Poor Reporting of Quality of Life Outcomes in Dermatology Randomized Controlled Clinical Trials

Cleach, Laurence Le; Chassany, Olivier; Levy, Amit; Wolkenstein, Pierre; Chosidow, Olivier

doi:10.1159/000109358

Cited by 37 publications

(21 citation statements)

References 140 publications

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“…A randomized controlled trial to assess the impact of the formal introduction of a QoL measure in a clinical setting would be of great interest [14]. …”

Section: Discussionmentioning

confidence: 99%

Health-Related Quality of Life in Patients with Neurofibromatosis Type 1

et al. 2008

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Background/Aims: Neurofibromatosis type 1 (NF1), a genetic condition most commonly characterized by the presence of dermal neurofibromas and café au lait macules, has a significant impact upon quality of life (QoL). The study aimed to assess the impact of NF1 on QoL. Methods: A total of 129 patients with NF1 completed the study questionnaires in an Italian academic dermatological centre and a neurofibromatosis clinic at the University of Rome. Results: All domains of general-health-related QoL were affected.Patients with serious cosmetic problemsreported a greater impact on the emotional domain. Conclusion: In our study, the impact of the cosmetic features on QoL had the greatest importance. This survey demonstrates the usefulness of QoL measurements in supplementing clinical assessments.

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“…A randomized controlled trial to assess the impact of the formal introduction of a QoL measure in a clinical setting would be of great interest [14]. …”

Section: Discussionmentioning

confidence: 99%

Health-Related Quality of Life in Patients with Neurofibromatosis Type 1

et al. 2008

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“…DLQI data showed an enhanced quality of life after augmentation. Although the DLQI has proven to be an effective tool for clinical routine and randomized trials, it has not been specifically used for facial lipoatrophy before and therefore comparison with other study results is not possible [5, 6,26,27,28]. The decision to utilize this questionnaire was based on positive experiences in our department for evaluating quality of life in a variety of skin disorders such as psoriasis, acne and atopic dermatitis.…”

Section: Discussionmentioning

confidence: 99%

Hyaluronic Acid New Formulation: Experience in HIV-Associated Facial Lipoatrophy

et al. 2008

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Background: Facial lipoatrophy (FLA) is a stigmatizing complication of antiretroviral therapy in patients with human immunodeficiency virus (HIV) infection. Objectives: To evaluate the efficacy and safety of facial volume restoration in patients with HIV-associated FLA, using a novel long-lasting, hyaluronic acid high-density formulation. Methods: Twenty-one males with FLA were enrolled in this prospective, open-label, monocenter pilot study. Each patient received subcutaneous implantation of high-density hyaluronic acid. The aesthetic outcome was evaluated using the Global Aesthetic Improvement Scale every 3 months until 12 months after implantation. Additionally, patient satisfaction was analyzed, changes in patient quality of life were recorded using the Dermatology Life Quality Index (DLQI), and side effects were documented. Results: Nineteen patients (n = 19; 90.5%) were much improved or better 3 months after implantation, while 2 patients (n = 2; 9.5%) were improved and received a touch-up. Twelve months after implantation, still 16 patients (n = 16; 76.2%) were much improved or better, and 4 patients (n = 4; 19%) were improved. Patient satisfaction was high at every evaluation point over 12 months. The median DLQI before treatment was 16 (range: 13–19). Twelve months after augmentation, a significant decrease in the DLQI was observed (median: 9; range: 6–14) resulting in a relative reduction and significant improvement of the DLQI of 43.75% (p < 0.05), respectively. Side effects were mild and temporary (ecchymosis, edema and erythema). Conclusion: We propose the use of this new formulated hyaluronic acid for HIV-associated FLA as an efficacious and safe therapeutic option causing immediate augmentation of the soft tissues. The implant showed sustained longevity of 12 months and resulted in significant aesthetic improvement. It is notable for its simple and safe method of implantation and results in high patient satisfaction.

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“…The Dermatology Life Quality Index (DLQI) was developed in 1994 [6,7] to measure dermatological patients' QoL and is the most commonly used measure in clinical trials [8,9] . The DLQI is a reliable and valid instrument [7,10,11] .…”

Section: Introductionmentioning

confidence: 99%

Determining the Minimal Clinically Important Difference and Responsiveness of the Dermatology Life Quality Index (DLQI): Further Data

et al. 2015

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Aims: To determine the minimal clinically important difference (MCID) of the Dermatology Life Quality Index (DLQI) and its responsiveness to change in inflammatory skin diseases. Methods: A longitudinal study: at stage 1, patients completed the DLQI and a disease severity global question; at stage 2, a global rating of change in quality of life (QoL; Global Rating of Change Questionnaire, GRCQ) was added and used as an anchor to measure the MCID of the DLQI. Results: 192 patients completed stage 1 and 107 completed stage 2. The mean DLQI score at stage 1 was 9.8 and 7.4 at stage 2 with a mean change of 2.4 (p < 0.0001). 31 patients experienced a ‘small change' in their QoL (±3 and ±2) on the GRCQ. The mean corresponding change in DLQI scores was 3.3, which is regarded as the approximate MCID. Conclusions: Previous estimates of the MCID of the DLQI have varied from 3 to 5. Although this study demonstrated a MCID of 3.3, we recommend that the MCID in inflammatory skin diseases should be 4.

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Poor Reporting of Quality of Life Outcomes in Dermatology Randomized Controlled Clinical Trials

Cited by 37 publications

References 140 publications

Health-Related Quality of Life in Patients with Neurofibromatosis Type 1

Health-Related Quality of Life in Patients with Neurofibromatosis Type 1

Hyaluronic Acid New Formulation: Experience in HIV-Associated Facial Lipoatrophy

Determining the Minimal Clinically Important Difference and Responsiveness of the Dermatology Life Quality Index (DLQI): Further Data

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