Evidence map›Paper›PMID 32868360›Full record

ArticleBMJ open2020

Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study).

Susanna J Lake, Sophie L Phelan, Daniel Engelman, Oliver Sokana, Titus Nasi, Dickson Boara, Christina Gorae, Tibor Schuster, Anneke C Grobler, Millicent H Osti and 6 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.5field-weighted citation impact, top 20% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Health-related quality of life impact of scabies in the Solomon Islands.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2022
    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

16 authors at 7 institutions in 3 countries.

Susanna J LakeTropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.ORCID 0000-0002-5508-5430
Sophie L PhelanThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Daniel EngelmanTropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
Oliver SokanaMinistry of Health and Medical Services, Honiara, Solomon Islands.
Titus NasiMinistry of Health and Medical Services, Honiara, Solomon Islands.
Dickson BoaraMinistry of Health and Medical Services, Honiara, Solomon Islands.
Christina GoraeMinistry of Health and Medical Services, Honiara, Solomon Islands.
Tibor SchusterClinical Epidemiology and Biostatistics Unit, McGill University, Montreal, Quebec, Canada.
Anneke C GroblerClinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
Millicent H OstiTropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
Ross AndrewsAustralian National University, Canberra, Australian Capital Territory, Australia.
Michael MarksClinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.ORCID 0000-0002-7585-4743
Margot J WhitfeldDepartment of Dermatology, St Vincent's Hospital, Sydney, New South Wales, Australia.
Lucia RomaniThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.ORCID 0000-0001-9038-5300
John KaldorThe Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia.
Andrew SteerTropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia andrew.steer@rch.org.au.
The University of Melbourne · AUUNSW Sydney · AUMurdoch Children's Research Institute · AUAustralian National University · AULondon School of Hygiene & Tropical Medicine · GBMcGill University · CASt Vincent's Hospital Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionScabies is a significant contributor to global morbidity, affecting approximately 200 million people at any time. Scabies is endemic in many resource-limited tropical settings. Bacterial skin infection (impetigo) frequently complicates scabies infestation in these settings. Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%. However, current two-dose regimens present a number of barriers to programmatic MDA implementation. We designed the Regimens of Ivermectin for Scabies Elimination (RISE) trial to investigate whether one-dose MDA may be as effective as two-dose MDA in controlling scabies in high-prevalence settings. METHODS AND ANALYSIS: RISE is a cluster-randomised non-inferiority trial. The study will be conducted in 20 isolated villages in Western Province of Solomon Islands where population prevalence of scabies is approximately 20%. Villages will be randomly allocated to receive either one dose or two doses of ivermectin-based MDA in a 1:1 ratio. The primary objective of the study is to determine if ivermectin-based MDA with one dose is as effective as MDA with two doses in reducing the prevalence of scabies after 12 months. Secondary objectives include the effect of ivermectin-based MDA on impetigo prevalence after 12 and 24 months, the prevalence of scabies at 24 months after the intervention, the impact on presentation to health facilities with scabies and impetigo, and the safety of one-dose and two-dose MDA. ETHICS AND DISSEMINATION: This trial has been approved by the ethics review committees of the Solomon Islands and the Royal Children's Hospital, Australia. Results will be disseminated in peer-reviewed publications and in meetings with the Solomon Islands Ministry of Health and Medical Services and participating communities. TRIAL REGISTRATION DETAILS: Australian New Zealand Clinical Trials Registry: ACTRN12618001086257. Date registered: 28 June 2018.

Indexed as

Antiparasitic AgentsIvermectinScabiesAustraliaChildEquivalence Trials as TopicHumansMass Drug AdministrationMelanesiaRandomized Controlled Trials as TopicAntiparasitic AgentsIvermectindermatologyinfectious diseasesinternational health servicestropical medicine

Identifiers

PMID32868360
PMCPMC7462236
OpenAlexW3081934785

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.