Experts and Doctors on research design in Denmark


Locale: Denmark
Topic: research design

Top Publications

  1. la Cour J, Brok J, Gøtzsche P. Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study. BMJ. 2010;341:c3653 pubmed publisher
    ..Only about one third of authors of randomised clinical trials that used a surrogate as a primary outcome reported adequately on the surrogate. Better reporting is needed. ..
  2. Holst L, Haase N, Wetterslev J, Wernerman J, Aneman A, Guttormsen A, et al. Transfusion requirements in septic shock (TRISS) trial - comparing the effects and safety of liberal versus restrictive red blood cell transfusion in septic shock patients in the ICU: protocol for a randomised controlled trial. Trials. 2013;14:150 pubmed publisher
    ..The effect of restrictive versus liberal RBC transfusion strategy on mortality, organ failure, ischaemic events and SARs will be evaluated. ..
  3. Hyttel Sorensen S, Austin T, van Bel F, Benders M, Claris O, Dempsey E, et al. A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled. Trials. 2013;14:120 pubmed publisher
    ..It is a logical first step to test if it is possible to reduce the burden of hypoxia and hyperoxia., NCT01590316. ..
  4. Pedersen H, Hansen H, Bertelsen S, Fischerman K. Combined modality therapy for oesophageal squamous cell carcinoma. Acta Oncol. 1987;26:175-8 pubmed
    ..It is concluded, that the combined treatment was curative only in a few cases and that future studies should be focused on more intensive preoperative treatment and more critical selection of patients for surgery. ..
  5. Ridderstråle M, Svaerd R, Zeller C, Kim G, Woerle H, Broedl U. Rationale, design and baseline characteristics of a 4-year (208-week) phase III trial of empagliflozin, an SGLT2 inhibitor, versus glimepiride as add-on to metformin in patients with type 2 diabetes mellitus with insufficient glycemic control. Cardiovasc Diabetol. 2013;12:129 pubmed publisher
    ..The results will help to inform the choice of second-line treatment in patients with T2DM who have failed on metformin. NCT01167881. ..
  6. Handberg C, Thorne S, Midtgaard J, Nielsen C, Lomborg K. Revisiting Symbolic Interactionism as a Theoretical Framework Beyond the Grounded Theory Tradition. Qual Health Res. 2015;25:1023-32 pubmed publisher
    ..We conclude that using SI as a lens can serve as a translation mechanism in our quest to interpret the subjective world underlying patients' health and illness behavior. ..
  7. Beck A, Kjær S, Hansen B, Storm R, Thal Jantzen K. Study protocol: follow-up home visits with nutrition: a randomised controlled trial. BMC Geriatr. 2011;11:90 pubmed publisher 2010 NCT01249716. ..
  8. Sørensen J, Kragstrup J, Kjaer K, Puggaard L. Exercise on prescription: trial protocol and evaluation of outcomes. BMC Health Serv Res. 2007;7:36 pubmed
    ..The trial is part of a health technology assessment of EoP, which besides the effectiveness covers the patient perspective, the organization, and the health economy. All three methods validated were found useful for the EoP trial. ..
  9. Watt T, Cramon P, Bjorner J, Bonnema S, Feldt Rasmussen U, Gluud C, et al. Selenium supplementation for patients with Graves' hyperthyroidism (the GRASS trial): study protocol for a randomized controlled trial. Trials. 2013;14:119 pubmed publisher
    ..Usually, patients are treated for 12 to 18 months with anti-thyroid drugs, yielding a total intervention period of 24 to 30 months. NCT01611896. ..

More Information


  1. Knudsen J, Fuursted K, Petersen E, Wierup P, Mølgaard H, Poulsen S, et al. Procalcitonin in 759 patients clinically suspected of infective endocarditis. Am J Med. 2010;123:1121-7 pubmed publisher
    ..The clinical importance of this is questionable, because a suitable procalcitonin threshold for diagnosing or excluding infective endocarditis was not established. ..
  2. Kroijer R, Eldrup N, Paaske W, Torp P, Sivesgaard K, Sloth E. Left ventricular longitudinal strain for perioperative cardiac monitoring in aortic aneurysm surgery using transthoracic 2-dimensional echocardiography: a feasibility and repeatability study. J Cardiothorac Vasc Anesth. 2010;24:37-42 pubmed publisher
    ..2DSE was more feasible and repeatable when echocardiographic images were good. Feasibility and repeatability of 2DSE is good but affected by image quality. This study shows that 2DSE can be used in a clinical setting. ..
  3. Nielsen M, Ørnbøl E, Vestergaard M, Bech P, Larsen F, Lasgaard M, et al. The construct validity of the Perceived Stress Scale. J Psychosom Res. 2016;84:22-30 pubmed publisher
    ..Our large population-based study indicated scalability problems in the current version of the PSS-10. The conducted analysis overall revealed better statistical fit for a two-dimensional than a unidimensional model. ..
