The aim in radiotherapy treatment planning is to have sufficient target coverage and as low a dose to the Organs at Risk (OARs) as possible, adhering to the relevant guidelines. A high and consistent ...radiotherapy plan quality is vital when treatment plans are used as the foundation for patient selection in clinical trials. Proton therapy, being a substantially newer treatment modality than conventional photon therapy, is at risk of having a steeper learning curve in treatment planning. This inequality is important to investigate in a clinical study comparing the two, as this could influence the trial results.
This study aims to evaluate the development of radiotherapy treatment plan quality for head and neck cancer patients receiving photon and proton therapy over time in the context of the DAHANCA 35 trial.
From May 2019 to June 2023,189 patients were included in the ongoing DAHANCA 35 trial, with 63 patients in the pilot phase and 126 in the subsequent randomisation phase. In the pilot phase, all included patients were offered proton treatment, and in the randomisation phase, patients were randomised 1:2 (photon:proton). Patients were first seen at a local treatment centre, where a photon and comparative proton plan were prepared. If patients were offered proton treatment, a new clinical proton plan was made at the proton treatment centre and subsequently used for treatment. This study analysed 189 photon plans, 189 comparative proton plans, and 140 clinical proton plans.
The treatment plans were prepared conforming to the DAHANCA guidelines 1 to ensure the clinical relevance of all treatment plans
The plan quality was assessed separately for photon plans, comparative proton plans, and clinical proton plans in three time intervals.
The mean dose was investigated individually for 13 OARs relevant for head and neck cancer: oesophagus, glottic larynx, supraglottic larynx, mandible, extended oral cavity, left and right parotid glands, upper-, middle-, and lower pharyngeal constrictor muscles, left and right submandibular glands, and thyroid gland.
Furthermore, treatment plan quality was analysed using a new metric called Normalised Toxicity Index (NTI), calculated as a normalised average of the mean dose to the OARs compared to the threshold mean dose recommended by the DAHANCA guidelines.
An NTI > 1 indicated that the OARs, on average, received a dose higher than the recommended thresholds, and an NTI < 1 indicated that the OARs received a dose below the thresholds. Hence, a lower NTI indicated better plan quality concerning OAR doses.
The Kruskal-Wallis test was used to investigate a potential difference in the intervals for mean dose and NTI for each treatment type. The significance level was Bonferroni adjusted to account for multiple testing.
The three time intervals were defined with 63 patients in the pilot phase constituting one interval (Pilot phase), the subsequent 64 patients from the randomisation phase in the next interval (Randomisation 1), and the remaining 62 patients from the randomisation phase in the third interval (Randomisation 2). The periods were 22 months for the Pilot phase, 19 months for Randomisation 1, and 14 months for Randomisation 2.
Across the 13 OARs, the mean dose to individual OARs did not show a general time-dependent change, except for the right parotid gland in the clinical proton plans. Figure 1 shows a box plot with samples overlaid for the mean dose to the extended oral cavity as an example of the OARs. Display omitted
The NTI was not significantly different for the photon plans, comparative proton plans, and clinical proton plans in the three consecutive intervals, as shown in Figure 2. The median NTI for the clinical proton plans was 0.88 (interquartile range 0.70,1.00) for the Pilot phase, 0.83 0.75,0.89 for Randomization 1, and 0.79 0.67,0.98 for Randomization 2. The plan quality of the clinical proton plans appears stable from this new NTI metric. Display omitted
The analyses conducted in this study did not show a general time-dependent change in plan quality in any of the three types of plans. This could be caused by the nationally developed proton treatment planning template.
A stable treatment plan quality can help ensure a consistent selection for clinical trials, thus providing transparency for analysis of the outcome of the trials. The plan quality will continuously be followed to ensure consistency.
Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown ...reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist's perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change.
All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (α's from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions.
The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned.
