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INTRODUCTION: In recent years, primary surgical treatment of older women with non-metastatic breast cancer has decreased in favor of primary endocrine therapy (PET). PET can be considered in women with a remaining life expectancy of less than five years. The aim of this study was to (1) assess the risk of distant metastases and other cause mortality over ten years in women aged 65 and older with stage I-III breast cancer treated with PET, (2) whether this was associated with geriatric characteristics and comorbidities and to (3) describe the reasons on which the choice for PET was made. METHODS: Women were included from the retrospective FOCUS cohort, which comprises all incident women diagnosed with breast cancer aged 65 or older between January 1997 and December 2004 in the Comprehensive Cancer Center Region West in the Netherlands. We selected women (N = 257) with stage I-III breast cancer and treated with PET from this cohort. Patient characteristics (including comorbidity, polypharmacy, walking, cognitive and sensory impairment), treatment and tumor characteristics were retrospectively extracted from charts. Outcomes were distant metastasis and other cause mortality. Cumulative incidences were calculated using the Cumulative Incidence for Competing Risks method (CICR); and subdistribution hazard ratios (SHR) were tested between groups based on age, geriatric characteristics and comorbidity with the Fine and Gray model. RESULTS: Women treated with PET were on average 84 years old and 41% had one or more geriatric characteristics. Other cause mortality exceeded the cumulative incidence of distant metastasis over ten years (83 versus 5.6%). The risk of dying from another cause further increased in women with geriatric characteristics (SHR 2.06, p < 0.001) or two or more comorbidities (SHR 1.72, p < 0.001). Often the reason for omitting surgery was not recorded (52.9%), but if recorded surgery was omitted mainly at the patient's request (18.7%). DISCUSSION: This study shows that the cumulative incidence of distant metastasis is much lower than other cause mortality in older women with breast cancer treated with PET, especially in the presence of geriatric characteristics or comorbidities. This confirms the importance of assessment of geriatric characteristics to aid counseling of older women.
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Neoplasias da Mama , Feminino , Humanos , Idoso , Idoso de 80 Anos ou mais , Estudos Retrospectivos , Neoplasias da Mama/tratamento farmacológico , Comorbidade , Expectativa de Vida , Países Baixos/epidemiologiaRESUMO
BACKGROUND: Many studies have compared real-world clinical outcomes of immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC) with reported outcomes data from pivotal trials. However, any differences observed could be only limitedly explored further for causation because of the unavailability of individual patient data (IPD) from trial participants. The present study aims to explore the additional benefit of comparison with IPD. METHODS: This study compares progression free survival (PFS) and overall survival (OS) of metastatic NSCLC patients treated with second line nivolumab in real-world clinical practice (n = 141) with IPD from participants in the Checkmate-057 clinical trial (n = 292). Univariate and multivariate Cox proportional hazards models were used to construct HRs for real-world practice versus clinical trial. RESULTS: Real-world patients were older (64 vs. 61 years), had more often ECOG PS ≥ 2 (5 vs. 0%) and were less often treated with subsequent anti-cancer treatment (28.4 vs. 42.5%) compared to trial patients. The median PFS in real-world patients was longer (3.84 (95%CI: 3.19-5.49) vs 2.30 (2.20-3.50) months) and the OS shorter than in trial participants (8.25 (6.93-13.2) vs. 12.2 (9.90-15.1) months). Adjustment with available patient characteristics, led to a shift in the hazard ratio (HR) for OS, but not for PFS (HRs from 1.13 (0.88-1.44) to 1.07 (0.83-1.38), and from 0.82 (0.66-1.03) to 0.79 (0.63-1.00), respectively). CONCLUSIONS: This study is an example how IPD from both real-world and trial patients can be applied to search for factors that could explain an efficacy-effectiveness gap. Making IPD from clinical trials available to the international research community allows this.
