Study group SBS-AE. Version
|
|
- Cecily Lambert
- 6 years ago
- Views:
Transcription
1 Study group SBS-AE a. Dipl.-Psych. Michael Köhler Investigators a. Prof. Dr. med. Thomas Fischer a. Prof. Dr. med. Jörg Frommer, M.A. b. Universitätsklinik für Psychosomatische Medizin und Psychotherapie, Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg, Universitätsklinikum Magdeburg d. Tel.: , Fax: ; Biometry / Data management a. Dipl.-Psych. Michael Köhler michael.koehler@med.ovgu.de a. Prof. Dr. rer. nat. Siegfried Kropf b. Institut für Biometrie und Medizinische Informatik, Medizinische Fakultät der, d. Tel.: , Fax: ; siegfried.kropf@med.ovgu.de
2 Synopsis Project title Acronym Responsible Clinic analogue GCP-guideline The Somatic Burden Score: Development and validation of a quantitative tool to evaluate the somatic burden due to chemotherapy-induced adverse events SBS-AE Department of Haematology and Oncology, Otto-von-Guericke-University Magdeburg Principal Investigator Approval voting Study sample Study design Inclusion criteria Exclusion criteria Purpose Dipl.-Psych. Michael Köhler A study protocol was approved by the Institutional Review Board of University Hospital Magdeburg. Patients with haematological malignancies and autologous hematopoietic stem cell transplantation (HSCT) following high-dose chemotherapy (HDC) a. Prospective, monocentric, non-interventional design analogue to the state-of-the-art-recommendations for clinical studies according to Faller (2004) b. Follow-up-questionnaire-design with a priori specified hypotheses. It was accomplished as part of an observational study with T1, at beginning of stem cell mobilisation therapy with following separation; T2, at beginning, and T3, at discharge after HDC. c. This study is registered with German Clinical Trials Register (Main ID: DRKS ). a. Acute / chronic haematological malignancy AND / OR b. autologous hematopoietic stem cell transplantation (HSCT) following high-dose chemotherapy (HDC) c. ECOG Performance Status 2 d. 18 years old e. Patients who were able to read and understand a German-language questionnaire f. Patients who were able to cognitive understand diagnosis and treatment g. Patients first autologous HSCT h. written informed consent a. current psychiatric treatment/medication b. use of sedative medication c. ECOG Performance Status > 2 Development, theoretical background, and validation of a new summary tool for evaluation of the somatic burden due to chemotherapy-induced adverse events.
3 Theoretical background The AE-data-concept by Bentzen et al. (2003) Primary objective To determine SBS-AE s criterion validity and construct validity Secondary objectives Instruments Target value Sample size Biometry Publication Descriptive evaluation of: a. Health-related quality of life b. Adverse-event reporting (toxicity): fever, diarrhoea, vomiting, mucositis, and pain c. Somatic burden due to chemotherapy-induced adverse events a. NCI-CTCAE v3.0 b. SF-36 c. PHQ-9 d. General Self-Efficacy Scale e. Basic Documentation for Psycho- Oncology (PO-Bado) a. Weighted, relative duration of an AE grade using CTCAE v3.0 (Grading-SBS) a. Power calculation with G*power both for the primary hypotheses analysis for multiple correlations with k=5 predictors and in order to support secondary analyses resulted in at least 38 participants (R , 80% power, p<0.05). b. For the primary hypotheses analysis for differences an a priori analysis resulted in n 50 required participants (d>0.5, 80% power, p<0.05%). a. The primary analysis comprised the summary scores using the O- SBS-AE, the SF-36 physical health summary-score, and the summarized AE profiles. b. Age was excluded as potentially confounding variable after calculation of correlation between age and variables of primary analysis. c. Criterion validity: Multiple correlations per linear regression analyses d. Convergent validity: e. Discriminant validity: t-tests and analyses of variance (ANOVA) f. A one-sided p value of less than 0.05 was considered to be significant in all analyses. g. Effect sizes were calculated: 1) Effect size for group differences Cohen s d=t[(1/n 1 )+(1/n 2 )] 1/2 ; 2) Effect size for multiple correlation f 2 =R 2 /1-R 2. Concerning coherent use of effect sizes we converted correlation coefficients in Cohen s d using the following formula: d=2r/(1 r 2 ) 1/2 h. A Cohen s d of 0.8 was considered large (f 2 >0.35), 0.5 was considered medium (f 2 >0.15), and 0.2 was considered small (f 2 >0.02) a. According to STROBE checklist
4 The STROBE statement-checklist Quantitative tool to evaluate the somatic burden due to chemotherapy-induced adverse events: the somatic burden score Michael Koehler 1, Thomas Fischer MD 1, Siegfried Kropf MD 2, Joerg Frommer MD 3 1 Department of Haematology and Oncology, Otto-von-Guericke-University Magdeburg, Leipziger Straße 44, Magdeburg, Germany 2 Institute for Biometry and Medical Informatics, Otto-von-Guericke-University Magdeburg, Leipziger Straße 44, Magdeburg, Germany 3 Department of Psychosomatic Medicine and Psychotherapy, Otto-von-Guericke-University Magdeburg, Leipziger Straße 44, Magdeburg, Germany Corresponding author: Michael Koehler Department of Haematology and Oncology Otto-von-Guericke-University Magdeburg Leipziger Straße Magdeburg, Germany address: michael.koehler@med.ovgu.de Tel.: ; Fax:
