Feasibility of an iPad application for studying menopause-related symptom clusters and women's heuristics.

Informatics for Health and Social Care

ISSN: 1753-8157 (Print) 1753-8165 (Online) Journal homepage: http://www.tandfonline.com/loi/imif20

Feasibility of an iPad application for studying menopause-related symptom clusters and women’s heuristics Rita Ismail, Lauri A. Linder, Catherine Fiona MacPherson & Nancy Fugate Woods To cite this article: Rita Ismail, Lauri A. Linder, Catherine Fiona MacPherson & Nancy Fugate Woods (2015): Feasibility of an iPad application for studying menopause-related symptom clusters and women’s heuristics, Informatics for Health and Social Care, DOI: 10.3109/17538157.2015.1008489 To link to this article: http://dx.doi.org/10.3109/17538157.2015.1008489

Published online: 10 Jul 2015.

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Date: 29 September 2015, At: 07:13

Inform Health Soc Care, Early Online: 1–20, 2015 ! Informa UK Ltd. ISSN: 1753-8157 print / 1753-8165 online DOI: 10.3109/17538157.2015.1008489

Feasibility of an iPad application for studying menopause-related symptom clusters and women’s heuristics Rita Ismail,1,2 Lauri A. Linder,3 Catherine Fiona MacPherson,4,5 and Nancy Fugate Woods1

Downloaded by [Universite Laval] at 07:13 29 September 2015

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Biobehavioral Nursing and Health Systems, School of Nursing, University of Washington, Seattle, WA, USA, 2 Ministry of Health, Jakarta, Republic of Indonesia, 3 Primary Children’s Hospital, University of Utah College of Nursing, Salt Lake City, UT, USA, 4 Seattle Children’s Hospital, Seattle, WA, USA, and 5 Family and Child Nursing, School of Nursing, University of Washington, Seattle, WA, USA Purpose: To evaluate feasibility, including usability and utility, of the Computerized Symptom Capture Tool for Menopause (C-SCAT-M), a symptom heuristics application (app) for the iPad, with midlife women. Methods: Thirty midlife women aged 40–60 and experiencing symptoms they associated with menopause were recruited through flyers posted on a university campus, primary care and women’s health clinics. The C-SCAT-M guided participants to identify symptoms they experienced, draw temporal and causal relationships between symptoms and identify symptom clusters. Women were encouraged to think aloud as they encountered questions or problems and their comments were audio recorded. After completing the C-SCAT-M, they completed a 22-item acceptability survey and a demographic survey. Data were downloaded from catalyst website and analyzed using SPSS. Results: Women completed the C-SCAT-M with minimal difficulty, with most indicating that using the app was very/extremely easy and most (57%) preferred using the iPad app to paper. Most women stated that the final diagrams were very/extremely accurate depictions of their symptom clusters and relationships (77%). Conclusion: The C-SCAT-M demonstrated initial feasibility, including usability and utility, for collecting data about symptom clusters experienced by midlife women. Keywords Mobile health application, symptoms, women’s health

BACKGROUND Research about symptoms women experience during the menopausal transition has focused predominantly on hot flashes and a variety of interventions for their relief, yet studies of women’s symptom experiences during the menopausal transition and early postmenopause indicate that women experiences clusters of symptoms (1,2). Symptom clusters are multiple symptoms Correspondence: Nancy Fugate Woods, Biobehavioral Nursing and Health Systems, School of Nursing, University of Washington, Seattle, 1959 Northeast Pacific Street, Box 357260, Seattle, WA 98195, USA. Tel: +1 206 616 1406. E-mail: [email protected]