  4. Ramskov D, Nielsen R, Sørensen H, Parner E, Lind M, Rasmussen S. The design of the run Clever randomized trial: running volume, -intensity and running-related injuries. BMC Musculoskelet Disord. 2016;17:177 pubmed publisher
    ..Clinical Trials NCT02349373 - January 23, 2015. ..
  5. Hougaard K, Hjort N, Zeidler D, Sørensen L, Nørgaard A, Thomsen R, et al. Remote ischemic perconditioning in thrombolysed stroke patients: randomized study of activating endogenous neuroprotection - design and MRI measurements. Int J Stroke. 2013;8:141-6 pubmed publisher
  6. Neergaard M, Olesen F, Andersen R, Sondergaard J. Qualitative description - the poor cousin of health research?. BMC Med Res Methodol. 2009;9:52 pubmed publisher
    ..Qualitative description might be a useful alternative approach to consider. ..
  7. Henriksen M, Alkjaer T, Lund H, Simonsen E, Graven Nielsen T, Danneskiold Samsøe B, et al. Experimental quadriceps muscle pain impairs knee joint control during walking. J Appl Physiol (1985). 2007;103:132-9 pubmed
  8. Engsig F, Kronborg G, Larsen C, Pedersen G, Pedersen C, Gerstoft J, et al. Lung cancer in HIV patients and their parents: a Danish cohort study. BMC Cancer. 2011;11:272 pubmed publisher
    ..HIV appears to be a marker of behavioural or family related risk factors that affect the incidence of lung cancer in HIV patients. ..
  9. Schröder A, Oernboel E, Licht R, Sharpe M, Fink P. Outcome measurement in functional somatic syndromes: SF-36 summary scores and some scales were not valid. J Clin Epidemiol. 2012;65:30-41 pubmed publisher
    ..The SF-36 PCS may, therefore, not accurately measure the physical health status of these patients. Alternative summary measures are needed. ..
  10. Mollerup A, Veien N, Johansen J. Chronic hand eczema--self-management and prognosis: a study protocol for a randomised clinical trial. BMC Dermatol. 2012;12:6 pubmed publisher
    ..Inclusion criterions are wide in order to increase transferability of the results. The trial is registered in ClinicalTrials.Gov with registration number NCT01482663. ..
  11. Tørring M, Frydenberg M, Hamilton W, Hansen R, Lautrup M, Vedsted P. Diagnostic interval and mortality in colorectal cancer: U-shaped association demonstrated for three different datasets. J Clin Epidemiol. 2012;65:669-78 pubmed publisher
    ..The results support the theory that longer diagnostic intervals cause higher mortality in patients with CRC. ..
  12. Maindal H, Kirkevold M, Sandbaek A, Lauritzen T. Lifting the lid of the "black intervention box" - the systematic development of an action competence programme for people with screen-detected dysglycaemia. BMC Health Serv Res. 2010;10:114 pubmed publisher
    ..The MRC model provides the necessary steps to inform intervention development but should be prioritised according to existing evidence in order to save time. ..
  13. Olsen O, Albertsen K, Nielsen M, Poulsen K, Gron S, Brunnberg H. Workplace restructurings in intervention studies - a challenge for design, analysis and interpretation. BMC Med Res Methodol. 2008;8:39 pubmed publisher
    ..We urge researchers and editors to prioritize this subject in order to improve the quality of future intervention research and preventive action. ..
  14. Diederichsen S, Haugan K, Køber L, Højberg S, Brandes A, Kronborg C, et al. Atrial fibrillation detected by continuous electrocardiographic monitoring using implantable loop recorder to prevent stroke in individuals at risk (the LOOP study): Rationale and design of a large randomized controlled trial. Am Heart J. 2017;187:122-132 pubmed publisher
    ..Secondary objectives include identification of risk factors for the development of AF and characterization of arrhythmias in the population. The trial holds the potential to influence the future of stroke prevention. ..
  15. Hansen T, Kjaersgaard A, Faber J. Measuring elderly dysphagic patients' performance in eating--a review. Disabil Rehabil. 2011;33:1931-40 pubmed publisher
    ..However, further research on their psychometric properties is needed. ..
  16. Nielsen K, Cabrera A, do Nascimento O. EEG based BCI-towards a better control. Brain-computer interface research at Aalborg University. IEEE Trans Neural Syst Rehabil Eng. 2006;14:202-4 pubmed
    ..Namely, an online synchronized BCI system using steady-state visual evoked potentials, and investigations on cortical modulation of movement-related parameters are presented. ..
  17. Hansen B, Hanash J, Rasmussen A, Hansen J, Birket Smith M. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD). Trials. 2009;10:20 pubmed publisher
    ..This is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor. Identifier: NCT00140257. ..
