Methodological issues in the diagnostic work-up of food allergy: A real challenge

Journal of Investigational Allergology and Clinical Immunology

Volumn 17, Issue 6, 2007, Pages 350-356

  Gellerstedt, Martin ^a   Bengtsson, U ^b   Niggemann, B ^c  

^a UNIVERSITY WEST   (Sweden)

^b SAHLGRENSKA UNIVERSITY HOSPITAL   (Sweden)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

Diagnostic accuracy; Food allergy; Food challenge; Methodological issues

Indexed keywords

ALLERGY TEST; DIAGNOSTIC ACCURACY; DIAGNOSTIC PROCEDURE; FOOD ALLERGY; GOLD STANDARD; HUMAN; PATCH TEST; PRICK TEST; PROVOCATION TEST; REVIEW; SENSITIVITY AND SPECIFICITY; SKIN TEST;

CLINICAL TRIALS AS TOPIC; DOUBLE-BLIND METHOD; FOOD HYPERSENSITIVITY; HUMANS; REFERENCE STANDARDS; SENSITIVITY AND SPECIFICITY; SKIN TESTS;

EID: 36849082377     PISSN: 10189068     EISSN: 16980808     Source Type: Journal    
DOI: None     Document Type: Review

References (52)

1. Reid MC, Lachs MS, Feinstein AR. Use of methodological standards in diagnostic test research: getting better but still not good. JAMA. 1995;274:645-51.
2. Whiting P, Rutjes AW, Reitsma JB, Glas AS, Bossuyt PM, Kleijnen J. Sources of Variation and Bias in Studies of Diagnostic Accuracy - a systematic review. Ann Intern Med. 2004;140:189-202.
3. Knottnerus JA, Van Weel C, Muris JWM. Evaluation of diagnostic procedures. BMJ. 2002;324:477-80.
4. Sacket DL, Haynes RB. The architecture of diagnostic research. BMJ 2002;324:539-41.
5. Irwig L, Bossuyt P, Glasziou P, Gatsonis C, Lijmer J. Designing studies to ensure that estimates of test accuracy are transferable. BMJ. 2002;324:669-71.
6. Knottnerus JA editor. The evidence base of clinical diagnosis. London: BMJ books; 2002.
7. Pepe M. Statistical evaluation of medical tests for classification and prediction. Oxford: Oxford University Press; 2004.
8. Jaeschke R, Guyatt GH, Sacket DL. Users' guides to the medical literature III. How to use an article about a diagnostic test. Are the results of the study valid? JAMA. 1994;271:389-91.
9. Van Der Schouw YT, Verbeek ALM, Ruijs JHJ. Guidelines for the assessment of new diagnostic tests. Invest Radiol. 1995;30:334-40.
10. Moons KG, Grobbee DE. Diagnostic studies as multivariable, prediction research. J Epidemiol Community Health. 2002;56:337-8.
11. The STARD Statement for Reporting Studies of Diagnostic Accuracy. Available from: http://www.consort-statement.org/stardstatement.htm
12. Solberg HE. Approved recommendation (1986) on the Theory of Reference Values. Part 1. The Concept of Reference Values. J Clin Chem Clin Biochem. 1987;25:337-42.
13. Petitclerc C, Solberg HE. Approved recommendation (1987) on the Theory of Reference Values. Part 2. Selection of Individuals for the production of reference values. J Clin Chem Clin Biochem. 1987;25:639-44.
14. Solberg HE, Petitclerc C. Approved recommendation (1988) on the Theory of Reference Values. Part 3. Preparation of Individuals and Collection of Specimens for the production of Reference Values. J Clin Chem Clin Biochem. 1988;26:593-98.
15. Solberg HE, Stamm D. Approved recommendation on the Theory of Reference Values. Part 4. Control of Analytical Variation in the Production, Transfer and Application of Reference Values. Eur. J Clin Chem Clin Biochem. 1991;29:531-35.
16. Solberg HE. Approved recommendation (1987) on the Theory of Reference Values. Part 5. Statistical Treatment of Collected Reference Values. Determination of Reference Limits. J Clin Chem Clin Biochem. 1987;25:645-56.
17. Dybkaer R, Solberg HE. Approved recommendation (1987) on the Theory of Reference Values. Part 6. Presentation of Observed Values Related to Reference Values. J Clin Chem Clin Biochem. 1987;25:657-62.
18. The declaration of Helsinki. Available from: http://www.wma.net/e/ ethicsunit/helsinki.htm
19. Bock SA. Food challenges in the diagnosis of food hypersensitivity. In: De Weck AL, Sampson HA, editors. Intestinal immunology and food allergy. New York: Raven Press; 1995. p.105-17.
20. Bindslev-Jensen C. Standardization of double-blind, placebo-controlled, food challenges. Allergy. 2001;56 Suppl 67:S83-5.
21. Briggs D, Aspinall L, Dickens A, Bindslev-Jensen C. Statistical model for assessing the proportion of subjects with subjective sensitisations in adverse reactions to foods. Allergy. 2001;56 Suppl 67 :S83-5.
22. Bindslev-Jensen C, Briggs D, Osterballe M. Can we determine a threshold level for allergenic foods by statistical analysis of published data in the literature? Allergy. 2002;57:741-6.
23. Niggemann B, Wahn U, Sampson HA. Proposals for standardization of oral food challenge tests in infants and children. Pediatr Allergy Immunol. 1994;5:11-13.
