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Responsiveness was supported by trends across the global impression of change (GIC) groups for nine scales that correlated r ≥ 0.30
Source publication
Purpose
Head-to-head comparison of reliability, validity and responsiveness of four patient-reported outcome measures (PROMS) suitable for assessing health-related quality of life (HRQOL) in palliative care settings: EORTC QLQ-C15-PAL, FACT-G7, FACIT-Pal and short-form FACIT-Pal-14.
Methods
Secondary analysis of two phase III randomised trials: ke...
Citations
... Items are used to calculate scores on 2 multi-item functional scales (emotional and physical), 2 multi-item symptom scales (fatigue and pain), and finally, they contribute to 5 single-item symptom scales (nausea or vomiting, lack of appetite, shortness of breath, constipation, and sleeping difficulties). The EORTC QLQ-C15-PAL is considered to have good content validity [24], and a recent study comparing measures of QoL in palliative care found acceptable internal consistency and test-retest reliability as well as sensitivity of the EORTC QLQ-C15-PAL, while overall results indicated that no other QoL measure is superior to use in this patient group [25]. ...
Background
The World Health Organization defines end-of-life palliative care as “prevention and relief of suffering, by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.” Over 20 million people worldwide are in need of palliative care. In Denmark, palliative care is given at a general and a specialist level. The general level comprises health care professionals (HCPs) who do not perform palliative care full-time. The specialist level comprises specialized palliative care (SPC), where HCPs perform palliative care full-time. In total, 20%-30% of patients who need palliative care are referred to SPC. Challenges with SPC include a short time span from referral to end of life, patients who are very ill and may therefore find it hard to travel to an outpatient clinic, and the SPC unit having a relatively small staff. The need for SPC is expected to rise, as the number of patients dying from terminal diseases is increasing. Telehealth has been successfully implemented in different home care settings, including palliative care.
Objective
The aim of the study is to present the research design of the clinical testing of a telepalliation program by the use of a digital platform for patients in palliative care and their relatives.
Methods
The telepalliation program will be conducted as a multimethod randomized controlled trial. The intervention group will follow the telepalliation program, while the control group will follow the traditional standard of care program for palliative care. The primary outcome of the study is increased quality of life. Secondary outcomes include enhanced sense of security; reduced experience of pain; satisfactory experiences of patients and relatives with the TelePal platform and degree of satisfaction in being a part of the program; experiences with the use of the TelePal platform on the part of HCPs and the professionals’ experiences of being a part of the program; the use of a cross-sector communication platform and the telepalliation program by patients, relatives, and HCPs; and the projected lower cost of health care services. These outcomes will be assessed using questionnaires, data generated by digital technologies, and semistructured interviews.
Results
The collection of data began in May 2021 and will be completed in August 2024. The results of the study will be published in peer-reviewed journals and presented at international conferences. Results from the telepalliation program are expected to be published by fall 2024.
Conclusions
The expected outcomes of the study are increased quality of life and increased sense of security. We also expect that the study will have a clinical impact on future telepalliation for those patients who are referred to a palliative team.
Trial Registration
ClinicalTrials.gov NCT04995848; https://clinicaltrials.gov/study/NCT04995848
International Registered Report Identifier (IRRID)
DERR1-10.2196/49946
... The original FACT-G7 scale showed good internal consistency and criterion validity (8). Studies (15,16) have demonstrated that the FACT-G7 exhibited good test-retest reliability, fit for a single-factor structure, convergent, and discriminant validity, and responsiveness to change in the quality of life over time after interventions. This rapid questionnaire takes only a few minutes to complete and requires little assistance (8). ...
Background
It is essential to evaluate the quality of life in patients with hematologic malignancies to reflect the therapeutic effect and prognosis, but lengthy assessments are often burdensome. The 7-Item Functional Assessment of Cancer Therapy-General (FACT-G7) is a brief, easy, and rapid index for evaluating quality of life. Nevertheless, there is no report about its application in Chinese patients with hematologic malignancies.