5 Item Recommendation Reported on manuscript page Title and abstract 1 (a) Indicate the study s design with a commonly used term in the title or the 2 abstract (b) Provide in the abstract an informative and balanced summary of what was 2 done and what was found Introduction Background/ 2 Explain the scientific background and rationale for the investigation being 3, 4 rationale reported Objectives 3 State specific objectives, including any pre-specified hypotheses 4, table 12 Methods Study design 4 Present key elements of study design early in the paper 5 Setting 5 Describe the setting, locations, and relevant dates, including periods of 5, recruitment, exposure, follow-up, and data collection Participants 6 (a) Cohort study give the eligibility criteria, and the sources and methods of 5 selection of participants. Describe methods of follow-up Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable 5-8 Data sources/ measurement 8 For each variable of interest give sources of data and details of methods of assessment (measurement). Describe comparability of assessment methods if there is more than one group Bias 9 Describe any efforts to address potential sources of bias 8-9 Study size 10 Explain how the study size was arrived at 9 Quantitative 11 Explain how quantitative variables were handled in the analyses. If applicable, 8-9 variables describe which groupings were chosen, and why Statistical methods 12 (a) Describe all statistical methods, including those used to control for 8-9 confounding (b) Describe any methods used to examine subgroups and interactions 8-9 (c) Explain how missing data were addressed 8-9 (d) Cohort study if applicable, explain how loss to follow-up was addressed - (e) Describe any sensitivity analyses - Results Participants 13 (a) Report the numbers of individuals at each stage of the study eg, numbers 10 potentially eligible, examined for eligibility, confirmed eligible, included in the study, completing follow-up, and analysed (b) Give reasons for non-participation at each stage 10 (c) Consider use of a flow diagram - Descriptive data 14 (a) Give characteristics of study participants (eg, demographic, clinical, social) table 2 and information on exposures and potential confounders (b) Indicate the number of participants with missing data for each variable of 10 interest (c) Cohort study summarise follow-up time (eg, average and total amount) - Outcome data 15 Cohort study report numbers of outcome events or summary measures over time 10, table 3-6 Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates - and their precision (eg, 95% confidence interval). Make clear which confounders were adjusted for and why they were included (b) Report category boundaries when continuous variables were categorised - (c) If relevant, consider translating estimates of relative risk into absolute risk for - a meaningful time period Other analyses 17 Report other analyses done eg, analyses of subgroups and interactions, and sensitivity analyses 11 table 7-11 Discussion Key results 18 Summarise key results with reference to study objectives 12 table 12 Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or imprecision. Discuss both direction and magnitude of any potential bias Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations, multiplicity of analyses, results from similar studies, and other 13, table 13 relevant evidence Generalizability 21 Discuss the generalizability (external validity) of the study results Other information Funding 22 Give the source of funding and the role of the funders for the present study and, if applicable, for the original study on which the present article is based 9 5-8
CONSORT 2010 checklist of information to include when reporting a randomised trial*
CONSORT 2010 checklist of information to include when reporting a randomised trial* Section/Topic Title and abstract Introduction Background and objectives Item No Checklist item 1a Identification as a
More informationComorbidome, Pattern, and Impact of Asthma-COPD Overlap Syndrome in Real Life
Comorbidome, Pattern, and Impact of Asthma-COPD Overlap Syndrome in Real Life Job F. M. van Boven, PharmD, PhD; Miguel Román-Rodríguez, MD; Josep F. Palmer, MD; Núria Toledo-Pons, MD; Borja G. Cosío, MD,
More informationUse of nicorandil is Associated with Increased Risk for Gastrointestinal Ulceration and Perforation- A Nationally Representative Populationbased
Use of nicorandil is Associated with Increased Risk for Gastrointestinal Ulceration and Perforation- A Nationally Representative Populationbased study Chien-Chang Lee, Shy-Shin Chang, Shih-Hao Lee, Yueh-Sheng
More informationCHECK-LISTS AND Tools DR F. R E Z A E I DR E. G H A D E R I K U R D I S TA N U N I V E R S I T Y O F M E D I C A L S C I E N C E S
CHECK-LISTS AND Tools DR F. R E Z A E I DR E. G H A D E R I K U R D I S TA N U N I V E R S I T Y O F M E D I C A L S C I E N C E S What is critical appraisal? Critical appraisal is the assessment of evidence
More informationSystematic reviews and meta-analyses of observational studies (MOOSE): Checklist.
