Background: The EORTC QLQ-C15-PAL is a shortened version of the widely used EORTC QLQ-C30. This questionnaire was developed to measure the symptoms and functional health of patients receiving palliative care.
Objective: To enhance clinical interpretability of the EORTC QLQ-C15-PAL, our aim was to evaluate the sensitivity and specificity of thresholds for clinical importance developed previously for the QLQ-C30 when applied to the QLQ-C15-PAL scales.
Design: Cross-sectional observational study.
Setting/Subjects: Patients with cancer receiving any type of palliative treatment.
Measurement: Patients completed the EORTC QLQ-C15-PAL and anchor items on limitations, worries, and need for help for each of the health domains covered by the questionnaire. The anchor items were summarized in a binary criterion for clinical importance to calculate the sensitivity and specificity of the thresholds for clinical importance.
Results: In total, 225 patients participated in the study (mean age 64.5 years). Patients were recruited from Austria, Italy, the Netherlands, Poland, Spain, and the United Kingdom. The thresholds for clinical importance for the QLQ-C15-PAL scales showed a median sensitivity of 0.88 (range: 0.82 for sleep disturbances to 1.00 for dyspnea) and a median specificity of 0.74 (range: 0.54 for dyspnea to 0.89 for constipation).
Conclusion: The thresholds for clinical importance showed high sensitivity and mostly high specificity in identifying clinically important symptoms and functional health impairments as assessed by the QLQ-C15-PAL. These thresholds will facilitate interpretation of EORTC QLQ-C15-PAL scores in daily clinical practice and clinical research.
Background: The assessment of patients’ quality of life (QOL) is essential when evaluating the outcome of palliative care; however, no instruments have been validated for measuring symptoms and QOL in patients receiving palliative care in Chile. We aimed to investigate the content validity of the EORTC Quality of Life Questionnaire Core 15 Palliative Care (QLQ-C15-PAL), replicating the methods used previously to shorten the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) for use among patients in palliative care.
Methods: This cross-sectional study was conducted from October to November 2017 in four palliative care services. Patients with advanced cancer and health care professionals (HCPs) were invited to individual interviews to determine the relevance, appropriateness and relative importance of the 30 items of the QLQ-C30 for evaluating the outcome of palliative care, and whether relevant additional issues should be included.
Results: A total of 48 patients and 35 HCPs participated. The most important dimensions selected were pain, physical functioning, sleeping difficulties, emotional functioning, nausea/vomiting, fatigue, social functioning, lack of appetite, role functioning and constipation. Qualitative data identified important additional issues not covered by the questionnaire such as satisfaction with care, emotions and psychological support, as well as linguistic issues in the dyspnea and constipation items.
Conclusions: The EORTC QLQ-C15-PAL showed good content validity in the assessment of symptoms and QOL of advanced cancer patients; therefore, we recommend the use of this questionnaire in palliative care in Chile. Dyspnea and constipation items were revised by the EORTC group. More research is needed to add a social dimension for a comprehensive assessment of patients’ QOL.
Background: Previous studies suggest that the symptomatology threshold (i.e. the level and types of symptoms) for a referral to specialized palliative care might differ for doctors in different parts of the healthcare system; however, it has not yet been investigated.
Aim: To investigate if the number and level of symptoms/problems differed for patients referred from the primary and secondary healthcare sectors (i.e. general practitioner versus hospital physician).
Setting/participants: Adult cancer patients registered in the Danish Palliative Care Database who reported their symptoms/problems at admittance to specialized palliative care between 2010 and 2017 were included. Ordinal logistic regression analyses were performed with each symptom/problem as outcome to study the association between referral sector and symptoms/problems, controlled for the effect of gender, age, cancer diagnosis and the specialized palliative care service referred to.
Results: The study included 31,139 patients. The average age was 69 years and 49% were women. Clinically neglectable associations were found between referral sector and pain, appetite loss, fatigue, number of symptoms/problems, number of severe symptoms/problems (odds ratios between 1.05 and 1.20, all p < 0.05) and physical functioning (odds ratio = 0.81 (inpatient care) and 1.32 (outpatient), both p < 0.05). The remaining six outcomes were not significantly associated with referral sector.
