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Text message link to online survey: A new highly effective method of longitudinal data collection
Journal Pre-proofs Original Research Article Text message link to online survey: a new highly effective method of longitudinal data collection EmmaKate B Friedlander, Reni Soon, Jennifer Salcedo, Mary Tschann, Tiana Fontanilla, Bliss Kaneshiro PII: DOI: Reference:
S0010-7824(19)30484-6 https://doi.org/10.1016/j.contraception.2019.11.008 CON 9362
To appear in:
Contraception
Received Date: Revised Date: Accepted Date:
5 May 2019 18 November 2019 18 November 2019
Please cite this article as: E.B. Friedlander, R. Soon, J. Salcedo, M. Tschann, T. Fontanilla, B. Kaneshiro, Text message link to online survey: a new highly effective method of longitudinal data collection, Contraception (2019), doi: https://doi.org/10.1016/j.contraception.2019.11.008
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
© 2019 Elsevier Inc. All rights reserved.
1
Title: Text message link to online survey: a new highly effective method of longitudinal data
2
collection
3 4
Authors: EmmaKate B Friedlander MD PhD, Reni Soon, MD MPH, Jennifer Salcedo, MD
5
MPH MPP, Mary Tschann PhD MPH, Tiana Fontanilla MPH, Bliss Kaneshiro, MD MPH
6 7
Institution: John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI.
8 9
Corresponding Author:
10
EmmaKate Friedlander, MD PhD
11
[email protected]
12
808-203-6500
13
Department of Obstetrics and Gynecology
14
John A Burns School of Medicine, University of Hawaii at Manoa
15
1319 Punahou St. Ste 824
16
Honolulu, HI 96826
17 18
Short Title: Text to survey data collection
19 20
Abstract Word Count: 250
21
Manuscript Word Count: 2240
22 23
This data was presented as a poster abstract at the North American Forum on Family Planning in
1
24
Atlanta, Georgia, October 13-15th 2017.
25 26
Portions of this study were filed within Dr. Friedlander’s dissertation with ProQuest dissertation
27
filing service, June 2017.
28 29
Declarations of interest: none
30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46
2
47
Abstract
48 49
Objectives: To evaluate response rate to a text message link for an online survey as a method of
50
data collection over the course of a medication abortion.
51
Study Design: This is a secondary analysis of a randomized, double-blind, placebo-controlled
52
trial of 110 women initiating a medication abortion up to 70 days gestation. We sent a text
53
message containing a link to an online survey collecting pain scores, analgesic use, and adverse
54
effects at six time points over 72 hours from time of misoprostol administration (0-, 2-, 6-, 12-,
55
24-, and 72-hours). Our primary outcome was the proportion of all text messages sent for which
56
an online survey response was received. Secondary outcomes included the proportion of
57
complete responses (all six surveys), responses received more than two hours after text prompt
58
(defined as late), and differences in response rate by time of day.
59
Results: From June 2015 to October 2016, we screened 241 women, and 110 were randomized.
60
We excluded three (1.2%) due to lack of a cellular phone with text capability, and three (2.7%)
61
were lost to follow-up after enrollment. We received a response to 95.9% (633/660) of the
62
delivered surveys, and 93.6% (103/110) of participants completed all six surveys. Over three-
63
quarters of all responses were received within two hours of the requested time. Surveys sent
64
before 08:00 were more likely to be returned late.
65
Conclusions: In this population of women seeking medication abortion, text message link to
66
online survey response appears to be an effective mode of data collection.
67
Key words: Data collection, survey, text message, SMS
68
Implications: Text message prompts for an online survey may optimize longitudinal real-time
69
data collection response rates of sensitive data.
3
70 71
1. Introduction Complete data collection is critical for validity in longitudinal studies with repeated
72
measurements. Loss to follow-up and missing data can introduce bias. Common methods of
73
prospective data collection include in-person study visits, phone calls, and paper surveys or
74
diaries. Recently, mobile phone short message service (SMS) text messaging has been
75
introduced for health care educational interventions and service delivery, with up to a 100%
76
response rate [1-4]. However, study participants prefer and are more likely to complete online
77
surveys over SMS text message responses or paper surveys [3]. Most text messaging studies
78
have focused on SMS reminder texts or simple binary responses, rather than full surveys. When
79
a study includes multiple data points for several different variables, surveys are better suited for
80
direct responses rather than multiple binary text responses. To our knowledge, no studies have
81
combined SMS text prompt with an online survey, which may be preferred when collecting data
82
for several variables longitudinally.
