No full-text available
To read the full-text of this research,
you can request a copy directly from the author.
Seguridad del paciente en las unidades de fototerapia
ResearchGate has not been able to resolve any citations for this publication.
An increasing focus on the prevention of medical errors is a direct result of a growing patient safety movement. Although the reduction of technical errors has been the focus of most interventions, cognitive errors, usually more than one error linked together, actually cause the majority of misdiagnoses. This article examines the most common types of cognitive errors in dermatology. Two methods to minimize these errors are recommended: first, cognitive debiasing techniques reduce the common initiating factor of error cascades; and secondly, the application of prospective hindsight attacks the final common pathway that leads to misdiagnosis.
It is essential to develop a consensus document on phototherapy in order to adapt this procedure to the specific characteristics, needs and reality of our milieu.Using a review of existing literature on the subject and the experience of its own members as a reference, the Spanish Photobiology Group (GEF) of the Spanish Academy of Dermatology and Venereology (AEDV) has developed some therapeutic guidelines for the most widely used modes of phototherapy: PUVA therapy and narrow-band UVB (NBUVB) therapy. These guidelines deal with generalities about the equipment, calibration and regulation in phototherapy booths, and the concept and indications for these forms of treatment are reviewed. Recommendations are also proposed regarding patient selection, therapeutic procedures, associated pharmacological agents of interest and the prevention and management of adverse effects.The consensus document is designed as a flexible and practical instrument intended for use in daily clinical practice, aimed at optimizing the possibilities of phototherapy while reducing risks for patients and therapists.
Background:
To date, no study to our knowledge has examined the nature and scope of medical error in dermatology practice.
Objective:
We sought to collect and categorize physician-reported errors in dermatology practice.
Methods:
A survey regarding most recent and most serious errors was developed and distributed to dermatologists attending US meetings. A total of 150 responses were received outlining 152 most recent errors and 130 most serious errors. Survey responses, along with classification systems for other specialties, were used to develop a classification system for medical error in dermatology.
Results:
The respondents' demographics reflected the specialty: 63% were male, 60% were older than 50 years, and 60% were in solo or group private practice. Of the most recent errors reported, 85% happened once a year or less, and 86% did not result in harm to patients. The most common categories of both most recent and most serious errors were related to assessment (41% and 31%, respectively) and interventions (44% and 52%, respectively). Assessment errors were primarily related to investigations, and commonly involved the biopsy pathway. Intervention errors in the most recent and most serious errors were split between those related to medication (54% and 27%) and those related to procedures (46% and 73%). Of note, 5 and 21 wrong-site surgeries were reported in the most recent and most serious errors groups, respectively.
Limitations:
Our findings are subject to respondent and recall bias and our classification system, although an important first step, is likely incomplete.
Conclusion:
Our findings highlight several key areas of patient care in need of safety initiatives, namely the biopsy pathway, medication management, and prevention of wrong-site surgery.
Oral 8-methoxypsoralen-UV-A (PUVA) and narrowband UV-B (NB-UVB or UVB TL-01) are effective and widely used treatments for chronic plaque psoriasis. Although the role of PUVA therapy in skin carcinogenesis in humans with psoriasis has been clearly demonstrated, there is still controversy regarding the risk of skin cancer with NB-UVB. Furthermore, there is no clear evidence about the maximum cumulative number of sessions not to be exceeded in a lifetime.
To assess the respective cutaneous carcinogenic risks of PUVA or NB-UVB in psoriasis; to estimate the respective dose-relationship between skin cancers and PUVA or NB-UVB; to estimate a maximum number of sessions for PUVA or NB-UVB not to be exceeded in a lifetime.
A systematic literature search was carried out in Medline, Embase and Cochrane Library databases from1980 to December 2010 in English and French, with the keywords 'Psoriasis' AND 'UVB therapy' AND 'UVA therapy' AND 'cancer' AND 'skin' OR 'neoplasm' OR 'cutaneous carcinoma' OR 'melanoma'.
