| Literature DB >> 32370140 |
Patricia Gual-Montolio1, Verónica Martínez-Borba1, Juana María Bretón-López1, Jorge Osma2, Carlos Suso-Ribera1.
Abstract
Psychotherapy has proven to be effective for a wide range of mental health problems. However, not all patients respond to the treatment as expected (not-on-track patients). Routine outcome monitoring (ROM) and measurement-based care (MBC), which consist of monitoring patients between appointments and using this data to guide the intervention, have been shown to be particularly useful for these not-on-track patients. Traditionally, though, ROM and MBC have been challenging, due to the difficulties associated with repeated monitoring of patients and providing real-time feedback to therapists. The use of information and communication technologies (ICTs) might help reduce these challenges. Therefore, we systematically reviewed evidence regarding the use of ICTs for ROM and MBC in face-to-face psychological interventions for mental health problems. The search included published and unpublished studies indexed in the electronic databases PubMed, PsycINFO, and SCOPUS. Main search terms were variations of the terms "psychological treatment", "progress monitoring or measurement-based care", and "technology". Eighteen studies met eligibility criteria. In these, ICTs were frequently handheld technologies, such as smartphone apps, tablets, or laptops, which were involved in the whole process (assessment and feedback). Overall, the use of technology for ROM and MBC during psychological interventions was feasible and acceptable. In addition, the use of ICTs was found to be effective, particularly for not-on-track patients, which is consistent with similar non-ICT research. Given the heterogeneity of reviewed studies, more research and replication is needed to obtain robust findings with different technological solutions and to facilitate the generalization of findings to different mental health populations.Entities:
Keywords: information and communication technologies; measurement-based care; mental health; outcome monitoring; therapist feedback
Year: 2020 PMID: 32370140 PMCID: PMC7246636 DOI: 10.3390/ijerph17093170
Source DB: PubMed Journal: Int J Environ Res Public Health ISSN: 1660-4601 Impact factor: 3.390
Figure 1Flow diagram of study selection following PRISMA guidelines [26].
Characteristics of the included studies.
| Reference | Country | Setting | Psychological Disorder | Sample size | Study Design | Type of Psychological Intervention |
|---|---|---|---|---|---|---|
| [ | California (USA) | Specialist inpatient treatment center | PTSD | 27 Tx | SG (feasibility study) | Residential group psychotherapy (4–5 months) |
| [ | Pittsburgh (USA) | Outpatient Psychiatric Institute and Clinic | Anxiety disorders (children from 9 to 14 years old) | 9 Tx (3 received 16-sessions CBT, 6 received 8-sessions Brief CBT) | SG (feasibility pilot trial) | “Coping Cat”: 16 CBT sessions“Brief Coping Cat”: 8 CBT sessions |
| [ | Evanston, Illinois (USA) | Outpatient clinic at the Family Institute at Northwestern University | Couple problems | 1 Tx | Case study | Four Couple Multisystemic Psychotherapy sessions |
| [ | California University: Berkeley (USA) | Outpatient behavioural health clinic | Depression | 85 (40 cont. + 45 Tx) | nRCT (not blinded) | 16 weeks of weekly group CBT therapy |
| [ | California (USA) | 4 Outpatient Early Psychosis clinics | Psychotic disorder | 61 Tx | SG (feasibility study) | Early Psychosis Program (up to 5 months) |
| [ | New York (USA) | Outpatient primary care | Substance use | 240 (83 cont. + 77 Tx + 80 Tx HealthCall) | Three-arm RCT (1:1:1 allocation ratio) | Brief (25–30 min) individual (motivational interview) psychoeducation (3 sessions: every 30 days) |
| [ | California University (USA) | Outpatient specialist clinic | Psychotic disorder (adolescent and young) | 76 Tx | SG (feasibility pilot trial) | Early Psychosis Program (minimum 3 months) |
| [ | Washington University (USA) | Outpatient primary care clinic affiliated with the Washington University | Depression and Anxiety | 17 Tx | SG (feasibility and acceptability pilot study) | Collaborative care program (over 6 months) |
| [ | Melbourne (Australia) | Outpatient Specialist Voices Clinic and clinical services | Schizophrenia | 34 (17 cont. + 17 Tx) | A single-blind, parallel group, pilot RCT (1:1 allocation ratio) | Brief CBT (four in-person therapy sessions) + EMA + EMI |