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that co-occur and may be related to one another through a common mechanism or etiology, a common shared variance or the production of different outcomes than individual symptoms, e.g. pain, nausea and fatigue (3,4). Our experience with the Seattle Midlife Women’s Health Study (SMWHS), as well as that of others, has revealed that women do not experience a menopausal syndrome (5). They do, however, experience multiple related groups or ‘‘clusters’’ or two or more symptoms that vary with their progression through stages of reproductive aging and with endocrine changes accompanying menopause (6,7). The majority of studies of symptom clusters have been informed by empiricist methodology and have incorporated measures of symptoms and clusters using quantitative ratings and analytic strategies such as principal component analysis, cluster analysis and multilevel classification analysis to group symptoms (8–19). To date few studies have been informed by interpretive methods that engage participants in clustering symptoms based on their own experience and eliciting their heuristics about the clusters. In this context, heuristics refers to the mental models women have of their symptoms, how they cluster and explanatory models for why their symptoms occur as well as what exacerbates or ameliorates them. Our pilot interviews with participants of the SMWHS revealed that women could provide narrative information about their heuristics about how symptoms cluster, presumed causes of symptom clusters, temporal relationships among symptoms in the clusters and experiences with symptom management (19). Our prior data collection approaches have been dependent on resourceintensive in-person or telephone interviews to elicit symptom cluster heuristics and the mechanics of drawing models of symptom clusters and the relationships among symptoms proved difficult for women with multiple symptoms. A recent collaboration with pediatric oncology nurse researchers (Consortium to Study Symptoms in Adolescents with Cancer – CS2AC) testing the feasibility of an iPad application (app), the Computerized Symptom Capture Assessment Tool (C-SCAT), incorporated several items from the symptom clusters heuristic interview questions originally pilot tested with SMWHS participants (20). Early analyses from that study indicate that adolescents and young adults (AYA) experiencing cancer therapy can readily provide data about their symptoms and heuristics using the C-SCAT iPad app (21). Potential benefits of this innovative approach for studies of midlife women would include ability to collect data from women in ways that: promote their privacy, do not require the expense of a researcher to conduct interviews, allow for data entry in real time as women respond to the questions in the app and enhance efficiency of data collection for large studies. Moreover, unlike a paper and pencil method of drawing symptom clusters and the relationship among symptoms, an iPad app could allow women to depict their symptoms, the relationships among them and the clusters they form with relatively easy approaches to modifying the drawings without having to erase and begin again. Whether the use of the application with midlife women is feasible to use for research, including its usability (being relatively easy to use, efficiency, satisfaction) and utility (accurately reflecting the data and providing for realtime data entry), remained to be evaluated. Therefore, the C-SCAT app was adapted to study symptom cluster heuristics related to menopause (Computerized Symptom Capture Tool for Menopause [C-SCAT-M]).

Feasibility of iPad app

The purpose of this exploratory, descriptive study was to evaluate the feasibility of the C-SCAT-M, including its usability and utility for research data collection, with midlife women. Our aims were to determine the (1) usability (e.g. completion rates, need for assistance, accuracy of final image, time for completion, participant fatigue and frustration, technical problems, ease of use) and (2) utility (accuracy of data capture, accuracy of final image, providing real time entry of data) of the C-SCAT-M as a research tool.


METHODS Sample and setting Eligible participants were women recruited through advertisements posted on a university campus and in primary care and women’s health clinics. Women from the Pacific Northwest between the ages of 40 and 60 and experiencing symptoms they associated with menopause were recruited. Inclusion criteria were women experiencing symptoms such as hot flashes which they believe may be related to menopause, and the ability to read, write and speak English. Women with conditions that interfered with their ability to use the iPad app (e.g. visual limitations) were excluded. Study measures Computerized Symptom Capture Tool for Menopause (C-SCAT-M) The C-SCAT-M features 54 symptoms commonly reported by women during the menopausal transition and early postmenopause based on results from the SMWHS, a longitudinal study of a cohort of midlife women as they experienced the menopausal transition (6). The C-SCAT-M combines graphical images and free text responses in an innovative heuristics approach to gain participants’ perspectives of their symptoms and symptom clusters. The C-SCAT-M presents the symptom menu and directs participants to drag and drop those symptoms experienced within the past 24 h into a designated area on the iPad screen. Participants are prompted to draw connecting lines to indicate which symptoms are related and arrows to indicate causal relationships among symptoms. They also are asked to draw boxes around clusters of symptoms that they perceived to be related and denote the key symptom in each cluster as well as the most bothersome cluster. In addition, they are invited to provide descriptive information on the temporal nature of the symptoms, and names for clusters. Women were also asked to reveal their heuristics, including the cluster’s cause, effects on daily life and strategies they had found to exacerbate or alleviate the cluster. The C-SCAT-M generates a final graphical image that includes individual symptoms, relationships between symptoms, symptom clusters and key symptoms within clusters. See Figure 1 for an example C-SCAT-M image from this study. The CS2AC, composed of five early-career nurse scientists and two senior nurse scientist mentors, conceptualized the C-SCAT based on a symptom cluster heuristics interview guide developed by one of the authors (N. F. W.). The C-SCAT app for AYA with cancer was developed for delivery via the iPad by computer programmers at Intermountain Healthcare’s Homer Warner Center for Informatics Research (HWCIR), which is recognized nationally for

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Figure 1. An example of C-SCAT-M image.

