Telemonitoring in Chronic Pain Management Using Smartphone Apps: A Randomized Controlled Trial Comparing Usual Assessment against App-Based Monitoring with and without Clinical Alarms
Open accessAbstract
Background. The usefulness of mHealth in helping to target face-to-face interventions for chronic pain more effectively remains unclear. In the present study, we aim to test whether the Pain Monitor mobile phone application (app) is well accepted by clinicians, and can help improve existent medical treatments for patients with chronic musculoskeletal pain. Regarding this last goal, we compared three treatment conditions, namely usual treatment, usual treatment with an app without alarms and usual treatment with an app with alarms. All treatments lasted one month. The three treatments were compared for all outcomes, i.e., pain severity and interference, fatigue, depressed mood, anxiety and anger. Methods. In this randomized controlled trial, the usual monitoring method (i.e., onsite; n = 44) was compared with daily ecological momentary assessment using the Pain Monitor app—both with (n = 43) and without alarms (n = 45). Alarms were sent to the clinicians in the presence of pre-established undesired clinical events and could be used to make treatment adjustments throughout the one-month study. Results. With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups). The clinicians were willing to use the app, especially the version with alarms. Conclusions. The use of apps may have some benefits in individual health care, especially when using alarms to tailor treatments.
AI snapshot
Written from the paper’s full text.
TL;DR
This superiority RCT compared usual episodic monitoring, app-based daily monitoring without alarms, and app-based monitoring with clinical alarms added to usual treatment for chronic musculoskeletal pain over one month. It found no significant between-group differences at the group level, but more patients in the app + alarm condition achieved clinically significant improvements on most outcomes, and clinicians accepted the app, especially with alarms.
Key findings
- Final analyzed samples were 44 (TAU), 45 (TAU + app), and 43 (TAU + app + alarm); average daily app response was 77.0%.
- Group-level analyses showed no significant between-group differences (all Kruskal–Wallis p > 0.01); only the TAU + app + alarm condition showed a significant reduction in pain interference (Z = −3.32, p < 0.001).
- Clinically significant change (≥30% improvement) was consistently higher in the app + alarm condition except for anger: pain severity 33.3% vs 15.4% (TAU) and 16.7% (TAU + app); sadness/depressed mood 43.6% vs less than 29% in the other groups; anxiety 30.8% vs less than 22%.
- Clinicians (n = 6) generally perceived the app as useful and preferred the alarm version; helping patients download/use the app took a median of 15 min, and responding to all daily alarms took a median of 27.5 min. There were 51 alarms, and 93% were considered relevant enough to call the patient.
Methods
- Superiority RCT in adults with chronic musculoskeletal pain at a tertiary care pain unit in Barcelona (2017–2018), randomized to TAU, TAU + app, or TAU + app + alarms; all received usual medical treatment for one month.
- The Pain Monitor Android app prompted twice-daily ecological momentary assessment for 30 days; alarms were sent to clinicians for pre-established undesired clinical events. Primary outcomes included pain severity and medication side effects; secondary outcomes included fatigue, pain interference, depression, anxiety, and anger, mostly measured with 11-point numerical rating scales.
- Analyses included MANOVA for baseline comparability, Kruskal–Wallis and Friedman tests with alpha set to 0.01, an individual-level ≥30% clinically significant change analysis, ANOVA for side-effect frequency, and a clinician survey.
Limitations
- The paper states sample loss and reduced power, with anticipated 10% dropout proving insufficient and at least 25% expected; it also notes reliance on subjective outcomes only, focus on musculoskeletal pain only, use of an uncorrected alpha of 0.05 (correcting to 0.01 would increase required sample from 150 to 222), no evaluation of patient technological ability, possible influence of the 30% cutoff, midpoint response issues, and no cost analysis.
- Evident from the text: patients and treating physicians were not blinded, TAU follow-up was conducted by phone, the app was only available for Android, and daily symptoms were not assessed in the TAU condition.
- Evident from the text: technical/phone-related problems caused nearly 20% sample loss, and the study did not include objective measures such as wearable devices.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
0 of 69 cited sources checked · 0 supported · 0 flagged
- Findingown data
93% of alarms were considered sufficiently relevant to call the patient and further investigate whether an action was required.
“In total, 93% of alarms were considered sufficiently relevant to call the patient and further investigate whether an action (e.g., a change in the medication) was required.”
Quote in the paperNot a substantial claim - Findingown data
The statistical analyses did not indicate significant differences in the proportion of clinically improved patients across conditions.
“Again, the statistical analyses did not indicate significant differences in the proportion of clinically improved patients across conditions.”
Quote in the paperSubstantial claim - Findingown data
The burden of using the app was generally perceived as low or average.
“As reported in Table 3, the burden was generally perceived as low or average.”
Quote in the paperNot a substantial claim - Findingown data
In the TAU + app + alarm condition, a reduction in pain interference was revealed (Z = −3.32, p < 0.001).
“Only in the TAU + app + alarm condition a change (e.g., reduction) in pain interference was revealed (Z = −3.32, p < 0.001).”
Quote in the paperSubstantial claim - Findingown data
The physicians were keener on using the app version with alarms than the version without alarms.
“Importantly, they were keener on using the app version with alarms than the version without alarms.”
- Also stated in: § Abstract · plain
“The clinicians were willing to use the app, especially the version with alarms.”
Quote in the paperNot a substantial claim - Also stated in: § Abstract · plain
- Findingown data
None of the change scores differed across conditions (all p > 0.01).
“The Kruskal–Wallis test revealed that none of the change scores differed across conditions (all p > 0.01).”
Quote in the paperSubstantial claim - Findingown data
The average daily number of unwanted symptoms was slightly but not significantly higher in the group without alarms (mean = 1.47, SD = 0.64) compared to the group with alarms (mean = 1.33, SD = 0.38).
“The ANOVA results indicated that the average daily number of unwanted symptoms was slightly, but not significantly higher (F = 1.49, p = 0.226) in the group without alarms (mean = 1.47, SD = 0.64) compared to the group with alarms (mean = 1.33, 0.38).”
Quote in the paperNot a substantial claim - Findingown data
In the TAU and TAU + app conditions, no treatment main effect was observed for any outcome.
“As indicated in Table 1, the Friedman test indicated that a treatment main effect was not observed for any outcome in the TAU and the TAU + app conditions.”
Quote in the paperSubstantial claim - Findingcitation
The system was well accepted by the pain physicians involved.
“One of the findings regarding the implementation of mHealth in chronic pain management was that this system was well accepted by the pain physicians involved”
Quote in the paperSubstantial claim - Findingreasoning
An algorithm can be used to effectively send an alarm to professionals so that action can be taken.
“the contribution of the present study is that an algorithm can be used to effectively send an alarm to professionals, so that action can be taken.”
Quote in the paperSubstantial claim - Findingown data
Clinicians found the alarms beneficial, as indicated by reports showing overall low burden and high perceived usefulness of alarms.
