The advent of fair treatment allocation schedules in clinical trials during the 19th and early 20th centuries

Chalmers, Iain; Dukan, Estela; Podolsky, Scott H.; Smith, George Davey

doi:10.1258/jrsm.2012.12k029

Cited by 62 publications

(18 citation statements)

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“…(Herschell 1896a, 414) Perhaps most strikingly, in the realm of therapeutic assessment, researchers could combine methods meant to ensure fair comparison of treatment and "control" groups (such as the strict alternation of patients to treatment versus no-treatment groups) with such blinding to ensure the objective evaluation of treatment outcomes. (On the history of such alternate allocation trials, see Chalmers et al 2012). In 1913, Michigan's A. W. Hewlett noted specifically with respect to therapeutic trials:…”

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confidence: 99%

The Rise and Fall of the “Personal Equation” in American and British Medicine, 1855–1952

Brinkmann¹,

Turner²,

Podolsky³

2019

Perspectives in Biology and Medicine

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Originating within astronomy as a technical term in the first half of the 18th century, the term "personal equation" spread into a litany of other fields including medicine, where it was used widely and variously from the late 19th century to the middle of the 20th century. We explore the personal equation in the medical literatures of the United States and Britain through a systematic analysis of over 700 articles in four prominent medical journals in conjunction with additional relevant source materials. After tracing the term's dispersion from astronomy into medically allied fields, we examine its striking polysemy while using its rich usage as a lens to examine prevailing tensions within contemporary American and British medicine. Stretching from patient and clinician variability to observer variability and error, the personal equation's various meanings reflect debates about the art and science of medical care that persist into the present day. Perspectives in Biology and Medicine M edicine today, as both art and science, embodies a split personality. The ensuing tension-between individualized consideration, experience, and judgment on the one hand, and standardization, objective evidence, and guidelines on the other-plays out in the simultaneous aspirations of the medical humanities and evidence-based medicine, and in a host of other telling terms and movements. This is not a new tension, however. We turn in this paper to the critical but complex history of the term "personal equation" as both reflective and generative of this tension on both sides of the Atlantic during a formative period in medicine from the mid-19th through the mid-20th centuries. The term was featured in almost every realm of medical practice, entering prominent medical dictionaries, books, journal articles, orations, and conference proceedings. 1 In clinical, laboratory, and research settings, medical authors at various times considered the personal equation to be worthy of consideration, study, admiration, dread, cultivation, and control. The tension it reflected and engendered remains long after the term has been discarded. As we consider the language we mobilize and are influenced by today (including terms like "personalized medicine"), it is instructive to dig down into the complex manner by which terms can be introduced, invoked, and even discarded by an evolving and ever-complex profession. Historians of medicine have largely ignored the "personal equation," while historians of science have principally associated it with the disciplines of astronomy and psychology, leading one observer to claim that the personal equation was rarely used outside of these disciplines (Olesko 2003). In recent years, Jimena Canales (2009) has revised the standard account of the personal equation in the history of science by showing the wide disciplinary breadth of usage of the term (in fields ranging from anthropology to physics and mathematics), opening up the history of the personal equation in a way that has yet to be built upon in the history of ...

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mentioning

confidence: 99%

The Rise and Fall of the “Personal Equation” in American and British Medicine, 1855–1952

Brinkmann¹,

Turner²,

Podolsky³

2019

Perspectives in Biology and Medicine

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“…Nødvendigheten av å sammenlikne likt med likt ble, blant andre, påpekt av Isaac Massey i 1723: "To form a just Comparison, and calculate right in this Case, the Circumstances of the Patients, must and ought to be as near as may be on a Par" (3).…”

Section: På Vei Mot Moderne Klinisk Forskningunclassified

“…Han hadde 12 sjømenn med skjørbuk ombord på skipet der han var skipslege, og han prøvet ut seks forskjellige behandlingsmetoder ved å dele mennene inn i grupper på to. Lind beskriver mennene som omtrent like syke, men hvordan han foretok selve fordelingen til de forskjellige behandlingene er ikke kjent (3).…”

