Forskningsmetode

Generell innføring i livskvalitetsforskning:

“Quality of Life: The Assessment, Analysis and Interpretation of Patient-reported Outcomes” av Fayers & Machin

http://eu.wiley.com/WileyCDA/WileyTitle/productCd-1118699459.html

 

Planlegging av klinisk studie med PROM:

Norcrin har utarbeidet en protokollmal for kliniske studier.

 

Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: The SPIRIT-PRO extension

Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan AW, King MT; the SPIRIT-PRO Group. JAMA. 2018;319(5):483-494. doi: 10.1001/jama.2017.21903.

 

Avdeling for biobank- og registerstøtte i Helse Sør-Øst har laget oversikt over hvilke datafangstverktøy som er godkjente for bruk i regionen. 

 

Retningslinjer for valg og rapportering av PROM:

ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research.

Reeve BB, Wyrwich KW, Wu AW, Velikova G, Terwee CB, Snyder CF, et al. Qual Life Res. 2013;22(8):1889-905. doi: 10.1007/s11136-012-0344-y. PMID: 23288613

 

Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.

Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD; CONSORT PRO Group. JAMA. 2013;309(8):814-22. doi: 10.1001/jama.2013.879. PMID: 23443445

 

Patient-reported outcomes in randomized clinical trials: development of ISOQOL reporting standards.

Brundage M, Blazeby J, Revicki D, Bass B, de Vet H, Duffy H, et al. Qual Life Res. 2013;22(6):1161-75. doi: 10.1007/s11136-012-0252-1. PMID: 22987144

 

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

Bottomley A, Pe M, Sloan J, Basch E, Bonnetain F, Calvert M, et al; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium. Lancet Oncol. 2016;17(11):e510-e514. doi: 10.1016/S1470-2045(16)30510-1. PMID: 27769798