83
Medication abortion studies often collect data on pain, bleeding, and analgesic use over
84
time. Though the medication abortion process is initiated with mifepristone in a health care
85
providers’ office, misoprostol is administered at home with patients passing the pregnancy
86
within a 24- to 48-hour time frame outside of a health care facility. Early medication abortion
87
studies to understand pain and bleeding used in-person visits where women remained at a health
88
care facility for the medication abortion process, a scenario that is uncommon today and may not
89
be reflective of the experience at home [5-8]. Researchers have studied the home medication
90
abortion experience using paper diaries, though the real-time completion of paper diaries is
91
difficult to confirm and may rely on recall [9].
4
92
Retrospective accounts of the medication abortion experience, collected at the time of a
93
follow-up visit, are subject to recall bias. After a process has ended, the memory of the event
94
may be different than that experienced in real-time. This concept was examined in a longitudinal
95
study of chronic pain patients that used paper diary cards kept in a binder with a hidden sensor
96
that recorded when the binder was opened. This allowed them to compare participant self-
97
reported response time with recorded times of binder use. Though participants reported
98
answering the surveys within the allotted window 90% of the time, the electronic data from the
99
sensor matched only 11% of the time. The second arm of the study used an electronic device
100
with timed prompts instead of a paper binder, and recorded over 93% accurate compliance [10].
101
To collect repeated real-time accounts while maintaining home data collection, we used
102
an SMS text that connected participants to an online survey. The SMS text served as a real-time
103
reminder to complete the online survey without the intrusiveness of multiple phone call
104
interviews or office evaluation. We describe the feasibility and data collection completion rate
105
of using a text message link to an online survey platform as a method of data collection for
106
medication abortion.
107 108 109
2. Materials and Methods We present a secondary analysis of data that was collected as part of a clinical trial at the
110
University of Hawaii (Honolulu, Hawaii) exploring pregabalin for pain management with
111
mifepristone and buccal misoprostol medication abortion up to 70 days gestation [11]. We
112
obtained approval from the University of Hawaii Committee on Human Studies and were
113
registered at clinicaltrials.gov (NCT02782169).
5
114
We enrolled women aged 18 years or older with a pregnancy up to and including 70 days
115
gestation by ultrasound dating, who were capable and willing to receive cellular phone text
116
messages and complete multiple electronic surveys over the 72-hour study period. Exclusion
117
criteria included: a contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or
118
pregabalin; alternative methods of misoprostol use (i.e. vaginal administration or use in less than
119
24 hours); inability to speak or read English; and participation in the same trial during a prior
120
pregnancy. Patients were approached for study participation after they were consented to the
121
medication abortion and took the mifepristone with their provider in the office.
122
Participants took misoprostol at home 24 to 48 hours after the mifepristone, according to
123
study protocol. While the participant was in the office, a research assistant used the designated
124
study phone to send an SMS text to confirm their ability to receive messages. Participants each
125
chose a time to take the misoprostol and the research assistant programmed a text message with a
126
link to the first online survey at that time. If the participant took the misoprostol at a different
127
time, the research assistant instructed her to access the survey via a URL address and QR code
128
printed on the misoprostol package, directing her to the first survey.
129
We sent SMS text prompt links to surveys at six specified points over 72 hours following
130
misoprostol administration (0-, 2-, 6-, 12-, 24-, and 72-hours) to assess current pain on an 11-
131
point numerical rating scale (NRS), maximum pain and the time it occurred, analgesic tablets
132
taken, adverse effects (checklist including a space for free text), and satisfaction with the
133
abortion and the pain control (5-point Likert scale) (Appendix A). All survey responses were
134
identifiable by participant identification number, and were electronically time-stamped at
135
submission. Each survey had a title that designated which survey number it was, though other
136
questions remained identical. Satisfaction scores were only assessed at the 24-hour survey.
6
137
During enrollment, the research assistant reviewed a chart of the times that participants could
138
expect to receive prompts to complete surveys depending on the time that they chose to take the
139
misoprostol (start time). We reviewed that taking the misoprostol at 09:00 start time would
140
avoid early morning or late night disturbances; however, participants could elect to start at any
141
time that suited them.
142
We used a secure cellular phone, dedicated to this trial and held by an investigator, to
143
send all SMS text prompts and make study-related calls. The automated SMS prompts were
144
scheduled through the Android application “SMS Scheduler” (Ulka International). The SMS text
145
provided a link to an online survey where participants could enter information without storing
146
any data on their phones. Participants entered their identification number and a code word of
147
their choosing, for double identification in case of a forgotten or incorrect identification number,
148
into the online survey. We did not collect protected health information in the survey.