Conclusion: Differences across healthcare sectors in, for example, competences and patient population did not seem to result in different symptomatology thresholds for referring patients to palliative care since only small, and probably not clinically relevant, differences in symptomatology was found across referral sectors.
Background: There is an increased interest in the analysis of large, national palliative care data sets including patient reported outcomes (PROs). No study has investigated if it was best to include or exclude data from services with low response rates in order to obtain the patient reported outcomes most representative of the national palliative care population. Thus, the aim of this study was to investigate whether services with low response rates should be excluded from analyses to prevent effects of possible selection bias.
Methods: Data from the Danish Palliative Care Database from 24,589 specialized palliative care admittances of cancer patients was included. Patients reported ten aspects of quality of life using the EORTC QLQ-C15-PAL-questionnaire. Multiple linear regression was performed to test if response rate was associated with the ten aspects of quality of life.
Results: The score of six quality of life aspects were significantly associated with response rate. However, in only two cases patients from specialized palliative care services with lower response rates (< 20.0%, 20.0–29.9%, 30.0–39.9%, 40.0–49.9% or 50.0–59.9) were feeling better than patients from services with high response rates (=60%) and in both cases it was less than 2 points on a 0–100 scale.
Conclusions: The study hypothesis, that patients from specialized palliative care services with lower response rates were reporting better quality of life than those from specialized palliative care services with high response rates, was not supported. This suggests that there is no reason to exclude data from specialized palliative care services with low response rates.
Background: Few studies have investigated the content of interventions provided in early specialised palliative care (SPC).
Objectives: To characterise the content of interventions delivered in early SPC in the Danish Palliative Care Trial (DanPaCT), a multicentre trial with six participating sites.
Methods: A retrospective qualitative and quantitative study coding all new interventions initiated by the palliative teams and documented in the medical records during the 8-week study period of DanPaCT. Interventions were categorised according to (a) symptom/problem prompting the intervention, (b) type of intervention and (c) professional(s) providing the intervention.
Results: In total, 145 patients were randomised to the SPC teams. According to the medical records, patients received a median of 3.5 (range 0–22) new interventions in the 8-week intervention-period from the palliative teams. For 24 (18%) of the patients there was no documented interventions in the medical records. The most frequent symptom/problems treated were pain, (100 interventions; 20% of interventions given) and impaired physical function (62; 13% of interventions given). The most frequent type of intervention was pharmacological (232; 42% of interventions given).
Conclusions: This is one of the first studies to meticulously investigate the content of interventions documented in the medical records for patients receiving early SPC. Diverse symptoms were treated with many different interventions. However, a relatively low number of interventions were documented. This may explain the lack of effect in DanPaCT but also questions whether all interventions were adequately documented
Trial registration number: NCT01348048
Background: Large, nationally representative studies of the association between quality of life and survival time in cancer patients in specialized palliative care are missing.
Aim: The aim of this study was to investigate whether symptoms/problems at admission to specialized palliative care were associated with survival and if the symptoms/problems may improve prediction of death within 1 week and 1 month, respectively.
Setting/participants: All cancer patients who had filled in the EORTC QLQ-C15-PAL at admission to specialized palliative care in Denmark in 2010–2017 were included through the Danish Palliative Care Database. Cox regression was used to identify clinical variables (gender, age, type of contact (inpatient vs outpatient), and cancer site) and symptoms/problems significantly associated with survival. To test whether symptoms/problems improved survival predictions, the overall accuracy (area under the receiver operating characteristic curve) for different prediction models was compared. The validity of the prediction models was tested with data on 5,508 patients admitted to palliative care in 2018.
Results: The study included 30,969 patients with an average age of 68.9 years; 50% were women. Gender, age, type of contact, cancer site, and most symptoms/problems were significantly associated with survival time. The predictive value of symptoms/problems was trivial except for physical function, which clearly improved the overall accuracy for 1-week and 1-month predictions of death when added to models including only clinical variables.