its work in clinical decision support and the implementation of innovative information technologies to improve clinical care (22). The C-SCAT-M instrument was adapted from the C-SCAT app for AYA with cancer. The C-SCAT app was evaluated by 72 AYA aged 13–29 years old. Most of AYA (74%) indicated that the final image generated by the app was either an ‘‘accurate’’ or a ‘‘very accurate’’ representation of their symptoms experience (22). The HWCIR programmers revised the original C-SCAT app to create the C-SCAT-M for use with midlife women experiencing menopause-related symptoms. The questions and symptoms of the C-SCAT-M were modified based on the SMWHS. Acceptability questionnaire After completing the C-SCAT-M, participants completed a 22-item acceptability questionnaire adapted from the acceptability questionnaire created by CS2AC investigators (21). Items addressed perceived ease of use (usability) and perceived utility (23,24). The questionnaire was delivered electronically via the iPad using a Catalyst survey, a secure online platform for survey delivery (25). The questionnaire included eight items rated on a five-point scale as well as 12 free text items to allow participants to explain their responses or offer suggestions for improvement. Items pertaining to ease of use included clarity of questions posed by the app, ease of following instructions, ease of typing and drawing within the app and judgment of appropriateness of length of time required to complete the app. Items pertaining to the app’s perceived usefulness included perceptions of boredom while completing the app, how the participant felt having to think about her symptoms while completing the app, whether the app asked important questions about her symptoms, whether there were other questions that should have been asked, and the participant’s


preference for a computer-based or paper version. The internal consistency, Cronbach’s alpha coefficient, of the seven-scaled items included in the acceptability questionnaire in the AYA with cancer study was 0.68. Item-to-total correlations of individual items ranged from 0.05 to 0.48 (26). For this study, the items addressing the ease of typing and drawing in the app were separated into two individual items, resulting in a total of eight-scaled items.


Demographic and clinical data Demographic data were obtained from participants to describe the study sample. These included their current age, educational attainment, menstrual/ menopause status, current computer use and history of having ever used of an iPad. Procedures Recruitment and enrollment Following IRB approval, midlife women who self-identified as experiencing symptoms related to menopause were recruited from advertisements in public places on a university campus and in primary care clinics. Each enrolled participant received a $20 gift card as a token of appreciation. Modification of the study instruments Before collecting data with participants, the instruments, the C-SCAT-M and the acceptability questionnaire were pretested with eight women. They were students at the University of Washington between 27 and 53 years of age. They completed the instruments using an iPad and gave feedback about the instruments and issues in completing the questionnaire as well as their concerns related to using an iPad. Modification to making the instruments easier to be completed includes clarifying some items and the procedure for those who never use an iPad. Data collection Participants completed the C-SCAT-M and the acceptability questionnaire on a dedicated study iPad in a quiet private location in either an investigator’s office or another area of the university, e.g. conference room in the library. A research associate (RI) instructed women in the use of the C-SCAT app and observed them as they completed the questions, providing coaching if necessary in how to report their responses. Using the C-SCAT-M, women identified symptoms they had experienced during the past 24 h from a list of 54 commonly reported symptoms (6). The C-SCAT-M then guided participants to draw temporal and causal relationships between symptoms, identify symptom clusters (Figure 2). While completing the C-SCAT-M, women were asked to ‘‘think aloud’’ while completing the app. The ‘‘think aloud’’ method is a userbased approach to evaluating usability that allows users to state what they think as they complete a given task, thereby providing insight into their cognitive processes (27). Women’s ‘‘think aloud’’ comments were audio recorded. The RI remained available during participant sessions to answer questions, to provide coaching if needed, to observe women as they completed the app and to maintain field notes about women’s responses while using the app.

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Figure 2. An example of the C-SCAT screenshots for steps to completion.


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After completing the C-SCAT-M app, women completed the acceptability questionnaire and provided demographic data. Feasibility The app’s potential for success as a symptom assessment tool was evaluated through assessment of its usability and utility. Usability was assessed by: (1) C-SCAT-M completion rates and reasons for any noncompletion selected by participants from a predeveloped list of probable reasons; (2) need for an additional session to complete the C-SCAT-M (to be offered if a participant was unable to complete in a single session); (3) time to complete the C-SCAT-M; (4) items requiring clarification or coaching to complete; (5) observable fatigue or frustration while completing the C-SCAT-M and (6) technical problems. Utility was assessed by: (1) participant judgment of accuracy of final image as representative of symptom experience and (2) quality of data obtained using the C-SCAT-M. Data management and analysis As the C-SCAT-M was completed, graphic and text data generated by participants were encrypted and wirelessly transmitted securely to a password-protected Amazon Simple Storage Service (S3) account. Amazon S3 is a secure, distributed network for storing and retrieving data that is compliant with Health Insurance Portability and Accountability Act standards (28). Data from each participant included screen shot images of each stage of the app’s completion and an Excel worksheet containing free text responses. Data were downloaded from the Amazon Web Services S3 site and stored on an encrypted, password-protected computer in preparation for data analysis. Data from the acceptability questionnaire (Excel and SPSS version) were downloaded from the Catalyst website (25). SPSS version 21 (SPSS Inc., Chicago, IL) was used to create data files for statistical analysis.

