The Melanoma Genomics Managing Your Risk Study randomised controlled trial: statistical analysis plan.

BACKGROUND: The Melanoma Genomics Managing Your Risk Study is a randomised controlled trial that aims to evaluate the efficacy of providing information on personal genomic risk of melanoma in reducing ultraviolet radiation (UV) exposure, stratified by traditional risk group (low or high phenotypic risk) in the general population. The primary outcome is objectively measured total daily Standard Erythemal Doses at 12 months. Secondary outcomes include UV exposure at specific time periods, self-reported sun protection and skin-examination behaviours, psychosocial outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the cost-effectiveness of the intervention. OBJECTIVE: To publish the pre-determined statistical analysis plan (SAP) before database lock and the start of analysis. METHODS: This SAP describes the data synthesis, analysis principles and statistical procedures for analysing the outcomes from this trial. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid potential analysis bias that may arise from knowledge of the outcome data. RESULTS: This SAP is consistent with best practice and should enable transparent reporting. CONCLUSION: This SAP has been developed for the Melanoma Genomics Managing Your Risk Study and will be followed to ensure high-quality standards of internal validity and to minimise analysis bias. TRIAL REGISTRATION: Prospectively registered with the Australian New Zealand Clinical Trials Registry, ID: ACTR N12617000691347 . Registered on 15 May 2017.

Insomnia and excessive daytime sleepiness in women and men receiving methadone and buprenorphine maintenance treatment.

Background: Insomnia and excessive daytime sleepiness (EDS) are reported to be common in methadone maintenance treatment (MMT) but much less is known about these symptoms in buprenorphine maintenance treatment (BMT) and in women compared with men. Methods: Cross sectional study of recipients of BMT (n = 113, 47 women), MMT (n = 184, 94 women), people using opioids nonmedically (nonopioid agonist treatment, non-OAT: n = 87, 31 women) and a reference group with no opioid use (RG; n = 105, 53 women) in Australia. Measures included Athens Insomnia Scale, Epworth Sleepiness Scale, the Hospital Anxiety and Depression Scale, and other substance use. Results: Insomnia (Athens Insomnia Scale, total ≥10) was highly prevalent among all people who use opioids (BMT 46.0-68.1%; MMT 55.4-69.6%; non-OAT 58.6-80.5%), did not differ significantly among these groups, and was significantly associated with anxiety and depression. EDS (Epworth score >10) was found in 14.2% of BMT, 22.8% of MMT, 35.6% of non-OAT groups, and 11.4% of the RG, and was significantly associated with depression overall. Fewer people had Epworth score >15 indicating more severe EDS (BMT 4.4%, MMT 6.0%; non-OAT 13.8%; RG 1.9%). Insomnia and EDS did not differ by sex or by opioid dose, nor were they significantly associated with other drug use, housing stress or social security status. Conclusions: Insomnia was common in people receiving OAT and using opioids non-medically, and associated with anxiety and depression. Clinicians should consider the possibility of daytime sleepiness in people receiving BMT and MMT, and in people using opioids nonmedically.

Sentinel-Lymph-Node-Based Management or Routine Axillary Clearance? Five-Year Outcomes of the RACS Sentinel Node Biopsy Versus Axillary Clearance (SNAC) 1 Trial: Assessment and Incidence of True Lymphedema.

PURPOSE: To determine whether the benefits of sentinel-node-based management (SNBM) over routine axillary clearance (RAC) persisted to 5 years. METHODS: A total of 1088 women with breast cancer less than 3 cm in diameter and clinically negative axillary nodes were randomized to SNBM with axillary clearance if the sentinel node was positive or RAC preceded by sentinel-node biopsy. The outcomes were: (1) objectively measured change in the volume of the operated and contralateral nonoperated arms; (2) the proportion with an increase in arm volume <15%; and (3) subjectively assessed arm morbidity for the domains swelling, symptoms, dysfunction, and disability. Assessments were performed at 1 and 6 months after surgery and then annually. RESULTS: Limb volume increased progressively in the operated and nonoperated arms for 2 years and persisted unchanged to year 5, accompanied by weight gain. Correction by change in the nonoperated arm showed a mean volume increase of 70 mL in the RAC group and 26 mL in the SNBM group (P < 0.001) at 5 years. Only 28 patients (3.3%) had a corrected increase >15% from baseline (RAC 5.0% vs. SNBM 1.7%). Significant predictors were surgery type (RAC vs. SNBM), obesity, diabetes, palpable tumor, and weight gain exceeding 10% of baseline value. CONCLUSIONS: Subjective assessments revealed persisting patient concerns about swelling and symptoms but not overall disability at 5 years. Subjective scores were only moderately correlated with volume increase. SNAC1 has demonstrated that objective morbidity and subjective morbidity persist for 5 years after surgery and that SNBM significantly lowers the risk of both.

Criterios o elementos determinantes de la libre escogencia de EPS e IPS en Bogotá D. C. por parte de los usuarios del régimen contributivo / Critérios ou elementos determinantes da livre escolha de eps e ips em bogotá D.C. Pelos usuários do regime contributivo / Determining criteria for free choice of health promotion entities and health providing institutions (Eps and Ips in Spanish) in the users of the contributive regime of Bogota, Colombia

En el presente artículo se aborda el análisis de la problemática del Sistema de Seguridad Social en Salud, centrándose en la problemática que se desprende de las relaciones del sistema con sus usuarios, aspecto éste que ha permanecido desatendido en los estudios y en los análisis sobre el tema. En particular se analizan los criterios y los aspectos determinantes que definen la elección de EPS (Entidades Promotoras de Salud) e IPS (Instituciones Prestadores de Servicios de Salud) por parte de los usuarios del régimen contributivo en la ciudad de Bogotá, prestando particular atención al ejercicio de la libre elección y la toma de decisiones informadas. El análisis de los resultados cualitativos y cuantitativos permite concluir que la información relevante disponible y el ejercicio de la libre elección son limitados.

This paper presents the analysis of the problems in Social Security and Health System due to the relations of the system with its users; problems that have been neglected in the studies and in the analyses on this subject. The determining criteria and aspects that define the election of Health Promotion Entities (EPS) and health providing institutions (IPS ) by the users of Bogota are analyzed whereby free election and an informed decision are pointed out. The analysis of the qualitative and quantitative results allows concluding that the available information and the exercise of the free election are limited.

No presente artigo analisa-se o Sistema de Seguridade Social em saúde concentrando-se na problemática que surge a partir das relações do sistema com os seus usuários, aspecto que tem sido negligenciado nos estudos e nas análises sobre o assunto. Em particular analisam-se os critérios e aspectos determinantes que definem a escolha da EPS (Entidades Promotoras de Saúde) e IPS (Instituições Prestadoras de Serviços de Saúde) pelos usuários do regime contributivo na cidade de Bogotá, com especial atenção ao exercício da liberdade de escolha e a tomada de decisão informada. A análise dos resultados qualitativos e quantitativos permite chegar à conclusão de que as informações relevantes disponíveis e o exercício da livre escolha são limitados.