Conclusion: Most symptoms/problems were significantly associated with survival and mainly physical function improved predictions of death. Interestingly, the predictive value of physical function was the same as all clinical variables combined (in hospice) or even higher (in palliative care teams).
BACKGROUND: Early and integrated specialized palliative care is often recommended but has still only been investigated in relatively few randomized clinical trials.
OBJECTIVE: To investigate the effect of early specialized palliative care plus standard care versus standard care on the explorative outcomes in the Danish Palliative Care Trial (DanPaCT).
METHODS: We conducted a randomized multicentre, parallel-group clinical trial. Consecutive patients with metastatic cancer were included if they had symptoms or problems that exceeded a predefined threshold according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Outcomes were estimated as the differences between the intervention and the control groups in the change from baseline to the weighted mean of the 3- and 8-week follow-ups measured as areas under the curve.
RESULTS: In total, 145 patients were randomized to early specialized palliative care plus standard care versus 152 to standard care only. Early specialized palliative care had no significant effect on any of the symptoms or problems. Of the 21 items addressing satisfaction, specialized palliative care improved the item ‘overall satisfaction with the help received from the health care system’ with 9 points (95% confidence interval 3.8 to 14.2, p = 0.0006) and three other items (all p < 0.05).
CONCLUSION: In line with the analyses of the primary and secondary outcomes in DanPaCT, we did not find that specialized palliative care, as provided in DanPaCT, affected symptoms and problems. However, patients in the intervention group seemed more satisfied with the health care received than those in the standard care group.
TRIAL REGISTRATION: NCT01348048.
PURPOSE: Patients in palliative care are willing to answer short questionnaires, like the EORTC QLQ-C15-PAL; however, patients may suffer from other symptoms and problems (S/Ps) not covered by such questionnaires. Therefore, to identify which other S/Ps patients experience, in addition to those already included in the EORTC QLQ-C15-PAL, we developed a brief instrument to supplement this questionnaire named WISP (Write In three Symptoms/Problems), permitting patients to report 1-3 additional S/Ps and their severity. We aim to investigate the nature, prevalence, and severity of S/Ps reported on WISP.
METHODS: A register-based study with data obtained from the Danish Palliative Care Database. This study included adults with advanced cancer admitted to specialized palliative care in Denmark, who reported S/Ps on WISP. S/Ps were categorized qualitatively, and their prevalence and severity were calculated.
RESULTS: Of the 5447 patients who completed the EORTC QLQ-C15-PAL, 1788 (32.8%) reported at least one symptom/problem using WISP. In total, 2796 S/Ps were reported; 24.8% were already covered by EORTC QLQ-C15-PAL; 63.6% were new, 10.1% were diagnoses and 1.6% could not be coded. S/Ps already covered and new were grouped into 61 categories. The most prevalent S/Ps reported were (in decreasing order) pain, edema, dizziness, impaired physical or emotional function, cough, and sweats. Overall, 85% of the S/Ps were rated as moderate to severe.
CONCLUSIONS: The WISP instrument strongly improves the recognition of S/Ps by combining standardization with individualization. We recommend its use for comprehensive symptom assessment alongside the EORTC QLQ-C15-PAL, and potentially also alongside the EORTC QLQ-C30.
PURPOSE: The aim of this paper is to describe a model of palliative rehabilitation for newly diagnosed advanced cancer patients and present data on how it was utilised during a randomised controlled trial (RCT).
METHODS: We designed a highly flexible, multidisciplinary model of palliative rehabilitation consisting of a "basic offer" and tailored elements. The model was evaluated in the setting on an RCT investigating the effect of systematic referral to a palliative rehabilitation clinic concurrently with standard oncology treatment or standard treatment alone. The basic offer of palliative rehabilitation was two consultations and a 12-week possibility of contacting a palliative rehabilitation team, if needed. In addition, patients and family caregivers could be offered participation in a 12-week patient/caregiver school combined with individually tailored physical exercise in groups, individual consultations, or both. Contacts with the palliative rehabilitation team and participant evaluation were registered prospectively.
