Systems-level barriers to treatment in a cervical cancer prevention program in Kenya: Several observational studies.

OBJECTIVE: To identify health systems-level barriers to treatment for women who screened positive for high-risk human papillomavirus (hrHPV) in a cervical cancer prevention program in Kenya. METHODS: In a trial of implementation strategies for hrHPV-based cervical cancer screening in western Kenya in 2018-2019, women underwent hrHPV testing offered through community health campaigns, and women who tested positive were referred to government health facilities for cryotherapy. The current analysis draws on treatment data from this trial, as well as two observational studies that were conducted: 1) periodic assessments of the treatment sites to ascertain availability of resources for treatment and 2) surveys with treatment providers to elicit their views on barriers to care. Bivariate analyses were performed for the site assessment data, and the provider survey data were analyzed descriptively. RESULTS: Seventeen site assessments were performed across three treatment sites. All three sites reported instances of supply stockouts, two sites reported treatment delays due to lack of supplies, and two sites reported treatment delays due to provider factors. Of the 16 providers surveyed, ten (67%) perceived lack of knowledge of HPV and cervical cancer as the main barrier in women's decision to get treated, and seven (47%) perceived financial barriers for transportation and childcare as the main barrier to accessing treatment. Eight (50%) endorsed that providing treatment free of cost was the greatest facilitator of treatment. CONCLUSION: Patient education and financial support to reach treatment are potential areas for intervention to increase rates of hrHPV+ women presenting for treatment. It is also essential to eliminate barriers that prevent treatment of women who present, including ensuring adequate supplies and staff for treatment.

Influence of sociodemographic factors on treatment's choice for localized prostate cancer in Portugal.

INTRODUCTION: Patients with localized prostate cancer (PCa) are active participants in the choice of treatment. OBJECTIVES: To access the effects of social and demographic factors in the choice of treatment in cases of localized PCa, in a Portuguese population. METHODS: Identification of all patients with the diagnosis of localized PCa in the last four years in an oncological centre. Evaluation of the effects of sociodemographic factors (age, profession, literacy, marital status, district and number of inhabitants of the place of residence) in the choice of treatment. RESULTS: 300 patients with localized PCa were evaluated: 17.3% (n = 52) opted for radical prostatectomy (RP); 39,3% had (n = 118) external radiotherapy; brachytherapy in 29.3% (n = 88) and other options (active surveillance, cryotherapy and hormonal therapy) in 14.1% (n = 42). In relation to surgical treatment (RP) the following results were obtained: a) > 70 years: 3.9% (n = 5); ≤ 70 years: 27.5% (n = 47), p < 0.001; b) primary sector: 10.3% (n = 3); secondary sector: 16.2% (n = 27); tertiary sector: 24.1% (n = 21); quaternary sector: 8.3% (n = 1), p = 0.296; c) marital status married: 17.9% (n = 47); single: 0% (n = 0); divorced: 25.0% (n = 5); widow: 0% (n = 0), p = 0.734; d) residency in a city: 14.1% (n = 13); city > 4000 habitants: 22.7% (n = 15); city ≤ 4000 habitants: 16.9% (n = 24), p = 0.701. Using multinomial regression with age (p = 0.001), district (p = 0.035), marital status (p = 0.027) and profession (0.179), this model explained 17.2%-28.4% of therapeutic choices (p < 0.001). CONCLUSIONS: The main socioeconomical factor that influence treatment choice was age. Unmarried patients over 70 years choose less radical prostatectomy. Other sociodemographic factors have minor influence in the choice of the treatment.

Thermo-coagulation versus cryotherapy for treatment of cervical precancers: A prospective analytical study in a low-resource African setting.

AIMS: To evaluate the outcomes of cryotherapy and thermo-coagulation in the treatment of cervical precancers. METHOD: Prospective analytical study. Women who screened positive to visual inspection with acetic acid and confirmed by colposcopy using the Swede's score were randomized to receive either cryotherapy or thermo-coagulation. Participants were re-evaluated 6 months later. RESULTS: A total of 11 124 women were screened. Only 1023 of the 1294 colposcopically confirmed positive cases were eligible for ablative therapy. Five hundred and twelve women received cryotherapy while 511 women received thermo-coagulation. Cryotherapy had similar cure rate with thermo-coagulation (85.5 vs 89.2%, P = 0.09). The mean patient satisfaction score for thermo-coagulation was higher than that for cryotherapy (3.9 ± 1.3 vs 2.8 ± 1.7; P < 0.0001). The mean duration of treatment per patient was higher for cryotherapy than thermo-coagulation (660.0 ± 0.0 vs 50.9 ± 15.3 s, P < 0.0001). The mean cost of treatment per patient was significantly higher for cryotherapy than for thermo-coagulation (2613.1 ± 254.9 vs 533.2 ± 45.2 Nigerian Naira, P < 0.0001). Higher proportion of women who had thermo-coagulation reported no side effect (55.2 vs 12.5%, P < 0.0001). CONCLUSION: Cryotherapy and thermo-coagulation have similar efficacy in the treatment of cervical precancers. Thermo-coagulation offers lower cost and lower duration of treatment, less side effects and higher patient satisfaction than cryotherapy. Thermo-coagulation should be the recommended ablative treatment method for low-resource settings of the world.