| [ | Melbourne (Australia) | Outpatient Specialist Voices clinic | Schizophrenia | 1 Tx | Case study | Brief CBT (four in-person therapy sessions) + EMA+ EMI |
| [ | Perth (Australia) | Private inpatients and day-patients psychiatric hospital | Mood and Anxiety | 1308 (408 Tx Fb +, 439 nFb + 461 cont.) | nRCT | 10 days of intensive CBT group |
| [ | Leeds (England) | Outpatient clinic | Depression and Anxiety | 594 (349 cont. + 245 Tx) | Quasi-experimental pre-post study | Low-intensity guided self-help CBT or High-intensity CBT, interpersonal psychotherapy and counselling |
| [ | England | 8 outpatient clinics | Depression and Anxiety | 2233 (1057 cont. + 1176 Tx) | Multisite, open-label, cluster RCT | Low-intensity guided self-help CBT or High-intensity CBT, interpersonal psychotherapy and counselling |
| [ | Oxford (UK) | Outpatient specialist mental health | Bipolar disorder | 19 Tx | SG (pre-post) | five sessions of psychoeducational intervention (FIMM) + pharmacotherapy |
| [ | Salzburg (Austria) | Inpatient and a day-treatment clinic | Mood disorders; Psychoactive substance use mental disorders; Schizophrenia, schizotypal, and delusional disorders; Neurotic, stress-related, and somatoform disorders; Personality disorders, and others | 151 Tx | SG (feasibility pilot trial) | Psychotherapy (8 weeks in the day-treatment clinic and 12 weeks in the inpatient clinic) |
| [ | Salzburg (Austria) | Outpatient clinic | Bulimia nervosa | 1 Tx | Case study | six Rogerian person-centred psychotherapy sessions |
| [ | Thessaloniki (Greece) | Alzheimer day care centre (at home) | Dementia | 4 Tx | Case study | 15 Individual psychotherapy sessions (psychosocial intervention, CBT, relaxation techniques, etc.) |
| [ | The Netherlands | Outpatient mental health institutions or private practices | Mood disorder, Adjustment disorder, Anxiety disorder, Relational problems, Personality disorders, and others | 475 (159 Tx FbT; 172 Tx FbTP; 144 cont. nFb) | RCT | Long and short psychotherapy (CBT, client-centered, psychodynamics) |
Note: Cont., control group; Tx, treatment group; nRCT, non-randomized controlled trial; CBT, Cognitive-Behavioural Therapy; RCT, randomized controlled trial; EMA, ecological momentary assessment; EMI, ecological momentary intervention; FbT, feedback to the therapist; FbTP, feedback to the therapist and the patient; Fb, feedback; nFb, no-feedback; FIMM, Facilitated Integrated Mood Management; SG, single group design.
Measurement-based care characteristics.
| Reference | Assessment Frequency and Setting | Primary Outcome Measures | Feedback to | Feedback Frequency and Setting | Type of Technology Used |
|---|---|---|---|---|---|
| [ | Daily at a random time | Adapted questionnaire from Symptom Checklist-6, the BriefCOPE and Beck Depression Inventory-II | T and P | P: T regularly shared P progress in order to incorporate strategies in therapy sessions and treatment plan.T: They got patient information several times a week in a graph format to discuss with them during sessions, to encourage them and monitor them. | EMA and Text messages |
| [ | Daily questions about recent emotional events (e.g., emotions, scenario, somatic symptoms, automatic thoughts) + answers on demand by the participant | Skills entries and satisfaction with the treatment. | P and T | P: They received personalized feedback from therapists.T: Information and graphs from the portal about patients’ progress were discussed in weekly CBT sessions with the patients. | Smartphone app: SmartCAT app + SmartCAT therapist portal.. |
| [ | Online before every session | STIC: set of questionnaires | T and clinicians stakeholders | T: On-demand graphs of patient progress were provided to the therapist through STIC | STIC online |
| [ | Once daily mood monitoring messages at random between 8 a.m. and 8 p.m. | Attendance to therapy, duration of therapy and PHQ-9 | P and T | P: They received feedback about their mood responsesT: T reviewed information from an online dashboard were patient progress is shown. T can periodically review the graphs, identify key aspects and address any important event during or between sessions. | Automated text messages and Web-based platform (HealthySMS) |
