's opinions regarding the OPT invitation letters and the attitudes influencing their decision to participate in or decline OPT., Methods: We conducted semi-structured telephone interviews with 30 men (nine participants and 21 non-participants) from Stockholm County who received OPT invitations. We employed an abductive thematic analysis, a reflexive process of identifying theoretical explanations of emerging patterns, to identify themes in men's responses., Key Findings and Limitations: Informants found the invitation letters informative and appreciated the screening opportunity, but suggested improvements regarding conciseness and clarity about the risks and benefits of testing. Barriers to participation included lack of time or motivation, fear of discovering illness, inaccessibility, and distrust of health care or medical procedures. Facilitators included a desire to confirm or rule out PCa, and taking advantage of the available screening opportunity. Limitations include the study's single-county focus and a potential recall bias affecting responses., Conclusions and Clinical Implications: Men's attitudes towards OPT participation are multifaceted. While men appreciate screening opportunities, practical considerations as well as personal and psychological factors influence their participation decisions. To improve informed decision-making, OPT communication should be clear about the benefits and risks, and accessibility and logistical challenges should be addressed. Enhancing understanding and reducing fears are essential for refining screening practices and aligning these with men's needs., Patient Summary: Men value the option for prostate cancer screening, but face barriers such as low motivation and fear of a cancer diagnosis. Clear communication could improve their understanding of screening and encourage informed decision-making regarding participation in organised prostate cancer testing. Improved accessibility to testing could enhance participant opportunity., (© 2024 The Author(s).)
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- 2024
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26. Climate worry: associations with functional impairment, pro-environmental behaviors and perceived need for support.
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Lenhard F, Fernández de la Cruz L, Wahlund T, Andersson E, Åhlén J, Fuso Nerini F, Akay H, and Mataix-Cols D
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- Humans, Female, Male, Cross-Sectional Studies, Middle Aged, Adult, Sweden, Depression psychology, Social Support, Aged, Surveys and Questionnaires, Sleep Wake Disorders psychology, Young Adult, Anxiety psychology
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Background: A large proportion of individuals experience functional impairment in everyday life due to climate worry. However, the current understanding of this functional impairment is limited by the use of suboptimal measures. Furthermore, it is not known whether functional impairment due to climate worry affects pro-environmental behaviors (PEBs) or whether individuals who experience such impairment perceive a need for support. The aims of the current study were (1) to extend previous research using an established measure of functional impairment (the Work and Social Adjustment Scale, WSAS), (2) to explore the associations between climate worry, functional impairment, and PEBs, and (3) to describe the characteristics and the perceived need for support of individuals with functional impairment due to climate worry., Methods: A cross-sectional survey targeting adult individuals who experience climate worry. Participants were recruited nationally in Sweden between September and October 2022. The survey included measures of climate worry severity, climate worry frequency, functional impairment, PEBs, depressive symptoms, sleep problems, and questions related to perceived need for support., Results: A total of 1221 adults (75% women, mean age 46.3 years) were included in the analyses. Multivariate structural equation modeling revealed that climate worry severity and frequency were significantly associated with PEBs (β = 0.34 and β = 0.45, respectively). Climate worry frequency was associated with functional impairment (β = 0.41). Functional impairment was only marginally associated with PEBs (β = 0.05). Approximately 40% of the sample (n = 484) reported a high frequency and high severity of climate worry. Among these, one-third (n = 153) scored above the cutoff for significant impairment on the WSAS. Individuals in this group (high severity and frequency of climate worry as well as significant functional impairment) were more likely to experience depressed mood and sleep problems and were more interested in receiving support, specifically concerning strategies for worry management and sustainable behavior change., Conclusions: Using an established measure of functional impairment, we found an association of climate worry with functional impairment and PEBs. Importantly, as there is a perceived need for support in individuals with impairment due to climate worry, interventions targeting this specific subgroup should be developed., Competing Interests: Declarations. Ethics approval and consent to participate: All participants provided informed consent prior to study participation. Due to the anonymity and nonexperimental nature of the data collection procedures, this study was exempt from ethical review according to the Swedish Ethics Review Act. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)
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- 2024
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27. Evidence is not enough: health technology reassessment to de-implement low-value care.
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Ingvarsson S, Hasson H, von Thiele Schwarz U, Nilsen P, Roczniewska M, and Augustsson H
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- Humans, Sweden, Stakeholder Participation, Biomedical Technology, Evidence-Based Medicine, Technology Assessment, Biomedical, Qualitative Research, Delivery of Health Care
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Background: The use of low-value care (LVC) is a persistent challenge in health care. Health technology reassessment (HTR) assesses the effects of technologies currently used in the health care system to guide optimal use of these technologies. Consequently, HTR holds promises for identifying and reducing, i.e., de-implementing, the use of LVC. There is limited research on how HTR is executed to support the de-implementation of LVC and whether and how HTR outcomes are translated into practical application. The aim of this study is to investigate how HTR is conducted to facilitate de-implementation of LVC and to investigate how the results of HTR are received and acted on in health care settings., Methods: This study is a qualitative interview study with representatives from health technology assessment agencies (n = 16) that support the regional health care organizations in Sweden and with representatives from the health care organizations (n = 7). Interviews were analysed with qualitative content analysis., Results: We identified three overarching categories for how HTR facilitates de-implementation of LVC and how the results are received and acted on in health care settings: (1) involving key stakeholders to facilitate de-implementation of LVC in identifying potential LVC practices, having criteria for accepting HTR targets, ascertaining high-quality reports and disseminating the reports; (2) actions taken by health care organization to de-implement LVC by priority setting and decision-making, networking between health care organizations and monitoring changes in the use of LVC practices; and (3) sustaining use of LVC by not questioning continued use, continued funding of LVC and by creating opinion against de-implementation., Conclusions: Evidence is not enough to achieve de-implementation of LVC. This has made health technology assessment agencies and health care organizations widen the scope of HTR to encompass strategies to facilitate de-implementation, including involving key stakeholders in the HTR process and taking actions to support de-implementation. Despite these efforts, there can still be resistance to de-implementation of LVC in passive forms, involving continued use of the practice and more active resistance such as continued funding and opinion-making opposing de-implementation. Knowledge from implementation and de-implementation research can offer guidance in how to support the execution phase of HTR., Competing Interests: Declarations. Ethics approval and consent to participate: The study was reviewed by the Swedish Ethical Review Authority, which judged that approval was not required under Swedish national law [reference number 2019:02467]. All participants were treated in accordance with ethical guidelines. Written informed consent was obtained from all study participants. Consent for publication: Informed written consent was obtained from all study participants. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)
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- 2024
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28. Population Trends and Individual Fluidity of Sexual Identity Among Stockholm County Residents.
