26. Included studies of compliance.

Study	Methods	Participants	Interventions	Outcomes (compliance	Summary findings	Notes	Allocation concealment
Balkrishnan 2003	DESIGN: uncontrolled study patient delivery ALLOCATION: non‐random Method of randomisation: NA Concealment: NA BLINDING: single‐blind (participants unaware of electronic compliance assessment) WITHDRAWAL/DROPOUT: described	N: 10 TD: 1 wk; FU: 1 wk LF: 0 (0%) BC: NA Age: NR Gender (per cent men): NR Severity: NR INCLUSION CRITERIA: participants with psoriasis who already enrolling in a study with salicylic acid and topical tacrolimus ointment (Protopic) combination therapy. EXCLUSION CRITERIA: NR	Topical salicylic acid 6% No control	Medication adherence: (1) MEMS cap: medication bottle cap with microprocessor to record time/date of every opening of the bottle. (2) Patient log (self report) of compliance Mean adherence rate: method 1: 67% (32% SD); method 2: 92% (7% SD)	Medication adherence measured by method 1 (electronic) much lower than by method 2 (patient log)	Sponsorship not reported	D
Carroll 2004a; Carroll 2004b; Carroll 2005	DESIGN: within‐patient patient delivery ALLOCATION: random Method of randomisation: NR Concealment: unclear BLINDING: Single‐blind (participants unaware of electronic compliance assessment) WITHDRAWAL/DROPOUT: described	N: 30 TD: 8 wks; FU: 12 wks LF: 6 (20%) BC: Yes Age: 43.6 (range 18 to 70) Gender (per cent men): 50% Severity: TSS (0 to 8): 5.3 INCLUSION CRITERIA: participants aged ≥18; symmetrical plaque‐type psoriasis; BSA < = 10%; symmetrical target plaque 1cm² with each with a score of at least 1 for erythema, thickness, and scale EXCLUSION CRITERIA: pregnancy or risk thereof; topical treatment within previous 2 wks; phototherapy or systemic therapy within previous 4 wks	Topical salicylic acid 6% plus 0.1% tacrolimus ointment BD Topical salicylic acid 6% plus placebo BD	Medication adherence: (1) MEMS cap: medication bottle cap with microprocessor to record time/date of every opening of the bottle. (2) Patient log (self report) of compliance (3) medication weights	Adherence decreased over time. On the intervention side, a decrease in adherence rate of 10% was associated with a 1‐point increase in severity (P < 0.05). For the placebo‐treated side, adherence was not significantly correlated with changes in severity. Poor compliance appears to have an impact on treatment outcomes in psoriasis Mean adherence (method 1): % (doses taken/doses expected): 55%; % (days with twice‐daily dose/total days): 39.1% Higher adherence rate for women and older participants	Sponsored by Fujisawa Healthcare, Inc. and by Wake Forest University School of Medicine. Excluded from effectiveness review (comparator is not placebo)	B
Feldman 2007	DESIGN: uncontrolled study patient delivery ALLOCATION: non‐random Method of randomisation: NA Concealment: NA BLINDING: single‐blind (participants unaware of electronic compliance assessment) WITHDRAWAL/DROPOUT: described	N: 29 TD: 8 wks; FU: 8 wks LF: NR BC: NA Age: 43.5 Gender (per cent men): NR Severity: NR INCLUSION CRITERIA: NR EXCLUSION CRITERIA: NR	6% salicylic acid gel BD No control	Impact of office visits on participants' adherence to topical treatment. Adherence assessed using MEMS cap: medication bottle cap	Adherence statistically significantly higher at time of office visit. Mean adherence over the study duration was 55%. Mean applications/day: 1.1 (range: 0.72 to 1.4)	Sponsored in part by Astellas Pharma US, Inc. The Center for Dermatology Research is funded by a grant from GaldermaLaboratories, LP. (see also Balkrishnan 2003; Carroll 2004a, 2004b, 2005)	D
Ferrandiz 1998	DESIGN: between‐patient patient delivery (therapy) Clinician delivery (programme) ALLOCATION: random Method of randomisation: NR Concealment: unclear BLINDING: open WITHDRAWAL/DROPOUT: described	N: 881 TD: 16 wks; FU: 16 wks LF: 127 (12.6%) BC: Yes Age: 43.3 (16.9SD) Gender (per cent men): NR Severity: mean PASI: 7.0 INCLUSION CRITERIA: moderately severe chronic plaque psoriasis; BSA < = 30%; aged 18 to 70; under specialist supervision EXCLUSION CRITERIA: pregnancy or lactation; history of intolerance to calcipotriol/excipients; concurrent vitamin D (> 400 units/day) or calcium tablets; psoriasis mainly on face or hirsute areas	Calcipotriol plus reinforcement programme Calcipotriol without reinforcement programme	Reinforcement therapeutic programme to enhance adherence: dermatologist provided participant education with explanation of disease characteristics and treatment efficacy and application, plus written information card	The reinforcement programme had no effect on treatment efficacy	Sponsorship not reported	B
