Evidence map›Paper›PMID 27451869›Full record

Trial reportThe Journal of surgical research2016

Clinical breast examination screening by trained laywomen in Malawi integrated with other health services.

Lily Gutnik, Clara Lee, Vanessa Msosa, Agnes Moses, Christopher Stanley, Suzgo Mzumara, N George Liomba, Satish Gopal

Abstract readClinical Trial
In one paragraph

Trial report in The Journal of surgical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 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.

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

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

8 authors.

Lily GutnikUNC Project-Malawi, Lilongwe, Malawi. Electronic address: lily.gutnik@mail.harvard.edu.
Clara LeeUNC Project-Malawi, Lilongwe, Malawi; University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina.
Vanessa MsosaDepartment of Surgery, Kamuzu Central Hospital, Lilongwe, Malawi.
Agnes MosesUNC Project-Malawi, Lilongwe, Malawi; University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina; Department of Medicine, Kamuzu Central Hospital, Lilongwe, Malawi; University of Malawi College of Medicine, Blantyre, Malawi.
Christopher StanleyUNC Project-Malawi, Lilongwe, Malawi.
Suzgo MzumaraDepartment or Radiology, Kamuzu Central Hospital, Lilongwe, Malawi; University of Malawi College of Medicine, Blantyre, Malawi.
N George LiombaUNC Project-Malawi, Lilongwe, Malawi.
Satish GopalUNC Project-Malawi, Lilongwe, Malawi; University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina; University of Malawi College of Medicine, Blantyre, Malawi.

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Deborah F. Tate · 1985 to 2026
$201.5M
Tissue Procurement & PathologyP50CA058223 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KATHERINE A. HOADLEY · 1992 to 2026
$59.3M
SUPPORTING THE SCALE-UP HIGH QUALITY HIV CARE AND TREATMENT PROGRAMS IN MALAWI U2GPS001965 · PS · UNIVERSITY OF MALAWI · PI KAMIZA, DR. STEVE · 2009 to 2014
$12.9M
Fogarty Global Health Fellows Coordinating CenterR25TW009340 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CHI, BENJAMIN H. · 2012 to 2016
$6.9M
Project 3U54CA190152 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAMANIA, BLOSSOM A, GOPAL, SATISH · 2014 to 2019
$4.2M
Patient Decision Making about Breast Reconstruction after MastectomyK07CA154850 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI LEE, CLARA NAN-HI · 2011 to 2015
$859k
Developing a clinical cohort of histopathologically characterized lymphomaK01TW009488 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GOPAL, SATISH · 2012 to 2016
$701k
Molecular profiling of HIV-associated lymphoma in the US and MalawiR21CA180815 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GOPAL, SATISH · 2013 to 2014
$341k
FIC NIH HHS K01 TW009488FIC NIH HHS R25 TW009340NCHHSTP CDC HHS U2G PS001965NCI NIH HHS K07 CA154850NCI NIH HHS P30 CA016086NCI NIH HHS P50 CA058223NCI NIH HHS R21 CA180815NCI NIH HHS U54 CA190152
6 · The paper itself

Abstract

backgroundBreast cancer awareness and early detection are limited in sub-Saharan Africa. Resource limitations make screening mammography or clinical breast examination (CBE) by physicians or nurses impractical in many settings. We aimed to assess feasibility and performance of CBE by laywomen in urban health clinics in Malawi.

methodsFour laywomen were trained to deliver breast cancer educational talks and conduct CBE. After training, screening was implemented in diverse urban health clinics. Eligible women were ≥30 y, with no prior breast cancer or breast surgery, and clinic attendance for reasons other than a breast concern. Women with abnormal CBE were referred to a study surgeon. All palpable masses confirmed by surgeon examination were pathologically sampled. Patients with abnormal screening CBE but normal surgeon examination underwent breast ultrasound confirmation. In addition, 50 randomly selected women with normal screening CBE underwent breast ultrasound, and 45 different women with normal CBE were randomly assigned to surgeon examination.

resultsAmong 1220 eligible women, 1000 (82%) agreed to CBE. Lack of time (69%) was the commonest reason for refusal. Educational talk attendance was associated with higher CBE participation (83% versus 77%, P = 0.012). Among 1000 women screened, 7% had abnormal CBE. Of 45 women with normal CBE randomized to physician examination, 43 had normal examinations and two had axillary lymphadenopathy not detected by CBE. Sixty of 67 women (90%) with abnormal CBE attended the referral visit. Of these, 29 (48%) had concordant abnormal physician examination. Thirty-one women (52%) had discordant normal physician examination, all of whom also had normal breast ultrasounds. Compared with physician examination, sensitivity for CBE by laywomen was 94% (confidence interval [CI] 79%-99%), specificity 58% (CI, 46%-70%), positive predictive value 48% (CI, 35%-62%), and negative predictive value 96% (CI, 85%-100%). Of 13 women who underwent recommended pathologic sampling of a breast lesion, two had cytologic dysplasia and all others benign results.

conclusionsCBE uptake in Lilongwe clinics was high. CBE by laywomen compared favorably with physician examination and follow-up was good. Our intervention can serve as a model for wider implementation. Performance in rural areas, effects on cancer stage and mortality, and cost effectiveness require evaluation.

Indexed as

Community Health WorkersDelivery of Health Care, IntegratedAdultAgedBreast NeoplasmsEarly Detection of CancerFeasibility StudiesFemaleFollow-Up StudiesHumansMalawiMiddle AgedPatient Acceptance of Health CarePhysical ExaminationReferral and ConsultationSensitivity and SpecificityBreast cancerGlobal healthLaywomenScreening

Identifiers

PMID27451869
PMCPMC4963624

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Registered trials

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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.