Objective
The purpose of this study was to validate the Chinese version of the FACT-G7 for patients with hematologic malignancies.
Methods
This study is a cross-sectional study. A total of 855 patients with hematologic malignancies completed the Functional Assessment of Cancer Therapy-General (FACT-G) and were scored the Eastern Cooperative Oncology Group Performance Status (ECOG-PS) by nurses. Cronbach’s alpha, confirmatory factor analyses, Pearson’s correlation, and one-way analysis of variance were conducted to evaluate internal consistent reliability, structural validity and concurrent validity.
Results
The FACT-G7 showed acceptable internal consistency, as indicated by a Cronbach’s alpha of 0.73. The confirmatory factor analyses test for single-factor model fit for the FACT-G7 scale was almost adequate. The satisfactory correlations between the FACT-G7 and the FACT-G and its subscales, and ECOG-PS groups differed in FACT-G7 scores demonstrating concurrent validity.
Conclusion
This study suggested that the Chinese version of the FACT-G7 provides a useful and rapid measure for assessing quality of life in Chinese patients with hematologic malignancies, which providing a reference for further evaluation and care.
... (Henseler et al., 2014). The Cronbach alpha reported exceeded the minimum level of 0.60 (Cox et al., 2020;Guo et al., 2020) or 0.70 (King et al., 2020;Kourmousi et al., 2015;Quittner et al., 2015). ...
... Validated Spanish versions exist for SF-36 and EORT-QOL-C30, and the 39-item Evaluating the Measurement of Patient-Reported Outcomes (EMPRO) questionnaire [117]. Among these instruments, there is no one that is clearly superior to the others [118]. ...
Cancer incidence in Latin America is lower than in Europe or the United States but morbidity and mortality rates are disproportionately high. A barrier to adequate pain control is inadequate pain assessment, which is a relatively easy and inexpensive metric. The objective of this narrative review is to describe pain assessment for cancer patients in Latin America. Cultural factors may influence pain perception, including contextualizing pain as noble or natural suffering and aspects of what is now called “spiritual pain.” Unlike other painful conditions, cancer pain may be strongly associated with existential fear, psychosocial distress, anxiety, and spiritual concerns. Pain assessment allows not just quantification of pain intensity but may
elucidate pain mechanisms involved or psychosocial aspects that may color the pain. Many current pain assessment instruments capture only pain intensity, which is but one aspect of the pain experience; some have expanded to include functional assessments, mental health status evaluations, and quality of life metrics. A quality-of-life assessment may be appropriate for cancer patients since chronic pain can severely impact function, which can in turn create a vicious cycle by exacerbating pain. The incidence of cancer in Latin America is expected to increase in the ensuing years. Better pain assessment and clinician education are needed to help manage pain in this large and growing patient population.
... Items are used to calculate scores on 2 multi-item functional scales (emotional and physical), 2 multi-item symptom scales (fatigue and pain), and finally, they contribute to 5 single-item symptom scales (nausea or vomiting, lack of appetite, shortness of breath, constipation, and sleeping difficulties). The EORTC QLQ-C15-PAL is considered to have good content validity [24], and a recent study comparing measures of QoL in palliative care found acceptable internal consistency and test-retest reliability as well as sensitivity of the EORTC QLQ-C15-PAL, while overall results indicated that no other QoL measure is superior to use in this patient group [25]. ...