“clinicians found it beneficial—as indicated by reports showing overall low burden and high perceived usefulness of alarms.”
Quote in the paperSubstantial claim - Findingnone given
On average, it took around 30 minutes for each alarm, considering the time to check the electronic medical record, call the patient and make adjustments to the treatment if necessary.
“on average, it took around 30 min for each alarm, considering the time to check the electronic medical record, call the patient and make adjustments to the treatment if necessary”
Quote in the paperNot a substantial claim - Findingown data
The proportion of patients reporting a clinically meaningful reduction of over 30% in almost all outcomes, namely pain severity, pain interference, fatigue, depression and anxiety, was higher in patients monitored using the app with alarms.
“the proportion of patients reporting a clinically meaningful reduction (i.e., over 30%) in almost all outcomes, namely pain severity, pain interference, fatigue, depression and anxiety, was higher in patients who were monitored using the app with alarms.”
- Also stated in: § 4. Discussion · plain
“the percentage of patients reporting a clinically meaningful improvement in almost all outcomes, i.e., pain severity, pain interference, fatigue, sadness and anxiety was always higher in the app + alarm condition.”
Quote in the paperSubstantial claim - Also stated in: § 4. Discussion · plain
- Findingown data
There was only a reduction in pain interference in the group of patients using the app with clinical alarms for telemonitoring.
“there was only a reduction in pain interference in the group of patients using the app with clinical alarms for telemonitoring.”
- Also stated in: § 4. Discussion · plain
“even when pain interference only significantly improved in the app + alarm condition.”
Quote in the paperSubstantial claim - Also stated in: § 4. Discussion · plain
- Findingreasoning
Algorithms can be effectively created so that the determination of when an event becomes alarming no longer depends solely on the interpretation of the patient.
“an important finding was that algorithms can be effectively created so that the determination of when an event becomes alarming (e.g., experiencing nausea or dizziness for a given number of days) no longer depends solely on the interpretation of the patient.”
Quote in the paperSubstantial claim - Findingown data
Visual inspection of mean-level differences across conditions suggested somewhat larger improvements in the app plus alarm condition in pain interference, sadness and anxiety.
“even though a visual inspection of mean-level differences across conditions suggested somewhat larger improvements in the app + alarm condition in pain interference, sadness and anxiety, these results should not be overemphasized.”
Quote in the paperNot a substantial claim - Findingnone given
The Pain Monitor app allowed collection of a large number of data associated with pain and treatment in an automated way.
“the Pain Monitor app allowed us to collect a large number of data associated with pain and treatment in an automated way.”
Quote in the paperSubstantial claim - Findingown data
Patient follow-up using phone calls was difficult.
“the study revealed that patient follow-up using phone calls was difficult”
Quote in the paperSubstantial claim - Findingown data
The RCT provided data on the impact that telemonitoring is likely to have on physical and mental health outcomes in patients with musculoskeletal chronic pain.
“this RCT may serve guide future research in a more effective matter as it provided data on the impact that telemonitoring is likely to have on physical and mental health outcomes in patients with musculoskeletal chronic pain.”
Quote in the paperSubstantial claim - Premisecitation
Existing reviews provide only modest support for the most popular chronic pain treatments, including medical interventions, physical therapy, psychological treatment, or a combination of these.
“However, existing reviews only provide modest support for the most popular chronic pain treatments, including medical interventions, physical therapy, psychological treatment—or a combination of these [13,14,15].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [13] Geneen, 2017, Physical activity and exercise for chronic pain in adults: An overview of Cochrane Reviews, Cochrane Database Syst. Rev.
Not checked in the free run.
- cites [14] Gatchel, 2014, Interdisciplinary chronic pain management: Past, present, and future, Am. Psychol. source
Not checked in the free run.
- cites [15] Hughes, 2017, Acceptance and commitment therapy (ACT) for chronic pain: A systematic review and meta-analyses, Clin. J. Pain source
Not checked in the free run.
- Interpretationreasoning
A single measure may not be representative of the entire experience of chronic pain.
“The aforementioned variability of symptoms in patients with chronic pain means that a single measure may not be representative of the entire experience.”
Quote in the paperSubstantial claim - Premisecitation
Pain-related variables such as pain intensity, mood, and fatigue can vary across and within days in patients with chronic pain.
“This is problematic because pain-related variables, such as pain intensity, mood, and fatigue can vary across and within days [22,23], even in patients with chronic pain such as osteoarthritis [24], rheumatic diseases [25], multiple sclerosis [23] and fibromyalgia [26].”
Quote in the paperSubstantial claim0 of 4 sources checked- cites [22] Kikuchi, 2006, Reliability of recalled self-report on headache intensity: Investigation using ecological momentary assessment technique, Cephalalgia source
Not checked in the free run.
- cites [23] Kratz, 2017, Ecological Momentary Assessment of Pain, Fatigue, Depressive, and Cognitive Symptoms Reveals Significant Daily Variability in Multiple Sclerosis, Arch. Phys. Med. Rehabil. source
Not checked in the free run.
- cites [24] Allen, 2009, Daily pain variations among patients with hand, hip, and knee osteoarthritis, Osteoarthr. Cartil. source
Not checked in the free run.
- cites [26] Bartley, 2018, Pain and fatigue variability patterns distinguish subgroups of Fibromyalgia patients, J. Pain source
Not checked in the free run.
- Premisecitation
Neither episodic on-site assessment nor paper diaries permit timely communication and response to undesired events experienced by the patient during treatment.
“Additionally, neither episodic on-site assessment nor paper diaries permit timely communication and response to undesired events experienced by the patient during the course of treatment [20].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [20] OECD, and EU (2016). Health at a Glance: Europe 2016—State of Health in the EU Cycle, OECD Publishing.
Not checked in the free run.
- Premisecitation
Patients with chronic pain combine appointments with their general practitioner, emergency services, and specialized pain clinics for treatment of their pain and related symptoms.
“For patients with chronic pain, an added problem is that patients combine appointments with their general practitioner, emergency services and specialized pain clinics for the treatment of their pain and related symptoms [33].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [33] Hong, 2013, Costs associated with treatment of chronic low back pain: An analysis of the UK general practice research database, Spine (Phila. Pa. 1976) source
Not checked in the free run.
- Premisecitation
The current approach to care requires patients to judge when an undesired event is problematic and what action to take in the face of that event.
“Specifically, the current approach to care requires patients to judge when an undesired event is problematic and what is the preferred action to take in the face of that event [30,31,32].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [30] Deyo, 2009, Overtreating chronic back pain: Time to back off?, J. Am. Board Fam. Med. source
Not checked in the free run.
- cites [31] Dargan, 2014, New approaches towards chronic pain: Patient experiences of a solution-focused pain management programme, Br. J. Pain source
Not checked in the free run.
- cites [32] Fashler, 2016, Systematic review of multidisciplinary chronic pain treatment facilities, Pain Res. Manag. source
Not checked in the free run.
- Interpretationreasoning
The alternation of different specialized and nonspecialized services could lead to unpredictable treatment plans in response to unwanted events.