Systematic reviews and meta-analyses of observational studies (MOOSE): Checklist. MOOSE Checklist Infliximab reduces hospitalizations and surgery interventions in patients with inflammatory bowel disease:
More informationTitle:BE SMART AGAINST CANCER! A school-based program concerning cancer-related risk behavior: a randomized controlled intervention study
Author's response to reviews Title:BE SMART AGAINST CANCER! A school-based program concerning cancer-related risk behavior: a randomized controlled intervention study Authors: Friederike Stölzel (friederike.stoelzel@uniklinikum-dresden.de)
More informationAuthor's response to reviews
Author's response to reviews Title: Evaluation of an internet-based aftercare programme to improve vocational reintegration after inpatient medical rehabilitation: study protocol for a cluster-randomised
More informationCONSORT 2010 checklist of information to include when reporting a randomised trial*
Supplemental Figures for: Ramosetron Versus Ondansetron in Combination with Aprepitant and Dexamethasone for the Prevention of Highly Emetogenic Chemotherapy-induced Nausea and Vomiting: A Multicenter,
More informationCover Page. The handle holds various files of this Leiden University dissertation
Cover Page The handle http://hdl.handle.net/1887/28958 holds various files of this Leiden University dissertation Author: Keurentjes, Johan Christiaan Title: Predictors of clinical outcome in total hip
More informationResponse styles in rating scales: Potential causes, correlates, and detrimental effects on measurement
Response styles in rating scales: Potential causes, correlates, and detrimental effects on measurement Symposium held at the 11th European Conference on Psychological Assessment (ECPA) 31st August 3rd
More informationUV-2005/01. Chronic Prostatitis and Chronic Pelvic Pain Syndrom (CP/CPPS) Karl-Bickleder-Str. 44C Straubing - Germany
SYNOPSIS UV-2005/01 Title: Short Title: Indication: Phase: Study Code: Study Director Co-ordinating Investigator: Study Centres: Multicentre, randomised, double-blind, placebo-controlled clinical study
More informationThe QUOROM Statement: revised recommendations for improving the quality of reports of systematic reviews
The QUOROM Statement: revised recommendations for improving the quality of reports of systematic reviews David Moher 1, Alessandro Liberati 2, Douglas G Altman 3, Jennifer Tetzlaff 1 for the QUOROM Group
More informationThe study investigates potential cross-addiction following bariatric surgery.
PLEASE NOTE: This trial has been registered retrospectively. Trial Description Title Addiction Transfer following Bariatric Surgery Trial Acronym TransAddict-BS URL of the trial [---]* Brief Summary in
More informationDetails on the procedure and devices used for assessment and calculation of
SUPPLEMENTAL METHODS Details on the procedure and devices used for assessment and calculation of cardiovascular parameters The peripheral psychophysiological activation was registered via impedance cardiography
More informationGuidelines for Reporting Non-Randomised Studies
Revised and edited by Renatus Ziegler B.C. Reeves a W. Gaus b a Department of Public Health and Policy, London School of Hygiene and Tropical Medicine, Great Britain b Biometrie und Medizinische Dokumentation,
More informationARBEITSKREIS MEDIZINISCHER ETHIK-KOMMISSIONEN
ARBEITSKREIS MEDIZINISCHER ETHIK-KOMMISSIONEN IN DER BUNDESREPUBLIK DEUTSCHLAND - DER VORSTAND - The Permanent Working Party of Research Ethics Committees in Germany Prof. Dr. med. ELMAR DOPPELFELD (Vorsitzender)
More informationThe Somatic Symptom Disorder B Criteria Scale (SSD-12) in a Dutch Clinical Sample. A validation study.