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Zhang G, Tynelius P, Mathur MB, Quartagno M, Brandén G, Liljeros F, and Kosidou K
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- 2024
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29. Parents' comprehensive health literacy and child health after attending extended home visiting in Swedish multicultural settings-A case-comparison study.
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Mekhail KT, Burström B, Marttila A, Wångdahl J, and Lindberg L
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- Humans, Sweden, Female, Male, Infant, Case-Control Studies, Adult, Child Health, Infant, Newborn, Cultural Diversity, Health Literacy statistics & numerical data, Parents psychology, House Calls statistics & numerical data
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Background: Parents' low health literacy (HL) has negative impacts on child health. Parental interventions may improve parents' HL and thus impact child health positively., Objectives: This study aimed to gain knowledge about associations between parents' comprehensive HL (CHL) and child health after an extended postnatal home visiting program in Swedish multicultural, disadvantaged settings compared to parents receiving regular child healthcare (CHC)., Materials and Methods: This quasi-experimental study used a case-control sampling method to recruit first-time parents through two CHC centres in Stockholm (2017-2020). Participants (N = 151) were interviewed twice through structured questionnaires when their child was <2 months and 15-18 months old. HLS-EU-Q16 assessed parents' CHL. Children's medical records (0-18 months) were reviewed regarding breastfeeding, children's exposure to smoking, language development and healthcare utilisation. Data were analysed with regression models and non-parametric tests., Results: No significant association was found between parents' CHL and child health. However, significantly fewer unplanned visits to the CHC centre were observed among children (0-18 months) in the intervention group irrespective of CHL, compared with children to parents with improved CHL in the comparison group (F = 3.856, p = 0.011)., Conclusions: Postnatal home visiting interventions practicing proportional universalism and family-centred care may reduce unplanned visits within CHC in disadvantaged settings despite parents' CHL. Further studies with long-term follow-up are suggested to explore associations between parents' CHL and child health., Trial Registration: As a clinical study (not a clinical trial) with appropriate ethical permission with participants' consents, this study was retrospectively registered (18 February 2020) in the ISRCTN registry (ISRCTN10336603)., (© 2024 The Author(s). Scandinavian Journal of Caring Sciences published by John Wiley & Sons Ltd on behalf of Nordic College of Caring Science.)
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- 2024
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30. Gender variability in palpation performance for temporomandibular disorders with three different methods: An experimental study.
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Faghihian H, Böthun A, Häggman-Henrikson B, Lalouni M, Svensson P, Hellström F, Andersson L, and Lövgren A
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- Humans, Female, Male, Sex Factors, Adult, Pain Measurement methods, Pressure, Facial Pain physiopathology, Facial Pain diagnosis, Young Adult, Feedback, Sensory, Palpation, Temporomandibular Joint Disorders diagnosis, Temporomandibular Joint Disorders physiopathology
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Gender differences in pain reporting and prevalence have been demonstrated. As gender of examiner also affects reporting of pain on palpation, the aim of this study was to evaluate the effects of examiner gender on palpation performance using three different palpation methods. Examiners of both genders were instructed on the correct technique for each palpation method by either a female or male instructor. The target was to achieve a pressure of 100 kPa, corresponding to the 1 kg of force for muscle palpation described in the diagnostic criteria for temporomandibular disorders (DC/TMD). All examiners performed traditional palpation with the index finger, palpation with a palpometer, and a novel bimanual palpation with visual feedback, in a randomized order. The examiner's gender, and its interaction with the gender of the instructor did not significantly affect magnitude, accuracy, or precision of the pressure applied. The method of palpation was the only factor that significantly impacted all metrics. The palpometer achieved the lowest palpation magnitude (mean pressure applied = 113.7 kPa, 95% CI: 109.8-117.6), the highest accuracy (absolute difference = 15.7 kPa, 95% CI: 12.3-19.1), and the highest precision (mean coefficient of variation = 6.8, 95% CI: 6.0-7.6), followed by bimanual palpation and traditional palpation. The results suggest that gender differences in pain reporting in patients are not likely to be a result of the technical aspects associated with the gender of the examiner. Instead, these differences may be attributed to other factors, such as sociocultural influences., (© 2024 The Author(s). European Journal of Oral Sciences published by John Wiley & Sons Ltd on behalf of Scandinavian Division of the International Association for Dental Research.)
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- 2024
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31. What is person-centred care in Swedish ambulance service? - A qualitative exploratory study.
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Jacobsen A, Tistad M, Bergström A, Hörberg A, Wallin L, and Rantala A
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- Humans, Sweden, Female, Interviews as Topic, Male, Adult, Middle Aged, Qualitative Research, Ambulances, Patient-Centered Care
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Introduction: Healthcare in Sweden is moving towards a more person-centred approach in which patients are respected as capable individuals with unique needs. Partnership, the co-creation of health plans, and documentation are core components of this approach. The ambulance service is medical- and task-oriented, possibly placing it in conflict with the goals of person-centred care (PCC)., Aim: To explore how nurses in the Swedish ambulance service describe PCC., Method: A qualitative interview study with eight nurses who served as facilitators for implementing ambulance PCC. Data was analysed using content analysis., Findings: The analysis resulted in the main category Ambulance PCC is diffuse but applicable and in the three categories: Do good based on an ethical approach, Assemble the patient's narrative from multiple sources and Create and agree on a plan., Conclusion: Ambulance PCC is perceived as a diffuse concept, with unclear translation into practice. The findings highlight the need to determine appropriate levels of care, manage technical equipment without disrupting communication and embody attributes such as calmness and empathy. Despite its ambiguity, ambulance PCC was seen as applicable across all care stages, although requiring adjustments based on urgency, individual circumstances and care setting., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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32. Advancing composite outcome measures: Insights on weighting components from OMERACT 2023.
