Research barriers in children and young people with life-limiting conditions: a survey.

Studies indicate research ethics committee (REC) approval and clinician gatekeeping are two key barriers in recruiting children and young people (CYP) with life-limiting conditions (LLCs) and life-threatening illnesses (LTIs) and their families to research. OBJECTIVES: To explore the reported experiences, difficulties and proposed solutions of chief investigators (CIs) recruiting CYP with LLCs/LTIs and families in the UK. METHODS: 61 CIs conducting studies with CYP with LLCs/LTIs and their families, identified from the UK National Institute of Health Research portfolio, completed an anonymous, web-based questionnaire, including both closed and open-ended questions. Descriptive statistics and inductive and deductive coding were used to analyse responses. RESULTS: UK CIs cited limitations on funding, governance procedures including Research and Development, Site-Specific and REC approval processes, and clinician gatekeeping as challenges to research. CIs offered some solutions to overcome identified barriers such as working with CYP and their families to ensure their needs are adequately considered in study design and communicated to ethics committees; and designing studies with broad inclusion criteria and developing effective relationships with clinicians in order to overcome clinician gatekeeping. CONCLUSIONS: Many of the challenges and solutions reported by UK CIs have applicability beyond the UK setting. The involvement of clinicians, patients and their families at the inception of and throughout paediatric palliative care research studies is essential. Other important strategies include having clinician research champions and increasing the visibility of research. Further research on the perspectives of all stakeholders, leading to mutually agreed guidance, is required if care and treatment are to improve.

Comparing the performance of the palliative prognostic (PaP) score with clinical predictions of survival: A systematic review.

BACKGROUND: In patients with advanced cancer, prognosis is usually determined using clinicians' predictions of survival (CPS). The palliative prognostic (PaP) score is a prognostic algorithm that was developed to predict survival in patients with advanced cancer. The score categorises patients into three risk groups in accordance with their probability of surviving for 30 days. The relative accuracy of PaP and CPS is unclear. DESIGN: This was a systematic review of MEDLINE, Embase, AMED, CINAHL Plus and the Cochrane Database of Systematic Reviews and Trials from inception up to June 2021. The inclusion criteria were studies in adults with advanced cancer reporting data on performance of both PaP and CPS. Data were extracted on accuracy of prognoses and where available on discrimination (area under the receiver operating characteristic curve or C-index) and/or diagnostic performance (sensitivity, specificity). RESULTS: Eleven studies were included. One study reported a direct comparison between PaP risk groups and equivalent risk groups defined by CPS and found that PaP was as accurate as CPS. Five studies reported discrimination of PaP as a continuous total score (rather than using the previously validated risk categories) and reported C-statistics that ranged from 0.64 (95% confidence interval [CI] 0.54, 0.74) up to 0.90 (95% CI 0.87, 0.92). Other studies compared PaP against CPS using non-equivalent metrics (e.g. comparing probability estimates against length of survival estimates). CONCLUSIONS: PaP risk categories and CPS are equally able to discriminate between patients with different survival probabilities. Total PaP scores show good discrimination between patients in accordance with their length of survival. The role of PaP in clinical practice still needs to be defined. TRIAL REGISTRATION: PROSPERO (CRD42021241074, 5th March 2021).

Decision aids for second-line palliative chemotherapy: a randomised phase II multicentre trial.