The Somatic Symptom Disorder B Criteria Scale (SSD-12) in a Dutch Clinical Sample. A validation study. C.A.D. Kamp 1,2, L. de Vroege 1,2, J. F. van Eck van der Sluijs 1,2, W.J. Kop 3, & C.M. van der Feltz-
More informationPROSPERO International prospective register of systematic reviews
PROSPERO International prospective register of systematic reviews High-dose chemotherapy followed by autologous haematopoietic cell transplantation for children, adolescents and young adults with first
More information1. Draft checklist for judging on quality of animal studies (Van der Worp et al., 2010)
Appendix C Quality appraisal tools (QATs) 1. Draft checklist for judging on quality of animal studies (Van der Worp et al., 2010) 2. NICE Checklist for qualitative studies (2012) 3. The Critical Appraisal
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical
More informationProblem solving therapy
Introduction People with severe mental illnesses such as schizophrenia may show impairments in problem-solving ability. Remediation interventions such as problem solving skills training can help people
More informationResearch Questions and Survey Development
Research Questions and Survey Development R. Eric Heidel, PhD Associate Professor of Biostatistics Department of Surgery University of Tennessee Graduate School of Medicine Research Questions 1 Research
More informationMeasurement is the process of observing and recording the observations. Two important issues:
Farzad Eskandanian Measurement is the process of observing and recording the observations. Two important issues: 1. Understanding the fundamental ideas: Levels of measurement: nominal, ordinal, interval
More informationTitle:Subjective Memory Complaints and Memory Performance in Patients with Borderline Personality Disorder
Author's response to reviews Title:Subjective Memory Complaints and Memory Performance in Patients with Borderline Personality Disorder Authors: Thomas Beblo (thomas.beblo@evkb.de) Christoph Mensebach
More informationBIOSTATISTICAL METHODS
BIOSTATISTICAL METHODS FOR TRANSLATIONAL & CLINICAL RESEARCH PROPENSITY SCORE Confounding Definition: A situation in which the effect or association between an exposure (a predictor or risk factor) and
More informationResults. NeuRA Hypnosis June 2016
Introduction may be experienced as an altered state of consciousness or as a state of relaxation. There is no agreed framework for administering hypnosis, but the procedure often involves induction (such
More informationThe legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION. 16 December 2009
The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 16 December 2009 MOZOBIL 20 mg/ml, solution for injection Box containing 1 vial (CIP: 397 153-7) Applicant: GENZYME
More informationCommon Errors. ClinicalTrials.gov Basic Results Database
Common Errors ClinicalTrials.gov Basic Results Database 1 Principles for Using the Basic Results Database Submitted data are used to develop basic tables for the public display Tables must be interpretable
More informationNew biomarkers for diagnosis
Diabetesforschung 07.11.2016 The presence of certain proteins in blood samples can predict incipient type 1 diabetes. The researchers identify these in their measurements using so-called peptide peaks
More informationTraumatic brain injury
Introduction It is well established that traumatic brain injury increases the risk for a wide range of neuropsychiatric disturbances, however there is little consensus on whether it is a risk factor for
More informationNeuRA Sleep disturbance April 2016
Introduction People with schizophrenia may show disturbances in the amount, or the quality of sleep they generally receive. Typically sleep follows a characteristic pattern of four stages, where stage
More informationTemplate 1 for summarising studies addressing prognostic questions
Template 1 for summarising studies addressing prognostic questions Instructions to fill the table: When no element can be added under one or more heading, include the mention: O Not applicable when an
More informationResults. NeuRA Mindfulness and acceptance therapies August 2018
Introduction involve intentional and non-judgmental focus of one's attention on emotions, thoughts and sensations that are occurring in the present moment. The aim is to open awareness to present experiences,
More informationReviewer No. 1 checklist for application of: inclusion of Nifurtimox + eflornithine in the WHO Essential Medicines List
Reviewer No. 1 checklist for application of: inclusion of Nifurtimox + eflornithine in the WHO Essential Medicines List (1) Have all important studies that you are aware of been included? No additional
More informationPubH 7405: REGRESSION ANALYSIS. Propensity Score
PubH 7405: REGRESSION ANALYSIS Propensity Score INTRODUCTION: There is a growing interest in using observational (or nonrandomized) studies to estimate the effects of treatments on outcomes. In observational
More informationResults. NeuRA Worldwide incidence April 2016
Introduction The incidence of schizophrenia refers to how many new cases there are per population in a specified time period. It is different from prevalence, which refers to how many existing cases there
More informationCHAPTER VI RESEARCH METHODOLOGY
CHAPTER VI RESEARCH METHODOLOGY 6.1 Research Design Research is an organized, systematic, data based, critical, objective, scientific inquiry or investigation into a specific problem, undertaken with the
More informationNature and significance of the local problem
Revised Standards for Quality Improvement Reporting Excellence (SQUIRE 2.0) September 15, 2015 Text Section and Item Section or Item Description Name The SQUIRE guidelines provide a framework for reporting
More informationTitle: Effect of heptavalent pneumococcal conjugate vaccination on invasive pneumococcal disease in preterm born infants
Author's response to reviews Title: Effect of heptavalent pneumococcal conjugate vaccination on invasive pneumococcal disease in preterm born infants Authors: Simon Rueckinger (simon.rueckinger@med.uni-muenchen.de)
More informationAndreas Ziegler.