RESULTS Demographics Thirty midlife women between the ages of 40 and 60 completed the C-SCAT-M (Table 1). Although the majority were 50 years and older, 33% were younger than 50 years of age. Over 75% had completed college or graduate degrees. Approximately 40% had not menstruated in more than a year, but 60% were in varying stages of the transition to menopause or were in the late reproductive stage by Stages of Reproductive Aging Workshop criteria (29). Although 87% of the participants used a computer daily at work, only 60% had ever used an iPad. Feasibility Usability All 30 participants completed the C-SCAT-M successfully in a single session. Women reported a median of 10 symptoms (range 1–22). The mean time required to complete the C-SCAT-M was 26 min, median 22 min (range 2–65 min) and was calculated using time/date stamps that were generated as participants completed each component of the app. Five women worked

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Table 1. Demographic data describing participants in C-SCAT-M feasibility study (N ¼ 30).

Age 40–44 45–49 50–54 55–60 Highest level of education completed High school 2-year college 4-year college/school Graduate school Menstrual periods Haven’t had menstrual period in more than a year Had a menstrual period in the last year, but not in the last 3 months Had a menstrual period in the last three months, but irregular or unpredictable Have regular menstrual periods in the past year Other Computer use Personal reasons Everyday at work Ever used iPad No Yes

Frequency

Percent

3 7 11 9

10.00 23.30 36.70 30.00

2 5 11 12

6.70 16.70 36.70 40.0

13

43.30

4

13.30

6

20.00

1 6

3.30 20.00

4 26

13.30 86.70

12 18

40.00 60.00

through the app 2–3 times because of technical problems such as missing the continue button. Most women (70%) felt that the length of time required for completion was acceptable. The Cronbach’s alpha coefficient of the eight-scaled items included in the acceptability questionnaire for the C-SCAT-M was 0.76, demonstrating good internal consistency. Item-to-total correlations ranged from 0.03 to 0.55. Women did not show fatigue symptoms while completing the app. However, some women were hesitant and feared making a mistake, especially when this was the first occasion they had used an iPad. Some women experienced hot flashes while completing the app after they became irritated when they had problems. Others commented that they felt secure and were able to complete the app because the research assistant was in the room and helped when they had issues with the app. Women frequently required additional clarification or coaching when they were grouping the symptoms into clusters using the technique of moving the items on the screen. Participants evaluated the C-SCAT-M’s ease of use and perceived usefulness positively (Table 2) and offered a variety of comments about how to improve both (Table 4). Suggestions for improvement included providing an introduction on how to fill out the instrument, asking specific questions relative to individual symptoms and having easier ways to group the symptoms. Ninety percent indicated they thought the C-SCAT-M asked moderately to extremely

Feasibility of iPad app Table 2. Usability ratings of the C-SCAT-M (N ¼ 30).


Items

Frequency

How clear was the question? Moderately clear Very clear Extremely clear Easy to follow the instructions? Slightly easy Moderately easy Very easy Extremely easy How easy to type? Not easy at all Slightly easy Moderately easy Very easy Extremely easy How easy to draw? Not easy at all Slightly easy Moderately easy Very easy Extremely easy Time to complete the app Too long Slightly Neither too long or too short How bored Moderately bored Slightly bored Not at all bored How important were questions? Slightly important Moderately important Very important Extremely important How accurate was symptom cluster diagram? Slightly accurate Moderately accurate Very accurate Extremely accurate Preference Paper iPad No preferences – either is fine

Percent

7 22 1

23.30 73.30 3.30

3 7 16 4

10.00 23.30 53.30 13.30

1 3 4 10 12

3.30 10.00 13.30 33.30 40.00

3 2 10 9 6

10.00 6.70 33.30 30.00 20.00

2 7 21

6.70 23.30 70.00

3 1 26

10.00 3.30 86.70

3 8 12 7

10.00 26.70 40.00 23.30

2 5 16 7

6.70 16.70 53.30 23.30

7 17 6

23.30 56.70 20.00

important questions about their symptoms, and by 87% indicated they were not bored while completing the app. In terms of ease of use, 76% of participants judged the questions to be ‘‘clear’’ or ‘‘very clear’’. Two-thirds of participants rated the ease of following instructions as ‘‘very easy’’ or ‘‘extremely easy’’. Participants also rated the ease of typing and drawing within the app with 86% indicating that it was ‘‘moderately to extremely easy to type’’ and 83% indicating that it was ‘‘moderately easy to extremely easy to draw’’.

