Abstract
Women in low- and middle-income countries (LMICs) have limited access to long-acting contraceptives. Access to long-acting contraceptives, such as subcutaneous contraceptive implants, could be increased by task-shifting implant administration from advanced to minimally trained healthcare providers. The objective of this study was to investigate the usability of a task-shifting device for administering subcutaneous contraceptive implants. Healthcare providers (n = 128) from multiple health centers in Ethiopia were trained to administer implants on an arm simulator with the traditional method and a method using the device. Participants were observed while inserting implants into the arm simulator, and procedural error rates were calculated. Observations were analyzed using an iterative inductive coding methodology. For the device-assisted method, minimally trained healthcare providers had larger procedural error rates than other professions (p = 0.002). For the traditional method, physicians had larger procedural error rates than nurses and midwives (p = 0.03). Several procedural errors were identified such as participants inserting and removing the trocar and plunger completely or inserting and/or removing the trocar too far or not enough. These findings reinforce the importance of performing formative usability testing during the early phases of a medical device design process, considering users' mental models, and avoiding assumptions about healthcare providers' abilities.
Issue Section:
Special Papers
References
1.
Sedgh
,
G.
,
Hussain
,
R.
,
Bankole
,
A.
, and
Singh
,
S.
, 2007
, Women With an Unmet Need for Contraception in Developing Countries and Their Reasons for Not Using a Method
, Occasional Report, 37, pp. 5
–40
.2.
Fulton
,
B. D.
,
Scheffler
,
R. M.
,
Sparkes
,
S. P.
,
Auh
,
E. Y.
,
Vujicic
,
M.
, and
Soucat
,
A.
, 2011
, “
Health Workforce Skill Mix and Task Shifting in Low-Income Countries: A Review of Recent Evidence
,” Hum. Resour. Health
,
9
(1
), p. 1
.10.1186/1478-4491-9-13.
Asnake
,
M.
,
Henry
,
E. G.
,
Tilahun
,
Y.
, and
Oliveras
,
E.
, 2013
, “
Addressing Unmet Need for Long-Acting Family Planning in Ethiopia: Uptake of Single-Rod Progestogen Contraceptive Implants (Implanon) and Characteristics of Users
,” Int. J. Gynecol. Obstet.
,
123
, pp. e29
–e32
.10.1016/j.ijgo.2013.07.0034.
Neukom
,
J.
,
Chilambwe
,
J.
,
Mkandawire
,
J.
,
Mbewe
,
R. K.
, and
Hubacher
,
D.
, 2011
, “
Dedicated Providers of Long-Acting Reversible Contraception: New Approach in Zambia
,” Contraception
,
83
(5
), pp. 447
–452
.10.1016/j.contraception.2010.08.0215.
Wickstrom
,
J.
, and
Jacobstein
,
R.
, 2011
, “
Contraceptive Security: Incomplete Without Long-Acting and Permanent Methods of Family Planning
,” Stud. Fam. Plann.
,
42
(4
), pp. 291
–298
.10.1111/j.1728-4465.2011.00292.x6.
Jacobstein
,
R.
, and
Stanley
,
H.
, 2013
, “
Contraceptive Implants: Providing Better Choice to Meet Growing Family Planning Demand
,” Glob. Heal. Sci. Pract.
,
1
(1
), pp. 11
–17
.10.9745/GHSP-D-12-000037.
Alemayehu
,
M.
,
Belachew
,
T.
, and
Tilahun
,
T.
, 2012
, “
Factors Associated With Utilization of Long Acting and Permanent Contraceptive Methods Among Married Women of Reproductive Age in Mekelle Town, Tigray Region, North Ethiopia
,” BMC Pregnancy Childbirth
,
12
(1
), p. 6
.10.1186/1471-2393-12-68.
Van Lith
,
L. M.
,
Yahner
,
M.
, and
Bakamjian
,
L.
, 2013
, “
Women's Growing Desire to Limit Births in Sub-Saharan Africa: Meeting the Challenge
,” Glob. Heal. Sci. Pract.