Andreas Ziegler ziegler@imbs.uni-luebeck.de Institut für Medizinische Biometrie und Statistik Universität zu Lübeck, Universitätsklinikum Schleswig-Holstein Berlin, 10.09.2013 Levels of Evidence Important
More informationSUPPLEMENTARY DATA. Supplementary Figure S1. Search terms*
Supplementary Figure S1. Search terms* *mh = exploded MeSH: Medical subject heading (Medline medical index term); tw = text word; pt = publication type; the asterisk (*) stands for any character(s) #1:
More informationThe Research Roadmap Checklist
1/5 The Research Roadmap Checklist Version: December 1, 2007 All enquires to bwhitworth@acm.org This checklist is at http://brianwhitworth.com/researchchecklist.pdf The element details are explained at
More informationPlattenepithelkarzinom des Ösophagus, 1 st -line
Plattenepithelkarzinom des Ösophagus, 1 st -line AIO-STO-0309 An open-label, randomized phase III trial of cisplatin and 5-fluorouracil with or without panitumumab for patients with nonresectable, advanced
More informationTable of Contents. Plots. Essential Statistics for Nursing Research 1/12/2017
Essential Statistics for Nursing Research Kristen Carlin, MPH Seattle Nursing Research Workshop January 30, 2017 Table of Contents Plots Descriptive statistics Sample size/power Correlations Hypothesis
More informationThe Meta on Meta-Analysis. Presented by Endia J. Lindo, Ph.D. University of North Texas
The Meta on Meta-Analysis Presented by Endia J. Lindo, Ph.D. University of North Texas Meta-Analysis What is it? Why use it? How to do it? Challenges and benefits? Current trends? What is meta-analysis?
More informationEVIDENCE-BASED DERMATOLOGY: STUDY
EVIDENCE-BASED DERMATOLOGY: STUDY SECTION EDITOR: MICHAEL BIGBY, MD; ASSISTANT SECTION EDITORS: OLIVIER CHOSIDOW, MD, PhD; ROBERT P. DELLAVALLE, MD, PhD, MSPH; DAIHUNG DO, MD; URBÀ GONZÁLEZ, MD, PhD; CATALIN
More informationBMJ Open. For peer review only -
Self Reported Feelings Of Anger And Aggression Towards Others In Patients On Levetiracetam: A Cohort study using the UK Anti Epileptic Drug Register Journal: BMJ Open Manuscript ID: bmjopen-0-00 Article
More informationTable S1- PRISMA 2009 Checklist
Table S1- PRISMA 2009 Checklist Section/topic TITLE # Checklist item Title 1 Identify the report as a systematic review, meta-analysis, or both. 1 ABSTRACT Structured summary 2 Provide a structured summary
More informationFUJI study: Follow-Up of Jevtana in real life
Pharmacologie médicale Bordeaux PharmacoEpi CIC Bordeaux CIC1401 FUJI study: Follow-Up of Jevtana in real life English version of the synopsis Version 2.0: 24 June 2016 EU PAS register: ENCEPP/SDPP/10391
More informationResults. NeuRA Herbal medicines August 2016
Introduction have been suggested as a potential alternative treatment which may positively contribute to the treatment of schizophrenia. Herbal therapies can include traditional Chinese medicines and Indian
More informationFirst author. Title: Journal
First author Title: Journal Year: Volume: Issue: First page: Last Page: 1. Type of study Controlled trial without randomization Section B Observational cohort study Section B 2. Type of report Full paper
More informationDistraction techniques
Introduction are a form of coping skills enhancement, taught during cognitive behavioural therapy. These techniques are used to distract and draw attention away from the auditory symptoms of schizophrenia,
More informationAnimal-assisted therapy
Introduction Animal-assisted interventions use trained animals to help improve physical, mental and social functions in people with schizophrenia. It is a goal-directed intervention in which an animal
More informationChapter 2. The Research Process: Coming to Terms Pearson Prentice Hall, Salkind. 1
Chapter 2 The Research Process: Coming to Terms 2009 Pearson Prentice Hall, Salkind. 1 CHAPTER OBJECTIVES - STUDENTS SHOULD BE ABLE TO: Describe the research process from formulating questions to seeking
More informationResults. NeuRA Motor dysfunction April 2016
Introduction Subtle deviations in various developmental trajectories during childhood and adolescence may foreshadow the later development of schizophrenia. Studies exploring these deviations (antecedents)
More informationMultiple Regression Models
Multiple Regression Models Advantages of multiple regression Parts of a multiple regression model & interpretation Raw score vs. Standardized models Differences between r, b biv, b mult & β mult Steps
More informationResults. NeuRA Treatments for internalised stigma December 2017
Introduction Internalised stigma occurs within an individual, such that a person s attitude may reinforce a negative self-perception of mental disorders, resulting in reduced sense of selfworth, anticipation