Assessing Nurses' Adherence to the See-and-Treat Guidelines of Botswana's National Cervical Cancer Prevention Programme.

The see-and-treat approach for cervical cancer screening [visual inspection with acetic acid (VIA) followed by immediate cryotherapy] was first pilot tested in Botswana in 2009. Botswana's Ministry of Health and the Botswana-UPenn Partnership collaborated to expand see-and-treat to five additional sites throughout the country in 2014. The purpose of this study was to evaluate whether nurses' adherence to guideline-based screening was maintained during scale-up. Therefore, we compared nurses' adherence between the pilot and scaled-up sites and determined main drivers of nonadherence across all sites. We conducted a retrospective review of 6,644 medical charts from Botswana's National Cervical Cancer Prevention Programme between February 2014 and October 2015. Using multivariable regression modeled with generalized estimating equations, we determined whether nurses' adherence to the see-and-treat guideline differed between the pilot and scale-up sites after controlling for significant covariates. Overall, adherence to the guideline was high (88.4%). Although the scaled-up sites had higher adherence compared with the pilot site (90.9% vs. 80.2%, respectively), the difference between sites was not statistically significant in the multivariable model (P = 0.221). Of the nonadherent clinical encounters, the three most frequent visit types were VIA not performed (178, 23.3%), VIA negative: HIV unknown (163, 21.3%), and VIA negative: HIV negative (144, 18.9%). The most common reason for nonadherence was misspecification of follow-up times. Despite known challenges of scaling-up health innovations in resource-limited settings, our study shows that nurses maintained guideline-adherent care in Botswana's national see-and-treat program. The successful scale-up may have been attributable to the program's intensive quality assurance monitoring.

Assessment of the scale-up of cervical cancer screening in Abidjan stratified by HIV status.

OBJECTIVE: To report the successes and challenges of scaling up a population-based cervical cancer (CC) screening program from HIV clinics to various healthcare facilities in Abidjan, Côte d'Ivoire. METHOD: A retrospective analysis of characteristics, outcomes, and follow-up of women attending an initial CC screening visit in Abidjan between January 2010 and December 2014. Data were collected via forms that were systematically completed during CC screening visits. Data from the 2014 population census were used to estimate screening coverage. RESULTS: Among 16 169 women attending an initial CC screening, 1616 (10.0%) had a positive VIA test. Among 848 women eligible for immediate cryotherapy, 618 (72.9%) underwent the "see-and-treat" approach. The 1-year follow-up rate after cryotherapy was 23.1% (143/618), and was higher among women with HIV (111/362, 30.7%) than among other women (32/256, 12.5%) (P=0.001). The estimated coverage of CC screening in Abidjan was 1.2% (95% confidence interval, 0.6-3.1). CONCLUSION: Despite successful expansion of CC screening from HIV clinics to other facilities, the estimated screening coverage of the targeted population remained low. Follow-up of positively screened and treated women is a major challenge, especially outside HIV clinics, and would benefit from an innovative information system proving unique identification and tracking systems.

Active treatment in low-risk prostate cancer: a population-based study.

