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La gestión de las actividades recreativas en Áreas Naturales Protegidas es compleja por el número de actores sociales que aprovechan y administran los recursos naturales con actividades, intereses y necesidades distintas. El objetivo del estudio fue analizar la dinámica relacional entre los actores sociales involucrados en tres Unidades Socio-Ecológicas, y sus implicaciones en el manejo de las actividades recreativas en el Área de Protección de Flora y Fauna Nevado de Toluca, México. A partir de una revisión de literatura, entrevistas semiestructuradas y Análisis de Redes Sociales se encontró que los actores sociales presentes, no son suficientes para un buen manejo de las actividades recreativas. La principal función de todos los actores sociales es la conservación de recursos naturales, pero también asumen funciones para el manejo de las actividades recreativas. La dinámica entre actores sociales presenta lazos débiles e intermitencia en las relaciones debido a la ausencia de vínculos institucionalizados y metas comunes. Es necesario desarrollar redes de colaboración donde los actores asuman corresponsabilidades y acciones conjuntas para la planeación y manejo de las actividades recreativas.

In 2009, the European Commission was mandated by the Parliament to draw up a development strategy for the development of wilderness areas. However, Europe is not known to have vast areas of wilderness or virgin nature, and in this context, considering wilderness areas in Europe seems counter-intuitive. The term has played a major cultural role since the 19th century in the countries born of British colonisation, before becoming a recurrent term in nature conservation strategies. However, its cultural and scientific meanings remain heterogeneous. The aim of this article is to reflect on what "wilderness" Europe can claim to refer to in order to promote an ecological strategy. The article draws on recent literature on wilderness in Europe, the evolution and greening of the concept, and promotional actions supported by environmental NGOs in various regions of Europe. It explores the limits and contradictions involved in promoting a concept that tends to be naturalized and ecologized. The results show that in the field of wilderness, faced with the relative slowness of European public authorities, private and associative initiatives are outpacing government actions, which raises questions about the relevance, and even the effectiveness of this new designation of conservation strategies.

A governmental project intending to downgrade a National Park into an Area of Protection of Flora and Fauna has encountered both scientific and legal opposition. During this recategorization period, participation has become a major issue mobilizing various groups of interest related to the Nevado de Toluca. These groups include agrarian communities living within the park and others, living in neighboring urban areas, who value the park for its material resources and its biodiversity. This paper will analyze the way this change of category has engaged territorial actors to use participation procedures to gain power over decision-making regarding the future of the protected area. In exploiting the possibilities of the law and regaining legitimacy, local communities have been able to partially redesign actors’ relationships and to regain a central actor status, leading to a renewed governance system.

Mexico’s agrarian and forest history established an original forestry land tenure system based upon social property. Mexican National Parks have a unique place in North America where such protected areas have more commonly been under a strict and sole control of Federal authorities. In Mexico, they are places of intense complexity where laws and regulations, economic and social needs are intertwined with policy issues. The Mexican Revolution’s legacy ensured tenure rights to agrarian communities that are contested by governments’ conservation policies : on the one hand, parks’ communities have been excluded from forest uses, while in the same time, logging companies, both private and para-governmental, have been allowed to operate within Protected Areas. This paper intends to retrace the evolution of public policies regarding control and access over forest lands and resources in Mexico, focusing particularly on the Nevado de Toluca National Park. The analysis focuses on how public policies, both at the national and local park levels, have overlapped for about a century. The lack of clear resource management policies that would be readable to members of the local communities ­– whether legally in relation to their agrarian rights, or illegally in light of the law regarding National Parks ­– is the cause of major difficulties resonating with wider problems of governance within this protected territory.

Public involvement has become a key concept in conservation management worldwide. This paper provides an overview of the situation in four countries where national parks have been established for over a century, and where their creation often involved clearing the land of earlier indigenous settlements. Since the 1970s, public participation has become common practice in park management, even though such participation has taken on a variety of forms. The paper analyses the general trends in public participation in park management practices, participation that most authors consider has contributed to successful governance policies and helped build participative democracy. Analyses at different levels, however, reveal that public participation can also divide stakeholders, making it really difficult for any effective coalition of stakeholders to emerge.