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Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Imunoterapia , Neoplasias Pulmonares/tratamento farmacológico , Nivolumabe/uso terapêutico , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Ensaios Clínicos como AssuntoRESUMO
Background: Supporting unemployed or work-disabled cancer survivors in their work participation can have extensive individual and societal benefits. We aimed to identify and summarise interventions for work participation of unemployed or work-disabled cancer survivors.Methods: Five databases (Medline, Embase, PsycINFO, CINAHL and Cochrane Library) were systematically searched for quantitative studies on interventions aimed at enhancing work participation of unemployed or work-disabled cancer survivors. Work participation refers to participation in the workforce, fulfilling one's work role. Manual and automatic screening (with ASReview software) were performed on titles and abstracts, followed by manual full-text screening. Data were extracted regarding study, patient and intervention characteristics, and work participation outcomes. Risk of bias (RoB) was assessed using the Cochrane RoB2 and QUIPS tools.Results: We identified 10,771 articles, of which we included two randomised controlled trials (RCTs), of which one feasibility RCT, and three cohort studies. In total, 1862 cancer survivors were included, with predominantly breast cancer. Work participation was mainly measured as time to return to work (RTW) and RTW rate. Interventions included components of coaching (e.g., psychological or rehabilitation), training (e.g., building confidence and managing fatigue) and self-management. Two RCTs with unclear RoB did not show an effect of multicomponent interventions compared to care as usual. One cohort study found a significant effect of a psycho-educational intervention on RTW rates, with moderate RoB. The other two cohort studies, with moderate RoB, reported significant associations between components including job search and placement assistance, and work participation.Discussion: Only few interventions aimed at enhancing work participation of unemployed or work-disabled cancer survivors, have been evaluated. In two cohort studies, promising components for future multicomponent interventions were identified. However, findings suggest that more evidence is necessary on such multicomponent interventions, in which elements explicitly directed at work and including the workplace should be included.
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Neoplasias da Mama , Sobreviventes de Câncer , Humanos , Feminino , Neoplasias da Mama/reabilitação , Retorno ao TrabalhoRESUMO
BACKGROUND: MiLES is a web-based intervention targeted at managers with the aim of enhancing the successful return to work (RTW) of employees with cancer. The purpose of this study was to identify barriers to and facilitators of implementing MiLES in organizations, from a manager's perspective. MATERIAL AND METHODS: MiLES was implemented as a pilot in four organizations for six weeks. Sixteen managers were included, of which fourteen were interviewed regarding their perceived barriers to and facilitators of implementation of MiLES in their organization. Interviews were recorded, transcribed verbatim and analyzed with content analysis. RESULTS: The managers experienced barriers to and facilitators of implementation related to: (1) implementation responsibilities, (2) the intervention's content, and (3) organizational characteristics. Regarding implementation responsibilities, management board approval and an organizational infrastructure with distinct described implementation responsibilities were perceived as facilitators. Regarding the intervention's content, its accessibility, user-friendliness and completeness were perceived as facilitators. If the content did not meet the manager's specific needs, this was perceived as a barrier. Regarding organizational characteristics, several intangible (e.g., added value of MiLES within different organizations) and tangible (e.g., integration into absenteeism registration) organizational characteristics were perceived as facilitators. The absence of a quiet place to use MiLES was perceived as barrier. CONCLUSION: Implementation of MiLES in organizations may benefit from an infrastructure within the organization that defines responsibilities regarding intervention delivery to managers of employees with cancer. Such an infrastructure should be aligned to existing organizational structures. As per interviewed managers, MiLES has added value in diverse organizations.
