Linguistic and content validation of a German-language PRO-CTCAE-based patient-reported outcomes instrument to evaluate the late effect symptom experience after allogeneic hematopoietic stem cell transplantation.

[1]  H. Greinix,et al.  National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease , 2015 .

[2]  Daniel Wolff,et al.  National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report. , 2005, Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.

[3]  Amy P Abernethy,et al.  Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). , 2014, Journal of the National Cancer Institute.

[4]  G. Gifford,et al.  Health status, late effects and long‐term survivorship of allogeneic bone marrow transplantation: a retrospective study , 2014, Internal medicine journal.

[5]  E. Basch New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment. , 2014, Annual review of medicine.

[6]  R. Polomano,et al.  Comparison Between Patient-Reported and Clinician-Observed Symptoms in Oncology , 2013, Cancer nursing.

[7]  A. Abernethy,et al.  Feasibility of frequent patient-reported outcome surveillance in patients undergoing hematopoietic cell transplantation. , 2013, Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.

[8]  N. Majhail,et al.  Surviving the cure: long term followup of hematopoietic cell transplant recipients , 2013, Bone Marrow Transplantation.

[9]  Stephanie J. Lee,et al.  Delivering care to long-term adult survivors of hematopoietic cell transplantation. , 2012, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[10]  C. Cleeland,et al.  Symptoms and quality of life in diverse patients undergoing hematopoietic stem cell transplantation. , 2012, Journal of pain and symptom management.

[11]  A. Velardi,et al.  The EBMT activity survey: 1990–2010 , 2012, Bone Marrow Transplantation.

[12]  B. Savani How can we improve life expectancy and quality of life in long-term survivors after allogeneic stem cell transplantation? , 2012, Seminars in hematology.

[13]  N. Leidy,et al.  Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. , 2011, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[14]  Elizabeth Molsen,et al.  Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. , 2011, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[15]  Bryant T Karras,et al.  Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. , 2011, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[16]  P. Selby,et al.  Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: secondary outcomes of a randomised controlled trial. , 2010, European journal of cancer.

[17]  N. Leidy,et al.  Determinants of functional performance in long-term survivors of allogeneic hematopoietic stem cell transplantation with chronic graft-versus-host disease (cGVHD) , 2010, Bone Marrow Transplantation.

[18]  J. Lester,et al.  Survivorship care for adult recipients of hematopoietic cell transplantations. , 2010, Clinical journal of oncology nursing.

[19]  G. Kemmler,et al.  Impact of GvHD on quality of life in long-term survivors of haematopoietic transplantation , 2010, Bone Marrow Transplantation.

[20]  C. Cleeland,et al.  A New Measure Of Symptom Burden In Chronic Graft-Versus-Host Disease , 2010 .

[21]  J. Passweg,et al.  Late complications after hematopoietic stem cell transplantation , 2009, Expert review of hematology.

[22]  Elizabeth Molsen,et al.  Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force report. , 2009, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[23]  D. Stull,et al.  Optimal recall periods for patient-reported outcomes: challenges and potential solutions. , 2009, Current medical research and opinion.

[24]  Catherine Acquadro,et al.  Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. , 2008, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[25]  Ethan Basch,et al.  Patient-reported outcomes and the evolution of adverse event reporting in oncology. , 2007, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[26]  M. Hjermstad,et al.  The EORTC QLQ-HDC29: a supplementary module assessing the quality of life during and after high-dose chemotherapy and stem cell transplantation. , 2007, European journal of cancer.

[27]  Cheryl Tatano Beck,et al.  The content validity index: are you sure you know what's being reported? Critique and recommendations. , 2006, Research in nursing & health.

[28]  L. Gerber,et al.  Ancillary therapy and supportive care of chronic graft-versus-host disease: national institutes of health consensus development project on criteria for clinical trials in chronic Graft-versus-host disease: V. Ancillary Therapy and Supportive Care Working Group Report. , 2006, Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.

[29]  E. McColl Cognitive Interviewing. A Tool for Improving Questionnaire Design , 2006, Quality of Life Research.

[30]  D. Wild,et al.  Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. , 2005, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[31]  M. Turner,et al.  National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. , 2005, Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.

[32]  G. Willis,et al.  Cognitive Interviewing: A Tool for Improving Questionnaire Design , 2004 .

[33]  Howard Leventhal,et al.  The common-sense model of self-regulation of health and illness. , 2003 .

[34]  Howard Leventhal,et al.  The self-regulation of health and illness behaviour. , 2003 .

[35]  E. Cook,et al.  Development and validation of a scale to measure symptoms of chronic graft-versus-host disease. , 2002, Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.

[36]  M. Horowitz,et al.  Reporting of adverse event data in hematopoietic stem cell transplantation clinical trials involving investigational new drugs or devices: a report from the William Guy Forbeck Foundation 2001 focus meeting on clinical trials in hematopoietic stem cell transplantation. , 2002, Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation.

[37]  M. Patton Qualitative research & evaluation methods , 2002 .

[38]  C. Cleeland,et al.  Assessing symptom distress in cancer patients , 2000 .

[39]  C. Cleeland,et al.  Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. , 2000, Cancer.

[40]  A. Bonomi,et al.  Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale , 1997, Bone Marrow Transplantation.

[41]  John W. Creswell,et al.  Research Design: Qualitative, Quantitative, and Mixed Methods Approaches , 2010 .