Public involvement has become a key concept in conservation management worldwide. This paper intends to give an overview on four countries known to have established national parks for over a century, and often in clearing the land from previous ‘indigenous’ or local occupation. Since the seventies, public participation has become a common practice in parks’ management, even if reality does not fit always perfectly with theory. The paper analyses general trends of public participation in parks management practices, which are most often considered as a successful governance policies by most authors, and is also considered as a way to build participative democracy. The analysis using the level of scale intends to show that public participation can also fragment the stakeholders, making really difficult the emergence of any efficient coalition of stakeholders.

Based on the articles published in this special issue, the purpose of this conclusion is to provide a framework permitting the understanding of ecological colonization processes. The point is to go beyond post-colonial interpretations of the notion of ecological frontier. To do this it starts by bringing conceptual clarifications to the idea of ecological front. Giving this notion two dimensions appears essential to its understanding, even though this duality has not been sufficiently underlined in the proposed definitions. The first dimension is the temporality of ecological frontier: these prove to be particularly unstable, in perpetual flux and therefore can only be understood over the long term. The second dimension is the “where”, in what space do the decisions and effects of this ecological colonization take place? Based on these two dimensions (time and space) a framework is proposed to interpret the process of ecological colonization. This is based on the actual study of three areas in different parts of the globe (the Canadian north, Brazilian Amazon and the Alps) which are emblematic of the diversity of ecological frontiers.

This article explores the notion of “Ecological frontier.” Created on the basis of historical and geographical research in South Africa focusing, the notion of "ecological frontier" can be "resigned" and used to present a better understanding of recent geographical processes in northern Alberta. The aim is to transfer the notion developed in a different historical context to highlight its usefulness for out understanding of how environments - deeply transformed by commoditization of resources at geographical margins - have evolved. Alberta's ecological frontier is a competitive space marked by both horizontal confrontations (conflicting human and environmental issues surrounding extraction and protection), and by vertical confrontations (land claims or legal uses made both by the private sector and Aboriginal groups). Alberta’s emerging ecological frontier presents a complex adaptive ecological-political process echoing the notion of panarchy.

Abstract Risk adjustment is often necessary for outcome quality indicators (QIs) to provide fair and accurate feedback to healthcare professionals. However, traditional risk adjustment models are generally oversimplified and not equipped to disentangle complex factors influencing outcomes that are out of a healthcare professional’s control. We present VIRGO, a novel variational Bayes model trained on routinely collected, large administrative datasets to risk-adjust outcome QIs. VIRGO uses detailed demographics, diagnosis, and procedure codes to provide individualized risk adjustment and explanations on patient factors affecting outcomes. VIRGO achieves state-of-the-art on external datasets and features capabilities of uncertainty expression, explainable features, and counterfactual analysis capabilities. VIRGO facilitates risk adjustment by explaining how patient factors led to adverse outcomes and expresses the uncertainty of each prediction, allowing healthcare professionals to not only explore patient factors with unexplained variance that are associated with worse outcomes but also reflect on the quality of their clinical practice.

Background: Chronic low back pain is a major cause of pain and disability with limited effective therapies. Metformin is a safe, inexpensive, well-tolerated drug that has pleotropic effects, including effects on pain pathways that may influence low back pain. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether metformin reduces low back pain over 4 months in individuals with chronic low back pain. Methods and analysis: One hundred and twenty-three participants with chronic low back pain will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either metformin 2g or identical placebo daily for 4 months. The primary outcome will be change in pain intensity assessed using a 100 ​mm visual analogue scale at 4 months and the secondary outcomes will be change in low back disability, physical activity and narcotic use. Adverse events will be recorded. The primary analysis will be by intention to treat. Discussion: Given the societal burden of LBP and the limited effective treatment options available, this study that evaluates the efficacy of metformin in LBP, if proves to be effective, will offer an important therapeutic approach for this disabling condition. Ethics and dissemination: Ethics approval has been obtained from the Alfred Hospital Ethics Committee (392/21) and Monash University Human Research Ethics Committee (30607). Written informed consent will be obtained from all the participants. The findings will be disseminated through peer-review publications and conference presentations. Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12621001453875 (registered 25th October 2021).