Background: Active surveillance instead of active treatment (at) is preferred for patients with low-risk prostate cancer (lr-pca), but practice varies widely. We conducted a population-based study to assess the proportion of patients who underwent at between January 2011 and December 2014, and to evaluate factors associated with at. Methods: The provincial cancer registry was linked to administrative health datasets to identify patients with lr-pca and to acquire demographic, tumour, and treatment data. The primary outcome was receipt of at during the first 12 months after diagnosis, defined as any receipt of external-beam radiotherapy, brachytherapy, radical prostatectomy, cryotherapy, or androgen deprivation. Univariate and multivariate logistic regression were used to analyze the correlation between patient and tumour factors and at. Results: Of 1565 patients with lr-pca, 554 (35.4%) underwent at within 12 months of diagnosis. Radical prostatectomy was the most common treatment (58%), followed by brachytherapy (29.6%). Younger age [odds ratio (or) 0.92; 95% confidence interval (ci): 0.91 to 0.94], lower score (≥3) on the Charlson comorbidity index (OR: 0.36; 95% ci: 0.19 to 0.68), T2 stage (or: 3.05; 95% ci: 2.03 to 4.58), higher prostate-specific antigen (psa) at diagnosis (or: 1.13; 95% ci: 1.06 to 1.21), radiation oncologist consultation (or: 3.35; 95% ci: 2.55 to 4.39), and earlier diagnosis year (2012 or: 0.46; 95% ci: 0.34 to 0.63; 2013 or: 0.45; 95% ci: 0.32 to 0.63; 2014 or: 0.33; 95% ci: 0.23 to 0.47) were associated with a higher probability of at. Conclusions: This contemporary population-based study demonstrates that approximately one third of patients with lr-pca undergo at. Patients of younger age, with less comorbidity, a higher tumour stage, higher psa, earlier year of diagnosis, and radiation oncologist consultation were more likely to undergo at. Further investigation is needed to identify strategies that could minimize overtreatment.

Patient factors affecting successful linkage to treatment in a cervical cancer prevention program in Kenya: A prospective cohort study.

OBJECTIVE: To identify patient factors associated with whether women who screened positive for high-risk human papillomavirus (hrHPV) successfully accessed treatment in a cervical cancer prevention program in Kenya. METHODS: A prospective cohort study was conducted as part of a trial of implementation strategies for hrHPV-based cervical cancer screening in western Kenya from January 2018 to February 2019. In this larger trial, women underwent hrHPV testing during community health campaigns (CHCs), and hrHPV+ women were referred to government facilities for cryotherapy. For this analysis, we looked at rates of and predictors of presenting for treatment and presenting within 30 days of receiving positive hrHPV results ("timely" presentation). Data came from questionnaires completed at the time of screening and treatment. Multivariable logistic regression was used to identify factors associated with each outcome. RESULTS: Of the 505 hrHPV+ women, 266 (53%) presented for treatment. Cryotherapy was performed in 236 (89%) of the women who presented, while 30 (11%) were not treated: 15 (6%) due to gas outage, six (2%) due to pregnancy, five (2%) due to concern for cervical cancer, and four (2%) due to an unknown or other reason. After adjusting for other factors in the multivariable analysis, higher education level and missing work to come to the CHC were associated with presenting for treatment. Variables that were associated with increased likelihood of timely presentation were missing work to come to the CHC, absence of depressive symptoms, told by someone important to come to the CHC, and shorter distance to the treatment site. CONCLUSION: The majority of hrHPV+ women who did not get treated were lost at the stage of decision-making or accessing treatment, with a small number encountering barriers at the treatment sites. Patient education and financial support are potential areas for intervention to increase rates of hrHPV+ women seeking treatment.

'I'm here to save my life': a qualitative study of experiences navigating a cryotherapy referral system for human papillomavirus-positive women in western Kenya.

BACKGROUND: We sought to understand the beliefs, social norms and logistical factors that affect human papillomavirus (HPV)-positive women's uptake of cryotherapy treatment as part of a two-part cervical cancer screening strategy in rural Kenya. METHODS: In-depth interviews within a parent cluster-randomised trial. SETTING: Government-run county hospital in western Kenya. PARTICIPANTS: 273 of 372 (73.4%) HPV-positive women who underwent cryotherapy RESULTS: Many women feared that an HPV infection meant they would develop cancer. Almost all women reported initial fear of the treatment procedure, followed by a more positive experience than anticipated. Lacking funds for transportation to the treatment site was the most common barrier. Women felt that decentralised treatment would be the most important facilitator of greater access. Spousal encouragement and financial support were key facilitators of treatment access, however many women felt that other husbands in the community would not be supportive. Women described successfully acquiring treatment as empowering, and almost all would recommend seeking cryotherapy to other women who test HPV-positive. Most felt eager to share their own experiences with others to encourage treatment. CONCLUSIONS: The main facilitators of treatment access were understanding of the health risks and sense of empowerment. A decentralised treatment model or transportation support may facilitate access, along with improved health messaging about HPV infection, cancer and the treatment process. Focusing on women's personal feelings of empowerment may further improve uptake and satisfaction. These data will be used to design a strategy to improve linkage to treatment. TRIAL REGISTRATION: NCT02124252.

Healthcare utilization and management of actinic keratosis in primary and secondary care: a complementary database analysis.