RESULTS: Between December 2014 and December 2017, 132 adults with newly diagnosed advanced cancer were seen in the palliative rehabilitation outpatient clinic. Twenty percent of the participants received the basic offer only (n = 26), 45% additionally participated in the group program (n = 59), and 35% received supplementary individual consultations without participating in the group program (n = 47). The intervention was primarily led by nurses, and the main themes of the individual consultations were coping, pain, and nutrition. When asked if they would recommend the intervention to others in the same situation, 93% of the respondents agreed, 7% partly agreed, and no one disagreed.
CONCLUSION: The new model of palliative rehabilitation presented here had a flexibility to meet the needs of the participants and led to a very high degree of patient satisfaction. It could serve as an inspiration to other cancer centres wanting to integrate palliative care into standard oncology services.
BACKGROUND: The utilization of the health care system varies in relation to cohabitation status, but conflicting results have been found in studies investigating the association in relation to specialized palliative care (SPC).
OBJECTIVE: To investigate the association between cohabitation status and admittance to SPC; to establish whether this association differed between hospital-based palliative care team/units (mainly outpatient/home care) and hospice (mainly inpatient care).
DESIGN: A nationwide study based on the Danish Palliative Care Database, which is linked with additional registers.
MEASUREMENTS: The study population included all patients dying from cancer in Denmark between 2010 and 2012 (n = 44,480). The associations were investigated using logistic regression analysis adjusted for sex, age, diagnosis, and geography and standardized absolute prevalences.
RESULTS: Comparison with cohabiting patients showed that overall admittance to SPC was lowest among patients who were widows/widowers (odds ratio [OR] = 0.86; 95% confidence interval [CI]: 0.81–0.91) and those who had never married (OR = 0.74; 95% CI: 0.68–0.80). Patients living alone were more likely to be admitted to a hospice [e.g., divorced OR = 1.41 (95% CI: 1.31–1.52)] than to a hospital-based palliative care team/unit [e.g., never married OR = 0.64 (95% CI: 0.59–0.70)] compared with cohabiting patients. Standardized prevalences of overall admittance to SPC showed a similar pattern, for example, admittance was highest (41%) for patients cohabiting and lowest (30%) for patients who had never married..
CONCLUSION: Cohabiting individuals were favored in admittance to SPC.
Compared with cohabiting patients it is unlikely that patients living alone have lower needs for SPC: results point toward inequity in admittance to specialist health care, a problem that should be addressed.
BACKGROUND: The use of chemotherapy in the last 14 days of life should be as low as possible.
AIM: To study the factors related to the use of chemotherapy in the last 14 days of life and the factors related to concurrent antineoplastic treatment and specialized palliative care.
DESIGN: This was a population-based cohort study. The data were collected from the Danish Register of Causes of Death, the Danish National Patient Register, and the Danish Palliative Care Database. Analyses were descriptive and multivariate logistic regression.
SETTING/PARTICIPANTS: Cancer decedents between 2010 and 2013 in the Capital Region of Denmark.
RESULTS: During the study period, 17,246 individuals died of cancer and 33% received specialized palliative care. In the last 14 days of life, 4.2% received chemotherapy. Younger patients and patients with hematological cancers were more likely to receive chemotherapy in the last 14 days of life. Receiving specialized palliative care was associated with a lower risk of receiving chemotherapy in the last 14 days of life-odds ratio 0.15 for hospices and 0.53 for palliative hospital units. A total of 8% of the population received concurrent antineoplastic treatment and specialized palliative care. Female gender, younger age, and breast and prostate cancer were significantly associated with this concurrent model.
CONCLUSION: Overall, the incidence of antineoplastic treatment in the last 14 days of life was low compared to other studies. Patients in specialized palliative care had a reduced risk of receiving chemotherapy at the end of life.