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Intervenção Baseada em Internet , Neoplasias , Humanos , Retorno ao Trabalho , Neoplasias/terapiaRESUMO
INTRODUCTION: Our aim was to gain insight into the effect of COVID-19 measures on SARS-CoV-2 incidence in secondary schools and the association with classroom CO2 concentration and airborne contamination. METHODS: Between October 2020-June 2021, 18 schools weekly reported SARS-CoV-2 incidence and completed surveys on school-initiated COVID-19 measures (e.g. improving hygiene or minimizing contacts). CO2 was measured in occupied classrooms twice, and SARS-CoV-2 air contamination longitudinally using electrostatic dust collectors (EDC) and analyzed using RT-qPCR. National COVID-19 policy measures varied during pre-lockdown, lockdown and post-lockdown periods. During the entire study, schools were recommended to improve ventilation. SARS-CoV-2 incidence rate ratios (IRR) were estimated by Generalized Estimating Equation (GEE) models. RESULTS: During 18 weeks follow-up (range: 10-22) SARS-CoV-2 school-incidence decreased during national lockdown (adjusted IRR: 0.41, 95%CI: 0.21-0.80) and post-lockdown (IRR: 0.60, 0.39-0.93) compared to pre-lockdown. School-initiated COVID-19 measures had no additional effect. Pre-lockdown, IRRs per 10% increase in time CO2 exceeded 400, 550 and 800 ppm above outdoor level respectively, were 1.08 (1.00-1.16), 1.10 (1.02-1.19), and 1.08 (0.95-1.22). Post-lockdown, CO2-concentrations were considerably lower and not associated with SARS-CoV-2 incidence. No SARS-CoV-2 RNA was detected in any of the EDC samples. CONCLUSION: During a period with low SARS-CoV-2 population immunity and increased attention to ventilation, with CO2 levels most of the time below acceptable thresholds, only the national policy during and post-lockdown of reduced class-occupancy, stringent quarantine, and contact testing reduced SARS-CoV-2 incidence in Dutch secondary schools. Widespread SARS-CoV-2 air contamination could not be demonstrated in schools under the prevailing conditions during the study.
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COVID-19 , SARS-CoV-2 , Humanos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Incidência , Dióxido de Carbono , Controle de Doenças Transmissíveis , Instituições Acadêmicas , PoeiraRESUMO
AIM: The aim of the study was to explore the perspectives of adults born prematurely on guidelines for management at extreme premature birth and personalisation at the limit of viability. METHODS: We conducted four 2-h online focus group interviews in the Netherlands. RESULTS: Twenty-three participants born prematurely were included in this study, ranging in age from 19 to 56 years and representing a variety of health outcomes. Participants shared their perspectives on different types of guidelines for managing extremely premature birth. They agreed that a guideline was necessary to prevent arbitrary treatment decisions and to avoid physician bias. All participants favoured a guideline that is based upon multiple prognostic factors beyond gestational age. They emphasised the importance of discretion, regardless of the type of guideline used. Discussions centred mainly on the heterogeneity of value judgements about outcomes after extreme premature birth. Participants defined personalisation as 'not just looking at numbers and statistics'. They associated personalisation mainly with information provision and decision-making. Participants stressed the importance of involving families in decision-making and taking their care needs seriously. CONCLUSION: Adults born prematurely prefer a periviability guideline that considers multiple prognostic factors and allows for discretion.
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Recém-Nascido Prematuro , Nascimento Prematuro , Recém-Nascido , Gravidez , Feminino , Humanos , Adulto , Adulto Jovem , Pessoa de Meia-Idade , Idade Gestacional , Prognóstico , PartoRESUMO
BACKGROUND: To support occupational physicians (OPs) in the implementation of workers' health surveillance (WHS), a training programme was developed. AIMS: (i) To evaluate the effects of a WHS training programme for OPs on knowledge, self-efficacy and skills to implement WHS. (ii) To evaluate to what extent a WHS training programme is acceptable and feasible for implementation in practice. METHODS: A single-blinded randomized controlled trial with waiting-list control group was used. The WHS training programme consisted of an e-learning and a 4.5-h online training session. OPs completed a knowledge test (0-8), self-efficacy questionnaires on knowledge and skills (6-60), and vignette assignments (0-16) to measure skills. OPs completed the questionnaires, either before and after the WHS training programme (intervention group), or before the training programme (control group) while receiving the training programme after the waiting period. All OPs completed questionnaires about the training's acceptability, and feasibility for implementation in practice. ANCOVA and Poisson regression analyses were conducted. RESULTS: The self-efficacy score (M = 44.1 versus M = 37.2) (P < 0.001) and skills score (M = 9.6 versus M = 8.3) (P < 0.05) of OPs in the training group (N = 16) were higher than the control group (N = 23). No effect was found on knowledge. Evaluation of acceptability and feasibility showed that 21 (58%) OPs were very satisfied with the training part on initiating WHS, and 29 (85%) would recommend the WHS training programme to colleagues. CONCLUSIONS: This WHS training programme has a positive effect on self-efficacy and skills of OPs to implement WHS, and may be acceptable and feasible to implement in practice.
