Methods for data collection and analysis
The review authors created and adapted a two-dimensional classification list with recommended elements of 9 healthcare subjects (hi, i=1,..,9) and 7 technological aspects (tj, j=1,..,7). Consequently, each trial is classified into one healthcare subject and one or more technological aspects. Table 5.1 (Additional file mmc5.docx) depicts the classification of the trials per Health Care Domain and Technological field. The horizontal axis corresponds to the technological (Tech) features of the trials, namely the following 7 aspects:
1. Internet
2. Mobile
3. Social support
4. Computer-based; Computer- assisted decision support
5. Tele-health
6. Virtual advisor and
7. Electronic health record–based.
The vertical axis represents the Health Care (HC) features of the trials. The review authors adapted the healthcare elements of this classification list to a broader classification scheme by unifying many medical/health areas in one unified category. Accordingly it contains the following 8 healthcare subjects:
1. Cancer
2. Cardiovascular; Hypertension
3. Diabetes; Dyslipidemia
4. Diet and Nutrition; Exercise; Activities of Daily Living; Health Behavior, Lifestyle; Public Health and other Healthy subjects
5. Infections
6. Mental health; Depression; Addictions
7. Respiratory and
8. Other subjects with the following sub-categories i.e., Older adults, Reproductive Health and Childbirth, Screening for Partner Violence and Stroke.
Consequently, according to the PRISMA 2009 study flow diagram (Fig. 1) C.S review author conducted the initial survey for the collection of the clinical trials from the registry databases and the articles from electronic databases. After a short survey on the respective sources, many of the studies were excluded either because they did not meet basic inclusion criteria or for other reasons (i.e. because the articles did not have a corresponding RCT, the RCTs did not have a corresponding article, observed as double-displayed records, were out of scope or were published as plain abstracts).
The abstracts of the articles were subsequently studied by K.T. review author who removed those which did not thematically fit, while the review authors compiled a final set of articles and imported them in the Qiqqa reference management system.
Then, the review authors attempted to find the appropriate records that do not meet certain additional criteria for being considered in the study (e.g. to identify double records, to exclude articles that they do not include a refereed registration number, to remove articles that are published prior to 2008). In order to do that, the review authors searched within each article for the existence of the terms ‘trial’, ‘registration number’, or through the abbreviations that characterize a registration number (e.g. ACTRN, DRKS, IRCT, NCT00, PACTR, ANZCTR, ChiCTR, CTR-I, ICTRP, ISRCTN etc.).
Subsequently, this list was imported in RevMan 5.3 for further study, editing and full text analysis. Curation methods were employed to correct failures or errors met in previous steps (duplicate articles, articles published before 2008, not interventional and RCT studies, articles without registration number etc.). Data management and statistical analysis, were performed using the Cochrane Review Manager.
Finally, two review authors (C.S., K.T.), independently assessed the risk of bias in the trials, undertook data extraction and classified them into the predefined two dimensional classification list as described above. Any critical or doubtful judgment at any stage of this study was discussed and in case of disagreement it was recorded for further consideration by all review authors. Final decisions are consensus.
Data Extraction and Analysis
The bibliographic metadata about each primary study were recorded using Qiqqa and RevMan 5.3 bibliography management platforms. However, a rational scheme that includes the proper information of the clinical trials was designed and implemented in MS Access for further processing and deployment.
Data extraction process
In this environment, the review authors extracted and stored the following data (primary outputs) for each article:
● The Registry of the clinical trial and its registration number.
● The journal and the relevant article that published the clinical trial methodology-results.
● The technological field of the study, according to the technology applied to the respective clinical trial.
● The health domain of the study (e.g. cancer, cardiovascular, hypertension, diabetes etc.).
● Type of the trial (i.e. prevention, screening, treatment, supportive care, health services research).
● Type of the trial in accordance of the involved HITs that support the relative healthcare issues.
● Interventions
● Outcomes
● Methods
● Conclusion
● Other data: the Registration year of the RCT and the Publication year of its relative article, the target size (or enrollment size), the Year or the first received date of the RCT (i.e. the date that the summary clinical study protocol information was first submitted to the registry), Classification of the RCT (i.e. double blinded, single blinded, not blinded, unclear), Notes and Used keywords in the articles.
Data analysis process
The data analysis process led to the secondary outputs of this review which are the following:
● Bias evaluation of the included articles (i.e. Random sequence generation (selection bias), Allocation concealment (selection bias), Blinding of participants and personnel (performance bias), Blinding of outcome assessment (detection bias), Incomplete outcome data (attrition bias), Selective reporting (reporting bias) and other bias)
● Authors’ judgment (i.e. unclear, high or low risk).
● Support for judgment with quotes and comments of the review authors to justify the assessments.
● Mapping and description of specialized themes related with the management of care (i.e. Outcome and Process Assessments - OPAs and Clinical Practice Guidelines - CPGs as computerized tools).
● Classification of studies according to the technological domain, health domain, type of the trial etc.
● Calculations as derived from the extracted data. Furthermore statistical analysis, and resulting from the analysis of data of the including studies.
All data were extracted either from the relevant articles or from the registries and have been approved and adapted by the review authors. Thus, output data were imported from LinkedCT that aims at publishing the first open Semantic Web data source for clinical trials data. Moreover, if data of the trials were not found in LinkedCT, the review authors retrieved the necessary information either from the relevant articles or the registries that have been approved and then classified and adapted by the review authors. Finally, in some individual clinical trials in which the information was unclear or incomplete, the review authors attempted to clarify some issues in the respective study protocols.