Of 243 identified references, 49 published studies were included. Most of them (45/49) concerned PUVA therapy, with 41 assessing the risk of non-melanoma skin cancers (NMSC) following PUVA. All publications referring to the US prospective PUVA follow-up study revealed an increased risk of NMSC with the following characteristics: risk most pronounced for squamous cell carcinomas developing even with low exposures and increasing linearly with the number of sessions, tumors occurring also on non-exposed skin including invasive penile tumors, risk persisting after cessation of treatment. An increased risk of basal cell carcinomas was observed in patients receiving more than hundred PUVA sessions. The four prospective European studies selected in our review and most of the pre-1990 European and US retrospective studies failed to find a link between exposure to PUVA and skin cancer. Only the most recent cohorts, including three large long-term retrospective European studies comparing records with their respective national cancer registries reported on an independent increased risk of NMSC with PUVA, The risk was lower as compared to the US prospective PUVA follow-up study. Six studies assessed the risk of melanoma following PUVA therapy: two of the three US publications coming from the same PUVA prospective follow-up study revealed an increased risk with more than doubled incidence of both invasive and in situ melanoma among patients exposed to at least 200 PUVA treatments compared with patients exposed to lower doses, whereas the three retrospectives European studies, comparing the incidence of melanoma in PUVA users with national cancer registers, did not find any increased risk of melanoma. No increased risk of skin cancer was evidenced in the four studies specifically assessing the potential carcinogenic risk of NB-UVB.
There is an increased risk of skin cancer following PUVA, shown by both US and European studies. The greater risk measured by the US studies may be at least partly explained by high UVA dose exposure and the lighter phototypes of the treated patients. The lack of prospective studies in psoriasis patients treated with NB-UVB constitutes a barrier to the robust assessment of carcinogenic risk of this phototherapy technique.
BackgroundPhototherapy, PUVA therapy and narrow-band UVB are recognised forms of first-line therapy for extensive and severe plaque psoriasis. Based on a systematic review of the medical literature, we propose a good practice guideline for the use of narrow-band UVB phototherapy in this indication.MethodsWe carried out a review of the literature published over the 20 years (1998 to 2009) in the online PubMed database. Our conclusions are based on the results of control studies or where these are absent, on a synthesis of the recommendations common practice approved by the experts of the French Society of Photodermatology. The levels of scientific proof given are based on the criteria defined by Sackett.Results Recommendations(1) Practical aspects. Irradiation cabins equipped with Philips TL01 tubes, either for monotherapy (42 tubes) or for combined therapy (21 UVB tubes and 21 UVA tubes), were to be certified (CE marking, ISO-DIN certification) and equipped with an accurate dosimetry system. Several valid and usable protocols exist. The indication was based on the severity and extent of the episode of psoriasis, the psychological consequences of the dermatosis, comparison of the benefit/risk ratios of the various available treatments, the ability of the patient to attend sessions (a vital factor in therapeutic compliance), the cumulative doses of UV from previous courses of treatment, and absence of contraindications, including the use of photosensitising medication. Informed consent was to be obtained from patients, who were given a validated information sheet (available at www.sfdermato.org). The study results and the value of maintenance therapy were not confirmed. (2) Adverse effects. The immediate adverse effects were generally of little consequence, with later effects alone posing problems. Because of the risk of induction of cataract, ocular protection must be used during sessions. In the absence of symptoms or known ocular disorder, prior ophthalmologic control is not considered necessary. The risk of skin cancer remains poorly defined, and this risk has not been clearly shown to be lower than with broad-spectrum UVB therapy or PUVA. The studies give no indication of the number of sessions after which therapy must be completely discontinued. In the absence of clear evaluation of oncogenic risk, it seems reasonable to set the maximum number of sessions of UVB TL01 phototherapy at 250 as with PUVA, and to include in this limit the total of all PUVA and TL01 phototherapy sessions for patients receiving both types of