| [ | Daily and weekly surveys (between 5 p.m. and 10:30 p.m.) | Mood, medication use, socialization and conflict | P and T | P: They discussed their feedback with the T at every session.T: They reviewed and discussed patient information (plots of symptoms over time, etc.) on the dashboard with P during sessions and between sessions. | Smartphone app: RealLife Exp + web-based platform |
| [ | Once daily call (HealthCall) for self- monitoring | Primary drug use (frequency and amount), use of other drugs, medication adherence, and mood | P and T | P: They received the feedback at 30 and 60 days, where their information was discussed with the T.T: At 30 and 60 days, T discussed with P the generated graphs based on HealthCall about their drug use, moods and health behaviors. | Phone IVR system |
| [ | Daily surveys (at 5 p.m. until 11:55 p.m.), weekly surveys (Sundays at 10 a.m. until Monday 11:55) and monthly in-person psychosocial assessments with research staff | Daily surveys assessing mood, medication adherence, and social interaction, weekly surveys assessing symptoms, sleep, and medication adherence | T | T: They received alerts from the dashboard when P scores were clinically significant and took the proper decisions according to the patient demand. | Ginger.io (software) = Smartphone app + Clinician dashboard |
| [ | 3/4 times daily, weekly; 8/12 weeks | PHQ-9 and GAD-7 | P and T | P: P received notifications about their progress in the app, becoming more aware of their symptoms.T: T reviewed patient-reported information via an online dashboard and visualized patient progress graphs. | Smartphone app + online platform |
| [ | Session 1 and 2: 10 daily evening EMA for 6 days. Session 3 and 4: 8 evening daily EMA (monitor changes in voices and coping strategies) | SEPS, PSYRATS-AH, and DASS-21 | P and T | P: In session 2, P received a summary sheet with their EMA progress.T: In session 2, EMA feedback was discussed with the P in order to guarantee understanding, detect predictors and avoid causation. | Smartphone app: MovisensXS + web-based platform |
| [ | Session 1 and 2: 10 daily evening EMA for 6 days. Session 3 and 4: 8 evening daily EMA (monitor changes in voices and coping strategies) | SEPS, PSYRATS-AH, and DASS-21 | P and T | P: In session 2, P received a summary sheet with their EMA progress.T: In session 2, EMA feedback was discussed with the P in order to guarantee understanding, detect predictors and avoid causation. | Smartphone app: RealLife Exp + web-based platform |
| [ | Daily self-reported measures of well-being | Well-being (WHO-5) | P and T | P: They received routinely individualized information about their progress in group discussion with the therapist.T: T received daily automatic plots of each patient’s outcomes within trajectories. | Touch-screen technology in therapy rooms |
| [ | Weekly (session-by-session) | PHQ-9 and GAD-7 | P and T | P: They received their feedback in session with the therapist, where the information was reviewed, discussed and used to guide the treatment plan.T: They had access to patient progress graphs and response curves from the monitoring system, and they were warned automatically when a P was not-on-track. | Computer PCMIS |
| [ | Weekly (session-by-session) | PHQ-9 and GAD-7 | P and T | P: They received their feedback in session with the therapist, where the information was reviewed, discussed and used to guide the treatment plan.T: They had access to patient progress graphs and response curves from the monitoring system, and they were warned automatically when a P was not-on-track. | Computer PCMIS |
| [ | Twice a day (only during psychoeducation sessions) and once a week | Daily: mood and sleepWeekly: QIDS, ASRM and mood management strategies questionnaire | P and T | P: P received their feedback at every session with the T.T: T reviewed patient progress from daily mood rating and weekly scales from the previous week and discussed with the P the relationship between his/her mood changes and stressors. | Phone text messages or e-mails (True Colours mood monitoring system) |
| [ | Daily process monitoring (during evenings). | TPQ | T | T: On demand. Feedback was used for individualizing therapeutic decisions. | SNS |
| [ | Daily measures of psychotherapy process. Weekly measure of therapy outcome. | IEQ daily, weekly SCL-90 (Bulimia) | P, T and researchers | P: They viewed their progress and estimated their moods and symptoms during the past day.T: They had access to P data from the system in order to adapt the intervention delivered. | Smartphone: DynAMo web app |
