Methods |
Study design: crossover trial
Country: Spain
Incentives provided: free psychological sessions for the treatment of fibromyalgia syndrome
Type of device & platform: F‐EMA, an app running on a HTC Diamond 1 smartphone (Windows Mobile OS)
Functionality: configurable number of questions displayed on each day; and time stamping of data entries
Human Computer Interaction: audio signals indicating that participants should fill out the rating scales (alerts); configurable alert schedule; reminders every minute during the first 15 minutes after the initial alert and then every 15 minutes during the next hour; audio‐recorded instructions
Data collection protocol: 3 times a day for 7 days
Additional interventional factors: none reported
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Data |
Name of survey questionnaire: EMA measures assessing pain intensity, fatigue intensity, and mood
Validation status: unclear
Application of the survey questionnaire: functional status assessment, pain assessment, and mental health assessment
Population: 47 patients diagnosed with fibromyalgia syndrome
Age group: adults, mean age 48.1 years (SD 7.95), range 37 to 65 years
Gender composition of the sample: all female participants
Setting of data collection: naturalistic setting
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Comparisons |
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Outcomes |
Equivalence: mean score differences
Adherence to data collection protocol: mean number of both complete and incomplete records
Acceptability: acceptability and preference
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Notes |
A technological profile questionnaire was developed for this study. Participants were asked to attend the clinic at the end of each sampling period and complete a weekly rating of pain and fatigue |
Risk of bias |
Item |
Authors' judgement |
Description |
Random Sequence Generation? |
Yes |
Irrelevant to crossover designs. |
Allocation Concealment? |
Yes |
Irrelevant to crossover designs. |
Blinding of Participants and Personnel? |
Yes |
Irrelevant to crossover designs. |
Blinding of Outcome Assessment? |
Yes |
Irrelevant to crossover designs. |
Incomplete Outcome Assessment? |
Yes |
Irrelevant to crossover designs. |
Selective Reporting? |
Yes |
Irrelevant to crossover designs. |
Other Bias? |
Yes |
Irrelevant to crossover designs. |
Suitability of crossover design? |
Yes |
Coons 2009 recommends the use of crossover design when assessing data equivalence between alternative delivery modes using the same survey questionnaire. Fewer participants are needed, and variability between participants is minimised as each participant acts as her/his own control. |
Carry‐over effect? |
No |
The presence of carry‐over effect was not formally assessed; the washout period was insufficient (participants attended the clinic after the first sampling period for an assessment, and to switch over to the alternative delivery mode). |
First period data available? |
Yes |
Data from both sampling periods were included in the statistical analyses. |
Correct Analysis? |
No |
Data on mood assessments were not reported; data from 7 participants were excluded as they failed to show up to the assessment session at the end of the first week of sampling. |
Comparability of results with those from parallel trials? |
Unclear |
Randomisation procedure was not specified; presence of carry‐over effect was not explored; and unclear whether the washout period was appropriate. |