“This practice is likely to be problematic, as the alternation of different specialized and nonspecialized services could lead to unpredictable treatment plans in response to unwanted events.”
Quote in the paperSubstantial claim - Study design and conductcitation
The assessment protocol used in the app was validated in a previous study.
“The assessment protocol used in the app was validated in a previous study which allowed a reduction of items which can be more effectively used in ecological momentary assessments [42].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [42] Castilla, 2018, Validity, reliability, feasibility, and usefulness of Pain Monitor. A multidimensional smartphone app for daily monitoring of adults with heterogeneous chronic pain, Clin. J. Pain source
Not checked in the free run.
- Premisecitation
Reviews have evidenced that randomized controlled trials evaluating the usefulness of mHealth tools are lacking in the chronic pain literature.
“In fact, although it has been argued that mobile technology (mHealth)—especially the use of smartphone apps—facilitates this paradigm shift towards telemonitoring in chronic pain care, reviews on this topic have evidenced that randomized controlled trials (RCT) evaluating the usefulness of these tools are lacking in the chronic pain literature [39,41,43,44,45].”
Quote in the paperSubstantial claim0 of 5 sources checked- cites [39] Rosser, 2011, Smartphone applications for pain management, J. Telemed. Telecare source
Not checked in the free run.
- cites [41] Portelli, 2016, A quality review of smartphone applications for the management of pain, Br. J. Pain source
Not checked in the free run.
- cites [43] Alexander, 2016, Smartphone applications for chronic pain management: A critical appraisal, J. Pain Res. source
Not checked in the free run.
- cites [44] Wallace, 2014, A systematic review of smartphone applications for chronic pain available for download in the United States, J. Opioid Manag. source
Not checked in the free run.
- cites [45] Sundararaman, 2017, Integration of Mobile Health Technology in the Treatment of Chronic Pain, Reg. Anesth. Pain Med. source
Not checked in the free run.
- Study design and conductreasoning
Patients and treating physicians were not blinded to allocation.
“Patients and treating physicians were not blinded to allocation.”
Quote in the paperSubstantial claim - Study design and conductown data
Randomization resulted in comparable groups at baseline for pain severity, pain interference, fatigue, sadness, anxiety, anger, and sociodemographic characteristics.
“The results supported the success of randomization. Specifically, baseline pain severity (F = 1.65, p = 0.196), pain interference (F = 1.58, p = 0.211), fatigue (F = 0.42, p = 0.656), sadness (F = 0.22, p = 0.806), anxiety (F = 1.01, p = 0.368) and anger (F = 0.42, p = 0.656) were comparable across conditions.”
- Also stated in: § 3.2. Baseline Differences in Study Variables · plain
“The same occurred with sociodemographic characteristics, namely age (F = 2.33, p = 0.101), gender (χ2 = 1.86, p = 0.395), marital status (χ2 = 7.9, p = 0.660), educational level (χ2 = 4.72, p = 0.318), job status (χ2 = 7.59, p = 0.669) and pain duration (χ2 = 3.16, p = 0.789).”
Quote in the paperSubstantial claim - Also stated in: § 3.2. Baseline Differences in Study Variables · plain
- Premisecitation
Existing eHealth and mHealth solutions in pain settings have focused mostly on self-administered treatments, mostly psychological or physical therapy.
“To date, the focus of existing eHealth and mHealth solutions in pain settings has been mostly placed on self-administered treatments, mostly of psychological or alternatively of physical therapy nature [64,65,66].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [64] Thurnheer, 2018, Benefits of mobile apps in pain management: Systematic review, JMIR mHealth uHealth source
Not checked in the free run.
- cites [65] Martorella, 2017, Tailored web-based interventions for pain: Systematic review and meta-analysis, J. Med. Internet Res. source
Not checked in the free run.
- cites [66] Mehta, 2019, Internet-delivered cognitive behaviour therapy for chronic health conditions: A systematic review and meta-analysis, J. Behav. Med. source
Not checked in the free run.
- Interpretationown data
At the individual level, the results support the idea that use of the app with alarms may result in more patients benefiting from medical treatment.
“At the individual level, our results support the idea that the use of the app with alarms may indeed result in more patients benefiting from medical treatment.”
Quote in the paperSubstantial claim - Premisecitation
First-line treatments for chronic pain, namely medical interventions, have shown to exert a modest effect on daily functioning and especially on mental health status, even when pain is effectively reduced.
“the first-line treatments for the disease, namely medical interventions, have shown to exert a modest effect on daily functioning and, especially, on the mental health status of individuals, even when pain is effectively reduced [72,73,74].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [72] Mahera, 2011, Self-efficacy is more important than fear of movement in mediating the relationship between pain and disability in chronic low back pain, Eur. J. Pain source
Not checked in the free run.
- cites [73] Sullivan, 2008, The role of perceived injustice in the experience of chronic pain and disability: Scale development and validation, J. Occup. Rehabil. source
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- cites [74] McCracken, 2016, A reduction in pain intensity is more strongly associated with improved physical functioning in frustration tolerant individuals, J. Clin. Psychol. Med. Settings
Not checked in the free run.
- Interpretationreasoning
The first-line intervention for chronic pain, medical treatment, will probably continue to require some patient-professional face-to-face interaction.
“the first-line intervention for patients with chronic pain, namely medical treatment, will probably continue to require some patient-professional face-to-face interaction.”
Quote in the paperNot a substantial claim - Premisecitation
Most patients still advocate individual, face-to-face treatments.
“most patients still advocate individual, face-to-face treatments [67]”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [67] Osma, 2020, Content and format preferences of a depression prevention program: A study in perinatal women, An. Psicol. source
Not checked in the free run.
- Study design and conductnone given
One problem in the study was sample loss.
“One problem was sample loss.”
Quote in the paperSubstantial claim - Interpretationown data
Use of the app with alarms as an adjunct to medical treatments for pain may provide some benefits on functioning and mental well-being of individuals when explored at the individual level.
“the use of the app with alarms as adjunct to medical treatments for pain may as well provide some benefits on the functioning and mental well-being of individuals, again when explored at the individual level.”
Quote in the paperSubstantial claim - Study design and conductcitation
The patient's ability to use the technology was not evaluated in the present investigation because excellent usability findings had already been reported in the original validation study.
“the patient’s ability to use the technology was not evaluated in the present investigation because excellent usability findings had already been reported in the original validation study [42].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [42] Castilla, 2018, Validity, reliability, feasibility, and usefulness of Pain Monitor. A multidimensional smartphone app for daily monitoring of adults with heterogeneous chronic pain, Clin. J. Pain source
Not checked in the free run.
- Premisecitation
Technical problems in telemonitoring in chronic pain are something that will probably have to be accepted.
“Recent research into telemonitoring in chronic pain states that these technical problems are something we will probably have to accept [37].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [37] Eccleston, 2020, Managing patients with chronic pain during the COVID-19 outbreak, Pain source
Not checked in the free run.