BACKGROUND
The World Health Organization defines end of life Palliative Care (PC) as ‘prevention and relief of suffering, by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual’. More than 20 million people worldwide are estimated of being in need of palliative care. In Denmark, as in most other Western countries, PC is given at two different levels, basic and advanced. The basic level comprises health care professionals (HCPs), such as general practitioners (GPs) and primary care nurses, who do not perform palliative care on a full-time basis. The advanced level comprises specialized palliative care (SPC) where HCPs perform palliative care on a full-time basis at a specialist level. 20-30% of patients in need of PC are referred to SPC. There are several challenges connected with SPC, such as the very short time span from referral to the end of the patient’s life, the fact that patients are very ill and may therefore find it hard to travel to an outpatient clinic, and that the SPC unit has a relatively small staff. The need for SPC is expected to rise in the future, as the number of patients dying from life-threatening diseases, including cancer, is increasing. As an increasing number of these patients prefer to be cared for at home, the demand for SPC is expected to increase. The use of telehealth has been introduced in different settings and at different levels of home care and has also been used with success in palliative care. Demand for telehealth solutions has also increased due to the Covid-19 pandemic.
OBJECTIVE
This paper aims to describe the clinical test of a Telepalliation program, a digital platform for patients in palliation and their relatives. The paper describes the research design, outcome measures and techniques used for data collection.
METHODS
The Telepalliation program will be conducted as a randomized controlled study. The intervention group will follow the Telepalliation program, while the control group will follow the traditional standard of care program for palliative care. The primary outcome of the study is increased quality of life, measured by EORTC QLQ-C15-PAL. Secondary outcomes include the enhanced sense of security; reduced experience of pain; satisfactory experiences of both patients and relatives on the use of TelePal.dk platform and degree of satisfaction in being a part of a Telepalliation program; experiences with the actual use of the TelePal.dk platform from healthcare professionals and the professionals’ experiences of being a part of a telepalliation program; the usability of a cross-sector communication platform and telepalliation program by patients, relatives, and health care professionals; and the projected lower cost of healthcare services, in terms of quantity of phone/video calls, equipment, etc. These outcomes will be assessed using questionnaires, through data generated by digital technologies and through semi-structured interviews.
RESULTS
Collection of data began in May 2021 and will be completed in June 2024. The results of the study will be published in peer-reviewed journals and presented at international conferences. Results from the Telepalliation program are expected to be published by fall 2024.
CONCLUSIONS
The expected outcomes of the study are increased quality of life and increased sense of security. We also expect that the study will have a clinical impact for future telepalliative care for those patients who are referred to a Palliative Team.
CLINICALTRIAL
NCT04995848 and N-202000094
... The 13-item Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) was originally developed for cancer patients. Most validation studies were therefore performed in cancer patients [100][101][102], but it has been validated and used across many other conditions. Evidence on structural validity (i.e. ...
Patient-reported outcomes (PROs) are valuable for shared decision making and research. Patient-reported outcome measures (PROMs) are questionnaires used to measure PROs, such as health-related quality of life (HRQL). Although core outcome sets for trials and clinical practice have been developed separately, they, as well as other initiatives, recommend different PROs and PROMs. In research and clinical practice, different PROMs are used (some generic, some disease-specific), which measure many different things. This is a threat to the validity of research and clinical findings in the field of diabetes. In this narrative review, we aim to provide recommendations for the selection of relevant PROs and psychometrically sound PROMs for people with diabetes for use in clinical practice and research. Based on a general conceptual framework of PROs, we suggest that relevant PROs to measure in people with diabetes are: disease-specific symptoms (e.g. worries about hypoglycaemia and diabetes distress), general symptoms (e.g. fatigue and depression), functional status, general health perceptions and overall quality of life. Generic PROMs such as the 36-Item Short Form Health Survey (SF-36), WHO Disability Assessment Schedule (WHODAS 2.0), or Patient-Reported Outcomes Measurement Information System (PROMIS) measures could be considered to measure commonly relevant PROs, supplemented with disease-specific PROMs where needed. However, none of the existing diabetes-specific PROM scales has been sufficiently validated, although the Diabetes Symptom Self-Care Inventory (DSSCI) for measuring diabetes-specific symptoms and the Diabetes Distress Scale (DDS) and Problem Areas in Diabetes (PAID) for measuring distress showed sufficient content validity. Standardisation and use of relevant PROs and psychometrically sound PROMs can help inform people with diabetes about the expected course of disease and treatment, for shared decision making, to monitor outcomes and to improve healthcare. We recommend further validation studies of diabetes-specific PROMs that have sufficient content validity for measuring disease-specific symptoms and consider generic item banks developed based on item response theory for measuring commonly relevant PROs.
