Using normalization process theory to evaluate the use of patient-centred outcome measures in specialist palliative home care-a qualitative interview study.

BACKGROUND: Standardised use of patient-centred outcome measures (PCOMs) improves aspects of quality of care. Normalization Process Theory (NPT) considers the social (inter-)actions of implementation processes operationalised through four constructs: coherence-building, cognitive participation, collective action and reflexive monitoring. The aim of the study was to identify barriers and enablers for the successful use of PCOMs in specialist palliative home care (SPHC) using NPT, to collect clinically meaningful and reliable data to improve patient outcomes. METHODS: Qualitative study using semi-structured interviews with palliative care professionals from German SPHC teams who participated in a study using PCOMs. Data were analysed using Framework analysis, and contextualised within NPT. RESULTS: Seventeen interviews across five teams were conducted. Some teams already had an understanding of what PCOMs are and how to use them, based on previous experience. In other teams, this understanding developed through the perception of the benefits (coherence). Participation and engagement depended on individuals and was decisive for coherence-building. The attitude of the management level also played a major role (cognitive participation). Integration of PCOMs into everyday clinical practice varied and depended on the manifestation of the first two constructs and other already established routines (collective action). In the context of appraisal, both positive (e.g. focus on patient) and negative aspects (e.g. additional work) of using PCOMs were mentioned (reflexive monitoring). CONCLUSIONS: Although benefits of using PCOMs were partly recognised, not all teams continued standardised use. Here, not only the social (inter-)actions, but also the influence of the context (working environment) were decisive. Future implementation strategies should consider integrating PCOMs in existing electronic patient records, education sessions supporting coherence-building, internal facilitators/local champions, and ensuring frequent data analyses as it is beneficial and increases the readiness of using PCOMs.

Are nurse`s needs assessment methods robust enough to recognise palliative care needs in people with dementia? A scoping review.

BACKGROUND: People with dementia are most at risk of experiencing serious health related suffering, if they do not have a palliative care approach introduced early enough in the illness. It can be challenging for nurses to assess experienced needs of people, who are thought no longer able to self-report such as people with dementia. Assessment help to understand the care the patient and their family need promptly. It is unknown how nurses recognise holistic palliative care needs in people with dementia during routine care. METHODS: Scoping review where EMBASE, MEDLINE, CINAHL, PsycInfo databases, and references were searched with an advanced search strategy, which was built on three concepts (nurses, dementia, and nursing assessment) using corresponding Medical Subject Headings. Data were charted in a piloted extraction form, based on the assessment domains within the nursing process followed by summarise and synthesise results narratively. RESULTS: 37 out of 2,028 qualitative and quantitative articles published between 2000 and 2021, and relating to 2600 + nurses, were identified. Pain was sole focus of assessment in 29 articles, leaving 8 articles to describe assessment of additional needs (e.g., discomfort). Nurses working in a nursing home assess pain and other needs by observing the persons with dementia behaviour during routine care. Nurses in the acute care setting are more likely to assess symptoms with standard assessment tools at admission and evaluate symptoms by observational methods. Across settings, about one third of pain assessments are supported by person-centred pain assessment tools. Assessments were mostly triggered when the person with dementia vocalised discomfort or a change in usual behaviour was observed. Nurses rely on family members and colleagues to gain more information about needs experienced by people with dementia. CONCLUSION: There is a scarcity of evidence about techniques and methods used by nurses to assess needs other than pain experienced by people with dementia. A holistic, person-centred screening tool to aid real-time observations at the bedside and used in conversations with health care professionals and families/friends, may improve need recognition other than pain, to ensure holistic needs could then be addressed timely to improve care in people with dementia.

Antecedents of unfinished nursing care: a systematic review of the literature.