Table 4. 1 includes the characteristics and the risk of bias of the included studies with matching clinical trials employed. Also the study quality assessment (Fig. 4.1) and the Cochrane risk of bias summary (Fig. 4.2) are presented in this.
Table 4. 1: Characteristics of included studies
Characteristics of included studies
ACTRN12606000476538[1]
Methods / A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self- selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks.Participants / The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8).
Interventions / A randomized controlled trial was undertaken between November 2007 and August 2009 to determine whether a video-based smoking cessation intervention delivered via mobile phone was effective at increasing smoking cessation rates compared with a control group over a 6-month period.
Outcomes / Feedback from participants indicated that the support provided by the video role models was important and appreciated.
Health Care Domain / smoking and tobacco cessation counseling
Technology Field / Mobile phone
Conclusion / This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was sufficient positive feedback about the ease of use of this novel intervention, and the support obtained by observing the role model video messages, to warrant further investigation.
Notes / Comment: No blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding
Comment: Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken, and the outcome islikely to be influenced by lack of blinding.
Risk of bias table
Bias / Authors' judgement / Support for judgementRandom sequence generation (selection bias) / Low risk / Quote: "Computer randomization allocated participants to an intervention or control group, using stratified minimization for age (25 years and under, over 25 years), ethnicity (Maori, non-Maori), and level of nicotine dependence (time to first cigarette 30 minutes or less, more than 30 minutes)."
Comment: Propably
Allocation concealment (selection bias) / High risk / Quote: "The nature of the intervention ensured the study could only be single blinded – that is, participants were aware of which group they were allocated to".
Comment: Participants or investigators enrolling participants could possibly foresee assignments
Blinding of participants and personnel (performance bias) / High risk / Quote:"The nature of the intervention ensured the study could only be single blinded – that is, participants were aware of which group they were allocated to".
Blinding of outcome assessment (detection bias) / Low risk / Quote: "However, most data were collected via web-based forms completed by participants, and researchers involved in data collection, particularly outcome assessment, were blind to allocation".
Incomplete outcome data (attrition bias) / Low risk / Quote: "Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8).
Comment: Review authors believe that clearly reported lossed data".
Selective reporting (reporting bias) / Unclear risk / Comment: The results concerning whether the video role model is accepted (important and appreciated) by the participants and whether the model had a positive impact on smoking cessation.
However, the measurements are highly specialized and therefore can hardly be compared with those from other studies.
Other bias / Low risk / Comment: None were identified
ACTRN12607000437460
Methods / We compared treatment acceptability, in terms of treatment dropout/participation and therapeutic alliance, of therapist-delivered versus CAC (clinician-assisted computer-based) psychological treatment via a Randomized Controlled Trial,Participants / We randomly assigned 97 participants with current depression and problematic alcohol/cannabis use. Treatment retention and attendance rates were equal between therapist- delivered and CAC conditions, with 51% (34/67) completing all 10 treatment sessions. No significant differences existed between participants in therapist-delivered and CAC conditions at any point in therapy on the majority of therapeutic alliance subscales. However, relative to therapist-delivered treatment, the subscale of Client Initiative was rated significantly higher among participants allocated to the BI (F2,54 = 4.86, P = .01) and CAC participants after session 5 (F1,29 = 9.24, P = .005), and this domain was related to better alcohol outcomes.
Interventions / Be applied three-arm interventions: brief intervention (BI, one individual session delivered face to face), therapist-delivered (one initial face-to-face session plus 9 individual sessions delivered by a therapist), and CAC interventions (one initial face-to-face session plus 9 individual CAC sessions).
Outcomes / Measures:
1. Demographic information.
2. BDI-II a 21-item self-report questionnaire screening for the presence of depressive symptoms
3. Opiate Treatment Index (OTI).
4. Hazardous Use Index: an aggregate global AOD use score.
5. Beck Hopelessness Scale (BHS): a 20-item self-report instrument that measures optimism about the future and indirectly estimates suicide risk.
6. Readiness to Change: a questionnaire based on the stage-of-change model. Participants completed one questionnaire for each drug they were using at baseline (alcohol, cannabis) and rated their agreement with 15 statements relating to their baseline AOD use according to a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). The scale is divided into three subsections that relate to the following stages of change: precontemplation, contemplation, and action. Scores are totaled for the items particular to each subsection, and the subsection with the highest total score is the baseline stage of change for that drug. For the purposes of this analysis, stage of change was dichotomized into precontemplation versus not (ie, contemplation or action).
7. Agnew-Davies Relationship Measure (ARM): a measure of therapeutic alliance containing 28 self-report items regarding client- and therapist-based domains and impressions of the client-therapist relationship.
8. Treatment attendance
Health Care Domain / cognitive function and mental health
Technology Field / computer-based; computerized cognitive behavior therapy
Conclusion / Participants in a trial of CAC versus therapist-delivered treatment were equally able to engage, bond, and commit to treatment, despite comorbidity typically being associated with increased treatment dropout, problematic engagement, and complexities in treatment planning.The extent to which a client feels that they are directing therapy (Client initiative) may be an important component of change in BI and CAC intervention, especially for hazardous alcohol use.
Notes
Risk of bias table
Bias / Authors' judgement / Support for judgementRandom sequence generation (selection bias) / Unclear risk / Quote: "..participants were randomized to no further treatment (BI only), nine weekly sessions of combination CBT and motivational interviewing (MI) delivered exclusively by a therapist, or nine sessions of CAC CBT/MI with weekly brief check sessions (approximately 12.5 minutes) delivered face to face by a therapist".