- Study design and conductnone given
The study relied on subjective outcomes only.
“the reliance on subjective outcomes only (e.g., the inclusion of wearable devices could have provided more objective data on physical functioning)”
Quote in the paperNot a substantial claim - Interpretationown data
Mobile apps can be effectively implemented for patient monitoring.
“the study showed that mobile apps can be effectively implemented for patient monitoring.”
Quote in the paperSubstantial claim - Interpretationown data
Technical and phone-related problems are likely to occur when implementing mHealth.
“technical and phone-related problems are likely to occur when implementing mHealth.”
Quote in the paperNot a substantial claim - Interpretationreasoning
These technical problems would probably have remained undetected otherwise.
“These problems would have probably remained undetected otherwise.”
Quote in the paperNot a substantial claim - Study design and conductown data
The anticipation of a 10% drop-out was clearly insufficient; at least 25% should have been expected based on the study results.
“the anticipation of a 10% drop-out was clearly insufficient. At least 25% should have been expected based on our results.”
Quote in the paperNot a substantial claim
- May combine two claims. 40
- Classified as probably not a substantial claim. 40
- The quote only partly states this claim. 1
May combine two claims.
Findingown dataOverall, the response to the prompted daily questions in the app was good, with patients responding to 77.0% of daily evaluations on average, comparable to past research.
“Overall, the response to the prompted daily questions in app was good (on average, patients responded to 77.0% of daily evaluations) and comparable to past research [42].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [42] Castilla, 2018, Validity, reliability, feasibility, and usefulness of Pain Monitor. A multidimensional smartphone app for daily monitoring of adults with heterogeneous chronic pain, Clin. J. Pain source
Not checked in the free run.
May combine two claims.
Findingown dataThe proportion of patients showing a clinically significant change in outcomes was consistently higher in the TAU + app + alarm condition, with the exception of anger, where the numbers were similar to the TAU condition.
“Note, however, that the proportion of patients showing a CSC in outcomes was consistently higher in the TAU + app + alarm condition, with the only exception of anger, where the numbers were similar in the previous and the TAU condition.”
- Also stated in: § Abstract · plain
“With the exception of anger, clinically significant changes (CSC; 30% improvement) were greater in the app + alarm condition across outcomes (e.g., 43.6% of patients experienced a CSC in depressed mood in the app + alarm condition, which occurred in less than 29% of patients in the other groups).”
Quote in the paperSubstantial claim- Also stated in: § Abstract · plain
May combine two claims.
Findingown dataIn total, 51 alarms were received in the TAU + app + alarm condition; the most frequent were recurrent headache (n = 11), gait instability (n = 10), interference of pain on sleep (n = 5), urine retention (n = 4), very severe pain levels that do not improve with treatment (n = 3), and sleepiness (n = 3).
“In total, 51 alarms were received in the TAU + app + alarm condition. The most frequent were related to recurrent headache (n = 11), gait instability (n = 10), interference of pain on sleep (n = 5), urine retention (n = 4), very severe pain levels that do not improve with treatment (n = 3) and sleepiness (n = 3).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataPatients had musculoskeletal pain, most frequently pain in the low back or in the neck.
“Patients had musculoskeletal pain, most frequently pain in the low back or in the neck.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data33.3% of patients in the TAU + app + alarm condition experienced a clinically significant reduction in pain severity after one month, compared with 15.4% in TAU and 16.7% in TAU + app.
“For example, 33.3% of patients in the TAU + app + alarm condition experienced a CSC reduction in pain severity after one month of treatment, while only half of this proportion improved in the other two conditions (15.4 in TAU and 16.7 in TAU + app).”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataThe pain clinic physicians (n = 6) generally perceived that the app was useful for pain management and for their own comfort as health care providers.
“As indicated in Table 3, the pain clinic physicians (n = 6) generally perceived that the app was useful for pain management (e.g., increased treatment safety and effectiveness) and for their own comfort as health care providers.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataOn average, physicians perceived that helping the patient download the app and guiding them during first use required 13 min (range 7-20 min, median 15 min), and responding to all daily alarms required 28 min in total (range 10-45 min, median 27.5 min).
“On average, the physicians perceived that helping the patient download the app and guiding them during the first use required 13 min (7–20 min range, median = 15 min) and responding to all daily alarms (e.g., looking at the patient’s medical record and calling them) required 28 min in total (10–45-min range; median = 27.5 min).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataThe healthcare professionals believed that the app increased their sense of comfort as healthcare providers.
“They also believed that it increased their sense of comfort as healthcare providers.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataDepression and anxiety levels were meaningfully reduced in 43.6% and 30.8% of patients in the app plus alarm condition, while reductions in the other two conditions occurred in less than 29% and 22%, respectively.
“depression and anxiety levels were meaningfully reduced in 43.6% and 30.8% of patients in the app + alarm condition, while reductions in depression and anxiety in the other two conditions occurred in less than 29% and 22%”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataA clinically significant change in sadness was obtained by 43.6% of patients in the TAU + app + alarm condition and less than 30% of patients in the other two groups.
“Similarly, a CSC in sadness was obtained by 43.6% of patients in the TAU + app + alarm condition and less than 30% of patients in the other two groups.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataThe healthcare professionals involved generally perceived that the app was useful for pain management in the sense that it improved treatment safety and effectiveness.
“the healthcare professionals involved generally perceived that the app was useful for pain management in the sense that it improved treatment safety and effectiveness.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataComparable results were revealed for pain interference, fatigue, and anxiety, always in favor of the TAU + app + alarm condition.
“Comparable results were revealed for pain interference, fatigue and anxiety, always in favor of the TAU + app + alarm condition.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataIn pain severity, 15.4% and 16.7% of patients in the TAU and TAU plus app conditions showed a clinically significant reduction, while 33.3% in the TAU plus app plus alarm condition showed such reductions.
“while 15.4% and 16.7% of patients in the TAU and TAU + app conditions showed a clinically significant reduction in pain severity, twice the number of patients in the TAU + app + alarm condition (33.3%) showed such reductions.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataMonitoring with the app and alarms did not have a significantly greater impact on outcomes compared to usual monitoring or the app without alarms, both at the group and individual level.
“In relation to the first goal and contrary to our expectations, monitoring with the app and alarms did not have a significantly greater impact on outcomes compared to the usual monitoring method or the app without alarms condition, both at the group and individual level.”
- Also stated in: § 4. Discussion · hedged
“the analyses at the group level indicated that the effect of the condition was insufficient to reveal group differences with the recruited sample”
Quote in the paperSubstantial claim- Also stated in: § 4. Discussion · hedged
May combine two claims.
Findingown dataHelping patients download the app and respond to alarms required some extra time, but the healthcare professionals found this burden to be low or moderate.
“they reported that helping patients download the app and respond to alarms required some extra time, but they found this burden to be low or moderate.”
Quote in the paperNot a substantial claimMay combine two claims. The quote only partly states this claim.
