Disease severity measures
Appendix 4 Data extraction tables: clinical effectiveness
Reference and
design Intervention Participants Outcome measures
Author and year: Balato et al., 201385 Study ID: 51 Source: published Country/location: Italy Setting: home Trial design: RCT Includes process evaluation: yes Number of study centres: 1 (assumed) Funding: none Conflicts of interest: none Trial/study number: not reported Study dates: September 2011–not stated
Was the educational intervention an adjunct to standard medical care? Yes
Treatment intervention
Overview: text message education
Intervention aims: not stated explicitly but implicit from the paper that aim was to use text messaging to improve treatment adherence and patient outcomes including HRQoL
Where delivered: via mobile phone
Self-help, individual- and/or group-based? (state group size): individual-based intervention
Mode: text messaging
Materials: text messages
Provider: not stated who the ‘investigators’ were but physicians enrolled participants
Duration and intensity: 1 text message per day for a period of 12 weeks
Scripting (level of detail guiding interaction between interventionist and
participants): general educational statements and reminders sent in a random order with four educational and three reminders sent each week. Details of the types of information provided in the paper but no details of the coverage of these (i.e. if all were eventually sent to each participant)
Sensitivity to participant characteristics: text messages were created using simple language
Skin condition: plaque psoriasis
Diagnostic criteria: not reported
Specify if patients, parents and/or carers: patients
Patient general age group (specify if children, young adults and/or adults): adults
Stated target group: no details
How recruited: consecutive patients
Eligibility criteria: aged between 18 and 65 years, current systemic and topical treatment, PASI between 5 and 15, owner of a mobile phone capable of receiving text messages and the ability to use it. The presence of comorbidities was not an exclusion criteria
Numbers involved (randomised/ allocated): total 40;
intervention: 20; control: 20
Numbers (%) completing, attrition and reasons: attrition: intervention group= 0; control group= 0
Reasons: not applicable
Completing: 100%
Sample cross-overs: none
Baseline characteristics
Comorbidities, n (%) as reported in paper is percentage of those with any comorbidity, reviewer also calculated % of total group [%]:
Hypertension
Intervention: 3/6 (50) [15]; Control: 4/7 (57) [20]
Primary outcomes: not reported as primary or secondary outcomes. PASI, PGA, BSA, SAPASI; HRQoL (DLQI)
Other outcomes: evaluation of patient–physician relationship; treatment adherence
Secondary outcomes: adverse events: not reported
Process evaluation measures: usability and satisfaction with the text messaging education
Individual preferred learning style addressed? No
Any sub groups: none reported
How outcomes assessed? DLQI, SAPASI and adherence are self-report; PASI, BSA and PGA are clinician reported but not clear who assessed. Unclear for the patient–physician relationship. DLQI, PASI and SAPASI details of measure not stated; patient–physician relationship was a scale of 0–10; treatment adherence through a multiple-choice question about how often they forgot to use products/medications in days per week in the past week. Also a 7-day calendar marking days when they were adherent as outlined in a cited reference. States the PASI, BSA and PGA were used to support the results of the self-reported adherence
Normal range(s) for outcomes/ clinically meaningful
improvement defined: not reported
Reference and
design Intervention Participants Outcome measures
Interventionist characteristics and training: no details
Content and topics:
summary– covered frequently asked questions about psoriasis drugs (e.g. administration and adverse effects) and general recommendations to take care of overall health. All text messages between one and three sentences. Educational topics included daily care statements (e.g. use moisturisers, wear light clothes), healthy lifestyle statements (e.g. avoid smoking, pay attention to your diet), prompts about the use of treatments (e.g. do not abuse steroids, common side effects of certain drugs) and one statement about the psychosocial effects of psoriasis (e.g. do not feel ashamed or guilty, psoriasis is not contagious). Reminders reinforced many of the same principles
Tailoring: does not appear to be tailored
Ongoing support: none reported
Theory: none reported
Control intervention:
Description: no details of the control intervention
Duration and intensity: not reported Dysplipidemia Intervention: 2/6 (33) [10]; Control: 2/7 (28.5) [10] Type 2 diabetes Intervention: 1/6 (17) [5]; Control: 1/7 (14.5) [5] Co-medications/interventions:
Intervention group: acitretin 2 (10%); biologics 10 (50%); ciclosporin 3 (15%); methotrexate 5 (25%)
Control group: acitretin 3 (15%); biologics 11 (55%); ciclosporin 2 (10%); methotrexate 4 (20%)
Duration of disease, mean (SD):
Intervention 10.7 (5.3) years
Control 12.1 (5.8) years
Sex (M/F) n/N:
Intervention 10/10
Control 12/8
Average age: mean (SD) age, years
Intervention 38.4 (9.5); Control 39.3 (10.2)
Ethnic groups: not reported
Socioeconomic characteristics:
Education, n (%)
Intervention: middle school 5 (25); high school 12 (60); college graduate 3 (15)
Control: middle school 6 (30); high school 10 (50); some college 1 (5); college graduate 3 (15)
Currently employed, n (%)
Intervention: 16 (80)
Control 15 (75)
Validated? Yes for all measures except
patient–physician relationship and adherence (therefore not data extracted)
Timing of outcomes same for both groups: yes
Length of follow-up: 12 weeks
Methods
Statistical analysis, including how missing data dealt with: minimal details about statistical approaches used, data presented as means (SDs). No missing data
Power calculation: not reported. Described as a pilot study
Study adequately powered? Unclear
ITT used? No missing data or drop outs so ITT (although not described as such by authors)
Groups comparable at baseline? Yes
Subgroup analyses: none reported
Process evaluation methods (if relevant): in the treatment group only, usability and satisfaction with the text messaging intervention were assessed using a series of questions
Outcome evaluation results
HRQoL Outcomes Intervention (n= 20) Control (n= 20) p-value/CIs
DLQI, mean (SD) baseline 7.9 (3.2) 7 (3)
DLQI, mean 12 weeks 4.2 5.8 p< 0.05
Comments: 12 weeks scores estimated from figure by reviewer
Other relevant outcomes Intervention (n= 20) Control (n= 20) p-value/CIs
PASI, mean (SD) baseline 10.64 (4.2) 10.13 (4.7)
PASI, mean 12 weeks 5.8 6.8 p< 0.05
SAPASI, mean (SD) baseline 11 (6.6) 10.90 (5.9)
SAPASI, mean, 12 weeks 5.9 8 p< 0.05
BSA, mean (SD) baseline 16 (7.5) 14.2 (8)
BSA, mean 12 weeks 5.8 8 p< 0.05
PGA, mean (SD) baseline 2.6 (1.04) 2.3 (1.3)
PGA score 0.7 1.5 p< 0.05
Comments: all 12 weeks’ data estimated from figure by reviewer
Treatment adherence scores and patient–physician relationship scores not data extracted as not validated measures
Adverse events Intervention Control p-value/CIs
Comments:
Subgroup analysis results
Comments: no subgroups reported
Outcome Intervention Control p-value/CI
Comments:
Process evaluation results
Usability and satisfaction with the text messaging education:
85% found text messaging useful
75% would recommend to a friend
75% would like to continue using the text messaging
15% would be willing to pay a small fee for the service
Outcome Intervention Control p-value/CI
Generalisability: Italian population all with plaque psoriasis of moderate-to-large effect based on baseline PASI scores (reviewer observation). Participants on a range of different treatments, unclear how generalisable these are to UK standards of care
Other: no details of the control group so unclear whether they were seen as usual care or not seen at all