149
We programmed each survey to be prompted by SMS text at a specified time, and time
150
stamps were collected on each survey response. The study phone was alerted when the first
151
survey was completed, allowing the investigator to change the timing of subsequent surveys if
152
the participant chose a different time to take the misoprostol. Surveys were considered on-time
153
if they were received within two hours of when the text message was sent. Two hours was
154
designated as late because that was the shortest time interval between surveys. We sent text
155
messages at two and six hours if participants did not provide survey responses. We called
156
participants after 24 hours of the study period and sent an e-mail after 72 hours to request a
157
retrospective report if no responses were received. We included all survey responses in the
158
analysis, whether on-time or late. Surveys were defined as missing if no response was received
159
by four hours after the 72-hour reminder e-mail was sent. Participants received an electronic gift
7
160
card at the end of the study period corresponding to how many surveys they responded to, with a
161
bonus for completing all six surveys.
162
Our primary outcome was the proportion of all SMS text messages sent for which a
163
survey response was received. Secondary outcomes included the proportion of participants
164
responding to all six surveys, how often surveys were completed late (received more than 2
165
hours after the text was sent), and whether response rates differed by time of day the abortion
166
began (before or after noon) or time the survey was requested (by two-hour intervals). This is a
167
descriptive analysis, and no statistical comparisons were made.
168 169
3. Results
170
From June 2015 to October 2016, we screened 241 women for inclusion, and excluded
171
three women (1.2%) due to lack of access to a cellular phone with text messaging and Internet
172
capability. Forty-nine additional women did not meet the inclusion criteria, and 79 declined
173
participation [11]. We enrolled and randomized 110 women. Table 1 describes the
174
demographics of the study population (n=110).
175
Of 660 survey prompts sent, participants responded to 633 (95.9%). One hundred and
176
three (93.6%) participants completed all six surveys. Three participants (2.7%) were lost to
177
follow-up after enrollment. Without these participants, the overall response rate was 98.6%
178
(633/642 surveys returned), with all six surveys returned by 96.3% (103/107) of participants.
179
Two (1.8%) completed five out of six surveys, one (0.9%) completed four surveys, and one
180
(0.9%) completed one survey.
181 182
Participants answered 511 of 660 surveys (77.4%) within two hours of receiving the text message prompt. We received 122 surveys (18.5%) more than two hours late. We did not receive
8
183
a response for 27 surveys (4.1%). All survey responses were submitted consecutively, confirmed
184
by time stamp at response. Figure 1 shows the response rate to each survey.
185
To examine whether time of day the abortion started impacted response rates, we
186
examined on-time responses to each survey depending on whether the misoprostol (survey start)
187
was taken in the morning or after noon, including participants that did not respond to each survey
188
(Figure 2). Fifty-one participants started in the morning, and 46 started after noon. Morning
189
start surveys had fairly consistent on-time responses to all surveys (82.4-92%). Afternoon and
190
evening start times had on-time responses of 54.5-87.3%. Both start times had the lowest on-
191
time response rates for the 12-hour survey.
192
To examine if the time of day that each survey was requested (separate from the study
193
start time) significantly impacted response rates, we evaluated the number and percentage of late
194
responses throughout the day in two-hour intervals (Figure 3). When participants received SMS
195
texts in the daytime and evening, from 08:00 to midnight, 15.5% of survey responses had times
196
stamps more than two hours later than the prompt (range 7.1-22.2%). We observed the highest
197
proportion of late survey responses (46.6%) when the prompts arrived in the late-night hours of
198
midnight to 08:00, ranging from 27.3% (06:00 to 08:00) to 70% (02:00 to 04:00).
199 200 201
4. Discussion The validity and generalizability of any study is dependent on loss to follow up and
202
response rates. Minimizing loss to follow up and achieving a high response rate can be
203
challenging when data collection occurs outside of a health care facility and requires multiple
204
responses at different time points. We demonstrated that using SMS text messaging linked to an
9
205
online survey resulted in a low loss to follow up and an excellent response rate, even with serial
206
surveys over a three-day period involving sensitive subject matter.
207
Prior studies have characterized pain during medication abortion in an inpatient setting
208
[5-8]. Many women choose a medication abortion because they prefer to end the pregnancy at
209
home; thus, the inpatient study setting may not be representative of the typical in-home
210
experience. In our study, we had excellent response rates for in-home data collection using an
211
SMS text message prompt to an online survey.