Purpose: This study aimed at expanding the knowledge of nausea in patients with advanced cancer by elucidating (a) the prevalences of patients having nausea, experiencing nausea as a problem, and having a need for help with their nausea, respectively, (b) determining variables associated with nausea, and (c) investigating the relation between nausea and the need for help regarding nausea.
Methods: In 2004–2006, the EORTC QLQ-C30 and the Three-Levels-of-Needs Questionnaire (3LNQ) were mailed to 2364 patients with advanced cancer who had been in contact with one of the 54 hospital departments within the past year. Further information was collected from medical records.
Results: Patient-response rate was 61%. Twenty-two percent reported having had some degree of nausea within the past week, with a mean nausea score of 10.4 and a two-item combined nausea and vomiting score of 7.5 (0–100, 100 = “very much”). Factors associated with nausea on the multivariate level were contact type (inpatient/outpatient) and treatment status (receiving ongoing oncologic treatment yes/no).
“Nausea intensity” and “nausea problem burden” showed acceptable abilities to distinguish between patients having or not having an unmet need for help regarding nausea with areas under the curve (AUCs) of 0.81 and 0.82, respectively.
Conclusions: Around one in four patients with advanced cancer reported nausea within the past week, highest in patients who were inpatients or undergoing active oncologic treatment. Almost all patients reporting nausea on the EORTC QLQ-C30 experienced this to be a problem, and the 3LNQ can therefore be restricted to cases where additional details are needed.
Background: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal.
Aim: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments.
Setting/participants: The Danish Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients with advanced cancer were screened for palliative needs. Patients with scores exceeding a predefined threshold for problems with physical, emotional or role function, or nausea/vomiting, pain, dyspnoea or lack of appetite according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) were eligible. The primary outcome was the change in each patient's primary need (the most severe of the seven QLQ-C30 scales) at 3- and 8-week follow-up (0-100 scale). Five sensitivity analyses were conducted. Secondary outcomes were change in the seven QLQ-C30 scales and survival.
Results: Totally 145 patients were randomised to early specialist palliative care versus 152 to standard care. Early specialist palliative care showed no effect on the primary outcome of change in primary need (-4.9 points (95% confidence interval -11.3 to +1.5 points); p = 0.14). The sensitivity analyses showed similar results. Analyses of the secondary outcomes, including survival, also showed no differences, maybe with the exception of nausea/vomiting where early specialist palliative care might have had a beneficial effect.
Conclusion: We did not observe beneficial or harmful effects of early specialist palliative care, but important beneficial effects cannot be excluded.
BACKGROUND: The perspectives of patients and relatives are important in the improvement of the quality of health care. However, the quality of end-of-life care has not been systematically evaluated in Scandinavia.
AIM: To develop or adapt and subsequently validate a questionnaire assessing the quality of end-of-life care in Denmark. The questionnaire was intended for bereaved relatives in order to assess the quality of care in the last 3 months of the patient's life and the circumstances surrounding death.
DESIGN AND DATA SOURCES: Based on the literature and interviews with 15 bereaved relatives and 17 healthcare professionals, relevant topics to include in a questionnaire were identified. The topics were prioritized by 100 bereaved relatives and subsequently compared to existing questionnaires. The chosen questionnaire was tested by cognitive interviews with 36 bereaved relatives.
RESULTS: Most of the important topics were covered by the Views of Informal Carers' Evaluation of Services-Short Form, but not all Danish settings (e.g. home care by a palliative team) were covered. These settings were added to the Views of Informal Carers' Evaluation of Services-Short Form, and a few adaptations were made before a Danish version of the Views of Informal Carers' Evaluation of Services-Short Form was tested by cognitive interviews. This cultural validation showed that the slightly adapted Danish version was perceived as relevant, understandable, and acceptable. Furthermore, the cognitive interviews gave insight in the comprehension and interpretation of Views of Informal Carers' Evaluation of Services-Short Form items.
CONCLUSION: With a few adaptations, the British Views of Informal Carers' Evaluation of Services-Short Form was relevant in a Danish setting.