More informationTitle: Associations between depression and different measures of obesity (BMI, WC, WHtR, WHR)
Author's response to reviews Title: Associations between depression and different measures of obesity (BMI, WC, WHtR, WHR) Authors: Jörg Wiltink (joerg.wiltink@unimedizin-mainz.de) Matthias Michal (matthias.michal@unimedizin-mainz.de)
More informationBMJ Open. The Incidence of Eating Disorders in the UK in : findings from the General Practice Research Database
The Incidence of Eating Disorders in the UK in 000-00: findings from the General Practice Research Database Journal: Manuscript ID: bmjopen-0-00 Article Type: Research Date Submitted by the Author: -Jan-0
More informationLearning to Rank Authenticity from Facial Activity Descriptors Otto von Guericke University, Magdeburg - Germany
Learning to Rank Authenticity from Facial s Otto von Guericke University, Magdeburg - Germany Frerk Saxen, Philipp Werner, Ayoub Al-Hamadi The Task Real or Fake? Dataset statistics Training set 40 Subjects
More informationResults. NeuRA Family relationships May 2017
Introduction Familial expressed emotion involving hostility, emotional over-involvement, and critical comments has been associated with increased psychotic relapse in people with schizophrenia, so these
More informationSYNOPSIS. Publications No publications at the time of writing this report.
Drug product: TOPROL-XL Drug substance(s): Metoprolol succinate Study code: D4020C00033 (307A) Date: 8 February 2006 SYNOPSIS Dose Ranging, Safety and Tolerability of TOPROL-XL (metoprolol succinate) Extended-release
More informationThe Role of Personal and Social Resources and Coping For Finding Meaning in Cancer: A Longitudinal Study
Fachbereich Erziehungswissenschaft und Psychologie Der Freien Universität Berlin The Role of Personal and Social Resources and Coping For Finding Meaning in Cancer: A Longitudinal Study Dissertation zur
More informationUNIVERSITY OF THE FREE STATE DEPARTMENT OF COMPUTER SCIENCE AND INFORMATICS CSIS6813 MODULE TEST 2
UNIVERSITY OF THE FREE STATE DEPARTMENT OF COMPUTER SCIENCE AND INFORMATICS CSIS6813 MODULE TEST 2 DATE: 3 May 2017 MARKS: 75 ASSESSOR: Prof PJ Blignaut MODERATOR: Prof C de Villiers (UP) TIME: 2 hours
More informationCOGNITIVE FUNCTION. PROMIS Pediatric Item Bank v1.0 Cognitive Function PROMIS Pediatric Short Form v1.0 Cognitive Function 7a
COGNITIVE FUNCTION A brief guide to the PROMIS Cognitive Function instruments: ADULT PEDIATRIC PARENT PROXY PROMIS Item Bank v1.0 Applied Cognition - Abilities* PROMIS Item Bank v1.0 Applied Cognition
More informationZhengtao Liu 1,2,3*, Shuping Que 4*, Lin Zhou 1,2,3 Author affiliation:
Dose-response Relationship of Serum Uric Acid with Metabolic Syndrome and Non-alcoholic Fatty Liver Disease Incidence: AMeta-analysis of Prospective Studies Zhengtao Liu 1,2,3*, Shuping Que 4*, Lin Zhou
More informationThe Research Process: Coming to Terms
The Research Process: Coming to Terms Describe the research process from formulating questions to seeking and finding solutions. Describe the difference between dependent and independent variables. Identify
More informationChristine Englschalk
Author s response to reviews Title: Benefit in liver transplantation. A survey among medical staff, patients, medical students and non-medical university staff and students Authors: Christine Englschalk
More informationSystematic Reviews and Meta- Analysis in Kidney Transplantation
Systematic Reviews and Meta- Analysis in Kidney Transplantation Greg Knoll MD MSc Associate Professor of Medicine Medical Director, Kidney Transplantation University of Ottawa and The Ottawa Hospital KRESCENT
More informationINTRODUCTION TO ASSESSMENT OPTIONS
DEPRESSION A brief guide to the PROMIS Depression instruments: ADULT ADULT CANCER PEDIATRIC PARENT PROXY PROMIS-Ca Bank v1.0 Depression PROMIS Pediatric Item Bank v2.0 Depressive Symptoms PROMIS Pediatric
More informationBlood draws up to 3% of body weight in clinical trials are safe in children
1 Blood draws up to 3% of body weight in clinical trials are safe in children Claudia Peplow a, Robin Assfalg PhD a, Andreas Beyerlein PhD a, Joerg Hasford MD d, Ezio Bonifacio PhD c, Anette-G. Ziegler
More informationUniversity of Wollongong. Research Online. Australian Health Services Research Institute
University of Wollongong Research Online Australian Health Services Research Institute Faculty of Business 2011 Measurement of error Janet E. Sansoni University of Wollongong, jans@uow.edu.au Publication
More informationResults. NeuRA Forensic settings April 2016
Introduction Prevalence quantifies the proportion of individuals in a population who have a disease during a specific time period. Many studies have reported a high prevalence of various health problems,