212
This methodology has the advantage of additional confidentiality for participants,
213
allowing them to use a secure online platform instead of direct submission via text message.
214
SMS text message responses alone would require multiple messages at each time point to collect
215
such a large amount of data, which is not as desirable for participants, and would not be feasible
216
to program electronically in advance to allow time for each response.
217
Examination of the times that the surveys were returned provides guidance for future
218
studies using this method of data collection. We received the highest proportion of late survey
219
responses when we requested responses between midnight and 08:00. To optimize response
220
rates, investigators may consider avoiding data collection at these times.
221
In order to accommodate participant’s choice in timing misoprostol, we did not have
222
standardized timing of the text messages. This methodology allowed us to make observations of
223
differences depending on time of day. When the survey time fell during the early morning hours,
224
we obtained fewer on-time responses. We also allowed participants to take misoprostol at a time
225
different from the time they planned for at enrollment, and the investigator holding the study
226
phone made adjustments to the schedule of subsequent surveys once the first response was
227
received. This is a limitation, as it may not be easily duplicated in a larger scale trial.
10
228
Only three women out of 241 screened (1.2%) were excluded from study participation
229
because they did not have a phone with text messaging and Internet capabilities, suggesting this
230
method of data collection is accessible to most reproductive age women. According to the
231
Nielsen Mobile Consumer Report 2013, 94% of consumers aged 16 or over in the United States
232
used a mobile phone [12]. This may have contributed to our high response rates, as more people
233
are using phones throughout the day for multiple tasks, and are less likely to miss a text message
234
prompt. Of note, the timeliness and completeness of survey responses may vary among
235
individuals who are less accustomed to text messaging or online survey submission.
236
SMS text message prompts that link to an online survey platform yielded high timely
237
response rates in a population of women submitting longitudinal data on pain and use of
238
analgesics. Investigators may consider this method for collecting repeated measures in other
239
study settings.
240 241
Acknowledgements: Thanks to Katelyn Stevens, MSHS, PA-C and Chelsea Yin, BS for their
242
contributions to this work as study coordinators.
243 244
This work was supported by the Society of Family Planning Research Fund [grant number
245
SFPRF15-12].
246 247 248 249 250
11
251
Figures:
252 253
Figure 1: Percentage of survey responses received on-time, over two hours late, or not at all, at 0-
254
, 2-, 6-, 12-, 24-, and 72-hours after misoprostol administration in women undergoing medication
255
abortion at the University of Hawaii.
256 257
Figure 2: Percentage of survey responses received on-time at 0-, 2-, 6-, 12-, 24-, and 72-hours
258
after misoprostol administration in women undergoing medication abortion at the University of
259
Hawaii, depending on whether the misoprostol was taken before or after 12:00.
260 261
Figure 3: Number of survey responses received on-time, over two hours late, or not at all, in
262
women undergoing medication abortion at the University of Hawaii, depending on the time the
263
survey was requested (in two hour intervals).
264 265 266
Tables:
267 268
Table 1: Characteristics of women participating in a study of medication abortion at the
269
University of Hawaii.
270 271 272 273
12
274
Appendices:
275 276
Appendix A: Sample of survey received at two hours after misoprostol administration for women
277
participating in a study on medication abortion at the University of Hawaii.
278
http://goo.gl/forms/Hel52TZlZw
279 280 281
References:
282 283
[1] Kew S. Text messaging: an innovative method of data collection in medical research. BMC
284
Res Notes 2010; 3: 342.
285
[2] Brabyn S, Adamson J, MacPherson H, Tilbrook H, Torgerson DJ. Short message service text
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messaging was feasible as a tool for data collection in a trial of treatment for irritable bowel
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syndrome. J Clin Epidemiol 2014; 67: 993-1000.
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[3] Lim MS, Sacks-Davis R, Aitken CK, Hocking JS, Hellard ME. Randomised controlled trial
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of paper, online and SMS diaries for collecting sexual behaviour information from young people.
290
J Epidemiol Community Health 2010; 64: 885-9.
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[4] Richmond SJ, Keding A, Hover M, Gabe R, Cross B, Torgerson D, MacPherson H.
292
Feasibility, acceptability and validity of SMS text messaging for measuring change in depression
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during a randomised controlled trial. BMC Psychiatry 2015; 15: 68.