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Wells GA, Guillemin F, Merkel PA, de Wit M, Mackie S, March L, Tómasson G, King LK, Cembalo SM, Grosskleg S, Maxwell LJ, Monti S, Quinn KA, Shea BJ, Tugwell P, and Beaton D
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- Humans, Rheumatology, Outcome Assessment, Health Care, Rheumatic Diseases therapy
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Objective: The OMERACT Composite Working Group hosted a workshop at OMERACT 2023 to explore the complexities of weighting components in the development of composite outcomes. This study presents the methodology and findings of this workshop, exploring the complexities of weighting the individual components of composite outcome measures., Methods: The workshop featured a multifaceted program, beginning with a plenary session that introduced the concept of composite outcomes, shared a patient's journey with rheumatic disease through a narrative, illustrated a composite outcome for Osteoarthritis Flares, and outlined the five domains selected for this composite outcome. A breakout exercise engaged participants in ranking and assigning weights to these domains, followed by group discussions to reach a consensus on weights. The workshop concluded with another plenary session that discussed various weighting approaches, including discrete choice and conjoint analysis from the ANCA-Associated Vasculitis working group, and outlined future directions for research on composite outcome methods., Results: The breakout exercise revealed the challenges in assigning relative importance to different domains, highlighting the variability in participant perspectives. Consensus discussions highlighted the diversity in approaches to weighting, the need for appropriate methods to determine domain weights and the impact of such weights on the interpretation of composite scores., Conclusion: The OMERACT 2023 workshop underscored the significance of a systematic approach to weighting components in composite outcome development. It highlighted the complexity of achieving consensus on the importance of domains and the role of incorporating the perspectives of patient research partners in this process. Future research directions include refining weighting methodologies, moving composites through the OMERACT Filter and enhancing understanding of their implications for clinical trials. The findings contribute to the ongoing discourse on optimizing composite outcome measures in rheumatology and beyond, advocating for a balanced integration of scientific rigour and patient-centeredness in their development., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Peter Tugwell receives consulting fees from Reformulary Group for providing independent medical consultation professional services to the firms listed in this section. Participation on a Data Safety Monitoring Board or Advisory Board for UCB Biopharma GmbH & SPRL Parexel International Prahealth Sciences. Is an independent Committee Member for clinical trial Data Safety Monitoring Boards for FDA approved trials being conducted by: UCB Biopharma GmbH & SPRL Parexel International Prahealth Sciences Other financial or non-financial interests with Abbvie, Astra Zenaca, Aurinia, BMS, Centrexion, GSK, Horizon Pharma Inc, Janssen, Novartis, Pfizer & Sparrow. He is [unpaid] Chair of the Management Group of a registered non-profit independent medical research organization, OMERACT, whose goal is to improve and advance the health outcomes for patients suffering from musculoskeletal conditions. OMERACT receives arms-length funding from 8 companies. Dorcas Beaton has an unpaid leadership role as a member of the Management team at OMERACT, co-chair of the methods group, and technical advisory group of OMERACT. Maarten de Wit receives consulting fees from Evidera (Patient Partner Advisory Council), honoraria from UCB 2022, 2023 for facilitating a workshop. Sara Monti received consulting fees from CLS-Vi for AstraZeneca All other authors have no conflicts to declare., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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33. Aromatherapy Using Lavender Oil Effectiveness on Pain and Anxiety After C-Section: A Randomized Controlled Trial.
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Nouira M, Souayeh N, Kanzari SA, Rouis H, Lika A, Mbarki C, Rahali FZ, and Bettaieb H
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- Humans, Female, Adult, Double-Blind Method, Pregnancy, Treatment Outcome, Oils, Volatile therapeutic use, Oils, Volatile administration & dosage, Aromatherapy methods, Lavandula, Cesarean Section adverse effects, Cesarean Section psychology, Plant Oils therapeutic use, Plant Oils administration & dosage, Pain, Postoperative drug therapy, Pain, Postoperative therapy, Pain, Postoperative etiology, Pain, Postoperative prevention & control, Anxiety therapy, Anxiety etiology, Anxiety prevention & control
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Background: Managing postoperative setting, regarding pain and anxiety after cesarean delivery is crucial for the mother's recovery, her emotional well-being, mother-infant bonding and initiating breastfeeding. Although some research have suggested that aromatherapy with lavender essential oil can be effective in reducing pain and anxiety in various medical settings, the efficacy of lavender aromatherapy in the postoperative setting after cesarean delivery is less well-studied. We aimed to assess the effectiveness of lavender essential oil therapy in the management of pain and anxiety after cesarean delivery., Methods: This was a monocentric randomized controlled double-blind trial conducted over a period of five months during 2023. A hundred women undergoing c-sections under spinal anesthesia were enrolled and randomly assigned; using block randomization of 4 items per block with allocation ratio 1:1, into two groups: The aromatherapy group (receiving inhaled Lavender essential oil) versus the placebo group (receiving distilled water instead). The primary outcomes were pain (at rest and after mobilization) and anxiety levels and after the intervention. This trial was registered on clinical-trials.org (NCT06387849)., Results: A total of 100 women were included (50 women in each group aromatherapy and the placebo group). The two groups were comparable regarding baseline characteristics and pre-intervention parameters with no statistically significant difference. After the intervention, the pain at rest (38,76 ± 22,9 vs. 23,84 ± 18,01; p < 0.001), the pain after mobilization (60,28 ± 23,72 vs. 40,12 ± 22,18; p < 0.001), and degree of anxiety (46,76 ± 6,59 vs. 44,3 ± 5,17; p = 0.03) were all significantly lower in the aromatherapy group. No adverse effects were reported by participants in both groups., Conclusion: Aromatherapy using Lavender essential oil is effective in reducing pain and anxiety after cesarean delivery without adverse effects., Competing Interests: Declarations. Ethics Approval and Consent to Participate: The study protocol was approved by the local Institutional Review Board (approval no. 03/2023). This trial was registered on clinical-trials.org (NCT06387849) on April 2024. Competing Interests: The authors declare no competing interests. All included women gave their informed written consent to take part in the study after explaining its purpose., (© 2024. The Author(s).)
