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September 13, 1995, Vol 274, No. 10 >
ARTICLE | September 13, 1995

A Comparison of Meta-analytic Results Using Literature vs Individual Patient Data: Title and subTitle BreakPaternal Cell Immunization for Recurrent Miscarriage FREE

Gary T. Jeng, MS; James R. Scott, MD; Leon F. Burmeister, PhD
[+] Author Affiliations

Reprints not available.


JAMA. 1995;274(10):830-836. doi:10.1001/jama.1995.03530100070037
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Published online
Article
References

Objective.  —To compare the meta-analytic results from published literature vs those obtained from pooling original patient data.

Data Sources.  —Individual patient data from 15 completed or ongoing trials on paternal white blood cell immunization as treatment for recurrent miscarriage were obtained through the American Society for Reproductive Immunology.

Study Selection.  —Only randomized controlled trials were selected. Within these eight selected trials, 202 patients were from four published studies, 43 were added by the same investigators after publication, and 140 were from four unpublished trials.

Data Extraction.  —Individual patient data were collected using a standardized form and double data entry.

Data Synthesis.  —Using the fixed treatment effect model, we found that the effect of immunization, denoted as the relative live-birth ratio (RR), was greater by pooling summary data from published articles (RR, 1.29; 95% confidence interval [CI], 1.03 to 1.60) than by pooling all individual patient data from the same investigators (RR, 1.17; 95% CI, 0.97 to 1.37) or when individual patient data were pooled from four unpublished trials (RR, 1.01; 95% CI, 0.74 to 1.28). A similar diminishing treatment effect for the same comparisons was observed using the random treatment effect model (RR, 1.38; 95% CI, 0.89 to 1.87 using published summary data; RR, 1.18; 95% CI, 0.98 to 1.42 using individual patient data; RR, 1.01; 95% CI, 0.74 to 1.28 using unpublished trials).

Conclusions.  —Meta-analytic results may differ depending on the use of various data sources: whether the source was from summary statistics in the literature, from individual patient data provided by trialists, or from unpublished trials.(JAMA. 1995;274:830-836)

REFERENCES

1 +
Cook DJ, Sackett DL, Spitzer WO.  Methodologic guidelines for systematic reviews of randomized control trials in health care from the Potsdam consultation meta-analysis. J Clin Epidemiol . 1995;; 48:167-171.
2 +
Chalmers TC, Berrier J, Sacks HS, Lewin H, Reitman D, Nagalingam R.  Meta-analysis of clinical trials as a scientific discipline, II: replicate variability and comparison of studies that agree and disagree. Stat Med . 1987;;6:733-744.
3 +
Scott JR.  Recurrent miscarriage: overview and recommendation. Clin Obstet Gynecol . 1994;;37:768-773.
4 +
Clark DA, Daya S.  Trials and tribulation in the treatment of recurrent spontaneous abortion. Am J Reprod Immunol . 1991;;25:18-24.
5 +
Cowchock S.  What's a mother to do? analysis of trials evaluating new treatments for unexplained recurrent miscarriages and other complaints. Am J Reprod Immunol . 1991;;26:156-159.
6 +
Coulam CB, Coulam CH.  Updated on immunotherapy for recurrent pregnancy loss. Am J Reprod Immunol . 1992;;27:124-127.
7 +
Gatenby PA, Cameron K, Simes RJ, et al.  Treatment of recurrent spontaneous abortion by immunization with paternal lymphocytes: results of a controlled trial. Am J Reprod Immunol . 1993;;29:88-94.
8 +
Fraser EJ, Grimes DA, Schulz KF.  Immunization as therapy for recurrent spontaneous abortion: a review and meta-analysis. Obstet Gynecol . 1993;; 82:854-859.
9 +
The Recurrent Miscarriage Immunotherapy Trialists Group.  Worldwide collaborative observational study and meta-analysis on allogenic leukocyte immunotherapy for recurrent spontaneous abortion. Am J Reprod Immunol . 1994;;32:55-72.
10 +
Stewart LA, Parmar MKB.  Meta-analysis of the literature or of individual patient data: is there a difference? Lancet . 1993;;341:418-422.
11 +
Hasselblad V, Mosteller F, Littenberg B, et al.  A survey of current problems in meta-analysis. Med Care . 1995;;33:202-220.
12 +
Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC.  Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med . 1992;;327:248-254.
13 +
Chalmers TC, Lau J.  Meta-analytic stimulus for changes in clinical trials. Stat Methods Med Res . 1993;;2:161-172.
14 +
Thompson SG.  Controversies in meta-analysis: the case of the trials of serum cholesterol reduction. Stat Methods Med Res . 1993;;2:173-192.
15 +
Sinclair JC, Bracken MB.  Clinically useful measures of effect in binary analyses of randomized trials. J Clin Epidemiol . 1994;;47:881-889.
16 +
Fleiss JL.  The statistical basis of meta-analysis. Stat Methods Med Res . 1993;;2:121-145.
17 +
Breslow NE, Day NE. Statistical Methods in Cancer Research . New York, NY: Oxford University Press Inc; 1987;;1:142-143.
18 +
Jones MP, O'Gorman TW, Lemke JH, Woolson RF.  A Monte Carlo investigation of homogeneity tests of the odds ratio under various sample size configurations. Biometrics . 1989;;45:171-181.
19 +
DerSimonian R, Laird N.  Meta-analysis in clinical trials. Control Clin Trials . 1986;;7:177-188.
20 +
Greenland S, Salvan A.  Bias in the one-step method for pooling study results. Stat Med . 1990;; 9:247-252.
21 +
Cauchi MN, Lim D, Kloss YM, Pepperell RJ.  Treatment of recurrent aborters by immunization with paternal cells—controlled trials. Am J Reprod Immunol . 1991;;25:16-17.
22 +
Ho HN, Gill TJ, Hsieh HJ, Jiang JJ, Lee IY, Hsieh CY.  Immunotherapy for recurrent spontaneous abortions in a Chinese population. Am J Reprod Immunol . 1991;;25:10-15.
23 +
Mowbray JF, Liddell H, Underwood JL, Gibbings C, Reginald PW, Beard RW.  Controlled trial of treatment of recurrent spontaneous abortion by immunization with paternal cells. Lancet . 1985;;1: 941-943.
24 +
Christiansen OB, Mathiesen O, Husth M, Lauritsen JG, Grunnet N.  Placebo-controlled trial of active immunization with third party leukocytes in recurrent miscarriage. Acta Obstet Gynecol Scand . 1993;;72:1-8.
25 +
Wittes RE.  Problems in the medical interpretation of overview. Stat Med . 1987;;6:269-276.
26 +
Demets DL.  Methods for combining randomized clinical trials: strengths and limitations. Stat Med . 1987;;6:341-348.
27 +
Wachter KW.  Disturbed by meta-analysis? Science . 1988;;241:1407-1408.
28 +