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[5] Spitz IM, Bardin CW, Benton L, Robbins A. Early pregnancy termination with mifepristone
295
and misoprostol in the United States. N Engl J Med 1998; 338: 1241-7.
13
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[6] Livshits A, Machtinger R, David LB, Spira M, Moshe-Zahav A, Seidman DS. Ibuprofen and
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paracetamol for pain relief during medical abortion: a double-blind randomized controlled study.
298
Fertil Steril 2009; 91: 1877-80.
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[7] Hamoda H, Ashok PW, Dow J, Flett GM, Templeton A. A pilot study of mifepristone in
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combination with sublingual or vaginal misoprostol for medical termination of pregnancy up to
301
63 days gestation. Contraception 2003; 68: 335-8.
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[8] Hamoda H, Ashok PW, Flett GM, Templeton A. A randomised controlled trial of
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mifepristone in combination with misoprostol administered sublingually or vaginally for medical
304
abortion up to 13 weeks of gestation. BJOG 2005; 112: 1102-8.
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[9] Raymond EG, Weaver MA, Louie KS, Dean G, Porsch L, Lichtenberg ES, Ali R, Arnesen
306
M. Prophylactic compared with therapeutic ibuprofen analgesia in first-trimester medical
307
abortion: a randomized controlled trial. Obstet Gynecol 2013; 122: 558-64.
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[10] Stone AA, Shiffman S, Schwartz JE, Broderick JE, Huffort MR. Patient compliance with
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paper and electronic diaries. Controlled Clinical Trials 2003; 24: 182-99.
310
[11] Friedlander EB, Soon R, Salcedo J, Davis J, Tschann M, Kaneshiro B. Prophylactic
311
pregabalin to decrease pain during medication abortion: a randomized controlled trial. Obstet
312
Gynecol 2018; 132(3): 612-8.
313
[12] Nielson: The mobile consumer, a global snapshot, Feb 2013:
314
http://www.nielsen.com/content/dam/corporate/uk/en/documents/Mobile-Consumer-Report-
315
2013.pdf
316 317 318
14
S0010-7824(19)30484-6 https://doi.org/10.1016/j.contraception.2019.11.008 CON 9362
To appear in:
Contraception
Received Date: Revised Date: Accepted Date:
5 May 2019 18 November 2019 18 November 2019
Please cite this article as: E.B. Friedlander, R. Soon, J. Salcedo, M. Tschann, T. Fontanilla, B. Kaneshiro, Text message link to online survey: a new highly effective method of longitudinal data collection, Contraception (2019), doi: https://doi.org/10.1016/j.contraception.2019.11.008
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
© 2019 Elsevier Inc. All rights reserved.
1
Title: Text message link to online survey: a new highly effective method of longitudinal data
2
collection
3 4
Authors: EmmaKate B Friedlander MD PhD, Reni Soon, MD MPH, Jennifer Salcedo, MD
5
MPH MPP, Mary Tschann PhD MPH, Tiana Fontanilla MPH, Bliss Kaneshiro, MD MPH
6 7
Institution: John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI.
8 9
Corresponding Author:
10
EmmaKate Friedlander, MD PhD
11
[email protected]
12
808-203-6500
13
Department of Obstetrics and Gynecology
14
John A Burns School of Medicine, University of Hawaii at Manoa
15
1319 Punahou St. Ste 824
16
Honolulu, HI 96826
17 18
Short Title: Text to survey data collection
19 20
Abstract Word Count: 250
21
Manuscript Word Count: 2240
22 23
This data was presented as a poster abstract at the North American Forum on Family Planning in
1
24
Atlanta, Georgia, October 13-15th 2017.
25 26
Portions of this study were filed within Dr. Friedlander’s dissertation with ProQuest dissertation
27
filing service, June 2017.
28 29
Declarations of interest: none
30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46
2
47
Abstract
48 49
Objectives: To evaluate response rate to a text message link for an online survey as a method of
50
data collection over the course of a medication abortion.
51
Study Design: This is a secondary analysis of a randomized, double-blind, placebo-controlled
52
trial of 110 women initiating a medication abortion up to 70 days gestation. We sent a text
53
message containing a link to an online survey collecting pain scores, analgesic use, and adverse
54
effects at six time points over 72 hours from time of misoprostol administration (0-, 2-, 6-, 12-,
55
24-, and 72-hours). Our primary outcome was the proportion of all text messages sent for which
56
an online survey response was received. Secondary outcomes included the proportion of
57
complete responses (all six surveys), responses received more than two hours after text prompt
58
(defined as late), and differences in response rate by time of day.
