Recommendations for managing missing data, attrition and response shift in palliative and end-of-life care research: Part of the MORECare research method guidance on statistical issues

Background: Statistical analysis in palliative and end-of-life care research can be problematic due to high levels of missing data, attrition and response shift as disease progresses. Aim: To develop recommendations about managing missing data, attrition and response shift in palliative and end-of-life care research data. Design: We used the MORECare Transparent Expert Consultation approach to conduct a consultation workshop with experts in statistical methods in palliative and end-of-life care research. Following presentations and discussion, nominal group techniques were used to produce recommendations about attrition, missing data and response shift. These were rated online by experts and analysed using descriptive statistics for consensus and importance. Results: In total, 20 participants attended the workshop and 19 recommendations were subsequently ranked. There was broad agreement across recommendations. The top five recommendations were as follows: A taxonomy should be devised to define types of attrition. Types and amount of missing data should be reported with details of imputation methods. The pattern of missing data should be investigated to inform the imputation approach. A statistical analysis plan should be pre-specified in the protocol. High rates of attrition should be assumed when planning studies and specifying analyses. The leading recommendation for response shift was for more research. Conclusions: When designing studies in palliative and end-of-life care, it is recommended that high rates of attrition should not be seen as indicative of poor design and that a clear statistical analysis plan is in place to account for missing data and attrition.

[1]  I. Higginson,et al.  The Selection and Use of Outcome Measures in Palliative and End-of-Life Care Research: The MORECare International Consensus Workshop , 2013, Journal of pain and symptom management.

[2]  I. Higginson,et al.  MORECare research methods guidance development: Recommendations for ethical issues in palliative and end-of-life care research , 2013, Palliative medicine.

[3]  M. Hotopf,et al.  Evaluating complex interventions in End of Life Care: the MORECare Statement on good practice generated by a synthesis of transparent expert consultations and systematic reviews , 2013, BMC Medicine.

[4]  I. Higginson,et al.  MoreCare research methods guidance development:recommendations for using mixed methods to develop and evaluate complex interventions in palliative and end of life care , 2012 .

[5]  I. Higginson,et al.  MORECare research methods guidance development: recommendations for health economic evaluations in palliative and end of life care research , 2012 .

[6]  Stef van Buuren,et al.  Flexible Imputation of Missing Data , 2012 .

[7]  D. Mitchell,et al.  The Preferred Priorities for Care document in Motor Neurone Disease: Views of bereaved relatives and carers , 2012, Palliative medicine.

[8]  森田 達也 「緩和ケア」として行われた介入と副次的評価項目であることの限界 (論文を読み,理解する--Early palliative care for patients with metastatic non-small-cell lung cancer) , 2011 .

[9]  P. Fayers,et al.  Implicit self-comparisons against others could bias quality of life assessments. , 2007, Journal of clinical epidemiology.

[10]  C. Ballinger,et al.  Recommendations for promoting the engagement of older people in activities to prevent falls , 2007, Quality and Safety in Health Care.

[11]  D. Altman,et al.  Missing data , 2007, BMJ : British Medical Journal.

[12]  Rosalind Raine,et al.  Developing clinical guidelines: a challenge to current methods , 2005, BMJ : British Medical Journal.

[13]  A. Bezjak,et al.  Quality of life in a randomized trial of group psychosocial support in metastatic breast cancer: overall effects of the intervention and an exploration of missing data. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[14]  Kenneth F Schulz,et al.  For Personal Use. Only Reproduce with Permission from the Lancet Publishing Group. Exclusions before Randomisation Exclusions after Randomisation Sample Size Slippages in Randomised Trials: Exclusions and the Lost and Wayward , 2022 .

[15]  S. Satya‐Murti Evidence-based Medicine: How to Practice and Teach EBM , 1997 .

[16]  H. R. Anderson,et al.  Randomised controlled trial of effects of coordinating care for terminally ill cancer patients. , 1992, BMJ.

[17]  C. Moinpour,et al.  A randomized clinical trial of home nursing care for lung cancer patients , 1989, Cancer.

[18]  Zhang Jing,et al.  Guideline on missing data in confirmatory clinical trials , 2012 .

[19]  S. Buuren Multipele Imputatie in Vogelvlucht , 2012 .

[20]  P. Fayers,et al.  Response shift: you know it's there but how do you capture it? Challenges for the next phase of research [ch 4.4] , 2005 .