BACKGROUND: The high prevalence of actinic keratosis (AK) requires the optimal use of healthcare resources. OBJECTIVES: To gain insight in to the healthcare utilization of people with AK in a population-based cohort, and the management of AK in a primary and secondary care setting. METHODS: A retrospective cohort study using three complementary data sources was conducted to describe the use of care, diagnosis, treatment and follow-up of patients with AK in the Netherlands. Data sources consisted of a population-based cohort study (Rotterdam Study), routine general practitioner (GP) records (Integrated Primary Care Information) and nationwide claims data (DRG Information System). RESULTS: In the population-based cohort (Rotterdam Study), 69% (918 of 1322) of participants diagnosed with AK during a skin-screening visit had no previous AK-related visit in their GP record. This proportion was 50% for participants with extensive AK (i.e. ≥ 10 AKs; n = 270). Cryotherapy was the most used AK treatment by both GPs (78%) and dermatologists (41-56%). Topical agents were the second most used treatment by dermatologists (13-21%) but were rarely applied in primary care (2%). During the first AK-related GP visit, 31% (171 of 554) were referred to a dermatologist, and the likelihood of being referred was comparable between low- and high-risk patients, which is inconsistent with the Dutch general practitioner guidelines for 'suspicious skin lesions' from 2017. Annually, 40 000 new claims representing 13% of all dermatology claims were labelled as cutaneous premalignancy. Extensive follow-up rates (56%) in secondary care were registered, while only 18% received a claim for a subsequent cutaneous malignancy in 5 years. CONCLUSIONS: AK management seems to diverge from guidelines in both primary and secondary care. Underutilization of field treatments, inappropriate treatments and high referral rates without proper risk stratification in primary care, combined with extensive follow-up in secondary care result in the inefficient use of healthcare resources and overburdening in secondary care. Efforts directed to better risk differentiation and guideline adherence may prove useful in increasing the efficiency in AK management. What's already known about this topic? The prevalence of actinic keratosis (AK) is high and, in particular, multiple AKs are a strong skin cancer predictor. The high prevalence of AK requires optimal use of healthcare resources. Nevertheless, (population based) AK healthcare utilization and management data are very rare. What does this study add? Although AK-related care already consumes substantial resources, about 70% of the AK population has never received care. Primary care AK management demonstrated underutilization of topical therapies and high referral rates without proper risk stratification, while in secondary care the extensive follow-up schedules were applied. This inefficient use of healthcare resources highlights the need for better harmonization and risk stratification to increase the efficiency of AK care.

Risks of cervical intraepithelial neoplasia grade 3 or invasive cancers in ASCUS women with different management: a population-based cohort study.

OBJECTIVE: To investigate the progression risk of atypical squamous cells of undetermined significance (ASCUS) with different clinical managements. METHODS: Women with their first diagnosis of ASCUS cytology were retrieved from the national cervical cancer screening database and linked to the national health insurance research database to identify the management of these women. The incidences of developing cervical intraepithelial neoplasia grade 3 and invasive cervical cancer (CIN3+) were calculated, and the hazard ratios (HRs) were estimated using a Cox proportional hazards model. This study was approved by the Research Ethics Committee of the National Taiwan University Hospital and is registered at ClinicalTrials.gov (Identifier: NCT02063152). RESULTS: There were total 69,741 women included. Various management strategies including colposcopy, cervical biopsies and/or endocervical curettage, and cryotherapy, failed to reduce the risk of subsequent CIN3+ compared with repeat cervical smears. Loop electrosurgical excision procedure/conization significantly decreased risk of subsequent CIN3+ lesions (HR=0.22; 95% confidence interval [CI]=0.07-0.68; p=0.010). Women in their 40s-50s had an approximately 30% risk reduction compared to other age groups. Women with a previous screening history >5 years from the present ASCUS diagnosis were at increased risk for CIN3+ (HR=1.24; 95% CI=1.03-1.49; p=0.020). CONCLUSION: In women of first-time ASCUS cytology, a program of repeat cytology can be an acceptable clinical option in low-resource settings. Caution should be taken especially in women with remote cervical screening history more than 5 years.

Effect of primary admission to burn centers on the outcomes of severely burned patients.