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- 2024
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34. Antiseizure medication use during pregnancy and children's neurodevelopmental outcomes.
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Madley-Dowd P, Ahlqvist VH, Forbes H, Rast JE, Martin FZ, Zhong C, Barry CS, Berglind D, Lundberg M, Lyall K, Newschaffer CJ, Tomson T, Davies NM, Magnusson C, Rai D, and Lee BK
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- Humans, Pregnancy, Female, Child, Sweden epidemiology, Pregnancy Complications drug therapy, Lamotrigine adverse effects, Lamotrigine therapeutic use, Male, United Kingdom epidemiology, Child, Preschool, Registries, Topiramate adverse effects, Topiramate therapeutic use, Autistic Disorder drug therapy, Autistic Disorder chemically induced, Adult, Attention Deficit Disorder with Hyperactivity drug therapy, Attention Deficit Disorder with Hyperactivity epidemiology, Neurodevelopmental Disorders chemically induced, Neurodevelopmental Disorders epidemiology, Epilepsy drug therapy, Cohort Studies, Adolescent, Infant, Anticonvulsants adverse effects, Anticonvulsants therapeutic use, Prenatal Exposure Delayed Effects chemically induced, Prenatal Exposure Delayed Effects epidemiology, Intellectual Disability epidemiology, Valproic Acid adverse effects, Valproic Acid therapeutic use, Carbamazepine adverse effects, Carbamazepine therapeutic use
- Abstract
The teratogenic potential of valproate in pregnancy is well established; however, evidence regarding the long-term safety of other antiseizure medications (ASMs) during pregnancy remains limited. Using routinely collected primary care data from the UK and nationwide Swedish registries to create a cohort of 3,182,773 children, of which 17,495 were exposed to ASMs in pregnancy, we show that those exposed to valproate were more likely to receive a diagnosis of autism, intellectual disability, and ADHD, when compared to children not exposed to ASMs. Additionally, children exposed to topiramate were 2.5 times more likely to be diagnosed with intellectual disability (95% CI: 1.23-4.98), and those exposed to carbamazepine were 1.25 times more likely to be diagnosed with autism (95% CI: 1.05-1.48) and 1.30 times more likely to be diagnosed with intellectual disability (95% CI: 1.01-1.69). There was little evidence that children exposed to lamotrigine in pregnancy were more likely to receive neurodevelopmental diagnoses. While further research is needed, these findings may support considering safer treatment alternatives well before conception when clinically appropriate., Competing Interests: Competing interests T.T. has received support to the EURAP pregnancy registry from Accord, Eisai, GSK, UCB, Bial, Sanofi, GW Pharma, Teva, Angelini Pharma, Zentiva, SF Group, Glenmark and personal fees from Eisai, Sanofi, UCB and Angelini Pharma outside the submitted work. BL reports receiving consulting fees from Beasley Allen Law Firm, Patterson Belknap Webb & Tyler LLP and AlphaSights. None of the above entities had any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The remaining authors have no conflicts of interest., (© 2024. The Author(s).)
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- 2024
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35. Corrigendum to "Residential exposure to transportation noise and risk of incident atrial fibrillation: a pooled study of 11 prospective Nordic cohorts" [The Lancet Regional Health - Europe, Volume 46, November 2024, 101091].
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Thacher JD, Roswall N, Ögren M, Pyko A, Åkesson A, Oudin A, Rosengren A, Poulsen AH, Eriksson C, Segersson D, Rizzuto D, Helte E, Andersson EM, Aasvang GM, Engström G, Gudjonsdottir H, Selander J, Christensen JH, Brandt J, Leander K, Overvad K, Mattisson K, Eneroth K, Stucki L, Barregard L, Stockfelt L, Albin M, Simonsen MK, Raaschou-Nielsen O, Jousilahti P, Tiittanen P, Ljungman PLS, Jensen SS, Gustafsson S, Yli-Tuomi T, Cole-Hunter T, Lanki T, Lim YH, Andersen ZJ, Pershagen G, and Sørensen M
- Abstract
[This corrects the article DOI: 10.1016/j.lanepe.2024.101091.]., (© 2024 The Author(s).)
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- 2024
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36. Effect of a multicomponent school-based intervention with parental involvement on socioeconomic inequalities in smoking initiation: equity impact analysis of the TOPAS study.
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Beeres D, Galanti MR, Nilsson M, and Pulkki-Brännström AM
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Background: As prevalence of tobacco use falls, socioeconomic inequalities in tobacco use are increasing in many high-income countries. Evidence is lacking on the effect of preventive interventions on socioeconomic inequalities in smoking initiation among adolescents. We evaluated whether a multicomponent school-based prevention programme with parental involvement has differential effects on smoking initiation across socioeconomic groups and affects the magnitude of socioeconomic inequalities in smoking initiation., Methods: A secondary analysis of data from a 3-year cluster randomised controlled trial, the TOPAS study, conducted in Sweden from 2018 to 2021. Schools were randomised either to the full programme (Tobacco-Free Duo, T-DUO) or minimal intervention (EDU). The analysis was conducted according to intention to treat for the primary outcome, the probability of remaining a non-user of cigarettes at the end of compulsory school (ages 15-16). Parents' educational attainment was the socioeconomic variable. Differential effects were analysed by comparing adolescents exposed to T-DUO with those exposed to EDU within each socioeconomic group. The effect of the intervention on the magnitude of inequalities was analysed by comparing several measures of absolute and relative inequalities between T-DUO and EDU., Results: At the end of follow-up, the full programme had a similar, at most moderate effect on smoking initiation in all socioeconomic groups (relative risk 1.13 (95% CI 1.02 to 1.25) in the middle group). The programme did not significantly affect the magnitude of inequalities (Slope Index of Inequality difference 1.49 (95% CI -15.34 to 18.32))., Discussion: Socioeconomic inequalities in smoking initiation remain substantial. Our results indicate the absence of an effect of the programme T-DUO on these inequalities., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)
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- 2024
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37. KNOWLEDGE AND PERCEPTION OF HUMAN PAPILLOMAVIRUS VACCINE AMONG ADOLESCENTS AND CAREGIVERS IN JOS METROPOLIS, PLATEAU STATE, NIGERIA.