| [ | Daily monitoring | Sleep patterns, physical activity, and activities of daily living | P, T and caregivers | P and caregiver: They could see a proportionate share of the information adapted to their needs.T: Information collected was available at all times in order to design personalized interventions. | Tablet app (assistive technology: wearable, sleep, movement, presence sensors) |
| [ | Once a week just before therapy session (at waiting room) | OQ-45 | P and T, or only T | P: P can access the feedback via email or into their portal system.T: T could access the feedback via email or in their portal system and could discuss the feedback information (progress charts and a message) with the P based on the OQ-45 patient’s scores. | Computer: Web-based monitoring app |
Note: PHQ-9, Patient Health Questionnaire-9; P, patient; T, therapist; GAD-7, Generalised Anxiety Disorder-7; EMA, Ecological Momentary Assessment; SEPS, Subjective Experiences of Psychosis Scale; PSYRATS-AH, Auditory Hallucinations subscale of the Psychotic Symptom Rating Scales; DASS-21, Depression Anxiety Stress Scale; OQ-45, Outcome Questionnaire; IEQ, Intersession Experience Questionnaire; SCL-90, Symptom Checklist-90; QIDS, Quick Inventory of Depressive Symptomatology; ASRM, Altman Self Rating Mania Scale; WHO-5, World Health Organization’s Wellbeing Index; STIC, Systemic Therapy Inventory of Change System; CBT, Cognitive Behavioral Therapy; TPQ, Therapy Process Questionnaire; IVR, interactive voice response; App, mobile application; STIC, Systemic Therapy Inventory of Change System; SNS, Synergetic Navigation System; PCMIS, Patient Case Management Information System.
Usability, acceptability, and effectiveness of technology-supported measurement-based care.
| Reference | Sample Size | Feasibility of Technology | Clinical Effectiveness |
|---|---|---|---|
| [ | 27 Tx | Monthly: 92.7% | NA |
| [ | 9 Tx | Completion rate was 82.8%. Patients reported the app being easy to use. All parents report treatment satisfaction and would recommend the program. | NA |
| [ | 85 (40 cont. + 45 Tx) | NA | Technology-supported MBC significantly increased treatment adherence (median of 13.5 weeks before dropping out) compared to traditional CBT (median of 3 weeks before dropping out). |
| [ | 61 Tx | Moderate survey completion (daily = 40%; weekly = 39%). In general, both T (66%) and P (85%) reported they would continue using the app as part of the treatment. | NA |
| [ | 240 (83 cont. + 77 Tx + 80 Tx) | HealthCall shows a great retention rate and response rate (64.1%), supporting feasibility, patient acceptability and generalizability. | At 12-month follow-up, reductions in non-injection drug use were comparable in traditional and technology-supported MBC motivational interviewing and superior than in the control condition. In the subset of patients with drug dependence, drug use was significantly lower in the technology-supported MBC condition at 12 months post-treatment. At 60 days, treatment retention in the technology-supported MBC group (88.8%) was superior than in the motivational intervention only condition (81.8%) and the control condition (78.3%) |
| [ | 76 Tx | Feasibility and acceptability of the smartphone app as an adjunct treatment tool is supported by the high response rate sate (weekly surveys: 77%; daily surveys: 69%) | NA |
| [ | 17 Tx | The feasibility and acceptability of the mobile platform is supported by the high early response rate (weekly = 88%). | NA |
| [ | 34 (17 cont. + 17 Tx) | High completion rates (74%) of EMA questionnaires and good satisfaction of participants support the feasibility and acceptability of the study, respectively. | Compared with the usual treatment, the technology-supported MBC treatment resulted in large improvements in confidence in coping with voices (Hedges g = 1.45) and medium improvements in understanding of voices (Hedges g = 0.61) and in psychotic symptoms (Hedges g = 0.51). Both groups showed similar changes in the impact of psychosis. |
| [ | 1308 (408 Tx Fb +, 439 nFb + 461 cont.) | High rates of touch-screen questionnaire completion (over 90%). | Technology-supported MBC for NOT patients was more effective than traditional CBT or monitoring without feedback in reducing depressive symptoms and the impact of emotions on functioning, as well as on increasing vitality. By contrast, changes in well-being, anxiety, and stress were comparable across conditions. |