59
Results: From June 2015 to October 2016, we screened 241 women, and 110 were randomized.
60
We excluded three (1.2%) due to lack of a cellular phone with text capability, and three (2.7%)
61
were lost to follow-up after enrollment. We received a response to 95.9% (633/660) of the
62
delivered surveys, and 93.6% (103/110) of participants completed all six surveys. Over three-
63
quarters of all responses were received within two hours of the requested time. Surveys sent
64
before 08:00 were more likely to be returned late.
65
Conclusions: In this population of women seeking medication abortion, text message link to
66
online survey response appears to be an effective mode of data collection.
67
Key words: Data collection, survey, text message, SMS
68
Implications: Text message prompts for an online survey may optimize longitudinal real-time
69
data collection response rates of sensitive data.
3
70 71
1. Introduction Complete data collection is critical for validity in longitudinal studies with repeated
72
measurements. Loss to follow-up and missing data can introduce bias. Common methods of
73
prospective data collection include in-person study visits, phone calls, and paper surveys or
74
diaries. Recently, mobile phone short message service (SMS) text messaging has been
75
introduced for health care educational interventions and service delivery, with up to a 100%
76
response rate [1-4]. However, study participants prefer and are more likely to complete online
77
surveys over SMS text message responses or paper surveys [3]. Most text messaging studies
78
have focused on SMS reminder texts or simple binary responses, rather than full surveys. When
79
a study includes multiple data points for several different variables, surveys are better suited for
80
direct responses rather than multiple binary text responses. To our knowledge, no studies have
81
combined SMS text prompt with an online survey, which may be preferred when collecting data
82
for several variables longitudinally.
83
Medication abortion studies often collect data on pain, bleeding, and analgesic use over
84
time. Though the medication abortion process is initiated with mifepristone in a health care
85
providers’ office, misoprostol is administered at home with patients passing the pregnancy
86
within a 24- to 48-hour time frame outside of a health care facility. Early medication abortion
87
studies to understand pain and bleeding used in-person visits where women remained at a health
88
care facility for the medication abortion process, a scenario that is uncommon today and may not
89
be reflective of the experience at home [5-8]. Researchers have studied the home medication
90
abortion experience using paper diaries, though the real-time completion of paper diaries is
91
difficult to confirm and may rely on recall [9].
4
92
Retrospective accounts of the medication abortion experience, collected at the time of a
93
follow-up visit, are subject to recall bias. After a process has ended, the memory of the event
94
may be different than that experienced in real-time. This concept was examined in a longitudinal
95
study of chronic pain patients that used paper diary cards kept in a binder with a hidden sensor
96
that recorded when the binder was opened. This allowed them to compare participant self-
97
reported response time with recorded times of binder use. Though participants reported
98
answering the surveys within the allotted window 90% of the time, the electronic data from the
99
sensor matched only 11% of the time. The second arm of the study used an electronic device
100
with timed prompts instead of a paper binder, and recorded over 93% accurate compliance [10].
101
To collect repeated real-time accounts while maintaining home data collection, we used
102
an SMS text that connected participants to an online survey. The SMS text served as a real-time
103
reminder to complete the online survey without the intrusiveness of multiple phone call
104
interviews or office evaluation. We describe the feasibility and data collection completion rate
105
of using a text message link to an online survey platform as a method of data collection for
106
medication abortion.
107 108 109
2. Materials and Methods We present a secondary analysis of data that was collected as part of a clinical trial at the
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University of Hawaii (Honolulu, Hawaii) exploring pregabalin for pain management with
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mifepristone and buccal misoprostol medication abortion up to 70 days gestation [11]. We
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obtained approval from the University of Hawaii Committee on Human Studies and were
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registered at clinicaltrials.gov (NCT02782169).
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We enrolled women aged 18 years or older with a pregnancy up to and including 70 days
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gestation by ultrasound dating, who were capable and willing to receive cellular phone text
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messages and complete multiple electronic surveys over the 72-hour study period. Exclusion
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criteria included: a contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or
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pregabalin; alternative methods of misoprostol use (i.e. vaginal administration or use in less than
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24 hours); inability to speak or read English; and participation in the same trial during a prior
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pregnancy. Patients were approached for study participation after they were consented to the
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medication abortion and took the mifepristone with their provider in the office.