ABSTRACT Background In Australia, lung cancer is the leading cause of cancer‐related deaths. In Victoria, the mortality risk is assumed to vary across Local Government Areas (LGAs) due to variations in socioeconomic advantage, remoteness, and healthcare accessibility. Thus, we applied Bayesian spatial survival models to examine the geographic variation in lung cancer survival in Victoria. Methods Data on lung cancer cases were extracted from the Victorian Lung Cancer Registry (VLCR). To account for spatial dependence and risk factors of survival in lung cancer patients, we employed a Bayesian spatial survival model. Conditional Autoregressive (CAR) prior was assigned to model the spatial dependence. Deviance Information Criterion (DIC), Watanabe Akaike Information Criterion (WAIC), and Log Pseudo Marginal Likelihood (LPML) were used for model comparison. In the final best‐fitted model, the Adjusted Hazard Ratio (AHR) with the 95% Credible Interval (CrI) was reported. The outcome variable was the survival status of lung cancer patients, defined as whether they survived or died during the follow‐up period (death was our interest). Results Our study revealed substantial variations in lung cancer mortality in Victoria. Poor Eastern Cooperative Oncology Group (ECOG) performance status, diagnosed at a regional hospital, Small Cell Lung Cancer (SCLC), advanced age, and advanced clinical stage were associated with a higher risk of mortality, whereas being female, presented at Multidisciplinary Team (MDT) meeting, and diagnosed at a metropolitan private hospital were significantly associated with a lower risk of mortality. Conclusion Identifying geographical disparities in lung cancer survival may help shape healthcare policy to implement more targeted and effective lung cancer care services.

Objective To determine whether a chemokine receptor type 2 antagonist, DMX-200 (repagermanium), in combination with an angiotensin receptor blocker, candesartan, improves clinical outcomes in people with COVID-19.Design Prospective, multicentre, double-blind, placebo-controlled trial.Setting Ten acute care hospitals in India.Participants Adults

Background Patients with shock treated by emergency medical services (EMS) have high morbidity and mortality. Knowledge of prehospital factors predicting outcomes in patients with shock remains limited. We aimed to describe the prehospital predictors of mortality in patients with non-traumatic shock transported to hospital by EMS.Method This is a retrospective cohort study of consecutive ambulance attendances for non-traumatic shock in Victoria, Australia (January 2015–June 2019) linked with government-held administrative data (emergency, admissions and mortality records). Predictors of 30-day mortality were assessed using Cox proportional regressions. The primary outcome was 30-day all-cause mortality.Results Overall, 21 334 patients with non-traumatic shock (median age 69 years, 54.8% female) were successfully linked with state administrative records. Among this cohort, 9 149 (43%) patients died within 30-days. Compared with survivors, non-survivors had a longer median on-scene time: 60 (35–98) versus 30 (19–50), p

Introduction Immunosuppressive therapy (IST) with antithymocyte globulin (ATG) and ciclosporin is standard of care for patients with severe aplastic anaemia (sAA) not eligible or suitable for allogeneic stem cell transplant. While patients respond to IST, few achieve complete responses and a significant proportion are refractory or relapse. The addition of eltrombopag, a thrombopoietin-receptor agonist (TPO-A), to IST has been shown to improve haematological responses in sAA. Avatrombopag is a second-generation TPO-A with potential advantages over eltrombopag. However, to date avatrombopag has not been studied in sAA.Methods and analysis Investigator-initiated, single-arm registry-based Bayesian Optimal Phase II trial of avatrombopag conducted in two cohorts, patients with untreated sAA (FIRST cohort) and in patients with sAA that has relapsed or is refractory to IST (NEXT cohort). In the FIRST cohort, participants receive IST (equine ATG and ciclosporin) plus avatrombopag from day 1 until day 180 at 60 mg oral daily, with dose adjusted according to platelet count. Participants in the NEXT cohort receive avatrombopag at 60 mg oral daily from day 1 until day 180, with or without additional IST at the discretion of the treating clinician.For each cohort, two primary endpoints (haematological response and acquired clonal evolution) are jointly monitored and the trial reviewed at each interim analysis where a ‘go/no-go’ decision is made by evaluating the posterior probability of the events of interests.Ethics and dissemination The trial has received ethics approval (Monash Health RES-18-0000707A). The trial conduct will comply with ICH-GCP and all applicable regulatory requirements. The results of the trial will be submitted to a peer-review journal for publication.Trial registration number ACTRN12619001042134, ACTRN12619001043123.