| [ | 594 (349 cont. + 245 Tx) | MBC technology was generally acceptable and feasible to integrate in routine practice. | Technology-supported MBC achieved comparable reductions in depression and anxiety compared to controls, but with significantly less time (adjusted mean = 10.25, SE = 0.45 vs. adjusted mean = 6.59, SE = 0.51) and cost (between £65.88 and £129.20 cost reductions per treatment). Cases in the control condition were twice as likely to become not-on-track patients compared to those in the technology-supported MBC. |
| [ | 2233 (1057 cont. + 1176 Tx) | NA | NOT patients in the technology-enhanced MBC condition obtained significantly larger reductions in depressive ( |
| [ | 19 Tx | High response rate (daily = 81%, weekly = 88%) | NA |
| [ | 151 Tx | High average compliance rates (78.3%) and low average missing data rates (13%) amongst the inpatients support the feasibility. | NA |
| [ | 475 (159 Tx FbT; 172 Tx FbTP; 144 cont. nFb) | NA | In short-term interventions (less than 35 weeks), receiving feedback was protective of negative outcomes in NOT cases ( |
Note: Cont., Control Group; Tx, Treatment Group; FbT, Feedback to The Therapist; FbTP, Feedback to The Therapist and The Patient; Fb, Feedback; nFb, No Feedback; NA, Not Applicable/Not Specified; IVR, Interactive Voice Response; App, Mobile Application; EMA, Ecological Momentary Assessment; MBC, Measurement-Based Care; NOT, Not-on-Track patients; T, Therapist; P, Patient. The feasibility and effectiveness reports are not provided for case studies due to the reduced number of patients (n ≤ 4).
Quality assessment of case studies.
| [ | [ | [ | [ | |
|---|---|---|---|---|
| 1. Was the study question or objective clearly stated? | Yes | Yes | Yes | Yes |
| 2. Was the study population clearly and fully described, including a case definition? | No | Yes | No | Yes |
| 3. Were the cases consecutive? | NA | NA | NA | No |
| 4. Were the subjects comparable? | NA | NA | No | Yes |
| 5. Was the intervention clearly described? | Yes | Yes | Yes | Yes |
| 6. Were the outcome measures clearly defined, valid, reliable, and implemented consistently across all study participants? | Yes | Yes | Yes | Yes |
| 7. Was the length of follow-up adequate? | NR | No | No | NR |
| 8. Were the statistical methods well-described? | Yes | Yes | Yes | Yes |
| 9. Were the results well-described? | Yes | Yes | Yes | Yes |
| Total score (maximum 9 points) | 5 | 6 | 5 | 7 |
Note: CD, Cannot Determine; NA, Not Applicable; NR, Not Reported.
Quality assessment of before–after studies.
| [ | [ | |
|---|---|---|
| 1. Was the study question or objective clearly stated? | Yes | Yes |
| 2. Were eligibility/selection criteria for the study population prespecified and clearly described? | Yes | Yes |
| 3. Were the participants in the study representative of those who would be eligible for the test/service/intervention in the general or clinical population of interest? | NR | Yes |
| 4. Were all eligible participants that met the prespecified entry criteria enrolled? | NR | No |
| 5. Was the sample size sufficiently large to provide confidence in the findings? | Yes | No |
| 6. Was the test/service/intervention clearly described and delivered consistently across the study population? | Yes | Yes |
| 7. Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants? | Yes | Yes |
| 8. Were the people assessing the outcomes blinded to the participants’ exposures/interventions? | No | NA |
| 9. Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis? | Yes/Yes | Yes/Yes |
| 10. Did the statistical methods examine changes in outcome measures from before to after the intervention? Were statistical tests done that provided p values for the pre-to-post changes? | Yes | Yes |
| 11. Were outcome measures of interest taken multiple times before the intervention and multiple times after the intervention (i.e., did they use an interrupted time-series design)? | Yes | Yes |
| 12. If the intervention was conducted at a group level (e.g., a whole hospital, a community, etc.) did the statistical analysis take into account the use of individual-level data to determine effects at the group level? | Yes | Yes |
| Total score (maximum 12 points) | 9 | 9 |
Note: CD, Cannot Determine; NA, Not Applicable; NR, Not Reported.