phototherapy (level of proof: B). In the absence of lesions requiring treatment in these areas, the face and male genital organs should be protected during treatment sessions. There is no currently available data concerning carcinogenic risk induced by TL01 in patients also on cyclosporine, methotrexate or biotherapies. In order to reduce risk and maintain patients’ capacity to undergo further phototherapy sessions, we suggest (level of proof: A) the following measures: strict patient selection, use of combined synergistic therapies, annual examination of the skin and appendages of subjects receiving more than 150 phototherapy sessions, and the creation of nationally accessible patient phototherapy files. (3) Combined treatments. The purpose of such treatment is twofold: to reduce the risk of adverse effects while increasing the efficacy of TL01 phototherapy. Lesions should be sloughed before the start of phototherapy. Synergistic effects have been demonstrated for dermal corticosteroids and tazarotene, but such effects are less noticeable with topical vitamin D3 derivatives. If there are no contraindications to its prescription, we feel that acitretine has demonstrated efficacy in enhancing the effect of TL01 phototherapy. (4) Efficacy. Narrow-spectrum UVB phototherapy is considered highly effective in extensive psoriasis. At a rate of three sessions per week, it results in complete (or almost complete) eradication of lesions in 60 to 90 % of patients within 20 to 40 sessions (level of proof: A). However, the efficacy of this therapy varies according to plaque size and noticeably better results are obtained in guttate and nummular psoriasis than in psoriasis involving large plaques.ConclusionNarrow-spectrum UVB phototherapy offers a good alternative to PUVA therapy since concomitant psoralen is not required, but there are few immediate adverse effects, there is less risk of drug-induced photosensitisation, and there is no need for skin or ocular photoprotection after sessions. We recommend this approach as the first-line phototherapy (level of proof: A) in children and adolescents, and in adults with extensive moderate psoriasis involving small superficial plaques. It may also be used in pregnant or breastfeeding women and in patients with renal or hepatic insufficiency. In addition, it is preferable for HIV-positive subjects (level of proof: C). However, PUVA therapy is preferable as first-line treatment in extensive severe psoriasis involving large thick plaques (level of proof: A) and in adults of phototypes IV to VI (level of proof: B); it should also be contemplated for psoriasis refractory to UVB TL01 (level of proof: B).
By 1977, psoralen and ultraviolet A (PUVA) was established as a highly effective therapy for psoriasis. Because of concerns about potential long-term adverse effects, particularly cancer, the PUVA Follow-Up Study was established to assess long-term risk and benefits of PUVA.
We sought to determine the association of certain squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) risk with exposure to PUVA.
For nearly 30 years, this prospective cohort study of 1380 patients with psoriasis first treated with PUVA in 1975 to 1976 documented exposures and incident events including biopsy-proven skin cancers.
From 1975 to 2005, 351 of 1380 (25%) cohort patients developed 2973 biopsy-proven SCC and 330 (24%) developed 1729 BCCs. After adjusting for age, gender, and significant confounders, the risk of developing one or more SCC in a year was strongly associated with total number of PUVA treatments (350-450 vs <50 treatments, incidence rate ratio [IRR] = 6.01, 95% confidence interval [CI] = 4.41-8.20). When all tumors are included this risk is significantly higher (IRR = 20.92, 95% CI = 14.08-31.08). Corresponding risks for BCC were much lower (person counts IRR = 3.09, 95% CI = 2.36-4.06; tumor counts IRR = 2.12, 95% CI = 1.47-3.05).
This was an observational prospective study of a cohort with severe psoriasis. An unknown factor associated with higher dose exposure to PUVA in our cohort that was not included in our analysis could account for the observed associations.
Exposure to more than 350 PUVA treatments greatly increases the risk of SCC. Exposure to fewer than 150 PUVA treatments has, at most, modest effects on SCC risk. Even high-dose exposure to PUVA does not greatly increase BCC risk. The risks of SCC in long-term PUVA-treated patients should be considered in determining the risk of this therapy relative to other treatments for severe psoriasis.
Phototherapy, PUVA therapy and narrow-band UVB are recognised forms of first-line therapy for extensive and severe plaque psoriasis. Based on a systematic review of the medical literature, we propose a good practice guideline for the use of narrow-band UVB phototherapy in this indication.