BACKGROUND: There is increasing recognition of the delicate balance between the modest benefits of palliative chemotherapy and the burden of treatment. Decision aids (DAs) can potentially help patients with advanced cancer with these difficult treatment decisions, but providing detailed information could have an adverse impact on patients' well-being. The objective of this randomised phase II study was to evaluate the safety and efficacy of DAs for patients with advanced cancer considering second-line chemotherapy. METHODS: Patients with advanced breast or colorectal cancer considering second-line treatment were randomly assigned to usual care (control group) or usual care plus a DA (intervention group) in a 1:2 ratio. A nurse offered a DA with information on adverse events, tumour response and survival. Outcome measures included patient-reported well-being (primary outcome: anxiety) and quality of the decision-making process and the resulting choice. RESULTS: Of 128 patients randomised, 45 were assigned to the control group and 83 to the intervention group. Median age was 62 years (range 32-81), 63% were female, and 73% had colorectal cancer. The large majority of patients preferred treatment with chemotherapy (87%) and subsequently commenced treatment with chemotherapy (86%). No adverse impact on patients' well-being was found and nurses reported that consultations in which the DAs were offered went well. Being offered the DA was associated with stronger treatment preferences (3.0 vs. 2.5; p=0.030) and increased subjective knowledge (6.7 vs. 6.3; p=0.022). Objective knowledge, risk perception and perceived involvement were comparable between the groups. CONCLUSIONS: DAs containing detailed risk information on second-line palliative treatment could be delivered to patients with advanced cancer without having an adverse impact on patient well-being. Surprisingly, the DAs only marginally improved the quality of the decision-making process. The effectiveness of DAs for palliative treatment decisions needs further exploration. TRIAL REGISTRATION: Netherlands Trial Registry (NTR): NTR1113 (registered on 2 November 2007).

Patients' Preferences for Information About the Benefits and Risks of Second-Line Palliative Chemotherapy and Their Oncologist's Awareness of These Preferences.

Communication about palliative treatment options requires a balance between providing patients with sufficient information and not providing unwanted information. Surveys have indicated that many patients with advanced cancer express a wish to receive detailed information. In this prospective multicenter study, the information desire of patients with advanced breast or colorectal cancer was further investigated by offering treatment-related information to patients using a decision aid (DA). In addition, this study explored oncologists' awareness of their patients' information desire. Seventy-seven patients with advanced breast or colorectal cancer facing the decision whether to start second-line palliative chemotherapy were offered a DA by a nurse. This DA contained information on adverse events, tumor response, and survival. The nurse asked the patient whether each information item was desired. Ninety-five percent of patients chose to receive information on adverse events, 91 % chose to receive information on tumor response, and 74 % chose to receive information on survival. Oncologists' judgment of patients' information desire was 100, 97, and 81 %, respectively. For all three information items together, oncologists correctly judged the information desire of 62 % of patients. This study confirms that many patients with advanced cancer wish to receive detailed information on the benefits and risks of palliative treatment options when the information is actually available. Oncologists were adequately aware of this high information desire, but had some difficulty judging the information desire of individual patients. A stepped approach to giving information ("preview, ask, tell, ask") may help to better meet patients' information needs.

Measuring organisational readiness for patient engagement (MORE): an international online Delphi consensus study.

BACKGROUND: Widespread implementation of patient engagement by organisations and clinical teams is not a reality yet. The aim of this study is to develop a measure of organisational readiness for patient engagement designed to monitor and facilitate a healthcare organisation's willingness and ability to effectively implement patient engagement in healthcare. METHODS: The development of the MORE (Measuring Organisational Readiness for patient Engagement) scale was guided by Weiner's theory of organisational readiness for change. Weiner postulates that an organisation's readiness is determined by both the willingness and ability to implement the change (i.e. in this context: patient engagement). A first version of the scale was developed based on a literature search and evaluation of pre-existing tools. We invited multi-disciplinary stakeholders to participate in a two-round online Delphi survey. Respondents were asked to rate the importance of each proposed item, and to comment on the proposed domains and items. Second round participants received feedback from the first round and were asked to re-rate the importance of the revised, new and unchanged items, and to provide comments. RESULTS: The first version of the scale contained 51 items divided into three domains: (1) Respondents' characteristics; (2) the organisation's willingness to implement patient engagement; and (3) the organisation's ability to implement patient engagement. 131 respondents from 16 countries (health care managers, policy makers, clinicians, patients and patient representatives, researchers, and other stakeholders) completed the first survey, and 72 of them also completed the second survey. During the Delphi process, 34 items were reworded, 8 new items were added, 5 items were removed, and 18 were combined. The scale's instructions were revised. The final version of MORE totalled 38 items; 5 on stakeholders, 13 on an organisation's willingness to implement, and 20 on an organisation's ability to implement patient engagement in healthcare. CONCLUSIONS: The Delphi technique was successfully used to refine the scale's instructions, domains and items, using input from a broad range of international stakeholders, hoping that MORE can be applied in a variety of healthcare contexts worldwide. Further assessment is needed to determine the psychometric properties of the scale.