Graphical Abstract
... A scoring algorithm is used to convert the response categories to a score (0-100), where lower scores indicate a reduced symptom burden, reduced levels of functioning and lower HrQOL [37,38]. The C15-PAL is a reliable, responsive and valid measure in advanced cancer settings [39][40][41][42][43][44][45][46][47][48] but does not produce an overall total score derived from all the items. Responses to the C15-PAL questionnaire were collected at weeks one, two and four for participants who consented to provide secondary outcome data [49,50]. ...
Background:
About 70% of patients with advanced cancer experience pain. Few studies have investigated the use of healthcare in this population and the relationship between pain intensity and costs.
Methods:
Adults with advanced cancer and scored worst pain ≥ 2/10 on a numeric rating scale (NRS) were recruited from 6 Australian oncology/palliative care outpatient services to the Stop Cancer PAIN trial (08/15-06/19). Out-of-hospital, publicly funded services, prescriptions and costs were estimated for the three months before pain screening. Descriptive statistics summarize the clinico-demographic variables, health services and costs, treatments and pain scores. Relationships with costs were explored using Spearman correlations, Mann-Whitney U and Kruskal-Wallis tests, and a gamma log-link generalized linear model.
Results:
Overall, 212 participants had median worst pain scores of five (inter-quartile range 4). The most frequently prescribed medications were opioids (60.1%) and peptic ulcer/gastro-oesophageal reflux disease (GORD) drugs (51.6%). The total average healthcare cost in the three months before the census date was A$6,742 (95% CI $5,637, $7,847), approximately $27,000 annually. Men had higher mean healthcare costs than women, adjusting for age, cancer type and pain levels (men $7,872, women $4,493, p<0.01) and higher expenditure on prescriptions (men $5,559, women $2,034, p<0.01).
Conclusions:
In this population with pain and cancer, there was no clear relationship between healthcare costs and pain severity. These treatment patterns requiring further exploration including the prevalence of peptic ulcer/GORD drugs, and lipid lowering agents and the higher healthcare costs for men.
Trial registration:
ACTRN12615000064505. World Health Organisation unique trial number U1111-1164-4649. Registered 23 January 2015.
... Their results showed that FACT-G fulfills this important criterion in the concept of patient-centered care, and it also maintains its equivalence to the EORTC-30. (26) Furthermore, the FACT-G validation process, aiming to meet the profile of the Brazilian population, also had its translation and adaptation applied to a public service by using as sample a population of oncology inpatients and outpatients -which included the most varied cancer subgroups. For this reason, the test can be considered reliability to be adopted in Brazilian clinical trials. ...
Objective:
To describe of the translation from English to Portuguese and adaption process of subitems of the Functional Assessment of Cancer Therapy - Multiple Myeloma.
Methods:
In the first phase, translations from English into Portuguese of two subitems of Functional Assessment of Cancer Therapy - Multiple Myeloma were performed. Subsequently, a consensus and back translation were conducted, and, finally, translation and back translations were reviewed by four independent bilingual experts. In the second phase, the translated subitems were applied, along with a questionnaire, to 10 native Portuguese speakers patients with multiple myeloma.
Results:
There was a recognition of the translation process in its first version applied to 10 patients with multiple myeloma, whose reported no difficult to understand the translated and validated instrument. Patients also did not find the content irrelevant or offensive, and they did not suggested changes.
Conclusion:
The subitems of the Functional Assessment of Cancer Therapy - Multiple Myeloma were translated from English into Portuguese following the proposed methodology and there was not need of readjustments. This process allowed this instrument of quality of life, which is widely known to be beneficial in the management of patients with multiple myeloma, to be used among our population.
