Evidence map›Paper›PMID 31852499›Full record

ArticleMalaria journal2019

Intracluster correlation coefficients in the Greater Mekong Subregion for sample size calculations of cluster randomized malaria trials.

Pimnara Peerawaranun, Jordi Landier, Francois H Nosten, Thuy-Nhien Nguyen, Tran Tinh Hien, Rupam Tripura, Thomas J Peto, Koukeo Phommasone, Mayfong Mayxay, Nicholas P J Day and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Malaria journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01872702 (Targeted Chemo-elimination), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–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.

NCT01872702 nacompletednot on this map

Targeted Chemo-elimination (TCE) to Eradicate Malaria in Areas of Suspected or Proven Artemisinin Resistance in Southeast Asia and South Asia

TypeinterventionalSponsorUniversity of OxfordRan2013 to 2017Enrolled8,000ConditionsPlasmodium Falciparum MalariaArmsmalaria elimination using DP and low-dose primaquine
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
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

14 authors.

Pimnara PeerawaranunMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 60th Anniversary Chalermprakiat Building, 3rd Floor, 420/6 Ratchawithi Rd, Ratchathewi District, Bangkok, 10400, Thailand.
Jordi LandierShoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.
Francois H NostenShoklo Malaria Research Unit, Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Mae Sot, Thailand.
Thuy-Nhien NguyenOxford University Clinical Research Unit, Wellcome Trust Major Oversea Programme, Ho Chi Minh City, Vietnam.
Tran Tinh HienCentre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
Rupam TripuraMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 60th Anniversary Chalermprakiat Building, 3rd Floor, 420/6 Ratchawithi Rd, Ratchathewi District, Bangkok, 10400, Thailand.
Thomas J PetoMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 60th Anniversary Chalermprakiat Building, 3rd Floor, 420/6 Ratchawithi Rd, Ratchathewi District, Bangkok, 10400, Thailand.
Koukeo PhommasoneLao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR.
Mayfong MayxayLao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR.
Nicholas P J DayMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 60th Anniversary Chalermprakiat Building, 3rd Floor, 420/6 Ratchawithi Rd, Ratchathewi District, Bangkok, 10400, Thailand.
Arjen DondorpMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 60th Anniversary Chalermprakiat Building, 3rd Floor, 420/6 Ratchawithi Rd, Ratchathewi District, Bangkok, 10400, Thailand.
Nick WhiteMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 60th Anniversary Chalermprakiat Building, 3rd Floor, 420/6 Ratchawithi Rd, Ratchathewi District, Bangkok, 10400, Thailand.
Lorenz von SeidleinMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 60th Anniversary Chalermprakiat Building, 3rd Floor, 420/6 Ratchawithi Rd, Ratchathewi District, Bangkok, 10400, Thailand.
Mavuto MukakaMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 60th Anniversary Chalermprakiat Building, 3rd Floor, 420/6 Ratchawithi Rd, Ratchathewi District, Bangkok, 10400, Thailand. mmukaka@gmail.com.ORCID http://orcid.org/0000-0002-5036-6583

Funding

Bill and Melinda Gates Foundation OPP1081420Wellcome TrustWellcome Trust 101148/Z/13/Z
6 · The paper itself

Abstract

backgroundSample size calculations for cluster randomized trials are a recognized methodological challenge for malaria research in pre-elimination settings. Positively correlated responses from the participants in the same cluster are a key feature in the estimated sample size required for a cluster randomized trial. The degree of correlation is measured by the intracluster correlation coefficient (ICC) where a higher coefficient suggests a closer correlation hence less heterogeneity within clusters but more heterogeneity between clusters.

methodsData on uPCR-detected Plasmodium falciparum and Plasmodium vivax infections from a recent cluster randomized trial which aimed at interrupting malaria transmission through mass drug administrations were used to calculate the ICCs for prevalence and incidence of Plasmodium infections. The trial was conducted in four countries in the Greater Mekong Subregion, Laos, Myanmar, Vietnam and Cambodia. Exact and simulation approaches were used to estimate ICC values for both the prevalence and the incidence of parasitaemia. In addition, the latent variable approach to estimate ICCs for the prevalence was utilized.

resultsThe ICCs for prevalence ranged between 0.001 and 0.082 for all countries. The ICC from the combined 16 villages in the Greater Mekong Subregion were 0.26 and 0.21 for P. falciparum and P. vivax respectively. The ICCs for incidence of parasitaemia ranged between 0.002 and 0.075 for Myanmar, Cambodia and Vietnam. There were very high ICCs for incidence in the range of 0.701 to 0.806 in Laos during follow-up.

conclusionICC estimates can help researchers when designing malaria cluster randomized trials. A high variability in ICCs and hence sample size requirements between study sites was observed. Realistic sample size estimates for cluster randomized malaria trials in the Greater Mekong Subregion have to assume high between cluster heterogeneity and ICCs. This work focused on uPCR-detected infections; there remains a need to develop more ICC references for trials designed around prevalence and incidence of clinical outcomes. Adequately powered trials are critical to estimate the benefit of interventions to malaria in a reliable and reproducible fashion.

trial registrationClinicalTrials.govNCT01872702. Registered 7 June 2013. Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT01872702.

Indexed as

AntimalarialsCambodiaHumansIncidenceLaosMalaria, FalciparumMalaria, VivaxMass Drug AdministrationMyanmarPlasmodium falciparumPlasmodium vivaxPrevalenceRandomized Controlled Trials as TopicVietnamAntimalarialsBootstrappingCluster randomized trialICCIncidenceMalariaP. falciparumPrevalenceP. vivaxSample size

Identifiers

PMID31852499
PMCPMC6921387

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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.