Dataset Information

Development and Evaluation of an Ethical Guideline for Decisions to Limit Life-Prolonging Treatment in Advanced Cancer: Protocol for a Monocentric Mixed-Method Interventional Study.

ABSTRACT: BACKGROUND:Many patients with advanced cancer receive chemotherapy close to death and are referred too late to palliative or hospice care, and therefore die under therapy or in intensive care units. Oncologists still have difficulties in involving patients appropriately in decisions about limiting tumor-specific or life-prolonging treatment. OBJECTIVE:The aim of this Ethics Policy for Advanced Care Planning and Limiting Treatment Study is to develop an ethical guideline for end-of-life decisions and to evaluate the impact of this guideline on clinical practice regarding the following target goals: reduction of decisional conflicts, improvement of documentation transparency and traceability, reduction of distress of the caregiver team, and better knowledge and consideration of patients' preferences. METHODS:This is a protocol for a pre-post interventional study that analyzes the clinical practice on treatment limitation before and after the guideline implementation. An embedded researcher design with a mixed-method approach encompassing both qualitative and quantitative methods is used. The study consists of three stages: (1) the preinterventional phase, (2) the intervention (development and implementation of the guideline), and 3) the postinterventional phase (evaluation of the guideline's impact on clinical practice). We evaluate the process of decision-making related to limiting treatment from different perspectives of oncologists, nurses, and patients; comparing them to each other will allow us to develop the guideline based on the interests of all parties. RESULTS:The first preintervention data of the project have already been published, which detailed a qualitative study with oncologists and oncology nurses (n=29), where different approaches to initiation of end-of-life discussions were ethically weighted. A framework for oncologists was elaborated, and the study favored an anticipatory approach of preparing patients for forgoing therapy throughout the course of disease. Another preimplementational study of current decision-making practice (n=567 patients documented) demonstrated that decisions to limit treatment preceded the death of many cancer patients (62/76, 82% of deceased patients). However, such decisions were usually made in the last week of life, which was relatively late. CONCLUSIONS:The intervention will be evaluated with respect to the following endpoints: better knowledge and consideration of patients' treatment wishes; reduction of decisional conflicts; improvement of documentation transparency and traceability; and reduction of the psychological and moral distress of a caregiver team. REGISTERED REPORT IDENTIFIER:RR1-10.2196/9698.

SUBMITTER: Laryionava K

PROVIDER: S-EPMC6026302 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Development and Evaluation of an Ethical Guideline for Decisions to Limit Life-Prolonging Treatment in Advanced Cancer: Protocol for a Monocentric Mixed-Method Interventional Study.

Laryionava Katsiaryna K Mehlis Katja K Bierwirth Elena E Mumm Friederike F Hiddemann Wolfgang W Heußner Pia P Winkler Eva C EC

JMIR research protocols 20180615 6

<h4>Background</h4>Many patients with advanced cancer receive chemotherapy close to death and are referred too late to palliative or hospice care, and therefore die under therapy or in intensive care units. Oncologists still have difficulties in involving patients appropriately in decisions about limiting tumor-specific or life-prolonging treatment.<h4>Objective</h4>The aim of this Ethics Policy for Advanced Care Planning and Limiting Treatment Study is to develop an ethical guideline for end-of ...[more]

PMID: 29907553

Similar Datasets

Project description:BackgroundBest formats for summarising and presenting evidence for use in clinical guideline development remain less well defined. We aimed to assess the effectiveness of different evidence summary formats to address this gap.MethodsHealthcare professionals attending a one-week Kenyan, national guideline development workshop were randomly allocated to receive evidence packaged in three different formats: systematic reviews (SRs) alone, systematic reviews with summary-of-findings tables, and 'graded-entry' formats (a 'front-end' summary and a contextually framed narrative report plus the SR). The influence of format on the proportion of correct responses to key clinical questions, the primary outcome, was assessed using a written test. The secondary outcome was a composite endpoint, measured on a 5-point scale, of the clarity of presentation and ease of locating the quality of evidence for critical neonatal outcomes. Interviews conducted within two months following completion of trial data collection explored panel members' views on the evidence summary formats and experiences with appraisal and use of research information.Results65 (93%) of 70 participants completed questions on the prespecified outcome measures. There were no differences between groups in the odds of correct responses to key clinical questions. 'Graded-entry' formats were associated with a higher mean composite score for clarity and accessibility of information about the quality of evidence for critical neonatal outcomes compared to systematic reviews alone (adjusted mean difference 0.52, 95% CI 0.06 to 0.99). There was no difference in the mean composite score between SR with SoF tables and SR alone. Findings from interviews with 16 panelists indicated that short narrative evidence reports were preferred for the improved clarity of information presentation and ease of use.ConclusionsOur findings suggest that 'graded-entry' evidence summary formats may improve clarity and accessibility of research evidence in clinical guideline development.Trial registrationControlled-Trials.com ISRCTN05154264.