Fouere 2005	DESIGN: questionnaire survey (observational cross‐sectional study) ALLOCATION: non‐random Method of randomisation: NA Concealment: NA BLINDING: open WITHDRAWAL/DROPOUT: response rate not reported	N: 1281 TD: NA; FU: NA LF: NA BC: NA Age: 51.9 (SD 14.8) Gender (per cent men): 48% Severity: 74% considered their psoriasis as at least moderately severe INCLUSION CRITERIA: members of the national psoriasis patient associations in France, UK, Belgium, Germany, and the Netherlands. EXCLUSION CRITERIA: not stated	Any antipsoriatic therapy	Compliance measured against PMAQ‐3w scale (patient medication adherence questionnaire): strict adherence to prescribed regimen over previous 3 days and last weekend Reasons for non‐compliance Perceived necessary measures to increase compliance	73% reported non‐compliance with current treatment Main reasons for non‐compliance: lack of efficacy, messiness, and time constraints To improve compliance, patients suggested improved efficacy, less greasy, sticky and smelly treatment, and fewer side‐effects.	Sponsorship not reported. 70% of responders used topical therapy	D
Gokdemir 2008	DESIGN: open uncontrolled study patient delivery ALLOCATION: non‐random Method of randomisation: NA Concealment: NA BLINDING: open WITHDRAWAL/DROPOUT: described	N: 109 TD: 8 wks; FU: 8 wks LF: 6 (6%) BC: NA Age: 40 (range: 16 to 70) Gender (per cent men): 43% Severity: PASI: 9.1 (range: 1.2 to 35) INCLUSION CRITERIA: chronic plaque psoriasis; received prescribed antipsoriatic therapy; aged ≥16; attending outpatient clinic in Istanbul. EXCLUSION CRITERIA: other types of psoriasis; hospitalised; pregnancy	Any prescribed antipsoriatic therapy	Medication adherence: number prescribed doses taken/number prescribed doses prescribed (see Zaghloul 2004).	Mean adherence for topical therapy: 72% (31%SD) Adherence rate was correlated with being unmarried, more highly educated, and being satisfied with treatment Main reasons for non‐adherence were busyness and 'being fed up'	Findings relate to any treatment for psoriasis (not just topical therapy) Sponsorship not reported	D
Richards 1999	DESIGN: questionnaire survey (cross‐sectional uncontrolled study) patient delivery ALLOCATION: non‐random Method of randomisation: NA Concealment: NA BLINDING: open WITHDRAWAL/DROPOUT: Response rate not reported	N: 120 TD: NA; FU: NA LF: NA BC: NA Age: 49 (18 to 84) Gender (per cent men): 54% Severity: Duration: range: 1 to 63 yrs INCLUSION CRITERIA: consecutive participants attending tertiary psoriasis specialty clinic; psoriasis. EXCLUSION CRITERIA: not stated	Any antipsoriatic therapy	Per cent complying with treatment (self report): scale not reported	39 per cent reported non‐compliance (sometimes/never complying) with prescribed treatment. The non‐compliant group had a higher self‐rated disease severity, were younger, and had a younger age at onset. The non‐compliant group reported that psoriasis had a greater impact on daily life Factors affecting compliance included the doctor‐participant relationship; optimism with the treatment prescribed; and a limited 'nuisance' value of treatment in terms of side‐effects and hassle of use	Sponsorship not reported 55% of participants were using topical therapies	D
van de Kerkhof 1998	DESIGN: questionnaire survey (uncontrolled study) patient delivery ALLOCATION: non‐random Method of randomisation: NA Concealment: NA BLINDING: NA WITHDRAWAL/DROPOUT: Response rate reported	N: 972 TD: NA; FU: NA Response rate: 13% BC: NA Age: 45.8 (range: 5 to 87) Gender (per cent men): 43% Severity: duration of psoriasis > 10 yrs in 67% of responders INCLUSION CRITERIA: subscribers to 'Psoriasis', the journal of the Dutch Psoriasis Patient Organisation EXCLUSION CRITERIA: none stated	Any topical antipsoriatic therapy	Per cent complying with frequency of application of prescribed topical therapies Reason for non‐compliance	29% of responders reported that the prescriber did not specify dosage frequency. Where dosage frequency was specified, 33% (39%) complied with twice (once) daily regimens Main reasons for non‐adherence were preference for less frequent dosage; greasiness; lack of efficacy; and higher‐than expected efficacy	Sponsorship not reported. 14‐item questionnaire mailed in 1996 to 6100 subscribers of Psoriasis, the Journal of the Dutch Psoriasis Patient Organisation Responders asked to report on compliance over past 6 mths	D