Findingown dataThe healthcare professionals were more satisfied with and preferred the version of the app that included alarms.
“they were more satisfied with the version of the app that included alarms.”
- Also stated in: § 4. Discussion · plain
“they preferred the app version that included alarms, even when these generated some burden.”
Quote in the paperNot a substantial claim- Also stated in: § 4. Discussion · plain
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
FindingcitationIn the present study, the prevalence of midpoint responses was 8.3%, which appears to be an acceptable level of uncertainty according to past research.
“In the present study, the prevalence of midpoint responses was 8.3%, which appears to be an acceptable level of uncertainty according to past research [80].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [80] Garland, 1991, The mid-point on a rating scale: Is it desirable, Mark. Bull.
Not checked in the free run.
May combine two claims.
FindingreasoningPatient daily self-monitoring eliminated the need for physician active monitoring, so only when the app algorithm detected an undesired event was the physician notified and only then was a phone call made.
“patient daily self-monitoring eliminated the need for physician active monitoring, so only when the app algorithm detected an undesired event, this was notified to the physician and only then a phone call was made.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataThe missing-response alarm strategy was implemented and helped identify some technical problems, such as patients who changed their phone or were not receiving push notifications.
“This strategy was implemented in the present investigation and it helped us identify some technical problems (e.g., patients that changed their phone or patients that were not receiving the push notifications).”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataIt often took several calls to get in contact with participants, and they were not always available to complete the survey at the time of the call.
“if often took several calls to get in contact with the participants and these were not always available to complete the survey at the time of the call.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenCorrecting the alpha level to 0.01 due to multiple comparisons in the present study would have increased the sample size needed from 150 to 222.
“by correcting the alpha level to 0.01 due to multiple comparisons in the present study, the sample size needed would have increased from 150 to 222.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataCalling patients in the TAU condition for follow-up assessment was very time consuming and largely ineffective.
“calling patients in the TAU condition for follow-up assessment was very time consuming and largely ineffective.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationRetrospective pain assessment leads to recall bias and reduces accuracy.
“Furthermore, retrospective pain assessment leads to recall bias and reduces accuracy [27].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [27] Herrero, 2014, Ecological momentary assessment for chronic pain in fibromyalgia using a smartphone: A randomized crossover study, Eur. J. Pain source
Not checked in the free run.
May combine two claims.
PremisecitationTelemonitoring with episodic phone calls is resource-consuming and ineffective because such phone calls require the active participation of a healthcare professional.
“Additionally, because such phone calls require the active participation of a healthcare professional, which makes this procedure resource-consuming and ineffective [18].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [18] Mesas, 2018, Improving pain treatment with a smartphone app: Study protocol for a randomized controlled trial, Trials source
Not checked in the free run.
May combine two claims.
PremisecitationTelemonitoring with episodic phone calls only partially solves the problems of monitoring because undesired events can occur at different treatment stages, so control calls often occur before or long after unwanted events occur.
“Telemonitoring with episodic phone calls, which is becoming an increasingly common practice, also only partially solves the aforementioned problems. First, because undesired events (e.g., side medication effects or decreased treatment effectiveness) can occur at different treatment stages [34], which means that control calls will often occur before or long after unwanted events occur.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [34] Breivik, 2008, Assessment of pain, Br. J. Anaesth. source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe Pain Monitor app was developed by a multidisciplinary team including physicians, nurses, psychologists, and engineers following guidelines on pain research and eHealth.
“The app, which has been developed by a multidisciplinary team including physicians, nurses, psychologists and engineers following guidelines on pain research and eHealth [38,39,40,41], was found to have valid content”
Quote in the paperNot a substantial claim0 of 4 sources checked- cites [38] Dworkin, 2005, Core outcome measures for chronic pain clinical trials: IMMPACT recommendations, Pain source
Not checked in the free run.
- cites [39] Rosser, 2011, Smartphone applications for pain management, J. Telemed. Telecare source
Not checked in the free run.
- cites [40] Kaiser, 2017, Developing a core outcome-domain set to assessing effectiveness of interdisciplinary multimodal pain therapy, Pain
Not checked in the free run.
- cites [41] Portelli, 2016, A quality review of smartphone applications for the management of pain, Br. J. Pain source
Not checked in the free run.
May combine two claims.
InterpretationreasoningThis approach is problematic because some patients may tolerate serious or urgent problems for too long, while others may seek care for symptoms that are less urgent or not problematic.
“This approach is problematic, as some patients may tolerate serious or even urgent problems (e.g., tachycardia, severe drowsiness, or persistent vomiting, diarrhea or urine retention) for too long, while others may seek care for symptoms that are less urgent or not problematic (e.g., very mild or short-term).”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
PremisecitationSocieties will not be able to sustain the current model of care for chronic pain.
“Taking all the previous into account, it has been argued that our societies will not be able to sustain the current model of care for this condition [20,21,35,36], especially due to the aging of the population and the dramatic increase in the prevalence of this disease in the elderly [9].”
Quote in the paperNot a substantial claim0 of 4 sources checked- cites [20] OECD, and EU (2016). Health at a Glance: Europe 2016—State of Health in the EU Cycle, OECD Publishing.
Not checked in the free run.
- cites [21] Busse, R., Blümel, M., Scheller-Kreinsen, D., and Zentner, A. (2010). Tackling Chronic Disease in Europe: Strategies, Interventions and Challenges, WHO.
Not checked in the free run.
- cites [35] World Health Organization (2002). Innovative Care for Chronic Conditions, WHO.
Not checked in the free run.
- cites [36] Christensen, 2010, Using e-health applications to deliver new mental health services, Med. J. Aust.
Not checked in the free run.
May combine two claims.
PremisecitationPaper diaries are problematic due to participant noncompliance (missing data and back-filling) and errors associated with manual data entry.
“However, research has shown that the use of paper diaries is problematic due to participant noncompliance (missing data and back-filling) and errors associated with manual data entry [28,29].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [28] MacKillop, J., and de Wit, H. (2013). Ecological Momentary Assessment. Wiley-Blackwell Handb. Addict. Psychopharmacology, John Wiley & Sons. source
Not checked in the free run.
- cites [29] Smyth, 2003, Ecological momentary assessment research in behavioral medicine, J. Happiness Stud. source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationThe study protocol, including planned procedures and analyses, was published before starting recruitment.
“The study protocol—including a description of the planned procedures and analyses—was published before starting the recruitment [18].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [18] Mesas, 2018, Improving pain treatment with a smartphone app: Study protocol for a randomized controlled trial, Trials source
Not checked in the free run.
May combine two claims.
Study design and conductcitationSingle items for each construct were validated against well-established measures of pain severity, pain interference, fatigue, and mood, and the correlations were significant and moderate in strength.
“In past research, single items for each of these constructs were validated to be used in the Pain Monitor app [42].”
- Also stated in: § 2.4. Pain Monitor App · plain
“The correlations were found to be significant and moderate in strength.”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [42] Castilla, 2018, Validity, reliability, feasibility, and usefulness of Pain Monitor. A multidimensional smartphone app for daily monitoring of adults with heterogeneous chronic pain, Clin. J. Pain source
Not checked in the free run.
