Guidelines for reporting observational studies

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Reporting guidance provided for: Name & website (where available) References including PMID
Observational studies in epidemiology

STROBE

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
PLoS Med. 2007;4(10):e296. PMID: 17941714
BMJ. 2007;335(7624):806-808. PMID: 17947786
Prev Med. 2007;45(4):247-251. PMID: 17950122
Epidemiology. 2007;18(6):800-804. PMID: 18049194
Lancet. 2007;370(9596):1453-1457.
PMID: 18064739

Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration.
PLoS Med 2007; 4(10):e297. PMID: 17941715
Epidemiology. 2007; 18(6):805-35. PMID: 18049195
Ann Intern Med. 2007;147(8):W163-94.
PMID: 17938389


The STROBE Statement has been extended to cover genetic association studies:

STREGA
Genetic association studies
Little J, Higgins JP, Ioannidis JP, Moher D, Gagnon F, von Elm E, et al. STrengthening the REporting of Genetic Association Studies (STREGA): An Extension of the STROBE Statement.
PLoS Med 2009;6(2):e22. PMID: 19192942
Hum Genet 2009; 125(2):131-151. PMID: 19184668
Eur J Epidemiol 2009;24(1):37-55. PMID: 19189221
Ann Intern Med 2009;150(3):206-215.
PMID: 19189911
J Clin Epidemiol 2009;62(6):597-608.e4.
PMID: 19217256
Genet Epidemiol 2009;33(7):581-598.
PMID: 19278015
Eur J Clin Invest 2009;39(4):247-266.
PMID: 19297801
Molecular epidemiology (biomarker) studies
STROBE-ME
Gallo V, Egger M, McCormack V, Farmer PB, Ioannidis JP, Kirsch-Volders M, Matullo G, Phillips DH, Schoket B, Stromberg U, Vermeulen R, Wild C, Porta M, Vineis P. STrengthening the Reporting of OBservational studies in Epidemiology - Molecular Epidemiology (STROBE-ME): An extension of the STROBE statement. Eur J Clin Invest 2012; 42(1):1-16. PMID: 22023344
Observational studies of menopause and aging
STROMA
Melby MK, Sievert LL, Anderson D, Obermeyer CM. Overview of methods used in cross-cultural comparisons of menopausal symptoms and their determinants: Guidelines for Strengthening the Reporting of Menopause and Aging (STROMA) studies. Maturitas. 2011;70(2):99-109. PMID: 21840143
Immunogenomic studies
STREIS
Hollenbach JA, Mack SJ, Gourraud PA, Single RM, Maiers M, Middleton D, Thomson G, Marsh SG, Varney MD; for the Immunogenomics Data Analysis Working Group. A community standard for immunogenomic data reporting and analysis: proposal for a STrengthening the REporting of Immunogenomic Studies statement. Tissue Antigens. 2011; 78(5):333-344. PMID: 21988720
Infection control intervention studies
ORION

Stone SP, Cooper BS, Kibbler CC, Cookson BD, Roberts JA, Medley GF, Duckworth G, Lai R, Ebrahim S, Brown EM, Wiffen PJ, Davey PG. The ORION statement: guidelines for transparent reporting of Outbreak Reports and Intervention studies Of Nosocomial infection.
J Antimicrob Chemother 2007; 59(5):833-840.
PMID: 17387116
Lancet Infect Dis 2007; 7(4): 282–288.
PMID: 17376385

Longitudinal observational studies in rheumatology
Wolfe F, Lassere M, van der HD, Stucki G, Suarez-Almazor M, Pincus T, Eberhardt K, Kvien TK, Symmons D, Silman A, van Riel P, Tugwell P, Boers M. Preliminary core set of domains and reporting requirements for longitudinal observational studies in rheumatology. J Rheumatol 1999; 26(2):484-489.
PMID: 9972992
Safety studies of biological therapies/data from biologics registers in rheumatology

Dixon WG, Carmona L, Finckh A, Hetland ML, Kvien TK, Landewe R, Listing J, Nicola PJ, Tarp U, Zink A, Askling J. EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology. Ann Rheum Dis. 2010; 69(9):1596-602. PMID: 20525843
Comparative effectiveness research

Berger ML, Mamdani M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: Defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: The ISPOR good research practices for retrospective database analysis task force report - Part i. Value in Health 2009; 12(8):1044-52.
PMID: 19793072
Case series
Jabs DA. Improving the Reporting of Clinical Case Series. American Journal of Ophthalmology 2005; 139(5):900-905.
PMID: 15860297
Case series

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
Case series - acupuncture (conduct, reporting)
White A. Conducting and reporting case series and audits--author guidelines for acupuncture in medicine. Acupunct Med 2005; 23(4):181-187.
PMID: 16430126
Case-control studies (participation)
Olson SH, Voigt LF, Begg CB, Weiss NS. Reporting participation in case-control studies. Epidemiology 2002; 13(2):123-126.
PMID: 11880750
Case reports
Sorinola O, Olufowobi O, Coomarasamy A, Khan KS. Instructions to authors for case reporting are limited: a review of a core journal list. BMC Med Educ 2004; 4:4.
PMID: 15043755

Case reports

Cases Journal No published guideline available - journal's instructions.
Case reports
BMJ guidance No published guideline available - journal's instructions.
Case reports in behavioural clinical psychology