More informationTitle 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents* Section/item Item No Description Addressed on page number Administrative information Title 1 Descriptive
More informationEvidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 4: Observational Studies
Pain Physician 2009; 12:73-108 ISSN 1533-3159 Evidence-Based Medicine Evidence-Based Medicine, Systematic Reviews, and Guidelines in Interventional Pain Management: Part 4: Observational Studies Laxmaiah
More informationTitle: Differences between patients' and clinicians' report of sleep disturbance: A field study in mental health care in Norway.
Author's response to reviews Title: Differences between patients' and clinicians' report of sleep disturbance: A field study in mental health care in Norway. Authors: Håvard Kallestad (havard.kallestad@ntnu.no)
More informationHEMATOPOIETIC CELL TRANSPLANTATION FOR EPITHELIAL OVARIAN CARCINOMA
CARCINOMA Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent
More informationGRADE. Grading of Recommendations Assessment, Development and Evaluation. British Association of Dermatologists April 2018
GRADE Grading of Recommendations Assessment, Development and Evaluation British Association of Dermatologists April 2018 Previous grading system Level of evidence Strength of recommendation Level of evidence
More informationA methodological review of the Short Form Health Survey 36 (SF-36) and its derivatives among breast cancer survivors
DOI 10.1007/s11136-014-0785-6 REVIEW A methodological review of the Short Form Health Survey 36 (SF-36) and its derivatives among breast cancer survivors Charlene Treanor Michael Donnelly Accepted: 11
More informationTitle: TIMP-1 and VEGF-165 serum concentration during first-line therapy of ovarian cancer patients
Author's response to reviews Title: TIMP-1 and VEGF-165 serum concentration during first-line therapy of ovarian cancer patients Authors: Sven Mahner (Sven.Mahner@gmx.de) Linn Woelber (lwoelber@uke.uni-hamburg.de)
More informationRecent developments for combining evidence within evidence streams: bias-adjusted meta-analysis
EFSA/EBTC Colloquium, 25 October 2017 Recent developments for combining evidence within evidence streams: bias-adjusted meta-analysis Julian Higgins University of Bristol 1 Introduction to concepts Standard
More informationThe HeartQol questionnaire. Reliability, validity and responsiveness?
The HeartQol questionnaire. Reliability, validity and responsiveness? Stefan Höfer, PhD, MSc Associate Professor Medical University Innsbruck The HeartQoL Story Data collection: 2000 2010 Presentations:
More informationThe clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.
The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall
More informationPSYCHOLOGICAL STRESS EXPERIENCES
PSYCHOLOGICAL STRESS EXPERIENCES A brief guide to the PROMIS Pediatric and Parent Proxy Report Psychological Stress Experiences instruments: PEDIATRIC PROMIS Pediatric Item Bank v1.0 Psychological Stress
More informationCopyright is owned by the Author of the thesis. Permission is given for a copy to be downloaded by an individual for the purpose of research and
Copyright is owned by the Author of the thesis. Permission is given for a copy to be downloaded by an individual for the purpose of research and private study only. The thesis may not be reproduced elsewhere
More informationTest Validity. What is validity? Types of validity IOP 301-T. Content validity. Content-description Criterion-description Construct-identification
What is? IOP 301-T Test Validity It is the accuracy of the measure in reflecting the concept it is supposed to measure. In simple English, the of a test concerns what the test measures and how well it
More informationDoing Quantitative Research 26E02900, 6 ECTS Lecture 6: Structural Equations Modeling. Olli-Pekka Kauppila Daria Kautto
Doing Quantitative Research 26E02900, 6 ECTS Lecture 6: Structural Equations Modeling Olli-Pekka Kauppila Daria Kautto Session VI, September 20 2017 Learning objectives 1. Get familiar with the basic idea
More informationReference: NHS England 1602
Clinical Commissioning Policy Proposition: Clofarabine for refractory or relapsed acute myeloid leukaemia (AML) as a bridge to stem cell transplantation Reference: NHS England 1602 First published: TBC
More informationCHAMP: CHecklist for the Appraisal of Moderators and Predictors
CHAMP - Page 1 of 13 CHAMP: CHecklist for the Appraisal of Moderators and Predictors About the checklist In this document, a CHecklist for the Appraisal of Moderators and Predictors (CHAMP) is presented.
