Studiedesign
I praksis er det langt fra alle projekter der egner sig til et prospektivt randomiseret studie og generelt gælder det om at opveje fordele og ulemper ved hvert design. Oxford University’s Center for Evidence-Based Medicine har lavet en liste med fordele og ulemper for hvert design: Study designs
Desuden kan det være svært at holde rede på terminologien, da det samme design kan angives på flere forskellige måder og et cohort study kan både være prospektivt eller retrospektivt designet.
Hermed en oversigt over terminologien som den angives i Gordis L. Epidemiology 4th ed., 2008:
Case-control study = Retrospective study
Cohort study = Longitudinal study = Prospective study
Prospective cohort study = Concurrent cohort study = Concurrent prospective study
Retrospective cohort study = Historical cohort study = Nonconcurrent prospective study
Randomized trial = Experimental study
Cross-sectional study = Prevalence survey
Guidelines til rapportering
– Begynd din søgning efter en passende guideline til rapportering af netop dit projekt på EQUATOR Network
“The EQUATOR Network is an international initiative that seeks to improve the reliability and value of published health research literature by promoting transparent and accurate reporting and wider use of robust reporting guidelines.
It is the first coordinated attempt to tackle the problems of inadequate reporting systematically and on a global scale; it advances the work done by individual groups over the last 15 years.”
“The EQUATOR Network maintains the Library for health research reporting providing direct links to the following key reporting guidelines, also including their bibliographic references, lists of all relevant literature, and links to all available translations.” – Cochrane Community (beta)
– Herefter kan du lede under author information hos det tidsskrift du stiler mod.
– Til sidst kan du lede her på siden, hvor vi har samlet guidelines fra The Spine Journal og andre guidelines vi selv er stødt på eller har brugt:
1. Controlled trials
A controlled trial is defined by the ICMJE as any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. A controlled trial, whether randomized or not, must be registered in a public registry meeting ICMJE requirements prior to submission to The Spine Journal.
1a. Randomized Controlled Trials:
CONSORT checklist and flow diagram
Referencer:
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med 2010;152 (11):726-32. PMID: 20335313.
Moher D, Hopewell S, Schulz KF, Montori V, Gtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG, for the CONSORT Group. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trial. BMJ 2010;340:c869. PMID: 20332511.
Ioannidis JPA, Evans SJW, Gotzsche PC, O’Neill RT, Altman DG, Schulz K, Moher D, for the CONSORT Group*. Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement. Ann Intern Med 2004; 141(10):781-788. PMID: 15545678.
Referencer vedr. udvidelser af CONSORT:
i. Non-inferiority and Equivalence RCTs:
Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW, for the CONSORT Group. Reporting of Noninferiority and Equivalence Randomized Trials: An Extension of the CONSORT Statement. JAMA: The Journal of the American Medical Association 2006; 295(10):1152-1160. PMID: 16522836.
ii. Cluster RCTs:
Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328(7441):702-708. PMID: 15031246.
iii. Non-pharmacological treatment interventions:
Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments. Ann Intern Med. 2008:W60-W67. PMID: 18283201
Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008 Feb 19;148(4):295-309. PMID: 18283207.
iv. Health-Related Quality of Life Studies:
Calvert M, Blazeby J, Recicki D, Moher D, Brundage M. Reporting quality of life in clinical trials: a CONSORT extension. The Lancet 2011;378(9804):1684-1685. PMID: 22078674
v. RCTs with Patient-Reported Outcomes (CONSORT PRO):
Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, for the CONSORT PRO Group. Reporting of Patient-Reported Outcomes in Randomized Trials: The CONSORT PRO Extension. JAMA 2013;309(8):814-822. doi: 10.1001/jama2013.879. PMID: 23443445
vi. N-of-1 trails (CENT):
Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. Bmj [Internet]. 2015;350(may14 17):h1738–h1738. PMID: 25976398
1b. Non-Randomized Controlled trials:
TREND: checklist and flow diagram
Reference:
Des Jarlais DC, Lyles C, Crepaz N, and the TREND Group. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: The TREND statement. Am J Public Health. 2004;94:361-366. PMID: 14998794
2. Observational Studies
Cohort, case-control, and cross-sectional studies
STROBE checklist and flowdiagram (if applicable)
Referencer:
von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Ann Intern Med 2007; 147(8):573-577. PMID: 17938396.
Sheffler LC, Yoo B, Bhandari M, et al. Observational studies in orthopaedic surgery: the STROBE statement as a tool for transparent reporting. J. Bone Joint Surg. Am. [Internet]. 2013 Feb 6 [cited 2013 Aug 21];95(3):e14(1–12). PMID: 23389794
3. Diagnostic Test Studies
STARD checklist and flow diagram
Referencer:
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. BMJ 2003; 326(7379):41-4. PMID: 12511463.
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, et al. The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med 2003; 138(1):W1-12. PMID: 12513067.
4. Reliability and agreement Studies
GRRAS checklist
Reference:
Kottner J, Audigé L, Brorson S, Donner A, Gajewski BJ, Hróbjartsson A, et al. Guidelines for Reporting Reliability and Agreement Studies (GRRAS) were proposed. Journal of clinical epidemiology [Internet]. 2011;64(1):96–106. PMID: 2113035
5. Cost-Effectiveness Studies
Reference:
Ramsey S, Willke R, Briggs A, Brown R, Buxton M, Chawla A, Cook J, Glick H, Liljas B, Petitti D, Reed S. Good research practices for cost-effectiveness analysis alongside clinical trials: the ISPOR RCT-CEA Task Force report. Value Health. 2005 Sep-Oct;8(5):521-33. Review. PubMed PMID: 16176491
6. Systematic reviews and meta-analyses
Reference:
Wright RW, Brand R a, Dunn W, Spindler KP. How to write a systematic review. Clinical orthopaedics and related research [Internet]. 2007 Feb [cited 2013 Mar 3];455(455):23–9. PMID: 17279036
6a. Reviews of RCTs:
PRISMA checklist and flow diagram
Referencer:
Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group. Preferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement. BMJ 2009; 339:b2535. PMID: 19622551.
Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gtzsche PC, et al. The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration. BMJ 2009; 339:b2700. PMID: 19622552.
6b) Reviews of observational studies
Reference:
Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000; 283(15):2008-2012. PMID: 10789670.
6c) Network Meta-analyses (user’s guides)
Foote CJ, Chaudhry H, Bhandari M, et al. Network Meta-analysis: Users’ Guide for Surgeons: Part I – Credibility. Clin. Orthop. Relat. Res. [Internet]. Springer US; 2015. PMID: 25869061
Chaudhry H, Foote CJ, Guyatt G, et al. Network Meta-analysis: Users’ Guide for Surgeons: Part II – Certainty. Clin. Orthop. Relat. Res. [Internet]. 2015. PMID: 25869062
7.Uncontrolled case studies
Reference:
Kempen JH. Appropriate use and reporting of uncontrolled case series in the medical literature. Am J Ophthalmol. 2011;151(1):7-10.e1. PMID: 21163373
8. Quality improvement studies
SQUIRE guidelines
9. Survival studies
Reference:
Abraira V, Muriel A, Emparanza JI, et al. Reporting quality of survival analyses in medical journals still needs improvement. A minimal requirements proposal. J. Clin. Epidemiol. 2013;66(12):1340–6. PMID: 24018345