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Saúde Ocupacional , Médicos , Humanos , Vigilância da População , Pessoal de Saúde , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Person-centered care is needed to effectively support workers with chronic health conditions. Person-centered care aims to provide care tailored to an individual person's preferences, needs and values. To achieve this, a more active, supportive, and coaching role of occupational and insurance physicians is required. In previous research, two training programs and an e-learning training with accompanying tools that can be used in the context of person-centered occupational health care were developed to contribute to this changing role. The aim was to investigate the feasibility of the developed training programs and e-learning training to enhance the active, supportive, and coaching role of occupational and insurance physicians needed for person-centered occupational health care. Information about this is important to facilitate implementation of the tools and training into educational structures and occupational health practice. METHODS: A qualitative study was conducted, with N = 29 semi-structured interviews with occupational physicians, insurance physicians, and representatives from occupational educational institutes. The aim was to elicit feasibility factors concerning the implementation, practicality and integration with regard to embedding the training programs and e-learning training in educational structures and the use of the tools and acquired knowledge and skills in occupational health care practice after following the trainings and e-learning training. Deductive analysis was conducted based on pre-selected focus areas for a feasibility study. RESULTS: From an educational perspective, adapting the face-to-face training programs to online versions, good coordination with educational managers and train-the-trainer approaches were mentioned as facilitating factors for successful implementation. Participants underlined the importance of aligning the occupational physicians' and insurance physicians' competences with the educational content and attention for the costs concerning the facilitation of the trainings and e-learning training. From the professional perspective, factors concerning the content of the training and e-learning training, the use of actual cases from practice, as well as follow-up training sessions were reported. Professionals expressed good fit of the acquired skills into their consultation hour in practice. CONCLUSION: The developed training programs, e-learning training and accompanying tools were perceived feasible in terms of implementation, practicality, and integration by occupational physicians, insurance physicians and educational institutes.
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Saúde Ocupacional , Humanos , Estudos de Viabilidade , Aprendizagem , Pessoal de Saúde/educação , Assistência Centrada no PacienteRESUMO
BACKGROUND: Managers are considered to be main stakeholders in the return to work (RTW) of cancer survivors. However, the perspectives of cancer survivors and managers differ on what managerial actions should be taken during the RTW of cancer survivors. This difference might put effective collaboration and successful RTW at risk. Therefore, this study aims to reach consensus among managers and cancer survivors on the managerial actions to be taken during the four different RTW phases of cancer survivors (i.e., Disclosure, Treatment, RTW plan, Actual RTW). METHODS: The Technique for Research of Information by Animation of a Group of Experts (TRIAGE) was implemented with managers and cancer survivors (hereafter referred to as "experts"). An initial list of 24 actions was derived from a previous study. Firstly, for each action, fifteen experts were asked to indicate individually how important this action is per RTW phase (Likert scale from 1 - "Not important at all" to 6 - "Very important"). Consensus was reached when ≥ 80% (i.e., ≥ twelve experts) of the experts rated that action ≥5. Secondly, for each phase of the RTW process, the 15 actions with the highest percentage were discussed with eight experts during the collective consultation, except for the actions that already reached consensus. After discussion, the experts voted whether each action was important ("yes" / "no") and consensus required ≥ 87.5% (i.e., ≥ seven experts) of the experts to consider an action as important. RESULTS: Twenty-five managerial actions were finally retained for at least one of the RTW phases, e.g., Disclosure: "respect privacy" and "radiate a positive attitude", Treatment: "show appreciation" and "allow sufficient sick leave", RTW Plan: "tailor" and "communicate", and Actual RTW: "support practically" and "balance interest". CONCLUSION: Cancer survivors and managers reached consensus on the importance of 25 managerial actions, distributed into each phase of the RTW process. These actions should be considered an interplay of managerial actions by different stakeholders on the part of the employer (e.g., direct supervisor, HR-manager), and should be a responsibility that is shared by these stakeholders. The collective implementation of these actions within the company will help cancer survivors feel fully supported.