Exploring the Routine Administration of Decision Aids for Palliative Chemotherapy to Patients by Nurses: A Qualitative Study Among Nurses and Oncologists.

BACKGROUND: Decision aids (DAs) effectively support patient decision making but are rarely used in daily practice. OBJECTIVE: To explore nurses' and oncologists' views on routinely offering DAs on palliative chemotherapy to patients by nurses. Most interviewees had clinical experience with the DAs, which were booklets administered to patients by nurses. METHODS: The study was guided by 3 theoretical implementation models of innovations in clinical practice, including factors related to the innovation, the professionals (nurses and oncologists), the patient, and the organization. Semistructured interviews were conducted among 12 nurses and 14 oncologists. Interviews were audio taped and fully transcribed. RESULTS: The main barriers to routinely offering DAs to patients were found in nurses' and oncologists' opinions and attitudes (eg, concerns about the impact in this vulnerable population) and in the logistics of organizations (eg, the decision is already made before the nurse sees the patient). Twenty-two of 26 interviewees were open to the future use of the DAs. Disseminating information to professionals (eg, about positive effects of DAs) and embedding DAs in the existing workflow would facilitate implementation. CONCLUSIONS: Most nurses and oncologists were open to the future use of the DAs by nurses, provided that certain barriers, particularly related to professionals' opinions and attitudes and logistical procedures in the organization, could be overcome. IMPLICATIONS FOR PRACTICE: These findings can inform a tailored strategy to implement DAs on palliative chemotherapy. Implementation should start with interventions to motivate professionals, for example, educational meetings.

Expected survival with and without second-line palliative chemotherapy: who wants to know?

BACKGROUND: According to surveys, many patients with advanced cancer wish to receive survival information. OBJECTIVE: This study investigated information preferences by offering patients a decision aid (DA) with information on expected survival for two treatment options: supportive care with or without second-line palliative chemotherapy. Predictors of accepting survival information were explored. DESIGN: Eligible patients in this multicentre prospective study were offered second-line chemotherapy for advanced breast or colorectal cancer. A nurse presented a DA on second-line treatment and asked patients whether they desired information on (i) adverse events, (ii) tumour response and (iii) survival. Data on 50 clinical and psychosocial patient characteristics were collected from inclusion forms and patient questionnaires. RESULTS: Seventy-seven patients received a DA; median age 62 years (range 32-80), 61% female, 77% colorectal cancer. Fifty-seven patients (74%; 95% CI 64-84) desired survival information. Four psychosocial characteristics (e.g. deliberative decision style) independently predicted information desire. However, the use of these characteristics to predict information desire hardly outperformed a simple prediction rule. CONCLUSIONS: Many patients desired information on expected survival when deciding about second-line treatment. However, our exploratory analysis indicated that patients desiring this information could not be identified based on their clinical or psychosocial characteristics. These findings can help encourage candid discussions about expected survival. Health professionals should be careful not to make implicit assumptions of information desire based on patient characteristics, but to explicitly ask patients if survival information is desired, and act accordingly.

Efficacy and safety of palliative chemotherapy for patients with advanced breast cancer pretreated with anthracyclines and taxanes: a systematic review.

No standard monotherapy or combination palliative chemotherapy currently exists for patients with advanced breast cancer pretreated with anthracyclines and taxanes. In this systematic review we assess the current knowledge on the efficacy and safety of palliative single-agent chemotherapy drugs--capecitabine, vinorelbine, gemcitabine, and liposomal doxorubicin--commonly used in daily clinical practice. We identified 22 studies, of which ten investigated capecitabine, nine investigated vinorelbine, three investigated gemcitabine, and one investigated liposomal doxorubicin. The greatest amount of information was available for capecitabine and vinorelbine. These two drugs showed good efficacy. The disease control rate differed significantly between the four drugs, which is relevant in terms of how well tumour symptoms can be improved and whether quality of life can be maintained or even improved. To obtain more evidence of the efficacy and safety of chemotherapeutic agents used in this pretreated population of advanced breast cancer patients, randomised comparisons of the various drugs, as monotherapy and in combination with targeted agents, are needed.