24. Bindslev-Jensen C, Ballmer-Weber BK, Bengtsson U, Blanco C, Ebner C, Hourihane J, Knulst A C, Moneret-Vautrin D A, Nekam K, Niggemann B, Osterballe M, Ortolani C, Ring J, Schnopp C, Werfel T. Standardization of food challenges in patients with immediate reactions to foods -position paper from the European Academy of Allergology and Clinical immunology. Allergy. 2004;59:690-97.
25. Niggemann B, Beyer K. Diagnostic pitfalls in food allergy in children. Allergy. 2005; 60:104-107.
26. Vila L, Sanz ML, Sánchez-Lópes G, García- Avilés C, Diéguez I. Variation of serum eosinophil cationic protein and tryptase, measured in serum and saliva, during the course of immediate allergic reactions to foods. Allergy. 2001;56:568-72.
27. Magnusson J, Gellerstedt M, Ahlstedt S, Andersson B, Bengtsson, Telemo E, Hansson T, Peterson C.G. A kinetic study in adults with food hypersensitivity assessed as eosinophil activation in fecal samples. Clin Exp Allergy. 2003;33:1052-1059.
28. Roehr C, Reibel S, Ziegert M, Sommerfeld C, Wahn U, Niggemann B. Atopy patch test together with level of specific IgE reduces the need for oral food challenges in children with atopic dermatitis. J Allergy Clin Immunol. 2001;107:548-553.
29. Sampson H.A. Utility of food-specific IgE concentrations in predicting symptomatic food allergy. J Allergy Clin Immunol. 2001;107:891-896.
30. Sampson H.A. Food allergy - accurately identifying clinical reactivity. Allergy. 2005:60 Suppl 79:S19-24.
31. Celik-Bilgili S, Mehl A, Verstege A, Staden U, Nocon M, Beyer K, Niggemann B. The predictive value of specific immunoglobulin E levels in serum for the outcome of oral food challenges. Clin Exp Allergy. 2005;35:268-73.
32. Verstege A, Mehl A, Rolinck-Werninghaus C, Staden U, Nocon M, Beyer K, Niggemann B. The predictive value of the skin prick test wheal size for the outcome of oral food challenges. Clin Exp Allergy. 2005;35:1220-6.
33. Niggemann B, Rolinck-Werninghaus C, Mehl, A, Binder C, Ziegert M, Beyer K. Controlled oral food challenges in children - when indicated, when superfluous? Allergy. 2005;60:865-70.
34. Rutjes AW, Reitsma JB, Vandenbroucke JP, Glas AS, Bossuyt PM Case-control and two-gate designs in diagnostic accuracy studies. Clin Chem. 2005; 51(8):1335-41.
35. Ransohoff DF, Feinstein AR. Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med. 1978;299:926-30.
36. Begg CB. Biases in the assessment of diagnostic tests. Statistics Med. 1987;6:411-23.
37. Begg CB, Greenes RA. Assessment of diagnostic tests when disease verification is subject to selection bias. Biometrics. 1983;39:207-15.
38. Knottnerus JA, Leffers JP. The influence of referral patterns on the characteristics of diagnostic tests. J Clin Epid. 1992;45:1143-54.
39. Diamond GA. Selection bias and the evaluation of diagnostic tests: a metadissent. J Chron Dis. 1986;39:359-60.
40. Lachs MS, Nachamkin I, Edelstein PH, Goldman J, Feinstein AR, Schwartz JS. Spectrum bias in the evaluation of diagnostic tests: lessons from the rapid dipstick test for urinary tract infection. Ann Intern Med. 1992;117:135-140.
41. Mulherin SA, Miller CW. Spectrum bias or spectrum effect? Subgroup variation in diagnostic test evaluation. Ann Intern Med. 2002;137:598-602.
42. Moons KG, Van Es GA, Deckers JW, Habbema JD, Grobbee DE. Limitations of sensitivity, specificity, likelihood ratio, and bayes' theorem in assessing diagnostic probabilities: a clinical example. Epidemiology. 1997;8:12-7.
43. Fraser CG, Harris EK. Generation and application of data in biological variation in clinical chemistry. Crit Rev Clin Lab Sci. 1989;27:409-37.
44. Vohlonen I, Terho EO, Koivikko A, vanto T, Holmen A, Heinonen OP. Reproducibility of the skin prick test. Allergy. 1989;44:525-31.
45. Gellerstedt M, Magnusson J, Gråsjö U, Ahlstedt S, Bengtsson U. Interpretations of subjective symptoms in double blind placebo controlled food challenges - Inter-observer-relibility. Allergy. 2004;59:354-6.
46. Bindslev-Jensen C. Food allergy: A diagnostic challenge. Curr Probl Dermatol. 1999;28:74-80.
47. Hawkins D, Garrett M and Stephenson B. Some issues in resolution of diagnostic tests using an imperfect gold standard. Stat. Med. 20:1987-2001.
48. Justice AC, Covinsky KE, Berlin JA. Assessing the generalizability of prognostic information. Ann Intern Med. 1999;130:515-24.
49. Harrell FE JR, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 1996;15:361-87.
50. International Conference On Harmonisation Steering Committee. ICH harmonised tripartite guideline. General considerations for clinical trials. Available from: http://www.ich.org/MediaServer:jser?@_ID=484&@_MODE=GLB
51. Moons KG, Van Es GA, Michel BC, Buller HR, Habbema JD, Grobbee DE. Redundancy of single diagnostic test evaluation. Epidemiology. 1999;10:276-81.
52. Moons KG , Biesheuvel CJ, Grobbee DE. Test research vs diagnostic research. Clinical Chemistry. 2004;50:473-76