Project description:BackgroundDuring the beginning of the COVID-19 pandemic there was an urgent need for accelerated review of COVID-19 research by Medical Research Ethics Committees (MRECs). In the Netherlands this led to the implementation of so-called 'fast-track-review-procedures' (FTRPs) to enable a swift start of urgent and relevant research. The objective of this study is to evaluate FTRPs of MRECs in the Netherlands during the COVID-19 pandemic and to compare them with the regular review procedures (RRPs).Methods and findingsAn explanatory sequential mixed method study was conducted. Online questionnaires and four group interviews were conducted among MREC representatives and investigators of COVID-19 research. In addition, data from a national research registration system was requested. Main outcome measures are differences in timelines, quality of the review and satisfaction between FTRPs and RRPs. The total number of review days was shorter in FTRP (median 10.5) compared to RRPs (median 98.0). Review days attributable to the MRECs also declined in FTRPs (median 8.0 versus 50.0). This shortening can be explained by installing ad hoc (sub)committees, full priority given to COVID-19 research, regular research put on hold, online review meetings and administrative leniency. The shorter timelines did not affect the perceived quality of the review and ethical and legal aspects were not weighted differently. Both MREC representatives and investigators were generally satisfied with the review of COVID-19 research. Weaknesses identified were the lack of overview of COVID-19 research and central collaboration and coordination, the delay of review of regular research, and limited reachability of secretariats.ConclusionsThis study shows that accelerated review is feasible during emergency situations. We did not find evidence that review quality was compromised and both investigators and MRECs were content with the FTRP. To improve future medical ethical review during pandemic situations and beyond, distinguishing main and side issues, working digitally, and (inter)national collaboration and coordination are important.

Project description:Background: The high potential risks involved in working in a healthcare setting during a pandemic and the associated fear that may affect health care workers' (HCWs') willingness to work are important to understand to eliminate potential barriers to working. This study aimed to assess Palestinian HCWs' willingness to work and the related factors as well as to explore their ethical dilemmas during the coronavirus disease 2019 (COVID-19) pandemic. Materials and Methods: Quantitative (survey questionnaire) and qualitative (semi-structured interviews) data were collected. Frontline HCWs (n = 550) received an online survey link via closed institutional networks. Frequencies summarized the data, and chi-square compared variables and outcomes. Odds ratios (ORs) and multivariable analysis examined predictors for willingness to work. Fifteen HCWs (physicians, nurses, and lab and radiology technicians) were purposefully sampled and agreed to interviews to explore their thoughts, motivations, and worries. Thematic analysis focused on ethical dilemmas to enhance the breadth and the depth of the study. Results: Almost 25% of surveyed HCWs were not willing to work during the pandemic. Logistic model results showed that physicians and nurses had higher willingness to work than others (p = 0.004, Adj. OR = 3.5). Lower stress levels and longer professional experience were predictors of more willing to work (p = 0.03, Adj. OR = 2.5; p = 0.03, Adj. OR = 2.6, respectively). Interviews showed that willingness to work did not preclude HCWs from fulfilling their duties despite grueling workloads and grave fears about safety and security. HCWs felt poorly prepared, unappreciated, and frustrated by unfair work distribution. The occupation presented additional safety issues. Conclusion: Physicians and nurses were more likely to comply with a commitment to their professional ethics and the duty or obligation to work. Stress levels could be mitigated in the future with better leadership, adding supports to address mental health and psychosocial challenges to enhance HCWs' well-being and improve quality of care. The realities of the occupation added additional threats and uncertainty.

Project description:BackgroundWith increasing interest in direct access to physiotherapy, it is important to consider the physiotherapists (PTs) ability to make correct management decisions, because identification of differential diagnostic pathologies and timely referral for specialist care is vital for patient safety. The aims of the study were to investigate PTs ability to make correct management decisions in patients presenting with musculoskeletal conditions and to identify explanatory factors associated with this ability. Furthermore, we wanted to explore the PTs views on the identified factors.MethodsThe study was a mixed methods study with an explanatory sequential design consisting of a questionnaire survey and semi-structured interviews. The questionnaire comprised 12 clinical vignettes describing patient scenarios for musculoskeletal conditions, non-critical medical conditions and critical medical conditions. Based on this, the PTs indicated whether the patient should be managed by the PT or were in need of medical referral. Associations between correct decisions and explanatory variables was analyzed by mixed- effects logistic regression. Interviews were performed with nine PTs to explore their reactions to the results. A directed content analysis was performed.ResultsA total of 195 PTs participated in the questionnaire survey and 9 PTs were interviewed. Overall, PTs were more likely to make correct management decisions in the musculoskeletal conditions category, whereas wrong decisions were more often chosen for underlying medical conditions categories. Positive associations between correct management decision in the critical medical category were found for experience: odds ratio (OR) 2.73 (1.33;5.57) and passed quality audit OR 2.90 (1.50;5.58). In the interviews, PTs expressed concerns about the differential diagnostic abilities. They all noted, that experience is immensely important in the clinical reasoning process because the ability to recognise diagnostic patterns evolves over time. Furthermore, the quality audit seems to address and systematize the clinical reasoning process and workflow within the clinics.ConclusionThe lack of ability to make correct management decision in critical medical categories and the uncertainties expressed by PT's should raise concern, as direct access to physiotherapy is already well-established and the results indicate that patient safety could be at risk. The findings that experience and passed quality audit was associated with correct management decisions highlights the need for ongoing awareness and education into differential diagnostics.

Dataset Information

Development and Evaluation of an Ethical Guideline for Decisions to Limit Life-Prolonging Treatment in Advanced Cancer: Protocol for a Monocentric Mixed-Method Interventional Study.

Publications

Development and Evaluation of an Ethical Guideline for Decisions to Limit Life-Prolonging Treatment in Advanced Cancer: Protocol for a Monocentric Mixed-Method Interventional Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets