Chemotherapy Versus Combined Chemotherapy and Serum

Plummer, Norman; Liebmann, James; Solomon, Saul; Kammerer, William H.; Kalkstein, Mennasch; Ensworth, Herbert K.

doi:10.1001/jama.1941.02820210012002

Cited by 28 publications

(4 citation statements)

References 9 publications

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“…We included patients who received serum therapy in addition to drugs, to include the more seriously ill patients. In addition, studies done during the 1940s did not show a clear additive benefit of serum therapy combined with antimicrobials [31]. …”

Section: Estimates Of Effectiveness For Potential Active Control Regimentioning

confidence: 99%

“…However, if mortality data for patients receiving penicillin or a sulfonamide are added from those articles [31, 33, 34, 50–52] that provide data by age alone (rather than by age and bacteremia status), with care to avoid double counting from articles that have overlapping samples, then one can provide more-precise estimates of the magnitude of treatment effect in nonbacteremic patients in the <30-year and 30–49-year age categories. Use of this added information likely underestimates the effect of antimicrobials in younger nonbacteremic patients, given that some of the patients in these 6 additional articles who received antimicrobials were bacteremic.…”

Section: Estimates Of Effectiveness For Potential Active Control Regimentioning

confidence: 99%

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Issues in Noninferiority Trials: The Evidence in Community‐Acquired Pneumonia

Fleming

Powers

2008

CLIN INFECT DIS

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When investigators hypothesize that experimental interventions provide advantages other than improved effectiveness, they can use noninferiority (NI) trials to determine whether one can rule out the possibility that those interventions have unacceptably worse effectiveness than the standard "active control" regimen. To conduct valid NI trials, there must be evidence from historical studies that provides reliable, reproducible, and precise estimates of the effect of the active control, compared with that of placebo, on the specific outcomes investigators plan to use in the NI trial; this effect should be of substantial magnitude, and the estimates of the active control's effect from historical studies must represent its effect in the planned NI trial had a placebo group been included. These conditions allow formulation of an NI margin such that, if the NI trial establishes that the effectiveness of the experimental intervention is not worse than the effectiveness of the active control by more than the NI margin, then one can conclude that the experimental regimen (1) preserves a substantial fraction of the effect of the active control and (2) will not result in a clinically meaningful loss of effectiveness. After general discussion of NI trial design issues, we consider the design of NI trials to evaluate antimicrobials in the treatment of community-acquired pneumonia. We present an extensive literature review, allowing estimation of the historical effect of active control regimens in community-acquired pneumonia primarily on the basis of evidence related to use of sulfonamides or penicillin. This review allows formulation of NI margins that are specific to age and bacteremia status of patients.When effective interventions are available to treat or prevent a disease, there are instances in which investigators are interested in evaluating new experimental agents because they hypothesize that these agents provide advantages other than enhancing effectiveness. For instance, in the treatment of invasive aspergillosis, voriconazole may provide a better adverseReprints or correspondence: Dr. Thomas R. Fleming, Dept. of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195 (E-mail: tfleming@u.washington.edu).. The content of this publication does not necessarily reflect the views or policies of the US Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government. Potential conflicts of interest. T.R.F. has received consulting fees from Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, Roche, Schering-Plough, Theravance, and Wyeth; interactions with these companies were not on projects related to communityacquired pneumonia. J.H.P. has received consulting fees from Acureon, Astellas, Astra-Zeneca, Basilea, Centegen, Cerexa, Concert, Cubist, Destiny, Forest, Johnson & Johnson, Merck, Methylgene, MPEX, Octoplus, Takeda, Theravance, and Wyeth. NIH Public Access Author Manu...

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Section: Estimates Of Effectiveness For Potential Active Control Regimentioning

confidence: 99%

Section: Estimates Of Effectiveness For Potential Active Control Regimentioning

confidence: 99%

Issues in Noninferiority Trials: The Evidence in Community‐Acquired Pneumonia

Fleming

Powers

2008

CLIN INFECT DIS

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“…That the use of serum actually did harm cannot be stated with certainty. In this connexion the recent study of Plummer et al (1941) on the comparable problem in pneumococcal pneumonia is of interest. In an alternate series of cases a slightly higher fatality rate was observed in a group of patients receiving serum in addition to sulphonamide than in patients treated with drug alone.…”

Section: Discussionmentioning

confidence: 99%

Cerebrospinal Fever and Sulphonamides

Beeson¹,

Westerman²

1943

BMJ

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Many articles have appeared within the past five years showing that sulphonamide therapy has effected a considerable reduction in the number of fatalities due to cerebrospinal fever. These reports, most of which are based on groups of less than a hundred cases, are not in agreement on certain matters, such as the sulphonamide compound of choice, its proper dosage, and the value of serum as an adjuvant to chemotherapy. Such differences in experience with cerebrospinal fever are to be expected, since the disease is notoriously variable in severity and in its effect on persons of different ages. In the present communication an attempt is made to obtain information on some of the points in question by means of an analysis of a large number of case reports.

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“…Comparative trials of combined treatment and of sulphonamides alone have been reported from America (e.g., Plummer et al, 1941). The results do not encourage a belief that added benefit is secured by combined therapy.…”

Section: Physician-superintendent Knightswood Fever Hospitalmentioning

confidence: 93%

Aspects of the Chemotherapy of Pneumonia

Anderson¹

1943

BMJ

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Chemotherapy Versus Combined Chemotherapy and Serum

Cited by 28 publications

References 9 publications

Issues in Noninferiority Trials: The Evidence in Community‐Acquired Pneumonia

Issues in Noninferiority Trials: The Evidence in Community‐Acquired Pneumonia

Cerebrospinal Fever and Sulphonamides

Aspects of the Chemotherapy of Pneumonia

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