OBJECTIVE: Burns represent a special form of severe trauma. Due to long hospitalization, rehabilitation, and extensive scar treatment, severe burn injuries rank among the most expensive traumatic injuries regarding associated health care costs. The presented single-burn-center experiences evaluated the effects of primary versus secondary burn intensive care unit (BICU) admissions on outcomes in severely burned patients. METHODS: Within 30 months, 186 patients were admitted to the BICU. The cases were divided into two groups depending on their admission type: "primary" vs. "secondary". All patients were analyzed retrospectively regarding the need for surgery, encountered complications, time of hospitalization and overall survival. RESULTS: The incidence of primary BICU-admissions was 65.1%. Both patient groups were comparable regarding demographics, comorbidities, % TBSA burn, associated inhalation injuries, ABSI scores and intubation rates (p>0.05). Both groups received similar numbers of operations and had overall comparable mortality rates (p>0.05). However, duration until first burn excision, length of ventilation, as well as BICU- and overall hospital length of stay were significantly shorter in the "primary"- compared to the "secondary" group (p<0.05). CONCLUSION: Several burn societies have published precise criteria of when a patient needs to be referred to a burn center. In the presented series, patients that were primarily treated at a BICU showed significantly better outcomes regarding several parameters. In order to further optimize treatment of burn patients it therefore appears that precise initial assessment and if appropriate respective primary transport to dedicated burn centers needs to be re-emphasized, especially among first- and emergency care providers.

Variation in the diagnosis and clinical management of lentigo maligna across Europe: a survey study among European Association of Dermatologists and Venereologists members.

BACKGROUND: Lentigo maligna (LM), a form of melanoma in situ, is treated to prevent progression to lentigo maligna melanoma (LMM). Surgical treatment is the gold standard. However, treatment guidelines are based on expert opinion, and comparative studies are lacking. OBJECTIVE: The objective of this study was to assess the diagnostic methods and clinical management of LM patients among European dermatologists and residents. METHODS: A survey consisting of 29 questions about diagnostic methods and treatment options used for LM patients was sent to 3308 members of the European Association of Dermatologists and Venereologists (EADV). RESULTS: Most questions were multiple choice, and multiple answers could be ticked per question. A total of N = 415 (12.5%) completed surveys were included in the analyses. A combination of clinical diagnosis (65.7%), dermatoscopy (83.4%) and histopathology (88.2%) is used by most respondents to diagnose LM. Tissue for histopathological evaluation was collected most often using a single punch biopsy in 61.0%. The most common treatment for LM patients <60 years of age is surgery (97.6%). For LM patients >70 years of age, 66.8% of the respondents preferred surgical treatment. Non-surgical options such as radiotherapy (17.0%), topical imiquimod (30.6%), watchful waiting (19.6%) or cryotherapy (20.4%) were used in this elderly group. Subanalysis showed that respondents who take into account patient preference used topical imiquimod, radiotherapy and watchful waiting more often. CONCLUSION: In conclusion, the results of this survey show that there is a variance in the diagnostic methods and treatment modalities used for LM across Europe. Surgery remains the most utilized option. However, non-surgical options, such as topical imiquimod and radiotherapy, are most often used for elderly patients. We recommend that future studies focus on patient preference and compare surgical to non-surgical therapy.

Nondrug Interventions Reduce Pain and Opioid Use After Total Knee Arthroplasty.

According to this study.

Effects of Localized Cold Therapy on Pain in Postoperative Spinal Fusion Patients: A Randomized Control Trial.

BACKGROUND: Cold therapy used in the sports medicine settings has been found to be effective in reducing postoperative pain; however, there are limited studies that examine the effect of cold therapy on postoperative pain in patients with posterior lumbar spinal fusion. PURPOSE: The purpose of this study was to determine the effects of cold on postoperative spine pain and add to the body of knowledge specific to practical application of cold therapy in the spine surgery setting. METHODS: Researchers used a two-group randomized control design to evaluate the effects of local cold therapy on postoperative pain and analgesia use after lumbar spinal fusion surgery. The primary outcome was postoperative pain. Secondary outcomes included analgesia use and perceived benefit of cold therapy. RESULTS: The intervention (cold) group had a marginally greater reduction in mean Numerical Rating Scale score across all 12 pain checks (M ± SD = -1.1 ± 0.8 points reduction vs. -1.0 ± 0.8 points reduction, p = .589). On average, the intervention group used less morphine equivalents (M ± SD = 12.6 ± 31.5 vs. 23.7 ± 40.0) than the control group across pain checks seven to 12 (p = .042). CONCLUSIONS: This study provides additional evidence to support the use of cold therapy as an adjuvant pain management strategy to optimize pain control and reduce opioid consumption following spine fusion surgical procedures.

Cryotherapy Treatment After Arthroscopic Knee Debridement and ACL Reconstruction: A Review.

