Evidence map›Paper›PMID 27829371›Full record

ArticleBMC medical research methodology2016

Inverse probability weighting to estimate causal effect of a singular phase in a multiphase randomized clinical trial for multiple myeloma.

Annalisa Pezzi, Michele Cavo, Annibale Biggeri, Elena Zamagni, Oriana Nanni

Registry-linked trialAbstract read
In one paragraph

Article in BMC medical research methodology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01134484 (A Phase 3, Prospective, Randomized Clinical Study of VELCADE-Thalidomide-Dexamethasone), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01134484 phase3unknown statusnot on this map

A Phase 3, Prospective, Randomized Clinical Study of VELCADE-Thalidomide-Dexamethasone (VTD) Versus Thalidomide-Dexamethasone (TD) for Previously Untreated Multiple Myeloma (MM) Patients Who Are Candidates to Receive Double Autologous Transplantation

TypeinterventionalSponsorMichele CavoRan2006 to 2015Enrolled480ConditionsMultiple MyelomaArmsVelcade, Thalidomide, Dexamethasone, Peripheral Blood Stem Cell (PBSC) collection, First Autologous Transplantation
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Trial
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  6. The longitudinal role of sleep on self-harm during adolescence: A birth cohort study.Journal of child psychology and psychiatry, and allied disciplines · 2026
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  9. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Annalisa PezziIstituto di Ematologia Seràgnoli, Università degli Studi di Bologna, Policlinico Sant'Orsola-Malpighi, Via Massarenti 9, 40138, Bologna, BO, Italy.
Michele CavoIstituto di Ematologia Seràgnoli, Università degli Studi di Bologna, Policlinico Sant'Orsola-Malpighi, Via Massarenti 9, 40138, Bologna, BO, Italy.
Annibale BiggeriDipartimento di Statistica, Informatica, Applicazioni "Giuseppe Parenti" (DiSIA), Università di Firenze, Via Morgagni 57-59, 50134, Firenze, FI, Italy.
Elena ZamagniIstituto di Ematologia Seràgnoli, Università degli Studi di Bologna, Policlinico Sant'Orsola-Malpighi, Via Massarenti 9, 40138, Bologna, BO, Italy.
Oriana NanniIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via Maroncelli 40, 47014, Meldola, FC, Italy. oriana.nanni@irst.emr.it.ORCID 0000-0001-7338-2896

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRandomization procedure in randomized controlled trials (RCTs) permits an unbiased estimation of causal effects. However, in clinical practice, differential compliance between arms may cause a strong violation of randomization balance and biased treatment effect among those who comply. We evaluated the effect of the consolidation phase on disease-free survival of patients with multiple myeloma in an RCT designed for another purpose, adjusting for potential selection bias due to different compliance to previous treatment phases.

methodsWe computed two propensity scores (PS) to model two different selection processes: the first to undergo autologous stem cell transplantation, the second to begin consolidation therapy. Combined stabilized inverse probability treatment weights were then introduced in the Cox model to estimate the causal effect of consolidation therapy miming an ad hoc RCT protocol.

resultsWe found that the effect of consolidation therapy was restricted to the first 18 months of the phase (HR: 0.40, robust 95 % CI: 0.17-0.96), after which it disappeared.

conclusionsPS-based methods could be a complementary approach within an RCT context to evaluate the effect of the last phase of a complex therapeutic strategy, adjusting for potential selection bias caused by different compliance to the previous phases of the therapeutic scheme, in order to simulate an ad hoc randomization procedure.

trial registrationClinicalTrials.gov: NCT01134484 May 28, 2010 (retrospectively registered) EudraCT: 2005-003723-39 December 17, 2008 (retrospectively registered).

Indexed as

Clinical Trials, Phase III as TopicRandomized Controlled Trials as TopicAdolescentAdultAgedFemaleHumansKaplan-Meier EstimateMaleMiddle AgedMultiple MyelomaOutcome Assessment, Health CarePropensity ScoreProportional Hazards ModelsResearch DesignTime FactorsCausal effectCompliancePropensity scoreRCTSelection biasWeighting sample

Identifiers

PMID27829371
PMCPMC5103416

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.