Dataset Information

Cost effectiveness of home ultraviolet B phototherapy for psoriasis: economic evaluation of a randomised controlled trial (PLUTO study).

ABSTRACT:

Objective

To assess the costs and cost effectiveness of phototherapy with ultraviolet B light provided at home compared with outpatient ultraviolet B phototherapy for psoriasis.

Design

Cost utility, cost effectiveness, and cost minimisation analyses performed alongside a pragmatic randomised clinical trial (the PLUTO study) at the end of phototherapy (mean 17.6 weeks) and at one year after the end of phototherapy (mean 68.4 weeks).

Setting

Secondary care, provided by a dermatologist in the Netherlands.

Participants

196 adults with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy were recruited from the dermatology departments of 14 hospitals and were followed until the end of phototherapy. From the end of phototherapy onwards, follow-up was continued for an unselected, consecutive group of 105 patients for one year after end of phototherapy.

Interventions

Ultraviolet B phototherapy provided at home (intervention) and conventional outpatient ultraviolet B phototherapy (control) in a setting reflecting routine practice in the Netherlands. Both treatments used narrowband ultraviolet B lamps (TL-01).

Main outcome measures

Total costs to society, quality adjusted life years (QALYs) as calculated using utilities measured by the EQ-5D questionnaire, and the number of days with a relevant treatment effect (>/=50% improvement of the baseline self administered psoriasis area and severity index (SAPASI)).

Results

Home phototherapy is at least as effective and safe as outpatient phototherapy, therefore allowing cost minimisation analyses (simply comparing costs). The average total costs by the end of phototherapy were euro800 for home treatment and euro752 for outpatient treatment, showing an incremental cost per patient of euro48 (95% CI euro-77 to euro174). The average total costs by one year after the end of phototherapy were euro1272 and euro1148 respectively (difference euro124, 95% CI euro-155 to euro403). Cost utility analyses revealed that patients experienced equal health benefits-that is, a gain of 0.296 versus 0.291 QALY (home v outpatient) by the end of phototherapy (difference 0.0052, -0.0244 to 0.0348) and 1.153 versus 1.126 QALY by one year after the end of phototherapy (difference 0.0267, -0.024 to 0.078). Incremental costs per QALY gained were euro9276 and euro4646 respectively, both amounts well below the normally accepted standard of euro20 000 per QALY. Cost effectiveness analyses indicated that the mean number of days with a relevant treatment effect was 42.4 versus 55.3 by the end of phototherapy (difference -12.9, -23.4 to -2.4). By one year after the end of phototherapy the number of days with a relevant treatment effect were 216.5 and 210.4 respectively (6.1, -41.1 to 53.2), yielding an incremental cost of euro20 per additional day with a relevant treatment effect.

Conclusions

Home ultraviolet B phototherapy for psoriasis is not more expensive than phototherapy in an outpatient setting and proved to be cost effective. As both treatments are at least equally effective and patients express a preference for home treatment, the authors conclude that home phototherapy should be the primary treatment option for patients who are eligible for phototherapy with ultraviolet B light.

Trial registration

Current Controlled Trials ISRCTN83025173 and Clinicaltrials.gov NCT00150930.

SUBMITTER: Koek MB

PROVIDER: S-EPMC2857750 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo determine whether ultraviolet B phototherapy at home is equally safe and equally effective as ultraviolet B phototherapy in an outpatient setting for patients with psoriasis.DesignPragmatic multicentre single blind randomised clinical trial (PLUTO study).SettingDermatology departments of 14 hospitals in the Netherlands.Participants196 patients with psoriasis who were clinically eligible for narrowband (TL-01) ultraviolet B phototherapy. The first 105 consecutive patients were also followed for one year after therapy.InterventionUltraviolet B phototherapy at home using a TL-01 home phototherapy unit compared with standard narrowband ultraviolet B phototherapy in an outpatient setting. Both therapies were done in a setting reflecting routine daily practice in the Netherlands.Main outcome measuresThe main outcome measure was effectiveness as measured by the proportion of patients with a 50% or more reduction of the baseline psoriasis area and severity index (PASI) or self administered psoriasis area and severity index (SAPASI), called the PASI 50 and SAPASI 50 (relevant treatment effect). Another outcome of effectiveness was the percentage reduction in median scores on the PASI as well as SAPASI. Also the proportions of patients reaching the PASI 75 and SAPASI 75 (successful treatment effect), and the PASI 90 and SAPASI 90 (almost complete clearance) were calculated. Other secondary outcomes were quality of life (SF-36, psoriasis disability index), burden of treatment (questionnaire), patients' preferences and satisfaction (questionnaire), and dosimetry and short term side effects (diary).Results82% of the patients treated at home compared with 79% of the patients treated in an outpatient setting reached the SAPASI 50 (difference 2.8%, 95% confidence interval -8.6% to 14.2%), and 70% compared with 73% reached the PASI 50 (-2.3%, -15.7% to 11.1%). For patients treated at home the median SAPASI score decreased 82% (from 6.7 to 1.2) and the median PASI score decreased 74% (from 8.4 to 2.2), compared with 79% (from 7.0 to 1.4) and 70% (from 7.0 to 2.1) for patients treated in an outpatient setting. Treatment effect as defined by the mean decline in PASI and SAPASI scores was significant (P<0.001) and similar across groups (P>0.3). Total cumulative doses of ultraviolet B light were similar (51.5 v 46.1 J/cm(2), difference 5.4, 95% confidence interval -5.2 to 16.0), and the occurrence of short term side effects did not differ. The burden of undergoing ultraviolet B phototherapy was significantly lower for patients treated at home (differences 1.23 to 3.01, all P</=0.001). Quality of life increased equally regardless of treatment, but patients treated at home more often rated their experience with the therapy as "excellent" (42%, 38/90) compared with patients treated in the outpatient department (23%, 20/88; P=0.001).ConclusionUltraviolet B phototherapy administered at home is equally safe and equally effective, both clinically and for quality of life, as ultraviolet B phototherapy administered in an outpatient setting. Furthermore, ultraviolet B phototherapy at home resulted in a lower burden of treatment and led to greater patients' satisfaction. Trial registration Current Controlled Trials ISRCTN83025173 and Clinicaltrials.gov NCT00150930.