Pain, swelling, and inflammation of the knee joint and its surrounding soft-tissue structures are common during the postoperative period after arthroscopic knee debridement and anterior cruciate ligament reconstruction. These challenges can make patient recovery difficult immediately after surgery. Several options exist, however, to help patients overcome these challenges. Cryotherapy has been noted to decrease pain, swelling, and inflammation. However, while a number of studies exist characterizing the use of cryotherapy after knee surgery, no definitive cryotherapy devices and modalities have been identified. Therefore, the purpose of this review was to evaluate randomized controlled trials to assess the use of cryotherapy after: 1) arthroscopic debridement; and 2) anterior cruciate ligament reconstruction.

Low-Dose-Rate Brachytherapy Versus Cryotherapy in Low- and Intermediate-Risk Prostate Cancer.

PURPOSE: Cryotherapy and brachytherapy are definitive local treatment options for low- to intermediate-risk prostate cancer. There are both prospective and retrospective data for brachytherapy, but the use of cryotherapy has been limited primarily to single-institution retrospective studies. Currently, no published evidence has compared low-dose-rate brachytherapy versus cryotherapy. METHODS AND MATERIALS: Institutional review board approval was obtained to conduct a retrospective chart review of consecutive patients treated at our institution from 1990 to 2012. For inclusion, patients must have received a prostate cancer diagnosis and have been considered to have low- to intermediate-risk disease according to the National Comprehensive Cancer Network criteria. All patients received brachytherapy or cryotherapy treatment. Disease specifics and failure details were collected for all patients. Failure was defined as prostate-specific antigen nadir +2 ng/mL. RESULTS: A total of 359 patients were analyzed. The groups comprised 50 low-risk cryotherapy (LRC), 92 intermediate-risk cryotherapy (IRC), 133 low-risk brachytherapy (LRB), and 84 intermediate-risk brachytherapy (IRB) patients. The median prostate-specific antigen follow-up periods were 85.6 months (LRC), 59.2 months (IRC), 74.9 months (LRB), and 59.8 months (IRB). The 5-year biochemical progression-free survival (bPFS) rate was 57.9% in the cryotherapy group versus 89.6% in the brachytherapy group (P<.0001). The 5-year bPFS rate was 70.0% (LRC), 51.4% (IRC), 89.4% (LRB), and 89.7% (IRB). The bPFS rate was significantly different between brachytherapy and cryotherapy for low- and intermediate-risk groups (P<.05). The mean nadir temperature reached for cryotherapy patients was -35°C (range, -96°C to -6°C). Cryotherapy used a median of 2 freeze-thaw cycles (range, 2-4 freeze-thaw cycles). CONCLUSIONS: Results from this study suggest that cryotherapy is inferior to brachytherapy for patients with low- to intermediate-risk prostate cancer. Patient selection criteria for consideration of cryotherapy and brachytherapy are similar in terms of anesthesia candidacy. Therefore, cryotherapy would not be recommended as a first-line local therapy for this particular patient subset.

National Trends and Predictors of Androgen Deprivation Therapy Use in Low-Risk Prostate Cancer.

PURPOSE: Androgen deprivation therapy (ADT) is not recommended for low-risk prostate cancer because of its lack of benefit and potential for harm. We evaluated the incidence and predictors of ADT use in low-risk disease. METHODS AND MATERIALS: Using the National Cancer Database, we identified 197,957 patients with low-risk prostate cancer (Gleason score of 3 + 3 = 6, prostate-specific antigen level <10 ng/mL, and cT1-T2a) diagnosed from 2004 to 2012 with complete demographic and treatment information. We used multiple logistic regression to evaluate predictors of ADT use and Cox regression to examine its association with all-cause mortality. RESULTS: Overall ADT use decreased from 17.6% in 2004 to 3.5% in 2012. In 2012, 11.5% of low-risk brachytherapy patients and 7.6% of external beam radiation therapy patients received ADT. Among 82,352 irradiation-managed patients, predictors of ADT use included treatment in a community versus academic cancer program (adjusted odds ratio [AOR], 1.60; 95% confidence interval [CI], 1.50-1.71; P<.001; incidence, 14.0% vs 6.0% in 2012); treatment in the South (AOR, 1.51), Midwest (AOR, 1.81), or Northeast (AOR, 1.90) versus West (P<.001); and brachytherapy use versus external beam radiation therapy (AOR, 1.32; 95% CI, 1.27-1.37; P<.001). Among 25,196 patients who did not receive local therapy, predictors of primary ADT use included a Charlson-Deyo comorbidity score of ≥2 versus 0 (AOR, 1.42; 95% CI, 1.06-1.91; P=.018); treatment in a community versus academic cancer program (AOR, 1.61; 95% CI, 1.37-1.90; P<.001); and treatment in the South (AOR, 1.26), Midwest (AOR, 1.52), or Northeast (AOR, 1.28) versus West (P≤.008). Primary ADT use was associated with increased all-cause mortality in patients who did not receive local therapy (adjusted hazard ratio, 1.28; 95% CI, 1.14-1.43; P<.001) after adjustment for age and comorbidity. CONCLUSIONS: ADT use in low-risk prostate cancer has declined nationally but may remain an issue of concern in certain populations and regions.

