When a dying patient is asked to participate in a double-blind, placebo-controlled clinical trial on symptom control: The decision-making process and experiences of relatives.

BACKGROUND: Placebo-controlled trials can provide evidence to inform end-of-life care, but it is contested whether asking dying patients to participate in such trials is morally justifiable. To investigate the experiences of these patients is even more complex. Therefore, proxy assessments by relatives can be a good alternative. AIM: To explore the experience of participating in a placebo-controlled trial at the end of life from the perspective of bereaved relatives. DESIGN: Mixed-method study, including questionnaires and interviews. SETTING/PARTICIPANTS: The SILENCE study was a randomized, double-blind, placebo-controlled trial on the efficacy of scopolamine butylbromide to prevent death rattle. The study was performed in six inpatient hospice facilities. Patients were asked to participate at admission in the hospice. Three months after the death of the patient, bereaved relatives were invited to fill in a questionnaire and to participate in an interview. One hundred four questionnaires were completed and 17 relatives were interviewed. RESULTS: Fourteen percent of the relatives participating in the questionnaire study considered the participation of their loved one in research a bit burdensome and 10% considered it a bit stressful. Seventeen percent thought that it was a bit burdensome for the patient. Eighty-three percent considered participation in this type of research (very) valuable. The in-depth interviews showed that patients and relatives jointly decided about participation in this double-blind placebo-controlled medication trial. Relatives generally respected and felt proud about patients' decision to participate. CONCLUSION: The large majority of bereaved relatives experienced the participation of their dying love one in this RCT as acceptable and valuable.

The development of the ADO-SQ model to predict 1-year mortality in patients with COPD.

BACKGROUND: Goals of end-of-life care must be adapted to the needs of patients with chronic obstructive pulmonary disease (COPD) who are in the last phase of life. However, identification of those patients is limited by moderate performances of existing prognostic models and by limited validation of the often-recommended surprise question. AIM: To develop a clinical prediction model to predict 1-year mortality in patients with COPD. DESIGN: Prospective study using logistic regression to develop a model in two steps: (1) external validation of the ADO, BODEX, or CODEX models (A = age; B = body mass index; C = comorbidity; D = dyspnea; EX = exacerbations; O = airflow obstruction); (2) updating of best performing model and extending it with the surprise question. Discriminative performance of the new model was assessed using internal-external validation and measured with area under the curve (AUC). A nomogram and web application were developed. SETTINGS/PARTICIPANTS: Patients with COPD from five hospitals (September-November 2017). RESULTS: Of the 358 included patients (median age 69.5 years, 50% male), 63 (17%) died within a year. The ADO index (AUC 0.73) had the best discriminative ability compared to the BODEX (AUC 0.71) or CODEX (AUC 0.68), and was extended with the surprise question. The resulting ADO-surprise question (SQ) model had an AUC of 0.79. CONCLUSION: The ADO-SQ model offers improved discriminative performance for predicting 1-year mortality compared to the surprise question, ADO, BODEX, or CODEX. A user-friendly nomogram and web application (https://dnieboer.shinyapps.io/copd) were developed. Further external validation of the ADO-SQ in patient groups is needed.

Asian patients' perspectives on advance care planning: A mixed-method systematic review and conceptual framework.

BACKGROUND: Asian healthcare professionals hold that patients' families play an essential role in advance care planning. AIM: To systematically synthesize evidence regarding Asian patients' perspectives on advance care planning and their underlying motives. DESIGN: Mixed-method systematic review and the development of a conceptual framework (PROSPERO: CRD42018099980). DATA SOURCES: EMBASE, MEDLINE, Web of Science, and Google Scholar were searched for studies published until July 27, 2020. We included studies concerning seriously-ill Asian patients' perspectives on advance care planning or their underlying motives for engaging or not engaging in it. RESULTS: Thirty-six articles were included; 22 were quantitative and 27 were from high-income countries. Thirty-nine to ninety percent of Asian patients were willing to engage in advance care planning. Our framework highlighted that this willingness was influenced not only by their knowledge of their disease and of advance care planning, but also by their beliefs regarding: (1) its consequences; (2) whether its concept was in accordance with their faith and their families' or physicians' wishes; and (3) the presence of its barriers. Essential considerations of patients' engagement were their preferences: (1) for being actively engaged or, alternatively, for delegating autonomy to others; (2) the timing, and (3) whether or not the conversations would be documented. CONCLUSION: The essential first step to engaging patients in advance care planning is to educate them on it and on their diseases. Asian patients' various beliefs about advance care planning should be accommodated, especially their preferences regarding their role in it, its timing, and its documentation.