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Tony-Okeke TO, Zoakah JH, Odoh AF, Nnorom OC, Aule SK, Mathew M, and Envuladu EA
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- Humans, Nigeria, Female, Adolescent, Male, Adult, Uterine Cervical Neoplasms prevention & control, Young Adult, Middle Aged, Health Knowledge, Attitudes, Practice, Papillomavirus Vaccines administration & dosage, Papillomavirus Infections prevention & control, Caregivers psychology, Focus Groups, Patient Acceptance of Health Care psychology, Parents psychology
- Abstract
Introduction: HPV infection is well-recognized as a cause of nearly all cases of cervical cancer. There are currently three prophylactic HPV vaccines; a bivalent (Cervarix), a quadrivalent (Gardasil), and a nonavalent vaccine (Gardasil- 9). With the recent rollout of HPV vaccines in Nigeria, it is imperative to understand potential barriers and facilitators to its uptake., Objectives: The objectives of this study were to evaluate the awareness, perception, and willingness to accept HPV vaccine and explore enablers and barriers to HPV vaccine uptake among adolescents and caregivers., Methods: Four focus group discussions were conducted with adolescents from public and private secondary schools in Plateau, 4 with the parents of adolescents, and one IDI with the head of ANCOPSS. Each FGD had between 8-12 participants. Interviews were recorded and notes were taken. The interviews were transcribed, codes were generated and analysis was conducted using a thematic framework approach with NVIVO version 11 software., Results: Most participants demonstrated inadequate knowledge and poor perception of HPV and the vaccine. Girls were willing to accept the vaccine, while boys saw it as a female problem. Parents had limited knowledge but expressed willingness to allow their children to be vaccinated. The fear of side effects, poor vaccine quality, and lack of parental approval were major barriers expressed by the girls while myths and misconceptions regarding the vaccine interference with fertility and as a means of population control were significant barriers on the parts of the parents., Conclusion: Low awareness and poor perception of HPV vaccine exist among adolescents and caregivers. Long-term individual and community-level interventions are needed to provide accurate information address knowledge gaps and promote inclusive access., Competing Interests: The Authors declare that no competing interest exists, (Copyright © 2024 by West African Journal of Medicine.)
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- 2024
38. Can a smoking cessation app benefit individuals in disadvantaged areas? A qualitative study on motivation, barriers, and perceptions of a digital app.
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Åsbring N, Dini S, Madsen S, and Stjernschantz Forsberg J
- Abstract
Objective: In Sweden, the prevalence of daily smoking has decreased substantially over the past few decades. However, a socioeconomic divide is evident, contributing to health inequities. The current study focuses on the needs, facilitators, and barriers in relation to quitting smoking among individuals in disadvantaged areas and explores their perception of digital tools for smoking cessation., Method: Semi-structured interviews were conducted with 30 participants in Stockholm County between 2022 and 2023. Participants were recruited through health care centres, dental clinics, and civil society actors. A thematic analysis was performed., Results: Two cross-cutting main themes were identified; 1) Motivational factors and barriers in smoking cessation, including the subthemes "health, concern for loved ones and economic aspects" and "emotional, environmental, and cultural barriers" and 2) Benefits and limitations of a digital tool for smoking cessation, including the subthemes"important/relevant features in a digital app" and "limitations of digital support"., Conclusions: The results reveal that most participants want to quit smoking but perceive it as difficult. The study highlights the importance of addressing social disparities in smoking and the need for accessible smoking cessation support. While mobile apps are viewed as promising for smoking cessation by some of the participants, scepticism exists among others. Moving forward, personalized approaches that integrate digital tools with traditional methods for smoking cessation can be important to reduce smoking prevalence. Ensuring accessibility of effective smoking cessation support for all is a key public health interest., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)
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- 2024
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39. Perceived social support and symptoms of depression and anxiety in emerging adulthood: A Swedish prospective cohort study.
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Låftman SB, Lundin A, and Östberg V
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Aims: The transition from adolescence to young adulthood, often referred to as 'emerging adulthood', is a challenging period in life, and mental health problems are common. Although a large number of studies have shown that social support is linked with fewer mental health problems, few longitudinal studies have examined these associations during this life phase. The aim of the current study was to examine the associations between perceived social support from different sources - family, friends and significant other - at age 17-18 and symptoms of depression and anxiety at age 20-21., Methods: Data were obtained from the cohort study Futura01 based on a Swedish national sample of adolescents attending grade 9 in 2016/2017. We used survey information from 2019 (age 17-18) and 2022 (age 20-21) and linked registry information ( N =2722). Symptoms of depression and anxiety were measured by the Patient Health Questionnaire-4 (PHQ-4) at age 20-21. Perceived social support was measured by the Multidimensional Scale of Perceived Social Support (MSPSS) at age 17-18. Control variables included sociodemographic characteristics and indicators of mental health problems at age 17-18. Binary logistic regressions were performed., Results: When mutually adjusting for all sources of perceived social support, family support at age 17-18 had inverse associations with symptoms of both depression and anxiety at age 20-21. Perceived support from friends was associated with subsequent symptoms of anxiety only., Conclusions: Perceived social support can be a protective factor against mental health problems in emerging adulthood. The family serves a particularly important source of social support., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
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- 2024
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40. The Urgent Need for a Multi-Dimensional Campus Mental Health Intervention in Nigerian Universities: The Case of Unilorin Tim-Healthcare Programme.