Pulmonary Vein Isolation with the Cryoballoon Technique: Feasibility, Procedural Outcomes, and Adoption in the Real World: Data from One Shot Technologies TO Pulmonary Vein Isolation (1STOP) Project.

BACKGROUND: Catheter ablation (CA) is recommended for patients with drug refractory symptomatic atrial fibrillation (AF). "One Shot" catheters have been introduced to simplify CA and cryoballoon ablation (CBA) is spreading rapidly. Few real-world data are available on standard clinical practice, mainly from single-center experience. We aimed to evaluate clinical settings, demographics, and acute procedural outcomes in a large cohort of patients treated with CBA. METHODS: A total of 903 patients (73% male, mean age 59 ± 11) underwent pulmonary vein CBA. Correlations between the patient's inclusion time and clinical characteristics, procedure duration, acute success rate, and intraprocedural complications were evaluated. RESULTS: Seventy-seven percent of patients were affected by paroxysmal AF and 23% by persistent AF. Overall, acute success rate was 97.9% and periprocedural complications were observed in 35 (3.9%) patients, 13 (1.4%) of which were classified as major complications. With respect to the patient's inclusion time analysis, an increase in treatment of persistent AF was observed, a significant decrease in CBA times (procedure, ablation, and fluoroscopy: 136.0 ± 46.5 minutes, 28.8 ± 19.6 minutes, and 34.3 ± 15.4 minutes, respectively) was observed, with comparable acute success rate and intraprocedural complications over time. The rate of major complications was extremely low (1.4%); no death, atrioesophageal fistula, stroke, or other major periinterventional or late complications occurred. CONCLUSION: This series represents the largest experience of CBA in the treatment of AF that also describes the adoption curve of this relatively recent technology. CBA showed an excellent safety profile when performed in a large real-world clinical setting, with satisfactory acute success rate and, on average, short procedural times. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).

Moderate Sedation Reduces Lab Time Compared to General Anesthesia during Cryoballoon Ablation for AF Without Compromising Safety or Long-Term Efficacy.

BACKGROUND: Cryoballoon ablation (CBA) for paroxysmal atrial fibrillation (pAF) can be performed under general anesthesia (GA) or moderate sedation (MS). Our objective was to compare the effectiveness, safety, procedure duration, and time spent in the electrophysiology (EP) laboratory for CBA performed under GA and MS. METHODS: Patients undergoing a first CBA for pAF were identified. Patients received either GA administered by an anesthesiologist or MS with midazolam and fentanyl administered by EP laboratory staff. Total time in laboratory (sum of procedure and nonprocedure time); fluoroscopy time; freedom from documented AF, atrial flutter, and atrial tachycardia (FFAF); acute pulmonary vein isolation (PVI) rate; and 30-day complication rate were assessed. RESULTS: A total of 55 patients received GA and 119 patients received MS. PVI success rate was 100% in GA and 98.1% in MS (P = 0.04). Total laboratory time was longer for GA (280.4 ± 54.1 minutes vs 245.5 ± 54.7 minutes; P < 0.001), related to longer nonprocedure time (92.2 ± 28.8 minutes GA vs 71.0 ± 30.0 minutes MS; P < 0.001), but not procedure time (188.3 ± 49.3 minutes GA vs 174.5 ± 50.2 minutes MS; P = 0.09). FFAF was not significantly different over a median follow-up duration of 0.9 (interquartile range 0.4-1.9) years (61.8% GA vs 63.0% MS; log-rank P = 0.90). There was no significant difference in complication rate. CONCLUSION: Compared to GA, MS during CBA for pAF was independently associated with shorter total EP laboratory time without compromising FFAF or complication rates.

