Process evaluation of a multicentre randomised clinical trial of substituting surgical excisions of low-risk basal cell carcinomas from secondary to primary care

OBJECTIVES: In 2016, the SKINCATCH Trial, a clustered multi-centre randomised trial, was initiated to assess whether low-risk basal cell carcinomas (BCCs) can be treated by general practitioners (GPs) without loss of quality of care. The trial intervention consisted of a tailored 2-day educational course on skin cancer management. The aim of this process evaluation was to investigate GPs’ exposure to the intervention, implementation of the intervention and experiences with the intervention and trial. RESEARCH DESIGN AND METHODS: Data on exposure to the intervention, implementation and experiences were obtained at several points during the trial. Complementary quantitative components (ie, surveys, database analysis, medical record analysis) and qualitative components (ie, interviews and focus groups) were used. Quantitative data were analysed using descriptive statistics; qualitative data were summarised (barrier interviews) or audiorecorded, transcribed verbatim and thematically analysed using Atlas.Ti (focus groups). RESULTS: Following a 100% intervention exposure, results concerning the implementation of the trial showed that aside from the low inclusion rate of patients with low-risk BCCs (n=54), even less excisions of low-risk BCCs were performed (n=40). Although the intervention was experienced as highly positive, several barriers were mentioned regarding the trial including administrative challenges, lack of time and high workload of GPs, low volume of BCC patients and patients declining to participate or requesting a referral to a dermatologist. CONCLUSIONS: Although GPs’ participation in the highly valued training was optimal, several barriers may have contributed to the low inclusion and excision rate of low-risk BCCs. While some of the issues were trial-related, other barriers such as low patient-volume and patients requesting referrals are applicable outside the trial setting as well. This may question the feasibility of substitution of surgical excisions of low-risks BCCs from secondary to primary care in the current Dutch setting. TRIAL REGISTRATION NUMBER: Trial NL5631 (NTR5746)

Development and External Validation of a Prediction Model for Patients with Varicose Veins Suitable for Isolated Ambulatory Phlebectomy

Objective: Isolated ambulatory phlebectomy is a potential treatment option for patients with an incompetent great saphenous vein (GSV) or anterior accessory saphenous vein and one or more incompetent tributaries. Being able to determine which patients will most likely benefit from isolated phlebectomy is important. This study aimed to identify predictors for avoidance of secondary axial ablation after isolated phlebectomy and to develop and externally validate a multivariable model for predicting this outcome. Methods: For model development, data from patients included in the SAPTAP trial were used. The investigated outcome was avoidance of ablation of the saphenous trunk one year after isolated ambulatory phlebectomy. Pre-defined candidate predictors were analysed with multivariable logistic regression. Predictors were selected using Akaike information criterion backward selection. Discriminative ability was assessed by the concordance index. Bootstrapping was used to correct regression coefficients, and the C index for overfitting. The model was externally validated using a population of 94 patients, with an incompetent GSV and one or more incompetent tributaries, who underwent isolated phlebectomy. Results: For model development, 225 patients were used, of whom 167 (74.2%) did not undergo additional ablation of the saphenous trunk one year after isolated phlebectomy. The final model consisted of three predictors for avoidance of axial ablation: tributary length (&lt; 15 cm vs. &gt; 30 cm: odds ratio [OR] 0.09, 95% confidence interval [CI] 0.02 – 0.40; 15 – 30 cm vs. &gt; 30 cm: OR 0.18, 95% CI 0.09 – 0.38); saphenofemoral junction (SFJ) reflux (absent vs. present: OR 2.53, 95% CI 0.81 – 7.87); and diameter of the saphenous trunk (per millimetre change: OR 0.63, 95% CI 0.41 – 0.96). The discriminative ability of the model was moderate (0.72 at internal validation; 0.73 at external validation). Conclusion: A model was developed for predicting avoidance of secondary ablation of the saphenous trunk one year after isolated ambulatory phlebectomy, which can be helpful in daily practice to determine the suitable treatment strategy in patients with an incompetent saphenous trunk and one or more incompetent tributaries. Patients having a longer tributary, smaller diameter saphenous trunk, and absence of terminal valve reflux in the SFJ are more likely to benefit from isolated phlebectomy.</p

Carbonized blood deposited on fibres during 810, 940 and 1,470 nm endovenous laser ablation: thickness and absorption by optical coherence tomography