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Sobreviventes de Câncer , Neoplasias , Consenso , Emprego , Humanos , Neoplasias/terapia , Retorno ao Trabalho , Licença MédicaRESUMO
BACKGROUND: Health care coverage decisions deal with health care technology provision or reimbursement at a national level. The coverage decision report, i.e., the publicly available document giving reasons for the decision, may contain various elements: quantitative calculations like cost and clinical effectiveness analyses and formalised and non-formalised qualitative considerations. We know little about the process of combining these heterogeneous elements into robust decisions. METHODS: This study describes a model for combining different elements in coverage decisions. We build on two qualitative cases of coverage appraisals at the Dutch National Health Care Institute, for which we analysed observations at committee meetings (n = 2, with field notes taken) and the corresponding audio files (n = 3), interviews with appraisal committee members (n = 10 in seven interviews) and with Institute employees (n = 5 in three interviews), and relevant documents (n = 4). RESULTS: We conceptualise decisions as combinations of elements, specifically (quantitative) findings and (qualitative) arguments and values. Our model contains three steps: 1) identifying elements; 2) designing the combinations of elements, which entails articulating links, broadening the scope of designed combinations, and black-boxing links; and 3) testing these combinations and choosing one as the final decision. CONCLUSIONS: Based on the proposed model, we suggest actively identifying a wider variety of elements and stepping up in terms of engaging patients and the public, including facilitating appeals. Future research could explore how different actors perceive the robustness of decisions and how this relates to their perceived legitimacy.
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Tecnologia Biomédica , Atenção à Saúde , Academias e Institutos , Instalações de Saúde , HumanosRESUMO
BACKGROUND: Mental health complaints occur frequently among healthcare workers. A workers' health surveillance mental health module (WHS-MH) was found to be effective in improving work functioning of nurses, although not implemented regularly. Therefore, training for occupational physicians and nurses to facilitate the implementation of WHS-MH was developed and evaluated. AIMS: This study was aimed to evaluate the effect of training on knowledge, self-efficacy and motivation to implement WHS-MH, and to evaluate participants' satisfaction with the training. METHODS: Three-hour training was held among 49 occupational physicians and nurses in the Netherlands. Effect on knowledge, self-efficacy and motivation was assessed using knowledge tests and questionnaires before and immediately after the training. Satisfaction with the training was measured using questionnaires after the training. RESULTS: A mean knowledge test score of 5.3 (SD = 1.6) was found before training, which did not significantly increase after training (M = 5.6, SD = 1.8). In total, 43% agreed or strongly agreed to have sufficient skills to implement WHS-MH, which significantly increased to 78% after the training. Furthermore, 87% agreed or strongly agreed to be motivated to initiate WHS, which significantly increased to 94% after the training. The majority of participants were satisfied with the training. CONCLUSIONS: Training may enhance the implementation of the WHS-MH through increasing self-efficacy and motivation. However, no effect on level of knowledge to implement WHS-MH was found.
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Saúde Mental , Saúde Ocupacional , Pessoal de Saúde , Humanos , Vigilância da População , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Preserving personal dignity is an important aim of palliative care. Little is known about how physicians perceive and preserve dignity of patients from non-western migration backgrounds. Insight in this is important given the increased demand for culturally sensitive palliative care. AIM: To gain insight in how Dutch physicians perceive and preserve dignity in the last phase of life for patients from non-western migration backgrounds. DESIGN: Qualitative thematic analysis of semi-structured interviews. PARTICIPANTS: Fifteen physicians experienced in palliative care. RESULTS: Physicians experienced dilemmas in preserving dignity of non-western patients in three situations: (a) relief of suffering in the terminal phase, (b) termination of interventions and treatment, and (c) disclosure of diagnosis. Physicians wanted to grant the needs of patients in the last phase of their lives, which was central to physicians' view on dignity, but dilemmas arose when this conflicted with physicians' other personal and professional values. To make the dilemmas manageable, physicians assessed whether needs of patients were authentic, but due to linguistic, cultural, and communication barriers, this was difficult with non-western patients. To find a way out of the dilemmas, physicians had three strategies: accept and go along with patient's wishes, convince or overrule the patient or family, or seek solutions that were acceptable for all. CONCLUSIONS: Physicians encounter dilemmas providing palliative care for people from non-western backgrounds. Future physicians can be trained in connective strategies and seeking middle grounds to optimally preserve patients' dignity while being in concordance with their personal and professional values.