- cites [53] Cleeland, 1994, Pain assessment: Global use of the brief pain inventory, Ann. Acad. Med. Singapore
Not checked in the free run.
- cites [54] McNair, D., Lorr, M., and Droppleman, L. (1971). Profile of Mood States, Educational and Industrial Testing Service.
Not checked in the free run.
- Also stated in: § 2.4. Pain Monitor App · plain
Classified as probably not a substantial claim. May combine two claims.
Study design and conductnone givenRandomization was performed by an independent researcher with an online randomization tool.
“Randomization was performed by an independent researcher with an online randomization tool.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Study design and conductown dataAn analysis of clinically meaningful improvements at the individual level was added due to insufficient power and loss in sample size.
“Again different from that which was planned, we added an analysis of clinically meaningful improvements at the individual level due to insufficient power and loss in sample size (see the results section).”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
PremisereasoningThe utility of the Pain Monitor app in terms of increased treatment effectiveness remains unclear.
“While important milestones have been achieved, the utility of the app in terms of increased treatment effectiveness (e.g., further reduction in pain severity and associated symptoms) remains unclear.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Study design and conductreasoningDue to multiple comparisons, a more restrictive alpha level of 0.01 was set for the analyses.
“Due to multiple comparisons, a more restrictive alpha level of 0.01 was set for the analyses.”
Quote in the paperSubstantial claimMay combine two claims.
Study design and conductreasoningSample size was calculated a priori with G*Power, expecting moderate between-group differences, with 80% power, alpha 0.05, Cohen's d of 0.5, yielding 50 participants needed per condition.
“Sample size was calculated a priori with the statistical software G*Power [49] considering previous studies on complications of pain treatments [30,50].”
- Also stated in: § 2.2. Participants · plain
“Taking 80% power, an alpha level of 0.05 and an expected Cohen’s d of 0.5, we calculated that 50 participants would be needed in each condition.”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [49] Faul, 2007, G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences, Behav. Res. Methods source
Not checked in the free run.
- cites [30] Deyo, 2009, Overtreating chronic back pain: Time to back off?, J. Am. Board Fam. Med. source
Not checked in the free run.
- cites [50] Furlan, 2006, Opioids for chronic noncancer pain: A meta-analysis of effectiveness and side effects, Can. Med. Assoc. J. source
Not checked in the free run.
- Also stated in: § 2.2. Participants · plain
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataThe study was approved by the ethical review board of Vall d'Hebron Hospital and registered on clinicaltrials.gov.
“All procedures were approved by the ethical review board of the Vall d’Hebron Hospital in Barcelona on 25th, June 2017 and registered on clinicaltrials.gov on 25th, July 2017 (NCT03247725).”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationThe Pain Monitor app was found to have valid content comparable to well-established paper-and-pencil measures and high patient acceptability, with response rates greater than 70% for daily responses over one month.
“was found to have valid content (i.e., comparable to well-established paper-and-pencil measures) and high patient acceptability (i.e., response rates greater than 70% for daily responses over a period of one month) [42].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [42] Castilla, 2018, Validity, reliability, feasibility, and usefulness of Pain Monitor. A multidimensional smartphone app for daily monitoring of adults with heterogeneous chronic pain, Clin. J. Pain source
Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductcitationThe comparability of the paper-and-pencil and app assessments was not conducted in this study because the validity of the assessment protocol across measurement modalities was already performed in past research.
“The comparability of the paper-and-pencil and app assessments was not conducted here because the validity of the current assessment protocol across measurement modalities was already performed in past research [42].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [42] Castilla, 2018, Validity, reliability, feasibility, and usefulness of Pain Monitor. A multidimensional smartphone app for daily monitoring of adults with heterogeneous chronic pain, Clin. J. Pain source
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationA reduction of 30% in severity of symptoms is a useful benchmark representing at least moderate clinically significant changes for individuals.
“This analysis is recommended in guidelines for pain trials and a reduction in 30% of severity of symptoms is argued to be a useful benchmark, representing at least moderate clinically significant changes (CSC) for the individuals [61,62].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [61] Scott, 2014, Clinically meaningful scores on pain catastrophizing before and after multidisciplinary rehabilitation: A prospective study of individuals with subacute pain after whiplash injury, Clin. J. Pain source
Not checked in the free run.
- cites [62] Ostelo, 2008, Interpreting change scores for pain and functional status in low back pain, Spine (Phila. Pa. 1976). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationThe list of adverse symptoms included the most frequent side effects of treatments for pain.
“The list of adverse symptoms included the most frequent side effects of treatments for pain [52,57,58].”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [52] Attal, 2010, EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision, Eur. J. Neurol. source
Not checked in the free run.
- cites [57] Trescot, 2008, Effectiveness of opioids in the treatment of chronic non-cancer pain, Pain Physician source
Not checked in the free run.
- cites [58] Varrassi, 2010, Pharmacological treatment of chronic pain—The need for CHANGE, Curr. Med. Res. Opin. source
Not checked in the free run.
May combine two claims.
Study design and conductcitationThe app was only available for Android at the time of the study for economic reasons, and Android was the operating system used by more than 90% of phones in Spain.
“In relation to the limitation to Android operating systems, note that by the time the study was conducted the app was only available for Android for economic reasons, as this is the operating system used by more than 90% of phones in Spain [48].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [48] (2020, September 08). Ericsson Mobility Report. Available online: https://www.ericsson.com/en/mobility-report/reports.
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationInterim analyses were not conducted because no harm was expected from adding the app to treatment as usual.
“As planned, interim analyses were not conducted because no harm was expected from adding the app to TAU [18].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [18] Mesas, 2018, Improving pain treatment with a smartphone app: Study protocol for a randomized controlled trial, Trials source
Not checked in the free run.
May combine two claims.
Study design and conductreasoningThe study was as naturalistic as possible and the sample representative of patients treated at the clinic because there were no exclusion criteria in terms of previous or existing treatment for pain at study onset or treatment changes during the study.
“There were no exclusion criterion in terms of previous or existing treatment for pain at study onset or treatment changes during the study, so that the study was as naturalistic as possible, and the sample representative of patients treated at the clinic.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationOriginally, the planned repeated measures MANOVA was changed to nonparametric statistics because the measures used were ordinal (11-point numerical rating scales).
“Originally, we planned to explore between and within changes in all study outcomes using a repeated measures MANOVA. However, during the review process it was noted that nonparametric statistics should be used due to the ordinal nature of the measures used (11-point numerical rating scales) [60].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [60] Kersten, P., White, P.J., and Tennant, A. (2014). Is the pain visual analogue scale linear and responsive to change? An exploration using rasch analysis. PLoS ONE, 9. source
Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductreasoningThe study duration was set to one month because the clinicians considered this a critical period in which most problems with the treatment occur.