BACKGROUND: Unfinished Nursing Care (UNC) concept, that express the condition when nurses are forced to delay or omit required nursing care, has been largely investigated as tasks left undone, missed care, and implicit rationing of nursing care. However, no summary of the available evidence regarding UNC antecedents has been published. The aim of this study is to identify and summarise antecedents of UNC as documented in primary studies to date. METHODS: A systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted. MEDLINE, CINAHL, SCOPUS, and PROSPERO databases were searched for quantitative studies reporting the relationships between antecedents and UNC published after 2004 up to 21 January 2020. The reference lists of secondary studies have been scrutinised to identify additional studies. Two reviewers independently identified studies and evaluated them for their eligibility and disagreements were resolved by the research team. The quality appraisal was based on the Joanna Briggs Institute Critical Appraisal tools, according to the study designs. A data extraction grid was piloted and then used to extract data. The antecedents that emerged were thematically categorised with an inductive approach. RESULTS: Fifty-eight studies were included; among them, 54 were cross-sectional, three were cohort studies, and one was a quasi-experimental study. They were conducted mainly in the United States and in hospital settings. The UNC antecedents have been investigated to date at the (a) unit (e.g., workloads, non-nursing tasks), (b) nurse (e.g., age, gender), and (c) patient levels (clinical instability). CONCLUSIONS: At the unit level, it is highly recommended to provide an adequate staff level, strategies to deal with unpredictable workloads, and to promote good practice environments to reduce or minimise UNC. By contrast, at the nurse and patient levels, there were no clear trends regarding modifiable factors that could decrease the occurrence of UNC. The map of antecedents that emerged can be used to design interventional studies aimed at changing research from merely descriptive to that which evaluates the effectiveness of interventions.

Improving caring quality for people with dementia in nursing homes using IPOS-Dem: A stepped-wedge cluster randomized controlled trial protocol.

AIMS: We aim to evaluate the effectiveness of the Integrated Palliative Care Outcome Scale for people with dementia-based case studies to improve the caring quality for people with dementia in nursing homes by frontline staff and family members. BACKGROUND: Swiss nursing homes mostly care for people with dementia. This population is at high risk of receiving little to no palliation for their complex needs. The majority of Swiss frontline healthcare staff do not systematically report on the needs of their residents. Additionally, family members do not routinely participate in assessment processes. DESIGN: We will conduct a stepped-wedge cluster randomized trial of repeated assessment using the Integrated Palliative Care Outcome Scale for people with dementia (IPOS-Dem) and subsequent case studies. Clusters will consist of Swiss nursing homes randomly assigned to one of three sequential intervention time points. METHODS: The study population will consist of people with dementia living in nursing homes with and without specialized dementia care facilities. Over 16 months, staff working at the frontline and family members will assess the needs and concerns of people with dementia using IPOS-Dem. Depending on sequence allocation, facilitated case studies will start after 3, 6 or 9 months. The primary outcome will be caring quality measured by QUALIDEM. The secondary outcome will be symptoms and concerns, as indicated by the IPOS-Dem sum-score. The Zürich Ethics Committee approved the study in 2019 (2019-01847). IMPACT: The results of this study will contribute to improving the effectiveness of person-centred care for people with dementia. Collaboration between healthcare staff and family members will be systematically developed and built upon thorough assessment using the IPOS-Dem and related case studies. The use of IPOS-Dem will offer all frontline staff a systematic approach to have an independent voice within the nursing process, regardless of their qualification or grade.

Culture in the spotlight-cultural adaptation and content validity of the integrated palliative care outcome scale for dementia: A cognitive interview study.

BACKGROUND: Dementia is a life-limiting disease with high symptom burden. The Integrated Palliative Care Outcome Scale for Dementia (IPOS-Dem) is the first comprehensive person-centered measure to identify and measure palliative care needs of people with dementia. However, such a measure is missing in the German health care system. AIM: To develop a culturally adapted German version of the IPOS-Dem and determine its content validity as a foundation for comprehensive psychometric testing. DESIGN: Cognitive interview study with intermittent analysis and questionnaire adaptation. Interview guide and coding frame followed thematic analysis according to Willis complemented by Tourangeau's model of cognitive aspects of survey methodology: comprehension, retrieval, judgment, response. PARTICIPANTS: Purposive sample with professionals (n = 29) and family carers (n = 6) of people with advanced dementia in seven nursing homes and person's own home care in four interview rounds (n = 11; 10; 7; 7). RESULTS: IPOS-Dem was regarded as comprehensive and accessible. Cultural adaption pertained to issues of comprehension and judgment. Comprehension challenges referred to the person-centered concept of "being affected by" used in the POS-measures. Judgment problems related to persons with limited communication causing challenges in assessment. CONCLUSION: Most issues of cultural adaptation could be addressed by questionnaire modifications. However, interviews unveiled fundamental challenges for using proxy reported person-centered assessments. Continuous training on how to use the instrument is imperative to integrate the person-centered approach of palliative care into nursing homes as a key provider of generalist palliative care for people with dementia. The refined version is ready for psychometric testing.