We carried out a review of the literature published over the 20 years (1998 to 2009) in the online PubMed database. Our conclusions are based on the results of control studies or where these are absent, on a synthesis of the recommendations common practice approved by the experts of the French Society of Photodermatology. The levels of scientific proof given are based on the criteria defined by Sackett. RESULTS RECOMMENDATIONS: (1) Practical aspects. Irradiation cabins equipped with Philips TL01 tubes, either for monotherapy (42 tubes) or for combined therapy (21 UVB tubes and 21 UVA tubes), were to be certified (CE marking, ISO-DIN certification) and equipped with an accurate dosimetry system. Several valid and usable protocols exist. The indication was based on the severity and extent of the episode of psoriasis, the psychological consequences of the dermatosis, comparison of the benefit/risk ratios of the various available treatments, the ability of the patient to attend sessions (a vital factor in therapeutic compliance), the cumulative doses of UV from previous courses of treatment, and absence of contraindications, including the use of photosensitising medication. Informed consent was to be obtained from patients, who were given a validated information sheet (available at www.sfdermato.org). The study results and the value of maintenance therapy were not confirmed. (2) Adverse effects. The immediate adverse effects were generally of little consequence, with later effects alone posing problems. Because of the risk of induction of cataract, ocular protection must be used during sessions. In the absence of symptoms or known ocular disorder, prior ophthalmologic control is not considered necessary. The risk of skin cancer remains poorly defined, and this risk has not been clearly shown to be lower than with broad-spectrum UVB therapy or PUVA. The studies give no indication of the number of sessions after which therapy must be completely discontinued. In the absence of clear evaluation of oncogenic risk, it seems reasonable to set the maximum number of sessions of UVB TL01 phototherapy at 250 as with PUVA, and to include in this limit the total of all PUVA and TL01 phototherapy sessions for patients receiving both types of phototherapy (level of proof: B). In the absence of lesions requiring treatment in these areas, the face and male genital organs should be protected during treatment sessions. There is no currently available data concerning carcinogenic risk induced by TL01 in patients also on cyclosporine, methotrexate or biotherapies. In order to reduce risk and maintain patients' capacity to undergo further phototherapy sessions, we suggest (level of proof: A) the following measures: strict patient selection, use of combined synergistic therapies, annual examination of the skin and appendages of subjects receiving more than 150 phototherapy sessions, and the creation of nationally accessible patient phototherapy files. (3) Combined treatments. The purpose of such treatment is twofold: to reduce the risk of adverse effects while increasing the efficacy of TL01 phototherapy. Lesions should be sloughed before the start of phototherapy. Synergistic effects have been demonstrated for dermal corticosteroids and tazarotene, but such effects are less noticeable with topical vitamin D3 derivatives. If there are no contraindications to its prescription, we feel that acitretine has demonstrated efficacy in enhancing the effect of TL01 phototherapy. (4) Efficacy. Narrow-spectrum UVB phototherapy is considered highly effective in extensive psoriasis. At a rate of three sessions per week, it results in complete (or almost complete) eradication of lesions in 60 to 90 % of patients within 20 to 40 sessions (level of proof: A). However, the efficacy of this therapy varies according to plaque size and noticeably better results are obtained in guttate and nummular psoriasis than in psoriasis involving large plaques.
Narrow-spectrum UVB phototherapy offers a good alternative to PUVA therapy since concomitant psoralen is not required, but there are few immediate adverse effects, there is less risk of drug-induced photosensitisation, and there is no need for skin or ocular photoprotection after sessions. We recommend this approach as the first-line phototherapy (level of proof: A) in children and adolescents, and in adults with extensive moderate psoriasis involving small superficial plaques. It may also be used in pregnant or breastfeeding women and in patients with renal or hepatic insufficiency. In addition, it is preferable for HIV-positive subjects (level of proof: C). However, PUVA therapy is preferable as first-line treatment in extensive severe psoriasis involving large thick plaques (level of proof: A) and in adults of phototypes IV to VI (level of proof: B); it should also be contemplated for psoriasis refractory to UVB TL01 (level of proof: B).
Phototoxicity is the most significant short-term adverse effect of PUVA therapy.
We attempted to determine the incidence and possible causes of phototoxicity of sufficient degree to cause interruption of treatment.