BACKGROUND: The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer.
METHODS: This single center, randomized, controlled trial will include 300 patients with newly diagnosed advanced cancer recruited from the Department of Oncology, Vejle Hospital. The patients are randomized to a specialized palliative rehabilitation intervention integrated in standard oncology care or to standard oncology care alone. The intervention consists of a multidisciplinary group program, individual consultations, or a combination of both. At baseline and after six and 12 weeks the patients will be asked to fill out questionnaires on symptoms, quality of life, and symptoms of depression and anxiety. Among the symptoms and problems assessed, patients are asked to indicate the problem they need help with to the largest extent. The effect of the intervention on this problem is the primary outcome measure of the study. Secondary outcome measures include survival and economic consequences.
DISCUSSION: To our knowledge the Pal-Rehab study is the first randomized, controlled, phase III trial to evaluate individually tailored, palliative rehabilitation in standard oncology care initiated shortly after an advanced cancer diagnosis. The study will contribute with evidence on the effectiveness of implementing early palliative care in standard oncology treatment and hopefully offer new knowledge and future directions as to the content of palliative rehabilitation programs.
TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02332317 , registered retrospectively on December 30, 2014. One study participant had been enrolled at the time.
Background and Objective : The goal was to develop a shortened version of the EORTC QLQ-C30 for use in palliative care. We wanted to keep as few items as possible in each scale while still being able to compare results with studies using the original scales. We examined the possibilities of shortening the physical functioning, cognitive functioning, fatigue, and nausea and vomiting scales. Study Design and Setting : The shortening was based on 2.366 (physical functioning) and 10,815 (three other scales) observations, respectively. We used item response theory to construct scoring algorithms for predicting scores on the original scales. Results : Evaluations showed that a three-item physical scale, a two-item fatigue scale, and a one-item nausea or vomiting scale predicted the scores on the original scales with excellent agreement and had measurement abilities similar to the original scales with no loss or only a little loss in power to detect group differences. The results of the cognitive functioning scale indicated problems when predicting scores from a shortened version. Conclusion : Given the favorable results for the physical functioning, fatigue, and nausea or vomiting scales we expect that the shortened versions of these scales will be included in the abbreviated version of the EORTC QLQ-C30 for palliative care.
Origine : BDSP. Notice produite par INIST-CNRS nAR0x9rn. Diffusion soumise à autorisation
Contexte et objectifs : Le but est de développer une version courte du EORTC QLQ-C30 pour une utilisation en soins palliatifs. Nous avons cherché à garder aussi peu d'items que possible dans chaque échelle tout en étant capable de comparer les résultats avec les études utilisant les échelles originelles. Nous avons étudié les possibilités de raccourcir les échelles de fonctionnement physique, de fonctionnement cognitif, de fatigue et de nausée ou de vomissement.
Conception de l'étude et lieu d'investigation : Le raccourcissement est basé sur 2 366 (fonctionnement physique) et 10 815 (trois autres échelles) observations, respectivement. Nous avons utilisé la théorie de réponse aux items pour construire les algorithmes de score pour prédire les scores sur les échelles originelles.
Résultats : Les évaluations montrent qu'une échelle physique à trois items, une échelle de fatigue à deux items, et une échelle de nausée ou de vomissement à un item prédisent les scores sur les échelles originelles avecun excellent accord et a des capacités de mesure semblables aux échelles originelles sans perte ou seulement une petite perte dans le pouvoir de détection des différences de groupe. Les résultats de l'échelle de fonctionnement cognitif indique des problèmes dans la prédiction des scores provenant de la version courte.
Conclusion : Etant donné les résultats favorables pour les échelles de fonctionnement physique, de fatigue et de nausée ou vomissement, nous nous attendons à ce que les versions courtes de ces échelles soient incluses dans la version abrégée de l'EORTC QLQ-C30 pour les soins palliatifs.
Origine : BDSP. Notice produite par INIST-CNRS nAR0x9rn. Diffusion soumise à autorisation