Natural ghrelin in advanced cancer patients with cachexia, a case series.

BACKGROUND: Natural ghrelin, a peptide growth hormone secretagogue, has a therapeutic potential in cachexia. We designed a dose-finding trial of subcutaneous natural ghrelin to improve nutritional intake (NI) in advanced cancer patients. METHODS: Advanced cancer patients with cachexia management (symptom management, physiotherapy, nutritional, and psychosocial support) started with ghrelin at 32 µg/kg body weight, followed by 50% dose increases. Patients self-injected ghrelin twice daily for 4 days followed by a wash-out period. After reaching the primary endpoint, maximal NI (minimal dose for maximal NI), a maintenance period followed during which patients injected 10 doses of ghrelin per week. Safety parameters, NI, and cachexia outcomes (symptoms, narratives, muscle mass, and strength) were measured over 6 weeks. RESULTS: Ten patients with metastatic solid tumours were included, and six (100% male, mean age 61.8 ± 8.5 SD) received ghrelin. Minimal dose for maximal NI was reached in four patients. Three patients reached the end-of study visit. Ghrelin was well tolerated with variable results on appetite and eating-related symptoms but a positive effect in the narratives. Mean Functional Assessment of Appetite & Cachexia Therapy score was 6.8 points lower at final measurement compared with baseline, t(5) = 5.98, P < .01. Muscle mass was stable in two patients and increased in one patient, and muscle strength was stable in three patients. Subjective tolerability was high. Patients showed a fluctuating trajectory, and median survival was 88 days (51-412 days). CONCLUSIONS: Ghrelin was safe in advanced patients with cancer cachexia without dose-limiting toxicity and well tolerated. The intervention was very complex, and the number of patients included was small. There was a positive effect on nutritional intake and patient narratives.

Strategies to prevent missed nursing care: An international qualitative study based upon a positive deviance approach.

AIM: To identify the strategies to prevent missed nursing care (MNC) that can be implemented by nurse managers/directors on a daily basis. BACKGROUND: Only few recommendations have been established to date aiming at supporting nurse managers/ directors in preventing MNC. However, several strategies are implemented on a daily basis, suggesting that a body of tacit, practical and wise knowledge is already in place. METHOD(S): An international qualitative descriptive study based on the positive deviance approach conducted in 2019-2020 and reported according to the Consolidated Criteria for Reporting Qualitative Research. A purposeful sample of 35 nurse managers/directors working in hospitals in Cyprus, Italy, Germany and Switzerland was involved. Codes were extracted from each country, and a thematic analysis was performed at the transnational level to identify strategies and interventions preformed to prevent MNC. RESULTS: Eight strategies and 22 interventions, mainly with preventive intent and designed at the hospital level, affecting both the processes and the structural dimensions, have been reported as effective in preventing MNC. CONCLUSION: Nurse leaders are involved daily in implementing strategies to minimise MNC at the nursing and at the hospital system levels, integrated with each other. IMPLICATIONS FOR NURSING MANAGEMENT: Preventing MNC should be a core value of the entire hospital, and not merely a nursing issue. Therefore, complex interventions at the system level are required.

Patient and public involvement in palliative care research: What works, and why? A qualitative evaluation.

BACKGROUND: Public involvement is increasingly considered a prerequisite for high-quality research. However, involvement in palliative care is impeded by limited evidence on the best approaches for populations affected by life-limiting illness. AIM: To evaluate a strategy for public involvement in palliative care and rehabilitation research, to identify successful approaches and areas for improvement. DESIGN: Co-produced qualitative evaluation using focus groups and interviews. Thematic analysis undertaken by research team comprising public contributors and researchers. SETTING/PARTICIPANTS: Researchers and public members from a palliative care and rehabilitation research institute, UK. RESULTS: Seven public members and 19 researchers participated. Building and maintaining relationships, taking a flexible approach and finding the 'right' people were important for successful public involvement. Relationship building created a safe environment for discussing sensitive topics, although public members felt greater consideration of emotional support was needed. Flexibility supported involvement alongside unpredictable circumstances of chronic and life-limiting illness, and was facilitated by responsive communication, and opportunities for in-person and virtual involvement at a project- and institution-level. However, more opportunities for two-way feedback throughout projects was suggested. Finding the 'right' people was crucial given the diverse population served by palliative care, and participants suggested more care needed to be taken to identify public members with experience relevant to specific projects. CONCLUSION: Within palliative care research, it is important for involvement to focus on building and maintaining relationships, working flexibly, and identifying those with relevant experience. Taking a strategic approach and developing adequate infrastructure and networks can facilitate public involvement within this field.