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Participants were asked about their feelings in response to being requested to think about their symptoms while completing the C-SCAT-M. Women said they felt ‘‘fine’’, ‘‘surprised’’, ‘‘sad,’’ ‘‘annoyed,’’ ‘‘depressed’’ and ‘‘more aware about their symptoms.’’ Some women did not feel bothered by answering the questions, indicating that they felt, ‘‘just fine, no problem’’. Completing the app made some women realize what had happened to them. Some women indicated that the app had stimulated them to consider their symptoms as ‘‘Not good, looking from the outside in,’’ and ‘‘Brings it into focus, enlightening and a little depressing.’’ Other women even reported finding solutions to their symptoms as they completed the app. Technical problems and individual challenges in using the C-SCAT-M are described in Table 3. In brief, women identified several technical problems that interfered with their use of the app. In a few instances, participants with many symptoms were unable to see the entire group of symptoms on the screen, which prevented them from advancing to the next screen. Some women found the screen too sensitive and experienced advancing to the next screen before they had completed the prior screen. In some instances participants skipped parts of the instructions, for example adding causal arrows, because consecutive screens appeared too similar for them to differentiate the required tasks. Some women had individual challenges while completing the app. Drawing a box around their symptoms to delineate a cluster was challenging for some women, especially for those with multiple symptoms (20). For women who identified multiple symptoms and multiple complex relationships between their symptoms, discerning the lines drawn between symptoms to show relationships or to draw the boxes around the clusters was challenging (Figure 3 provides an example of a screen from a woman with multiple symptoms and clusters). Notes from women’s ‘‘think aloud’’ comments indicated that typing and thinking aloud can be a challenge. Some women preferred to enter their responses first and then talk about their symptoms. Having technical problems and thinking aloud likely resulted in women requiring a longer time to complete the app. When women were thinking aloud, they expressed much greater details about their heuristics, for example women described the causes of their symptoms and their approaches to managing them in greater detail than when they typed their answers on the iPad app. When women encountered technical difficulties using the app, they described the symptoms and technical issues in greater detail while thinking aloud than typing on the app, which also likely contributed to the length of time required to complete the app. The most important individual issues with the use of the iPad app with midlife women included difficulty or inability to read the screen without reading glasses, difficulty using the screen for women with long fingernails and having fingers that were too large to isolate responses to the questions in the app that were in small fonts or spaced too close together. One woman mentioned concern about hygienic problems related to using the screen that had been used by many others even though it had been cleaned. Being stressed by completing the app resulted in some women experiencing hot flashes and then becoming irritable due to the technical problems. Most participants indicated support for completing a computer-based tool (57%) versus a paper version and 20% expressed no preference. Some women



Table 3. Technical problems and individual issues identified from think aloud comments from participants using the C-SCAT-M (N ¼ 30). Issues

Description of issues

Technical problems

Could not advance to the next screen due to an unseen group of symptoms; participant began again from the beginning of the program The symptom color box changes when participants looked back at their symptoms on a prior screen When the iPad screen rotation is unlocked, the diagram shrinks after the iPad is put in a different position There were no symptoms on the first screen The screen frizzed and did not respond even though it was tapped several times The screen is too sensitive and the answer recorded before the participant chose the answer Having the same color for all screens made participants keep tapping the continue button and missed some questions Unable to connect to amazon S3 because of internet connection problem The continue button was missing Small space between answer options (Participants who had large fingers had difficulty to tap their answer on the iPad screen)

Individual issues

Participants with many symptoms had difficulties to see the connecting lines or draw the box around clusters Difficulty to tap the iPad screen because of long nails Difficult/not able to read the text because participants did not bring their glasses Concern on germs because the iPad was used by many people Questionnaire included sensitive questions Participants forgot their symptoms or the name of their symptom groups when answering the questions Participants had difficulties drawing the line between symptoms Participants had difficulty drawing the box of their symptoms cluster Participants had a hot flash while completing the app or had problem with the app

Frequency 4

2

3

2 1 4

2

4 1 1

3 5

3 4 1 1 5

2 5 3

stated that they had no difficulty completing the app but believed that it would be hard for older women to learn and use a new technology. Although many participants indicated familiarity and ease of using touchscreens, some were challenged by technical aspects of using the touchscreens related to their

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Figure 3. An example of a screen from a woman with multiple symptoms and clusters.


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ability to see the screen when the fonts were small, the high sensitivity of the screens and the amount of room between options on questions with multiple choice answers. Participants made multiple thoughtful substantive suggestions for improvement in content and format of the C-SCAT-M (Table 4). These included suggestions for improving: clarity of individual questions (providing examples and directions on the side), ease of following instructions (providing direction and a reminder for the instructions), ease of typing (using stylus or voice recognition system), ease of drawing (providing more room/screen and an easier design to draw the group) and appropriateness of length of time to complete (being able to see all symptoms and giving an overview such as power point slides). Utility Most women (76%) reported that the final image was a very accurate or extremely accurate representation of their symptom experience. Women reported that the images showed their symptoms and connection to each other accurately (see Table 5). Women commented that ‘‘It covered everything,’’ ‘‘It graphically demonstrated the connection between symptoms’’ and ‘‘arrows and groupings were a good representation of my symptoms’’, and ‘‘I am the person who put it together so it should be accurate.’’ Twenty-four percent of the total sample of 30 indicted that the final images were slightly or moderately accurate. Their rationale for these ratings was because the symptoms that they had experienced in the last 24 h did not represent all the symptoms that they usually had and because some women had symptoms that were not included in the app such as phenomenon of mental fog thinning hair, fragile skin, bruising and eye dryness. Some women commented that the app was ‘‘accurate for past 24 hours, but that’s not typical for me’’ and ‘‘I have other symptoms.’’