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Enfermagem de Cuidados Paliativos na Terminalidade da Vida , Médicos , Humanos , Cuidados Paliativos , Pesquisa Qualitativa , RespeitoRESUMO
INTRODUCTION: In the past decade, the atrial fibrillation (AF) landscape, including the treatment modalities, has drastically changed. This raises the question how AF prevalence and choices in antithrombotic therapy prescription have developed in the community over time. METHODS: Routine care data from the Julius General Practitioners' Network (JGPN) were used to calculate the yearly prevalence of AF and to quantify the percentage of all patients who were prescribed a platelet inhibitor, vitamin K antagonist (VKA), non-VKA oral anticoagulant (NOAC) or no antithrombotic medication. To explore whether certain patient characteristics are associated with selective prescription of oral anticoagulants (OAC), we applied logistic regression analyses. RESULTS: From 2008 through 2017, the JGPN database included 7459 unique AF patients. During this period, the prevalence of AF increased from 0.4% to 1.4%. The percentage of patients prescribed a VKA declined from 47% to 41%, whereas the percentage of patients prescribed a NOAC rose from 0% to 20%. In patients with new-onset AF, older age, heart failure, diabetes mellitus, vascular disease and dementia were independently associated with a higher likelihood of VKA rather than NOAC prescription. In 2017, 25% of all patients with AF and a CHA2DS2-VASc score ≥â¯2 were not prescribed OAC therapy (i.e. 8% with platelet inhibitor monotherapy and 17% without any antithrombotic therapy). CONCLUSION: Between 2008 and 2017, AF prevalence in the community more than tripled. Prescription patterns showed possible 'channelling' of VKAs over NOACs in frailer, elderly patients, whereas still about one in every four AF patients with a CHA2DS2-VASc score ≥â¯2 was not prescribed any prophylactic OAC therapy.
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BACKGROUND: The aim was to identify the most important determinants of practice for the implementation of person-centered tools which enhance work participation for patients with chronic health conditions. METHODS: A mixed-method study was conducted consisting of semi-structured interviews, a focus group and a survey. Various stakeholders were involved including (representatives of) workers with chronic health conditions, insurance physicians, occupational physicians, other healthcare professionals, researchers, employers, and policymakers. The semi-structured interviews were performed to identify implementation determinants, followed by a focus group to validate resulting determinants. To conclude, a survey was conducted to select the most important implementation determinants through prioritization by ranking the order of importance. The Tailored Implementation of Chronic Diseases checklist (TICD) was used as concept-driven coding frame for the qualitative analysis of the interviews and focus group. The self-developed survey was based on the domains of the TICD. The survey was analyzed by frequency count of first ranking of determinants per and between domains of the TICD. RESULTS: Various stakeholders participated (N = 27) in the interviews and focus group. The qualitative data retrieved yielded a list of determinants with additional in-depth themes according to the TICD. For the selection of the most important determinants, a survey with 101 respondents was conducted, consisting of occupational physicians, insurance physicians and workers with a chronic health condition. From the seven domains of the TICD, respondents emphasized the importance of taking into account the needs and factors associated with workers with a chronic health condition as this determinant ranked highest. Taking into account the individual needs and wishes of workers was mentioned to enable successful implementation, whereas stress of the workers was indicated to impede implementation. Other important determinants included 'being able to work with the tools' in terms of time and usability or 'cognitions, beliefs and attitudes of occupational and insurance physicians' to be able to use the tools. CONCLUSION: This study identified the most important determinants from the perspective of various stakeholders involved in the implementation of client-centered tools in occupational health for workers with chronic health conditions. Furthermore, by prioritizing the most important determinants, targeted implementation strategies can be developed.