Virues-Ortega J and Moreno-Rodriguez R. Guidelines for clinical case reports in behavioral clinical psychology. Int J Clin Health Psychology 2008; 8(3): 765-777
Adverse event reports
Kelly WN, Arellano FM, Barnes J, Bergman U, Edwards RI, Fernandez AM, et al. Guidelines for submitting adverse event reports for publication. Drug Saf 2007;30(5):367-73. PMID: 17472416
Pharmacoepidemiol Drug Saf. 2007;16(5):581-7.
PMID: 17471601
Adverse event reports - traditional Chinese medicine

Wu T, Shang H, Bian Z, Zhang J, Li T, Li Y, Zhang B. Recommendations for reporting adverse drug reactions and adverse events of traditional Chinese medicine. J Evid Based Med. 2010; 3(1):11-7. PMID: 21349035
Anecdotes of suspected drug adverse reactions

PHARMA


Aronson JK. Anecdotes as evidence. BMJ 2003; 326(7403):1346.
PMID: 12816800
Tumour marker prognostic studies REMARK

McShane LM, Altman DG, Sauerbrei W, Taube SE, Gion M, Clark GM. REporting recommendations for tumour MARKer prognostic studies (REMARK). Br J Cancer 2005; 93(4):387-391.
PMID: 16106245

Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration.
BMC Med. 2012;10:51. PMID: 22642691
PLoS Med 9(5): e1001216. Link to full-text

Prognostic signature studies - non-small cell lung cancer

Subramanian J, Simon R. Gene expression-based prognostic signatures in lung cancer: ready for clinical use? J Natl Cancer Inst. 2010; 102(7):464-74. PMID: 20233996
Prognostic studies with missing covariate data
Burton A, Altman DG. Missing covariate data within cancer prognostic studies: a review of current reporting and proposed guidelines. Br J Cancer 2004; 91(1):4-8.
PMID: 15188004
Clinical proteomic biomarker studies

Mischak H, Allmaier G, Apweiler R, Attwood T, Baumann M, Benigni A et al.: Recommendations for biomarker identification and qualification in clinical proteomics. Sci Transl Med 2010, 2: 46ps42.
PMID: 20739680
Genetic risk prediction studies
GRIPS
Janssens AC, Ioannidis JP, van Duijn CM, Little J, Khoury MJ; GRIPS Group. Strengthening the reporting of Genetic RIsk Prediction Studies: the GRIPS Statement.
PLoS Med. 2011 8(3):e1000420. PMID: 21423587
Genet Med 2011;13(5):453-6. PMID: 21502867
Eur J Clin Inves 2011;41(9):1004-9. PMID: 21434891
Eur J Epidemiol 2011;26(4):255-9. PMID: 21431409
J Clin Epid 2011;64(8):843-7. PMID: 21414754
BMJ 2011;16:342:d631. PMID: 21411493
Genome Med 2011;3(3):16. PMID: 21410995
Eur J Hum Genet 2011;19(8):833-6. PMID: 21407265
Circ Cardiovasc Genet 2011;4(2):206-9. PMID: 21406688
Ann Intern Med 2011;154(6):421-5. PMID: 21403077

ACJW Janssens, JPA Ioannidis, S Bedrosian, P Boffetta, SM Dolan, N Dowling, I Fortier, AN Freedman, JM Grimshaw, J Gulcher, M Gwinn, MA Hlatky, H Janes, P Kraft, S Melillo, CJ O’Donnell, MJ Pencina, D Ransohoff, SD Schully, D Seminara, DM Winn, CF Wright, CM van Duijn, J Little, MJ Khoury. Strengthening the reporting of genetic risk prediction studies (GRIPS): explanation and elaboration.
Eur J Clin Invest 2011;41(9):1010-35. PMID: 21434890
Eur J Epid 2011;26(4):313-37. PMID: 21424820
J Clin Epid 2011;64(8):e1-22. PMID: 21414753
Eur J Hum Genet 2011;19(5):18. PMID: 21407270
Genetic results in research studies
Bookman E, Langehorne A, Eckfeldt J, Glass K, Jarvik G, Klag M, Koski G, Motulsky A, Wilfond B, Manolio T, Fabsitz R, Luepker R, V. Reporting genetic results in research studies: summary and recommendations of an NHLBI working group. American journal of medical genetics Part A 2006; 140(10):1033-1040.
PMID: 16575896
Survey research (conduct, reporting)

Kelley K, Clark B, Brown V, Sitzia J. Good practice in the conduct and reporting of survey research. Int J Qual Health Care 2003; 15(3):261-266.
PMID: 12803354


Burns KE, Duffett M, Kho ME, Meade MO, Adhikari NK, Sinuff T, et al. A guide for the design and conduct of self-administered surveys of clinicians. CMAJ 2008 Jul 29;179(3):245-52.
PMID: 18663204

Quality of medicine surveys



Newton PN, Lee SJ, Goodman C, Fernandez FM, Yeung S, Phanouvong S, et al. Guidelines for field surveys of the quality of medicines: a proposal.
PLoS Med 2009 Mar 24;6(3):e52.
PMID: 19320538
Internet e-surveys

Eysenbach G. Improving the quality of Web surveys: the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). J Med Internet Res 2004; 6(3):e34.
PMID: 15471760
A correction has been made to table 1 in this paper: link to correction

Momentary self-report data
Stone AA, Shiffman S. Capturing momentary, self-report data: a proposal for reporting guidelines. Ann Behav Med 2002; 24(3):236-243.
PMID: 12173681

Page last edited: 05 October 2012