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Participants took misoprostol at home 24 to 48 hours after the mifepristone, according to
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study protocol. While the participant was in the office, a research assistant used the designated
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study phone to send an SMS text to confirm their ability to receive messages. Participants each
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chose a time to take the misoprostol and the research assistant programmed a text message with a
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link to the first online survey at that time. If the participant took the misoprostol at a different
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time, the research assistant instructed her to access the survey via a URL address and QR code
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printed on the misoprostol package, directing her to the first survey.
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We sent SMS text prompt links to surveys at six specified points over 72 hours following
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misoprostol administration (0-, 2-, 6-, 12-, 24-, and 72-hours) to assess current pain on an 11-
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point numerical rating scale (NRS), maximum pain and the time it occurred, analgesic tablets
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taken, adverse effects (checklist including a space for free text), and satisfaction with the
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abortion and the pain control (5-point Likert scale) (Appendix A). All survey responses were
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identifiable by participant identification number, and were electronically time-stamped at
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submission. Each survey had a title that designated which survey number it was, though other
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questions remained identical. Satisfaction scores were only assessed at the 24-hour survey.
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During enrollment, the research assistant reviewed a chart of the times that participants could
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expect to receive prompts to complete surveys depending on the time that they chose to take the
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misoprostol (start time). We reviewed that taking the misoprostol at 09:00 start time would
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avoid early morning or late night disturbances; however, participants could elect to start at any
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time that suited them.
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We used a secure cellular phone, dedicated to this trial and held by an investigator, to
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send all SMS text prompts and make study-related calls. The automated SMS prompts were
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scheduled through the Android application “SMS Scheduler” (Ulka International). The SMS text
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provided a link to an online survey where participants could enter information without storing
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any data on their phones. Participants entered their identification number and a code word of
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their choosing, for double identification in case of a forgotten or incorrect identification number,
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into the online survey. We did not collect protected health information in the survey.
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We programmed each survey to be prompted by SMS text at a specified time, and time
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stamps were collected on each survey response. The study phone was alerted when the first
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survey was completed, allowing the investigator to change the timing of subsequent surveys if
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the participant chose a different time to take the misoprostol. Surveys were considered on-time
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if they were received within two hours of when the text message was sent. Two hours was
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designated as late because that was the shortest time interval between surveys. We sent text
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messages at two and six hours if participants did not provide survey responses. We called
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participants after 24 hours of the study period and sent an e-mail after 72 hours to request a
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retrospective report if no responses were received. We included all survey responses in the
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analysis, whether on-time or late. Surveys were defined as missing if no response was received
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by four hours after the 72-hour reminder e-mail was sent. Participants received an electronic gift
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card at the end of the study period corresponding to how many surveys they responded to, with a
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bonus for completing all six surveys.
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Our primary outcome was the proportion of all SMS text messages sent for which a
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survey response was received. Secondary outcomes included the proportion of participants
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responding to all six surveys, how often surveys were completed late (received more than 2
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hours after the text was sent), and whether response rates differed by time of day the abortion
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began (before or after noon) or time the survey was requested (by two-hour intervals). This is a
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descriptive analysis, and no statistical comparisons were made.
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3. Results
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From June 2015 to October 2016, we screened 241 women for inclusion, and excluded
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three women (1.2%) due to lack of access to a cellular phone with text messaging and Internet
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capability. Forty-nine additional women did not meet the inclusion criteria, and 79 declined
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participation [11]. We enrolled and randomized 110 women. Table 1 describes the
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demographics of the study population (n=110).
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Of 660 survey prompts sent, participants responded to 633 (95.9%). One hundred and
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three (93.6%) participants completed all six surveys. Three participants (2.7%) were lost to
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follow-up after enrollment. Without these participants, the overall response rate was 98.6%
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(633/642 surveys returned), with all six surveys returned by 96.3% (103/107) of participants.
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Two (1.8%) completed five out of six surveys, one (0.9%) completed four surveys, and one
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(0.9%) completed one survey.
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Participants answered 511 of 660 surveys (77.4%) within two hours of receiving the text message prompt. We received 122 surveys (18.5%) more than two hours late. We did not receive
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a response for 27 surveys (4.1%). All survey responses were submitted consecutively, confirmed
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by time stamp at response. Figure 1 shows the response rate to each survey.
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To examine whether time of day the abortion started impacted response rates, we
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examined on-time responses to each survey depending on whether the misoprostol (survey start)
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was taken in the morning or after noon, including participants that did not respond to each survey
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(Figure 2). Fifty-one participants started in the morning, and 46 started after noon. Morning
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start surveys had fairly consistent on-time responses to all surveys (82.4-92%). Afternoon and
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evening start times had on-time responses of 54.5-87.3%. Both start times had the lowest on-
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time response rates for the 12-hour survey.