More informationFactor Analysis of Gulf War Illness: What Does It Add to Our Understanding of Possible Health Effects of Deployment?
October 3, 2006 Factor Analysis Examples: Example 1: Factor Analysis of Gulf War Illness: What Does It Add to Our Understanding of Possible Health Effects of Deployment? 1 2 2 Susan E. Shapiro, Michael
More informationINTRODUCTION TO ASSESSMENT OPTIONS
ASTHMA IMPACT A brief guide to the PROMIS Asthma Impact instruments: PEDIATRIC PROMIS Pediatric Item Bank v2.0 Asthma Impact PROMIS Pediatric Item Bank v1.0 Asthma Impact* PROMIS Pediatric Short Form v2.0
More informationDEUTSCH-CHINESISCHE AKADEMIE FÜR PSYCHOTHERAPIE
DEUTSCH-CHINESISCHE AKADEMIE FÜR PSYCHOTHERAPIE Department of Psychosomatic Medicine and Psychotherapy, University Hospital Freiburg (Prof. Dr. med. Michael Wirsching, Prof. Dr. med. Kurt Fritzsche) Current
More informationCAMPUS INNENSTADT. 5. Münchener Kraepelin-Symposium and Symposium of the Clinical Research Group 241
KLINIKUM DER UNIVERSITÄT MÜNCHEN CAMPUS INNENSTADT KLINIK FÜR PSYCHIATRIE UND PSYCHOTHERAPIE INSTITUT FÜR PSYCHIATRISCHE PHÄNOMIK UND GENOMIK and Symposium of the Clinical Research Group 241 Recovery in
More informationCHAPTER NINE DATA ANALYSIS / EVALUATING QUALITY (VALIDITY) OF BETWEEN GROUP EXPERIMENTS
CHAPTER NINE DATA ANALYSIS / EVALUATING QUALITY (VALIDITY) OF BETWEEN GROUP EXPERIMENTS Chapter Objectives: Understand Null Hypothesis Significance Testing (NHST) Understand statistical significance and
More informationANZGOG Update. Symptom Working Group. Presentation prepared by Michael Friedlander
ANZGOG Update Symptom Working Group Presentation prepared by Michael Friedlander GCIG Symptom Benefit Study Baseline quality of life as a predictor of early cessation of chemotherapy and survival in platinum
More informationAbout Reading Scientific Studies
About Reading Scientific Studies TABLE OF CONTENTS About Reading Scientific Studies... 1 Why are these skills important?... 1 Create a Checklist... 1 Introduction... 1 Abstract... 1 Background... 2 Methods...
More informationHEMATOPOIETIC CELL TRANSPLANTATION FOR HODGKIN LYMPHOMA
HEMATOPOIETIC CELL TRANSPLANTATION FOR HODGKIN LYMPHOMA Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services,
More informationSLEEP DISTURBANCE ABOUT SLEEP DISTURBANCE INTRODUCTION TO ASSESSMENT OPTIONS. 6/27/2018 PROMIS Sleep Disturbance Page 1
SLEEP DISTURBANCE A brief guide to the PROMIS Sleep Disturbance instruments: ADULT PROMIS Item Bank v1.0 Sleep Disturbance PROMIS Short Form v1.0 Sleep Disturbance 4a PROMIS Short Form v1.0 Sleep Disturbance
More informationSummary of Changes Page BMT CTN 1205 Protocol Amendment #4 (Version 5.0) Dated July 22, 2016
Page 1 of 8 Date: July 22, 2016 Summary of Changes Page BMT CTN 1205 Protocol #4 Dated July 22, 2016 The following changes, and the rationale for the changes, were made to the attached protocol in this
More informationHEMATOPOIETIC CELL TRANSPLANTATION FOR CHRONIC MYELOID LEUKEMIA
LEUKEMIA Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent
More information