“The duration of the study was set to one month since treatment onset because the clinicians considered that this is a critical period in which most problems with the treatment occur (e.g., poor effect on outcomes or side effects).”
Quote in the paperSubstantial claimMay combine two claims.
Study design and conductown dataData were obtained from 44 patients in the TAU condition, 45 in the TAU + app condition, and 43 in the TAU + app + alarm condition, corresponding to 78.6%, 80.4%, and 81.1% of the initial sample, respectively.
“Finally, data were obtained from 44 patients in the TAU condition, 45 patients in the TAU + app condition and 43 patients in the TAU + app + alarm condition, which corresponds to 78.6%, 80.4% and 81.1% of the initial sample, respectively.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
PremisecitationChange scores have ranged from 30% to 60% across investigations depending on the outcomes and measures used, so the generalizability of findings should be taken with caution.
“However, change scores have ranged from 30% to 60% across investigations depending on the outcomes and the measures used [61], so the generalizability of our findings should be taken with caution.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [61] Scott, 2014, Clinically meaningful scores on pain catastrophizing before and after multidisciplinary rehabilitation: A prospective study of individuals with subacute pain after whiplash injury, Clin. J. Pain source
Not checked in the free run.
May combine two claims.
Interpretationown dataThe use of apps may have some benefits in individual health care, especially when using alarms to tailor treatments.
“The use of apps may have some benefits in individual health care, especially when using alarms to tailor treatments.”
Quote in the paperSubstantial claim- The authors state this as an assumption: Differences in outcomes across monitoring conditions are due to the assigned monitoring condition.
Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
Study design and conductnone givenConclusions about the actual sustainability and cost-effectiveness of this new approach to monitoring at a large scale should be taken with caution.
“conclusions about the actual sustainability and cost-effectiveness of this new approach to monitoring at a large scale should be taken with caution.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisecitationClinician acceptance is critical for implementation purposes.
“which is critical for implementation purposes [69].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [69] Peters, D.H., Tran, N.T., and Adam, T. (2013). Implementation research in health: A practical guide. Alliance for Health Policy and Systems Research, World Health Organization.
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.
PremisecitationeHealth and particularly mHealth will inevitably change health systems in general and pain management in particular.
“For several years, it has been argued that eHealth and particularly mHealth will inevitably change our health systems in general [63] and pain management in particular [45].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [63] Borrelli, 2015, Special issue on ehealth and mhealth: Challenges and future directions for assessment, treatment, and dissemination, Health Psychol. source
Not checked in the free run.
- cites [45] Sundararaman, 2017, Integration of Mobile Health Technology in the Treatment of Chronic Pain, Reg. Anesth. Pain Med. source
Not checked in the free run.
Classified as probably not a substantial claim.
Study design and conductnone givenPatients may experience unusual symptoms for reasons other than the onset of a new pain treatment, such as infection, hormonal changes or a stressful daily event.
“it is also possible for patients to experience unusual symptoms for reasons other than the onset of a new pain treatment (e.g., an infection, hormonal changes or a stressful daily event, to name some examples).”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Study design and conductreasoningThere is no guarantee that the physical symptoms reported by patients are actually due to the recently proposed pain treatment.
“there is no guarantee that these physical symptoms are actually due to the recently proposed pain treatment.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningIt is difficult to know to what extent technical ability impacted study completion and the final sample size.
“it is difficult to know to what extent technical ability impacted on study completion and, ultimately, on the final sample size.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
PremisecitationA technical team will probably be needed to address technical problems if technological solutions are to be implemented in routine care.
“a technical team will probably be needed to address such technical problems if technological solutions are to be implemented in routine care.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [75] Lubans, 2014, Development and implementation of a smartphone application to promote physical activity and reduce screen-time in adolescent boys, Front. Public Health source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationEcological momentary assessment with the app is feasible in terms of patient response rates.
“these alarms could be generated because of the ecological momentary assessment with the app, which current and past research has revealed to be feasible in terms of patient response rates [42].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [42] Castilla, 2018, Validity, reliability, feasibility, and usefulness of Pain Monitor. A multidimensional smartphone app for daily monitoring of adults with heterogeneous chronic pain, Clin. J. Pain source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
InterpretationreasoningMore restrictive benchmarks would possibly have resulted in different percentages of change across conditions and therefore different conclusions.
“It is possible that more restrictive benchmarks would have resulted in different percentages of change across conditions and, therefore, to different conclusions.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Interpretationnone givenThis information has never before been collected with this level of accuracy, using daily assessment as opposed to traditional retrospective assessment.
“This information has never before been collected with this level accuracy (i.e., daily assessment as opposed to the traditional retrospective assessment).”
Quote in the paperNot a substantial claim- Rests on an assumption: This is the first randomized controlled trial exploring the utility of telemonitoring adults with chronic pain between onsite appointments using a smartphone app, and the first study to use an alarm-based telemonitoring system in a randomized controlled trial in chronic pain settings.
May combine two claims.
Study design and conductreasoningThe focus on musculoskeletal pain only prevents generalizing the findings to specific populations or to all chronic pain populations.
“the focus on musculoskeletal pain only, which prevents us from generalizing the findings to specific populations or to all chronic pain populations.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningBecause no analysis of costs was made, it is difficult to know to what extent the implementation of mHealth was cost-effective.
“because no analysis of costs was made, it is difficult to know to what extent the implementation of mHealth was cost-effective.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
InterpretationreasoningInclusion of wearable devices in routine practice may be less ecological than the use of smartphones because smartphones are much more frequently utilized by the population.
“their inclusion in routine practice may be less ecological than the use of smartphones since the latter are much more frequently utilized by the population.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationUse of midpoint responses negatively impacts score reliability.
“the use of midpoint responses negatively impacts score reliability [79].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [79] Weems, 2001, The impact of midpoint responses and reverse coding on survey data, Meas. Eval. Couns. Dev. source
Not checked in the free run.
May combine two claims.
Study design and conductown dataThe study had limitations including loss of sample due to technical or phone-related problems and reduced power in the analyses.
“Some study limitations, including loss of sample due to technical or phone-related problems or the reduced power in the analyses have been already discussed.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
Interpretationown dataInclusion of an alarm that sends a notification when patient responses are missing for a number of days may be a good strategy to minimize technical problems.
“the inclusion of an alarm that sends a notification when patient responses are missing for a number of days (e.g., two in the present study) may be a good strategy to minimize technical problems.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningThe inclusion of a midpoint response in the healthcare professionals' questionnaire may have been problematic.
“The inclusion of a midpoint response, as in the “Neither agree nor disagree” option in the healthcare professionals’ questionnaire, may have also been problematic.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationEcological momentary assessment could help obtain a more accurate picture of treatment response, which may help guide interventions more effectively.
“ecological momentary assessment could help us obtain a more accurate picture of treatment response which may help guide interventions in a more effective manner [42].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [42] Castilla, 2018, Validity, reliability, feasibility, and usefulness of Pain Monitor. A multidimensional smartphone app for daily monitoring of adults with heterogeneous chronic pain, Clin. J. Pain source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningThe selection of a 30% cutoff to determine the benchmark for a clinically significant change may have influenced the results.