Which outcome domains are important in palliative care and when? An international expert consensus workshop, using the nominal group technique.

BACKGROUND: When capturing patient-level outcomes in palliative care, it is essential to identify which outcome domains are most important and focus efforts to capture these, in order to improve quality of care and minimise collection burden. AIM: To determine which domains of palliative care are most important for measurement of outcomes, and the optimal time period over which these should be measured. DESIGN: An international expert consensus workshop using nominal group technique. Data were analysed descriptively, and weighted according to ranking (1-5, lowest to highest priority) of domains. Participants' rationales for their choices were analysed thematically. SETTING/PARTICIPANTS: In all, 33 clinicians and researchers working globally in palliative care outcome measurement participated. Two groups (n = 16; n = 17) answered one question each (either on domains or optimal timing). This workshop was conducted at the 9th World Research Congress of the European Association for Palliative Care in 2016. RESULTS: Participants' years of experience in palliative care and in outcome measurement ranged from 10.9 to 14.7 years and 5.8 to 6.4 years, respectively. The mean scores (weighted by rank) for the top-ranked domains were 'overall wellbeing/quality of life' (2.75), 'pain' (2.06), and 'information needs/preferences' (2.06), respectively. The palliative measure 'Phase of Illness' was recommended as the preferred measure of time period over which the domains were measured. CONCLUSION: The domains of 'overall wellbeing/quality of life', 'pain', and 'information needs/preferences' are recommended for regular measurement, assessed using 'Phase of Illness'. International adoption of these recommendations will help standardise approaches to improving the quality of palliative care.

Perspectives of patients, family caregivers and health professionals on the use of outcome measures in palliative care and lessons for implementation: a multi-method qualitative study.

BACKGROUND: Routine use of outcome measures in palliative care is recommended to demonstrate and improve quality of care. The use of outcome measures is relatively recent in UK specialist palliative care services and understanding their use in practice is key to successful implementation. We therefore aimed to explore how patient-centred outcome measures are used in specialist palliative care, and identify key considerations for implementation. METHODS: Multi-method qualitative study (semi-structured interviews and non-participant observation). Patients, family caregivers and health professionals were purposively sampled from nine specialist palliative care services (hospice, hospital and community settings) in London, UK. Framework analysis, informed by the Consolidated Framework for Implementation Research (CFIR), was undertaken. RESULTS: Thirty eight interviews and nine observations were conducted. Findings are presented according to the five CFIR domains: (I) intervention: participants highlighted advantages, disadvantages and appropriateness of outcome measures in palliative care; (II) outer setting: policy and national drivers are necessary to encourage use of outcome measures; (III) inner setting: information technology infrastructure, organisational drive, and support from peers and leadership were institutional factors that shaped the use of outcome measures; (IV) individual: clear rationale for using outcome measures and skills to use them in practice were essential; (V) implementation: stepwise introduction of outcome measures, regular feedback sessions, and champions/facilitators were important to strengthen routine use. CONCLUSIONS: All CFIR domains need consideration for effective implementation. Outcome data needs to be fed back to and interpreted for professionals in order to improve and sustain outcome data collection, and drive meaningful improvements in palliative care.

Taking patient and public involvement online: qualitative evaluation of an online forum for palliative care and rehabilitation research.