Assessing the information desire of patients with advanced cancer by providing information with a decision aid, which is evaluated in a randomized trial: a study protocol.

BACKGROUND: There is a continuing debate on the desirability of informing patients with cancer and thereby involving them in treatment decisions. On the one hand, information uptake may be hampered, and additional stress could be inflicted by involving these patients. On the other hand, even patients with advanced cancer desire information on risks and prognosis. To settle the debate, a decision aid will be developed and presented to patients with advanced disease at the point of decision making. The aid is used to assess the amount of information desired. Factors related to information desire are explored, as well as the ability of the medical oncologist to judge the patient's information desire. The effects of the information on patient well-being are assessed by comparing the decision aid group with a usual care group. METHODS/DESIGN: This study is a randomized controlled trial of patients with advanced colorectal, breast, or ovarian cancer who have started treatment with first-line palliative chemotherapy. The trial will consist of 100 patients in the decision aid group and 70 patients in the usual care group. To collect complete data of 170 patients, 246 patients will be approached for the study. Patients will complete a baseline questionnaire on sociodemographic data, well-being measures, and psychological measures, believed to predict information desire. The medical oncologist will judge the patient's information desire. After disease progression is diagnosed, the medical oncologist offers the choice between second-line palliative chemotherapy plus best supportive care (BSC) and BSC alone. Randomization will take place to determine whether patients will receive usual care (n = 70) or usual care and the decision aid (n = 100). The aid offers information about the potential risks and benefits of both treatment options, in terms of adverse events, tumour response, and survival. Patients decide for each item whether they desire the information or not. Two follow-up questionnaires will evaluate the effect of the decision aid. DISCUSSION: This study attempts to settle the debate on the desirability of informing patients with cancer. In contrast to several earlier studies, we will actually deliver information on treatment options to patients at the point of decision making.

Systematic review of benefits and risks of second-line irinotecan monotherapy for advanced colorectal cancer.

This study was performed to obtain a comprehensive overview of the benefits and risks of second-line irinotecan monotherapy for advanced colorectal cancer. The literature was systematically reviewed to identify phase II and phase III trials that investigated the effect of second-line monotherapy with irinotecan. Thirty studies were included in this review: 25 phase II studies including 32 samples and five phase III studies including six samples. A disease control rate of greater than or equal to 50% was found in 23 out of 32 phase II samples, and one out of two phase III samples that reported disease control rate. Median time to progression was 2.7-6.0 months in phase II samples and 3.0-4.3 months in phase III samples. Median overall survival ranged from 6.6 to 16.1 months in phase II samples and 9.1-10.8 months in phase III samples. The most important severe adverse event in both phase II and phase III trials was diarrhea (5-39 and 15-36%, respectively), followed by nausea (1-24 and 5-14%), vomiting (2-22 and 6-14%), and asthenia (0-31 and 4-21%). Treatment-related mortality was 0-2% in phase II samples and 0-5% in phase III samples. Quality-of-life scores in phase II studies were associated with tumor response. In phase III studies, the quality of life while on treatment with irinotecan was similar to that of 5-fluorouracil, but better than supportive care alone. The quality of life on the weekly schedule was similar to the 3-weekly schedule. This study provides a comprehensive overview of the benefits and risks of second-line irinotecan. In general, second-line treatment with irinotecan is beneficial to patients.

The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review.

OBJECTIVE: Analysis of the available evidence on the improvement of walking in stroke patients with a dropped foot when using peroneus stimulation. METHODS: A systematic review was performed to identify trials that investigated the orthotic effect of functional electrical stimulation (FES) on walking in stroke patients with a dropped foot. Two independent raters scored the methodological quality of the included articles. Walking speed and physiological cost index (PCI) were selected as the primary outcome measures. Studies that measured walking speed were pooled and a pooled difference including confidence interval was calculated. RESULTS: Eight studies were included in the review, of which one was a randomized controlled trial. Methodological score ranged from 8 to 18 out of 19. Six studies measured walking speed. The pooled improvement in walking speed was 0.13 m/s (0.07-0.2) or 38% (22.18-53.8). CONCLUSIONS: The present review suggests a positive orthotic effect of functional electrical stimulation on walking speed.