Endovenous laser ablation (EVLA) is commonly used to treat saphenous varicosities. Very high temperatures at the laser fibre tip have been reported during EVLA. We hypothesized that the laser irradiation deposits a layer of strongly absorbing carbonized blood of very high temperature on the fibre tip. We sought to prove the existence of these layers and study their properties by optical transmission, optical coherence tomography (OCT) and microscopy. We analysed 23 EVLA fibres, 8 used at 810 nm, 7 at 940 nm and 8 at 1,470 nm. We measured the transmission of these fibres in two wavelength bands (450–950 nm; 950–1,650 nm). We used 1,310 nm OCT to assess the thickness of the layers and the attenuation as a function of depth to determine the absorption coefficient. Microscopy was used to view the tip surface. All fibres showed a slightly increasing transmission with wavelength in the 450–950 nm band, and a virtually wavelength-independent transmission in the 950–1,650 nm band. OCT scans showed a thin layer deposited on all 13 fibres investigated, 6 used at 810 nm, 4 at 940 nm and 3 at 1,470 nm, some with inhomogeneities over the tip area. The average absorption coefficient of the 13 layers was 72 ± 16 mm−1. The average layer thickness estimated from the transmission and absorption measurements was 8.0 ± 2.7 µm. From the OCT data, the average maximal thickness was 26 ± 6 µm. Microscopy of three fibre tips, one for each EVLA wavelength, showed rough, cracked and sometimes seriously damaged tip surfaces. There was no clear correlation between the properties of the layers and the EVLA parameters such as wavelength, except for a positive correlation between layer thickness and total delivered energy. In conclusion, we found strong evidence that all EVLA procedures in blood filled veins deposit a heavily absorbing hot layer of carbonized blood on the fibre tip, with concomitant tip damage. This major EVLA mechanism is unlikely to have much wavelength dependence at similar delivered energies per centimetre of vein. Optical–thermal interaction between the vein wall and the transmitted laser light depends on wavelength

Quality of Life after Venous Stenting for Post-thrombotic Syndrome and the Effect of Inflow Disease

Objective: Patients with PTS experience an impaired quality of life (QoL). We aimed to study QoL in patients stented for post thrombotic syndrome (PTS) and analyze the influence of different parameters. Methods: Patients stented for PTS after iliofemoral deep vein thrombosis were asked to complete the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36) in this cross-sectional study. All other data were collected retrospectively. Primary endpoints were median CIVIQ-20 and physical (PCS) and mental (MCS) component summary SF-36 scores. The influence of age, sex, and years between the procedure and completion of questionnaire were investigated using a multivariate linear regression model. Wilcoxon signed rank test compared the PCS and MCS with the normative. Effects of inflow from the deep femoral vein (DFV) and/or the femoral vein (FV) on QoL was analyzed in patients with patent stents. Results: The response rate was 70.3% (n = 45/64). Time period (median) from stenting to questionnaire completion was 6.6 years (IQR: 8.0). Most stents were placed unilateral left-sided (73.3%). For patients with patent stents (n = 42) median CIVIQ-20 was 35.5 (IQR: 17.3), higher than the minimum of 20.0 (P &lt; .001). Median PCS of 44.7 (IQR: 14.2) was lower (P &lt; .001), and MCS of 55.9 (IQR: 7.1) higher (P = .001) than the normative (50.0). Time since stenting and sex were not associated with QoL. Age was a significant predictor [standardized coefficient ss = .36, P = .04] for QoL using the CIVIQ-20, but not for the SF-36. Inflow disease did not impact QoL, but patients with occluded stents (n = 3) had poor functioning levels. Conclusion: Quality of life is impaired after venous stenting for PTS, particularly physical functioning, among patients with an open stent, but was similar between patients with good and impaired inflow. Patients with a permanent stent occlusion had the lowest QoL

Quality of Life after Venous Stenting for Post-thrombotic Syndrome and the Effect of Inflow Disease

Objective: Patients with PTS experience an impaired quality of life (QoL). We aimed to study QoL in patients stented for post thrombotic syndrome (PTS) and analyze the influence of different parameters. Methods: Patients stented for PTS after iliofemoral deep vein thrombosis were asked to complete the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36) in this cross-sectional study. All other data were collected retrospectively. Primary endpoints were median CIVIQ-20 and physical (PCS) and mental (MCS) component summary SF-36 scores. The influence of age, sex, and years between the procedure and completion of questionnaire were investigated using a multivariate linear regression model. Wilcoxon signed rank test compared the PCS and MCS with the normative. Effects of inflow from the deep femoral vein (DFV) and/or the femoral vein (FV) on QoL was analyzed in patients with patent stents. Results: The response rate was 70.3% (n = 45/64). Time period (median) from stenting to questionnaire completion was 6.6 years (IQR: 8.0). Most stents were placed unilateral left-sided (73.3%). For patients with patent stents (n = 42) median CIVIQ-20 was 35.5 (IQR: 17.3), higher than the minimum of 20.0 (P &lt;.001). Median PCS of 44.7 (IQR: 14.2) was lower (P &lt;.001), and MCS of 55.9 (IQR: 7.1) higher (P =.001) than the normative (50.0). Time since stenting and sex were not associated with QoL. Age was a significant predictor [standardized coefficient ß =.36, P =.04] for QoL using the CIVIQ-20, but not for the SF-36. Inflow disease did not impact QoL, but patients with occluded stents (n = 3) had poor functioning levels. Conclusion: Quality of life is impaired after venous stenting for PTS, particularly physical functioning, among patients with an open stent, but was similar between patients with good and impaired inflow. Patients with a permanent stent occlusion had the lowest QoL.</p