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Buhari OIN, Olalusi K, Alatishe-Muhammad BW, Ajokpaniovo M, Ogunmodede AJ, and Bolarinwa AO
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The mental health of university students has become a significant cause for worry and public health concerns globally. Studies suggest that many mental health problems for example, depression, anxiety, phobia, suicidal behaviour, and substance use disorder among others, typically arise within the age bracket of 15-25 years, which coincides with the period when many individuals are pursuing higher education. Implementing structural interventions and broad organizational reforms to address student mental health has proven to be advantageous. The potential benefits that can be achieved from investing in students' mental health are improved academic performance, student success and a reduction in discontinuous school enrolment or dropout especially in resource-limited environments. This report presents a research-based multidisciplinary mental health program being implemented at a Nigerian University called the University of Ilorin Tertiary Institution Mental Health Programme (Unilorin TIM Healthcare Programme), aimed at addressing the mental health needs of tertiary institution students. The programme which incorporates preventive education such as enlightenment programs on campus, workshops on stress management, resilience building and coping strategies, amongst other initiatives has recorded significant benefits with positive feedback from the beneficiaries. It is hoped that it will be a model for other institutions within and outside Nigeria. Newborn jaundice (NNJ), especially due to ABO incompatibility, is a major global health concern. Phototherapy is the standard treatment, with exchange transfusions reserved for severe cases. However, in some babies these therapies may be ineffective, requiring additional immunomodulatory treatments. Limited access to these., (Copyright © 2024 Nigerian Medical Association.)
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- 2024
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41. Defining mode of delivery as "instrumental vaginal delivery".
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Larsdotter Zweygberg A, Ahlqvist VH, and Magnusson C
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- 2025
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42. Associations between Balance Measures and Risk of Fractures in 70-Year-Old Individuals: A Population-Based Cohort Study.
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Nordström P, Ballin M, and Nordström A
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Context: There are uncertainties regarding to what extent poor vision and distracting tasks reduce balance and associate with fracture risk., Objective: To investigate the associations between body sway assessed under different visual and multitasking conditions and later risk of fractures in older adults., Design: Cohort study., Setting: Umeå municipality, Sweden., Patients or Other Participants: N=5,437 community-dwelling 70-year-old individuals who participated in a population-based health examination., Main Outcome Measure: Body sway at baseline was measured using a Wii balance board in the lateral and anterior-posterior direction during three different tests, including with eyes open, dual-tasking, and eyes closed. Fractures during follow-up were ascertained using nationwide registers., Results: During a mean (range) follow-up of 4.8 (0.0-10.6) years, 348 women (12.3%) and 149 men (5.7%) sustained a fracture. In women, both anterior-posterior sway velocity (hazard ratio [HR], 1.05 95% CI, 1.01-1.08, per mm/s increase) and variation in sway velocity (HR, 1.05, 95% CI, 1.01-1.09, per standard deviation [SD] increase) during dual-tasking testing were associated with higher risk of fracture after adjustment for covariates. During testing with eyes closed, all measures of lateral sway were associated with the risk of fracture (P<0.01 for all). In men, variation in lateral (HR, 1.03, 95% CI, 1.00-1.07 per SD increase) and anterior-posterior sway velocity (HR 1.05, 95% CI, 1.01-1.10 per SD increase) during dual-tasking testing were associated with higher risk of fracture., Conclusions: Higher body sway velocity and larger variation in sway velocity were associated with higher risk of fractures in both 70-year-old men and women, especially under more challenging testing conditions., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. See the journal About page for additional terms.)
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- 2024
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43. Polygenic risk analysis in physical activity and health: why are the same results interpreted differently?
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Ahlqvist VH and Ballin M
- Abstract
Competing Interests: Competing interests: None declared.
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- 2024
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44. Role of Biomarkers Diagnostic Tools in Patients with COVID-19: Stratification Made Easy.
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Salman AA, Abdallah HM, Eldahdouh S, Elkhadry SW, Awad SM, Gaballah GMK, Awaad EK, Saad MG, Taha AE, and Gaballa NK
- Abstract
Background and Aims: In coronavirus disease 2019 (COVID-19) patients, several serum biomarkers have been identified. Upon intensive care unit (ICU) admission, these laboratory markers become more crucial to distinguish between patients with severe cases of COVID-19. It might assist doctors in predicting the course of illnesses and treating patients appropriately. This work was to investigate the role of biomarkers in patients with COVID-19 classification admitted to the hospital and identified by reverse transcription polymerase chain reaction (RT-PCR)., Methods: Peripheral blood sample was taken from COVID-19 cases isolated on admission to determine C-reactive protein (CRP), D-dimer, Fibrinogen, neutrophil-lymphocyte ratio (NLR), leukocytes CRP ratio (LeCR), lymphocyte-CRP ratio (LCR), interleukin-6 (IL6), leukocytes interleukin 6 ratio (LeIL6), systemic inflammatory index (SII), platelet-to-lymphocyte ratio (PLR), and tissue plasminogen activator inhibitor one (tPAI-1). Follow-up for IL6, Ferritin, D-dimer, and tPAI-1 were determined on the 3
rd and 7th days., Results: Comparisons of severity revealed that hypertension, chronic obstructive pulmonary disease (COPD), and Ischemia were major risk factors in COVID-19 patients. There was a statistically significant difference between the test groups for fibrinogen (p < 0.000), IL6 (p < 0.009), LeCR (p < 0.006), and LCR (p < 0.011)., Conclusion: Based on laboratory test findings at the time of ICU admission, we can distinguish severe cases of COVID-19., Competing Interests: The authors declare no competing interests in this work., (© 2024 Salman et al.)- Published
- 2024
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45. Tobacco Use and Uptake of COVID-19 Vaccinations in Finland: A Population-Based Study.