Introduction Over half of the populations with knee osteoarthritis (OA) have obesity. These individuals have many other shared metabolic risk factors. Metformin is a safe, inexpensive, well-tolerated drug that has pleiotropic effects, including structural protection, anti-inflammatory and analgesic effects in OA, specifically the knee. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether metformin reduces knee pain over 6 months in individuals with symptomatic knee OA who are overweight or obese.Methods and analysis One hundred and two participants with symptomatic knee OA and overweight or obesity will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either metformin 2 g or identical placebo daily for 6 months. The primary outcome is reduction of knee pain [assessed by 100 mm Visual Analogue Scale (VAS)] at 6 months. The secondary outcomes are OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) responder criteria [Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function and participant’s global assessment (VAS)] at 6 months; change in knee pain, stiffness, function using WOMAC at 6 months and quality of life at 6 months. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups.Ethics and dissemination Ethics approval has been obtained from the Alfred Hospital Ethics Committee (708/20) and Monash University Human Research Ethics Committee (28498). Written informed consent will be obtained from all the participants. The findings will be disseminated through peer-review publications and conference presentations.Trial registration number ACTRN12621000710820 .

Introduction Cerebrovascular disease and neurodegeneration are causes of cognitive decline and dementia, for which primary prevention options are currently lacking. Statins are well-tolerated and widely available medications that potentially have neuroprotective effects. The STAREE-Mind Imaging Study is a randomised, double-blind, placebo-controlled clinical trial that will investigate the impact of atorvastatin on markers of neurovascular health and brain atrophy in a healthy, older population using MRI. This is a nested substudy of the ‘Statins for Reducing Events in the Elderly’ (STAREE) primary prevention trial.Methods Participants aged 70 years or older (n=340) will be randomised to atorvastatin or placebo. Comprehensive brain MRI assessment will be undertaken at baseline and up to 4 years follow-up, including structural, diffusion, perfusion and susceptibility imaging. The primary outcome measures will be change in brain free water fraction (a composite marker of vascular leakage, neuroinflammation and neurodegeneration) and white matter hyperintensity volume (small vessel disease). Secondary outcomes will include change in perivascular space volume (glymphatic drainage), cortical thickness, hippocampal volume, microbleeds and lacunae, prefrontal cerebral perfusion and white matter microstructure.Ethics and dissemination Academic publications from this work will address the current uncertainty regarding the impact of statins on brain structure and vascular integrity. This study will inform the utility of repurposing these well-tolerated, inexpensive and widely available drugs for primary prevention of neurological outcomes in older individuals. Ethics approval was given by Monash University Human Research Ethics Committee, Protocol 12206.Trial registration number ClinicalTrials.gov Identifier: NCT05586750.

Objective: To examine the efficacy and safety of topical corticosteroid over 6 weeks in patients with symptomatic hand osteoarthritis. Design: In a randomized, double-blind, placebo-controlled trial, community-based participants with hand osteoarthritis were randomly assigned (1:1) to topical Diprosone OV (betamethasone dipropionate 0.5 ​mg/g in optimised vehicle, n=54) or placebo (plain paraffin, n=52) ointment to painful joints 3 times daily for 6 weeks. Primary outcome was pain reduction [assessed by 100 ​mm visual analogue scale (VAS)] at 6 weeks. Secondary outcomes included changes in pain and function using the Australian Canadian Osteoarthritis Hand Index (AUSCAN), Functional Index for Hand Osteoarthritis (FIHOA), and Michigan Hand Outcomes Questionnaire (MHQ) at 6 weeks. Adverse events were recorded. Results: Of 106 participants (mean age 64.2 years, 85.9% female), 103 (97.2%) completed the study. Change in VAS at 6 weeks was similar in the Diprosone OV and placebo groups (−19.9 vs. −20.9, adjusted difference 0.6, 95% CI -8.9 to 10.2). There were no significant between-group differences in change in AUSCAN pain [adjusted difference 25.8 (−16.0 to 67.5)], AUSCAN function [21.2 (−55.0 to 97.4)], FIHOA [-0.1 (−1.7 to 1.5)], or MHQ [-1.2 (−6.0 to 3.6)]. Incidence of adverse events was 16.7% in Diprosone OV and 19.2% in placebo group. Conclusions: Topical Diprosone OV ointment, although well-tolerated, was no better than placebo in improving pain or function over 6 weeks in patient with symptomatic hand osteoarthritis. Future studies should consider examining joints with synovitis and whether delivery approaches enhancing transdermal penetration of corticosteroids into joints are effective in hand osteoarthritis. Trial registration: ACTRN 12620000599976. Registered May 22, 2020.