Feasibility of assessing patients' acceptable pain in a randomized controlled trial on a patient pain education program.

BACKGROUND: For patients with cancer-related pain, the numeric rating scale is the most frequently used instrument to measure pain intensity. In the literature, it has been suggested to interpret patient-reported ratings of pain in relation to the pain intensity which is acceptable to the individual patient. AIM: We aimed to examine the feasibility and course of acceptable pain intensity. DESIGN: A secondary analysis of a randomized controlled trial that tested the effectiveness of standard care versus standard care supplemented by a pain consultation combined with a patient pain education program. SETTING: A total of 72 patients were included from an outpatient oncology clinic of a university hospital. They were diagnosed with cancer-related nociceptive pain with an average pain intensity ⩾4. RESULTS: Most patients (97%) were able to give a score for acceptable pain. Almost half of the patients scored their acceptable pain in the range of moderate to severe. Patients' ratings of acceptable pain were stable; after 8 weeks, 69% of patients had a variation of up to 1 point compared to baseline. However, the mean acceptable pain intensity remained equal in the standard care group (from 4.6 (range: 0-8) to 5.0 (range: 2-8)) and decreased in the intervention group (from 4.6 (range: 2-8) to 3.8 (range: 0-7, p < 0.01), difference between groups p < 0.05). CONCLUSION: Measurement of acceptable pain intensity is feasible. Patients with additional pain treatment became more critical and accepted less pain. More research is needed before we can use acceptable pain intensity as a reference for the interpretation of pain ratings.

The effect of the Liverpool Care Pathway for the dying: a multi-centre study.

We studied the effect of the Liverpool Care Pathway (LCP) on the documentation of care, symptom burden and communication in three health care settings. Between November 2003 and February 2005 (baseline period), the care was provided as usual. Between February 2005 and February 2006 (intervention period), the LCP was used for all patients for whom the dying phase had started. After death of the patient, a nurse and a relative filled in a questionnaire. In the baseline period, 219 nurses and 130 relatives filled in a questionnaire for 220 deceased patients. In the intervention period, 253 nurses and 139 relatives filled in a questionnaire for 255 deceased patients. The LCP was used for 197 of them. In the intervention period, the documentation of care was significantly more comprehensive compared with the baseline period, whereas the average total symptom burden was significantly lower in the intervention period. LCP use contributes to the quality of documentation and symptom control.

Patient evaluation of end-of-life care.

The Dutch health care system is characterized by a strong emphasis on primary care. To get insight into the strengths and gaps in end-of-life care in the Netherlands, data are needed about use and patient evaluation of end-of-life care. We assessed the experiences of patients with end-of-life care during the last months of life. We followed 128 patients with incurable lung, breast, ovarian, colorectal or prostate cancer. At inclusion they were interviewed personally at home. During follow-up, every 6 months, we asked them to fill out a questionnaire on the end-of-life care they had received. One-hundred of them died during the research period. Eighty-seven of the deceased patients were able to fill out a questionnaire in the last 6 months of their lives. They reported that, on average, 4.2 disciplines were involved in their care. Most patients indicated to be satisfied with the care offered by their caregivers. Problems in end-of-life care concerned communication, difficulties in coordination, accessibility of end-of-life care and responding quickly to acute problems. We conclude that comprehensive and interdisciplinary end-of-life care may address patients' needs, but that it simultaneously is a challenge to optimal communication among disciplines and between caregivers and the patient.