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Lista de Checagem , Projetos de Pesquisa , Doença Crônica , Grupos Focais , Pessoal de Saúde , Humanos , Pesquisa QualitativaRESUMO
BACKGROUND: Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors' successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. METHODS: A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18-63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. RESULTS: Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study's reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81-1.03); no difference were found with regard to secondary effect measures. CONCLUSIONS: With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. TRIAL REGISTRATION: The study has been registered in the Dutch Trial Register ( NL6758/NTR7627 ).
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Neoplasias da Mama , Sobreviventes de Câncer , Emprego , Estudos de Viabilidade , Feminino , Humanos , Retorno ao Trabalho , Licença MédicaRESUMO
BACKGROUND: Food systems are associated with severe and persistent problems worldwide. Governance approaches aiming to foster sustainable transformation of food systems face several challenges due to the complex nature of food systems. SCOPE AND APPROACH: In this commentary we argue that addressing these governance challenges requires the development and adoption of novel research and innovation (R&I) approaches that will provide evidence to inform food system transformation and will serve as catalysts for change. We first elaborate on the complexity of food systems (transformation) and stress the need to move beyond traditional linear R&I approaches to be able to respond to persistent problems that affect food systems. Though integrated transdisciplinary approaches are promising, current R&I systems do not sufficiently support such endeavors. As such, we argue, we need strategies that trigger a double transformation - of food systems and of their R&I systems. KEY FINDINGS AND CONCLUSIONS: Seizing the opportunities to transform R&I systems has implications for how research is done - pointing to the need for competence development among researchers, policy makers and society in general - and requires specific governance interventions that stimulate a systemic approach. Such interventions should foster transdisciplinary and transformative research agendas that stimulate portfolios of projects that will reinforce one another, and stimulate innovative experiments to shape conditions for systemic change. In short, a thorough rethinking of the role of R&I as well as how it is funded is a crucial step towards the development of the integrative policies that are necessary to engender systemic change - in the food system and beyond.
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PURPOSE: The MiLES intervention is a web-based intervention targeted at employers with the objective of enhancing successful return to work (RTW) of cancer survivors. The aim of this study is to gain insight into the employers' use and perceived usefulness of the MiLES intervention. METHODS: Employer representatives (e.g. Human Resource managers and supervisors) were given access to the MiLES intervention, which contains, among others, interactive videos, conversation checklists and tailored tips. After six weeks, an online questionnaire gathered data on employers' use and the perceived usefulness of the intervention. In-depth qualitative data on these topics were gathered during semi-structured interviews, which were analyzed using a content analysis. RESULTS: Thirty-one eligible employers were included. Twenty-two of them filled out the questionnaire and twenty were interviewed. Typically, employers used the intervention 2-3 times, for 26 min per visit. The usefulness of the intervention scored 7.6 out of 10 points, and all employers would recommend it to colleagues. Employers' use decreased when support needs were low and when the intervention did not correspond with their specific situation (e.g. complex reintegration trajectories). Employers perceived the intervention to be supporting and practically oriented. They appreciated the fact that the intervention was web-based and combined visual and textual content. The possibility of consulting specialized services for complex situations would further enhance its usefulness. CONCLUSION: The MiLES intervention provides employers with a useful tool in their daily practice. Its effectiveness for enhancing employers' managerial skills and cancer survivors' successful RTW is subject for further research.
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Sobreviventes de Câncer , Neoplasias , Retorno ao Trabalho , Comunicação , Emprego , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
Purpose The aim of this research was to study the effectiveness on return to work (RTW) of an early tailored work-related support intervention in patients diagnosed with curative gastrointestinal cancer. Methods A multicenter randomized controlled trial was undertaken, in which patients were assigned randomly to the intervention or the control group (usual care). The intervention encompassed three psychosocial work-related support meetings, starting before treatment. Five self-reported questionnaires were sent over twelve months of follow-up. Primary outcome was days until RTW (fulltime or partial) and secondary outcomes included work status, quality of life, work ability, and work limitations. Descriptive analysis, Kaplan-Meier analysis, relative risk ratio and linear mixed models were applied. Results Participants (N = 88) had a mean age of 55 years; 67% were male and the most common cancer type was colon cancer (66%). Of the participants, 42 were randomized to the intervention group. The median time from sick leave until RTW was 233 days (range 187-279 days) for the control group, versus 190 days (range 139-240 days) for the intervention group (log-rank p = 0.37). The RTW rate at twelve months after baseline was 83.3% for the intervention group and 73.5% for the control group. Work limitations did statistically differ between the groups over time (p = 0.01), but quality of life and work ability did not. Conclusion Patients in the intervention group seem to take fewer days to RTW, albeit not to a statistically significant extent.Trial registration Trial NL4920 (NTR5022) (Dutch Trial Register https://www.trialregister.nl ).