Abstract Background For the design and analysis of clinical trials with time-to-event outcomes, the Cox proportional hazards model and the logrank test have been the cornerstone methods for many decades. Increasingly, the key assumption of proportionality—or time-fixed effects—that underpins these methods has been called into question. The availability of novel therapies with new mechanisms of action and clinical trials of longer duration mean that non-proportional hazards are now more frequently encountered. Methods We compared several regression-based methods to model time-dependent treatment effects. For illustration purposes, we used selected endpoints from a large, community-based clinical trial of low dose daily aspirin in older persons. Relative and absolute estimands were defined, and analyses were conducted in all participants. Additional exploratory analyses were undertaken by selected subgroups of interest using interaction terms in the regression models. Discussion In the trial with median 4.7 years follow-up, we found evidence for non-proportionality and a time-dependent treatment effect of aspirin on cancer mortality not previously reported in trial findings. We also found some evidence of time-dependence to an aspirin by age interaction for major adverse cardiovascular events. For other endpoints, time-fixed treatment effect estimates were confirmed as appropriate. Conclusions The consideration of treatment effects using both absolute and relative estimands enhanced clinical insights into potential dynamic treatment effects. We recommend these analytical approaches as an adjunct to primary analyses to fully explore findings from clinical trials.

Abstract Background Stepped wedge trials are an appealing and potentially powerful cluster randomized trial design. However, they are frequently implemented with a small number of clusters. Standard analysis methods for these trials such as a linear mixed model with estimation via maximum likelihood or restricted maximum likelihood (REML) rely on asymptotic properties and have been shown to yield inflated type I error when applied to studies with a small number of clusters. Small-sample methods such as the Kenward-Roger approximation in combination with REML can potentially improve estimation of the fixed effects such as the treatment effect. A Bayesian approach may also be promising for such multilevel models but has not yet seen much application in cluster randomized trials. Methods We conducted a simulation study comparing the performance of REML with and without a Kenward-Roger approximation to a Bayesian approach using weakly informative prior distributions on the intracluster correlation parameters. We considered a continuous outcome and a range of stepped wedge trial configurations with between 4 and 40 clusters. To assess method performance we calculated bias and mean squared error for the treatment effect and correlation parameters and the coverage of 95% confidence/credible intervals and relative percent error in model-based standard error for the treatment effect. Results Both REML with a Kenward-Roger standard error and degrees of freedom correction and the Bayesian method performed similarly well for the estimation of the treatment effect, while intracluster correlation parameter estimates obtained via the Bayesian method were less variable than REML estimates with different relative levels of bias. Conclusions The use of REML with a Kenward-Roger approximation may be sufficient for the analysis of stepped wedge cluster randomized trials with a small number of clusters. However, a Bayesian approach with weakly informative prior distributions on the intracluster correlation parameters offers a viable alternative, particularly when there is interest in the probability-based inferences permitted within this paradigm.