Project description:BackgroundHome ultraviolet B (UVB) treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis").MethodsWe designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI) and the Self Administered PASI (SAPASI) scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006.DiscussionIn the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population. Because, in addition to effectiveness, aspects such as quality of life and cost-effectiveness are also taken into consideration, this study will produce valuable evidence to either support or discourage prescription of home UVB phototherapy.Trial registrationCurrent controlled trials/Nederlands Trial register: ISRCTN83025173. Clinicaltrials.gov: NCT00150930.

Project description:ObjectiveThis study aims to estimate the cost-effectiveness of oral spironolactone plus routine topical treatment compared with routine topical treatment alone for persistent acne in adult women from a British NHS perspective over 24 weeks.DesignEconomic evaluation undertaken alongside a pragmatic, parallel, double-blind, randomised trial.SettingPrimary and secondary healthcare, community and social media advertising.ParticipantsWomen ≥18 years with persistent facial acne judged to warrant oral antibiotic treatment.InterventionsParticipants were randomised 1:1 to 50 mg/day spironolactone (increasing to 100 mg/day after 6 weeks) or matched placebo until week 24. Participants in both groups could continue topical treatment.Main outcome measuresCost-utility analysis assessed incremental cost per quality-adjusted life year (QALY) using the EQ-5D-5L. Cost-effectiveness analysis estimated incremental cost per unit change on the Acne-QoL symptom subscale. Adjusted analysis included randomisation stratification variables (centre, baseline severity (investigator's global assessment, IGA <3 vs ≥3)) and baseline variables (Acne-QoL symptom subscale score, resource use costs, EQ-5D score and use of topical treatments).ResultsSpironolactone did not appear cost-effective in the complete case analysis (n=126 spironolactone, n=109 control), compared with no active systemic treatment (adjusted incremental cost per QALY £67 191; unadjusted £34 770). Incremental cost per QALY was £27 879 (adjusted), just below the upper National Institute for Health and Care Excellence's threshold value of £30 000, where multiple imputation took account of missing data. Incremental cost per QALY for other sensitivity analyses varied around the base-case, highlighting the degree of uncertainty. The adjusted incremental cost per point change on the Acne-QoL symptom subscale for spironolactone compared with no active systemic treatment was £38.21 (complete case analysis).ConclusionsThe results demonstrate a high level of uncertainty, particularly with respect to estimates of incremental QALYs. Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis.Trial registration numberISRCTN registry (ISRCTN12892056).

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Project description:OBJECTIVE:To assess whether telephone coaching is a cost-effective method for increasing physical activity and health-related quality of life for insufficiently active adults presenting to an ambulatory care clinic in a public hospital. DESIGN:An economic evaluation was performed alongside a randomised controlled trial. SETTING:Participants were recruited from an ambulatory care clinic in a public hospital in regional Australia. PARTICIPANTS:Seventy-two adults (aged 18-69) deemed insufficiently physically active via self-report. INTERVENTIONS:Participants were randomised to either an intervention group that received an education session and eight sessions of telephone coaching over a 12-week period, or to a control group that received the education session only. The intervention used in the telephone coaching was integrated motivational interviewing and cognitive behavioural therapy. OUTCOME MEASURES:The primary health outcome was change in moderate-to-vigorous physical activity (MVPA), objectively measured via accelerometry. The secondary outcome was the quality-adjusted life-year (QALY) determined by the 12-item Short Form Health Survey Questionnaire. Outcome data were measured at baseline, postintervention (3 months) and follow-up (6 months). Incremental cost-effectiveness ratios (ICERs) were calculated for each outcome. Non-parametric bootstrapping techniques and sensitivity analyses were performed to account for uncertainty. RESULTS:The mean intervention cost was $279±$13 per person. At 6 months follow-up, relative to control, the intervention group undertook 18 more minutes of daily MVPA at an ICER of $15/min for each additional minute of MVPA. With regard to QALYs, the intervention yielded an ICER of $36 857 per QALY gained. Sensitivity analyses indicated that results were robust to varied assumptions. CONCLUSION:Telephone coaching was a low-cost strategy for increasing MVPA and QALYs in insufficiently physically active ambulatory care hospital patients. Additional research could explore the potential economic impact of the intervention from a broader healthcare perspective. TRIAL REGISTRATION NUMBER:ANZCTR: ACTRN12616001331426.

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