DISCUSSION In an effort to evaluate the feasibility, including usability and utility, of the C-SCAT-M, we recruited 30 midlife women between ages of 40 and 60 who were experiencing multiple symptoms they associated with menopause from a university campus and primary care and women’s health clinics. Women were able to identify symptoms and clusters they had experienced within the previous 24 h using the C-SCAT-M and found the final diagram they had created an accurate representation of their symptoms and the relationships among them. Moreover, they were able to illustrate causal relationships and the temporal order of their symptoms. Midlife women in this study were born between 1953 and 1973, an era that preceded widespread use of personal computers and touch screen technology while they were attending school. Nonetheless, the majority of women participating in this feasibility study used computers in their work or for personal reasons, and the majority had used an iPad device prior to the study. While not digital natives, these women were not inexperienced with some aspects of the technology they used in this study. Despite their experience, however, some did experience difficulty with the technology that was a

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R. Ismail et al. Table 4. Suggestions for improvement in content and format of the C-SCAT-M. Items

Example comments

Suggestions for improved clarity of questions


Suggestions for improved ease of following instructions

Suggestions for improved ease of typing

Suggestions for improved ease of drawing

‘‘Make y [Yes] n [No] button where applicable. Make it where you can see all symptoms’’ ‘‘To see the diagram/pictures while answering the questions’’ ‘‘Could have provided examples’’ ‘‘List all symptoms at the top of each question group’’ ‘‘Having directions on the side, esp without numbering, is so unusual that people may not look there, or read them, or even understand that those are stand alone questions’’ ‘‘Each question should remind you that it is for the last 24 hrs [hours]’’ ‘‘Maybe a little more specific or elaborate’’ ‘‘Instead of using the term ‘losing your urine’ to say urgency before urinating or urgency before eliminating your bladder’’ ‘‘A more standard form format, e.g. like this questionnaire will ensure better compliance and easier usability’’ ‘‘Be more specific’’ ‘‘Number instruction, give directions about what to do’’ ‘‘List all symptoms at the top each question group’’ ‘‘Larger font, numbered questions, more standard layout of questions and subsequent directions. Would try to mimic common web-based survey layouts’’ ‘‘Maybe a reminder to look to the left for the instructions’’ ‘‘Tell subjects to speak all questions and answers’’ ‘‘It would be difficult for someone not used to using iPad, drawing lines, categorizing symptoms if not familiar with technology or organizing symptoms’’ ‘‘Using my finger was easier and worked better than using the stylus’’ ‘‘Using the stylus for touch screen and keyboard itself has been easy’’ ‘‘. . .I would use a voice recognition system instead of typing text, for subjects. Then they can just speak their answers’’ ‘‘Need to be able to go back and review what you wrote. Editing or spell checking would have been a nice option’’ ‘‘Concerned of difficulty for older individuals who are not in workforce and familiar with technology’’ ‘‘Answers to question should not be filling in automatically they are too sensitive’’ ‘‘It is easier to do using a keyboard’’ ‘‘This was easy it just took a try or two for the arrow directions, I just figured out the iPad has larger font capability through touch’’ ‘‘I had lots of symptoms, I needed much, much more room’’ ‘‘Need a technique to do it, The technician who design the app should make it easier. we have difficultly to move box as the symptoms move as well’’ ‘‘Boxes and arrows didn’t respond very easily, have to tap several times to get what you want’’ ‘‘Maybe having a bigger screen but I really don’t like the use of iPad’’ ‘‘Probably only hard for me because I’ve not done this before. Maybe a practice diagram first’’ (Continued )

