Dataset Information

Development of guidelines to reduce, handle and report missing data in palliative care trials: A multi-stakeholder modified nominal group technique.

ABSTRACT:

Background

Missing data can introduce bias and reduce the power, precision and generalisability of study findings. Guidelines on how to address missing data are limited in scope and detail, and poorly implemented.

Aim

To develop guidelines on how best to (i) reduce, (ii) handle and (iii) report missing data in palliative care clinical trials.

Design

Modified nominal group technique.

Setting/participants

Patient and public research partners, palliative care clinicians, trialists, methodologists and statisticians attended a 1-day workshop, following which a multi-stakeholder development group drafted the guidelines.

Results

Seven main recommendations for reducing missing data, nine for handling missing data and twelve for reporting missing data were developed. The top five recommendations were: (i) train all research staff on missing data, (ii) prepare for missing data at the trial design stage, (iii) address missing data in the statistical analysis plan, (iv) collect the reasons for missing data and (v) report descriptive statistics comparing the baseline characteristics of those with missing and observed data. Reducing missing data, preparing for missing data and understanding the reasons for missing data were greater priorities for stakeholders than how to deal with missing data once they had occurred.

Conclusion

Comprehensive guidelines on how to address missing data were developed by stakeholders involved in palliative care trials. Implementation of the guidelines will require endorsement of research funders and research journals.

SUBMITTER: Hussain JA

PROVIDER: S-EPMC8796167 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background:Discharge from acute mental health services has long been associated with mortality, risk, and related adverse outcomes for patients. Many of the interventions that currently aim to reduce adverse outcomes focus on a single group of healthcare professionals within a single healthcare setting. A recent systematic review highlights very few robust interventions that specifically aim to improve communication across services. However the importance of promoting interagency working and improving information flow between services is continually highlighted as a key priority. Methods:Using a novel codesign and experience based approach we worked with a multistakeholder group to develop possible solutions to reduce the adverse outcomes commonly associated with discharge from acute mental health services. This utilized a modified Nominal Group Technique and creative problem solving method to follow a four-stage process: Problem Identification, Solution Generation, Decision-Making, Prioritization and Implementation. Thirty-two healthcare professionals and an expert by lived experienced engaged with the process that took place over two stakeholder events. Results:Stakeholders at the first event identified and agreed upon 24 potential ideas to improve discharge from acute mental health services. These were refined at the second event to four elements of an interagency intervention: a multiagency 'Discharge Team' (with designated discharge coordinator), inclusive technology enabled team meetings, universal documentation and a patient generated discharge plan. Conclusion:This is the first study to codesign an interagency mental health discharge intervention based around a discharge team. We developed a model for working that places a greater focus on a patient generated discharge plan, interagency working, and information flow. A pilot of the proposed intervention is now needed to test the feasibility and effectiveness in reducing adverse outcomes.

Project description:IntroductionChimeric antigen receptor T-cell (CAR-T) therapy is a class of immunotherapy. An economic evaluation conducted at an early stage of development of CAR-T therapy for treatment of adult relapsed or refractory acute lymphoblastic leukaemia could provide insight into factors contributing to the cost of treatment, the potential clinical benefits, and what the health system can afford. Traditionally, stakeholders are engaged in certain parts of health technology assessment processes, such as in the identification and selection of technologies, formulation of recommendations, and implementation of recommendations; however, little is known about processes for stakeholder engagement during the conduct of the assessment. This is especially the case for economic evaluations. Stakeholders, such as clinicians, policy-makers, patients, and their support networks, have insight into factors that can enhance the validity of an economic evaluation model. This research outlines a specific methodology for stakeholder engagement and represents an avenue to enhance health economic evaluations and support the use of these models to inform decision making for resource allocation. This protocol may inform a tailored framework for stakeholder engagement processes in future economic evaluation model development.Methods and analysisWe will involve clinicians, healthcare researchers, payers, and policy-makers, as well as patients and their support networks in the conduct and verification of an early economic evaluation of a novel health technology to incorporate stakeholder-generated knowledge. Three stakeholder-specific focus groups will be conducted using an online adaptation of the nominal group technique to elicit considerations from each. This study will use CAR-T therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia as a basis for investigating broader stakeholder engagement processes.Ethics and disseminationThis study received ethics approval from the Ottawa Hospital Research Institute Research Ethics Board (REB 20200320-01HT) and the results will be shared via conference presentations, peer-reviewed publications, and ongoing stakeholder engagement.

Project description:OBJECTIVES:The objective was to the undertake nominal group technique (NGT) to evaluate current exercise adherence measures and isolated domains to develop stakeholder consensus on the domains to include in the measurement of therapeutic exercise adherence for patients with musculoskeletal disorders. DESIGN:A 1-day NGT workshop was convened. Six exercise adherence measures were presented to the group that were identified in our recent systematic review. Discussions considered these measures and isolated domains of exercise adherence. Following discussions, consensus voting identified stakeholder agreement on the suitability of the six offered adherence measures and the inclusion of isolated domains of exercise adherence in future measurement. SETTING:One stakeholder NGT workshop held in Sheffield, UK. PARTICIPANTS:Key stakeholders from the UK were invited to participate from four identified populations. 14 participants represented patients, clinicians, researchers and service managers. RESULTS:All six exercise adherence measures were deemed not appropriate for use in clinical research or routine practice with no measure reaching 70% group agreement for suitability, relevance, acceptability or appropriateness. Three measures were deemed feasible to use in clinical practice. 25 constructs of exercise adherence did reach consensus threshold and were supported to be included as domains in the future measurement of exercise adherence. CONCLUSION:A mixed UK-based stakeholder group felt these six measures of exercise adherence were unacceptable. Differences in opinion within the stakeholder group highlighted the lack of consensus as to what should be measured, the type of assessment that is required and whose perspective should be sought when assessing exercise adherence. Previously unused domains may be needed alongside current ones, from both a clinician's and patient's perspective, to gain understanding and to inform future measurement development. Further conceptualisation of exercise adherence is required from similar mixed stakeholder groups in various socioeconomic and cultural populations.