Section: På Vei Mot Moderne Klinisk Forskningunclassified

Medisinsk kunnskap før og nå:Fra teori til systematiske oversikter

Fretheim¹

2013

Nor J Epidemiol

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Teorien om balansen mellom de fire kroppsvæskene – humoralpatologien – dominerte sykdomsforståelse og dermed også medisinsk behandling i 2000 år. Brekkmidler, årelating og avføringsmidler var hyppig brukte virkemidler for å rette opp i ”ubalanse” mellom kroppsvæskene, som var regnet som årsak til sykdom.Det var ikke før på 1700-tallet at faktisk empirisk kunnskap ble etterspurt som begrunnelse for valg av behandlingsmetoder. Det å telle opp hvordan det gikk med pasienter som fikk en behandling, og sammenlikne med pasienter som ikke fikk behandlingen, var en ny måte å presentere behandlingseffekter på. Fra 1800-tallet av er det mange eksempler på at behandlingsmetoder ble prøvet ut ved å la annenhver pasient motta behandlingen.Streptomycinstudien til UK Medical Research Council (1946) regnes for å være det første randomiserte kontrollerte forsøket innen medisinsk forskning, og for å ha satt standarden for hvordan kliniske utprøvninger bør utføres.I boka ”Effectiveness and Efficiency. Random Reflections on Health Services” (1972) kritiserte Archie Cochrane mangelen på dokumentasjon for mange av tiltakene som utføres i helsetjenesten. Han ønsket seg langt flere randomiserte studier. Dessuten tok han til orde for at alle randomiserte studier burde samles, og at resultatene burde oppsummeres jevnlig. Iain Chalmers tok utfordringen og påbegynte et omfattende arbeid med å utarbeide en database over randomiserte kontrollerte forsøk. Med utgangspunkt i denne databasen ble det så utarbeidet systematiske oversikter over gjeldende kunnskap om effekt av tiltak i helsetjenesten. Dette ble starten på Cochrane-samarbeidet.Fretheim A. Medical knowledge then and now: From theory to systematic reviews. Nor J Epidemiol 2013; 23 (2): 113-118.ENGLISH SUMMARYThe humoral medicine-theory dominated the understanding of diseases and thus also medical treatments over 2,000 years. Purgatives, bloodletting and laxatives were frequently used to correct ”imbalances” between body fluids, which were seen as the cause of disease.It was not until the 18th century that actual empirical knowledge was seen as important as a basis for making decisions about choice of treatment. At this time, the idea of counting the outcomes among patients receiving a treatment and compare with patients who did not, was a new approach for presenting treatment effects. As of the 19th century there are many examples of treatments being tested by the use of alternation, i.e. allocating every other patient to the treatment under evaluation.The UK Medical Research Council’s streptomycin-trial (1946) is regarded as the first randomised controlled trial in medicine, and for having set the standard for clinical trials.In his book, ”Effectiveness and Efficiency. Random Reflections on Health Services” (1972), Archie Cochrane criticised the lack of evidence for many of the interventions being performed in the health services. He called for far more randomised trials. He also proposed that findings from randomised trials should be collated, and that the results should be summarised on a regular basis. Iain Chalmers took the challenge and engaged in the huge task of developing a database of randomised controlled trials. With the database as a starting point, several systematic reviews of current evidence on the effects of interventions in the health services were produced. This was the start of the Cochrane Collaboration.

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“…Thus, various alternatives to randomized designs have been developed and used to evaluate healthcare interventions [ 6 , 7 ]. Historically, and prior to the advent of randomized trials in the 1940s, alternation was a common form of patient allocation to treatment comparison groups [ 8 , 9 ]. The on-off design is an example of a NCT study design based on the concept of alternation, but which has not been widely described in the literature.…”

Section: Introductionmentioning

confidence: 99%

Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design

Mathe

Johnson

Wozniak

et al. 2015

Trials

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BackgroundRandomized controlled trials are considered the “gold standard” for scientific rigor in the assessment of benefits and harms of interventions in healthcare. They may not always be feasible, however, when evaluating quality improvement interventions in real-world healthcare settings. Non-randomized controlled trials (NCTs) are designed to answer questions of effectiveness of interventions in routine clinical practice to inform a decision or process. The on-off NCT design is a relatively new design where participant allocation is by alternation. In alternation, eligible patients are allocated to the intervention “on” or control “off ” groups in time series dependent sequential clusters.MethodsWe used two quality improvement studies undertaken in a Canadian primary care setting to illustrate the features of the on-off design. We also explored the perceptions and experiences of healthcare providers tasked with implementing the on-off study design.Results and discussionThe on-off design successfully allocated patients to intervention and control groups. Imbalances between baseline variables were attributed to chance, with no detectable biases. However, healthcare providers’ perspectives and experiences with the design in practice reveal some conflict. Specifically, providers described the process of allocating patients to the off group as unethical and immoral, feeling it was in direct conflict with their professional principle of providing care for all. The degree of dissatisfaction seemed exacerbated by: 1) the patient population involved (e.g., patient population viewed as high-risk (e.g., depressed or suicidal)), 2) conducting assessments without taking action (e.g., administering the PHQ-9 and not acting on the results), and 3) the (non-blinded) allocation process.ConclusionsAlternation, as in the on-off design, is a credible form of allocation. The conflict reported by healthcare providers in implementing the design, while not unique to the on-off design, may be alleviated by greater emphasis on the purpose of the research and having research assistants allocate patients and collect data instead of the healthcare providers implementing the trial. In addition, consultation with front-line staff implementing the trials with an on-off design on appropriateness to the setting (e.g., alignment with professional values and the patient population served) may be beneficial.Trial registrationHealth Eating and Active Living with Diabetes: ClinicalTrials.gov identifier: NCT00991380 Date registered: 7 October 2009.Controlled trial of a collaborative primary care team model for patients with diabetes and depression: Clintrials.gov Identifier: NCT01328639 Date registered: 30 March 2011.

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The advent of fair treatment allocation schedules in clinical trials during the 19th and early 20th centuries

Cited by 62 publications

References 36 publications

The Rise and Fall of the “Personal Equation” in American and British Medicine, 1855–1952

The Rise and Fall of the “Personal Equation” in American and British Medicine, 1855–1952

Medisinsk kunnskap før og nå:Fra teori til systematiske oversikter

Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design

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