Rockette HE, Redmond CK.  Limitations and advantages of meta-analysis in clinical trials. Recent Results Cancer Res . 1988;;111:99-104.
29 +
Spector TD, Thompson SG.  The potential and limitations of meta-analysis. J Epidemiol Community Health . 1991;;45:89-92.
30 +
Thompson SG, Pocock SJ.  Can meta-analysis be trusted? Lancet . 1991;;338:1127-1130.
31 +
Oakes M.  The logic and role of meta-analysis in clinical research. Stat Methods Med Res . 1993;;2: 147-160.
32 +
Begg CB, Berlin JA.  Publication bias: problems in interpreting medical data (with discussion). J R Soc Stat A . 1988;;151:419-463.
33 +
Felson DT.  Bias in meta-analytic research. J Clin Epidemiol . 1992;;45:885-892.
34 +
Simes RJ.  Confronting publication bias: a cohort design for meta-analysis. Stat Med . 1987;;6:11-29.
35 +
Hetherington J, Dickersin K, Chalmers I, Meinert CL.  Retrospective and prospective identification of unpublished controlled trials: lessons from a survey of obstetricians and pediatricians. Pediatrics . 1989;;84:374-380.
36 +
Denton FT.  The effects of publication selection on test probabilities and estimator distributions. Risk Anal . 1990;;10:131-136.
37 +
Easterbook PJ, Berlin JA, Gopalan R, Matthews DK.  Publication bias in clinical research. Lancet . 1991;;337:867-872.
38 +
Cook DJ, Guyatt GH, Ryan G, et al.  Should unpublished data be included in meta-analyses? JAMA . 1993;;269:2749-2753.
39 +
Green SJ, Fleming TR, Emerson S.  Effects on overviews of early stopping rules for clinical trials. Stat Med . 1987;;6:361-367.
40 +
Hughes MD, Freedman LS, Pocock SJ.  The impact of stopping rules on heterogeneity of results in overviews of clinical trials. Biometrics . 1992;;48: 41-53.
41 +
Yusuf S, Collins R, Peto R.  Why do we need some large, simple randomized trials? Stat Med . 1984;;3:409-420.
42 +
ISIS-3 (Third International Study of Infarct Survival) Collaborative Group.  ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41 299 cases of suspected acute myocardial infarction. Lancet . 1992;;339:753-770.
43 +
Matthews JNS.  Small clinical trials: are they all bad? Stat Med . 1995;;14:115-126.
44 +
Ozminkowski RJ, Wortman PM, Roloff DW.  Inborn/outborn status and neonatal survival: a meta-analysis of non-randomized studies. Stat Med . 1988;; 7:1207-1221.
45 +
Colditz GA, Miller JN, Mosteller F.  How study design affects outcomes in comparisons of therapy, I: medical. Stat Med . 1989;;8:441-454.
46 +
Temple R.  Problems in the use of large data sets to assess effectiveness. Int J Technol Assess Health Care . 1990;;6:211-219.
47 +
Droitcour J, Silberman G, Chelimsky E.  Cross-design synthesis: a new form of meta-analysis for combining results from randomized clinical trials and medical-practice databases. Int J Technol Assess Health Care . 1993;;9:440-449.
48 +
Laird NM, Mosteller F.  Some statistical methods for combining experimental results. Int J Technol Assess Health Care . 1990;;6:5-30.
49 +
McGilchrist CA, Zhaorong J.  Multicenter clinical trials and variance components. Biometrical J . 1990;;32:335-346.
50 +
Graubrard BI, Korn EL.  Regression analysis with clustered data. Stat Med . 1994;;13:509-522.
51 +
Houwelinger HCV, Zwinderman KH, Stijnen T.  A bivariate approach to meta-analysis. Stat Med . 1993;;12:2273-2284.
52 +
Friedenreich CM.  Methods for pooled analysis of epidemiologic studies. Epidemiology . 1993;;4:295-302.
53 +
Thompson SG.  Why sources of heterogeneity in meta-analysis should be investigated. BMJ . 1994;; 309:1351-1355.
54 +
Smith SJ, Steinberg KK, Thacker SB.  Pooled analyses in epidemiologic studies. Epidemiology . 1994;;5:381-382.
55 +
Chalmers I, Enkin M, Meirse M.  Preparing and updating systematic reviews of randomized controlled trials of health care. Milbank Q . 1993;;71: 411-437.
56 +
Olkin I.  Statistical and theoretical considerations in meta-analysis. J Clin Epidemiol . 1995;;48:133-146.
57 +
Sandercock P.  Collaborative worldwide overviews of randomized trials. Ann N Y Acad Sci . 1993;;703:149-154.
58 +
Chalmers I.  The Cochrane collaboration: preparing, maintaining, and disseminating systematic reviews of the effects of health care. Ann N Y Acad Sci . 1993;;703:156-163.