“the selection of a 30% cutoff to determine the benchmark for a clinically significant change may also have influenced the results.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Interpretationown dataThe difficulty of phone follow-up supports the need for more flexible and patient-dependent assessment tools, such as smartphone apps.
“This supports the need for more flexible and patient-dependent assessment tools, such as smartphone apps.”
Quote in the paperSubstantial claimMay combine two claims.
Interpretationown dataIf effective, telemonitoring is more likely to have an impact on outcomes if an alarm system allows rapid response to unwanted events, suggesting that daily assessment only is not likely to be sufficient to have an impact on outcomes.
“it showed that, if effective, telemonitoring is more likely to have an impact on outcomes if an alarm system that allows for a rapid response to unwanted events occurs, which suggests that daily assessment only is not likely to be sufficient to have an impact on outcomes.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationMidpoint responses may be used when participants have no opinion or when they want to provide a socially desirable response.
“they may also be used when participants have no opinion or when they want to provide a response that is socially desirable [78].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [78] Nadler, 2015, Stuck in the middle: The use and interpretation of mid-points in items on questionnaires, J. Gen. Psychol. source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe required sample size was obtained based on an uncorrected alpha level of 0.05.
“the required sample size was obtained based on an uncorrected alpha level of 0.05.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
InterpretationcitationCreating a plan to maintain the app after initial development may help reduce technical problems associated with operating system updates.
“another option to minimize missing data are to create a plan to maintain the app after the initial development is completed, which may help reduce technical problems associated with operating system updates [76].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [76] Price, 2014, mHealth: A mechanism to deliver more accessible, more effective mental health care, Clin. Psychol. Psychother. source
Not checked in the free run.
May combine two claims.
Study design and conductown dataTechnical problems such as app malfunctioning or phone problems occurred in the study and resulted in almost 20% loss in sample size.
“such as app malfunctioning or problems with the patients’ phone, such as crashing or low battery or memory, these did occur in the study and resulted in almost 20% of loss in sample size.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Pain treatment follow-up is predominantly discrete during on-site appointments.
“For example, pain treatment follow-up is still predominantly discrete during on-site appointments.”
The authors state this as an assumption.
Differences in outcomes across monitoring conditions are due to the assigned monitoring condition.
“All patients received the usual treatment for their pain, so differences in outcomes (pain severity and interference, fatigue and mood) across outcomes were expected to occur as a consequence of the assigned monitoring condition.”
The authors state this as an assumption.
Daily response to pain-related items in the app does not by itself produce patient benefits; any benefit of the app + alarm condition is due to telemonitoring.
“Because we want to ensure that telemonitoring and not the daily response to pain-related items in the app is responsible for patient benefits, we allocated patients using the app into two conditions: telemonitoring (i.e., use of the app with alarms to the physician in the presence of unwanted events detected by the app) and daily app use without alarms.”
The paper relies on this without support.
This is the first randomized controlled trial exploring the utility of telemonitoring adults with chronic pain between onsite appointments using a smartphone app, and the first study to use an alarm-based telemonitoring system in a randomized controlled trial in chronic pain settings.
“to the best of our knowledge, this is the first randomized controlled trial that explored the utility of telemonitoring adults with chronic pain between onsite appointments using a smartphone app.”
“To the best of our knowledge, this is the first study to use an alarm-based telemonitoring system in a randomized controlled trial in chronic pain settings.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Suso-Ribera et al.'s results were suggestive of the effectiveness of telemonitoring in pain and other mental health outcomes (e.g., depressive symptoms), particularly if an alarm system that allows changes in pain management can be implemented.
“the results of this study were suggestive of the effectiveness of telemonitoring in pain and other mental health outcomes (e.g., depressive symptoms), particularly if an alarm system that allow changes in pain management can be implemented.”
From Using Information and Communication Technologies (ICT) for Mental Health Prevention and Treatment (2021) · cites this paper as [11]
Statistics recomputed
Every reported test result, recomputed from its test statistic and degrees of freedom. A result shows as not adding up only once an independent check has confirmed it.
- Consistentz = -3.32reported p < .001 · recomputed p < .001
“(Z = −3.32, p < .001”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Alarm-handling time is described as both a daily total and a per-alarm cost
MinorThe reported 28 minutes is the time physicians spent responding to all daily alarms, but the discussion treats approximately 30 minutes as the time required for each alarm. Those are different denominators for the same workload estimate.
“responding to all daily alarms (e.g., looking at the patient’s medical record and calling them) required 28 min in total (10–45-min range; median = 27.5 min).”
“on average, it took around 30 min for each alarm, considering the time to check the electronic medical record, call the patient and make adjustments to the treatment if necessary”
Cites
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Soares, L. M. D. S. G., de Moraes, É. B., Seixas, F. L., Cunha, K. C. D. S., Goulart, M. D. C. E. L., & Costa, L. R. B. (2024) · Revista Eletrônica Acervo Saúde · doi:10.25248/reas.e16941.2024
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- Authors
- Suso-Ribera, C., Castilla, D., Zaragozá, I., Mesas, Á., Server, A., Medel, J., & García-Palacios, A.
- Affiliations
- Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, 12071 Castellón, Spain
- Universitat de València (ES)
- Instituto de Salud Carlos III (ES)
- Pain Clinic, Vall d’Hebron Hospital, 08035 Barcelona, Spain
- Vall d'Hebron Hospital Universitari (ES)
- Venue
- International Journal of Environmental Research and Public Health
- Publisher
- MDPI AG
- Published
- 2020-09-09
- Volume
- 17
- Issue
- 18
- Pages
- 6568
- ISSN
- 1660-4601 (ISSN-L)
- PMC
- PMC7559749
- OpenAlex
- W3084131226
- Semantic Scholar
- bd5d6e57fb4c45784ce9770204a34afcbfd21e2a
- Cited by
- 38
- References
- 77
- Citations by year
- 2026: 4 · 2025: 6 · 2024: 11 · 2023: 5 · 2022: 4 · 2021: 8
- FWCI
- 4.43
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- International Journal of Environmental Research and Public Health (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Repositori UJI (Universitat Jaume I) (acceptedVersion, cc-by-sa)
- RePEc: Research Papers in Economics (submittedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-sa)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Repository of Digital Objects for Teaching Research and Culture (University of Valencia) (submittedVersion, other-oa)
- Funders
- Universitat Jaume I (POSDOC/2016/15)
- Valencian Community Government (GV_2019_095)
- Topics
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Keywords
- remote patient monitoring, chronic pain, musculoskeletal pain, mobile application, mobile health, clinical alarm systems, pain intensity, pain interference, fatigue, depression, anxiety, anger, clinician acceptance, personalized treatment
- MeSH terms
- Smartphone, Humans, Clinical Alarms, Chronic Pain, Pain Management, Mobile Applications
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