PLAIN ENGLISH SUMMARY: Patient and public involvement (PPI) is increasingly recognised as important in research. Most PPI takes place face-to-face, but this can be difficult for people who are unwell or have caring responsibilities. As these challenges are particularly common in palliative care and rehabilitation research, we developed an online forum for PPI: www.csipublicinvolvement.co.uk. In this study, we explored how well the online forum worked, if it is a suitable method for PPI, and how PPI members and researchers reacted to using it. We used an existing theory about online interventions to help choose the 'right' questions to ask participants. We invited PPI members and researchers who had used the online forum to participate in focus groups, and identified the most important themes discussed. Within this study, PPI members have helped with the interview questions, analysis, and write up. Overall, four PPI members and five researchers participated in the focus groups. Participants felt the online forum worked well and had multiple benefits. From the discussions, we identified four key questions to consider when developing online methods for PPI: how does the forum work, how does it engage people, how does it empower people, and what is the impact? Participants suggested the forum could be improved by being more PPI and less researcher focused. We conclude that when developing online methods of PPI, a functioning forum is not enough: it also needs to be engaging and empowering to have an impact. Future work can use these four domains when developing their own online PPI methods. BACKGROUND: Patient and public involvement (PPI) in research is increasingly recognised as important. Most PPI activities take place face-to-face, yet this can be difficult for people with ill health or caring responsibilities, and may exclude people from hard-to-reach populations (e.g. living in vulnerable social circumstances and/or remote geographical locations). These challenges are particularly pertinent in palliative care and rehabilitation research where people often live with, or care for someone with, advanced illness. In response to this, we aimed to test the functionality, feasibility, and acceptability of an online forum for PPI for palliative care and rehabilitation research (www.csipublicinvolvement.co.uk). METHODS: We conducted separate focus groups with PPI members and researchers who had used the online forum. Data collection was underpinned by DeLone and Mclean's model of information systems success. Focus groups were recorded, transcribed, and analysed using inductive thematic analysis. Dual coding by two authors ensured rigour, and attention was paid to divergent cases. RESULTS: Four PPI members and five researchers participated in the focus groups (two PPI focus groups, one researcher focus group). The online forum was perceived as functional, feasible, and acceptable. Our analysis identified four key questions to consider when developing online methods for PPI: (1) how does the forum work, (2) how does it engage people, (3) how does it empower people, and (4) what is the impact? PPI members felt that the online forum was too researcher led, and needed to be more PPI focussed. CONCLUSIONS: When developing online methods of PPI, a functioning forum is not enough: it also needs to be engaging and empowering to have an impact. To optimise online involvement, future work should refer to these four domains and balance the needs of researchers and PPI members.

Results of a transparent expert consultation on patient and public involvement in palliative care research.

BACKGROUND: Support and evidence for patient, unpaid caregiver and public involvement in research (user involvement) are growing. Consensus on how best to involve users in palliative care research is lacking. AIM: To determine an optimal user-involvement model for palliative care research. DESIGN: We hosted a consultation workshop using expert presentations, discussion and nominal group technique to generate recommendations and consensus on agreement of importance. A total of 35 users and 32 researchers were approached to attend the workshop, which included break-out groups and a ranking exercise. Descriptive statistical analysis to establish consensus and highlight divergence was applied. Qualitative analysis of discussions was completed to aid interpretation of findings. SETTING/PARTICIPANTS: Participants involved in palliative care research were invited to a global research institute, UK. RESULTS: A total of 12 users and 5 researchers participated. Users wanted their involvement to be more visible, including during dissemination, with a greater emphasis on the difference their involvement makes. Researchers wanted to improve productivity, relevance and quality through involvement. Users and researchers agreed that an optimal model should consist of (a) early involvement to ensure meaningful involvement and impact and (b) diverse virtual and face-to-face involvement methods to ensure flexibility. CONCLUSION: For involvement in palliative care research to succeed, early and flexible involvement is required. Researchers should advertise opportunities for involvement and promote impact of involvement via dissemination plans. Users should prioritise adding value to research through enhancing productivity, quality and relevance. More research is needed not only to inform implementation and ensure effectiveness but also to investigate the cost-effectiveness of involvement in palliative care research.

Understanding what matters most to people with multiple myeloma: a qualitative study of views on quality of life.