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To examine if the time of day that each survey was requested (separate from the study
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start time) significantly impacted response rates, we evaluated the number and percentage of late
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responses throughout the day in two-hour intervals (Figure 3). When participants received SMS
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texts in the daytime and evening, from 08:00 to midnight, 15.5% of survey responses had times
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stamps more than two hours later than the prompt (range 7.1-22.2%). We observed the highest
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proportion of late survey responses (46.6%) when the prompts arrived in the late-night hours of
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midnight to 08:00, ranging from 27.3% (06:00 to 08:00) to 70% (02:00 to 04:00).
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4. Discussion The validity and generalizability of any study is dependent on loss to follow up and
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response rates. Minimizing loss to follow up and achieving a high response rate can be
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challenging when data collection occurs outside of a health care facility and requires multiple
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responses at different time points. We demonstrated that using SMS text messaging linked to an
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online survey resulted in a low loss to follow up and an excellent response rate, even with serial
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surveys over a three-day period involving sensitive subject matter.
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Prior studies have characterized pain during medication abortion in an inpatient setting
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[5-8]. Many women choose a medication abortion because they prefer to end the pregnancy at
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home; thus, the inpatient study setting may not be representative of the typical in-home
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experience. In our study, we had excellent response rates for in-home data collection using an
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SMS text message prompt to an online survey.
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This methodology has the advantage of additional confidentiality for participants,
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allowing them to use a secure online platform instead of direct submission via text message.
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SMS text message responses alone would require multiple messages at each time point to collect
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such a large amount of data, which is not as desirable for participants, and would not be feasible
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to program electronically in advance to allow time for each response.
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Examination of the times that the surveys were returned provides guidance for future
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studies using this method of data collection. We received the highest proportion of late survey
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responses when we requested responses between midnight and 08:00. To optimize response
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rates, investigators may consider avoiding data collection at these times.
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In order to accommodate participant’s choice in timing misoprostol, we did not have
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standardized timing of the text messages. This methodology allowed us to make observations of
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differences depending on time of day. When the survey time fell during the early morning hours,
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we obtained fewer on-time responses. We also allowed participants to take misoprostol at a time
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different from the time they planned for at enrollment, and the investigator holding the study
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phone made adjustments to the schedule of subsequent surveys once the first response was
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received. This is a limitation, as it may not be easily duplicated in a larger scale trial.
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Only three women out of 241 screened (1.2%) were excluded from study participation
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because they did not have a phone with text messaging and Internet capabilities, suggesting this
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method of data collection is accessible to most reproductive age women. According to the
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Nielsen Mobile Consumer Report 2013, 94% of consumers aged 16 or over in the United States
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used a mobile phone [12]. This may have contributed to our high response rates, as more people
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are using phones throughout the day for multiple tasks, and are less likely to miss a text message
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prompt. Of note, the timeliness and completeness of survey responses may vary among
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individuals who are less accustomed to text messaging or online survey submission.
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SMS text message prompts that link to an online survey platform yielded high timely
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response rates in a population of women submitting longitudinal data on pain and use of
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analgesics. Investigators may consider this method for collecting repeated measures in other
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study settings.
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Acknowledgements: Thanks to Katelyn Stevens, MSHS, PA-C and Chelsea Yin, BS for their
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contributions to this work as study coordinators.
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This work was supported by the Society of Family Planning Research Fund [grant number
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SFPRF15-12].
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Figures:
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Figure 1: Percentage of survey responses received on-time, over two hours late, or not at all, at 0-
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, 2-, 6-, 12-, 24-, and 72-hours after misoprostol administration in women undergoing medication
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abortion at the University of Hawaii.
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Figure 2: Percentage of survey responses received on-time at 0-, 2-, 6-, 12-, 24-, and 72-hours
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after misoprostol administration in women undergoing medication abortion at the University of
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Hawaii, depending on whether the misoprostol was taken before or after 12:00.
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Figure 3: Number of survey responses received on-time, over two hours late, or not at all, in
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women undergoing medication abortion at the University of Hawaii, depending on the time the
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survey was requested (in two hour intervals).
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Tables:
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Table 1: Characteristics of women participating in a study of medication abortion at the
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University of Hawaii.
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Appendices:
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Appendix A: Sample of survey received at two hours after misoprostol administration for women
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participating in a study on medication abortion at the University of Hawaii.
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http://goo.gl/forms/Hel52TZlZw
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