van de Kerkhof 2000	DESIGN: questionnaire survey (uncontrolled study) ALLOCATION: non‐random Method of randomisation: NA Concealment: NA BLINDING: single‐blind WITHDRAWAL/DROPOUT: response rate reported	N: 839 TD: NA; FU: NA LF: NA Response rate: 14% BC: NA Age: 48.5 (range: 4 to 91) Gender (per cent men): 46% Severity: duration of psoriasis ≥ 11 years in 62% of responders INCLUSION CRITERIA: subscribers to 'Psoriasis', the Journal of the Dutch Psoriasis Patient Organisation EXCLUSION CRITERIA: none stated	Any antipsoriatic therapy including topical treatments, photo(chemo)therapy and systemic therapy	Per cent complying with duration of prescribed treatment (topical therapies) Per cent complying with frequency of application of prescribed treatment (topical therapies) Reason for non‐compliance	Per cent complying with duration of prescribed treatment (topical therapies): 71% Per cent complying with frequency of application of prescribed treatment (topical therapies): 51% Main reasons for non‐adherence were preference for minimum dosage; time constraints; and lack of confidence in efficacy	Sponsorship not reported 41‐item questionnaire mailed to 6100 subscribers of Psoriasis, the Journal of the Dutch Psoriasis Patient Organisation Responders asked to report on compliance over past 6 mths	D
van de Kerkhof 2001	DESIGN: within‐patient (see Notes) patient delivery ALLOCATION: non‐random Method of randomisation: NA concealment: NA BLINDING: open WITHDRAWAL/DROPOUT: described	N: 976 TD: 8 wks; FU: 8 wks LF: 93 (9.5%) BC: NR Age: 45.6 (range: 7.4 to 88.4) Gender (per cent men): 52% Severity: BSA ≥ 10% in 51% of participants INCLUSION CRITERIA: psoriasis (type NR); eligible for treatment with calcipotriol EXCLUSION CRITERIA: concomitant topical or systemic antipsoriatic therapy; co‐existing skin disorder other than psoriasis	Calcipotriol cream OM plus calcipotriol ointment ON Calcipotriol ointment BD	Compliance: self‐reported number of days cream/ointment regimen applied	At wk 3, 72% of participants applied the regimen on most days. By wk 8, this statistic had fallen to 61% 51% of the 309 participants with previous experience of calcipotriol ointment monotherapy reported that their compliance with the cream/ointment regimen was higher	Sponsorship not reported Control group comprised retrospective self‐reported experience of calcipotriol ointment monotherapy by 35% of participants in the intervention group	D
Zaghloul 2004	DESIGN: uncontrolled study patient delivery ALLOCATION: non‐random Method of randomisation: NA Concealment: NA BLINDING: single‐blind (participants unaware that study focused on compliance) WITHDRAWAL/DROPOUT: described	N: 294 TD: 12 wks; FU: 12 wks LF: 93 (31.6%) BC: NA Age: 45.1 (range: 20 to 65) Gender (per cent men): 44.3% Severity: NR INCLUSION CRITERIA: psoriasis (unclear if chronic plaque only); aged 18 to 65; prescribed oral, topical or combined treatment EXCLUSION CRITERIA: pregnancy, lactation, concomitant disease	Topical, oral, or combined antipsoriatic medication No control	Medication adherence: (1) number prescribed doses taken/number prescribed doses prescribed (2) patient self‐report Quality of Life (DLQI) (0 to 30; higher score implies lower quality of life)	Medication adherence measured by method 1 (objective) much lower than by method 2 (patient self report). Mean rate: 60.6% (33.0%SD); (range: 0% to169%) Direct correlation observed between medication adherence and quality of life Adherence rate higher for participants who were women, married, employed, or not paying for prescriptions Adherence greater for topical (vs. systemic) therapy, once daily, or first‐time use	Authors report no relevant financial interests	D

per cent men: per cent male; AE(L): number local adverse events/number participants; AE(S): number systemic adverse events/number participants; AE: adverse events; BC: baseline comparability; BD: twice daily; BSA: body surface area; FU: follow up (includes TD); N: number enrolled; NA: not applicable; NR: not reported; OD: once daily; PASI: Psoriasis Area and Severity Index; PRN: as required; TD: treatment duration; TSS: Total Severity Score; WA: withdrawal due to adverse events