,
1
(1
), pp. 97
–107
.10.9745/GHSP-D-12-000369.
The World Bank
, 2017
, “
World Development Indicators
,” World Bank Group, Washington, DC, accessed Jan. 30, 2020, https://openknowledge.worldbank.org/handle/10986/2644710.
Sivin
,
I.
, 2003
, “
Risks and Benefits, Advantages and Disadvantages of Levonorgestrel-Releasing Contraceptive Implants
,” Drug Saf.
,
26
(5
), pp. 303
–335
.10.2165/00002018-200326050-0000211.
United States Food and Drug Administration
, 2016
, “
Jadelle (Levonorgestrel Implants) for Subdermal Use
,” United States Food and Drug Administration, Silver Spring, MD, accessed Jan. 30, 2020, https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020544s010lbl.pdf12.
World Health Organization
, 2017
, “
Task Sharing to Improve Access to Family Planning/Contraception
,” Geneva, Switzerland.13.
McPake
,
B.
, and
Mensah
,
K.
, 2008
, “
Task Shifting in Health Care in Resource-Poor Countries
,” Lancet
,
372
(9642
), pp. 870
–871
.10.1016/S0140-6736(08)61375-614.
Janowitz
,
B.
,
Stanback
,
J.
, and
Boyer
,
B.
, 2012
, “
Task Sharing in Family Planning
,” Stud. Fam. Plann.
,
43
(1
), pp. 57
–62
.10.1111/j.1728-4465.2012.00302.x15.
Sabet Sarvestani
,
A.
, 2015
, Designing Task Shifting Medical Devices for Low-Resource Settings
,
University of Michigan
,
Ann Arbor, MI
.16.
Association for the Advancement of Medical Instrumentation
, 2013
, “
Human Factors Engineering—Design of Medical Devices
,” Association for the Advancement of Medical Instrumentation, Arlington, VA, Report No. ANSI/AAMI HE75:2009(R2013).17.
Sawyer
,
D.
, 1996
, “
Do It by Design: An Introduction to Human Factors in Medical Devices
,” accessed Jan. 30, 2020, https://www.semanticscholar.org/paper/Do-it-by-design%3A-an-introduction-to-human-factors-Sawyer/ca5b0f6c35a6876fe5590bb90b791bf6d1f21b1518.
Furniss
,
D.
,
Masci
,
P.
,
Curzon
,
P.
,
Mayer
,
A.
, and
Blandford
,
A.
, 2014
, “
7 Themes for Guiding Situated Ergonomic Assessments of Medical Devices: A Case Study of an Inpatient Glucometer
,” Appl. Ergon.
,
45
(6
), pp. 1668
–1677
.10.1016/j.apergo.2014.05.01219.
Zhang
,
J.
,
Johnson
,
T. R.
,
Patel
,
V. L.
,
Paige
,
D. L.
, and
Kubose
,
T.
, 2003
, “
Using Usability Heuristics to Evaluate Patient Safety of Medical Devices
,” J. Biomed. Inform.
,
36
(1–2
), pp. 23
–30
.10.1016/S1532-0464(03)00060-120.
Kaufman
,
D. R.
,
Patel
,
V. L.
,
Hilliman
,
C.
,
Morin
,
P. C.
,
Pevzner
,
J.
,
Weinstock
,
R. S.
,
Goland
,
R.
,
Shea
,
S.
, and
Starren
,
J.
, 2003
, “
Usability in the Real World: Assessing Medical Information Technologies in Patients' Homes
,” J. Biomed. Inform.
,
36
(1–2
), pp. 45
–60
.10.1016/S1532-0464(03)00056-X21.
Mohedas
,
I.
,
Sarvestani
,
A. S.
,
Bertch
,
C.
,
Franklin
,
A.
,
Joyce
,
A.
,
McCormick
,
J.
,
Shoemaker
,
M.
,
Bell
,
C.
,
Johnson
,
T.
,
Bekele
,
D.
,
Fisseha
,
S.
, and
Sienko
,
K.