Focal Cryotherapy for localized prostate cáncer / Crioterapia Focal para el cáncer de próstata localizado

OBJECTIVE: To systematically review the oncological and functional outcomes of contemporary primary prostate focal cryotherapy for localized prostate cancer in the context of current developments in prostate focal therapy. METHODS: We performed a systematic search of the Pubmed, Cochrane and Embase databases to identify studies where primary prostate focal cryotherapy was performed to treat prostate cancer. These included reports on focal/ lesion/ sector ablation, hemi-ablation and partial prostate ablation. We excluded salvage focal therapy studies. Where multiple reports were published over time from a single cohort, the latest one was used. RESULTS: Our search yielded 290 publications, including 17 primary reports on eight single-center cohort studies and one multi-center registry report. Of 1,595 men identified, mean age was 60.5-69.5 years and mean PSA 5.1-7.8 ng/ml. When stratified Arch. Esp. Urol. 2016; 69 (6): 317-326 317 by D'Amico risk criteria, 52% of the aggregate total number of men were low-risk, 38% intermediate-risk and 10% high-risk. Besides 12-core TRUS biopsy, 3 cohorts reported using TTMB and one included mpMRI to select men for focal treatment. Median follow-up ranged from 13-63 months. BPFS ranged from 71-98%. The overall post-treatment positive biopsy rate was 8-25%. Among 5 cohorts with a mandatory 6-12 month posttreatment biopsy, 216 of 272 men (79%) did undergo biopsy, with 47 positive (21.8%). Of these, 15 were infield, 26 outfield, 2 bilateral and 4 undeclared. Ten upgraded to Gleason ≥ 7. Overall, two men had metastatic disease and none died of prostate cancer. Post-treatment continence rates were 96-100% and rates of erectile dysfunction ranged from 0-42%. The rate of post-treatment urinary retention ranged from 0-15%. The rate of recto-urethral fistula was 0-0.1%. CONCLUSION: Focal cryotherapy for localized prostate cancer is a safe and provides good preservation of sexual and urinary function. Accurate cancer localization and risk stratification is key to patient selection. In highly selected patients, focal therapy has good short to medium term oncological efficacy

OBJETIVO: Revisión sistemática de los resultados oncológicos y funcionales de la crioterapia focal primaria de la próstata contemporánea en el contexto de los desarrollos actuales en terapia focal prostática. MÉTODOS: Realizamos una búsqueda sistemática de las bases de datos PubMed, Cochrane y Embase para identificar estudios donde se realizara crioterapia focal primaria prostática para el tratamiento del cáncer de próstata. Éstos incluían comunicaciones de ablación focal/lesional/sectorial, hemiablación y ablación prostática parcial. Excluimos los estudios de terapia focal de salvamento. En los casos en que había múltiples artículos de una única cohorte publicados en el tiempo se utilizó el último. RESULTADOS: Nuestra búsqueda obtuvo 290 publicaciones, incluyendo 17 comunicaciones primarias de ocho estudios de cohortes de un único centro y una comunicación de un registro multicéntrico. De 1595 hombres identificados, la edad media era 60,5-69,5años y el PSA medio 5,1-7,8 ng/ml. Estratificando por los criterios de riesgo de D`Amico, el 52% del numero total agregado de hombres eran de bajo riesgo, el 38% de riesgo intermedio y el 10% de alto riesgo. Aparte de la biopsia transrectal de 12 muestras, 3 cohortes comunicaban la utilización de la biopsia por mapeo transperineal con plantilla y una incluía la RMN multiparamétrica para seleccionar casos para terapia focal. La mediana de seguimiento tenía un rango entre 13-63 meses. La supervivencia libre de progresión bioquímica estaba en un rango del 71 al 98%. La tasa global de biopsia positiva después de tratamiento era del 8-25%. Entre 5 cohortes con una biopsia obligatoria a los 6-12 meses post-tratamiento, 216 de 272 hombres (79%) fueron sometidos a biopsia, con 47 biopsias positivas (21,8%). De éstos, 15 estaban dentro del campo, 26 fuera, 2 bilaterales y 4 no declaradas. 10 casos ascendieron a Gleason≥7. Globalmente, dos hombres tuvieron enfermedad metastática y ninguno murió del cáncer de próstata. Las tasas de continencia post-tratamiento fueron del 96-100% y las de disfunción eréctil en el rango entre 0-42%. Las tasa de retención urinaria post tratamiento estaban en el rango entre 0-15%. La tasa de fístula recto-uretral fue de 0-0,1%. CONCLUSIÓN: La crioterapia focal para el cáncer de próstata localizado es segura y ofrece una buena preservación de las funciones urinaria y sexual. La localización precisa del cáncer y la estratificación por riesgos son esenciales para la selección del paciente. En pacientes altamente seleccionados la terapia focal tiene una buena eficacia oncológica a corto y medio plazo