... Prior to the session, participants completed the Functional Assessment of Chronic Illness Therapy-Palliative Care 14 Item Version 4 (FACIT-Pal-14). The FACIT system is a collection of evidence-based quality of life (QOL) questionnaires targeted to the management of chronic disease [30]. The FACIT-Pal-14 was developed to specifically assess health-related wellbeing among palliative care patients and covers the impact of disease treatment across four domains: physical, social and family, emotional, and functional [31]. ...
... The FACIT-Pal-14 contains the 14 most important items for adult palliative care patients from the full 47-item FACIT-Pal, as identified by a convenience sample of 56 health care providers and 60 palliative care patients, and takes less than 5 min to complete [31]. The FACIT-Pal-14 has higher internal consistency, better test-retest reliability, and provides the best coverage of psychological wellbeing compared to other patient-reported outcome measures of health-related wellbeing [30], making it an appropriate tool to capture participant wellbeing quickly and accurately. ...
Background
This study aims to measure the effect of guided imagery and hand massage on self-rated wellbeing and pain for palliative care patients.
Methods
This study adopted a quasi-experimental one-group pre-test post-test design. The sample consisted of n = 20 adult palliative care patients who received one session of guided imagery and hand massage. Self-reported levels of wellbeing and pain were measured on a scale of 0–10 before and after the intervention. Results were analyzed using a one-tailed sign test in SPSS Software.
Results
The intervention elicited a statistically significant improvement in self-reported levels of wellbeing (p = .029) and pain (p = .001). Feedback from participants showed the intervention was helpful and relaxing.
Conclusion
The intervention had an immediate positive effect on wellbeing and pain among palliative care patients. Considering the promising results of this pilot study, guided imagery and hand massage should be studied further in the palliative care setting.
... This "anchor" was chosen based on relevance and strength of association with the carer-related scores. 54,69 Differences among carer groups were tested with Dunn's pairwise test and the P-value adjusted using the Bonferroni correction. 70 Statistical analyses were conducted within IBM SPSS Statistics for Windows, Version 25 (IBM Corp., Armonk, NY) and pairwise deletion was used for all statistical analyses. ...
Objectives:
To compare the psychometric properties of the Adult Social Care Outcomes Toolkit for carers (ASCOT-Carer), the Carer Experience Scale (CES), and the Care-related Quality of Life (CarerQol) to inform the choice of instrument in future studies.
Methods:
Data were derived from a 2018 online survey of informal carers in Australia. Reliability was assessed via internal consistency (Cronbach alpha, α) and test-retest reliability (intraclass correlation coefficient, ICC) for respondents who self-reported no change in their quality of life as a carer over 2 weeks. Convergent validity was evaluated via predetermined hypotheses about associations (Spearman's rank correlation) with existing, validated measures. Discriminative validity was assessed based on the ability of the carer-related scores to distinguish between different informal care situations (Mann-Whitney U, Kruskal-Wallis one-way analysis of variance).
Results:
Data from 500 carers were analyzed. The ASCOT-Carer demonstrated a higher degree of internal consistency, possibly due to a unidimensional structure, and test-retest reliability than the CarerQol and CES (α = 0.87, 0.65, 0.59; ICC, 0.87, 0.67, 0.81, respectively). All 3 instruments exhibited convergent validity and detected statistically significant associations between carer-related scores and different informal care situations, except for the CarerQol-7D and sole carer status.
Conclusions:
The ASCOT-Carer, CarerQol, and CES performed reasonably well psychometrically; the ASCOT-Carer exhibited the best psychometric properties overall in this sample of Australian informal carers. Findings should be used in conjunction with consideration of research goals, carer population, targeted carer-related constructs, and prevailing perspectives on the economic evaluation to inform choice of instrument in future studies.
