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Table 3 MMAP quality appraisal of included articles

From: Distant mood monitoring for depressive and bipolar disorders: a systematic review

MMAP Quantitative non-RCT quality appraisal

 

Lauritsen et al., 2017 [36]

Piette et al., 2013 [37]

Van der Watt, Suryapranate et al., 2018

Yeung et al., 2012 [39]

Zulueta et al., 2018 [34]

1. Are the participants representative of the target population?

Yes: Patients suffering from MDD were recruited to participate post discharge. The authors acknowledge that patients referred to the facility may belong to a more severely depressed subset of inpatients.

No: The included participants were not representative of the target population in terms of race, sex, and education.

Yes: Inpatients with a primary mood or anxiety disorder were recruited pre-discharge.

Partially: Participants were recruited based on a physician’s diagnosis of MDD. The authors acknowledge the influence physician selection bias and that standard diagnostic criteria of patients may not have been met.

Partially: Patients suffering from bipolar disorder were recruited to participate in the study. The authors acknowledge that the sample is not representative of the target population in terms of sex.

2. Are the measurements appropriate regarding both the outcome and intervention (or exposure)?

Yes: The intervention involved monitoring mood and quality of sleep, daily, using a Visual Analog Scale (VAS). Depression outcome was measured using the well-established HAM-D-17 measure.

Yes: The intervention involved monitoring mood and medication adherence using Interactive Voice Response (IVR) technology. Depression outcome was measured using the well-established PHQ-9.

Yes: The intervention involved interepisodal telephonic mood monitoring and the outcomes were measured weekly for 26 weeks using established tools, the ASRM and QIDS.

Yes: The intervention involved monthly telephonic monitoring of depression symptom severity using the well-established PHQ-9.

Partially: The intervention involved weekly telephonic mood monitoring using well-established measures (HAM-D-17; YMRS) and ecological monitoring using keystroke data. The use of keystroke data as indicators of mood symptoms is partially motivated in the introduction section; yet well-established evidence is lacking.

3. Are there complete outcome data?

Yes: Mood, sleep, and activity outcomes were analysed using available data from all included patients. The completion rate is relatively high (76%) and the authors clearly indicate the reasons for attrition. Outcome data is reported for all measurements used.

Yes: Mood and medication adherence were analysed using available data from all included participants. Reasons for attrition were not provided.

Yes: Although the drop-out rate was quite high, results showed a significant decline in depression scores. ASRM scores were not indicative of significant mania and the authors also reported data for suicidality.

No: In both the intervention and control group, data were excluded from analysis due to the lack of an interview at 6 months or a too low PHQ-9 score at baseline.

Partially: Missing data were handled with pairwise deletion.

4. Are the confounders accounted for in the design and analysis?

Partially: Analyses model of mood included time, sleep-onset, sleep-offset, sleep quality, activity, and interactions between sleep-onset and day, sleep-offset and day, sleep quality and day, and activity and day.

The authors acknowledged confounders that may have had an influence on the data, was not included in the present study data.

Partially: Analyses of completion rates controlled for demographic characteristics, measures of baseline vulnerability, baseline depression scores, and weeks of follow-up.

No other confounders are mentioned.

Partially: The authors collected data on traumatic childhood experiences but did not state if these were accounted for as confounders in the data analysis. No other confounders are mentioned.

Partially: Covariates to control for patient demographics and clinical history were included in the logistic regression models.

The authors acknowledge that may have had an influence on the data, was not included in the present study data.

No: Possible confounders were not clearly identified, or how they were controlled for.

5. During the study period, is the intervention administered (or exposure occurred) as intended?

Yes: The intervention was administered as intended.

Yes: The intervention was administered as intended.

Yes: The intervention was administered as intended.

Yes: The intervention was administered as intended

Yes: The intervention was administered as intended

MMAP Quantitative RCT quality appraisal

MMAP Mixed Methods quality appraisal

 

Faurholt-Jepsen et al., 2015

Martinez et al., 2018

Ross et al., 2018 [38]

 

Van der Watt, Roos, et al., 2018

1. Is randomization appropriately performed?

Yes: Participants were randomized with a balanced ration of 1:1 to receive either an intervention Android smartphone (the intervention group) or a control Android smartphone (the control group) for a 6-month trial period.

Yes: Randomization was conducted using computer-generated random numbers

Unclear: Consented clinicians were randomly assigned to either usual care or close monitoring. Randomization was stratified by clinic. However, it is unclear how participants were randomized.

1. Is there an adequate rationale for using a mixed methods design to address the research question?

No: There is no rationale provided

2. Are the groups comparable at baseline?

Yes: Randomization was stratified on age (< 29 or ≥ 29 years) and former hospitalization (yes/no) since these were considered to be possible prognostic variables, and a fixed block size of 10 within each stratum was used.

Yes: Participants’ baseline sociodemographic characteristics were similar, with the exception of socioeconomic status (p = 0.03)

Partial: See Table 1 in the article. At baseline the two groups statistically differed in terms of sex, finance, and the experience of a disturbing traumatic event.

2. Are the different components of the study effectively integrated to answer the research question?

Yes: The qualitative and quantitative components complement each other and function well as a unified whole to answer the research question.

3. Are there complete outcome data?

Yes: 82.62% of the intervention group data, and 87.18% of the control group data could be analysed.

Yes: It appears as if all the data mentioned in the measurement section is reported

Yes: 72.31% of the intervention group data, and 77.42% of the control group data could be analysed.

3. Are the outputs of the integration of qualitative and quantitative components adequately interpreted?

Yes: The qualitative component provides detailed evidence for acceptability and perceived effectiveness of mood monitoring and reasons for participant drop-out. This information is effectively supported by quantitative data including baseline assessment and post-discharge assessment using established questionnaires.

4. Are outcome assessors blinded to the intervention provided?

Partially: Due to the type of intervention, this trial was single-blinded since blinding of the participants, the clinicians, and the study nurse handling the intervention was not possible.

Yes: Patient baseline data and outcomes at 12-week follow-up were evaluated via telephone by a trained consultant who was blinded to treatment allocation.

No: Due to the nature of the intervention, blinding was not possible.

4. Are divergences and inconsistencies between quantitative and qualitative results adequately addressed?

Unclear: There appears to be no mention of any divergence or inconsistencies between quantitative and qualitative results.

5. Did the participants adhere to the assigned intervention?

Yes: A total of 3.7% of participant visits were missing (3.6% in the intervention group and 3.8% in the control group) due to participants not attending.

Partially: No participants assigned to the intervention were lost to follow-up. However, only one-third of the patients displayed an adequate adherence to the pharmacological treatment

Unclear: Follow-up data is reported for 75.3% (6 months) for the participants in general. However, it is not clear how many completed the weekly assessments.

5. Do the different components of the study adhere to the quality criteria of each tradition of the methods involved?

Yes: It is reflected in the analysis and reporting of the data.

  1. ASRM Altman Self-Rating Mania scale, HAM-D-17 Hamilton Depression rating scale, MDD Major Depressive Disorder, PHQ Patient Health Questionnaire