BACKGROUND: Multiple myeloma is an incurable haematological cancer that affects physical, psychological and social domains of quality of life (QOL). Treatment decisions are increasingly guided by QOL issues, creating a need to monitor QOL within clinical practice. The development of myeloma-specific QOL questionnaires has been limited by a paucity of research to fully characterise QOL in this group. Aims of the present study are to (1) explore the issues important to QOL from the perspective of people with multiple myeloma, and (2) explore the views of patients and clinical staff on existing QOL questionnaires and their use in clinical practice. METHODS: The 'Issues Interviews' were semi-structured qualitative interviews to explore the issues important to QOL in a purposive sample of myeloma patients (n = 20). The 'Questionnaire Interviews' were semi-structured qualitative interviews in a separate purposive sample of myeloma patients (n = 20) to explore views on existing QOL questionnaires and their clinical use. Two patient focus groups (n = 7, n = 4) and a focus group of clinical staff (n = 6) complemented the semi-structured interviews. Thematic content analysis resulted in the development of a theoretical model of QOL in myeloma. RESULTS: Main themes important to QOL were Biological Status, Treatment Factors, Symptoms Status, Activity & Participation, Emotional Status, Support Factors, Expectations, Adaptation & Coping and Spirituality. Symptoms had an indirect effect on QOL, only affecting overall QOL if they impacted upon Activity & Participation, Emotional Status or Support Factors. This indirect relationship has implications for the design of QOL questionnaires, which often focus on symptom status. Health-service factors emerged as important but are often absent from QOL questionnaires. Sexual function was important to patients and difficult for clinicians to discuss, so inclusion in clinical QOL tools may flag hidden problems and facilitate better care. Patients and staff expressed preferences for questionnaires to be no more than 2 pages long and to include a mixture of structured and open questions to focus the goals of care on what is most important to patients. CONCLUSION: Existing QOL questionnaires developed and validated for use in myeloma do not capture all that is important to patients and may not be well suited to clinical use.

Ankle dorsiflexor muscle size, composition and force with ageing and chronic obstructive pulmonary disease.

Loss of skeletal muscle strength is a well-recognized feature of ageing and chronic obstructive pulmonary disease (COPD). Reductions in muscle size provide only a partial explanation for this loss of strength, and additional contributory factors remain undetermined. We hypothesized that reductions in skeletal muscle strength, as measured in the ankle dorsiflexor muscles, would be reduced with ageing and COPD as a result of changes in both size and composition of the tibialis anterior muscle. Twenty healthy young subjects, 18 healthy elderly subjects and 17 patients with COPD were studied. Ankle dorsiflexor muscle strength was assessed by maximal voluntary contraction (ADMVC) and 100 Hz supramaximal electrical stimulation of the peroneal nerve (100 HzAD). Tibialis anterior cross-sectional area (TACSA) and composition, as assessed by echo intensity (TAEI), were measured using ultrasonography. Despite a lack of differences in TACSA between groups, ADMVC and 100 HzAD were significantly reduced in COPD patients compared with both healthy elderly and healthy young subjects, when expressed as absolute values and when normalized to TACSA (P < 0.01). The TAEI was, however, higher in COPD patients compared with healthy elderly (P = 0.025) and healthy young subjects (P = 0.0008), suggesting increased levels of non-contractile tissue. Across all participants, ADMVC and 100 HzAD correlated positively with TACSA (r = 0.78, P < 0.0001) and negatively with TAEI (r = -0.46, P < 0.0005). The variance in 100 HzAD was best explained with a regression model incorporating TACSA, TAEI, age and COPD status (r(2) = 0.822, P = 0.001). These data demonstrate that the loss of skeletal muscle strength in COPD is related to changes in muscle composition, with infiltration of non-contractile tissue beyond that seen during normal ageing.

Psychosocial consequences of cancer cachexia: the development of an item bank.

CONTEXT: Cancer cachexia syndrome (CCS) is often accompanied by psychosocial consequences (PSC). To alleviate PSC, a systematic assessment method is required. Currently, few assessment tools are available (e.g., Functional Assessment of Anorexia/Cachexia Therapy). There is no systematic assessment tool that captures the PSC of CCS. OBJECTIVES: To develop a pilot item bank to assess the PSC of CCS. METHODS: A total of 132 questions, generated from patient answers in a previous study, were reduced to 121 items by content analysis and evaluation by multidisciplinary experts (doctor, nutritionists, and nurses). In our two-step, cross-sectional study, patients, judged by staff to have PSC of CCS, were included, and the questions were randomly allocated to the patients. Questions were evaluated for understandability and triggering emotions, and patients were asked to provide a response using a four-point Likert scale. Subsequently, problematic questions were revised, reformulated, and retested. RESULTS: A total of 20 patients with a variety of tumor types participated. Of the 121 questions, 31 had to be reformulated after Step 1 and were retested in Step 2, after which seven were again evaluated as not being perfectly comprehensible. In Step 1, 22 questions were found to trigger emotions, but no item required remodeling. Item performance using the Likert scale revealed no consistent floor or ceiling effects. Our final pilot question bank comprised 117 questions. CONCLUSION: The final item bank contains questions that are understood and accepted by the patients. This item bank now needs to be developed into a measurement tool that groups items into domains and can be used in future research studies.