Figures

Tables

Interactive Graphics

Video

Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Cook DJ, Sackett DL, Spitzer WO.  Methodologic guidelines for systematic reviews of randomized control trials in health care from the Potsdam consultation meta-analysis. J Clin Epidemiol . 1995;; 48:167-171.
2 +
Chalmers TC, Berrier J, Sacks HS, Lewin H, Reitman D, Nagalingam R.  Meta-analysis of clinical trials as a scientific discipline, II: replicate variability and comparison of studies that agree and disagree. Stat Med . 1987;;6:733-744.
3 +
Scott JR.  Recurrent miscarriage: overview and recommendation. Clin Obstet Gynecol . 1994;;37:768-773.
4 +
Clark DA, Daya S.  Trials and tribulation in the treatment of recurrent spontaneous abortion. Am J Reprod Immunol . 1991;;25:18-24.
5 +
Cowchock S.  What's a mother to do? analysis of trials evaluating new treatments for unexplained recurrent miscarriages and other complaints. Am J Reprod Immunol . 1991;;26:156-159.
6 +
Coulam CB, Coulam CH.  Updated on immunotherapy for recurrent pregnancy loss. Am J Reprod Immunol . 1992;;27:124-127.
7 +
Gatenby PA, Cameron K, Simes RJ, et al.  Treatment of recurrent spontaneous abortion by immunization with paternal lymphocytes: results of a controlled trial. Am J Reprod Immunol . 1993;;29:88-94.
8 +
Fraser EJ, Grimes DA, Schulz KF.  Immunization as therapy for recurrent spontaneous abortion: a review and meta-analysis. Obstet Gynecol . 1993;; 82:854-859.
9 +
The Recurrent Miscarriage Immunotherapy Trialists Group.  Worldwide collaborative observational study and meta-analysis on allogenic leukocyte immunotherapy for recurrent spontaneous abortion. Am J Reprod Immunol . 1994;;32:55-72.
10 +
Stewart LA, Parmar MKB.  Meta-analysis of the literature or of individual patient data: is there a difference? Lancet . 1993;;341:418-422.
11 +
Hasselblad V, Mosteller F, Littenberg B, et al.  A survey of current problems in meta-analysis. Med Care . 1995;;33:202-220.
12 +
Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC.  Cumulative meta-analysis of therapeutic trials for myocardial infarction. N Engl J Med . 1992;;327:248-254.
13 +
Chalmers TC, Lau J.  Meta-analytic stimulus for changes in clinical trials. Stat Methods Med Res . 1993;;2:161-172.
14 +
Thompson SG.  Controversies in meta-analysis: the case of the trials of serum cholesterol reduction. Stat Methods Med Res . 1993;;2:173-192.
15 +
Sinclair JC, Bracken MB.  Clinically useful measures of effect in binary analyses of randomized trials. J Clin Epidemiol . 1994;;47:881-889.
16 +
Fleiss JL.  The statistical basis of meta-analysis. Stat Methods Med Res . 1993;;2:121-145.
17 +
Breslow NE, Day NE. Statistical Methods in Cancer Research . New York, NY: Oxford University Press Inc; 1987;;1:142-143.
18 +
Jones MP, O'Gorman TW, Lemke JH, Woolson RF.  A Monte Carlo investigation of homogeneity tests of the odds ratio under various sample size configurations. Biometrics . 1989;;45:171-181.
19 +
DerSimonian R, Laird N.  Meta-analysis in clinical trials. Control Clin Trials . 1986;;7:177-188.
20 +
Greenland S, Salvan A.  Bias in the one-step method for pooling study results. Stat Med . 1990;; 9:247-252.
21 +
Cauchi MN, Lim D, Kloss YM, Pepperell RJ.  Treatment of recurrent aborters by immunization with paternal cells—controlled trials. Am J Reprod Immunol . 1991;;25:16-17.
22 +
Ho HN, Gill TJ, Hsieh HJ, Jiang JJ, Lee IY, Hsieh CY.  Immunotherapy for recurrent spontaneous abortions in a Chinese population. Am J Reprod Immunol . 1991;;25:10-15.
23 +
Mowbray JF, Liddell H, Underwood JL, Gibbings C, Reginald PW, Beard RW.  Controlled trial of treatment of recurrent spontaneous abortion by immunization with paternal cells. Lancet . 1985;;1: 941-943.
24 +
Christiansen OB, Mathiesen O, Husth M, Lauritsen JG, Grunnet N.  Placebo-controlled trial of active immunization with third party leukocytes in recurrent miscarriage. Acta Obstet Gynecol Scand . 1993;;72:1-8.
25 +
Wittes RE.  Problems in the medical interpretation of overview. Stat Med . 1987;;6:269-276.
26 +
Demets DL.  Methods for combining randomized clinical trials: strengths and limitations. Stat Med . 1987;;6:341-348.
27 +
Wachter KW.  Disturbed by meta-analysis? Science . 1988;;241:1407-1408.