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Peña S, Zhou Z, Kestilä L, Galanti MR, Shaaban AN, Caspersen IH, Magnus P, Geraldo P, Rojas-Saunero P, Parikka S, Nohynek H, and Karvonen S
- Subjects
- Humans, Finland epidemiology, Female, Male, Middle Aged, Adult, Cohort Studies, Vaccination statistics & numerical data, Aged, Young Adult, SARS-CoV-2, Adolescent, Tobacco, Smokeless statistics & numerical data, COVID-19 prevention & control, COVID-19 epidemiology, COVID-19 Vaccines administration & dosage, Tobacco Use epidemiology
- Abstract
Introduction: People who smoke are at higher risk of Coronavirus Disease-2019 (COVID-19) hospitalizations and deaths and might benefit greatly from high COVID-19 vaccination coverage. Studies on tobacco use and COVID-19 vaccine uptake in the general population are lacking., Aims and Methods: We conducted a cohort study utilizing linked data from 42 935 participants from two national surveys in Finland (FinSote 2018 and 2020). Exposures were smoking and smokeless tobacco (snus) use. The primary outcome was the uptake of two COVID-19 vaccine doses. Secondary outcomes were the uptake of one COVID-19 vaccine dose; three COVID-19 vaccine doses; time between the first and second dose; and time between the second and third dose. We examined the association between tobacco use and COVID-19 vaccine uptake and between-dose spacing in Finland., Results: People who smoke had a 7% lower risk of receiving two COVID-19 vaccine doses (95% confidence interval [CI] = 0.91; 0.96) and a 14% lower risk of receiving three doses (95% CI = 0.78; 0.94) compared to never smokers. People who smoked occasionally had a lower risk of receiving three vaccine doses. People who currently used snus had a 28% lower uptake of three doses (95% CI = 0.56; 0.93) compared to never users but we did not find evidence of an association for one or two doses. We did not find evidence of an association between tobacco use and spacing between COVID-19 vaccine doses., Conclusions: People who smoke tobacco products daily, occasionally, and use snus had a lower uptake of COVID-19 vaccines. Our findings support a growing body of literature on lower vaccination uptake among people who use tobacco products., Implications: People who smoke or use snus might be a crucial target group of public health efforts to increase COVID-19 vaccinations and plan future vaccination campaigns., Clinical Trials Registration Number: NCT05479383., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)
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- 2024
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46. The Global Burden of Absenteeism Related to COVID-19 Vaccine Side Effects Among Healthcare Workers: A Systematic Review and Meta-Analysis.
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Politis M, Rachiotis G, Mouchtouri VA, and Hadjichristodoulou C
- Abstract
Background: A rise in absenteeism among healthcare workers (HCWs) was recorded during the COVID-19 pandemic, mostly attributed to SARS-CoV-2 infections. However, evidence suggests that COVID-19 vaccine-related side effects may have also contributed to absenteeism during this period. This study aimed to synthesize the evidence on the prevalence of absenteeism related to COVID-19 vaccine side effects among HCWs. Methods: The inclusion criteria for this review were original quantitative studies of any design, written in English, that addressed absenteeism related to the side effects of COVID-19 vaccines among HCWs. Four databases (PubMed, Scopus, Embase, and the Web of Science) were searched for eligible articles on 7 June 2024. The risk of bias was assessed using the Newcastle-Ottawa scale. Narrative synthesis and a meta-analysis were used to synthesize the evidence. Results: Nineteen observational studies with 96,786 participants were included. The pooled prevalence of absenteeism related to COVID-19 vaccine side effects was 17% (95% CI: 13-20%), while 83% (95% CI: 80-87%) of the vaccination events did not lead in any absenteeism. Study design, sex, vaccination dose, region, and vaccine type were identified as significant sources of heterogeneity. Conclusions: A non-negligible proportion of HCWs were absent from work after reporting side effects of the COVID-19 vaccine. Various demographic factors should be considered in future vaccination schedules for HCWs to potentially decrease the burden of absenteeism related to vaccine side effects. As most studies included self-reported questionnaire data, our results may be limited due to a recall bias. Other: The protocol of the study was preregistered in the PROSPERO database (CRD42024552517).
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- 2024
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47. Psychometric evaluation of the Swedish version of ages and stages questionnaire social-emotional: second edition for parents of children 18 months of age.
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Edenius A, Bergström M, Lindberg L, Bergqvist K, Fröjlinger A, Enebrink P, and Åhlén J
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- Humans, Infant, Male, Female, Surveys and Questionnaires standards, Sweden, Reproducibility of Results, Emotions, Factor Analysis, Statistical, Adult, Psychometrics instrumentation, Parents psychology, Child Development
- Abstract
Background: Social and emotional development are important aspects of young children's well-being but can be difficult to assess during the first years of life. The Ages and Stages Questionnaire: Social-Emotional Second Edition (ASQ:SE-2) is a parent-rated assessment tool for child socioemotional development between 1 and 72 months of age. In this study, we examined the psychometric properties of this instrument in 18-month-old Swedish children., Methods: Data from 586 Swedish-speaking parents of 18-month-old children were included. In addition to the ASQ:SE-2, parents also completed the Social-Emotional Assessment/Evaluation Measure (SEAM), and the child's socioemotional development was assessed by a nurse at the Child Health Services. We used exploratory factor analysis and Rasch methodology to explore dimensionality and item properties of the ASQ:SE-2. Furthermore, we used Pearson and Spearman rank correlations to study associations with the SEAM and the nurse assessment., Results: An exploratory factor analysis suggested a one-factor model for the ASQ:SE-2 items. However, several items showed weak factor loadings, and a final scale including 18 of the original 29 items was further explored. The Rasch analysis revealed problems with targeting, and the final scale showed acceptable reliability only in the 22% with the highest levels of socioemotional difficulties. The total score of the final version showed a strong association with the parent-rated SEAM but a weak association with the nurse observations. We labeled the reduced 18-item scale Social Interaction., Conclusions: The results of this study highlight that the original Swedish version of the ASQ:SE-2 for 18-month-old children may not be an adequate tool for assessing social and emotional competencies in a normal population since acceptable reliability was reached only in children with the greatest difficulties (above the 78th percentile). In conclusion, the suggested 18-item version works best either as a screening instrument for problems with social interaction or as a continuous measure of such problems in children with high levels of social interaction difficulties., (© 2024. The Author(s).)