Most program evaluation efforts concentrate on assessments of program implementation and program outcomes. However, another area of programs that has not received sufficient attention in the ...literature is evaluating the plan of the program. Since the quality of the plan and planning process can influence program implementation and outcomes, there is a need to expand program evaluation efforts to cover program plans, and thus bridge plan evaluation and program evaluation. This paper utilizes the program evaluation literature to illustrate two approaches to participatory program plan evaluation— ex-ante or proactive and ex-post or reactive—including a conceptual framework that identifies the requirements, barriers, and strategies for evaluating program plans. Concrete examples are provided to illustrate the application of these two approaches.
Eight conventions make up the biodiversity cluster of multilateral environmental agreements (MEAs) that provide the critical international legal framework for the conservation and sustainable use of ...nature. However, concerns about the rate of implementation of the conventions at the national level have triggered discussions about the effectiveness of these MEAs in halting the loss of biodiversity. Two main concerns have emerged: lack of capacity and resources and lack of coherence in implementing multiple conventions. We focused on the latter and considered the mechanisms by which international conventions are translated into national policy. Specifically, we examined how the Strategic Plan for Biodiversity 2011–2020 and the associated Aichi Biodiversity Targets have functioned as a unifying grand plan for biodiversity conservation. This strategic plan has been used to coordinate and align targets to promote and enable more effective implementation across all biodiversity‐related conventions. Results of a survey of 139 key stakeholders from 88 countries suggests streamlining across ministries and agencies, improved coordination mechanisms with all relevant stakeholders, and better knowledge sharing between conventions could improve cooperation among biodiversity‐related conventions. The roadmap for improving synergies among conventions agreed to at the 13th Convention on Biological Diversity's Conference of Parties in 2016 includes actions such as mechanisms to avoid duplication in national reporting and monitoring on conventions and capacity building related to information and knowledge sharing. We suggest the scientific community can actively engage and contribute to the policy process by establishing a science‐policy platform to address knowledge gaps; improving data gathering, reporting, and monitoring; developing indicators that adequately support implementation of national plans and strategies; and providing evidence‐based recommendations to policy makers. The latter will be particularly important as 2020 approaches and work to develop a new biodiversity agenda for the next decade is beginning.
Mejora en la Colaboración en la Implementación de las Convenciones Mundiales sobre la Biodiversidad
Resumen
Ocho convenciones son las que forman la agrupación multilateral de acuerdos ambientales (MEAs, en inglés), los cuales proporcionan el marco de trabajo legal importante para la conservación y el uso sustentable de la naturaleza. Sin embargo, la preocupación por la tasa de implementación de estas convenciones a nivel nacional ha disparado discusiones sobre la efectividad de estas MEAs para detener la pérdida de la biodiversidad. Han surgido dos preocupaciones principales: la falta de capacidad y recursos y la falta de coherencia en la implementación de múltiples convenciones. Nos enfocamos en la segunda y consideramos los mecanismos mediante los cuales las convenciones internacionales se transforman en reglamentos y políticas nacionales. En específico, examinamos cómo el Plan Estratégico para la Biodiversidad 2011 – 2020 y los Objetivos de Biodiversidad de Aichi asociados han funcionado como un gran plan unificador para la conservación de la biodiversidad. Este plan estratégico se ha usado para coordinar y alinear los objetivos para promover y habilitar una implementación más efectiva a lo largo de todas las convenciones relacionadas con la biodiversidad. Los resultados de una encuesta entre 139 accionistas clave de 88 países sugieren la optimización en los ministerios y en las agencias, una coordinación mejorada de los mecanismos entre todos los accionistas relevantes, y una mejor partición del conocimiento entre las convenciones podría aumentar la cooperación entre las convenciones relacionadas con la biodiversidad. La hoja de ruta para mejorar las sinergias entre las convenciones, acordada en la Conferencia de Participantes de la 13ra Convención sobre la Diversidad Biológica en 2016, incluye acciones como los mecanismos para evitar la duplicación de reportes y monitoreos nacionales sobre las convenciones y la capacidad de construcción relacionada con la partición de la información y el conocimiento. Sugerimos que la comunidad científica pueda participar activamente y contribuir al proceso de políticas al establecer una plataforma política‐científica que resuelva los vacíos en el conocimiento; mejore la recolección, reporte y monitoreo de datos, desarrolle indicadores que respalden adecuadamente a la implementación de planes y estrategias nacionales; y proporcione recomendaciones basadas en evidencia para los políticos. La última acción será de particular importancia conforme se aproxima el 2020 y se inicie la labor por desarrollar una nueva agenda de biodiversidad para la siguiente década.