  18. Kirkegaard H, Rasmussen B, de Haas I, Nielsen J, Ilkjær S, Kaltoft A, et al. Time-differentiated target temperature management after out-of-hospital cardiac arrest: a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial. Trials. 2016;17:228 pubmed publisher
    ..We anticipate that the results of this trial will add significant knowledge regarding the management of cooling procedures in OHCA patients. NCT01689077. ..
  19. Humaidan P, Polyzos N. (Meta)analyze this: Systematic reviews might lose credibility. Nat Med. 2012;18:1321 pubmed publisher
  20. Cordoba G, Schwartz L, Woloshin S, Bae H, Gøtzsche P. Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review. BMJ. 2010;341:c3920 pubmed publisher
    ..Components are often unreasonably combined, inconsistently defined, and inadequately reported. These problems will leave many readers confused, often with an exaggerated perception of how well interventions work. ..
  21. Andersen R, Vedsted P, Olesen F, Bro F, Søndergaard J. Patient delay in cancer studies: a discussion of methods and measures. BMC Health Serv Res. 2009;9:189 pubmed publisher
  22. Keall P, Nguyen D, O Brien R, Booth J, Greer P, Poulsen P, et al. Stereotactic prostate adaptive radiotherapy utilising kilovoltage intrafraction monitoring: the TROG 15.01 SPARK trial. BMC Cancer. 2017;17:180 pubmed publisher
    ..The SPARK trial will be conducted under the auspices of the Trans-Tasman Radiation Oncology Group (TROG). This trial was registered on on 09 March 2015. The identifier is: NCT02397317. ..
  23. Kirkegaard P, Edwards A, Hansen B, Hansen M, Jensen M, Lauritzen T, et al. The RISAP-study: a complex intervention in risk communication and shared decision-making in general practice. BMC Fam Pract. 2010;11:70 pubmed publisher Protocol Registration System NCT01187056. ..
  24. Schou M. The early European lithium studies. Aust N Z J Psychiatry. 1999;33 Suppl:S39-47 pubmed
    ..The review ends with personal memories of John Cade. ..
  25. Schwämmle V, León I, Jensen O. Assessment and improvement of statistical tools for comparative proteomics analysis of sparse data sets with few experimental replicates. J Proteome Res. 2013;12:3874-83 pubmed publisher
    ..An R script that implements the improved rank products algorithm and the combined analysis is available. ..
  26. Månsson A, Elmose M, Dalsgaard S, Roessler K. The influence of participation in target-shooting sport for children with inattentive, hyperactive and impulsive symptoms - A controlled study of best practice. BMC Psychiatry. 2017;17:115 pubmed publisher
    ..Current Controlled Trials NCT02898532 . Retrospectively registered 14 September 2016. ..
  27. Harutyunyan M, Christiansen M, Johansen J, Køber L, Torp Petersen C, Kastrup J. The inflammatory biomarker YKL-40 as a new prognostic marker for all-cause mortality in patients with heart failure. Immunobiology. 2012;217:652-6 pubmed publisher
    ..Serum YKL-40 is significantly associated with all-cause mortality in patients with HF and could potentially be a new prognostic biomarker in these patients. ..
  28. Birch S, Stilling M, Mechlenburg I, Hansen T. Effectiveness of a physiotherapist delivered cognitive-behavioral patient education for patients who undergoes operation for total knee arthroplasty: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2017;18:116 pubmed publisher
    ..We expect that the results can provide important new knowledge to the current care recommendations. Clinical Trials ( NCT02587429 ). Registered 23 October 2015. ..
  29. Knudsen B, Miyamoto M, Laipis P, Silverman D. Using evolutionary rates to investigate protein functional divergence and conservation. A case study of the carbonic anhydrases. Genetics. 2003;164:1261-9 pubmed
    ..As illustrated by the CAs, these LRTs, in combination with other biological evidence, offer a powerful and cost-effective approach for testing hypotheses, making predictions, and designing experiments in protein functional studies. ..
  30. Makransky G, Mortensen E, Glas C. Improving personality facet scores with multidimensional computer adaptive testing: an illustration with the NEO PI-R. Assessment. 2013;20:3-13 pubmed publisher
    ..Furthermore, the study shows that the MCAT methodology is particularly appropriate for constructs that have many highly correlated facets. ..
  31. Dreyer P, Pedersen B. Distanciation in Ricoeur's theory of interpretation: narrations in a study of life experiences of living with chronic illness and home mechanical ventilation. Nurs Inq. 2009;16:64-73 pubmed publisher
    ..This way of objectifying the text through narration can contribute yet another perspective to Ricoeur's rich and varied theory of interpretation. ..