Feasibility of iPad app Table 4. Continued Items

Example comments

Suggestions for improved appropriateness of length of time to complete


Reasons for the amount of boredom while completing

Suggestions to improve amount of boredom while completing

Feelings when thinking about symptoms while completing

‘‘See all symptoms’’ ‘‘Speak don’t type, and give text or voice answers for associations, not draw them’’ ‘‘More room. If I could have seen all the arrows, etc, I could have done this in much less time’’ ‘‘Give an overview i.e. at time of sign-up similar to a 3 slide powerpoint’’ Not bored at all ‘‘This is an interesting and meaningful to me because it directly affects my life’’ ‘‘Interesting since I don’t normally think about it’’ ‘‘It was fun, made me think’’ ‘‘Important to study women’s symptoms which are not boring’’ ‘‘Because I have had issues with urgency and urinating and I do not mind talking about natural methods for those symptoms’’ ‘‘The application and the instructor were both very intelligent’’ ‘‘. . .No one asks me any questions about this menopausal change, and it’s really important. . .It’s ethically absurd that still so little is known about menopause. I want my body back’’ ‘‘It kept me on my toes’’ ‘‘I think it was helpful to see, graphically how the symptoms are related’’ ‘‘Questions applied to me and fun working with the iPad’’ ‘‘Made me feel, like ‘‘wow’’ I’m not alone in what I’m experiencing’’ ‘‘When you have to express your feeling you realize what happen on you’’ Slightly/moderately bored ‘‘I don’t enjoy using an iPad’’ ‘‘Repetition’’ ‘‘Not something I think too much about’’ ‘‘Because it had to be retyped numerous times’’ ‘‘I would suggest to open the questioning to within the last 2 weeks’’ ‘‘Use animation-more fun’’ ‘‘Perhaps some warm colors, like blue, purple, green as background, but nothing distracting’’ ‘‘People would be interested to do the voice recognition side of it, esp if they could see the text appear as they spoke. Like magic!’’ ‘‘Maybe incorporating some kind of video’’ ‘‘Maybe some graphics or pictures on the screens’’ ‘‘I guess I was surprised to see that there might be so many other types of symptoms correlated to menopause’’ ‘‘Interesting to see correlations in that manner’’ ‘‘I felt fine’’ ‘‘A little sad and aware’’ ‘‘Good-reflective and made me more aware of all the symptoms. I didn’t think I had as many as I did’’ ‘‘Annoyed’’ (Continued )

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R. Ismail et al. Table 4. Continued Items

Example comments


Questions should have asked

What else would like to tell about symptom experience

Reasons for preferring iPad

‘‘I am aware of my symptoms and think of ways to relieve stress in a healthy constructive manner’’ ‘‘It made me wish I did not have them’’ ‘‘Empowering’’ ‘‘A little intimate, but not bad. My symptoms were pretty benign though. I can imagine people with vaginal dryness would not want to give this information out loud with someone in the room’’ ‘‘Not good, looking from the outside in’’ ‘‘Interesting’’ ‘‘Brings it into focus, enlightening and a little depressing’’ ‘‘It did not bother me. I live with them daily’’ ‘‘Added symptoms about increase in sexual desire’’ ‘‘I think there could have been more questions about sleep patterns and not being able to sleep at night’’ ‘‘You didn’t ask me about mental fog’’ ‘‘Ranking severity, for example, how often are you awakened at night by your symptoms. This could help put the problem in perspective’’ ‘‘Age and onset of symptoms in comparison to menstrual cycle. Include physical symptoms such as thinning hair, fragile skin, bruising, eye dryness. Midsection weight gain’’ ‘‘How long you’ve had these symptoms and a rating scale of impact to quality of life/function’’ ‘‘The time before 24 hours. 24 hours is too short. ask at least for the last 5 months’’ ‘‘I want them to go away!’’ ‘‘I feel I have articulated my experiences and verbally shared as well in this process’’ ‘‘It’s not fair!’’ ‘‘Mental fog is an acute problem.’’ ‘‘Everyone has a story, some are deeper than others. Mine happens to be very deep’’ ‘‘Just how debilitating the symptoms are. How much this change is affecting activities of daily living’’ ‘‘How about a longer timeframe for sxs [symptoms]’’ ‘‘Just that it’s nice to know I’m not alone in what I’m going through’’ ‘‘I wish they would end’’ ‘‘Because it is quicker and easier’’ ‘‘Drawing on the iPad is more engaging than drawing on paper’’ ‘‘Fast and easy and fun to play on an iPad’’ ‘‘If you asked me before test I would have answered paper, the touch screen is easy to use with diagram creation’’ ‘‘Ease of use and efficiency. also, women of my generation are more aware of the need to save natural resources (i.e. less paper)’’ ‘‘Easier to edit’’ ‘‘Flexible’’ ‘‘Just saving paper and pens and making the study much (Continued )

Feasibility of iPad app Table 4. Continued Items

Example comments

Reasons for preferring paper


Reasons for preference for completing on either paper or iPad

more manageable’’ ‘‘More fun’’ ‘‘Easier to do’’ ‘‘People my age are not very tech savvy’’ ‘‘The IT demands will distract many older females from thinking, organizing symptoms’’ ‘‘I find the iPad irritating and I’m sure others my age will also think so’’ ‘‘Probably faster!’’ ‘‘I think at this exact moment in time, everyone has a smart phone or has experienced touch screens. So it’s okay to be techno here’’ ‘‘Answer to question 21 is actually ‘neither, use a laptop for easier keyboarding and lower frustration levels’. I also encourage the voice recogn application I mentioned earlier. If committed to an iPad, okay still. Paper would be 3rd choice’’