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- 2024
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48. The association between tobacco use and COVID-19 diagnoses in three Nordic countries: a pooled analysis.
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Shaaban AN, Andersson F, Thiesmeier R, Orsini N, Peña S, Caspersen IH, Magnusson C, Karvonen S, Magnus PM, Hergens MP, Qazi B, and Galanti MR
- Abstract
Previous research has suggested an unexpected negative association between smoking and susceptibility to COVID-19. This study, drawing on population-based data from three Nordic countries-Sweden, Norway, and Finland-aims to investigate this association further, capitalizing on diversity introduced by different containment measures. The objective of this research was to examine the association between cigarette smoking and snus (smokeless tobacco) use and the risk of confirmed COVID-19 infection. A pooled analysis integrating original data from 547,685 participants across three countries. We used a multiple imputation approach based on conditional probabilities to impute the systematically missing covariates. The associations between tobacco use and COVID-19 infection were assessed, controlling for potential confounding factors. Current cigarette smokers had a lower risk of a confirmed COVID-19 case, whereas there was an increased risk among snus users. Our sensitivity analysis confirmed that the associations between tobacco use and COVID-19 infection risk are robust, remaining consistent regardless of whether covariate imputation was applied. Findings support a negative association between smoking and SARS-CoV-2 infection, but not the hypothesis that nicotine may be protective against the risk of contracting SARS-CoV-2 infection., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Public Health Association.)
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- 2024
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49. When words fail us: An integrative review of innovative elicitation techniques for qualitative interviews.
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Kahlke R, Maggio LA, Lee MC, Cristancho S, LaDonna K, Abdallah Z, Khehra A, Kshatri K, Horsley T, and Varpio L
- Abstract
Introduction: Interviews are central to many qualitative studies in health professions education (HPE). However, researchers often struggle to elicit rich data and engage diverse participants who may find this strategy exclusionary. Elicitation techniques are strategies tailored to address these challenges, enhancing oral conversations through other forms of interaction-for example, participant photography and neighbourhood walks. These strategies are tailored to elicit the rich data needed to address complex problems and meaningfully engage participants. Unfortunately, guidance on these techniques is scattered across literatures from diverse fields. In this synthesis, we offer an overview of the elicitation techniques available and advice about how to choose between them., Methods: We conducted an integrative review, drawing on methodological literature from across the health and social sciences. Our interdisciplinary searches yielded 3056 citations. We included 293 citations that were methodologically focused and discussed elicitation techniques used in interviews with adults. We then extracted specific elicitation techniques, summarising each technique to capture key features, as well as strengths and weaknesses. From this, we developed a framework to help researchers identify challenges in their interview-based research and to select elicitation techniques that address their challenges., Results: To enrich data, researchers might seek to shift conversations away from participants' entrenched narratives, to externalise conversations on sensitive topics, or to elicit affect, tacit knowledge or contextual details. When empowering participants, researchers might seek to increase equity between the researcher and participant or foster interview accessibility across diverse participant populations., Discussion: When chosen with study goals in mind, elicitation techniques can enrich interview data. To harness this potential, we need to re-conceptualise interviews as co-production of knowledge by researcher(s) and participant(s). To make interviews more equitable and accessible, we need to consider flexibility so that each participant can engage in ways that best suit their needs and preferences., (© 2024 The Author(s). Medical Education published by Association for the Study of Medical Education and John Wiley & Sons Ltd.)
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- 2024
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50. Single-blinded, randomised, parallel-group, controlled trial comparing the efficacy and cost-effectiveness of therapist- and self-guided internet-delivered behavioural activation versus treatment as usual for adolescents with mild to moderate depression: study protocol.
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Andersson R, Vigerland S, Lenhard F, Ahlen J, Bottai M, Mataix-Cols D, and Serlachius E
- Subjects
- Adolescent, Female, Humans, Male, Behavior Therapy methods, Behavior Therapy economics, Internet, Internet-Based Intervention economics, Randomized Controlled Trials as Topic, Single-Blind Method, Treatment Outcome, Cost-Benefit Analysis, Depression therapy
- Abstract
Introduction: The number of adolescents seeking professional help for depression is increasing and, despite advances in treatment, large unmet treatment needs remain. In the current protocol, we describe the design and methodology of a randomised controlled trial (RCT) to evaluate the clinical efficacy of two forms of internet-delivered behavioural activation (I-BA), with and without therapist support, in reducing depressive symptoms, compared with treatment as usual (TAU). Secondary objectives include examining the 12-month maintenance of the treatment effects and conducting a health economic evaluation of the interventions., Methods and Analysis: In this single-blinded RCT, we aim to include 215 participants aged 13-17 years with mild to moderate depression who will be randomised (1:1:1 ratio) to 10 weeks of either therapist-guided or self-guided I-BA, or TAU provided by regular mental health clinics. Data will be collected at baseline, weekly for the initial 10 weeks, post-treatment and at 3 and 12-month follow-ups. The primary endpoint is the 3-month follow-up. The primary outcome is blinded clinician-rated severity of depressive symptoms, measured by the Children's Depression Rating Scale-Revised. Treatment response is defined as a score of 'Much improved' or 'Very much improved' on the Clinical Global Impression-Improvement Scale, administered at the primary endpoint. Outcome assessors will be blinded to treatment conditions at all assessment points. A health economic evaluation of I-BA will be performed, both in the short term (primary endpoint) and the long term (12-month follow-up)., Ethics and Dissemination: Ethical approval was obtained from the Swedish Ethical Review Authority in June 2021. The final participant was enrolled on 3 May 2024 and expected to reach the primary endpoint by November 2024. The results of this study will be disseminated through publication in peer-reviewed journals, presented at conferences and communicated to healthcare providers and the public., Trial Registration Number: NCT04977856., Competing Interests: Competing interests: DM-C receives royalties for contributing articles to UpToDate, outside the current work. DM-C and ES are part owners of Scandinavian E-Health AB. Scandinavian E-Health AB was not involved in the funding, design, interpretation of study results or writing of the manuscript., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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