  32. Groenwold R, Dekkers O. Designing pragmatic trials-what can we learn from lessons learned?. J Clin Epidemiol. 2017;90:3-5 pubmed publisher
    ..However, it is yet unclear how e.g., possible dependencies between PRECIS domains, or conducting a pragmatic trial within an existing data registry (e.g., electronic health records) affect the applicability of the tool. ..
  33. Lynge E, Beau A, Christiansen P, von Euler Chelpin M, Kroman N, Njor S, et al. Overdiagnosis in breast cancer screening: The impact of study design and calculations. Eur J Cancer. 2017;80:26-29 pubmed publisher
    ..Screening affects cohorts of screened women. Danish registers allow very accurate mapping of the fate of every woman. We should be past the phase where studies of overdiagnosis are based on the fixed age groups from routine statistics. ..
  34. Brodersen J. How to conduct research on overdiagnosis. A keynote paper from the EGPRN May 2016, Tel Aviv. Eur J Gen Pract. 2017;23:78-82 pubmed publisher
  35. Soendergaard B, Kirkeby B, Dinsen C, Herborg H, Kjellberg J, Staehr P. Drug-related problems in general practice: results from a development project in Denmark. Pharm World Sci. 2006;28:61-4 pubmed
    ..The GPs accepted and implemented the pharmacist's recommendations. It was feasible to implement the services and to establish well-functioning co-operation between the pharmacist and the GPs. ..
  36. Pickersgill L, Mandrup Poulsen T. The anti-interleukin-1 in type 1 diabetes action trial--background and rationale. Diabetes Metab Res Rev. 2009;25:321-4 pubmed publisher
  37. Koushede V, Brixval C, Axelsen S, Lindschou J, Winkel P, Maimburg R, et al. Group-based antenatal birth and parent preparation for improving birth outcomes and parenting resources: study protocol for a randomised trial. Sex Reprod Healthc. 2013;4:121-6 pubmed publisher
    ..To the best of our knowledge this is the largest well-designed randomised trial of its kind to date. The trial will bring much-needed evidence for decision makers of the content and form of antenatal education. ..
  38. Lundh A, Krogsbøll L, Gøtzsche P. Sponsors' participation in conduct and reporting of industry trials: a descriptive study. Trials. 2012;13:146 pubmed publisher
  39. Nielsen S, Toft N, Gardner I. Structured approach to design of diagnostic test evaluation studies for chronic progressive infections in animals. Vet Microbiol. 2011;150:115-25 pubmed publisher
    ..The description provides input on the process and deductive reasoning which are integral parts to develop a high-quality design of a DTE for chronic infectious diseases...
  40. Scheel M, Pedersen B, Rosenkrands V. Interactional nursing--a practice-theory in the dynamic field between the natural, human and social sciences. Scand J Caring Sci. 2008;22:629-36 pubmed publisher
    ..Finally, a comparison is drawn between Interactional nursing practice and Benner's theory of nursing practice. ..
  41. Rathleff M, Roos E, Olesen J, Rasmussen S. Early intervention for adolescents with patellofemoral pain syndrome--a pragmatic cluster randomised controlled trial. BMC Musculoskelet Disord. 2012;13:9 pubmed publisher
    ..The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents...
  42. Rambaldi A, Jacobs B, Iaquinto G, Gluud C. Milk thistle for alcoholic and/or hepatitis B or C liver diseases--a systematic cochrane hepato-biliary group review with meta-analyses of randomized clinical trials. Am J Gastroenterol. 2005;100:2583-91 pubmed
    ..MT could potentially affect liver injury. Adequately conducted randomized clinical trials on MT versus placebo may be needed. ..
  43. Azzarello A, Hoest T, Mikkelsen A. The impact of pronuclei morphology and dynamicity on live birth outcome after time-lapse culture. Hum Reprod. 2012;27:2649-57 pubmed publisher
    ..Although the assessment of the PN morphology does not improve embryo selection, the timing of PNB should be included in embryo selection parameters. ..
  44. Rejnmark L, Vestergaard P, Heickendorff L, Andreasen F, Mosekilde L. Effects of thiazide- and loop-diuretics, alone or in combination, on calcitropic hormones and biochemical bone markers: a randomized controlled study. J Intern Med. 2001;250:144-53 pubmed
    ..In clinical practice, treatment with diuretics has to be considered as a cause of parathyroid stimulation. ..
  45. Mathiasen A, Jørgensen E, Qayyum A, Haack Sørensen M, Ekblond A, Kastrup J. Rationale and design of the first randomized, double-blind, placebo-controlled trial of intramyocardial injection of autologous bone-marrow derived Mesenchymal Stromal Cells in chronic ischemic Heart Failure (MSC-HF Trial). Am Heart J. 2012;164:285-91 pubmed publisher
    ..A randomized, double-blind, placebo-controlled, clinical trial of intramyocardial delivery of MSCs in patients with ischemic heart failure has been set up to confirm the positive findings in open-labeled clinical trials. ..