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Neoplasias Gastrointestinais , Qualidade de Vida , Emprego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Retorno ao Trabalho , Licença MédicaRESUMO
Ankle and hindfoot fractures are often associated with a considerable amount of pain and need for systemic analgesics. Cooling devices have been developed to reduce swelling, pain, analgesics need, and complications. The primary aim was to examine the effect of cooling versus no cooling on pain levels in adult patients treated operatively for an ankle or hindfoot fracture. Secondary aims were to assess the effect of cooling on (1) analgesics use, (2) patient satisfaction, (3) hospital length of stay (HLOS), (4) the rate of complications, and (5) the rate of secondary interventions. In this single center, retrospective case-control study patients who used a computer-controlled cooling device before and after surgery of an ankle or hindfoot fracture between January 1, 2015 and January 1, 2017 were included. Matched patients without using cooling served as control. Patient, injury and treatment characteristics, pain scores and analgesics use during hospital admission were extracted from patient's medical files. Pain scores in the cooling group (18 patients) did not statistically differ from the non-cooling group (17 patients). After surgery, less patients in the cooling group used paracetamol (p = .041), and nonsteroidal anti-inflammatory drugs (p = .006). Patient satisfaction of both groups was eight out of ten points. The total HLOS was 14 days (P25-P75 9.0-17.3) in the cooling group and 9 days (P25-P75 5.0-16.5) in the non-cooling group. This was mostly contributable to the difference in preoperative HLOS (8 days; P25-P75 4.8-13.0 versus 4 days; P25-P75 2.0-7.0) and time to surgery (13.5 days; P25-P75 9.3-16.3) versus 8 days; P25-P75 2.5-12.0). Complications and revision surgery did not differ. Patients with ankle or hindfoot fractures seem to benefit from computer-controlled cooling, since equal pain sensation is feasible with less analgesics postoperatively, whereas rates of complications and revision surgeries were comparable in both groups. Patients were highly satisfied with cooling.
Assuntos
Fraturas do Tornozelo , Tornozelo , Adulto , Fraturas do Tornozelo/diagnóstico por imagem , Fraturas do Tornozelo/cirurgia , Articulação do Tornozelo/cirurgia , Estudos de Casos e Controles , Computadores , Humanos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: The relative new subspecialty 'cardio-oncology' was established to meet the growing demand for an interdisciplinary approach to the management of cancer therapy-related cardiovascular adverse events. In recent years, specialised cardio-oncology services have been implemented worldwide, which all strive to improve the cardiovascular health of cancer patients. However, limited data are currently available on the outcomes and experiences of these specialised services, and optimal strategies for cardio-oncological care have not been established. AIM: The ONCOR registry has been created for prospective data collection and evaluation of cardio-oncological care in daily practice. METHODS: Dutch hospitals using a standardised cardio-oncology care pathway are included in this national, multicentre, observational cohort study. All patients visiting these cardio-oncology services are eligible for study inclusion. Data collection at baseline consists of the (planned) cancer treatment and the cardiovascular risk profile, which are used to estimate the cardiotoxic risk. Information regarding invasive and noninvasive tests is collected during the time patients receive cardio-oncological care. Outcome data consist of the incidence of cardiovascular complications and major adverse cardiac events, and the impact of these events on the oncological treatment. DISCUSSION: Outcomes of the ONCOR registry may aid in gaining more insight into the incidence of cancer therapy-related cardiovascular complications. The registry facilitates research on mechanisms of cardiovascular complications and on diagnostic, prognostic and therapeutic strategies. In addition, it provides a platform for future (interventional) studies. Centres with cardio-oncology services that are interested in contributing to the ONCOR registry are hereby invited to participate.