28 +
Rockette HE, Redmond CK.  Limitations and advantages of meta-analysis in clinical trials. Recent Results Cancer Res . 1988;;111:99-104.
29 +
Spector TD, Thompson SG.  The potential and limitations of meta-analysis. J Epidemiol Community Health . 1991;;45:89-92.
30 +
Thompson SG, Pocock SJ.  Can meta-analysis be trusted? Lancet . 1991;;338:1127-1130.
31 +
Oakes M.  The logic and role of meta-analysis in clinical research. Stat Methods Med Res . 1993;;2: 147-160.
32 +
Begg CB, Berlin JA.  Publication bias: problems in interpreting medical data (with discussion). J R Soc Stat A . 1988;;151:419-463.
33 +
Felson DT.  Bias in meta-analytic research. J Clin Epidemiol . 1992;;45:885-892.
34 +
Simes RJ.  Confronting publication bias: a cohort design for meta-analysis. Stat Med . 1987;;6:11-29.
35 +
Hetherington J, Dickersin K, Chalmers I, Meinert CL.  Retrospective and prospective identification of unpublished controlled trials: lessons from a survey of obstetricians and pediatricians. Pediatrics . 1989;;84:374-380.
36 +
Denton FT.  The effects of publication selection on test probabilities and estimator distributions. Risk Anal . 1990;;10:131-136.
37 +
Easterbook PJ, Berlin JA, Gopalan R, Matthews DK.  Publication bias in clinical research. Lancet . 1991;;337:867-872.
38 +
Cook DJ, Guyatt GH, Ryan G, et al.  Should unpublished data be included in meta-analyses? JAMA . 1993;;269:2749-2753.
39 +
Green SJ, Fleming TR, Emerson S.  Effects on overviews of early stopping rules for clinical trials. Stat Med . 1987;;6:361-367.
40 +
Hughes MD, Freedman LS, Pocock SJ.  The impact of stopping rules on heterogeneity of results in overviews of clinical trials. Biometrics . 1992;;48: 41-53.
41 +
Yusuf S, Collins R, Peto R.  Why do we need some large, simple randomized trials? Stat Med . 1984;;3:409-420.
42 +
ISIS-3 (Third International Study of Infarct Survival) Collaborative Group.  ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41 299 cases of suspected acute myocardial infarction. Lancet . 1992;;339:753-770.
43 +
Matthews JNS.  Small clinical trials: are they all bad? Stat Med . 1995;;14:115-126.
44 +
Ozminkowski RJ, Wortman PM, Roloff DW.  Inborn/outborn status and neonatal survival: a meta-analysis of non-randomized studies. Stat Med . 1988;; 7:1207-1221.
45 +
Colditz GA, Miller JN, Mosteller F.  How study design affects outcomes in comparisons of therapy, I: medical. Stat Med . 1989;;8:441-454.
46 +
Temple R.  Problems in the use of large data sets to assess effectiveness. Int J Technol Assess Health Care . 1990;;6:211-219.
47 +
Droitcour J, Silberman G, Chelimsky E.  Cross-design synthesis: a new form of meta-analysis for combining results from randomized clinical trials and medical-practice databases. Int J Technol Assess Health Care . 1993;;9:440-449.
48 +
Laird NM, Mosteller F.  Some statistical methods for combining experimental results. Int J Technol Assess Health Care . 1990;;6:5-30.
49 +
McGilchrist CA, Zhaorong J.  Multicenter clinical trials and variance components. Biometrical J . 1990;;32:335-346.
50 +
Graubrard BI, Korn EL.  Regression analysis with clustered data. Stat Med . 1994;;13:509-522.
51 +
Houwelinger HCV, Zwinderman KH, Stijnen T.  A bivariate approach to meta-analysis. Stat Med . 1993;;12:2273-2284.
52 +
Friedenreich CM.  Methods for pooled analysis of epidemiologic studies. Epidemiology . 1993;;4:295-302.
53 +
Thompson SG.  Why sources of heterogeneity in meta-analysis should be investigated. BMJ . 1994;; 309:1351-1355.
54 +
Smith SJ, Steinberg KK, Thacker SB.  Pooled analyses in epidemiologic studies. Epidemiology . 1994;;5:381-382.
55 +
Chalmers I, Enkin M, Meirse M.  Preparing and updating systematic reviews of randomized controlled trials of health care. Milbank Q . 1993;;71: 411-437.
56 +
Olkin I.  Statistical and theoretical considerations in meta-analysis. J Clin Epidemiol . 1995;;48:133-146.
57 +
Sandercock P.  Collaborative worldwide overviews of randomized trials. Ann N Y Acad Sci . 1993;;703:149-154.
58 +
Chalmers I.  The Cochrane collaboration: preparing, maintaining, and disseminating systematic reviews of the effects of health care. Ann N Y Acad Sci . 1993;;703:156-163.

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