Abstract Background Pre-operative anaemia has been associated independently with worse outcomes after cardiac surgery in adults and is often caused by absolute or functional iron deficiency. Iron deficiency is a continuum ending with anaemia, and therefore it is plausible that pre-operative early or ‘non-anaemic’ iron deficiency may also be associated with worse outcomes in patients undergoing cardiac surgery. Methods We have designed a prospective, observational study to determine if there is an association between non-anaemic iron deficiency and worse outcomes after cardiac surgery in adults. Patients without anaemia undergoing elective cardiac surgery will be allocated to an iron-deficient and an iron-replete group based on standard pre-operative blood tests (ferritin, transferrin saturation and C-reactive protein). The primary outcome is days alive and at home on postoperative day 30. The key secondary outcomes are days alive and at home on postoperative day 90 and readmission to acute care. Other secondary outcomes include health-related quality of life questionnaires, quality of postoperative recovery, postoperative complications, changes in haemoglobin concentration, and requirement for allogeneic blood products. The planned study sample size is 240 patients per group, which has 83% power to detect a median difference of 1.25 days in the primary outcome. The study commenced in March 2018, and recently completed recruitment, with data audit and cleaning ongoing. Discussion This study will be conducted using a rigorous, prospective observational design; it will provide peak bodies and clinicians with high-quality evidence concerning the associations between non-anaemic iron deficiency and patient-centred outcomes after elective cardiac surgery. Our primary and key secondary outcomes are known to have great importance to clinicians and patients alike and align with the recommendations of the StEP-COMPAC group for outcomes in prospective peri-operative research. The definition used for iron deficiency accounts for both absolute and functional iron deficiency and make use of standard pre-operative blood tests to make this determination, easing the transition of results into clinical practice. The study will be conducted in two relatively high-volume centres in a single high-income country. This limits the generalisability of study results to similar centres. Trial registration Australian and New Zealand Clinical Trials Registry ( ACTRN12618000185268 ). Registered 5 February 2018.

Abstract Background Hand osteoarthritis is a common and disabling chronic joint disease with a lack of effective therapies. Emerging evidence suggests the role of local inflammation in causing pain in hand osteoarthritis. Corticosteroids are potent anti-inflammatory drugs used in many rheumatic diseases. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether topical corticosteroid reduces pain over 6 weeks in patients with hand osteoarthritis. Methods One hundred participants with hand osteoarthritis will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either topical Diprosone OV or placebo ointment administered 3 times daily on the painful hand joints for 6 weeks. The primary outcome is pain reduction (assessed by 100 mm visual analogue scale) at 6 weeks. The secondary outcomes include changes in pain and function assessed using Functional Index for Hand Osteoarthritis, Australian Canadian Osteoarthritis Hand Index, Michigan Hand Outcomes Questionnaire, and tender and swollen joint count at 6 weeks. Adverse events will be recorded. The primary analysis will be by intention to treat, including all participants in their randomised groups. Discussion This study will provide high-quality evidence to determine whether topical corticosteroid reduces pain over 6 weeks in patients with hand osteoarthritis, with major clinical and public health importance by informing clinical practice guidelines for the management of hand osteoarthritis and reducing the burden of the disabling disease. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000599976 . Registered 22 May 2020.

Abstract Background Non-proportional hazards are common with time-to-event data but the majority of randomised clinical trials (RCTs) are designed and analysed using approaches which assume the treatment effect follows proportional hazards (PH). Recent advances in oncology treatments have identified two forms of non-PH of particular importance - a time lag until treatment becomes effective, and an early effect of treatment that ceases after a period of time. In sample size calculations for treatment effects on time-to-event outcomes where information is based on the number of events rather than the number of participants, there is crucial importance in correct specification of the baseline hazard rate amongst other considerations. Under PH, the shape of the baseline hazard has no effect on the resultant power and magnitude of treatment effects using standard analytical approaches. However, in a non-PH context the appropriateness of analytical approaches can depend on the shape of the underlying hazard. Methods A simulation study was undertaken to assess the impact of clinically plausible non-constant baseline hazard rates on the power, magnitude and coverage of commonly utilized regression-based measures of treatment effect and tests of survival curve difference for these two forms of non-PH used in RCTs with time-to-event outcomes. Results In the presence of even mild departures from PH, the power, average treatment effect size and coverage were adversely affected. Depending on the nature of the non-proportionality, non-constant event rates could further exacerbate or somewhat ameliorate the losses in power, treatment effect magnitude and coverage observed. No single summary measure of treatment effect was able to adequately describe the full extent of a potentially time-limited treatment benefit whilst maintaining power at nominal levels. Conclusions Our results show the increased importance of considering plausible potentially non-constant event rates when non-proportionality of treatment effects could be anticipated. In planning clinical trials with the potential for non-PH, even modest departures from an assumed constant baseline hazard could appreciably impact the power to detect treatment effects depending on the nature of the non-PH. Comprehensive analysis plans may be required to accommodate the description of time-dependent treatment effects.