摘要
八项多边环境协定中关于生物多样性的公约为自然的保护和可持续利用提供了重要的国际法律框架。然而, 对这些公约在国家层面执行情况的担忧已经引发了关于多边环境协定能否有效阻止生物多样性丧失的讨论。其中主要存在两个问题: 能力和资源的不足, 以及多项公约的执行缺乏连贯性。我们重点关注后者, 并分析了国际公约向国家政策转化的机制。具体来说, 我们研究了《2011‐2020 年生物多样性战略规划》及相应的爱知生物多样性目标是如何作为一个整体统一的生物多样性保护计划发挥作用的。这一战略规划被用于协调和统一各项目标, 以促进和实现所有与生物多样性相关的公约更有效的实施。对来自 88 个国家 139 个主要利益相关者的调查表明, 要提高生物多样性相关的公约之间的合作, 需要精简各部委和机构, 改进利益相关者之间的协调机制, 并推动公约之间更好的知识共享。 2016 年《生物多样性公约》第十三次缔约国会议商定的加强公约间协作的路线图中, 包括了避免重复对公约进行国家报告工作和监督检查的机制、发展信息与知识共享能力等行动。我们建议, 科学界可以通过建立科学–政策平台来弥补知识空缺; 加强数据的收集、报告和监督; 制定充分支持国家规划和战略实施的指标; 为决策者提供基于证据的建议等途径来积极参与并促进政策过程。随着 2020 年的临近, 为下一个十年制定新的生物多样性议程的工作也已经开始, 这一点将尤为重要。翻译: 胡怡思; 审校: 聂永刚
Article impact statement: To strengthen the global biodiversity conventions, the scientific community needs to engage in enhancing cooperation among them.
Abstract Objective To evaluate the effectiveness of crisis response planning for the prevention of suicide attempts. Method Randomized clinical trial of active duty Army Soldiers (N=97) at Fort ...Carson, Colorado, presenting for an emergency behavioral health appointment. Participants were randomly assigned to receive a contract for safety, a standard crisis response plan, or an enhanced crisis response plan. Incidence of suicide attempts during follow-up was assessed with the Suicide Attempt Self-Injury Interview. Inclusion criteria were the presence of suicidal ideation during the past week and/or a lifetime history of suicide attempt. Exclusion criteria were the presence of a medical condition that precluded informed consent (e.g., active psychosis, mania). Survival curve analyses were used to determine efficacy on time to first suicide attempt. Longitudinal mixed effects models were used to determine efficacy on severity of suicide ideation and follow-up mental health care utilization. Results From baseline to the 6-month follow-up, 3 participants receiving a crisis response plan (estimated proportion: 5%) and 5 participants receiving a contract for safety (estimated proportion: 19%) attempted suicide (log-rank χ2 (1)=4.85, p=0.028; hazard ratio=0.24, 95% CI=0.06–0.96), suggesting a 76% reduction in suicide attempts. Crisis response planning was associated with significantly faster decline in suicide ideation (F(3,195)=18.64, p<0.001) and fewer inpatient hospitalization days (F(1,82)=7.41, p<0.001). There were no differences between the enhanced and standard crisis response plan conditions. Conclusion Crisis response planning was more effective than a contract for safety in preventing suicide attempts, resolving suicide ideation, and reducing inpatient hospitalization among high-risk active duty Soldiers.
Las enfermedades infecciosas constituían la principal causa de mortalidad en América Latina hasta hace pocas décadas. Recientemente, las enfermedades cardiovasculares (ECV) han surgido como una ...importante causa de muerte, reflejando la "transición epidemiológica" observada en países en vías de desarollo.