A retrospective study was conducted of 16,506 PUVA treatments given to 414 patients in two treatment centers.
Phototoxicity occurred in 10.9% of patients and was an adverse effect in 0.3% of treatments. Problems with the treatment protocol were the main cause.
Phototoxicity is a common adverse effect, and patients should be warned of this potential occurrence. Awareness of the causes may help to reduce the incidence of this problem.
Photochemotherapy with oral methoxsalen (psoralen) and ultraviolet A radiation (PUVA) is an effective treatment for psoriasis. However, PUVA is mutagenic, increases the risk of squamous-cell skin cancer, and can cause irregular, pigmented skin lesions. We studied the occurrence of melanoma among patients treated with PUVA.
We prospectively identified cases of melanoma and documented the extent of exposure to PUVA among 1380 patients with psoriasis who were first treated with PUVA in 1975 or 1976. Using incidence data, we calculated the expected incidence of melanoma in this cohort and compared it with the observed incidence. Using regression models, we assessed the risks of melanoma associated with a long time (> or = 15 years) since the first treatment and with a large number of PUVA treatments (> or = 250).
From 1975 through 1990, we detected four malignant melanomas, about the number expected in the overall population (relative risk, 1.1). From 1991 through 1996, we detected seven malignant melanomas (relative risk, 5.4; 95 percent confidence interval, 2.2 to 11.1). The risk of melanoma was higher in the later period than in the earlier one (incidence-rate ratio, 3.8) and higher among patients who received at least 250 PUVA treatments than among those who received fewer treatments (incidence-rate ratio, 3.1).
About 15 years after the first treatment with PUVA, the risk of malignant melanoma increases, especially among patients who receive 250 treatments or more.
PUVA and UVB phototherapy are very effective and popular treatments for a variety of dermatological problems. This article gives an overview of the possible acute and chronic adverse effects of these therapies.
Systems for reporting adverse events can reduce medical errors by uncovering remediable problems in processes of care; however, current reporting systems are neither widely used nor highly effective. Reporting systems work best when they are confidential and easy to use, provide expert analysis of reports, and give timely feedback.
Summary These guidelines for use of narrowband (TL-01) ultraviolet B have been prepared for dermatologists by the British Photodermatology Group on behalf of the British Association of Dermatologists. They present evidence-based guidance for treatment of patients with a variety of dermatoses and photodermatoses, with identification of the strength of evidence available at the time of preparation of the guidelines, and a brief overview of background photobiology.
Ultraviolet (UV) radiation therapies are commonly used to treat a wide range of dermatological conditions. However, no published data exist regarding the rate of acute adverse events occurring within the different UV therapy modalities.
The aim of this study was to determine the rate of acute adverse events experienced by patients receiving narrow-band UVB or photochemotherapy in 3 neighboring dermatology units.
Standardized adverse event forms from all 3 units were retrospectively analysed over a 12-month period between October 2003 and September 2004. The treatments included were narrow-band UVB and systemic, bath and hand/foot PUVA.
A total of 8784 treatments were given over the study period. The total number of acute adverse events recorded for all phototherapy treatments was 70 (0.8%). The rates of acute adverse events for each treatment modality were 0.6% for narrow-band UVB, 1.3% for systemic PUVA, 1.3% for bath PUVA and 0.8% for hand/foot PUVA. Adverse events were due to patient non-compliance with standard operating procedures in 15 cases (21%) and operator error in 2 (3%). Only 4 of the acute adverse events were considered to be severe, accounting for 0.05% of all treatments.
The rates of acute adverse events with phototherapy in this analysis were low, in particular the rate of severe adverse events. The highest rate was seen with both systemic and bath PUVA. The number of adverse events resulting from operator error was low. These published rates for adverse events associated with narrow-band UVB and PUVA may help other units when analyzing their own rate of adverse events.
Ultraviolet phototherapy management of moderate-to-severe plaque psoriasis: an evidence-based, analysis
- Health Quality
- Ontario
Health Quality Ontario. Ultraviolet phototherapy management of moderate-to-severe plaque psoriasis: an evidence-based, analysis. Ont Health Technol Assess Ser. 2009;9:1–66.