Quality assessment of observational cohort and cross-sectional studies.
| [ | [ | [ | [ | [ | [ | |
|---|---|---|---|---|---|---|
| 1. Was the research question or objective in this paper clearly stated? | Yes | Yes | Yes | Yes | Yes | Yes |
| 2. Was the study population clearly specified and defined? | Yes | Yes | Yes | Yes | Yes | Yes |
| 3. Was the participation rate of eligible persons at least 50%? | NR | NR | Yes | Yes | No | NR |
| 4. Were all the subjects selected or recruited from the same or similar populations? Were inclusion and exclusion criteria for being in the study prespecified and applied uniformly to all participants? | Yes | Yes | Yes | Yes | Yes | Yes |
| 5. Was a sample size justification, power description, or variance and effect estimates provided? | NR | NR | NR | NR | NR | NR |
| 6. For the analyses in this paper, were the exposure(s) of interest measured prior to the outcome(s) being measured? | Yes | Yes | Yes | NA | Yes | Yes |
| 7. Was the timeframe sufficient so that one could reasonably expect to see an association between exposure and outcome if it existed? | NA | NA | NA | NA | NA | NA |
| 8. For exposures that can vary in amount or level, did the study examine different levels of the exposure as related to the outcome (e.g., categories of exposure, or exposure measured as continuous variable)? | NA | NA | NA | NA | NA | NA |
| 9. Were the exposure measures clearly defined, valid, reliable, and implemented consistently across all study participants? | Yes | Yes | Yes | Yes | Yes | Yes |
| 10. Was the exposure(s) assessed more than once over time? | Yes | Yes | Yes | Yes | Yes | Yes |
| 11. Were the outcome measures clearly defined, valid, reliable, and implemented consistently across all study participants? | Yes | Yes | Yes | Yes | Yes | Yes |
| 12. Were the outcome assessors blinded to the exposure status of participants? | NA | NA | NA | NA | NA | NA |
| 13. Was loss to follow-up after baseline 20% or less? | Yes | Yes | No | No | No | No |
| 14. Were key potential confounding variables measured for their impact on the relationship between exposure(s) and outcome(s)? | NA | NA | NA | NA | NA | NA |
| Total score (maximum 14 points) | 8 | 8 | 8 | 7 | 7 | 7 |
Note: CD, Cannot Determine; NA, Not Applicable; NR, Not Reported.
Quality assessment of controlled intervention studies.
| [ | [ | [ | [ | [ | [ | |
|---|---|---|---|---|---|---|
| 1. Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT? | No | Yes | Yes | No | Yes | Yes |
| 2. Was the method of randomization adequate (i.e., use of randomly generated assignment)? | NA | Yes | Yes | NA | Yes | Yes |
| 3. Was the treatment allocation concealed (so that assignments could not be predicted)? | NA | Yes | Yes | NA | Yes | Yes |
| 4. Were study participants and providers blinded to treatment group assignment? | No | No | No | No | No | No |
| 5. Were the people assessing the outcomes blinded to the participants’ group assignments? | No | NA | Yes | No | No | NA |
| 6. Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)? | Yes | Yes | Yes | Yes | Yes | No |
| 7. Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment? | Yes | Yes | Yes | NR | No | No |
| 8. Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower? | Yes | Yes | Yes | NR | Yes | Yes |
| 9. Was there high adherence to the intervention protocols for each treatment group? | Yes | Yes | Yes | NR | Yes | Yes |
| 10. Were other interventions avoided or similar in the groups (e.g., similar background treatments)? | Yes | NR | Yes | NR | Yes | NR |
| 11. Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants? | Yes | Yes | Yes | No | Yes | Yes |
| 12. Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power? | No | Yes | No | NR | Yes | Yes |
| 13. Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)? | Yes | Yes | Yes | Yes | Yes | Yes |
| 14. Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis? | Yes | No | Yes | NR | Yes | Yes |
| Total score (maximum 14 points) | 8 | 10 | 12 | 2 | 11 | 9 |
Note: CD, Cannot Determine; NA, Not Applicable; NR, Not Reported.