, 2015
, “
Assistive Device for the Insertion of Subcutaneous Contraceptive Implants
,” ASME J. Med. Device
,
9
(2
), p. 020943
.10.1115/1.403022022.
Flyvbjerg
,
B.
, 2011
, “
Case Study
,” The Sage Handbook of Qualitative Research
,
N. K.
Denzin
, and
Y. S.
Lincoln
, eds., SAGE Publications,
Thousand Oaks, CA
, pp. 301
–316
.23.
Strauss
,
A.
, and
Corbin
,
J.
, 1998
, Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory
,
SAGE Publications
,
London
.24.
Creswell
,
J. W.
, 2014
, Research Design: Qualitative, Quantitative, and Mixed Methods Approaches
,
SAGE Publications
,
Thousand Oaks, CA
.25.
Patton
,
M. Q.
, 2014
, Qualitative Research & Evaluation Methods: Integrating Theory and Practice
,
SAGE Publications
,
Thousand Oaks, CA
.26.
Ryan
,
G. W.
, and
Bernard
,
H. R.
, 2003
, “
Techniques to Identify Themes
,” Field Methods
,
15
(1
), pp. 85
–109
.10.1177/1525822X0223956927.
Westbrook
,
L.
, 1994
, “
Qualitative Research Methods: A Review of Major Stages, Data Analysis Techniques, and Quality Controls
,” Libr. Inf. Sci. Res.
,
16
(3
), pp. 241
–254
.10.1016/0740-8188(94)90026-428.
Bitega
,
J. P.
,
Ngeruka
,
M. L.
,
Hategekimana
,
T.
,
Asiimwe
,
A.
, and
Binagwaho
,
A.
, 2011
, “
Safety and Efficacy of the PrePex Device for Rapid Scale-Up of Male Circumcision for HIV Prevention in Resource-Limited Settings
,” J. Acquir. Immune Defic. Syndr.
,
58
(5
), pp. e127
–e134
.10.1097/QAI.0b013e3182354e6529.
Ash
,
J. S. S.
,
Berg
,
M.
, and
Coiera
,
E.
, 2003
, “
Some Unintended Consequences of Information Technology in Health Care: The Nature of Patient Care Information System-Related Errors
,” J. Am. Med. Inf. Assoc.
,
11
(2
), pp. 104
–112
.10.1197/jamia.M147130.
Henriksen
,
K.
,
Joseph
,
A.
, and
Zayas-Cabán
,
T.
, 2009
, “
The Human Factors of Home Health Care: A Conceptual Model for Examining Safety and Quality Concerns
,” J. Patient Saf.
,
5
(4
), pp. 229
–236
.10.1097/PTS.0b013e3181bd1c2a31.
Polus
,
S.
,
Lewin
,
S.
,
Glenton
,
C.
,
Lerberg
,
P. M.
,
Rehfuess
,
E.
, and
Gülmezoglu
,
A. M.
, 2015
, “
Optimizing the Delivery of Contraceptives in Low- and Middle-Income Countries Through Task Shifting: A Systematic Review of Effectiveness and Safety
,” Reprod. Health
,
12
(1
), p. 27
.10.1186/s12978-015-0002-232.
World Health Organization
, 2012
, “
Optimizing Health Workers Roles to Improve Access to Key Maternal and Newborn Health Interventions through Task Shifting
,” World Health Organization, Geneva, Switzerland.33.
Thanel
,
K.
, on behalf of the FPwatch Group,
Garfinkel
,
D.
,
Riley
,
C.
,
Esch
,
K.
,
Girma
,
W.
,
Kebede
,
T.
,
Kasongo
,
G.
,
Afolabi
,
K.
,
Kalamar
,
A.
,
Thurston
,
S.
,
Longfield
,
K.
,
Bertrand
,
J.
, and
Shaw
,
B.
, 2018
, “
Leveraging Long Acting Reversible Contraceptives to Achieve FP2020 Commitments in Sub-Saharan Africa: The Potential of Implants
,” PLoS One
,
13
(4
), p. e0195228
.10.1371/journal.pone.0195228Copyright © 2020 by ASME
You do not currently have access to this content.
