Evidence map›Paper›PMID 33022866›Full record

ArticleJournal of clinical hypertension (Greenwich, Conn.)2020

Weak and fragmented regulatory frameworks on the accuracy of blood pressure-measuring devices pose a major impediment for the implementation of HEARTS in the Americas.

Cintia Lombardi, James E Sharman, Raj Padwal, Dean Picone, Ernesto Alcolea, Roberto Ayala, Anselm Gittens, Patrice Lawrence-Williams, Taraleen Malcolm, Carolina Neira and 6 more

Abstract read
In one paragraph

Article in Journal of clinical hypertension (Greenwich, Conn.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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.

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

18 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Revista panamericana de salud publica = Pan American journal of public health · 2022
    Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. HEARTS in the Americas: innovations for improving hypertension and cardiovascular disease risk management in primary care.Revista panamericana de salud publica = Pan American journal of public health · 2022
    Article
  15. Article
  16. Review
  17. How to check whether a blood pressure monitor has been properly validated for accuracy.Journal of clinical hypertension (Greenwich, Conn.) · 2020
    Review
  18. Article
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.

Cintia LombardiDepartment of Non-Communicable Diseases and Mental Health, Pan American Health Organization, Washington, DC, USA.ORCID 0000-0001-7376-7243
James E SharmanMenzies Institute for Medical Research, University of Tasmania, Hobart, Tas, Australia.ORCID 0000-0003-2792-0811
Raj PadwalDepartment of Medicine, University of Alberta, Edmonton, AB, Canada.ORCID 0000-0003-3541-2817
Dean PiconeMenzies Institute for Medical Research, University of Tasmania, Hobart, Tas, Australia.ORCID 0000-0002-4760-1634
Ernesto AlcoleaCenter for the Estate Control of Medicines and Medical Devices (CECMED), A WHO Collaborative Center, Havana, Cuba.ORCID 0000-0002-3287-3645
Roberto AyalaNational Center for Health Technology Excellence (CENETEC), Ministry of Health, Mexico City, Mexico.ORCID 0000-0003-4958-0483
Anselm GittensMetrology Department, Saint Lucia Bureau of Standards, Castries, Saint Lucia.ORCID 0000-0002-2616-0833
Patrice Lawrence-WilliamsPan American Health Organization, Barbados and the Eastern Caribbean Countries, Bridgetown, Barbados.ORCID 0000-0002-0453-8073
Taraleen MalcolmPan American Health Organization, Port of Spain, Trinidad and Tobago.ORCID 0000-0002-3971-8859
Carolina NeiraDepartment of Noncommunicable Diseases, Ministry of Health, Santiago, Chile.ORCID 0000-0001-9133-8354
Vivian PerezPan American Health Organization, Lima, Peru.ORCID 0000-0002-8382-7649
Andres RosendeNational Program of Prevention of Cardiovascular Diseases, Ministry of Health, Buenos Aires, Argentina.ORCID 0000-0001-8173-0686
Juliano TesserNational Sanitary Surveillance Agency (ANVISA), Brasilia, Brazil.ORCID 0000-0002-3780-4171
Nilda VillacresPan American Health Organization, Quito, Ecuador.ORCID 0000-0001-7736-6308
Norm R C CampbellDepartment of Medicine, Physiology and Pharmacology and Community Health Sciences, O'Brien Institute for Public Health and Libin Cardiovascular Institute of Alberta, University of Calgary, Calgary, AB, Canada.ORCID 0000-0002-1093-4742
Pedro OrdunezDepartment of Non-Communicable Diseases and Mental Health, Pan American Health Organization, Washington, DC, USA.ORCID 0000-0002-9871-6845

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Global HEARTS is a WHO initiative for cardiovascular disease prevention and control. Accurate blood pressure (BP) measurement is an essential component of the initiative. This study aimed to determine the regulatory frameworks governing the accuracy of BPMDs in countries of the Americas participating in the HEARTS initiative. Quantitative and qualitative analysis of the laws and regulations relevant to ensuring the accuracy of BPMDs were determined from the Ministries of Health/Regulatory Agencies among 13 countries in Latin America and the Caribbean. Analysis included characterizing the scope of regulations (ie, pre-market approval, sales and promotion, labeling, cuff sizes, and procurement), information systems for monitoring the models of BPMDs used in primary health care (PHC), and systems to enforce compliance with regulations. Ten of the 13 countries had medical device laws, but regulations that specifically address BPMDs only existed in three countries. Only one country (Brazil) had regulations for mandatory accuracy validation testing and only two countries regulated internet sales of BPMDs. Labeling and cuff size regulations existed in four and two countries, respectively. Less than half the countries reported having a data repository on the BPMD models being used in PHC facilities (four countries) or sold (five countries). Weak and fragmented regulatory frameworks on the accuracy of BPMDs exist among countries of the Americas. This will adversely affect the accuracy of blood pressure assessment and hence poses a major impediment for successful implementation of HEARTS initiative.

Indexed as

HypertensionAmericasBlood PressureBrazilCaribbean RegionHumansLatin Americacardiovascular disease risk managementdiagnosishealth policyhypertension

Identifiers

PMID33022866
PMCPMC8030047

What OpenQuestion holds

Textmetadata
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.