function of their eyesight (age-related presbyopia), the font size of the items they were requested to manipulate, and the dexterity required to arrange objects on the touch screen. These experiences could limit midlife women’s effective use of touch screen technology when items are presented on a small screen. Indeed, some women advised that using a laptop or a computer with a larger touch screen and a mouse would be more effective. These results contrast with those obtained in a similar study of AYA, suggesting that developmental stages and age as well as prior experience with similar technology are important considerations in developing research and clinical apps (21). An important finding was that women were able to impose a framework on their symptoms, enabling them to group symptoms into clusters and identify relationships among symptoms including hypothesized causal paths. These findings are significant and support a paradigm shift from relying on statistical approaches to cluster symptoms to an inductive approach to the clustering of symptoms whereby women, themselves, can define the clusters they experience (16,17,30–32). This discovery could empower women to define their own symptoms and clusters more clearly, providing a foundation for working collaboratively with healthcare providers to manage their symptoms. As was the case with the AYA who tested the C-SCAT for cancer-related symptoms, women in this study indicated that using the C-SCAT-M helped them to achieve new perspectives on their symptoms. As some commented, grouping their symptoms in clusters and hypothesizing what exacerbated and ameliorated their symptoms enabled them to see their own personal models in a way they had not prior to the study. As we pointed out in the study of AYA, completing the C-SCAT could provide insights about symptom experiences that could inform their self-management efforts. Most women could identify what approaches they had used to manage their symptoms and which were or were not successful.

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Table 5. Reasons for the accuracy of final pictures. Items

Reasons

Very – extremely accurate

‘‘If all those other symptoms are common and I don’t experience them, maybe I have it pretty good!’’ ‘‘Pretty comprehensive though they avoid sexuality which is an important part of the experience’’ ‘‘It showed my sx [symptoms] and their connection to each other’’ ‘‘I was able to group symptoms with like symptoms and separate symptoms that most likely are no connected’’ ‘‘It was a very detailed application and did not, in my opinion, leave anything out’’ ‘‘Because I answered the questions as completely as I could’’ ‘‘It graphically demonstrated the connection between symptoms’’ ‘‘It covered everything’’ ‘‘Arrows and groupings were a good representation of my symptoms’’ ‘‘Timing is somewhat hard to differentiate’’ ‘‘I have other symptoms’’ ‘‘It showed me how certain symptoms that I didn’t think are related actually are related’’ ‘‘Accurate for past 24 hours, but that’s not typical for me’’

Slightly – moderate accurate

Midlife women indicated they were able to see the totality of their symptom experiences and most could identify priority clusters and priority symptoms. Indeed, some commented that having a printed picture of their symptom cluster diagram would help them explain what they were experiencing to their healthcare providers. Generating a report that includes the symptom cluster diagram could enhance women’s ability to communicate clearly to healthcare providers about the symptom clusters (or symptom) of greatest priority while also communicating to healthcare providers the totality of their symptom experiences. As with AYA with cancer, use of the graphical image generated by the C-SCAT-M could facilitate communication about symptom management with healthcare providers. Use of such a report could provide a busy clinician with a rich data source that might enhance their ability to focus an encounter on a cluster of symptoms of greatest concern to the patient (21). Completing an app such as the C-SCAT-M prior to a clinic appointment could enhance women’s ability to summarize their symptoms, their attempts at management and results. Some women commented that they did not know how to talk about all of these symptoms in front of a healthcare professional when they had so many problems and some requested a copy of their symptom cluster diagram to share with their healthcare providers. Such an app could enhance the clarity of communication with healthcare providers and a drawing of their symptoms



and clusters might provide a graphic map of where to begin the conversation, such as with a priority cluster of symptoms. Moreover, an explicit communication about women’s heuristics regarding their symptoms could provide cues to healthcare providers about women’s needs for health education. A limitation of the study included having studies a convenience sample of relatively welleducated women. The number of participants was relatively small (n ¼ 30); therefore, there was limited power to support the extensive statistical testing for group differences and inference to other population. Nonetheless, the number of women was adequate for a preliminary study on which to base decisions to further develop the app (33). Many of these participants also had experience using an iPad, limiting ability to generalizing results to all midlife women who may or may not have comparable experience with and confidence using technology. In conclusion, use of the C-SCAT-M with midlife women provided promising evidence that it is feasible to use this technology for research data collection. The C-SCAT-M was both usable for midlife women and useful to both the investigators as well as the women who completed it. Revisions to the current app format and content that will permit better tailoring to the age/life stage of the intended end users were identified and will be incorporated in the next iteration of the app. Potential clinical uses of the app should be explored in future studies.

DECLARATION OF INTEREST This study was funded by University of Washington School of Nursing, Research Intramural Funding Program and R21 (NINR 1R21NR012218-01 Menopause Symptoms Clusters: Refocusing Therapeutics).

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