AbstractObjectivesTo determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes.DesignMulticentre, parallel, cluster ...randomised controlled trial.SettingLong term care homes in the UK, registered to care for older people or those with dementia.Participants1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care.InterventionsGuide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care.Main outcome measuresPrimary outcome measure was fall rate at 91-180 days after randomisation. The economic evaluation measured health related quality of life using quality adjusted life years (QALYs) derived from the five domain five level version of the EuroQoL index (EQ-5D-5L) or proxy version (EQ-5D-5L-P) and the Dementia Quality of Life utility measure (DEMQOL-U), which were self-completed by competent residents and by a care home staff member proxy (DEMQOL-P-U) for all residents (in case the ability to complete changed during the study) until 12 months after randomisation. Secondary outcome measures were falls at 1-90, 181-270, and 271-360 days after randomisation, Barthel index score, and the Physical Activity Measure-Residential Care Homes (PAM-RC) score at 91, 180, 270, and 360 days after randomisation.ResultsMean age of residents was 85 years. 32% were men. GtACH training was delivered to 1051/1480 staff (71%). Primary outcome data were available for 630 participants in the GtACH group and 712 in the usual care group. The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P<0.001) in favour of the GtACH programme (GtACH: six falls/1000 residents v usual care: 10 falls/1000). Barthel activities of daily living indices and PAM-RC scores were similar between groups at all time points. The incremental cost was £108 (95% confidence interval −£271.06 to 487.58), incremental QALYs gained for EQ-5D-5L-P was 0.024 (95% confidence interval 0.004 to 0.044) and for DEMQOL-P-U was 0.005 (−0.019 to 0.03). The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4544 and £20 889, respectively.ConclusionsThe GtACH programme was associated with a reduction in fall rate and cost effectiveness, without a decrease in activity or increase in dependency.Trial registrationISRCTN34353836.
Each year, the Internal Revenue Service (IRS) and Treasury jointly develop and publish a list of areas in which they intend to release guidance intended to help plan sponsors and the benefits ...community comply with the Internal Revenue Code (Code) and maintain the tax-favored status of qualified retirement plans. Notably, the list does not cover IRS exam guidelines, IRS forms, field directives, and similar types of guidance, and intervening legislation often throws a monkey-wrench into the best-laid plans. ...we take a look at the July 2021-June 2022 Priority Guidance Plan that was announced on September 9, 2021, and summarize the key items below. Missing (and unresponsive) participants has historically presented difficult compliance issues with both the IRS and DOL within and outside of examinations. ...uniform, coordinated rules that are manageable (and provide some flexibility and generous lead time for rollout) would be welcomed in this area. #11.
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•Survey on control and evaluation of complexity and robustness with 126 participants.•Large inter-centre variability in assessment of complexity, robustness, and 3D dose.•Complexity ...mainly evaluated by number of MU, aperture shape, and PSQA measurements.•21% of photon clinics used robust optimisation for robustness control, 98% used PTV.•Participants desired improved commercial tools for complexity and robustness.
Plan complexity and robustness are two essential aspects of treatment plan quality but there is a great variability in their management in clinical practice. This study reports the results of the 2020 ESTRO survey on plan complexity and robustness to identify needs and guide future discussions and consensus.
A survey was distributed online to ESTRO members. Plan complexity was defined as the modulation of machine parameters and increased uncertainty in dose calculation and delivery. Robustness was defined as a dose distribution’s sensitivity towards errors stemming from treatment uncertainties, patient setup, or anatomical changes.
A total of 126 radiotherapy centres from 33 countries participated, 95 of them (75%) from Europe and Central Asia. The majority controlled and evaluated plan complexity using monitor units (56 centres) and aperture shapes (38 centres). To control robustness, 98 (97% of question responses) photon and 5 (50%) proton centres used PTV margins for plan optimization while 75 (94%) and 5 (50%), respectively, used margins for plan evaluation. Seventeen (21%) photon and 8 (80%) proton centres used robust optimisation, while 10 (13%) and 8 (80%), respectively, used robust evaluation. Primary uncertainties considered were patient setup (photons and protons) and range calculation uncertainties (protons). Participants expressed the need for improved commercial tools to control and evaluate plan complexity and robustness.
Clinical implementation of methods to control and evaluate plan complexity and robustness is very heterogeneous. Better tools are needed to manage complexity and robustness in treatment planning systems. International guidelines may promote harmonization.
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