The heat-pipe resembling action of boiling bubbles in endovenous laser ablation

Endovenous laser ablation (EVLA) produces boiling bubbles emerging from pores within the hot fiber tip and traveling over a distal length of about 20 mm before condensing. This evaporation-condensation mechanism makes the vein act like a heat pipe, where very efficient heat transport maintains a constant temperature, the saturation temperature of 100°C, over the volume where these non-condensing bubbles exist. During EVLA the above-mentioned observations indicate that a venous cylindrical volume with a length of about 20 mm is kept at 100°C. Pullback velocities of a few mm/s then cause at least the upper part of the treated vein wall to remain close to 100°C for a time sufficient to cause irreversible injury. In conclusion, we propose that the mechanism of action of boiling bubbles during EVLA is an efficient heat-pipe resembling way of heating of the vein wall

Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins

BackgroundMany case series have been published on treatments of varicose veins, but comparative randomized controlled trials remain sparse.ObjectiveTo compare the anatomic success rate, frequency of major complications, and quality-of-life improvement of endovenous laser ablation (EVLA), ultrasound-guided foam sclerotherapy (UGFS), and conventional surgery (CS), after 1-year follow-up.MethodsA total of 240 consecutive patients with primary symptomatic great saphenous vein reflux were randomized to EVLA, UGFS, or CS, consisting of high ligation and short stripping. Primary outcome was anatomic success defined as obliteration or absence of the treated vein on ultrasound examination after 1 year. Secondary outcomes were complications, improvement of the “C” class of the CEAP classification, and improvement of disease-specific (Chronic Venous Insufficiency Quality-of-Life Questionnaire) and general (EuroQol 5) quality-of-life scores.ResultsMore than 80% of the study population was classified as C2 or C3 venous disease. After 1 year, the anatomic success rate was highest after EVLA (88.5%), followed by CS (88.2%) and UGFS (72.2%) (P < .001). The complication rate was low and comparable between treatment groups. All groups showed significant (P < .001) improvement of EuroQol 5 and Chronic Venous Insufficiency Quality-of-Life Questionnaire scores after therapy; 84.3% of all treated patients showed an improvement of the “C” of the CEAP classification.ConclusionsAfter 1-year follow-up, EVLA is as effective as CS and superior to UGFS according to occlusion on ultrasound duplex. Quality of life improves after treatment in all groups significantly

Long-term outcomes, quality of life, and costs of treatment modalities for T1–T2 lip carcinomas

Purpose: Early stage lip squamous cell carcinoma (lip SCC) can be treated with conventional excision, Mohs micrographic surgery (MMS), or brachytherapy. The aim of this retrospective study was to describe the medical outcomes, patient-reported outcomes, and costs of these treatments. Methods: A retrospective cohort study of T1–T2 lip SSCs treated between 1996 and 2019. Medical outcomes, recurrences, and survival were retrieved from medical records. Facial appearance, facial function, and Quality of Life (QoL) were measured with the Face-Q H&amp;N and EQ-5D-5L questionnaires. Costs were also calculated. Results: Of the 336 lip SCCs, 122 were treated with excision, 139 with MMS, and 75 with brachytherapy. Locally, the recurrence rate was 2.7% and regionally 4.8%. There were 2% disease-related deaths. T2-stage and poor tumor differentiation were associated with recurrences. Posttreatment QoL, facial function, and appearance were rated as good. Brachytherapy was the most expensive treatment modality. Conclusion: Early-stage lip SCC has a good prognosis, with a disease-specific survival of 98.2% after a median follow-up of 36 months, there was a high QoL and satisfaction at long-term follow-up. Based on the costs and the risk of locoregional recurrences, we believe that, for most noncomplex lip SCCs, MMS would be the most logical treatment option.</p